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[null,null,"This Excel workbook contains the Evidence Map  on \nPRO instruments in prostate cancer "]
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[]
[]
[]
[null,null,"How this Evidence Map was generated"]
[null,null,"We searched heoro.com on the 10th January 2018 with the following field settings:"]
[null,null,"Disease: Prostatic neoplasms AND Study type:  PRO studies"]
[null,null,"The search identified a total of 763 relevant abstracts published since 1960, which were  segmented with the following standard heoro.com fields:"]
[null,null,null,"Locations - the geographical setting of the study, or, where this is unknown, the authors' location."]
[null,null,null,"Disease - the stage of the disease e.g. local, advanced, metastatic, at risk"]
[null,null,null,"Interventions - the interventions evaluated int eh study, if any."]
[null,null,null,"PRO tools - the PRO intruments that were cited in the title or abstract."]
[null,null,null,"Study methodology - the type of study that was conducted, e.g. clinical trial, observational, systematic review."]
[null,null,null,"Subpopulation - whether the study assessed patients, caregivers, the general public or healthcare professionals (HCPs)"]
[]
[null,null,"We also categorised the type of PRO tools as follows, based on what they were assessing:"]
[null,null,null,"Carer - assessing quality of life specifically in caregivers "]
[null,null,null,"Comorbidity - assessing a different disease or condition, especially depression and anxiety "]
[null,null,null,"Complication - assessing a compliciton of treatment, especially urinary and sexual dysfunction"]
[null,null,null,"Costs - assessing cost burden on patients or their caregivers "]
[null,null,null,"Disease - assessing prostate cancer specifically"]
[null,null,null,"General - assessing general quality of life"]
[null,null,null,"Knowledge - assessing patient or caregiver knowledge of the disease or its management "]
[null,null,null,"Satisfaction - assessing patient satisfaction with treatment"]
[null,null,null,"Social - assessing social aspects of life"]
[null,null,null,"Symptom - assessing a symptom of prostate cancer"]
[null,null,null,"Treatment - assessing the impact of treatment, including adverse events"]
[null,null,null,"Utility - directly or indirect measures of utility "]
[null,null,null,"Views - assessing the patient's or caregiver's views on the disease or its management"]
[]
[null,null,"In addition the following publication date segmentations are used:"]
[null,null,null,"1960 to 1990, 1991 to 1995, 1996 to 1999, 2000 to 2004, 2005 to 2009, 2010 to 2014, 2015 to 2017"]
[]
[null,null,"All data in this Evidence Map is taken from the heoro.com database"]
[]
[null,null,"Details of the PubMed search strategy used to populate the heoro.com database can be found here."]
[]
[null,null,"Contact us:"]
[null,null,"Address: Crystallise Ltd. Unit 21, Thames Enterpise Centre, Thames Industrial Park, East Tilbury, Essex, UK RM18 8RH"]
[null,null,"Tel: +44 (0)1375 488020"]
[null,null,"Email: alison.martin@crystallise.com"]

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[{"$f":"COUNT(A2:A764)","v":763},"Full citation","DOI","Authors","Title","Abstract","Citation","Locations","Year","Diseases","Interventions","PROtools","Subpopulations","Study types","Study methodologies","LocationsTags","SubpopulationsTags","DiseaseTags","InterventionsTags","StudytypesTags","StudyMethodologyTags","PROtoolTags","DateBand","C1","C2","C3","C4","C5"]
[1,"Abbott,R. R.,et al. (1998). \"A comparison of prostate knowledge of African-American and Caucasian men: changes from prescreening baseline to postintervention.\" Cancer J Sci Am 4(3): 175-177.",null,"Abbott,R. R.,et al.","A comparison of prostate knowledge of African-American and Caucasian men: changes from prescreening baseline to postintervention","PURPOSE: This study was undertaken to determine if a community screening program designed to overcome key barriers (lack of awareness,cost of program,ease of access to care) could successfully impact on African-American males' knowledge,attitudes,and behaviors regarding prostate cancer screening. The focus of this report is knowledge. To date,there are no reported studies that examine differences in knowledge from a prescreening baseline to a postintervention level for minority participants. PATIENTS AND METHODS: A total of 944 men were enrolled in the study in a 20-month period. Prostate screening and education were offered as a new service at an existing senior health clinic. In addition,mass screenings were offered approximately monthly at various locations in the community (including senior community centers,senior apartment complexes,and some public housing projects). Screening included both the digital rectal examination and the prostate specific antigen test. A brief questionnaire was administered during client intake (the pretest) and repeated after the education and screening participation (the posttest). Test items targeted three constructs: (1) etiology,(2) risk status,and (3) clinical factors. RESULTS: The largest difference on pretest scores between the racial groups resulted from clinical factor knowledge. African-American men were significantly less likely than Caucasian men to correctly identify early symptoms of prostate cancer and the basic components of a prostate checkup. Although scores were initially significantly lower for African-American participants,these differences were not evident after program involvement. There was a significant increase in knowledge level for all men when comparing pretest and posttest scores. Significant improvement was noted for each test item,with the exception of one key item. Even after participation in the program,African-American men were still more likely to believe that \"pain\" was the first symptom of prostate cancer. DISCUSSION: An item-by-item analysis revealed that there was only one test item in which program participation did not \"correct\" knowledge. African-American men were still more likely to believe that pain was the first symptom that would alert them to the presence of cancer. The screening program included information (both printed and oral content) that emphasized the importance of routine screening to detect cancer at an early stage,because most men would experience no symptoms. The only other reported study that examined knowledge documented similar findings with respect to an understanding of symptomology. These findings can be used to direct or guide the educational component of future screening programs that hope to target African-American men.","Cancer J Sci Am,4(3): 175-177","USA",1998,"At risk","None","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Knowledge"]
[2,"Ahles,T. A.,et al. (2004). \"Quality of life impact of three different doses of suramin in patients with metastatic hormone-refractory prostate carcinoma: results of Intergroup O159/Cancer and Leukemia Group B 9480.\" Cancer 101(10): 2202-2208.",null,"Ahles,T. A.,et al.","Quality of life impact of three different doses of suramin in patients with metastatic hormone-refractory prostate carcinoma: results of Intergroup O159/Cancer and Leukemia Group B 9480","BACKGROUND: Research has suggested that men with hormone-refractory prostate carcinoma have a lower quality of life (QOL) compared with men who have hormone-sensitive prostate carcinoma and that quality of life (QOL) steadily declines over the last year of life for men with prostate carcinoma. The primary purpose of the current study was to evaluate whether there was evidence of palliative effects associated with suramin at any of the three doses administered in the original clinical trial. METHODS: Patients with histologically confirmed advanced hormone-refractory adenocarcinoma of the prostate were randomized to receive suramin at a low dose (n = 129; median age,69 years),an intermediate dose (n = 129; median age,71 years),or a high dose (n = 127; median age,70 years) as part of the Intergroup 0159/Cancer and Leukemia Group B 9480 trial. Patients completed a battery of assessment tools,including the Functional Assessment of Cancer Therapy (FACT)-Prostate,the Center for Epidemiological Studies-Depression Scale (CES-D),the Brief Pain Inventory,and an opioid medication log,at baseline,on Day 1 of the sixth week of active therapy,during the second week after treatment termination,and 3 months after administration of the final suramin dose. RESULTS: Patients who received low-dose suramin reported improvement in QOL (FACT-General: P < 0.01; FACT-Treatment Outcome Index: P < 0.01) and decreased levels of depression (CES-D: P < 0.0006) during treatment compared with patients in the intermediate- and high-dose arms. After treatment,all groups experienced equal decreases in FACT and CES-D scores. CONCLUSIONS: The pattern of results suggests that the lowest dose of suramin administered had a palliative effect in terms of improvement in QOL and decreased levels of depression and that this effect was lost once suramin was discontinued.","Cancer,101(10): 2202-2208","USA",2004,"Advanced,Metastatic","Various","FACT-P,CES-D,BPI,FACT-G,FACT-TOI","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,Comorbidity,Treatment,Symptom"]
[3,"Ahmad,I. U.,et al. (2010). \"Soy isoflavones in conjunction with radiation therapy in patients with prostate cancer.\" Nutr Cancer 62(7): 996-1000.",null,"Ahmad,I. U.,et al.","Soy isoflavones in conjunction with radiation therapy in patients with prostate cancer","Soy isoflavones sensitize prostate cancer cells to radiation therapy by inhibiting cell survival pathways activated by radiation. At the same time,soy isoflavones have significant antioxidant and anti-inflammatory activity,which may help prevent the side effects of radiation. Therefore,we hypothesized that soy isoflavones could be useful when given in conjunction with curative radiation therapy in patients with localized prostate cancer. In addition to enhancing the efficacy of radiation therapy,soy isoflavones could prevent the adverse effects of radiation. We conducted a pilot study to investigate the effects of soy isoflavone supplementation on acute and subacute toxicity (</=6 mo) of external beam radiation therapy in patients with localized prostate cancer. Forty-two patients with prostate cancer were randomly assigned to receive 200 mg soy isoflavone (Group 1) or placebo (Group 2) daily for 6 mo beginning with the first day of radiation therapy,which was administered in 1.8 to 2.5 Gy fractions for a total of 73.8 to 77.5 Gy. Adverse effects of radiation therapy on bladder,bowel,and sexual function were assessed by a self-administered quality of life questionnaire at 3 and 6 mo. Only 26 and 27 patients returned completed questionnaires at 3 and 6 mo,respectively. At each time point,urinary,bowel,and sexual adverse symptoms induced by radiation therapy were decreased in the soy isoflavone group compared to placebo group. At 3 mo,soy-treated patients had less urinary incontinence,less urgency,and better erectile function as compared to the placebo group. At 6 mo,the symptoms in soy-treated patients were further improved as compared to the placebo group. These patients had less dripping/leakage of urine (7.7% in Group 1 vs. 28.4% in Group 2),less rectal cramping/diarrhea (7.7% vs. 21.4%),and less pain with bowel movements (0% vs. 14.8%) than placebo-treated patients. There was also a higher overall ability to have erections (77% vs. 57.1%). The results suggest that soy isoflavones taken in conjunction with radiation therapy could reduce the urinary,intestinal,and sexual adverse effects in patients with prostate cancer.","Nutr Cancer,62(7): 996-1000","USA",2010,"Local","Radiotherapy,Various","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Complication"]
[4,"Ahmed,H. U.,et al. (2011). \"Focal therapy for localized prostate cancer: a phase I/II trial.\" J Urol 185(4): 1246-1254.",null,"Ahmed,H. U.,et al.","Focal therapy for localized prostate cancer: a phase I/II trial","PURPOSE: Men with localized prostate cancer currently face a number of treatment options that treat the entire prostate. These can cause significant sexual and urinary side effects. Focal therapy offers a novel strategy that targets the cancer rather than the prostate in an attempt to preserve tissue and function. MATERIALS AND METHODS: A prospective,ethics committee approved trial was conducted to determine the side effects of focal therapy using high intensity focused ultrasound. Multiparametric magnetic resonance imaging (T2-weighted,dynamic contrast enhanced,diffusion-weighted) and template transperineal prostate mapping biopsies were used to identify unilateral disease. Genitourinary side effects and quality of life outcomes were assessed using validated questionnaires. Posttreatment biopsies were performed at 6 months and followup was completed to 12 months. RESULTS: A total of 20 men underwent high intensity focused ultrasound hemiablation. Mean age was 60.4 years (SD 5.4,range 50 to 70) with mean prostate specific antigen 7.3 ng/ml (SD 2.8,range 3.4 to 11.8). Of the men 25% had low risk and 75% had intermediate risk cancer. Return of erections sufficient for penetrative sex occurred in 95% of men (19 of 20). In addition,90% of men (18 of 20) were pad-free,leak-free continent while 95% were pad-free. Mean prostate specific antigen decreased 80% to 1.5 ng/ml (SD 1.3) at 12 months. Of the men 89% (17 of 19,1 refused biopsy) had no histological evidence of any cancer,and none had histological evidence of high volume or Gleason 7 or greater cancer in the treated lobe. In addition,89% of men achieved the trifecta status of pad-free,leak-free continence,erections sufficient for intercourse and cancer control at 12 months. CONCLUSIONS: Our results appear sufficiently promising to support the further evaluation of focal therapy as a strategy to decrease some of the harms and costs associated with standard whole gland treatments.","J Urol,185(4): 1246-1254","UK",2011,"Local","HIFU","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Complication,General"]
[5,"Ahmed,H. U.,et al. (2012). \"Focal salvage therapy for localized prostate cancer recurrence after external beam radiotherapy: a pilot study.\" Cancer 118(17): 4148-4155.",null,"Ahmed,H. U.,et al.","Focal salvage therapy for localized prostate cancer recurrence after external beam radiotherapy: a pilot study","BACKGROUND: The objective of this study was to evaluate the safety,feasibility,side-effect profile,and proof of concept for focal salvage therapy using high-intensity focused ultrasound (HIFU). METHODS: A registry-based analysis was conducted between 2004 and 2009 of 430 patients who underwent HIFU. Thirty-nine patients received focal salvage therapy for localized recurrence after external beam radiotherapy. Multiparametric magnetic resonance imaging studies combined with transperineal template prostate mapping biopsies or transrectal biopsies were used to localize disease. Validated questionnaires were used to assess functional outcomes. Biochemical failure was defined by using both Phoenix criteria (prostate-specific antigen [PSA] nadir plus 2 ng/mL) and Stuttgart criteria (PSA nadir plus 1.2 ng/mL). RESULTS: The mean pre-HIFU PSA level was 4.6 ng/mL. The median follow-up was 17 months (interquartile range,10-29 months). International Index of Erectile Function-5 scores decreased from a median +/- standard deviation (SD) of 18 +/- 16 to 13 +/- 21 at 6 months,demonstrating worsening function. Scores on the University of California Los Angeles-Expanded Prostate Cancer Index Composite Urinary domain indicate that pad-free,leak-free continence status was 64%,and the pad-free rate was 87.2% at last follow-up. One rectourethral fistula occurred and spontaneously resolved with urinary and bowel diversion. The actuarial progression-free survival rate (including PSA nonresponders) was 69% at 1 year and 49% at 2 years according to Phoenix criteria. Excluding PSA nonresponders,these rates were 74% and 58%,respectively (Phoenix criteria). CONCLUSIONS: The results from this study indicated that focal salvage therapy is a potential strategy for localized recurrence after radiotherapy that may reduce the harms resulting from whole-gland salvage therapies.","Cancer,118(17): 4148-4155","UK",2012,"Recurrent","HIFU","IIEF-5,EPIC","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease,Complication"]
[6,"Akakura,K.,et al. (1999). \"Long-term results of a randomized trial for the treatment of Stages B2 and C prostate cancer: radical prostatectomy versus external beam radiation therapy with a common endocrine therapy in both modalities.\" Urology 54(2): 313-318.",null,"Akakura,K.,et al.","Long-term results of a randomized trial for the treatment of Stages B2 and C prostate cancer: radical prostatectomy versus external beam radiation therapy with a common endocrine therapy in both modalities","OBJECTIVES: To improve the treatment of locally advanced prostate cancer (Stages B2 and C),a prospective randomized trial was conducted to compare radical prostatectomy versus external beam radiotherapy with the combination of endocrine therapy in both modalities. METHODS: One hundred patients were enrolled and 95 were evaluated. Forty-six patients underwent radical prostatectomy with pelvic lymph node dissection,and 49 were treated with radiation by linear accelerator with 40 to 50 Gy to the whole pelvis and a 20-Gy boost to the prostatic area. For all patients,endocrine therapy was initiated 8 weeks before surgery or radiation,and continued thereafter. The living patients were asked to respond to a quality-of-life questionnaire. RESULTS: The follow-up period ranged from 6.0 to 94.4 months (median 58.5). The progression-free and cause-specific survival rates at 5 years were 90.5% and 96.6% in the surgery group and 81.2% and 84.6% in the radiation group,respectively. The surgery group had better progression-free and cause-specific survival rates (P = 0.044 and 0.024,respectively). More patients in the surgery group complained of urinary incontinence. The questionnaire revealed that quality of life was less disturbed in the radiation group. CONCLUSIONS: Radical prostatectomy combined with endocrine therapy may contribute to the survival benefit of patients with locally advanced prostate cancer. External beam radiotherapy in combination with endocrine therapy can be used in selected patients because of its low morbidity.","Urology,54(2): 313-318","Japan",1999,"Advanced","Surgery,Radiotherapy,Hormonal","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Complication,General"]
[7,"Akaza,H.,et al. (2004). \"The 3rd Conference on Asian Trends in Prostate Cancer Hormone Therapy.\" Gan To Kagaku Ryoho 31(8): 1285-1295.",null,"Akaza,H.,et al.","The 3rd Conference on Asian Trends in Prostate Cancer Hormone Therapy","From its inception in 2001,the Conference on Asian Trends in Prostate Cancer Hormone Therapy has served as an annual forum for Asian urologists to compare data on prostate cancer and to discuss issues regarding the use of hormone therapy. The 3rd conference,held in Tokyo in December 2003,began with participants from China,Indonesia,Japan,Korea,Singapore,and Taiwan presenting QOL data deriving from a survey of patients with prostate cancer. For this purpose,each country translated the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire into its own language. Although the surveys conducted in each country included a heterogeneous cohort of patients and gave very mixed results,the trial of FACT-P in Asian countries seemed propitious and in future may provide insights that could prove beneficial to patients. Day 2 of the conference included 2 discussions,focusing on the most appropriate number of biopsy cores and the implementation of prospective trials involving the collaboration of Asian countries,respectively. In the latter discussion,although a varied assortment of proposals were put forth,the participants generally agreed that any collaborative study must be a prospective outcome study conducted in a relatively short time not exceeding 2-3 years,and that patient registration should be done using the Internet.","Gan To Kagaku Ryoho,31(8): 1285-1295","Japan,China,Indonesia,Korea,Singapore,Taiwan",2004,"Any or unknown","None","FACT-P","Patient",null,"Narrative review",null,null,null,null,null,null,null,null,"Disease"]
[8,"Albertsen,P. C.,et al. (1997). \"Health-related quality of life among patients with metastatic prostate cancer.\" Urology 49(2): 207-216; discussion 216-207.",null,"Albertsen,P. C.,et al.","Health-related quality of life among patients with metastatic prostate cancer","OBJECTIVES: To assess and compare the quality of life of men with advanced prostate cancer who are in remission receiving treatment with a luteinizing hormone-releasing hormone (LHRH) agonist and flutamide or who are in progression. METHODS: We conducted a cross-sectional survey to measure health-related quality of life in a cohort of 113 patients with metastatic prostate cancer,60 in remission and 53 with disease progression,using a battery of questionnaires,including the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30,the Medical Outcomes Study Short Form Health Survey SF-36,and a prostate cancer-specific module. RESULTS: Patients in remission receiving an LHRH agonist and flutamide reported a significantly better quality of life compared with patients with disease progression (P < 0.011). Men with hormone-sensitive cancer had significantly less bodily pain,more vitality,more social interactions,and better mental health than patients with hormone-resistant disease. No differences were noted between the two groups concerning treatment-related problems such as diarrhea,constipation,urinary symptoms,sexual function,sexual satisfaction or hot flashes,although men in remission tended to rate each of these items more favorably than did men with disease progression. Men in remission have a health-related quality of life that is similar to an equivalent norm for men in the United States general population as compared with men with disease progression,who demonstrate significant compromise in all domains measured. CONCLUSIONS: Patients in remission receiving an LHRH agonist and flutamide have a quality of life that is indistinguishable from a matched male population without prostate cancer and a quality of life significantly better than that of men with androgen-resistant disease. Among patients who respond to total androgen ablation,flutamide and an LHRH agonist provide significant,measurable benefits to recipients independent of any possible improvement in longevity.","Urology,49(2): 207-216; discussion 216-207","USA",1997,"Metastatic","Hormonal","EORTC QLQ-C30,SF-36","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Disease,General,Utility"]
[9,"Albertsen,P. C.,et al. (1998). \"Assessment of patient preferences among men with prostate cancer.\" J Urol 159(1): 158-163.",null,"Albertsen,P. C.,et al.","Assessment of patient preferences among men with prostate cancer","PURPOSE: We developed a self-administered paper based instrument to assess patient preferences quantified as utilities for common outcomes associated with the management of prostate cancer. MATERIALS AND METHODS: A total of 50 patients was invited to test a self-administered paper based instrument designed to assess preferences for health outcomes associated with the management of localized prostate cancer. The 50 patients were selected from a group of 625 randomly identified men with prostate cancer who responded to a survey instrument designed to assess health related quality of life. The 50 patients selected for this pilot project were chosen because of the wide range of responses to the quality of life survey. Patient utilities were assessed for the 5 health states of overall quality of life,problems related to prostate cancer,and problems related to urinary,bowel and sexual dysfunction. RESULTS: Patients were able to complete the assigned tasks. The self-administered instrument had high test-retest reliability. In addition results obtained from this instrument showed a correlation with results obtained from assessments using other instruments,including an analog scale,a computer based system known as U-Titer,a quality of life survey and the Health Utility Index:3. CONCLUSIONS: A self-administered paper based instrument can be used to assess patient utilities for health states associated with prostate cancer management. Results from the instrument tested appear to be reliable and valid,and are comparable to those obtained from other assessment techniques. A self-administered paper based instrument has distinct advantages when conducting large survey studies because it can be incorporated at relatively low cost.","J Urol,159(1): 158-163","USA",1998,"Any or unknown","None","HUI,VAS,U-Titer","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Utility"]
[10,"Alibhai,S. M.,et al. (2010). \"Impact of androgen-deprivation therapy on physical function and quality of life in men with nonmetastatic prostate cancer.\" J Clin Oncol 28(34): 5038-5045.",null,"Alibhai,S. M.,et al.","Impact of androgen-deprivation therapy on physical function and quality of life in men with nonmetastatic prostate cancer","PURPOSE: This prospective longitudinal study evaluated the effect of androgen deprivation therapy (ADT) on objective and self-reported physical function. PATIENTS AND METHODS: Men with nonmetastatic prostate cancer (PC) starting continuous ADT were enrolled in this matched cohort study. Physical function was assessed with the 6-minute walk test (6MWT),grip strength,and the timed-up-and-go (TUG) test,representing endurance and upper and lower extremity strength,respectively. Quality of life (QOL) was measured with the Medical Outcomes Study Short-Form 36 (SF-36) questionnaire. Subjects were assessed at baseline,3,6,and 12 months. Two control groups (PC without ADT; no PC),matched on age,education,and baseline function were enrolled. Mixed effects regression models were fitted,adjusting for baseline covariates. RESULTS: We enrolled 87 patients on ADT,86 PC controls,and 86 healthy controls; groups were similar in age (mean,69.1 years; range,50 to 87) and physical function. The 6MWT distance remained stable in the ADT group (P = .96) but improved in both control groups (P < .05). Grip strength declined in the ADT group (P = .04),remained stable in PC controls (P = .31),and improved in healthy controls (P = .008). TUG scores remained stable over time and across groups (P > .10). The SF-36 physical function summary score declined in the ADT group (P < .001),but increased in both control groups (P < .001). Negative effects on outcomes were observed within 3 months of starting ADT and were generally independent of age. CONCLUSION: Endurance,upper extremity strength,and physical components of QOL are affected within 3 months of starting ADT. Up-front exercise interventions to counteract these losses are warranted.","J Clin Oncol,28(34): 5038-5045","Canada",2010,"Advanced,Local","Hormonal","SF-36","Patient",null,"Case-control",null,null,null,null,null,null,null,null,"Utility"]
[11,"Alibhai,S. M.,et al. (2015). \"A phase II RCT and economic analysis of three exercise delivery methods in men with prostate cancer on androgen deprivation therapy.\" BMC Cancer 15: 312.",null,"Alibhai,S. M.,et al.","A phase II RCT and economic analysis of three exercise delivery methods in men with prostate cancer on androgen deprivation therapy","BACKGROUND: Androgen deprivation therapy is commonly used to treat prostate cancer,the most common visceral cancer in men. However,various side effects often worsen physical functioning and reduce well-being among men on this treatment. Based on existing evidence,both resistance and aerobic training provide benefits for this population yet adherence rates are often low. The method of exercise delivery (supervised in-center or home-based) may be important,yet few studies have compared different models. Additionally,long-term exercise adherence is critical to achieve sustained benefits but long-term adherence data and predictors of adherence are lacking. The primary aim of this phase II,non-inferiority randomized controlled trial is to determine whether three exercise training delivery models are equivalent in terms of benefits in quality of life and physical fitness in this population. Secondary aims include examination of long-term adherence and cost-effectiveness. DESIGN: Men diagnosed with prostate cancer,starting or continuing on androgen deprivation therapy for at least 6 months,fluent in English,and living close to one of two experienced Canadian study centers are eligible. Participants complete five assessments over one year,including a fitness assessment and self-report questionnaires. Socio-demographic and clinical data collection occur at baseline,bone mineral density testing at two time points,and blood work is performed at three time points. Participants are randomized in a 1:1:1 fashion to supervised personal training,supervised group training,or home-based smartphone- and health coach-supported training. Each participant receives a detailed exercise manual,including illustrations of exercises and safety precautions. Participants are asked to complete 4 to 5 exercise sessions per week,incorporating aerobic,resistance and flexibility training. Participant intensity levels will be monitored. The intervention duration is 6 months,with 6 months additional follow-up. Outcomes include: body composition,fitness testing,quality of life and fatigue,biological outcomes,and program adherence. Cost information will be obtained using patient diary-based self-report. DISCUSSION: The goals of this study are to gain a better understanding of health benefits and costs associated with commonly used yet currently not compared exercise delivery models as well as an increased understanding of adherence to exercise. TRIAL REGISTRATION: The trial has been registered at clinicaltrials.gov (Registration # NCT02046837),registered January 20(th),2014.","BMC Cancer,15(312","Canada",2015,"Any or unknown","Various,Hormonal","Unclear","Patient",null,"Protocol",null,null,null,null,null,null,null,null,"Unclear"]
[12,"Al-Mamgani,A.,et al. (2011). \"Dose escalation and quality of life in patients with localized prostate cancer treated with radiotherapy: long-term results of the Dutch randomized dose-escalation trial (CKTO 96-10 trial).\" Int J Radiat Oncol Biol Phys 79(4): 1004-1012.",null,"Al-Mamgani,A.,et al.","Dose escalation and quality of life in patients with localized prostate cancer treated with radiotherapy: long-term results of the Dutch randomized dose-escalation trial (CKTO 96-10 trial)","PURPOSE: To assess the impact of dose escalation of radiotherapy on quality of life (QoL) in prostate cancer patients. PATIENTS AND METHODS: Three hundred prostate cancer patients participating in the Dutch randomized trial (CKTO 69-10) comparing 68 Gy with 78 Gy were the subject of this analysis. These patients filled out the SF-36 QoL questionnaire before radiotherapy (baseline) and 6,12,24,and 36 months thereafter. Changes in QoL over time of >/=10 points were considered clinically relevant. Repeated-measures regression analyses were applied to estimate and test the QoL changes over time,the differences between the two arms,and for association with a number of covariates. RESULTS: At 3-year follow-up,the summary score physical health was 73.2 for the 68-Gy arm vs. 71.6 for the 78-Gy arm (p = 0.81),and the summary score mental health was 76.7 for the 68-Gy arm vs. 76.1 for the 78-Gy arm (p = 0.97). Statistically significant (p < 0.01) deterioration in QoL scores over time was registered in both arms in six scales. The deterioration over time was more pronounced in the high-dose arm for most scales. However,clinically relevant deterioration (>10 points) was seen for only two scales. None of the tested covariates were significantly correlated with QoL scores. CONCLUSION: Dose escalation did not result in significant deterioration of QoL in prostate cancer patients. In both randomization arms,statistically significant decreases in QoL scores over time were seen in six scales. The deterioration of QoL was more pronounced in the physical than in the mental health domain and in some scales more in the high- than in the low-dose arm,but the differences between arms were not statistically significant.","Int J Radiat Oncol Biol Phys,79(4): 1004-1012","Netherlands",2011,"Local","Radiotherapy","SF-36","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Utility"]
[13,"Altwein,J.,et al. (1997). \"How is quality of life in prostate cancer patients influenced by modern treatment? The Wallenberg Symposium.\" Urology 49(4A Suppl): 66-76.",null,"Altwein,J.,et al.","How is quality of life in prostate cancer patients influenced by modern treatment? The Wallenberg Symposium","OBJECTIVES: To identify complications of various forms of treatments for prostate cancer and their influence on patients' quality of life with the ultimate goal of suggesting a Quality of Life Questionnaire specific for prostate cancer for further validation. METHODS: The literature was screened for reports on the more common complications following various forms of therapy for prostate cancer. Frequencies were summarized. The scarce literature reporting on quality of life in prostate cancer was reviewed and conflicting data were discussed and reassessed. Suggested questionnaires used in other studies were critically scrutinized and the various questions recorded. RESULTS: Following radical surgery,impotence and incontinence were the most common complications reducing patients' quality of life. The literature was not uniform with regard to whether loss of sexual function was regarded as a worse complication than loss of urinary control. Following radiotherapy,intestinal problems and sexual dysfunction were the dominating side effects. Quality of life was best preserved in surveillance-only series. Following endocrine therapy,not only impotence and hot flushes were focused upon,but also mental dysfunction and intestinal dysfunction from nonsteroidal antiandrogens,additionally,the importance of effective palliation was highlighted. A Quality of Life Questionnaire should contain general domains relevant to cancer patients,cancer-specific questions,and prostate-cancer-specific questions. The latter group includes: worry for prostate cancer and its prognosis,bone/pelvic pain,lower urinary tract symptoms,urinary incontinence,urinary diversion,bowel function,sexual function,endocrine effects,and satisfaction with medical care for prostate cancer. CONCLUSIONS: A modern trial of prostate cancer treatment should be regarded as insufficient without including a validated Quality of Life Questionnaire.","Urology,49(4A Suppl): 66-76","Germany",1997,"Any or unknown","Unclear","Unclear","Patient",null,"Systematic review",null,null,null,null,null,null,null,null,"Complication,General"]
[14,"Alvarez-Maestro,M.,et al. (2014). \"Evaluation of the clinical usefulness of a health-related quality of life questionnaire in patients with prostate cancer.\" Actas Urol Esp 38(10): 669-677.",null,"Alvarez-Maestro,M.,et al.","Evaluation of the clinical usefulness of a health-related quality of life questionnaire in patients with prostate cancer","OBJECTIVES: The PROSQoLI questionnaire evaluates health related quality of life in patients with advanced prostate cancer. Although its utility in different clinical settings has never been assessed,its brevity and good measurement properties make its use recommendable in clinical practice. The objective is to evaluate the clinical usefulness of PROSQoLI in clinical treatment decision-making in patients with prostate cancer. MATERIALS AND METHODS: An observational,prospective longitudinal and multi-center study conducted in different Spanish centers. Sociodemographic and clinical data of patients and researchers were collected. Each patient fulfilled PROSQoLI questionnaire in each visit. Besides,physicians answered a survey about clinical usefulness of PROSQoLI questionnaire. RESULTS: The mean age of patients was 74.7 (7.4) years (standard deviation) and of researchers 51.8 (9.7) years. The usefulness in clinical decision-making was considered high by 66.1% of physicians; regarding questionnaire characteristics 71.3% of physicians considered it highly useful and 73.4% of them regarding doctor-patient communication. CONCLUSIONS: The use of health-related quality of life questionnaires improves doctor-patient communication. It is demonstrated that PROSQoLI can be an additional tool in clinical decision-making as well as a means of facilitating doctor-patient communication.","Actas Urol Esp,38(10): 669-677","Spain",2014,"Any or unknown","None","PROSQoLI","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease"]
[15,"Alves,E.,et al. (2013). \"Validation of the Brazilian version of the Expanded Prostate Cancer Index Composite (EPIC) for patients submitted to radical prostatectomy.\" Int Braz J Urol 39(3): 344-352.",null,"Alves,E.,et al.","Validation of the Brazilian version of the Expanded Prostate Cancer Index Composite (EPIC) for patients submitted to radical prostatectomy","OBJECTIVES: Validation of the Expanded Prostate Cancer Index Composite (EPIC) questionnaire translated to Portuguese. This is an evaluation tool of the effects of treatment on quality of life of patients with prostate cancer. MATERIALS AND METHODS: In order to translate and validate,several recommended methodological techniques in the literature were included: initial translation,synthesis of translation,board committee review and back translation. Sample included 40 patients with localized prostate cancer submitted to surgical retropubic radical prostatectomy from 2008 to 2010. RESULTS: The internal consistency analysis of the scales of the questionnaire resulted in alpha Cronbach coefficients \"very good\" (> 0.9) and \"good\" (> 0.8) to 8 of 14 domains. The higher coefficients (0.94) were assigned to sexual score,subscales incontinence and sexual function. Post-operatory follow-up ranged from 3 to 35 months,median 18.7 months. CONCLUSIONS: The Brazilian version of EPIC is reliable and valid,and is a useful tool to evaluate the impact of retropubic radical prostatectomy on quality of life of Brazilian patients with localized prostate cancer,in national and internationals studies.","Int Braz J Urol,39(3): 344-352","Brazil",2013,"Local","Surgery","EPIC","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease"]
[16,"Ames,S. C.,et al. (2011). \"A pilot investigation of a multidisciplinary quality of life intervention for men with biochemical recurrence of prostate cancer.\" Psychooncology 20(4): 435-440.",null,"Ames,S. C.,et al.","A pilot investigation of a multidisciplinary quality of life intervention for men with biochemical recurrence of prostate cancer","OBJECTIVE: This pilot project evaluated the acceptability and estimated the effect size of a tailored multidisciplinary quality of life (MQOL) intervention for men who have biochemical recurrence of prostate cancer. METHODS: Participants included 57 men with localized prostate cancer with biochemical recurrence (Median=76 years; 89% White). Participants were randomized to wait list control which offered the intervention upon conclusion of the study (n=27) or to an eight-session group-based,MQOL (n=30) intervention. Assessments were completed at baseline,end of treatment,and 6 months post-treatment. RESULTS: MQOL was acceptable as indicated by favorable participant retention (100% retained),treatment compliance (97% attended > 6 treatment sessions),and high ratings of helpfulness (80% rated helpfulness > 4 on 5-point scale). MQOL had a favorable impact on the mental health composite score of the Short Form-36 at the end of treatment but not at 6 months (effect size=0.52 and -0.04); health-related QOL as measured by the Functional Assessment of Cancer Therapy-Prostate at the end of treatment and 6 months (effect size=0.14 and 0.10); and prostate cancer specific anxiety as measured by the Memorial Anxiety Scale for Prostate Cancer at the end of treatment and 6 months (effect size=0.45 and 0.23). CONCLUSIONS: This pilot project provides preliminary data supporting the premise that a tailored behaviorally based MQOL intervention for men with biochemical recurrence of prostate cancer is acceptable to men and might reduce prostate cancer specific anxiety and enhance QOL. Further research examining the efficacy of this intervention in a larger randomized trial is warranted.","Psychooncology,20(4): 435-440","USA",2011,"Local","Psychological","FACT-P,SF-36,MAS","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,Comorbidity,Utility"]
[17,"Anandadas,C. N.,et al. (2011). \"Early prostate cancer--which treatment do men prefer and why?\" BJU Int 107(11): 1762-1768.",null,"Anandadas,C. N.,et al.","Early prostate cancer--which treatment do men prefer and why?","STUDY TYPE: Preference (prospective cohort). LEVEL OF EVIDENCE: 1b. What's known on the subject? and What does the study add? In general the literature suggests that there is a need for improvement in aiding men diagnosed with early prostate cancer in their decision making about treatment options and that our understanding of this process is inadequate. There is limited data analyzing the reasons why these men decide between potentially curative or observational treatments and data evaluating patients' views before and after definitive therapy are scarce. This study begins the process of understanding the reasons underlying a patient's final treatment decision. Being a prospective study,it looks at the thought processes of these men before treatment during the time the decision is made. It also documents how satisfied patients are with their choice after their treatment and whether they would choose the same treatment again. OBJECTIVE: To identify the reasons for patients with localised prostate cancer choosing between treatments and the relationship of procedure type to patient satisfaction post-treatment. PATIENTS AND METHODS: 768 men with prostate cancer (stage T1/2,Gleason</=7,PSA<20 ug/L) chose between four treatments: radical prostatectomy,brachytherapy,conformal radiotherapy and active surveillance. Prior to choosing,patients were counselled by a urological surgeon,clinical (radiation) oncologist and uro-oncology specialist nurse. Pre-treatment reasons for choice were recorded. Post-treatment satisfaction was examined via postal questionnaire. RESULTS: Of the 768 patients,305 (40%) chose surgery,237 (31%) conformal beam radiotherapy,165 (21%) brachytherapy and 61 (8%) active surveillance. Sixty percent of men who opted for radical prostatectomy were motivated by the need for physical removal of the cancer. Conformal radiotherapy was mainly chosen by patients who feared other treatments (n=63,27%). Most men chose brachytherapy because it was more convenient for their lifestyle (n=64,39%). Active surveillance was chosen by patients for more varied reasons. Post-treatment satisfaction was assessed in a subgroup who took part in the QOL aspect of this study. Of the respondents to the questionnaire,212(87.6%) stated that they were satisfied/extremely satisfied with their choice and 171(92.9%) indicated they would choose the same treatment again. CONCLUSION: Men with early prostate cancer have clear reasons for making decisions about treatment. Overall,patients were satisfied with the treatment and indicated that despite different reasons for choosing treatment,they would make the same choice again.","BJU Int,107(11): 1762-1768","UK",2011,"Local","Radiotherapy,Surveillance,Brachytherapy,Surgery","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Satisfaction"]
[18,"Anast,J. W.,et al. (2005). \"The impact of obesity on health related quality of life before and after radical prostatectomy (data from CaPSURE).\" J Urol 173(4): 1132-1138.",null,"Anast,J. W.,et al.","The impact of obesity on health related quality of life before and after radical prostatectomy (data from CaPSURE)","PURPOSE: Health related quality of life (HRQOL) is an important measure of outcomes among patients with prostate cancer due to disease related and treatment related effects on physical and emotional health. We determined if there are differences in the HRQOL of obese men at diagnosis and after radical prostatectomy compared to the HRQOL of men with normal body mass index (BMI). MATERIALS AND METHODS: Data were abstracted from Cancer of the Prostate Strategic Urological Research Endeavor (CaPSURE),a disease registry of 10,018 men with prostate cancer. A total of 1,884 men were included in study who were treated with radical prostatectomy between 1989 and 2002,had BMI information available and had completed 1 initial HRQOL questionnaire. Of these men 672 who completed at least 2 followup questionnaires were assessed further. RESULTS: The BMI (kg/m) distributions were 24% normal (less than 24.9 kg/m),56% overweight (25 to 29.9),16% obese (30 to 34.9) and 4% very obese (greater than 35 kg/m). Higher BMI was associated with worse physical function,bodily pain,general health,vitality and role physical,but better bowel bother at diagnosis independent of race. Higher BMI was also associated with worse HRQOL after radical prostatectomy for physical function,general health and vitality,but better bowel bother. HRQOL differences between BMI groups were similar among times for all measured variables. Compared to the normal group,the higher BMI groups had similar HRQOL after radical prostatectomy. CONCLUSIONS: In the majority of domains men with higher BMI had lower HRQOL at diagnosis than men of normal BMI. Obese men have a similar recovery pattern of HRQOL after radical prostatectomy,with minimal additive long-term impairment in HRQOL relative to men of normal weight.","J Urol,173(4): 1132-1138","USA",2005,"Any or unknown","Surgery","Unclear","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"General"]
[19,"Anastasiadis,A. G.,et al. (2003). \"Comparison of health-related quality of life and prostate-associated symptoms after primary and salvage cryotherapy for prostate cancer.\" J Cancer Res Clin Oncol 129(12): 676-682.",null,"Anastasiadis,A. G.,et al.","Comparison of health-related quality of life and prostate-associated symptoms after primary and salvage cryotherapy for prostate cancer","PURPOSE: Recent advances in cryosurgery of the prostate have led to the ability to treat tumors successfully with decreased morbidity. The patients' perspectives of this relatively new technique,however,have not yet been addressed. The purpose of this study was to compare health related quality of life (QoL) as well as prostate-associated symptoms in patients after primary and salvage cryoablation for clinically localized prostate cancer using a self-administered questionnaire. METHODS: A total of 131 consecutive patients who underwent cryoablation of the prostate between 1997 and 2001 were included in this confidential mailing study. The patients were either (a) patients with localized prostate cancer with contraindications for radical surgery,including patients refusing other forms of therapy,or (b) had locally recurrent prostate cancer after failure of radiation therapy. All patients received 3 months of neoadjuvant androgen deprivation therapy prior to cryosurgery and were surgically treated by the same surgeon using an argon-based system. We used the EORTC QLQ-C30,a commonly used,multidimensional instrument together with a supplementing,prostate-cancer-specific module. RESULTS: Eighty-one of the 131 patients (response rate 62%) returned the questionnaires. The two groups were comparable regarding age (mean age 72.8 vs 70.1 for the primary and the salvage group,respectively; p=0.22). The overall QoL scores were high in both groups. Primary cryotherapy patients fared significantly better regarding physical (p=0.005) and social (p=0.024) functioning compared with salvage cryotherapy patients. The most prominent prostate-related symptom in both patient groups was sexual dysfunction,followed by urinary symptoms,which were significantly more severe in the salvage group (p=0.001). Incontinence rates were 5.9 and 10% in the primary and the salvage group,respectively. Severe erectile dysfunction was reported in 86 and 90% of the primary and the salvage group,respectively. CONCLUSIONS: The present study demonstrates that,in selected patients,cryotherapy is a treatment option which has a functional outcome comparable to traditionally used prostate cancer treatments. More information regarding QoL is necessary for appropriate patient counseling and individual decision-making in the presence of various treatment alternatives.","J Cancer Res Clin Oncol,129(12): 676-682","USA",2003,"Local,Recurrent","Various","EORTC QLQ-C30,EORTC QLQ-PR25","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"General,Disease"]
[20,"Andronis,L.,et al. (2017). \"Cost-effectiveness of zoledronic acid and strontium-89 as bone protecting treatments in addition to chemotherapy in patients with metastatic castrate-refractory prostate cancer: results from the TRAPEZE trial (ISRCTN 12808747).\" BJU Int 119(4): 522-529.",null,"Andronis,L.,et al.","Cost-effectiveness of zoledronic acid and strontium-89 as bone protecting treatments in addition to chemotherapy in patients with metastatic castrate-refractory prostate cancer: results from the TRAPEZE trial (ISRCTN 12808747)","OBJECTIVE: To evaluate the cost-effectiveness of adding zoledronic acid or strontium-89 to standard docetaxel chemotherapy for patients with castrate-refractory prostate cancer (CRPC). PATIENTS AND METHODS: Data on resource use and quality of life for 707 patients collected prospectively in the TRAPEZE 2 x 2 factorial randomised trial (ISRCTN 12808747) were used to assess the cost-effectiveness of i) zoledronic acid versus no zoledronic acid (ZA vs. no ZA),and ii) strontium-89 versus no strontium-89 (Sr89 vs. no Sr89). Costs were estimated from the perspective of the National Health Service in the UK and included expenditures for trial treatments,concomitant medications,and use of related hospital and primary care services. Quality-adjusted life-years (QALYs) were calculated according to patients' responses to the generic EuroQol EQ-5D-3L instrument,which evaluates health status. Results are expressed as incremental cost-effectiveness ratios (ICERs) and cost-effectiveness acceptability curves. RESULTS: The per-patient cost for ZA was pound12 667,pound251 higher than the equivalent cost in the no ZA group. Patients in the ZA group had on average 0.03 QALYs more than their counterparts in no ZA group. The ICER for this comparison was pound8 005. Sr89 was associated with a cost of pound13 230,pound1365 higher than no Sr89,and a gain of 0.08 QALYs compared to no Sr89. The ICER for Sr89 was pound16 884. The probabilities of ZA and Sr89 being cost-effective were 0.64 and 0.60,respectively. CONCLUSIONS: The addition of bone-targeting treatments to standard chemotherapy led to a small improvement in QALYs for a modest increase in cost (or cost-savings). ZA and Sr89 resulted in ICERs below conventional willingness-to-pay per QALY thresholds,suggesting that their addition to chemotherapy may represent a cost-effective use of resources.","BJU Int,119(4): 522-529","UK",2017,"Metastatic,Refractory","Chemotherapy,Bisphosphonate","EQ-5D","Patient",null,"Economic model",null,null,null,null,null,null,null,null,"Utility"]
[21,"Anonymous (2002). \"A preliminary report on a patient-preference study to compare treatment options in early prostate cancer.\" BJU Int 90(3): 253-256.",null,"Anonymous","A preliminary report on a patient-preference study to compare treatment options in early prostate cancer","OBJECTIVE: To prospectively record prognostic factors,quality-of-life and outcome data in a patient-preference controlled study comparing radical prostatectomy with radical radiotherapy for the treatment of early prostate cancer. PATIENTS AND METHODS: All patients suitable for radical treatment of early prostate cancer were identified and provided with information from a urologist,oncologist and nurse to allow them to choose a treatment option. Prognostic and demographic data were recorded for all patients and patients followed up uniformly,with the additional collection of quality-of-life data. RESULTS: In a 38-month period,196 patients were recruited to the trial; of these,81 chose surgery,81 radiotherapy,30 brachytherapy and four 'watchful waiting'. The distribution of acknowledged prognostic factors was similar between the groups. CONCLUSION: If patient preference continues to divide this population into roughly equal and comparable arms,it should be possible to answer the underlying questions on the treatment of early prostate cancer using this study design.","BJU Int,90(3): 253-256","Unclear",2002,"Local","Radiotherapy,Surgery,Brachytherapy,Surveillance","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"General"]
[22,"Anota,A.,et al. (2016). \"Cross-cultural adaptation and validation of the French version of the Expanded Prostate cancer Index Composite questionnaire for health-related quality of life in prostate cancer patients.\" Health Qual Life Outcomes 14(1): 168.",null,"Anota,A.,et al.","Cross-cultural adaptation and validation of the French version of the Expanded Prostate cancer Index Composite questionnaire for health-related quality of life in prostate cancer patients","BACKGROUND: Health-related quality of life (HRQoL) has been positioned as one of the major endpoints in oncology. Thus,there is a need to validate cancer-site specific survey instruments. This study aimed to perform a transcultural adaptation of the 50-item Expanded Prostate cancer Index Composite (EPIC) questionnaire for HRQoL in prostate cancer patients and to validate the psychometric properties of the French-language version. METHODS: The EPIC questionnaire measures urinary,bowel,sexual and hormonal domains. The first step,corresponding to transcultural adaptation of the original English version of the EPIC was performed according to the back translation technique. The second step,comprising the validation of the psychometric properties of the EPIC questionnaire,was performed in patients under treatment for localized prostate cancer (treatment group) and in patients cured of prostate cancer (cured group). The EORTC QLQ-C30 and QLQ-PR25 prostate cancer module were also completed by patients to assess criterion validity. Two assessments were performed,i.e.,before and at the end of treatment for the Treatment group,to assess sensitivity to change; and at 2 weeks' interval in the Cured group to assess test-retest reliability. Psychometric properties were explored according to classical test theory. RESULTS: The first step showed overall good acceptability and understanding of the questionnaire. In the second step,215 patients were included from January 2012 to June 2014: 125 in the Treatment group,and 90 in the Cured group. All domains exhibited good internal consistency,except the bowel domain (Cronbach's alpha = 0.61). No floor effect was observed. Test-retest reliability assessed in the cured group was acceptable,expect for bowel function (intraclass coefficient = 0.68). Criterion validity was good for each domain and subscale. Construct validity was not demonstrated for the hormonal and bowel domains. Sensitivity to change was exhibited for 5/8 subscales and 2/4 summary scores for patients who experienced toxicities during treatment. CONCLUSIONS: The French EPIC questionnaire seems to have adequate psychometric properties,comparable to those exhibited by the original English-language version,except for the construct validity,which was not available in original version.","Health Qual Life Outcomes,14(1): 168","France",2016,"Local,Survivors","None","EPIC,EORTC QLQ-C30,EORTC QLQ-PR25","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease,General"]
[23,"Arai,Y.,et al. (1999). \"Patient-reported quality of life after radical prostatectomy for prostate cancer.\" Int J Urol 6(2): 78-86.",null,"Arai,Y.,et al.","Patient-reported quality of life after radical prostatectomy for prostate cancer","BACKGROUND: Increasingly,quality of life (QOL) assessments are receiving greater attention in the management of malignancies,including prostate cancer. We evaluated the impact of radical prostatectomy on patient QOL 12 months or longer after surgery. PATIENTS AND METHODS: We evaluated the impact of radical prostatectomy on QOL in 60 patients with prostate cancer. The patients comprised two groups: the first group (n = 32) was evaluated 12 months or longer after radical prostatectomy; the second group (n = 28) was evaluated while awaiting radical prostatectomy. General health-related QOL was measured with the European Organization for Research and Treatment of Cancer Prostate Cancer QOL Questionnaire. Sexual function was assessed with the Sapporo Medical University Sexual Function Questionnaire. A newly developed instrument assessing urinary function was prepared only for the postoperative group. RESULTS: No differences between the two groups were seen in comparisons of general health-related QOL subscales. Men who underwent surgery reported significant deterioration in sexual function (decreased quality of erection,decreased sexual activity and decreased satisfaction with sex life) than those awaiting surgery. Of the 32 postoperative patients,26 (81%) did not use pads at all,five (16%) used one or fewer pads per day due to occasional spotting and only one patient (3%) used two to four pads per day to deal with urine dripping. Twenty-six postoperative patients (81%) stated that,given the choice,they would undergo radical prostatectomy again. CONCLUSIONS: General health-related QOL does not appear to be compromised following radical prostatectomy. Patients are willing to accept some morbidity for a perceived survival benefit. Although minimal urinary dysfunction was reported,most patients were dissatisfied with postoperative sexual function. In preoperative counselling,greater emphasis should be placed on the risk of postoperative impotence.","Int J Urol,6(2): 78-86","Japan",1999,"Any or unknown","Surgery","EORTC QLQ-PR25,SMUF","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Complication,Disease"]
[24,"Arai,Y.,et al. (2008). \"Evaluation of quality of life in patients with previously untreated advanced prostate cancer receiving maximum androgen blockade therapy or LHRHa monotherapy: a multicenter,randomized,double-blind,comparative study.\" J Cancer Res Clin Oncol 134(12): 1385-1396.",null,"Arai,Y.,et al.","Evaluation of quality of life in patients with previously untreated advanced prostate cancer receiving maximum androgen blockade therapy or LHRHa monotherapy: a multicenter,randomized,double-blind,comparative study","PURPOSE: To assess quality of life (QOL) data from a double-blind Phase III study evaluating bicalutamide (Casodex) 80 mg as part of maximum androgen blockade (MAB) in patients with previously untreated advanced prostate cancer. METHODS: Patients with untreated stage C/D prostate cancer were randomized to MAB with bicalutamide plus a luteinizing hormone-releasing hormone agonist (LHRHa) or LHRHa monotherapy. QOL was evaluated at baseline and at weeks 1,5,and 24 using the Japanese version of the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire. RESULTS: A total of 203 patients were assessed for QOL. The MAB group had more rapid and greater improvements in \"emotional well-being\" and \"prostate cancer-specific issues\" domain scores than the monotherapy group. Further analysis of \"prostate cancer-specific issues\" revealed that,compared with monotherapy,MAB provided a greater improvement in \"micturition disorder\"-related QOL. Complete improvement rates for items related to \"pain and micturition disorder\" were also higher with MAB. Item scores of \"pain and micturition disorder\" did not correlate strongly with prostate-specific antigen levels or tumor size. Fewer patients who had deterioration in their \"pain and micturition disorder\" item scores at week 1 in the MAB group than the monotherapy group. CONCLUSIONS: Maximum androgen blockade with bicalutamide plus LHRHa did not reduce the overall QOL of patients with previously untreated advanced prostate cancer. MAB was superior to monotherapy in achieving early improvement of QOL related to micturition disorder and pain.","J Cancer Res Clin Oncol,134(12): 1385-1396","Japan",2008,"Advanced","Hormonal","FACT-P","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease"]
[25,"Arraras Urdaniz,J. I.,et al. (2008). \"The eortc quality of life questionnaire QLQ-C30 (version 3.0). Validation study for Spanish prostate cancer patients.\" Arch Esp Urol 61(8): 949-954.",null,"Arraras Urdaniz,J. I.,et al.","The eortc quality of life questionnaire QLQ-C30 (version 3.0). Validation study for Spanish prostate cancer patients","OBJECTIVE: The EORTC Quality of Life Group has developed a questionnaire for evaluating Quality of Life in international clinical trials: EORTC QLQ-C30,which is widely used in many countries. The purpose of this study was to assess the psychometric properties of the third version of this questionnaire,EORTC QLQ-C30 (version 3.0),when applied to Spanish prostate cancer patients. METHODS: A sample of 137 prostate cancer patients prospectively filled in the questionnaire three times: on the first and last day of the treatment,and in the followup period. Psychometric evaluation of the structure,reliability and validity was made. RESULTS: Multitrait scaling analysis showed that most item-scale correlation coefficients met the standards of convergent and discriminant validity. Few exceptions appeared mainly in CF Most scales had low to moderate inter-correlations. Cronbach's coefficients of the scales were above 0.7,except for the CF and NV values. Group comparison analyses showed better QL in patients with higher Performance Status. Changes in functioning and symptom areas appeared throughout the different measurements,which were in line with the treatment process. CONCLUSIONS: The EORTC QLQC30 (version 3.0) appeared as a reliable and valid instrument when applied to a sample of Spanish prostrate cancer patients. The results are in line with previous studies.","Arch Esp Urol,61(8): 949-954","Spain",2008,"Any or unknown","None","EORTC QLQ-C30","Patient",null,"Validation",null,null,null,null,null,null,null,null,"General"]
[26,"Arredondo,S. A.,et al. (2004). \"Watchful waiting and health related quality of life for patients with localized prostate cancer: data from CaPSURE.\" J Urol 172(5 Pt 1): 1830-1834.",null,"Arredondo,S. A.,et al.","Watchful waiting and health related quality of life for patients with localized prostate cancer: data from CaPSURE","PURPOSE: Watchful waiting is an alternative to active treatment for men with low risk prostate cancer but it is unclear how health related quality of life (HRQoL) may change over time for men who select this option. We report on HRQoL in men with localized prostate cancer who selected watchful waiting. MATERIALS AND METHODS: HRQoL outcomes were reviewed for 310 men diagnosed with prostate cancer from 1990 to 2001 within Cancer of the Prostate Strategic Urological Research Endeavor who chose watchful waiting. The UCLA Prostate Cancer Index and RAND 36-Item Health Survey were completed at enrollment and approximately every 6 months. A random slopes model was developed to assess time trends in HRQoL for up to 5 years after diagnosis,adjusting for age at diagnosis and specific comorbidities. RESULTS: Significant decreases with time were observed in 7 domains of the RAND 36-Item Health Survey and 4 of the UCLA Prostate Cancer Index scales. CONCLUSIONS: Men with prostate cancer who chose watchful waiting in the current study had better or similar HRQoL outcomes compared to men without prostate cancer at the start of the study. Many of these scores were significantly affected by increasing age and decreased with time. The physical domain scores as well as sexual function scores decreased more than expected from the aging process alone.","J Urol,172(5 Pt 1): 1830-1834","USA",2004,"Local","Surveillance","UCLA-PCI,SF-36","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease,Utility"]
[27,"Arredondo,S. A.,et al. (2007). \"Quality of life for men receiving a second treatment for prostate cancer.\" J Urol 177(1): 273-278; discussion 278-279.",null,"Arredondo,S. A.,et al.","Quality of life for men receiving a second treatment for prostate cancer","PURPOSE: We assessed the impact of second treatment on health related quality of life for men with prostate cancer. This issue is important because second treatment resulting from prostate specific antigen recurrence has the potential to further negatively impact health related quality of life and affect the overall value of treatment. We compared differences in health related quality of life before and after second treatment for men who had asymptomatic prostate specific antigen recurrence with those who did not have biochemical failure. MATERIALS AND METHODS: Men in this analysis (897) had localized disease,initially underwent radical prostatectomy monotherapy,and completed at least 1 health related quality of life questionnaire before and after radical prostatectomy. In this cohort 175 men underwent second treatment (nonadjuvant). The Medical Outcomes Survey Short Form-36 and UCLA Prostate Cancer Index were used to measure health related quality of life. Associations between patient groups and time on health related quality of life were analyzed using repeated measures. RESULTS: Men who received a second treatment presented with more severe disease before radical prostatectomy and had worse general health related quality of life. Although health related quality of life differed significantly with time for the 2 groups,most domains for the second treatment group improved or remained stable until 15 months before second treatment,at which point they declined. Scores in the sexual functioning and role-physical domains showed clinically and statistically significant patterns of decreasing with time. CONCLUSIONS: Health related quality of life is affected following second treatment but starts to decline approximately 1 year before second treatment. Not all aspects of health related quality of life decreased at the same rate,so patients should be counseled that certain domains may be affected more by additional treatment.","J Urol,177(1): 273-278; discussion 278-279","USA",2007,"Local","Surgery","SF-36,UCLA-PCI","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease,Utility"]
[28,"Arterbery,V. E.,et al. (1997). \"Quality of life after permanent prostate implant.\" Semin Surg Oncol 13(6): 461-464.",null,"Arterbery,V. E.,et al.","Quality of life after permanent prostate implant","Quality of life is one of several endpoints commonly studied in prostate cancer treatment. It refers to how well an individual is functioning in life and his total sense of well being. There is increasing recognition that cancer therapy impacts significantly on the patient's ability to pursue relational,occupational and social interests. Fifty-one patients with clinically localized prostate cancer who had undergone transperineal permanent prostate implantation were evaluated. All patients were clinically staged as T1c or T2a and received an implant alone with Iodine 125 or Palladium 103 as definitive treatment. Six months after implant,data was collected using the European Organization for Research and Treatment of Cancer (EORTC) genitourinary group questionnaire and supplemental questions. Urinary symptoms such as nocturia,hesitancy,frequency,and dysuria were the most pronounced in the first few months after the implant and then decreased in most of patients; 40% noticed that they urinated more frequently and 17% had mild dysuria. All patients denied hematuria and none reported incontinence. Few patients reported any psychological distress or disruption in social or family life; none reported disruption in economic status or viability. All fifty-one patients said that they would have an implant again as definitive treatment. Seventy-nine percent reported an excellent quality of life post-implant. While survival is clearly a central goal of treatment for prostate cancer,the nature of this malignancy compels clinical attention to the quality of the patient's life after treatment. Sexual quality and function are maintained in the majority of patients and there is minimal interruption of their social and economic function.","Semin Surg Oncol,13(6): 461-464","USA",1997,"Local","Brachytherapy","EORTC QLQ-PR25","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Disease"]
[29,"Arving,C.,et al. (2013). \"Early rehabilitation of cancer patients - a randomized controlled intervention study.\" BMC Cancer 13: 9.",null,"Arving,C.,et al.","Early rehabilitation of cancer patients - a randomized controlled intervention study","BACKGROUND: Faced with a life-threatening illness,such as cancer,many patients develop stress symptoms,i.e. avoidance behaviour,intrusive thoughts and worry. Stress management interventions have proven to be effective; however,they are mostly performed in group settings and it is commonly breast cancer patients who are studied. We hereby present the design of a randomized controlled trial (RCT) evaluating the effectiveness and cost-effectiveness of an individual stress-management intervention with a stepped-care approach in several cancer diagnoses. METHOD: Patients (>/= 18 years) with a recent diagnosis of breast cancer,colorectal cancer,lymphoma,prostate cancer or testicle cancer and scheduled for adjuvant/curative oncology treatment,will consecutively be included in the study. In this prospective longitudinal intervention study with a stepped-care approach,patients will be randomized to control,treatment as usual,or an individual stress-management intervention in two steps. The first step is a low-intensity stress-management intervention,given to all patients randomized to intervention. Patients who continue to report stress symptoms after the first step will thereafter be given more intensive treatment at the second step of the programme. In the intervention patients will also be motivated to be physically active. Avoidance and intrusion are the primary outcomes. According to the power analyses,300 patients are planned to be included in the study and will be followed for two years. Other outcomes are physical activity level,sleep duration and quality recorded objectively,and anxiety,depression,quality of life,fatigue,stress in daily living,and patient satisfaction assessed using valid and standardized psychometric tested questionnaires. Utilization of hospital services will be derived from the computerized patient administration systems used by the hospital. The cost-effectiveness of the intervention will be evaluated through a cost-utility analysis. DISCUSSION: This RCT will provide empirical evidence of whether an individually administered stress-management programme in two steps can decrease stress as well as maintain or enhance patients' physical activity level,quality of life and psychological well-being. Further,this RCT,with a stepped-care approach,will provide knowledge regarding the cost-effectiveness of an individually administered stress-management programme whose aim is to help and support individual patients at the right level of care. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT 01588262.","BMC Cancer,13(9","Norway",2013,"Any or unknown","Psychological","Unclear","Patient",null,"Protocol",null,null,null,null,null,null,null,null,"General,Comorbidity,Symptom,Satisfaction"]
[30,"Ashford,A. R.,et al. (2001). \"Prostate carcinoma knowledge,attitudes,and screening behavior among African-American men in Central Harlem,New York City.\" Cancer 91(1): 164-172.",null,"Ashford,A. R.,et al.","Prostate carcinoma knowledge,attitudes,and screening behavior among African-American men in Central Harlem,New York City","BACKGROUND: Although the benefits of prostate carcinoma screening in reducing mortality rates have not been proven or shown to be cost-effective,screening,particularly using prostate specific antigen (PSA) tests,is widespread. A better understanding of screening behavior,knowledge of prostate carcinoma risk,and attitudes toward screening among men at high risk,such as African-American men,would be valuable. METHODS: A prevalence survey was conducted using 2 samples of African-American men,aged 50-74 years: a clinic sample drawn from all clinics in Central Harlem (n = 404) and a random-digit dial sample from the same geographic region (n = 319). The prevalence of self-reported PSA screening was estimated using a cognitive survey methodology based on the internal consistency of answers to four different questions. Prevalence estimates were adjusted to take into account the high proportion of nontelephone residences. RESULTS: The clinic sample,representing a poorer,more ill population (as determined by MOS Physical Function Scores,was less likely to report PSA screening than the community sample (11.1% in clinic sample vs. 25.5% in community). The prevalence of PSA testing in Central Harlem overall in this age group by using two different techniques was estimated to be 24%. In multiple logistic models,self-reported PSA screening was associated with age,education,favorable attitudes toward screening,and knowing someone who had prostate carcinoma. However,the association between these factors and the likelihood of self-reported PSA screening differed between clinic and community samples. CONCLUSIONS: The prevalence of self-reported PSA screening in Central Harlem was lower than that reported for other populations. These findings may be useful in the design of health education campaigns and for counseling innercity,low-income African-American patients appropriately about the disease.","Cancer,91(1): 164-172","USA",2001,"At risk","Screening","SF-36","General population",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Utility"]
[31,"Augustin,H.,et al. (2002). \"Patient self-reporting questionnaire on urological morbidity and bother after radical retropubic prostatectomy.\" Eur Urol 42(2): 112-117.",null,"Augustin,H.,et al.","Patient self-reporting questionnaire on urological morbidity and bother after radical retropubic prostatectomy","OBJECTIVES: We assessed the incidence of morbidity and bother on quality-of-life (QL) after radical retropubic prostatectomy for prostate cancer. METHODS: At least 12 months after surgery,self-reporting questionnaires were completed and returned by 368 (77.8%) of 473 eligible patients. Surgery related morbidity was evaluated by adhoc constructed questions. QL was assessed by the European Organization for Research and Treatment of Cancer QL core questionnaire (EORTC QLQ-C30). Multivariate and univariate analysis as well as regression analysis were used to assess the bother factors. RESULTS: Postoperative urinary incontinence significant enough for the patient to use some kind of protection was reported by 27.2%. After surgery,14.2% of preoperative potent men were able to get and maintain an erection sufficient enough for sexual intercourse without any aid. Overall 10.6% of respondents had undergone surgery for anastomotic stricture and 23.6% reported on adjuvant therapy. Furthermore,43.2% reported on fear of not being cured from cancer. Postoperative urinary incontinence and fear of not being cured were associated with significant lower global QL scores and turned out as independent predictors for global QL. In contrast,postoperative erectile dysfunction,anastomotic stricture and adjuvant therapy were not independent predictors. In addition,82.1% would vote for surgery again. CONCLUSION: The majority of the patients would opt for surgical treatment again,although morbidity is common after radical prostatectomy and may impair QL. Particularly urinary incontinence and fear of not being cured are independent predictors for global QL after surgery. Therefore,surgical techniques with a low morbidity are requested as well as some kind of psychological support in order to cope with existential fear.","Eur Urol,42(2): 112-117","Austria",2002,"Any or unknown","Surgery","EORTC QLQ-C30","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"General"]
[32,"Avila,M.,et al. (2014). \"Adaptation and validation of the Spanish version of the Patient-Oriented Prostate Utility Scale (PORPUS).\" Qual Life Res 23(9): 2481-2487.",null,"Avila,M.,et al.","Adaptation and validation of the Spanish version of the Patient-Oriented Prostate Utility Scale (PORPUS)","OBJECTIVE: The Patient-Oriented Prostate Utility Scale (PORPUS) is a combined profile and utility-based quality of life measure for prostate cancer patients. Our objectives were to adapt the PORPUS into Spanish and to assess its acceptability,reliability,and validity. METHODS: The PORPUS was adapted into Spanish using forward and back translations and cognitive debriefing. PORPUS was administered jointly with the SF-36 and the Expanded Prostate Index Composite (EPIC) to 480 Spanish prostate cancer patients treated with radical prostatectomy or radiotherapy. The Spanish PORPUS scores' distribution and reliability were examined and compared with the original instrument. To evaluate construct validity,relationships were assessed between PORPUS and other instruments (testing hypotheses of the original PORPUS study),and among known groups defined by side effect severity. RESULTS: Reliability coefficient was 0.76 (similar to the original PORPUS' 0.81). Spanish PORPUS items presented correlations ranging 0.57-0.88 with the corresponding EPIC domains,as in the original PORPUS study (0.60-0.83). Both PORPUS-P and PORPUS-U showed significant differences and large effect sizes (0.94-1.90) when comparing severe versus no problem groups on urinary,bowel,sexual and hormonal side effects defined by EPIC. CONCLUSIONS: A conceptually equivalent Spanish version was obtained,with high reliability and good construct validity,similar to the original Canadian PORPUS version. It can therefore be used to measure health-related quality of life and utilities in Spanish prostate cancer patients.","Qual Life Res,23(9): 2481-2487","Spain",2014,"Any or unknown","Radiotherapy,Surgery","SF-36,EPIC,PORPUS","Patient",null,"Mapping to utility,Validation",null,null,null,null,null,null,null,null,"Disease,Utility"]
[33,"Avila,M.,et al. (2015). \"Estimating preferences for treatments in patients with localized prostate cancer.\" Int J Radiat Oncol Biol Phys 91(2): 277-287.",null,"Avila,M.,et al.","Estimating preferences for treatments in patients with localized prostate cancer","PURPOSE: Studies of patients' preferences for localized prostate cancer treatments have assessed radical prostatectomy and external radiation therapy,but none of them has evaluated brachytherapy. The aim of our study was to assess the preferences and willingness to pay of patients with localized prostate cancer who had been treated with radical prostatectomy,external radiation therapy,or brachytherapy,and their related urinary,sexual,and bowel side effects. METHODS AND MATERIALS: This was an observational,prospective cohort study with follow-up until 5 years after treatment. A total of 704 patients with low or intermediate risk localized prostate cancer were consecutively recruited from 2003 to 2005. The estimation of preferences was conducted using time trade-off,standard gamble,and willingness-to-pay methods. Side effects were measured with the Expanded Prostate Index Composite (EPIC),a prostate cancer-specific questionnaire. Tobit models were constructed to assess the impact of treatment and side effects on patients' preferences. Propensity score was applied to adjust for treatment selection bias. RESULTS: Of the 580 patients reporting preferences,165 were treated with radical prostatectomy,152 with external radiation therapy,and 263 with brachytherapy. Both time trade-off and standard gamble results indicated that the preferences of patients treated with brachytherapy were 0.06 utilities higher than those treated with radical prostatectomy (P=.01). Similarly,willingness-to-pay responses showed a difference of euro57/month (P=.004) between these 2 treatments. Severe urinary incontinence presented an independent impact on the preferences elicited (P<.05),whereas no significant differences were found by bowel and sexual side effects. CONCLUSIONS: Our findings indicate that urinary incontinence is the side effect with the highest impact on preferences and that brachytherapy and external radiation therapy are more valued than radical prostatectomy. These time trade-off and standard gamble preference assessments as well as the willingness-to-pay estimation could be useful to perform respectively cost-utility or cost-benefit analyses,which can guide health policy decisions.","Int J Radiat Oncol Biol Phys,91(2): 277-287","Spain",2015,"Local","Radiotherapy,Surgery","EPIC,TTO,SG,WTP","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Utility,Disease"]
[34,"Baco,E.,et al. (2014). \"Hemi salvage high-intensity focused ultrasound (HIFU) in unilateral radiorecurrent prostate cancer: a prospective two-centre study.\" BJU Int 114(4): 532-540.",null,"Baco,E.,et al.","Hemi salvage high-intensity focused ultrasound (HIFU) in unilateral radiorecurrent prostate cancer: a prospective two-centre study","OBJECTIVE: To report the oncological and functional outcomes of hemi salvage high-intensity focused ultrasound (HSH) in patients with unilateral radiorecurrent prostate cancer. PATIENTS AND METHODS: Between 2009 and 2012,48 patients were prospectively enrolled in two European centres. Inclusion criteria were biochemical recurrence (BCR) after primary radiotherapy (RT),positive magnetic resonance imaging and >/=1 positive biopsy in only one lobe. BCR was defined using Phoenix criteria (a rise by >/=2 ng/mL above the nadir prostate specific antigen [PSA] level). The following schemes and criteria for functional outcomes were used: Ingelman-Sundberg score using International Continence Society (ICS) questionnaire (A and B),International prostate symptom score (IPSS),International Index of Erectile Function-5 (IIEF-5) points,the European Organisation for the Research and Treatment of Cancer (EORTC) quality of life questionnaires (QLQ C-30). HSH was performed under spinal or general anaesthesia using the Ablatherm(R) Integrated Imaging device. Patients with obstructive voiding symptoms at the time of treatment underwent an endoscopic bladder neck resection or incision during the same anaesthesia to prevent the risk of postoperative obstruction. RESULTS: After HSH the mean (sd) PSA nadir was 0.69 (0.83) ng/mL at a median (interquartile range) follow-up of 16.3 (10.5-24.5) months. Disease progression occurred in 16/48 (33%). Of these,four had local recurrence in the untreated lobe and four bilaterally,six developed metastases,and two had rising PSA levels without local recurrence or radiological confirmed metastasis. Progression-free survival rates at 12,18,and 24 months were 83%,64%,and 52%. Severe incontinence occurred in four of the 48 patients (8%),eight (17%) required one pad a day,and 36/48 (75%) were pad-free. The ICS questionnaire showed a mean (sd) deterioration from 0.7 (2.0) to 2.3 (4.5) for scores A and 0.6 (1.4) to 1.6 (3.0) for B. The mean (sd) IPSS and erectile function (IIEF-5) scores decreased from a mean (sd) of 7.01 (5.6) to 8.6 (5.1) and from 11.2 (8.6) to 7.0 (5.8),respectively. The mean (sd) EORTC QLC-30 scores before and after HSH were 35.7 (8.6) vs 36.8 (8.6). CONCLUSION: HSH is a feasible therapeutic option in patients with unilateral radiorecurrent prostate cancer,which offers limited urinary and rectal morbidity,and preserves health-related quality of life.","BJU Int,114(4): 532-540","Norway",2014,"Recurrent","HIFU","ICSQ,IPSS,IIEF-5,EORTC QLQ-C30","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Symptom,Complication,General"]
[35,"Bacon, C. G., et al. (2001). \"The impact of cancer treatment on quality of life outcomes for patients with localized prostate cancer.\" J Urol 166(5): 1804-1810.",null,"Bacon, C. G., et al.","The impact of cancer treatment on quality of life outcomes for patients with localized prostate cancer","PURPOSE: We evaluated the impact of localized prostate cancer treatment on general, cancer specific and symptom domains of quality of life for up to 5 years after diagnosis. MATERIALS AND METHODS: A total of 842 men from the Health Professionals Followup Study, diagnosed between 1993 and 1998, were included in cross-sectional analyses of quality of life associated with prostate cancer treatment. A subset of 146 men diagnosed after 1995 were followed prospectively. Quality of life was assessed with the Medical Outcomes Study Short-Form 36 Health Status Survey, Cancer Rehabilitation Evaluation System Short Form and University of California Los Angeles Prostate Cancer Index by mailed questionnaires. Primary treatment modality was taken from medical records and patient self-report. RESULTS: Significant treatment differences were observed in all quality of life measures, with the largest occurring in sexual, urinary and bowel symptoms. Bowel function was significantly worse in patients who received external radiation and brachytherapy compared with prostatectomy (p <0.05). Although they had better or equivalent urinary and sexual function (p <0.05), patients treated with external radiation, hormones or watchful waiting had lower generic quality of life scores in multiple domains compared with those who underwent prostatectomy. Patients who had brachytherapy had similar generic quality of life outcomes compared with prostatectomy in all domains. CONCLUSIONS: Our findings suggest that important differences in quality of life go beyond known physical symptoms associated with various prostate cancer treatment options, many of which involve making a trade-off. It is important for patients with prostate cancer and health care providers to consider these differences while making treatment decisions.","J Urol, 166(5): 1804-1810","USA",2001,"Local","Radiotherapy,Surgery,Hormonal,Surveillance,Brachytherapy","SF-36,CARES-SF,UCLA-PCI","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Disease,Utility,Treatment"]
[36,"Bacon, C. G., et al. (2002). \"The association of treatment-related symptoms with quality-of-life outcomes for localized prostate carcinoma patients.\" Cancer 94(3): 862-871.",null,"Bacon, C. G., et al.","The association of treatment-related symptoms with quality-of-life outcomes for localized prostate carcinoma patients","BACKGROUND: Most studies of treatment outcomes in men with localized prostate carcinoma have emphasized sexual, urinary, and bowel symptoms with the assumption that they have an impact on quality of life. However, very few studies have directly examined and compared the impact of these symptoms on overall and cancer specific quality of life. METHODS: The authors examined 783 incident cases of localized prostate carcinoma, diagnosed from 1993 to 1998, and 1928 age-matched healthy controls from the Health Professionals Follow-Up Study cohort. Information on frequency of ejaculation and urinary symptoms were collected before cancer diagnosis. After cancer diagnosis, the authors mailed a questionnaire including the Medical Outcomes Study Short Form-36 Health Status Survey (SF-36), the Cancer Rehabilitation Evaluation System-Short Form (CARES-SF), and the University of California at Los Angeles Prostate Cancer Index in 1998. RESULTS: Cases had slightly lower scores on most of the SF-36 scales and reported much more bother from sexual, urinary, and bowel symptoms compared with healthy controls. Among prostate carcinoma patients, bowel symptoms had the greatest negative impact on quality of life, followed by sexual and urinary symptoms. As expected, treatment-related symptoms were associated with the physical domains of quality of life, but psychosocial domains were just as strongly affected. CONCLUSIONS: Patients and health care providers need to consider the potential mental quality-of-life impacts associated with prostate carcinoma treatment symptoms when making treatment decisions. Even after patients have completed cancer treatment, significant health impairments may remain. Health care providers should continue to address the mental and physical well-being of prostate carcinoma patients in follow-up care.","Cancer, 94(3): 862-871","USA",2002,"Local","Unclear","SF-36,CARES-SF,UCLA-PCI","Patient",null,"Case-control",null,null,null,null,null,null,null,null,"Disease,Treatment,Utility"]
[37,"Badalament, R. A., et al. (1999). \"Patient-reported complications after cryoablation therapy for prostate cancer.\" Urology 54(2): 295-300.",null,"Badalament, R. A., et al.","Patient-reported complications after cryoablation therapy for prostate cancer","OBJECTIVES: To define the patient-reported complications after cryoablation therapy for prostate cancer and to compare these results to previously published patient-reported complications for radical prostatectomy and external beam irradiation. METHODS: A questionnaire similar to previously published patient-reported complication studies was sent to the first 290 patients treated by cryoablation therapy at our institution. The questionnaire was returned by 267 patients. Forty-four patients were excluded from analysis because of prior irradiation, transurethral prostatectomy, or cryoablation, resulting in a study group of 223 patients. RESULTS: Of the 208 patients with good urinary control preoperatively, 9 (4.3%) patients used incontinence pads after cryoablation. Seven of the 8 patients who used one pad daily reported leakage of only a few drops. Impotency, defined as an inability to obtain erections adequate for vaginal penetration, occurred in 85% of men who were potent preoperatively. Urethrorectal fistula occurred in 1 patient (0.4%). Bladder outlet obstruction caused by stricture or sloughed necrotic prostatic tissue required dilation or transurethral resection in 10% of patients. Scrotal swelling, penile tingling, and pelvic pain occurred in 18%, 15%, and 12% of patients, respectively; typically, these resolved spontaneously within 3 months. CONCLUSIONS: Patient-reported complications for cryoablation compared favorably to those reported for radical prostatectomy and external beam irradiation. Patient satisfaction was high; 96% of patients reported that they would choose cryosurgery as a treatment option again.","Urology, 54(2): 295-300","USA",1999,"Any or unknown","Various","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Complication,Satisfaction"]
[38,"Badalament, R. A., et al. (2000). \"Patient-reported complications after cryoablation therapy for prostate cancer.\" Arch Ital Urol Androl 72(4): 305-312.",null,"Badalament, R. A., et al.","Patient-reported complications after cryoablation therapy for prostate cancer","To define the patient-reported complications after cryoablation therapy for prostate cancer and to compare these results to previously published patient-reported complications for radical prostatectomy and external beam irradiation. A questionnaire similar to previously published patient-reported complication studies was sent to the first 290 patients treated by cryoablation therapy at our Institution. The questionnaire was returned by 267 patients. Forty-four patients were excluded from analysis because of prior irradiation, transurethral prostatectomy, or cryoablation, resulting in a study group of 223 patients. Of the 208 patients with good urinary control preoperatively, 9 (4.3%) patients used incontinence pads after cryoablation. Seven of the 8 patients who used one pad daily reported leakage of only a few drops. Impotency, defined as an inability to obtain erections adequate for vaginal penetration, occurred in 85% of men who were potent preoperatively. Urethrorectal fistula occurred in 1 patient (0.4%). Bladder outlet obstruction caused by stricture of sloughed necrotic prostatic tissue required dilation or transurethral resection in 10% of patients. Scrotal swelling, penile tingling, and pelvic pain occurred in 18, 15, and 12% of patients, respectively; typically, these resolved spontaneously within 3 months. Patient-reported complications for cryoblation compared favorably to those reported for radical prostatectomy and external beam irradiation. Patient satisfaction was high; 96% of patients reported that they would choose cryosurgery as a treatment option again.","Arch Ital Urol Androl, 72(4): 305-312","USA",2000,"Any or unknown","Various","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Complication,Satisfaction"]
[39,"Bahl, A., et al. (2015). \"Final quality of life and safety data for patients with metastatic castration-resistant prostate cancer treated with cabazitaxel in the UK Early Access Programme (EAP) (NCT01254279).\" BJU Int 116(6): 880-887.",null,"Bahl, A., et al.","Final quality of life and safety data for patients with metastatic castration-resistant prostate cancer treated with cabazitaxel in the UK Early Access Programme (EAP) (NCT01254279)","OBJECTIVE: To compile the safety profile and quality of life (QoL) data for patients with metastatic castration-resistant prostate cancer (mCRPC) treated with cabazitaxel in the UK Early Access Programme (UK EAP). PATIENTS AND METHODS: A total of 112 patients participated at 12 UK cancer centres. All had mCRPC with disease progression during or after docetaxel. Patients received cabazitaxel 25 mg/m(2) every 3 weeks with prednisolone 10 mg daily for up to 10 cycles. Safety assessments were performed before each cycle and QoL was recorded at alternate cycles using the EQ-5D-3L questionnaire and visual analogue scale (VAS). The safety profile was compiled after completion of the UK EAP and QoL measures were analysed to record trends. No formal statistical analysis was carried out. RESULTS: The incidences of neutropenic sepsis (6.3%), grade 3 and 4 diarrhoea (4.5%) and grade 3 and 4 cardiac toxicity (0%) were low. Neutropenic sepsis episodes, though low, occurred only in patients who did not receive prophylactic granulocyte-colony stimulating factor. There were trends towards improved VAS and EQ-5D-3L pain scores during treatment. CONCLUSIONS: The UK EAP experience indicates that cabazitaxel might improve QoL in mCRPC and represents an advance and a useful addition to the armamentarium of treatment for patients whose disease has progressed during or after docetaxel. In view of the potential toxicity, careful patient selection is important.","BJU Int, 116(6): 880-887","UK",2015,"Metastatic","Taxane","EQ-5D,VAS","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Utility"]
[40,"Bales, G. T. and G. W. Chodak (1996). \"A controlled trial of bicalutamide versus castration in patients with advanced prostate cancer.\" Urology 47(1A Suppl): 38-43; discussion 48-53.",null,"Bales, G. T. and G. W. Chodak","A controlled trial of bicalutamide versus castration in patients with advanced prostate cancer","OBJECTIVES: Bicalutamide is a new, potent antiandrogen with potential efficacy in the treatment of men with advanced prostate cancer. Although no pure antiandrogen has been well studied versus castration, potentially fewer adverse effects could occur, making such an agent a potentially useful alternative therapy. To date, three randomized controlled trials have been performed comparing these two treatments. In preliminary studies, a dose of 50 mg bicalutamide per day was selected for these trials. In two of the studies (0302, 0303), this drug was compared to either medical or surgical castration, the latter choice being made by the patient. In the third study (0301), bicalutamide was compared to bilateral orchiectomy. METHODS: Using an intention-to-treat format, the outcomes assessed were time-to-treatment failure, time-to-objective disease progression, subjective response, and survival time in men with previously untreated metastatic disease. The incidence of breast tenderness, gynecomastia, and hot flushes was also determined in both treatment arms. A quality-of-life questionnaire was administered on multiple occasions after initiation of therapy. RESULTS: Based on an analysis of > 1000 patients, the objective and subjective results favored castration over bicalutamide (50 mg/day). The hazard ratios for time-to-treatment failure (1.59), time-to-disease progression (1.62), and median survival (1.44) were all significantly greater in the castration group (P > 0.001). Another difference noted at 3 months was a significantly lower median fall in prostate-specific antigen values in the bicalutamide group (86-88% versus 96-97%). Symptomatic patients receiving bicalutamide were only 0.43 times as likely to have subjective improvement as the patients treated by castration. A comparison of pharmacologic effects showed that only the incidence of hot flushes was lower in the bicalutamide group, whereas breast tenderness and gynecomastia were more common. This difference in hot flushes, however, translated into better quality of life during the first several months with regard to sexual relations and sexual functioning. CONCLUSIONS: Bicalutamide monotherapy at 50 mg/day appears inferior to castration in overall objective and subjective response rates. Whether higher doses of bicalutamide can compete more favorably will need to be tested in further clinical trials.","Urology, 47(1A Suppl): 38-43; discussion 48-53","USA",1996,"Metastatic","Surgery,Hormonal","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General"]
[41,"Ball, A. J., et al. (2006). \"Prospective longitudinal comparative study of early health-related quality-of-life outcomes in patients undergoing surgical treatment for localized prostate cancer: a short-term evaluation of five approaches from a single institution.\" J Endourol 20(10): 723-731.",null,"Ball, A. J., et al.","Prospective longitudinal comparative study of early health-related quality-of-life outcomes in patients undergoing surgical treatment for localized prostate cancer: a short-term evaluation of five approaches from a single institution","BACKGROUND AND PURPOSE: Quality of life (QoL) issues are a vital concern for the majority of patients seeking therapeutic intervention once they are found to have prostate cancer. A prospective longitudinal comparison using validated QoL instruments is a valuable technique to evaluate outcome differences. We evaluated the short-term QoL changes from baseline of five surgical approaches for localized prostate carcinoma delivered at a single institution. PATIENTS AND METHODS: A prospective longitudinal survey of 719 patients with newly diagnosed prostate cancer was initiated in 2001. The surgical procedures performed during this time period were open radical prostatectomy (ORP), laparoscopic radical prostatectomy (LRP), da Vinci robotic prostatectomy (dVP), (103)Pd brachytherapy ((103)Pd), and prostate cryoablation (PCryo). An Institutional Review Board-approved questionnaire comprised of validated QoL instruments (UCLA Prostate Cancer Index and American Urological Association Symptom Index [SI]) was mailed to enrolled patients prior to their selected surgery and again at 1, 3, 6, 9, 12, 18, 24, and 36 months after therapy. A percent of baseline score calculation including data from all five treatment cohorts for follow-up months 1, 3, and 6 was compared within groups. Group I consisted of patients undergoing ORP, LRP, or dVP. Group II consisted of patients undergoing (103)Pd or PCryo. RESULTS: Between January 2000 and April 2005, 498 patients (69%) were enrolled who completed the baseline questionnaire and at least one follow-up survey at 1, 3, or 6 months. The mean patient age at ORP, LRP, dVP, (103)Pd, and PCryo was 59, 61, 60, 67, and 72 years, respectively. Within Group I, early recovery of sexual function (at 3 months) appeared to occur sooner after dVP (35% return to baseline [RTB]) than ORP (24% RTB) and LRP (21% RTB) (P = 0.03). No other significant differences were noted, and trends toward improvement were seen in all groups. Within Group II, PCryo (18% RTB) had a more negative impact on sexual function at 3 months than did 103Pd (63% RTB) (P = 0.007), although a significant difference in baseline sexual function was also noted (P = 0.001). Early urinary function (at 1 month) was better after (103)Pd (82% RTB) than PCryo (72%) (P = 0.05), but this difference was lost at 6 months. In addition, the irritative and obstructive symptoms evaluated by the AUA SI were significantly worse (P = 0.003) at 3 months after (103)Pd than after PCryo. CONCLUSIONS: Different surgical approaches for the treatment of localized prostate cancer affect the shortterm QoL results in different ways. Urinary, sexual, and bowel function and bother are affected to a similar degree by ORP, LRP, and dVP. In an older population, the tissue destruction resulting from PCryo appears to relieve obstructive and irritative urinary symptoms but at the sacrifice of sexual function compared with (103)Pd.","J Endourol, 20(10): 723-731","USA",2006,"Local","Various,Brachytherapy,Surgery","UCLA-PCI,AUA-SI","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease,Symptom"]
[42,"Barkati, M., et al. (2012). \"High-dose-rate brachytherapy as a monotherapy for favorable-risk prostate cancer: a Phase II trial.\" Int J Radiat Oncol Biol Phys 82(5): 1889-1896.",null,"Barkati, M., et al.","High-dose-rate brachytherapy as a monotherapy for favorable-risk prostate cancer: a Phase II trial","PURPOSE: There are multiple treatment options for favorable-risk prostate cancer. High-dose-rate (HDR) brachytherapy as a monotherapy is appealing, but its use is still investigational. A Phase II trial was undertaken to explore the value of such treatment in low-to-intermediate risk prostate cancer. METHODS AND MATERIALS: This was a single-institution, prospective study. Eligible patients had low-risk prostate cancer features but also Gleason scores of 7 (51% of patients) and stage T2b to T2c cancer. Treatment with HDR brachytherapy with a single implant was administered over 2 days. One of four fractionation schedules was used in a dose escalation study design: 3 fractions of 10, 10.5, 11, or 11.5 Gy. Patients were assessed with the Common Terminology Criteria for Adverse Events version 2.0 for urinary toxicity, the Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer scoring schema for rectal toxicity, and the Expanded Prostate Cancer Index Composite (EPIC) questionnaire to measure patient-reported health-related quality of life. Biochemical failure was defined as a prostate-specific antigen (PSA) nadir plus 2 ng/ml. RESULTS: Between 2003 and 2008, 79 patients were enrolled. With a median follow-up of 39.5 months, biochemical relapse occurred in 7 patients. Three- and 5-year actuarial biochemical control rates were 88.4% (95% confidence interval [CI], 78.0-96.2%) and 85.1% (95% CI, 72.5-94.5%), respectively. Acute grade 3 urinary toxicity was seen in only 1 patient. There was no instance of acute grade 3 rectal toxicity. Rates of late grade 3 rectal toxicity, dysuria, hematuria, urinary retention, and urinary incontinence were 0%, 10.3%, 1.3%, 9.0%, and 0%, respectively. No grade 4 or greater toxicity was recorded. Among the four (urinary, bowel, sexual, and hormonal) domains assessed with the EPIC questionnaire, only the sexual domain did not recover with time. CONCLUSIONS: HDR brachytherapy as a monotherapy for favorable-risk prostate cancer, administered using a single implant over 2 days, is feasible and has acceptable acute and late toxicities. Further follow-up is still required to better evaluate the efficacy of such treatment.","Int J Radiat Oncol Biol Phys, 82(5): 1889-1896","Australia",2012,"Local","Brachytherapy","EPIC,CTCAE,RTOG-EORTC-SS","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,Treatment"]
[43,"Basaria, S., et al. (2002). \"Long-term effects of androgen deprivation therapy in prostate cancer patients.\" Clin Endocrinol (Oxf) 56(6): 779-786.",null,"Basaria, S., et al.","Long-term effects of androgen deprivation therapy in prostate cancer patients","BACKGROUND: Prostate cancer (PCa) is one of the most common cancers in men and has an increasing incidence. In 1999, 37 000 men died from PCa in the USA. Androgen deprivation therapy (ADT) with GnRH agonists is frequently employed in the treatment of recurrent and metastatic PCa by inducing medical castration, rendering these men hypogonadal. Because hypogonadism in men is associated with a wide range of complications, we attempted to determine the effects of long-term ADT in men with PCa. METHODS: We conducted a cross-sectional study at a tertiary care centre to determine the effect of ADT on lean body mass (LBM), muscle strength, bone mineral density (BMD), sexual function, and quality of life (QOL) in men with PCa. Three groups of men were enrolled: (1) 20 men with PCa who were undergoing medical castration with GnRH agonists for at least 12 months prior to the onset of the study (ADT group); (2) 18 age-matched men with nonmetastatic PCa who were post prostatectomy and/or radiotherapy but had not yet undergone ADT (non-ADT group); and (3) 20 age-matched normal men who were healthy and ambulatory (control group). RESULTS: Men on ADT had castrate levels of serum total testosterone (P < 0.0001), free testosterone (P < 0.0001) and oestradiol (P < 0.0001), which were significantly lower than in the other groups. Total body (P = 0.03) and lumbar spine (P < 0.0001) BMD was significantly lower in patients on ADT compared to other groups and was associated with higher levels of urinary N-telopeptide (P = 0.02). The ADT group had higher fat mass compared to the other groups (P = 0.0001) and significantly reduced upper body strength (P = 0.001) when compared to non-ADT patients. The ADT group had lower overall scores on Watt's Sexual Function Questionnaire compared to other groups (P = 0.0001), in particular a decrease in desire, arousal and frequency of spontaneous early morning erections. The ADT group also had lower overall QOL scores, resulting in significant limitation of physical function (P = 0.001), role limitation (P = 0.02) and perception of physical health (P = 0.004). CONCLUSIONS: This study suggests that osteoporosis, unfavourable body composition, sexual dysfunction and reduced quality of life are seen in patients receiving androgen deprivation therapy for at least 12 months. Longitudinal studies in this patient population will shed further light on the timing of the development and the extent of these complications. Meanwhile, this information will assist both physicians and patients with prostate cancer to make informed decisions regarding androgen deprivation therapy.","Clin Endocrinol (Oxf), 56(6): 779-786","USA",2002,"Local,Advanced","Hormonal","WSFQ","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Complication"]
[44,"Basch, E., et al. (2013). \"Abiraterone acetate plus prednisone versus prednisone alone in chemotherapy-naive men with metastatic castration-resistant prostate cancer: patient-reported outcome results of a randomised phase 3 trial.\" Lancet Oncol 14(12): 1193-1199.",null,"Basch, E., et al.","Abiraterone acetate plus prednisone versus prednisone alone in chemotherapy-naive men with metastatic castration-resistant prostate cancer: patient-reported outcome results of a randomised phase 3 trial","BACKGROUND: Abiraterone acetate plus prednisone significantly improves radiographic progression-free survival in asymptomatic or mildly symptomatic, chemotherapy-naive patients with metastatic castration-resistant prostate cancer compared with prednisone alone. We describe analyses of data for patient-reported pain and functional status in a preplanned interim analysis of a phase 3 trial. METHODS: Between April 28, 2009, and June 23, 2010, patients with progressive, metastatic castration-resistant prostate cancer were enrolled into a multinational, double-blind, placebo-controlled trial. Patients were eligible if they were asymptomatic (score of 0 or 1 on item three of the Brief Pain Inventory Short Form [BPI-SF] questionnaire) or mildly symptomatic (score of 2 or 3) and had not previously received chemotherapy. Patients were randomly assigned (1:1) to receive oral abiraterone (1 g daily) plus prednisone (5 mg twice daily) or placebo plus prednisone in continuous 4-week cycles. Pain was assessed with the BPI-SF questionnaire, and health-related quality of life (HRQoL) with the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire. We analysed data with prespecified criteria for clinically meaningful pain progression and deterioration in HRQoL. All patients who underwent randomisation were included in analyses. FINDINGS: 1088 patients underwent randomisation: 546 were assigned to abiraterone plus prednisone and 542 to placebo plus prednisone. At the time of the second prespecified interim analysis, median follow-up was 22.2 months (IQR 20.2-24.8). Median time to progression of mean pain intensity was longer in patients assigned to abiraterone plus prednisone (26.7 months [95% CI 19.3-not estimable]) than in those assigned to placebo plus prednisone (18.4 months [14.9-not estimable]; hazard ratio [HR] 0.82, 95% CI 0.67-1.00; p=0.0490), as was median time to progression of pain interference with daily activities (10.3 months [95% CI 9.3-13.0] vs 7.4 months [6.4-8.6]; HR 0.79, 95% CI 0.67-0.93; p=0.005). Median time to progression of worst pain was also longer with abiraterone plus prednisone (26.7 months [95% CI 19.4-not estimable]) than with placebo plus prednisone (19.4 months [16.6-not estimable]), but the difference was not significant (HR 0.85, 95% CI 0.69-1.04; p=0.109). Median time to HRQoL deterioration was longer in patients assigned to abiraterone plus prednisone than in those assigned to placebo plus prednisone as assessed by the FACT-P total score (12.7 months [95% CI 11.1-14.0] vs 8.3 months [7.4-10.6]; HR 0.78, 95% CI 0.66-0.92; p=0.003) and by the score on its prostate-cancer-specific subscale (11.1 months [8.6-13.8] vs 5.8 months [5.5-8.3]; HR 0.70, 95% CI 0.60-0.83; p<0.0001). INTERPRETATION: Abiraterone plus prednisone delays patient-reported pain progression and HRQoL deterioration in chemotherapy-naive patients with metastatic castration-resistant prostate cancer. These results provide further support for the efficacy of abiraterone in this population.","Lancet Oncol, 14(12): 1193-1199","USA",2013,"Metastatic","Abiraterone","BPI,FACT-P","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,Symptom"]
[45,"Basu, A., et al. (2010). \"A time tradeoff method for eliciting partner's quality of life due to patient's health states in prostate cancer.\" Med Decis Making 30(3): 355-365.",null,"Basu, A., et al.","A time tradeoff method for eliciting partner's quality of life due to patient's health states in prostate cancer","BACKGROUND: Cost-effectiveness analyses may better reflect the full costs and benefits of medical interventions if they incorporate the effects of patients' health on their family members. OBJECTIVE: To develop and apply a time tradeoff (TTO) technique to measure the impact of potential prostate cancer-related health states of the patients on the quality of life (QOL) of their partners. METHODS: We developed modified TTO questions and applied them in a pilot study in which we asked the partner of the patient to tradeoff his or her own life in order to reduce the burden that he himself or she herself expects to experience if the patient developed one of the prostate cancer-related health states. We reviewed the theoretical justification for this question and carefully framed the question so as to reduce measurement error and also to avoid possible double counting with the effect on the partner's health. RESULTS: We collected data from 26 partners about their preferences for their own health, which is influenced by the patient's health condition. The mean QOL weights for the partners when the patients are the following states are healthy, 0.81; impotent, 0.66; incontinent, 0.68; have metastatic disease, 0.50; and dead, 0.28. Partners' responses varied by how close they felt to the patients. Low correlations between partners' and patients' QOL ratings (n = 15) suggest that the partners were not responding as proxies for the patient. CONCLUSIONS: A new TTO method is proposed to measure a partner's QOL due to a patient's health. Preliminary test results of validity were promising.","Med Decis Making, 30(3): 355-365","USA",2010,"Any or unknown","None","TTO","Caregiver",null,"Validation",null,null,null,null,null,null,null,null,"Utility"]
[46,"Bates, T. S., et al. (1998). \"Prevalence and impact of incontinence and impotence following total prostatectomy assessed anonymously by the ICS-male questionnaire.\" Eur Urol 33(2): 165-169.",null,"Bates, T. S., et al.","Prevalence and impact of incontinence and impotence following total prostatectomy assessed anonymously by the ICS-male questionnaire","OBJECTIVES: The aim of this study was to assess the incidence of incontinence and impotence in patients following total prostatectomy and assess the impact their symptoms have on their quality of life. PATIENTS AND METHODS: Between 1987 and 1994, one surgeon performed retropubic total prostatectomies on 89 patients, of which 87 were available for follow-up. All patients were sent an ICS-male questionnaire. Patients' ages ranged from 49 to 73 years (median 65). The interval between surgery and completing the questionnaire ranged from 7 to 87 months (median 22). RESULTS: The response rate was 95%. No patients reported incontinence pre-operatively. Postoperatively, 69% (57/83) of patients suffered to some degree of leakage of urine and 24% (29/83) used pads. Of these, 60% used 1 pad per day, 15% 2 pads and 25% (5 patients) used 3 or more. Nocturnal incontinence was reported by 20% of patients. Urinary incontinence was considered a problem in only 34% (28/83) of patients. Sixty-five percent of patients using pads considered urinary leakage to be a problem, but only 1 considered it a serious problem. 89% claimed to have been potent prior to surgery. The overall postoperative potency rate was 41% (30/74) in those potent pre-operatively. However, 67% of patients reporting potency had severely reduced rigidity, and only 12% (9/74) achieved what they considered full erections. Ten percent of all patients considered postoperative impotence to be a serious problem, and 47% stated that it was not a problem at all. CONCLUSIONS: The incidence of incontinence and impotence following total prostatectomy is higher than earlier reports suggest, but the impact of these complications appears to be surprisingly low. These results allow patients to be given realistic expectations when counselled prior to this operation.","Eur Urol, 33(2): 165-169","UK",1998,"Any or unknown","Surgery","ICSQ","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Complication"]
[47,"Batista-Miranda, J. E., et al. (2003). \"Quality of life in prostate cancer patients and controls: psychometric validation of the FACTP-4 in Spanish, and relation to urinary symptoms.\" Arch Esp Urol 56(4): 447-454.",null,"Batista-Miranda, J. E., et al.","Quality of life in prostate cancer patients and controls: psychometric validation of the FACTP-4 in Spanish, and relation to urinary symptoms","OBJECTIVES: To assess the feasibility and a validity of the Spanish version of the FACT-P and its relation to urinary symptoms. METHODS: The Spanish version of the FACT-P was self-administered to 60 Prostate Cancer patients (pts) waiting to undergo radical treatment and 20 age-matched controls (con) with a negative biopsy. Clinical stage for patients was T1c in 34 and T2 in 26. FACT-P was analysed for internal consistency (Chronbach's a) and relation to symptom scales (IPSS, IPSS bother score and incontinence questionnaire (ICI-SF)). RESULTS: Feasibility (evaluable questionnaires) was 80.9 for con and 95% for pts. Internal consistency was high for all sub-scales (alpha > 0.7). Emotional well-being subscale and IPSS were significantly higher in pts. (worse emotional wellbeing and more lower urinary tract symptoms). There were no statistically significant differences between pts and con. in any of the other FACT-P sub-scores nor in symptom scores. Correlations were found between some FACT-P sub-scores and bother score. CONCLUSIONS: The Spanish version of the FACTP is feasible and psychometrically valid. Pts undergoing treatment for localized disease have similar QoL that a control group, but higher scores for emotional distress and IPSS.","Arch Esp Urol, 56(4): 447-454","Spain",2003,"Any or unknown","Surgery","FACT-P,IPSS,ICI-SF","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Complication,Utility,Symptom"]
[48,"Bauer, R. M., et al. (2017). \"36-month data for the AdVance XP((R)) male sling: results of a prospective multicentre study.\" BJU Int 119(4): 626-630.",null,"Bauer, R. M., et al.","36-month data for the AdVance XP((R)) male sling: results of a prospective multicentre study","OBJECTIVES: To evaluate the efficacy and safety of the AdVance XP((R)) sling (Boston Scientific, formerly American Medical Systems) in male stress urinary incontinence (SUI) after radical prostatectomy in a prospective multicentre study, as in recent years several studies have shown the effectiveness and safety of the AdVance sling for treating male SUI and in 2010 the second-generation AdVance XP was introduced with several changes in the sling design and a new needle shape. PATIENTS AND METHODS: In all, 115 patients were included. Patients with nocturnal UI, previous UI surgery, previous radiotherapy and a coaptive zone of <1 cm in the preoperative repositioning test were excluded. Postoperatively, a standardised 24-h pad test, quality-of-life scores [International Quality of Life score (IQOL) and International Consultation on Incontinence Questionnaire short form (ICIQ-UI SF)], visual analogue scale (VAS) for pain, five-item version of the International Index of Erectile Function (IIEF-5), International Prostate Symptom Score (IPSS) and Patient Global Impression of Improvement (PGI-I) score, were performed. All patients with a 0-5 g pad test were defined as cured and improved with a reduction of urine loss of >50%. All others were classified as failures. Significance analysis was performed using the Wilcoxon test. RESULTS: The mean (median) preoperative urine loss in the 24-h pad test was 272.0 (272.0) g. After a follow-up of 3 months (114 patients), 64.9% of the patients were cured and 31.6% had an improved continence status. The mean urine loss decreased significantly to 34.9 g (P < 0.001), with a mean VAS score of 0.5, and mean PGI-I of 1.5. After a follow-up of 24 months (80 patients), 68.8% of the patients were cured and 22.5% had improved. The mean urine loss decreased significantly to 19.1 g (P < 0.001), with a mean VAS score of 0.3, and mean PGI-I of 1.5. After a follow-up of 36 months (47 patients), 66.0% of the patients were cured and 23.4% had improved. The mean urine loss decreased significantly to 21.8 g (P < 0.001), with a mean VAS score of 0.0, and mean PGI-I of 1.6. The mean IQOL and ICIQ-UI SF improved significantly (both P < 0.001) after 36 months. There were no significant postoperative changes in IIEF-5 and IPSS. No intraoperative and no long-term complications occurred. No erosion or explanations occurred. CONCLUSION: The AdVance XP shows good and stable effectiveness and low complication rates even at a mid-term follow-up of up to 36 months.","BJU Int, 119(4): 626-630","Germany",2017,"Any or unknown","Surgery","IQOL,ICIQ,VAS,IPSS,IIEF-5,PGI-I","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Symptom,Complication,Treatment,General"]
[49,"Beard, C. J., et al. (1997). \"Complications after treatment with external-beam irradiation in early-stage prostate cancer patients: a prospective multiinstitutional outcomes study.\" J Clin Oncol 15(1): 223-229.",null,"Beard, C. J., et al.","Complications after treatment with external-beam irradiation in early-stage prostate cancer patients: a prospective multiinstitutional outcomes study","PURPOSE: To use data from a prospective quality-of-life study to assess differences in disease-specific and general health-related quality-of-life changes after treatment with different external-beam irradiation techniques for prostate cancer. PATIENTS AND METHODS: Patients were divided into three groups based on their pretreatment field size and planning technique: whole pelvis, small field, or conformal. Measures of bowel, urinary, and sexual function and of global health-related quality-of-life parameters (from the Health Survey Short Form [SF-36] and the Profile of Mood States [POMS]) were obtained from self-report questionnaires completed before initiation of therapy and at 3 and 12 months after therapy. RESULTS: Irritative gastrointestinal and genitourinary side effects were frequent 3 months after treatment, but were substantially improved at 12 months. Sexual dysfunction increased steadily over the study period. The POMS and the SF-36 did not demonstrate significant changes over time. Despite small patient numbers, we found trends in favor of conformal therapy across several symptom measures, including sexual function. In the fatigue, energy, and vigor subscales, patients who received whole-pelvis treatment fared significantly worse than those in the other two groups. CONCLUSION: Prospective, detailed data from a feasibility study allowed us to assess the effect of technique on quality of life following external-beam irradiation. Although limited by the small planned sample size, these results suggest that smaller radiation fields limit treatment-related complications, including, unexpectedly, sexual dysfunction. However, confirmation in a larger study is necessary.","J Clin Oncol, 15(1): 223-229","USA",1997,"Local","Radiotherapy","SF-36,POMS","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Utility,Comorbidity"]
[50,"Beckendorf, V., et al. (2011). \"70 Gy versus 80 Gy in localized prostate cancer: 5-year results of GETUG 06 randomized trial.\" Int J Radiat Oncol Biol Phys 80(4): 1056-1063.",null,"Beckendorf, V., et al.","70 Gy versus 80 Gy in localized prostate cancer: 5-year results of GETUG 06 randomized trial","PURPOSE: To perform a randomized trial comparing 70 and 80 Gy radiotherapy for prostate cancer. PATIENTS AND METHODS: A total of 306 patients with localized prostate cancer were randomized. No androgen deprivation was allowed. The primary endpoint was biochemical relapse according to the modified 1997-American Society for Therapeutic Radiology and Oncology and Phoenix definitions. Toxicity was graded using the Radiation Therapy Oncology Group 1991 criteria and the late effects on normal tissues-subjective, objective, management, analytic scales (LENT-SOMA) scales. The patients' quality of life was scored using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item cancer-specific and 25-item prostate-specific modules. RESULTS: The median follow-up was 61 months. According to the 1997-American Society for Therapeutic Radiology and Oncology definition, the 5-year biochemical relapse rate was 39% and 28% in the 70- and 80-Gy arms, respectively (p = .036). Using the Phoenix definition, the 5-year biochemical relapse rate was 32% and 23.5%, respectively (p = .09). The subgroup analysis showed a better biochemical outcome for the higher dose group with an initial prostate-specific antigen level >15 ng/mL. At the last follow-up date, 26 patients had died, 10 of their disease and none of toxicity, with no differences between the two arms. According to the Radiation Therapy Oncology Group scale, the Grade 2 or greater rectal toxicity rate was 14% and 19.5% for the 70- and 80-Gy arms (p = .22), respectively. The Grade 2 or greater urinary toxicity was 10% at 70 Gy and 17.5% at 80 Gy (p = .046). Similar results were observed using the LENT-SOMA scale. Bladder toxicity was more frequent at 80 Gy than at 70 Gy (p = .039). The quality-of-life questionnaire results before and 5 years after treatment were available for 103 patients with no differences found between the 70- and 80-Gy arms. CONCLUSION: High-dose radiotherapy provided a better 5-year biochemical outcome with slightly greater toxicity.","Int J Radiat Oncol Biol Phys, 80(4): 1056-1063","France",2011,"Local","Radiotherapy","EORTC QLQ-C30, EORTC QLQ-PR25,LENT-SOMA,RTOG-EORTC-SS","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,General,Treatment"]
[51,"Beer, T. M., et al. (2004). \"Quality of life and pain relief during treatment with calcitriol and docetaxel in symptomatic metastatic androgen-independent prostate carcinoma.\" Cancer 100(4): 758-763.",null,"Beer, T. M., et al.","Quality of life and pain relief during treatment with calcitriol and docetaxel in symptomatic metastatic androgen-independent prostate carcinoma","BACKGROUND: The current study evaluated the analgesic activity and impact on quality of life (QOL) of a new chemotherapy regimen of calcitriol and docetaxel in men with androgen-independent prostate carcinoma. METHODS: Analgesic response was defined as a 2-point reduction on the Present Pain Intensity (PPI) scale (or compete relief if baseline PPI was 1) without an increase in analgesic use or a 50% decrease in analgesic medication use without an increase in pain, maintained for > or = 4 weeks. Pain, pain medication consumption, and QOL (measured by the European Organization for Research and Treatment of Cancer QLQ-C30) were evaluated every 4 weeks. RESULTS: Treatment resulted in an analgesic response in 14 of 29 evaluable patients (48%; 95% confidence interval [95% CI], 30-67%). The median time to symptomatic progression in the 14 patients who met criteria for analgesic response was 41 weeks (95% CI, 26-56 weeks). Worsening in physical and role functioning, fatigue, appetite, and global health status and improvement in constipation were detected using the QLQ-C30 QOL questionnaire. CONCLUSIONS: Significant analgesic activity was demonstrated, although worsening in several QOL domains was observed in a patient population with relatively low pain intensity (median PPI, 2).","Cancer, 100(4): 758-763","USA",2004,"Metastatic","Chemotherapy","MPQ,EORTC QLQ-C30","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General,Symptom"]
[52,"Befort, C. A., et al. (2005). \"A measure of health-related quality of life among patients with localized prostate cancer: results from ongoing scale development.\" Clin Prostate Cancer 4(2): 100-108.",null,"Befort, C. A., et al.","A measure of health-related quality of life among patients with localized prostate cancer: results from ongoing scale development","BACKGROUND: We revised our prostate cancer-specific measure to better address the physiologic complications of the 3 major therapies for clinically localized prostate cancer and to assess the impact of symptoms on broader aspects of patient functioning. The study used a cross-sectional design, and participants completed the measure in a clinical setting. PATIENTS AND METHODS: Participants underwent radical prostatectomy (n = 130), external beam radiation therapy (n = 120), or brachytherapy (n = 129). Their mean age was 66 years (standard deviation [SD], 8.2 years), and the median time since treatment was 12.36 months (mean, 21.7; SD, 25.4). Items were derived from previously validated instruments or developed based on the clinical experience of a multidisciplinary group of health professionals. RESULTS: The revised instrument included 46 items that formed 8 physiologic scales (2 urinary, 3 sexual, and 3 bowel function); 3 associated bother scales; and cancer worry, treatment regret, and treatment satisfaction scales. Correlations among scales provided evidence of convergent/divergent validity. Significant group differences were found using analysis of covariance (with time since treatment and age as covariates) on 6 of the 8 physiologic scales and on bowel bother and treatment satisfaction. CONCLUSION: The instrument provides a sensitive measure of physiologic differences across the 3 primary treatment groups and indicates that there are few differences across treatment groups on broader aspects of health-related quality of life. Further development of the measure is recommended.","Clin Prostate Cancer, 4(2): 100-108","USA",2005,"Local","Radiotherapy,Surgery,Brachytherapy","Unclear","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease"]
[53,"Bellardita, L., et al. (2016). \"Adaptation and validation of an Italian version of the Prostate Cancer Specific Quality of Life Instrument (PROSQOLI).\" Eur Rev Med Pharmacol Sci 20(13): 2773-2778.",null,"Bellardita, L., et al.","Adaptation and validation of an Italian version of the Prostate Cancer Specific Quality of Life Instrument (PROSQOLI)","OBJECTIVE: The Prostate Cancer Specific Quality of Life Instrument (PROSQOLI) is a measure of health-related quality of life (HRQoL) in advanced hormone-resistant prostate cancer. In this study, we aimed at performing a cross-cultural adaptation and validation of the Italian version of the PROSQOLI. PATIENTS AND METHODS: The original version of the PROSQOLI underwent several turnarounds of translations. A total of 472 patients treated with radical prostatectomy, radiotherapy or medical therapy were enrolled for the validation of the questionnaire. The PROSQOLI was administered together with the SF-12. Reliability indexes were calculated by using Cronbach alpha. To evaluate the validity of the construct, relationships between PROSQOLI and SF12 were assessed. The ANOVA test was used to evaluate the differences between groups of patients who had received different treatments. RESULTS: The reliability coefficient was 0.91. Item-to-total correlation indices were in most cases >0.70. The correlation between the scores of the PROSQOLI and those of the SF-12 questionnaire was high (r=0.8139, p<0.0001). The ANOVA test showed significant differences between groups (p<0.01) based on age, recurrence risk and treatment. CONCLUSIONS: The adaptation process showed that the PROSQOLI Italian version has high reliability and presents both convergent and discriminant validity. This version of the tool can be used to assess HRQoL in Italian men who underwent radical treatment for advanced prostate cancer.","Eur Rev Med Pharmacol Sci, 20(13): 2773-2778","Italy",2016,"Advanced","Radiotherapy,Surgery","PROSQoLI,SF-12","Patient",null,"Validation,Mapping to utility",null,null,null,null,null,null,null,null,"Disease,Utility"]
[54,"Ben-Josef, A. M., et al. (2017). \"Effect of Eischens Yoga During Radiation Therapy on Prostate Cancer Patient Symptoms and Quality of Life: A Randomized Phase II Trial.\" Int J Radiat Oncol Biol Phys 98(5): 1036-1044.",null,"Ben-Josef, A. M., et al.","Effect of Eischens Yoga During Radiation Therapy on Prostate Cancer Patient Symptoms and Quality of Life: A Randomized Phase II Trial","PURPOSE: A randomized phase II study was performed to measure the potential therapeutic effects of yoga on fatigue, erectile dysfunction, urinary incontinence, and overall quality of life (QOL) in prostate cancer (PCa) patients undergoing external beam radiation therapy (RT). METHODS AND MATERIALS: The participants were randomized to yoga and no-yoga cohorts (1:1). Twice-weekly yoga interventions were offered throughout the 6- to 9-week courses of RT. Comparisons of standardized assessments were performed between the 2 cohorts for the primary endpoint of fatigue and the secondary endpoints of erectile dysfunction, urinary incontinence, and QOL before, during, and after RT. RESULTS: From October 2014 to January 2016, 68 eligible PCa patients underwent informed consent and agreed to participate in the study. Of the 68 patients, 18 withdrew early, mostly because of treatment schedule-related time constraints, resulting in 22 and 28 patients in the yoga and no-yoga groups, respectively. Throughout treatment, those in the yoga arm reported less fatigue than those in the control arm, with global fatigue, effect of fatigue, and severity of fatigue subscales showing statistically significant interactions (P<.0001). The sexual health scores (International Index of Erectile Function Questionnaire) also displayed a statistically significant interaction (P=.0333). The International Prostate Symptom Score revealed a statistically significant effect of time (P<.0001) but no significant effect of treatment (P=.1022). The QOL measures had mixed results, with yoga having a significant time by treatment effect on the emotional, physical, and social scores but not on functional scores. CONCLUSIONS: A structured yoga intervention of twice-weekly classes during a course of RT was associated with a significant reduction in pre-existing and RT-related fatigue and urinary and sexual dysfunction in PCa patients.","Int J Radiat Oncol Biol Phys, 98(5): 1036-1044","USA",2017,"Any or unknown","Radiotherapy,Various","IIEF-5,IPSS","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Complication,Symptom"]
[55,"Ben-Tovim, D. I., et al. (2002). \"Coping with prostate cancer: a quantitative analysis using a new instrument, the centre for clinical excellence in urological research coping with cancer instrument.\" Urology 59(3): 383-388.",null,"Ben-Tovim, D. I., et al.","Coping with prostate cancer: a quantitative analysis using a new instrument, the centre for clinical excellence in urological research coping with cancer instrument","OBJECTIVES: To assess the reliability (internal and interrater) and validity (concurrent) of a new interview measure for assessing patients' ability to cope with cancer, the Centre for Clinical Excellence in Urological Research Coping with Cancer Instrument (CCCI), and to determine whether there is an underlying structure to the various coping strategies used by patients with prostate cancer. METHODS: Eighty patients with prostate cancer were interviewed using the CCCI. The participants also completed measures of quality of life and anxiety and depression. RESULTS: The psychometric properties of the CCCI were acceptable. Factor analysis revealed that coping with prostate cancer can be described along five dimensions: positive problem solving (fighting against the illness, seeking information); self-reliance (developing a lay explanation, distrusting doctors); emotional availability (not withdrawing from others); distress (brooding, self-pity); and solace (taking alcohol or drugs to improve mood). These coping styles were correlated with age, quality of life, self-reported prostate-specific antigen level, and measures of anxiety and depression. CONCLUSIONS: The results of the present study have led to a greater understanding of the underlying coping styles used by patients with prostate cancer. Although some of these are similar to those found in other cancer populations, others, such as self-reliance and solace, represent unique and potentially clinically significant responses to prostate cancer diagnosis and treatment. A larger scale longitudinal study is needed to determine the wider clinical implications associated with each coping style.","Urology, 59(3): 383-388","Australia",2002,"Any or unknown","None","CCCI","Patient",null,"Validation",null,null,null,null,null,null,null,null,"General"]
[56,"Berg, R. S., et al. (2009). \"Half body irradiation of patients with multiple bone metastases: a phase II trial.\" Acta Oncol 48(4): 556-561.",null,"Berg, R. S., et al.","Half body irradiation of patients with multiple bone metastases: a phase II trial","AIM OF STUDY: The primary aim of this study was to evaluate the effect of half-body irradiation (HBI) on pain and quality of life in cancer patients with multiple bone metastases. The secondary aim was to evaluate side effects of the treatment. PATIENTS AND METHODS: A total of 44 patients received lower (n = 37), upper (n = 5), or sequential HBI (n = 2). The dose for lower HBI was 8 Gy in one fraction and for upper HBI 7 Gy in one fraction, with reduction of the lung dose to 6 Gy in one fraction by partial shielding. The majority of patients (n = 41) were males with prostate cancers (93%). Outcome and side effects were measured by the EORTC Quality of Life Questionnaire C30 (QLQ-C30), and by the doctors' toxicity scores in the medical record. Pain relief was defined as a reduction of more than 10 points on the QLQ-C30 scale. Evaluations were performed before and 2, 4, 8, 16, and 24 weeks after treatment. RESULTS: Relief of pain was observed in 76% of the patients receiving HBI with 8.8% of the patients experiencing complete pain relief with no residual pain in the treated field. For most patients, the pain relief was lasting throughout the follow-up period. About one third of the patients were able to reduce their intake of analgesics. Grade 1-2 diarrhoea was the most common side effect observed in 49% of the patients two weeks after treatment. Mild pulmonary symptoms (grade 1-2) were observed in four of seven patients receiving upper HBI. No clear effect was observed on the patients' global quality of life. CONCLUSION: Single fraction HBI is safe and effective providing long lasting pain reduction in 76% of patients with multiple bone metastases.","Acta Oncol, 48(4): 556-561","Denmark",2009,"Metastatic","Radiotherapy","EORTC QLQ-C30","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General"]
[57,"Bergman, J., et al. (2010). \"Responsiveness of the University of California-Los Angeles Prostate Cancer Index.\" Urology 75(6): 1418-1423.",null,"Bergman, J., et al.","Responsiveness of the University of California-Los Angeles Prostate Cancer Index","OBJECTIVES: To determine the responsiveness of the University of California-Los Angeles Prostate Cancer Index (UCLA-PCI) by studying its sensitivity to clinically perceptible changes in health over time in men treated for localized prostate cancer. METHODS: All subjects underwent radical prostatectomy (n=253), external beam radiotherapy (n=66), or interstitial seed brachytherapy (n=73). We assessed health-related quality of life (HRQOL) outcomes using the UCLA-PCI to capture disease-specific outcomes and the Medical Outcomes Study Short Form-36 to study general HRQOL. We assessed the UCLA-PCI's responsiveness to change by comparison with the health change item of the Medical Outcomes Study Short Form-36. We measured responsiveness by calculating effect sizes and Guyatt statistics when comparing UCLA-PCI scores between baseline and 1 year and between 1 and 2 years. RESULTS: Of the 475 men who completed all baseline questionnaires, 392 (83%) completed all surveys at 12-month follow-up. Although sexual function decreased from baseline to 12 months in all groups, the magnitude of the negative change was inversely proportional to general health. For those whose general health worsened, effect sizes were >0.50 across all 6 domains. Effect sizes and Guyatt statistics were lowest (<0.25) for urinary bother, bowel function, and bowel bother in the groups demonstrating either no change or improvement in general health. Responsiveness of the UCLA-PCI in the short-term recovery period (12 months post-treatment) was better than in the chronic recovery phase (12-24 months) across almost all domains. CONCLUSIONS: The UCLA-PCI is responsive to change in assessing HRQOL in men treated for prostate cancer.","Urology, 75(6): 1418-1423","USA",2010,"Local","Radiotherapy,Surgery","SF-36,UCLA-PCI","Patient",null,"Validation,Mapping to utility",null,null,null,null,null,null,null,null,"Disease,Utility"]
[58,"Berlin, A., et al. (2015). \"Phase 2 trial of guideline-based postoperative image guided intensity modulated radiation therapy for prostate cancer: Toxicity, biochemical, and patient-reported health-related quality-of-life outcomes.\" Pract Radiat Oncol 5(5): e473-482.",null,"Berlin, A., et al.","Phase 2 trial of guideline-based postoperative image guided intensity modulated radiation therapy for prostate cancer: Toxicity, biochemical, and patient-reported health-related quality-of-life outcomes","PURPOSE: The purpose of this study was to characterize treatment-related toxicities, health-related quality of life (HRQOL), and biochemical outcomes in patients treated with postoperative image guided intensity modulated radiation therapy (IMRT) for prostate cancer using a consensus guideline for defining the clinical target volume. METHODS AND MATERIALS: Between August 2007 and October 2008, patients considered for radiation therapy (RT) after prostatectomy were enrolled. The clinical target volume (prostate bed) was delineated according to published consensus guidelines, and patients were prescribed a dose of 66 Gy in 33 fractions. Radiation treatment planning prioritized rectal dose constraints over target volume coverage. Treatment was delivered by use of IMRT and daily cone beam computed tomographic guidance. Toxicity (graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events) and HRQOL assessments according to the Expanded Prostate Cancer Index Composite (EPIC) questionnaire were collected prospectively at baseline, at week 5 (during RT), at 3 months, and at yearly follow-up visits. Cumulative toxicity and biochemical relapse-free rates were calculated by the Kaplan-Meier method. Paired Student t tests with multiple testing correction were used to assess changes in HRQOL. RESULTS: A total of 68 men were evaluated, with median follow-up of 5.9 years. Fifty-three patients (77.9%) and 15 patients (22.1%) were treated with salvage and adjuvant RT, respectively. Primary planning objectives were met in most cases (97.1%), but planning target volume coverage was compromised in 40% of cases because of large planning target volumes (mean 347.6 cm(3)). There were no grade 3 or 4 acute toxicities. Cumulative 5-year incidence of late gastrointestinal and genitourinary grade 2 toxicities was 12.3% (95% confidence interval [CI], 11.1%-13.5%) and 10.6% (95% CI, 9.5%-11.6%), respectively. No grade 3 or 4 late toxicities were observed. Transient declines in EPIC gastrointestinal domain summary score (mean 87.66 at 3 months vs 92.76 at baseline; P = .006) and genitourinary irritative subscale (week 5 mean score 83.37 vs 89.45 at baseline; P = .007) were observed. Complete recovery occurred between 3 and 12 months after therapy, remaining stable compared with baseline at 5-year follow-up. Sexual HRQOL remained stable at 5 years, with an improving trend in bother subscale. Biochemical relapse-free rate at 5 years was 72.7% (95% CI, 61.9%-83.5%). CONCLUSIONS: Guideline-based postprostatectomy image guided IMRT with rigid rectal dose constraints resulted in favorable toxicity profiles; long-term stability in gastrointestinal, genitourinary, and sexual HRQOL; and expected biochemical control rates. Concerns regarding toxicity and HRQOL should not preclude recommendation for RT after prostatectomy.","Pract Radiat Oncol, 5(5): e473-482","Canada,Chile,USA",2015,"Any or unknown","Radiotherapy","EPIC,CTCAE","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,Treatment"]
[59,"Berry, D. L., et al. (2006). \"Quality of life and pain in advanced stage prostate cancer: results of a Southwest Oncology Group randomized trial comparing docetaxel and estramustine to mitoxantrone and prednisone.\" J Clin Oncol 24(18): 2828-2835.",null,"Berry, D. L., et al.","Quality of life and pain in advanced stage prostate cancer: results of a Southwest Oncology Group randomized trial comparing docetaxel and estramustine to mitoxantrone and prednisone","PURPOSE: Palliation of bone pain can be achieved in men with androgen-independent prostate cancer treated with docetaxel and estramustine (DE) or mitoxantrone and prednisone (MP). While Southwest Oncology Group trial 99-16 demonstrated a survival improvement of DE over MP, the study also was designed to compare the palliation of disease-related symptoms. METHODS: Pain palliation and global quality of life (QOL) were the two primary patient-reported outcomes. Pain was measured with the Present Pain Intensity scale of the McGill Pain Questionnaire-Short Form. The European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire C30 (QLQ-C30) and its Prostate Cancer Module (PR25) measured QOL and symptom status. Pain and analgesic use were measured at random assignment, every cycle for eight cycles, and 1 year from random assignment; the QLQ-C30 and the PR25 were administered at random assignment, before cycle four (week 10) and cycle eight (month 6) and at 1 year. In addition to the primary intent-to-treat, missing at random analysis, sensitivity analyses were performed to assess robustness of global QOL conclusions under alternative informative missing data assumptions. RESULTS: Six hundred seventy four eligible patients received DE (n = 338) or MP (n = 336). In an intention-to-treat analysis, median overall survival was 17.5 months for the DE arm and 15.6 months for the MP arm (P = .02). There were no statistically significant differences in pain palliation between the treatment arms. The sensitivity analyses showed a consistent lack of statistically significant global QOL differences for the two arms. CONCLUSION: DE had superior clinical efficacy (overall survival, time-to-progression, and prostate-specific antigen declines) with similar global QOL and pain palliation in the MP arm.","J Clin Oncol, 24(18): 2828-2835","USA",2006,"Advanced","Taxane,Chemotherapy","MPQ,EORTC QLQ-C30,EORTC QLQ-PR25","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,Symptom,General"]
[60,"Berry, W. R., et al. (2004). \"Phase II randomized trial of weekly paclitaxel with or without estramustine phosphate in progressive, metastatic, hormone-refractory prostate cancer.\" Clin Prostate Cancer 3(2): 104-111.",null,"Berry, W. R., et al.","Phase II randomized trial of weekly paclitaxel with or without estramustine phosphate in progressive, metastatic, hormone-refractory prostate cancer","This study was conducted to determine the similarity of response rates and safety produced by weekly paclitaxel with or without oral estramustine in patients with metastatic hormone-refractory prostate cancer. Between December 1998 and December 1999, 163 patients were randomized to receive 28-day cycles of paclitaxel 100 mg/m2 on days 2, 9, and 16 plus estramustine 280 mg orally 3 times a day on days 1-3, 8-10, and 15-17, or to receive paclitaxel 100 mg/m2 alone on days 1, 8, and 15. Objective response was defined as a > oe = 50% decrease in prostate-specific antigen (PSA) maintained for 4 weeks with stable or improved performance status. Response rates included 37 partial responses for paclitaxel/estramustine (47%) and 22 partial responses for paclitaxel (27%; P < 0.01). Median duration of response was 15.1 months for paclitaxel/estramustine and 15.5 months for paclitaxel; median survival was 16.1 months and 13.1 months, respectively (P = 0.049). Common toxicities for both treatments included neutropenia, gastrointestinal events, neuropathy, and asthenia. Thromboembolic events were more frequent in the paclitaxel/estramustine arm (no prophylactic anticoagulants). The rate of PSA decline for paclitaxel/estramustine was almost 2 times that of paclitaxel (47% vs. 27%), with acceptable toxicity. Multivariate analysis of prognostic factors affecting survival was not significant for treatment arm (P = 0.08). Although the incidence of thromboembolic events appeared to be increased in the paclitaxel/ estramustine arm, the addition of estramustine was responsible for a 20% increase in the rate of PSA decline. Neither treatment arm had significant impact on quality of life as measured by the Functional Assessment of Cancer Therapy-Prostate quality of life questionnaire. This study produced encouraging data; further studies of paclitaxel/ estramustine are recommended.","Clin Prostate Cancer, 3(2): 104-111","USA",2004,"Metastatic","Taxane,Chemotherapy","FACT-P","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease"]
[61,"Bertaccini, A., et al. (2003). \"BSP-PC (Bononian Satisfaction Profile--Prostate Cancer): development and validation of a \"disease-specific\" questionnaire for the evaluation of health-related quality of life in patients with prostate cancer.\" Arch Ital Urol Androl 75(4): 187-194.",null,"Bertaccini, A., et al.","BSP-PC (Bononian Satisfaction Profile--Prostate Cancer): development and validation of a \"disease-specific\" questionnaire for the evaluation of health-related quality of life in patients with prostate cancer","OBJECTIVES: Prostate cancer (PC) is the most common neoplasia in men over 50 years of age in western countries. Nowadays, since there are several alternative medical-surgical treatments for this cancer, health-related quality of life (HQoL) evaluation has become very important. The present study deals with the development and the validation of a questionnaire (BSP-PC), considering the HQoL in prostate cancer patients. The BSP-PC items are mainly related to the subjects' satisfaction. As far as we know, it does not exist any disease specific instrument based on such aspect. MATERIALS AND METHODS: Questionnaire development: During three different meetings, with ten experts and twenty patients, we have defined the life aspects which are the most affected by prostate cancer. Subsequently we have created a first 40-item version of the BSP-PC. Patients were asked to fill in this particular questionnaire in addition to a generic and validated one (the EuroQol). A final 24 item questionnaire version, was finally achieved by other statistical analysis and meetings with experts. Questionnaire validation: the BSP-PC was filled in by 261 patients divided into 3 groups: \"healthy\" (57), \"prostate cancer\" (103), \"other diseases\" (100). RESULTS: Questionnaire development: participants' mean age was 59 years (N=71); 46% had prostate cancer, while 53% of the sample did not report notable diseases. The 24 items were selected on the basis of the following criteria: a) r>0.50, p<0.05 (correlation test re-test), b) p<0.05 (ANOVA presence vs absence of PC), c) r>0.50, p<0.05 (correlation with EuroQol). Questionnaire validation: participants' mean age was 68 years (N=261). Four factors were identified: 1) satisfaction about physical functionality (Crombach alpha=0.95), 2) satisfaction about sexual functionality (alpha=0.94), 3) satisfaction about social functionality (alpha=0.77), 4) satisfaction about urinary functionality (alpha=0.89); total Crombach alpha was 0.94. CONCLUSIONS: The BSP-PC questionnaire can be used as an instrument in the evaluation of HQoL in PC patients by principally considering their subjective satisfaction.","Arch Ital Urol Androl, 75(4): 187-194","Italy",2003,"Any or unknown","None","BSP-PC,EQ-5D","Patient",null,"Validation,Mapping to utility",null,null,null,null,null,null,null,null,"Treatment,Utility"]
[62,"Bertetto, O., et al. (2001). \"Quality of life studies and genito-urinary tumors.\" Ann Oncol 12 Suppl 3: S43-48.",null,"Bertetto, O., et al.","Quality of life studies and genito-urinary tumors","BACKGROUND: Genitourinary (GU) tumors represent a large proportion of solid cancers (1 of 4) and a wide variety of natural histories, based on various prognostic factors and resulting in different treatment options and end points. In some cases, for the same stage of disease, different treatment strategies do not impact differently on overall survival (OS): surgery vs. radiation, or radical vs. conservative multidisciplinary approach, adjuvant or neoadjuvant, chemotherapy vs. BSC. Quality of life (QoL) is considered a reasonable end point when differences in OS do not seem to be striking. DESIGN: A review of the literature on different disease stages was undertaken to show where and when QoL was used as the end point of treatment efficacy. RESULTS: Very few studies have been performed in prostate, bladder and testicular cancer to show the impact of different treatment approaches on QoL. Although these studies might be considered as non-conclusive, some data may allow a better choice for the patients. CONCLUSIONS: QoL as the principal end point has not been used in clinical trials of GU tumors comparing different treatment approaches. This makes the choice between treatments offering similar survival but different toxicity patterns, body and behavioral consequences more difficult. We suggest that future prospective randomized studies should be planned taking into account the QoL as the main end point.","Ann Oncol, 12 Suppl 3(S43-48","Italy",2001,"Any or unknown","Unclear","Unclear","Patient",null,"Systematic review",null,null,null,null,null,null,null,null,"General"]
[63,"Bestmann, B., et al. (2006). \"Validation of the German prostate-specific module.\" World J Urol 24(1): 94-100.",null,"Bestmann, B., et al.","Validation of the German prostate-specific module","Theoretically, all patients newly diagnosed with prostate cancer are faced with a choice of treatment options: radical prostatectomy or radio therapy. Although these different treatments may have no differences in terms of survival, they may have very different consequences on the subsequent quality of life (QoL). Prerequisite to analyze QoL is a reliable and valid instrument to assess these differences not only in terms of general QoL (EORTC QLQ-C30) but prostate specific symptoms with a prostate specific module as well. Therefore, the aim of this study was a psychometric evaluation (validation) of the prostate-specific module (PSM). Five historical cohort studies were put together for an empirical meta-analysis. The main objective was to analyze the module's psychometric properties. The total sample consisted of 1,185 patients, of whom 950 completed the QoL questionnaires (EORTC QLQ-C30 and a prostate specific module developed by Kuechler et al.). First step of analysis was a principal component analysis that revealed the following scales: urinary problems, incontinence, erectile dysfunction, sexual problems, problems with partner, pain, heat, nutrition, and psychic strain. The module showed good reliability and concurrent validity and very good construct validity, since the module is able to discriminate between different treatment regimes, tumor stages and age. The German PSM is a reliable, valid and applicable tool for QoL in patients with prostate cancer.","World J Urol, 24(1): 94-100","Germany",2006,"Any or unknown","Surgery,Radiotherapy","EORTC QLQ-C30,EORTC QLQ-PR25","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease,General"]
[64,"Beydoun, H. A., et al. (2010). \"Development of a scale to assess patient misperceptions about treatment choices for localized prostate cancer.\" BJU Int 106(3): 334-341.",null,"Beydoun, H. A., et al.","Development of a scale to assess patient misperceptions about treatment choices for localized prostate cancer","OBJECTIVES: To develop a questionnaire to assess a patient's knowledge of his cancer, understanding of treatment choices, and judgement of his survival (KUJ) with and without treatment, as treatment for localized prostate cancer (LPC) can lead to urinary, sexual and bowel side-effects and might not improve survival in 75% of patients. PATIENTS AND METHODS: Although >90% of patients in the USA are diagnosed with LPC, approximately 94% of them choose treatment, such that newly diagnosed patients need individualized counselling to address misperceptions about the management of LPC. The internal consistency of an 18-item KUJ scale was evaluated among 184 patients recently diagnosed with LPC at a major urology practice. Principal-component analyses were applied for computing a KUJ index. Logistic regression modelling was used to identify predictors of the KUJ index. RESULTS: Cronbach's alpha for the KUJ scale was 0.76. Nearly half of the patients provided incorrect answers to most KUJ items. Of the patients, 68% had an income of >US$50,000 and 90% had at least high (or secondary) school literacy level. Quality-of-life measures suggested that most patients were physically, mentally and socially healthy. Higher education, income and functional capacity were associated with worse KUJ. CONCLUSION: The KUJ scale is internally consistent and clinicians can use it to identify the educational needs of patients with LPC before treatment selection. Overall, patients who were socioeconomically disadvantaged and those with physical ailments were better informed about the diagnosis, treatment options and prognosis of prostate cancer.","BJU Int, 106(3): 334-341","USA",2010,"Local","Unclear","KUJ","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease"]
[65,"Bhatnagar, V., et al. (2009). \"Evaluation of an internet-based disease trajectory decision tool for prostate cancer screening.\" Value Health 12(1): 101-108.",null,"Bhatnagar, V., et al.","Evaluation of an internet-based disease trajectory decision tool for prostate cancer screening","OBJECTIVE: To evaluate the application of a chronic disease model (CDM) for prostate cancer to visual analog scale (VAS) and time trade-off (TTO) decision tools. METHODS: A total of 138 men (mean age 58 years) viewed a CDM module for prostate cancer with and without prostate specific antigen (PSA) screening. Participants rated their hypothetical quality of life with potential prostate cancer treatment complications using a CDM-based VAS decision tool. They were then asked to estimate how many years they would be willing to trade to be free of treatment complications using a CDM-based TTO decision tool. The consistency between VAS and TTO scores and the relationship between scores and preferences for PSA screening test and hypothetical treatment choice for prostate cancer were then evaluated. RESULTS: There was a significant relationship between the VAS and TTO ratings (regression P < 0.001). The TTO tool was sensitive to age. Mean scores with standard deviations for those less than 58 years compared to those 58 years and more were 7.78 (1.75) and 8.41 (1.52), respectively (P = 0.04). Using the VAS tool, men who chose PSA screening had higher quality of life ratings compared to men who did not choose PSA screening: 7.73 (1.78) and 6.59 (2.39), respectively (P = 0.01). Similar results were found with the TTO decision tool: 8.33 (1.45) and 7.04 (2.00), respectively (P = 0.005). Men who would hypothetically prefer treatment for moderately differentiated prostate cancer also had higher TTO scores compared to men who preferred watchful waiting: 8.54 (1.39) and 7.85 (1.73), respectively (P = 0.04). CONCLUSION: CDM-based for prostate cancer, VAS and TTO ratings were consistent and were concordant with patient preferences for screening; TTO ratings were also concordant with treatment choice. The use of the CDM-based TTO ratings to adjust for quality of life in decision analytic modeling needs to be explored.","Value Health, 12(1): 101-108","USA",2009,"At risk","Screening","VAS,TTO","General population",null,"Validation",null,null,null,null,null,null,null,null,"Utility"]
[66,"Bill-Axelson, A., et al. (2013). \"Long-term distress after radical prostatectomy versus watchful waiting in prostate cancer: a longitudinal study from the Scandinavian Prostate Cancer Group-4 randomized clinical trial.\" Eur Urol 64(6): 920-928.",null,"Bill-Axelson, A., et al.","Long-term distress after radical prostatectomy versus watchful waiting in prostate cancer: a longitudinal study from the Scandinavian Prostate Cancer Group-4 randomized clinical trial","BACKGROUND: Studies enumerating the dynamics of physical and emotional symptoms following prostate cancer (PCa) treatment are needed to guide therapeutic strategy. Yet, overcoming patient selection forces is a formidable challenge for observational studies comparing treatment groups. OBJECTIVE: To compare patterns of symptom burden and distress in men with localized PCa randomized to radical prostatectomy (RP) or watchful waiting (WW) and followed up longitudinally. DESIGN, SETTING, AND PARTICIPANTS: The three largest, Swedish, randomization centers for the Scandinavian Prostate Cancer Group-4 trial conducted a longitudinal study to assess symptoms and distress from several psychological and physical domains by mailed questionnaire every 6 mo for 2 yr and then yearly through 8 yr of follow-up. INTERVENTION: RP compared with WW. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: A questionnaire was mailed at baseline and then repeatedly during follow-up with questions concerning physical and mental symptoms. Each analysis of quality of life was based on a dichotomization of the outcome (yes vs no) studied in a binomial response, generalized linear mixed model. RESULTS AND LIMITATIONS: Of 347 randomized men, 272 completed at least five questionnaires during an 8-yr follow-up period. Almost all men reported that PCa negatively influenced daily activities and relationships. Health-related distress, worry, feeling low, and insomnia were consistently reported by approximately 30-40% in both groups. Men in the RP group consistently reported more leakage, impaired erection and libido, and fewer obstructive voiding symptoms. For men in the WW group, distress related to erectile symptoms increased gradually over time. Symptom burden and distress at baseline was predictive of long-term outlook. CONCLUSIONS: Cancer negatively influenced daily activities among almost all men in both treatment groups; health-related distress was common. Trade-offs exist between physiologic symptoms, highlighting the importance of tailored treatment decision-making. Men who are likely to experience profound long-term distress can be identified early in disease management.","Eur Urol, 64(6): 920-928","Sweden",2013,"Local","Surgery,Surveillance","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Comorbidity,Symptom"]
[67,"Bisson, J. I., et al. (2002). \"The prevalence and predictors of psychological distress in patients with early localized prostate cancer.\" BJU Int 90(1): 56-61.",null,"Bisson, J. I., et al.","The prevalence and predictors of psychological distress in patients with early localized prostate cancer","OBJECTIVE: To determine the level of psychopathology, traumatic distress and quality of life in men with newly diagnosed clinically localized prostate cancer, the effect on these of a consultation in a combined-specialist early-prostate clinic, and predictors of psychopathology. PATIENTS AND METHODS: Eighty-eight patients were recruited from the combined clinic; they completed a battery of questionnaires including the Hospital Anxiety and Depression Scale (HADS), the revised Impact of Event Scale (IES) and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, before their first appointment. Two weeks later they completed the HADS, IES and a patient-satisfaction survey. RESULTS: The overall level of psychopathology varied among the questionnaires used, from 0% on the HADS depression scale, 8% on the HADS anxiety scale and 14% on the IES. Anxiety and traumatic stress symptoms were commoner than depressive symptoms. The quality-of-life scores showed a relatively good level of functioning. Pre-morbid factors and disease status did not predict psychological distress. Younger age was mildly predictive of poorer psychological functioning. Anxiety symptoms reduced slightly after a joint clinic appointment, whereas depressive symptoms showed a slight increase. CONCLUSION: This study suggests that men with early localized prostate cancer have low levels of psychopathology overall. However, some men experience distressing psychological symptoms and it is important that future research is conducted to help develop clear guidelines on the optimal methods of detecting and managing men with prostate cancer who have mental health difficulties.","BJU Int, 90(1): 56-61","UK",2002,"Local","None","HADS,IES,EORTC-QOL-C30","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"General,Complication,Comorbidity,Disease"]
[68,"Black, P. C., et al. (2007). \"A randomized prospective trial evaluating testosterone, haemoglobin kinetics and quality of life, during and after 12 months of androgen deprivation after prostatectomy: results from the Postoperative Adjuvant Androgen Deprivation trial.\" BJU Int 100(1): 63-69.",null,"Black, P. C., et al.","A randomized prospective trial evaluating testosterone, haemoglobin kinetics and quality of life, during and after 12 months of androgen deprivation after prostatectomy: results from the Postoperative Adjuvant Androgen Deprivation trial","OBJECTIVE: To assess testosterone and haemoglobin kinetics in the Postoperative Adjuvant Androgen Deprivation (PAAD) trial, and correlate these with quality of life (QoL) in this prospective randomized study. PATIENTS AND METHODS: Forty-three patients met the criteria for high-risk cancer after RRP (Gleason score > or = 8, pT3c or Gleason score 7 concomitant with pT3a/b and positive surgical margins) and were prospectively randomized to either observation or AD for 12 months. Haemoglobin and testosterone levels were determined and QoL surveyed at regular intervals for 24 months. RESULTS: Serum testosterone levels were castrate in 19 of 21 treated patients at 3 months and all at 6 months after starting AD. Levels failed to return to normal at 6 months after stopping treatment in six of 16 (38%) patients, and at 12 months in three of 17 (18%). AD caused a delay in the recovery of haemoglobin levels to normal after RRP. There was no statistically significant decline in the Short Form-36 QoL score with AD. Scores on the University of California-Los Angeles Sexual Functioning Scale were decreased during AD, but returned to a level not statistically significantly different from controls after stopping treatment. CONCLUSION: A year of adjuvant AD after RRP affected serum haemoglobin, testosterone and sexual function reversibly, with return to control levels within the subsequent year in most patients. No significant effect on overall QoL with AD was detected in the study.","BJU Int, 100(1): 63-69","USA",2007,"Advanced","Surgery,Hormonal","SF-36,UCLA-SFS","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Utility,Complication"]
[69,"Blanchard, C. M., et al. (2010). \"Body mass index, physical activity, and health-related quality of life in cancer survivors.\" Med Sci Sports Exerc 42(4): 665-671.",null,"Blanchard, C. M., et al.","Body mass index, physical activity, and health-related quality of life in cancer survivors","PURPOSE: To determine the independent and interactive associations among body mass index (BMI), physical activity (PA), and health-related quality of life (HRQoL) in breast, prostate, colorectal, bladder, uterine, and skin melanoma cancer survivors. METHODS: A total of 3241 cancer survivors completed a national cross-sectional survey that included PA questions and the RAND-36 Health Status Inventory. RESULTS: Compared with healthy-weight survivors, obese breast, prostate, bladder, and skin melanoma cancer survivors were significantly less likely to meet the PA guideline. Furthermore, healthy-weight and/or overweight breast, prostate, colorectal, uterine cancer, and skin melanoma survivors reported significantly better physical functioning compared with their obese counterparts, whereas overweight colorectal cancer survivors reported significantly better mental health compared with obese survivors. Finally, hierarchical linear regressions showed that none of the BMI x PA interactions was significant for the physical or mental component composite scores across the cancer types. CONCLUSIONS: The percentage of cancer survivors meeting the American Cancer Society's PA guideline seems to vary by weight status in breast, prostate, bladder, and skin melanoma cancer survivors. In addition, BMI and PA have independent associations with HRQoL; however, the interactive association of BMI and PA on HRQoL was negligible. Clarifying the relationship between BMI and PA across different cancer types will help identify potential target groups for future PA interventions that will help ameliorate the negative side effects of cancer and improve HRQoL.","Med Sci Sports Exerc, 42(4): 665-671","Canada",2010,"Survivors","None","SF-36","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Utility"]
[70,"Bloomfield, D. J., et al. (1998). \"Economic evaluation of chemotherapy with mitoxantrone plus prednisone for symptomatic hormone-resistant prostate cancer: based on a Canadian randomized trial with palliative end points.\" J Clin Oncol 16(6): 2272-2279.",null,"Bloomfield, D. J., et al.","Economic evaluation of chemotherapy with mitoxantrone plus prednisone for symptomatic hormone-resistant prostate cancer: based on a Canadian randomized trial with palliative end points","PURPOSE: To evaluate the economic consequences of the use of chemotherapy in patients with symptomatic hormone-resistant prostate cancer (HRPC) in the context of a previously published Canadian open-label, phase III, randomized trial with palliative end points. PATIENTS AND METHODS: The trial randomized 161 patients to initial treatment with mitoxantrone and prednisone (M + P) or to prednisone alone (P) and showed better palliation with M + P. There was no significant difference in survival. A detailed retrospective chart review was performed of resources used from randomization until death of 114 of 161 patients enrolled at the three largest centers: these included hospital admissions, outpatient visits, investigations, therapies (which included all chemotherapy and radiation), and palliative care. Cancer center and community hospital costs were calculated by using the hotel approximation method and case costing from the Ontario Case Cost Project, respectively. Cost-utility analysis was performed by transforming the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 global quality-of-life item measured every 3 weeks on trial to an estimate of utility, and extending the last known value through to death or last follow-up. RESULTS: The mean total cost until death or last follow-up by intention-to-treat was M + P CDN $27,300; P CDN $29,000. The 95% confidence intervals on the observed cost difference ranged from a saving of $9,200 for M + P (with palliative benefit) to an increased cost of $5,800 for M + P. The major proportion of cost (M + P 53% v P 66%; CDN $14,500 v $19,100) was for inpatient care. Initial M + P was consistently less expensive in whichever time period was used to compare costs. Cost-utility analysis showed M + P to be the preferred strategy with an upper 95% confidence interval for the incremental cost-utility ratio of CDN $19,700 per quality-adjusted life-year (QALY). CONCLUSION: A treatment that reduces symptoms and improves quality of life has the potential to reduce costs in other areas. Economic factors should not influence the clinical decision as to whether to use M + P in a symptomatic patient.","J Clin Oncol, 16(6): 2272-2279","Canada",1998,"Any or unknown","Chemotherapy","EORTC QLQ-C30","Patient",null,"Clinical trial,Economic model",null,null,null,null,null,null,null,null,"General"]
[71,"Bogdanos, J., et al. (2004). \"Epoetin beta (NeoRecormon) corrects anaemia in patients with hormone-refractory prostate cancer and bone metastases.\" Anticancer Res 24(3b): 1957-1961.",null,"Bogdanos, J., et al.","Epoetin beta (NeoRecormon) corrects anaemia in patients with hormone-refractory prostate cancer and bone metastases","BACKGROUND: Severe anaemia is common in patients with metastatic, hormone-refractory prostate cancer (HRPC). PATIENTS AND METHODS: We evaluated the efficacy of epoetin beta in correcting anaemia and maintaining haemoglobin (Hb) levels in this group of patients. Patients with HRPC, bone metastases and anaemia (Hb < 12 g/dl) were included. Epoetin beta, 30,000 IU per week in three divided doses, was administered subcutaneously, with iron supplementation when needed. If Hb increased by < 1 g/dl during the first 4 weeks of therapy the epoetin dose was increased (increments of 5,000 IU per dose) at fortnightly intervals to a maximum of 60,000 IU per week. Patients with haematopoietic response (Hb increase > or = 2 g/dl from baseline or Hb level > or = 12 g/dl without blood transfusions) went on to receive epoetin beta 10,000 IU once weekly for up to 24 weeks. RESULTS: All 29 evaluable patients demonstrated a haematopoietic response to epoetin beta treatment. None of the patients required blood transfusions. All patients showed improvements in quality of life (assessed using the EORTC QLQ-C30 questionnaire). Hb levels were maintained for the remainder of the trial. Epoetin beta was very well tolerated. CONCLUSION: Epoetin beta therapy resulted in a rapid and sustained improvement in Hb levels in patients with HRPC metastatic to bone.","Anticancer Res, 24(3b): 1957-1961","Greece",2004,"Metastatic","Various","EORTC QLQ-C30","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General"]
[72,"Boisen, S., et al. (2016). \"A Cross-Sectional Comparison of Quality of Life Between Physically Active and Underactive Older Men With Prostate Cancer.\" J Aging Phys Act 24(4): 642-648.",null,"Boisen, S., et al.","A Cross-Sectional Comparison of Quality of Life Between Physically Active and Underactive Older Men With Prostate Cancer","Men with prostate cancer experience many side effects and symptoms that may be improved by a physically active lifestyle. It was hypothesized that older men with prostate cancer who were physically active would report significantly higher levels of quality of life (QOL) as assessed by the WHOQOL-BREF and the WHOQOL-OLD. Of the 348 prostate cancer survivors who were invited to participate in the present postal survey, 137 men returned the questionnaires. Those who were physically active had significantly lower prostate specific antigen (PSA) scores and higher social participation than those insufficiently active. These findings offer some support for the benefits of physical activity (PA) within the prostate cancer population in managing the adverse side effects of their treatments on aspects of their QOL. Future research should more closely examine what types of PA best promote improvements in varying aspects of QOL and psychological well-being for prostate cancer survivors.","J Aging Phys Act, 24(4): 642-648","Unclear",2016,"Survivors","None","WHOQOL-BREF,WHOQOL-OLD","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"General"]
[73,"Borghede, G. and M. Sullivan (1996). \"Measurement of quality of life in localized prostatic cancer patients treated with radiotherapy. Development of a prostate cancer-specific module supplementing the EORTC QLQ-C30.\" Qual Life Res 5(2): 212-222.",null,"Borghede, G. and M. Sullivan","Measurement of quality of life in localized prostatic cancer patients treated with radiotherapy. Development of a prostate cancer-specific module supplementing the EORTC QLQ-C30","The purpose of this study was to construct a multidimensional self-administered quality of life questionnaire specific to prostate cancer within the EORTC framework and to test its applicability, clinical relevance and psychometry. A proposed prostate cancer-specific module and the standardized EORTC QLQ-C30 version 1.0 were tested in 192 post-irradiated patients. Psychometric analyses comprised item convergent and discriminant validity for scaling success, analysis of the internal consistency of the multi-item scales and the validity of the scales. The clinical relevance was explored by correlation analysis including disease and treatment related parameters. The minimum psychometric criteria were met. The measurements revealed problem areas in sexuality with a mean score of 54 (SD = 33) on a 0-100 scale, and in bowel functioning, scoring 25 on average (SD = 17). Urinary complaints only reached a mean score of 6 (SD = 19). Compared to earlier measurements on untreated or irradiated localized cancer patients using the same core questionnaire, the physical and psychological scales showed higher values and the symptom scales lower symptom burden. The constructed questionnaire seems applicable and clinically relevant. The psychometric analysis revealed a few items to be revised. Patients with localized prostatic carcinoma treated with radiotherapy have a high quality of life compared to patients with localized cancer of other origin.","Qual Life Res, 5(2): 212-222","Sweden",1996,"Local","Radiotherapy","EORTC QLQ-C30, EORTC QLQ-PR25","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease,General"]
[74,"Borghede, G., et al. (1997). \"Quality of life in patients with prostatic cancer: results from a Swedish population study.\" J Urol 158(4): 1477-1485; discussion 1486.",null,"Borghede, G., et al.","Quality of life in patients with prostatic cancer: results from a Swedish population study","PURPOSE: We evaluated a prostate cancer-specific module in an unselected patient population. MATERIALS AND METHODS: A population study design was used to confirm the psychometric properties and clinical relevance of a prostate cancer-specific module, supplementing the standardized EORTC QLQ-C30 in Sweden. The study sample comprised 1,138 patients (81% response rate) examined by a mailout/mailback procedure 1.5 to 3.5 years after diagnosis. The standardized multitrait analysis method estimated the internal consistency and convergent and discriminant validity of 3 multi-item scales on sexuality, urinary symptoms and bowel symptoms. Confirmation of prostate-specific scales by disease stage and treatment used principal components analysis. The clinical relevance was tested by correlation analysis including disease and treatment-related parameters. RESULTS: Convergent and discriminant validity of all 3 prostate-specific scales was confirmed. The internal consistency was satisfactory for the sexuality and urinary scales (alpha 0.92 and 0.76, respectively), while the bowel scale failed to reach the alpha level of 0.70 required for group comparisons. The former scales showed invariance over all principal components analyses of subgroups (disease stage and treatment). The latter scale comprised differing numbers of items in the subgroup analyses, suggesting the use of single items at present. Descriptive data of the core and module questionnaires by disease and treatment-related parameters confirmed their interpretability and thus their clinical usefulness. CONCLUSIONS: The presented self-report questionnaire technique has great potential to inform clinicians about the quality of life in patients suffering from prostate cancer.","J Urol, 158(4): 1477-1485; discussion 1486","Sweden",1997,"Any or unknown","None","EORTC QLQ-C30, EORTC QLQ-PR25","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease,General"]
[75,"Bourke, L., et al. (2015). \"Survivorship and improving quality of life in men with prostate cancer.\" Eur Urol 68(3): 374-383.",null,"Bourke, L., et al.","Survivorship and improving quality of life in men with prostate cancer","CONTEXT: Long-term survival following a diagnosis of cancer is improving in developed nations. However, living longer does not necessarily equate to living well. OBJECTIVE: To search systematically and synthesise narratively the evidence from randomised controlled trials (RCTs) of supportive interventions designed to improve prostate cancer (PCa)-specific quality of life (QoL). EVIDENCE ACQUISITION: A systematic search of Medline and Embase was carried out from inception to July 2014 to identify interventions targeting PCa QoL outcomes. We did not include nonrandomised studies or trials of mixed cancer groups. In addition to database searches, citations from included papers were hand-searched for any potentially eligible trials. EVIDENCE SYNTHESIS: A total of 2654 PCa survivors from 20 eligible RCTs were identified from our database searches and reference checks. Disease-specific QoL was assessed most frequently by the Functional Assessment of Cancer Therapy-Prostate questionnaire. Included studies involved men across all stages of disease. Supportive interventions that featured individually tailored approaches and supportive interaction with dedicated staff produced the most convincing evidence of a benefit for PCa-specific QoL. Much of these data come from lifestyle interventions. Our review found little supportive evidence for simple literature provision (either in booklets or via online platforms) or cognitive behavioural approaches. CONCLUSIONS: Physical and psychological health problems can have a serious negative impact on QoL in PCa survivors. Individually tailored supportive interventions such as exercise prescription/referral should be considered by multidisciplinary clinical teams where available. Cost-effectiveness data and an understanding of how to sustain benefits over the long term are important areas for future research. PATIENT SUMMARY: This review of supportive interventions for improving quality of life in prostate cancer survivors found that supervised and individually tailored patient-centred interventions such as lifestyle programmes are of benefit.","Eur Urol, 68(3): 374-383","International",2015,"Survivors","Various","FACT-P","Patient",null,"Systematic review",null,null,null,null,null,null,null,null,"Disease"]
[76,"Boyer, M. J., et al. (2017). \"Toxicity and quality of life report of a phase II study of stereotactic body radiotherapy (SBRT) for low and intermediate risk prostate cancer.\" Radiat Oncol 12(1): 14.",null,"Boyer, M. J., et al.","Toxicity and quality of life report of a phase II study of stereotactic body radiotherapy (SBRT) for low and intermediate risk prostate cancer","BACKGROUND: Clinical data indicates that delivery of larger daily doses of radiation may improve the therapeutic ratio for prostate cancer compared to conventional fractionation. A phase II study of stereotactic body radiotherapy with real-time motion management and daily plan re-optimization for low to intermediate risk prostate cancer was undertaken to evaluate this hypothesis. This report details the toxicity and quality of life following treatment. METHODS: From 2009 to 2013, 60 patients with T1-T2c prostate cancer with a Gleason score of 6 and PSA </= 15 or Gleason score of 7 and PSA </= 10 were enrolled. Patients with nodal metastases, an American Urological Association symptom score > 18, or gland size > 100 g were not eligible. Patients were treated to 37 Gy in 5 fractions. Early and late genitourinary and gastrointestinal toxicity were graded based on NCI CTCAE v4.0 and quality of life was assessed by the American Urological Association symptom score, International Index of Erectile Function, and Expanded Prostate cancer Index Composite Short Form up to 36 months after treatment. RESULTS: After a median follow-up of 27.6 months, no grade 3 or greater genitourinary toxicity was observed. Four patients (6.7%) reported a late grade 2 genitourinary toxicity. One patient (1.7%) reported a late grade 3 gastrointestinal toxicity. Five patients (8.3%) developed a late grade 2 gastrointestinal toxicity. The median American Urological Association symptom score increased from 4.5 prior to treatment to 11 while on treatment (p < 0.01), but was 5 at 36 months post-treatment (p = 0.65). Median International Index of Erectile Function scores decreased from 19 to 17 over the course of follow-up (p < 0.01). Only median scores within the Expanded Prostate Cancer Index Composite Short Form sexual domain were significantly decreased at 36 months post-treatment (67.9 vs 45.2, p = 0.02). There was no significant difference in median score within the urinary, bowel, or hormonal domains at 36 months of follow-up. CONCLUSIONS: Stereotactic body radiotherapy for low to intermediate risk prostate cancer is well tolerated with limited toxicity or decrease in quality of life. Longer follow-up is necessary to assess the efficacy of treatment. TRIAL REGISTRATION: Clinicaltrials.gov NCT00941915 Registered 17 June 2009.","Radiat Oncol, 12(1): 14","USA",2017,"Local","Radiotherapy","EPIC,IIEF-5,AUA-SI,CTCAE","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,Complication,Symptom,Treatment"]
[77,"Bradley, E. B., et al. (2004). \"Determinants of long-term quality of life and voiding function of patients treated with radical prostatectomy or permanent brachytherapy for prostate cancer.\" BJU Int 94(7): 1003-1009.",null,"Bradley, E. B., et al.","Determinants of long-term quality of life and voiding function of patients treated with radical prostatectomy or permanent brachytherapy for prostate cancer","OBJECTIVE: To assess the long-term quality of life (QoL) outcomes of three treatments for localized prostate cancer: radical prostatectomy (RP); brachytherapy monotherapy (BTM); and BT combined with external beam radiotherapy (BTC). PATIENTS AND METHODS: In August 2000, questionnaires were mailed to men with T1c-T3 adenocarcinoma of the prostate treated with either RP, BTM ((103)Pd monotherapy) or BTC. Questionnaires included validated outcome measures, i.e. the Functional Assessment of Cancer Therapy - General (FACT-G), American Urological Association Symptom Score (AUA-SS), Urinary Function Questionnaire for men after RP, and the Brief Sexual Function Inventory. Returned questionnaires were assessed using cross-sectional analysis. RESULTS: Data from 214 patients were included in the analysis (60 RP, 102 BTM and 52 BTC); the median follow-up was 18.8, 25.5 and 29.9 months, respectively. There were differences between both BT groups and the RP group in total AUA-SS and obstructive subscale symptom scores, with the former having worse symptom scores at a longer follow-up. Differences in overall QoL were not detected between groups using the total FACT-G but the BTC group generally had worse scores in the physical well-being subscale. The BT groups had higher continence rates with time after treatment. Sexual function was better with BT initially, but these differences did not persist at a longer follow-up. There were significant correlations between the FACT-G and the urinary symptom scores, and the degree of sexual function. CONCLUSIONS: Although patients treated with BTM and RP have a different spectrum of side-effects, their overall long-term QoL is similar, with urinary and sexual function being the primary determinants of this outcome. Men treated with BTC have a worse QoL.","BJU Int, 94(7): 1003-1009","USA",2004,"Local","Brachytherapy,Surgery,Radiotherapy","FACT-G,AUA-SI,BSFI,UFQ-RP","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"General,Complication,Symptom"]
[78,"Brandeis, J. M., et al. (2000). \"Quality of life outcomes after brachytherapy for early stage prostate cancer.\" J Urol 163(3): 851-857.",null,"Brandeis, J. M., et al.","Quality of life outcomes after brachytherapy for early stage prostate cancer","PURPOSE: We compare general and disease specific health related quality of life in men undergoing brachytherapy for early stage prostate cancer to those undergoing radical prostatectomy and age matched healthy controls. MATERIALS AND METHODS: Cohorts consisted of 48 men treated with brachytherapy with and without pretreatment external beam radiation therapy (brachytherapy group), 74 who underwent radical prostatectomy (prostatectomy group) and age matched healthy controls from the literature. The RAND 36-item general health survey, University of California Los Angeles Prostate Cancer Index, American Urological Association symptom index, validated Cancer Interference with Life and Family Scales, and sociodemographic and co-morbidity questionnaires were completed 3 to 17 months after treatment. RESULTS: General health related quality of life did not differ greatly among the 3 groups. Urinary function (leakage) was worse in the brachytherapy group than in controls but better than in the prostatectomy group. Brachytherapy group patients had more irritative urinary symptoms and worse bowel function than controls. Sexual function and bother were worse in prostatectomy and brachytherapy groups than in healthy controls. Physical function, bodily pain, urinary function, and bother and American Urological Association symptom index scores improved with time after brachytherapy. Patients who underwent brachytherapy after external beam radiation performed worse in all general and disease specific health related quality of life domains compared to those who did not undergo pretreatment radiation therapy. CONCLUSIONS: At an average of 7.5 months after treatment the general health related quality of life of patients undergoing brachytherapy with and without pretreatment external beam radiation was similar to age matched controls, although urinary, bowel and sexual problems were reported. These problems appeared to improve during the first year after treatment. Much of the impairment in disease specific health related quality of life among patients undergoing brachytherapy may be attributed to pretreatment radiation.","J Urol, 163(3): 851-857","USA",2000,"Local","Brachytherapy,Surgery","SF-36,UCLA-PCI,AUA-SI,CILFS","Patient",null,"Case-control",null,null,null,null,null,null,null,null,"Disease,Symptom,Carer,Utility"]
[79,"Bratt, O., et al. (2013). \"The Study of Active Monitoring in Sweden (SAMS): a randomized study comparing two different follow-up schedules for active surveillance of low-risk prostate cancer.\" Scand J Urol 47(5): 347-355.",null,"Bratt, O., et al.","The Study of Active Monitoring in Sweden (SAMS): a randomized study comparing two different follow-up schedules for active surveillance of low-risk prostate cancer","OBJECTIVE: Only a minority of patients with low-risk prostate cancer needs treatment, but the methods for optimal selection of patients for treatment are not established. This article describes the Study of Active Monitoring in Sweden (SAMS), which aims to improve those methods. MATERIAL AND METHODS: SAMS is a prospective, multicentre study of active surveillance for low-risk prostate cancer. It consists of a randomized part comparing standard rebiopsy and follow-up with an extensive initial rebiopsy coupled with less intensive follow-up and no further scheduled biopsies (SAMS-FU), as well as an observational part (SAMS-ObsQoL). Quality of life is assessed with questionnaires and compared with patients receiving primary curative treatment. SAMS-FU is planned to randomize 500 patients and SAMS-ObsQoL to include at least 500 patients during 5 years. The primary endpoint is conversion to active treatment. The secondary endpoints include symptoms, distant metastases and mortality. All patients will be followed for 10-15 years. RESULTS: Inclusion started in October 2011. In March 2013, 148 patients were included at 13 Swedish urological centres. CONCLUSIONS: It is hoped that the results of SAMS will contribute to fewer patients with indolent, low-risk prostate cancer receiving unnecessary treatment and more patients on active surveillance who need treatment receiving it when the disease is still curable. The less intensive investigational follow-up in the SAMS-FU trial would reduce the healthcare resources allocated to this large group of patients if it replaced the present standard schedule.","Scand J Urol, 47(5): 347-355","Sweden",2013,"Local","Surveillance","Unclear","Patient",null,"Protocol",null,null,null,null,null,null,null,null,"General"]
[80,"Bremner, K. E., et al. (2007). \"A review and meta-analysis of prostate cancer utilities.\" Med Decis Making 27(3): 288-298.",null,"Bremner, K. E., et al.","A review and meta-analysis of prostate cancer utilities","BACKGROUND: Health-related quality of life is a key issue in prostate cancer (PC) management. The authors summarized published utilities for common health-related quality of life outcomes of PC and determined how methodological factors affect them. METHODS: In their systematic review, the authors identified 23 articles in English, providing 173 unique utilities for PC health states, each obtained from 2 to 422 respondents. Data were pooled using linear mixed-effects modeling with utilities clustered within the study, weighted by the number of respondents divided by the variance of each utility. RESULTS: In the base model, the estimated utility of the reference case (scenario of a metastatic PC patient with severe sexual symptoms, rated by non-PC patients using time tradeoff) was 0.76. Disease stage, symptom type and severity, source of utility, and scaling method were associated with utility differences of 0.10 to 0.32 (P < 0.05). Utilities from PC patients rating their own health were 0.14 higher than those from the reference case, but utilities from PC patients rating scenarios were lowest. Time tradeoff yielded the highest utilities. Computer administration yielded lower utilities than personal interview (P = 0.02). Neither the scale's high anchor nor study purpose had significant effects on utilities. CONCLUSIONS: This study provides pooled utility estimates for common PC health states and describes how clinical and methodological factors can significantly affect these values. When possible, utility estimates for a modeling application should be derived similarly. Formal data synthesis methods might be useful to researchers integrating utility data from heterogeneous sources. Further exploration of these methods for this purpose is warranted.","Med Decis Making, 27(3): 288-298","Canada",2007,"Metastatic","None","TTO","Patient",null,"Systematic review",null,null,null,null,null,null,null,null,"Utility"]
[81,"Bremner, K. E., et al. (2014). \"Predicting utility scores for prostate cancer: mapping the Prostate Cancer Index to the Patient-Oriented Prostate Utility Scale (PORPUS).\" Prostate Cancer Prostatic Dis 17(1): 47-56.",null,"Bremner, K. E., et al.","Predicting utility scores for prostate cancer: mapping the Prostate Cancer Index to the Patient-Oriented Prostate Utility Scale (PORPUS)","BACKGROUND: The Prostate Cancer Index (PCI) is a health profile instrument that measures health-related quality of life with six subscales: urinary, sexual, and bowel function and bother. The Patient-Oriented Prostate Utility Scale (PORPUS-U) measures utility (0=dead and 1=full health). Utility is a preference-based approach to measure health-related quality of life, required for decision analyses and cost-effectiveness analyses. We developed a function to estimate PORPUS-U utilities from PCI scores. METHODS: The development data set included 676 community-dwelling prostate cancer (PC) survivors who completed the PCI and PORPUS-U by mail. We fit three linear regression models: one used original PORPUS-U scores and two used log-transformed PORPUS-U scores, one with a hierarchy constraint and one without. The model selection was performed using stepwise selection and fivefold cross validation. The validation data included 248 PC outpatients with three assessments on the PCI and PORPUS-U. Scores were retransformed for validation, with Duan's smearing estimator applied to correct potential bias. The predictive ability of the models was assessed with R(2), root mean square error (RMSE) and by comparing predicted and observed utilities. RESULTS: The best-fitting model used the log-transformed PORPUS-U with no hierarchy constraint. The R(2) was 0.72. The RMSE ranged from 0.040 to 0.061 for the three validation data sets. Differences between predicted and observed utilities ranged from 0.000 to 0.006 but predicted utilities overestimated the lowest 5% of observed PORPUS-U scores and underestimated the highest observed scores. CONCLUSIONS: Our algorithm can calculate PORPUS-U utility scores from PCI scores, thus supplementing descriptive quality of life measures with utility scores in PC patients. Utilities derived from mapping algorithms are useful for assigning utility to groups of patients but are less accurate at predicting utility of individual patients. We are exploring statistical methods to improve the mapping of utilities from descriptive instruments.","Prostate Cancer Prostatic Dis, 17(1): 47-56","USA,Canada",2014,"Survivors","None","PORPUS,PCIn","Patient",null,"Mapping to utility",null,null,null,null,null,null,null,null,"Disease,Utility"]
[82,"Brien, J. C., et al. (2011). \"Posterior reconstruction before vesicourethral anastomosis in patients undergoing robot-assisted laparoscopic prostatectomy leads to earlier return to baseline continence.\" J Endourol 25(3): 441-445.",null,"Brien, J. C., et al.","Posterior reconstruction before vesicourethral anastomosis in patients undergoing robot-assisted laparoscopic prostatectomy leads to earlier return to baseline continence","INTRODUCTION: Reapproximation of Denonvilliers' fascia adjacent to bladder neck to the rectourethralis, or posterior reconstruction (PR), has been suggested to improve continence in postprostatectomy patients. We examined the impact of the PR on postoperative urinary and other quality-of-life (QoL) outcomes in patients undergoing robot-assisted laparoscopic prostatectomy (RALP). METHODS: We identified 89 patients who underwent RALP for prostate cancer between 2006 and 2009 by a single surgeon (R.G.), consented to participate in our prospective QoL study, which collects RAND-UCLA QoL and AUA symptom scores for all patients undergoing treatment for prostate cancer, and completed a baseline and a 3- or 6-month questionnaire. Of these, 31 patients had PR before vesicourethral anastomosis. We compared return to baseline function percentage at 3 and 6 months by PR group. Differences found in univariate analysis were further investigated using multiple linear regression models adjusting for demographics, clinical variables, and nerve-sparing status. RESULTS: While most patients had both 3- and 6-month follow-up (n = 74, 83%), sample size at 3 months was n = 86 and at 6 months was n = 77. Groups were comparable by preoperative characteristics, pathologic stage, nerve-sparing status, and baseline QoL/AUA symptom scores. At 3-months, there was a statistically significant improvement comparing PR to non-PR groups in return to baseline score for urinary bother (72% vs. 53%; p = 0.008) and urinary function (64% vs. 50%; p = 0.05), as well as change in absolute AUA symptom score (+0.2 vs. +3.8; p = 0.005). Differences in urinary bother (+20%; 95% confidence interval 5%, 34%) and AUA symptom score (-2.8; 95% confidence interval, -5.4, -0.2) persisted after multivariate adjustment. Groups had similar scores for all parameters by 6 months postprostatectomy. CONCLUSIONS: PR in patients undergoing RALP has a significant impact on early return to baseline parameters relating to urinary bother, urinary function, and AUA symptom score.","J Endourol, 25(3): 441-445","USA",2011,"Any or unknown","Surgery","UCLA-PCI,AUA-SI","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Symptom,Disease"]
[83,"Broering, J. M., et al. (2014). \"Measurement equivalence using a mixed-mode approach to administer health-related quality of life instruments.\" Qual Life Res 23(2): 495-508.",null,"Broering, J. M., et al.","Measurement equivalence using a mixed-mode approach to administer health-related quality of life instruments","PURPOSE: To evaluate the effects of mode, order of administration, and the interaction of mode and order on health-related quality of life scales when self-administered by mixed mode (paper-mode and web-mode) for measurement equivalence. METHODS: Health-related quality of life data was analyzed from the Cancer of the Prostate Strategic Urologic Research Endeavor using the Medical Outcomes Study (MOS) Short Form-36 (SF-36) and the University of California Los Angeles Prostate Cancer Index (UCLA-PCI). A randomized crossover design assigned participants to two groups with a preferred 2-5-day washout period. Cognitive debriefing evaluated participants' mode preference. RESULTS: Of the 245 men enrolled, 85 % completed both modes. The majority were White (97 %), college educated (66 %), reported an annual income >$75,000 (46 %), and a median age of 69 years. Intraclass correlation coefficients were high for each item on both instruments (r = .54-.97). Exact percentage agreement for yes/no items was high (>/=.88). For the SF-36, significant differences were observed for order of administration (physical component and physical function scores) and for the interaction between mode and order (mental component, role emotional, social function, vitality, and mental health scores). For the UCLA-PCI, the largest difference was 12.8 points lower for sexual bother for order of administration by web-mode first (p = .03). Seventy percent preferred the web-mode, 21 % had no preference, and 9 % preferred the paper-mode. CONCLUSION: Web-mode and paper-mode administrations of the SF-36 and UCLA-PCI are equivalent in men with prostate cancer, implying that mixed-mode survey administration is warranted.","Qual Life Res, 23(2): 495-508","USA",2014,"Any or unknown","None","SF-36,UCLA-PCI","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,Utility"]
[84,"Brown, G. C., et al. (2005). \"The burden of age-related macular degeneration: a value-based medicine analysis.\" Trans Am Ophthalmol Soc 103: 173-184; discussion 184-176.",null,"Brown, G. C., et al.","The burden of age-related macular degeneration: a value-based medicine analysis","PURPOSE: To assess the quality-of-life loss and the macroeconomic financial consequences associated with age-related macular degeneration (ARMD). METHODS: Time tradeoff utility analysis was performed to assess the quality-of-life diminution caused by ARMD (both dry and neovascular) in cohorts consisting of (1) patients with ARMD, (2) ophthalmologists asked to assume they had various degrees of severity of ARMD, (3) healthcare providers asked to assume they had various degrees of severity of ARMD, and (4) participants from the general community asked to assume they had various degrees of severity of ARMD. ARMD was classified according to vision in the better-seeing eye as (1) mild: 20/20 to 20/40, (2) moderate: 20/50 to 20/100, (3) severe: < or = 20/200, or (4) very severe: < or = 20/800. RESULTS: Mild ARMD caused a 17% decrement in the quality of life of the average patient, similar to that encountered with moderate cardiac angina or symptomatic human immunodeficiency virus syndrome. Moderate ARMD caused a 32% decrease in the average patient's quality of life, similar to that associated with severe cardiac angina or a fractured hip. Severe ARMD caused a 53% decrease in quality, more than that of dialysis, and very severe ARMD caused a 60% decrease in the average ARMD patient's quality of life, similar to that encountered with end-stage prostate cancer or a catastrophic stroke that leaves a person bedridden, incontinent, and requiring constant nursing care. Patients with varying degrees of severity of ARMD were found to have quality-of-life impairment ranging from 96% to 750% greater than that estimated by treating ophthalmologists for the same condition. An economic analysis based upon losses to the gross domestic product suggests that ARMD has approximately a $30 billion annual negative impact. The return on investment is therefore potentially high for both treatment with current ARMD therapies and the research costs invested in the development of new ARMD treatment modalities. CONCLUSIONS: ARMD is a major public health problem that has a devastating effect upon patients and marked adverse financial consequences for the economy.","Trans Am Ophthalmol Soc, 103(173-184; discussion 184-176","USA",2005,"End of life","None","TTO","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Utility"]
[85,"Brown, M. M., et al. (2006). \"The burden of age-related macular degeneration: a value-based analysis.\" Curr Opin Ophthalmol 17(3): 257-266.",null,"Brown, M. M., et al.","The burden of age-related macular degeneration: a value-based analysis","PURPOSE OF REVIEW: The quality-of-life loss and the financial consequences associated with age-related macular degeneration are assessed. RECENT FINDINGS: The quality-of-life loss associated with macular degeneration is markedly underestimated by the general public, nonophthalmic physicians, and ophthalmologists who treat patients with this condition. Mild age-related macular degeneration causes a 17% decrement in the quality of life of the average patient, similar to that encountered with moderate cardiac angina or symptomatic human immunodeficiency virus syndrome. Moderate age-related macular degeneration causes a 40% decrease in the average patient's quality of life, similar to that associated with severe cardiac angina or renal dialysis. Very severe age-related macular degeneration causes a large 63% decrease in the average patient's quality of life, similar to that encountered with end-stage prostatic cancer or a catastrophic stroke that leaves a person bedridden, incontinent and requiring constant nursing care. The return on investment is high for both treatment with current age-related macular degeneration therapies and the research costs invested in the development of age-related macular degeneration treatment modalities. SUMMARY: Age-related macular degeneration is a major public health problem that has a devastating effect upon patients and marked adverse financial consequences for the economy.","Curr Opin Ophthalmol, 17(3): 257-266","USA",2006,"Any or unknown","None","Unclear","Patient",null,"Narrative review",null,null,null,null,null,null,null,null,"General"]
[86,"Bruner, D. W., et al. (2004). \"Predictors of preferences and utilities in men treated with 3D-CRT for prostate cancer.\" Int J Radiat Oncol Biol Phys 58(1): 34-42.",null,"Bruner, D. W., et al.","Predictors of preferences and utilities in men treated with 3D-CRT for prostate cancer","PURPOSE: To assess the preferences and utilities for prostate cancer health state scenarios of men treated with three-dimensional conformal radiotherapy and the predictors of treatment preferences. METHODS AND MATERIALS: The preferences and utilities for probabilistic health states of impotence and incontinence associated with prostate cancer therapies were elicited from prostate cancer registry participants using a modified time trade-off interview. Sociodemographic, disease, and treatment characteristics, as well as quality-of-life scores, were assessed to determine the predictors of preferences. RESULTS: Fifty-seven men treated with three-dimensional conformal radiotherapy completed the time trade-off interview. Of these men, 83% had Stage T1-T2 and 30% were receiving hormonal therapy. The utilities followed a linear trend with declining scores for increasing risk of poorer health states. Men showed an increased preference for health states associated with radiotherapy compared with surgery or hormonal therapy. Univariate predictors of preference included income and marital status. Multivariate predictors of preferences included more aggressive therapy and better prognostic indicators. Current quality-of-life scores in terms of global, sexual, or urinary function were poor predictors of preferences. CONCLUSION: Preference elicitation can assist in decision-making, and understanding the predictors of patient preferences can assist in identifying factors that may increase patient perceptions of poorer outcomes.","Int J Radiat Oncol Biol Phys, 58(1): 34-42","USA",2004,"Local","Radiotherapy,Hormonal,Surgery","TTO","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Utility"]
[87,"Buckley, B. S., et al. (2012). \"The effect of urinary incontinence on health utility and health-related quality of life in men following prostate surgery.\" Neurourol Urodyn 31(4): 465-469.",null,"Buckley, B. S., et al.","The effect of urinary incontinence on health utility and health-related quality of life in men following prostate surgery","AIMS: The impact of urinary incontinence (UI) on health-related quality of life (HRQoL) has been less well researched in men than women and the general population. This study aims to assess the association between UI and HRQoL in men 1 year after prostate surgery. METHODS: Planned secondary analysis of data from two parallel randomized controlled trials of active conservative treatment for UI in 853 men following radical prostatectomy (RP) and transurethral resection of the prostate (TURP). Men of any age were eligible for trial inclusion if they were experiencing UI 6 weeks after undergoing RP or TURP at 34 centers in the United Kingdom. Univariate and multivariate analysis considered associations between health status (SF-12 and EQ-5D) and self-reported UI. Multivariate analysis controlled for age, obesity, UI prior to surgery, and concomitant fecal incontinence. RESULTS: Mean age of 411 men in the RP trial was 62.3 years (SD 5.7) and 442 men in the TURP trial was 68.0 (SD 7.9). Of men with UI at 6 weeks after surgery, 76.7% in the RP group and 63.2% in the TURP group still had UI at 12 months. Any UI at 12 months was significantly associated with reduced HRQoL in the RP group and lower EQ-5D and SF-12 Mental Component Scores in the TURP group. CONCLUSION: Any UI is a significant factor in reduced HRQoL in men following prostate surgery, particularly younger men who undergo RP. Its importance to patients as an adverse outcome should not be underestimated.","Neurourol Urodyn, 31(4): 465-469","Ireland",2012,"Any or unknown","Surgery","SF-12,EQ-5D","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Complication,Utility"]
[88,"Burgio, K. L., et al. (2006). \"Preoperative biofeedback assisted behavioral training to decrease post-prostatectomy incontinence: a randomized, controlled trial.\" J Urol 175(1): 196-201; discussion 201.",null,"Burgio, K. L., et al.","Preoperative biofeedback assisted behavioral training to decrease post-prostatectomy incontinence: a randomized, controlled trial","PURPOSE: We tested the effectiveness of preoperative biofeedback assisted behavioral training for decreasing the duration and severity of incontinence, and improving quality of life in the 6 months following radical prostatectomy. MATERIALS AND METHODS: We performed a prospective, randomized, controlled trial comparing preoperative behavioral training to usual care. The volunteer sample included 125 men 53 to 68 years old who elected radical prostatectomy for prostate cancer. Patients were stratified according to age and tumor differentiation, and randomized to 1 preoperative session of biofeedback assisted behavioral training plus daily home exercise or a usual care control condition, consisting of simple postoperative instructions to interrupt the urinary stream. The main outcome measurements were duration of incontinence (time to continence), as derived from bladder diaries, incontinence severity (the proportion with severe/continual leakage), pad use, Incontinence Impact Questionnaire, psychological distress (Hopkins Symptom Checklist) and health related quality of life (Medical Outcomes Study Short Form Health Survey). RESULTS: Preoperative behavioral training significantly decreased time to continence (p = 0.03) and the proportion of patients with severe/continual leakage at the 6-month end point (5.9% vs 19.6%, p = 0.04). There were also significant differences between the groups for self-reported urine loss with coughing (22.0% vs 51.1%, p = 0.003), sneezing (26.0% vs 48.9%, p = 0.02) and getting up from lying down (14.0% vs 31.9%, p = 0.04). No differences were found on return to work and usual activities or quality of life measures. CONCLUSIONS: Preoperative behavioral training can hasten the recovery of urine control and decrease the severity of incontinence following radical prostatectomy.","J Urol, 175(1): 196-201; discussion 201","USA",2006,"Any or unknown","Surgery,Psychological","SF-36,IIQ,HSC","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Symptom,Complication,Utility"]
[89,"Burns-Cox, N., et al. (2002). \"Prospective randomised trial comparing diethylstilboestrol and flutamide in the treatment of hormone relapsed prostate cancer.\" Int J Urol 9(8): 431-434.",null,"Burns-Cox, N., et al.","Prospective randomised trial comparing diethylstilboestrol and flutamide in the treatment of hormone relapsed prostate cancer","BACKGROUND: Patients with hormone relapsed prostate cancer (HRPC) are often treated with flutamide or diethylstilboestrol. However, which of these two options is the best treatment for HRPC remains unclear. METHODS: We carried out a prospective study to determine and compare the prostate-specific antigen (PSA) response and survival in patients with hormone relapsed prostate cancer (HRPC), all of whom had previously shown a good response to medical or surgical castration. The patients were randomised to treatment with diethylstilboestrol (DES) and aspirin, or the antiandrogen flutamide. In addition, quality of life was determined by interview and questionnaire. RESULTS: Twenty-eight patients were randomised for treatment options. There was a significantly greater fall in the PSA (65% vs 35%; P = 0.034) after treatment with diethylstilboestrol compared to treatment with flutamide. Median survival also rose after treatment with diethylstilboestrol (18 months) compared to flutamide (11 months), but this difference did not reach statistical significance. There was no difference in the quality of life parameters between the two groups. There were no cardiovascular complications in the stilboestrol group. CONCLUSIONS: In HRPC, treatment with stilboestrol is associated with a greater PSA fall and an increase in median survival when compared to flutamide treatment.","Int J Urol, 9(8): 431-434","UK",2002,"Refractory","Hormonal","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General"]
[90,"Buron, C., et al. (2007). \"Brachytherapy versus prostatectomy in localized prostate cancer: results of a French multicenter prospective medico-economic study.\" Int J Radiat Oncol Biol Phys 67(3): 812-822.",null,"Buron, C., et al.","Brachytherapy versus prostatectomy in localized prostate cancer: results of a French multicenter prospective medico-economic study","PURPOSE: To prospectively compare health-related quality of life (HRQOL), patient-reported treatment-related symptoms, and costs of iodine-125 permanent implant interstitial brachytherapy (IB) with those of radical prostatectomy (RP) during the first 2 years after these treatments for localized prostate cancer. METHODS AND MATERIALS: A total of 435 men with localized low-risk prostate cancer, from 11 French hospitals, treated with IB (308) or RP (127), were offered to complete the European Organization for Research and Treatment of Cancer core Quality of Life Questionnaire QLQ-C30 version 3 (EORTC QLQ-C30) and the prostate cancer specific EORTC QLQ-PR25 module before and at the end of treatment, 2, 6, 12, 18, and 24 months after treatment. Repeated measures analysis of variance and analysis of covariance were conducted on HRQOL changes. Comparative cost analysis covered initial treatment, hospital follow-up, outpatient and production loss costs. RESULTS: Just after treatment, the decrease of global HRQOL was less pronounced in the IB than in the RP group, with a 13.5 points difference (p < 0.0001). A difference slightly in favor of RP was observed 6 months after treatment (-7.5 points, p = 0.0164) and was maintained at 24 months (-8.2 points, p = 0.0379). Impotence and urinary incontinence were more pronounced after RP, whereas urinary frequency, urgency, and urination pain were more frequent after IB. Mean societal costs did not differ between IB (8,019 euros at T24) and RP (8,715 euros at T24, p = 0.0843) regardless of the period. CONCLUSIONS: This study suggests a similar cost profile in France for IB and RP but with different HRQOL and side effect profiles. Those findings may be used to tailor localized prostate cancer treatments to suit individual patients' needs.","Int J Radiat Oncol Biol Phys, 67(3): 812-822","France",2007,"Local","Brachytherapy,Surgery","EORTC QLQ-C30,EORTC QLQ-PR25","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease,General"]
[91,"Butler, L., et al. (2006). \"Prevalence, correlates, and costs of patients with poor adjustment to mixed cancers.\" Cancer Nurs 29(1): 9-16.",null,"Butler, L., et al.","Prevalence, correlates, and costs of patients with poor adjustment to mixed cancers","Approximately 2% to 3% of the Canadian society has experienced cancer. Literature indicates that there is poor adjustment to chronic illness. Individuals with poor adjustment to chronic illness have been found to disproportionately use more health services. The purpose of this study was to determine the prevalence, correlates, and costs associated with poor adjustment to mixed cancer. A consecutive sample (n = 171) of breast, lung, and prostate cancer patients at the Nova Scotia Regional Cancer Center were surveyed. Twenty-eight percent of the cancer group showed fair to poor adjustment to illness using the Psychological Adjustment to Illness Self-report Scale Psychological Adjustment to Illness Self-Report Scale raw score. Poor adjustment was moderately correlated with depression (r = 0.50, P < .0001) and evasive coping (r = 0.38, P < .0001) and unrelated to demographic variables. Depression explained 25% of the variance in poor adjustment to illness in regression analysis. Cancer patients with fair to poor adjustment to illness had statistically significantly higher annual healthcare expenditures (P < .002) than those with good adjustment to illness. Expenditure findings agree with previous literature on chronic illnesses. The prevalence of fair to poor adjustment in this cancer population using the Psychological Adjustment to Illness Self-Report Scale measure is similar to that reported for chronic illness to date, suggesting that only those with better adjustment consented to this study.","Cancer Nurs, 29(1): 9-16","Canada",2006,"Any or unknown","None","PAIS","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"General"]
[92,"Caffo, O., et al. (1996). \"Assessment of quality of life after radical radiotherapy for prostate cancer.\" Br J Urol 78(4): 557-563.",null,"Caffo, O., et al.","Assessment of quality of life after radical radiotherapy for prostate cancer","OBJECTIVE: To assess the quality of life (QoL) of patients with localized prostate cancer (LPC) after treatment by radical radiotherapy (RR). PATIENTS AND METHODS: An \"ad hoc' self-administered questionnaire was developed, which comprised a series of 41 items grouped into seven subscales reflecting the main QoL domains, and the questionnaire's psychometric properties were assessed. A consecutive series of 118 patients treated with RR for LPC from 1981 to 1994 were then selected for a retrospective study and asked to complete the questionnaire. RESULTS: Ninety patients (76%) completed the questionnaire; because 20 of them were also treated with hormonal therapy, QoL was assessed only in the remaining 70 patients, to avoid confusion. The assessment of the psychometric properties showed that the questionnaire was valid and reliable (Cronbach's alpha coefficient > 0.8 for each subscale). The main side-effects of RR were urinary symptoms and sexual impairment, while physical, psychological and relational well-being were good. The degree of information available about the therapy and the disease seemed to play a major role in the patients' QoL adjustment after RR. CONCLUSION: The study assessed a sample of patients with LPC treated with RR and showed that QoL was acceptable after RR. Prospective studies are needed to improve knowledge of the factors involved in the restoration of the QoL after therapy for LPC.","Br J Urol, 78(4): 557-563","Italy",1996,"Local","Radiotherapy","Unclear","Patient",null,"Validation",null,null,null,null,null,null,null,null,"General"]
[93,"Caffo, O., et al. (2006). \"Prospective evaluation of quality of life after interstitial brachytherapy for localized prostate cancer.\" Int J Radiat Oncol Biol Phys 66(1): 31-37.",null,"Caffo, O., et al.","Prospective evaluation of quality of life after interstitial brachytherapy for localized prostate cancer","PURPOSE: Permanent interstitial brachytherapy (IB) has become an increasingly appealing therapeutic option for localized prostate cancer (LPC) among physicians and patients because it involves short hospitalization and treatment and its postulated low degree of toxicity may reduce its impact on the patients' quality of life (QoL). The aim of this prospective study was to assess the impact of IB on the QoL of patients with LPC. METHODS AND MATERIALS: A validated self-completed questionnaire was administered to the patients before and after IB and then at yearly intervals. The items allowed the identification of seven subscales exploring physical well-being (PHY), physical autonomy (POW), psychological well-being (PSY), relational life (REL), urinary function (URI), rectal function (REC), and sexual function (SEX). RESULTS: The assessment of the QoL of 147 patients treated between May 2000 and February 2005 revealed no relevant differences in the PHY scale scores 1 month after IB or later, and the same was true of the POW, PSY, and REL scales. Urinary function significantly worsened after IB and returned to pretreatment levels only after 3 years; the impact of the treatment on the URI scale was greater in the patients with good baseline urinary function than in those presenting more urinary symptoms before IB. Rectal and sexual functions were significantly worse only at the post-IB evaluation. CONCLUSIONS: The results of the present study confirm that the impact of IB on the patients' QoL is low despite its transient negative effects on some function, and extend existing knowledge concerning QoL after IB.","Int J Radiat Oncol Biol Phys, 66(1): 31-37","Italy",2006,"Local","Brachytherapy","Unclear","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"General"]
[94,"Caffo, O., et al. (2011). \"Impact of docetaxel-based chemotherapy on quality of life of patients with castration-resistant prostate cancer: results from a prospective phase II randomized trial.\" BJU Int 108(11): 1825-1832.",null,"Caffo, O., et al.","Impact of docetaxel-based chemotherapy on quality of life of patients with castration-resistant prostate cancer: results from a prospective phase II randomized trial","What's known on the subject? and What does the study add? Data on quality of life during docetaxel treatment in castration resistant prostate cancer was mainly provided by SWOG and TAX327 trials. In the TAX327 trial biochemical response and pain predicted survival, whereas quality of life outcomes did not. In the present study, there were no statistically significant changes in the quality of life scales during treatment except in the case of patients receiving docetaxel and estramustine, who experienced a significant decrease in pain. Our data seem to suggest that patients with a better baseline quality of life (and consequently with fewer symptoms) are more likely to achieve a biochemical response. OBJECTIVES: * To assess quality of life (QoL) outcomes and pain changes in patients affected by castration-resistant prostate cancer enrolled in a phase II randomized trial of 3-week docetaxel (DOC)-based chemotherapy. * To provide further data to clarify the conflicting published data concerning the impact of DOC on the patients' QoL. PATIENTS AND METHODS: * QoL outcomes were assessed using the European Organisation for the Research and Treatment of Cancer QLQ-C30 questionnaire. * Pain changes were evaluated by means of the Brief Pain Inventory at baseline and after every two DOC courses. * The patients completing at least two questionnaires (at baseline and before the third course) were considered evaluable. RESULTS: * In all, 59 patients were evaluable. * Asymptomatic patients and responders had a better baseline QoL than symptomatic patients and non-responders. * There were no statistically significant changes in the QLQ-C30 scales during treatment except in the case of patients receiving DOC and estramustine, who experienced a significant decrease in pain. * There was a progressive improvement in the mean intensity and interference scores of the Brief Pain Inventory. CONCLUSIONS: * Our data confirm that QoL is generally maintained during chemotherapy. * There is a substantial reduction in pain. * Our results also suggest that baseline QoL may predict treatment response.","BJU Int, 108(11): 1825-1832","Italy",2011,"Any or unknown","Taxane","EORTC QLQ-C30,BPI","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General,Symptom"]
[95,"Calais da Silva, F. E., et al. (2009). \"Intermittent androgen deprivation for locally advanced and metastatic prostate cancer: results from a randomised phase 3 study of the South European Uroncological Group.\" Eur Urol 55(6): 1269-1277.",null,"Calais da Silva, F. E., et al.","Intermittent androgen deprivation for locally advanced and metastatic prostate cancer: results from a randomised phase 3 study of the South European Uroncological Group","BACKGROUND: Few randomised studies have compared intermittent hormonal therapy (IHT) with continuous therapy for the treatment of advanced prostate cancer (PCa). OBJECTIVE: To determine whether intermittent therapy is associated with a shorter time to progression. DESIGN, SETTING, AND PARTICIPANTS: 766 patients with locally advanced or metastatic PCa received a 3-mo induction treatment. The 626 patients whose prostate-specific antigen (PSA) level decreased to <4 ng/ml or to 80% below the initial value were randomised. INTERVENTION: Patients received cyproterone acetate (CPA) 200mg for 2 wk and then monthly depot injections of a luteinising hormone-releasing hormone (LHRH) analogue plus 200mg of CPA daily during induction. Patients randomised to the intermittent arm ceased treatment, while those randomised to the continuous arm received 200mg of CPA daily plus an LHRH analogue. MEASUREMENTS: Primary outcome measurement was time to subjective or objective progression. Secondary outcomes were survival and quality of life (QoL). Time off therapy in the intermittent arm was also recorded. RESULTS AND LIMITATIONS: 127 patients from the intermittent arm and 107 patients from the continuous arm progressed, with a hazard ratio (HR) of 0.81 (95% confidence interval [CI]: 0.63-1.05, p=0.11). There was no difference in survival, with an HR of 0.99 (95% CI: 0.80-1.23) and 170 deaths in the intermittent arm and 169 deaths in the continuous arm. The greater number of cancer deaths in the intermittent treatment arm (106 vs 84) was balanced by a greater number of cardiovascular deaths in the continuous arm (52 vs 41). Side-effects were more pronounced in the continuous arm. Men treated with intermittent therapy reported better sexual function. Median time off therapy for the intermittent patients was 52 wk (95% CI: 39.4-65.7). CONCLUSIONS: IHT should be considered for use in routine practice because it is associated with no reduction in survival, no clinically meaningful impairment in QoL, better sexual activity, and considerable economic benefit to the individual and the community.","Eur Urol, 55(6): 1269-1277","Portugal",2009,"Advanced,Metastatic","Hormonal","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General"]
[96,"Carlson, L. E., et al. (2004). \"Mindfulness-based stress reduction in relation to quality of life, mood, symptoms of stress and levels of cortisol, dehydroepiandrosterone sulfate (DHEAS) and melatonin in breast and prostate cancer outpatients.\" Psychoneuroendocrinology 29(4): 448-474.",null,"Carlson, L. E., et al.","Mindfulness-based stress reduction in relation to quality of life, mood, symptoms of stress and levels of cortisol, dehydroepiandrosterone sulfate (DHEAS) and melatonin in breast and prostate cancer outpatients","OBJECTIVES: This study investigated the relationships between a mindfulness-based stress reduction meditation program for early stage breast and prostate cancer patients and quality of life, mood states, stress symptoms, and levels of cortisol, dehydroepiandrosterone-sulfate (DHEAS) and melatonin. METHODS: Fifty-nine patients with breast cancer and 10 with prostate cancer enrolled in an eight-week Mindfulness-Based Stress Reduction (MBSR) program that incorporated relaxation, meditation, gentle yoga, and daily home practice. Demographic and health behavior variables, quality of life, mood, stress, and the hormone measures of salivary cortisol (assessed three times/day), plasma DHEAS, and salivary melatonin were assessed pre- and post-intervention. RESULTS: Fifty-eight and 42 patients were assessed pre- and post-intervention, respectively. Significant improvements were seen in overall quality of life, symptoms of stress, and sleep quality, but these improvements were not significantly correlated with the degree of program attendance or minutes of home practice. No significant improvements were seen in mood disturbance. Improvements in quality of life were associated with decreases in afternoon cortisol levels, but not with morning or evening levels. Changes in stress symptoms or mood were not related to changes in hormone levels. Approximately 40% of the sample demonstrated abnormal cortisol secretion patterns both pre- and post-intervention, but within that group patterns shifted from \"inverted-V-shaped\" patterns towards more \"V-shaped\" patterns of secretion. No overall changes in DHEAS or melatonin were found, but nonsignificant shifts in DHEAS patterns were consistent with healthier profiles for both men and women. CONCLUSIONS: MBSR program enrollment was associated with enhanced quality of life and decreased stress symptoms in breast and prostate cancer patients, and resulted in possibly beneficial changes in hypothalamic-pituitary-adrenal (HPA) axis functioning. These pilot data represent a preliminary investigation of the relationships between MBSR program participation and hormone levels, highlighting the need for better-controlled studies in this area.","Psychoneuroendocrinology, 29(4): 448-474","Canada",2004,"Local","Psychological","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General"]
[97,"Carlsson, S., et al. (2011). \"The excess burden of side-effects from treatment in men allocated to screening for prostate cancer. The Goteborg randomised population-based prostate cancer screening trial.\" Eur J Cancer 47(4): 545-553.",null,"Carlsson, S., et al.","The excess burden of side-effects from treatment in men allocated to screening for prostate cancer. The Goteborg randomised population-based prostate cancer screening trial","BACKGROUND: The number of men needed to treat to prevent one death is rather high in prostate cancer screening. How this affects the burden of treatment-related side-effects is unclear. The aim of this study was to evaluate the treatment related morbidity following radical prostatectomy in men participating in the Goteborg randomised population-based prostate cancer screening trial. METHODS: In 1995, 20,000 men aged 50-64 years were randomly allocated (1:1) to biennial PSA-screening or to a control group not invited. A subset of prostate cancer patients undergoing radical prostatectomy between 2001 and 2008 responded to questionnaires preoperatively and at 18 months postoperatively. The primary endpoint was patient-reported frequencies of erectile dysfunction as measured by the validated International Index of Erectile Function-5 questionnaire and urinary incontinence as assessed by use of pads. Analyses were made according to intention to screen. FINDINGS: After 14 years of follow-up, a total of 1849 men were detected with prostate cancer (1138 screened versus 711 controls, excluding 7 cancers detected at autopsy in the control group). Overall, 1047 received treatment with curative intent and radical prostatectomy was performed in 829 cases (79.2%). In this study, 294 of these men participated (205 screened and 89 controls). Of preoperatively potent men 79.1% (91/115) in the screening-group and 90.7% (49/54) in the control-group became impotent or sexually inactive 18 months postoperatively, whereas 14.3% (29/203) of screened men and 20.5% (18/88) of controls were considered postoperatively incontinent (regular use of pads). Extrapolated data yields that 120/10,000 more men become impotent and 25/10,000 more men will have the need of pads among men invited to regular PSA screening. The 'cost' per life saved at the same follow-up of screening is four men impotent and less than one man incontinent. INTERPRETATION: Despite the relatively high risk of erectile dysfunction and incontinence following radical prostatectomy for prostate cancer, the excess burden of permanent side-effects after population-based screening can be regarded as relatively low, when related to the number of men saved from prostate cancer death. These data can be useful when calculating the harms and benefits of screening. However, the outcome on a population-level may differ from the benefit for the individual.","Eur J Cancer, 47(4): 545-553","Sweden",2011,"Any or unknown","Surgery","IIEF-5","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Complication"]
[98,"Carlsson, S., et al. (2016). \"Population-based study of long-term functional outcomes after prostate cancer treatment.\" BJU Int 117(6b): E36-45.",null,"Carlsson, S., et al.","Population-based study of long-term functional outcomes after prostate cancer treatment","OBJECTIVE: To evaluate long-term urinary, sexual and bowel functional outcomes after prostate cancer treatment at a median (interquartile range) follow-up of 12 (11-13) years. PATIENTS AND METHODS: In this nationwide, population-based study, we identified 6 003 men diagnosed with localized prostate cancer (clinical local stage T1-2, any Gleason score, prostate-specific antigen <20 ng/mL, NX or N0, MX or M0) between 1997 and 2002 from the National Prostate Cancer Register, Sweden. The men were aged </=70 years at diagnosis. A control group of 1 000 men without prostate cancer were also selected, matched for age and county of residence. Functional outcomes were evaluated with a validated self-reported questionnaire. RESULTS: Responses were obtained from 3 937/6 003 cases (66%) and 459/1 000 (46%) controls. At 12 years after diagnosis and at a median age of 75 years, the proportion of cases with adverse symptoms was 87% for erectile dysfunction/sexual inactivity, 20% for urinary incontinence and 14% for bowel disturbances. The corresponding proportions for controls were 62, 6 and 7%, respectively. Men with prostate cancer, except those on surveillance, had an increased risk of erectile dysfunction compared with the men in the control group. Radical prostatectomy was associated with an increased risk of urinary incontinence (odds ratio [OR] 1.89, 95% confidence interval [CI] 1.36-2.62) and radiotherapy increased the risk of bowel dysfunction (OR 2.46, 95% CI 1.73-3.49) compared with men in the control group. Multi-modal treatment, in particular treatment including androgen deprivation therapy (ADT), was associated with the highest risk of adverse effects; for instance, radical prostatectomy followed by radiotherapy and ADT was associated with an OR of 3.74 (95% CI 1.76-7.95) for erectile dysfunction and an OR of 3.22 (95% CI 1.93-5.37) for urinary incontinence. CONCLUSION: The proportion of men who experienced a long-term impact on functional outcomes after prostate cancer treatment was substantial.","BJU Int, 117(6b): E36-45","Sweden",2016,"Local","Surgery,Radiotherapy,Hormonal","Unclear","Patient",null,"Case-control",null,null,null,null,null,null,null,null,"General"]
[99,"Carmack Taylor, C. L., et al. (2004). \"Quality of life intervention for prostate cancer patients: design and baseline characteristics of the active for life after cancer trial.\" Control Clin Trials 25(3): 265-285.",null,"Carmack Taylor, C. L., et al.","Quality of life intervention for prostate cancer patients: design and baseline characteristics of the active for life after cancer trial","Prostate cancer patients receiving androgen ablation therapy experience significant physical and psychological sequelae associated with their disease and treatment. Because physical activity improves physical and psychological well-being, a lifestyle physical activity intervention may help slow or reverse the associated decline in quality of life (QOL). No studies have evaluated an intervention to improve multiple QOL domains in patients receiving androgen ablation therapy. Active for Life After Cancer is a three-group randomized controlled trial designed to evaluate the effectiveness of a lifestyle physical activity intervention (Lifestyle Program) in improving QOL. The Lifestyle Program, a 6-month behavioral skills training group, is compared to an Educational Support Program and Standard Care. The purpose of this paper is to describe the design of the randomized trial and present baseline data that will characterize the QOL of the sample. Challenges to recruitment for the trial also will be presented and discussed.","Control Clin Trials, 25(3): 265-285","USA",2004,"Any or unknown","Various","Unclear","Patient",null,"Protocol",null,null,null,null,null,null,null,null,"General"]
[100,"Carter, J. A., et al. (2011). \"Cost effectiveness of zoledronic acid in the management of skeletal metastases in hormone-refractory prostate cancer patients in France, Germany, Portugal, and the Netherlands.\" J Med Econ 14(3): 288-298.",null,"Carter, J. A., et al.","Cost effectiveness of zoledronic acid in the management of skeletal metastases in hormone-refractory prostate cancer patients in France, Germany, Portugal, and the Netherlands","OBJECTIVE: Zoledronic acid (ZOL) reduces the risk of skeletal related events (SREs) in hormone-refractory prostate cancer (HRPC) patients with bone metastases. This study assessed the cost effectiveness of ZOL for SRE management in French, German, Portuguese, and Dutch HRPC patients. METHODS: This analysis was based on the results of a randomized phase III clinical trial wherein HRPC patients received up to 15 months of ZOL (n = 214) or placebo (n = 208). Clinical inputs were obtained from the trial. Costs were estimated using hospital tariffs, published, and internet sources. Quality adjusted life-years (QALYs) gained were estimated from a separate analysis of EQ-5D scores reported in the trial. Uncertainty surrounding outcomes was addressed via univariate sensitivity analyses. RESULTS: ZOL patients experienced an estimated 0.759 fewer SREs and gained an estimated 0.03566 QALYs versus placebo patients. ZOL was associated with reduced SRE-related costs [net costs] (-euro2396 [euro1284] in France, -euro2606 [euro841] in Germany, -euro3326 [euro309] in Portugal and -euro3617 [euro87] in the Netherlands). Costs per QALY ranged from euro2430 (Netherlands) to euro36,007 (France). CONCLUSIONS: This analysis is subject to the limitations of most cost-effectiveness analyses: it combines data from multiple sources. Nevertheless, the results strongly suggest that ZOL is cost effective versus placebo in French, German, Portuguese, and Dutch HRPC patients.","J Med Econ, 14(3): 288-298","France,Germany,Portugal,Netherlands",2011,"Metastatic","Bisphosphonate","EQ-5D","Patient",null,"Economic model",null,null,null,null,null,null,null,null,"Utility"]
[101,"Carter, J. P., et al. (1993). \"Hypothesis: dietary management may improve survival from nutritionally linked cancers based on analysis of representative cases.\" J Am Coll Nutr 12(3): 209-226.",null,"Carter, J. P., et al.","Hypothesis: dietary management may improve survival from nutritionally linked cancers based on analysis of representative cases","A limited number of case histories was analyzed and verified to examine the effect of a very low fat, moderately high fiber, and moderately reduced calorie diet on the survival and quality of life of patients with primary cancer of the pancreas, metastatic stage D2 prostate cancer, and other nutritionally linked cancers. The retrospective study of pancreatic cancer patients disclosed that 1-year survival was higher among those who modified their diets than in those for whom there was no evidence as to diet alteration. For patients with metastatic prostate cancer (stage D2), a case control study demonstrated a statistical association of dietary modification with longer survival and improved quality of life. A retrospective study utilizing questionnaires supported such dietary modifications as a useful tool in the management of nutritionally linked cancers.","J Am Coll Nutr, 12(3): 209-226","USA",1993,"Metastatic","Various","Unclear","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"General"]
[102,"Cary, K. C., et al. (2014). \"Impact of androgen deprivation therapy on mental and emotional well-being in men with prostate cancer: analysis from the CaPSURE registry.\" J Urol 191(4): 964-970.",null,"Cary, K. C., et al.","Impact of androgen deprivation therapy on mental and emotional well-being in men with prostate cancer: analysis from the CaPSURE registry","PURPOSE: While androgen deprivation therapy can delay cancer progression and reduce tumor burden, its use can be limited by adverse side effects. We evaluated the effect of androgen deprivation therapy on mental and emotional well-being in men with nonmetastatic prostate cancer. MATERIALS AND METHODS: Participants were enrolled in the national CaPSURE (Cancer of the Prostate Strategic Urologic Research Endeavor) registry, and treated with radical prostatectomy, external beam radiation therapy or brachytherapy with no androgen deprivation therapy (local); local with androgen deprivation therapy (combination); or primary androgen deprivation therapy. Emotional quality of life was evaluated by SF-36(R) social function, role emotional, vitality and mental health subscales before and up to 24 months after treatment. Subscales were assessed as continuous scores and as clinically meaningful declines of at least half a standard deviation since pretreatment. Associations between treatment and quality of life changes over time were evaluated with mixed modeling. Quality of life declines were evaluated with logistic regression. RESULTS: Among 3,068 men the combination and primary androgen deprivation therapy groups were older, single, with less education and higher clinical CAPRA (Cancer of the Prostate Risk Assessment) score risk than the local group (all values p <0.01). Androgen deprivation therapy exposure was associated with significant changes with time in adjusted role emotional (-8.4 points, p = 0.01) and vitality (-9.2 points, p = 0.02) scores. Treatment group was not associated with any clinically meaningful quality of life declines. A potential limitation is the observational nature of the study. CONCLUSIONS: Use of androgen deprivation therapy was associated with changes in mental and emotional well-being but did not result in clinically meaningful declines at 24 months. Patients must be counseled on possible quality of life changes related to androgen deprivation therapy as well as interventions to attenuate these effects before receiving treatment for prostate cancer.","J Urol, 191(4): 964-970","USA",2014,"Advanced,Local","Hormonal,Surgery,Radiotherapy","SF-36","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Utility"]
[103,"Cathala, N., et al. (2003). \"Patient followup after radical prostatectomy by Internet medical file.\" J Urol 170(6 Pt 1): 2284-2287.",null,"Cathala, N., et al.","Patient followup after radical prostatectomy by Internet medical file","PURPOSE: The development of the Internet and the need for regular followup of patients often living a long way from the hospital led us to develop a followup dossier for those with localized prostate cancer treated with laparoscopic radical prostatectomy. MATERIALS AND METHODS: This feasibility study was based on 140 patients who agreed to test this system. The website was opened on a server specifically devoted to this project with all required computer security. The website is composed of pages comprising the hospital discharge summary, and operative and histology reports. A quality of life questionnaire based on the assessment of urinary continence and sex life, and a prostate specific antigen (PSA) assay form are also included. RESULTS: The patient is able to enter his PSA data and complete the questionnaire at home. Results are then sent to the treating physician. A contact page allows the patient and physician to exchange information by text. Of these 100 patients 92 connected regularly to the site with a mean connection rate of 8 per patient (range 1 to 22). Of the patients 98% were satisfied with the various sections of the site, 95% were satisfied with the medical file, 11% noticed connection problems and 14% reported technical problems essentially attributable to incorrect PSA data entry or incorrect functioning of videos due to the absence of appropriate software. CONCLUSIONS: This type of Internet medical service for patients who have undergone surgery requiring regular followup appears to be a useful approach for the future by allowing the maintenance of close contact between the patient and physicians, while avoiding problems related to hospital visits regardless of the patient place of residence. It also provides general practitioners with access to the patient file with patient permission.","J Urol, 170(6 Pt 1): 2284-2287","France",2003,"Local","Surgery","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Complication"]
[104,"Cella, D., et al. (2003). \"What are the most important symptom targets when treating advanced cancer? A survey of providers in the National Comprehensive Cancer Network (NCCN).\" Cancer Invest 21(4): 526-535.",null,"Cella, D., et al.","What are the most important symptom targets when treating advanced cancer? A survey of providers in the National Comprehensive Cancer Network (NCCN)","We derived a set of brief, clinically relevant symptom indices for assessing symptomatic response to chemotherapy for advanced bladder, brain, breast, colorectal, head and neck, hepatobiliary/pancreas, lung, ovarian, and prostate cancers. Questions were extracted from a multidimensional cancer quality of life (QOL) measurement system, the Functional Assessment of Cancer Therapy (FACT). Surveys of disease-related symptoms were presented to expert physicians and nurses at 17 National Comprehensive Cancer Network (NCCN) member institutions. In a two-step procedure, each expert narrowed the list to no more than five of the very most important to attend to when assessing the value of drug treatment for advanced disease. Symptoms endorsed at a frequency greater than chance probability were retained for the nine symptom indices. The resulting NCCN/FACT symptom indices are comprised of 6-15 items, depending on disease. Fatigue, pain, nausea, weight loss, worry about worsening condition, and contentment with current QOL were consistently selected by experts as priority symptoms across tumor sites. These nine tumor-specific symptom indices indicate the most important clinician-rated targets of chemotherapy for many advanced cancers. These results await validation in patient populations and examination of the extent to which changes in symptomatology translate into meaningful improvement to the patient.","Cancer Invest, 21(4): 526-535","USA",2003,"Advanced","Chemotherapy","FACT-G","HCP",null,"Validation",null,null,null,null,null,null,null,null,"Treatment"]
[105,"Cessna, J. M., et al. (2016). \"Evaluation of the psychometric properties of the PROMIS Cancer Fatigue Short Form with cancer patients.\" J Psychosom Res 81: 9-13.",null,"Cessna, J. M., et al.","Evaluation of the psychometric properties of the PROMIS Cancer Fatigue Short Form with cancer patients","OBJECTIVE: Fatigue is common among cancer patients and adversely impacts quality of life. As such, it is important to measure fatigue accurately in a way that is not burdensome to patients. The 7-item Patient Reported Outcome Measurement Information System (PROMIS) Cancer Fatigue Short Form scale was recently developed using item response theory (IRT). The current study evaluated the psychometric properties of this scale in two samples of cancer patients using classical test theory (CTT). METHODS: Two samples were used: 121 men with prostate cancer and 136 patients scheduled to undergo hematopoietic cell transplantation (HCT) for hematologic cancer. All participants completed the PROMIS Cancer Fatigue Short Form as well as validated measures of fatigue, vitality, and depression. HCT patients also completed measures of anxiety, perceived stress, and a clinical interview designed to identify cases of cancer-related fatigue. RESULTS: PROMIS Cancer Fatigue Short Form items loaded on a single factor (CFI=0.948) and the scale demonstrated good internal consistency reliability in both samples (Cronbach's alphas>0.86). Correlations with psychosocial measures were significant (p values<.0001) and in the expected direction, offering evidence for convergent and concurrent validity. PROMIS Fatigue scores were significantly higher in patients who met case definition criteria for cancer-related fatigue (p<.0001), demonstrating criterion validity. CONCLUSION: The current study provides evidence that the PROMIS Cancer Fatigue Short Form is a reliable and valid measure of fatigue in cancer patients.","J Psychosom Res, 81(9-13","USA",2016,"Any or unknown","None","PROMIS","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Symptom"]
[106,"Chan, J. S., et al. (2008). \"A phase II study of high-dose calcitriol combined with mitoxantrone and prednisone for androgen-independent prostate cancer.\" BJU Int 102(11): 1601-1606.",null,"Chan, J. S., et al.","A phase II study of high-dose calcitriol combined with mitoxantrone and prednisone for androgen-independent prostate cancer","OBJECTIVE: To evaluate the preliminary efficacy, safety, and impact on quality of life (QoL) of high-dose calcitriol (DN-101) combined with mitoxantrone and glucocorticoids in androgen-independent prostate cancer (AIPC). PATIENTS AND METHODS: Nineteen patients with metastatic AIPC and no previous chemotherapy received DN-101 180 microg orally on day 1 and mitoxantrone 12 mg/m(2) intravenously on day 2 every 21 days with continuous daily prednisone 10 mg orally for a maximum of 12 cycles. A confirmed decline in prostate-specific antigen (PSA) levels by half was the primary endpoint. QoL was evaluated using the European Organization for Research and Treatment of Cancer QLQ-C30 questionnaire, and pain and analgesic use were evaluated. RESULTS: Five of 19 patients (26%; 95% confidence interval, CI, 9-51) achieved a >/=50% decline in PSA level. The median (95% CI) time to PSA progression was 16 (6-26) weeks. The overall median (95% CI) survival was 16 (6-26) months; 47 (21-73)% of patients achieved an analgesic response. Toxicity was similar to that expected with mitoxantrone and prednisone alone. The QoL analysis suggested a decrease in physical functioning and increase in fatigue, insomnia, and diarrhoea. CONCLUSIONS: DN-101 given every 3 weeks does not add significant activity to mitoxantrone and prednisone in AIPC, as measured by the PSA decline. The high rate of analgesic response is encouraging. The addition of DN-101 does not appear to increase the toxicity of mitoxantrone.","BJU Int, 102(11): 1601-1606","USA",2008,"Metastatic","Chemotherapy","EORTC QLQ-C30","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General"]
[107,"Chang, P., et al. (2011). \"Expanded prostate cancer index composite for clinical practice: development and validation of a practical health related quality of life instrument for use in the routine clinical care of patients with prostate cancer.\" J Urol 186(3): 865-872.",null,"Chang, P., et al.","Expanded prostate cancer index composite for clinical practice: development and validation of a practical health related quality of life instrument for use in the routine clinical care of patients with prostate cancer","PURPOSE: Measuring the health related quality of life of patients with prostate cancer in routine clinical practice is hindered by the lack of instruments enabling efficient, real-time, point of care scoring of multiple health related quality of life domains. Thus, we developed an instrument for this purpose. MATERIALS AND METHODS: The Expanded Prostate Cancer Index Composite for Clinical Practice is a 1-page, 16-item questionnaire that we constructed to measure urinary incontinence, urinary irritation, and the bowel, sexual and hormonal health related quality of life domains. We eliminated conceptually overlapping items from the 3-page Expanded Prostate Cancer Index Composite-26 and revised the questionnaire format to mirror the AUA symptom index, thereby enabling practitioners to calculate health related quality of life scores at the point of care. We administered the Expanded Prostate Cancer Index Composite for Clinical Practice to a new cohort of patients with prostate cancer in community based and academic oncology, radiation, and urology practices to evaluate instrument validity as well as ease of use in clinical practice. RESULTS: A total of 175 treated and 132 untreated subjects with prostate cancer completed the Expanded Prostate Cancer Index Composite for Clinical Practice. The domain scores of the Expanded Prostate Cancer Index Composite for Clinical Practice correlated highly with the respective domain scores from longer versions of the Expanded Prostate Cancer Index Composite (r>/=0.93 for all domains). The Expanded Prostate Cancer Index Composite for Clinical Practice showed high internal consistency (Cronbach's alpha 0.64-0.84) and sensitivity to prostate cancer treatment related effects (p<0.05 in each of 5 health related quality of life domains). Patients completed the Expanded Prostate Cancer Index Composite for Clinical Practice efficiently (96% in less than 10 minutes and with 11% missing items). It was deemed very convenient by clinicians in 87% of routine clinical encounters and clinicians accurately scored completed questionnaires 94% of the time. CONCLUSIONS: The Expanded Prostate Cancer Index Composite for Clinical Practice is a valid instrument that enables patient reported, health related quality of life to be measured efficiently and accurately at the point of care, and thereby facilitates improved emphasis and management of patient reported outcomes.","J Urol, 186(3): 865-872","USA",2011,"Any or unknown","None","EPIC","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease"]
[108,"Chang, V. T., et al. (2004). \"Shorter symptom assessment instruments: the Condensed Memorial Symptom Assessment Scale (CMSAS).\" Cancer Invest 22(4): 526-536.",null,"Chang, V. T., et al.","Shorter symptom assessment instruments: the Condensed Memorial Symptom Assessment Scale (CMSAS)","BACKGROUND: Rapid and efficient symptom assessment is an important aspect of palliative care. The objective was to determine whether a smaller number of symptoms from the 32-item Memorial Symptom Assessment Scale Short-Form (MSAS-SF) could convey equivalent quality of life (QOL) information. METHODS: Responses from 479 medical oncology patients who completed the MSAS-SF and the Functional Assessment Cancer Therapy (FACT-G) were analyzed. Canonical correlations were performed to assess the relationships of 32 MSAS-SF symptoms to quality of life (FACT-G domains) and clinical variables [age, Karnofsky performance status (KPS), stage of disease, and inpatient status]. The relation of the subscales of the Condensed MSAS (CMSAS) and FACT-G to survival was assessed in a multivariate model. RESULTS: The median age was 67 years (range, 20-89) and median KPS was 80% (range, 20-100). Primary sites were prostate in 141 (29%) patients, lung in 121 (26%) patients, colorectal in 53 (11%) patients, hematologic in 50 (10%) patients, head and neck in 30 (6%) patients and other in 84 (18%) patients. Median survival was 245 days (range, 1-2,215 days). Canonical correlation analyses identified a five-dimensional QOL factor structure. Symptoms important for QOL also correlated significantly with survival and provided the basis for the CMSAS with 14 symptoms and 3 subscales (CMSAS SUM, CMSAS PHYS, and CMSAS PSYCH). In multivariate analyses, the CMSAS PSYCH predicted survival independently of stage, performance status, and QOL. The CMSAS takes 2-4 minutes to complete. CONCLUSION: The CMSAS contains both QOL and survival information approximately equivalent to the original 32 items.","Cancer Invest, 22(4): 526-536","USA",2004,"Any or unknown","None","FACT-G,MSAS","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Treatment,Symptom"]
[109,"Chang, V. T., et al. (2015). \"Patient-Reported Outcomes for Determining Prognostic Groups in Veterans With Advanced Cancer.\" J Pain Symptom Manage 50(3): 313-320.",null,"Chang, V. T., et al.","Patient-Reported Outcomes for Determining Prognostic Groups in Veterans With Advanced Cancer","CONTEXT: Physicians overestimate survival in patients with advanced cancer. Patient-reported outcomes could provide another way to estimate survival. We previously reported four prognostic groups based on Karnofsky Performance Status, Functional Assessment of Cancer Therapy physical well-being subscale, and Memorial Symptom Assessment Scale-Short Form physical symptom distress subscale scores. OBJECTIVES: To determine the validity of these four prognostic groups. METHODS: We performed prospective surveys. Data from a total of 880 Veterans Affairs Medical Center patients, 417 in the First Cohort and 463 in the Validation Cohort, were analyzed. Both inpatients and outpatients were prospectively recruited in Institutional Review Board-approved studies from August 1999 to September 2009. Survival was measured from the date of entry until death or December 1, 2009. Patients completed self-assessments with the Functional Assessment of Cancer Therapy and Memorial Symptom Assessment Scale-Short Form. Analysis of variance was used to test differences between groups in continuous variables; a generalized Wilcoxon test was used for differences between groups for survival. RESULTS: The average age in the Validation Cohort was 66.5 years and 98% were men. The majority of patients had metastatic cancer (90%), with lung (28%) and prostate (26%) cancers being predominant. The median Karnofsky Performance Status was 70. Median survival was 33, 46.5, 124, and 209.5 days for the four prognostic groups (P < 0.0001, all pair-wise comparisons P < 0.02). CONCLUSION: The four prognostic groups remained distinct in the prospective cohort. Small differences in patient-reported physical well-being can halve survival estimates. Patient-reported outcomes can correct for physician overestimate of prognosis. This study provides a way to use patient-reported outcomes for prognosis in patients with advanced cancer, with important implications for assessment.","J Pain Symptom Manage, 50(3): 313-320","USA",2015,"Advanced,Metastatic","None","FACT-G,SF-36,MSAS","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Treatment,Utility,Symptom"]
[110,"Chang, Y. J., et al. (2012). \"Psychometric evaluation of the Taiwan Chinese version of the EORTC QLQ-PR25 for HRQOL assessment in prostate cancer patients.\" Health Qual Life Outcomes 10: 96.",null,"Chang, Y. J., et al.","Psychometric evaluation of the Taiwan Chinese version of the EORTC QLQ-PR25 for HRQOL assessment in prostate cancer patients","OBJECTIVE: To evaluate the psychometric properties of the Taiwan Chinese Version of the EORTC QLQ-PR25 health-related quality of life (HRQOL) questionnaire for patients with prostate cancer. METHODS: 135 prostate cancer patients were recruited in the urology outpatient clinic of a university teaching hospital. Each patient completed the EORTC QLQ-PR25 at every clinic visit between 2004 and 2008, totaling 633 assessments. Confirmatory factor analysis and Rasch analysis were used to evaluate the domain- and item-level psychometric properties. RESULTS: The results supported the unidimensionality of each of the four EORTC QLQ-PR25 domains (urinary, bowel, and hormonal-treatment-related symptoms, and sexual functioning). Item calibrations for each domain were found invariant across the three assessment time periods. The item-person maps showed 71.3% of item coverage for the urinary symptoms domain and 13-42.7% for the other three domains. CONCLUSIONS: The Taiwan Chinese Version of the EORTC QLQ-PR25 questionnaire is reliable and can be used to measure HRQOL over time. Adding new items to each domain may improve its clinical content coverage and measurement precision.","Health Qual Life Outcomes, 10(96","Taiwan",2012,"Any or unknown","None","EORTC QLQ-PR25","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease"]
[111,"Chang, Y. J., et al. (2014). \"Measurement equivalence and feasibility of the EORTC QLQ-PR25: paper-and-pencil versus touch-screen administration.\" Health Qual Life Outcomes 12: 23.",null,"Chang, Y. J., et al.","Measurement equivalence and feasibility of the EORTC QLQ-PR25: paper-and-pencil versus touch-screen administration","OBJECTIVE: We assessed the measurement equivalence and feasibility of the paper-and-pencil and touch-screen modes of administration of the Taiwan Chinese version of the EORTC QLQ-PR25, a commonly used questionnaire to evaluate the health-related quality of life (HRQOL) in patients with prostate cancer in Taiwan. METHODS: A cross-over design study was conducted in 99 prostate cancer patients at an urology outpatient clinic. Descriptive exact and global agreement percentages, intraclass correlation, and equivalence test based on minimal clinically important difference (MCID) approach were used to examine the equity of HRQOL scores between these two modes of administration. We also evaluated the feasibility of computerized assessment based on patients' acceptability and preference. Additionally, we used Rasch rating scale model to assess differential item functioning (DIF) between the two modes of administration. RESULTS: The percentages of global agreement in all domains were greater than 85% in the EORTC QLQ-PR25. All results from equivalence tests were significant, except for Sexual functioning, indicating good equivalence. Only one item exhibited DIF between the two modes. Although nearly 80% of the study patients had no prior computer-use experience, the overall proportion of acceptance and preference for the touch-screen mode were quite high and there was no significant difference across age groups or between computer-use experience groups. CONCLUSIONS: The study results showed that the data obtained from the modes of administration were equivalent. The touch-screen mode of administration can be a feasible and suitable alternative to the paper-and-pencil mode for assessment of patient-reported outcomes in patients with prostate cancer.","Health Qual Life Outcomes, 12(23","Taiwan",2014,"Any or unknown","None","EORTC QLQ-PR25","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease"]
[112,"Chapman, G. B., et al. (1998). \"Prostate cancer patients' utilities for health states: how it looks depends on where you stand.\" Med Decis Making 18(3): 278-286.",null,"Chapman, G. B., et al.","Prostate cancer patients' utilities for health states: how it looks depends on where you stand","Two versions of the time-tradeoff (TTO) method were compared. In the personal TTO version, 31 prostate cancer patients decided whether they personally would give up some longevity to have perfect health rather than a longer life in a state of poor health associated with prostate cancer. In the impersonal version, 28 patients compared two hypothetical friends, one of whom has perfect health but will live less time than the other who is in poor health, and decided which person they would rather be. All patients evaluated three hypothetical health states. The two TTO methods were assessed by examining 1) how well they distinguished three health states of varying degrees of dysfunction and 2) patients' willingness to trade time for quality of life. Patients using the impersonal TTO version were more likely than those using the personal version to order the three health states appropriately (68% vs 16%, p < 0.0001) and were more willing to trade off length of life for quality of life (p < 0.05).","Med Decis Making, 18(3): 278-286","USA",1998,"Any or unknown","None","TTO","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Utility"]
[113,"Chen, J. Y., et al. (2011). \"Patient-reported outcomes of prostate high-dose-rate brachytherapy boost comparing an outpatient and inpatient protocol: a two-center chronologic cohort study.\" Brachytherapy 10(6): 454-460.",null,"Chen, J. Y., et al.","Patient-reported outcomes of prostate high-dose-rate brachytherapy boost comparing an outpatient and inpatient protocol: a two-center chronologic cohort study","PURPOSE: To determine patients' self-reported experiences of outpatient high-dose-rate prostate brachytherapy boost, and compare with previous cohort treated as inpatients. METHODS AND MATERIALS: Using the Prostate Brachytherapy Questionnaire, we previously examined patients' subjective experience of the brachytherapy procedure when it involved one implant and hospitalization with the template in situ for 2 days (Group 1). The protocol was subsequently changed to two implants, 2 weeks apart as outpatients. Fifty-eight patients treated with the new protocol (Group 2) completed the same questionnaire. We compared the self-reported experiences between Groups 1 and 2 and also between the first and second implant for those in Group 2. Our hypothesis was that the worst rated issues in Group 1 might be reduced with the new approach. RESULTS: Group 2 patients were less troubled overall by the procedure (mean scores 2.3 vs. 3.2, p=0.0293). Specifically, they were less troubled by \"discomfort\" (2.8 vs. 3.8, p=0.0254); \"being stuck in bed\" (1.7 vs. 4.2 p<0.0001); \"feeling helpless\" (1.3 vs. 2.8, p=0.0009); \"fear of opening my bowels\" (2.1 vs. 3.3, p=0.0055); and \"fear of coping with the implant\" (1.3 vs. 2.5, p=0.0004). There was no significant increase in \"thought of implant\" or \"fear of implant\" before the second implant. However, more patients rated worse than expected \"fear of passing urine\" during the second implant. CONCLUSIONS: Patients rated high-dose-rate brachytherapy less troublesome when delivered as outpatient with two implants, 2 weeks apart than as inpatient over 3 days, despite the additional invasive procedure and anesthesia.","Brachytherapy, 10(6): 454-460","Australia",2011,"Any or unknown","Brachytherapy","PBQ","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Treatment"]
[114,"Chen, R. C., et al. (2012). \"Patient-reported quality of life during radiation treatment for localized prostate cancer: results from a prospective phase II trial.\" BJU Int 110(11): 1690-1695.",null,"Chen, R. C., et al.","Patient-reported quality of life during radiation treatment for localized prostate cancer: results from a prospective phase II trial","Study Type--Therapy (cohort) Level of Evidence 2a. What's known on the subject? and What does the study add? Patient-reported quality of life (QoL) in prostate cancer is recognized as an important outcome, and has been shown in multiple studies to capture the incidence and timing of patient symptoms more accurately than physician-graded toxicity reports. Although the long-term QoL after completing radiation therapy (RT) has been previously studied, patient experience during RT is not well described in the literature. The present study collected patient-reported QoL during RT in a prospective phase II clinical trial. The study describes in detail the time course and severity of gastrointestinal and genitourinary symptoms during radiation, providing clinically useful information for patients and physicians considering RT during the treatment decision-making process. OBJECTIVE: * To evaluate data collected from a phase II trial to describe the time course and trajectory of patient-reported acute urinary and bowel symptom development during radiation therapy (RT) for prostate cancer. PATIENTS AND METHODS: * In all, 100 patients with intermediate- or high-risk prostate cancer received 72 Gy of RT to the prostate and seminal vesicles, with 6 months of concurrent androgen deprivation therapy; a rectal balloon was used for prostate immobilization. * Patients completed the validated Prostate Cancer Symptom Indices questionnaire every 1-2 weeks, reporting urinary and bowel symptoms on a four- or five-point Likert scale. * A score of >/= 3 in a symptom is associated with clinically meaningful distress. Cumulative incidence of each symptom is reported. Bonferroni corrections of P values were used to adjust for multiple comparisons. RESULTS: * Urinary symptoms were frequent at baseline and worsened during treatment. By the end of RT, 28-50% of patients developed clinically meaningful obstructive and irritative urinary symptoms. * Acute bowel symptoms were less frequent. Each bowel symptom increased in frequency by 9-26% from baseline to end of RT. * Urinary incontinence was rare. * Overall, symptom burden at the end of treatment was modest. CONCLUSIONS: * Urinary symptoms were common during RT, and bowel symptoms were less frequent. * These results inform patients and physicians during the decision-making process about potential patient quality of life experiences during RT, and also provide a benchmark for comparative effectiveness studies against newer treatments and technologies.","BJU Int, 110(11): 1690-1695","USA",2012,"Local","Radiotherapy","PCSI","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Symptom"]
[115,"Chen, R. C., et al. (2017). \"Association Between Choice of Radical Prostatectomy, External Beam Radiotherapy, Brachytherapy, or Active Surveillance and Patient-Reported Quality of Life Among Men With Localized Prostate Cancer.\" Jama 317(11): 1141-1150.",null,"Chen, R. C., et al.","Association Between Choice of Radical Prostatectomy, External Beam Radiotherapy, Brachytherapy, or Active Surveillance and Patient-Reported Quality of Life Among Men With Localized Prostate Cancer","Importance: Patients diagnosed with localized prostate cancer have to decide among treatment strategies that may differ in their likelihood of adverse effects. Objective: To compare quality of life (QOL) after radical prostatectomy, external beam radiotherapy, and brachytherapy vs active surveillance. Design, Setting, and Participants: Population-based prospective cohort of 1141 men (57% participation among eligible men) with newly diagnosed prostate cancer were enrolled from January 2011 through June 2013 in collaboration with the North Carolina Central Cancer Registry. Median time from diagnosis to enrollment was 5 weeks, and all men were enrolled with written informed consent prior to treatment. Final follow-up date for current analysis was September 9, 2015. Exposures: Treatment with radical prostatectomy, external beam radiotherapy, brachytherapy, or active surveillance. Main Outcomes and Measures: Quality of life using the validated instrument Prostate Cancer Symptom Indices was assessed at baseline (pretreatment) and 3, 12, and 24 months after treatment. The instrument contains 4 domains-sexual dysfunction, urinary obstruction and irritation, urinary incontinence, and bowel problems-each scored from 0 (no dysfunction) to 100 (maximum dysfunction). Propensity-weighted mean domain scores were compared between each treatment group vs active surveillance at each time point. Results: Of 1141 enrolled men, 314 pursued active surveillance (27.5%), 469 radical prostatectomy (41.1%), 249 external beam radiotherapy (21.8%), and 109 brachytherapy (9.6%). After propensity weighting, median age was 66 to 67 years across groups, and 77% to 80% of participants were white. Across groups, propensity-weighted mean baseline scores were 41.8 to 46.4 for sexual dysfunction, 20.8 to 22.8 for urinary obstruction and irritation, 9.7 to 10.5 for urinary incontinence, and 5.7 to 6.1 for bowel problems. Compared with active surveillance, mean sexual dysfunction scores worsened by 3 months for patients who received radical prostatectomy (36.2 [95% CI, 30.4-42.0]), external beam radiotherapy (13.9 [95% CI, 6.7-21.2]), and brachytherapy (17.1 [95% CI, 7.8-26.6]). Compared with active surveillance at 3 months, worsened urinary incontinence was associated with radical prostatectomy (33.6 [95% CI, 27.8-39.2]); acute worsening of urinary obstruction and irritation with external beam radiotherapy (11.7 [95% CI, 8.7-14.8]) and brachytherapy (20.5 [95% CI, 15.1-25.9]); and worsened bowel symptoms with external beam radiotherapy (4.9 [95% CI, 2.4-7.4]). By 24 months, mean scores between treatment groups vs active surveillance were not significantly different in most domains. Conclusions and Relevance: In this cohort of men with localized prostate cancer, each treatment strategy was associated with distinct patterns of adverse effects over 2 years. These findings can be used to promote treatment decisions that incorporate individual preferences.","Jama, 317(11): 1141-1150","USA",2017,"Local","Surgery,Radiotherapy,Surveillance,Brachytherapy","PCSI","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Symptom"]
[116,"Chi, K. N., et al. (2012). \"A phase 2 study of patupilone in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel: Canadian Urologic Oncology Group study P07a.\" Ann Oncol 23(1): 53-58.",null,"Chi, K. N., et al.","A phase 2 study of patupilone in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel: Canadian Urologic Oncology Group study P07a","BACKGROUND: The purpose of this study was to determine the clinical activity of patupilone in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel. PATIENTS AND METHODS: Eligible patients had progressive disease within 6 months of receiving docetaxel. Patupilone was administered 10 mg/m2 i.v. every 3 weeks. The primary end point was the proportion of patients with a confirmed>/=50% prostate-specific antigen (PSA) decline. RESULTS: Eighty-three patients were enrolled. At baseline, the median time to progression after prior docetaxel was 1.4 months (range 0-5.7). Gastrointestinal serious adverse events occurred in four of the six initial patients leading to a reduction of the starting dose of patupilone to 8 mg/m2 for subsequent patients. Grade 3-4 toxicity at this dose included diarrhea (22%), fatigue (21%), and anorexia (10%). One patient experienced grade 3-4 hematologic toxicity. A PSA decline of >/=50% occurred in 47% of patients. A partial measurable disease response occurred in 24% of assessable patients. A patient-reported pain response was observed in 59% of assessable patients. Median time to PSA progression was 6.1 months [95% confidence interval (CI) 4.7-8.0] and median overall survival was 11.3 months (95% CI 9.8-15.4). CONCLUSIONS: Patupilone at 8 mg/m2 was tolerable, had antitumor activity, and was associated with symptomatic improvement in patients previously treated with docetaxel.","Ann Oncol, 23(1): 53-58","Canada",2012,"Metastatic","Chemotherapy","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Symptom"]
[117,"Chien, G. W., et al. (2017). \"Health-related quality of life outcomes from a contemporary prostate cancer registry in a large diverse population.\" BJU Int 120(4): 520-529.",null,"Chien, G. W., et al.","Health-related quality of life outcomes from a contemporary prostate cancer registry in a large diverse population","OBJECTIVE: To assess the health-related quality of life (HRQoL) of patients with prostate cancer up to 24 months after treatment in a contemporary large diverse population. PATIENTS AND METHODS: Patients with newly diagnosed prostate cancer from March 2011 to January 2014 in our healthcare system were included. The Expanded Prostate Cancer Index Composite (EPIC-26) questionnaire was administered before treatment, and at 1, 3, 6, 12, 18, and 24 months after treatment up to November 2014 for all methods of treatment. The Kruskall-Wallis test was used to compare the distribution of each EPIC-26 domain score at each time point, and mixed models were used to assess the overall scores over the period after treatment. RESULTS: In all, 5 727 patients were included. There were data for 3 422, 2 329, 2 017, 1 922, 1 772, 1 260, and 837 patients before treatment, and at 1, 3, 6, 12, 18, and 24 months after treatment, respectively. At 1 month, bowel scores were the lowest for patients that had had radiation therapy, and urinary irritative symptoms were the lowest for those who had had brachytherapy. There were sexual function declines for all the treatment methods, with surgery having the steepest decline; open radical prostatectomy (ORP) had a greater decline than robot-assisted laparoscopic prostatectomy (RALP). Patients who underwent RALP had a better return of sexual function, approaching that of brachytherapy and radiation therapy at 24 months. Urinary incontinence (UI) also declined the most in surgical patients, with RALP patients improving slightly more than ORP patients at 12-24 months. CONCLUSIONS: Patients' HRQoL after prostate cancer treatment varies by treatment method. Notably, sexual function recovers most for RALP patients. UI remains worse at 24 months after surgery, compared to other methods of prostate cancer treatment.","BJU Int, 120(4): 520-529","USA",2017,"Any or unknown","Radiotherapy,Surgery,Brachytherapy","EPIC","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease"]
[118,"Chipperfield, K., et al. (2013). \"Factors associated with adherence to physical activity guidelines in patients with prostate cancer.\" Psychooncology 22(11): 2478-2486.",null,"Chipperfield, K., et al.","Factors associated with adherence to physical activity guidelines in patients with prostate cancer","OBJECTIVE: This study aimed to estimate the proportion of patients with prostate cancer (PCa) meeting the National Physical Activity Guidelines of Australia (NPAGA) and determine sociodemographic and medical factors associated with meeting these guidelines. Secondary aims included examining physical activity (PA) levels by treatment type and domain (leisure, work, transport and domestic) and establishing a predictive model of the likelihood that men with PCa would meet NPAGA. METHODS: A questionnaire was mailed to 638 men with PCa attending for treatment at the Alfred, Cabrini or Latrobe Regional Hospitals during 2010 and 2011, with a response rate of 59%. Measures included International Physical Activity Questionnaire, Hospital Anxiety and Depression Scale, Functional Assessment of Cancer Therapy - Prostate and sociodemographic items. Inclusion criteria were English speaking men aged 40 to 80 years, who had undergone radiotherapy (RT) between 9 and 30 months prior to the survey. RESULTS: Of 356 men with PCa, less than half were meeting NPAGA (41.9%). Lower education and quality of life (QoL), a higher number of comorbid conditions and symptoms of depression and anxiety were associated with decreased leisure-time PA. Patients treated with androgen deprivation therapy were significantly less active than patients treated with RT only. Logistic regression analyses indicated that the likelihood of meeting NPAGA was significantly lower with higher levels of depressive symptoms and lower levels of education. CONCLUSIONS: Meeting NPAGA is associated with higher QoL and psychosocial well-being in men with PCa. These findings contribute important information for targeting PA interventions to PCa survivors.","Psychooncology, 22(11): 2478-2486","Australia",2013,"Any or unknown","Radiotherapy,Hormonal","IPAQ,HADS,FACT-P","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Disease,Comorbidity,General"]
[119,"Chipperfield, K., et al. (2014). \"The impact of physical activity on psychosocial outcomes in men receiving androgen deprivation therapy for prostate cancer: a systematic review.\" Health Psychol 33(11): 1288-1297.",null,"Chipperfield, K., et al.","The impact of physical activity on psychosocial outcomes in men receiving androgen deprivation therapy for prostate cancer: a systematic review","OBJECTIVE: Depression, anxiety, and cognitive dysfunction are common complaints in men with prostate cancer (PCa) receiving androgen deprivation therapy (ADT). Consequently, the quality of life (QoL) of these men is negatively impacted. This systematic review evaluated the effectiveness of physical activity (PA) as an intervention to improve depression and anxiety symptoms, cognitive function, and QoL in patients receiving ADT for PCa. METHODS: Inclusion criteria and search strategy were defined and documented in a protocol registered with the International Prospective Register of Systematic Reviews (Registration # CRD42012002666). Due to the limited number of studies examining these outcomes in this patient group, no limitations were placed on study designs included. A systematic search of Ovid MEDLINE, PsycINFO, EMBASE, Informit, Scopus, Cochrane Library, and CINAHL databases identified 7 relevant peer-reviewed studies: 4 clinical PA interventions, 2 pilot studies, and 1 cross-sectional survey. Data extraction and risk of bias assessment tools developed by the Cochrane Collaboration were used to evaluate evidence. RESULTS: Existing data suggest that PA improved QoL in men with PCa receiving ADT. The existing evidence, however, is not sufficiently robust to determine the adequacy of PA as an intervention to improve depression, anxiety, and cognitive function outcomes in this patient group. CONCLUSIONS: Despite the lack of studies conducted, preliminary findings support the utility of PA for improving QoL in men undergoing ADT for PCa. A clear gap in the current literature was identified, confirming the need for further clinical trials in which depression, anxiety, and cognitive function are evaluated.","Health Psychol, 33(11): 1288-1297","International",2014,"Any or unknown","Various,Hormonal","Unclear","Patient",null,"Systematic review",null,null,null,null,null,null,null,null,"General"]
[120,"Choudhury, A., et al. (2014). \"Patient-reported outcomes and health-related quality of life in prostate cancer treated with a single fraction of high dose rate brachytherapy combined with hypofractionated external beam radiotherapy.\" Clin Oncol (R Coll Radiol) 26(10): 661-667.",null,"Choudhury, A., et al.","Patient-reported outcomes and health-related quality of life in prostate cancer treated with a single fraction of high dose rate brachytherapy combined with hypofractionated external beam radiotherapy","AIMS: High dose rate (HDR) brachytherapy offers a highly conformal approach to radiotherapy delivery, enabling dose escalation. We report our experience using a combined HDR boost and external beam radiotherapy (EBRT) approach and its associated toxicity and effect on quality of life. MATERIALS AND METHODS: Patients with intermediate- or high-risk prostate cancer were treated with a single fraction HDR boost and EBRT between July 2008 and March 2010. Patient-reported toxicity data were collected at baseline and regular intervals after radiotherapy using International Prostate Symptom Score and Late Effects in Normal Tissues-Subjective, Objective, Management and Analytic scales (LENT-SOMA) questionnaires; health-related quality of life data were captured by the Expanded Prostate Cancer Index Composite (EPIC) questionnaire. RESULTS: Ninety-five patients received an HDR boost of 12.5 Gy followed by EBRT delivered as 37.5 Gy in 15 fractions over 3 weeks. The International Prostate Symptom Score peaked 6 weeks after radiotherapy (median value: 9). The LENT-SOMA bladder/urethra mean baseline score was 0.35 and peaked 6 weeks after radiotherapy (mean = 0.59). Difficulties with urinary flow and frequency were the most common reported symptoms. LENT-SOMA rectum/bowel mean scores at baseline were 0.24 and peaked after 6 months (mean = 0.37). Bowel urgency was the most common reported toxicity. EPIC urinary scores returned to baseline values at 6 months and bowel median scores recovered after 24 months. There were no statistically significant associations between patient or dosimetric parameters and patient-reported outcomes. CONCLUSION: A combined HDR boost and hypofractionated EBRT regimen offers a well-tolerated method of dose escalation with acceptable levels of patient-reported toxicity.","Clin Oncol (R Coll Radiol), 26(10): 661-667","UK",2014,"Any or unknown","Radiotherapy,Brachytherapy","IPSS,LENT-SOMA,EPIC","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,Treatment,Symptom"]
[121,"Chu, S., et al. (2015). \"Veterans Affairs Telemedicine: Bringing Urologic Care to Remote Clinics.\" Urology 86(2): 255-260.",null,"Chu, S., et al.","Veterans Affairs Telemedicine: Bringing Urologic Care to Remote Clinics","OBJECTIVE: To report the use of telemedicine to deliver general urologic care to remote locations within the Veterans Affairs Greater Los Angeles Healthcare System. We describe the diagnoses managed, patient satisfaction, safety, and benefit to patients in terms of saved travel time and expense. METHODS: We conducted a retrospective chart review examining care delivered through urology telemedicine clinics over a 6-month period. We examined the urologic conditions, patient satisfaction, and emergency department visits within 30 days of the visit. We estimated patient benefit by calculating travel distance and time and the saved travel-associated costs using Google Maps and US Census income data. RESULTS: Ninety-seven unique telemedicine visits were conducted and a total of 171 urologic diseases were assessed. The most common conditions were lower urinary tract symptoms (35%), elevated prostate-specific antigen level (15%), and prostate cancer (14%). One patient was seen in the emergency department within 30 days with an unpreventable urologic complaint. Patient satisfaction was \"very good\" to \"excellent\" in 95% of cases, and 97% would refer another veteran to the urology telemedicine clinic. Patients saved an average of 277 travel miles, 290 minutes of travel time, $67 in travel expenses, and $126 in lost opportunity cost. CONCLUSION: Telemedicine was successfully and safely used to evaluate and treat a wide range of urologic conditions within the Veterans Affairs Greater Los Angeles Healthcare System, and saves patients nearly 5 hours and up to $193 per visit. Further investigation of the potential of telemedicine for the delivery of urologic care in a cost-effective manner is warranted.","Urology, 86(2): 255-260","USA",2015,"Any or unknown","Various","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Satisfaction"]
[122,"Clark, J. A. and J. A. Talcott (2001). \"Symptom indexes to assess outcomes of treatment for early prostate cancer.\" Med Care 39(10): 1118-1130.",null,"Clark, J. A. and J. A. Talcott","Symptom indexes to assess outcomes of treatment for early prostate cancer","BACKGROUND: Patients' perceptions of treatment outcomes are important in the management of early prostate cancer, but few studies have offered reliable and responsive measures to assess the likely side effects of the most common treatments. OBJECTIVE: To develop indexes of urinary, bowel, and sexual function, and related distress. RESEARCH DESIGN: Prospective cohort study of the outcomes of treatment for early prostate cancer, with self-administered questionnaires completed before treatment, and 3 and 12 months afterward. Hypothesized indexes, based on a clinical model of pathophysiological side effects of treatment, were defined and evaluated with respect to reliability and validity. SUBJECTS: Patients (n = 184) undergoing radical prostatectomy or external beam radiotherapy for early prostate cancer. MEASURES: Urinary and bowel items pertained to frequency or intensity of symptoms of dysfunction; parallel items assessed symptom-related distress. Sexual dysfunction items assessed the quality of erections, orgasm, and ejaculation; distress was assessed by 2 items adapted from the MOS Sexual Problems (MOS-SP) scale. HRQoL was assessed by the SF-36 and Profile of Mood States. RESULTS: Symptom and symptom-related distress indexes for urinary incontinence, urinary obstruction/irritation, bowel dysfunction, and sexual dysfunction were defined. Symptom and distress indexes in each domain were highly correlated. Responsiveness was substantial and varied by treatment in ways consistent with clinical experience. The indexes accounted for significant proportions of the variance in HRQoL measures. CONCLUSIONS: These indexes may be used in monitoring outcomes of treatment for early prostate cancer.","Med Care, 39(10): 1118-1130","USA",2001,"Local","Surgery,Radiotherapy","MOS-SP,SF-36,POMS","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Comorbidity,Utility,Complication"]
[123,"Clark, J. A., et al. (1997). \"Dimensions of quality of life expressed by men treated for metastatic prostate cancer.\" Soc Sci Med 45(8): 1299-1309.",null,"Clark, J. A., et al.","Dimensions of quality of life expressed by men treated for metastatic prostate cancer","Men who pursue active treatment for metastatic prostate cancer face a choice between medical or surgical castration. While both alternatives have documented side-effects (e.g. loss of libido, breast enlargement and tenderness, hot flashes, and nausea), their psychosocial impacts are not well understood. As part of a study of patients' treatment decision making, we have sought to construct a patient-based measure of the salient disease and treatment-related qualities of life experienced by these men subsequent to treatment. Focus groups (15 with patients, two with wives) were used to develop candidate Likert scale questionnaire items representing quality of life issues that patients said were important. These items were combined with assessments of symptoms, comorbidity, and generic measures of functional status and well-being in a mail survey of patients treated at the Houston VAMC and two other Houston hospitals (n = 201, response rate = 63%). Psychometric analyses (principal components and multitrait scaling) were used to identify distinct dimensions of life quality; correlations with generic measures, and symptom reports were used in validation analyses. Qualitative analyses of focus group data identified three major domains of life quality: self-perceptions, anxiety about the effects of treatment, and concern with the process of decision making and treatment. Psychometric analyses identified nine reliable and valid indicators of prostate cancer-related quality of life: body image, sexual problems, spouse affection, spouse worry, masculinity, cancer-related self-image, cancer distress, cancer acceptance, and regret of treatment decision. Internal consistency (alpha) ranged form 0.71 to 0.90. Correlations with reference scales (e.g. MOS Mental Health Index, Profile of Mood States) and symptom status supported concurrent validity. Prostate cancer patients perceive a number of important psychosocial consequences of their treatment. These consequences are represented by nine scales comprising a brief (35 items) disease and treatment sensitive health-related quality of life instrument, which we will use in monitoring the outcomes of patients' treatment choices.","Soc Sci Med, 45(8): 1299-1309","USA",1997,"Metastatic","Hormonal,Surgery","Likert scale,POMS,MOS-MHI","Patient",null,"Validation",null,null,null,null,null,null,null,null,"General,Comorbidity"]
[124,"Clark, J. A., et al. (1999). \"Changes in quality of life following treatment for early prostate cancer.\" Urology 53(1): 161-168.",null,"Clark, J. A., et al.","Changes in quality of life following treatment for early prostate cancer","OBJECTIVES: To explore the effects of urinary, bowel, and sexual symptoms following treatment for early (nonmetastatic) prostate cancer on health-related quality of life through an examination of the responsiveness of the Medical Outcomes Study Short Form Health Survey (SF-36). METHODS: We conducted a prospective observational cohort study of 125 men with early prostate cancer who underwent either radical prostatectomy or radical, external beam radiotherapy. Patients completed questionnaires, which included assessments of urinary, bowel, and sexual symptoms and the SF-36 at the time of their clinical consultation prior to deciding on primary therapy and at 3 and 12-month follow-up. RESULTS: Although cross-sectional analysis showed substantial associations between symptoms and the eight scales of the SF-36 12 months after the initiation of treatment, longitudinal analyses of changes in these scales showed only modest effects. Three scales registered changes associated with the development of new symptoms: General Health Perceptions, Vitality, and Social Function. Role Performance with Emotional Limitations demonstrated a surprising response: slight improvements in men with new symptoms, compared with substantial gains in men who survived treatment without developing new urinary, bowel, or sexual symptoms. Overall, the SF-36 demonstrated a pattern of decline at 3 months and recovery to baseline at 12 months. Rather than registering declines in response to increasing symptoms, negative changes occurred primarily in men who presented symptoms prior to treatment and whose symptoms were unchanged 12 months later. CONCLUSIONS: The SF-36 is associated with the presence of physical symptoms but demonstrates a complicated pattern of change following treatment and the development of new urinary, bowel, and sexual problems. Multidimensional approaches to the outcomes of treatment for early prostate cancer help to clarify the magnitude of both gains and losses in quality of life.","Urology, 53(1): 161-168","USA",1999,"Local","Radiotherapy,Surgery","SF-36","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Utiilty"]
[125,"Clark, J. A., et al. (2001). \"Living with treatment decisions: regrets and quality of life among men treated for metastatic prostate cancer.\" J Clin Oncol 19(1): 72-80.",null,"Clark, J. A., et al.","Living with treatment decisions: regrets and quality of life among men treated for metastatic prostate cancer","PURPOSE: To examine variation in men's long-term regret of treatment decisions, ie, surgical versus chemical castration, for metastatic prostate cancer and its associations with quality of life. METHODS: Survey of previously treated patients to assess treatment decisions and quality of life, supplemented with focus groups. Two items addressing whether a patient wished he could change his mind and the belief that he would have been better off with the treatment not chosen were combined in classifying survey respondents as either satisfied or regretful. Chi(2) and t tests were used to test associations between regret and treatment history, complications, and quality of life. RESULTS: Survey respondents included 201 men aged 45 to 93 years (median, 71 years), who had begun treatment (71% chemical castration, 29% orchiectomy) a median of 2 years previously. Most reported complications: hot flashes (70%), nausea (34%), and erectile dysfunction (81%). Most were satisfied with the treatment decision, but 23% expressed regret. Regretful men more frequently reported surgical (43%) versus chemical (36%) castration (P: = .030) and nausea in the past week (54% v 32%; P: = .010) but less frequently reported erectile dysfunction (56% v 72%; P: = .048). Regretful men indicated poorer scores on every measure of generic and prostate cancer-related quality of life. Qualitative analyses revealed substantial uncertainty about the progress of their disease and the quality of the decisions in which patients participated. CONCLUSION: Regret was substantial and associated with treatment choice and quality of life. It may derive from underlying psychosocial distress and problematic communication with physicians when decisions are being reached and over subsequent years.","J Clin Oncol, 19(1): 72-80","USA",2001,"Metastatic","Surgery,Hormonal","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Satisfaction"]
[126,"Clark, J. A., et al. (2003). \"Measuring patients' perceptions of the outcomes of treatment for early prostate cancer.\" Med Care 41(8): 923-936.",null,"Clark, J. A., et al.","Measuring patients' perceptions of the outcomes of treatment for early prostate cancer","BACKGROUND: Compared with careful attention to the physical (eg, urinary, bowel, sexual) dysfunction that may follow treatment, little attention has been given to the behavioral, emotional, and interpersonal changes that the diagnosis of early prostate cancer and subsequent physical dysfunction may bring. OBJECTIVE: To construct patient-centered measures of the outcomes of treatment for early prostate cancer. RESEARCH DESIGN: Qualitative study followed by survey of early prostate cancer patients and group of comparable patients with no history of prostate cancer. Analysis of focus groups identified relevant domains of quality of life, which were represented by Likert scale items included in survey questionnaires. Psychometric analyses of survey data defined scales evaluated with respect to internal consistency and validity. RESULTS: Qualitative analysis identified three domains: urinary control, sexuality, and uncertainty about the cancer and its treatment. Psychometric analysis defined 11 scales. Seven were generically relevant to most older men: urinary control (eg, embarrassment with leakage), sexual intimacy (eg, anxiety about completing intercourse), sexual confidence (eg, comfort with sexuality), marital affection (eg, emotional distance from spouse/partner), masculine self esteem (eg, feeling oneself a whole man), health worry (eg, apprehensiveness about health changes), and PSA concern (eg, closely attending to one's PSA). Four scales were specific to the treatment experience: perceived cancer control, quality of treatment decision making, regret of treatment choice, and cancer-related outlook. CONCLUSION: The scales provide definition and metrics for patient-centered research in this area. They complement measures of physical dysfunction and bring into resolution outcomes of treatment that have gone unnoticed in previous studies.","Med Care, 41(8): 923-936","USA",2003,"Local","Unclear","Likert scale","Patient",null,"Validation",null,null,null,null,null,null,null,null,"General"]
[127,"Clark, J. A., et al. (2003). \"Patients' perceptions of quality of life after treatment for early prostate cancer.\" J Clin Oncol 21(20): 3777-3784.",null,"Clark, J. A., et al.","Patients' perceptions of quality of life after treatment for early prostate cancer","PURPOSE: Treatment for early prostate cancer produces problematic physical side effects, but prior studies have found little influence on patients' perceived health status. We examined psychosocial outcomes of treatment for early prostate cancer. PATIENTS AND METHODS: Patients with previously treated prostate cancer and a reference group of men with a normal prostate-specific antigen (PSA) level and no history of prostate cancer completed questionnaires. Innovative scales assessed behavioral consequences of urinary dysfunction, sexuality, health worry, PSA concern, perceived cancer control, treatment decision making, decision regret, and cancer-related outlook. Urinary, bowel, and sexual dysfunction were assessed with symptom indexes; health status was assessed by the Physical and Mental Summaries of the Short Form (SF-12) Health Survey. RESULTS: Compared with men without prostate cancer, prostate cancer patients reported greater urinary, bowel, and sexual dysfunction, but similar health status. They reported worse problems of urinary control, sexual intimacy and confidence, and masculinity, and greater PSA concern. Perceptions of cancer control and treatment decisions were positive, but varied by treatment: prostatectomy patients indicated the highest and observation patients indicated the lowest cancer control. Bowel and sexual dysfunction were associated with poorer sexual intimacy, masculinity, and perceived cancer control; masculinity and PSA concern were associated with greater confidence in treatment choice; and diminished sexual intimacy and less interest in PSA were associated with greater regret. CONCLUSION: The lack of change in global measures of health status after treatment for early prostate cancer obscures important influences in men's lives; cancer diagnosis and treatment complications may result in complex outcomes. Aggressive treatment may confer confidence in cancer control, yet be countered by diminished intimate relationships and masculinity, which accompany sexual dysfunction.","J Clin Oncol, 21(20): 3777-3784","USA",2003,"Local","Unclear","SF-12","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Utility"]
[128,"Clark, M. J., et al. (2014). \"Patient-reported outcome labeling claims and measurement approach for metastatic castration-resistant prostate cancer treatments in the United States and European Union.\" Health Qual Life Outcomes 12: 104.",null,"Clark, M. J., et al.","Patient-reported outcome labeling claims and measurement approach for metastatic castration-resistant prostate cancer treatments in the United States and European Union","BACKGROUND: Metastatic castration-resistant prostate cancer (mCRPC) and its treatment significantly affect health-related quality of life (HRQOL). Our objectives were to evaluate and compare patient-reported outcome (PRO) claims granted by the Food and Drug Administration (FDA) and European Medicines Agency (EMA) for 5 recently approved mCRPC treatments and to examine key characteristics, development, and measurement properties of the PRO measures supporting these claims against current regulatory standards. METHODS: Five products approved for treatment of mCRPC by the FDA and the EMA (2010-2013) were examined: enzalutamide, abiraterone, sipuleucel-T, cabazitaxel, and radium Ra 223 dichloride. United States (US) drug approval packages and European Public Assessment Reports were reviewed. PRO claims in the US labels and European Summaries of Product Characteristics and supporting measures were identified. For PRO measures supporting claims, a targeted literature review was conducted to identify information on key characteristics and measurement properties; this information was compared against FDA PRO guidance criteria. RESULTS: Nine PRO \"claims\" were granted across 4 of 5 products reviewed. The EMA granted more claims (7 claims-4 for pain, 3 for HRQOL) than the FDA (2 claims, both for pain). The Brief Pain Inventory-Short Form (BPI-SF) worst pain item supported most pain claims and was the only measure supporting US claims. EMA pain claims were supported by BPI-SF worst pain (n = 2) and average pain (n = 1) items and the McGill Pain Questionnaire Present Pain Intensity component (n = 1). EMA HRQOL claims were supported by the Functional Assessment of Cancer Therapy-Prostate Module (n = 2) and the EuroQol 5 Dimensions with visual analogue scale (n = 1). Pain and prostate cancer-specific HRQOL measures supporting claims met US regulatory standards for construct validity, reliability, and responsiveness; these properties were strongest for the BPI-SF worst pain item. Only the BPI-SF worst pain item has documented content validity in mCRPC. CONCLUSIONS: PRO label claims were commonly granted across the mCRPC products reviewed. Among the measures reviewed, only the BPI-SF worst pain item supported US label claims. The BPI-SF worst pain item is recommended for pain assessment for the evaluation of new mCRPC treatments.","Health Qual Life Outcomes, 12(104","USA,Europe",2014,"Metastatic","Taxane,Chemotherapy,Brachytherapy","BPI,MPQ,FACT-P,EQ-5D","Patient",null,"Narrative review",null,null,null,null,null,null,null,null,"Symptom,Disease,Utility"]
[129,"Cleary, P. D., et al. (1995). \"Health-related quality of life in patients with advanced prostate cancer: a multinational perspective.\" Qual Life Res 4(3): 207-220.",null,"Cleary, P. D., et al.","Health-related quality of life in patients with advanced prostate cancer: a multinational perspective","To explore the value of antiandrogen therapy for advanced prostate cancer, two clinical trials of similar design were recently conducted in six countries throughout Europe. A total of 550 patients with previously untreated metastatic prostate cancer were randomized either to treatment with an antiandrogen or castration. While time to treatment failure, objective tumour response and survival were expected to be similar between study treatments, their effects on health-related quality of life (HRQOL) were expected to differ and were therefore a focus of concern in this trial. To assess these effects, we developed a brief self-administered patient questionnaire covering 10 domains of HRQOL (general health perceptions, pain, emotional well-being, vitality, social functioning, physical capacity, sexual interest, sexual functioning, activity limitation and bed disability), which we translated from English into several other languages. In this paper, we describe the development, content and translation of this survey instrument and report on its reliability and validity in six countries based on data collected for the first 487 patients to complete questionnaires at study entry.","Qual Life Res, 4(3): 207-220","USA",1995,"Advanced,Metastatic","Hormonal","Unclear","Patient",null,"Validation",null,null,null,null,null,null,null,null,"General"]
[130,"Collette, L., et al. (2004). \"Is baseline quality of life useful for predicting survival with hormone-refractory prostate cancer? A pooled analysis of three studies of the European Organisation for Research and Treatment of Cancer Genitourinary Group.\" J Clin Oncol 22(19): 3877-3885.",null,"Collette, L., et al.","Is baseline quality of life useful for predicting survival with hormone-refractory prostate cancer? A pooled analysis of three studies of the European Organisation for Research and Treatment of Cancer Genitourinary Group","PURPOSE: Patients with symptomatic metastatic hormone-resistant prostate cancer (HRPC) survive a median of 10 months and are often regarded as a homogeneous group. Few prognostic factors have been identified so far. We examined whether baseline health-related quality of life (HRQOL) parameters assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) were independent prognostic factors of survival and whether they bring extra precision to the predictions achievable with models based on clinical and biochemical factors only. PATIENTS AND METHODS: Data of 391 symptomatic (bone) metastatic HRPC patients from three randomized EORTC trials were used in multivariate Cox proportional hazards models. The significance level was set at alpha =.05. RESULTS: Of the 391 patients, 371 died, most of prostate cancer. Bone scan result, performance status, hemoglobin level, and insomnia and appetite loss as measured by the EORTC QLQ-C30 were independent predictors of survival. This model's area under the receiver operating curve was 0.65 compared with 0.63 without the two HRQOL factors. CONCLUSION: Certain HRQOL sores, at baseline, seem to be predictors for duration of survival in HRPC. However, such measurements do not add to the predictive ability of models based only on clinical and biochemical factors.","J Clin Oncol, 22(19): 3877-3885","Belgium",2004,"Metastatic","Unclear","EORTC QLQ-C30","Patient",null,"Systematic review",null,null,null,null,null,null,null,null,"General"]
[131,"Collingwood, S. A., et al. (2014). \"Decisional regret after robotic-assisted laparoscopic prostatectomy is higher in African American men.\" Urol Oncol 32(4): 419-425.",null,"Collingwood, S. A., et al.","Decisional regret after robotic-assisted laparoscopic prostatectomy is higher in African American men","OBJECTIVES: Longitudinal studies report racial disparities in prostate cancer (PCa) including greater incidence, more aggressive tumor biology, and increased cancer-specific mortality in African American (AA) men. Regret concerning primary treatment selection is underevaluated in patients with PCa. We investigated the relationships between clinicopathologic variables across racial and socioeconomic lines following robotic-assisted laparoscopic prostatectomy. MATERIALS AND METHODS: We assessed treatment decisional regret using a validated questionnaire in a total of 484 white and 72 AA patients with PCa who were followed up for a median of 16.6 months post-robotic-assisted laparoscopic prostatectomy. Socioeconomic status (SES) information was aggregated from 2010 US census zip code data. Perioperative clinicopathologic characteristics and functional outcomes were compared between groups. Univariate and multivariate regression analyses were used to evaluate the influence of race, aggregate SES, and other clinical and demographic characteristics on decisional regret. RESULTS: The majority (87.7%) of the population was not regretful of their decision to undergo treatment. However, a greater proportion of AA vs. white patients were regretful (20.6% vs. 11.2%, respectively; P = 0.03). AA and white men were similar on all functional, clinical, and pathologic features with the exception of younger age among AA men (56 vs. 60 y, respectively; P<0.001). Although there were significant differences in SES by race (P<0.001), regret did not differ by SES (beta =-1.53; P = 0.15). Race, postoperative sexual dysfunction, pad usage, and length of hospital stay, however, were significantly associated with decisional regret. CONCLUSIONS: AA men were more regretful than white men, after adjusting for clinicopathologic characteristics and postoperative functional outcomes.","Urol Oncol, 32(4): 419-425","USA",2014,"Any or unknown","Surgery","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Satisfaction"]
[132,"Cook, K. F., et al. (2001). \"A psychometric analysis of the measurement level of the rating scale, time trade-off, and standard gamble.\" Soc Sci Med 53(10): 1275-1285.",null,"Cook, K. F., et al.","A psychometric analysis of the measurement level of the rating scale, time trade-off, and standard gamble","A fundamental assumption of utility-based analyses is that patient utilities for health states can be measured on an equal-interval scale. This assumption, however, has not been widely examined. The objective of this study was to assess whether the rating scale (RS), standard gamble (SG), and time trade-off (TTO) utility elicitation methods function as equal-interval level scales. We wrote descriptions of eight prostate-cancer-related health states. In interviews with patients who had newly diagnosed, advanced prostate cancer, utilities for the health states were elicited using the RS, SG, and TTO methods. At the time of the study, 77 initial and 73 follow-up interviews had. been conducted with a consecutive sample of 77 participants. Using a Rasch model, the boundaries (Thurstone Thresholds) between four equal score sub-ranges of the raw utilities were mapped onto an equal-interval logit scale. The distance between adjacent thresholds in logit units was calculated to determine whether the raw utilities were equal-interval. None of the utility scales functioned as interval-level scales in our sample. Therefore, since interval-level estimates are assumed in utility-based analyses, doubt is raised regarding the validity of findings from previous analyses based on these scales. Our findings need to be replicated in other contexts, and the practical impact of non-interval measurement on utility-based analyses should be explored. If cost-effectiveness analyses are not found to be robust to violations of the assumption that utilities are interval, serious doubt will be cast upon findings from utility-based analyses and upon the wisdom of expending millions in research dollars on utility-based studies.","Soc Sci Med, 53(10): 1275-1285","USA",2001,"Advanced","None","TTO,SG,RatingS","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Utility"]
[133,"Cooperberg, M. R., et al. (2003). \"How potent is potent? Evaluation of sexual function and bother in men who report potency after treatment for prostate cancer: data from CaPSURE.\" Urology 61(1): 190-196.",null,"Cooperberg, M. R., et al.","How potent is potent? Evaluation of sexual function and bother in men who report potency after treatment for prostate cancer: data from CaPSURE","OBJECTIVES: To characterize the association between potency and comprehensive sexual function. The accurate assessment of sexual function is critical for the evaluation of outcomes after treatment of prostate cancer. The assessments of potency typically used in this context, however, may be oversimplified. METHODS: CaPSURE is a large, observational database of men with prostate cancer. Participants complete health-related quality-of-life questionnaires, including the University of California, Los Angeles Prostate Cancer Index, every 6 months after treatment. A total of 5135 men completed at least one questionnaire and did not use medications for erectile function. The men were categorized as potent or impotent based on their ability to have erections and/or intercourse in the prior 4 weeks. Using the remaining questions on the Prostate Cancer Index, sexual function and bother scores were calculated for each group. RESULTS: Of the 5135 men, 27.4% were potent. The mean sexual function scores were 56 and 13 for potent and impotent men, respectively (P <0.0001). The corresponding mean bother scores were 62 and 36 (P <0.0001). The function scores ranged from 0 to 100 and 0 to 92 among potent and impotent men, respectively, and bother scores from 0 to 100 in both groups. Function was inversely associated with age in both groups, but bother did not change among potent men and ameliorated among impotent men. Individual Prostate Cancer Index questions correlated with potency to a variable extent. CONCLUSIONS: Although potent and impotent men have divergent sexual function and bother scores after treatment, the wide range of these scores in both groups denotes a complex picture of sexual function. The simple documentation of potency after treatment provides an insufficient measure of sexual health-related quality of life and should be supplemented with more comprehensive measures.","Urology, 61(1): 190-196","USA",2003,"Any or unknown","Unclear","UCLA-PCI","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease"]
[134,"Cooperberg, M. R., et al. (2004). \"The contemporary management of prostate cancer in the United States: lessons from the cancer of the prostate strategic urologic research endeavor (CapSURE), a national disease registry.\" J Urol 171(4): 1393-1401.",null,"Cooperberg, M. R., et al.","The contemporary management of prostate cancer in the United States: lessons from the cancer of the prostate strategic urologic research endeavor (CapSURE), a national disease registry","PURPOSE: The epidemiology and treatment of prostate cancer have changed dramatically in the prostate specific antigen era. A large disease registry facilitates the longitudinal observation of trends in disease presentation, management and outcomes. MATERIALS AND METHODS: The Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) is a national disease registry of more than 10000 men with prostate cancer accrued at 31 primarily community based sites across the United States. Demographic, clinical, quality of life and resource use variables are collected on each patient. We reviewed key findings from the data base in the last 8 years in the areas of disease management trends, and oncological and quality of life outcomes. RESULTS: Prostate cancer is increasingly diagnosed with low risk clinical characteristics. With time patients have become less likely to receive pretreatment imaging tests, less likely to pursue watchful waiting and more likely to receive brachytherapy or hormonal therapy. Relatively few patients treated with radical prostatectomy in the database are under graded or under staged before surgery, whereas the surgical margin rate is comparable to that in academic series. CaPSURE data confirm the usefulness of percent positive biopsies in risk assessment and they have further been used to validate multiple preoperative nomograms. CaPSURE results strongly affirm the necessity of patient reported quality of life assessment. Multiple studies have compared the quality of life impact of various treatment options, particularly in terms of urinary and sexual function, and bother. CONCLUSIONS: The presentation and management of prostate cancer have changed substantially in the last decade. CaPSURE will continue to track these trends as well as oncological and quality of life outcomes, and will continue to be an invaluable resource for the study of prostate cancer at the national level.","J Urol, 171(4): 1393-1401","USA",2004,"Any or unknown","Radiotherapy,Surgery,Hormonal,Brachytherapy","Unclear","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"General"]
[135,"Cormie, P., et al. (2013). \"Exercise maintains sexual activity in men undergoing androgen suppression for prostate cancer: a randomized controlled trial.\" Prostate Cancer Prostatic Dis 16(2): 170-175.",null,"Cormie, P., et al.","Exercise maintains sexual activity in men undergoing androgen suppression for prostate cancer: a randomized controlled trial","BACKGROUND: Previous research has shown exercise to be an effective method to mitigate many adverse treatment-related effects of androgen suppression therapy (AST) but the potential impact of exercise on sexual activity remains unknown. The purpose of this investigation was to report the effect of a 12-week exercise program on sexual activity in prostate cancer patients undergoing AST. METHODS: Fifty-seven prostate cancer patients undergoing AST were randomly assigned to an exercise program (resistance and aerobic modes; n=29) or usual care control (n=28). Sexual activity was assessed by the European Organization for Research and Treatment of Cancer prostate cancer-specific quality of life questionnaire (QLQ-PR25). RESULTS: QLQ-PR25 data were log transformed and analysis of covariance was used to compare sexual activity between groups following the intervention adjusted for baseline activity. No differences in sexual activity were observed between the exercise and control groups before the intervention. There was a significant (P=0.045) adjusted group difference in sexual activity following the 12-week intervention. Patients undergoing usual care decreased sexual activity while patients in the exercise program maintained their level of sexual activity. At baseline, 20.6 and 22.2% of participants in the exercise and control groups reported a major interest in sex (that is, high libido). Following the intervention, the exercise group had a significantly higher percentage of participants reporting a major interest in sex (exercise=17.2% vs control=0%; P=0.024). CONCLUSIONS: Participation in a short-term exercise program resulted in the maintenance of sexual activity in prostate cancer patients undergoing AST.","Prostate Cancer Prostatic Dis, 16(2): 170-175","Australia",2013,"Any or unknown","Hormonal,Various","EORTC QLQ-PR25","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease"]
[136,"Cormier, L., et al. (2002). \"Impact of prostate cancer screening on health-related quality of life in at-risk families.\" Urology 59(6): 901-906.",null,"Cormier, L., et al.","Impact of prostate cancer screening on health-related quality of life in at-risk families","OBJECTIVES: To describe the impact of prostate-specific antigen (PSA) screening on the health-related quality of life (HRQOL) and anxiety of men with a family history of prostate cancer. METHODS: We asked 334 brothers or sons of men with prostate cancer who agreed to undergo PSA testing to fill out HRQOL questionnaires. The questionnaires were the RAND SF-36 (generic HRQOL) and State-Trait Anxiety Inventory (anxiety-specific). Participants completed the questionnaires at the time of screening, while waiting for the results, and after receiving normal results. Sociodemographic and HRQOL variables were entered into a logistic regression model to identify factors associated with the deterioration of HRQOL, defined as a decrease of at least one standard error of measurement. Only men with normal PSA results were considered. RESULTS: Among 334 candidates, 273 underwent PSA measurement and 220 candidates with a PSA of 4 ng/mL or less returned completed questionnaires. Of these, in 20% their anxiety moderately deteriorated and in 20% their HRQOL minimally deteriorated during the screening process. Factors associated with HRQOL deterioration included age between 50 and 60 years, having more than two relatives with prostate cancer, an anxious personality, a high level of education, and having no children presently living at home. CONCLUSIONS: Screening with normal PSA results is accompanied by a minimally to moderate deterioration of HRQOL in some subjects. The identification of such individuals before screening provides opportunities to improve their HRQOL during the screening process.","Urology, 59(6): 901-906","France",2002,"At risk","Screening","STAI,SF-36","General population",null,"Cohort",null,null,null,null,null,null,null,null,"Comorbidity,Utility"]
[137,"Couper, J. W., et al. (2009). \"The psychological aftermath of prostate cancer treatment choices: a comparison of depression, anxiety and quality of life outcomes over the 12 months following diagnosis.\" Med J Aust 190(7 Suppl): S86-89.",null,"Couper, J. W., et al.","The psychological aftermath of prostate cancer treatment choices: a comparison of depression, anxiety and quality of life outcomes over the 12 months following diagnosis","OBJECTIVE: To assess the psychological impact of the different treatments for localised prostate cancer (PCA). DESIGN, PARTICIPANTS AND SETTING: Observational, prospective study of consecutive patients with PCA attending clinics in public hospitals and private practices in metropolitan Melbourne between 1 April 2001 and 30 December 2005. Data were collected at initial diagnosis of histologically confirmed localised PCA, and close to the commencement of definitive treatment (Time 1), and 12 months later (Time 2). Patients were stratified according to treatment type (radical prostatectomy [RP], hormone therapy [HT] or other early treatment including radiation therapies [OET]). Patients who elected to undergo active surveillance/watchful waiting (WW) rather than active treatment were treated as a naturalistic control group. MAIN OUTCOME MEASURES: Levels of depression and anxiety were assessed by the Brief Symptom Inventory, and physical and psychosocial aspects of health-related quality of life (HRQOL) were assessed by the 36-item Short-Form Health Survey. RESULTS: 211 patients with PCA were recruited; 193 completed the Time 1 questionnaires (38 RP, 56 HT, 38 OET and 61 WW); and 172 completed the Time 2 questionnaires (33 RP, 51 HT, 33 OET and 55 WW). At Time 1, the three active treatment groups all reported greater dysfunction in work role and daily activities compared with the WW group. The RP group also reported worse social and emotional role functioning, while the HT and OET groups reported poorer vitality levels. The HT group reported significantly higher depression scores. At Time 2, the RP and OET groups did not differ from the WW group on either HRQOL or psychological status. By contrast, the HT group reported significantly worse HRQOL (physical functioning, role-physical and vitality domains) and greater psychological distress compared with the WW group. CONCLUSIONS: Compared with the other active treatments for localised PCA, HT appears to be associated with poorer HRQOL and greater psychological distress 12 months after commencing treatment.","Med J Aust, 190(7 Suppl): S86-89","Australia",2009,"Local","Surgery,Hormonal,Radiotherapy,Surveillance","BSI,SF-36","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Symptom,Utility"]
[138,"Couper, J. W., et al. (2010). \"Predictors of psychosocial distress 12 months after diagnosis with early and advanced prostate cancer.\" Med J Aust 193(5 Suppl): S58-61.",null,"Couper, J. W., et al.","Predictors of psychosocial distress 12 months after diagnosis with early and advanced prostate cancer","OBJECTIVE: To assess psychosocial distress in patients with early (localised) and advanced (metastatic) prostate cancer (PCA) at diagnosis (Time 1) and 12 months later (Time 2), and identify psychosocial factors predictive of later distress. DESIGN, PARTICIPANTS AND SETTING: Observational, prospective study of 367 men with early (211) or advanced (156) PCA recruited as consecutive attendees at clinics at seven public hospitals and practices in metropolitan Melbourne between 1 April 2001 and 30 December 2005. Both groups completed questionnaires at Time 1 and Time 2. MAIN OUTCOME MEASURES: Health-related quality of life as assessed by the Short Form 36-item Health Survey; psychological distress, including depression and anxiety as assessed by the Brief Symptom Inventory; and coping patterns as assessed by the Mini-Mental Adjustment to Cancer scale. RESULTS: Over the 12 months, both the early and advanced PCA group showed reduced vitality and increased depression and anxiety; this effect was greater in the advanced PCA group. Mental health, social functioning and role-emotional functioning also deteriorated in the advanced group. Predictors of depression at Time 2 for the early PCA group were depression, vitality and a fatalistic coping pattern at Time 1; anxiety at Time 2 was predicted by anxiety and vitality at Time 1. In the advanced PCA group, depression at Time 2 was predicted by depression and mental health at Time 1; anxiety at Time 2 was predicted by anxiety, mental health, cognitive avoidance and lower anxious preoccupation at Time 1. CONCLUSIONS: Men with early PCA experience decreasing vitality and increasing psychological distress over the 12 months following diagnosis; this trend is accelerated after diagnosis with advanced PCA. A fatalistic coping pattern at diagnosis of early PCA predicts later depression while cognitive avoidance and lower anxious preoccupation at diagnosis of advanced PCA predict later anxiety.","Med J Aust, 193(5 Suppl): S58-61","Australia",2010,"Local,Advanced","None","SF-36,MMAC,BSI","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease,Utility,Symptom"]
[139,"Courneya, K. S., et al. (2004). \"Three independent factors predicted adherence in a randomized controlled trial of resistance exercise training among prostate cancer survivors.\" J Clin Epidemiol 57(6): 571-579.",null,"Courneya, K. S., et al.","Three independent factors predicted adherence in a randomized controlled trial of resistance exercise training among prostate cancer survivors","OBJECTIVE: To examine predictors of adherence in a randomized controlled trial of resistance exercise training (RET) in prostate cancer survivors receiving androgen deprivation therapy. STUDY DESIGN AND SETTING: A randomized controlled trial conducted at fitness centers in Ottawa and Edmonton, Canada. Prostate cancer survivors (n=155) completed measures of social cognitive variables, quality of life (QOL), behavior, and fitness before being randomized to either an exercise (n=82) or control (n=73) group. The exercise group was asked to perform supervised RET three times per week for 12 weeks. RESULTS: The exercise group attended 28.2 of the 36 (78.3%) RET sessions. Univariate analyses revealed eight different significant (Ps <.05) predictors of exercise adherence including exercise stage of change, intention, age, QOL, fatigue, subjective norm, leg-press test, and perceived behavioral control. A multivariate analysis indicated that there were three independent predictors of adherence that explained 20.4% of the variance: exercise stage of change (beta=0.26; P=.013), age (beta=-0.22; P=.037), and intention (beta=0.19; P=.073). CONCLUSION: Exercise adherence in the trial was very good but not optimal. Adherence was predicted by variables from many different categories including social cognitive, QOL, behavioral, fitness, and demographic. These findings may have important implications for maximizing adherence during clinical trials of exercise in prostate cancer survivors.","J Clin Epidemiol, 57(6): 571-579","Canada",2004,"Survivors","Hormonal,Various","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General"]
[140,"Cozzarini, C., et al. (2017). \"Patient-reported urinary incontinence after radiotherapy for prostate cancer: Quantifying the dose-effect.\" Radiother Oncol 125(1): 101-106.",null,"Cozzarini, C., et al.","Patient-reported urinary incontinence after radiotherapy for prostate cancer: Quantifying the dose-effect","BACKGROUND AND PURPOSE: Urinary incontinence following radiotherapy (RT) for prostate cancer (PCa) has a relevant impact on patient's quality of life. The aim of the study was to assess the unknown dose-effect relationship for late patient-reported urinary incontinence (LPRUI). METHODS AND MATERIALS: Patients were enrolled within the multi-centric study DUE01. Clinical and dosimetry data including the prescribed 2Gy equivalent dose (EQD2) were prospectively collected. LPRUI was evaluated through the ICIQ-SF questionnaire filled in by the patients at RT start/end and therefore every 6months. Patients were treated with conventional (74-80Gy, 1.8-2Gy/fr) or moderately hypo-fractionated RT (65-75.2Gy, 2.2-2.7Gy/fr) in 5 fractions/week with intensity-modulated radiotherapy. Six different end-points of 3-year LPRUI, including or not patient's perception (respectively, subjective and objective end-points), were considered. Multivariable logistic models were developed for each end-point. RESULTS: Data of 298 patients were analyzed. The incidence of the most severe end-point (ICIQ-SF>12) was 5.1%. EQD2 calculated with alpha-beta=0.8Gy showed the best performance in fitting data: the risk of LPRUI markedly increased for EQD2>80Gy. Previous abdominal/pelvic surgery and previous TURP were the clinical factors more significantly predictive of LPRUI. Models showed excellent performances in terms of goodness-of-fit and calibration, confirmed by bootstrap-based internal validation. When included in the analyses, baseline symptoms were a major predictor for 5 out of six end-points. CONCLUSIONS: LPRUI after RT for PCa dramatically depends on EQD2 and few clinical factors. Results are consistent with a larger than expected impact of moderate hypo-fractionation on the risk of LPRUI. As expected, baseline symptoms, as captured by ICIQ-SF, are associated to an increased risk of LPRUI.","Radiother Oncol, 125(1): 101-106","Italy",2017,"Any or unknown","Radiotherapy","ICIQ","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Complication"]
[141,"Crawford, E. D., et al. (1997). \"Comparison of perspectives on prostate cancer: analyses of survey data.\" Urology 50(3): 366-372.",null,"Crawford, E. D., et al.","Comparison of perspectives on prostate cancer: analyses of survey data","OBJECTIVES: Prostate cancer will account for 334,500 new cases and 41,800 deaths among men in the United States in 1997. Patients and physicians are faced with many concerns related to benefits and side effects of alternative treatments, educational needs, emotional support, and costs of care. Support groups for prostate cancer patients have been established to help satisfy needs in these areas. Therefore, we addressed three issues among patients who belong to a prostate cancer support group as well as among a second group of urologists who treat prostate cancer: (1) goals for prostate cancer treatment, (2) information that is given and recalled about the disease and therapy, and (3) extent to which educational and emotional needs are being met. METHODS: Random telephone surveys were made of 1000 men with prostate cancer who belong to the prostate cancer support group US TOO, the largest prostate cancer support group in the United States, and 200 urologists who provide care to men with prostate cancer. The surveys were conducted by the Louis Harris & Associates survey research firm. RESULTS: About four fifths of patients and urologists prefer aggressive therapy for prostate cancer. Patient goals with therapy included preservation of quality of life (45%), extension of life (29%), and delaying disease progression (13%), whereas physicians overwhelmingly focused on treatment efficacy (86%), with side effects (43%) and costs (29%) being secondary considerations. Urologists and patients differed markedly in the description of the patient-physician discussion. Whereas almost 100% of physicians stated that they always discussed important considerations such as options for no therapy, life expectancy with and without therapy, patient preferences, costs, and changes in sexual function, only about one fifth of patients recalled similar discussions. Patients and physicians both believed that physicians were an excellent source of educational support, but often did not report provision of emotional support. Although support groups were viewed as good providers of educational and emotional support by 85% to 90% of patients, physicians appeared to underestimate the benefit of support groups in these areas. CONCLUSIONS: Patients who belong to US TOO have many emotional and educational needs that are not currently being fulfilled by physicians. Although the goals of therapy are viewed similarly by patients and physicians, much of the important cancer- and treatment-related information that physicians report they have provided is not recalled by patients. Policy makers would be wise to devise systematic strategies such as shared decision-making tools and better linkages to support groups to ensure that patients' needs are being met.","Urology, 50(3): 366-372","USA",1997,"Any or unknown","Unclear","Unclear","HCP,Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Views"]
[142,"Crawford, E. D., et al. (2011). \"Validation of the modified American Urological Association symptom score.\" J Urol 186(3): 945-948.",null,"Crawford, E. D., et al.","Validation of the modified American Urological Association symptom score","PURPOSE: We created a shorter version of the American Urological Association symptom score, called UWIN (urgency, weak stream, incomplete emptying and nocturia). MATERIALS AND METHODS: Participants in Prostate Cancer Awareness Week from 2006 and 2007 were administered the regular American Urological Association symptom score and UWIN. A total of 278 participants completed each questionnaire. Total scores of each participant for the American Urological Association symptom score (range 0 to 35) and UWIN (range 0 to 12) were evaluated using Spearman's correlation coefficients and Bland-Altman plots to determine the level of agreement between the 2 questionnaires. RESULTS: The correlation between the total American Urological Association symptom score (range 0 to 35) and the total UWIN score (range 0 to 12) was 0.913 (p<0.0001). The correlation between the quality of life question on the American Urological Association symptom score and UWIN was 0.821 using the Spearman correlation coefficient (p<0.0001). A second analysis performed using Bland-Altman plots showed good agreement between the American Urological Association symptom score and UWIN. Overall, respondents tended to have slightly higher UWIN total scores than their American Urological Association symptom scores. CONCLUSIONS: This study validates that the UWIN questionnaire can be used in place of the American Urological Association symptom score. The UWIN questionnaire will lessen the burden on the respondent, broaden the applicability of the instrument and make collecting data as efficient and effective as possible.","J Urol, 186(3): 945-948","USA",2011,"At risk","None","AUA-SI,UWIN","General population",null,"Validation",null,null,null,null,null,null,null,null,"Complication,Symptom"]
[143,"Cresswell, S. M., et al. (1995). \"Pain relief and quality-of-life assessment following intravenous and oral clodronate in hormone-escaped metastatic prostate cancer.\" Br J Urol 76(3): 360-365.",null,"Cresswell, S. M., et al.","Pain relief and quality-of-life assessment following intravenous and oral clodronate in hormone-escaped metastatic prostate cancer","OBJECTIVE: To establish the efficacy of intravenous clodronate followed by maintenance oral clodronate in patients with painful bone metastases resulting from hormone-resistant prostate cancer. PATIENTS AND METHODS: A multicentre open study of 27 patients assessed the efficacy of clodronate treatment by estimating the reduction in World Health Organization (WHO) Pain Score, the increase in WHO Performance Status and by a novel quality-of-life/activity score. RESULTS: Ten of 27 patients achieved significant pain relief after receiving 300 mg/day of intravenous clodronate for 10 days. This was matched by an improvement in the activity score and WHO Performance Status. Three of 27 patients continued to have relief from pain after 3 months of oral clodronate therapy. CONCLUSION: Intravenous clodronate therapy was effective in relieving the pain resulting from prostate cancer bone metastases in 10 of 27 patients but the benefit was shortlived. The use of a personal quality-of-life/activity questionnaire which assesses aspects of everyday life that are important to the patient may be more appropriate for patients with very advanced prostate cancer than are other quality-of-life questionnaires in current use.","Br J Urol, 76(3): 360-365","UK",1995,"Metastatic","Bisphosphonate","WHO-Pain,WHO-PS","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General,Symptom"]
[144,"Crevenna, R., et al. (2009). \"Strength of skeletal muscle and quality of life in patients suffering from \"typical male\" carcinomas.\" Support Care Cancer 17(10): 1325-1328.",null,"Crevenna, R., et al.","Strength of skeletal muscle and quality of life in patients suffering from \"typical male\" carcinomas","AIM: This pilot study aimed to compare muscle strength and quality of life (QOL) in cancer patients suffering from two different \"typical male\" cancer entities (prostate cancer and head and neck cancer). METHODS: The Biodex System 3 device was used for isokinetic strength testing of thigh muscles in both groups. QOL was evaluated by using the SF-36 Health Survey. RESULTS AND DISCUSSION: Surprisingly, prostate cancer patients showed significantly higher values for muscular strength of thigh muscles than significant younger patients with head and neck cancer. Furthermore, prostate cancer patients revealed significantly better values in QOL subscales \"bodily pain\" and \"physical functioning\".","Support Care Cancer, 17(10): 1325-1328","Austria",2009,"Any or unknown","None","SF-36","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Utility"]
[145,"Crook, J. M., et al. (2011). \"Comparison of health-related quality of life 5 years after SPIRIT: Surgical Prostatectomy Versus Interstitial Radiation Intervention Trial.\" J Clin Oncol 29(4): 362-368.",null,"Crook, J. M., et al.","Comparison of health-related quality of life 5 years after SPIRIT: Surgical Prostatectomy Versus Interstitial Radiation Intervention Trial","PURPOSE: The American College of Surgeons Oncology Group phase III Surgical Prostatectomy Versus Interstitial Radiation Intervention Trial comparing radical prostatectomy (RP) and brachytherapy (BT) closed after 2 years due to poor accrual. We report health-related quality of life (HRQOL) at a mean of 5.3 years for 168 trial-eligible men who either chose or were randomly assigned to RP or BT following a multidisciplinary educational session. PATIENTS AND METHODS: After initial lack of accrual, a multidisciplinary educational session was introduced for eligible patients. In all, 263 men attended 47 sessions. Of those, 34 consented to random assignment, 62 chose RP, and 94 chose BT. Five years later, these 190 men underwent HRQOL evaluation by using the cancer-specific 50-item Expanded Prostate Cancer Index Composite, the Short Form 12 Physical Component Score, and Short Form 12 Mental Component Score. Response rate was 88.4%. The Wilcoxon rank sum test was used to compare summary scores between the two interventions. RESULTS: Of 168 survey responders, 60.7% had BT (9.5% randomly assigned) and 39.3% had RP (9.5% randomly assigned). Median age was 61.4 years for BT and 59.4 for RP (P = .05). Median follow-up was 5.2 years (range, 3.2 to 6.5 years). For BT versus RP, there was no difference in bowel or hormonal domains, but men treated with BT scored better in urinary (91.8 v 88.1; P = .02) and sexual (52.5 v 39.2; P = .001) domains, and in patient satisfaction (93.6 v 76.9; P < .001). CONCLUSION: Although treatment allocation was random in only 19%, all patients received identical information in a multidisciplinary setting before selecting RP, BT, or random assignment. HRQOL evaluated 3.2 to 6.5 years after treatment showed an advantage for BT in urinary and sexual domains and in patient satisfaction.","J Clin Oncol, 29(4): 362-368","Canada",2011,"Any or unknown","Brachytherapy,Surgery,Various","EPIC,SF-12","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,Utility"]
[146,"Culine, S. and J. P. Droz (2000). \"Chemotherapy in advanced androgen-independent prostate cancer 1990-1999: a decade of progress?\" Ann Oncol 11(12): 1523-1530.",null,"Culine, S. and J. P. Droz","Chemotherapy in advanced androgen-independent prostate cancer 1990-1999: a decade of progress?","BACKGROUND AND PURPOSE: A great number of clinical research studies have been reported in the field of chemotherapy for advanced androgen-independent prostate cancer during the last ten years. The aims of the present review were to assess their impact on management of the disease and on survival of patients. METHODS: The review of full published reports was facilited by the use of a MEDLINE computer search. RESULTS: Clinical research studies have focused on defining guidelines for eligibility criteria and accurate endpoints for patients to be enrolled onto clinical trials and developing new agents or combination of drugs including estramustine phosphate. Any combination of current chemotherapy has no impact on overall survival of patients. Among drugs in development, only the promising activity observed with docetaxel deserves randomized trials to assess its impact on survival. The major innovative advance of the 90s is the demonstration of the impact of chemotherapy (mitoxantrone + prednisone) on quality of life as compared to prednisone alone. A greater and longer-lasting improvement in quality of life along with a concomitant decrease in costs was observed. CONCLUSIONS: At the present time, chemotherapy should be considered as a palliative treatment in patients with symptomatic androgen-independent disease. The enrollment of patients into clinical trials dealing with quality of life as primary endpoint is strongly solicited. A standard methodology should be used in phase II trials with a primary goal of selection of agents which should progress to randomized trials using survival as an endpoint. Hopefully new specific strategies targeted to reverse the molecular changes that underlie prostate tumorigenesis should rapidly impact the multimodality management of AIPC in the third millenium.","Ann Oncol, 11(12): 1523-1530","International",2000,"Advanced","Taxane,Chemotherapy","Unclear","Patient",null,"Systematic review",null,null,null,null,null,null,null,null,"General"]
[147,"Curigliano, G., et al. (2009). \"Health-related quality of life in patients with hormone refractory prostate cancer receiving gefitinib.\" Urol Int 82(2): 196-202.",null,"Curigliano, G., et al.","Health-related quality of life in patients with hormone refractory prostate cancer receiving gefitinib","OBJECTIVES: Improvements in quality of life (QoL) and disease-related symptoms are key goals in the treatment of hormone refractory prostate cancer (HRPC). Our aim was to evaluate the impact of gefitinib on QoL of patients with HRPC. METHODS: Patients with HRPC received gefitinib 250 mg daily in addition to antiandrogen plus luteinizing hormone-releasing hormone (LHRH) analogue for at least 2 months or until disease progression. QoL was evaluated monthly by the European Organisation for Research on the Treatment of Cancer (EORTC) QLQ-C30 questionnaire. Pain was assessed daily by patients and scored by visual analogue scale and analgesic consumption in a diary. Monthly pain intensity was estimated using the McGill-Melzack questionnaire. RESULTS: Analysis of global health status according to EORTC QLQ-C30 showed an improvement of the status in only 6 patients (26%). The greatest benefit in the patients was in the subscale representing prostate-specific concerns (including appetite, pain, physical comfort, and genitourinary function). Improvement of symptoms was correlated with antiandrogen withdrawal. Global health status and QoL decreased during treatment according to tumor progression. CONCLUSIONS: Among HRPC patients treated with gefitinib, improvement of symptoms preceded evidence of biochemical response of prostate-specific antigen following antiandrogen withdrawal. These findings suggest no beneficial effect of gefitinib in QoL improvement.","Urol Int, 82(2): 196-202","Italy",2009,"Any or unknown","Gefitinib,Hormonal","EORTC QLQ-C30,VAS,MPI","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General,Symptom"]
[148,"Curran, D., et al. (1997). \"Baseline quality of life of patients with advanced prostate cancer. European Organization for Research and Treatment of Cancer (EORTC), Genito-Urinary Tract Cancer Cooperative Group (GUT-CCG).\" Eur J Cancer 33(11): 1809-1814.",null,"Curran, D., et al.","Baseline quality of life of patients with advanced prostate cancer. European Organization for Research and Treatment of Cancer (EORTC), Genito-Urinary Tract Cancer Cooperative Group (GUT-CCG)","Quality of life (QoL) is now commonly studied in prostate cancer. However, little is known about the appropriateness of the various QoL instruments in this group of patients. The purpose of this work was to study the baseline QoL assessment of patients with prostate cancer who were randomised into three EORTC phase III studies. The three trials included locoregional prostate cancer patients, poor prognosis metastatic patients and hormone resistance patients, respectively. In the three trials, patients were asked to complete a questionnaire assessing their physical and psychosocial functioning and their symptom levels. These questionnaires included questions from the EORTC QLQ-C30 (version 1): the physical functioning, role functioning, global health/QoL scales and a single pain item. The psychometric properties of the scales were assessed and an analysis was performed to investigate if differences existed in the scale scores between the three groups of patients, 638 baseline questionnaires were available for patients entered into the three trials. The Gutman coefficients of reproducibility and scalability were 0.94 and 0.71, respectively, for the physical functioning scale and 0.97 and 0.90, respectively, for the role functioning scale. The Cronbach's alpha reliability coefficients were 0.68, 0.48 and 0.90 for the physical functioning, role functioning and global health/QoL scales, respectively. The four scales were able to distinguish clearly between the patient populations under study. The physical functioning, role functioning, global health/QoL scales and the single pain item scale from the EORTC QLQ-C30 (version 1) are valid measures when used in the setting of prostate cancer.","Eur J Cancer, 33(11): 1809-1814","Belgium",1997,"Metastatic,Local","None","EORTC QLQ-C30","Patient",null,"Validation",null,null,null,null,null,null,null,null,"General"]
[149,"da Silva, F. C. (1993). \"Quality of life in prostatic carcinoma.\" Eur Urol 24 Suppl 2: 113-117.",null,"da Silva, F. C.","Quality of life in prostatic carcinoma","Subjective quality-of-life assessments obtained from investigators and patients were compared in a subset of 76 patients from an EORTC study (protocol 30853) on metastatic prostatic carcinoma. In this study the therapeutic effect of orchiectomy was compared with a luteinizing hormone-releasing hormone analogue depot preparation and flutamide in 327 patients in total. Pretreatment, 6- and 12-month quality-of-life assessments revealed large variations between the patients' and the investigators' evaluation of performance status and sexual status (potency). Correlation analysis showed that reduced social life, impaired sexual potency and fatigue played important roles in overall psychological well-being. It was concluded that quality-of-life assessments obtained by self-administration questionnaires is a feasible approach and provides a tool to evaluate the benefits of treatment in prostate cancer.","Eur Urol, 24 Suppl 2(113-117","Portugal",1993,"Metastatic","Surgery,Hormonal","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General,Complication"]
[150,"da Silva, F. C., et al. (1996). \"The quality of life of patients with newly diagnosed M1 prostate cancer: experience with EORTC clinical trial 30853.\" Eur J Cancer 32a(1): 72-77.",null,"da Silva, F. C., et al.","The quality of life of patients with newly diagnosed M1 prostate cancer: experience with EORTC clinical trial 30853","This study was undertaken to evaluate the quality of life (QoL) of previously untreated patients with M1 prostate cancer before and during androgen-suppressive treatment. Assessment of QoL was included as an optimal component of EORTC protocol 30853, a phase III trial comparing LH-RH (luteinising hormone-releasing hormone) analogue combined with a non-steroidal anti-androgen versus orchiectomy in patients with M1 prostate cancer. At pretreatment and during the follow-up period, patients were asked to complete a questionnaire assessing their physical and psychosocial functioning, and their symptom levels. Physicians rated the patients' performance status, pain, urological symptoms and erectile function. Due to its optional nature, only a minority of the patients in the trial were recruited for the QoL investigation. 63 patients completed a pretreatment questionnaire, of whom 49 completed a second questionnaire at least once during the initial 15 month follow-up period. While statistically significant correlations were observed between patients' and physicians' ratings of physical functioning and pain, these were of only a moderate magnitude (r = 0.43 and 0.30, respectively). No significant association was observed between physicians' and patients' ratings of micturation problems or of erectile function. Before treatment, fatigue, pain and decreased social role and sexual functioning were the problems most frequently reported by patients. With an average of approximately 1 year follow-up, statistically significant improvements were observed in patients' self-reported urological symptoms and metastatic pain. No significant changes were noted for the other QoL domains assessed. The results of this study confirm earlier findings that physicians' ratings may not reflect accurately the functional health and symptom experience of their patients. Patient-based QoL questionnaires offer the most direct means of evaluating the subjective morbidity associated with prostate cancer and its treatment. To increase participation and compliance rates in future studies, it is recommended that QoL assessment be made mandatory in those clinical trials in which QoL is considered to be an important study endpoint.","Eur J Cancer, 32a(1): 72-77","Portugal",1996,"Metastatic","Hormonal,Surgery","Unclear","Patient,HCP",null,"Clinical trial",null,null,null,null,null,null,null,null,"Symptom,Complication"]
[151,"D'Agostino, G., et al. (2016). \"High-quality Linac-based Stereotactic Body Radiation Therapy with Flattening Filter Free Beams and Volumetric Modulated Arc Therapy for Low-Intermediate Risk Prostate Cancer. A Mono-institutional Experience with 90 Patients.\" Clin Oncol (R Coll Radiol) 28(12): e173-e178.",null,"D'Agostino, G., et al.","High-quality Linac-based Stereotactic Body Radiation Therapy with Flattening Filter Free Beams and Volumetric Modulated Arc Therapy for Low-Intermediate Risk Prostate Cancer. A Mono-institutional Experience with 90 Patients","AIMS: The aim of this phase II study was to evaluate the efficacy and toxicity of stereotactic body radiotherapy in patients with low or intermediate risk prostate cancer. MATERIALS AND METHODS: Biopsy-confirmed prostate cancer patients were enrolled, provided that they had the following characteristics: initial prostate-specific antigen (PSA) </= 20 ng/ml, Gleason Score < 7, International Prostate Symptom Score < 7. The treatment schedule was 35 Gy in five fractions, delivered with volumetric modulated arcs with flattening filter free beams. Toxicity was recorded according to CTCAE criteria v4.0. Biochemical failure was calculated according to the Phoenix definition. The Expanded Prostate Cancer Index Composite questionnaire was used to record health-related quality of life. RESULTS: Between December 2011 and March 2015, 90 patients were enrolled (53 low risk, 37 intermediate risk). The median age was 71 years (range 48-82). In total, 58 (64.5%) of the patients had Gleason Score=6, the remaining had Gleason Score=7.The median initial PSA was 6.9 ng/ml (range 2.7-17.0). Acute toxicity was mild, with 32.2 patients presenting grade 1 urinary toxicity and 32.2% of patients presenting grade 2 urinary toxicity, mainly represented by urgency, dysuria and stranguria. Rectal grade 1 toxicity was found in 15.5% of patients, whereas grade 2 toxicity was recorded in 6.6% of patients. Regarding late toxicity, grade 1 proctitis was recorded in 11.1% of patients and grade 1 urinary in 38.8%; only two events of grade 2 urinary toxicity were observed (transient urethral stenosis, resolved by a 24 h catheterisation). At a median follow-up of 27 months (6-62 months) only two intermediate risk patients experienced a biochemical failure. Health-related quality of life revealed a slight worsening in all the domains during treatment, with a return to baseline 3 months after treatment. CONCLUSIONS: Stereotactic body radiotherapy delivered using linac-based flattening filter free volumetric modulated arc radiotherapy in low and intermediate risk prostate cancer patients is associated with mild toxicity profiles and good patient-reported quality of life.","Clin Oncol (R Coll Radiol), 28(12): e173-e178","Italy",2016,"Local","Radiotherapy","EPIC,IPSS,CTCAE","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,Treatment,Symptom"]
[152,"Dahn, J. R., et al. (2004). \"Sexual functioning and quality of life after prostate cancer treatment: considering sexual desire.\" Urology 63(2): 273-277.",null,"Dahn, J. R., et al.","Sexual functioning and quality of life after prostate cancer treatment: considering sexual desire","OBJECTIVES: To evaluate whether the relationship between sexual desire and quality of life (QOL) is moderated by sexual functioning in 91 men who had received treatment for localized prostate cancer within the past 18 months. METHODS: Items from the University of California, Los Angeles, Prostate Cancer Index and Expanded Prostate Cancer Index Composite were used to assess sexual factors, and the Functional Assessment of Cancer Therapy--General Module was administered to evaluate QOL. Education, income, and the Charlson comorbidity index were significantly related to QOL and controlled in all analyses. We tested a moderated regression model to predict QOL. RESULTS: Although a main effect was detected for sexual functioning, the interaction of sexual desire and sexual functioning added a significant amount to the explained variance in QOL. Post hoc tests of moderation revealed that men with lower sexual functioning had significantly lower QOL scores as the level of sexual desire increased, suggesting that desire in the absence of adequate functioning may result in poorer QOL. Additionally, a tendency was found for men with better sexual functioning to have higher QOL scores as the level of sexual desire increased. CONCLUSIONS: The results of our study suggest that both sexual desire and sexual functioning are necessary for optimal QOL and highlight the utility of considering these two facets of sexuality independently to maximize the prediction of variance in QOL scores.","Urology, 63(2): 273-277","USA",2004,"Local","Unclear","EPIC,FACT-G,UCLA-PCI","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Disease,Treatment"]
[153,"Dale, W., et al. (1999). \"Self-assessed health-related quality of life in men being treated for prostate cancer with radiotherapy: instrument validation and its relation to patient-assessed bother of symptoms.\" Urology 53(2): 359-366.",null,"Dale, W., et al.","Self-assessed health-related quality of life in men being treated for prostate cancer with radiotherapy: instrument validation and its relation to patient-assessed bother of symptoms","OBJECTIVES: To develop a psychometrically valid and clinically useful questionnaire to assess health-related quality of life (HRQOL) in patients with prostate cancer (PCa) undergoing external beam radiotherapy. The most important factors in three dimensions (bowel function [BF], urinary function [UF], and sexual function [SF]) were identified by patient survey. METHODS: Three HRQOL dimensions were assessed using Likert-type questions. Responses were analyzed by factor analysis to create HRQOL scales. Reliability and validity of the scales were assessed. Because patients can suffer symptoms yet not report their lives to be affected, the scales were compared with patient-reported bother. RESULTS: Two scales were identified within each dimension: BF, urgency and daily living; UF, urgency and weakness of stream; and SF, interest/satisfaction and impotence. Cronbach's alpha for the scales ranged from 0.63 to 0.94, and item-scale correlations and item-scale divergence correlations supported scale validity. Rising median scores correlated with rising levels of perceived bother. CONCLUSIONS: The questionnaire is a suitable tool for assessing HRQOL in three distinct dimensions for patients undergoing radiotherapy for PCa. Six dimensions of HRQOL were found to be related to bother, suggesting important relationships to be monitored for patients. Urgency of bowel movements, urgency of urination, and level of interest/satisfaction in sex correlated most strongly with bother.","Urology, 53(2): 359-366","USA",1999,"Any or unknown","Radiotherapy","Likert scale","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Symptom,Complication"]
[154,"Dale, W., et al. (2011). \"The prevalence, correlates, and impact of logically inconsistent preferences in utility assessments for joint health states in prostate cancer.\" Med Care 49(1): 59-66.",null,"Dale, W., et al.","The prevalence, correlates, and impact of logically inconsistent preferences in utility assessments for joint health states in prostate cancer","BACKGROUND: Variations in health state utilities can impact cost-effectiveness analyses. One potential source of error is when joint health state (JS) utilities are rated higher than the embedded single state (SS) utilities. Knowing when and in whom this occurs can improve cost-effectiveness analyses. METHODS: Men (n = 323) were surveyed at the time of prostate biopsy. Time tradeoff SS and JS utilities for prevalent prostate cancer (PCa) health states were collected. JS utilities assessed included those most prevalent for PCa. \"Inconsistency\" was defined in the following 3 ways: (1) any size rank order violation; (2) total number of violations; and (3) differences greater than 1 standard deviation (SD). Regression analysis assessed independent patient characteristics associated with inconsistent responses. RESULTS: Aggregate JS utilities were consistent. At the individual level, 36% to 41% of responses violated rank order and 12% to 14% were larger than 1 SD. In all, 69% of respondents had at least 1 JS inconsistency, and 24% had >1 SD inconsistencies. Being married and feeling anxious were independently correlated with giving all types of inconsistent ratings, and lower education correlated with making >SD errors. SS utilities, and not JS utilities, were significantly lower for the inconsistent group. \"Correcting\" JS inconsistencies decreased aggregate utilities 1 to 9 units. CONCLUSIONS: Inconsistent JS utilities for PCa are prevalent in men at biopsy. Being married, more anxious, and having less education are correlated with inconsistencies. It is the SS utilities, rather than the JS utilities, that differ between consistent and inconsistent raters. Better understanding of the source of these inconsistencies is needed.","Med Care, 49(1): 59-66","USA",2011,"At risk","None","TTO","General population",null,"Validation",null,null,null,null,null,null,null,null,"Utility"]
[155,"Daubenmier, J. J., et al. (2006). \"Lifestyle and health-related quality of life of men with prostate cancer managed with active surveillance.\" Urology 67(1): 125-130.",null,"Daubenmier, J. J., et al.","Lifestyle and health-related quality of life of men with prostate cancer managed with active surveillance","OBJECTIVES: To assess the impact of lifestyle on health-related quality of life (HR-QOL), perceived stress, and self-reported sexual function in men with early-stage prostate cancer electing active surveillance. METHODS: A total of 44 intervention and 49 usual-care control participants were enrolled in a randomized clinical trial examining the effects of lifestyle changes on prostate cancer progression. The intervention consisted of a low-fat, vegan diet, exercise, and stress management. Participants completed the Medical Outcomes Study Short Form-36 Health Status Survey (a measure of mental and physical HR-QOL), the Perceived Stress Scale, the Sexual Function subscale of the University of California, Los Angeles, Prostate Cancer Index, and measures of lifestyle behaviors (to yield an overall lifestyle index) at baseline and 12 months. The data were analyzed using analysis of variance for repeated measures. The relationship between lifestyle and QOL was also analyzed using multiple linear regression analyses. RESULTS: Intervention participants had significantly improved their lifestyle compared with controls at 12 months. The quality-of-life scores were high across groups and time points. However, a healthier lifestyle was related to better QOL at baseline. Participants in both groups who reported a healthier lifestyle also reported better mental and physical HR-QOL and sexual function. Furthermore, participants whose lifestyle improved over time showed enhanced physical HR-QOL and decreased perceived stress. CONCLUSIONS: Men who choose active surveillance for early-stage prostate cancer are able to make comprehensive lifestyle changes. Although the average QOL was already high in this sample, individuals who improved their lifestyle enhanced their QOL further.","Urology, 67(1): 125-130","USA",2006,"Local","Surveillance","SF-36,UCLA-PCI,PcSS","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Utility,Disease,General"]
[156,"Davis, J. W., et al. (2001). \"Quality of life after treatment for localized prostate cancer: differences based on treatment modality.\" J Urol 166(3): 947-952.",null,"Davis, J. W., et al.","Quality of life after treatment for localized prostate cancer: differences based on treatment modality","PURPOSE: Brachytherapy with 103palladium (103Pd) is an increasingly administered treatment modality for localized prostate cancer. We compared general and disease specific health related quality of life after 103Pd treatment, radical prostatectomy and external beam radiation therapy given during the same time frame. MATERIALS AND METHODS: We performed a retrospective cross-sectional survey study of patients treated at a single community medical center between 1995 and 1999. We mailed 5 validated health related quality of life survey instruments to 269, 142 and 222 men who underwent radical prostatectomy, 103Pd treatment and external beam radiation therapy, respectively, with a response rate of greater than 80% in all groups. RESULTS: General health related quality of life assessed by the SF-36 showed the same scores in patients who underwent prostatectomy and 103Pd treatment. The University of California-Los Angeles Prostate Cancer Index was used to assess bowel, urinary and sexual function/bothersomeness. External beam radiation therapy reported was associated with worse bowel function and greater bowel bothersomeness. Prostatectomy was associated with worse urinary function compared to 103Pd and external beam radiation therapy. Prostatectomy was associated with worse sexual function than 103Pd or external beam radiation therapy, although nerve sparing surgery and erectile aids minimized the difference. American Urological Association symptom scores were initially higher for 103Pd but became equal to those in the other groups in patients treated greater than 12 months from survey time. Disease-free men who underwent prostatectomy and 103Pd brachytherapy were equally confident that cancer would not recur in the future. Satisfaction rates were equivalent and biochemical failure significantly decreased satisfaction in all groups. CONCLUSIONS: While general health related quality of life was mostly unaffected by the 3 most common treatments for prostate cancer, there were differences in bowel, urinary and sexual function. This information may aid patients in the decision making process.","J Urol, 166(3): 947-952","USA",2001,"Local","Radiotherapy,Surgery,Brachytherapy","SF-36,UCLA-PCI,AUA-SI","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Disease,Utility,Symptom"]
[157,"Davison, B. J. and S. L. Goldenberg (2003). \"Decisional regret and quality of life after participating in medical decision-making for early-stage prostate cancer.\" BJU Int 91(1): 14-17.",null,"Davison, B. J. and S. L. Goldenberg","Decisional regret and quality of life after participating in medical decision-making for early-stage prostate cancer","OBJECTIVE: To determine the effect of men's reported levels of involvement in medical decision-making and quality of life (QoL) on their levels of decisional regret after definitive treatment. PATIENTS AND METHODS: Men referred to a hospital-based resource centre completed QoL and decisional-regret measures after definitive treatment for localized prostate cancer. Data from these questionnaires were linked with a previous study conducted to determine if providing individualized information to men newly diagnosed with prostate cancer would lower their levels of psychological distress and enable them to become more active participants in treatment decision-making. The preferred role in medical decision-making and QoL had previously been measured at the time of diagnosis and the assumed role at 4 months after the definitive treatment decision. This postal survey was conducted approximately 18 months after diagnosis. RESULTS: Of 74 men, 67 (91%) responded; the mean (sd) time since definitive treatment was 10.3 (4.7) months and the mean age of the men 62.5 (6.9) years. Radical prostatectomy was the most frequent treatment (72%). Most (94%) patients participated in medical decision-making either actively or collaboratively and did not regret their treatment choice. The type of definitive treatment received had no effect on decisional regret; patients' QoL scores were similar to the levels before treatment. Levels of sexual function were significantly lower after definitive treatment, but urinary incontinence was not significantly affected. Men who had neoadjuvant hormone therapy reported having significantly more treatment-related symptoms. CONCLUSIONS: There is no evidence that providing information to facilitate participation in medical decision-making causes decisional regret or psychological distress within the first year after definitive treatment. A longitudinal follow-up of these patients is required to adequately assess the long-term effects of treatment on QoL and decisional regret.","BJU Int, 91(1): 14-17","Canada",2003,"Local","Surgery","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"General,Satisfaction"]
[158,"Dawson, N. A., et al. (2000). \"A randomized study comparing standard versus moderately high dose megestrol acetate for patients with advanced prostate carcinoma: cancer and leukemia group B study 9181.\" Cancer 88(4): 825-834.",null,"Dawson, N. A., et al.","A randomized study comparing standard versus moderately high dose megestrol acetate for patients with advanced prostate carcinoma: cancer and leukemia group B study 9181","BACKGROUND: Megestrol acetate (MA) is a synthetic progestin with reported activity in both hormone-sensitive and hormone-refractory prostate carcinoma (HRPC). Based on limited data suggesting a possible dose-response effect, a trial was initiated to compare standard versus moderately high dose MA in HRPC. METHODS: One hundred forty-nine men with hormone-refractory prostate carcinoma were randomized to receive oral MA either at 160 mg/day (low dose) or 640 mg/day (high dose). Patients were stratified by performance status and measurable versus evaluable disease. The primary end point was tumor response. Secondary end points were survival, quality-of-life measures, and prostate specific antigen (PSA) decline. RESULTS: The median survival times of 11.2 months for patients who received the low dose and 12.1 months for patients who received the high dose therapy were not significantly different. Best response was equivalent in the 2 arms: 2 partial responses and 22 patients with stable disease for the 160 mg/day dose, and 1 partial response and 28 patients with stable disease for the 640 mg/day dose. A greater than 50% decline in PSA occurred in 13.8% and 8.8% of patients in the low and high dose treatment arms, respectively. There were no differences in the toxicity or quality-of-life outcomes between the two arms. Poorer performance status (2 vs. 0-1), greater than 5% weight loss, higher baseline PSA, and measurable disease all predicted shorter survival. CONCLUSIONS: MA has limited activity in hormone-refractory prostate carcinoma, and there is no apparent dose-response correlation.","Cancer, 88(4): 825-834","USA",2000,"Advanced","Hormonal","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General"]
[159,"Dawson, N., et al. (2011). \"Health-related quality of life in pain-free or mildly symptomatic patients with metastatic hormone-resistant prostate cancer following treatment with the specific endothelin A receptor antagonist zibotentan (ZD4054).\" J Cancer Res Clin Oncol 137(1): 99-113.",null,"Dawson, N., et al.","Health-related quality of life in pain-free or mildly symptomatic patients with metastatic hormone-resistant prostate cancer following treatment with the specific endothelin A receptor antagonist zibotentan (ZD4054)","PURPOSE: Zibotentan (ZD4054) is a specific endothelin A receptor antagonist in clinical development for the treatment of hormone-resistant prostate cancer (HRPC). In a Phase II trial in patients with pain-free or mildly symptomatic metastatic HRPC, zibotentan was well tolerated with a promising signal for prolonged overall survival compared with placebo. As part of this trial, the impact of zibotentan compared with placebo on health-related quality of life (HRQoL) was assessed. METHODS: Patients were randomized to receive once-daily oral zibotentan 10 or 15 mg, or matching placebo. Patients were allocated to one of two questionnaires; the Functional Assessment of Cancer Therapy-Prostate (FACT-P) or the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), supplemented by PR25, specific for prostate cancer. Questionnaires were completed at baseline and every 4 weeks until disease progression when study treatment was discontinued. RESULTS: Compliance with questionnaire completion was >90% (286 of 312 patients) of the intention-to-treat population at baseline. Of baseline completers who were available for assessment (i.e., had not clinically progressed), 89% (164 of 184) and 83% (73 of 88) completed questionnaires at 12 and 24 weeks, respectively. HRQoL scores from both questionnaires were high at baseline and remained high throughout the study, with scores being similar in the zibotentan and placebo groups. However, some floor and ceiling effects were seen in the EORTC QLQ-C30 questionnaire. CONCLUSIONS: High-baseline HRQoL scores were maintained throughout treatment with zibotentan. The FACT-P instrument was selected to further assess the impact of zibotentan on HRQoL in the Phase III clinical trial program.","J Cancer Res Clin Oncol, 137(1): 99-113","UK",2011,"Metastatic","PDEi","FACT-P,EORTC QLQ-C30,EORTC QLQ-PR25","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,General"]
[160,"de Cerqueira, M. A., et al. (2015). \"Burden of focal cryoablation versus brachytherapy versus active surveillance in the treatment of very low-risk prostate cancer: a preliminary head-to-head comprehensive assessment.\" Eur J Cancer Care (Engl) 24(6): 929-937.",null,"de Cerqueira, M. A., et al.","Burden of focal cryoablation versus brachytherapy versus active surveillance in the treatment of very low-risk prostate cancer: a preliminary head-to-head comprehensive assessment","Focal cryoablation (FC), brachytherapy (B) and active surveillance (AS) were offered to patients diagnosed with very low-risk prostate cancer (VLRPC) in an equal access protocol. Comprehensive validated self-report questionnaires accessed patients' erectile (IIEF-5) and voiding (IPSS) functions, Beck scales measured anxiety (BAI), hopelessness (BHS) and depression (BDI), SF-36 reflected patients' quality of life added to the emotional thermometers including five visual analogue scales (distress, anxiety, depression, anger and need for help). Kruskal-Wallis or ANOVA tests and Spearman's correlations were obtained among groups and studied variables. Thirty patients were included, median follow-up 18 months (15-21). Those on AS (n = 11) were older, presented higher hopelessness (BHS) and lower general health perceptions (SF-36) scores than patients opting for FC (n = 10) and B (n = 9), P = 0.0014, P = 0.0268 and P = 0.0168 respectively. Patients on B had higher IPSS scores compared to those under FC and AC, P = 0.0223. For all 30 included patients, Spearman's correlation (rs ) was very strong between BHS and general health perceptions (rs = -0.800, P < 0.0001), and weak/moderate between age and BHS (rs = 0.405, P = 0.026) and age and general health perceptions (rs = -0.564, P = 0.001). The sample power was >60%. To be considered in patients' counselling and care, current study supports the hypothesis that even VLRPC when untreated undermines psychosocial domains.","Eur J Cancer Care (Engl), 24(6): 929-937","Brazil",2015,"Local","Various,Brachytherapy,Surveillance","IIEF-5,IPSS,BAI,BHS,BDI,SF-36,VAS","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,Complication,Comorbidity,Utility"]
[161,"De Souza, P. L., et al. (2010). \"A phase II trial of weekly i.v. KW-2170 in advanced castrate-resistant prostate cancer.\" Asia Pac J Clin Oncol 6(4): 292-297.",null,"De Souza, P. L., et al.","A phase II trial of weekly i.v. KW-2170 in advanced castrate-resistant prostate cancer","AIM: KW-2170 is a novel pyrazoloacridone derivative that intercalates nucleic acids. It has promising in vitro properties against prostate and other cancers and is active in vivo against doxorubicin-resistant cell lines. We wished to investigate its activity and toxicity profile in this Phase II trial in androgen independent prostate cancer. METHODS: Overall 44 men were recruited to this multicenter, open label, non-randomized study, with 35 evaluable for prostatic specific antigen (PSA) response. RESULTS: Five patients had a PSA fall greater than 50% (overall RR 14.3%, 95% CI 4.8-30.3%). Overall median survival was 16 months. In the evaluable group (n = 35), median survival was 18.9 months. The drug was very well tolerated, with the most common toxicities being hematological (anemia, leucopenia, thrombocytopenia), alopecia, fatigue, and nausea. However, most of these were National Cancer Institute Grade 1 or 2; Grade 3 neutropenia occurred in only 11% of patients, and there was no Grade 4 neutropenia. Quality of life as measured by the FACT-P scale was not compromised. CONCLUSION: KW-2170 is a very well tolerated chemotherapy agent. It has a relatively low PSA response rate, and did not meet the pre-specified criteria for further studies.","Asia Pac J Clin Oncol, 6(4): 292-297","Australia",2010,"Advanced","Chemotherapy","FACT-P","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease"]
[162,"Dearnaley, D. P., et al. (2007). \"Escalated-dose versus standard-dose conformal radiotherapy in prostate cancer: first results from the MRC RT01 randomised controlled trial.\" Lancet Oncol 8(6): 475-487.",null,"Dearnaley, D. P., et al.","Escalated-dose versus standard-dose conformal radiotherapy in prostate cancer: first results from the MRC RT01 randomised controlled trial","BACKGROUND: In men with localised prostate cancer, conformal radiotherapy (CFRT) could deliver higher doses of radiation than does standard-dose conventional radical external-beam radiotherapy, and could improve long-term efficacy, potentially at the cost of increased toxicity. We aimed to present the first analyses of effectiveness from the MRC RT01 randomised controlled trial. METHODS: The MRC RT01 trial included 843 men with localised prostate cancer who were randomly assigned to standard-dose CFRT or escalated-dose CFRT, both administered with neoadjuvant androgen suppression. Primary endpoints were biochemical-progression-free survival (bPFS), freedom from local progression, metastases-free survival, overall survival, and late toxicity scores. The toxicity scores were measured with questionnaires for physicians and patients that included the Radiation Therapy Oncology Group (RTOG), the Late Effects on Normal Tissue: Subjective/Objective/Management (LENT/SOM) scales, and the University of California, Los Angeles Prostate Cancer Index (UCLA PCI) scales. Analysis was done by intention to treat. This trial is registered at the Current Controlled Trials website http://www.controlled-trials.com/ISRCTN47772397. FINDINGS: Between January, 1998, and December, 2002, 843 men were randomly assigned to escalated-dose CFRT (n=422) or standard-dose CFRT (n=421). In the escalated group, the hazard ratio (HR) for bPFS was 0.67 (95% CI 0.53-0.85, p=0.0007). We noted 71% bPFS (108 cumulative events) and 60% bPFS (149 cumulative events) by 5 years in the escalated and standard groups, respectively. HR for clinical progression-free survival was 0.69 (0.47-1.02; p=0.064); local control was 0.65 (0.36-1.18; p=0.16); freedom from salvage androgen suppression was 0.78 (0.57-1.07; p=0.12); and metastases-free survival was 0.74 (0.47-1.18; p=0.21). HR for late bowel toxicity in the escalated group was 1.47 (1.12-1.92) according to the RTOG (grade >/=2) scale; 1.44 (1.16-1.80) according to the LENT/SOM (grade >/=2) scales; and 1.28 (1.03-1.60) according to the UCLA PCI (score >/=30) scale. 33% of the escalated and 24% of the standard group reported late bowel toxicity within 5 years of starting treatment. HR for late bladder toxicity according to the RTOG (grade >/=2) scale was 1.36 (0.90-2.06), but this finding was not supported by the LENT/SOM (grade >/=2) scales (HR 1.07 [0.90-1.29]), nor the UCLA PCI (score >/=30) scale (HR 1.05 [0.81-1.36]). INTERPRETATION: Escalated-dose CFRT with neoadjuvant androgen suppression seems clinically worthwhile in terms of bPFS, progression-free survival, and decreased use of salvage androgen suppression. This additional efficacy is offset by an increased incidence of longer term adverse events.","Lancet Oncol, 8(6): 475-487","UK",2007,"Local","Radiotherapy","LENT-SOMA,UCLA-PCI,RTOG-EORTC-SS","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,Treatment"]
[163,"Dearnaley, D. P., et al. (2007). \"The early toxicity of escalated versus standard dose conformal radiotherapy with neo-adjuvant androgen suppression for patients with localised prostate cancer: results from the MRC RT01 trial (ISRCTN47772397).\" Radiother Oncol 83(1): 31-41.",null,"Dearnaley, D. P., et al.","The early toxicity of escalated versus standard dose conformal radiotherapy with neo-adjuvant androgen suppression for patients with localised prostate cancer: results from the MRC RT01 trial (ISRCTN47772397)","BACKGROUND: Five-year disease-free survival rates for localised prostate cancer following standard doses of conventional radical external beam radiotherapy are around 80%. Conformal radiotherapy (CFRT) raises the possibility that radiotherapy doses can be increased and long-term efficacy outcomes improved, with safety an important consideration. METHODS: MRC RT01 is a randomised controlled trial of 862 men with localised prostate cancer comparing Standard CFRT (64Gy/32f) versus Escalated CFRT (74Gy/37f), both administered with neo-adjuvant androgen suppression. Early toxicity was measured using physician-reported instruments (RTOG, LENT/SOM, Royal Marsden Scales) and patient-reported questionnaires (MOS SF-36, UCLA Prostate Cancer Index, FACT-P). RESULTS: Overall early radiotherapy toxicity was similar, apart from increased bladder, bowel and sexual toxicity, in the Escalated Group during a short immediate post-radiotherapy period. Toxicity in both groups had abated by week 12. Using RTOG Acute Toxicity scores, cumulative Grade 2 bladder and bowel toxicity was 38% and 30% for Standard Group and 39% and 33% in Escalated Group, respectively. Urinary frequency (Royal Marsden Scale) improved in both groups from pre-androgen suppression to 6 months post-radiotherapy (p<0.001), but bowel and sexual functioning deteriorated. This pattern was supported by patient-completed assessments. Six months after starting radiotherapy the incidence of RTOG Grade > or = 2 side-effects was low (<1%); but there were six reports of rectal ulceration (6 Escalated Group), six haematuria (5 Escalated Group) and eight urethral stricture (6 Escalated Group). CONCLUSIONS: The two CFRT schedules with neo-adjuvant androgen suppression have broadly similar early toxicity profiles except for the immediate post-RT period. At 6 months and compared to before hormone therapy, bladder symptoms improved, whereas bowel and sexual symptoms worsened. These assessments of early treatment safety will be complemented by further follow-up to document late side-effects and efficacy.","Radiother Oncol, 83(1): 31-41","UK",2007,"Local","Radiotherapy,Hormonal","SF-36,UCLA-PCI,FACT-P,LENT-SOMA,RTOG-EORTC-SS,RMS","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,Treatment,Utility"]
[164,"Debruyne, F. J., et al. (1998). \"Liarozole--a novel treatment approach for advanced prostate cancer: results of a large randomized trial versus cyproterone acetate. Liarozole Study Group.\" Urology 52(1): 72-81.",null,"Debruyne, F. J., et al.","Liarozole--a novel treatment approach for advanced prostate cancer: results of a large randomized trial versus cyproterone acetate. Liarozole Study Group","OBJECTIVES: To compare the efficacy of oral liarozole, the first retinoic acid metabolism-blocking agent (RAMBA) to be developed as differentiation therapy for human solid tumors, with that of cyproterone acetate (CPA), an antiandrogen for the treatment of metastatic prostate cancer. Liarozole promotes differentiation of cancer cells by increasing the intratumoral levels of retinoic acid. METHODS: A total of 321 patients with metastatic prostate cancer in relapse after first-line endocrine therapy entered a Phase III international multicenter study (recruitment from February 1992 to August 1994) comparing liarozole (300 mg two times daily) with CPA (100 mg two times daily). RESULTS: Accounting for differences in baseline prognostic factors, the adjusted hazard ratio for survival was 0.74 in favor of liarozole (P = 0.039), indicating a 26% lower risk of death than in patients treated with CPA. Median crude (unadjusted) survival time was the same in the liarozole group as in the CPA group (10.3 months). More patients showed a PSA response (at least 50% reduction in PSA from baseline) when treated with liarozole (20%) than with CPA (4%) (P < 0.001). Prostate-specific antigen (PSA) responders had a median survival benefit of 10 months over nonresponders, irrespective of treatment (hazard ratio 0.43; P = 0.0018). PSA response was apparent within 3 months in approximately 90% of patients who responded. Pain improved more in the liarozole group than in the CPA group (P = 0.03). PSA responders had lower median pain scores than nonresponders (1.7 versus 2.5) and better quality of life (median Functional Living Index-Cancer score 108 versus 98) at end point, ie, treatment discontinuation, as well as throughout the treatment period. Among the most frequently occurring adverse events in the liarozole group were dry skin (51% of patients), pruritus (25%), rash (16%), nail disorders (16%), and hair loss (15%). These adverse events were generally mild to moderate in severity and did not affect the overall quality of life score. There were no detectable effects of either treatment on vital signs such as blood pressure, heart rate, electrocardiogram, and body weight. CONCLUSIONS: Liarozole is superior to CPA in terms of PSA response, PSA progression, and survival, and is capable of maintaining patients' quality of life. The observed adverse events were mild to moderate in nature. These results show that liarozole is a possible treatment option after first-line endocrine therapy has failed.","Urology, 52(1): 72-81","Netherlands",1998,"Metastatic","Various,Hormonal","FLIC","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General"]
[165,"Deliveliotis, C., et al. (2004). \"Prostate operations: long-term effects on sexual and urinary function and quality of life. Comparison with an age-matched control population.\" Urol Res 32(4): 283-289.",null,"Deliveliotis, C., et al.","Prostate operations: long-term effects on sexual and urinary function and quality of life. Comparison with an age-matched control population","The purpose of this study was to investigate the effects of radical prostatectomy (RP) for prostate cancer, transurethral resection of the prostate (TURP) for benign prostate hyperplasia (BPH), and the alterations induced by ageing on quality of life, urinary and sexual function, and bother. We evaluated 283 patients who filled in and returned the questionnaire used. A total of 105 were treated with RP and were selected prostate cancer patients with localised disease without recurrences. An additional 98 underwent TURP for BPH and a third group consisted of 80 apparently healthy men. The general quality of life was estimated by the Rand 36-Item Health Survey 1.0. Urinary function was estimated by the AUA Symptom Index and the UCLA Prostate Cancer Index (urinary function and bother scale). Sexual function and bother, were explored using the Brief Male Sexual Function Inventory for Urology. Patient outcome 2 years post treatment was compared to the pre-treatment status and to that of the matched control population. General quality of life was not affected by RP or TURP, with the exception of an increase in the emotional/well being domain in RP patients to control group levels. After RP there was more bother reported for the urinary function than urinary malfunction itself, while TURP, as expected, restored urinary function and bother to normal population norms. Elderly males had urinary function and bother similar to the operated patients. Estimating sexual function on RP patients, erectile dysfunction (ED) predominates, leading to decreased sexual life. TURP marginally affects sexual life, mainly due to the loss of ejaculation, while in men from the control group, sexual function, although affected, was still present.","Urol Res, 32(4): 283-289","Greece",2004,"Local","Surgery","UCLA-PCI,BSFI,AUA-SI,SF-36","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Disease,Complication,Utility,Symptom"]
[166,"Demark-Wahnefried, W., et al. (2006). \"Lifestyle intervention development study to improve physical function in older adults with cancer: outcomes from Project LEAD.\" J Clin Oncol 24(21): 3465-3473.",null,"Demark-Wahnefried, W., et al.","Lifestyle intervention development study to improve physical function in older adults with cancer: outcomes from Project LEAD","PURPOSE: Declines in physical functioning (PF) among elderly cancer patients threaten quality of life and the ability to maintain independence. Adherence to healthy lifestyle behaviors may prevent functional decline. PATIENTS AND METHODS: Project Leading the Way in Exercise and Diet (LEAD), an intervention development study of the Pepper Older Americans Independence Center, aimed to determine whether breast and prostate cancer survivors (age 65+ years) assigned to a 6-month home-based diet and exercise intervention experienced improvements in PF when compared with an attention control arm receiving general health information. An accrual target was set at 420, and PF (Short Form-36 subscale), physical activity (Community Healthy Activities Models Program for Seniors), and diet quality (index from 3-day recalls) were assessed at baseline and at 6 and 12 months (6 months after intervention). RESULTS: This developmental project did not achieve its accrual target (N = 182); however, PF change scores were in the direction and of the magnitude projected. Baseline to 6-month change scores in the intervention versus the control arms were as follows: PF, +3.1 v -0.5 (P = .23); physical activity energy expenditure, +111 kcal/wk v -400 kcal/wk (P = .13); and diet quality index, +2.2 v -2.9 (P = .003), respectively. Differences between arms diminished during the postintervention period. CONCLUSION: These findings suggest that home-based diet and exercise interventions hold promise in improving lifestyle behaviors among older cancer survivors, changes that trend toward improved PF. Future studies should incorporate larger sample sizes and interventions that sustain long-term effects and also take into account secular trends; these efforts will require adequate planning and resources to overcome the numerous barriers to intervening in this difficult to reach yet vulnerable population.","J Clin Oncol, 24(21): 3465-3473","USA",2006,"Survivors","Various","SF-36,CHAMPS","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Utility,General"]
[167,"Demark-Wahnefried, W., et al. (2007). \"Main outcomes of the FRESH START trial: a sequentially tailored, diet and exercise mailed print intervention among breast and prostate cancer survivors.\" J Clin Oncol 25(19): 2709-2718.",null,"Demark-Wahnefried, W., et al.","Main outcomes of the FRESH START trial: a sequentially tailored, diet and exercise mailed print intervention among breast and prostate cancer survivors","PURPOSE: Cancer survivors are at increased risk for cardiovascular disease, diabetes, osteoporosis, and second primary tumors. Healthful lifestyle practices may improve the health and well-being of survivors. The FRESH START trial tested the efficacy of sequentially tailored versus standardized mailed materials on improving cancer survivors' diet and exercise behaviors. METHODS: Five hundred forty-three individuals with newly diagnosed locoregional breast or prostate cancer were recruited from 39 states and two provinces within North America. Participants were randomly assigned either to a 10-month program of tailored mailed print materials promoting fruit and vegetable (F&V) consumption, reducing total/saturated fat intake, and/or increasing exercise or to a 10-month program of nontailored mailed materials on diet and exercise available in the public domain. Telephone surveys conducted at baseline and 1 year assessed body mass index (BMI), dietary consumption, physical activity, and other psychosocial/behavioral indices. Clinical assessments were conducted on a 23% subsample; information was used to validate self-reports. RESULTS: Five hundred nineteen participants completed the 1-year follow-up (4.4% attrition; sample characteristics: 57 +/- 10.8 years old, 83% white, 56% female, 64% overweight/obese, and 0% underweight). Although both arms significantly improved their lifestyle behaviors (P < .05), significantly greater gains occurred in the FRESH START intervention versus the control arm (practice of two or more goal behaviors: +34% v +18%, P < .0001; exercise minutes per week: +59.3 v +39.2 minutes, P = .02; F&V per day: +1.1 v +0.6 servings, P = .01; total fat: -4.4% v -2.1%, P < .0001; saturated fat: -1.3% v -0.3%, P < .0001; and BMI: -0.3 v +0.1 kg/m2, respectively, P = .004). CONCLUSION: Mailed material interventions, especially those that are tailored, are effective in promoting healthful lifestyle changes among cancer survivors. Further study is needed to determine sustainability, cost to benefit, and generalizability to other cancer populations.","J Clin Oncol, 25(19): 2709-2718","USA",2007,"Survivors","Various","Interview","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General"]
[168,"Descazeaud, A., et al. (2005). \"Evolution of health-related quality of life two to seven years after retropubic radical prostatectomy: evaluation by UCLA prostate cancer index.\" World J Urol 23(4): 257-262.",null,"Descazeaud, A., et al.","Evolution of health-related quality of life two to seven years after retropubic radical prostatectomy: evaluation by UCLA prostate cancer index","To determine changes in health-related quality of life (HRQOL) in patients treated with retropubic radical prostatectomy (RP) between two and seven years after surgery. A questionnaire from the University of California Los Angeles Prostate Index was sent to 142 patients previously treated with retropubic RP as mono-therapy for clinically localized prostate cancer. Patients were divided into five groups according to time from surgery. Demographics, clinical and pathological characteristics of patients were compared between these groups. Correlation coefficients controlled for age at the time of questionnaire between HRQOL scores and time from RP were assessed. A total of 105 patients (74%) returned the questionnaire. The mean time from surgery was 48 months (range 25-84). Demographics, clinical and pathological characteristics of patients were not statistically different between time groups. Several recoding items were found to decrease significantly with the time from RP including physical functioning, role limitations due to physical health problem, vitality, and general health. In contrary, urinary, bowel and sexual scores were not significantly correlated to time from RP. Although sexual, urinary and bowel scores seem to remain stable from 2 to 7 years following RP, general health appears to significantly deteriorate with time after RP, independent of the patient's age at the time of the questionnaire.","World J Urol, 23(4): 257-262","France",2005,"Local","Surgery","UCLA-PCI","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Disease"]
[169,"Devlin, N., et al. (2017). \"Health-related quality of life effects of enzalutamide in patients with metastatic castration-resistant prostate cancer: an in-depth post hoc analysis of EQ-5D data from the PREVAIL trial.\" Health Qual Life Outcomes 15(1): 130.",null,"Devlin, N., et al.","Health-related quality of life effects of enzalutamide in patients with metastatic castration-resistant prostate cancer: an in-depth post hoc analysis of EQ-5D data from the PREVAIL trial","BACKGROUND: The effect of enzalutamide on health-related quality of life (HRQoL) in the PREVAIL trial in chemotherapy-naive men with metastatic castration-resistant prostate cancer was analyzed using the generic EQ-5D instrument. METHODS: Patients received oral enzalutamide 160 mg/day (n = 872) or placebo (n = 845). EQ-5D index and EQ-5D visual analogue scale (EQ-5D VAS) scores were evaluated at baseline, week 13, and every 12 weeks until week 61 due to sample size reduction thereafter. Changes on individual dimensions were assessed, and Paretian Classification of Health Change (PCHC) and time-to-event analyses were conducted. RESULTS: With enzalutamide, EQ-5D index and EQ-5D VAS scores declined more slowly versus placebo and time to diverge from full health was prolonged. Average decline in EQ-5D index (-0.042 vs. -0.070; P < .0001) and EQ-5D VAS (-1.3 vs. -4.4; P < .0001) was significantly smaller with enzalutamide. There were significant (P < .05) between-group differences favoring enzalutamide in Pain/Discomfort to week 37, Anxiety/Depression at week 13, and Usual Activities at week 25, but no significant differences for Mobility and Self-care. The PCHC analysis showed more enzalutamide patients reporting improvement than placebo patients at weeks 13, 25, and 49 (all P < .05) and week 37 (P = .0512). Enzalutamide was superior (P </= .0003) to placebo for time to diverge from full health and time to first deterioration on Pain/Discomfort and Anxiety/Depression dimensions. CONCLUSIONS: This in-depth post hoc analysis showed that enzalutamide delayed HRQoL deterioration and had beneficial effects on several HRQoL domains, including Pain/Discomfort and the proportion of patients in full health, compared with placebo, and may help to support future analyses of this type. TRIAL REGISTRATION: NCT01212991.","Health Qual Life Outcomes, 15(1): 130","UK,Spain,Netherlands,Belgium,France,USA",2017,"Metastatic","Chemotherapy","EQ-5D","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Utility"]
[170,"Di Lorenzo, G., et al. (2003). \"External beam radiotherapy in bone metastatic prostate cancer: impact on patients' pain relief and quality of life.\" Oncol Rep 10(2): 399-404.",null,"Di Lorenzo, G., et al.","External beam radiotherapy in bone metastatic prostate cancer: impact on patients' pain relief and quality of life","Bone metastases are a severe problem in oncology, since they usually are associated with pain. External beam radiation therapy (EBRT) has been, for many years, an important component of the treatment regimen to relieve pain. We have performed a clinical study to evaluate the relationship of response to EBRT in terms of pain relief and improvement in quality of life (QoL). We were also interested in the incidence of acute toxicity with EBRT. We have prospectively evaluated 75 patients (median age 68 years, range 64-79 years) with bone metastases from prostate cancer treated with EBRT, radiographically documented from June 1999 to September 2000. Additional therapies in these patients included: second-line hormonal therapy (HT) in 20 patients, chemotherapy (CT) in 25 patients, biphosphonates in 45 patients. For all patients a pain and narcotic evaluation was done before entering the study. Assessment of response was carried out by evaluating pain relief. QoL was measured by using the EORTC QLQ-C30 questionnaire. Toxicity analysis was based on the ROTG grading system. Survival was calculated by Kaplan-Meier estimate from the start of EBRT treatment until the last follow-up or death. A total of 61 out of 75 patients (81%) experienced some type of pain relief after treatment. The complete response rate was 23%. No significant difference in the response rates was found between the group treated with EBRT alone versus the groups treated with EBRT + CT or EBRT + HT. We noted a significant improvement in some of the scales of the considered EORTC-QLQC30 questionnaire. As expected all treatment-related complications were either grade 1-2 acute or subacute and transitory in nature. The group treated with EBRT + CT experienced slightly higher toxicity rates. There were no treatment-related fatalities. Forteen patients of 61 (23%) responders was alive at 12 months. Our results confirm the ability of EBRT to relieve bony pain in the majority of the cancer patients treated as measured by prospective analysis of pain scales prior to and after EBRT. Minimal side effects were experienced and QoL improved as shown by the results of the specific questionnaire.","Oncol Rep, 10(2): 399-404","Italy",2003,"Metastatic","Radiotherapy,Chemotherapy,Hormonal,Bisphosphonate","EORTC QLQ-C30","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General"]
[171,"Dickinson, L., et al. (2013). \"A multi-centre prospective development study evaluating focal therapy using high intensity focused ultrasound for localised prostate cancer: The INDEX study.\" Contemp Clin Trials 36(1): 68-80.",null,"Dickinson, L., et al.","A multi-centre prospective development study evaluating focal therapy using high intensity focused ultrasound for localised prostate cancer: The INDEX study","INTRODUCTION: Focal therapy offers the possibility of cancer control, without the side effect profile of radical therapies. Early single centre prospective development studies using high intensity focused ultrasound (HIFU) have demonstrated encouraging genitourinary functional preservation and short-term cancer control. Large multi-centre trials are required to evaluate medium-term cancer control and reproduce functional recovery. We describe the study design of an investigator-led UK multi-centre, single arm trial using HIFU to deliver focal therapy for men with localised prostate cancer. METHODS: One-hundred and forty men with histologically proven localised low or intermediate risk prostate cancer (PSA < 15, Gleason </= 7, </= T2cN0M0) will undergo precise characterisation of the prostate using a combination of multi-parametric (mp)MRI and transperineal template prostate mapping (TPM) biopsies. Unilateral dominant tumours, the so-called index lesion, will be eligible for treatment provided the contra-lateral side is free of 'clinically significant' disease (as defined by Gleason >/= 7 or maximum cancer core length >/=4 mm). Patients will receive focal therapy using HIFU (Sonablate 500(R)). Treatment effect will be assessed by targeted biopsies of the treated area and TPM biopsies at 36-months. RESULTS: Primary outcome is the absence of clinically significant disease based on 36-month post-treatment TPM biopsies. Secondary outcomes address a) genitourinary function using validated patient questionnaires (IPSS, IPSS-QoL, IIEF-15, EPIC-Urinary, EPIC-Bowel, FACT-P, EQ-5D), b) the predictive validity of imaging, and c) risk factors for treatment failure. CONCLUSIONS: INDEX will be the first multi-centre, medium term follow-up trial to evaluate the outcomes of a tissue preserving strategy for men with localised prostate cancer using the TPM-ablate-TPM strategy.","Contemp Clin Trials, 36(1): 68-80","UK",2013,"Local","HIFU","IPSS,IIEF-5,EPIC,FACT-P,EQ-5D","Patient",null,"Protocol",null,null,null,null,null,null,null,null,"Disease,Complication,Utility,Symptom"]
[172,"Diefenbach, M. A., et al. (2003). \"Clinical, demographic and psychosocial correlates of complementary and alternative medicine use by men diagnosed with localized prostate cancer.\" J Urol 170(1): 166-169.",null,"Diefenbach, M. A., et al.","Clinical, demographic and psychosocial correlates of complementary and alternative medicine use by men diagnosed with localized prostate cancer","PURPOSE: We examined complementary and alternative medicine (CAM) use among men who received standard therapy for localized prostate cancer. MATERIALS AND METHODS: A total of 417 men completed a questionnaire 6 months after their treatment decision assessing clinical and psychosocial variables and use of 41 available CAM therapies grouped into the 2 general categories of herbal/dietary and nonherbal (i.e. mind-body, bioelectromagnetic, traditional/folk medicine, pharmacological/biological). RESULTS: The prostate cancer diagnosis prompted 19% of our sample to start using some form of CAM for prostate health, and 67% of men reported having used some form of CAM for prostate health before being diagnosed. Initiation of CAM was associated with being a member of an ethnic minority group and a higher level of education. Initiation of nonherbal CAM was associated with being married, while use of herbal CAM therapies was significantly associated with choosing observation. Herbal use before diagnosis was associated with being white, higher level of education and being single. Prostate specific antigen at diagnosis, Gleason score, quality of life, participant perceptions of seriousness of prostate cancer or self-reported worry about prostate cancer were not related to initiation or prior use. Of those men reporting current use almost 50% did not inform their treating physician of using CAM therapies. CONCLUSIONS: Initiation of CAM therapies as a result of a prostate cancer diagnosis was fairly low, although two-thirds of men had used it before diagnosis. Half of the patients did not inform their physicians about such use and physicians should continue to probe patients about CAM use.","J Urol, 170(1): 166-169","USA",2003,"Local","Psychological,Various","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"General,Views"]
[173,"Dieperink, K. B., et al. (2013). \"The effects of multidisciplinary rehabilitation: RePCa-a randomised study among primary prostate cancer patients.\" Br J Cancer 109(12): 3005-3013.",null,"Dieperink, K. B., et al.","The effects of multidisciplinary rehabilitation: RePCa-a randomised study among primary prostate cancer patients","BACKGROUND: The objective of this study is the effectiveness of multidisciplinary rehabilitation on treatment-related adverse effects after completed radiotherapy in patients with prostate cancer (PCa). METHODS: In a single-centre oncology unit in Odense, Denmark, 161 PCa patients treated with radiotherapy and androgen deprivation therapy were randomly assigned to either a programme of two nursing counselling sessions and two instructive sessions with a physical therapist (n=79) or to usual care (n=82). Primary outcome was Expanded Prostate Cancer Index Composite (EPIC-26) urinary irritative sum-score. Before radiotherapy, pre-intervention 4 weeks after radiotherapy, and after a 20-week intervention, measurements included self-reported disease-specific quality of life (QoL; EPIC-26, including urinary, bowel, sexual, and hormonal symptoms), general QoL (Short-form-12, SF-12), pelvic floor muscle strength (Modified Oxford Scale), and pelvic floor electromyography. Intension-to-treat analyses were made with adjusted linear regression. RESULTS: The intervention improved, as compared with controls, urinary irritative sum-score 5.8 point (Cohen's d=0.40; P=0.011), urinary sum-score (d=0.34; P=0.023), hormonal sum-score (d=0.19; P=0.018), and the SF-12 Physical Component Summary, d=0.35; P=0.002. Patients with more severe impairment gained most. Pelvic floor muscle strength measured by electromyography declined in both groups, P=0.0001. CONCLUSION: Multidisciplinary rehabilitation in irradiated PCa patients improved urinary and hormonal symptoms, and SF-12 physical QoL.","Br J Cancer, 109(12): 3005-3013","Denmark",2013,"Any or unknown","Radiotherapy,Various,Hormonal","EPIC,SF-12","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,Utility"]
[174,"Doria, C., et al. (2017). \"Treatment of osteoporosis secondary to hypogonadism in prostate cancer patients: a prospective randomized multicenter international study with denosumab vs. alendronate.\" Minerva Urol Nefrol 69(3): 271-277.",null,"Doria, C., et al.","Treatment of osteoporosis secondary to hypogonadism in prostate cancer patients: a prospective randomized multicenter international study with denosumab vs. alendronate","BACKGROUND: Osteoporosis is a complication of androgen deprivation therapy (ADT) in men with prostate carcinoma. This is a multicenter, randomized, double-blind prospective study on use of denosumab versus alendronate in the therapy of secondary osteoporosis related to ADT. METHODS: A total of 234 patients with diagnosis of osteoporosis underwent ADT for prostate cancer were enrolled. Patients were randomly assigned 1:1 to receive denosumab 60 mg subcutaneously every 6 months or alendronate (70 mg/week) for 2 years. All patient received supplemental vitamin D (600 IU/day) and supplemental calcium to maintain a calcium intake of 1200 mg per day. Effectiveness of therapy in both groups (denosumab group and alendronate group) was assessed by changes in bone turnover markers (BTMs), bone mineral density, fracture incidence, Visual Analogue Scale score for back pain, and Short Form-8 health survey score for health-related quality of life. RESULTS: In the denosumab study group, level of BTMs for bone formation were significantly increased from baseline at all time points during the study (P<0.001); in the alendronate study group level of BTMs for bone formation were increased too (P>0.05). Mean changes in BMD at final follow-up differed significantly between two groups. BMD changes at the lumbar spine at 24 months were 5.6% with denosumab vs. -1.1% with alendronate (P<0.001). CONCLUSIONS: Denosumab and alendronate showed similar clinical efficacy in the therapy of ADT-related osteoporosis in men with prostate carcinoma; both drugs provided significant improvements in back pain and general health conditions. Denosumab showed significant increase of BTMs and BMD than alendronate with lower rate of new vertebral fractures.","Minerva Urol Nefrol, 69(3): 271-277","Italy,France,Switzerland",2017,"Any or unknown","Various,Bisphosphonate","VAS,SF-8","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Utility,Complication"]
[175,"Dragicevic, S. (2010). \"Evaluation of health-related quality of life in patients with prostate cancer after treatment with radical retropubic prostatectomy and permanent prostate brachytherapy.\" Urol Int 85(2): 173-179.",null,"Dragicevic, S.","Evaluation of health-related quality of life in patients with prostate cancer after treatment with radical retropubic prostatectomy and permanent prostate brachytherapy","AIM: The aims of this study were to evaluate the health-related quality of life (HRQOL) and make the treatment decision less difficult. METHODS: Between 2007 and 2009 radical retropubic prostatectomy (RRP) was performed in 96 patients and permanent prostate brachytherapy (PPB) in 88 patients at our hospital. The general and disease-specific HRQOL was measured using two instruments, the Medical Outcome Study 8-Item Short-Form Health Survey (SF-8) and the expanded prostate index composite (EPIC). RESULTS: Comparing RRP and PPB, there were significant differences in all scores except for general health in the 1st month after treatment which had the same score in both groups. The baseline quality of life scores in physical function (p < 0.05), physical role (p < 0.01), social functioning (p < 0.01), emotional role (p < 0.01) and mental health (p < 0.01) showed significant differences between the group and were better in the PPB group than in the RRP group. The physical component summary score in the PPB group was better than in the RRP group in the 1st month (p < 0.01) but recovered up to 3 months in the RRP group. The urinary bother and irritative/obstructive scores in the 1st month were worse from baseline in both groups (p < 0.05) and remained significantly worse up to 6 months in the PPB group than in the RRP group where these scores recovered within 3 months. The urinary incontinence score in the RRP group was still worse than in the PPB group up to 12 months (p < 0.01). Bowel function and bother were significantly better in the RRP group at 3 (p < 0.05) and 6 months (p < 0.01) than in the PPB group where bowel function at 12 months was worse than at baseline and in the RRP group. Sexual function (p < 0.01) and sexual bother were better in the PPB group and did not change until 12 months. CONCLUSION: The difference in disease-specific quality of life has become clearer using EPIC. As with other published studies, our results provide important information that will therefore be useful for selecting the optimal treatments for localized prostate cancer.","Urol Int, 85(2): 173-179","Serbia",2010,"Any or unknown","Brachytherapy,Surgery","EPIC,SF-8","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease,Utility"]
[176,"Duncan, G. G., et al. (2000). \"Report on the quality of life analysis from the phase III trial of pion versus photon radiotherapy in locally advanced prostate cancer.\" Eur J Cancer 36(6): 759-765.",null,"Duncan, G. G., et al.","Report on the quality of life analysis from the phase III trial of pion versus photon radiotherapy in locally advanced prostate cancer","This report examines the quality of life (QOL) of 215 patients entered into a randomised trial between pion and photon radiotherapy for prostate cancer at a single institution. The survival and local control results of the trial were equivalent in both arms. A modification of the Rotterdam Symptom Checklist (RSCL) was used to assess QOL. Global QOL, toxicity and physical scores were found to be worse in pion-treated patients at the end of treatment (P<0.001, P<0.001, and P=0.02 respectively). There are no long-term differences in the QOL of pion- versus photon-treated patients. Sexual function was a concern for patients even at baseline. There was a progressive loss of sexual interest and erectile function. There was a significant impact from hormonal therapy at relapse. Hormonal treatment produced a stepwise significant worsening in global QOL, particularly for physical and psychological domains.","Eur J Cancer, 36(6): 759-765","Canada",2000,"Any or unknown","Radiotherapy","RSCL","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Symptom"]
[177,"Eandi, J. A., et al. (2002). \"Can single dose preoperative intrathecal morphine sulfate provide cost-effective postoperative analgesia and patient satisfaction during radical prostatectomy in the current era of cost containment?\" Prostate Cancer Prostatic Dis 5(3): 226-230.",null,"Eandi, J. A., et al.","Can single dose preoperative intrathecal morphine sulfate provide cost-effective postoperative analgesia and patient satisfaction during radical prostatectomy in the current era of cost containment?","We retrospectively analyzed the analgesic efficacy and surgical outcomes of a single preoperative intrathecal long-acting morphine sulfate injection (0.25-0.5 mg) and postoperative intravenous (i.v.) ketorolac in 62 patients who underwent radical retropubic prostatectomy (RRP). Total postoperative analgesic requirement was documented along with assessment of length of hospital stay, pain control and time for resumption of normal activity. Postoperatively, 45% of patients required only nonsteroidal agents (ketorolac), whereas 55% needed a mean of 13.3 mg of supplemental i.v. morphine sulfate. Mean hospital stay was 2.3+/-0.3 days. Eighty-two per cent of patients felt the length of hospital stay adequate. Ninety-seven per cent of patients were satisfied with anesthesia selected and 95% of patients considered pain control on postoperative days 1 and 2 as effective. All patients resumed to full physical activity by 5.3+/-0.4 weeks after surgery. We conclude that a single preoperative injection of intrathecal morphine sulfate combined with i.v. ketorolac postoperatively results in effective analgesia, diminished supplemental narcotic requirement and high patient satisfaction during radical retropubic prostatectomy.","Prostate Cancer Prostatic Dis, 5(3): 226-230","USA",2002,"Any or unknown","Surgery,Various","Unclear","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Satisfaction"]
[178,"Efficace, F., et al. (2003). \"Beyond the development of health-related quality-of-life (HRQOL) measures: a checklist for evaluating HRQOL outcomes in cancer clinical trials--does HRQOL evaluation in prostate cancer research inform clinical decision making?\" J Clin Oncol 21(18): 3502-3511.",null,"Efficace, F., et al.","Beyond the development of health-related quality-of-life (HRQOL) measures: a checklist for evaluating HRQOL outcomes in cancer clinical trials--does HRQOL evaluation in prostate cancer research inform clinical decision making?","PURPOSE: The aim of this study was to evaluate whether the inclusion of health-related quality of life (HRQOL), as a part of the trial design in a randomized controlled trial (RCT) setting, has supported clinical decision making for the planning of future medical treatments in prostate cancer. MATERIALS AND METHODS: A minimum standard checklist for evaluating HRQOL outcomes in cancer clinical trials was devised to assess the quality of the HRQOL reporting and to classify the studies on the grounds of their robustness. It comprises 11 key HRQOL issues grouped into four broader sections: conceptual, measurement, methodology, and interpretation. Relevant studies were identified in a number of databases, including MEDLINE and the Cochrane Controlled Trials Register. Both their HRQOL and traditional clinical reported outcomes were systematically analyzed to evaluate their consistency and their relevance for supporting clinical decision making. RESULTS: Although 54% of the identified studies did not show any differences in traditional clinical end points between treatment arms and 17% showed a difference in overall survival, 74% of the studies showed some difference in terms of HRQOL outcomes. One third of the RCTs provided a comprehensive picture of the whole treatment including HRQOL outcomes to support their conclusions. CONCLUSION: A minimum set of criteria for assessing the reported outcomes in cancer clinical trials is necessary to make informed decisions in clinical practice. Using a checklist developed for this study, it was found that HRQOL is a valuable source of information in RCTs of treatment in metastatic prostate cancer.","J Clin Oncol, 21(18): 3502-3511","International",2003,"Metastatic","None","Unclear","Patient",null,"Systematic review",null,null,null,null,null,null,null,null,"General"]
[179,"Efficace, F., et al. (2003). \"Health related quality of life in prostate carcinoma patients: a systematic review of randomized controlled trials.\" Cancer 97(2): 377-388.",null,"Efficace, F., et al.","Health related quality of life in prostate carcinoma patients: a systematic review of randomized controlled trials","BACKGROUND: Health related quality of life (HRQOL) is increasingly reported as an important endpoint in cancer clinical trials. However, evidence suggests that HRQOL reporting is often inadequate. Given this, the authors undertook a systematic review to evaluate HRQOL assessment methodology and reported outcomes of randomized controlled clinical trials (RCTs) with prostate carcinoma patients. METHODS: A comprehensive search of the literature from 1980 to 2001, mainly on the following databases, was undertaken: MedLine, Cancerlit, and the Cochrane Controlled Trials Register. Studies were identified according to a predefined coding scheme, including HRQOL measure, cultural validity, compliance data reported and the clinical significance of the results. RESULTS: Twenty-five RCTs were identified, involving 8015 patients primarily with metastatic cancer. Bicalutamide was the medical treatment against which most treatment comparisons were made. Limitations identified included the fact that only 44% of the studies gave a rationale for selecting a specific HRQOL measure, 64% of the studies failed to report information about the administration of the HRQOL measure, and 56% failed to report compliance at baseline. The measure most often used was the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Care 30 (EORTC QLQ-C30), although some studies used non-validated HRQOL tools. CONCLUSIONS: The current study revealed a lack of a uniform approach to HRQOL assessment and several methodologic limitations. It is possible that such methodologic limitations have influenced trial findings for HRQOL outcomes.","Cancer, 97(2): 377-388","International",2003,"Metastatic","Hormonal","EORTC QLQ-C30","Patient",null,"Systematic review",null,null,null,null,null,null,null,null,"General"]
[180,"Efficace, F., et al. (2014). \"Patient-reported outcomes in randomised controlled trials of prostate cancer: methodological quality and impact on clinical decision making.\" Eur Urol 66(3): 416-427.",null,"Efficace, F., et al.","Patient-reported outcomes in randomised controlled trials of prostate cancer: methodological quality and impact on clinical decision making","CONTEXT: Patient-reported outcomes (PRO) data from randomised controlled trials (RCTs) are increasingly used to inform patient-centred care as well as clinical and health policy decisions. OBJECTIVE: The main objective of this study was to investigate the methodological quality of PRO assessment in RCTs of prostate cancer (PCa) and to estimate the likely impact of these studies on clinical decision making. EVIDENCE ACQUISITION: A systematic literature search of studies was undertaken on main electronic databases to retrieve articles published between January 2004 and March 2012. RCTs were evaluated on a predetermined extraction form, including (1) basic trial demographics and clinical and PRO characteristics; (2) level of PRO reporting based on the recently published recommendations by the International Society for Quality of Life Research; and (3) bias, assessed using the Cochrane Risk of Bias tool. Studies were systematically analysed to evaluate their relevance for supporting clinical decision making. EVIDENCE SYNTHESIS: Sixty-five RCTs enrolling a total of 22 071 patients were evaluated, with 31 (48%) in patients with nonmetastatic disease. When a PRO difference between treatments was found, it related in most cases to symptoms only (n=29, 58%). Although the extent of missing data was generally documented (72% of RCTs), few reported details on statistical handling of this data (18%) and reasons for dropout (35%). Improvements in key methodological aspects over time were found. Thirteen (20%) RCTs were judged as likely to be robust in informing clinical decision making. Higher-quality PRO studies were generally associated with those RCTs that had higher internal validity. CONCLUSIONS: Including PRO in RCTs of PCa patients is critical for better evaluating the treatment effectiveness of new therapeutic approaches. Marked improvements in PRO quality reporting over time were found, and it is estimated that at least one-fifth of PRO RCTs have provided sufficient details to allow health policy makers and physicians to make critical appraisals of results. PATIENT SUMMARY: In this report, we have investigated the methodological quality of PCa trials that have included a PRO assessment. We conclude that including PRO is critical to better evaluating the treatment effectiveness of new therapeutic approaches from the patient's perspective. Also, at least one-fifth of PRO RCTs in PCa have provided sufficient details to allow health policy makers and physicians to make a critical appraisal of results.","Eur Urol, 66(3): 416-427","International",2014,"Advanced,Local","Unclear","Unclear","Patient",null,"Systematic review",null,null,null,null,null,null,null,null,"Unclear"]
[181,"Egawa, S., et al. (2001). \"Toxicity and health-related quality of life during and after high dose rate brachytherapy followed by external beam radiotherapy for prostate cancer.\" Jpn J Clin Oncol 31(11): 541-547.",null,"Egawa, S., et al.","Toxicity and health-related quality of life during and after high dose rate brachytherapy followed by external beam radiotherapy for prostate cancer","BACKGROUND: The optimal protocol for combining high dose rate brachytherapy and external beam irradiation as treatment for localized prostate cancer is unknown. Toxicity rates and clinical and biochemical outcomes should be evaluated to validate the current treatment protocol. METHODS: Fifty-eight patients were treated for prostate cancer with high dose rate brachytherapy followed by 30 Gy of external beam radiation therapy. Toxicity during treatment and for 12-18 months thereafter, and treatment-related morbidity, were evaluated. Physician-assessed treatment-related toxicity was graded at the time of occurrence using the Radiation Therapy Oncology Group morbidity criteria. Four separate self-administered questionnaires were used to collect longitudinally demographic data and general and prostate disease-related measures of quality of life. RESULTS: Various degrees of rectal bleeding due to radiation proctitis were experienced by 13 patients (22%) at a median time of 11 months. Two of these patients needed hospitalization to undergo laser coagulation of the rectal mucosa. Study patients had statistically significant decreases in five SF-36 domains during the first month of treatment. All measures recovered by 12 months. Sexual function was not affected by irradiation. Lower urinary tract symptoms assessed by IPSS/QOL scores worsened significantly during the first month of treatment but later recovered to baseline levels. Physician-assessed RTOG scores failed to detect these changes. CONCLUSIONS: Morbidity associated with combined radiation therapy was greatest during the first month of treatment and affected quality of life significantly. Most measures recovered to baseline levels by 12 months following radiation therapy. Although the current protocol appears acceptable, measures should be taken to decrease treatment-related morbidity further.","Jpn J Clin Oncol, 31(11): 541-547","Japan",2001,"Local","Radiotherapy,Brachytherapy","SF-36,IPSS,RTOG-EORTC-SS","Patient,HCP",null,"Cohort",null,null,null,null,null,null,null,null,"Symptom,Treatment,Utility"]
[182,"Elliott, S. P., et al. (2011). \"Projecting the clinical benefits of adjuvant radiotherapy versus observation and selective salvage radiotherapy after radical prostatectomy: a decision analysis.\" Prostate Cancer Prostatic Dis 14(3): 270-277.",null,"Elliott, S. P., et al.","Projecting the clinical benefits of adjuvant radiotherapy versus observation and selective salvage radiotherapy after radical prostatectomy: a decision analysis","Our purpose was to project and compare clinical and quality-adjusted life year (QALY) outcomes of adjuvant radiotherapy (ART) versus salvage RT (SRT) after radical prostatectomy for men with locally advanced prostate cancer. We constructed a Markov model to simulate the randomized studies of observation versus ART, assuming 75% of observation patients would receive SRT at PSA recurrence. Transition probabilities and utility inputs were drawn from randomized trials of ART and cohort studies of SRT. We projected 10-year PSA recurrence-free survival, metastasis-free survival and overall survival. We found that observation with selective SRT yielded slightly worse outcomes than ART for post-RT PSA recurrence-free survival (47 and 52%), metastasis-free survival (69 and 70%) and overall survival (72 and 73%). Findings were robust to sensitivity analyses. After adjusting for the disutility of RT, observation plus SRT yielded better QALYs at 10 years than ART (6.80 and 6.13 QALYs). Thus, observation plus SRT may be optimal for men likely to comply with surveillance who wish to minimize side effects of the treatment. These findings reflect outcomes for the average patient given the current level of evidence and are meant to help inform current decision-making as we await future clinical studies of comparative effectiveness.","Prostate Cancer Prostatic Dis, 14(3): 270-277","USA",2011,"Advanced,Recurrent","Radiotherapy,Surgery","Unclear","Patient",null,"Systematic review",null,null,null,null,null,null,null,null,"Utility"]
[183,"Emberton, M., et al. (1995). \"The feasibility and cost of a large multicentre audit of process and outcome of prostatectomy.\" Qual Health Care 4(4): 256-262.",null,"Emberton, M., et al.","The feasibility and cost of a large multicentre audit of process and outcome of prostatectomy","Objective--To determine the feasibility of performing multicentre process and outcome audits of common interventions taking prostatic procedures as an example. Design--Prospective, cohort study. Setting--All National Health Service and independent hospitals in Northern, Wessex, Mersey, and South West Thames health regions. Patients--5361 men undergoing prostatectomy identified by 103 of the 107 urologists and general surgeons performing prostatectomy in the study regions. Main measures-- Rates of participation by surgeons and patients; completeness of clinical data provided by surgeons; patient response rate and completeness of patient derived data; and cost. Results--Most surgeons (103,96%) agreed to participate. Overall, the proportion of eligible patients invited to take part was high (89%), although this was only measured in South West Thames, where dedicated data collectors were employed. Few men (80, 1.5%) declined to participate. Of those surviving for three months after surgery, 82.4% (4226) completed and returned the postal questionnaire. The response rate was higher in South West Thames (86.7%) than in the other regions (80.6%-80.8%). The audit was well received: 91% of patients found the questionnaire easy to complete and only 2.3% of them disapproved. Completeness of data was high with both the hospital and patient questionnaires. Missing data occurred in less than 5% of responses to most questions. The attributable cost was 34.50 pounds per patient identified or 44 pounds for patients in whom either the treatment outcome or vital status was known three months after their prostatectomy. Conclusions--This multicentre audit of process and outcome of prostatectomy proved feasible in terms of surgeon participation, patient identification, and the quantity and quality of data collection. Whether the cost was warranted will depend on how surgeons use the audit data to modify their practice.","Qual Health Care, 4(4): 256-262","UK",1995,"Any or unknown","Surgery","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Unclear"]
[184,"Ernstmann, N., et al. (2017). \"Patient-physician communication and health-related quality of life of patients with localised prostate cancer undergoing radical prostatectomy - a longitudinal multilevel analysis.\" BJU Int 119(3): 396-405.",null,"Ernstmann, N., et al.","Patient-physician communication and health-related quality of life of patients with localised prostate cancer undergoing radical prostatectomy - a longitudinal multilevel analysis","OBJECTIVES: To examine whether patient-physician communication is associated with health-related quality of life (HRQoL) in a sample of patients with localised prostate cancer undergoing radical prostatectomy (RP). PATIENTS AND METHODS: HAROW (Hormonal therapy, Active Surveillance, Radiation, Operation, Watchful Waiting) is a prospective, observational study designed to collect data of the different treatment options for newly diagnosed patients with localised prostate cancer under real-life conditions. At 6-months intervals, clinical data (D'Amico risk categories, Charlson comorbidity index), aspects of patient-provider communication (standardised psychosocial-care instrument for patients' assessment of communication; Cologne Patient Questionnaire), and HRQoL (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire) were assessed. Data were analysed by longitudinal multilevel analysis. RESULTS: Completed questionnaires for 1772 patients undergoing a RP were analysed over a 3-year follow-up period. Patients rated the patient-provider communication generally high with slight variations over the course of treatment (3.2-3.8). The HRQoL of the patients varied substantial over time and between the reported subscales (global HRQoL 71.1-77.2; physical functioning 89.1-92.1; role functioning 81.0-88.1; emotional functioning 74.4-84.0; cognitive functioning 84.3-87.7; social functioning (77.7-84.0). The longitudinal multilevel models showed significant associations between patient-provider communication in terms of devotion, support and shared decision-making, and functional aspects of HRQoL. CONCLUSION: Patient-provider communication is a valuable resource to support patients with prostate cancer coping with the disease and to improve their HRQoL. Future interventions should be designed especially for urologists to enhance their awareness for the importance of communication and the relationship with their patients with prostate cancer for treatment outcomes.","BJU Int, 119(3): 396-405","Germany",2017,"Local","Hormonal,Surgery,Radiotherapy,Surveillance","EORTC QLQ-C30,CPQ","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"General"]
[185,"Escobar, A., et al. (2015). \"Cross-cultural adaptation, reliability and validity of the Spanish version of the Quality of Life in Adult Cancer Survivors (QLACS) questionnaire: application in a sample of short-term survivors.\" Health Qual Life Outcomes 13: 182.",null,"Escobar, A., et al.","Cross-cultural adaptation, reliability and validity of the Spanish version of the Quality of Life in Adult Cancer Survivors (QLACS) questionnaire: application in a sample of short-term survivors","BACKGROUND: The aim of this study was to validate the Quality of Life in Adult Cancer Survivors (QLACS) in short-term Spanish cancer survivor's patients. METHODS: Patients with breast, colorectal or prostate cancer that had finished their initial cancer treatment 3 years before the beginning of this study completed QLACS, WHOQOL, Short Form-36, Hospital Anxiety and Depression Scale, EORTC-QLQ-BR23 and EQ-5D. Cultural adaptation was made based on established guidelines. Reliability was evaluated using internal consistency and test-retest. Convergent validity was studied by mean of Pearson's correlation coefficient. Structural validity was determined by a second-order confirmatory factor analysis (CFA) and Rasch analysis was used to assess the unidimensionality of the Generic and Cancer-specific scales. RESULTS: Cronbach's alpha were above 0.7 in all domains and summary scales. Test-retest coefficients were 0.88 for Generic and 0.82 for Cancer-specific summary scales. QLACS generic summary scale was correlated with other generic criterion measures, SF-36 MCS (r = - 0.74) and EQ-VAS (r = - 0.63). QLACS cancer-specific scale had lower values with the same constructs. CFA provided satisfactory fit indices in all cases. The RMSEA value was 0.061 and CFI and TLI values were 0.929 and 0.925, respectively. All factor loadings were higher than 0.40 and statistically significant (P < 0.001). Generic summary scale had eight misfitting items. In the remaining 20 items, the unidimensionality was supported. Cancer Specific summary scale showed four misfitting items, the remaining showed unidimensionality. CONCLUSIONS: The findings support the validity and reliability of QLACS questionnaire to be used in short-term cancer survivors.","Health Qual Life Outcomes, 13(182","Spain",2015,"Survivors","Unclear","SF-36,HADS,EQ-5D,QLACS,WHOQOL-BREF","Patient",null,"Validation",null,null,null,null,null,null,null,null,"General,Comorbidity,utility"]
[186,"Esper, P., et al. (1997). \"Measuring quality of life in men with prostate cancer using the functional assessment of cancer therapy-prostate instrument.\" Urology 50(6): 920-928.",null,"Esper, P., et al.","Measuring quality of life in men with prostate cancer using the functional assessment of cancer therapy-prostate instrument","OBJECTIVES: As the incidence of prostate cancer in the United States exceeds 330,000 in 1997, increasingly more men are faced with treatment choices for which there is no clear approach. At every stage of disease, these treatment choices may involve clinically equivalent modalities that differ in side effects and impact upon quality of life (QOL). Comprehensive, yet efficient, questionnaires are needed to measure QOL in patients with prostate cancer. METHODS: Developed as a disease-specific adjunct to the Functional Assessment of Cancer Therapy (FACT) measurement system, a 12-item prostate cancer subscale (PCS) was developed and tested in three independent samples: a subscale development sample (n = 43), validity sample 1 (n = 34), and validity sample 2 (n = 96). The 12 items ask about symptoms and problems specific to prostate cancer. These questions are added to the general (FACT-G) instrument, thereby comprising a 47-item questionnaire. RESULTS: Internal consistency of the PCS ranged from 0.65 to 0.69, with coefficients for FACT-G subscales and aggregated scores ranging from 0.61 to 0.90. Concurrent validity was confirmed by the ability to discriminate patients by disease stage, performance status, and baseline prostate-specific antigen (PSA) level. Sensitivity to change in performance status and PSA score over a 2-month period suggested that some subscales of the FACT-Prostate (P) (including the PCS) are sensitive to meaningful clinical change. CONCLUSIONS: Our findings support use of the FACT-P as a meaningful component of QOL evaluation in men undergoing therapy for prostate cancer.","Urology, 50(6): 920-928","USA",1997,"Any or unknown","None","FACT-G,FACT-P","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease,General"]
[187,"Espie, C. A., et al. (2008). \"Randomized controlled clinical effectiveness trial of cognitive behavior therapy compared with treatment as usual for persistent insomnia in patients with cancer.\" J Clin Oncol 26(28): 4651-4658.",null,"Espie, C. A., et al.","Randomized controlled clinical effectiveness trial of cognitive behavior therapy compared with treatment as usual for persistent insomnia in patients with cancer","PURPOSE: Persistent insomnia is a common complaint in cancer survivors, but is seldom satisfactorily addressed. The adaptation to cancer care of a validated, cost-effective intervention may offer a practicable solution. The aim of this study was to investigate the clinical effectiveness of protocol-driven cognitive behavior therapy (CBT) for insomnia, delivered by oncology nurses. PATIENTS AND METHODS: Randomized, controlled, pragmatic, two-center trial of CBT versus treatment as usual (TAU) in 150 patients (103 females; mean age, 61 years.) who had completed active therapy for breast, prostate, colorectal, or gynecological cancer. The study conformed to CONSORT guidelines. Primary outcomes were sleep diary measures at baseline, post-treatment, and 6-month follow-up. Actigraphic sleep, health-related quality of life (QOL), psychopathology, and fatigue were secondary measures. CBT comprised five, small group sessions across consecutive weeks, after a manualized protocol. TAU represented normal clinical practice; the appropriate control for a clinical effectiveness study. RESULTS: CBT was associated with mean reductions in wakefulness of 55 minutes per night compared with no change in TAU. These outcomes were sustained 6 months after treatment. Standardized relative effect sizes were large for complaints of difficulty initiating sleep, waking from sleep during the night, and for sleep efficiency (percentage of time in bed spent asleep). CBT was associated with moderate to large effect sizes for five of seven QOL outcomes, including significant reduction in daytime fatigue. There was no significant interaction effect between any of these outcomes and baseline demographic, clinical, or sleep characteristics. CONCLUSION: CBT for insomnia may be both clinically effective and feasible to deliver in real world practice.","J Clin Oncol, 26(28): 4651-4658","UK",2008,"Survivors","Psychological","Diary","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General,Symptom"]
[188,"Essink-Bot, M. L., et al. (1998). \"Short-term effects of population-based screening for prostate cancer on health-related quality of life.\" J Natl Cancer Inst 90(12): 925-931.",null,"Essink-Bot, M. L., et al.","Short-term effects of population-based screening for prostate cancer on health-related quality of life","BACKGROUND: Population-based screening for prostate cancer is currently being evaluated in randomized clinical trials in the United States and in Europe. Side effects arising from the process of screening and from the earlier treatment of screen-detected prostate cancer may be important factors in the evaluation. To examine health-related quality of life (or health status) among men screened for prostate cancer, we conducted a longitudinal study of 626 attenders to the Rotterdam (The Netherlands) prostate cancer screening program and of 500 nonparticipants. METHODS: Attenders of the screening program and nonparticipants completed self-assessment questionnaires (SF-36 [i.e., Medical Outcomes Study 36-Item Short-Form Health Survey] and EQ-5D [i.e., EuroQol measure for health-related quality of life] health surveys) to measure generic health status, as well as an additional questionnaire for anxiety and items relating to prostate cancer screening. RESULTS: Physical discomfort during digital rectal examination and during transrectal ultrasound was reported by 181 (37%) of 491 men and by 139 (29%) of 487 men, respectively; discomfort during prostate biopsy was reported by 64 (55%) of 116 men. Mean scores for health status and anxiety indicated that the participants did not experience relevant changes in physical, psychological, and social functioning during the screening procedure. However, high levels of anxiety were observed throughout the screening process among men with a high predisposition to anxiety. Similar scores for anxiety predisposition were observed among attenders and nonparticipants. CONCLUSIONS: At the group level, we did not find evidence that prostate cancer screening induced important short-term health-status effects, despite the short-lasting side effects related to the biopsy procedure. However, subgroups may experience high levels of anxiety. The implication is that unfavorable health-status effects of prostate cancer screening occur mainly in the treatment phase.","J Natl Cancer Inst, 90(12): 925-931","Netherlands",1998,"At risk","Screening","SF-36,EQ-5D","General population",null,"Cohort",null,null,null,null,null,null,null,null,"Utility"]
[189,"Essink-Bot, M. L., et al. (2003). \"Including the quality-of-life effects in the evaluation of prostate cancer screening: expert opinions revisited?\" BJU Int 92 Suppl 2: 101-105.",null,"Essink-Bot, M. L., et al.","Including the quality-of-life effects in the evaluation of prostate cancer screening: expert opinions revisited?","OBJECTIVE: To apply the general empirical framework for estimating utilities in cost-utility analysis (CUA) of population-based prostate cancer screening, including an assessment of empirical health status with a classifying measure (e.g. the EQ-5D) and linking these descriptions to utility estimates using the standard preference-based algorithm, combining them with the appropriate duration into quality-adjusted life years, and sensitivity analysis. MATERIALS AND METHODS: Empirical studies to describe and value the health status effects of prostate cancer screening have been ongoing within the Rotterdam centre of the European Randomised Study on Screening for Prostate Cancer since 1995. The results of these studies, including the screening, the primary treatment phase and advanced disease, will be used in estimating utilities for cost-utility analysis. RESULTS: Estimation of cost-utility of population-based prostate cancer screening with the results of the three empirical health status studies yielded partly counterintuitive results, underestimating the unfavourable health status effects that are inevitably associated with prostate cancer screening. This may be caused by other than health effects of the screening itself ('process effects') and adaptive changes in perception of their situation in patients after curative primary treatment ('response shift'), among other elements. CONCLUSIONS: These results prompted us to reconsider the suitability of the general framework of CUA for screening programmes. Possible directions for solutions are indicated.","BJU Int, 92 Suppl 2(101-105","Netherlands",2003,"At risk","Screening","EQ-5D","General population",null,"Cohort",null,null,null,null,null,null,null,null,"Utility"]
[190,"Eton, D. T., et al. (2001). \"Early quality of life in patients with localized prostate carcinoma: an examination of treatment-related, demographic, and psychosocial factors.\" Cancer 92(6): 1451-1459.",null,"Eton, D. T., et al.","Early quality of life in patients with localized prostate carcinoma: an examination of treatment-related, demographic, and psychosocial factors","BACKGROUND: Men with localized prostate carcinoma are faced with important treatment decisions, and quality of life (QoL) information has become a crucial element of decision making. The first objective of this study was to compare the early, health-related QoL (HRQoL) of men with localized prostate carcinoma who were treated with radical prostatectomy, external beam radiotherapy, or brachytherapy. A second objective was to identify demographic and psychosocial variables that predict HRQoL. METHODS: Two-hundred fifty-six men with localized prostate carcinoma were interviewed within 7 weeks of treatment initiation. The interview included measures of prostate-specific HRQoL (the University of California-Los Angeles Prostate Cancer Index), general HRQoL (the SF-36), and psychosocial variables. RESULTS: After adjusting for covariates, treatment group differences were found for both prostate specific HRQoL and general HRQoL. Men who underwent prostatectomy reported more urinary and sexual problems and more general physical dysfunction compared with men who were treated with either form of radiation therapy. Men who were treated with brachytherapy reported the fewest problems in sexual function and the least general physical dysfunction. Few treatment group differences were found in mental functioning. Both demographic factors and psychosocial factors predicted HRQoL. Older men and African-American men reported more physical problems than younger men and Caucasian men, respectively. A supportive social environment, high self-efficacy, and high self-esteem were predictive of better HRQoL. CONCLUSIONS: Shortly after undergoing treatment for localized prostate carcinoma, men who underwent radical prostatectomy, older men, and African-American men are at heightened risk for experiencing prostate-specific and general deficits in HRQoL. Having psychosocial resources from which to draw may enhance HRQoL.","Cancer, 92(6): 1451-1459","USA",2001,"Local","Radiotherapy,Surgery,Brachytherapy","SF-36,UCLA-PCI","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Disease,Utility"]
[191,"Faithfull, S., et al. (2001). \"Evaluation of nurse-led follow up for patients undergoing pelvic radiotherapy.\" Br J Cancer 85(12): 1853-1864.",null,"Faithfull, S., et al.","Evaluation of nurse-led follow up for patients undergoing pelvic radiotherapy","This study reports results from a randomised controlled trial of nurse-led care and was designed to determine whether nurse-led follow up improved patients morbidity and satisfaction with care in men treated with radical radiotherapy for prostate and bladder cancer. The aim was to compare outcomes in terms of toxicity, symptoms experienced, quality of life, satisfaction with care and health care costs, between those receiving nurse-led care and a group receiving standard care. The study population was of men prescribed radical radiotherapy (greater than 60 Gy). Participants completed self-assessment questionnaires for symptoms and quality of life within the first week of radiotherapy treatment, at week 3, 6 and 12 weeks from start of radiotherapy. Satisfaction with clinical care was also assessed at 12 weeks post-treatment. Observer-rated RTOG toxicity scores were recorded pre-treatment, weeks 1, 3, 6 and 12 weeks from start of radiotherapy. The results presented in this paper are on 115 of 132 (87%) of eligible men who agreed to enter the randomised trial. 6 men (4%) refused and 11 (8%) were missed for inclusion in the study. Data were analysed as a comparison at cross-sectional time points and as a general linear model using multiple regression. There was no significant difference in maximum symptom scores over the time of the trial between nurse-led follow-up care and conventional medical care. Differences were seen in scores in the initial self assessment of symptoms (week 1) that may have been as a result of early nursing intervention. Those men who had received nurse-led care were significantly more satisfied (P < 0.002) at 12 weeks and valued the continuity of the service provided. There were also significant (P < 0.001) cost benefits, with a 31% reduction in costs with nurse-led, compared to medically led care. Evidence from this study suggests that a specialist nurse is able to provide safe follow up for men undergoing radiotherapy. The intervention focused on coping with symptoms, and provided continuity of care and telephone support. Further work is required to improve the management of patients during and after radiotherapy.","Br J Cancer, 85(12): 1853-1864","UK",2001,"Any or unknown","Radiotherapy,Various","RTOG-EORTC-SS","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Treatment"]
[192,"Faithfull, S., et al. (2011). \"Self-management after prostate cancer treatment: evaluating the feasibility of providing a cognitive and behavioural programme for lower urinary tract symptoms.\" BJU Int 107(5): 783-790.",null,"Faithfull, S., et al.","Self-management after prostate cancer treatment: evaluating the feasibility of providing a cognitive and behavioural programme for lower urinary tract symptoms","OBJECTIVE: * To test the feasibility of a self-management intervention to help men cope with lower urinary tract symptoms as a result of radiotherapy for prostate cancer. PATIENTS AND METHODS: * A quasi-experimental design was used incorporating a pre-post-test evaluation. In total, a population of 71 men were screened for moderate to severe urinary symptoms 3 months or longer post-radiotherapy. Of these mean, 22 were recruited into the intervention from an eligible population of 43 symptomatic men. * Urinary symptoms were measured before the intervention and again after 4 months of follow-up through International Prostate Symptom Scores (IPSS) and bladder diaries. * Health-related quality of life was measured in relation to cancer per se and prostate cancer specifically, and confidence to cope was measured by a self-efficacy questionnaire. * The self-management intervention comprised pelvic floor muscle exercises, bladder retraining, patient education and problem solving and coping strategies RESULTS: * Lower urinary tract symptoms, as measured by the IPSS, showed a significant improvement, with a median score change of 5 (P < 0.005). * This was supported by objective changes in median bladder void volume of +7.5 mL (P < 0.05) and the median number of daily voids of -1 (P < 0.005). * In addition, decreases in emotional distress and problems associated with urinary function suggest that the intervention had a positive impact on health-related quality of life. CONCLUSIONS: * The provision of such an intervention was feasible within the clinical setting and provided benefits for men. * Symptom change vs those of normative recovery values for IPSS showed an intervention effect. * This intervention could be applied in routine practice and further testing is required in a randomized controlled trial.","BJU Int, 107(5): 783-790","UK",2011,"Any or unknown","Radiotherapy","IPSS,Diary","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Symptom,Complication"]
[193,"Farnell, D. J., et al. (2010). \"Development of a patient-reported questionnaire for collecting toxicity data following prostate brachytherapy.\" Radiother Oncol 97(1): 136-142.",null,"Farnell, D. J., et al.","Development of a patient-reported questionnaire for collecting toxicity data following prostate brachytherapy","PURPOSE: To improve a questionnaire used to collect patient-reported outcomes from patients with early stage prostate cancer treated with brachytherapy. A secondary aim was to adapt the Late Effects of Normal Tissue (LENT) subjective toxicity questionnaire for use to collect Common Terminology Criteria for Adverse Events (CTCAE) data, the current preferred platform for assessing radiation toxicity. MATERIALS AND METHODS: Three hundred and seventy-seven patients were treated with permanent iodine-125 seed implant brachytherapy for early prostate cancer. Toxicity data were collected before and at nine time points post-treatment (0-36 months). Compliance rates for patients completing individual items and item-subsection correlation coefficients were calculated. A factor analysis was carried out to analyse responses to the questionnaire and identify less informative questions, which could be removed. Cronbach's alpha coefficient was used to measure reliability. RESULTS: Two thousand one hundred and eighty-eight questionnaires were analysed. There was poor compliance for questions specifically relating to operations and bowel medication. We found that the division of the questionnaire into subsections based on anatomical site was reasonable and that certain items could be safely removed. The high mean value for Cronbach's alpha across all questionnaires (0.752; 95% CI: 0.726-0.779) indicated that the questionnaire was reliable. Fifteen of the 44 questions were removed from the original questionnaires. Questions on urinary incontinence severity, management of urinary and bowel incontinence, effects of reduced flow of urine and the effects of symptoms on activity of daily living and change in sexual function were required to adapt the LENT subjective questionnaire for use to collect CTCAE data. CONCLUSIONS: A questionnaire, validated over 6 years to collect LENT subjective data were adapted and is a reliable approach for collecting CTCAE data after prostate brachytherapy.","Radiother Oncol, 97(1): 136-142","UK",2010,"Local","Brachytherapy","CTCAE,LENT-SOMA","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Treatment"]
[194,"Farnell, D. J., et al. (2010). \"Efficacy of data capture for patient-reported toxicity following radiotherapy for prostate or cervical cancer.\" Eur J Cancer 46(3): 534-540.",null,"Farnell, D. J., et al.","Efficacy of data capture for patient-reported toxicity following radiotherapy for prostate or cervical cancer","We investigated the efficacy of data capture of patient-reported toxicity following radiotherapy by comparing electronic and paper formats. Patient-reported toxicity questionnaires based on items from the NCI Common Terminology Criteria for Adverse Events (CTCAE) were created for patients receiving radiotherapy. Electronic and paper questionnaires had identical questions. Thirty seven gynaecological cancer and 40 prostate cancer patients completed questionnaires. Both questionnaire formats (electronic and paper) were completed by each patient at time points before and after radiotherapy. The average questionnaire and subsection scores for each format were compared directly and by using intra-class correlation (ICC) coefficients. The internal consistency/reliability was assessed by determining Cronbach's alpha coefficient. Patient preference for questionnaire format including clarity and ease-of-use was recorded. 324 questionnaires were collected as part of this study. A similar pattern of average subsection scores was found for the electronic and paper questionnaires. ICC coefficients for the mean overall questionnaire scores and subsection scores were high (>0.8). Cronbach's alpha was generally greater than 0.6, indicating that the reliability was high. Of the patients that responded, 27.3% preferred the electronic format, 25.7% preferred the paper format and 47% had no preference. The average time taken to complete a questionnaire was about 9 minutes for each format. The different questionnaire formats measured toxicity effects consistently and were reliable for both gynaecological cancer and prostate cancer patients. The survey indicated that patients found the questionnaires clear, easy to understand and straightforward to complete. Electronic data capture of patient-reported toxicity for CTCAE is feasible and acceptable.","Eur J Cancer, 46(3): 534-540","UK",2010,"Any or unknown","Radiotherapy","CTCAE","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Treatment"]
[195,"Feigenberg, S. J., et al. (2005). \"Health-related quality of life in men receiving prostate brachytherapy on RTOG 98-05.\" Int J Radiat Oncol Biol Phys 62(4): 956-964.",null,"Feigenberg, S. J., et al.","Health-related quality of life in men receiving prostate brachytherapy on RTOG 98-05","PURPOSE: To prospectively assess health-related quality of life (HRQOL) during the first year after treatment with prostate brachytherapy (PB) alone for T1c-2a prostate cancer. MATERIALS AND METHODS: Ninety-eight patients from 24 institutions were eligible and properly entered on this study. All patients were treated with PB alone using I-125 (Oncura Model 6711). The prescription dose was 145 Gy. Three separate health-related quality of life questionnaires (HRQOL) (Functional Assessment of Cancer Therapy-Prostate [FACT-P], Sexual Adjustment Questionnaire [SAQ], and International Prostate Symptom Score [IPSS]) were self-administered before and after PB (baseline; 3, 6, 9, and 12 months after PB). The standard error of the mean (SEM) was used to analyze changes in HRQOL scores over time. Patients who improved greater than the SEM were categorized as improved; patients that declined greater than the SEM were categorized as declined; patients were otherwise categorized as stable. All changes are measured using the pretreatment HRQOL score as baseline. RESULTS: The percentage of men who reported the ability to have an erection decreased from 73% at baseline (65% unassisted, 8% assisted) to 57% at 1 year (36% unassisted, 21% assisted). The rate of urinary incontinence increased to 14% at 6 months but had decreased to 1% at the 12-month follow-up. At 1 year after PB, 80% of men reported decreased sexual functioning according to SAQ scores. More than 60% of men reported decreased urinary function at 12 months compared with baseline. CONCLUSIONS: This article represents the first prospective, multi-institutional study of HRQOL in men treated with PB and demonstrates that patients undergoing PB have a very high overall HRQOL. The rate of incontinence by 1 year after PB is low, but many patients continue to have obstructive symptoms at 1 year. Although 78% of 1-year respondents state that they can achieve an erection with or without assistance, almost 50% report a decrease in sexual function.","Int J Radiat Oncol Biol Phys, 62(4): 956-964","USA",2005,"Local","Brachytherapy","FACT-P,SAQ,IPSS","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,Complication"]
[196,"Ferrer, M., et al. (2008). \"Health-related quality of life 2 years after treatment with radical prostatectomy, prostate brachytherapy, or external beam radiotherapy in patients with clinically localized prostate cancer.\" Int J Radiat Oncol Biol Phys 72(2): 421-432.",null,"Ferrer, M., et al.","Health-related quality of life 2 years after treatment with radical prostatectomy, prostate brachytherapy, or external beam radiotherapy in patients with clinically localized prostate cancer","PURPOSE: To compare treatment impact on health-related quality of life (HRQL) in patients with localized prostate cancer, from before treatment to 2 years after the intervention. METHODS AND MATERIALS: This was a longitudinal, prospective study of 614 patients with localized prostate cancer treated with radical prostatectomy (134), three-dimensional external conformal radiotherapy (205), and brachytherapy (275). The HRQL questionnaires administered before and after treatment (months 1, 3, 6, 12, and 24) were the Medical Outcomes Study 36-Item Short Form, the Functional Assessment of Cancer Therapy (General and Prostate Specific), the Expanded Prostate Cancer Index Composite (EPIC), and the American Urological Association Symptom Index. Differences between groups were tested by analysis of variance and within-group changes by univariate repeated-measures analysis of variance. Generalized estimating equations (GEE) models were constructed to assess between-group differences in HRQL at 2 years of follow-up after adjusting for clinical variables. RESULTS: In each treatment group, HRQL initially deteriorated after treatment with subsequent partial recovery. However, some dimension scores were still significantly lower after 2 years of treatment. The GEE models showed that, compared with the brachytherapy group, radical prostatectomy patients had worse EPIC sexual summary and urinary incontinence scores (-20.4 and -14.1; p < 0.001), and external radiotherapy patients had worse EPIC bowel, sexual, and hormonal summary scores (-3.55, -5.24, and -1.94; p < 0.05). Prostatectomy patients had significantly better EPIC urinary irritation scores than brachytherapy patients (+4.16; p < 0.001). CONCLUSIONS: Relevant differences between treatment groups persisted after 2 years of follow-up. Radical prostatectomy had a considerable negative effect on sexual functioning and urinary continence. Three-dimensional conformal radiotherapy had a moderate negative impact on bowel functioning, and brachytherapy caused moderate urinary irritation. These results provide relevant information for clinical decision making.","Int J Radiat Oncol Biol Phys, 72(2): 421-432","Spain",2008,"Local","Radiotherapy,Surgery,Brachytherapy","SF-36,FACT-G,FACT-P,EPIC,AUA-SI","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease,General,Utility,Symptom"]
[197,"Ferrer, M., et al. (2013). \"Quality of life impact of treatments for localized prostate cancer: cohort study with a 5 year follow-up.\" Radiother Oncol 108(2): 306-313.",null,"Ferrer, M., et al.","Quality of life impact of treatments for localized prostate cancer: cohort study with a 5 year follow-up","PURPOSE: To assess long-term quality of life (QoL) impact of treatments in localized prostate cancer patients treated with radical prostatectomy, external beam radiotherapy or brachytherapy. MATERIAL AND METHODS: Observational, prospective cohort study with pre-treatment QoL evaluation and follow-up until five years after treatment. 704 patients with low or intermediate risk localized prostate cancer were consecutively recruited in 2003-2005. QoL was measured by the EPIC questionnaire, with urinary irritative-obstructive, incontinence, bowel, sexual, and hormonal scores (ranging 0-100). RESULTS: Brachytherapy's QoL impact was restricted to the urinary domain, Generalized Estimating Equation models showed score changes at five years of -12.0 (95% CI=-15.0, -9.0) in incontinence and -5.3 (95% CI=-7.5, -3.1) in irritative-obstructive scales. Compared to brachytherapy, radical prostatectomy fared +3.3 (95% CI=+0.0, +6.5) points better in irritative-obstructive but -17.1 (95% CI=-22.7, -11.5) worse in incontinence. Sexual deterioration was observed in radical prostatectomy (-19.1; 95% CI=-25.1, -13.1) and external radiotherapy groups (-7.5; 95% CI=-12.5, -2.5). CONCLUSIONS: Brachytherapy is the treatment causing the least impact on QoL except for moderate urinary irritative-obstructive symptoms. Our study provides novel long-term valuable information for clinical decision making, supporting brachytherapy as a possible alternative to radical prostatectomy for patients seeking an attempted curative treatment, while limiting the risk for urinary incontinence and sexual impact on QoL.","Radiother Oncol, 108(2): 306-313","Spain",2013,"Local","Radiotherapy,Surgery,Brachytherapy","EPIC","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease"]
[198,"Ferro, T., et al. (2014). \"Health status and health resource use among long-term survivors of breast, colorectal and prostate cancer.\" Gac Sanit 28(2): 129-136.",null,"Ferro, T., et al.","Health status and health resource use among long-term survivors of breast, colorectal and prostate cancer","INTRODUCTION: The growing number of long-term cancer survivors poses a new challenge to health care systems. In Spain, follow-up is usually carried out in oncology services, but knowledge of cancer survivors' health care needs in this context is limited. The purpose of this study was to ascertain the health status of long-term survivors of breast, prostate, and colorectal cancer and to characterize their use of health care services. METHODS: Retrospective multicenter cohort study. We collected data from patients' clinical histories and through telephone interviews, using a specially designed questionnaire that included the SF-36v2 Quality of Life and Nottingham Health Profile scales. RESULTS: The questionnaire was completed by 51.2% (n= 583) of the potential sample. No significant differences were observed between 5-year and 10-year survivors. Overall, more than 80% of respondents were undergoing drug treatment for morbidity related to advanced age. Quality of life was good in most patients, and cancer-related morbidity was low and of little complexity. For the most part, participants reported using primary care services for care of chronic diseases and opportunistic treatment of sequelae related to the cancer treatment. Oncological follow-up was centralized at the hospital. CONCLUSIONS: Survivors of breast, prostate and colorectal cancer with tumoral detection at an early stage and without recurrences or second neoplasms experienced little morbidity and enjoyed good quality of life. This study proposes exploration of a follow-up model in the Spanish health system in which primary care plays a more important role than is customary in cancer survivors in Spain.","Gac Sanit, 28(2): 129-136","Spain",2014,"Survivors","None","SF-36,NHP","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"General,Utility"]
[199,"Ficarra, V., et al. (2006). \"Twelve-month self-reported quality of life after retropubic radical prostatectomy: a prospective study with Rand 36-Item Health Survey (Short Form-36).\" BJU Int 97(2): 274-278.",null,"Ficarra, V., et al.","Twelve-month self-reported quality of life after retropubic radical prostatectomy: a prospective study with Rand 36-Item Health Survey (Short Form-36)","OBJECTIVES: To evaluate the health-related quality of life (HRQoL) in patients undergoing retropubic radical prostatectomy (RRP) for clinically localized prostate cancer. PATIENTS AND METHODS: From February 2002 to September 2003 all patients undergoing RRP in our department were invited to participate in the study; the data from 75 of them comprised the present analysis. For evaluating HRQoL the RAND 36-Item Health Survey (SF-36) was used. RESULTS: Comparing the baseline scores of the SF-36 domains to those at 3, 6 and 12 months, there was a statistically significant difference in 'physical function', 'role limitations due to physical health problems', 'role limitations due to emotional problems', and 'energy/fatigue'. There were no statistically significant changes in the follow-up values for the other scales of the questionnaire. However, the baseline scores overlapped the 12-month follow-up values for all the SF-36 scales. The mean SF-36 scores reported by incontinent patients were lower than those of the continent patients, although this trend was not statistically significant. At the 12-month follow-up some variables were independent predictors of lower mean scores of some SF-36 scales, i.e. age >65 years, education level less than secondary school, pathological extracapsular extension of cancer and erectile dysfunction. CONCLUSION: At 1 year after RRP, HRQoL levels in each of the SF-36 domains overlapped those of the baseline in >80% of patients. The age, educational level of patients, local extension of the tumour, and erectile dysfunction could significantly affect the HRQoL scores.","BJU Int, 97(2): 274-278","Italy",2006,"Local","Surgery","SF-36","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Utility"]
[200,"Fillion, L., et al. (2003). \"Validation evidence for the French Canadian adaptation of the Multidimensional Fatigue Inventory as a measure of cancer-related fatigue.\" Cancer Nurs 26(2): 143-154.",null,"Fillion, L., et al.","Validation evidence for the French Canadian adaptation of the Multidimensional Fatigue Inventory as a measure of cancer-related fatigue","Cancer-related fatigue is the most reported symptom among patients with cancer. Researchers in the field of psychooncology have encouraged the development of short instruments, which allow for easier completion by clinical populations while still maintaining solid psychometric properties. The current study examined the validity and reliability of the French Canadian adaptation of the Multidimensional Fatigue Inventory (MFI) among women (n = 277) and men (n = 327) undergoing therapy for breast or prostate cancer, respectively. An exploratory factor analysis of the selected 15-item MFI yielded the following four factors: general/physical, mental, reduced motivation, and reduced activity. This was supported by a confirmatory factor analysis. The reliability, as evaluated by test-retest and Cronbach alpha internal consistency reliability coefficients of the French Canadian shortened MFI, was acceptable. In addition, the four factor-based scores correlated in a theoretically meaningful manner with existing measures of mood disturbance (Profile of Mood States and Hospital Anxiety and Depression Scale), cancer-related stressors (Inventory of Recent Life Experiences), coping with illness (Coping with Health Injuries and Problems Scale), quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire), and insomnia (Insomnia Severity Index), suggesting good construct, convergent, and concurrent criterion validity. Although further validation is recommended, the results for the French Canadian MFI in assessing cancer-related fatigue in both women and men undergoing cancer treatments showed good psychometric qualities.","Cancer Nurs, 26(2): 143-154","Canada",2003,"Any or unknown","Unclear","MFI,HADS,EORTC QLQ-C30,ISvI,IRLE,CHIPS,POMS","Patient",null,"Validation",null,null,null,null,null,null,null,null,"General,Symptom,Comorbidity"]
[201,"Filocamo, M. T., et al. (2007). \"Pharmacologic treatment in postprostatectomy stress urinary incontinence.\" Eur Urol 51(6): 1559-1564.",null,"Filocamo, M. T., et al.","Pharmacologic treatment in postprostatectomy stress urinary incontinence","OBJECTIVES: The aim of this study was to assess efficacy and safety of association of duloxetine and rehabilitation compared with rehabilitation alone in men with SUI after radical retropubic prostatectomy (RRP), and to compare continence rate even after planned duloxetine suspension. METHODS: After catheter removal, 112 patients were randomized to receive rehabilitation and duloxetine (group A) or rehabilitation alone (group B), for 16 wk. INCLUSION CRITERIA: postprostatectomy SUI with daily incontinent episodes frequency (IEF) of four or greater. After 16 wk both groups suspended duloxetine/placebo and continued rehabilitation. All patients completed incontinence quality of life (I-QoL) questionnaire and bladder diary. Wilcoxon test was used to analyse changes in IEF and in I-QoL score; Fisher exact test was used to compare continent patients between the groups. RESULTS: Adverse events for duloxetine was 15.2%. 102 men completed the study. There was a significant decrease in pad use in group A. After 16 wk, 39 patients versus 27 were dry (p=0.007). At 20 wk, 4 wk after planned interruption of duloxetine, we observed a U-turn, 23 patients were completely dry in group A versus 38 in group B (p=0.008). Whereas, after 24 wk, 31 in group A versus 41 in group B were dry (p=0.08). The decrease in IEF and improvements in I-QoL scores were significantly greater in group A for the first 16 wk. CONCLUSIONS: The data suggest that combination therapy might provide another treatment option for SUI in men that might increase the percentage of early postsurgery continence.","Eur Urol, 51(6): 1559-1564","Italy",2007,"Any or unknown","Surgery,Various","I-QoL,Diary","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Complication"]
[202,"Fizazi, K., et al. (2014). \"Effect of enzalutamide on time to first skeletal-related event, pain, and quality of life in men with castration-resistant prostate cancer: results from the randomised, phase 3 AFFIRM trial.\" Lancet Oncol 15(10): 1147-1156.",null,"Fizazi, K., et al.","Effect of enzalutamide on time to first skeletal-related event, pain, and quality of life in men with castration-resistant prostate cancer: results from the randomised, phase 3 AFFIRM trial","BACKGROUND: In the AFFIRM trial of patients with metastatic castration-resistant prostate cancer after progression with docetaxel treatment, enzalutamide significantly increased overall survival compared with placebo. Here we present the prospectively defined analyses of some secondary endpoints, including occurrence of skeletal-related events, measures of pain control, and patient-reported health-related quality of life (HRQoL). METHODS: In this phase 3, double-blind trial, patients were randomly assigned (2:1) to receive enzalutamide 160 mg/day or placebo orally, stratified by ECOG baseline performance status (0 or 1 vs 2) and mean pain score (Brief Pain Inventory-Short Form [BPI-SF] question 3 worst pain, score </=3 vs >/=4). Secondary endpoints were time to first skeletal-related event (defined as radiation therapy or surgery to bone); change from baseline to week 13 in pain severity and interference; pain palliation and progression at week 13; time to pain progression; overall improvement in HRQoL; improvements in HRQoL domains; and time to HRQoL deterioration. Analysis was done on the intention-to-treat population for each endpoint. AFFIRM is registered with ClinicalTrials.gov, number NCT00974311. FINDINGS: Median time to first skeletal-related event in the enzalutamide (n=800) and placebo (n=399) groups was 16.7 months (95% CI 14.6 to 19.1) and 13.3 months (95% CI 9.9 to not yet reached), respectively (hazard ratio [HR] 0.69 [95% CI 0.57-0.84]; p=0.0001). Pain progression at week 13 occurred in 174 (28%) of 625 evaluable patients in the enzalutamide group versus 101 (39%) of 259 patients in the placebo group (difference -11.2%, 95% CI -18.1 to -4.3; p=0.0018). Median time to pain progression was not yet reached in the enzalutamide group (95% CI not yet reached to not yet reached) versus 13.8 (13.8 to not yet reached) months in the placebo group (HR 0.56 [95% CI 0.41 to 0.78]; p=0.0004). Mean treatment effects for pain severity (mean change from baseline in the enzalutamide group -0.15, 95% CI -0.28 to -0.02, vs placebo 0.50, 0.29 to 0.70; difference -0.65, 95% CI -0.89 to -0.41; p<0.0001) and interference (-0.01, -0.18 to 0.16, vs 0.74, 0.47 to 1.00; respectively, difference -0.74, 95% -1.06 to -0.43; p<0.0001) were significantly better with enzalutamide than with placebo. 22 (45%) of 49 evaluable patients in the enzalutamide group reported pain palliation at week 13 versus one (7%) of 15 in the placebo group (difference 38.2%, 95% CI 19.4-57.0; p=0.0079). Overall improvement in HRQoL was reported in more patients receiving enzalutamide (275 [42%] of 652) than in those receiving placebo (36 [15%] of 248; p<0.0001). Patients in the enzalutamide group had longer median time to HRQoL deterioration than did those in the placebo group (9.0 months, 95% CI 8.3-11.1, vs 3.7 months, 95% CI 3.0-4.2; HR 0.45, 95% CI 0.37-0.55; p<0.0001) in risk of deterioration. INTERPRETATION: Our results show that, in addition to improving overall survival, enzalutamide improves wellbeing and everyday functioning of patients with metastatic castration-resistant prostate cancer. FUNDING: Astellas Pharma and Medivation.","Lancet Oncol, 15(10): 1147-1156","USA",2014,"Metastatic","Hormonal","BPI","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Symptom"]
[203,"Fizazi, K., et al. (2015). \"Phase III, randomized, double-blind, multicenter trial comparing orteronel (TAK-700) plus prednisone with placebo plus prednisone in patients with metastatic castration-resistant prostate cancer that has progressed during or after docetaxel-based therapy: ELM-PC 5.\" J Clin Oncol 33(7): 723-731.",null,"Fizazi, K., et al.","Phase III, randomized, double-blind, multicenter trial comparing orteronel (TAK-700) plus prednisone with placebo plus prednisone in patients with metastatic castration-resistant prostate cancer that has progressed during or after docetaxel-based therapy: ELM-PC 5","PURPOSE: Orteronel (TAK-700) is an investigational, nonsteroidal, reversible, selective 17,20-lyase inhibitor. This study examined orteronel in patients with metastatic castration-resistant prostate cancer that progressed after docetaxel therapy. PATIENTS AND METHODS: In our study, 1,099 men were randomly assigned in a 2:1 schedule to receive orteronel 400 mg plus prednisone 5 mg twice daily or placebo plus prednisone 5 mg twice daily, stratified by region (Europe, North America [NA], and non-Europe/NA) and Brief Pain Inventory-Short Form worst pain score. Primary end point was overall survival (OS). Key secondary end points (radiographic progression-free survival [rPFS], >/= 50% decrease of prostate-specific antigen [PSA50], and pain response at 12 weeks) were to undergo statistical testing only if the primary end point analysis was significant. RESULTS: The study was unblinded after crossing a prespecified OS futility boundary. The median OS was 17.0 months versus 15.2 months with orteronel-prednisone versus placebo-prednisone (hazard ratio [HR], 0.886; 95% CI, 0.739 to 1.062; P = .190). Improved rPFS was observed with orteronel-prednisone (median, 8.3 v 5.7 months; HR, 0.760; 95% CI, 0.653 to 0.885; P < .001). Orteronel-prednisone showed advantages over placebo-prednisone in PSA50 rate (25% v 10%, P < .001) and time to PSA progression (median, 5.5 v 2.9 months, P < .001) but not pain response rate (12% v 9%; P = .128). Adverse events (all grades) were generally more frequent with orteronel-prednisone, including nausea (42% v 26%), vomiting (36% v 17%), fatigue (29% v 23%), and increased amylase (14% v 2%). CONCLUSION: Our study did not meet the primary end point of OS. Longer rPFS and a higher PSA50 rate with orteronel-prednisone indicate antitumor activity.","J Clin Oncol, 33(7): 723-731","Greece,France,USA,Spain,UK,Netherlands,Canada,Brazil",2015,"Metastatic,Refractory","Chemotherapy","BPI","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Symptom"]
[204,"Forster, J. A., et al. (2009). \"Technical description and outcomes of a continuous anastomosis in open radical prostatectomy.\" BJU Int 104(7): 929-933.",null,"Forster, J. A., et al.","Technical description and outcomes of a continuous anastomosis in open radical prostatectomy","OBJECTIVE: To describe the surgical technique, objective and subjective medium-term outcomes of a novel continuous vesico-urethral anastomotic suture in open radical prostatectomy (ORP). PATIENTS AND METHODS: A continuous anastomosis comprising separate anterior and posterior monofilament 3-0 polydioxanone sutures, with the bladder neck 'parachuted' down on to the urethral stump, was used in 39 consecutive patients. A cystogram was taken after ORP in the first 23 patients. The catheter was removed as soon as patients were fully mobile. A validated postal questionnaire to determine continence and its effect on quality of life was sent to all patients >/=3 months after ORP. RESULTS: The mean follow-up was 18 months; there were no major complications. There was an insignificant or no leak in 91% of the patients who had a cystogram. Before discharge, 33 patients reported that they were continent, whilst five required a pad(s) for stress incontinence, and one was discharged with a catheter after failing the first catheter removal. Of the 95% who completed the questionnaire, 95% either did not leak urine, or only leaked a small amount; 84% of patients reported that leaking had a minimal effect on everyday life. No patients developed symptomatic urethral or bladder neck stricture/contracture. CONCLUSIONS: Our technique of continuous anastomotic suturing for ORP is safe, reliable and well tolerated. Further randomized studies are warranted to compare the outcome with the standard interrupted vesico-urethral anastomosis.","BJU Int, 104(7): 929-933","UK",2009,"Any or unknown","Surgery","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Complication"]
[205,"Forsythe, K., et al. (2012). \"Intensity-modulated radiotherapy causes fewer side effects than three-dimensional conformal radiotherapy when used in combination with brachytherapy for the treatment of prostate cancer.\" Int J Radiat Oncol Biol Phys 83(2): 630-635.",null,"Forsythe, K., et al.","Intensity-modulated radiotherapy causes fewer side effects than three-dimensional conformal radiotherapy when used in combination with brachytherapy for the treatment of prostate cancer","PURPOSE: To measure the benefits of intensity-modulated radiotherapy (IMRT) compared with three-dimensional conformal radiotherapy (3D-CRT) when used in combination with brachytherapy for the treatment of prostate cancer. METHODS AND MATERIALS: We conducted a retrospective review of all patients with localized prostate cancer who received external-beam radiotherapy (EBRT) in combination with brachytherapy with at least 1 year follow-up (n = 812). Combination therapy consisted of (103)Pd or (125)I implant, followed by a course of EBRT. From 1993 to March 2003 521 patients were treated with 3D-CRT, and from April 2003 to March 2009 291 patients were treated with IMRT. Urinary symptoms were prospectively measured with the International Prostate Symptom Score questionnaire with a single quality of life (QOL) question; rectal bleeding was assessed per the Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer Late Radiation Morbidity Scoring Schema. The Pearson chi(2) test was used to compare toxicities experienced by patients who were treated with either IMRT or 3D-CRT. Logistic regression analyses were also performed to rule out possible confounding factors. RESULTS: Within the first 3 months after treatment, patients treated with 3D-CRT scored their urinary symptoms as follows: 19% mild, 44% moderate, and 37% severe; patients treated with IMRT scored their urinary symptoms as follows: 36% mild, 47% moderate, and 17% severe (p < 0.001). The 3D-CRT patients rated their QOL as follows: 35% positive, 20% neutral, and 45% negative; IMRT patients rated their QOL as follows: 51% positive, 18% neutral, and 31% negative (p < 0.001). After 1 year of follow-up there was no longer any difference in urinary morbidity between the two groups. Logistic regression confirmed the differences in International Prostate Symptom Score and QOL in the acute setting (p < 0.001 for both). Grade >/= 2 rectal bleeding was reported by 11% of 3D-CRT patients and 7% of IMRT patients (p = 0.046); logistic regression analysis also confirmed this observation (p = 0.040). CONCLUSIONS: When used in combination with brachytherapy, IMRT offers less Grade >/= 2 rectal bleeding, less acute urinary toxicities, and is associated with a higher QOL compared with 3D-CRT.","Int J Radiat Oncol Biol Phys, 83(2): 630-635","USA",2012,"Local","Radiotherapy,Brachytherapy","IPSS,RTOG-EORTC-SS","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Symptom,Treatment"]
[206,"Fossa, S. D. (1994). \"Quality of life after palliative radiotherapy in patients with hormone-resistant prostate cancer: single institution experience.\" Br J Urol 74(3): 345-351.",null,"Fossa, S. D.","Quality of life after palliative radiotherapy in patients with hormone-resistant prostate cancer: single institution experience","OBJECTIVE: To review the development, methodology and difficulties of evaluating the quality of life (QoL) in patients with hormone-resistant prostate cancer, and to analyse the subjective effect of palliative radiotherapy among these patients. PATIENTS AND METHODS: Since 1986, a self-administered QoL questionnaire has been developed for patients with hormone-resistant prostate cancer. The study group included 137 such patients, with a median age of 70 years (range 48-87), who received either 89Sr (31) or external beam radiotherapy (106) because of painful bone metastases. Quality of life was assessed in all patients before treatment and, if possible, 3 months afterwards. RESULTS: The questionnaire had acceptable psychometric properties (validity, reliability). In these patients with very advanced disease, palliative radiotherapy proved less effective than reports in the literature might suggest. CONCLUSIONS: In patients with hormone-resistant prostate cancer, quality of life assessment is both possible and desirable for the evaluation of palliative treatment. The patients' perception of physical function represents an independent prognostic factor of overall survival together with alkaline phosphatase and performance status. Valid and reliable QoL questionnaires are now available, though further research is required to establish the most effective way of using them. At 3 months palliative radiotherapy was effective in only 25% of the patients investigated, two-thirds of whom had > or = 20 hot spots on bone scan. Palliative radiotherapy should probably be offered during an earlier phase of the disease.","Br J Urol, 74(3): 345-351","Norway",1994,"Metastatic","Radiotherapy","Unclear","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"General"]
[207,"Fossa, S. D., et al. (1989). \"Quality of life in patients with muscle-infiltrating bladder cancer and hormone-resistant prostatic cancer.\" Eur Urol 16(5): 335-339.",null,"Fossa, S. D., et al.","Quality of life in patients with muscle-infiltrating bladder cancer and hormone-resistant prostatic cancer","A questionnaire, filled in by the patient, was used to assess the quality of life of 65 patients with previously untreated T2-T4 NX MO bladder cancer and of 67 patients with hormone-resistant prostatic cancer. This study examines the initial questionnaire filled in before any nonsurgical treatment had been started in the patients referred to an oncological ward. The aim was to identify domains in which distress was frequent, in the hope of indicating where treatment directed forward improving the patients' quality of life should be directed. The questionnaires yielded reliable and valid data. Among bladder cancer patients micturition disturbances and sexual problems dominated. Bone pain, fatigue, sexual disturbances and interruption of social relationships were the most frequent and most severe complaints of prostatic cancer patients. It was concluded that routine quality of life evaluation by self-assessment questionnaires is possible in a clinical ward provided some assistance by the nursing staff is available. Future treatment in patients for whom palliation is the main goal of therapy should be concentrated on improving the quality of life in areas where distress is evident. The effect of treatment on quality of life could be monitored by similar questionnaires.","Eur Urol, 16(5): 335-339","Norway",1989,"Advanced","None","Unclear","Patient",null,"Validation",null,null,null,null,null,null,null,null,"General"]
[208,"Fossa, S. D., et al. (1990). \"Quality of life and treatment of hormone resistant metastatic prostatic cancer. The EORTC Genito-Urinary Group.\" Eur J Cancer 26(11-12): 1133-1136.",null,"Fossa, S. D., et al.","Quality of life and treatment of hormone resistant metastatic prostatic cancer. The EORTC Genito-Urinary Group","72 patients with hormone resistant, progressing prostatic cancer completed a self-administered questionnaire to assess subjective morbidity and quality of life before they were entered into a phase III trial of estramustine (34) vs. mitomycin (38). At least one post-treatment assessment was available in 43 patients. This considerable degree of non-compliance is explained by practical problems related to completion and collection of the questionnaires in these rapidly deteriorating patients. Doctors underestimated subjective morbidity (pain, decreased performance status, nausea) in 30-50% of the cases. Decreased functional status, fatigue and pain were identified as the most frequent major morbidities before study entry. In most patients, treatment did not reduce this morbidity. The routine application of self-administered quality of life questionnaires has considerable practical problems but yields clinically worthwhile information about subjective morbidity. Simple but relevant monitoring of subjective morbidity by the patient should be mandatory in cancer trials where palliation is a major endpoint.","Eur J Cancer, 26(11-12): 1133-1136","Norway",1990,"Metastatic","Chemotherapy","Unclear","Patient,HCP",null,"Clinical trial",null,null,null,null,null,null,null,null,"Symptom,General"]
[209,"Fossa, S. D., et al. (2000). \"Quality of life of patients with newly diagnosed poor prognosis M1 prostate cancer undergoing orchiectomy without or with mitomycin C. Results from the EORTC Phase-III trial 30893.\" Eur Urol 37(5): 541-551.",null,"Fossa, S. D., et al.","Quality of life of patients with newly diagnosed poor prognosis M1 prostate cancer undergoing orchiectomy without or with mitomycin C. Results from the EORTC Phase-III trial 30893","OBJECTIVES: To compare the quality of life (QL) of patients with poor prognosis M1 prostate cancer treated with orchiectomy alone (ORCH) or orchiectomy combined with adjuvant mitomycin C (MMC; 15 mg/m(2) i.v. q 6 weeks: ORCH+MMC; EORTC trial 30893). METHODS: Patients with newly diagnosed M1 poor prognosis prostate cancer completed a truncated version of the EORTC QLQ-C30 (V 1.0) at randomization (baseline) and every 6-12 weeks thereafter until going off the protocol. Five ad hoc questions assessing lower urinary tract symptoms were included in the QL questionnaire. RESULTS: At least one QL form was completed by 177 of the 189 patients included in the trial, with baseline questionnaires available for 113 patients (ORCH n = 52; ORCH+MMC n = 61). In both arms, pain and urinary dysfunction improved during treatment. Compared with patients from the ORCH arm, the use of adjuvant MMC was associated with a significant reduction in global health status/QL and with impairment in 7 of 11 QL dimensions covered by the questionnaire. Some improvement in QL was observed after discontinuation of MMC. A survival benefit was not observed in the ORCH+MMC arm. CONCLUSIONS: Intravenous MMC (15 mg/m(2) q 6 weeks) cannot be recommended as adjuvant treatment in M1 poor prognosis prostate cancer due to its negative impact on QL and lack of efficacy. In general, QL assessments should be mandatory when adjuvant chemotherapy is evaluated in patients with metastatic prostate cancer.","Eur Urol, 37(5): 541-551","Norway",2000,"Metastatic","Surgery,Chemotherapy","EORTC QLQ-C30","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General"]
[210,"Fossa, S. D., et al. (2001). \"Flutamide versus prednisone in patients with prostate cancer symptomatically progressing after androgen-ablative therapy: a phase III study of the European organization for research and treatment of cancer genitourinary group.\" J Clin Oncol 19(1): 62-71.",null,"Fossa, S. D., et al.","Flutamide versus prednisone in patients with prostate cancer symptomatically progressing after androgen-ablative therapy: a phase III study of the European organization for research and treatment of cancer genitourinary group","PURPOSE: Time to progression (TTP), overall survival, and quality of life (QL) were compared in patients with hormone-resistant prostate cancer (HRPC) treated with prednisone (5 mg orally, four times a day) or flutamide (250 mg orally, three times a day). PATIENTS AND METHODS: Symptomatic patients were randomized to receive either prednisone (101 patients) or flutamide (100 patients). Subjective response was assessed based on performance status, the use of analgesics, and the need to apply alternative palliative treatment. Prostate-specific antigen (PSA)-based biochemical response (>or= 50% reduction of baseline PSA) was recorded. At baseline and at 6-week intervals during follow-up, patients completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30. RESULTS: There was no difference between the groups in median TTP (prednisone, 3.4 months; flutamide, 2.3 months) or overall survival (prednisone, 10.6 months; flutamide, 11.2 months). In the prednisone group, 56% of the patients experienced a subjective response, compared with 45% in the flutamide group (P: = .18). The median response duration was 4.8 months for prednisone and 4.2 months for flutamide. A biochemical response was observed in 21% and 23% of the prednisone and flutamide groups, respectively. Gastrointestinal toxicity was the reason for trial discontinuation in seven patients receiving flutamide and two patients receiving prednisone. The QL assessment parameters favored the use of prednisone with statistically significant differences in pain, fatigue, role functioning, appetite loss, gastrointestinal distress, and overall QL. CONCLUSION: In symptomatic HRPC, treatment with prednisone or flutamide leads to similar rates of TTP and overall survival and no difference in subjective or biochemical response. The QL results favor the use of low-cost prednisone in patients with HRPC.","J Clin Oncol, 19(1): 62-71","Norway",2001,"Refractory","Hormonal","EORTC QLQ-C30","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General"]
[211,"Fowler, F. J., Jr., et al. (1995). \"Effect of radical prostatectomy for prostate cancer on patient quality of life: results from a Medicare survey.\" Urology 45(6): 1007-1013; discussion 1013-1005.",null,"Fowler, F. J., Jr., et al.","Effect of radical prostatectomy for prostate cancer on patient quality of life: results from a Medicare survey","OBJECTIVES: To assess patient responses to radical prostatectomy and its effects. METHODS: A national sample was taken of 1072 Medicare patients who underwent radical prostatectomy for prostate cancer (1988 through 1990) by mail, telephone, and personal interviews. The effects of the surgery and its complications on these patients' lives were studied through: (1) patient ratings of the extent to which sexual and urinary dysfunctions were \"problems\" in their lives; (2) two general measures of quality of life, the Mental Health Index and the General Health Index; (3) patient reports of how they felt about the results of treatment and whether they would choose surgery again. RESULTS: On average, dripping urine, particularly to the point where subjects were wearing pads, had a more significant effect on patients than loss of sexual function; incontinence had significant adverse effects on the measures of quality of life and self-reported results of surgery. Overall, postsurgical patients scored comparatively high on the quality of life measures (similar to a cohort of patients with benigh prostatic hyperplasia who had undergone transurethral resection of the prostate), reported feeling positive about the results (81%), and would choose surgical treatment again (89%). Nonetheless, there was variability in patient response to the effects of surgery. CONCLUSIONS: The results demonstrate the ability of many Medicare patients to adapt to adverse outcomes, such as loss of sexual function and incontinence. They also provide evidence of the variability of individual patients' responses to surgical results and reinforce the importance of individualized decision making for patients facing a decision about radical prostatectomy for prostate cancer.","Urology, 45(6): 1007-1013; discussion 1013-1005","USA",1995,"Any or unknown","Surgery","MHI,GHI","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"General,Comorbidity"]
[212,"Fowler, F. J., Jr., et al. (2002). \"The impact of androgen deprivation on quality of life after radical prostatectomy for prostate carcinoma.\" Cancer 95(2): 287-295.",null,"Fowler, F. J., Jr., et al.","The impact of androgen deprivation on quality of life after radical prostatectomy for prostate carcinoma","BACKGROUND: Androgen deprivation is commonly prescribed for men with a rising prostate specific antigen level after radical prostatectomy, despite scant evidence regarding its efficacy and side effects. In the current study, the authors compared measures of health-related quality of life (HRQOL) in men who were treated with androgen deprivation after radical prostatectomy with those for men who underwent surgery but were not treated with androgen deprivation. METHODS: Medicare Provider and Analysis and Review (MedPAR) files were used to identify men who had undergone radical prostatectomies between 1991-1992. Medicare Part B data then were used to select two samples: men who subsequently were androgen deprived and those who were not. In 1999, a mail survey was administered that addressed a range of disease-related and treatment-related issues, including HRQOL. Age-adjusted comparisons of responses to seven multiitem measures of HRQOL were performed. RESULTS: The overall response rate was 82%. On all seven HRQOL measures (impact of cancer and treatment, concern regarding body image, mental health, general health, activity, worries about cancer and dying, and energy), there were statistically significant decrements associated with androgen deprivation. CONCLUSIONS: Patients and physicians must weigh the price patients pay with regard to HRQOL against the uncertain benefits of early androgen deprivation.","Cancer, 95(2): 287-295","USA",2002,"Any or unknown","Surgery,Hormonal","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"General"]
[213,"Fowler, J. E., Jr. (2001). \"Patient-reported experience with the Viadur 12-month leuprolide implant for prostate cancer.\" Urology 58(3): 430-434.",null,"Fowler, J. E., Jr.","Patient-reported experience with the Viadur 12-month leuprolide implant for prostate cancer","OBJECTIVES: To assess patient-reported general satisfaction, effect on daily activities, and effect on health-related quality of life of a 12-month leuprolide implant for prostate cancer. METHODS: A total of 80 men with prostate cancer participated in an open-label Phase III study of the Viadur leuprolide implant. One implant was inserted in each patient at enrollment and was removed after 52 weeks. At 24 and 52 weeks after implantation, patients were asked to complete a questionnaire about their experience with the implant, and at 0, 12, 24, 36, and 52 weeks after implantation, the patients were asked to complete the Medical Outcome Study Short Form-36 health-related quality-of-life instrument. RESULTS: The surveys about the patients' experience with the implant were completed by 70 subjects, and two or more SF-36 questionnaires were completed by 72 patients. At weeks 24 and 52 after implantation, greater than 90% of patients were extremely satisfied or satisfied with the overall treatment, found the implant convenient, forgot about the implant most of the time or were occasionally aware of the implant, and found the implant very comfortable or somewhat comfortable. No meaningful change was found in the summary scores of the mental and physical aspects of the SF-36 assessments during treatment. Of 73 men who were eligible for reimplantation after the 12-month study period, 70 (96%) elected to undergo reimplantation. CONCLUSIONS: In this study, patients found the Viadur 12-month leuprolide implant convenient, and the implant did not affect their health-related quality of life.","Urology, 58(3): 430-434","USA",2001,"Any or unknown","Hormonal","SF-36","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Utility"]
[214,"Fransson, P. (2008). \"Patient-reported lower urinary tract symptoms, urinary incontinence, and quality of life after external beam radiotherapy for localized prostate cancer--15 years' follow-up. A comparison with age-matched controls.\" Acta Oncol 47(5): 852-861.",null,"Fransson, P.","Patient-reported lower urinary tract symptoms, urinary incontinence, and quality of life after external beam radiotherapy for localized prostate cancer--15 years' follow-up. A comparison with age-matched controls","BACKGROUND: To prospectively examine the urinary toxicity and quality of life (QOL) in patients 15 years after external beam radiotherapy (EBRT) for localized prostate cancer (LPC) and compare the outcomes with results for age-matched controls. MATERIAL AND METHODS: Urinary symptoms were assessed using the symptom-specific Prostate Cancer Symptom Scale (PCSS) questionnaire, and QOL was assessed with the European Organization for Research and Treatment of Cancer (EORTC)'s Quality of Life Questionnaire (QLQ-C30). Both questionnaires were sent to the surviving 41 patients(25%) and the PCSS questionnaire was sent to 69 age-matched controls for comparison. RESULTS: The response rate was 71% in the patient group and 59% in the control group. Two patients and four controls were excluded due to other cancer diagnoses, resulting in a total of 27 patients and 37 controls for inclusion in the analyses. The mean age in both groups was 78 years. In the patient group, incontinence had increased between the 8-year (mean 0.6) and the 15-year follow-up (mean 2.1; p0.038). No other differences in urinary problems were seen between these two follow-ups. Increased incontinence, stress incontinence, and pain while urinating were reported by the patients in comparison with the controls at 15 years. Role function was worse in the patient group (mean 67.3) compared with the controls (mean 82.4; p0.046). The patients also reported more appetite loss, diarrhea, nausea/vomiting, and pain than the controls. CONCLUSION: EBRT for LPC has divergent effects on urinary symptoms and QOL in comparison with age-matched controls. In our patient population, urinary incontinence increased between 8 and 15 years of follow-up. Otherwise, no differences in urinary symptoms were seen between 4 and 15 years. Incontinence, stress incontinence, and pain while urinating were increased after EBRT in comparison with the controls. Conventional EBRT did not result in a major deterioration in QOL 15 years after treatment.","Acta Oncol, 47(5): 852-861","Sweden",2008,"Local","Radiotherapy","PCSI,EORTC QLQ-C30","Patient",null,"Case-control",null,null,null,null,null,null,null,null,"Disease,General"]
[215,"Fransson, P. and A. Widmark (1996). \"Self-assessed sexual function after pelvic irradiation for prostate carcinoma. Comparison with an age-matched control group.\" Cancer 78(5): 1066-1078.",null,"Fransson, P. and A. Widmark","Self-assessed sexual function after pelvic irradiation for prostate carcinoma. Comparison with an age-matched control group","BACKGROUND: Treatment of localized prostate carcinoma is often accompanied by disturbances in sexual function. The patient's own opinion and experience with these problems can be of great importance for his quality of life. In men older than 50 years, disturbances in sexual function are common. Treatment such as radiotherapy (RT), which can induce sexual dysfunction, should be evaluated in relation to the problems in an age-matched population without prostate carcinoma. METHODS: Sexual function was evaluated with a self-assessment questionnaire using linear-analogue scales. The questionnaire was sent to 199 patients with prostate carcinoma, median age 71 years (range, 51-86 years), who had received pelvic RT with curative intent and to 200 age-matched men in northern Sweden. Mean follow-up time after RT was 48 months (range, 24-56 months). RESULTS: The response rate was high: 141 (71%) and 181 (91%) in the control and patient groups, respectively. Field reduction and treatment pause during RT was not associated with decreased problems in the patient groups. A failure to achieve erection was indicated in 12% of the control subjects, 56% of the patients who had received (RT only) and 87% of the RT + castration (RT + A) patients. In general, patients < 70 years treated with RT+A indicated more sexual problems than the RT only patients < 70 years. There was a strong negative correlation between age and sexual problems in the RT + A < 70 years group. However, in patients < 70 years, sexual activity after RT only, was not significantly different from the age-matched control population. CONCLUSIONS: Patients with prostate carcinoma treated with RT only indicated higher levels of sexual dysfunction than age-matched controls. This was most obvious in patients younger than 70 years, although their sexual activity was comparable to age-matched controls. The addition of castration to RT tended to increase sexual problems, especially in patients < 70 years. In men between 70 and 74 years, the maintenance of sexual function seems to be very susceptible to disturbances. For patients older than 74 years, decreased sexual function was not perceived as such a significant problem, despite abolished desire and erection.","Cancer, 78(5): 1066-1078","Sweden",1996,"Local","Radiotherapy","VAS","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Complication"]
[216,"Fransson, P., et al. (2001). \"Quality of life and symptoms in a randomized trial of radiotherapy versus deferred treatment of localized prostate carcinoma.\" Cancer 92(12): 3111-3119.",null,"Fransson, P., et al.","Quality of life and symptoms in a randomized trial of radiotherapy versus deferred treatment of localized prostate carcinoma","BACKGROUND: Treatment of localized prostate carcinoma (LPC) using radiotherapy (RT) can induce disturbances in a patient's quality of life (QOL) and urinary and intestinal function. Late symptoms and QOL were evaluated in a randomized trial between RT and deferred treatment (DT). METHODS: Quality of life was evaluated with European Organization for Research and Treatment of Cancer's QLQ-C30 (+3) formula. Urinary and intestinal problems were evaluated with a validated symptom specific self-assessment questionnaire, QUFW94. The questionnaires were sent to 108 randomized patients with LPC and to an age-matched control group (n = 68). Mean age was 72 years. Mean total dose was 65 grays (Gy; 62.3-70 Gy). The median follow-up time from randomization was 40.6 months for the RT group and 30.4 months for the DT group. RESULTS: Social functioning was the only QOL scale in which a significant difference was found between the two patient groups and compared with the control group. Multivariate regression analysis showed that hematuria, incontinence, mucus, and planning of daily activities in response to intestinal problems caused this decrease in QOL in the RT group. A significant increase of intestinal problems was observed in the RT versus DT groups regarding mucus, stool leakage, intestinal blood, and planning of daily activity in response to intestinal problems. CONCLUSIONS: The RT patients showed increased levels of minor intestinal side effects compared with the DT patients and the controls, but the RT patients reported no decreased QOL except for decreased social functioning. This could be because this group developed coping skills or because of a low magnitude of side effects to influence the QOL.","Cancer, 92(12): 3111-3119","Sweden",2001,"Local","Radiotherapy,Surveillance","EORTC QLQ-C30,QUFW94","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,General"]
[217,"Fransson, P., et al. (2009). \"Quality of life in patients with locally advanced prostate cancer given endocrine treatment with or without radiotherapy: 4-year follow-up of SPCG-7/SFUO-3, an open-label, randomised, phase III trial.\" Lancet Oncol 10(4): 370-380.",null,"Fransson, P., et al.","Quality of life in patients with locally advanced prostate cancer given endocrine treatment with or without radiotherapy: 4-year follow-up of SPCG-7/SFUO-3, an open-label, randomised, phase III trial","BACKGROUND: Androgen treatment for prostate cancer can adversely affect functional domains of quality of life. We aimed to assess quality of life in men with locally advanced prostate cancer in an open-label phase III randomised comparison between lifelong endocrine treatment with and without radiotherapy. METHODS: We obtained quality-of-life information from 872 (99%) of 875 eligible men with locally advanced prostate cancer (T3; 78%) who were randomly assigned, between 1996 and 2002, to 3 months of total androgen blockade followed by continuous endocrine treatment (439 patients) or the same hormonal treatment with radiotherapy 3 months after randomisation (436 patients). Prospective outcomes included patient-reported symptoms and quality of life assessed with questionnaires from baseline to 4 years after randomisation. Analysis was by intention to treat. This study is registered as an international standard randomised controlled trial, number ISRCTN01534787. FINDINGS: 438 of 439 men assigned endocrine treatment and 434 of 436 assigned endocrine plus radiotherapy completed at least one questionnaire. Missing data at baseline and during follow-up was equally distributed between groups. At 4 years, 64 (18%) of 353 patients on combined therapy and 39 (12%) of 337 on endocrine-alone therapy had moderate to severe urinary bother (p=0.005), and 16 (4%) of 355 on combined therapy and five (2%) of 338 on endocrine treatment alone had pain while urinating (p=0.024). 37 (11%) of 350 in the combined group and 23 (7%) of 35 in the endocrine-only group had overall bother from all bowel symptoms (p=0.022). 281 (85%) of 332 in the combined-treatment group and 227 (72%) of 313 in the endocrine-only group had erectile dysfunction (p=0.0002). Quality of life at 4 years was similar, with the exception of decreased social function in patients receiving endocrine treatment plus radiotherapy. INTERPRETATION: Although addition of radiotherapy to endocrine treatment significantly increased some treatment-related symptoms, none were serious. Given the substantial survival benefit of combined treatment, the increase of symptoms seems acceptable and has little extra effect on quality of life after 4 years compared with endocrine treatment alone.","Lancet Oncol, 10(4): 370-380","Sweden",2009,"Advanced","Hormonal,Radiotherapy","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General,Symptom"]
[218,"Frazer, G. H., et al. (1998). \"Assessment of quality of life indicators among selected patients in a community cancer center.\" Issues Ment Health Nurs 19(3): 241-262.",null,"Frazer, G. H., et al.","Assessment of quality of life indicators among selected patients in a community cancer center","Quality of life and outcome assessments are particularly critical for nurses in assessing clinical care for diseases such as cancer because of potential mortality and the exacting modalities of treatment. The 278 study participants were patients at the M.D. Anderson Cancer Center Orlando. The respondents were assessed with the Health Status Questionnaire (HSQ; D. M. Radosevich, H. Wetzler, & S. M. Wilson, 1995). Prostate cancer patients scored higher (had a higher quality of life) on average (6.08%) than breast cancer patients on all subscales except Physical Functioning. The diagnostic center patients scored higher (9.68%) than breast cancer patients and prostate cancer patients (3.47%). Breast cancer respondents scored 16.61% lower than the normative values for individuals less than 65 years of age, whereas prostate cancer respondents scored 10.91% higher than the normative values for those older than 65. The data analysis confirmed that breast cancer and prostate cancer patients have statistically different scores on the HSQ, implying different quality of life concerns for each group.","Issues Ment Health Nurs, 19(3): 241-262","USA",1998,"Any or unknown","None","HSQ","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"General"]
[219,"Froehner, M., et al. (2013). \"Urinary tract-related quality of life after radical prostatectomy: open retropubic versus robot-assisted laparoscopic approach.\" Urol Int 90(1): 36-40.",null,"Froehner, M., et al.","Urinary tract-related quality of life after radical prostatectomy: open retropubic versus robot-assisted laparoscopic approach","BACKGROUND: The best technique of radical prostatectomy--open retropubic versus robot-assisted surgery--is a subject of controversy. PATIENTS AND METHODS: Between January 1st, 2007 and December 31st, 2011, 2,177 men underwent radical prostatectomy at our department. 252 (12%) cases were laparoscopic robot-assisted, the remainder open retropubic procedures. In Germany, certified prostate cancer centers are required to collect urinary tract-related outcome data after radical prostatectomy using the International Consultation of Incontinence Questionnaire Male Lower Urinary Tract Symptoms. The questionnaire data were used to compare both surgical approaches concerning the urinary tract-related outcome 1, 2 and 3 years postoperatively. RESULTS: Neither the voiding score nor the incontinence score or the bother scale sum differed between the two cohorts at any of the measurement times. CONCLUSIONS: Concerning continence recovery, in this series, there were no detectable differences between robot-assisted and open radical prostatectomy.","Urol Int, 90(1): 36-40","Germany",2013,"Any or unknown","Surgery","ICIQ","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Complication"]
[220,"Frohmuller, H. G., et al. (1995). \"Survival and quality of life of patients with stage D1 (T1-3 pN1-2 M0) prostate cancer. Radical prostatectomy plus androgen deprivation versus androgen deprivation alone.\" Eur Urol 27(3): 202-206.",null,"Frohmuller, H. G., et al.","Survival and quality of life of patients with stage D1 (T1-3 pN1-2 M0) prostate cancer. Radical prostatectomy plus androgen deprivation versus androgen deprivation alone","A series of 139 patients with histologically proven stage D1 (T1-3 pN1-2 M0) prostate cancer was reviewed in order to determine the influence of radical surgery in addition to hormonal treatment on long-term outcome with respect to survival and quality of life. In all 139 patients a pelvic lymphadenectomy was performed. In 87 patients, lymphadenectomy was followed by androgen deprivation alone (group 1). Fifty-two patients underwent additional radical prostatectomy (group 2). The actuarial 10-year nonprogression rates were 14.6% in group 1 and 35.8% in group 2, respectively (p = 0.0016). The overall and disease-specific 10-year survival rates were found to be 29.7 and 32.1%, respectively, for group 1 and 50.8 and 70.7%, respectively, for group 2. Local progression as the main parameter influencing quality of life occurred in 60 of the 87 patients (69%) not subjected to radical prostatectomy. Transurethral resection of the prostate was required in 29 of these patients. In contrast, following radical prostatectomy, only 4 of the 52 patients (8%) had local progression and only 1 patient (2%) needed a dilatation of the vesicourethral anastomosis for relief of infravesical obstruction. Thus, radical prostatectomy plus androgen deprivation for patients with stage D1 prostate cancer appeared to be superior to androgen deprivation alone with respect to survival expectancy and quality of life. Prospective randomized trials, however, have to be undertaken to verify these results.","Eur Urol, 27(3): 202-206","Germany",1995,"Advanced","Surgery,Hormonal","Unclear","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"General"]
[221,"Fromme, E. K., et al. (2004). \"How accurate is clinician reporting of chemotherapy adverse effects? A comparison with patient-reported symptoms from the Quality-of-Life Questionnaire C30.\" J Clin Oncol 22(17): 3485-3490.",null,"Fromme, E. K., et al.","How accurate is clinician reporting of chemotherapy adverse effects? A comparison with patient-reported symptoms from the Quality-of-Life Questionnaire C30","PURPOSE: Adverse events in chemotherapy clinical trials are assessed and reported by clinicians, yet clinician accuracy in assessing symptoms has been questioned. We compared patient reporting of eight symptoms using a validated instrument, the European Organization for the Research and Treatment of Cancer Quality-of-Life Questionnaire C30 (QLQ-C30 or QLQ) with physicians' reporting of the same symptoms in the study's adverse events log. PATIENTS AND METHODS: Thirty-seven men with metastatic, androgen-independent prostate cancer enrolled onto a phase II trial of weekly calcitriol and docetaxel completed the QLQ every 4 weeks for up to 28 weeks. A patient-reported symptom was defined as an increase in a QLQ symptom score by at least 10 points (0 to 100 scale), sustained for at least 4 weeks. A physician-reported symptom was considered present if it was ever documented in the adverse event log. RESULTS: Forty-nine (new or worsened) symptoms were detected by both physician and QLQ, 48 symptoms were detected by the physician alone, and 55 symptoms were detected by the QLQ alone. They agreed on the absence of a symptom in 102 instances of 254 possible opportunities. Their uncorrected agreement was 59.4%, but Cohen's kappa, a coefficient of agreement that corrects for chance, was 0.15, indicating only slight agreement. Using the QLQ as the standard, overall physician sensitivity and specificity was 47% and 68%, respectively, although it varied considerably among symptoms. CONCLUSION: Even in a tightly controlled clinical trial, physician reporting was neither sensitive nor specific in detecting common chemotherapy adverse effects. Tools for collecting patient-reported adverse event data in chemotherapy clinical trials should be developed.","J Clin Oncol, 22(17): 3485-3490","USA",2004,"Metastatic","Taxane","EORTC QLQ-C30","Patient,HCP",null,"Clinical trial",null,null,null,null,null,null,null,null,"General"]
[222,"Frosch, D., et al. (2001). \"Comparison of German language versions of the QWB-SA and SF-36 evaluating outcomes for patients with prostate disease.\" Qual Life Res 10(2): 165-173.",null,"Frosch, D., et al.","Comparison of German language versions of the QWB-SA and SF-36 evaluating outcomes for patients with prostate disease","BACKGROUND: The quality of well-being scale (QWB) and the Medical Outcome Study 36-item short form (SF-36) are alternative methods for measuring general health outcomes. Few studies compare these approaches against one another and no studies have compared German language versions. METHOD: A German language version of the self-administered quality of well-being scale (QWB-SA) was developed using forward and back translation methods. The German QWB-SA and a German language version of the SF-36 were administered to clinical population groups with current diagnoses of prostate cancer, benign hyperplasia of the prostate, colon cancer, and rectal cancer. Data were obtained from four German clinics. In addition to the quality of life measures, data on cancer stage and disease state were obtained. RESULTS: The QWB-SA and SF-36 were highly correlated. The QWB-SA was systematically related to disease state. Those with no symptomatic evidence had the highest scores followed by those who were stable with no metastatic disease and those with metastatic progression. Similar patterns were found for most SF-36 scales although the SF-36 failed to discriminate between those with no evidence of disease and those with stable disease without metastasis. CONCLUSIONS: Both the QWB-SA and SF-36 perform as expected using German language translations. Although both measures differentiate patients with metastasis from those without symptoms, the QWB-SA better differentiated those with no evidence of disease from those with stable disease without metastasis.","Qual Life Res, 10(2): 165-173","Germany",2001,"Any or unknown","None","QWB,SF-36","Patient",null,"Validation",null,null,null,null,null,null,null,null,"General,Utility"]
[223,"Fujimura, T., et al. (2012). \"Assessment of lower urinary tract symptoms in men by international prostate symptom score and core lower urinary tract symptom score.\" BJU Int 109(10): 1512-1516.",null,"Fujimura, T., et al.","Assessment of lower urinary tract symptoms in men by international prostate symptom score and core lower urinary tract symptom score","Study Type - Therapy (symptom prevalence). Level of Evidence 2a. What's known on the subject? and What does the study add? The International Prostate Symptom Score (IPSS) has been most commonly used for the symptom assessment of men with lower urinary tract symptoms (LUTS). However, LUTS in men are so variable that they may not be fully captured by the IPSS questionnaire alone. This study has demonstrated that the Core Lower Urinary Tract Symptom Score (CLSS) questionnaire, which addresses 10 important symptoms, is an appropriate initial assessment tool for LUTS in men with various diseases/conditions. OBJECTIVE: International Prostate Symptom Score (IPSS) has been commonly used to assess lower urinary tract symptoms (LUTS). We have recently developed Core Lower Urinary Tract Symptom Score (CLSS). The aim of this study is to compare IPSS and CLSS for assessing LUTS in men. PATIENTS AND METHODS: Consecutive 515 men fulfilled IPSS and CLSS questionnaires. IPSS QOL Index was used as the QOL surrogate. The clinical diagnoses were BPH (n = 116), BPH with OAB wet (n =80), prostate cancer (n = 128), prostatitis (n = 68), underactive bladder (n = 8), others (n = 72), and controls (e.g., occult blood) (n = 42). Simple statistics and predictability of poor QOL (QOL Index 4 or greater) were examined. RESULTS: All symptom scores were significantly increased in symptomatic men compared with controls. Scores of corresponding symptoms of two questionnaires were significantly correlated (r = 0.58-0.85, all P < 0.0001). A multivariate regression model to predict poor QOL indicated nine symptoms (daytime frequency, nocturia, urgency, urgency incontinence, slow stream, straining, incomplete emptying, bladder pain and urethral pain) as independent factors. The hazard ratios for bladder pain (2.2) and urgency incontinence (2.0) were among the highest. All the nine symptoms are addressed in CLSS, while three symptoms (urgency incontinence, bladder, and urethral pain) are dismissed in IPSS. CONCLUSION: CLSS questionnaire is more comprehensive than IPSS questionnaire for symptom assessment of men with various diseases/conditions, although both questionnaires can capture LUTS with possible negative impact on QOL.","BJU Int, 109(10): 1512-1516","Japan",2012,"Any or unknown","None","IPSS,CLSS","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Symptom"]
[224,"Fulmer, B. R., et al. (2001). \"Prospective assessment of voiding and sexual function after treatment for localized prostate carcinoma: comparison of radical prostatectomy to hormonobrachytherapy with and without external beam radiotherapy.\" Cancer 91(11): 2046-2055.",null,"Fulmer, B. R., et al.","Prospective assessment of voiding and sexual function after treatment for localized prostate carcinoma: comparison of radical prostatectomy to hormonobrachytherapy with and without external beam radiotherapy","BACKGROUND: Voiding and sexual function after treatment are major determinants of quality of life in prostate carcinoma patients. Erectile dysfunction, incontinence, and urinary symptoms, both obstructive and irritative, have a significant negative impact on patient quality of life. This prospective study was undertaken to evaluate voiding, sexual function, and their impact on patients with localized prostate carcinoma who were treated with radical retropubic prostatectomy (RP) and to compare these patients with patients who were undergoing hormonobrachytherapy with external bean radiotherapy (HBTC) and patients who were undergoing hormonobrachytherapy without external beam radiotherapy (HBT). METHODS: Patients treated for localized prostate carcinoma with either RP or interstitial palladium-103 (103Pd) HBTC or HBT were prospectively administered a voiding and sexual function questionnaire before any treatment was initiated and at posttreatment visits. Questionnaire components included the American Urological Association Symptom Score (AUASS) and specific items that addressed urinary control and sexual function from the University of California at Los Angeles Prostate Cancer Index. Questionnaire results were compiled, and differences among treatment groups were assessed over time. RESULTS: From January 1997 to November 1999, 127 consecutive patients were treated with either unilateral or bilateral nerve-sparing RP (42 patients), HBTC (40 patients) or HBT (45 patients) by 2 surgeons proficient in all procedures. Using the overall score and the obstructive subscale (OAUA) of the AUASS, the RP group showed a posttreatment decrease in scores compared with both HBTC and HBT groups. OAUA scores of HBTC and HBT groups were significantly greater than scores in RP patients over the course of the study. HBTC patients had increased irritative symptoms initially when compared with RP patients, and, although not statistically significant, the magnitude of the difference persisted over the course of the study. Total AUASS and subscale scores for the RP group returned to near baseline levels within 12 months. The use of incontinence pads was a criterion for urinary incontinence, and the proportion of patients returning to baseline continence was lower in RP patients over the course of the study. No notable differences in Voiding Bother (VB) scores were found. Initially RP patients experienced worse Sexual Function (SF) scores; however, scores for RP patients changed over time and approached the levels seen in HBTC patients at 18 months. The Sexual Function Bother (SFB) scores also were higher initially in the RP group but then decreased to similar levels observed for HBTC patients by 18 months. None of the treatment groups returned to near baseline SF or SFB scores during the course of this study. CONCLUSIONS: Comparison of voiding function indicated that HBTC and HBT patients initially have more obstructive voiding symptoms, whereas urinary incon- tinence is initially worse in RP patients. Initially RP patients demonstrated worse SF and SFB scores, but RP patients returned to HBTC levels within 18 months.","Cancer, 91(11): 2046-2055","USA",2001,"Local","Surgery,Brachytherapy","AUA-SI,UCLA-PCI","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Symptom,Disease"]
[225,"Furst, C. J. (1996). \"Radiotherapy for cancer. Quality of life.\" Acta Oncol 35 Suppl 7: 141-148.",null,"Furst, C. J.","Radiotherapy for cancer. Quality of life","This synthesis of the literature on the quality of life in relation to radiotherapy is based on 78 scientific articles, including 12 randomized studies, 25 prospective studies, and 20 retrospective studies. These studies involve 9884 patients. Radiotherapy is often organ-preserving, which inherently promotes a better quality of life. Many quality of life aspects related to radiotherapy have been studied, but seldom by prospective randomized studies that compare radiotherapy to other treatment (eg, surgery or chemotherapy). Radiotherapy involves numerous physical and psychological symptoms, mainly during the course of treatment. Examples include skin irritation and fatigue. Radiotherapy directed at the brain has delayed effects, in children treatment carries a substantial risk for lowering the IQ. The risk for encephalopathy in adults is probably underestimated. Patients with cancer in the head and neck may experience adverse side effects in the irradiated area long after the conclusion of radiotherapy. There are no confirmed differences in quality of life between breast cancer patients receiving adjuvant radiotherapy and those receiving chemotherapy. Impotency problems and urinary incontinence appear following radical surgery and radiotherapy for prostate cancer. The risk for delayed complications is low after radiotherapy for testicular cancer. Patients receiving radiotherapy for gynecologic cancers are often troubled by local side effects long after the conclusion of treatment.","Acta Oncol, 35 Suppl 7(141-148","Sweden",1996,"Any or unknown","Radiotherapy","Unclear","Patient",null,"Systematic review",null,null,null,null,null,null,null,null,"Complication"]
[226,"Gacci, M., et al. (2005). \"Quality of life after radical treatment of prostate cancer: validation of the Italian version of the University of California-Los Angeles Prostate Cancer Index.\" Urology 66(2): 338-343.",null,"Gacci, M., et al.","Quality of life after radical treatment of prostate cancer: validation of the Italian version of the University of California-Los Angeles Prostate Cancer Index","OBJECTIVES: To validate an Italian version of the University of California-Los Angeles Prostate Cancer Index (UCLA-PCI). METHODS: Men with prostate cancer treated with radical retropubic prostatectomy (RRP) or external beam radiation (EBR) were retrospectively selected. Each subject was asked to complete the UCLA-PCI short form and the 36-item short-form health survey (SF-36) questionnaires (principal sample); a subgroup completed both questionnaires twice (retest sample). A linguistic translation and validation was performed. Psychometric properties were analyzed. RESULTS: A total of 595 men were included in the study: 394 from the Department of Urology (treated with RRP) and 201 from the Department of Radiotherapy (treated with EBR). Of these, 75 patients (50 from the RRP group and 25 from the EBR group) were selected as the retest cohort. Internal consistency reliability of the SF-36 and UCLA-PCI for the primary sample of the surgery and radiotherapy populations ranged from 0.82 to 0.94; the mean values of sexual function were superior in the principal urology group, whereas the principal radiotherapy group demonstrated superior mean values of urinary function and urinary bother. A strong correlation between urinary function and sexual and bowel function, and between urinary function and all bother scales, was reported only for patients treated with RRP. The expected correlation between sexual function and sexual bother was reported for the EBR group but not for the RRP group. CONCLUSIONS: Our study demonstrated the excellent psychometric properties of the Italian version of the UCLA-PCI; the Italian version of the UCLA-PCI questionnaire will allow cross-cultural comparative studies in men with prostate cancer.","Urology, 66(2): 338-343","Italy",2005,"Any or unknown","Surgery,Radiotherapy","SF-36,UCLA-PCI","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease,Utility"]
[227,"Galalae, R. M., et al. (2004). \"Health-related quality of life measurement in long-term survivors and outcome following radical radiotherapy for localized prostate cancer.\" Strahlenther Onkol 180(9): 582-589.",null,"Galalae, R. M., et al.","Health-related quality of life measurement in long-term survivors and outcome following radical radiotherapy for localized prostate cancer","PURPOSE: To report long-term outcomes in terms of health-related quality of life (HRQoL) and survival of a dose-escalating radiotherapy protocol and to validate a new disease-specific HRQoL instrument. PATIENTS AND METHODS: 189 consecutive men with prostate cancer were analyzed; 127 patients had T1-2 (1% T1, 66% T2) and 62 patients (33%) T3 tumors. The pelvic lymphatics were treated to a dose of 50 Gy by external-beam irradiation. The prostate dose was limited to 40 Gy using compensators. The prostate was treated to the total nominal dose of 70 Gy using high-dose-rate (HDR) brachytherapy. The fraction dose was 15 Gy in the McNeal zone (planning target volume [PTV] 1), while 8-9 Gy were applied in the entire prostate (PTV 2). The HRQoL of the 145 long-term survivors was assessed using the EORTC QLQ-C30 and a new prostate-specific instrument (PSM-G 1.0). The reliability of the instruments used and HRQoL scale scores were calculated. Uni-/multivariate analyses of variance were performed. RESULTS: At a mean follow-up of 6.5 years 86.3% of the patients were disease-free, and 78% were biochemically controlled. The mean Cronbach's alpha-values were 0.81 for the QLQ-C30, and 0.74 for the prostate-specific module. Univariate analyses of variance by T-stage, grading, prostata-specific antigen (PSA) status after therapy and adjuvant androgen suppression (AS) revealed that PSA elevation after irradiation and AS were associated with significantly diminished HRQoL. In multivariate analyses AS significantly lowered the HRQoL without survival benefit. CONCLUSION: The described radiotherapy regimen represents a curative and well-tolerated treatment for localized prostate cancer. The HRQoL assessment with both instruments used was reliable. Adjuvant AS and PSA elevation were associated with diminished HRQoL.","Strahlenther Onkol, 180(9): 582-589","Germany",2004,"Survivors","Radiotherapy","EORTC QLQ-C30,PSM-G","Patient",null,"Validation",null,null,null,null,null,null,null,null,"General,Disease"]
[228,"Galbraith, M. E., et al. (2001). \"Quality of life, health outcomes, and identity for patients with prostate cancer in five different treatment groups.\" Oncol Nurs Forum 28(3): 551-560.",null,"Galbraith, M. E., et al.","Quality of life, health outcomes, and identity for patients with prostate cancer in five different treatment groups","PURPOSE/OBJECTIVES: To describe how different treatments for prostate cancer affect health-related quality of life (QOL), health status, and masculinity. DESIGN: Longitudinal survey design with descriptive, correlational, and comparative elements. SETTING: A tertiary medical center and associated clinics in a suburban community in the Southwestern United States. SAMPLE: 185 men with localized prostate cancer were enrolled from five treatment groups: watchful waiting (n = 30), surgery (n = 59), conventional radiation (n = 25), proton-beam radiation (n = 24), and a combination of conventional radiation and proton-beam radiation or mixed-beam radiation (n = 47). At six months, 163 remained on the study; at 12 months, 154 remained: and at 18 months, 153 remained. The average age was 68 years, and 82% of the men were white. METHODS: Men were enrolled at treatment and given a questionnaire with a self-addressed, stamped envelope for return. Questionnaires were mailed again at 6, 12, and 18 months. MAIN RESEARCH VARIABLES: Health-related QOL health status, prostate treatment-specific symptoms, and sex-role identity. FINDINGS: No overall difference in health-related QOL or health status was found, but post-hoc analysis revealed specific differences. The differences existed in sexual functioning and gastrointestinal treatment-specific symptoms. No relationship existed between masculinity and health-related QOL. CONCLUSIONS: Health-related QOL and health status are similar regardless of type of treatment. Radiation tends to produce more gastrointestinal symptoms, and surgery tends to produce more sexual functioning symptoms. Watchful waiting is associated with poorer general health. IMPLICATIONS FOR NURSING PRACTICE: Nurses can provide specific treatment-related information to men who are faced with making treatment decisions for prostate cancer and, in consultation with the healthcare team, can select a treatment best sulted to them.","Oncol Nurs Forum, 28(3): 551-560","USA",2001,"Local","Radiotherapy,Surveillance,Surgery","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General,Symptom"]
[229,"Garcia-Sanchez, C., et al. (2017). \"Comparative analysis of short - term functional outcomes and quality of life in a prospective series of brachytherapy and Da Vinci robotic prostatectomy.\" Int Braz J Urol 43(2): 216-223.",null,"Garcia-Sanchez, C., et al.","Comparative analysis of short - term functional outcomes and quality of life in a prospective series of brachytherapy and Da Vinci robotic prostatectomy","INTRODUCTION: There is a growing interest in achieving higher survival rates with the lowest morbidity in localized prostate cancer (PC) treatment. Consequently, minimally invasive techniques such as low-dose rate brachytherapy (BT) and robotic-assisted prostatectomy (RALP) have been developed and improved. Comparative analysis of functional outcomes and quality of life in a prospective series of 51BT and 42Da Vinci prostatectomies DV Materials and Methods: Comparative analysis of functional outcomes and quality of life in a prospective series of 93 patients with low-risk localized PC diagnosed in 2011. 51patients underwent low-dose rate BT and the other 42 patients RALP. IIEF to assess erectile function, ICIQ to evaluate continence and SF36 test to quality of life wee employed. RESULTS: ICIQ at the first revision shows significant differences which favour the BT group, 79% present with continence or mild incontinence, whereas in the DV group 45% show these positive results. Differences disappear after 6 months, with 45 patients (89%) presenting with continence or mild incontinence in the BT group vs. 30 (71%) in the DV group. 65% of patients are potent in the first revision following BT and 39% following DV. Such differences are not significant and cannot be observed after 6 months. No significant differences were found in the comparative analysis of quality of life. CONCLUSIONS: ICIQ after surgery shows significant differences in favour of BT, which disappear after 6 months. Both procedures have a serious impact on erectile function, being even greater in the DV group. Differences between groups disappear after 6 months.","Int Braz J Urol, 43(2): 216-223","Spain",2017,"Local","Brachytherapy,Surgery","IIEF-5,ICIQ,SF-36","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Complication,Utility"]
[230,"Gavin, A. T., et al. (2016). \"Effect of investigation intensity and treatment differences on prostate cancer survivor's physical symptoms, psychological well-being and health-related quality of life: a two country cross-sectional study.\" BMJ Open 6(12): e012952.",null,"Gavin, A. T., et al.","Effect of investigation intensity and treatment differences on prostate cancer survivor's physical symptoms, psychological well-being and health-related quality of life: a two country cross-sectional study","AIM: To investigate effects on men's health and well-being of higher prostate cancer (PCa) investigation and treatment levels in similar populations. PARTICIPANTS: PCa survivors in Ireland where the Republic of Ireland (RoI) has a 50% higher PCa incidence than Northern Ireland (NI). METHOD: A cross-sectional postal questionnaire was sent to PCa survivors 2-18 years post-treatment, seeking information about current physical effects of treatment, health-related quality of life (HRQoL; EORTC QLQ-C30; EQ-5D-5L) and psychological well-being (21 question version of the Depression, Anxiety and Stress Scale, DASS-21). Outcomes in RoI and NI survivors were compared, stratifying into 'late disease' (stage III/IV and any Gleason grade (GG) at diagnosis) and 'early disease' (stage I/II and GG 2-7). Responses were weighted by age, jurisdiction and time since diagnosis. Between-country differences were investigated using multivariate logistic and linear regression. RESULTS: 3348 men responded (RoI n=2567; NI n=781; reflecting population sizes, response rate 54%). RoI responders were younger; less often had comorbidities (45% vs 38%); were more likely to present asymptomatically (66%; 41%) or with early disease (56%; 35%); and less often currently used androgen deprivation therapy (ADT; 2%; 28%). Current prevalence of incontinence (16%) and impotence (56% early disease, 67% late disease) did not differ between RoI and NI. In early disease, only current bowel problems (RoI 12%; NI 21%) differed significantly in multivariate analysis. In late disease, NI men reported significantly higher levels of gynaecomastia (23% vs 9%) and hot flashes(41% vs 19%), but when ADT users were analysed separately, differences disappeared. For HRQoL, in multivariate analysis, only pain (early disease: RoI 11.1, NI 19.4) and financial difficulties (late disease: RoI 10.4, NI 7.9) differed significantly between countries. There were no significant between-country differences in DASS-21 or index ED-5D-5L score. CONCLUSIONS: Treatment side effects were commonly reported and increased PCa detection in RoI has left more men with these side effects. We recommended that men be offered a PSA test only after informed discussion.","BMJ Open, 6(12): e012952","UK,Ireland",2016,"Survivors","None","EORTC QLQ-C30,EQ-5D,DASS-21","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"General,Comorbidity,Utility"]
[231,"Gay, H. A., et al. (2013). \"Neoadjuvant androgen deprivation therapy leads to immediate impairment of vitality/hormonal and sexual quality of life: results of a multicenter prospective study.\" Urology 82(6): 1363-1368.",null,"Gay, H. A., et al.","Neoadjuvant androgen deprivation therapy leads to immediate impairment of vitality/hormonal and sexual quality of life: results of a multicenter prospective study","OBJECTIVE: To evaluate the immediate effects of neoadjuvant androgen deprivation therapy (NADT) on health-related quality of life (HRQOL) among patients undergoing radiation therapy (RT) for newly diagnosed prostate cancer. METHODS: The Prostate Cancer Outcomes and Satisfaction with Treatment Quality Assessment Consortium is a prospective multi-institutional study. HRQOL is measured with the Expanded Prostate Cancer Index Composite-26 questionnaire. Differences in patient-reported HRQOL were observed between pretreatment and 2 months after NADT start (and before definitive RT) with significant differences evaluated by paired t test. RESULTS: From among 450 patients who completed the Expanded Prostate Cancer Index Composite-26 before and 2 months after NADT start, 71 received NADT before proceeding with definitive RT. Patients receiving NADT experienced significant impairment in vitality/hormonal (P <.0001) and sexual (P <.0001) HRQOL after NADT initiation. The mean +/- standard deviation vitality/hormonal score fell from an average of 94.1 +/- 9.7 before NADT to 78.7 +/- 16.3 two months after NADT initiation; and sexual HRQOL fell from a mean of 51.7 +/- 31.1 pretreatment to 32.3 +/- 26.1 after NADT initiation. Both these HRQOL domain changes exceeded the thresholds for clinical significance. Patients receiving NADT also experienced a significant impairment in urinary continence (P = .024), although this difference did not meet the criteria for clinical significance. CONCLUSION: In this analysis, patients receiving NADT experience significant impairment in sexual and vitality/hormonal HRQOL even before starting definitive RT. The significant effect of this therapy on HRQOL needs to be considered before initiating NADT in men where there is no clear evidence of clinical benefit.","Urology, 82(6): 1363-1368","USA",2013,"Any or unknown","Hormonal,Radiotherapy","EPIC","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease"]
[232,"Gay, H. A., et al. (2017). \"External Beam Radiation Therapy or Brachytherapy With or Without Short-course Neoadjuvant Androgen Deprivation Therapy: Results of a Multicenter, Prospective Study of Quality of Life.\" Int J Radiat Oncol Biol Phys 98(2): 304-317.",null,"Gay, H. A., et al.","External Beam Radiation Therapy or Brachytherapy With or Without Short-course Neoadjuvant Androgen Deprivation Therapy: Results of a Multicenter, Prospective Study of Quality of Life","PURPOSE: The long-term effects of neoadjuvant androgen deprivation therapy (NADT) with radiation therapy on participant-reported health-related quality of life (HRQOL) have not been characterized in prospective multicenter studies. We evaluated HRQOL for 2 years among participants undergoing radiation therapy (RT) with or without NADT for newly diagnosed, early-stage prostate cancer. METHODS AND MATERIALS: We analyzed longitudinal cohort data from the Prostate Cancer Outcomes and Satisfaction with Treatment Quality Assessment Consortium to ascertain the HRQOL trajectory of men receiving NADT with external beam RT (EBRT) or brachytherapy. HRQOL was measured using the expanded prostate cancer index composite 26-item questionnaire at 2, 6, 12, and 24 months after the initiation of NADT. We used the chi(2) or Fisher exact test to compare the shift in percentages between groups that did or did not receive NADT. Analyses were conducted at the 2-sided 5% significance level. RESULTS: For subjects receiving EBRT, questions regarding the ability to have an erection, ability to reach an orgasm, quality of erections, frequency of erections, ability to function sexually, and lack of energy were in a significantly worse dichotomized category for the patients receiving NADT. Comparing the baseline versus 24-month outcomes, 24%, 23%, and 30% of participants receiving EBRT plus NADT shifted to the worse dichotomized category for the ability to reach an orgasm, quality of erections, and ability to function sexually compared with 14%, 13%, and 16% in the EBRT group, respectively. CONCLUSIONS: Compared with baseline, at 2 years, participants receiving NADT plus EBRT compared with EBRT alone had worse HRQOL, as measured by the ability to reach orgasm, quality of erections, and ability to function sexually. However, no difference was found in the ability to have an erection, frequency of erections, overall sexual function, hot flashes, breast tenderness/enlargement, depression, lack of energy, or change in body weight. The improved survival in intermediate- and high-risk patients receiving NADT and EBRT necessitates pretreatment counseling of the HRQOL effect of NADT and EBRT.","Int J Radiat Oncol Biol Phys, 98(2): 304-317","USA",2017,"Local","Hormonal,Brachytherapy,Radiotherapy","EPIC","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease"]
[233,"Gaylis, F. D., et al. (1998). \"Radical retropubic prostatectomy outcomes at a community hospital.\" J Urol 159(1): 167-171.",null,"Gaylis, F. D., et al.","Radical retropubic prostatectomy outcomes at a community hospital","PURPOSE: We reviewed a 6-year experience performing radical retropubic prostatectomy at 2 community hospitals (for-profit and not-for-profit) to assess outcomes and to compare them to the published literature reflecting outcomes from major academic hospitals. MATERIALS AND METHODS: Charts of 116 patients who underwent radical retropubic prostatectomy (nerve sparing in select cases) between 1990 and 1996 were reviewed for clinical and pathological outcomes as well as hospital charges. Subjective patient reports of urinary continence, potency and satisfaction were evaluated postoperatively. RESULTS: Average patient age was 66.6 years and average preoperative prostate specific antigen level was 9.6 ng./ml. Of the patients 43% had T1c disease, 63% pT2 and 37% pT3. Positive margins were present in 17.2% of the specimens and 66% of the patients had Gleason scores of 5 and 6. No deaths occurred. Major complications occurred in 5.4% of patients and included deep venous thrombosis (1.8%), pulmonary embolism (1.8%), rectal injury requiring ileostomy (0.9%) and fascial dehiscence (0.9%). Mean blood loss was 872 cc and mean blood transfusion rate was 1.7 units (almost exclusively autologous blood). Hospital charges decreased at the not-for-profit hospital to $13,233 in 1996 from $17,743 in 1990 to 1995, whereas charges increased at the for-profit hospital to $25,979 in 1996 from $24,481 in 1990 to 1995. Mean length of stay decreased from 5 days in 1990 to 1995 to 3 days in 1996. Of the patients 80% were totally continent (pad-free), 12% wore a protective pad once per day for minimal incontinence and 8% wore 2 or more pads. Of the men who were potent preoperatively 18% retained potency and 46% remained sexually active postoperatively either spontaneously or with assistance. Of the patients 84% were satisfied with surgical outcomes, 11% were somewhat satisfied and 5% were dissatisfied. CONCLUSIONS: Radical retropubic prostatectomy can be performed safely and with acceptable clinical and pathological outcomes at a community hospital. Impotence continues to be one of the most bothersome morbidities, particularly in older men. Increasing cost awareness, coincident with the proliferation of managed care, has led to reductions in length of hospital stay and charges at certain hospitals.","J Urol, 159(1): 167-171","USA",1998,"Local,Advanced","Surgery","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Complication"]
[234,"Geiger-Gritsch, S., et al. (2015). \"Patient-reported urinary incontinence and erectile dysfunction following radical prostatectomy: results from the European Prostate Centre Innsbruck.\" Urol Int 94(4): 419-427.",null,"Geiger-Gritsch, S., et al.","Patient-reported urinary incontinence and erectile dysfunction following radical prostatectomy: results from the European Prostate Centre Innsbruck","INTRODUCTION: Urinary and erectile functions were assessed by using self-administered validated questionnaires in patients undergoing radical prostatectomy. MATERIALS AND METHODS: In a prospective observational study, a total of 253 consecutive patients diagnosed with clinically localised prostate cancer between 2008 and 2009 at the European Prostate Centre Innsbruck were included. Patient-reported outcomes were assessed before radical prostatectomy and 12 months postoperatively using the validated International Consultation on Incontinence Questionnaire (ICIQ) and the International Index of Erectile Function (IIEF). The Wilcoxon signed-rank test and Chi square statistics were used for analysis. RESULTS: The study showed that before radical prostatectomy, urinary incontinence of various severity grades was reported in 18.8, postoperatively in 63.0% (p < 0.001) and erectile dysfunction of various degrees was reported in 39.6 at baseline compared to 80.1% 12 months postoperatively (p < 0.001). CONCLUSIONS: This study suggests that radical prostatectomy is associated with a significantly increased risk of urinary incontinence and erectile dysfunction 12 months postoperatively.","Urol Int, 94(4): 419-427","Austria",2015,"Local","Surgery","ICIQ,IIEF-5","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Complication"]
[235,"Geinitz, H., et al. (2006). \"Late rectal symptoms and quality of life after conformal radiation therapy for prostate cancer.\" Radiother Oncol 79(3): 341-347.",null,"Geinitz, H., et al.","Late rectal symptoms and quality of life after conformal radiation therapy for prostate cancer","BACKGROUND AND PURPOSE: This study was carried out in order to analyze the prevalence of late rectal and anal symptoms after conformal radiation therapy for prostate cancer and to assess their association with quality of life. PATIENTS AND METHODS: Two-hundred and forty nine patients were interviewed at 24-111 months after definitive conformal radiation therapy of localized prostate cancer with a median dose of 70 Gy. Rectal symptoms and fecal incontinence were evaluated with standardized questionnaires. Quality of life was assessed with the EORTC Quality of Life Questionnaire-C30 and the prostate cancer module PR25. RESULTS: Rectal symptoms were mostly intermittent. Daily symptoms occurred in < or =5% of the patients. Incontinence was mostly mild with only 3% of the patients reporting daily incontinence episodes. Quality of life was comparable to that of the male German general population except that cognitive functioning and diarrhea were worse in the study population and pain was worse in the reference population. Global quality of life was associated with fecal incontinence, fecal urge, tenesmus, therapy for rectal symptoms and hormonal therapy for biochemical/clinical recurrence. CONCLUSIONS: Rectal symptoms and fecal incontinence after conformal radiation therapy for prostate cancer are mostly intermittent. Fecal incontinence, fecal urge and tenesmus are associated with lower global quality of life levels.","Radiother Oncol, 79(3): 341-347","Germany",2006,"Local","Radiotherapy","EORTC QLQ-C30,EORTC QLQ-PR25","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Disease,General"]
[236,"Giesler, R. B., et al. (2000). \"Assessing quality of life in men with clinically localized prostate cancer: development of a new instrument for use in multiple settings.\" Qual Life Res 9(6): 645-665.",null,"Giesler, R. B., et al.","Assessing quality of life in men with clinically localized prostate cancer: development of a new instrument for use in multiple settings","BACKGROUND: Quality of life in prostate cancer patients with clinically localized disease has become the focus of increasing attention over the past decade. However, few instruments have been developed and validated to assess quality of life specifically in this patient population. OBJECTIVE: The purpose of this investigation was to create a comprehensive, multi-scale quality of life instrument that can be tailored to the needs of the clinician/investigator in multiple settings. DESIGN, SUBJECTS, AND MEASURES: Patients diagnosed with clinically localized prostate cancer were mailed a questionnaire consisting of new and previously validated quality of life items and ancillary scales. Data from returned questionnaires were analyzed and used to create a multiscale instrument that assesses the effects of treatment and disease on urinary, sexual, and bowel domains, supplemented by a scale assessing anxiety over disease course/effectiveness of treatment. The instrument was then mailed to a second sample of prostate cancer patients once and then again two weeks later to assess test retest reliability. To assess feasibility in clinical settings, the instrument was self-administered to a third patient sample during a urology clinic visit. RESULTS: All scales exhibited good internal consistency and test retest reliability, convergent and discriminant validity, and significant correlations with disease specific, generic health-related, and global measures of quality of life. Men with greater physiologic impairment reported more limitations in role activities and more bother. Scales were also able to differentiate patients undergoing different therapies. All scales exhibited negligible correlations with a measure of socially desirable responding. Additionally, the instrument proved feasible when used as a self-administered questionnaire in a clinical setting. CONCLUSIONS: The current instrument possesses brief multi-item scales that can be successfully self-administered in multiple settings. The instrument is flexible, relatively quick, psychometrically reliable and valid, and permits a more comprehensive assessment of patients' quality of life.","Qual Life Res, 9(6): 645-665","USA",2000,"Local","None","Unclear","Patient",null,"Validation",null,null,null,null,null,null,null,null,"General"]
[237,"Gilbert, D. C., et al. (2017). \"Quality-of-life outcomes from the Prostate Adenocarcinoma: TransCutaneous Hormones (PATCH) trial evaluating luteinising hormone-releasing hormone agonists versus transdermal oestradiol for androgen suppression in advanced prostate cancer.\" BJU Int 119(5): 667-675.",null,"Gilbert, D. C., et al.","Quality-of-life outcomes from the Prostate Adenocarcinoma: TransCutaneous Hormones (PATCH) trial evaluating luteinising hormone-releasing hormone agonists versus transdermal oestradiol for androgen suppression in advanced prostate cancer","OBJECTIVES: To compare quality-of-life (QoL) outcomes at 6 months between men with advanced prostate cancer receiving either transdermal oestradiol (tE2) or luteinising hormone-releasing hormone agonists (LHRHa) for androgen-deprivation therapy (ADT). PATIENTS AND METHODS: Men with locally advanced or metastatic prostate cancer participating in an ongoing randomised, multicentre UK trial comparing tE2 versus LHRHa for ADT were enrolled into a QoL sub-study. tE2 was delivered via three or four transcutaneous patches containing oestradiol 100 mug/24 h. LHRHa was administered as per local practice. Patients completed questionnaires based on the European Organisation for Research and Treatment of Cancer quality of life questionnaire 30-item core (EORTC QLQ-C30) with prostate-specific module QLQ PR25. The primary outcome measure was global QoL score at 6 months, compared between randomised arms. RESULTS: In all, 727 men were enrolled between August 2007 and October 2015 (412 tE2, 315 LHRHa) with QoL questionnaires completed at both baseline and 6 months. Baseline clinical characteristics were similar between arms: median (interquartile range) age of 74 (68-79) years and PSA level of 44 (19-119) ng/mL, and 40% (294/727) had metastatic disease. At 6 months, patients on tE2 reported higher global QoL than those on LHRHa (mean difference +4.2, 95% confidence interval 1.2-7.1; P = 0.006), less fatigue, and improved physical function. Men in the tE2 arm were less likely to experience hot flushes (8% vs 46%), and report a lack of sexual interest (59% vs 74%) and sexual activity, but had higher rates of significant gynaecomastia (37% vs 5%). The higher incidence of hot flushes among LHRHa patients appear to account for both the reduced global QoL and increased fatigue in the LHRHa arm compared to the tE2 arm. CONCLUSION: Patients receiving tE2 for ADT had better 6-month self-reported QoL outcomes compared to those on LHRHa, but increased likelihood of gynaecomastia. The ongoing trial will evaluate clinical efficacy and longer term QoL. These findings are also potentially relevant for short-term neoadjuvant ADT.","BJU Int, 119(5): 667-675","UK",2017,"Advanced,Metastatic","Hormonal","EORTC QLQ-C30,EORTC QLQ-PR25","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General,Disease"]
[238,"Gladwish, A., et al. (2015). \"Accelerated hypofractioned postoperative radiotherapy for prostate cancer: a prospective phase I/II study.\" Clin Oncol (R Coll Radiol) 27(3): 145-152.",null,"Gladwish, A., et al.","Accelerated hypofractioned postoperative radiotherapy for prostate cancer: a prospective phase I/II study","AIMS: To present the initial findings of a single institution, phase I/II study investigating hypofractionated radiotherapy in patients undergoing post-prostatectomy treatment. MATERIALS AND METHODS: Patients requiring postoperative radiotherapy were prospectively enrolled. Dose was prescribed to the prostate bed with 51 Gy in 17 daily fractions. Androgen deprivation was optional. Acute and late gastrointestinal/genitourinary toxicity were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 and quality of life was assessed using the Expanded Prostate Cancer Index Composite evaluation tool. Prostate-specific antigen (PSA) was evaluated at every follow-up. RESULTS: Thirty patients were enrolled between 2009 and 2011. The median age was 65 years and most had Gleason 7 disease (86%) with pT2c or pT3a (82%). Positive margins were documented in 67% of the patients. The median pre-treatment PSA was 0.12 ng/ml. The median follow-up was 24 months. Overall toxicity was low, with >80% of patients having </= grade 1 acute toxicity in both genitourinary and gastrointestinal realms. Similarly, only two patients (6%) experienced grade 2/3 late gastrointestinal/genitourinary toxicity. Quality of life scores were also indicative of a well-tolerated treatment. PSA failure was seen in five patients (17%). CONCLUSIONS: We present a hypofractionated schedule of postoperative prostate radiotherapy that is both well tolerated in terms of both toxicity and quality of life measures. Initial PSA control is encouraging. Further evaluation with a longer follow-up and a larger cohort is warranted.","Clin Oncol (R Coll Radiol), 27(3): 145-152","Canada",2015,"Local,Advanced","Radiotherapy,Surgery,Hormonal","EPIC,CTCAE","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,Treatment"]
[239,"Glazener, C., et al. (2011). \"Conservative treatment for urinary incontinence in Men After Prostate Surgery (MAPS): two parallel randomised controlled trials.\" Health Technol Assess 15(24): 1-290, iii-iv.",null,"Glazener, C., et al.","Conservative treatment for urinary incontinence in Men After Prostate Surgery (MAPS): two parallel randomised controlled trials","OBJECTIVE: To determine the clinical effectiveness and cost-effectiveness of active conservative treatment, compared with standard management, in regaining urinary continence at 12 months in men with urinary incontinence at 6 weeks after a radical prostatectomy or a transurethral resection of the prostate (TURP). BACKGROUND: Urinary incontinence after radical prostate surgery is common immediately after surgery, although the chance of incontinence is less after TURP than following radical prostatectomy. DESIGN: Two multicentre, UK, parallel randomised controlled trials (RCTs) comparing active conservative treatment [pelvic floor muscle training (PFMT) delivered by a specialist continence physiotherapist or a specialist continence nurse] with standard management in men after radial prostatectomy and TURP. SETTING: Men having prostate surgery were identified in 34 centres across the UK. If they had urinary incontinence, they were invited to enroll in the RCT. PARTICIPANTS: Men with urinary incontinence at 6 weeks after prostate surgery were eligible to be randomised if they consented and were able to comply with the intervention. INTERVENTIONS: Eligible men were randomised to attend four sessions with a therapist over a 3-month period. The therapists provided standardised PFMT and bladder training for male urinary incontinence and erectile dysfunction. The control group continued with standard management. MAIN OUTCOME MEASURES: The primary outcome of clinical effectiveness was urinary incontinence at 12 months after randomisation, and the primary measure of cost-effectiveness was incremental cost per quality-adjusted life-year (QALY). Outcome data were collected by postal questionnaires at 3, 6, 9 and 12 months. RESULTS: Within the radical group (n = 411), 92% of the men in the intervention group attended at least one therapy visit and were more likely than those in the control group to be carrying out any PFMT at 12 months {adjusted risk ratio (RR) 1.30 [95% confidence interval (CI) 1.09 to 1.53]}. The absolute risk difference in urinary incontinence rates at 12 months between the intervention (75.5%) and control (77.4%) groups was -1.9% (95% CI -10% to 6%). NHS costs were higher in the intervention group [ pound 181.02 (95% CI pound 107 to pound 255)] but there was no evidence of a difference in societal costs, and QALYs were virtually identical for both groups. Within the TURP group (n = 442), over 85% of men in the intervention group attended at least one therapy visit and were more likely to be carrying out any PFMT at 12 months after randomisation [adjusted RR 3.20 (95% CI 2.37 to 4.32)]. The absolute risk difference in urinary incontinence rates at 12 months between the intervention (64.9%) and control (61.5%) groups for the unadjusted intention-to-treat analysis was 3.4% (95% CI -6% to 13%). NHS costs [ pound 209 (95% CI pound 147 to pound 271)] and societal costs [ pound 420 (95% CI pound 54 to pound 785)] were statistically significantly higher in the intervention group but QALYs were virtually identical. CONCLUSIONS: The provision of one-to-one conservative physical therapy for men with urinary incontinence after prostate surgery is unlikely to be effective or cost-effective compared with standard care that includes the provision of information about conducting PFMT. Future work should include research into the value of different surgical options in controlling urinary incontinence.","Health Technol Assess, 15(24): 1-290, iii-iv","UK",2011,"Any or unknown","Various,Surgery","Unclear","Patient",null,"Clinical trial,Economic model",null,null,null,null,null,null,null,null,"Complication"]
[240,"Glazener, C., et al. (2011). \"Urinary incontinence in men after formal one-to-one pelvic-floor muscle training following radical prostatectomy or transurethral resection of the prostate (MAPS): two parallel randomised controlled trials.\" Lancet 378(9788): 328-337.",null,"Glazener, C., et al.","Urinary incontinence in men after formal one-to-one pelvic-floor muscle training following radical prostatectomy or transurethral resection of the prostate (MAPS): two parallel randomised controlled trials","BACKGROUND: Urinary incontinence is common immediately after prostate surgery. Men are often advised to do pelvic-floor exercises, but evidence to support this is inconclusive. Our aim was to establish if formal one-to-one pelvic floor muscle training reduces incontinence. METHODS: We undertook two randomised trials in men in the UK who were incontinent 6 weeks after radical prostatectomy (trial 1) or transurethral resection of the prostate (TURP; trial 2) to compare four sessions with a therapist over 3 months with standard care and lifestyle advice only. Randomisation was by remote computer allocation. Our primary endpoints, collected via postal questionnaires, were participants' reports of urinary incontinence and incremental cost per quality-adjusted life year (QALY) after 12 months. Group assignment was masked from outcome assessors, but this masking was not possible for participants or caregivers. We used intention-to-treat analyses to compare the primary outcome at 12 months. This study is registered, number ISRCTN87696430. FINDINGS: In the intervention group in trial 1, the rate of urinary incontinence at 12 months (148 [76%] of 196) was not significantly different from the control group (151 [77%] of 195; absolute risk difference [RD] -1.9%, 95% CI -10 to 6). In trial 2, the difference in the rate of urinary incontinence at 12 months (126 [65%] of 194) from the control group was not significant (125 [62%] of 203; RD 3.4%, 95% CI -6 to 13). Adjusting for minimisation factors or doing treatment-received analyses did not change these results in either trial. No adverse effects were reported. In both trials, the intervention resulted in higher mean costs per patient ( pound180 and pound209 respectively) but we did not identify evidence of an economically important difference in QALYs (0.002 [95% CI -0.027 to 0.023] and -0.00003 [-0.026 to 0.026]). INTERPRETATION: In settings where information about pelvic-floor exercise is widely available, one-to-one conservative physical therapy for men who are incontinent after prostate surgery is unlikely to be effective or cost effective. The high rates of persisting incontinence after 12 months suggest a substantial unrecognised and unmet need for management in these men. FUNDING: National Institute of Health Research, Health Technology Assessment (NIHR HTA) Programme.","Lancet, 378(9788): 328-337","UK",2011,"Any or unknown","Various,Surgery","Unclear","Patient",null,"Clinical trial,Economic model",null,null,null,null,null,null,null,null,"Complication"]
[241,"Goldenberg, S. L., et al. (1995). \"Intermittent androgen suppression in the treatment of prostate cancer: a preliminary report.\" Urology 45(5): 839-844; discussion 844-835.",null,"Goldenberg, S. L., et al.","Intermittent androgen suppression in the treatment of prostate cancer: a preliminary report","OBJECTIVES: To test the feasibility of using intermittent androgen suppression in the treatment of prostate cancer by taking advantage of the reversible action of medical castration. METHODS: Observations were made on a group of 47 patients (clinical Stage D2, 14; D1, 10; C, 19; B2, 2; and A2, 2) with a mean follow-up time of 125 weeks. Treatment was initiated with combined androgen blockade and continued for at least 6 months until a serum prostate-specific antigen (PSA) nadir was observed. Medication was then withheld until the serum PSA increased to a mean value between 10 and 20 ng/mL. This cycle of treatment and no treatment was repeated until the regulation of serum PSA became androgen independent. RESULTS: The first two treatment cycles lasted 73 and 75 weeks, with a mean time off therapy of 30 and 33 weeks and an overall mean percentage time off therapy of 41% and 45%, respectively. The mean time to achieve a nadir level of serum PSA was 20 weeks in cycle 1 and 18 weeks in cycle 2. Serum testosterone returned to the normal range within 8 weeks (range, 1 to 26) of stopping treatment. The off-treatment period in both cycles was associated with an improvement in sense of well-being and the recovery of libido and potency in the men who reported normal or near-normal sexual function before the start of therapy. In 7 patients with Stage D2 disease, the cancer progressed to an androgen-independent state. The mean and median times to progression were 128 weeks and 108 weeks, respectively. Seven patients have died, 1 from a noncancer-related illness, with mean and median overall survival times of 210 weeks and 166 weeks, respectively. CONCLUSIONS: Prostate cancer is amenable to control by intermittent androgen suppression. This approach affords an improved quality of life when the patient is off therapy. It also results in reduced toxicity and cost of treatment and possibly delays tumor progression. Whether survival is affected in a beneficial or adverse way remains to be studied in a randomized, prospective study.","Urology, 45(5): 839-844; discussion 844-835","Canada",1995,"Local,Advanced,Metastatic","Hormonal","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General"]
[242,"Gomez Caamano, A., et al. (2016). \"Management of prostate cancer patients following radiation therapy after radical surgery referred from urology to radiation oncology departments in Spain.\" Clin Transl Oncol 18(9): 884-892.",null,"Gomez Caamano, A., et al.","Management of prostate cancer patients following radiation therapy after radical surgery referred from urology to radiation oncology departments in Spain","PURPOSE: To define usual clinical management of prostate cancer (PCa) patients following postoperative radiation therapy (RT) (adjuvant or salvage) and its evolution over time in radiation oncology (RO) departments in Spain. METHODS: An epidemiological, cross-sectional, multicentre study was conducted. 567 PCa patients that had undergone radical prostatectomy (RP) and received postoperative RT between February and December of both 2006 and 2011 participated in the study. In patients from 2006, health-related quality of life (HRQoL) was assessed using the EPIC questionnaire. Investigators completed a specific survey on two clinical cases of adjuvant and salvage RT. RESULTS: 70.6 % of patients received salvage RT versus 29.4 % who received adjuvant RT; no significant differences were found in terms of frequency for each procedure between both the years. Regarding the survey, a positive surgical margin was the main criteria used in adjuvant RT decision making. In terms of salvage RT scenario, 85.7 % of the investigators stated that adjuvant RT should have been offered instead, 81.4 % of the investigators agreed on a PSA score >0.2 ng/mL as the main criteria for identifying biochemical recurrence after RP, and 67.4 % of investigators did not consider any PSA score for ruling out salvage RT treatment. CONCLUSIONS: Most patients are referred to RO departments to receive salvage RT. Despite the publication of three IA evidence level randomized clinical trials, the patterns for using adjuvant and salvage RT did not change from 2006 to 2011, although patients' profile did. A consensus regarding postoperative RT indications should be reached in order to correct this controversial situation.","Clin Transl Oncol, 18(9): 884-892","Spain",2016,"Any or unknown","Radiotherapy,Surgery","EPIC","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Disease"]
[243,"Gomez-Veiga, F., et al. (2014). \"Reference values for the CAVIPRES-30 questionnaire, a global questionnaire on the health-related quality of life of patients with prostate cancer.\" Actas Urol Esp 38(5): 304-312.",null,"Gomez-Veiga, F., et al.","Reference values for the CAVIPRES-30 questionnaire, a global questionnaire on the health-related quality of life of patients with prostate cancer","OBJECTIVE: Define and establish the reference values of the CAVIPRES-30 Questionnaire, a health related quality of life questionnaire specific for prostate cancer patients. MATERIAL AND METHODS: The CAVIPRES-30 was administered to 2,630 males with prostate cancer included by 238 Urologist belonging to the Spanish National Healthcare System. Descriptive analysis on socio-demographic and clinical data were performed, and multivariate analyses were used to corroborate that stratification variables were statistically significantly and independently associated to the overall score of the questionnaire. RESULTS: The variables Time since diagnosis of the illness, whether the patient had a Stable partner or not, if he was, or not, undergoing Symptomatic treatment were statistically significantly and independently associated (P < .001) to the overall score of the questionnaire. The reference values table of the CAVIPRES-30 questionnaire is made up of different kinds of information of each patient profile: sample size, descriptive statistics with regard to the overall score, Cronbach's alpha value (between .791 and .875) and the questionnaire's values are reported by deciles. CONCLUSIONS: The results of this study contribute new proof as to the suitability and usefulness of the CAVIPRES-30 questionnaire as an instrument for assessing individually the quality of life of prostate cancer.","Actas Urol Esp, 38(5): 304-312","Spain",2014,"Any or unknown","None","CAVIPRES-30","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease"]
[244,"Good, D. W., et al. (2016). \"Consultation audio-recording reduces long-term decision regret after prostate cancer treatment: A non-randomised comparative cohort study.\" Surgeon 14(6): 308-314.",null,"Good, D. W., et al.","Consultation audio-recording reduces long-term decision regret after prostate cancer treatment: A non-randomised comparative cohort study","INTRODUCTION: The life expectancy of prostate patients is long and patients will spend many years carrying the burdens & benefits of the treatment decisions they have made, therefore, it is vital that decisions on treatments are shared between patient and physician. The objective was to determine if consultation audio-recording improves quality of life, reduces regret or improves patient satisfaction in comparison to standard counselling. PATIENTS AND METHODS: In 2012 we initiated consultation audio-recordings, where patients are given a CD of their consultation to keep and replay at home. We conducted a prospective non-randomised study of patient satisfaction, quality of life (QOL) and decision regret at 12 months follow-up using posted validated questionnaires for the audio-recording (AR) patients and a control cohort. Qualitative and thematic analyses were used. RESULTS: Forty of 59 patients in the AR group, and 27 of 45 patients in the control group returned the questionnaires. Patient demographics were similar in both groups with no statistically significant differences between the two groups. Decision regret was lower in the audio-recording group (11/100) vs control group (19/100) (p = 0.04). The risk ratio for not having any long-term decision regret was 5.539 (CI 1.643-18.674), with NNT to prevent regret being 4. Regression analysis showed that receiving audio-recording was strongest predictor for absence of regret even greater than potency and incontinence. CONCLUSION: The study has shown that audio-recording clinic consultation reduces long-term decision regret, increases patient information recall, understanding and confidence in their decision. There is great potential for further expansion of this low-cost intervention.","Surgeon, 14(6): 308-314","UK",2016,"Any or unknown","Unclear","Unclear","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Satisfaction"]
[245,"Gotay, C. C., et al. (2002). \"Ethnic differences in quality of life among early breast and prostate cancer survivors.\" Psychooncology 11(2): 103-113.",null,"Gotay, C. C., et al.","Ethnic differences in quality of life among early breast and prostate cancer survivors","This study assessed quality of life (QOL) in recently diagnosed breast and prostate cancer patients of European American and Asian Pacific Islanders (specifically, individuals of Filipino, Japanese, and Native Hawaiian ancestry) to investigate whether QOL varied according to ethnicity and the relative importance of ethnicity as a predictor of QOL. Participants were identified through consecutive registrations on the Hawaii Tumor Registry, based on a diagnosis of breast or prostate cancer 4-6 months previously. QOL was measured by the QLQ-C30, a standardized questionnaire widely used in cancer patient populations. Two hundred and twenty-seven individuals participated (101 prostate and 126 breast cancer patients). QOL was similar across ethnic groups in most areas of QOL. However, differences were found in several areas, all in the direction of Filipino patients reporting worse outcomes. Hierarchical stepwise regressions supported the importance of ethnicity, controlling for clinical and demographic predictors. We conclude that additional research is needed to understand the relationship between ethnicity and QOL in cancer survivors.","Psychooncology, 11(2): 103-113","USA",2002,"Any or unknown","None","EORTC QLQ-C30","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"General"]
[246,"Gravis, G., et al. (2014). \"Patients' self-assessment versus investigators' evaluation in a phase III trial in non-castrate metastatic prostate cancer (GETUG-AFU 15).\" Eur J Cancer 50(5): 953-962.",null,"Gravis, G., et al.","Patients' self-assessment versus investigators' evaluation in a phase III trial in non-castrate metastatic prostate cancer (GETUG-AFU 15)","BACKGROUND: Toxicity, which is a key parameter in the evaluation of cancer treatments, can be underestimated by clinicians. We investigated differences between patients and physicians in reporting adverse events of androgen deprivation therapy (ADT) with or without docetaxel in a multicentre phase III trial in non-castrate metastatic prostate cancer. METHODS: The 385 patients included were invited to complete a 26-symptom questionnaire 3 and 6 months after the start of treatment, among which eighteen symptoms were also assessed by physicians, reported in medical records and graded using the Common Toxicity Criteria of the National Cancer Institute. Positive and negative agreements as well as Kappa concordance coefficients were computed. FINDINGS: Data were available for 220 and 165 patients at 3 and 6 months respectively. Physicians systematically under-reported patients' symptoms. Positive agreement rates (at respectively 3 and 6 months) for the five most commonly reported symptoms were: 61.0% and 64.3% hot flushes, 50.0% and 43.6% fatigue, 29.4% and 31.1% sexual dysfunction, 24.4% and 14.4% weigh gain/loss, 16.7% and 19.3% for joint/muscle pain. For symptoms most frequently reported as disturbing or very disturbing by patients, the clinicians' failure to report them ranged from 50.8% (hot flushes) to 89.5% (joint/muscle pain) at 3 months, and from 48.2% (hot flushes) to 88.4% (joint/muscle pain) at 6 months. INTERPRETATION: Physicians often failed to report treatment-related symptoms, even the most common and disturbing ones. Patients' self-evaluation of toxicity should be used in clinical trials to improve the process of drug assessment in oncology. FUNDING: French Health Ministry and Institut National du Cancer (PHRC), Sanofi-Aventis, Astra-Zeneca, and Amgen.","Eur J Cancer, 50(5): 953-962","France",2014,"Metastatic","Hormonal,Taxane","CTCAE","Patient,HCP",null,"Clinical trial",null,null,null,null,null,null,null,null,"Treatment"]
[247,"Green, C. R., et al. (2009). \"Consistent and breakthrough pain in diverse advanced cancer patients: a longitudinal examination.\" J Pain Symptom Manage 37(5): 831-847.",null,"Green, C. R., et al.","Consistent and breakthrough pain in diverse advanced cancer patients: a longitudinal examination","Although cancer pain, both consistent and breakthrough pain ([BTP]; pain flares interrupting well-controlled baseline pain), is common among cancer patients, its prevalence, characteristics, etiology, and impact on health-related quality of life (HRQOL) are poorly understood. This longitudinal study examined the experience and treatment of cancer-related pain over six months, including an evaluation of ethnic differences. Patients with Stage III or IV breast, prostate, colorectal, or lung cancer, or Stage II-IV multiple myeloma with BTP completed surveys on initial assessment and at three and six months. Each survey assessed consistent pain, BTP, depressed affect, active coping ability, and HRQOL. Among the respondents (n=96), 70% were white, 66% were female, and had a mean age of 56+/-10 years. Nonwhites reported significantly greater severity for consistent pain at its worst (P = 0.009), least (P < or = 0.001), on average (P = 0.004), and upon initial assessment (P = 0.04), and greater severity for BTP at its worst (P = 0.03), least (P = 0.02), and at initial assessment (P = 0.008). Women also had higher levels of some BTP measures. Ethnic disparities persisted when data estimation techniques were used. Examined longitudinally, consistent pain on average and several BTP measures reduced over time, although not greatly, indicating the persistence of pain in the cancer experience. These data provide evidence for the significant toll of cancer pain, while demonstrating further health care disparities in the cancer pain experience.","J Pain Symptom Manage, 37(5): 831-847","USA",2009,"Advanced,Metastatic","None","Unclear","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Symptom"]
[248,"Green, H. J., et al. (2002). \"Coping and health-related quality of life in men with prostate cancer randomly assigned to hormonal medication or close monitoring.\" Psychooncology 11(5): 401-414.",null,"Green, H. J., et al.","Coping and health-related quality of life in men with prostate cancer randomly assigned to hormonal medication or close monitoring","Prostatic carcinoma and its treatment have been associated with adverse effects on health-related quality of life (HRQoL). Individual differences in appraisal and coping have been suggested to mediate these HRQoL outcomes. A randomized trial of 65 men with non-localized prostate cancer compared several treatments and tested associations between appraisal, coping, and HRQoL. These patients, and 16 community volunteers matched for age and general health, undertook psychosocial assessments before treatment and after 6 months of treatment. Compared with baseline assessments, men on hormonal treatments reported impaired sexual function. Groups did not differ on emotional distress, existential satisfaction, subjective cognitive function, physical symptoms, or social and role functioning. For individuals, hormonal treatments were more frequently associated with decreased sexual, social and role functioning, but were also associated with improved physical symptoms. In hierarchical regression analysis, HRQoL was lower for men who had more comorbid illnesses, a history of neurological dysfunction, higher threat appraisals, or higher use of coping strategies at baseline. These results showed that pharmacological hormonal ablation for prostate cancer can improve or decrease HRQoL in different domains. HRQoL in men with prostate cancer was associated more strongly with appraisal and coping than with medical variables.","Psychooncology, 11(5): 401-414","Australia",2002,"Advanced,Metastatic","Hormonal,Surveillance","Interview","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General"]
[249,"Green, H. J., et al. (2004). \"Quality of life compared during pharmacological treatments and clinical monitoring for non-localized prostate cancer: a randomized controlled trial.\" BJU Int 93(7): 975-979.",null,"Green, H. J., et al.","Quality of life compared during pharmacological treatments and clinical monitoring for non-localized prostate cancer: a randomized controlled trial","OBJECTIVES: To investigate the effects of different management strategies for non-localized prostate cancer on men's quality of life and cognitive functioning. PATIENTS, SUBJECTS AND METHODS: Men with prostate cancer were randomly assigned to one of four treatment arms: leuprorelin, goserelin, cyproterone acetate (CPA), or close clinical monitoring. In a repeated-measures design, men were assessed before treatment (baseline) and after 6 and 12 months of treatment. A community comparison group of men of the same age with no prostate cancer participated for the same length of time. The men were recruited from public and private urology departments from university teaching hospitals. All those with prostate cancer who were eligible for hormonal therapy had no symptoms requiring immediate therapy. In all, 82 patients were randomized and 62 completed the 1-year study, and of the 20 community participants, 15 completed the study. The main outcome measures were obtained from questionnaires on emotional distress, existential satisfaction, physical function and symptoms, social and role function, subjective cognitive function, and sexual function, combined with standard neuropsychological tests of memory, attention, and executive functions. RESULTS: Sexual dysfunction increased for patients on androgen-suppressing therapies, and emotional distress increased in those assigned to CPA or close clinical monitoring. Compared with before treatment there was evidence of an adverse effect of leuprorelin, goserelin, and CPA on cognitive function. CONCLUSIONS: In deciding the timing of androgen suppression therapy for prostate cancer, consideration should be given to potential adverse effects on quality of life and cognitive function.","BJU Int, 93(7): 975-979","Australia",2004,"Advanced,Metastatic","Hormonal,Surveillance","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General"]
[250,"Greene, K. L., et al. (2005). \"Who is the average patient presenting with prostate cancer?\" Urology 66(5 Suppl): 76-82.",null,"Greene, K. L., et al.","Who is the average patient presenting with prostate cancer?","Prostate cancer screening, diagnosis, and treatment have changed dramatically in the last 20 years. Patients with newly diagnosed prostate cancer have many treatment options available. We attempted to determine how patient demographics and quality of life (QOL) have changed, and we describe the average patient with newly diagnosed prostate cancer in the early 21st century. From the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) we identified 3003 men with prostate cancer diagnosed between 1997 and 2003 for whom pretreatment demographic and QOL data were available. All patients completed both the University of California-Los Angeles Prostate Cancer Index (UCLA-PCI) and the Rand Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) as self-administered questionnaires at the time of diagnosis. We compared demographic variables (age at diagnosis, race/ethnicity, education, number of comorbidities, body mass index [BMI], and insurance type), treatment choice, and pretreatment QOL scores on the SF-36 and UCLA-PCI scales for the periods 1997 to 1999 or 2000 to 2003. Stratified analysis by risk category was performed for demographic and QOL data for the 2 periods. Race/ethnicity and insurance demographics were statistically different for the 2 periods. Low-risk patients also showed a statistically increased BMI in the 2000 to 2003 period. Risk category predicted performance on both inventories, with low-risk patients having better function than intermediate-risk patients and high-risk patients in the areas of urinary bother, bowel function and bother, and sexual function and bother, as well as in many general well-being and emotional health scales on the SF-36. We conclude that the \"average\" prostate cancer patient is white, 65 years of age, overweight, educated at a college level, and has 1 to 2 comorbidities. Patients report average or above-average pretreatment health-related QOL for all scales based on 2 validated instruments. In this cohort, more patients chose radical prostatectomy than any other form of treatment.","Urology, 66(5 Suppl): 76-82","USA",2005,"Any or unknown","None","SF-36,UCLA-PCI","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease,Utility"]
[251,"Grise, P., et al. (2012). \"I-STOP TOMS transobturator male sling, a minimally invasive treatment for post-prostatectomy incontinence: continence improvement and tolerability.\" Urology 79(2): 458-463.",null,"Grise, P., et al.","I-STOP TOMS transobturator male sling, a minimally invasive treatment for post-prostatectomy incontinence: continence improvement and tolerability","OBJECTIVE: To prospectively evaluate the efficacy and tolerability of the I-STOP TOMS transobturator male sling in patients with post-prostatectomy stress urinary incontinence. Minimally invasive techniques, such as slings, are becoming the standard of care for mild to moderate post-prostatectomy incontinence. METHODS: From March 2007 to June 2009, 122 patients with post-prostatectomy stress urinary incontinence were treated with the I-STOP TOMS sling and followed up for 1 year in the Phase IV HOMme INContinence trial. The preoperative and postoperative evaluation included daily pad use, pad test, questionnaires evaluating urinary function and bother (University of California, Los Angeles, Prostate Cancer Index--urinary function short form, and International Consultation on Incontinence Modular Questionnaire--urinary incontinence short form) and uroflowmetry, including the post-void residual urine volume. Patient satisfaction and perineal pain were also assessed. RESULTS: A total of 103 patients were followed up for 12 months. The surgical procedure was considered easy to perform. The mean daily pad use decreased significantly from 2.4 to 0.6 at 12 months of follow-up; 87.0% of the patients reported improved continence (59.4% completely dry, 20.3% 1 pad/d, 7.3%>1 pad/d), and 13.0% reported no improvement. All quality-of-life scores (University of California, Los Angeles, Prostate Cancer Index--urinary function short form, and International Consultation on Incontinence Modular Questionnaire--urinary incontinence short form) improved significantly after sling implantation. Treatment satisfaction was >90%. The post-void residual urine volume did not increase substantially, and acute urinary retention did not occur. The perineal pain scores were very low at follow-up. Wound infection was seen in 2 patients at the 1-month follow-up visit. CONCLUSION: The I-STOP TOMS is a good treatment option for patients with post-prostatectomy stress urinary incontinence. With follow-up</=12 months, most patients were continent or had improved continence. The intervention was well tolerated, with few infections.","Urology, 79(2): 458-463","France",2012,"Any or unknown","Surgery","UCLA-PCI,ICIQ","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,Complication"]
[252,"Guerra, N. A. (2009). \"Outcomes of maximal androgen blockade in prostate cancer patients at a health area with type 2 reference hospital. Part 2. Quality of life: application of EORTC QLQ-PR25 instrument and global results. Quality-of-life adjusted survival. Pharmaceutical expenses and cost-utility.\" Arch Esp Urol 62(7): 543-570.",null,"Guerra, N. A.","Outcomes of maximal androgen blockade in prostate cancer patients at a health area with type 2 reference hospital. Part 2. Quality of life: application of EORTC QLQ-PR25 instrument and global results. Quality-of-life adjusted survival. Pharmaceutical expenses and cost-utility","OBJECTIVES: To study quality of life in patients from the health area of Zamora diagnosed of prostate adenocarcinoma between 2000-2005 treated with maximal androgen blockade (MAB). To evaluate the pharmacoeconomics of the treatment. METHODS: Basal, 12-month, 24-month and 36-month application of the health-related quality of life measurement instrument EORTC QLQ-C30 to the population sample (n= 111), as well as a control sample (n= 100). Comparative study of outcomes: between groups; between different time measurements in MAB patients; and inter-categories/ -intervals of some variables in patients with hormonal deprivation therapy (third year of follow-up). Analysis of health-related quality of life global outcomes (QLQ-C30 + QLQ-PR25). Description of the pharmaceutical expenses in androgen blockade patients. Cost-utility analysis by means of quality-adjusted life years (QALYs) obtained using preference-based weighted index from the EUROQOL 5-D tool. RESULTS: Hot flushes and sexual field worsening as mean expressions related to hormonal suppression. Treated patients had worse subjective perception of health condition and quality of life, in opposition to non-tumoral individuals. Positive bone scan, was a negative-influence factor on quality of life. Most patients undergoing MAB needed cost-utility figures of less than 5000 Euros/ QALY. CONCLUSIONS: There was a negative initial repercussion of MAB on quality of life, although tinged according to the different fields studied. The economic impact of this therapy on overall pharmaceutical expenses is relative.","Arch Esp Urol, 62(7): 543-570","Spain",2009,"Any or unknown","Hormonal","EORTC QLQ-C30,EORTC QLQ-PR25,EQ-5D","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease,General,Utility"]
[253,"Guidry, J. J., et al. (1997). \"Transportation as a barrier to cancer treatment.\" Cancer Pract 5(6): 361-366.",null,"Guidry, J. J., et al.","Transportation as a barrier to cancer treatment","PURPOSE: Patients with cancer must overcome many psychological, social, and economic barriers to obtain needed treatment. Because of the need for repeated visits for cancer treatment on either an outpatient or an inpatient basis, one of the major issues that patients with cancer must confront is that of arranging for transportation to care. METHODS: This study compares the distance and mode of transportation to radiotherapy and chemotherapy and perceptions of transportation as a barrier to care among white, black, and Hispanic cancer patients receiving treatment from a consortium of cancer treatment facilities in Texas. A mail questionnaire was developed to assess the perceived barriers to cancer treatment for patients who had been diagnosed clinically with breast, colon, cervical, or prostate cancer, or lymphoma between 1989 and 1993. A total of 910 surveys were mailed to prospective participants. Of the surveys mailed, 593 were returned, yielding a 65.2% response rate. By race, the respondents included whites (42%), blacks (40%), Hispanics (15%), and Asian-Pacific Islanders (3%). Two respondents were 17 years of age; the remaining respondents were 18 years or older. RESULTS: This study shows that some patients may forgo needed treatment because of problems with transportation. This was perceived as an issue more for minority patients than for white patients. Black and Hispanic patients consistently reported that barriers such as distance, access to an automobile, and availability of someone to drive them to the treatment center were potential major problems. The distance to the facilities was farther for whites than for blacks and Hispanics. Patients generally had to travel farther for chemotherapy than for radiotherapy. CLINICAL IMPLICATIONS: Patients, particularly minorities, may opt to forgo needed care in the absence of available and affordable means of transportation to treatment facilities. These findings demonstrate the need for healthcare providers to be aware of the transportation problems that patients with cancer experience in obtaining treatment. Healthcare providers must work with patients, their families, and volunteer agencies in the community to facilitate transportation to cancer treatment services.","Cancer Pract, 5(6): 361-366","USA",1997,"Any or unknown","Radiotherapy,Chemotherapy","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Costs"]
[254,"Guidry, J. J., et al. (1998). \"Cost considerations as potential barriers to cancer treatment.\" Cancer Pract 6(3): 182-187.",null,"Guidry, J. J., et al.","Cost considerations as potential barriers to cancer treatment","PURPOSE: An analytical cross-sectional survey was conducted to determine the prevalence of barriers to cancer treatment in Texas as perceived by diagnosed cancer patients. Results reported here address the role of insurance coverage, indirect costs (transportation, lodging, and work days lost), and direct costs of care as barriers to treatment for white, black, and Hispanic cancer patients. Specific objectives of the analyses undertaken here are to examine 1) racial/ethnic differences in insurance coverage; 2) barriers relating to insurance coverage experienced by cancer patients; and 3) role of treatment-related costs as barriers to cancer treatment. DESCRIPTION OF STUDY: A mail questionnaire was developed to assess the perceived barriers to cancer treatment in Texas for adult cancer patients, 17 years and older, who had been diagnosed with breast, colon, cervical, prostate, or lymphoma during the period of 1989 to 1993. The sampling frame for this study was obtained from a network of cancer treatment facilities throughout the state of Texas within the University of Texas M.D. Anderson Cancer Center Texas Community Oncology Network. A total of 593 cancer patients returned their surveys, yielding a 65.2% response rate. Weighting adjustments were then made to correct for differential sampling and response rates by racial groupings and type of cancer. All of the analyses used adjusted weights. RESULTS: The findings document the financial considerations (insurance, direct and indirect costs) as they relate to barriers to cancer treatment. Specific insurance premium-related barriers with regard to maintaining and affording coverage were more prevalent for blacks. Hispanics were less likely to have insurance coverage; however, more blacks reported being denied insurance coverage when they changed jobs compared with whites and Hispanics. Minorities, particularly Hispanics, were more likely to have experienced cost-related barriers associated with medications, diagnostic tests, and hospitalizations. In addition, Hispanics experienced significant out-of-pocket costs in paying for cancer treatment. CLINICAL IMPLICATIONS: This research shows the need for staff at cancer treatment facilities to be aware that there are nonclinical, financial factors that are important considerations in the treatment of cancer patients. Assessment of cancer patients during the diagnostic and treatment stages, possibly through case management, will provide information on potential barriers to treatment for individual patients. Hospital programs that reimburse out-of-pocket costs, transportation costs to obtain services, and lodging accommodations may be available. Additional services may be offered through cancer advocacy groups, such as the American Cancer Society and the National Coalition for Cancer Survivors, to assist patients with managing costs and overcoming barriers to care.","Cancer Pract, 6(3): 182-187","USA",1998,"Any or unknown","Unclear","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Costs"]
[255,"Guillonneau, B. and G. Vallancien (2000). \"Laparoscopic radical prostatectomy: the Montsouris experience.\" J Urol 163(2): 418-422.",null,"Guillonneau, B. and G. Vallancien","Laparoscopic radical prostatectomy: the Montsouris experience","PURPOSE: We evaluate our experience with laparoscopic radical prostatectomy. MATERIALS AND METHODS: Between February 1, 1998 and May 1, 1999, 120 consecutive patients underwent laparoscopic radical prostatectomy. Morbidity of the first 40 (group 1), next 40 (group 2) and last 40 (group 3) procedures was compared. Oncological data were assessed by pathological examination and postoperative prostate specific antigen (PSA). Functional results were assessed by a self-administered questionnaire for the first 60 patients and potency was assessed in the last 40. RESULTS: Mean operating time plus or minus standard deviation was 239+/-59 minutes (range 150 to 450) for the series, and 282, 247 and 231, respectively, for groups 1, 2 and 3. Surgical conversion was necessary in 7 cases (5.8%) overall, including 10% (4) in group 1, 7.5% (3) in group 2 and 0% in group 3. Mean intraoperative bleeding was 402+/-293 ml. (range 50 to 1,500) in the series, and 534, 517 and 277, respectively, for groups 1, 2 and 3. The transfusion rate was 10% overall, and 15%, 12.5% and 2.5%, respectively, in groups 1, 2 and 3. The reoperation rate was 1.7%. Mean postoperative bladder catheterization time was 6.6+/-2.4 days. The positive and questionable surgical margin rate was 15%. Pathological tumor stage was pT2a in 4 specimens (11%), pT2b in 11 (16%), pT3a in 0 and pT3b in 3 (50%) with positive surgical margins. PSA assays were available in 94 patients with a mean postoperative followup of 2.2 months (range 1 to 12). Serum PSA was 0.1 ng./ml. or less in 89 men (94.7%). The continence rate at 6 months postoperatively was 72% among the first 60 patients. Of 20 group 3 patients who were sexually active preoperatively 9 (45%) reported postoperative spontaneous erections. The overall cost of retropubic radical prostatectomy was about $1,237 more than that for laparoscopy. CONCLUSIONS: Laparoscopic radical prostatectomy is feasible and perioperative morbidity is low. Based on our postoperative followup, oncological results are identical to those of conventional surgery and functional results are encouraging.","J Urol, 163(2): 418-422","France",2000,"Advanced,Local","Surgery","Unclear","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"General,Complication"]
[256,"Haga, N., et al. (2015). \"Timing of Urinary Pad Exchanges Was the Most Important Factor Affecting Quality of Life in the Early Postoperative Period After Robot-Assisted Laparoscopic Radical Prostatectomy.\" J Endourol 29(9): 1044-1051.",null,"Haga, N., et al.","Timing of Urinary Pad Exchanges Was the Most Important Factor Affecting Quality of Life in the Early Postoperative Period After Robot-Assisted Laparoscopic Radical Prostatectomy","PURPOSE: The aim of the present study is to investigate the effect of pad use for postprostatectomy incontinence on urinary quality of life (QoL) after robot-assisted laparoscopic radical prostatectomy (RARP) in the early postoperative period. METHODS: Ninety patients underwent RARP simultaneously completed International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) and modified pad use questionnaire that evaluated pad use and urinary QoL and a 24-hour pad test. Pad use was also assessed by pad form, pad size, the number of pad exchanges per day, and the timing of pad exchanges (i.e., to what extent the pad was wet when the patients exchanged it.). The investigation involved patients visiting the outpatient clinic for the first time after RARP. The association between pad use and urinary QoL was investigated. RESULTS: The mean frequency of pad exchanges was 2+/-2/day. The mean 24-hour pad test was 139+/-193 g/day. Multivariate analyses revealed the timing of pad exchanges was significantly associated with QoL on the ICIQ-SF and the modified pad use questionnaire (P=0.007 and P<0.001, respectively) and the number of pad exchanges per day was significantly associated with QoL on the ICIQ-SF (P=0.01); QoL worsened with pad wetness and increasing frequency of pad exchange. The other factors relating to pad use were not significantly associated with aggravation of QoL. CONCLUSIONS: In the early postoperative period after RARP, the timing of pad exchanges was the most important factor affecting QoL. Namely, patients with postprostatectomy incontinence should wear the appropriate size of pad according to the volume of urinary incontinence and exchange pads when the pad is not too wet. On the other hand, pad form, pad size, and volume of urinary incontinence were not associated with decreased QoL.","J Endourol, 29(9): 1044-1051","Japan",2015,"Any or unknown","Surgery","ICIQ","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Complication"]
[257,"Hajjar, J. H., et al. (1998). \"Ambulatory radical retropubic prostatectomy.\" Urology 51(3): 443-448.",null,"Hajjar, J. H., et al.","Ambulatory radical retropubic prostatectomy","OBJECTIVES: To review the experience of 40 consecutive patients who underwent radical retropubic prostatectomy and to determine if and how the procedure could be performed safely on an ambulatory basis. METHODS: Between June 20, 1994 and November 26, 1996, 40 consecutive men with clinically localized prostate carcinoma underwent radical retropubic prostatectomy. Retrospective data regarding the patient population, patient satisfaction, clinical outcome, and length of hospitalization were evaluated. RESULTS: The average age for the patients was 62.6 years (range 44 to 75) with an average PSA of 10.44 ng/mL. Eighty percent (32 of 40) of the patients were discharged on postoperative day 1, 17.5% (7 of 40) were discharged on postoperative day 2, and 2.5% (1 of 40) were discharged on postoperative day 7. The average operative time was 89.5 minutes (range 65 to 135), measured from the time of incision to completion of closure. The organ-confined rate was 80% (32 of 40). The continence evaluated at 6 months was 90.9% (30 of 33). The potency at 4 months was 35% (10 of 28) and at 1 year was 55.6% (10 of 18). Postoperative complications were minimal, with 7.5% (3 of 40) bladder neck contractures and 2.5% (1 of 40) wound infections. Patient satisfaction assessed by questionnaires revealed that 90% (36 of 40) thought that the length of hospitalization was adequate and 97.5% (39 of 40) would choose to have the procedure again. A second series of 15 patients have also undergone radical retropubic prostatectomy utilizing a pelvic block to expedite discharge. Of these 15 procedures, 10 were performed on an ambulatory basis. CONCLUSIONS: Radical retropubic prostatectomy can be performed expediently with the maintenance of patient satisfaction, continence rates, potency rates, recurrence rates, complication rates, and pathologic results. The advantage to such an approach is expedited patient discharge, cost savings to the medical system, and no alteration in patient recovery or clinical outcome, such as organ-confined rate, potency, and continence. In this series, the majority of patients were discharged on postoperative day 1. On the basis of this experience, we have performed the procedure on an outpatient basis, while maintaining the same high quality of care. To date, 10 patients have undergone ambulatory radical retropubic prostatectomy and were discharged the same day of surgery without complications.","Urology, 51(3): 443-448","USA",1998,"Local","Surgery","Unclear","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Satisfaction"]
[258,"Hall, P. S., et al. (2015). \"Costs of cancer care for use in economic evaluation: a UK analysis of patient-level routine health system data.\" Br J Cancer 112(5): 948-956.",null,"Hall, P. S., et al.","Costs of cancer care for use in economic evaluation: a UK analysis of patient-level routine health system data","BACKGROUND: The rising financial burden of cancer on health-care systems worldwide has led to the increased demand for evidence-based research on which to base reimbursement decisions. Economic evaluations are an integral component of this necessary research. Ascertainment of reliable health-care cost and quality-of-life estimates to inform such studies has historically been challenging, but recent advances in informatics in the United Kingdom provide new opportunities. METHODS: The costs of hospital care for breast, colorectal and prostate cancer disease-free survivors were calculated over 15 months from initial diagnosis of cancer using routinely collected data within a UK National Health Service (NHS) Hospital Trust. Costs were linked at patient level to patient-reported outcomes and registry-derived sociodemographic factors. Predictors of cost and the relationship between costs and patient-reported utility were examined. RESULTS: The study population included 223 breast cancer patients, 145 colorectal and 104 prostate cancer patients. The mean 15-month cumulative health-care costs were pound12 595 (95% CI pound11 517- pound13 722), pound12 643 ( pound11 282- pound14 102) and pound3722 ( pound3263- pound4208), per-patient respectively. The majority of costs occurred within the first 6 months from diagnosis. Clinical stage was the most important predictor of costs for all cancer types. EQ-5D score was predictive of costs in colorectal cancer but not in breast or prostate cancer. CONCLUSION: It is now possible to evaluate health-care cost using routine NHS data sets. Such methods can be utilised in future retrospective and prospective studies to efficiently collect economic data.","Br J Cancer, 112(5): 948-956","UK",2015,"Survivors","Unclear","EQ-5D","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Utililty"]
[259,"Hamoen, E. H., et al. (2015). \"Measuring health-related quality of life in men with prostate cancer: A systematic review of the most used questionnaires and their validity.\" Urol Oncol 33(2): 69.e19-28.",null,"Hamoen, E. H., et al.","Measuring health-related quality of life in men with prostate cancer: A systematic review of the most used questionnaires and their validity","OBJECTIVES: To identify and study the psychometric properties of the most used health-related quality-of-life (HRQoL) instruments in men with prostate cancer. METHODS: We performed a literature search using PubMed and EMBASE to identify all studies on prostate cancer using a HRQoL instrument. The most often used HRQoL instruments were investigated in detail by 2 independent reviewers. Data were extracted regarding the characteristics and psychometric values of the instruments, i.e., content validity, internal consistency, criterion validity, construct validity, reproducibility, responsiveness, floor and ceiling effects, and interpretability. Good psychometric outcomes indicate a high methodological quality of the instrument. RESULTS: Our systematic search revealed 13,812 potential relevant articles, of which 2,258 appeared relevant after screening the titles and reading the abstracts. We studied the psychometric properties of the 20 most often used HRQoL instruments, the first 3 of which were the Expanded Prostate Index Composite, University of California-Los Angeles Prostate Cancer Index, and Short Form-36 (SF-36). Content validity, internal consistency (alpha>0.70), criterion validity, construct validity, and reproducibility were good in 60%, 90%, 10%, 35%, and 65% of the 20 instruments, respectively. Responsiveness was not reported for 12 of 20 instruments (60%). Floor and ceiling effects and the interpretability of the questionnaires were only reported in 3 (15%) and 6 (30%) instruments. CONCLUSIONS: Considering the psychometric properties, we advise to use the SF-12 as a generic instrument, the Cancer Rehabilitation Evaluation System-SF or the Functional Assessment of Cancer Therapy-General as cancer-specific HRQoL instruments, and the University of California-Los Angeles Prostate Cancer Index, the QUFW94, or the Functional Assessment of Cancer Therapy-Prostate as prostate cancer-specific instruments.","Urol Oncol, 33(2): 69.e19-28","International",2015,"Any or unknown","None","SF-36,FACT-G,FACT-P,EPIC,UCLA-PCI,CARES-SF,SF-12,QUFW94","Patient",null,"Systematic review,Validation",null,null,null,null,null,null,null,null,"Disease,General,Utility,Treatment"]
[260,"Hamstra, D. A., et al. (2013). \"Multi-institutional prospective evaluation of bowel quality of life after prostate external beam radiation therapy identifies patient and treatment factors associated with patient-reported outcomes: the PROSTQA experience.\" Int J Radiat Oncol Biol Phys 86(3): 546-553.",null,"Hamstra, D. A., et al.","Multi-institutional prospective evaluation of bowel quality of life after prostate external beam radiation therapy identifies patient and treatment factors associated with patient-reported outcomes: the PROSTQA experience","PURPOSE: To evaluate patients treated with external beam radiation therapy as part of the multicenter Prostate Cancer Outcomes and Satisfaction with Treatment Quality Assessment (PROSTQA), to identify factors associated with posttreatment patient-reported bowel health-related quality of life (HRQOL). METHODS AND MATERIALS: Pretreatment characteristics and treatment details among 292 men were evaluated using a general linear mixed model for their association with measured HRQOL by the Expanded Prostate Cancer Index Composite instrument through 2 years after enrollment. RESULTS: Bowel HRQOL had a median score of 100 (interquartile range 91.7-100) pretreatment and 95.8 (interquartile range 83.3-100) at 2 years, representing new moderate/big problems in 11% for urgency, 7% for frequency, 4% for bloody stools, and 8% for an overall bowel problems. Baseline bowel score was the strongest predictor for all 2-year endpoints. In multivariable models, a volume of rectum >/=25% treated to 70 Gy (V70) yielded a clinically significant 9.3-point lower bowel score (95% confidence interval [CI] 16.8-1.7, P=.015) and predicted increased risks for moderate to big fecal incontinence (P=.0008). No other radiation therapy treatment-related variables influenced moderate to big changes in rectal HRQOL. However, on multivariate analyses V70 >/=25% was associated with increases in small, moderate, or big problems with the following: incontinence (3.9-fold; 95% CI 1.1-13.4, P=.03), rectal bleeding (3.6-fold; 95% CI 1.3-10.2, P=.018), and bowel urgency (2.9-fold; 95% CI 1.1-7.6, P=.026). Aspirin use correlated with a clinically significant 4.7-point lower bowel summary score (95% CI 9.0-0.4, P=.03) and an increase in small, moderate, or big problems with bloody stools (2.8-fold; 95% CI 1.2-6.4, P=.018). Intensity modulated radiation therapy was associated with higher radiation therapy doses to the prostate and lower doses to the rectum but did not independently correlate with bowel HRQOL. CONCLUSION: After contemporary dose-escalated external beam radiation therapy up to 11% of patients have newly identified moderate/big problems with bowel HRQOL 2 years after treatment. Bowel HRQOL is related to baseline function, rectal V70, and aspirin use. Finally, our findings validate the commonly utilized cut-point of rectal V70 >/=25% as having significant impact on patient-reported outcomes.","Int J Radiat Oncol Biol Phys, 86(3): 546-553","USA",2013,"Any or unknown","Radiotherapy","EPIC","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease"]
[261,"Han, B. H., et al. (2001). \"Patient reported complications after prostate brachytherapy.\" J Urol 166(3): 953-957.",null,"Han, B. H., et al.","Patient reported complications after prostate brachytherapy","PURPOSE: Prostate brachytherapy has gained popularity due partly to the low rates of short-term complications shown in studies from highly select clinical practices. These series rely on medical records generated by the treating physician and are prone to underreport complications. We summarize the complication reports obtained directly from patients to establish a more realistic incidence of treatment related problems. MATERIALS AND METHODS: In 1997, 160 consecutive patients treated with prostate brachytherapy at the University of Washington were studied. A questionnaire was designed to determine the rate of complications occurring within 1 year of the procedure. The questions were formulated for ease of use and conciseness, while accounting for easily recalled events associated with complications. A total of 147 (92%) patients completed the questionnaire. RESULTS: There were 8 (5%) patients who required hospital admission for an average of 2 days (range 1 to 7) as a result of the procedure. A total of 56 (38%) patients required nonroutine visits with a physician in an office setting or at an emergency room. Radiation proctitis diagnosed by endoscopy developed in 8 (5%) patients but no one needed surgical intervention. A total of 47 (32%) patients required urinary catheterization at some point after implantation. CONCLUSIONS: We demonstrated a higher rate of short-term complications than those previously reported. Fortunately, the majority of side effects were self-limited and no treatment related mortality or cardiovascular morbidity was seen. Our findings may provide a more realistic account of the complications likely to occur after implantation than might be surmised from previous reports.","J Urol, 166(3): 953-957","USA",2001,"Any or unknown","Brachytherapy","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Complication"]
[262,"Hanssen, S. and J. Norum (2008). \"Bladder and rectal toxicity of BeamCath application in radiotherapy of prostate cancer.\" Anticancer Res 28(5b): 2865-2868.",null,"Hanssen, S. and J. Norum","Bladder and rectal toxicity of BeamCath application in radiotherapy of prostate cancer","BACKGROUND: Patient-reported toxicity in two radiotherapy regimens for early stage prostate cancer was investigated. In 2003, the Swedish BeamCath technique was adapted for Northern Norway. MATERIALS AND METHODS: Ninety men underwent radiotherapy for early-stage prostate cancer in February 2002 to March 2005. They were invited to participate in a telephone interview employing a questionnaire guide focusing on bladder, intestinal and sexual function. RESULTS: Eighty patients responded, which represents 89% of all patients. The treatment group (23 patients) had received 76 Gy with the BeamCath technique and the control group (57 patients) received 70 Gy employing a conformal technique. The BeamCath technique was associated with a lower median rectal (p=0.004; 50.6 Gy versus 56.2 Gy) and bladder dose (p=0.017; 48.5 Gy versus 61.5 Gy). There were no differences in scores on masculinity and sexual function. In conclusion, the BeamCath technique did not increase rectal or bladder toxicity.","Anticancer Res, 28(5b): 2865-2868","Norway",2008,"Local","Radiotherapy","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Complication"]
[263,"Hara, I., et al. (2003). \"Comparison of quality of life following laparoscopic and open prostatectomy for prostate cancer.\" J Urol 169(6): 2045-2048.",null,"Hara, I., et al.","Comparison of quality of life following laparoscopic and open prostatectomy for prostate cancer","PURPOSE: We compare the quality of life after laparoscopic prostatectomy to that after standard radical prostatectomy. MATERIAL AND METHODS: The quality of life of 52 and 54 patients who underwent laparoscopic and open radical prostatectomy, respectively, was analyzed using the European Organization for the Research and Treatment of Cancer Prostate Cancer quality of life questionnaire for general health related quality of life, International Index of Erectile Function 5 for screening erectile dysfunction and International Continence Society MaleSF questionnaire to evaluate urinary status. These questionnaires were given to patients before and 6 months after surgery. RESULTS: The general health related quality of life survey revealed no significant differences in health before and after laparoscopic and open prostatectomy. However, sexual quality of life was markedly lower after surgery (p <0.01). In addition, the International Index of Erectile Function score was markedly abrogated by surgery (p <0.05) and quality of life due to urinary incontinence was significantly disturbed by surgery (p <0.05). In contrast, quality of life due to voiding dysfunction was impaired before surgery and significantly improved by surgery (p <0.05). Patients were also asked if they would choose the same treatment if suffering from the same disease, with more patients treated laparoscopically choosing the same treatment than those treated with open surgery (p <0.05). CONCLUSIONS: While general health related quality of life was not impaired, sexual quality of life was diminished by surgery. Patients were generally satisfied with postoperative urinary status. Although patients who underwent laparoscopic prostatectomy expressed a more favorable attitude toward surgery, there was no significant difference in quality of life at 6 months after surgery between the 2 groups.","J Urol, 169(6): 2045-2048","Japan",2003,"Any or unknown","Surgery","EORTC QLQ-PR25,IIEF-5,ICSQ","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Disease,Complication"]
[264,"Harding, C., et al. (2009). \"Auricular acupuncture: a novel treatment for vasomotor symptoms associated with luteinizing-hormone releasing hormone agonist treatment for prostate cancer.\" BJU Int 103(2): 186-190.",null,"Harding, C., et al.","Auricular acupuncture: a novel treatment for vasomotor symptoms associated with luteinizing-hormone releasing hormone agonist treatment for prostate cancer","OBJECTIVES: To evaluate the role of auricular acupuncture (AA) in men receiving luteinizing-hormone releasing hormone (LHRH) analogues for carcinoma of the prostate, as vasomotor symptoms can affect the quality of life in such men, and similar symptoms in postmenopausal women have been successfully treated with AA. PATIENTS AND METHODS: In all, 60 consecutive patients with prostate cancer and on LHRH agonist treatment (median age 74 years, range 58-83) consented to weekly AA for 10 weeks. The validated 'Measure Yourself Concerns and Well-Being' questionnaire (a six-point scale to assess symptom severity) was used to assess concerns and well-being before and after treatment. RESULTS: All men completed the treatment with no adverse events recorded, apart from transient exacerbation of symptoms in two men; 95% of patients reported a decrease in the severity of symptoms, from a mean 5.0 to 2.1 (Student's t-test, P < 0.01). CONCLUSIONS: The symptomatic improvement was at levels comparable with that from pharmacotherapy, and cost analysis showed AA to be a viable alternative. Larger randomized studies are needed to fully evaluate AA against more conventional treatments, and these are planned.","BJU Int, 103(2): 186-190","UK",2009,"Any or unknown","Hormonal,Various","MYCWB","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General"]
[265,"Hardy, C., et al. (2007). \"Attitudes of prostate cancer patients towards the diagnosis and treatment of their disease: findings from a multinational survey.\" Curr Med Res Opin 23(9): 2107-2116.",null,"Hardy, C., et al.","Attitudes of prostate cancer patients towards the diagnosis and treatment of their disease: findings from a multinational survey","OBJECTIVE: To explore the attitudes of patients with locally advanced or metastatic prostate cancer towards the diagnosis and treatment of their disease. RESEARCH DESIGN AND METHODS: Patients who had been receiving hormonal therapy for > or = 1 year were recruited from France, Germany, Italy, Spain, the UK and the USA. All patients were required to complete a 10- to 15-minute fully structured questionnaire (either online or on paper) during September 2006. RESULTS: A total of 382 patients completed the questionnaire. Patients were currently receiving luteinising hormone-releasing hormone agonist monotherapy (73%), antiandrogen monotherapy (10%), or combined androgen blockade (17%). Since diagnosis, while being treated with hormonal therapy, many patients felt that they had a more reasonable quality of life (36%) and were more able to lead an active life (36%). Although patients generally wanted to be involved in treatment decisions, many felt they had missed out on hormonal treatment options (26%) and/or were unaware of all the treatment options available (29%). Patients felt that information on hormonal treatments from their specialist physician could be trusted more than that from other sources. The most important factors for patients in terms of their treatment were disease control (39%) and outliving their disease (31%). CONCLUSIONS: Patients can miss information regarding their disease and the hormonal treatments available. As patients place the most emphasis on disease control and outliving their disease, and may experience improved quality of life while on hormonal therapy, physicians should not exclude treatment options on the basis of potential side effects alone.","Curr Med Res Opin, 23(9): 2107-2116","UK,France,Germany,Italy,Spain,USA",2007,"Advanced,Metastatic","Hormonal","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Views"]
[266,"Harke, N., et al. (2017). \"Postoperative patient comfort in suprapubic drainage versus transurethral catheterization following robot-assisted radical prostatectomy: a prospective randomized clinical trial.\" World J Urol 35(3): 389-394.",null,"Harke, N., et al.","Postoperative patient comfort in suprapubic drainage versus transurethral catheterization following robot-assisted radical prostatectomy: a prospective randomized clinical trial","PURPOSE: To evaluate the impact of the type of urinary diversion (suprapubic vs. transurethral catheterization) on patients' postoperative pain after radical prostatectomy, development of bacteriuria and long-term functional results. METHODS: A randomized, prospective clinical trial was performed including 160 patients who underwent robot-assisted radical prostatectomy after randomization into two groups: intraoperatively, a transurethral catheter (control group) or an additional suprapubic tube (with removal of the transurethral catheter in the morning of postoperative day 1; intervention group) was placed. Primary study endpoint was postoperative pain objectified by the numeric rating scale questionnaire. Secondary endpoints were bacteriuria after catheter removal and functional outcomes after up to 2 years of follow-up. RESULTS: There were no significant differences in demographic and perioperative data. Starting on postoperative day 2, patients in the suprapubic diversion group had significantly less pain on every time point preceding the removal of the catheter compared to the control cohort with a median overall numeric rating score on postoperative day 1-4 of 2.4 points in the transurethral versus 1.3 in the intervention group (p = 0.012). No statistical difference was found in postoperative bacteriuria and complications as well as in functional results, quality of life and incontinence rates after a median follow-up of 22 months. CONCLUSIONS: Suprapubic drainage in robot-assisted radical prostatectomy shows significantly decreased pain levels during the catheterization period compared to the transurethral diversion without compromising long-term functional results. Intraoperative placement of a suprapubic tube should be discussed as a standard procedure for further improvement of patients' postoperative comfort.","World J Urol, 35(3): 389-394","Germany",2017,"Any or unknown","Surgery","NPS","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Symptom"]
[267,"Harland, S., et al. (2013). \"Effect of abiraterone acetate treatment on the quality of life of patients with metastatic castration-resistant prostate cancer after failure of docetaxel chemotherapy.\" Eur J Cancer 49(17): 3648-3657.",null,"Harland, S., et al.","Effect of abiraterone acetate treatment on the quality of life of patients with metastatic castration-resistant prostate cancer after failure of docetaxel chemotherapy","BACKGROUND: In a recent randomised, double-blind, phase III clinical trial among 1195 patients with metastatic castration-resistant prostate cancer (mCRPC) who had failed docetaxel chemotherapy, abiraterone acetate was shown to significantly prolong overall survival compared with prednisone alone. Here we report on the impact of abiraterone therapy on the health-related quality of life (HRQoL) observed during this trial, assessed using the validated Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire. METHODS: All analyses were conducted using prespecified criteria for clinically meaningful improvement and deterioration in FACT-P total score as well as subscale scores; all respective thresholds were defined using an accepted methodology. Improvement was assessed only in patients with clinically significant functional status impairment at baseline. RESULTS: Significant improvements in the FACT-P total score were observed in 48% of patients receiving abiraterone versus 32% of patients receiving prednisone (p < 0.0001). Also, the median time to deterioration in FACT-P total score was longer (p < 0.0001) in patients receiving abiraterone (59.9 weeks versus 36.1 weeks). Similar differences were observed in all FACT-P subscales, with the exception of the social/family well-being domain. Median time to improvement in the physical well-being domain and the trial outcome index was significantly shorter (p < 0.01) with abiraterone when compared with the prednisone arm. CONCLUSIONS: The previously demonstrated survival benefit for abiraterone is accompanied by improvements in patient-reported HRQoL and a significant delay in HRQoL deterioration when compared with prednisone.","Eur J Cancer, 49(17): 3648-3657","UK",2013,"Metastatic,Refractory","Abiraterone","FACT-P","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease"]
[268,"Harrington, C., et al. (2010). \"Randomised, placebo-controlled, crossover trial of sildenafil citrate in the treatment of erectile dysfunction following external beam radiation treatment of prostate cancer.\" J Med Imaging Radiat Oncol 54(3): 224-228.",null,"Harrington, C., et al.","Randomised, placebo-controlled, crossover trial of sildenafil citrate in the treatment of erectile dysfunction following external beam radiation treatment of prostate cancer","Erectile dysfunction (ED) commonly affects the quality of life of men after treatment of prostate cancer. We conducted a placebo-controlled, crossover randomised trial to assess the efficacy and tolerability of sildenafil citrate in the treatment of ED developing after external beam radiation treatment (EBRT) of localized prostate cancer. Sixty-six patients who had developed ED following radiation treatment agreed to participate and were allocated to sildenafil or placebo to be taken prior to four sexual attempts. In the crossover period, subjects received the alternative tablet for a further four attempts. Allocation was centrally randomized, and researchers and patients were both blinded to the trial arm. Efficacy was assessed using the International Index of Erectile Function (IIEF) questionnaire and with a separate global efficacy question. Forty-three subjects completed the study. There was a significant increase in mean scores from baseline for all domains of the IIEF with sildenafil compared with placebo (P < 0.001). Affirmative response to the global efficacy question was more common after taking sildenafil compared with placebo. In approximately half of the patients, the improvement in the erectile function domain score corresponded to a moderate improvement in ED (e.g. success 'sometimes' to 'most times'). Sildenafil was associated with mild flushing, nasal stuffiness or indigestion in 8-10% patients and moderate flushing in 10%. The current study adds to the evidence that phosphodiesterase inhibitors are an effective and well-tolerated treatment for ED after EBRT for prostate cancer.","J Med Imaging Radiat Oncol, 54(3): 224-228","New Zealand",2010,"Local","PDEi,Radiotherapy","IIEF-5","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Complication"]
[269,"Harris, M. J. (2003). \"Radical perineal prostatectomy: cost efficient, outcome effective, minimally invasive prostate cancer management.\" Eur Urol 44(3): 303-308; discussion 308.",null,"Harris, M. J.","Radical perineal prostatectomy: cost efficient, outcome effective, minimally invasive prostate cancer management","OBJECTIVE: Localized prostate cancer is a common disease for which minimally invasive treatment methods are being explored. Perineal prostatectomy, as a historical open procedure, is modified to incorporate contemporary surgical ideas. There is relatively little in the literature regarding modern adaptations of perineal prostatectomy. This method of anatomic radical perineal prostatectomy has been developed to accomplish a minimally invasive method of achieving goals of disease control and preservation of genito-urinary functions. METHODS: Prospective outcome data is accumulated on 508 consecutive radical perineal prostatectomies by a single surgeon. Pathologic stage and PSA detectability are measures of cancer control. Pad use and ability to complete intercourse measure urinary and sexual function. General complications and other outcome measures are evaluated. RESULTS: Freedom from PSA detectability by pathologic stage is 96.3%, 79.4%, and 69.4% for organ confined, specimen confined and margin positive in the absence of seminal vesical invasion with an average 4 years follow up (3-114 months). Margins are positive in 18% of cases. The average cancer size is 9.4g and 36% of cases have extracapsular invasion. By the first, third, sixth months and one year, 38%, 65%, 88% and 96% are free of pad use and report being dry. While over 80% of nerve-spared patients enjoy the return of spontaneous erectile function, the men with bilateral nerve preservation note earlier and more complete return of function. There are no cardiopulmonary complications or deaths. Transfusions occurred in 1%, none in the past 400 cases. Average total hospital charges are USD$4889.00 in 1999 and 2000. Anterior urethral strictures, anastomotic strictures and fecal urgency/stress flatus occur 2%, 2% and 2-4%, respectively. CONCLUSIONS: This method of prostatectomy is able to achieve complete cancer resection while preserving urinary and sexual function as well as laparoscopic or retropubic prostatectomy. The simplicity and minimally invasive nature of this procedure contribute to a short recovery and low overall cost of therapy. The anatomic radical perineal prostatectomy is a cost-efficient, outcome effective minimally invasive method of treating men with localized prostate cancer.","Eur Urol, 44(3): 303-308; discussion 308","USA",2003,"Local","Surgery","Unclear","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Complication"]
[270,"Harris, P., et al. (2003). \"Complementary and alternative medicine use by patients with cancer in Wales: a cross sectional survey.\" Complement Ther Med 11(4): 249-253.",null,"Harris, P., et al.","Complementary and alternative medicine use by patients with cancer in Wales: a cross sectional survey","OBJECTIVES: To determine the prevalence and cost of complementary and alternative medicine (CAM) use, and examine perceived satisfaction and reasons for using CAM. DESIGN AND SETTING: Cross sectional survey of 1697 patients with breast, prostate, lung or neurological cancer registered with a single NHS authority in Wales. PARTICIPANTS: One thousand and seventy-seven (64%) of patients, aged 18 years or over with cancer diagnosis of at least 3 months, returned analysable questionnaires. Thirty patients were interviewed by telephone. MAIN OUTCOME MEASURES: Number and proportion that had used CAM in the past 12 months, the types of CAM used, expenditure, satisfaction, demographic characteristics, and reasons for using CAM. RESULTS: Five hundred and thirty-four, 49.6% (95% CI 46.6-52.6) of participants, reported using at least one type of CAM during the past 12 months: 221, 16.4% (95% CI 14.3-18.8), had consulted a CAM practitioner (average cost per person, 28 lbs. per month); 166, 15.4% (95% CI 13.4-17.7), indicated using CAM techniques (average cost per person, 16 lbs. per month); 456, 42.3% (95% CI 39.4-45.3), reported using over-the-counter diets, remedies or supplements (average cost per person, 10 lbs. per month). Dissatisfaction with CAM use was low, and most users indicated that they represented value for money. CAM users were more likely to be female, younger, better qualified, and to have used CAM before their current illness than non-users. Patients used CAM primarily for symptom relief and relaxation. CONCLUSIONS: Nearly half the cancer patients in this study had used CAM. A co-ordinated approach to quality assurance, information and advice, and the assessment of risk/benefit and cost effectiveness of CAM use is needed.","Complement Ther Med, 11(4): 249-253","UK",2003,"Any or unknown","Various","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Views"]
[271,"Hartung, T. J., et al. (2017). \"The risk of being depressed is significantly higher in cancer patients than in the general population: Prevalence and severity of depressive symptoms across major cancer types.\" Eur J Cancer 72: 46-53.",null,"Hartung, T. J., et al.","The risk of being depressed is significantly higher in cancer patients than in the general population: Prevalence and severity of depressive symptoms across major cancer types","BACKGROUND: Depression is a common co-morbidity of cancer that has a detrimental effect on quality of life, treatment adherence and potentially survival. We conducted an epidemiological multi-center study including a population-based random comparison sample and estimated the prevalence of depressive symptoms by cancer site, thereby identifying cancer patients with the highest prevalence of depression. PATIENTS AND METHODS: We included 4020 adult cancer inpatients and outpatients from five distinct regions across Germany in a proportional stratified random sample based on the nationwide cancer incidence and a comparison group consisting of 5018 participants. Both groups reported depressive symptoms by filling in the Patient Health Questionnaire (PHQ-9). In multivariate analyses adjusted for age and sex, we calculated the odds of being depressed. RESULTS: Out of 5818 eligible patients, 69% participated (51% women, mean age = 58 years). We estimated that one in four cancer patients (24%) is depressed (PHQ-9 >/= 10). The odds of being depressed among cancer patients were more than five times higher than in the general population (OR, 5.4; 95% CI, 4.6-6.2). Patients with pancreatic (M = 8.0, SD = 5.0), thyroid (M = 7.8, SD = 6.3) and brain tumours (M = 7.6, SD = 4.9) showed the highest prevalence, whereas patients with prostate cancer (M = 4.3, SD = 3.8) and malignant melanoma (M = 5.3, SD = 4.3) had the lowest levels of depressive symptoms. CONCLUSION: Our results help clinicians identify cancer patients in need of psychosocial support when navigating in the growing survivor population.","Eur J Cancer, 72(46-53","Germany",2017,"Any or unknown","None","PHQ-9","Patient,General population",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Comorbidity"]
[272,"Hashine, K., et al. (2008). \"A prospective longitudinal study comparing a radical retropubic prostatectomy and permanent prostate brachytherapy regarding the health-related quality of life for localized prostate cancer.\" Jpn J Clin Oncol 38(7): 480-485.",null,"Hashine, K., et al.","A prospective longitudinal study comparing a radical retropubic prostatectomy and permanent prostate brachytherapy regarding the health-related quality of life for localized prostate cancer","OBJECTIVE: The health-related quality of life (HRQOL) after a radical retropubic prostatectomy (RRP) or a permanent prostate brachytherapy (PPB) was prospectively compared at a single institute. METHODS: Between 2003 and 2005, 122 patients were treated by RRP and 82 patients were treated by PPB. A QOL survey was completed at baseline, and 1, 3, 6 and 12 months after treatment, prospectively. RESULTS: The general HRQOL was not different between the RRP and PPB groups after 3 months. However, at 1 month after treatment, the general HRQOL scores, except for general health, were significantly better in the PPB group than that in the RRP group. Moreover, the disease-specific QOL was worse in urinary and sexual functions in the RRP group. Urinary function in the RRP group had not recovered to baseline after 12 months. Although the urinary function in the PPB group was better than that of the RRP group, urinary bother continued to worsen until 6 months and thereafter it recovered gradually. The bowel function was not worse in the PPB group but bowel bother was worse at 6 months in the PPB group. In the RRP group, the patients with nerve sparing demonstrated better in sexual function than those without nerve sparing, but the recovery did not reach the level of the PPB group. CONCLUSIONS: This prospective study revealed the differences in the QOL after RRP and PPB. These results will be helpful for making treatment decisions.","Jpn J Clin Oncol, 38(7): 480-485","Japan",2008,"Local","Brachytherapy,Surgery","Unclear","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"General"]
[273,"Hashine, K., et al. (2009). \"Health-related quality of life using SF-8 and EPIC questionnaires after treatment with radical retropubic prostatectomy and permanent prostate brachytherapy.\" Jpn J Clin Oncol 39(8): 502-508.",null,"Hashine, K., et al.","Health-related quality of life using SF-8 and EPIC questionnaires after treatment with radical retropubic prostatectomy and permanent prostate brachytherapy","OBJECTIVE: The health-related quality of life (HRQOL) after treatment of prostate cancer is examined using a new HRQOL tool. HRQOL, based on the expanded prostate cancer index composite (EPIC) and SF-8 questionnaires, was prospectively compared after either a radical retropubic prostatectomy (RRP) or a permanent prostate brachytherapy (PPB) at a single institute. METHODS: Between October 2005 and June 2007, 96 patients were treated by an RRP and 88 patients were treated by a PPB. A HRQOL survey was completed at baseline, and at 1, 3, 6 and 12 months after treatment, prospectively. RESULTS: The general HRQOL in the RRP and PPB groups was not different after 3 months. However, at baseline and 1 month after treatment, the mental component summary was significantly better in the PPB group than in the RRP group. Moreover, the disease-specific HRQOL was worse regarding urinary and sexual functions in the RRP group. Urinary irritative/obstructive was worse in the PPB group, but urinary incontinence was worse in the RRP group and had not recovered to baseline after 12 months. The bowel function and bother were worse in the PPB group than in the RRP group after 3 months. In the RRP group, the patients with nerve sparing demonstrated the same scores in sexual function as the PPB group. CONCLUSIONS: This prospective study revealed the differences in the HRQOL after an RRP and PPB. Disease-specific HRQOL is clarified by using EPIC survey. These results will be helpful for making treatment decisions.","Jpn J Clin Oncol, 39(8): 502-508","Japan",2009,"Any or unknown","Brachytherapy,Surgery","EPIC,SF-8","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease,Utility"]
[274,"Hashine, K., et al. (2014). \"Health-related quality of life in the first year after laparoscopic radical prostatectomy compared with open radical prostatectomy.\" Jpn J Clin Oncol 44(7): 686-691.",null,"Hashine, K., et al.","Health-related quality of life in the first year after laparoscopic radical prostatectomy compared with open radical prostatectomy","OBJECTIVE: To assess health-related quality of life in the first year after laparoscopic radical prostatectomy compared with that after open radical prostatectomy. METHODS: The subjects were 105 consecutive patients with localized prostate cancer treated with laparoscopic radical prostatectomy between January 2011 and June 2012. Health-related quality of life was evaluated using the International Prostate Symptom Score, Medical Outcome Study 8-Items Short Form Health Survey (SF-8) and Expanded Prostate Cancer Index Composite at baseline and 1, 3, 6 and 12 months after surgery. Comparisons were made with data for 107 consecutive patients treated with open radical prostatectomy between October 2005 and July 2007. RESULTS: The International Prostate Symptom Score change was similar in each group. The laparoscopic radical prostatectomy group had a better baseline Medical Outcome Study 8-Items Short Form Health Survey mental component summary score and a better Medical Outcome Study 8-Items Short Form Health Survey physical component summary score at 1 month after surgery. In Expanded Prostate Cancer Index Composite, obstructive/irritative symptoms did not differ between the groups, but urinary incontinence was worse until 12 months after surgery and particularly severe after 1 month in the laparoscopic radical prostatectomy group. The rate of severe urinary incontinence was much higher in the laparoscopic radical prostatectomy group in the early period. Urinary bother was worse in the laparoscopic radical prostatectomy group at 1 and 3 months, but did not differ between the groups thereafter. Urinary function and bother were good after nerve sparing procedures and did not differ between the groups. Bowel and sexual function and bother were similar in the two groups. CONCLUSION: Urinary function in the first year after laparoscopic radical prostatectomy is worse than that after open radical prostatectomy.","Jpn J Clin Oncol, 44(7): 686-691","Japan",2014,"Local","Surgery","SF-8,EPIC,IPSS","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease,Utility"]
[275,"Hays, R. D., et al. (2000). \"Health-related quality of life in patients with human immunodeficiency virus infection in the United States: results from the HIV Cost and Services Utilization Study.\" Am J Med 108(9): 714-722.",null,"Hays, R. D., et al.","Health-related quality of life in patients with human immunodeficiency virus infection in the United States: results from the HIV Cost and Services Utilization Study","PURPOSE: To measure health-related quality of life among adult patients with human immunodeficiency virus (HIV) disease; to compare the health-related quality of life of adults with HIV with that of the general population and with patients with other chronic conditions; and to determine the associations of demographic variables and disease severity with health-related quality of life. SUBJECTS AND METHODS: We studied 2,864 HIV-infected adults participating in the HIV Cost and Services Utilization Study, a probability sample of adults with HIV receiving health care in the contiguous United States (excluding military hospitals, prisons, or emergency rooms). A battery of 28 items covering eight domains of health (physical functioning, emotional well-being, role functioning, pain, general health perceptions, social functioning, energy, disability days) was administered. The eight domains were combined into physical and mental health summary scores. SF-36 physical functioning and emotional well-being scales were compared with the US general population and patients with other chronic diseases on a 0 to 100 scale. RESULTS: Physical functioning was about the same for adults with asymptomatic HIV disease as for the US population [mean (+/- SD) of 92+/-16 versus 90+/-17) but was much worse for those with symptomatic HIV disease (76+/-28) or who met criteria for the acquired immunodeficiency syndrome (AIDS; 58+/-31). Patients with AIDS had worse physical functioning than those with other chronic diseases (epilepsy, gastroesophageal reflux disease, clinically localized prostate cancer, clinical depression, diabetes) for which comparable data were available. Emotional well-being was comparable among patients with various stages of HIV disease (asymptomatic, 62+/-9; symptomatic, 59+/-11; AIDS, 59+/-11), but was significantly worse than the general population and patients with other chronic diseases except depression. In multivariate analyses, HIV-related symptoms were strongly associated with physical and mental health, whereas race, sex, health insurance status, disease stage, and CD4 count were at most weakly associated with physical and mental health. CONCLUSIONS: There is substantial morbidity associated with HIV disease in adults. The variability in health-related quality of life according to disease progression is relevant for health policy and allocation of resources, and merits the attention of clinicians who treat patients with HIV disease.","Am J Med, 108(9): 714-722","USA",2000,"Local","None","SF-36","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Utility"]
[276,"Haythornthwaite, J. A., et al. (1998). \"Pain and quality of life following radical retropubic prostatectomy.\" J Urol 160(5): 1761-1764.",null,"Haythornthwaite, J. A., et al.","Pain and quality of life following radical retropubic prostatectomy","PURPOSE: We assess pain and quality of life following radical retropubic prostatectomy and determine whether intraoperative anesthetic management has any long-term effects on outcomes. MATERIALS AND METHODS: A total of 110 patients undergoing radical retropubic prostatectomy were randomly assigned to receive epidural and/or general anesthesia. Patients responded to a questionnaire mailed 3 and 6 months following surgery that assessed prostate symptoms, pain related to surgery, quality of life and mood. RESULTS: No long-term effects of anesthesia were observed. Of the 103 respondents (94%) at 3 months 49% had some pain related to surgery. Although pain was not related to anesthesic technique, patients who had it at 3 months used significantly more pain medication on postoperative day 3. Pain at 3 months was mild, averaging 1.5 on a scale of 0 to 10, and associated with poor perceptions of overall health (p <0.02), and reduced physical (p <0.01) and social (p <0.01) functioning. Pain at 3 months was associated with higher levels of preoperative anxiety (p <0.05). At 6 months 36 of 90 patients (35%) had some pain related to surgery and the impact was similar. CONCLUSIONS: Long-term effects of intraoperative anesthesic technique were not apparent. Mild pain following radical retropubic prostatectomy was common and associated with reduced quality of life, particularly social functioning. Affective distress, particularly anxiety, before surgery and use of pain medications following surgery may be predictors of chronic pain following radical retropubic prostatectomy.","J Urol, 160(5): 1761-1764","USA",1998,"Any or unknown","Surgery,Various","NPS","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Symptom"]
[277,"Heathcote, P. S., et al. (1998). \"Health-related quality of life in Australian men remaining disease-free after radical prostatectomy.\" Med J Aust 168(10): 483-486.",null,"Heathcote, P. S., et al.","Health-related quality of life in Australian men remaining disease-free after radical prostatectomy","OBJECTIVE: To determine the health-related quality of life (HRQOL) of Australian men after radical prostatectomy. DESIGN: Cross-sectional study. SETTING: Private and public practices of three urologists in south-east Queensland, July 1989 to June 1995. PARTICIPANTS: 140 men with no evidence of disease recurrence 1 to 6 years after radical prostatectomy. MAIN OUTCOME MEASURES: Voiding and erectile potency and HRQOL. Recall of preoperative status and status at survey were established by an independently administered multi-item questionnaire. RESULTS: 112 men (80%) completed the study questionnaire. Difficulty with bladder control before the operation was reported by 25 (22%; 95% confidence interval [CI], 15%-31.2%), and the incontinence rate after treatment was 22/112 (20%; 95% CI, 12.7%-28.2%). Men with incontinence after operation were more likely to recall preoperative urinary symptoms. Eighty-four (75%) men were happy or coping with their sexual function after radical prostatectomy despite an erectile potency rate of only 12% (95% CI, 7%-20%). Twenty-eight (25%) had tried penile injections and three have had penile prostheses since their operation. Impotence was reported more frequently (40%) as the treatment-related problem most affecting life, followed by \"concern about cancer\" (12%) and incontinence (8%). Impotence was also the most common cause given for diminished HRQOL. CONCLUSIONS: Loss of sexual function after radical prostatectomy is more commonly perceived as a major problem and is more likely than urinary incontinence to adversely affect HRQOL. Loss of sexual function and its effect on HRQOL needs to be given greater emphasis in counselling before radical prostatectomy.","Med J Aust, 168(10): 483-486","Australia",1998,"Survivors","Surgery","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Complication"]
[278,"Hedgepeth, R. C., et al. (2009). \"Expanded Prostate Cancer Index Composite versus Incontinence Symptom Index and Sexual Health Inventory for Men to measure functional outcomes after prostatectomy.\" J Urol 182(1): 221-227; discussion 227-228.",null,"Hedgepeth, R. C., et al.","Expanded Prostate Cancer Index Composite versus Incontinence Symptom Index and Sexual Health Inventory for Men to measure functional outcomes after prostatectomy","PURPOSE: Evaluating quality of life outcomes following prostate cancer treatment is important because different treatments provide similar survival outcomes. A wide variety of quality of life surveys are used with an unknown correlation between domain specific and broad domain instruments. We compared the urinary and sexual outcome measures of the Expanded Prostate Cancer Index Composite, a broad domain instrument, to those of the Incontinence Symptom Index and the Sexual Health Inventory for Men, which are domain specific instruments. MATERIALS AND METHODS: A total of 640 patients undergoing radical prostatectomy at our institution completed a combination of the Expanded Prostate Cancer Index Composite, Incontinence Symptom Index and Sexual Health Inventory for Men questionnaires. Matching functional domains were compared and correlation coefficients were calculated. Subgroup analysis was performed to compare specific information pertinent to recovery from prostatectomy. RESULTS: Correlations between measures of incontinence were 0.26 to 0.84, while indicators of sexual function were 0.70 to 0.84. Subgroup analysis comparing measures of irritative symptoms demonstrated weaker correlations. Analysis in patients reporting no sexual activity also showed a significantly lower correlation of scores than that in patients reporting sexual activity. CONCLUSIONS: Expanded Prostate Cancer Index Composite scores generally demonstrate strong correlations with corresponding Incontinence Symptom Index and Sexual Health Inventory for Men scores, indicating similar measurements of information. Divergent correlations between irritative scores as well as scores in men who are not sexually active may indicate that the Expanded Prostate Cancer Index Composite has more descriptive validity in this population. Wider use of a single broad domain instrument such as the Expanded Prostate Cancer Index Composite to assess outcomes after prostate cancer treatment may improve clinical efficiency and allow comparative quality of life research across treatment types in the future.","J Urol, 182(1): 221-227; discussion 227-228","USA",2009,"Any or unknown","Surgery","EPIC,ISyI,SHIM","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease,Complication"]
[279,"Heedman, P. A. and P. Strang (2001). \"Symptom assessment in advanced palliative home care for cancer patients using the ESAS: clinical aspects.\" Anticancer Res 21(6a): 4077-4082.",null,"Heedman, P. A. and P. Strang","Symptom assessment in advanced palliative home care for cancer patients using the ESAS: clinical aspects","Four hundred and thirty-one cancer patients were assessed with the ESAS and a VAS-QoL at admission to Hospital-based home care (HBHC) and subsequently. RESULTS: Pain and nausea were well-controlled (mean 2.5 and 1.8) whereas patients were less satisfied with appetite, activity and sense of well-being. Dyspnoea and anxiety (lung cancer, p<0.001 and p<0.01) and pain (prostate cancer, p<0.01), were related to diagnosis while activity, drowsiness, appetite and well-being to survival (p<0.05 to p<0.001). The correlations between individual symptoms and well-being were low (0.2-0.5), whereas the correlation between well-being and the Symptom Distress Score (SDS) was 0.76. \"Well-being\" was a better word to use than QoL. DISCUSSION: ESAS is useful in HBHC and data show that symptoms other than merely pain and nausea are of importance. As the global measurement (one VAS) of well-being has a high correlation with SDS, this single measurement may be clinically adequate for quality assurance of symptom control in dying cancer patients.","Anticancer Res, 21(6a): 4077-4082","Sweden",2001,"End of life","None","VAS,ESAS","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Symptom"]
[280,"Hegarty, J. M., et al. (2008). \"Uncertainty and quality of life among men undergoing active surveillance for prostate cancer in the United States and Ireland.\" Am J Mens Health 2(2): 133-142.",null,"Hegarty, J. M., et al.","Uncertainty and quality of life among men undergoing active surveillance for prostate cancer in the United States and Ireland","BACKGROUND: Prostate cancer continues to be the most common site of male cancers, particularly among older men in Europe and the United States, and the second most common male cancer worldwide. Active surveillance involves the use of no local or systemic therapy once prostate cancer has been diagnosed. A description of uncertainty and quality of life among men undergoing active surveillance in samples from both the United States and Ireland has the potential to enhance global health care delivery. METHODS: The specific aim of this study is to enhance the understanding of the experience of active surveillance for prostate cancer among Irish and American men by measuring quality of life and levels of uncertainty among men over the age of 65 in receipt of the active surveillance management option for prostate cancer. A quantitative, descriptive survey design was used. RESULTS: Twenty-nine men completed questionnaires. The results reveal that men undergoing active surveillance in the United States have slightly higher levels of uncertainty. Primary appraisal, opportunity, and danger appraisal were consistent between samples from both countries. Total affective and health-related quality-of-life scores were similar among active surveillance participants in both countries, but subscale scores identified both similarities and differences. Irish men had lower mean role and social function than U.S. men, and higher general health and energy. Irish men reported more urine bother and less sexual bother than U.S. men. CONCLUSION: To assist men with prostate cancer who are treated with the active surveillance management option, health care professionals must develop an awareness of how prostate cancer affects the man's physical and psychological health care outcomes.","Am J Mens Health, 2(2): 133-142","USA,Ireland",2008,"Any or unknown","Surveillance","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"General"]
[281,"Hegarty, J., et al. (2010). \"Radical prostatectomy versus watchful waiting for prostate cancer.\" Cochrane Database Syst Rev (11): Cd006590.",null,"Hegarty, J., et al.","Radical prostatectomy versus watchful waiting for prostate cancer","BACKGROUND: The lack of evidence regarding the effectiveness of treatment options for clinically localised prostate cancer continues to impact on clinical decision-making. Two such options are radical prostatectomy (RP) and watchful waiting (WW). WW involves providing no initial treatment and monitoring the patient with the intention of providing palliative treatment if there is evidence of disease progression. OBJECTIVES: To compare the beneficial and harmful effects of RP versus WW for the treatment of localised prostate cancer. SEARCH STRATEGY: MEDLINE, EMBASE, The Cochrane Library, ISI Science Citation Index, DARE and LILACS were searched through 30 July 2010. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials comparing the effects of RP versus WW for clinically localised prostate cancer. DATA COLLECTION AND ANALYSIS: Data extraction and quality assessment were carried out independently by two authors. MAIN RESULTS: Two trials met the inclusion criteria. Both trials commenced prior to the widespread availability of prostate-specific antigen (PSA) screening; hence the results may not be applicable to men with PSA-detected disease.One trial (N = 142), conducted in the US, was judged to be of poor quality. All cause (overall) mortality was not significantly different between RP and WW groups after fifteen years of follow up (Hazard Ratio (HR) 0.9 (95% Confidence Interval (CI) 0.56 to 1.43).The second trial (N = 695), conducted in Scandinavia, was judged to be of good quality. After 12 years of follow up, the trial results were compatible with a beneficial effect of RP on the risks of overall mortality, prostate cancer mortality and distant metastases compared with WW but the precise magnitude of the effect is uncertain as indicated by the width of the confidence intervals for all estimates (risk difference (RD) -7.1% (95% CI -14.7 to 0.5); RD -5.4% (95% CI -11.1 to 0.2); RD -6.7% (95% CI -13.2 to -0.2), respectively). Compared to WW, RP increased the absolute risks of erectile dysfunction (RD 35% (95% CI 25 to 45)) and urinary leakage (RD 27% (95% CI 17 to 37)). These estimates must be interpreted cautiously as they are derived from data obtained from a self-administered questionnaire survey of a sample of the trial participants (N = 326), no baseline quality of life data were obtained and nerve-sparing surgery was not routinely performed on trial participants undergoing RP. AUTHORS' CONCLUSIONS: The existing trials provide insufficient evidence to allow confident statements to be made about the relative beneficial and harmful effects of RP and WW for patients with localised prostate cancer. The results of ongoing trials should help to inform treatment decisions for men with screen-detected localised prostate cancer.","Cochrane Database Syst Rev, 11): Cd006590","International",2010,"Local","Surgery,Surveillance","Unclear","Patient",null,"Systematic review",null,null,null,null,null,null,null,null,"Complication"]
[282,"Heidenreich, A., et al. (2004). \"Prospective randomized Phase II trial of pegylated doxorubicin in the management of symptomatic hormone-refractory prostate carcinoma.\" Cancer 101(5): 948-956.",null,"Heidenreich, A., et al.","Prospective randomized Phase II trial of pegylated doxorubicin in the management of symptomatic hormone-refractory prostate carcinoma","BACKGROUND: Liposomal encapsulation of doxorubicin has been shown to reduce nonspecific delivery of this agent to normal tissue and to increase specific delivery to malignant cells. On the basis of doxorubicin's demonstrated clinical efficacy against hormone-refractory prostate carcinoma (HRPCA), the authors conducted a prospective, randomized Phase II clinical trial to evaluate the feasibility, toxicity, and therapeutic efficacy associated with the pegylated form of this agent. METHODS: Forty-eight patients with symptomatic HRPCA were randomized to receive pegylated liposomal doxorubicin at either 25 mg/m2 every 2 weeks for 12 cycles (Group A) or 50 mg/m2 every 4 weeks for 6 cycles (Group B). Thirty-eight of these 48 patients (79%) presented with severe pain (corresponding to a pain score of 7.5 on a visual analog scale [VAS] ranging from 0 to 10) due to osseous metastases. Therapeutic efficacy was assessed by serial evaluation of serum prostate-specific antigen (PSA) concentrations and by serial measurement of pain levels (using a VAS ranging from 0 to 10). Toxicity data were obtained using the National Cancer Institute of Canada/Cancer and Leukemia Group B criteria and the 30-item European Organization for Research and Treatment of Cancer Quality of Life Questionnaire. RESULTS: The median patient age was 68.9 years (range, 58-79 years), and the mean follow-up duration was 42 months. The mean pretreatment PSA level was 660.4 ng/mL (mean, 8-6340 ng/mL); an objective decrease in PSA levels (i.e., a decrease of > 50%) was observed in 8 of 31 patients (25.8%) in Group B, whereas no other patient in either group experienced such a decrease. The mean time to disease progression was 6.5 months, and the mean survival duration was 13.4 months. Patients in Group B had a significantly higher rate of response with respect to pain (52.6% vs. 28.6%; P = 0.04), and the mean 1-year survival rate also was significantly higher in Group B (42% vs. 15%; P = 0.02). Severe side effects were observed, with 24 patients (50%) experiencing World Health Organization Grade 3/4 toxicity. Toxicity types differed significantly between Group A and Group B; palmar-plantar erythrodysesthesia developed in 60% of patients in the former group (P < 0.0005), whereas tachycardia was more common in the latter group (39% of patients; P < 0.0005). No dose-limiting cardiotoxicities or hematotoxicities were documented. CONCLUSIONS: Pegylated liposomal doxorubicin yielded a noteworthy objective palliative response rate and a mean survival of 13 months for patients with symptomatic HRPCA. The dosage tested in the current study should be used in future Phase II and Phase III trials of pegylated liposomal doxorubicin-containing combination regimens for patients with HRPCA.","Cancer, 101(5): 948-956","Germany",2004,"Advanced,Metastatic","Chemotherapy","VAS,EORTC QLQ-C30","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General,Symptom"]
[283,"Helgesen, F., et al. (2000). \"Follow-up of prostate cancer patients by on-demand contacts with a specialist nurse: a randomized study.\" Scand J Urol Nephrol 34(1): 55-61.",null,"Helgesen, F., et al.","Follow-up of prostate cancer patients by on-demand contacts with a specialist nurse: a randomized study","OBJECTIVE: The effectiveness of traditional follow-up programs and the intensive search for disease progression in men with prostate cancer have been questioned. The aims of this randomized multi-centre study were to evaluate medical safety, patient satisfaction and resource utilization in an on-demand follow-up by a specialist nurse compared with traditional follow-up by a urologist. MATERIAL AND METHODS: Four hundred consecutively approached men with newly diagnosed or previously known prostate cancer in any stage at three hospitals in Sweden were randomized to follow-up in the nurse group (NG, 200 patients) or the urologist group (UG, 200 patients). In the NG, the nurse contacted the patient by phone every 6 months unless the patient himself initiated the contact. Patient satisfaction was evaluated twice a year via questionnaire. The questionnaire included the validated Hospital Anxiety and Depression Scale (HADS). The costs of all medical interventions and adverse events related to prostate cancer were calculated for all patients. RESULTS: Medical safety, measured as complication frequency and lag time from symptoms to intervention, during the first 3 years of the observation period, was similar in the NG and the UG. The total number of interventions due to symptoms from prostate cancer was also similar in both groups. The analysis of accessibility and the HAD scale showed no significant differences between the groups. The mean outpatient cost (excluding pharmaceutical costs) per patient was lower in the NG compared to the UG, especially among patients without metastases at inclusion (37% lower cost). CONCLUSIONS: Our study indicates that men with prostate cancer can be safely followed up by a specialist nurse. The study results show that this alternative follow-up is cost-effective, especially in men without metastases.","Scand J Urol Nephrol, 34(1): 55-61","Sweden",2000,"Any or unknown","Various","HADS","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Comorbidity"]
[284,"Henderson, A., et al. (2004). \"Quality of life following treatment for early prostate cancer: does low dose rate (LDR) brachytherapy offer a better outcome? A review.\" Eur Urol 45(2): 134-141.",null,"Henderson, A., et al.","Quality of life following treatment for early prostate cancer: does low dose rate (LDR) brachytherapy offer a better outcome? A review","OBJECTIVE: Due to a lack of evidence from randomised studies, there is little agreement on the best form of treatment among men who require curative treatment for prostate cancer. The relative impact of the various treatments on symptoms and health-related quality of life is also controversial. We review the literature on quality of life changes following low dose rate brachytherapy (BXT) and compare BXT to other treatments for early prostate cancer. METHODS: Systematic literature review 1988-2003 (Medline). KEYWORDS: Brachytherapy; Radical prostatectomy; External beam radiotherapy; Quality of life; Symptoms. RESULTS: Review of the current literature suggests that radical prostatectomy, external beam radiotherapy and BXT either alone or in combination with supplementary external beam radiotherapy offer good long-term health-related quality of life. However differences exist in the toxicity of treatment in terms of erectile function, voiding difficulty, incontinence and bowel function. These differences seem to persist for at least 3-5 years post-treatment though longer-term quality of life outcomes from modern techniques are unknown. CONCLUSION: BXT offers a high probability of maintaining continence, potency and normal rectal function though both storage and voiding urinary symptoms have been reported. Addition of androgen deprivation and EBRT to BXT may increase urinary, bowel and sexual toxicity of treatment. Quality of life outcome following brachytherapy compares favourably with other radical treatment options for the management of early prostate cancer.","Eur Urol, 45(2): 134-141","International",2004,"Local","Surgery,Radiotherapy,Brachytherapy","Unclear","Patient",null,"Systematic review",null,null,null,null,null,null,null,null,"Unclear"]
[285,"Hoffman, R. M., et al. (2004). \"Cross-sectional and longitudinal comparisons of health-related quality of life between patients with prostate carcinoma and matched controls.\" Cancer 101(9): 2011-2019.",null,"Hoffman, R. M., et al.","Cross-sectional and longitudinal comparisons of health-related quality of life between patients with prostate carcinoma and matched controls","BACKGROUND: Prostate carcinoma and treatments affect health-related quality of life (HRQOL). The authors prospectively compared prostate and general HRQOL between prostate carcinoma cases and an age-matched and ethnicity-matched control group. METHODS: The case cohort consisted of 293 men with localized prostate carcinoma who were selected randomly from the population-based New Mexico Tumor Registry, and the control cohort consisted of 618 men who were selected randomly from administrative databases and matched for age and ethnicity. Subjects completed a baseline survey of demographics, socioeconomic status, comorbidity, and prostate and general HRQOL. Also, 210 cases (71.7%) and 421 controls (67.8%) completed a follow-up survey 5 years later. Multinomial logistic regression models compared baseline characteristics as well as 5-year general HRQOL outcomes measured by selected domains of the Medical Outcomes Study SF-36. The authors used a mixed-model repeated-measures analysis of variance and multinomial regression analyses to compare longitudinal changes in urinary, bowel, and sexual function between groups. RESULTS: At baseline, patients with prostate carcinoma had better urinary control and sexual function than controls. Over 5 years, sexual function declined significantly among controls, although urinary function remained stable. However, patients with cancer subsequently reported significant declines in both domains and were left with much worse function and more bother than controls. Bowel function and general HRQOL were similar for both groups at follow-up. CONCLUSIONS: Prostate carcinoma treatment led to significant 5-year declines in urinary and sexual function that far exceeded age-related changes in controls. Patients with cancer had significantly worse function and more bother than controls for these disease-specific domains of HRQOL. Bowel function and general HRQOL were not affected by cancer status.","Cancer, 101(9): 2011-2019","USA",2004,"Local","None","SF-36","Patient",null,"Case-control",null,null,null,null,null,null,null,null,"Utility"]
[286,"Holch, P., et al. (2017). \"Acute and Late Adverse Events Associated With Radical Radiation Therapy Prostate Cancer Treatment: A Systematic Review of Clinician and Patient Toxicity Reporting in Randomized Controlled Trials.\" Int J Radiat Oncol Biol Phys 97(3): 495-510.",null,"Holch, P., et al.","Acute and Late Adverse Events Associated With Radical Radiation Therapy Prostate Cancer Treatment: A Systematic Review of Clinician and Patient Toxicity Reporting in Randomized Controlled Trials","PURPOSE: This review aimed to determine the clinician and patient reported outcome (PRO) instruments currently usedin randomized controlled trials (RCTs) of radical radiation therapy for nonmetastatic prostate cancer to report acute and late adverse events (AEs), review the quality of methodology and PRO reporting, and report the prevalence of acute and late AEs. METHODS AND MATERIALS: The MEDLINE, EMBASE, and Cochrane databases were searched between April and August 2014 according to the Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) statement. Identified reports were reviewed according to the PRO Consolidated Standards of Reporting Trials (CONSORT) guidelines and the Cochrane Risk of Bias tool. In all, 1149 records were screened, and 21 articles were included in the final review. RESULTS: We determined the acute and late AEs for 9040 patients enrolled in 15 different RCTs. Only clinician reported instruments were used to report acute AEs <3 months (eg, Radiation Therapy Oncology Group [RTOG] and Common Terminology Criteria for Adverse Events [CTCAE]). For late clinician reporting, the Late Effects on Normal Tissues-Subjective, Objective, Management and Analytic scale and RTOG were used and were often augmented with additional items to provide comprehensive coverage of sexual functioning and anorectal symptoms. Some late AEs were reported (48% articles) using PROs (eg, ULCA-PCI [University of California, Los Angeles Prostate Cancer Index], FACT-G and P [Functional Assessment of Cancer Therapy General & Prostate Module], EORTC QLQC-30 + PR25 [European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire & Prostate Module]); however, a definitive \"preferred\" instrument was not evident. DISCUSSION: Our findings are at odds with recent movements toward including patient voices in reporting of AEs and patient engagement in clinical research. We recommend including PRO to evaluate radical radiation therapy before, during, and after the treatment to fully capture patient experiences, and we support the development of predictive models for late effects based on the severity of early toxicity. CONCLUSION: Patient reporting of acute and late AEs is underrepresented in radiation therapy trials. We recommend working toward a consistent approach to PRO assessment of radiation therapy-related AEs.","Int J Radiat Oncol Biol Phys, 97(3): 495-510","International",2017,"Advanced,Local","Radiotherapy","FACT-G,FACT-P,EORTC QLQ-C30,EORTC QLQ-PR25,UCLA-PCI,CTCAE,RTOG-EORTC-SS,LENT-SOMA","Patient",null,"Systematic review",null,null,null,null,null,null,null,null,"Disease,Treatment,General"]
[287,"Hollenbeck, B. K., et al. (2002). \"Neoadjuvant hormonal therapy and older age are associated with adverse sexual health-related quality-of-life outcome after prostate brachytherapy.\" Urology 59(4): 480-484.",null,"Hollenbeck, B. K., et al.","Neoadjuvant hormonal therapy and older age are associated with adverse sexual health-related quality-of-life outcome after prostate brachytherapy","OBJECTIVES: Brachytherapy is increasingly used as a treatment for localized prostate cancer but information regarding long-term, postimplantation, patient-reported sexual health-related quality-of-life (HRQOL) is scant. Neoadjuvant hormonal therapy is commonly administered with brachytherapy, yet its potentially adverse effects on subsequent sexual health have not been described using a validated HRQOL instrument. We used a validated HRQOL survey to characterize the significance of neoadjuvant hormonal therapy and other baseline factors on postimplantation sexual function and impairment. METHODS: A cross-sectional survey using the expanded prostate cancer index composite HRQOL instrument was administered to all 114 localized prostate cancer patients who underwent ultrasound-guided, transperineal brachytherapy during a 4-year period and to 142 age-matched control men. Multivariable models measured the association of baseline factors and covariates with postimplantation sexual HRQOL. RESULTS: Older age (P = 0.01) and neoadjuvant hormonal therapy (P = 0.009) were independently associated with diminished sexual HRQOL after prostate brachytherapy. Among patients younger than 69 years old, 33% reported at least fair sexual function after brachytherapy alone compared with 19% of men after brachytherapy with neoadjuvant hormonal therapy. Of the age-matched control men younger than 69 years old, 78% reported at least fair sexual function. Among patients older than 69 years, 26% reported at least fair sexual function after brachytherapy alone compared with 5% after brachytherapy with neoadjuvant hormonal therapy, and 61% of age-matched controls reported at least fair sexual function. CONCLUSIONS: Patient age and neoadjuvant hormonal therapy are independent, significant determinants of sexual HRQOL after prostate brachytherapy. These factors should be taken into consideration when counseling patients with localized prostate cancer regarding the expected, postimplantation sexual HRQOL outcome.","Urology, 59(4): 480-484","USA",2002,"Local","Brachytherapy,Hormonal","EPIC","Patient",null,"Case-control",null,null,null,null,null,null,null,null,"Disease"]
[288,"Hollenbeck, B. K., et al. (2003). \"Determinants of long-term sexual health outcome after radical prostatectomy measured by a validated instrument.\" J Urol 169(4): 1453-1457.",null,"Hollenbeck, B. K., et al.","Determinants of long-term sexual health outcome after radical prostatectomy measured by a validated instrument","PURPOSE: We combined the strengths of previous patient reported studies (that is use of a validated instrument) with the assets of previous single surgeon, physician reported series (that is prospective collection of operative data) by performing a multiple surgeon study to identify demographic and operative determinants of post-prostatectomy sexual health related quality of life outcomes. MATERIALS AND METHODS: Sexual outcome was measured after prostatectomy in 671 prostate cancer cases with a followup of 4 to 52 months treated by any of 7 urologists at a high volume medical center and 112 age matched controls by cross-sectional health related quality of life assessment using the Expanded Prostate Cancer Index Composite validated questionnaire. Multivariable ANCOVA was done to identify the baseline determinants affecting post-prostatectomy sexual health outcomes among 17 clinical and demographic factors. RESULTS: Factors independently associated with better sexual health outcome in patients included younger age (p <0.0001), nerve sparing technique (p <0.0001), time since prostatectomy (p = 0.0001), smaller prostate size (p = 0.003), higher education level (p = 0.02), and higher household income (p = 0.02). Orgasm was achieved at a higher rate than erection. In controls only age (p = 0.0004) and having a partner (p = 0.04) were significantly associated with sexual health. CONCLUSIONS: Larger prostate size adversely affected sexual health outcome after radical prostatectomy independent of all other measured factors. Patient sexual outcome did not differ significantly among surgeons who performed a broad range of such procedures yearly, suggesting that surgical expertise cannot be measured simply by the number of such operations that a surgeon performs. Stratifying patient reported sexual function by the principal determinants of age, nerve sparing and prostate size provides a basis for counseling patients.","J Urol, 169(4): 1453-1457","USA",2003,"Any or unknown","Surgery","EPIC","Patient",null,"Case-control",null,null,null,null,null,null,null,null,"Disease"]
[289,"Hollenbeck, B. K., et al. (2004). \"Neoadjuvant hormonal therapy impairs sexual outcome among younger men who undergo external beam radiotherapy for localized prostate cancer.\" Urology 63(5): 946-950.",null,"Hollenbeck, B. K., et al.","Neoadjuvant hormonal therapy impairs sexual outcome among younger men who undergo external beam radiotherapy for localized prostate cancer","OBJECTIVES: To evaluate the effects of treatment factors and other covariates on sexual health-related quality of life (HRQOL) after radiotherapy (RT) for prostate cancer. The effects of clinical and treatment factors on sexual health after external beam RT have not been fully characterized by patient-reported, validated questionnaires. METHODS: A total of 259 subjects (147 patients who had undergone RT for prostate cancer and 112 age-matched controls) participated in a cross-sectional assessment of HRQOL using the validated expanded prostate cancer index to measure patient-reported sexual function and bother. Multivariable models were used to determine the association of 13 prospectively measured clinical and treatment factors with post-RT sexual HRQOL. RESULTS: Increasing age, time since RT, and use of neoadjuvant hormonal therapy (NHT) were independently associated with sexual function (P <0.01) after RT. The effects of NHT on sexual HRQOL were most notable among the youngest (younger than 67 years) patients and among those closest to treatment. These effects may be conceptualized by examining the distribution of responses to individual Expanded Prostate Cancer Index Composite questions. For example, among the youngest patients, those treated with NHT were less than half as likely to report a fair ability to have erections compared with hormone-naive men. CONCLUSIONS: These patient-reported data, elicited using a validated HRQOL instrument, indicate that older age and NHT significantly and independently hinder post-RT sexual HRQOL outcome among men with localized prostate cancer and provide a framework for counseling patients regarding long-term sexual outcome on the basis of treatment plan and age.","Urology, 63(5): 946-950","USA",2004,"Local","Hormonal,Radiotherapy","EPIC","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Disease"]
[290,"Holmberg, L., et al. (2012). \"Results from the Scandinavian Prostate Cancer Group Trial Number 4: a randomized controlled trial of radical prostatectomy versus watchful waiting.\" J Natl Cancer Inst Monogr 2012(45): 230-233.",null,"Holmberg, L., et al.","Results from the Scandinavian Prostate Cancer Group Trial Number 4: a randomized controlled trial of radical prostatectomy versus watchful waiting","In the Scandinavian Prostate Cancer Group Trial Number 4 (SPCG-4), 347 men were randomly assigned to radical prostatectomy and 348 to watchful waiting. In the most recent analysis (median follow-up time = 12.8 years), the cumulative mortality curves had been stable over the follow-up. At 15 years, the absolute risk reduction of dying from prostate cancer was 6.1% following randomization to radical prostatectomy, compared with watchful waiting. Hence, 17 need to be randomized to operation to avert one death. Data on self-reported symptoms, stress from symptoms, and quality of life were collected at 4 and 12.2 years of median follow-up. These questionnaire studies show an intricate pattern of symptoms evolving after surgery, hormonal treatments, signs of tumor progression, and also from natural aging. This article discusses some of the main findings of the SPCG-4 study.","J Natl Cancer Inst Monogr, 2012(45): 230-233","UK",2012,"Any or unknown","Surgery,Surveillance","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General,Symptoms"]
[291,"Homma, Y., et al. (1999). \"Early results of radical prostatectomy and adjuvant endocrine therapy for prostate cancer with or without preoperative androgen deprivation. The Prostate Cancer Study Group.\" Int J Urol 6(5): 229-237; discussion 238-229.",null,"Homma, Y., et al.","Early results of radical prostatectomy and adjuvant endocrine therapy for prostate cancer with or without preoperative androgen deprivation. The Prostate Cancer Study Group","BACKGROUND: The effects of preoperative androgen deprivation were explored in the patients who received radical prostatectomy and subsequent adjuvant endocrine therapy for prostate cancer. METHODS: Stage A2, B or C prostate cancers were randomized to one of two groups: (i) group I (n=90), who received androgen deprivation (leuploride and chlormadinone acetate) for 3 months preoperatively followed by radical prostatectomy and adjuvant endocrine therapy (leuploride only); and (ii) group II (n=86), who underwent the surgery followed by 3 month androgen deprivation and subsequent adjuvant endocrine therapy. The effects of preoperative androgen deprivation on clinical relapse (serum prostate specific antigen (PSA) > 1.98 ng/mL, local recurrence or distant metastasis) and PSA relapse (PSA >0.2ng/mL) were evaluated at 2 years after randomization. RESULTS: There was no significant difference in clinical or PSA relapse-free survival and quality of life measures between the two groups, although relapses occurred significantly more frequently in patients who had more advanced stages, higher pretreatment PSA values or lower histologic differentiation in either group. Subgroup analysis indicated that clinical relapse-free survival in stage C cancer tended to be better in patients with preoperative androgen deprivation than in those patients without it (P< 0.1). CONCLUSIONS: Preoperative androgen deprivation may be beneficial for stage C prostate cancer patients receiving radical prostatectomy and adjuvant endocrine therapy over the 2 year observation period. A longer follow up is needed to clarify the exact extent of benefit in terms of survival and quality of life.","Int J Urol, 6(5): 229-237; discussion 238-229","Japan",1999,"Advanced,Local","Surgery,Hormonal","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General"]
[292,"Hong, J. H., et al. (2006). \"The Functional Assessment of Cancer Therapy-Prostate (FACT-P) scales in men with prostate cancer: reliability and validity of the Korean version.\" J Korean Med Sci 21(2): 295-299.",null,"Hong, J. H., et al.","The Functional Assessment of Cancer Therapy-Prostate (FACT-P) scales in men with prostate cancer: reliability and validity of the Korean version","The Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire is a relevant, worldwide tool used for assessing the health-related quality of life in men with prostate cancer. The purpose of this study was to translate the FACT-P into Korean, to assess its reliability and validity, and to test its discriminative ability between the cancer patients and normal controls. The Korean version was developed via the FACT multilingual translation project. The translated questionnaire was self-administered to 70 prostate cancer patients and 70 age-matched controls. In evaluating its psychometric properties for cancer patients, internal consistency and test-retest reliability were used. Validity was estimated by using inter-subscale correlations and discriminant validity between cancer patients and controls. Cronbach's alpha coefficient for the individual subscales were 0.7 or greater (range 0.73 to 0.89), except for emotional well-being (0.61). The test-retest reliability showed high correlations (intraclass coefficients ranged from 0.72 to 0.93). Inter-subscale correlations demonstrated each subscale was unrelated, but moderate correlation was observed between social/family well-being and functional well-being subscales (r=0.56). The FACT-P scale could discriminate reliably between the cancer patients and controls in most subscales. In conclusion, the Korean version of the FACT-P is a reliable and valid questionnaire in patients with prostate cancer.","J Korean Med Sci, 21(2): 295-299","Korea",2006,"Any or unknown","None","FACT-P","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease"]
[293,"Hong, S. J., et al. (2007). \"A prospective, multicenter, open-label trial of zoledronic acid in patients with hormone refractory prostate cancer.\" Yonsei Med J 48(6): 1001-1008.",null,"Hong, S. J., et al.","A prospective, multicenter, open-label trial of zoledronic acid in patients with hormone refractory prostate cancer","PURPOSE: The short-term safety and efficacy of zoledronic acid for the treatment of skeletal metastasis was evaluated in patients with hormone-refractory prostate cancer. PATIENTS AND METHODS: A total of 19 hormone-refractory prostate cancer patients with bone metastases were enrolled. All patients received up to six infusions of zoledronic acid (4 mg, given intravenously over 15 minutes, every 3-4 weeks). Safety was assessed by monitoring adverse events and serum creatinine levels. Efficacy was assessed by monitoring skeletal-related events, brief pain inventory score, quality of life score, type of pain medication, and analgesic score. Mean age of patients was 67.3 years (46-86 years), mean time from diagnosis of bone metastases was 27.6 months (0-117 months), and mean time from diagnosis of hormone-refractory disease was 7.5 months (0-26 months). RESULTS: There was no clinically significant change in serum creatinine levels. Eleven adverse events (musculoskeletal disorders and systemic disorders) in 8 patients were classed as having a possible relationship to study drug. Fifteen patients completed six courses of zoledronic acid infusion. There were no significant changes in the brief pain inventory composite scores, quality of life questionnaire scores or analgesic score. No new skeletal-related events developed during the treatment period. CONCLUSION: Zoledronic acid administered in this study as a 15-minute infusion demonstrated an acceptable and well-known safety profile in patients with refractory prostate cancer with bone metastases. However, prospective placebo- controlled clinical trials are required to elucidate the efficacy of zoledronic acid.","Yonsei Med J, 48(6): 1001-1008","Korea",2007,"Metastatic","Bisphosphonate","BPI","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Symptom"]
[294,"Hooper, G. and E. Gerber (2014). \"Measuring the quality of life in men with prostate cancer.\" Urol Nurs 34(4): 177-184.",null,"Hooper, G. and E. Gerber","Measuring the quality of life in men with prostate cancer","Men diagnosed with prostate cancer (PCa) choose treatments based on known side effects that impact health-related quality of life (HRQL). This study evaluated the psychometric properties of the UCLA Prostate Cancer Index (UCLA-PCI) and the Short Form Health Survey (SF-12v2).","Urol Nurs, 34(4): 177-184","Unclear",2014,"Any or unknown","Unclear","UCLA-PCI,SF-12","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease,Utility"]
[295,"Hoque, D. M., et al. (2017). \"Study protocol of an equivalence randomized controlled trial to evaluate the effectiveness of three different approaches to collecting Patient Reported Outcome Measures (PROMs) data using the Prostate Cancer Outcomes Registry-Victoria (PCOR-VIC).\" BMC Health Serv Res 17(1): 75.",null,"Hoque, D. M., et al.","Study protocol of an equivalence randomized controlled trial to evaluate the effectiveness of three different approaches to collecting Patient Reported Outcome Measures (PROMs) data using the Prostate Cancer Outcomes Registry-Victoria (PCOR-VIC)","BACKGROUND: Patient-reported outcome measures (PROMs) are used by clinical quality registries to assess patients' perspectives of care outcomes and quality of life. PROMs can be assessed through a self-administered survey or by a third party. Use of mixed mode approaches where PROMs are completed using a single or combination of administration method is emerging. The aim of this study is to identify the most cost-effective efficient approach to collecting PROMs among three modes (telephone, postal service/mail and email) in a population-based clinical quality registry monitoring survivorship after a diagnosis of prostate cancer. This is important to assist the registry in achieving representative PROMs capture using the most cost-effective technique and in developing cost projections for national scale-up. METHODS/DESIGN: This study will adopt an equivalence randomised controlled design. Participants are men diagnosed with and/or treated for prostate cancer (PCa) participating in PCOR-VIC and meet the criteria for 12-month follow-up. Participants will be individually randomized to three independent groups: telephone, mail/postal, or email to complete the 26-item Expanded Prostate Cancer Index Composite (EPIC-26) survey. It is estimated each group will have 229 respondents. We will compare the proportion of completed surveys across the three groups. The economic evaluation will be undertaken from the perspective of the data collection centre and consider all operating costs (personnel, supplies, training, operation and maintenance). Cost data will be captured using an Activity Based Costs method. To estimate the most cost-effective approach, we will calculate incremental cost-effectiveness ratios. A cost projection model will be developed based on most cost-effective approach for nationwide scale-up of the PROMs tool for follow-up of PCa patients in Australia. DISCUSSION: This study will identify the most cost-effective approach for collecting PROMs from men with PCa, and enable estimation of costs for national implementation of the PCa PROMs survey. The findings will be of interest to other registries embarking on PROMs data collection. TRIAL REGISTRATION: ACTRN12615001369516 (Registered on December 16, 2015).","BMC Health Serv Res, 17(1): 75","Australia,UK",2017,"Any or unknown","None","EPIC","Patient",null,"Protocol",null,null,null,null,null,null,null,null,"Disease"]
[296,"Hu, J. C., et al. (2003). \"Regret in men treated for localized prostate cancer.\" J Urol 169(6): 2279-2283.",null,"Hu, J. C., et al.","Regret in men treated for localized prostate cancer","PURPOSE: We identify the predictors of medical regret in men treated for localized prostate cancer. MATERIALS AND METHODS: Patients previously treated for early stage prostate cancer were assessed for treatment regret using validated items. Univariate and multivariate analyses identified associations between regret and demographic characteristics, clinical outcomes, medical knowledge, and general and disease specific health related quality of life as measured by the general health perceptions domain of the RAND 36-Item Health Survey and a validated short form of the University of California, Los Angeles Prostate Cancer Index. RESULTS: Of 96 respondents (mean age 64 years, mean followup 2.8 years) 16% expressed regret with treatment decisions. Regretful men were almost twice as likely as nonregretful men to have less than a college education (60% versus 33%, p = 0.05) and worse current health related quality of life (p <0.05). In addition, regretful men tended to be unable to recall the most recent prostate specific antigen accurately (p = 0.06). Men with and without regret did not differ in other demographic characteristics, treatment choice or clinical outcomes. Regretful men were more likely to say they would choose a different treatment if they could. In multivariate analyses worse quality of life predicted regret but decline in quality of life with time was not associated with regret. CONCLUSIONS: Men expressing regret over treatment choice for localized prostate cancer have poorer health related quality of life. Further study is needed to identify factors that predict posttreatment regret. Such information will allow patients and physicians to individualize treatment decisions, optimize quality of life and avoid medical regret.","J Urol, 169(6): 2279-2283","USA",2003,"Local","Unclear","SF-36,UCLA-PCI","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Disease,Utility"]
[297,"Hu, J. C., et al. (2004). \"Predicting quality of life after radical prostatectomy: results from CaPSURE.\" J Urol 171(2 Pt 1): 703-707; discussion 707-708.",null,"Hu, J. C., et al.","Predicting quality of life after radical prostatectomy: results from CaPSURE","PURPOSE: We investigated the usefulness of patient and tumor characteristics in predicting continence, potency, and physical and mental health 1 year after radical prostatectomy. MATERIALS AND METHODS: We studied 372 men drawn from Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE), a national, longitudinal cohort, who underwent radical prostatectomy alone for localized prostate cancer. Health related quality of life (HRQOL) was assessed before and 12 months after (range 9 to 15) surgery with the Physical and Mental Component Summaries of the RAND 36-Item Health Survey and the Sexual and Urinary Function scales of the UCLA Prostate Cancer Index. Covariates included clinical T stage, prostate specific antigen Gleason sum, age, race, income, education, relationship status, comorbidity and overall health self-rating. Chi-square and backward stepwise multivariate analysis identified differences between men who did and did not return to baseline HRQOL postoperatively. Return to baseline HRQOL score was set at 90% or greater for physical and mental health, 80% for continence and 75% for potency. RESULTS: After 1 year 63%, 20%, 80% and 86% returned to baseline continence, potency, physical health and mental health, respectively. Men younger than 65 years were more likely to return to baseline continence, potency, and physical but not mental health. Univariate analyses also revealed several other characteristics to predict (p <0.05) better outcomes including household income greater than 30,000 US dollars (potency, physical health), fewer comorbidities (potency, physical health), and excellent or very good health self-rating (mental health). In multivariate analyses subjects younger than 65 years were more likely to return to baseline urinary (OR 1.8, p <0.01), sexual (OR 2.5, p <0.01) and physical health (OR 1.8, p = 0.03). Furthermore, subjects with no comorbidities were more likely to return to baseline physical health (OR 2.5, p = 0.01), while those with an excellent or very good baseline health self-rating were more likely to return to baseline mental health (OR 2.3, p = 0.01). Clinical T stage, prostate specific antigen and Gleason sum did not predict return to baseline HRQOL. CONCLUSIONS: Younger patient age (less than 65) is associated with a greater likelihood of returning to baseline continence, potency and physical health after radical prostatectomy. In addition, patients who underwent radical prostatectomy without comorbidities and those with high health self-ratings are more likely to return to baseline physical and mental health, respectively. Preoperative tumor characteristics do not appear to be associated with regaining baseline HRQOL, suggesting that factors not measured in this model may be important in optimizing quality of life after radical prostatectomy.","J Urol, 171(2 Pt 1): 703-707; discussion 707-708","USA",2004,"Local","Surgery","SF-36,UCLA-PCI","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease,Utility"]
[298,"Huguenin, P. U., et al. (1999). \"Localized prostate cancer in elderly patients. Outcome after radiation therapy compared to matched younger patients.\" Strahlenther Onkol 175(11): 554-558.",null,"Huguenin, P. U., et al.","Localized prostate cancer in elderly patients. Outcome after radiation therapy compared to matched younger patients","PURPOSE: To detect a difference in outcome (disease-specific survival, local tumor progression, late toxicity, quality of life) after curative radiotherapy for localized prostate cancer in elderly as compared to younger patients. PATIENTS AND METHODS: In a retrospective analysis 59 elderly patients (> 74 years old) were matched 1:2 with younger patients from the data base according to tumor stage, grading, pre-treatment PSA values and year of radiotherapy. Surviving patients were contacted to fill in a validated questionnaire for quality of life measurement (EORTC QLQ-C30). Median follow-up for elderly and younger patients was 5.2 and 4.5 years, respectively. RESULTS: Overall survival at 5 years was 66% for the elderly and 80% for younger patients. Intercurrent deaths were observed more frequently in the elderly population. There was no age-specific difference in disease-specific survival (78% vs 82%), late toxicity or quality of life. Clinically meaningful local tumor progression was observed in 15% and 14%, respectively, corresponding to data from the literature following hormonal ablation. CONCLUSIONS: There is no obvious difference in outcome including disease-specific survival, late toxicity and quality of life in elderly patients, compared to a matched younger population. A clinically meaningful local tumor progression following radiotherapy or hormonal ablation only is rare. Local radiotherapy or, alternatively, hormonal ablation is recommended to preserve local progression-free survival in elderly patients except for very early stage of disease (i.e. T1 G1-2 M0).","Strahlenther Onkol, 175(11): 554-558","Switzerland",1999,"Local","Radiotherapy","EORTC QLQ-C30","Patient",null,"Case-control",null,null,null,null,null,null,null,null,"General"]
[299,"Hummel, S., et al. (2010). \"Intensity-modulated radiotherapy for the treatment of prostate cancer: a systematic review and economic evaluation.\" Health Technol Assess 14(47): 1-108, iii-iv.",null,"Hummel, S., et al.","Intensity-modulated radiotherapy for the treatment of prostate cancer: a systematic review and economic evaluation","BACKGROUND: Prostate cancer (PC) is the most common cancer in men in the UK. Radiotherapy (RT) is a recognised treatment for PC and high-dose conformal radiotherapy (CRT) is the recommended standard of care for localised or locally advanced tumours. Intensity-modulated radiotherapy (IMRT) allows better dose distributions in RT. OBJECTIVE: This report evaluates the clinical effectiveness and cost-effectiveness of IMRT for the radical treatment of PC. DATA SOURCES: The following databases were searched: MEDLINE (1950-present), EMBASE (1980-present), Cumulative Index to Nursing and Allied Health Literature (CINAHL) (1982-present), BIOSIS (1985-present), the Cochrane Database of Systematic Reviews (1991-present), the Cochrane Controlled Trials Register (1991-present), the Science Citation Index (1900-present) and the NHS Centre for Reviews and Dissemination databases (Database of Abstracts of Reviews of Effects, NHS Economic Evaluation Database, Health Technology Assessment) (1991-present). MEDLINE In-Process & Other Non-Indexed Citations was searched to identify any studies not yet indexed on MEDLINE. Current research was identified through searching the UK Clinical Research Network, National Research Register archive, the Current Controlled Trials register and the Medical Research Council Clinical Trials Register. In addition, abstracts of the American Society of Clinical Oncology, the American Society for Therapeutic Radiology and Oncology, and European Society for Therapeutic Radiology and Oncology conferences were browsed. REVIEW METHODS: A systematic literature review of the clinical effectiveness and cost-effectiveness of IMRT in PC was conducted. Comparators were three-dimensional conformal radiotherapy (3DCRT) or radical prostatectomy. Outcomes sought were overall survival, biochemical [prostate-specific antigen (PSA)] relapse-free survival, toxicity and health-related quality of life (HRQoL). Fifteen electronic bibliographic databases were searched in January 2009 and updated in May 2009, and the reference lists of relevant articles were checked. Studies only published in languages other than English were excluded. An economic model was developed to examine the cost-effectiveness of IMRT in comparison to 3DCRT. Four scenarios were modelled based on the studies which reported both PSA survival and late gastrointestinal (GI) toxicity. In two scenarios equal PSA survival was assumed for IMRT and 3DCRT, the other two having greater PSA survival for the IMRT cohort. As there was very limited data on clinical outcomes, the model estimates progression to clinical failure and PC death from the surrogate outcome of PSA failure. RESULTS: No randomised controlled trials (RCTs) of IMRT versus 3DCRT in PC were available, but 13 non-randomised studies comparing IMRT with 3DCRT were found, of which five were available only as abstracts. One abstract reported overall survival. Biochemical relapse-free survival was not affected by treatment group, except where there was a dose difference between groups, in which case higher dose IMRT was favoured over lower dose 3DCRT. Most studies reported an advantage for IMRT in GI toxicity, attributed to increased conformality of treatment compared with 3DCRT, particularly with regard to volume of rectum treated. There was some indication that genitourinary toxicity was worse for patients treated with dose escalated IMRT, although most studies did not find a significant treatment effect. HRQoL improved for both treatment groups following radiotherapy, with any group difference resolved by 6 months after treatment. No comparative studies of IMRT versus prostatectomy were identified. No comparative studies of IMRT in PC patients with bone metastasis were identified. LIMITATIONS: The strength of the conclusions of this review are limited by the lack of RCTs, and any comparative studies for some patient groups. CONCLUSIONS: The comparative data of IMRT versus 3DCRT seem to support the theory that higher doses, up to 81 Gy, can improve biochemical survival for patients with localised PC, concurring with data on CRT. The data also suggest that toxicity can be reduced by increasing conformality of treatment, particularly with regard to GI toxicity, which can be more easily achieved with IMRT than 3DCRT. Whether differences in GI toxicity between IMRT and 3DCRT are sufficient for IMRT to be cost-effective is uncertain, depending on the difference in incidence of GI toxicity, its duration and the cost difference between IMRT and 3DCRT.","Health Technol Assess, 14(47): 1-108, iii-iv","International",2010,"Local","Radiotherapy,Surgery","Unclear","Patient",null,"Systematic review",null,null,null,null,null,null,null,null,"General"]
[300,"Hunt-Shanks, T. T., et al. (2006). \"Exercise use as complementary therapy among breast and prostate cancer survivors receiving active treatment: examination of exercise intention.\" Integr Cancer Ther 5(2): 109-116.",null,"Hunt-Shanks, T. T., et al.","Exercise use as complementary therapy among breast and prostate cancer survivors receiving active treatment: examination of exercise intention","BACKGROUND: Exercise is associated with an improved quality of life among cancer survivors. Previous research has highlighted the utility of the theory of planned behavior in understanding cancer survivors' intention to exercise. The purpose of this study was to extend the research on the theory of planned behavior in relation to exercise intention in breast cancer survivors and to provide preliminary evidence supporting its application with prostate cancer survivors during treatment. METHODS: Participants consisted of 126 breast and 82 prostate cancer survivors receiving active treatment. Participants completed self-administered, mail-in questionnaires that assessed demographic and medical variables, past exercise, and the theory of planned behavior. RESULTS: For breast cancer survivors, the results revealed that attitudes, subjective norm, and perceived behavioral control explained 66% of the variance in exercise intention with the instrumental component of attitude, subjective norm, and perceived behavioral control making significant unique contributions to intention. For prostate cancer survivors, attitudes, subjective norm, and perceived behavioral control explained 57% of the variance in exercise intention, with subjective norm and perceived behavioral control making significant unique contributions to intention. CONCLUSIONS: The results provide further support that the theory of planned behavior is a useful framework for understanding determinants of exercise intention in breast cancer survivors undergoing active treatment and preliminary support for prostate cancer survivors undergoing active treatment. When designing exercise interventions, differences in breast and prostate cancer survivors' exercise intention merit consideration.","Integr Cancer Ther, 5(2): 109-116","Canada",2006,"Survivors","Various","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Views"]
[301,"Huri, M., et al. (2015). \"Effects of occupational therapy on quality of life of patients with metastatic prostate cancer. A randomized controlled study.\" Saudi Med J 36(8): 954-961.",null,"Huri, M., et al.","Effects of occupational therapy on quality of life of patients with metastatic prostate cancer. A randomized controlled study","OBJECTIVES: To evaluate the efficiency of occupational therapy relative to a home program in improving quality of life (QoL) among men who were treated for metastatic prostate cancer (MPC). METHODS: Fifty-five men were assigned randomly to either the 12-week cognitive behavioral therapy based occupational therapy (OT-CBSM) intervention (treatment group) or a home program (control group) between March 2012 and August 2014 in the Department of Occupational Therapy, Faculty of Health Sciences, Hacettepe University, Ankara, Turkey. The Canadian Occupational Performance Measure (COPM) was used to measure the occupational performance and identify difficulties in daily living activities. The QoL and symptom status were measured by The European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire C30 and its Prostate Cancer Module. A 12-week OT-CBSM intervention including client-centered training of daily living activities, recreational group activities, and cognitive behavioral stress management intervention were applied. RESULTS: The COPM performance and satisfaction scores, which indicate occupational participation and QoL increased statistically in the treatment group in relation to men who were included in the home-program (p less than or equal to 0.05). CONCLUSION: A 12-week OT-CBSM intervention was effective in improving QoL in men treated for MPC, and these changes were associated significantly with occupational performance.","Saudi Med J, 36(8): 954-961","Turkey",2015,"Metastatic","Psychological","EORTC QLQ-C30,EORTC QLQ-PR25,COPM","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,General,Work"]
[302,"Imbimbo, C., et al. (2011). \"Patients' desire to preserve sexual activity and final decision for a nerve-sparing approach: results from the MIRROR (Multicenter Italian Report on Radical Prostatectomy Outcomes and Research) Study.\" J Sex Med 8(5): 1495-1502.",null,"Imbimbo, C., et al.","Patients' desire to preserve sexual activity and final decision for a nerve-sparing approach: results from the MIRROR (Multicenter Italian Report on Radical Prostatectomy Outcomes and Research) Study","INTRODUCTION: Preservation of sexual function after surgery represents a major issue for patients undergoing radical prostatectomy (RP). AIM: To investigate determinants of patients' desire to preserve sexual activity before RP and surgeons' final decision to perform a nerve-sparing RP (NSRP). METHODS: Overall, 2,408 prostate cancer patients, candidates to RP, from 136 urologic departments across the Italian territory were evaluated in a multicenter prospective observational study. All patients underwent RP, according to single-center indications and procedures. MAIN OUTCOME MEASURES: Age, body mass index, previous benign prostatic hyperplasia history, preoperative tumor characteristics, quality of life through the Short Form Health Survey (SF-12), and the University of California Los Angeles Prostate Cancer Index (UCLA-PCI), erectile function through the International Index of Erectile Function (IIEF-5), desire to preserve sexual activity, NS operative outcomes, and surgical margins status were recorded. RESULTS: Overall, 1,667 were interested to preserve sexual activity. Age, physical component summary of SF12 (PCS-12), sexual function score of UCLA-PCI, and IIEF-5 score were the main determinants of such interest. Only 1,246 patients were suitable for a NSRP according to guidelines. Surgeons performed a non-NSRP (NNSRP) in 1,234 patients, a unilateral NSRP in 318 and a bilateral NSRP in 856. Age, bioptical Gleason score, percentage of positive cores, PCS-12, and patient's desire to preserve sexual activity were the main determinants of final decision for a NSRP. Surgeons performed a NSRP in 424 not suitable and in 121 not interested patients. Positive surgical margins in not suitable patients submitted to NSRP were not higher if compared to that obtained after NNSRP in the same subgroup. Limits include lack of oncological and functional follow-up. CONCLUSIONS: Most patients are interested to preserve sexual activity. Discrepancies exist among patients' preferences, guidelines' indications, and surgeon's final decision.","J Sex Med, 8(5): 1495-1502","Italy",2011,"Any or unknown","Surgery","UCLA-PCI,IIEF-5,SF-12","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease,Complication,Utility"]
[303,"Inoue, S., et al. (2009). \"Five-year longitudinal effect of radical perineal prostatectomy on health-related quality of life in Japanese men, using general and disease-specific measures.\" BJU Int 104(8): 1077-1084.",null,"Inoue, S., et al.","Five-year longitudinal effect of radical perineal prostatectomy on health-related quality of life in Japanese men, using general and disease-specific measures","OBJECTIVE: To investigate the longitudinal alteration of health-related quality of life (HRQL) up to 5 years after radical perineal prostatectomy (RPP) among Japanese patients with localized prostate cancer. PATIENTS AND METHODS: In all, 194 patients who had RPP were included in this longitudinal survey. The validated RAND 36-Item Health Survey (SF-36) and the University of California, Los Angeles Prostate Cancer Index (UCLA-PCI) were used to evaluate the HRQL. RESULTS: Among the UCLA-PCI urinary domains, urinary function scores decreased at 3 months after RPP, but they increased 6 months after RPP. Likewise, urinary bother showed a transient decrease at 3 months, but had returned to the baseline level 6 months after RPP. Sexual function (SF) was drastically decreased at 3 months after RPP, but had slightly increased 1 year after RPP. Patients who had a nerve-sparing (NS) RPP showed better SF-related HRQL than those who did not at 6 months after RPP. This favourable alteration involving SF-related HRQL was closely associated with the NS procedure, but not with the patient age. Multivariate analysis showed that later recovery of SF was essentially related to the use of NS RPP, while early recovery of sexual bother was closely related to the patient age. CONCLUSIONS: Our results confirmed the positive effect of RPP on the long-term HRQL in Japanese patients. Although NS surgery conferred the benefit of the recovery of SF, older Japanese patients were not greatly concerned about their decreased SF-related HRQL. The current results provide primary evidence for predicting the alteration of HRQL and understanding the effect of patient age and NS surgery on HRQL after RPP.","BJU Int, 104(8): 1077-1084","Japan",2009,"Local","Surgery","SF-36,UCLA-PCI","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Utility,Disease"]
[304,"Inoue, T., et al. (2016). \"Effective and Safe Administration of Low-Dose Estramustine Phosphate for Castration-Resistant Prostate Cancer.\" Clin Genitourin Cancer 14(1): e9-e17.",null,"Inoue, T., et al.","Effective and Safe Administration of Low-Dose Estramustine Phosphate for Castration-Resistant Prostate Cancer","Despite the favorable toxicity profile at the standard dose of 560 mg daily, the tolerability and toxicology of estramustine phosphate (EMP) have been a cause for concern at administration. Moreover, we do not know whether a lower dose of 280 mg of EMP daily can be administered with some efficacy and fewer side effects. The results of our phase II study suggest that low-dose EMP is a safe treatment option with the same efficacy in patients with castration-resistant prostate cancer. BACKGROUND: We evaluated the efficacy and safety of low-dose estramustine phosphate (EMP) in Japanese patients with castration-resistant prostate cancer (CRPC). PATIENTS AND METHODS: The present study was a single-arm, nonrandomized prospective study in which all patients received EMP orally twice daily for a total dose of 280 mg/day. A total of 31 patients with CRPC were enrolled from December 2009 to December 2012 at 5 institutions in Japan. The primary endpoint was the prostate-specific antigen (PSA) response, defined as a 50% decline in the serum PSA level, confirmed >/= 3 weeks later. The secondary endpoints included the objective response rate, interval to PSA progression, PSA response duration, progression-free survival, disease-specific survival, overall survival, safety, and quality-of-life assessment using the Functional Assessment of Cancer Therapy-Prostate scores. RESULTS: Ten patients (32%) had a PSA response, and no patient had an objective response. The treatment was well tolerated, and the most frequent toxicities were grade 1 to 2 nausea/vomiting, anorexia, and gynecomastia. The median interval to PSA progression was 140 days (95% confidence interval [CI], 117-260 days). The PSA response duration was 119 days (95% CI, 49-219 days). The median progression-free survival was 213 days (95% CI, 167-422 days). The 3-year disease-specific survival and overall survival rates were 68.6% (median not reached; 95% CI, 33 months to not available) and 59.9% (median 42 months, 95% CI, 28 months to not available), respectively. CONCLUSION: Low-dose EMP seems to be a safe treatment option with some efficacy in patients with CRPC.","Clin Genitourin Cancer, 14(1): e9-e17","Japan",2016,"Any or unknown","Chemotherapy","FACT-P","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease"]
[305,"Irani, J., et al. (2010). \"Efficacy of venlafaxine, medroxyprogesterone acetate, and cyproterone acetate for the treatment of vasomotor hot flushes in men taking gonadotropin-releasing hormone analogues for prostate cancer: a double-blind, randomised trial.\" Lancet Oncol 11(2): 147-154.",null,"Irani, J., et al.","Efficacy of venlafaxine, medroxyprogesterone acetate, and cyproterone acetate for the treatment of vasomotor hot flushes in men taking gonadotropin-releasing hormone analogues for prostate cancer: a double-blind, randomised trial","BACKGROUND: Hot flushes are the most common complaints reported by men undergoing androgen suppression treatment for prostate cancer. We designed a randomised double-blind trial to compare the efficacy of three drugs, each of which has proven effective for preventing hot flushes in previous studies. METHODS: Men with prostate cancer with an indication for androgen suppression were enrolled in the study at 106 urology centres in France between April 14, 2004, and April 20, 2007. All patients were treated for 6 months with leuprorelin (11.25 mg). At month 6, patients who spontaneously asked for treatment, or those who presented with 14 hot flushes or more during the week before the visit, were randomly assigned to either venlafaxine 75 mg daily, medroxyprogesterone acetate 20 mg daily, or cyproterone acetate 100 mg daily. All patients received two indistinguishable pills in the morning and one in the evening from week 1 to week 8, and one indistinguishable pill in the morning from week 9 to week 10, to comply with the double-blind design. Random assignment with a block size of three was done centrally, by fax, and each patient was given a randomisation number. The allocation sequence was stratified by centre. Assessment was done at inclusion, at randomisation, and then at 4 weeks, 8 weeks, and 12 weeks after randomisation. Participants completed a daily hot-flush diary for 1 week, and a quality of life questionnaire before each visit throughout the study. The primary outcome was the change in median daily hot-flush score between randomisation and 1 month. All patients who received at least one study treatment dose were included in the efficacy analysis. This trial is registered with ClinicalTrials.gov, number NCT01011751. FINDINGS: Of the 919 men initially enrolled, 311 were randomly assigned to one of the study treatments at 6 months: 102 to venlafaxine, 101 to cyproterone, and 108 to medroxyprogesterone. 309 patients were included in the efficacy analysis, since two were excluded for protocol deviations (one in the cyproterone and one in the medroxyprogesterone group; both were excluded because they were already undergoing treatment with serotonin reuptake inhibitor antidepressants at randomisation). The change in median daily hot-flush score between randomisation and 1 month was -47.2% (IQR -74.3 to -2.5) in the venlafaxine group, -94.5% (-100.0 to -74.5) in the cyproterone group, and -83.7% (-98.9 to -64.3) in the medroxyprogesterone group. The decrease from baseline was significant for all three groups (p<0.0001). Pairwise comparison of treatment groups adjusted by the Bonferroni method confirmed that the decreases in hot-flush score were significantly larger in the cyproterone and medroxyprogesterone groups than in the venlafaxine group, regardless of the interval considered (p<0.0001 in all cases). There was no significant difference between the cyproterone and medroxyprogesterone groups (p>0.2 in all cases). Serious side-effects occurred in four, seven, and five patients in the venlafaxine, cyproterone, and medroxyprogesterone groups, respectively, of which none, one (dyspnoea), and one (urticaria) were considered related to the drug, respectively. INTERPRETATION: After 6 months of treatment with leuprorelin, venlafaxine, cyproterone, and medroxyprogesterone proved to be effective in reducing hot flushes. However, the hormonal treatments cyproterone and medroxyprogesterone were significantly more effective than venlafaxine. As cyproterone is a recognised treatment in prostate cancer, and its use could interfere with hormonal therapy, medroxyprogesterone could be considered to be the standard treatment for hot flushes in men undergoing androgen suppression for prostate cancer. FUNDING: Takeda Laboratories, Puteaux, France.","Lancet Oncol, 11(2): 147-154","France",2010,"Any or unknown","Hormonal,Various","Diary","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Symptom,General"]
[306,"Isa, M. R., et al. (2013). \"Impact of applied progressive deep muscle relaxation training on the health related quality of life among prostate cancer patients--a quasi experimental trial.\" Prev Med 57 Suppl: S37-40.",null,"Isa, M. R., et al.","Impact of applied progressive deep muscle relaxation training on the health related quality of life among prostate cancer patients--a quasi experimental trial","PURPOSE: To determine the impact of applied progressive muscle relaxation training on health related quality of life among prostate cancer patients. METHOD: A quasi-experimental study was conducted at the University Malaya Medical Centre (UMMC) and Universiti Kebangsaan Malaysia Medical Centre (UKMMC) over six months. Patients from UMMC received the intervention and patients from UKMMC as a comparison group. The general health related quality of life was measured using Short Form-36 (SF-36). RESULTS: A total of 77 patients from the intervention group and 78 patients from the comparison group participated in the study. At the end of the study, only 90.9% in intervention group and 87.2% in comparison group completed the study. There were significant differences between intervention and comparison groups for mental component summary (MCS) (p=0.032) and overall health related quality of life (p=0.042) scores. However, there was no significant difference between groups for physical component summary (PCS) (p=0.965). CONCLUSION: The improvement in MCS and overall QOL showed the potential of APMRT in the management of prostate cancer patients. Future studies should be carried out over a longer duration to provide stronger evidence for the introduction of relaxation therapy among prostate cancer patients as a coping strategy to improve their QOL.","Prev Med, 57 Suppl(S37-40","Malaysia",2013,"Any or unknown","Various","SF-36","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Utility"]
[307,"Ishihara, M., et al. (2006). \"Baseline health-related quality of life in the management of prostate cancer.\" Int J Urol 13(7): 920-925.",null,"Ishihara, M., et al.","Baseline health-related quality of life in the management of prostate cancer","OBJECTIVE: The purpose of this study was to clarify characteristics of baseline health-related quality of life (HRQOL) during the diagnostic process of prostate cancer. METHODS: A prospective study was conducted to measure HRQOL in a cohort of 141 patients in whom prostate cancer was suspected and prostate biopsy was scheduled, using both generic and disease-specific HRQOL measures (SF-36, UCLA-Prostate Cancer Index) at two points: before prostate biopsy (prediagnosis) and after giving biopsy results (postdiagnosis). Seventy-three patients were diagnosed with prostate cancer and 68 were not. RESULTS: Compared to age-gender adjusted population norms, patients demonstrated better physical function (PF) and worse mental health (MH). Characteristic age-related changes were found in PF and sexual function (SXF); however, disease stage exhibited no relevant effects in HRQOL. No significant difference was detected between pre- and postdiagnosis SF-36 and UCLA-PCI scores. CONCLUSION: The present study discovered no relevant impact of the diagnostic process of prostate cancer on baseline HRQOL using SF-36 and UCLA-PCI. Combined with results of previous studies, it is supportive of regarding pretreatment levels of HRQOL as the baseline.","Int J Urol, 13(7): 920-925","Japan",2006,"At risk","Screening","SF-36,UCLA-PCI","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease,Utility"]
[308,"Ishikawa, H., et al. (2015). \"Carbon-ion Radiotherapy for Prostate Cancer: Analysis of Morbidities and Change in Health-related Quality of Life.\" Anticancer Res 35(10): 5559-5566.",null,"Ishikawa, H., et al.","Carbon-ion Radiotherapy for Prostate Cancer: Analysis of Morbidities and Change in Health-related Quality of Life","AIM: To prospectively evaluate the feasibility of carbon-ion radiotherapy (C-ion RT) for prostate cancer using a new compact-sized accelerator. PATIENTS AND METHODS: Seventy-six patients underwent C-ion RT at our center using a recommended dose fractionation of 57.6 GyE in 16 fractions established at the National Institute of Radiological Sciences. Health-related Quality of Life (HRQOL) assessment was also performed using the Medical Outcome Study 8-items Short Form Health Survey (SF-8) questionnaire. RESULTS: The median follow-up time was 51 months (range=8-58 months). Grade 2 gastrointestinal and genitourinary complications developed in 1 (1.3%) and 5 (6.6%) patients, respectively. Recurrences occurred in 4 patients, and the 4-year biochemical relapse-free rate was 94.6%. The HRQOL scores after C-ion RT were objectively well-maintained. CONCLUSION: Irrespective of the small number of patients of the study, C-ion RT for prostate cancer using the first commercial-based accelerator reproduced the toxicity outcomes at the NIRS.","Anticancer Res, 35(10): 5559-5566","Japan",2015,"Any or unknown","Radiotherapy","SF-8","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Utility"]
[309,"Izard, J., et al. (2014). \"User-centered design of quality of life reports for clinical care of patients with prostate cancer.\" Surgery 155(5): 789-796.",null,"Izard, J., et al.","User-centered design of quality of life reports for clinical care of patients with prostate cancer","BACKGROUND: Primary treatment of localized prostate cancer can result in bothersome urinary, sexual, and bowel symptoms. Yet clinical application of health-related quality-of-life (HRQOL) questionnaires is rare. We employed user-centered design to develop graphic dashboards of questionnaire responses from patients with prostate cancer to facilitate clinical integration of HRQOL measurement. METHODS: We interviewed 50 prostate cancer patients and 50 providers, assessed literacy with validated instruments (Rapid Estimate of Adult Literacy in Medicine short form, Subjective Numeracy Scale, Graphical Literacy Scale), and presented participants with prototype dashboards that display prostate cancer-specific HRQOL with graphic elements derived from patient focus groups. We assessed dashboard comprehension and preferences in table, bar, line, and pictograph formats with patient scores contextualized with HRQOL scores of similar patients serving as a comparison group. RESULTS: Health literacy (mean score, 6.8/7) and numeracy (mean score, 4.5/6) of patient participants was high. Patients favored the bar chart (mean rank, 1.8 [P = .12] vs line graph [P < .01] vs table and pictograph); providers demonstrated similar preference for table, bar, and line formats (ranked first by 30%, 34%, and 34% of providers, respectively). Providers expressed unsolicited concerns over presentation of comparison group scores (n = 19; 38%) and impact on clinic efficiency (n = 16; 32%). CONCLUSION: Based on preferences of prostate cancer patients and providers, we developed the design concept of a dynamic HRQOL dashboard that permits a base patient-centered report in bar chart format that can be toggled to other formats and include error bars that frame comparison group scores. Inclusion of lower literacy patients may yield different preferences.","Surgery, 155(5): 789-796","USA",2014,"Local","None","Unclear","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease"]
[310,"Jacobsen, N. E., et al. (2007). \"Open versus laparoscopic radical prostatectomy: a prospective comparison of postoperative urinary incontinence rates.\" J Urol 177(2): 615-619.",null,"Jacobsen, N. E., et al.","Open versus laparoscopic radical prostatectomy: a prospective comparison of postoperative urinary incontinence rates","PURPOSE: We compared the 12-month postoperative urinary incontinence rates of open radical retropubic and laparoscopic radical prostatectomy. MATERIALS AND METHODS: This prospective study included all men with clinically localized prostate cancer scheduled for radical prostatectomy (open retropubic or laparoscopic) at the University of Alberta between October 1999 and July 2002. Preoperative evaluation included a 24-hour pad test, fluid volume voiding diary and International Prostate Symptom Score questionnaire. Postoperative evaluation included a 24-hour pad test at 3 and 12 months, as well as a voiding diary and International Prostate Symptom Score questionnaire at 3, 6, 9 and 12 months. RESULTS: A total of 239 patients met the eligibility criteria and consented to participate (172 open radical retropubic prostatectomy, 67 laparoscopic radical prostatectomy). Of the patients 87% (148) treated with open radical retropubic prostatectomy and 88% (57) of those treated with laparoscopic radical prostatectomy completed 12-month followup (p = 0.50). According to 24-hour pad testing 13% of those treated with open radical retropubic prostatectomy and 17% of those treated with laparoscopic radical prostatectomy remained incontinent at 1 year (p = 0.26). There was no difference in 24-hour pad weight, urinary symptom score and urinary quality of life at 1 year between the open and laparoscopic groups overall, or when stratified according to 12-month continence status. The majority of subjects in both groups described mild symptoms and a general satisfaction with urinary quality of life. CONCLUSIONS: Based on objective and subjective measures, there were no differences in urinary functional outcomes 1 year after open radical retropubic prostatectomy or laparoscopic radical prostatectomy. Urinary incontinence was found to affect a similar proportion of patients who underwent open (13%) and laparoscopic (17%) radical prostatectomy 12 months postoperatively.","J Urol, 177(2): 615-619","Canada",2007,"Local","Surgery","IPSS","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease"]
[311,"Jain, R., et al. (2012). \"The effect of surgical intervention for stress urinary incontinence (UI) on post-prostatectomy UI during sexual activity.\" BJU Int 109(8): 1208-1212.",null,"Jain, R., et al.","The effect of surgical intervention for stress urinary incontinence (UI) on post-prostatectomy UI during sexual activity","OBJECTIVE: To determine the impact of anti-incontinence surgical procedures (artificial urinary sphincter [AUS] or male sling) on bother due to urinary incontinence (UI) during sexual activity after radical prostatectomy (RP). PATIENTS AND METHODS: Between October 2000 and December 2007, 27 men in a large single-surgeon RP series underwent anti-incontinence surgery with an AUS or male sling. In all, 16 of these 27 men completed a questionnaire retrospectively capturing bother attributable to UI during arousal and orgasm and the impact of the AUS/male sling on UI and sexual quality of life (QoL). RESULTS: In all, 15 men were evaluable. Of these, 11 were sexually active; four and seven men underwent AUS and sling placement, respectively. All 11 men had a marked improvement in stress UI symptoms, which was the primary indication for surgery. All men undergoing AUS had an improvement in their sexual QoL, and most (three of four men) indicated marked improvement. Slightly more than half of men undergoing the sling procedure reported marked improvement in sexual QoL. CONCLUSIONS: Our study shows a beneficial effect of anti-incontinence surgery on UI during sexual activity. Whether these surgical approaches would benefit men with significant bother due to UI limited to sexual activity warrants further investigation.","BJU Int, 109(8): 1208-1212","USA",2012,"Any or unknown","Surgery","Unclear","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Complication"]
[312,"Jakobsson, L. (2002). \"Indwelling catheter treatment and health-related quality of life in men with prostate cancer in comparison with men with benign prostatic hyperplasia.\" Scand J Caring Sci 16(3): 264-271.",null,"Jakobsson, L.","Indwelling catheter treatment and health-related quality of life in men with prostate cancer in comparison with men with benign prostatic hyperplasia","Experiences from indwelling urinary catheter treatment periods were studied. Little is known of what is felt from a male perspective although catheter treatment is a common pre- and postoperative measure for men with prostate cancer and benign prostatic hyperplasia (BPH). Also studied were health-related quality of life (HRQOL) and sense of coherence (SOC). Men with catheter experience (prostate cancer n = 71, BPH n = 37) were selected from a larger questionnaire study. Assessment was made with study-specific questions together with the QLQ C-30 assessing HRQOL and the SOC questionnaire measuring sense of coherence. Data reduction method was applied to study specific variables to determine problem patterns. Correlation between HRQOL and SOC was determined. Results showed similar problem patterns in men with prostate cancer and BPH: discomfort in wearing catheter (e.g. uneasiness 48.2%), practical and psychosocial difficulties in handling and wearing catheter (e.g. attaching catheter 32.4%) and discomfort at installation (e.g. pain 29.7%). There was lack of knowledge about wearing and practical handling of the catheter. Having a cancer diagnosis did not add to uneasiness or practical problems. Life quality was correlated to SOC (p <or= 0.001).","Scand J Caring Sci, 16(3): 264-271","Sweden",2002,"Any or unknown","Various","EORTC QLQ-C30,SOC","Patient",null,"Validation",null,null,null,null,null,null,null,null,"General"]
[313,"Jakobsson, L., et al. (1997). \"Experiences of daily life and life quality in men with prostate cancer. An explorative study. Part I.\" Eur J Cancer Care (Engl) 6(2): 108-116.",null,"Jakobsson, L., et al.","Experiences of daily life and life quality in men with prostate cancer. An explorative study. Part I","Eleven men with prostate cancer were randomly chosen and interviewed during an in-patient period at a southern Swedish hospital. The interview focused on functional health status in relation to daily life and life quality. In addition the sense of coherence scale was used, as well as the European Organization or Research and Treatment of Cancer (EORTC) QLQ C-30 questionnaire. The interview findings were analysed from a phenomenological-hermeneutic perspective and interpreted within the concept of transition. The entry to transition was marked by the men when experiencing an altered life continuum in terms of physical and existential fatigue, pain, micturition problems and an altered sex life. The passage phase was marked by descriptions of a new lifestyle where hope was a central internal resource, creating a positive illusion of life in order to endure. Their external resources were wives and family who supported physically (household matters, gardening) and psycho-logically (comfort, encouragement). The exit phase meant continuously adapting to a new life style, living with a slowly deteriorating functional health status, a new sense of dependency on others, daily life routine broken by in-patient hospital periods and contacts with primary health care. Thus the findings pointed more at continuously facing new passages than a stable exit, i.e. an ongoing transition. The areas of life imbalance described may serve as a basis for care assessment and intervention as well as supplying support of the transitional process.","Eur J Cancer Care (Engl), 6(2): 108-116","Sweden",1997,"Any or unknown","None","EORTC QLQ-C30,SOC","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"General"]
[314,"Janda, M., et al. (2000). \"Quality of life changes during conformal radiation therapy for prostate carcinoma.\" Cancer 89(6): 1322-1328.",null,"Janda, M., et al.","Quality of life changes during conformal radiation therapy for prostate carcinoma","BACKGROUND: The objective of this study was to describe prospectively quality of life (QOL) before and after radiotherapy for patients with prostate carcinoma. METHODS: Forty-three patients with T1-T3 prostate carcinoma who underwent conformal external beam radiation therapy were randomized either to the complete European Organization for Research and Treatment of Cancer (EORTC) QOL questionnaire (EORTC QLQ-C30) or the Medical Outcomes Study Group Short Form Health Survey (SF-36) at baseline, at 3 weeks and 6 weeks after initial treatment, and at 6 weeks and 5 months after the completion of radiotherapy. The measures were self-reported patient QOL, and values are given as the mean +/- standard error of the mean. Changes in QOL are described from baseline to the end of treatment in both questionnaire groups. RESULTS: Emotional role functioning, as measured with the SF-36 questionnaire, significantly improved from 68.2 +/- 9.9 at baseline to 93.3 +/- 5.2 at the end of therapy (P = 0.02). The EORTC QLQ-C30 questionnaire revealed consistent values of emotional functioning during treatment (72.7 +/- 5.9 at baseline) but showed a significant improvement 6 weeks after therapy (89.0 +/- 4.4; P = 0.01). Role functioning deteriorated from 80.1 +/- 6.5 at baseline to 62.5 +/- 8.8 at the end of radiotherapy (P = 0.02). Symptoms of fatigue were shown to increase significantly from 26.9 +/- 6.0 at baseline to 37.7 +/- 7.6 at the end of therapy (P = 0.02). No significant changes in the other dimensions were observed in either questionnaire. CONCLUSIONS: After radiotherapy for prostate carcinoma, patients experience a temporary deterioration of fatigue and role functioning, as measured with the EORTC QLQ-C-30. Despite physical deterioration, the authors observed an improvement in emotional functioning scores with both questionnaires. This may have been due to psychological adaptation and coping.","Cancer, 89(6): 1322-1328","Austria",2000,"Local,Advanced","Radiotherapy","EORTC QLQ-C30,SF-36","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"General,Utility"]
[315,"Jayadevappa, R., et al. (2006). \"Health-related quality of life and satisfaction with care among older men treated for prostate cancer with either radical prostatectomy or external beam radiation therapy.\" BJU Int 97(5): 955-962.",null,"Jayadevappa, R., et al.","Health-related quality of life and satisfaction with care among older men treated for prostate cancer with either radical prostatectomy or external beam radiation therapy","OBJECTIVE: To analyse health-related quality of life (HRQoL) and satisfaction with care across potential curative treatments for older patients newly diagnosed with prostate cancer. PATIENTS AND METHODS: In a prospective cohort study we recruited 115 older patients (> or =65 years) newly diagnosed with prostate cancer from the urology clinics of an urban academic and a Veterans' Administration (VA) hospital. Patients completed generic (Short Form-36), prostate-specific (University of California Los Angeles Prostate Cancer Index) HRQoL, and Client Satisfaction with Care (CSQ-8) surveys before treatment with either radical prostatectomy (RP) or external beam irradiation (EBRT) and at 3, 6 and 12 months afterward. Clinical and demographic data were obtained via medical chart review. A repeated-measures analysis of variance was used to examine changes in generic and prostate cancer-specific HRQoL between treatments. Log-linear regression was used to analyse the factors associated with 12-month HRQoL scores, and Kaplan-Meier survival curves were used to compare the return to baseline values for HRQoL. RESULTS: The RP group had significantly higher income, education and better general health than the EBRT group. Age (odds ratio 0.5, 95% confidence interval 0.32-0.82), non-VA hospital (28.8, 2-402) and prostate-specific antigen level at diagnosis (2.8, 1.05-7.5) were associated with RP. The analysis results indicated that the RP group had higher scores for generic HRQoL subscales of physical function (P = 0.019), role emotional (P = 0.037), vitality (P = 0.033) and general health (P = 0.05) than the EBRT group. A log-linear regression model for predicting the 12-month scores showed that RP was associated with higher scores for most of the generic HRQoL and bowel function (odds ratio 1.12, P = 0.03), urinary bother (1.6, P = 0.014) and bowel bother (1.5, P = 0.013). Being older was associated with a lower score on bowel function (0.98, P = 0.05) and sexual function (0.92, P = 0.05). Satisfaction with care was comparable between treatment groups at baseline and at the follow-up. CONCLUSIONS: Older patients tolerate RP well from the HRQoL perspective and thus decisions for therapy in this age cohort should not be based primarily on age.","BJU Int, 97(5): 955-962","USA",2006,"Any or unknown","Surgery,Radiotherapy","SF-36,UCLA-PCI,CSQ-8","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease,Utility,Satisfaction"]
[316,"Jayadevappa, R., et al. (2007). \"Ethnic variation in return to baseline values of patient-reported outcomes in older prostate cancer patients.\" Cancer 109(11): 2229-2238.",null,"Jayadevappa, R., et al.","Ethnic variation in return to baseline values of patient-reported outcomes in older prostate cancer patients","BACKGROUND: Ethnic variation in patient-reported outcomes such as health-related quality of life (HRQoL) and satisfaction with care are understudied areas in the management of elderly prostate cancer (PCa) patients. METHODS: In this prospective cohort study, between the years 2002 and 2004, the authors recruited 214 older (>or=65 years) men with newly diagnosed PCa from an urban academic hospital and a Veterans Administration hospital. Participants completed generic (SF-36), prostate-specific (UCLA-PCI) HRQoL, and satisfaction with care (CSQ-8) surveys at baseline and at 3, 6, and 12-months follow-up. Clinically significant difference was used to compute return to baseline. The authors compared time to return to baseline HRQoL after controlling for confounding variables by using ANOVA and log-linear models. Survival curves were used to compare time to return to baseline across ethnicity. RESULTS: Regression analysis revealed that age and marital status, not ethnicity, were independent predictors of radical prostatectomy, rather than radiation treatment. African Americans reported lower HRQoL scores at diagnosis and required a longer time to return to baseline. Log-linear analysis indicated that African-American ethnicity was associated with lower 12-month scores for role physical (odds ratio [OR], 0.46; standard error [SE], 0.40), role emotional (OR, 0.37; SE, 0.43), bodily pain (OR, 0.74; SE, 0.10), urinary function (OR, 0.90; SE, 0.11), and urinary bother (OR, 0.72; SE, 0.17). Both groups reported comparably high levels of satisfaction with care. CONCLUSIONS: African-American elderly exhibited poorer outcomes and required a longer time to return to baseline HRQoL. These differences highlight the need for discussion with patients and families prior to treatment about expectations and the need for support services post-treatment.","Cancer, 109(11): 2229-2238","USA",2007,"Any or unknown","Surgery,Radiotherapy","SF-36,UCLA-PCI,CSQ-8","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease,Utility,Treatment"]
[317,"Jayadevappa, R., et al. (2009). \"Predictors of patient reported outcomes and cost of care in younger men with newly diagnosed prostate cancer.\" Prostate 69(10): 1067-1076.",null,"Jayadevappa, R., et al.","Predictors of patient reported outcomes and cost of care in younger men with newly diagnosed prostate cancer","BACKGROUND: The proportion of younger men (<65 years) diagnosed with prostate cancer (PCa) has increased significantly. We sought to analyze the association between race/ethnicity, biochemical recurrence risk and outcomes in younger men with PCa. METHODS: In this prospective cohort study, we recruited 318 younger men with newly diagnosed PCa. Participants completed generic and prostate-specific Health Related Quality of Life (HRQoL), out-of-pocket cost and satisfaction with care surveys at baseline and at 3, 6, 12, and 24 months of follow-up. Health resource utilization and cost data were obtained from the hospital based administrative databases. We compared time to return to baseline (RTB) of HRQoL scores across groups. Survival curves were used to compare mean time to RTB across groups. Linear mixed effects (LMEs) and generalized linear (GLM) models were used to analyze the association of race/ethnicity and biochemical recurrence groups with outcomes. RESULTS: African Americans reported lower generic and prostate-specific HRQoL scores at diagnosis and required more time to RTB values for generic HRQoL. The results of LME models showed that low risk of biochemical recurrence was associated with better physical function, vitality, mental health, and general health. For prostate-specific HRQoL items, low risk of biochemical recurrence was associated with impaired urinary function and better bowel function and bowel bother. GLM model showed that treatment, hospital type and comorbidity were associated with cost. CONCLUSIONS: Biochemical recurrence risk and treatment groups, not ethnicity, were associated poorer post-treatment outcomes. This information is important in planning for and communicating with patients about post-treatment care.","Prostate, 69(10): 1067-1076","USA",2009,"Any or unknown","Unclear","Unclear","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"General,Costs,Satisfaction"]
[318,"Jayadevappa, R., et al. (2012). \"Comparison of distribution- and anchor-based approaches to infer changes in health-related quality of life of prostate cancer survivors.\" Health Serv Res 47(5): 1902-1925.",null,"Jayadevappa, R., et al.","Comparison of distribution- and anchor-based approaches to infer changes in health-related quality of life of prostate cancer survivors","OBJECTIVE: To determine the minimal important difference (MID) in generic and prostate-specific health-related quality of life (HRQoL) using distribution- and anchor-based methods. STUDY DESIGN AND SETTING: Prospective cohort study of 602 newly diagnosed prostate cancer patients recruited from an urban academic hospital and a Veterans Administration hospital. Participants completed generic (SF-36) and prostate-specific HRQoL surveys at baseline and at 3, 6, 12, and 24 months posttreatment. Anchor-based and distribution-based methods were used to develop MID estimates. We compared the proportion of participants returning to baseline based on MID estimates from the two methods. RESULTS: MID estimates derived from combining distribution- and anchor-based methods for the SF-36 subscales are physical function = 7, role physical = 14, role emotional = 12, vitality = 9, mental health = 6, social function = 9, bodily pain = 9, and general health = 8; and for the prostate-specific scales are urinary function = 8, bowel function = 7, sexual function = 8, urinary bother = 9, bowel bother = 8, and sexual bother = 11. Proportions of participants returning to baseline values corresponding to MID estimates from the two methods were comparable. CONCLUSIONS: This is the first study to assess the MID for generic and prostate-specific HRQoL using anchor-based and distribution-based methods. Although variation exists in the MID estimates derived from these two methods, the recovery patterns corresponding to these estimates were comparable.","Health Serv Res, 47(5): 1902-1925","USA",2012,"Any or unknown","Unclear","SF-36","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Utility,Disease"]
[319,"Jayadevappa, R., et al. (2015). \"Treatment preference and patient centered prostate cancer care: Design and rationale.\" Contemp Clin Trials 45(Pt B): 296-301.",null,"Jayadevappa, R., et al.","Treatment preference and patient centered prostate cancer care: Design and rationale","Prostate cancer is a slow progressing cancer that affects millions of men in the US. Due to uncertainties in outcomes and treatment complications, it is important that patients engage in informed decision making to choose the \"optimal treatment\". Patient centered care that encompasses informed decision-making can improve treatment choice and quality of care. Thus, assessing patient treatment preferences is critical for developing an effective decision support system. The objective of this patient-centered randomized clinical trial was to study the comparative effectiveness of a conjoint analysis intervention compared to usual care in improving subjective and objective outcomes in prostate cancer patients. We identified preferred attributes of alternative prostate cancer treatments that will aid in evaluating attributes of treatment options. In this two-phase study, in Phase 1 we used mixed methods to develop an adaptive conjoint task instrument. The conjoint task required the patients to trade-off attributes associated with treatments by assessing their relative importance. Phase 2 consisted of a randomized controlled trial of men with localized prostate cancer. We analyzed the effect of conjoint task intervention on the association between preferences, treatment and objective and subjective outcomes. Our conjoint task instrument can lead to a values-based patient-centered decision aid tool and help tailor treatment decision making to the values of prostate cancer patients. This will ultimately improve clinical decision making, clinical policy process, enhance patient centered care and improve prostate cancer outcomes.","Contemp Clin Trials, 45(Pt B): 296-301","USA",2015,"Any or unknown","Unclear","TTO","Patient",null,"Validation,Clinical trial",null,null,null,null,null,null,null,null,"Utility"]
[320,"Jayadevappa, R., et al. (2017). \"Minimal important difference to infer changes in health-related quality of life-a systematic review.\" J Clin Epidemiol 89: 188-198.",null,"Jayadevappa, R., et al.","Minimal important difference to infer changes in health-related quality of life-a systematic review","OBJECTIVES: The objective of the study was to assess the usability of minimal important difference (MID) and minimal clinically important difference (MCID) for measuring meaningful changes in disease-specific and generic health-related quality-of-life (HRQoL) outcomes in patient-centered care. STUDY DESIGN AND SETTING: We adopted a two-step literature review process. First, we used PubMed and Google scholar to identify a broad range of search terms. Next, we searched OVID Medline, JSTOR, and PubMed for terms \"MID,\" and \"MCID.\" We excluded non-English language studies, articles older than 1995, those not related to generic- and disease-specific HRQoL measures, and protocols of future studies. Studies were grouped according to generic- and disease-specific measures. We assessed MID or MCID calculation methods, effect sizes, estimated values, and significance. RESULTS: Eighty articles satisfied the inclusion criteria. Our synthesis provides a comprehensive assessment of MID or MCID for 10 generic-specific and 80 disease-specific instruments. We observed a lack of consistency in the application of methods for computing MID or MCID for generic and disease-specific HRQoL measures. Only 43 (54%) studies used both anchor and distribution methods to elicit MID or MCID. Thirty-four articles estimated MID values only, whereas 47 articles estimated MCID. CONCLUSION: The anchor-based method yields conservative estimates of MID or MCID, compared to the distribution-based method. The distribution method does not take into account patient perspectives and should be accompanied by anchor method while computing MID. The MID should be interpreted with caution, and available estimates for a particular instrument must be used. This will help in integrating the MID estimates into the overall research or clinical plan for a specific context.","J Clin Epidemiol, 89(188-198","USA",2017,"Any or unknown","None","Unclear","Patient",null,"Systematic review,Validation",null,null,null,null,null,null,null,null,"Disease,General"]
[321,"Jenkins, R., et al. (2004). \"Sexuality and health-related quality of life after prostate cancer in African-American and white men treated for localized disease.\" J Sex Marital Ther 30(2): 79-93.",null,"Jenkins, R., et al.","Sexuality and health-related quality of life after prostate cancer in African-American and white men treated for localized disease","The purpose of this study was to examine differences in sexual attitudes and quality of life of White and African-American men who have undergone radical prostatectomy or radiation therapy for localized prostate cancer. Respondents included 1,112 White and 118 African-American men. Response rates differed by race, with 51% of White men and 28% of African-American men returning the questionnaire assessing demographics, medical history, sexual functioning, attitudes about seeking help for sexual problems, sexual self-schema, and health-related quality of life. African Americans were more likely than Whites to have undergone radiation therapy (p <.0001) and were more likely to indicate that a desire to maintain sexual functioning influenced their treatment choice (p <.0001). African-American men also had more positive attitudes than did White men toward seeking help for sexual problems and were more likely to report seeking past help and intending to seek future help. African-American men reported more problems with sexual desire (p =.0003), although their sexual function scores did not differ significantly from those of Whites. African-American men may be more at risk for distress when prostate cancer treatment causes sexual dysfunction.","J Sex Marital Ther, 30(2): 79-93","USA",2004,"Local","Surgery,Radiotherapy","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"General,Complicaiton,Views"]
[322,"Jensen, R. E., et al. (2015). \"Validation of the PROMIS physical function measures in a diverse US population-based cohort of cancer patients.\" Qual Life Res 24(10): 2333-2344.",null,"Jensen, R. E., et al.","Validation of the PROMIS physical function measures in a diverse US population-based cohort of cancer patients","PURPOSE: To evaluate the validity of the Patient-Reported Outcomes Measurement Information System (PROMIS) physical function measures in a diverse, population-based cancer sample. METHODS: Cancer patients 6-13 months post-diagnosis (n = 4840) were recruited for the Measuring Your Health study. Participants were diagnosed between 2010 and 2013 with non-Hodgkin lymphoma or cancers of the colorectum, lung, breast, uterus, cervix, or prostate. Four PROMIS physical function short forms (4a, 6b, 10a, and 16) were evaluated for validity and reliability across age and race-ethnicity groups. Covariates included gender, marital status, education level, cancer site and stage, comorbidities, and functional status. RESULTS: PROMIS physical function short forms showed high internal consistency (Cronbach's alpha = 0.92-0.96), convergent validity (fatigue, pain interference, FACT physical well-being all r >/= 0.68), and discriminant validity (unrelated domains all r </= 0.3) across survey short forms, age, and race-ethnicity. Known-group differences by demographic, clinical, and functional characteristics performed as hypothesized. Ceiling effects for higher-functioning individuals were identified on most forms. CONCLUSIONS: This study provides strong evidence that PROMIS physical function measures are valid and reliable in multiple race-ethnicity and age groups. Researchers selecting specific PROMIS short forms should consider the degree of functional disability in their patient population to ensure that length and content are tailored to limit response burden.","Qual Life Res, 24(10): 2333-2344","USA",2015,"Any or unknown","None","PROMIS","Patient",null,"Validation",null,null,null,null,null,null,null,null,"General,Treatment"]
[323,"Jo, Y., et al. (2005). \"Radical prostatectomy versus high-dose rate brachytherapy for prostate cancer: effects on health-related quality of life.\" BJU Int 96(1): 43-47.",null,"Jo, Y., et al.","Radical prostatectomy versus high-dose rate brachytherapy for prostate cancer: effects on health-related quality of life","OBJECTIVE: To examine the effects of different treatments on the health-related quality of life (HRQoL) of men with localized prostate cancer. PATIENTS AND METHODS: Between October 1997 and August 2002, 182 men diagnosed with prostate cancer (T1c to T3bN0M0) had radical prostatectomy (RP, 89) or (192)iridium high-dose rate brachytherapy (HDR-BT, 93) with external beam radiotherapy, and were followed for > or = 6 months. A postal survey was sent in which HRQoL was assessed using the 36-item Short-Form Health Survey (SF-36) QoL questionnaire, and disease-specific QoL using the University of California Los Angeles Prostate Cancer Index (UCLA-PCI). RESULTS: Questionnaire responses were obtained from 151 of 182 patients; there was no significant difference in SF-36 scale scores between men treated with RP or HDR-BT. In the UCLA-PCI, the HDR-BT group had better urinary function (P < 0.001) and sexual function scores (P= 0.043). Men treated with RP had better bowel bother scores (P = 0.027). In patients with > or = 2 years of follow-up, urinary function (P < 0.001) and sexual bother (P = 0.029) were better for men treated with HDR-BT than for men treated with RP. Men treated with HDR-BT had significantly better urinary function (P = 0.009) and sexual bother (P = 0.013) even than 30 men treated with unilateral nerve-sparing RP. CONCLUSIONS: In terms of HRQoL, RP and HDR-BT did not differ, but HDR-BT resulted in better urinary and sexual function than RP. When planning treatment, QoL concerns, including mental health issues associated with prostate cancer, need to be addressed with the patients, as do the potential side-effects.","BJU Int, 96(1): 43-47","Japan",2005,"Local","Surgery,Brachytherapy","SF-36,UCLA-PCI","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Disease,Utility"]
[324,"Johansson, E., et al. (2009). \"Time, symptom burden, androgen deprivation, and self-assessed quality of life after radical prostatectomy or watchful waiting: the Randomized Scandinavian Prostate Cancer Group Study Number 4 (SPCG-4) clinical trial.\" Eur Urol 55(2): 422-430.",null,"Johansson, E., et al.","Time, symptom burden, androgen deprivation, and self-assessed quality of life after radical prostatectomy or watchful waiting: the Randomized Scandinavian Prostate Cancer Group Study Number 4 (SPCG-4) clinical trial","BACKGROUND: Quality-of-life outcomes are important in the choice of treatment strategy for men with localized prostate cancer. OBJECTIVE: To evaluate how follow-up time, number of physical symptoms, and presence of androgen deprivation affected quality of life among men randomized to radical prostatectomy or watchful waiting. DESIGN, SETTING, AND PARTICIPANTS: The study group was composed of all 376 living men included in the Swedish part of the Scandinavian Prostate Cancer Group Study Number 4 (SPCG-4) between January 1, 1989, and February 29, 1996. Quality-of-life data were collected after a mean follow-up time of 4.1 yr. INTERVENTION: All patients were randomly assigned to radical prostatectomy or watchful waiting. Forty-five men were androgen deprived. MEASUREMENTS: Data of specific symptoms, symptom-induced stress, sense of well-being, and self-assessed quality of life were obtained by means of a questionnaire. Psychological symptoms were assessed using seven-point visual digital scales. RESULTS AND LIMITATIONS: In analyses stratified on the basis of the numbers of physical symptoms, anxiety and depressed mood were less common, and sense of well-being and self-assessed quality of life were better throughout in the radical prostatectomy group than in the watchful waiting group. As the number of physical symptoms increased, all psychological variables became worse and more prominent in the watchful waiting group. After a follow-up time of 6-8 yr, a significant decrease in quality of life (p=0.03) was seen in the watchful waiting group. Twenty-four percent of androgen-deprived patients assigned to watchful waiting reported high self-assessed quality of life compared with 60% in the radical prostatectomy group. Eighty-eight percent of patients had clinically detected tumors. CONCLUSIONS: Androgen deprivation negatively affected self-assessed quality of life in men assigned to watchful waiting. The number of physical symptoms was associated with the level of quality of life. Quality of life was lower with longer follow-up time in both groups and was statistically significant in the watchful waiting group (p=0.03).","Eur Urol, 55(2): 422-430","Sweden",2009,"Local","Surgery,Surveillance","VAS","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Symptom"]
[325,"Johansson, E., et al. (2011). \"Long-term quality-of-life outcomes after radical prostatectomy or watchful waiting: the Scandinavian Prostate Cancer Group-4 randomised trial.\" Lancet Oncol 12(9): 891-899.",null,"Johansson, E., et al.","Long-term quality-of-life outcomes after radical prostatectomy or watchful waiting: the Scandinavian Prostate Cancer Group-4 randomised trial","BACKGROUND: For men with localised prostate cancer, surgery provides a survival benefit compared with watchful waiting. Treatments are associated with morbidity. Results for functional outcome and quality of life are rarely reported beyond 10 years and are lacking from randomised settings. We report results for quality of life for men in the Scandinavian Prostate Cancer Group Study Number 4 (SPCG-4) after a median follow-up of more than 12 years. METHODS: All living Swedish and Finnish men (400 of 695) randomly assigned to radical prostatectomy or watchful waiting in SPCG-4 from 1989 to 1999 were included in our analysis. An additional 281 men were included in a population-based control group matched for region and age. Physical symptoms, symptom-induced stress, and self-assessed quality of life were evaluated with a study-specific questionnaire. Longitudinal data were available for 166 Swedish men who had answered quality-of-life questionnaires at an earlier timepoint. FINDINGS: 182 (88%) of 208 men in the radical prostatectomy group, 167 (87%) of 192 men in the watchful-waiting group, and 214 (76%) of 281 men in the population-based control group answered the questionnaire. Men in SPCG-4 had a median follow-up of 12.2 years (range 7-17) and a median age of 77.0 years (range 61-88). High self-assessed quality of life was reported by 62 (35%) of 179 men allocated radical prostatectomy, 55 (34%) of 160 men assigned to watchful waiting, and 93 (45%) of 208 men in the control group. Anxiety was higher in the SPCG-4 groups (77 [43%] of 178 and 69 [43%] of 161 men) than in the control group (68 [33%] of 208 men; relative risk 1.42, 95% CI 1.07-1.88). Prevalence of erectile dysfunction was 84% (146 of 173 men) in the radical prostatectomy group, 80% (122 of 153) in the watchful-waiting group, and 46% (95 of 208) in the control group and prevalence of urinary leakage was 41% (71 of 173), 11% (18 of 164), and 3% (six of 209), respectively. Distress caused by these symptoms was reported significantly more often by men allocated radical prostatectomy than by men assigned to watchful waiting. In a longitudinal analysis of men in SPCG-4 who provided information at two follow-up points 9 years apart, 38 (45%) of 85 men allocated radical prostatectomy and 48 (60%) of 80 men allocated watchful waiting reported an increase in number of physical symptoms; 50 (61%) of 82 and 47 (64%) of 74 men, respectively, reported a reduction in quality of life. INTERPRETATION: For men in SPCG-4, negative side-effects were common and added more stress than was reported in the control population. In the radical prostatectomy group, erectile dysfunction and urinary leakage were often consequences of surgery. In the watchful-waiting group, side-effects can be caused by tumour progression. The number and severity of side-effects changes over time at a higher rate than is caused by normal ageing and a loss of sexual ability is a persistent psychological problem for both interventions. An understanding of the patterns of side-effects and time dimension of their occurrence for each treatment is important for full patient information. FUNDING: US National Institutes of Health; Swedish Cancer Society; Foundation in Memory of Johanna Hagstrand and Sigfrid Linner.","Lancet Oncol, 12(9): 891-899","Sweden",2011,"Local","Surgery,Surveillance","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General,Symptoms"]
[326,"Johansson, J. E., et al. (2001). \"Efficacy of epoetin beta on hemoglobin, quality of life, and transfusion needs in patients with anemia due to hormone-refractory prostate cancer--a randomized study.\" Scand J Urol Nephrol 35(4): 288-294.",null,"Johansson, J. E., et al.","Efficacy of epoetin beta on hemoglobin, quality of life, and transfusion needs in patients with anemia due to hormone-refractory prostate cancer--a randomized study","OBJECTIVE: Erythropoietin is shown to be an effective treatment for anemia in various types of cancers, however only limited studies have evaluated its benefits in advanced hormone-refractory prostate cancer (HRPC). This multi-center study investigated the influence of 2 different doses of epoetin beta on quality of life, hemoglobin level, need for blood transfusion, and safety, in the treatment of anemia in patients with metastatic HRPC. MATERIALS AND METHODS: This study randomized 180 patients to receive either epoetin beta 1000 IU or 5000 IU subcutaneously 3 times per week for 12 weeks. Hemoglobin was evaluated at study start and 6 time-points during the study. Quality of life (QoL) was assessed by the European Organization for Research and Treatment of Cancer questionnaire, QLC-C30, before treatment start and after 6 and 12 weeks of treatment. Best supportive care and blood transfusions were given, if clinically indicated. Additional laboratory values and adverse events were followed for safety. RESULTS: Hemoglobin increased significantly (>20 g/l) in 43% in the high dose (HD) group and 25% in the low dose (LD) group in response to treatment. Levels were significantly higher in the HD group than the LD group (p < 0.001) after 8 and 12 weeks. QoL improved significantly if the increase in hemoglobin was >20 g/l. Significantly more patients in the LD group received blood transfusions than the HD group (p < 0.005). There were no differences between the groups regarding overall quality of life and fatigue. The treatment was well tolerated in both groups. CONCLUSIONS: Epoetin beta is shown to be safe and effective for the treatment of anemia in many patients with HRPC. It is found to improve QoL and physical functioning, and relieve fatigue symptoms, in many of these critically ill patients.","Scand J Urol Nephrol, 35(4): 288-294","Sweden",2001,"Metastatic","Various","EORTC QLQ-C30","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General"]
[327,"Johnson, E. K., et al. (2011). \"The impact of anterior urethropexy during robotic prostatectomy on urinary and sexual outcomes.\" J Endourol 25(4): 615-619.",null,"Johnson, E. K., et al.","The impact of anterior urethropexy during robotic prostatectomy on urinary and sexual outcomes","OBJECTIVES: We determined the effect of an anterior urethropexy (AU) stitch on postoperative urinary continence, irritative urinary symptoms, and sexual function after robotic radical prostatectomy (RP). METHODS: Consecutive patients undergoing robotic RP for prostate cancer were prospectively evaluated. The Expanded Prostate Cancer Index Composite (EPIC) questionnaire was administered pre- and postoperatively to all patients. Patients were then grouped by AU status. A linear mixed model was used to compare the rate of recovery in incontinence (UIN), irritative (UIR), and sexual domain scores between the two groups. A t-test was used to compare UIN, UIR, and sexual domain scores at specific time points. RESULTS: A total of 229 patients underwent robotic RP and filled out a preoperative and at least one postoperative EPIC questionnaire. In this population, 87 did have and 142 did not have an AU performed. The mean EPIC-UIN score at 3 months was 68 in the AU group and 58 in the non-AU group (p = 0.015). Comparison of all other time points and overall urinary scores revealed no other statistically significant differences after surgery. Sexual domain scores were also improved at 3 months in the AU group (p = 0.002). CONCLUSIONS: AU during robotic RP leads to improved urinary continence and sexual functioning at 3 months of follow-up. An earlier return to continence may facilitate an earlier return to sexual activity. AU may offer a short-term quality-of-life advantage for patients undergoing robotic RP.","J Endourol, 25(4): 615-619","USA",2011,"Any or unknown","Surgery","EPIC","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease"]
[328,"Johnstone, P. A., et al. (2000). \"Quality of life in T1-3N0 prostate cancer patients treated with radiation therapy with minimum 10-year follow-up.\" Int J Radiat Oncol Biol Phys 46(4): 833-838.",null,"Johnstone, P. A., et al.","Quality of life in T1-3N0 prostate cancer patients treated with radiation therapy with minimum 10-year follow-up","PURPOSE: To describe patient-reported quality of life using a validated survey in a cohort of patients who are long-term survivors of definitive radiotherapy for T1-3N0 prostate cancer. METHODS AND MATERIALS: Survivors of a previously reported cohort of prostate cancer patients treated with staging pelvic lymphadenectomy and definitive radiotherapy between November 1974 and August 1988 were queried using a questionnaire incorporating the RAND 36-Item Health Survey and the University of California, Los Angeles Prostate Cancer Index. Responses were reviewed and analyzed. Of the 146 N0 patients, 88 have survived for 10 years postdiagnosis. Fifty-six (64%) of these patients were still alive with valid addresses and were mailed copies of the questionnaires, of which 46 (82%) responded. Median potential follow-up from date of diagnosis was 13.9 years, with a median age of responders of 80 years. RESULTS: The mean sexual function score was 15.4, with a bother score of 42. The mean urinary function score was 65, with a bother score of 61. The mean bowel function score was 72.6, with a bother score of 64.8. The amount of patient bother reported in the sexual category is similar to that previously reported for cohorts of prostate cancer patients undergoing radiotherapy or observation. This is despite the fact that sexual function was similar to that previously reported for patients postprostatectomy. Patient-reported function and bother scores in urinary and bowel categories were somewhat more severe than a previously reported radiotherapy cohort with shorter follow-up. CONCLUSIONS: With long follow-up, most patients who underwent radiotherapy for prostate cancer in the era described exhibit somewhat worse bladder, bowel, and erectile function than recently published controls without prostate cancer. In this cohort of older men with long follow-up, erectile function is similar to reported prostatectomy series. However, patient bother related to erectile function is similar to that of controls in earlier published radiotherapy series. Worse urinary and bowel function may be due to progressive symptoms with aging and longer follow-up, or to the radiotherapy techniques performed during the era in question.","Int J Radiat Oncol Biol Phys, 46(4): 833-838","USA",2000,"Survivors","Radiotherapy","SF-36,UCLA-PCI","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Utility,Disease"]
[329,"Joly, F., et al. (1998). \"Health-related quality of life and sequelae in patients treated with brachytherapy and external beam irradiation for localized prostate cancer.\" Ann Oncol 9(7): 751-757.",null,"Joly, F., et al.","Health-related quality of life and sequelae in patients treated with brachytherapy and external beam irradiation for localized prostate cancer","PURPOSE: To evaluate late physical and psychosocial sequelae in patients treated with an association of external beam irradiation (EBI) and brachytherapy (BT) for localized prostate cancer. PATIENTS AND METHODS: Seventy-one patients free of disease, treated at the Centre Francois Baclesse from 1988 to 1992, were enrolled in a case-control study. Seventy-one healthy controls, matched on age and residence, were selected at random from electoral rolls. Two self-administered questionnaires were mailed in January 1996. The French translation of the Nottingham Health Profile questionnaire and the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 core questionnaire were used to evaluate physical, role, emotional, cognitive and social functioning, global health status as well as energy and sleep disturbance. Specific problems related to prostate cancer were explored using the prostate specific module developed by the EORTC Genito-Urinary Tract Cancer Cooperative Group. Concordance between clinical complications reported by patients and those reported by physicians was also analyzed. RESULTS: General health quality of life scale scores did not significantly differ between patients and controls, nor did general symptom scale scores. Furthermore, no more late psychosocial sequelae were reported by patients than by controls. No major digestive complications were observed among patients. However, statistical differences were observed concerning interest in sex (P = 0.016) and sexual activity (P < 0.001), urinary incontinence (P < 0.001) and cystitis (P = 0.01). Late subjective morbidity (dysuria, nocturia, urinary incontinence, pelvic pain) appraisal differed slightly between patients and physicians who generally underestimate its severity. While nocturia was reported more often by physicians than by patients (P = 0.0016), patients reported urinary incontinence and pelvic pain more often than physicians (P < 0.001 and P < 0.001, respectively). CONCLUSIONS: The study demonstrates that survivors from localized prostate cancer treated with an association of BT and EBI have good global health status. Major problems that persist are sexual disorders, urinary incontinence and cystitis while digestive disorders were rare. This association could be an alternative to standard EBI in patients with localized prostate cancer. Whatever the treatment choice, patients should be involved in the therapeutic decision which should consider not only expected survival rate but also quality of life.","Ann Oncol, 9(7): 751-757","France",1998,"Local","Radiotherapy,Brachytherapy","NHP,EORTC QLQ-C30","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"General"]
[330,"Jones, J. S., et al. (2002). \"Saturation prostate biopsy with periprostatic block can be performed in office.\" J Urol 168(5): 2108-2110.",null,"Jones, J. S., et al.","Saturation prostate biopsy with periprostatic block can be performed in office","PURPOSE: Recent reports of saturation prostate biopsy performed in the operating room with the patient under anesthesia have shown increased cancer detection rates over repeat office based prostate biopsy. We report equivalent success and tolerability of saturation biopsy in the office using local anesthesia. MATERIALS AND METHODS: We performed 24 core saturation prostate biopsies in 15 patients using periprostatic local anesthesia. Before biopsy 20 cc 2% lidocaine (10 cc per side) were injected under ultrasound guidance into the periprostatic nerve entry into the prostate bilaterally. After measurements were made a random 24 core prostate biopsy was performed using a spring loaded biopsy gun. Pain was determined using a visual analog scale to assess tolerability. RESULTS: Complete 24 core biopsies were successful and well tolerated in all 15 patients. Cancer detected in 5 patients (33%) was clinical stage T1C. Mean prostate specific antigen before biopsy was 11.2 ng./dl. (range 5 to 24.1). The indication for biopsy was elevated prostate specific antigen after a previous normal biopsy in 12 patients. In 2 patients prostatic intraepithelial neoplasia was noted on a previous biopsy and in 1 previous atypia was identified on biopsy. The mean visual analog scale pain score was 0.7 (range 0 to 3). Prolonged minor hematuria greater than 5 days in duration occurred in 3 cases requiring no intervention. No other complications occurred. Nerve sparing was not more difficult in the single patient who underwent radical prostatectomy. CONCLUSIONS: Saturation prostate biopsy is well tolerated in the office setting with the patient under local anesthesia. The additional risk, time and cost of performing these procedures in the operating room using anesthesia may be safely avoided.","J Urol, 168(5): 2108-2110","USA",2002,"At risk","Screening","VAS","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Symptom"]
[331,"Jonler, M., et al. (1994). \"Sequelae of definitive radiation therapy for prostate cancer localized to the pelvis.\" Urology 44(6): 876-882.",null,"Jonler, M., et al.","Sequelae of definitive radiation therapy for prostate cancer localized to the pelvis","OBJECTIVES: To evaluate sequelae and estimate quality of life utilizing a survey instrument in 133 consecutive patients who have undergone definitive radiation therapy for localized prostate cancer. METHODS: All patients reported on have been followed for 14 to 60 months (median, 31 months) after radiation therapy and only patients with definitive prostate radiation therapy are included. Of the patients still alive at time of follow-up, 115 were mailed the questionnaire. Data regarding tumor grade and stage as well as treatment were extracted from patient files. RESULTS: Of the 91% of patients who returned the questionnaire, 11% used a pad and 13% leaked more than a few drops of urine daily. Of all the respondents, 9% stated that incontinence was a problem, and 31% found urinary leaking significantly worsened after radiation therapy compared with before their diagnosis of prostate cancer. With respect to sexual function, 77% recalled being able to have full or partial erections prior to radiation therapy. At some time after radiation therapy, 22% of previously potent respondents were able to have a full erection and 41% were able to have a partial erection. Twenty-nine percent of all patients who were able to establish an erection prior to radiation therapy reported that impotence was a problem at the time of follow-up. Forty-nine percent of patients had abdominal pain, diarrhea, or abdominal cramping during or after radiation therapy and 31% of all patients still had some intestinal symptoms at the time of follow-up. Eighteen percent of all patients were significantly bothered by one or more of these bowel problems. Overall, 31% of all patients reported a persistent degree of physical discomfort that they believed was secondary to their prostate cancer or the effect of treatment. Eighty-one percent were satisfied with radiation therapy and 97% of the patients said they would have radiation therapy again if faced with the decision. CONCLUSIONS: Utilizing a sensitive questionnaire on patients who had definitive radiation therapy for prostate cancer, we found the incidence of patients bothered by incontinence to be surprisingly frequent and higher than previously reported. The frequency of impotence is similar to previous studies. However, when our incontinence and impotence data were compared to Medicare patients who had undergone radical prostatectomy, the frequencies after radiation therapy were significantly lower. Despite the rates of sequelae, the patients were generally satisfied with the decision to undergo radiation therapy and with the medical treatment received.","Urology, 44(6): 876-882","USA",1994,"Local","Radiotherapy","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Complication"]
[332,"Jonler, M., et al. (1996). \"A prospective study of quantification of urinary incontinence and quality of life in patients undergoing radical retropubic prostatectomy.\" Urology 48(3): 433-440.",null,"Jonler, M., et al.","A prospective study of quantification of urinary incontinence and quality of life in patients undergoing radical retropubic prostatectomy","OBJECTIVES: To prospectively evaluate the level of urinary incontinence and its impact on quality of life in patients undergoing radical retropubic prostatectomy. METHODS: Patients completed a 24-hour pad test together with an incontinence and quality-of-life questionnaire before and after surgery. RESULTS: Patients were followed up for an average of 7.6 months (range 4.7 to 12.5) after radical prostatectomy. The 24-hour pad test demonstrated that 87% of patients had some incontinence at 1 month and 63% at 6 months after surgery. The median volume of urine leakage was 34 mL at the last follow-up visit; 55% of patients indicated substantial bother from incontinence at the 1-month follow-up visit and 29% at the 6-month follow-up visit. For most patients, there was a substantial discrepancy between the reported and the measured level of incontinence. Patient-reported bother regarding incontinence correlated best to the actual amount of urine loss. CONCLUSIONS: Patients become incontinent after surgery but improve over time. Seventeen percent of patients still experienced leakage of more than 150 mL daily at the last follow-up visit. The questionnaire utilized in this study identifies the presence of incontinence but was not accurate in estimating the amount of urine loss. Initially, quality of life was reduced by surgery but improved over time and nearly returned to the preoperative level.","Urology, 48(3): 433-440","USA",1996,"Any or unknown","Surgery","Unclear","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"General,Complication"]
[333,"Jonler, M., et al. (1998). \"Urinary symptoms, potency, and quality of life in patients with localized prostate cancer followed up with deferred treatment.\" Urology 52(6): 1055-1062; discussion 1063.",null,"Jonler, M., et al.","Urinary symptoms, potency, and quality of life in patients with localized prostate cancer followed up with deferred treatment","OBJECTIVES: To evaluate urinary symptoms, potency, and quality of life in a group of patients with prostate cancer followed up with deferred treatment. METHODS: A self-administered questionnaire was mailed to patients with localized prostate cancer who were followed up with deferred treatment. Data regarding clinical stage, pathologic grade, and treatment after diagnosis were obtained from patient files. RESULTS: A total of 71 consecutive patients (age 79 years or less) were included. Of the 52 patients (73%) who responded, 31% had undergone transurethral resection of the prostate, 8% underwent radiation therapy, and 44% underwent hormonal deprivation during the follow-up period. With respect to incontinence, 21% were using pads and 37% leaked urine daily; in 21% of the patients, urine dripping or leaking was a substantial problem. Before the diagnosis of their prostate cancer, 81% stated they were able to have an erection. At the time of the questionnaire, 77% stated that their ability to have erections was reduced and only 29% had had an erection after the prostate cancer was diagnosed. For 12%, impotence was a problem. With respect to quality of life, 52% of the patients rated their health as excellent or good and 61% would be happy to spend the rest of their life feeling the way they did at the time of the questionnaire. Eighty-five percent were satisfied with the treatment policy for their prostate cancer, and 96% would choose deferred treatment again if faced with the decision. CONCLUSIONS: By use of a self-administered questionnaire, a high frequency of incontinence and impotence was found in a group of patients with prostate cancer followed up with deferred treatment. Despite these problems, more than half of the patients rated their health as good and would undergo expectant management again if faced with the decision.","Urology, 52(6): 1055-1062; discussion 1063","Denmark",1998,"Local","Surgery,Radiotherapy,Hormonal","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Complication"]
[334,"Jonler, M., et al. (2005). \"Quality of life in patients with skeletal metastases of prostate cancer and status prior to start of endocrine therapy: results from the Scandinavian Prostate Cancer Group Study 5.\" Scand J Urol Nephrol 39(1): 42-48.",null,"Jonler, M., et al.","Quality of life in patients with skeletal metastases of prostate cancer and status prior to start of endocrine therapy: results from the Scandinavian Prostate Cancer Group Study 5","OBJECTIVES: Prostate cancer (PC) is a highly lethal neoplastic disease affecting the physical, mental and social well-being of patients, i.e. their quality of life (QOL). Patients suffering from metastatic PC are faced with serious decisions regarding treatment strategies. Therefore, QOL information has become a crucial element of decision making in this group of patients. The first objective of this study was to describe QOL in a group of patients diagnosed with metastatic PC and skeletal metastases. At the time of evaluation the patients had not received any treatment but were evaluated before entering a study of androgen-modulating therapy (the Scandinavian Prostate Cancer Group study 5). The second objective was to identify demographic and disease-related factors affecting QOL. MATERIAL AND METHODS: A total of 917 patients with metastatic PC were evaluated using a well-described and validated questionnaire [European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-C30 (EORTC QLQ-C30)]. The characteristics of the PC were noted, and simultaneously patients were evaluated with respect to use of analgesics, pain and performance status using a scoring system. Biochemical tests were performed when patients entered the study. A multivariate regression analysis was performed to analyse the correlations between QOL scores, patient demographics and disease-related data. RESULTS: The patients reported QOL scores significantly lower than those in the background population. Pain and fatigue were pronounced, whereas dyspnoea, insomnia, loss of appetite, constipation and diarrhoea were less prominent. Patients with high tumour grades, high PSPA scores (the sum of the pain score, the performance status and the use of analgesics) and those using analgesics had significantly lower QOL scores than the other patients. CONCLUSIONS: Patients with metastatic PC have reduced QOL. Our findings are in line with those of other studies of QOL among patients with this disease as evaluated by means of the EORTC QLQ-C30 questionnaire. Baseline data from studies like this provide important information when treatment modalities for PC are evaluated.","Scand J Urol Nephrol, 39(1): 42-48","Denmark",2005,"Metastatic","Hormonal","EORTC QLQ-C30","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General"]
[335,"Joshi, N., et al. (2010). \"Impact of posterior musculofascial reconstruction on early continence after robot-assisted laparoscopic radical prostatectomy: results of a prospective parallel group trial.\" Eur Urol 58(1): 84-89.",null,"Joshi, N., et al.","Impact of posterior musculofascial reconstruction on early continence after robot-assisted laparoscopic radical prostatectomy: results of a prospective parallel group trial","BACKGROUND: A significant proportion of patients develop urinary incontinence early after radical prostatectomy. Posterior reconstruction of supporting tissues has been found to reduce incontinence in open and conventional laparoscopic prostatectomy series. OBJECTIVE: To investigate whether our version of a posterior musculofascial reconstruction will reduce early incontinence and have a beneficial effect on patients' quality of life (QoL). DESIGN, SETTING, AND PARTICIPANTS: One hundred seven consecutive patients undergoing primary robot-assisted radical laparoscopic prostatectomy (RALP) performed by a single surgeon at one tertiary referral oncology institution were alternately assigned (not randomised) to intervention (n=53) or control groups (n=54). SURGICAL PROCEDURE: RALP with median fibrous raphe reconstruction (MFRR) followed by formation of the urethrovesical anastomosis (intervention group) versus standard anastomosis without posterior reconstruction (control group). MEASUREMENTS: Measurements included incontinence at baseline and 3-mo intervals; QoL as measured by a simple questionnaire, the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life-Core 30 (QLQ-C30), and Prostate Cancer Module (PR25) questionnaires preoperatively and at 6 mo postprocedure; tumour characteristics; operative time; fascial preservation score; duration of catheterisation; and anastomotic leakage on cystogram. RESULTS AND LIMITATIONS: For intervention and control groups respectively, mean catheter duration was 11.74 d and 12.74 d (p=0.451); leakage on cystogram was present in six and eight cases (p=0.28); and incontinence (any involuntary urine loss) at 3 mo was 75% and 69% (p=0.391) and at 6 mo was 51% and 43% (p=0.686). Urinary retention occurred only in one case (control group). The percentage of cases returning to baseline in all QoL domains (except insomnia) was similar at 6 mo between the two groups. Short follow-up, lack of blinding, and probable small differences in our method of MFRR performed compared with other studies were identified as significant limitations. CONCLUSIONS: No significant difference in any of the analysed outcome measures was observed. Posterior reconstruction of the musculofascial complex does not appear to improve early urinary incontinence after RALP.","Eur Urol, 58(1): 84-89","Netherlands",2010,"Any or unknown","Surgery","EORTC QLQ-C30,EORTC QLQ-PR25","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,General"]
[336,"Kakehi, Y., et al. (2002). \"Development of Japanese version of the UCLA Prostate Cancer Index: a pilot validation study.\" Int J Clin Oncol 7(5): 306-311.",null,"Kakehi, Y., et al.","Development of Japanese version of the UCLA Prostate Cancer Index: a pilot validation study","METHODS: The Japanese version (version 1.2) of the UCLA PCI was developed through a process of translation, back-translation, and refinement after interviewing patients. Reliability and validity were examined for 125 Japanese patients with localized prostate cancer. The patients simultaneously responded to the Japanese version of the RAND 36-Item Health Survey (SF-36) and five representative questions from the International Index of Erectile Function (IIEF). RESULTS: Internal consistency reliability was very high for both urinary and sexual function scales, and lower for bowel function. The test-retest reliability of the urinary and sexual function scales and the urinary bother scales was stable, while that of the bowel function and bother scales was relatively unstable. Sexual function scores did not correlate highly with sexual bother scores. Furthermore, poor sexual function and bother had little association with the SF-36 scores. Missing data as to urinary and bowel function/bother scales were minimal (0.8%-2.4%), while those for sexual function and bother were relatively high (4.8%-11.2%). CONCLUSIONS: The results of this pilot study, together with the previous American study, suggest ethnic or cultural difference in how impaired sexual function is integrated into overall QOL. A future cross-cultural comparative study using the UCLA PCI and SF-36 will provide useful information about the influence of cultural or ethnic differences on health-related QOL in prostate cancer patients.","Int J Clin Oncol, 7(5): 306-311","Japan",2002,"Local","None","UCLA-PCI,SF-36,IIEF-5","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease,Complication,Utility"]
[337,"Kalkner, K. M., et al. (1998). \"Pain figures are unsuitable for determination of palliative radiotherapy portals in patients with hormone refractory prostatic cancer.\" Anticancer Res 18(3b): 1983-1987.",null,"Kalkner, K. M., et al.","Pain figures are unsuitable for determination of palliative radiotherapy portals in patients with hormone refractory prostatic cancer","We aimed to compare bone scintigraphy with pain extension and other quality of life (QoL) factors in order to evaluate QoL and the appropriateness of using pain figures and a subjective pain description as the basis for palliative radiotherapy (RT) portals. Twenty-three patients with progressive hormone-refractory prostatic adenocarcinoma were investigated with bone scintigraphy and completed pain figures, VAS (visual analogue scales) and a comprehensive self-questionnaire concerning QoL. The Soloway score was significantly correlated with Impaired overall QoL (p = 0.05), and especially with questions regarding restriction of movements (p = 0.001). Weight bearing regions were significantly more often affected at bone scintigraphy than other locations in the group of patients reporting incidental pain during exercise. Surprisingly, a poor level of correlation existed when comparing location of pain with location of uptake on bone scintigraphy, even if an adjacent region was included in the comparison. The subjective description of pain extension in pain figures correlates poorly with the uptake patterns at bone scintigraphy--an interesting finding since pain extensions is regularly used for the definition of palliative RT portals. Furthermore, it appears that the tumour burden itself is not and indicator of the pain score at rest, but affects aspects of QoL. Moreover, it would appears as though the location of metastases in the skeleton significantly affects physical quality of life aspects. It is probably more important to irradiate weight bearing regions of skeleton in order to increase QoL.","Anticancer Res, 18(3b): 1983-1987","Sweden",1998,"Metastatic","Radiotherapy","VAS","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Symptom,General"]
[338,"Kang, S. G., et al. (2011). \"Efficacy and cost analysis of transrectal ultrasound-guided prostate biopsy under monitored anesthesia.\" Asian J Androl 13(5): 724-727.",null,"Kang, S. G., et al.","Efficacy and cost analysis of transrectal ultrasound-guided prostate biopsy under monitored anesthesia","Sedation may result in reduction in pain during transrectal ultrasound (TRUS)-guided prostate biopsies. We aimed to evaluate the efficacy and safety of a combination of propofol and remifentanil infusion during TRUS-guided prostate biopsy and the related increases in health care costs. From January to September 2010, 100 men undergoing a transrectal prostate biopsy were randomized into two groups. In Group 1, 50 patients received a combined infusion of propofol and remifentanil; in Group 2, 50 patients received lidocaine jelly. After TRUS-guided biopsies were performed, pain and patient satisfaction were evaluated by a 10-point visual analog scale (VAS), and a cost-related patient satisfaction questionnaire was completed by all patients. Patients were also asked whether they would be willing to undergo repeat biopsy by the same method. Patients in Group 1 showed a significantly lower VAS score than those in Group 2 (mean VAS score: 0.9+/-1.1 versus 6.3+/-2.5; P<0.001). In addition, the patient satisfaction scale was significantly higher in Group 1 (P=0.002). Although the overall cost was significantly higher in Group 1 (P=0.006), patient satisfaction scales considering cost were also higher in this group (P=0.009). A combination of propofol and remifentanil is a safe and effective way to decrease patient pain and increase patient satisfaction during TRUS-guided prostate biopsy. Although the costs were higher in the group that received sedation, as expected, the patients exhibited heightened satisfaction and willingness to repeat biopsies by the same method.","Asian J Androl, 13(5): 724-727","Korea",2011,"At risk","Screening","VAS","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Symptom,Costs"]
[339,"Kantrowitz, W., et al. (1995). \"Prostate cancer screening in a large corporation population.\" J Occup Environ Med 37(10): 1193-1198.",null,"Kantrowitz, W., et al.","Prostate cancer screening in a large corporation population","The Polaroid Medical Department conducted a prostate cancer screening program of all male employees over the age of 49 years. The screening consisted of a World Health Organization (WHO) questionnaire, a digital rectal examination (DRE) by an occupational medicine doctor, and a serum prostate-specific antigen (PSA) study. There were 2241 eligible employees (males between 50 and 65 years of age). 1219 (54%) took part in the screening. Thirty-seven PSAs above the 3.9 level were found (3%) and were further evaluated with ultrasound and/or biopsy. Twelve previously unknown cancers of the prostate (1%) were discovered. The cost of the entire program to the Polaroid Medical Department, including ultrasound and biopsy studies, was $72,130 ($6,012 per cancer detected). Of the 12 cancers, two were discovered by abnormal DRE alone, eight by an elevated PSA alone, and two by both an abnormal DRE and elevated PSA. There appeared to be no correlation between the WHO symptom score and the detection of prostate cancer. Our final conclusion was that a corporate medical department screening for cancer of the prostate is both effective and cost efficient.","J Occup Environ Med, 37(10): 1193-1198","USA",1995,"At risk","Screening","WHOQOL-BREF","General population",null,"Clinical trial",null,null,null,null,null,null,null,null,"General"]
[340,"Kao, T. C., et al. (2000). \"Multicenter patient self-reporting questionnaire on impotence, incontinence and stricture after radical prostatectomy.\" J Urol 163(3): 858-864.",null,"Kao, T. C., et al.","Multicenter patient self-reporting questionnaire on impotence, incontinence and stricture after radical prostatectomy","PURPOSE: We determined the incidence of patient self-reported post-prostatectomy incontinence, impotence, bladder neck contracture and/or urethral stricture, sexual function satisfaction, quality of life and willingness to undergo treatment again in a large multicenter group of men who underwent radical prostatectomy. We also determined whether the morbidities of sexual function satisfaction, quality of life and bladder neck contracture and/or urethral stricture are predictable from demographic and postoperative prostate cancer factors. MATERIALS AND METHODS: A self-reporting questionnaire was completed and returned by 1,069 of 1,396 eligible patients (77%) who underwent radical prostatectomy between 1962 and 1997. Of the respondents 868 (85.7%) underwent surgery after 1990 and in all prostatectomy had been done a minimum of 6 months previously. Questionnaire results were independently analyzed by a third party for morbidity tabulation and the association of patient reported satisfaction. RESULTS: The patient self-reported incidence of any degree of post-prostatectomy incontinence, impotence and bladder neck contracture or urethral stricture was 65.6%, 88.4% and 20.5%, respectively. The incidence of incontinence requiring protection was 33% and only 2.8% of respondents had persistent bladder neck contracture or urethral stricture. Although incontinence and impotence significantly affected self-reported sexual function satisfaction, quality of life and willingness to undergo treatment again (p = 0.001), 77.5% of patients would elect surgery again. This finding remained true even after adjusting for demographic variables, and the time between surgery and the survey by multiple logistic regression. CONCLUSIONS: Although radical prostatectomy morbidity is common and affects self-reported overall quality of life, most patients would elect the same treatment again. Impotence and post-prostatectomy incontinence were significantly associated with sexual function satisfaction, quality of life and willingness to undergo treatment again. Bladder neck contracture and/or urethral stricture was associated with willingness to undergo treatment again after adjusting for demographic variables and time from surgery to the survey.","J Urol, 163(3): 858-864","USA",2000,"Any or unknown","Surgery","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Complication"]
[341,"Karakiewicz, P. I., et al. (2003). \"Cross-cultural validation of the UCLA prostate cancer index.\" Urology 61(2): 302-307.",null,"Karakiewicz, P. I., et al.","Cross-cultural validation of the UCLA prostate cancer index","OBJECTIVES: To explore the impact of cross-cultural differences on University of California, Los Angeles, Prostate Cancer Index (PCI) reliability and validity, which is unknown. The PCI represents the most widely used prostate cancer-specific health-related quality-of-life assessment tool. METHODS: The PCI sexual and urinary scales, the RAND SF-36 survey, and the Prostate Outcomes Research Team (PORT) prostate cancer treatment complication profile were self-administered. The principal sample consisted of 2415 men (anglophone 256, francophone 2159) treated with radical prostatectomy in Quebec between 1988 and 1996. An additional 35 men (anglophone 17, francophone 18) formed the retest sample. RESULTS: The PCI demonstrated excellent internal consistency and test-retest reliability in tests based on the entire cohort and in tests addressing the two linguistically different groups. The instrument showed a lack of convergence with the SF-36 scales, confirming the distinctness of the generic and prostate cancer-specific constructs. The PCI sexual scales converged with the aggregate PORT sexual items (r = 0.8), and the PCI urinary scales were strongly related to the aggregate PORT urinary items (r = 0.7). Convergence between PCI urinary bother and function was strong (r = 0.8), but only moderate convergence was noted between PCI sexual bother and function (r = 0.4). The relation between bother and function in both urinary and sexual domains was weaker in anglophone participants relative to their francophone counterparts. CONCLUSIONS: The PCI is reliable and, at best, only modestly affected by cultural differences when administered to culturally distinct English-speaking men or when translated into French.","Urology, 61(2): 302-307","USA",2003,"Any or unknown","Surgery","SF-36,UCLA-PCI,PORT","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease,Utility,Treatment"]
[342,"Karakiewicz, P. I., et al. (2004). \"Erectile and urinary dysfunction after radical prostatectomy for prostate cancer in Quebec: a population-based study of 2415 men.\" Eur Urol 46(2): 188-194.",null,"Karakiewicz, P. I., et al.","Erectile and urinary dysfunction after radical prostatectomy for prostate cancer in Quebec: a population-based study of 2415 men","OBJECTIVE: To assess and quantify urinary and sexual function outcomes from a large scale cohort of Canadian men treated for localized prostate cancer. METHODS: A self-administered survey focusing on erectile (ED) and urinary dysfunction (UD) was completed by 2415 of 4546 men (response rate 53.1%) treated with prostatectomy for prostate cancer in the Province of Quebec between 1988 and 1996. The time between treatment and survey completion ranged from 17 months to 8.5 years. RESULTS: After prostatectomy, of 2227 men without ED before surgery, erections of adequate firmness for intercourse were reported by 25%. ED rate increased with age and ranged from 55% in men aged <60 years to 85% in men 75 years or older. Of all, 19.1% reported ED treatment. ED rate was significantly related to UD severity. Severe UD, quantified as urinary leakage exceeding one tablespoon, was reported by 6.6%. Severe UD rate ranged from 4% in men aged <60 years to 10% in men 75 years or older. Strictures were reported by 16.3% and were associated with a two-fold increase in severe UD rate (p<0.001). Finally, age and socioeconomic status represented important predictor variables in univariate and multivariate regression models. CONCLUSION: ED rate of 75% and severe UD rate of 6.6% could be anticipated after RP. These outcomes are similar to unselected large scale, patient reported outcomes from the United States.","Eur Urol, 46(2): 188-194","Canada",2004,"Local","Surgery","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Complication"]
[343,"Katz, A., et al. (2012). \"Comparison of quality of life after stereotactic body radiotherapy and surgery for early-stage prostate cancer.\" Radiat Oncol 7: 194.",null,"Katz, A., et al.","Comparison of quality of life after stereotactic body radiotherapy and surgery for early-stage prostate cancer","BACKGROUND: As the long-term efficacy of stereotactic body radiation therapy (SBRT) becomes established and other prostate cancer treatment approaches are refined and improved, examination of quality of life (QOL) following prostate cancer treatment is critical in driving both patient and clinical treatment decisions. We present the first study to compare QOL after SBRT and radical prostatectomy, with QOL assessed at approximately the same times pre- and post-treatment and using the same validated QOL instrument. METHODS: Patients with clinically localized prostate cancer were treated with either radical prostatectomy (n = 123 Spanish patients) or SBRT (n = 216 American patients). QOL was assessed using the Expanded Prostate Cancer Index Composite (EPIC) grouped into urinary, sexual, and bowel domains. For comparison purposes, SBRT EPIC data at baseline, 3 weeks, 5, 11, 24, and 36 months were compared to surgery data at baseline, 1, 6, 12, 24, and 36 months. Differences in patient characteristics between the two groups were assessed using Chi-squared tests for categorical variables and t-tests for continuous variables. Generalized estimating equation (GEE) models were constructed for each EPIC scale to account for correlation among repeated measures and used to assess the effect of treatment on QOL. RESULTS: The largest differences in QOL occurred in the first 1-6 months after treatment, with larger declines following surgery in urinary and sexual QOL as compared to SBRT, and a larger decline in bowel QOL following SBRT as compared to surgery. Long-term urinary and sexual QOL declines remained clinically significantly lower for surgery patients but not for SBRT patients. CONCLUSIONS: Overall, these results may have implications for patient and physician clinical decision making which are often influenced by QOL. These differences in sexual, urinary and bowel QOL should be closely considered in selecting the right treatment, especially in evaluating the value of non-invasive treatments, such as SBRT.","Radiat Oncol, 7(194","USA",2012,"Local","Surgery,Radiotherapy","EPIC","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease"]
[344,"Katz, D., et al. (2002). \"Sociodemographic characteristics and health related quality of life in men attending prostate cancer support groups.\" J Urol 168(5): 2092-2096.",null,"Katz, D., et al.","Sociodemographic characteristics and health related quality of life in men attending prostate cancer support groups","PURPOSE: Prostate cancer can be associated with anxiety, depression and fears of recurrence and side effects of treatment. Support groups may help meet the needs of patients with cancer by providing treatment information and emotional support. We describe men in prostate cancer support groups and compare them to a national registry. METHODS AND METHODS: Men attending prostate cancer support groups in the San Francisco Bay area completed a questionnaire including sociodemographic and clinical characteristics, health related quality of life items, satisfaction with treatment, relief of prostate cancer symptoms and bother from perceived side effects of treatment. Patients in support groups were compared to men enrolled in a national prostate cancer registry (Cancer of the Prostate Strategic Urological Research Endeavor). RESULTS: Men attending support groups had higher annual income and education levels, lower median serum prostate specific antigen and higher cancer grades than men in Cancer of the Prostate Strategic Urological Research Endeavor. Clinical stage was comparable for the 2 groups. Men in support groups were satisfied with treatment and alleviation from symptoms. Adjusting for ethnicity, marital status, age and type of treatment, sexual function scores were higher in men who attended support groups (p = 0.001). There was no statistically significant difference in bowel and urinary function between groups, although urinary function approached statistical significance at p = 0.05. Sexual and bowel bother scores indicated less bother for men in support groups (p < or = 0.025). CONCLUSIONS: Men enrolled in support groups have unique sociodemographic characteristics. Their health related quality of life appears to be better than that of other men with prostate cancer. Whether this is related to support group participation is not known. Additional studies are required to determine whether routine support group participation improves outcomes in men with prostate cancer.","J Urol, 168(5): 2092-2096","USA",2002,"Any or unknown","None","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"General,Symptom,Satisfaction,Treatment"]
[345,"Katz, G. and R. Rodriguez (2001). \"Use of a modified American Urological Association Symptom Score for the evaluation of the quality of life of patients with prostate cancer.\" Urology 57(1): 112-116.",null,"Katz, G. and R. Rodriguez","Use of a modified American Urological Association Symptom Score for the evaluation of the quality of life of patients with prostate cancer","OBJECTIVES: To present our experience with the clinical use of a modified American Urological Association Symptom Score (AUASS) and a quality-of-life (QOL) questionnaire in obtaining clinically available information and to investigate whether a relatively short questionnaire, administered in the clinic, can help in identifying symptoms and QOL issues associated with various types of definitive treatments (DTs) for prostate cancer (PCa) and its impact on patients' QOL. METHODS: The AUASS was modified to contain questions on continence and was combined with a short QOL questionnaire. It was administered to control groups and all patients with PCa during their clinic visit. The responses were analyzed and correlated with the DT of PCa. RESULTS: The questionnaire was administered 846 times to 375 patients with PCa and to 170 controls during clinic visits. We found that patients on watchful waiting had symptom scores and QOL responses similar to controls and that DT was associated with worse scores and a reduced QOL. DT with continence was associated with a better QOL than DT with incontinence. Incontinence of either urine or stool, among DT patients, had similar adverse impact on QOL, compared with continent DT patients. CONCLUSIONS: The questionnaire, administered in a clinical setting, provides insight into the QOL and symptoms associated with interventions aimed at curing PCa. The use of such a questionnaire enhances the objective documentation of treatment outcomes of PCa and benefits the patients by increasing their opportunities to express their problems.","Urology, 57(1): 112-116","USA",2001,"Any or unknown","None","AUA-SI","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Symptom"]
[346,"Katz, G. and R. Rodriguez (2007). \"Changes in continence and health-related quality of life after curative treatment and watchful waiting of prostate cancer.\" Urology 69(6): 1157-1160.",null,"Katz, G. and R. Rodriguez","Changes in continence and health-related quality of life after curative treatment and watchful waiting of prostate cancer","OBJECTIVES: To investigate the long-term changes in health-related quality of life (HRQOL), continence, and sexual function after curative therapy (CT) and watchful waiting (WW) for prostate cancer. METHODS: A self-reported questionnaire of HRQOL and continence was administered to patients with prostate cancer who were candidates for CT and WW. The questionnaire was re-administered during follow-up. The pretreatment and posttreatment HRQOL burden scores were compared and correlated with the treatment, continence, and sexual function. RESULTS: Of the 61 patients, 41 chose CT (26 chose prostatectomy and 15 radiotherapy). The average follow-up for the CT patients was 24.3 +/- 13.3 months. The pretreatment incontinence score was 0.38 +/- 0.9 and the HRQOL burden score was 16.3 +/- 8.8 (CT versus WW, P = 0.55). On follow-up, 23 (56%) of 41 CT patients were continent. The HRQOL burden score after treatment was similar between the CT and WW patients (20.4 +/- 9.6 versus 18.4 +/- 9.0, P = 0.45). The continent patients had a significantly lower HRQOL burden compared with the post-CT incontinent patients (17.41 +/- 7.4 versus 24.2 +/- 10.8, P = 0.02). The HRQOL burden score after treatment for CT patients who maintained sexual activity and CT patients who lost their sexual activity was similar (P = 0.28). CONCLUSIONS: The HRQOL after CT of prostate cancer was related to patients' self-perception of continence. Incontinence, either urinary or fecal, was associated with an increased self-reported HRQOL burden, although reduced sexual function was not associated with such a change. The WW patients maintain their HRQOL. Separating the continent and incontinent patients during the analysis of the posttreatment HRQOL brought to light the adverse outcomes associated with post-CT incontinence.","Urology, 69(6): 1157-1160","USA",2007,"Any or unknown","Surgery,Radiotherapy,Surveillance","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General,Complication"]
[347,"Katz, R., et al. (2002). \"Patient reported sexual function following laparoscopic radical prostatectomy.\" J Urol 168(5): 2078-2082.",null,"Katz, R., et al.","Patient reported sexual function following laparoscopic radical prostatectomy","PURPOSE: We evaluated the sexual function of patients who underwent laparoscopic radical prostatectomy. We assessed the effect of unilateral or bilateral preservation of the neurovascular bundle on the ability to achieve erections and have sexual intercourse postoperatively. MATERIAL AND METHODS: Between May 1998 and September 2001, 232 men underwent laparoscopic radical prostatectomy for localized prostate cancer at our institution. Sexual function questionnaires were given to the patients preoperatively. The study included 143 patients who were potent preoperatively. After the procedure the surgeon noted whether he performed unilateral, bilateral or no nerve sparing. Sexual function questionnaires were collected at 1, 3, 6 and 12 months after surgery. RESULTS: Of the 143 patients, 100, 80, 48 and 26 responded to the questionnaire at 1, 3, 6 and 12 months respectively. Of the nonnerve sparing group 11.7%, 11.1%, 16.6% and 30%, of the unilateral nerve sparing group 20%, 35%, 41.6% and 50% and of the bilateral nerve sparing group 32.5%, 41.1%, 29.1% and 87.5% respectively reported spontaneous erections 1, 3, 6 and 12 months after surgery, respectively. The overall incidence of positive lateral surgical margins in pT2 cases treated with a nerve sparing procedure was 8.4%. CONCLUSIONS: The overall rate of patients who had erections preoperatively and maintained erections after surgery (53.8%) is comparable to the results for open surgery. Patients with bilateral preservation did better than those with unilateral preservation. Our preliminary results show a promising rate of potency at 1 year after laparoscopic radical prostatectomy.","J Urol, 168(5): 2078-2082","France",2002,"Local","Surgery","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Complication"]
[348,"Keller, L. M., et al. (2012). \"Stamp test delivers message on erectile dysfunction after high-dose intensity-modulated radiotherapy for prostate cancer.\" Urology 80(2): 337-342.",null,"Keller, L. M., et al.","Stamp test delivers message on erectile dysfunction after high-dose intensity-modulated radiotherapy for prostate cancer","OBJECTIVE: To evaluate erectile function after high-dose radiotherapy for prostate cancer using the International Index of Erectile Function, Expanded Prostate Cancer Index Composite, and stamp test. METHODS: Men with favorable and intermediate-risk prostate cancer were assigned to receive prostate intensity-modulated radiotherapy (IMRT) versus an erectile tissue-sparing IMRT technique in a Phase III randomized, prospective study. The stamp test and International Index of Erectile Function and Expanded Prostate Cancer Index Composite questionnaires were completed at baseline and 6 months, 1 year, and 2 years after IMRT. The Sexual Health Inventory for Men scores were abstracted from the International Index of Erectile Function questionnaire. A partner questionnaire, designated IIEF-P, modeled after the International Index of Erectile Function questionnaire but from the perspective of the partner, was also collected. RESULTS: The data from 94 men who were enrolled in the trial and who had completed >/=1 questionnaire or 1 stamp test were analyzed. The median age of the patient population was 62.5 years. The median radiation dose was 76 Gy (range 74-80). At 6 months and 1 year after high-dose IMRT, a positive stamp result correlated significantly with the median Expanded Prostate Cancer Index Composite sexual summary, sexual function, and bother subscale scores. Additionally, 6 months after IMRT, the stamp test correlated with the median International Index of Erectile Function, International Index of Erectile Function sexual function domain, and Sexual Health Inventory for Men scores. Robust concordance for the International Index of Erectile Function and Sexual Health Inventory for Men scores was appreciated between responding patient and partner pairs. CONCLUSION: Nocturnal tumescence, as indicated by a positive stamp test, correlated well with established quality of life questionnaires after IMRT. The stamp test should strongly be considered as an objective measure of erectile function in future studies of erectile dysfunction in patients with prostate cancer.","Urology, 80(2): 337-342","USA",2012,"Any or unknown","Radiotherapy","EPIC,IIEF-5,SHIM","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease,Complication"]
[349,"Kendel, F., et al. (2016). \"Patients' perceptions of mortality risk for localized prostate cancer vary markedly depending on their treatment strategy.\" Int J Cancer 139(4): 749-753.",null,"Kendel, F., et al.","Patients' perceptions of mortality risk for localized prostate cancer vary markedly depending on their treatment strategy","Treatment choice for localized prostate cancer (PCa) is a controversial issue, and mortality risk is probably the most decisive factor in this regard. The study aimed to compare prostate-cancer-specific mortality risk estimates for different treatment options assigned by patients managed with active surveillance (AS), radical prostatectomy (RP) and patients who had discontinued AS (DAS). Patients initially managed with AS or RP (N = 370) were matched according to length of therapy. All patients completed mailed questionnaires assessing their mortality risk estimates (in %) and prostate-cancer-specific anxiety. Differences in risk estimates among the three treatment groups were analyzed using ANOVA, relationships of clinical and psychosocial variables with risk estimates using standard multiple regression. In all treatment groups, the prostate- cancer-specific mortality risk was overestimated. This applied whether it was the patient's own treatment or the alternative treatment option. RP patients assigned a mortality risk to AS that was almost three times higher than that assigned to RP (50.9 +/- 25.0 vs. 17.8 +/- 19.7, d = 1.48; p < 0.001). Anxiety was significantly associated with risk estimates for AS (p = 0.008) and RP (p = 0.001). Compared with clinical data that suggest that the prostate-cancer-specific mortality risk for AS is low and does not significantly differ from that for RP, patients strongly overestimated the mortality risk. This was most markedly so in RP patients, who drastically overestimated the benefits of RP compared to the risk of AS. This overestimation could increase overtreatment and should therefore be corrected by better patient education.","Int J Cancer, 139(4): 749-753","Germany",2016,"Local","Surgery,Surveillance","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Comorbidity"]
[350,"Keogh, J. W., et al. (2010). \"Predictors of physical activity and quality of life in New Zealand prostate cancer survivors undergoing androgen-deprivation therapy.\" N Z Med J 123(1325): 20-29.",null,"Keogh, J. W., et al.","Predictors of physical activity and quality of life in New Zealand prostate cancer survivors undergoing androgen-deprivation therapy","AIMS: The aims of this study were to: quantify the levels and predictors of physical activity in prostate cancer survivors on androgen-deprivation therapy (ADT); gain some insight into the effect of physical activity on the quality of life of prostate cancer survivors on ADT; and compare the quality of life of prostate cancer survivors on ADT with matched controls. METHODS: A sample of 84 prostate cancer survivors on ADT were recruited from a register held by the Auckland District Health Board. Participants were mailed a collection of self-report surveys probing quality of life, physical activity and determinants of physical activity. RESULT: Less than half the prostate cancer sample were categorised as physically active, and there was no relationship between physical activity and age, PSA levels, or time on ADT. Compared to a matched control group the sample had lower scores for global quality of life, as well as on the physical and environmental quality of life domains. Results also showed that those prostate cancer survivors classified as active had higher levels of quality of life on average than those classified as insufficiently active. Attitude towards physical activity was the dominant predictor of the intention to be physically active, while perceived behavioural control was the dominant predictor of actual behaviour. CONCLUSIONS: Our findings describe a positive relationship between physical activity and quality of life in men with prostate cancer currently undergoing ADT. However, only half the sample was physically active, indicating that physical activity interventions aimed at prostate cancer survivors are of utility. Our data suggests targeting both attitudes and factors related to the ability to perform physical activity will be fruitful approaches.","N Z Med J, 123(1325): 20-29","New Zealand",2010,"Survivors","Hormonal","Unclear","Patient",null,"Case-control",null,null,null,null,null,null,null,null,"General"]
[351,"Kim, S. P., et al. (1999). \"QOL and outcomes research in prostate cancer patients with low socioeconomic status.\" Oncology (Williston Park) 13(6): 823-832; discussion 835-828.",null,"Kim, S. P., et al.","QOL and outcomes research in prostate cancer patients with low socioeconomic status","The VA Cancer of the Prostate Outcomes Study (VA CaPOS) is collecting quality-of-life (QOL) information from prostate cancer patients, spouses, and physicians at six VA medical centers. Currently, 601 men with prostate cancer are included in the study, most of whom are of low socioeconomic status and over half of whom are African-American. Quality-of-life responses were most favorable for newly diagnosed patients, intermediate for those with stable metastatic disease, and poorest for those with progressive metastatic disease. Patients could not provide reliable estimates of their own preferences for future QOL states but responded reliably to questions phrased as a comparison of the preferences of two hypothetical patients. High out-of-pocket costs for hormonal therapies, lack of health insurance, and a belief that the non-VA system offered poorer services were the most common reasons for patient transferral to the VA system. Satisfaction with medical care was generally high. While African-American patients were more likely to have advanced prostate cancer at diagnosis, after adjustment for differences in health literacy, race was no longer a significant predictor of advanced disease. The VA CaPOS provides useful information on health status and patient satisfaction of VA prostate cancer patients. Long-term evaluations are needed to detect clinically meaningful QOL information as the disease progresses.","Oncology (Williston Park), 13(6): 823-832; discussion 835-828","USA",1999,"Any or unknown","None","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"General"]
[352,"Kim, S. P., et al. (2001). \"Health literacy and shared decision making for prostate cancer patients with low socioeconomic status.\" Cancer Invest 19(7): 684-691.",null,"Kim, S. P., et al.","Health literacy and shared decision making for prostate cancer patients with low socioeconomic status","Quality of life (QOL) considerations are important in the treatment decision making process for prostate cancer patients. Although patient involvement in the treatment decision process has been encouraged, low health literacy can limit patient understanding of the complex information about treatments and their probable QOL outcomes and is a barrier to patient participation in the decision-making process. The objectives of the study were to evaluate (i) knowledge, level of satisfaction, and treatment preferences and intentions of men newly diagnosed with prostate cancer after participation in a CD-ROM shared decision making program; and (ii) the relationship between prostate cancer knowledge and health literacy. Thirty newly diagnosed prostate cancer patients from two Veteran's Administration (VA) hospitals in Chicago completed a demographic questionnaire and participated in an interactive CD-ROM shared decision making program. Subsequently, knowledge of prostate cancer, satisfaction with the information in the computer CD-ROM program, treatment preferences, and likelihood of following treatment preferences were assessed using interviewer-administered questionnaires. Health literacy was assessed using the Rapid Estimate of Adult Literacy in Medicine (REALM). The Pearson correlation test was used to assess the relationship between health literacy and prostate cancer knowledge. The chi2 test and the Fischer exact test were used to evaluate relationships between patient demographics and other variables. More than three-quarters of the patients rated the information in the CD-ROM as \"very satisfactory\" (highest possible rating). Two-thirds of the patients (21 of 30) selected a treatment after participation in the CD-ROM program and 90.5% of these patients stated that they were very or somewhat likely to adhere to their selection. However, prostate cancer knowledge was variable, with one-third of the patients scoring 69.9% or lower. Participants' health literacy was equivalent to a 7th-8th grade reading level (mean = 57.1+/-10.9), and more than one-third of participants (36.7%) had lower than 9th grade literacy levels. Participants' prostate cancer knowledge was correlated with health literacy (Pearson correlation rhor = 0.65, rhop = 0.0001). Patients were satisfied with the interactive shared decision making CD-ROM program, and two-thirds of patients were able to select a preferred treatment based on the information presented in the program that they intended to follow. However, prostate cancer knowledge scores varied among participants after participation in the CD-ROM program, raising doubts that patients were adequately informed to make appropriate choices regarding their treatment. Lower prostate cancer knowledge scores corresponded to lower literacy scores, indicating that low literacy may have hindered patient understanding of the shared decision making program. The development of shared decision making tools should include collaborative efforts with the target population to improve the success of shared decision making programs among patients with low health literacy.","Cancer Invest, 19(7): 684-691","USA",2001,"Any or unknown","None","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Knowledge,Views"]
[353,"King, C. R., et al. (2013). \"Health-related quality of life after stereotactic body radiation therapy for localized prostate cancer: results from a multi-institutional consortium of prospective trials.\" Int J Radiat Oncol Biol Phys 87(5): 939-945.",null,"King, C. R., et al.","Health-related quality of life after stereotactic body radiation therapy for localized prostate cancer: results from a multi-institutional consortium of prospective trials","PURPOSE: To evaluate the early and late health-related quality of life (QOL) outcomes among prostate cancer patients following stereotactic body radiation therapy (SBRT). METHODS AND MATERIALS: Patient self-reported QOL was prospectively measured among 864 patients from phase 2 clinical trials of SBRT for localized prostate cancer. Data from the Expanded Prostate Cancer Index Composite (EPIC) instrument were obtained at baseline and at regular intervals up to 6 years. SBRT delivered a median dose of 36.25 Gy in 4 or 5 fractions. A short course of androgen deprivation therapy was given to 14% of patients. RESULTS: Median follow-up was 3 years and 194 patients remained evaluable at 5 years. A transient decline in the urinary and bowel domains was observed within the first 3 months after SBRT which returned to baseline status or better within 6 months and remained so beyond 5 years. The same pattern was observed among patients with good versus poor baseline function and was independent of the degree of early toxicities. Sexual QOL decline was predominantly observed within the first 9 months, a pattern not altered by the use of androgen deprivation therapy or patient age. CONCLUSION: Long-term outcome demonstrates that prostate SBRT is well tolerated and has little lasting impact on health-related QOL. A transient and modest decline in urinary and bowel QOL during the first few months after SBRT quickly recovers to baseline levels. With a large number of patients evaluable up to 5 years following SBRT, it is unlikely that unexpected late adverse effects will manifest themselves.","Int J Radiat Oncol Biol Phys, 87(5): 939-945","USA",2013,"Local","Radiotherapy,Hormonal","EPIC","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease"]
[354,"Klaff, R., et al. (2016). \"Clinical characteristics and quality-of-life in patients surviving a decade of prostate cancer with bone metastases.\" BJU Int 117(6): 904-913.",null,"Klaff, R., et al.","Clinical characteristics and quality-of-life in patients surviving a decade of prostate cancer with bone metastases","OBJECTIVE: To describe characteristics and quality-of-life (QoL), and to define factors associated with long-term survival in a subgroup of patients with prostate cancer with M1b disease. PATIENTS AND METHODS: The study was based on 915 patients from a prospective randomised multicentre trial (No. 5) by the Scandinavian Prostate Cancer Group, comparing parenteral oestrogen with total androgen blockade. Long-term survival was defined as patients having an overall survival of >/=10 years, and logistic regression models were constructed to identity clinical predictors of survival. QoL during follow-up was assessed using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire - C30 version 1 (EORTC-C30) ratings. RESULTS: In all, 40 (4.4%) of the 915 men survived for >10 years. Factors significantly associated with increased likelihood of surviving for >10 years in the univariate analyses were: absence of cancer-related pain; Eastern Cooperative Oncology Group (ECOG) performance status of <2; negligible analgesic consumption; T-category of 1-2; prostate-specific antigen (PSA) level of <231 mug/L; and a Soloway score of 1. In the multivariate analyses, ECOG performance status of <2, PSA level of <231 mug/L, and Soloway score of 1, were all independent predictors of long-term survival. All subscales of the EORTC-C30 were higher in this group than for patients with short survival, but slowly declined over the decade. CONCLUSION: A subgroup of patients with prostate cancer with M1b disease and certain characteristics showed a positive long-term response to androgen-deprivation therapy with an acceptable QoL over a decade or more. Independent predictors of long-term survival were identified as ECOG performance status of <2, limited extent of bone metastases (Soloway score of 1), and a PSA level of <231 mug/L at the time of enrolment.","BJU Int, 117(6): 904-913","Sweden",2016,"Survivors","None","EORTC QLQ-C30","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General"]
[355,"Klein, J., et al. (2016). \"Socioeconomic status and health-related quality of life among patients with prostate cancer 6 months after radical prostatectomy: a longitudinal analysis.\" BMJ Open 6(6): e010968.",null,"Klein, J., et al.","Socioeconomic status and health-related quality of life among patients with prostate cancer 6 months after radical prostatectomy: a longitudinal analysis","OBJECTIVES: To identify the associations between socioeconomic status (SES) and health-related quality of life (HRQOL) and the explanatory contribution of disease, patient and healthcare factors among patients with prostate cancer. DESIGN: Prospective cohort study. SETTING AND PARTICIPANTS: In all, 246 patients from 2 hospitals in Hamburg/Germany who underwent radical prostatectomy completed a questionnaire shortly before discharge from hospital and again 6 months later. OUTCOME MEASURES: HRQOL as assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ C-30 including global quality of life, 5 functional scales and 9 symptom scales/items. Generalised estimating equations were calculated to analyse longitudinal data. RESULTS: Lower SES measured by income, education and occupational status is significantly associated with lower HRQOL 6 months after treatment. This especially holds true for the functional scales. After introducing disease, patient and healthcare factors, associations remain significant in the majority of cases. The explanatory contribution of patient factors such as comorbidity or psychosocial characteristics and of healthcare factors is slightly stronger than that of disease factors. CONCLUSIONS: We identified strong social inequalities in HRQOL among patients with prostate cancer 6 months after surgery, in Germany. The underlying causes could not be sufficiently identified, and further research regarding these associations and their explanatory factors is needed.","BMJ Open, 6(6): e010968","Germany",2016,"Any or unknown","Surgery","EORTC QLQ-C30","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"General"]
[356,"Klotz, L. (2000). \"Hormone therapy for patients with prostate carcinoma.\" Cancer 88(12 Suppl): 3009-3014.",null,"Klotz, L.","Hormone therapy for patients with prostate carcinoma","BACKGROUND: Androgen ablation as a treatment for patients with prostate carcinoma was described 60 years ago. Despite the long pedigree for this treatment, the optimal use of androgen ablation therapy remains extremely controversial. Monitoring the level of prostate specific antigen (PSA) has created a dramatic shift in the population of patients in whom androgen ablation is initiated. This has resulted in a number of changing concepts of treatment. Patients with recurrent prostate carcinoma after the failure of local therapy are now diagnosed with recurrent disease on the basis of a rising PSA level. These patients have a median life expectancy of 10-15 years compared with 3 years for patients who present with metastatic disease. This means that the systemic side effects of androgen ablation and the impact on quality of life have become more important. Controversies exist with respect to the timing of therapy, the use of intermittent androgen ablation, and the role of total androgen blockade. METHODS: A critical review of the literature, with an emphasis on quality of life and recent publications, was performed. RESULTS: Data support the early initiation of androgen ablation for patients with locally advanced or lymph node positive prostate carcinoma. There are no data supporting a particular PSA trigger point or a PSA doubling time for the initiation of androgen ablation therapy after the failure of local radical therapy. The combined results of 27 prospective randomized trials of total androgen blockade support the finding of a modest survival benefit for patients who undergo androgen ablation with combined therapy. The average, absolute 5-year survival rate was improved by 3% (a 10% reduction in the risk of dying), with a 95% confidence interval between 0.4% and 6.0%. Intermittent therapy resulted in an improved quality of life in the off-treatment interval. Uncertainty remains with respect to the long term effect of intermittent androgen ablation therapy on patient survival. This is being studied in a prospective intergroup trial comparing continuous therapy with intermittent therapy carried out by the National Cancer Institute Criteria/Canadian Uro-Oncology Group and the Southwest Oncology Group. CONCLUSIONS: Androgen ablation therapy is an effective treatment for patients with advanced prostate carcinoma. It has serious limitations, however. Although it improves patient survival, it is not curative, and it is associated with a substantial adverse impact on the quality of life for patients, particularly when its use is prolonged. The advent of intermittent therapy may reduce this impact. The real challenge, however, is to develop better means to avert hormone-refractory prostate carcinoma and better treatments for patients with hormone-refractory disease when it occurs.","Cancer, 88(12 Suppl): 3009-3014","International",2000,"Advanced","Hormonal","Unclear","Patient",null,"Systematic review",null,null,null,null,null,null,null,null,"General"]
[357,"Knight, S. J., et al. (1998). \"Quality of life in metastatic prostate cancer among men of lower socioeconomic status: feasibility and criterion related validity of 3 measures.\" J Urol 160(5): 1765-1769.",null,"Knight, S. J., et al.","Quality of life in metastatic prostate cancer among men of lower socioeconomic status: feasibility and criterion related validity of 3 measures","PURPOSE: Identification of metastatic disease progression is often difficult but important. Previous studies of quality of life in metastatic disease have been limited by the small number of respondents who were not white or of lower socioeconomic status. Quality of life assessment is generally done using self-administration techniques but this method is of limited usefulness for patients of low socioeconomic status, many of whom have limited reading abilities. We evaluated the feasibility and validity of interviewer administration of 3 quality of life instruments for patients of low socioeconomic status with metastatic prostate cancer. MATERIALS AND METHODS: We used instruments previously validated with self-administration methodology, including the European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire-30, Functional Assessment of Cancer Therapy-General Scale and Quality of Life Index. Subjects were men with metastatic prostate cancer with stable (78) or progressive (32) disease at 4 Veterans Affairs medical centers and 1 other site. Of the patients 94% were Veterans Affairs patients and more than 60% were black. RESULTS: Each quality of life instrument required less than 10 minutes of interviewer administration and was able to discriminate between patients with stable versus progressive disease on several health status domains. CONCLUSIONS: These data support the feasibility and validity of quality of life measurement in patients of low socioeconomic status with metastatic prostate cancer. Consideration should be given to adding quality of life instruments to patient encounter even among low socioeconomic status, low literacy populations.","J Urol, 160(5): 1765-1769","USA",1998,"Metastatic","None","EORTC QLQ-C30,FACT-G,QLI","Patient",null,"Validation",null,null,null,null,null,null,null,null,"General,Treatment"]
[358,"Knight, S. J., et al. (2004). \"Ethnic variation in localized prostate cancer: a pilot study of preferences, optimism, and quality of life among black and white veterans.\" Clin Prostate Cancer 3(1): 31-37.",null,"Knight, S. J., et al.","Ethnic variation in localized prostate cancer: a pilot study of preferences, optimism, and quality of life among black and white veterans","Ethnic variations that may influence the preferences and outcomes associated with prostate cancer treatment are not well delineated. Our objective was to evaluate prospectively preferences, optimism, involvement in care, and quality of life (QOL) in black and white veterans newly diagnosed with localized prostate cancer. A total of 95 men who identified themselves as black/African-American or white who had newly diagnosed, localized prostate cancer completed a \"time trade-off\" task to assess utilities for current health and mild, moderate, and severe functional impairment; importance rankings for attributes associated with prostate cancer (eg, urinary function); and baseline and follow-up measures of optimism, involvement in care, and QOL. Interviews were scheduled before treatment, and at 3 and 12 months after treatment. At baseline, both blacks and whites ranked pain, bowel, and bladder function as their most important concerns. Optimism, involvement in care, and QOL were similar. Utilities for mild impairment were lower for blacks than whites, but were similar for moderate and severe problems. Decline in QOL at 3 and 12 months compared to baseline occurred for both groups. However, even with adjustment for marital status, education level, and treatment, blacks had less increase in nausea and vomiting and more increase in difficulty with sexual interest and weight gain compared with whites. Black and white veterans entered localized prostate cancer treatment with similar priorities, optimism, and involvement in care. Quality-of-life declines were common to both groups during the first year after diagnosis, but ethnic variation occurred with respect to nausea and vomiting, sexual interest, and weight gain.","Clin Prostate Cancer, 3(1): 31-37","USA",2004,"Local","Unclear","TTO","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Utility"]
[359,"Koch, M. O., et al. (2003). \"Early catheter removal after radical retropubic prostatectomy: long-term followup.\" J Urol 169(6): 2170-2172.",null,"Koch, M. O., et al.","Early catheter removal after radical retropubic prostatectomy: long-term followup","PURPOSE: We examine the complication and continence rates with early catheter removal (day 3 or 4) after radical retropubic prostatectomy. MATERIALS AND METHODS: A total of 365 patients with localized prostate cancer underwent radical retropubic prostatectomy at Indiana University Hospital with planned urethral catheter removal before discharge home. Low pressure cystograms were performed on postoperative day 3 or 4 to determine if catheter removal was possible. A subset of patients were analyzed using a validated prostate cancer specific questionnaire (University of California, Los Angeles Prostate Cancer Symptom Index) to determine quality of life outcomes. RESULTS: The catheter was removed on postoperative day 3 or 4 in 263 patients (72%). The reasons for leaving the catheter indwelling were significant leak on cystogram or excessive suprapubic drainage (21%), extensive bladder neck reconstruction (1%) and prolonged hospitalization because of an ileus or other complicating factor (6%). Thirteen patients (3.6%) were either unable to void after catheter removal or presented with retention (not associated with hematuria or clots) after hospital discharge, requiring reinsertion of the Foley catheter. A total of 41 patients (11%) had either an early or late complication (excluding incontinence). There were 3 complications (0.8%) that were considered major because they were potentially life threatening or required a return to the operating room. A pelvic abscess developed in 2 patients and a lymphocele in 1, which required percutaneous drainage. After at least 6 months (mean 20.9 months) 140 patients (89.2%) and 14 (8.9%) reported excellent and good continence, respectively. The patient questionnaire demonstrated bother scores to be minimal to no bother for 95% to 98% of patients at 6 and 12 months. CONCLUSIONS: This study confirms that it is safe to remove catheters in most patients 3 to 4 days after prostatectomy if a cystogram demonstrates no extravasation. Complication rates and continence rates with this approach compare favorably with series in which catheters are left indwelling for longer periods.","J Urol, 169(6): 2170-2172","USA",2003,"Local","Surgery","UCLA-PCI","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease"]
[360,"Komiya, A., et al. (2013). \"Early quality of life outcomes in patients with prostate cancer managed by high-dose-rate brachytherapy as monotherapy.\" Int J Urol 20(2): 185-192.",null,"Komiya, A., et al.","Early quality of life outcomes in patients with prostate cancer managed by high-dose-rate brachytherapy as monotherapy","OBJECTIVES: To evaluate the early quality of life outcomes in prostate cancer patients managed by high-dose-rate brachytherapy as monotherapy. METHODS: A total of 51 patients with cT1c-T3aN0M0 prostate cancer treated between July 2007 and January 2010 were included in this study. The average age was 69 years, and the average initial serum prostate-specific antigen was 10.98 ng/mL. A total of 25, 18 and eight patients were considered to be low, intermediate and high risk, respectively. All patients received one implant of Ir-192 and seven fractions of 6.5 Gy within 3.5 days for a total prescribed dose of 45.5 Gy. For high-risk prostate cancer, neoadjuvant androgen deprivation therapy was carried out for at least 6 months, and continued after high-dose-rate brachytherapy. Quality of life outcomes were measured by using the International Prostate Symptom Score, the Functional Assessment of Cancer Therapy-Prostate and the International Index of Erectile Function Questionnaire. The oncological outcome was assessed by serum prostate-specific antigen and diagnostic imaging. Adverse events were also recorded. RESULTS: The Functional Assessment of Cancer Therapy-Prostate scores decreased for a few months after high-dose-rate brachytherapy, and recovered to pretreatment condition thereafter. The International Prostate Symptom Score significantly increased 2 weeks after treatment for each of its items and their sum, and it returned to baseline after 12 weeks. Sexual function decreased at 2 and 4 weeks, and recovered after 12 weeks. Severe complications were rare. Within a median follow up of 17.2 months, two patients showed a prostate-specific antigen recurrence. CONCLUSIONS: High-dose-rate brachytherapy for prostate cancer is a feasible treatment modality with acceptable toxicity and only a limited impact on the quality of life.","Int J Urol, 20(2): 185-192","Japan",2013,"Local,Advanced","Brachytherapy","FACT-P,IIEF-5,IPSS","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease,Complication"]
[361,"Korfage, I. J., et al. (2003). \"Measuring disease specific quality of life in localized prostate cancer: the Dutch experience.\" Qual Life Res 12(4): 459-464.",null,"Korfage, I. J., et al.","Measuring disease specific quality of life in localized prostate cancer: the Dutch experience","OBJECTIVE: We aimed at developing and testing a Dutch health-related quality of life measure for localized prostate cancer patients. METHODS: Scales on urinary and bowel function and bother from the UCLA Prostate Cancer Index (PCI) underwent formal linguistic and cultural translation. PCI sexual scales were replaced by an existing Dutch sexual activities module (SAc). After qualitative pilot testing 389 patients with localized prostate cancer (mean age 67 +/- 7 years) completed the measure before and at 2 time points after primary treatment. Psychometric properties (feasibility, score distribution, reliability, construct validity and responsiveness to change) of the new instrument were analyzed. RESULTS: Response rates ranged from 93% at baseline to 87% after treatment. Urinary and bowel function scales showed Cronbach's alphas >0.7. Urinary function and bother, and bowel function and bother were significantly correlated. Pre- vs. post-prostatectomy effect sizes were >0.9 only for urinary scales; while pre- vs. post-radiotherapy effect sizes were >0.75 only for bowel scales. Six months after baseline erectile dysfunction was reported by 64% of respondents, either as a problem in sexual activity or as a reason for not being sexually active. CONCLUSION: The Dutch PCI and SAc performed well in men treated for early stage prostate cancer.","Qual Life Res, 12(4): 459-464","Netherlands",2003,"Local","Surgery,Radiotherapy","UCLA-PCI,SAc","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease,Complication"]
[362,"Kornblith, A. B., et al. (1994). \"Quality of life of patients with prostate cancer and their spouses. The value of a data base in clinical care.\" Cancer 73(11): 2791-2802.",null,"Kornblith, A. B., et al.","Quality of life of patients with prostate cancer and their spouses. The value of a data base in clinical care","BACKGROUND: Because of the dearth of information concerning the quality of life of patients with prostate cancer, a data base was established to examine the nature and extent of problems in patients' and spouses' adaptation and their interrelationships and to examine the effect of disease stage combined with treatment regimen on patients' quality of life. METHODS: One hundred seventy-two patients and 83 spouses/partners completed quality of life questionnaires in a prostate cancer health education lecture series. The measures used were the European Organization for Research and Treatment of Cancer (EORTC) Prostate Cancer Quality of Life Questionnaire, the Intrusion subscale (IS) of the Impact of Event Scale; and Selby's QL Uniscale. Fifty-five percent of patients had received medical and/or surgical hormonal therapy, 28% had received a radical prostatectomy and/or radiation therapy only, and 18% had not been placed on any treatment. RESULTS: Patients experiencing problems in adaptation were significantly more likely to have advanced stage disease; received surgical or medical hormonal therapy; and were reporting greater pain, fatigue, urinary problems, and deteriorating physical functioning. Spouses reported significantly greater psychological distress than did patients (EORTC Psychological Distress subscale, P < 0.001; IS, P < 0.001). CONCLUSIONS: A two-stage clinical evaluation is recommended, in which quality of life questionnaires would initially be used to identify patients and spouses experiencing problems in adaptation for further evaluation by a mental health professional for appropriate treatment.","Cancer, 73(11): 2791-2802","USA",1994,"Any or unknown","Surgery,Radiotherapy,Hormonal","EORTC QLQ-PR25,IES,SQLU","Caregiver,Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Disease,General,Complication"]
[363,"Kornblith, A. B., et al. (2006). \"Telephone monitoring of distress in patients aged 65 years or older with advanced stage cancer: a cancer and leukemia group B study.\" Cancer 107(11): 2706-2714.",null,"Kornblith, A. B., et al.","Telephone monitoring of distress in patients aged 65 years or older with advanced stage cancer: a cancer and leukemia group B study","BACKGROUND: Significant barriers to cancer patients receiving mental health treatment for distress have been reported in the literature. The objective of the current study was to determine whether distress in older patients (aged 65 years and older) would be reduced with educational materials (EM) supplemented by monthly telephone monitoring (TM) (TM + EM) compared with the use of EM alone because of more timely referrals to appropriate health professionals. METHODS: One hundred ninety-two older patients with breast, prostate, and colorectal cancers who had advanced disease and currently were receiving treatment were randomized to receive either TM + EM or EM alone. One hundred thirty-one patients were evaluated by telephone interview for psychologic and physical distress and for social support at baseline and at 6 months using the Hospital Anxiety and Depression Scale (HADS), the European Organization for Research and Treatment of Cancer (EORTC)-QLQ-C30 quality-of-life questionnaire, and the Medical Outcomes Study (MOS) Social Support Survey. Patients who in the TM + EM group were called monthly for 6 months to monitor their distress using the HADS and EORTC physical symptom items and the MOS Social Support Survey items, with cutoff levels were established to indicate which patients were in greater distress. Those patients who scored above the cutoff levels were referred to their oncology nurse for referral to the appropriate professional. Patients in the EM group received written materials regarding cancer-related psychosocial issues and available resources. RESULTS: At 6 months, patients in the TM + EM group reported significantly less anxiety (HADS; P < .0001), depression (HADS; P = .0004), and overall distress (HADS; P < .0001) compared with patients in the EM group. CONCLUSIONS: Monthly monitoring of older patients' distress with TM and EM along with referral for appropriate help was found to be an efficient means of reducing patients' anxiety and depression compared with patients who received only EM.","Cancer, 107(11): 2706-2714","USA",2006,"Advanced","Various","HADS,EORTC QLQ-C30,MOS-SSS","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General,Comorbidity,Social"]
[364,"Kouba, E., et al. (2007). \"A prospective evaluation of the short-term impact and recovery of health-related quality of life in men undergoing radical prostatectomy.\" BJU Int 99(1): 72-76.",null,"Kouba, E., et al.","A prospective evaluation of the short-term impact and recovery of health-related quality of life in men undergoing radical prostatectomy","OBJECTIVE: To prospectively evaluate the acute and short-term effects of radical retropubic prostatectomy (RRP) on health-related quality of life (HRQoL) using a validated generic HRQoL instrument that measures overall health status, as although there is increasing interest in the HRQoL of patients being treated for prostate cancer, most studies have focused on long-term outcomes. PATIENTS AND METHODS: In all, 121 men undergoing RRP for clinically localized prostate cancer were prospectively evaluated for short-term HRQoL using an acute Short Form-12 version-2 Physical and Mental Health Survey Acute Form before and serially each week from 1 to 6 weeks after RRP. The physical (PCS) and mental component score (MCS) were calculated from the questionnaires at each time and the data analysed by random coefficient modelling. Separate models were fitted for MCS and PCS using covariates of race, age, estimated blood loss (EBL), time after RRP, and their interaction terms. RESULTS: The PCS initially declined and improved linearly. and the baseline level was not achieved by 6 weeks, but modelling lines showed an expected return to baseline at 7-8 weeks for all patients. Age had a significant relationship with the PCS; older men (>60 years) scored higher, and their PCS remained significantly higher after RRP than younger men (< or =60 years) until 5 weeks. EBL also had a significant relationship with PCS; men with an EBL of >500 mL had a significantly lower PCS at 1 week and this remained significantly lower than for men with an EBL of < or = 500 mL until approximately 7 weeks. The MCS improved immediately after RRP and remained higher throughout the study than at baseline. Race was the only covariate for which there were significant differences in the MCS. The MCS was significantly lower at baseline for African-Americans than for Caucasian Americans, and remained lower until 6 weeks after RRP. CONCLUSIONS: There were significant changes in HRQoL during in the short-term after RRP. Younger men and those with a higher EBL might have a slower recovery of the PCS after RRP. African-Americans had a slower increase in MCS and might have a different initial emotional or mental health response to RRP than have Caucasians.","BJU Int, 99(1): 72-76","USA",2007,"Local","Surgery","SF-12","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Utility"]
[365,"Krahn, M. D., et al. (1994). \"Screening for prostate cancer. A decision analytic view.\" Jama 272(10): 773-780.",null,"Krahn, M. D., et al.","Screening for prostate cancer. A decision analytic view","OBJECTIVE: To determine the clinical and economic effects of screening for prostate cancer with prostate-specific antigen (PSA), transrectal ultrasound (TRUS), and digital rectal examination (DRE). DESIGN: Decision analytic cost-utility analysis comparing four screening strategies with a strategy of not screening. We assumed that the cancer detection rate and stage distribution were predicted by each combination of tests and that localized cancer was treated with radical prostatectomy. For each strategy, we calculated life expectancy, quality-adjusted life expectancy (QALE), and cost-utility ratios for unselected and high-prevalence populations. DATA: Probabilities and rates for clinical events were gathered from published data. We assessed utilities by the time-trade-off method using urologists, radiation oncologists, and internists as subjects. The Clinical Cost Manager at the New England Medical Center provided cost data. RESULTS: In unselected men between the ages of 50 and 70 years, screening with PSA or TRUS prolonged unadjusted life expectancy but diminished QALE. Screening with DRE alone yielded no reduction in mortality at any age. All programs increased costs. Results were sensitive only to assumptions about the efficacy of treatment. In high-prevalence populations, screening produced a similar pattern: gains in unadjusted life expectancy, losses in QALE, and increased costs. CONCLUSIONS: Our analysis does not support using PSA, TRUS, or DRE to screen asymptomatic men for prostatic cancer. Screening may result in poorer health outcomes and will increase costs dramatically. Assessment of comorbidity, risk attitude, and valuation of sexual function may identify individuals who will benefit from screening, but selecting high-prevalence populations will not improve the benefit of screening.","Jama, 272(10): 773-780","Canada",1994,"At risk","Screening","TTO","HCP",null,"Economic model",null,null,null,null,null,null,null,null,"Utility"]
[366,"Krahn, M. D., et al. (2013). \"A reference set of health utilities for long-term survivors of prostate cancer: population-based data from Ontario, Canada.\" Qual Life Res 22(10): 2951-2962.",null,"Krahn, M. D., et al.","A reference set of health utilities for long-term survivors of prostate cancer: population-based data from Ontario, Canada","PURPOSE: To measure quality of life (QOL) and utilities for prostate cancer (PC) patients and determine their predictors. METHODS: A population-based, community-dwelling, geographically diverse sample of long-term PC survivors in Ontario, Canada, was identified from the Ontario Cancer Registry and contacted through their referring physician. Consenting patients completed questionnaires by mail: Health Utilities Index (HUI 2/3), Patient Oriented Prostate Utility Scale PORPUS-U (utility), PORPUS-P (health profile), Functional Assessment of Cancer Therapy-Prostate (FACT-P), and Prostate Cancer Index (PCI). Clinical data were obtained from chart reviews. Regression models determined the effects of a series of variables on QOL and utility. RESULTS: We received questionnaires and reviewed charts for 585 patients (mean age 72.6, 2-13 years postdiagnosis). Mean utility scores were as follows: PORPUS-U = 0.92, HUI2 = 0.85, and HUI3 = 0.78. Mean health profile scores were as follows: PORPUS-P = 71.7, PCI sexual, urinary, and bowel function = 23.7, 79.1, and 84.6, respectively (0 = worst, 100 = best), and FACT-P = 125.1 (0 = worst, 156 = best). In multiple regression analyses, comorbidity and PCI urinary, sexual, and bowel function were significant predictors of other QOL measures. With all variables, 32-50 % of the variance in utilities was explained. CONCLUSIONS: Many variables affect global QOL of PC survivors; only prostate symptoms and comorbidity have independent effects. Our model allows estimation of the effects of multiple factors on utilities. These utilities for long-term outcomes of PC and its treatment are valuable for decision/cost-effectiveness models of PC treatment.","Qual Life Res, 22(10): 2951-2962","Canada",2013,"Survivors","None","PORPUS,FACT-P,UCLA-PCI,HUI","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Utility,Disease"]
[367,"Krahn, M., et al. (2000). \"Construction of the Patient-Oriented Prostate Utility Scale (PORPUS): a multiattribute health state classification system for prostate cancer.\" J Clin Epidemiol 53(9): 920-930.",null,"Krahn, M., et al.","Construction of the Patient-Oriented Prostate Utility Scale (PORPUS): a multiattribute health state classification system for prostate cancer","Health status indexes, such as the EuroQol, consist of a health state classification system and a set of utility weights. Indexes measure quality of life using a 0-1 utility score. Utilities for outcomes in prostate cancer (PC) are of unique importance, but generic indexes do not represent PC outcomes (e.g., sexual, urinary, bowel dysfunction) well, and may not capture their full impact. As a step toward improved utility measurement, we constructed a classification system for PC. We generated items for each of six health domains and rated their importance using interviews with 10 clinical experts and 80 patients. Key concepts were selected for each domain using item importance weightings, and a set of predetermined criteria. Text was developed to express levels of severity within each domain. Experts and two additional groups of patients (n = 40, n = 96) evaluated textual clarity and endorsed the content validity of the instrument. The final system consists of 10 domains with 4-6 levels each. The content validity of the system was endorsed by patients and experts. In conjunction with a set of utility weights, it may be used to develop a health status index, to improve utility measurement in patients, and to serve as a short psychometric (nonutility) instrument.","J Clin Epidemiol, 53(9): 920-930","Canada",2000,"Any or unknown","None","PORPUS","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Utility"]
[368,"Krahn, M., et al. (2003). \"Patient and community preferences for outcomes in prostate cancer: implications for clinical policy.\" Med Care 41(1): 153-164.",null,"Krahn, M., et al.","Patient and community preferences for outcomes in prostate cancer: implications for clinical policy","BACKGROUND: Preferences, or utilities, for health outcomes are central in prostate cancer decision-making. Utilities can be elicited directly from patients using standard techniques, or indirectly, using questionnaires that incorporate preference weights from community members. OBJECTIVES: To evaluate directly elicited and indirectly elicited (questionnaire-derived, community-weighted) utilities for prostate cancer outcomes and the effects of sexual, urinary, and bowel dysfunction on them. MATERIALS AND METHODS: Utilities for the current health of 141 prostate cancer patients, recruited from ambulatory clinics, were elicited directly with the Patient Oriented Prostate Utility Scale, rating scale (PORPUS-U(RS)) and standard gamble (PORPUS-U(SG)) subscales. Patients completed the Health Utilities Index (HUI) and Quality of Well Being Scale (QWB), utility instruments incorporating community preferences, and the UCLA Prostate Cancer Index. RESULTS: Patients' treatments included radical prostatectomy (18%), radiation (60%), and hormonal (42%). Mean utility scores for current health were 0.65 (QWB), 0.79 (PORPUS-U(RS)), 0.80 (HUI), 0.86 (PORPUS-U(SG)). Utility decrements for dysfunction were small (0.08-0.14 [sexual], 0.06 to 0.13 [urinary], and 0.01 to 0.13 [bowel]), and even smaller when adjusted for concomitant changes in other quality of life (QOL) domains. CONCLUSIONS: Patients' directly elicited utilities for their own health were higher than community-derived utilities obtained from HUI and QWB administration to the same patients. HUI scores of these patients were similar to those of age-matched Canadian men. Sexual, urinary, and bowel problems were common but had less impact on overall QOL than reported in previous utility studies. These results weaken the argument that prostate cancer screening and treatment should be limited because of severe and debilitative side effects.","Med Care, 41(1): 153-164","Canada",2003,"Any or unknown","Surgery,Radiotherapy,Hormonal","PORPUS,UCLA-PCI,QWB,HUI","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Disease,Utility"]
[369,"Krahn, M., et al. (2007). \"Responsiveness of disease-specific and generic utility instruments in prostate cancer patients.\" Qual Life Res 16(3): 509-522.",null,"Krahn, M., et al.","Responsiveness of disease-specific and generic utility instruments in prostate cancer patients","BACKGROUND: Preferences (utilities) for health outcomes have an important role in decisions about prostate cancer screening and treatment. The responsiveness of utility instruments has not been evaluated. SUBJECTS: Prostate cancer outpatients from the Princess Margaret Hospital, Toronto (n = 248) were allocated into three cohorts: N - newly diagnosed and treated; M - metastatic disease; O - all others. MEASURES: We measured quality of life at 3 points within 12 months using 3 disease-specific utility instruments (Patient Oriented Prostate Utility Scales), 3 generic utility instruments (Health Utilities Index, EQ-5D, Quality of Well-Being Scale), and 3 profile scales (PORPUS-P profile, Prostate Cancer Index, QLQ-C-30). Responsiveness was assessed using measures of internal responsiveness (standardized effect size, standardized response mean) and external responsiveness (receiver operator curve analysis, mixed model regression). RESULTS: Cohort N patients showed post-treatment declines followed by improvement in global health and functional status. Disease specific instruments detected moderate (0.4-1.3) decrements followed by small increments (0.1-0.4) in standardized effect size and standardized response mean. Most instruments detected change using external responsiveness measures (all cohorts). CONCLUSIONS: Disease-specific utility instruments appeared to be more responsive than generic instruments. Use of generic instruments should be supplemented with a responsive disease-specific instrument, particularly for applications in early prostate cancer.","Qual Life Res, 16(3): 509-522","Canada",2007,"Any or unknown","Unclear","PORPUS,EQ-5D,HUI,QWB,UCLA-PCI,EORTC QLQ-C30","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Utility"]
[370,"Krambeck, A. E., et al. (2009). \"Radical prostatectomy for prostatic adenocarcinoma: a matched comparison of open retropubic and robot-assisted techniques.\" BJU Int 103(4): 448-453.",null,"Krambeck, A. E., et al.","Radical prostatectomy for prostatic adenocarcinoma: a matched comparison of open retropubic and robot-assisted techniques","OBJECTIVE: To assess the perioperative complications and early oncological results in a comparative study matching open radical retropubic (RRP) and robot-assisted radical prostatectomy (RARP) groups. PATIENTS AND METHODS: From August 2002 to December 2005 we identified 294 patients undergoing RARP for clinically localized prostate cancer. A comparison RRP group of 588 patients from the same period was matched 2:1 for surgical year, age, preoperative prostate-specific antigen level, clinical stage and biopsy Gleason grade. Perioperative complications were compared. Patients completed a standardized quality-of-life questionnaire. Pathological features were assessed and Kaplan-Meier estimates of biochemical progression-free survival (PFS) were compared. RESULTS: There was no significant difference in overall perioperative complications between the RARP and RRP groups (8.0% vs 4.8%, P = 0.064). Wound herniation was more common after RARP (1.0% vs none, P = 0.038), and development of bladder neck contracture was more common after RRP (1.2% vs 4.6%; P < 0.018). The hospital stay was less after RARP (29.3% vs 19.4%, P = 0.004, for a stay of 1 day). At the 1-year follow-up there was no significant difference in continence (RARP 91.8%, RRP 93.7%, P = 0.344) or potency (RARP 70.0%, RRP 62.8%, P = 0.081) rates. The biochemical PFS was no different between treatments at 3 years (RARP 92.4%, RRP 92.2%; P = 0.69). CONCLUSION: There was no significant difference in overall early complication, long-term continence or potency rates between the RARP and RRP techniques. Furthermore, early oncological outcomes were similar, with equivalent margin positivity and PFS between the groups.","BJU Int, 103(4): 448-453","USA",2009,"Local","Surgery","Unclear","Patient",null,"Case-control",null,null,null,null,null,null,null,null,"General"]
[371,"Krongrad, A., et al. (1997). \"Reliability of Spanish translations of select urological quality of life instruments.\" J Urol 158(2): 493-496.",null,"Krongrad, A., et al.","Reliability of Spanish translations of select urological quality of life instruments","PURPOSE: Many patients with urological disease do not speak English. In medical studies restricting patients to those who speak only English undermines efforts to understand disease because restrictions decrease efficiency of patient recruitment, and because language and culture are associated with variable outcomes. In Spanish speaking locations, such as South Florida, studies would suffer severe selection bias if patients were required to speak English. To allow grouping in future studies of English and Spanish speaking patients we examined the English-Spanish reliability of select instruments that measure health related quality of life in patients with urological disease. MATERIALS AND METHODS: We assembled available Spanish versions and translated English versions of questions regarding satisfaction, the American Urological Association symptom index, the University of California, Los Angeles Prostate Cancer Index and a pain inventory. We then examined English-Spanish reliability by asking bilingual men 50 years old or older to complete English and Spanish versions at the same sitting. A convenience sample was recruited from outpatients and volunteers at the Miami Veterans Affairs Medical Center and population based subjects living in largely Hispanic Hialeah, Florida. Reliability estimates were calculated with kappa coefficients for categorical data and intraclass correlation coefficients for quantitative data. RESULTS: A total of 100 subjects a median of 59 years old completed the questionnaire, including 55 born in Puerto Rico or Cuba, while the remainder were born at various sites throughout the Americas and Spain. Reliability estimates showed that kappa = > 0.81 for almost all items. For 2 items relating to health and social interactions reliability was poor, and stratification showed that poor reliability was primarily a feature of subjects in good health who are theoretically socially active. CONCLUSIONS: Almost all items tested have excellent English-Spanish reliability in a mixed sample of bilingual men. Nonreliability of 2 items relating to health and social interactions probably originates from the effect of language on perception, and invalidates English and Spanish grouping of these items. Because the sample represents many dialects of Spanish, the translations tested may be transported to other cities. In studies that use these instruments investigators can reasonably group answers from English and Spanish speaking study subjects or study the effects of acculturation on quality of life.","J Urol, 158(2): 493-496","USA",1997,"Any or unknown","None","AUA-SI,UCLA-PCI","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease,Symptom"]
[372,"Krongrad, A., et al. (1998). \"Dimensions of quality of life in prostate cancer.\" J Urol 160(3 Pt 1): 807-810.",null,"Krongrad, A., et al.","Dimensions of quality of life in prostate cancer","PURPOSE: Quality of life research in prostate cancer involves the use of many questionnaires and specific items that may be partly redundant. We examine dimensions of quality of life in prostate cancer in the hope of somewhat simplifying communication of basic information. MATERIALS AND METHODS: We analyzed cross-sectional survey data on quality of life in patients with prostate cancer belonging to a Southern California HMO. Quality of life was assessed with the University of California, Los Angeles prostate cancer index. Scree plot and parallel analysis were used to identify factors for extraction and orthogonal (varimax) rotation to examine scale loadings. RESULTS: Four extracted factors explained a cumulative variance of 86%. The 8 physical and emotional scales loaded on 1 general factor explained 41% of the cumulative variance. Urinary function and bother, sexual function and bother, and bowel function and bother scales loaded on factors explained 16, 15 and 14% of the cumulative variance, respectively. CONCLUSIONS: The observation of only 1 general quality of life factor diverges from consistent previous observations of distinct physical and emotional factors in other types of patients, and the tight interaction of emotional and physical scales supports the vulnerability hypothesis, \"with age the increasing interactions across dimensions of health leave a patient vulnerable in all when any is affected.\" The tight interaction of physical and emotional scales in these but not other patients opens the door theoretically to better evaluation of and targeting of health services for patients with prostate cancer.","J Urol, 160(3 Pt 1): 807-810","USA",1998,"Any or unknown","None","UCLA-PCI","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease"]
[373,"Krupski, T. L., et al. (2003). \"Variation in continence and potency by definition.\" J Urol 170(4 Pt 1): 1291-1294.",null,"Krupski, T. L., et al.","Variation in continence and potency by definition","PURPOSE: The reporting of quality of life outcomes after prostate cancer treatment has improved with the use of validated instruments and third party data collection, and yet widely disparate continence and potency rates persist among providers. We assessed how well various definitions of these outcomes correspond with each other in the same patients. MATERIALS AND METHODS: A longitudinal cohort of 269 men undergoing radical prostatectomy for early stage prostate cancer completed quality of life questionnaires, including the University of California-Los Angeles Prostate Cancer Index. Six definitions of urinary continence and 6 definitions of potency represented by individual or aggregated items in the survey were analyzed. Using 2,506 questionnaires patients meeting the criteria for continence or potency by each definition were compared. RESULTS: Correspondence among continence definitions varied widely. Of the men who reported using no pads only 42% leaked urine not at all. Other definitions had higher rates of concordance with 98% of patients who reported total control also claiming no pads. Correspondence among potency definitions was even more disparate. Only 5% of men with erections firm enough for intercourse reported having morning erection very often, while 61% rated their ability to function sexually as good or very good. CONCLUSIONS: Variations in outcomes from items intended to measure the same domain reflect the idiosyncrasy of patient definitions of urinary and erectile function. Disease targeted, health related quality of life outcomes vary greatly depending on the specific definition used.","J Urol, 170(4 Pt 1): 1291-1294","USA",2003,"Local","Surgery","UCLA-PCI","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease"]
[374,"Krupski, T. L., et al. (2005). \"Health-related quality-of-life in low-income, uninsured men with prostate cancer.\" J Health Care Poor Underserved 16(2): 375-390.",null,"Krupski, T. L., et al.","Health-related quality-of-life in low-income, uninsured men with prostate cancer","The objective was to describe health-related quality-of-life (HRQOL) in low-income men with prostate cancer. Subjects were drawn from a statewide public assistance prostate cancer program. Telephone and mail surveys included the RAND 12-item Health Survey and UCLA Prostate Cancer Index Short Form and were compared with normative age-matched men without cancer from the general population reported on in the literature. Of 286 eligible men, 233 (81%) agreed to participate and completed the necessary items. The sample consisted of 51% Hispanics, 23% non-Hispanic whites, and 17% African Americans. The low-income men had worse scores in every domain of prostate-specific and general HRQOL than had the age-matched general population controls. The degree of disparity indicated substantial clinical differences in almost every domain of physical and emotional functioning between the sample group and the control group. Linear regression modeling determined that among the low-income men, Hispanic race, and income level were predictive of worse physical functioning, whereas only comorbidities predicted mental health. Low-income patients with prostate cancer appear to have quality-of-life profiles that are meaningfully worse than age-matched men from the general population without cancer reported on in the literature.","J Health Care Poor Underserved, 16(2): 375-390","USA",2005,"Any or unknown","None","UCLA-PCI,SF-12","Patient,General population",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Disease,Utility"]
[375,"Krupski, T., et al. (2000). \"Quality-of-life comparison of radical prostatectomy and interstitial brachytherapy in the treatment of clinically localized prostate cancer.\" Urology 55(5): 736-742.",null,"Krupski, T., et al.","Quality-of-life comparison of radical prostatectomy and interstitial brachytherapy in the treatment of clinically localized prostate cancer","OBJECTIVES: Interstitial brachytherapy (BT) is increasingly utilized as a curative treatment for localized prostate cancer because it is perceived as less morbid than surgical alternatives. However, to date no studies have directly compared the quality of life and symptoms of patients with localized prostate cancer treated with curative intent by radical prostatectomy with those treated by either BT alone or BT combined with external beam radiation. METHODS: On June 1, 1998, 242 men with clinically localized Stage T1c to T3 adenocarcinoma of the prostate, treated at our institution with curative intent from January 1, 1997 to June 1, 1998, were mailed a questionnaire. Cross-sectional analysis of returned questionnaires was carried out. Patients were treated with either radical prostatectomy (RP), palladium-103 (Pd(103)) brachytherapy (115 Gy) monotherapy (BTM), or Pd(103) combined brachytherapy (90 Gy) and external beam radiation (40 to 45 Gy) (BTC). The primary outcome measures were the Functional Assessment of Cancer Therapy scale (FACT-G), American Urological Association (AUA)/international prostate symptom score (IPSS), \"Urinary Function Questionnaire for Men after Radical Prostatectomy,\" and Brief Sexual Function Inventory. RESULTS: Data from 138 patients were included in the analysis; 27 had RP, 70 had BTM, and 41 had BTC. Total FACT-G and personal well-being scores were significantly lower in the BTC group. Brachytherapy monotherapy and RP had similar scores on the FACT-G, with surgical patients having the lowest IPSS scores. Correlations were noted between total FACT-G and urinary symptom score, degree of sexual function, frequency of diarrhea, and frequency of hot flashes. Bothersomeness of urinary function correlated with the degree of urinary control. The radical prostatectomy and BTM groups had improvement in quality of life, voiding, diarrhea, and sexual function with time, whereas the BTC group experienced a decline. CONCLUSIONS: Patients treated with BTC had an overall lower quality of life compared with those treated by RP and BTM, and RP patients reported fewer irritative or obstructive voiding complaints. Although the consistency and magnitude of these trends require further study, our data suggest that RP remains a well-tolerated and accepted option.","Urology, 55(5): 736-742","USA",2000,"Local","Surgery,Radiotherapy,Brachytherapy","FACT-G,IPSS,UFQ-RP,BSFI","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Disease,Treatment,Complication"]
[376,"Kubler, H. R., et al. (2007). \"Impact of nerve sparing technique on patient self-assessed outcomes after radical perineal prostatectomy.\" J Urol 178(2): 488-492; discussion 492.",null,"Kubler, H. R., et al.","Impact of nerve sparing technique on patient self-assessed outcomes after radical perineal prostatectomy","PURPOSE: We investigated the impact of nerve sparing technique on erectile function, urinary continence and health related quality of life after radical perineal prostatectomy using a validated self-assessment questionnaire. MATERIALS AND METHODS: The Expanded Prostate Cancer Index Composite questionnaire was administered preoperatively and at defined intervals after surgery to 265 patients who underwent radical perineal prostatectomy at 2 institutions between January 2001 and December 2004. Of these patients 153 (57.7%) and 112 (42.3%) underwent nonnerve sparing and nerve sparing approaches, respectively. Kaplan-Meier analysis was used to determine time to recovery of erectile function (erections firm enough for intercourse) and urinary continence (0 pads per day). RESULTS: Median patient age was 60.6 years. Median followup was 15 months. In multivariate analysis preoperative erectile function (p = 0.005) and preservation of the neurovascular bundle (p = 0.018) were independent predictors of earlier recovery of erectile function, with hazard ratios of 2.3 (95% CI 1.2-4.6) and 4.0 (95% CI 1.5-10.3), respectively. Median time to recovery of urinary continence was 4.8 months in the nerve sparing group and 6.1 months in the nonnerve sparing group (p = 0.001). In multivariate analysis nerve sparing technique (p = 0.001, HR 1.4, 95% CI 1.1-1.9) and age (p = 0.012, HR 1.7, 95% CI 1.3-2.2) were independent predictors of recovery of continence. CONCLUSIONS: This analysis suggests that nerve sparing radical perineal prostatectomy is associated with improved recovery of urinary continence and favorable health related quality of life scores and, therefore, should be considered a viable alternative to other nerve sparing approaches.","J Urol, 178(2): 488-492; discussion 492","USA",2007,"Any or unknown","Surgery","EPIC","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Disease"]
[377,"Kumar, V., et al. (2004). \"The benefits of radical prostatectomy beyond cancer control in symptomatic men with prostate cancer.\" BJU Int 93(4): 507-509.",null,"Kumar, V., et al.","The benefits of radical prostatectomy beyond cancer control in symptomatic men with prostate cancer","OBJECTIVE: To evaluate lower urinary tract symptoms (LUTS) and the symptom-associated quality of life (QoL) after radical prostatectomy. PATIENTS AND METHODS: We carried out a prospective study (January 1999 to March 2001) of 50 consecutive men initially assessed in the nurse-led prostate assessment clinic for their LUTS and subsequently diagnosed to have localized prostate cancer. They had a radical retropubic prostatectomy and were assessed before, 3 and 6 months after surgery with a self-administered International Prostate Symptom Score (IPSS) and QoL questionnaires, and measurements of urinary flow rate and postvoid residual urinary (PVR) volumes. Finally, each patient completed a self-administered continence questionnaire at 6 weeks, 3 and 6 months after surgery. RESULTS: In men with moderate to severe LUTS before surgery there were significant improvements in total IPSS, symptom-associated QoL, mean peak flow rate and PVR (P < 0.05). However, in eight men with mild LUTS, although there was a 33% improvement in the total symptom score, it was not statistically significant. Thirty-eight patients reported complete continence, nine had infrequent stress leaks only on heavy physical activity, and the remaining three used < 2 pads/day for protection before heavy physical activity at 3 months after surgery. CONCLUSIONS: Radical prostatectomy provides major benefits to men with LUTS besides cancer control. These data are important in counselling patients about the treatment options, especially in view of the current enthusiasm for brachytherapy and conformal radiotherapy, which may worsen LUTS.","BJU Int, 93(4): 507-509","UK",2004,"Local","Surgery","IPSS","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease"]
[378,"Kupelian, P. A., et al. (2001). \"Short-course intensity-modulated radiotherapy (70 GY at 2.5 GY per fraction) for localized prostate cancer: preliminary results on late toxicity and quality of life.\" Int J Radiat Oncol Biol Phys 51(4): 988-993.",null,"Kupelian, P. A., et al.","Short-course intensity-modulated radiotherapy (70 GY at 2.5 GY per fraction) for localized prostate cancer: preliminary results on late toxicity and quality of life","PURPOSE: To present our preliminary observations on the late toxicity and quality of life (QOL) of patients treated with short-course intensity-modulated radiotherapy (SCIM-RT). METHODS AND MATERIALS: Fifty-one patients were treated with SCIM-RT at the Cleveland Clinic Foundation between October 1998 and May 1999. The technique consisted of intensity-modulated radiotherapy using 5 static fields (anterior, 2 laterals, and 2 anterior obliques). Inverse plans were generated by the Corvus treatment-planning system. The treatment delivery was performed with a dynamic multileaf collimator. A total of 70.0 Gy was prescribed in all cases at 2.5 Gy per fraction to be delivered in 28 fractions over 5 and a half weeks. The location of the prostate gland was verified and adjusted daily with the BAT transabdominal ultrasound system. The median follow-up was 18 months (range: 11 to 26 months). The Radiation Therapy Oncology Group (RTOG) scales were used to evaluate late toxicity. The Expanded Prostate Cancer Index Composite (EPIC) was used to evaluate QOL. A total of 24 patients completed the EPIC questionnaire at approximately 2 years after therapy (median time from treatment to questionnaire administration: 24 months; range: 21 to 26 months). The results from the EPIC questionnaires were compared to scores from 46 patients treated during the same time period with conformal radiotherapy (CRT) to 78 Gy at 2 Gy per fraction. RESULTS: The dose was prescribed to an isodose line ranging from 82.0% to 90.0% (mean: 87.2%). The range of the individual prostate mean doses was 73.5 to 78.5 Gy (average: 75.3 Gy). To date, only 1 patient had Grade 1 late urinary toxicity. To date, only 4 patients had Grade 1 late rectal toxicity. No Grade 2 or 3 late urinary or rectal complications have occurred. The actuarial rectal bleeding rate observed at 18 months was 7%. There were no differences in scores from the urinary, bowel, hormonal, and overall QOL domains between SCIM-RT patients and patients treated with CRT. The overall physical and mental QOL scores were also nearly identical to scores reported for the general U.S. population. CONCLUSION: Preliminary late toxicity results up to 2 years after SCIM-RT are encouraging, with a median follow-up of 18 months (range 11 to 26 months). Late toxicity assessed by the physicians using RTOG late toxicity scores has been excellent. QOL reported by the patients using the EPIC questionnaire reveals no difference between patients treated with high-dose CRT at standard fractionation and patients treated with SCIM-RT. SCIM-RT is an alternative method of dose escalation in the treatment of localized prostate cancer. The proposed schedule significantly increases convenience to patients due to the decrease in overall treatment time.","Int J Radiat Oncol Biol Phys, 51(4): 988-993","USA",2001,"Local","Radiotherapy","EPIC,RTOG-EORTC-SS","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,Treatment"]
[379,"Kuwata, Y., et al. (2007). \"Dissociation of sexual function and sexual bother following autologous sural nerve grafting during radical prostatectomy.\" Int J Urol 14(6): 510-514.",null,"Kuwata, Y., et al.","Dissociation of sexual function and sexual bother following autologous sural nerve grafting during radical prostatectomy","AIM: We prospectively investigated health-related quality of life (HR-QOL), including sexual function and sexual bother, in patients who underwent nerve grafting during a radical prostatectomy in comparison with those who underwent a non-nerve-sparing radical prostatectomy. METHODS: Between August 2001 and May 2004, radical prostatectomies were performed on 69 patients with clinical T1-T2N0/M0 prostate cancer. Of these, 66 patients (22: nerve-grafting patients, 44: non-nerve-sparing and non-nerve-grafting patients) were enroled into this study. The observation periods ranged from 12-46 months (median: 29 months). The general HR-QOL was measured with the SF-36 General Health Survey and disease-specific HR-QOL was measured with the University of California Los Angeles-Prostate Cancer Index. RESULTS: Penile tumescence was observed in 11 out of 15 (73.3%) prostate-specific antigen failure-free patients who underwent unilateral nerve grafting with contra-lateral nerve-sparing or bilateral nerve grafting. Vaginal penetration was observed in six out of 15 (40.0%) patients. The time for partial erection and for intercourse, respectively, ranged from 3-21 months (median = 6 months) and 6-36 months (median = 13.5 months). There were no significant differences in general HR-QOL changes over time between the nerve-grafting patients and the patients without any nerve-preserving procedures. The sexual function score was significantly better in the nerve-grafting (bilateral nerve graft or unilateral nerve graft with contra-lateral nerve-sparing) patients than in the non-nerve-sparing/non-nerve-grafting patients. The sexual bother score, however, was more serious for the patients who underwent nerve-grafting surgery than for the non-nerve-sparing/non-nerve-grafting patients. CONCLUSION: Sexual bother is serious for patients who attempt to maintain sexual function after special surgical procedures, such as nerve-grafting surgery. We should be aware that careful counseling is needed to avoid impatient and excessive hope for the recovery of sexual function.","Int J Urol, 14(6): 510-514","Japan",2007,"Local","Surgery","SF-36,UCLA-PCI","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease,Utility"]
[380,"Ladoire, S., et al. (2010). \"Metronomic oral cyclophosphamide prednisolone chemotherapy is an effective treatment for metastatic hormone-refractory prostate cancer after docetaxel failure.\" Anticancer Res 30(10): 4317-4323.",null,"Ladoire, S., et al.","Metronomic oral cyclophosphamide prednisolone chemotherapy is an effective treatment for metastatic hormone-refractory prostate cancer after docetaxel failure","BACKGROUND: There is currently no standard of treatment for patients with hormone refractory prostate cancer (HRPC) after failure of docetaxel-based chemotherapy. The purpose of this study was to assess the anticancer activity and tolerance of metronomic cyclophosphamide prednisolone combination in this setting. PATIENTS AND METHODS: From 2005 to 2010, patients with HRPC who failed at least docetaxel-based chemotherapy were proposed metronomic cyclophosphamide-prednisolone regimen, and were prospectively registered. Twenty-three patients received 50 mg cyclophosphamide and 10 mg prednisolone per os daily until disease progression. Treatment tolerance and efficacy on PSA decrease and pain were studied. RESULTS: Metronomic cyclophosphamide prednisolone was safe, well tolerated, and demonstrated interesting clinical activity, yielding a prostate specific antigen decrease by >/=50% in 26% of patients and decrease by >/=30% in 48% of patients, but also favorable palliative effects on pain in 43% of patients. The median progression-free survival was 6 months (95% CI: 4-8 months) and the median overall survival was 11 months (95% CI: 7-19 months). CONCLUSION: For this patient population, low dose metronomic cyclophosphamide prednisolone might be a viable alternative. Its convenient oral administration, low cost, and lack of toxicity justify further studies alone, or in combination with other agents in HRPC patients.","Anticancer Res, 30(10): 4317-4323","France",2010,"Metastatic","Chemotherapy","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Symptom"]
[381,"Lamb, M. N., et al. (2011). \"Patients' perspectives on fecal incontinence after brachytherapy for localized prostate cancer.\" Dis Colon Rectum 54(5): 615-621.",null,"Lamb, M. N., et al.","Patients' perspectives on fecal incontinence after brachytherapy for localized prostate cancer","BACKGROUND: When a patient is deciding between treatment options for localized prostate cancer, brachytherapy is commonly chosen for its perceived low complication profile. Brachytherapy can frequently be complicated by the development of fecal incontinence. The potential long-term impact of this dysfunction on a patient's life should be discussed. OBJECTIVE: This study aimed to assess the long-term impact of brachytherapy for localized prostate cancer on fecal incontinence and to determine the impact and severity of the incontinence on patients' ability to engage in activities of daily living. DESIGN: A retrospective observational study was performed. A questionnaire packet was mailed to patients who had received brachytherapy treatment for localized prostate cancer and were now more than 2 years out from initial seed implantation. Each packet contained the Colon and Ano-Rectal Impact Questionnaire (assessing quality of life), the Colon and Ano-Rectal Distress Inventory, and the Cleveland Clinic Fecal Incontinence Score (both measured existence and severity of fecal incontinence). SETTINGS: This study was conducted at Caritas Christi St. Elizabeth's Medical Center, a tertiary referral center in Boston, Massachusetts from January 1, 1998 to December 31, 2007. PATIENTS: One hundred forty-three of 568 patients (a 25% response rate) responded and were analyzed. INTERVENTIONS: No interventions were performed. MAIN OUTCOME MEASURES: The main outcome was impact of fecal incontinence on quality of life. RESULTS: : Of the responses to the Colon and Ano-Rectal Impact Questionnaire, 13.2% (19 patients) (P < .001) stated that fecal incontinence was impacting their ability to participate in their daily activities. Sixty-three percent (12 patients) (P < .001) of patients described the impact of the incontinence as slight, 21% (4 patients) (P < .001) described it as moderate, and 15.8% (3 patients) (P < .001) described it as severe. LIMITATIONS: There were no case-matched controls and the response rate to the surveys was low. CONCLUSIONS: Postbrachytherapy fecal incontinence leaves a long-term impact on patients' ability to engage in activities of daily living.","Dis Colon Rectum, 54(5): 615-621","USA",2011,"Local","Brachytherapy","CARIQ,CARDI,CCFIS","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Complication"]
[382,"Landrey, A. R., et al. (2013). \"Shared decision making in prostate-specific antigen testing: the effect of a mailed patient flyer prior to an annual exam.\" J Prim Care Community Health 4(1): 67-74.",null,"Landrey, A. R., et al.","Shared decision making in prostate-specific antigen testing: the effect of a mailed patient flyer prior to an annual exam","INTRODUCTION AND AIMS: Professional societies recommend that the decision to screen for prostate cancer involves a shared discussion between patient and provider. Many men are tested without this discussion. Prostate cancer screening decision aids increase patient knowledge and participation in prostate-specific antigen (PSA) testing decisions under ideal circumstances but are often resource intensive and elaborate. There is a need for evaluation of interventions that are low cost, low literacy, and practical for widespread distribution. The authors evaluated the effect of a mailed low-literacy informational patient flyer about the PSA test on measures of shared decision making. METHODS: A pragmatic randomized controlled trial comparing the mailed flyer versus usual care was conducted among 303 men aged 50 to 74 years who were scheduled for annual health maintenance exams in 2 general internal medicine clinics (University of Colorado and University of Colorado Hospital). Charts were reviewed after the visits for documentation of PSA screening discussions and PSA testing rates. Follow-up patient surveys assessed include perceived participation in PSA screening decisions, knowledge of the PSA test, and flyer acceptability. RESULTS: Rates of chart-documented PSA discussions were low with no difference between the flyer and control groups (17.7% and 13.6%, respectively; P = .28). Rates of PSA testing were also similar in both groups (62.5% vs 58.5%; P = .48). Rates of patient-reported PSA discussions were higher than the documented rates but also without differences between the groups (71.8% vs 62.3%; P = .22). The intervention had no effect in the PSA knowledge scores (3.5/5 vs 3.3/5, P = .60). Patients found the flyer to be highly acceptable. CONCLUSIONS: A mailed low-literacy informational flyer was well received by patients but had no effect on rates of PSA discussions, PSA testing, or patient knowledge of prostate cancer screening.","J Prim Care Community Health, 4(1): 67-74","USA",2013,"At risk","Screening,Various","Unclear","General population",null,"Clinical trial",null,null,null,null,null,null,null,null,"Knowledge,Views"]
[383,"Lane, A., et al. (2016). \"Patient-reported outcomes in the ProtecT randomized trial of clinically localized prostate cancer treatments: study design, and baseline urinary, bowel and sexual function and quality of life.\" BJU Int 118(6): 869-879.",null,"Lane, A., et al.","Patient-reported outcomes in the ProtecT randomized trial of clinically localized prostate cancer treatments: study design, and baseline urinary, bowel and sexual function and quality of life","OBJECTIVES: To present the baseline patient-reported outcome measures (PROMs) in the Prostate Testing for Cancer and Treatment (ProtecT) randomized trial comparing active monitoring, radical prostatectomy and external-beam conformal radiotherapy for localized prostate cancer and to compare results with other populations. MATERIALS AND METHODS: A total of 1643 randomized men, aged 50-69 years and diagnosed with clinically localized disease identified by prostate-specific antigen (PSA) testing, in nine UK cities in the period 1999-2009 were included. Validated PROMs for disease-specific (urinary, bowel and sexual function) and condition-specific impact on quality of life (Expanded Prostate Index Composite [EPIC], 2005 onwards; International Consultation on Incontinence Questionnaire-Urinary Incontinence [ICIQ-UI], 2001 onwards; the International Continence Society short-form male survey [ICSmaleSF]; anxiety and depression (Hospital Anxiety and Depression Scale [HADS]), generic mental and physical health (12-item short-form health survey [SF-12]; EuroQol quality-of-life survey, the EQ-5D-3L) were assessed at prostate biopsy clinics before randomization. Descriptive statistics are presented by treatment allocation and by men's age at biopsy and PSA testing time points for selected measures. RESULTS: A total of 1438 participants completed biopsy questionnaires (88%) and 77-88% of these were analysed for individual PROMs. Fewer than 1% of participants were using pads daily (5/754). Storage lower urinary tract symptoms were frequent (e.g. nocturia 22%, 312/1423). Bowel symptoms were rare, except for loose stools (16%, 118/754). One third of participants reported erectile dysfunction (241/735) and for 16% (118/731) this was a moderate or large problem. Depression was infrequent (80/1399, 6%) but 20% of participants (278/1403) reported anxiety. Sexual function and bother were markedly worse in older men (65-70 years), whilst urinary bother and physical health were somewhat worse than in younger men (49-54 years, all P < 0.001). Bowel health, urinary function and depression were unaltered by age, whilst mental health and anxiety were better in older men (P < 0.001). Only minor differences existed in mental or physical health, anxiety and depression between PSA testing and biopsy assessments. CONCLUSION: The ProtecT trial baseline PROMs response rates were high. Symptom frequencies and generic quality of life were similar to those observed in populations screened for prostate cancer and control subjects without cancer.","BJU Int, 118(6): 869-879","UK",2016,"Local","Surgery,Radiotherapy,Surveillance","EPIC,ICIQ,ICSQ,HADS,SF-12,EQ-5D","general population",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,Complication,Comorbidity,Utility"]
[384,"Langenhuijsen, J. F., et al. (2013). \"Continuous vs. intermittent androgen deprivation therapy for metastatic prostate cancer.\" Urol Oncol 31(5): 549-556.",null,"Langenhuijsen, J. F., et al.","Continuous vs. intermittent androgen deprivation therapy for metastatic prostate cancer","OBJECTIVES: To analyze the predictive value of PSA for progression and the role of testosterone for quality of life (QOL) in patients with androgen deprivation therapy (ADT) for metastatic prostate cancer. MATERIALS AND METHODS: PSA and testosterone data were used from a phase III trial randomizing patients without progression and PSA < 4 ng/ml (n = 193), after 6 months induction course, between continuous (CAD) (n = 96) and intermittent (IAD) (n = 97) ADT. The 2-year risk of progression was calculated for baseline PSA, 'fast' and 'slow' PSA decline to < 4 ng/ml (60 days cut-off), PSA nadir, performance status and pain. Testosterone kinetics and QOL were also evaluated. Univariate Kaplan Meier survival analysis and log rank tests were used to compare the risk of progression. RESULTS: For progression analysis, 173 patients' data were available. The 2-year risk of progression for baseline PSA < 50 ng/ml, 50 to <500 ng/ml, and >/= 500 ng/ml was 25%, 55%, and 76% (P = 0.03) in CAD, and 38%, 64%, and 85% (P = 0.006) in IAD, respectively. The 2-year risk of progression for PSA nadir </= 0.2 ng/ml, and > 0.2 to 4 ng/ml in CAD was 31% and 70% (P < 0.001), respectively. In the IAD group, a similar trend was seen. Patients with PSA nadir </= 0.2 ng/ml, though had significantly higher 2-year risk of progression compared to CAD (53% vs. 31% (P = 0.03), respectively. PSA decline showed no predictive value. Patients without pain had a significantly lower 2-year risk of progression in both groups. Without ADT testosterone remained at castrate level for 4 months. After the first and second IAD cycle 92% and 46%, respectively, had a normalized testosterone. No QOL difference was found, although more side effects occurred in CAD. CONCLUSIONS: Metastatic prostate cancer patients with high baseline PSA, pain, and high PSA nadir have a poor prognosis with ADT. Patients with low PSA nadir do significantly worse with IAD compared with CAD. Low testosterone after ADT and incomplete testosterone recovery may explain similar QOL. Therefore, IAD is not a good treatment option for many metastatic prostate cancer patients.","Urol Oncol, 31(5): 549-556","Netherlands",2013,"Metastatic","Hormonal","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General"]
[385,"Lebeau, T., et al. (2005). \"Validation of prostate cancer index and SF-12 short forms.\" Can J Urol 12(6): 2873-2879.",null,"Lebeau, T., et al.","Validation of prostate cancer index and SF-12 short forms","BACKGROUND: Assessment of prostate cancer (PCa) specific and generic health-related quality-of-life (HRQOL) is frequently omitted due to several obstacles, such as respondent burden and infrastructure-related limitations. We attempted to reduce the number of items of two commonly used HRQOL assessment tools, namely the UCLA PCa Index (PCI) and the RAND SF-12, with the intent of generating the most parsimonious, yet psychometrically valid and reliable HRQOL assessment tool. METHODS: The PCI and SF-12 were administered to 2415 radical prostatectomy patients, and re-tested in a convenience sample of 35 men with PCa. Multivariate linear regression models defined the most predictive and item-reduced SF-12 and PCI item combinations. These were subjected to standard psychometric reliability and validity tests. RESULTS: The 8-item PCI sexual function (SF) scale was reduced to three items. The 5-item PCI urinary function (UF) scale was reduced to three items. The 6-item SF-12 mental health scale was reduced to three items, and the 6-item SF-12 physical scale was also reduced to three items. The total number of items was reduced from 27 to 12 (44%). The item-reduced scales accounted for over 85% of full-scale variance. All reliability and validity tests yielded highly satisfactory results. CONCLUSION: We developed SF-12 and PCI short-forms, which consist of 12 of 27 (44%) original items and can be completed by most men within 2 minutes. The short-forms represent a valid substitute for the full scales, as they provide over 85% of full-scale information and demonstrate excellent reliability statistics. The short forms have the potential for decreasing respondent burden and infrastructure-related requirements, which may in turn promote HRQOL assessment after radical prostatectomy.","Can J Urol, 12(6): 2873-2879","Canada",2005,"Any or unknown","Surgery","SF-12,UCLA-PCI","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease,Utility"]
[386,"Lebret, T. and A. Bouregba (2008). \"Roles of the urologist and nurse from the perspective of patients with prostate cancer receiving luteinizing hormone-releasing hormone analogue therapy.\" BJU Int 102(10): 1419-1424.",null,"Lebret, T. and A. Bouregba","Roles of the urologist and nurse from the perspective of patients with prostate cancer receiving luteinizing hormone-releasing hormone analogue therapy","OBJECTIVES: To establish the roles of the urologist, general practitioner (GP) and nurse from the perspective of the patient with prostate cancer receiving hormone therapy, and to assess patient satisfaction, in particular with management and information needs. PATIENTS AND METHODS: Patients with prostate cancer receiving luteinizing hormone-releasing hormone analogue (LHRH-a) therapy were recruited by a representative sample of 58 French urologists (March to April 2007) and invited to complete a 42-item questionnaire. RESULTS: In all, 350 representative patients participated in the study; >90% were totally or quite satisfied with the information given by their urologist at diagnosis and the start of treatment. Their main contact during treatment was with the nurse who gave the injection (84% of patients). The nurse's main role was to provide clarity (60% of patients), guidance (35%) and support to the family (28%). Fewer patients discussed disease stage and progression with their nurse (29%) than with a doctor (urologist, 63%; or GP, 61%). Fewer also discussed treatment (24% vs 32%) but as many patients discussed the impact of their disease and treatment with their nurse as with their doctor (e.g. 33% discussed general health and fatigue with the nurse, vs 26% with the urologist). The need for contact with a health professional was greater during the early stages of treatment. Patients treated for <12 months with 3-monthly injections were less likely to be in favour of spacing injections than patients treated for >or=3 years. CONCLUSION: The patient consults the urologist for reliable information on disease and treatment, and to the GP for further support, if needed, but the nurse has the pivotal role. A 3-monthly injection schedule enables regular face-to-face contact between the nurse and the patient and their family, and contributes towards the patient's coping strategies and quality of life.","BJU Int, 102(10): 1419-1424","France",2008,"Any or unknown","Hormonal","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Views"]
[387,"Lebret, T., et al. (2014). \"Quality of life of 1276 elderly patients with prostate cancer, starting treatment with a gonadotropin-releasing hormone agonist: results of a French observational study.\" Aging Male 17(2): 87-93.",null,"Lebret, T., et al.","Quality of life of 1276 elderly patients with prostate cancer, starting treatment with a gonadotropin-releasing hormone agonist: results of a French observational study","This French observational, longitudinal, prospective study described the health-related quality of life (HRQoL) of elderly men (>/=75 years old) with prostate cancer after initiating gonadotropin-releasing hormone (GnRH) agonist therapy. At baseline and 3-6 months after baseline, European Organisation for Research and Treatment of Cancer quality of life questionnaire-core 30 (QLQ-C30) and prostate-specific (QLQ-PR25) questionnaires were completed by patients. Data from 1276 patients were analyzed. At baseline, mean (+/-SD) age was 80 (+/-4.1) years, 29.1% of patients had Gleason scores >/=8 and 24.9% had metastases. At baseline, increasing age, presence of metastasis and presence of comorbidity had a negative impact on QLQ-C30 and QLQ-PR25 scores. At follow-up, improvement in emotional-functioning (2.8; p < 0.001), social-functioning (1.7; p = 0.011), global HRQoL (1.6; p = 0.029), sleep-disturbance (-2.1; p = 0.011), appetite-loss (-4.0; p < 0.001) and pain (-4.1; p < 0.001) QLQ-C30 scores were observed. In addition, there was a worsening in treatment-related symptom (8.6; p < 0.001), sexual-activity (-5.5; p < 0.001) and sexual-functioning (-22.6; p < 0.001) QLQ-PR25 scores, and an improvement in urinary symptoms (-3.7; p < 0.001) and incontinence aid (-2.9; p = 0.023) QLQ-PR25 scores. This study shows that, apart from the expected impact on sexual functioning domains, HRQoL is not adversely affected by 3-6 months of GnRH agonist therapy in older men with prostate cancer.","Aging Male, 17(2): 87-93","France",2014,"Any or unknown","Hormonal","EORTC QLQ-C30,EORTC QLQ-PR25","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease,General"]
[388,"Lee, C. E., et al. (2012). \"A pilot study of exercise in men with prostate cancer receiving androgen deprivation therapy.\" BMC Cancer 12: 103.",null,"Lee, C. E., et al.","A pilot study of exercise in men with prostate cancer receiving androgen deprivation therapy","BACKGROUND: Androgen deprivation therapy (ADT) is the mainstay therapy for men with prostate cancer. However, there are musculoskeletal side effects from ADT that increase the risk for osteoporosis and fracture, and can compromise the quality of life of these individuals. The objectives of this study are to determine the efficacy of a home-based walking exercise program in promoting bone health, physical function and quality of life in men with prostate cancer receiving ADT. METHODS/DESIGN: A 12-month prospective, single-blinded, randomized controlled trial will be conducted to compare the Exercise Group with the Control Group. Sixty men with prostate cancer who will be starting ADT will be recruited and randomly assigned to one of the two groups: the Exercise Group will receive instructions in setting up an individualized 12-month home-based walking exercise program, while the Control Group will receive standard medical advice from the attending physician. A number of outcome measures will be used to assess bone health, physical function, and health-related quality of life. At baseline and 12 months, bone health will be assessed using dual-energy X-ray absorptiometry. At baseline and every 3 months up to 12 months, physical function will be evaluated using the Functional Assessment of Chronic Illness Therapy - Fatigue Scale, Activities-specific Balance Confidence Scale, Short Physical Performance Battery, and Six-Minute Walk Test; and health-related quality of life will be assessed using the Functional Assessment of Cancer Therapy Prostate Module and the Medical Outcomes Study 12-item Short Form Health Survey Version 2. A mixed multiple analysis of variance will be used to analyze the data. DISCUSSION: Musculoskeletal health management remains a challenge in men with prostate cancer receiving ADT. This study addresses this issue by designing a simple and accessible home-based walking exercise program that will potentially have significant impact on reducing the risk of fracture, promoting physical function, and ultimately improving the health-related quality of life in men with prostate cancer receiving ADT. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00834392.","BMC Cancer, 12(103","Canada",2012,"Any or unknown","Hormonal,Various","FACT-P,SF-12,FACIT-F,ABC,PPB","Patient",null,"Protocol",null,null,null,null,null,null,null,null,"Disease,Symptom,Utility"]
[389,"Lee, J. Y., et al. (2016). \"Multinational Prospective Study of Patient-Reported Outcomes After Prostate Radiation Therapy: Detailed Assessment of Rectal Bleeding.\" Int J Radiat Oncol Biol Phys 96(4): 770-777.",null,"Lee, J. Y., et al.","Multinational Prospective Study of Patient-Reported Outcomes After Prostate Radiation Therapy: Detailed Assessment of Rectal Bleeding","PURPOSE: The new short Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) patient-reported health-related quality of life (HRQOL) tool has removed the rectal bleeding question from the previous much longer version, EPIC-26. Herein, we assess the impact of losing the dedicated rectal bleeding question in 2 independent prospective multicenter cohorts. METHODS AND MATERIALS: In a prospective multicenter test cohort (n=865), EPIC-26 patient-reported HRQOL data were collected for 2 years after treatment from patients treated with prostate radiation therapy from 2003 to 2011. A second prospective multicenter cohort (n=442) was used for independent validation. A repeated-effects model was used to predict the change from baseline in bowel summary scores from longer EPIC instruments using the change in EPIC-CP bowel summary scores with and without rectal bleeding scores. RESULTS: Two years after radiation therapy, 91% of patients were free of bleeding, and only 2.6% reported bothersome bleeding problems. Correlations between EPIC-26 and EPIC-CP bowel scores were very high (r(2)=0.90-0.96) and were statistically improved with the addition of rectal bleeding information (r(2)=0.94-0.98). Considering all patients, only 0.2% of patients in the test cohort and 0.7% in the validation cohort reported bothersome bleeding and had clinically relevant HRQOL changes missed with EPIC-CP. However, of the 2.6% (n=17) of men with bothersome rectal bleeding in the test cohort, EPIC-CP failed to capture 1 patient (6%) as experiencing meaningful declines in bowel HRQOL. CONCLUSIONS: Modern prostate radiation therapy results in exceptionally low rates of bothersome rectal bleeding, and <1% of patients experience bothersome bleeding and are not captured by EPIC-CP as having meaningful HRQOL declines after radiation therapy. However, in the small subset of patients with bothersome rectal bleeding, the longer EPIC-26 should strongly be considered, given its superior performance in this patient subset.","Int J Radiat Oncol Biol Phys, 96(4): 770-777","USA",2016,"Any or unknown","Radiotherapy","EPIC","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease"]
[390,"Lee, T. K., et al. (2015). \"A systematic review of expanded prostate cancer index composite (EPIC) quality of life after surgery or radiation treatment.\" Can J Urol 22(1): 7599-7606.",null,"Lee, T. K., et al.","A systematic review of expanded prostate cancer index composite (EPIC) quality of life after surgery or radiation treatment","INTRODUCTION: The Expanded Prostate Cancer Index Composite (EPIC) is a validated and widely adopted instrument that measures patient quality of life. This study aims to describe and compare patient quality of life in the bowel, urinary, and sexual domains across different prostate cancer treatments. MATERIALS AND METHODS: A systematic review of English articles published prior to 2012 was conducted. Peer reviewed articles reporting longitudinal EPIC data in a statistically analyzable form with clearly defined time points were included. Articles were assessed by content experts to ensure optimal treatment quality. Screening of studies and extraction of data were completed using a predefined data abstraction tool. Data on bowel, urinary, and sexual domains were documented. Scores in each domain range from a low of 0 to a high of 100. RESULTS: Twenty-six articles, representing 8302 patients, were included. All treatments were associated with short term or long term reductions in urinary, bowel, and sexual domains. Surgery patients had better post-treatment bowel quality of life; however, average declines were small regardless of treatment. Post-treatment urinary incontinence scores were lower for surgery patients; while radiation patients had worse urinary irritation. Average urinary bother and function were similar between treatment groups at 18 months post-treatment. Surgery patients had better baseline sexual function. A greater decline in sexual function was observed in surgery patients compared to radiation patients. CONCLUSIONS: Prostate cancer treatments have different impacts on patient quality of life and function. The magnitude of difference between treatment-related adverse effects may be important to patients when choosing therapy.","Can J Urol, 22(1): 7599-7606","International",2015,"Any or unknown","Radiotherapy,Surgery","EPIC","Patient",null,"Systematic review",null,null,null,null,null,null,null,null,"Disease"]
[391,"Lee, W. R., et al. (1999). \"Early quality of life assessment in men treated with permanent source interstitial brachytherapy for clinically localized prostate cancer.\" J Urol 162(2): 403-406.",null,"Lee, W. R., et al.","Early quality of life assessment in men treated with permanent source interstitial brachytherapy for clinically localized prostate cancer","PURPOSE: We prospectively assessed quality of life changes with time using validated instruments in men with clinically localized prostate cancer treated with permanent source interstitial brachytherapy. MATERIALS AND METHODS: A total of 46 men consecutively treated with permanent source interstitial brachytherapy between September 1997 and June 1998 completed quality of life (Functional Assessment of Cancer Therapy-Prostate [FACT-P]) and urinary symptom (International Prostate Symptom Score [I-PSS]) questionnaires before (T0), and 1 (T1) and 3 (T3) months after treatment. All participants were treated with 125iodine alone. Repeated measures analyses of variance were conducted on all quality of life and urinary outcome measures for 44 patients with data at all 3 time points. RESULTS: Median patient age was 68 years (range 51 to 80). All men had clinical T1c to T2b prostate cancer, Gleason score was 6 or less in 36 (78%) and median pretreatment prostate specific antigen was 7 ng./ml. (range 1.1 to 20.6). Mean score (and standard deviation) at T0, T1 and T3 for each questionnaire was FACT-P 138.9 (14.4), 128.6 (19.4) and 136.7 (17.4), TO versus T1 p = 0.0005 and T0 versus T3 p = 0.6612, and I-PSS 8.3 (5.4), 19.7 (9.0) and 15.7 (7.2), T0 versus T1 p = 0.0001 and T0 versus T3 p = 0.0001. For the global test across time statistically significant differences were observed for the cumulative scores of FACT-P, I-PSS, physical well-being and prostate cancer subscales of the FACT-P and the Trial Outcome Index. By 3 months all quality of life measures had returned to baseline. Urinary symptoms as measured by I-PSS persisted for at least 3 months. CONCLUSIONS: Clinically meaningful decreases in quality of life, as measured by the FACT-P instrument, were evident within weeks after permanent source interstitial brachytherapy. However, by 3 months FACT-P scores returned to near baseline levels. A validated instrument designed to measure urinary symptoms (I-PSS) demonstrated that moderate to severe urinary symptoms persisted for at least 3 months following permanent source interstitial brachytherapy. An instrument specifically designed to measure urinary symptoms can provide additional clinical information when combined with FACT-P.","J Urol, 162(2): 403-406","USA",1999,"Local","Brachytherapy","FACT-P,IPSS","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease"]
[392,"Lee, W. R., et al. (2000). \"A preliminary analysis of health-related quality of life in the first year after permanent source interstitial brachytherapy (PIB) for clinically localized prostate cancer.\" Int J Radiat Oncol Biol Phys 46(1): 77-81.",null,"Lee, W. R., et al.","A preliminary analysis of health-related quality of life in the first year after permanent source interstitial brachytherapy (PIB) for clinically localized prostate cancer","PURPOSE: To prospectively assess the health-related quality of life (HRQOL) and changes in HRQOL during the first year after permanent source interstitial brachytherapy (PIB). METHODS AND MATERIALS: Thirty-one men treated with PIB between September 1997 and March 1998 completed a quality of life (functional assessment of cancer therapy-prostate: FACT-P) and a urinary symptom questionnaire (international prostate symptom score: IPSS) prior to treatment (T0), 1 month (T1), 3 months (T3), 6 months (T6), and 12 months (T12) following PIB. All participants were treated with 125I alone. Repeated measures analyses of variance (ANOVA) were conducted on all quality of life and urinary outcome measures for all 31 patients at all time points. RESULTS: The median age of the study population was 66 (range 51-80). All men had clinical T1c-T2b prostate cancer. The Gleason score was < or =6 in 27/31 (87%). Median pretreatment PSA was 7.8 ng/ml (range 1.1-20.6). The mean score (and standard deviation) at T0, T1, T3, T6, and T12 for the FACT-P questionnaire are as follows: 140.5 (13.5), 132.7 (15.3), 137.2 (17.4), 140.1 (16.0), and 142.4 (15.3). For the global test across time, statistically significant differences were observed for the cumulative scores of FACT-P (p<0.0012). The decrease in HRQOL was most marked 1 month following PIB. Examination of the subscales within the FACT-P instrument demonstrated statistically significant changes over time for the following: physical well-being (PWB), functional well-being (FWB), and prostate cancer (PCS). By 3 months, all HRQOL measures had returned to near baseline. The mean score (and standard deviation) at T0, T1, T3, T6, and T12 for the IPSS questionnaire are as follows: 8.3 (5.5), 18.4 (8.0), 15.7 (7.4), 13.7 (7.4), and 10.2 (5.7). For the global test across time, statistically significant differences were observed for the IPSS scores (p<0.0001). The maximum increase in IPSS occurred 1 month following PIB. CONCLUSION: The results of this preliminary analysis suggest that clinically meaningful decreases in HRQOL, as measured by the FACT-P instrument, are evident within weeks after PIB. By 3 months, however, FACT-P scores return to near baseline levels. A validated instrument designed to measure urinary symptoms (IPSS) demonstrates that moderate to severe urinary symptoms persist for at least 3-6 months following PIB. One year following PIB, the scores on the FACT-P and IPSS questionnaires had returned to baseline.","Int J Radiat Oncol Biol Phys, 46(1): 77-81","USA",2000,"Local","Brachytherapy","FACT-P,IPSS","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease"]
[393,"Lee, W. R., et al. (2000). \"A prospective analysis of patient-reported quality of life after prostate brachytherapy.\" Semin Urol Oncol 18(2): 147-151.",null,"Lee, W. R., et al.","A prospective analysis of patient-reported quality of life after prostate brachytherapy","The purpose of this study was to prospectively assess the patient-reported quality of life (QOL) and changes in QOL during the first 3 months after prostate brachytherapy (PB). Seventy-four men treated with PB between September 1997 and December 1998 completed a QOL questionnaire (Functional Assessment of Cancer Therapy-Prostate [FACT-P]) and a measurement of urinary symptoms (International Prostate Symptom Score [IPSS]) before treatment (T0), 1 month (T1), and 3 months (T3) following PB. All participants were treated with (125)I alone. The mean score (and standard deviation) at T0, T1, and T3 FACT-P questionnaire are as follows: 139.2 (15.7), 125.4 (20.2), and 133.0 (18.2). For the global test across time, statistically significant differences were observed for the cumulative scores of FACT-P (P < .0001). Examination of the subscales within the FACT-P instrument demonstrated statistically significant changes over time for the following: physical well-being, functional well-being and the prostate cancer subscale. The mean score (and standard deviation) at T0, T1, and T3 for the IPSS questionnaire are as follows: 9.1 (5.9), 20.0 (7.8), and 16.6 (7.2). For the global test across time, statistically significant differences were observed for the IPSS scores (P < .0001). Clinically meaningful decreases in QOL are evident within weeks after PB. Moderate to severe urinary symptoms persist for at least 3 months following PB.","Semin Urol Oncol, 18(2): 147-151","USA",2000,"Any or unknown","Brachytherapy","FACT-P,IPSS","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease"]
[394,"Lee, W. R., et al. (2001). \"A prospective quality-of-life study in men with clinically localized prostate carcinoma treated with radical prostatectomy, external beam radiotherapy, or interstitial brachytherapy.\" Int J Radiat Oncol Biol Phys 51(3): 614-623.",null,"Lee, W. R., et al.","A prospective quality-of-life study in men with clinically localized prostate carcinoma treated with radical prostatectomy, external beam radiotherapy, or interstitial brachytherapy","PURPOSE: To prospectively assess the health-related quality of life (HRQOL) and changes in HRQOL during the first year after 3 different treatments for clinically localized prostate cancer. METHODS AND MATERIALS: Ninety men with T1-T2 adenocarcinoma of the prostate were treated with curative intent between May 1998 and June 1999 and completed a quality-of-life Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire before treatment (T0) and 1 month (T1), 3 months (T3), and 12 months (T12) after treatment. Forty-four men were treated with permanent source interstitial brachytherapy (IB), 23 received external beam radiotherapy (EBRT), and 23 men were treated with radical prostatectomy (RP). The mean age of the entire study population was 65.9 years (median 67, range 42-79). The mean pretreatment prostate-specific antigen level of the entire study population was 6.81 ng/mL (median 6.25, range 1.33-19.6). The Gleason score was <or=6 in 65 (72%) of 90. The repeated measures analysis of variance and analysis of covariance were conducted on all quality-of-life and urinary outcome measures. RESULTS: A comparison of the demographic characteristics of the 3 treatment groups demonstrated significant differences. The men treated with RP were significantly younger than the men in either the IB or EBRT group (median age 61.0 RP, 67.1 IB, 68.8 EBRT; p = 0.0006). The men in the IB group were more likely to have a Gleason score of <or=6 than the EBRT group (Gleason score <or=6, 86% IB and 48% EBRT; p = 0.015). The mean score (standard deviation) at T0, T1, T3, and T12 for the FACT-P questionnaire for each group was as follows: IB 138.4 (17.0), 120.5 (21.7), 130.0 (18.4), and 138.5 (14.2); EBRT 137.1 (12.1), 129.5 (21.0), 134.4 (19.2), and 136.9 (15.6); and RP 138.3 (14.7), 117.7 (18.3), 134.4 (17.8), and 140.4 (14.9), respectively. Statistically significant differences over time were observed for the FACT-P in the IB and RP groups (p <0.0001), but not for the EBRT group (p = 0.08). The examination of the subscales within the FACT-P instrument demonstrated statistically significant changes over time in the IB and RP groups for the following: physical well-being, functional well-being, and prostate cancer symptoms. After adjusting for age, race, T stage, Gleason score, use of hormonal therapy, and baseline FACT-P scores, statistically significant differences in the FACT-P score at T1 according to treatment group were observed. At T12, the FACT-P scores were not significantly different than the baseline FACT-P scores for any group. CONCLUSIONS: The results of this analysis suggest that significant decreases in HRQOL, as measured by the FACT-P instrument, are evident in the first month after IB or RP, but not after EBRT. One year after treatment, however, the FACT-P scores were not statistically different from the baseline measures for any group. For all treatment groups, most of the HRQOL decreases were observed in the physical, functional, and prostate cancer-specific domains. These results suggest that the HRQOL changes are likely to be treatment-specific, further emphasizing the importance of a randomized trial comparing the different treatment options in this population of men.","Int J Radiat Oncol Biol Phys, 51(3): 614-623","USA",2001,"Local","Radiotherapy,Surgery,Brachytherapy","FACT-P","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease"]
[395,"Lennernas, B., et al. (2015). \"Radical prostatectomy versus high-dose irradiation in localized/locally advanced prostate cancer: A Swedish multicenter randomized trial with patient-reported outcomes.\" Acta Oncol 54(6): 875-881.",null,"Lennernas, B., et al.","Radical prostatectomy versus high-dose irradiation in localized/locally advanced prostate cancer: A Swedish multicenter randomized trial with patient-reported outcomes","BACKGROUND: Treatment of localized prostate cancer (PC) is controversial. This is the first randomized study comparing an open surgery procedure (radical prostatectomy) with a combination of high-dose rate brachytherapy (2x10 Gy) and external beam radiotherapy (25x2 Gy) in PC patients in Sweden 1996-2001. The two randomization arms were compared regarding differences in patients-reported outcomes, such as complications and health-related quality of life (HRQoL). MATERIAL AND METHODS: The patients had localized/locally advanced PC, clinical category T1b-T3a, N0, M0 and PSA</=50 ng/ml. All underwent total androgen blockade (six months). Self-reported HRQoL and symptoms including urinary, bowel, and sexual side effects were investigated prospectively before randomization and 12 and 24 months after randomization. A total of 89 patients were randomized and completed the EORTC QLQ C-33 and EORTC PR-25 questionnaires. RESULTS: Over the study period, there were no discernible differences in HRQoL, or complications between the two groups. Emotional functioning, however, improved statistically significantly over time, whereas Social functioning decreased, and financial difficulties increased. No statistically significant differences in group-by-time interactions were found. The survival rate was 76%. Only eight patients (9%) died of PC. CONCLUSION: Open radical prostatectomy and the combined high-dose rate brachytherapy with external beam radiation appeared to be comparable in the measured outcomes. It was not possible to draw any conclusion on the efficacy of the two treatments due to insufficient power of the study.","Acta Oncol, 54(6): 875-881","Sweden",2015,"Advanced,Local","Radiotherapy,Surgery","EORTC QLQ-C30,EORTC QLQ-PR25","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,General"]
[396,"Lepore, S. J., et al. (2003). \"Improving quality of life in men with prostate cancer: a randomized controlled trial of group education interventions.\" Health Psychol 22(5): 443-452.",null,"Lepore, S. J., et al.","Improving quality of life in men with prostate cancer: a randomized controlled trial of group education interventions","Men who were recently treated for prostate cancer (N=250) were randomly assigned to a control group, a group education intervention (GE), or a group education-plus-discussion intervention (GED). Both GE and GED increased prostate cancer knowledge. In the year postintervention, men in the GED condition were less bothered by sexual problems than men in the control condition, and they were more likely to remain steadily employed (93.0%) than men in the GE (75.6%) or control (72.5%) conditions. Among noncollege graduates, GED and GE resulted in better physical functioning than the control condition, and GED resulted in more positive health behaviors than the control or GE condition. Among college graduates, controls were comparable with the GE and GED groups in physical functioning and positive health behaviors.","Health Psychol, 22(5): 443-452","USA",2003,"Any or unknown","Various","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Knowledge,Costs"]
[397,"Lev, E. L., et al. (2004). \"Quality of life of men treated with brachytherapies for prostate cancer.\" Health Qual Life Outcomes 2: 28.",null,"Lev, E. L., et al.","Quality of life of men treated with brachytherapies for prostate cancer","BACKGROUND: Most studies of men undergoing treatment for prostate cancer examine physical symptoms as predictors of Quality of Life (QOL). However, symptoms vary by treatment modality in this population, and psychosocial variables, shown to be important to QOL, have rarely been examined. Litwin noted a need for analysis of QOL data in men treated for prostate cancer with different modes of therapy, as studies focusing on specific treatments will increase the homogeneity of research findings. METHODS: This cross-sectional study explored physical and psychosocial predictors of QOL in men receiving one of two types of radiation treatment for prostate cancer: Intensity Modulated Radiation Therapy (IMRT) + High Dose Rate (HDR) Brachytherapy or IMRT + seed implantation. Subjects completed a biographic questionnaire; quality of life measures, which were the eight subscales of the Medical Outcome Study Short Form Health Survey (SF-36); measures of physical symptoms including the Radiation Therapy Oncology Group and the European Organization for Research and Treatment of Cancer (RTOG/EORTC) and the Prostate Symptom Self-Report (PSSR); and measures of psychological factors, the Ways of Coping Scale (WOC), Perceived Stress Scale, the Anxiety Subscale of the SCL-90, and Strategies Used by Patients to Promote Health (SUPPH). Eight regression models including both physical and psychosocial variables were used to predict quality of life. RESULTS: Sixty-three subjects with complete data on all variables were studied. Treatment effect sizes were medium to large in predicting each of the quality of life subscales of the SF-36. Psychosocial variables were related to physical function, role function, bodily pain, general health, social function, emotional role, and mental health. Physical symptoms were related to subjects' perceived general health and mental health. DISCUSSION: The number of significant relationships among psychosocial variables and indicators of QOL exceeded the number of relationships among symptoms and QOL suggesting that psychosocial variables associate strongly with prostate cancer patients' reports of quality of life. Findings of the study may provide patients and families with knowledge that contributes to their understanding of quality of life outcomes of IMRT+ HDR and IMRT + seed implantation and their ability to make more informed treatment choices.","Health Qual Life Outcomes, 2(28","USA",2004,"Any or unknown","Brachytherapy","SF-36,RTOG-EORTC-SS,PSSR,WOC,PcSS,SCL-90,SUPPH","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Disease,General,Utility,Treatment,Symptom"]
[398,"Levinson, A. W., et al. (2011). \"Is a return to baseline sexual function possible? An analysis of sexual function outcomes following laparoscopic radical prostatectomy.\" World J Urol 29(1): 29-34.",null,"Levinson, A. W., et al.","Is a return to baseline sexual function possible? An analysis of sexual function outcomes following laparoscopic radical prostatectomy","OBJECTIVES: Outcome measures following radical prostatectomy are not standardized. Though excellent potency rates are widely reported, few studies address a return to baseline function. We analyze validated sexual health-related quality-of-life outcomes by a strict definition, a return to baseline function, and compare them to less stringent, yet more frequently referenced, categorical definitions of potency. METHODS: Patients undergoing laparoscopic radical prostatectomy from April 2001 to September 2007 completed the Expanded Prostate Cancer Index Composite (EPIC) questionnaire at baseline and 3, 6, 12, and 24 months postoperatively. We defined a return to baseline as a recovery to greater than one-half standard deviation of the studied population below the patient's own baseline (clinically detectable threshold). We compared these outcomes to a categorical definition of potency involving intercourse frequency. To limit confounders, we performed subset analyses of preoperatively potent men who received bilateral nerve preservation. Factors predictive of return to baseline function were assessed in multivariable analysis. RESULTS: A total of 568 patients met inclusion criteria. Mean age and follow-up were 57.2 years and 16.9 months, respectively. Using the categorical definition, 85% of preoperatively potent men with bilateral nerve preservation were \"potent\" at 24 months; however, only 27% returned to their baseline sexual function. In multivariable analyses baseline function, number of nerves spared, and age were independent predictors of a return to baseline function. CONCLUSION: While most preoperatively potent men who receive bilateral nerve preservation engage in intercourse postoperatively, few return to their baseline sexual function. We believe that these data provide context for the expectations of patients who elect extirpative therapy.","World J Urol, 29(1): 29-34","USA",2011,"Any or unknown","Surgery","EPIC","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease"]
[399,"Lilleby, W., et al. (1999). \"Long-term morbidity and quality of life in patients with localized prostate cancer undergoing definitive radiotherapy or radical prostatectomy.\" Int J Radiat Oncol Biol Phys 43(4): 735-743.",null,"Lilleby, W., et al.","Long-term morbidity and quality of life in patients with localized prostate cancer undergoing definitive radiotherapy or radical prostatectomy","PURPOSE: To assess morbidity, side effects, and quality of life (QoL) in patients treated for localized prostate cancer with curative aim. METHODS AND MATERIALS: This descriptive cross-sectional study comprises 154 patients who had undergone definitive radiotherapy (RAD) and 108 patients with radical prostatectomy (PRECT) at the Norwegian Radium Hospital during 1987-1995. At least 1 year after treatment the patients completed several questionnaires assessing quality of life (European Organization for Research and Treatment of Cancer QLQ-C30 instrument [EORTC QLQ-C30]), lower urinary tract symptoms (LUTS): International Prostate Symptom Score (IPSS), or sexuality (selected questions from the Psychosocial Adjustment to Illness Scale [PAIS]). Urinary incontinence and bowel distress were evaluated by ad hoc constructed questionnaires. A control group (OBS) consisted of 38 patients following the watch-and-wait policy. RESULTS: Twenty percent of the patients from the RAD Group had moderate (14%) or severe (6%) LUTS as compared to 12% in the PRECT group. However, 35% of men from the latter group reported moderate to severe urinary incontinence. \"Overall\" sexuality was moderately or severely impaired in 71% of the PRECT and 50% of the RAD patients. In the former group high age was correlated with erectile impotency (p < 0.001). In the RAD comorbidity was associated with erectile impotency (p < 0.001). Between 13-38% of the patients recorded moderate or severe bowel distress (blood per rectum: 13%; bowel cramps: 26%; flatulence: 38%), without significant differences comparing patients who had received conventional small 4-field box radiotherapy and patients who had undergone strictly conformal radiotherapy. Despite malignancy and/or treatment-related morbidity, QoL was comparable in both groups with respectively 9% and 6% RAD and PRECT patients, reporting moderately or severely impaired QoL. In the multivariate analysis physical function, emotional function and fatigue were significantly correlated with QoL, whereas sexuality, lower urinary symptoms, and urinary incontinence correlated with QoL only in the univariate analysis. CONCLUSION: In spite of considerable malignancy and/or treatment-related morbidity QoL was good or only slightly impaired in the majority of patients with localized prostate cancer who presented with stable disease > 1 year after definitive radiotherapy or radical prostatectomy with no difference as compared to the age-matched normal population. Clinicians should be aware of the fact that general QoL dimensions (physical function, emotional function, fatigue) are as a rule of greater significance for QoL than sexuality and lower urinary tract symptoms.","Int J Radiat Oncol Biol Phys, 43(4): 735-743","Norway",1999,"Local","Radiotherapy,Surgery","EORTC QLQ-C30,IPSS,PAIS","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Disease,General"]
[400,"Lilleby, W., et al. (2014). \"Adding intensity-modulated radiotherapy to the pelvis does not worsen the adverse effect profiles compared to limited field radiotherapy in men with prostate cancer at 12-month follow-up.\" Acta Oncol 53(10): 1380-1389.",null,"Lilleby, W., et al.","Adding intensity-modulated radiotherapy to the pelvis does not worsen the adverse effect profiles compared to limited field radiotherapy in men with prostate cancer at 12-month follow-up","To compare adverse effects and toxicity in men with high-risk or locally advanced prostate cancer when adding intensity-modulated radiotherapy (IMRT) technique to the pelvis. PATIENTS AND METHODS: In this prospective follow-up study 180 patients treated with conformal radiotherapy (RAD) to the prostate and vesiculae seminales (boost volumes; PV) and long-term androgen deprivation therapy (LADT), were compared to 90 patients managed by LADT, RAD to the PV and additionally pelvic IMRT. Adverse effects were self-reported at baseline, at 3- and 12-month follow-up. At each time point, the patients rated a questionnaire covering urinary, bowel, and sexual function and bother, quality of life, fatigue, and mental distress. RESULTS: At 3-month follow-up urinary and bowel functions were significantly decreased among IMRT compared to RAD. At 12-month follow-up both groups showed the same reductions within the urinary, bowel and sexual domains. RAD patients had more mental distress than IMRT patients. The scores on quality of life, fatigue and mental distress hardly influenced function or bother within the urinary, bowel or sexual domains. CONCLUSIONS: Men treated for high-risk or locally advanced prostate cancer with a combination of LADT, RAD and IMRT including PV and pelvic structures had considerably more acute side effects at 3 months than men treated with LADT and RAD to the PV only. However, at 12-month follow-up, the observed genitourinary and gastrointestinal function and bother were similar in both groups.","Acta Oncol, 53(10): 1380-1389","Norway",2014,"Advanced","Radiotherapy,Hormonal","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General,Complication,Symptom"]
[401,"Lim, A. J., et al. (1995). \"Quality of life: radical prostatectomy versus radiation therapy for prostate cancer.\" J Urol 154(4): 1420-1425.",null,"Lim, A. J., et al.","Quality of life: radical prostatectomy versus radiation therapy for prostate cancer","PURPOSE: The impact of radical prostatectomy and external beam radiotherapy on the quality of life of patients was compared. MATERIALS AND METHODS: A total of 136 patients underwent radical prostatectomy and 60 underwent external beam radiotherapy for clinically localized prostate cancer. Patients were asked to complete a questionnaire containing The Functional Living Index: Cancer, the Profile of Moods States, and a series of questions evaluating bladder, bowel and sexual function. RESULTS: The radical prostatectomy group had worse sexual function and urinary incontinence, while the external beam radiotherapy group had worse bowel function. Of the patients 90% from both groups stated that they would undergo the treatment again. CONCLUSIONS: Radical prostatectomy and external beam radiotherapy have comparable impact upon quality of life.","J Urol, 154(4): 1420-1425","USA",1995,"Local","Radiotherapy,Surgery","FLIC,POMS","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General,Comorbidity"]
[402,"Lin, Y. H., et al. (2012). \"Comparison of health-related quality of life between subjects treated with radical prostatectomy and brachytherapy.\" J Clin Nurs 21(13-14): 1906-1912.",null,"Lin, Y. H., et al.","Comparison of health-related quality of life between subjects treated with radical prostatectomy and brachytherapy","AIMS AND OBJECTIVES: To evaluate the symptoms and self-assessment of quality of life in men with localised prostate cancer after having had a radical prostatectomy or brachytherapy treatment. BACKGROUND: Prostate cancer is a significant growing disease among men in Taiwan. Quality of life issues for the men who are living with this disease and the consequences of treatment. DESIGN: A postal questionnaire survey. METHODS: The study population came from one 1170-bed hospital in Kaohsiung County, Taiwan. Data was collected from 20 August 2007-20 November 2009. Seventy-eight men met the inclusion criteria. The researchers mailed a survey to each participant, which they completed at home and returned in a pre-stamped, addressed envelope. Sixty-four subjects participated and self-reported using a structured questionnaire. The reliability of overall prostate cancer index was 0.90 and 0.85, 0.93 and 0.72 for each subscale, respectively. RESULTS: The results indicate that the number of months post-treatment was positively correlated with urinary function and age was negatively correlated with sexual, bowel function and bowel bothers. One predictor (month post-treatment) was related to urinary function; one predictor (treatment method) was related to bowel function and four predictors (marital status, age, treatment method and month post-treatment) were related to sexual function. Findings showed that patients who received brachytherapy have better urinary functions, as compared with prostatectomy patients. CONCLUSION: Study findings suggest that healthcare providers should have a better understanding of patients' complications after treatment and this can ultimately raise the quality of life for prostate cancer patients. RELEVANCE TO CLINICAL PRACTICE: The impact of quality of life among post prostate cancer treatment is common. Urological nurses should therefore take the responsibility regarding the consequence of urinary incontinence and sexual function and seeking appropriate nursing interventions for these complications.","J Clin Nurs, 21(13-14): 1906-1912","Taiwan",2012,"Local","Brachytherapy,Surgery","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Complication"]
[403,"Lintz, K., et al. (2003). \"Prostate cancer patients' support and psychological care needs: Survey from a non-surgical oncology clinic.\" Psychooncology 12(8): 769-783.",null,"Lintz, K., et al.","Prostate cancer patients' support and psychological care needs: Survey from a non-surgical oncology clinic","While there are numerous uncertainties surrounding prostate cancer's detection and treatment, more research focusing on the psychological needs of prostate patients is required. This study investigated the support and psychological care needs of men with prostate cancer. Patients were approached during urological oncology clinics and asked to complete the: Support Care Needs Survey (SCNS), Support Care Preferences Questionnaire, EORTC QLQ-C30 (Version 3) Measure plus Prostate Module, and the Hospital Anxiety and Depression Scale (HADS). Of the 249 patients meeting study entry criteria, there was an 89% response rate resulting in a cohort of 210 patients. The data showed that significant unmet need exists across a number of domains in the areas of psychological and health system/information. The more commonly reported needs were 'fears about cancer spreading (44%),' 'concerns about the worries of those close to you (43%),' and 'changes in sexual feelings (41%).' Half of all patients reported some need in the domain of sexuality, especially men younger than 65 years. Needs were being well met in the domain of patient care and support. A significant number of patients reported having used or desiring support services, such as information about their illness, brochures about services and benefits for patients with cancer (55%), a series of talks by staff members about aspects of prostate cancer (44%), and one-on-one counselling (48%). Quality of life (QoL) was most negatively impacted in those who: were < or =65 years old, had been diagnosed within one year, or had metastatic disease. Men < or =65 had decreased social functioning, greater pain, increased sleep disturbance, and were more likely to be uncomfortable about being sexually intimate. Patients recently diagnosed had increased fatigue, more frequent urination, greater disturbance of sleep, and were more likely to have hot flushes. Those with advanced disease scored lower on 12 out of 15 QoL categories. PSA level had no effect on QoL or anxiety/depression scores. Men with advanced disease had greater levels of depression and those < or =65 years old were more likely to be anxious. Although most men with prostate cancer seem to function quite well, a substantial minority report areas of unmet need that may be targets for improving care.","Psychooncology, 12(8): 769-783","UK",2003,"Any or unknown","None","EORTC QLQ-C30,HADS,EORTC QLQ-PR25,SCN-SF34,SCPQ","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Disease,General,Comorbidity,Social"]
[404,"Lips, I., et al. (2007). \"Health-related quality of life in patients with locally advanced prostate cancer after 76 Gy intensity-modulated radiotherapy vs. 70 Gy conformal radiotherapy in a prospective and longitudinal study.\" Int J Radiat Oncol Biol Phys 69(3): 656-661.",null,"Lips, I., et al.","Health-related quality of life in patients with locally advanced prostate cancer after 76 Gy intensity-modulated radiotherapy vs. 70 Gy conformal radiotherapy in a prospective and longitudinal study","PURPOSE: To compare quality of life (QoL) after 70 Gy conformal radiotherapy with QoL after 76 Gy intensity-modulated radiotherapy (IMRT) in patients with locally advanced prostate carcinoma. METHODS AND MATERIALS: Seventy-eight patients with locally advanced prostate cancer were treated with 70 Gy three-field conformal radiotherapy, and 92 patients received 76 Gy IMRT with fiducial markers for position verification. Quality of life was measured by RAND-36, the European Organization for Research and Treatment of Cancer core questionnaire (EORTC QLQ-C30(+3)), and the prostate-specific EORTC QLQ-PR25, before radiotherapy (baseline) and 1 month and 6 months after treatment. Quality of life changes in time (baseline vs. 1 month and baseline vs. 6 months) of > or =10 points were considered clinically relevant. RESULTS: Differences between the treatment groups for QoL changes over time occurred in several QoL domains. The 76-Gy group revealed no significant deterioration in QoL compared with the 70-Gy group. The IMRT 76-Gy group even demonstrated a significantly better change in QoL from baseline to 1 month in several domains. The conformal 70-Gy group revealed temporary deterioration in pain, role functioning, and urinary symptoms; for the IMRT 76-Gy group a better QoL in terms of change in health existed after 1 month, which persisted after 6 months. For both treatment groups temporary deterioration in physical role restriction occurred after 1 month, and an improvement in emotional role restriction occurred after 6 months. Sexual activity was reduced after treatment for both groups and remained decreased after 6 months. CONCLUSIONS: Intensity-modulated radiotherapy and accurate position verification seem to provide a possibility to increase the radiation dose for prostate cancer without deterioration in QoL.","Int J Radiat Oncol Biol Phys, 69(3): 656-661","Netherlands",2007,"Advanced","Radiotherapy","EORTC QLQ-C30,EORTC QLQ-PR25,SF-36","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,General,Utility"]
[405,"Little, D. J., et al. (2003). \"Quality-of-life questionnaire results 2 and 3 years after radiotherapy for prostate cancer in a randomized dose-escalation study.\" Urology 62(4): 707-713.",null,"Little, D. J., et al.","Quality-of-life questionnaire results 2 and 3 years after radiotherapy for prostate cancer in a randomized dose-escalation study","OBJECTIVES: To assess patient-reported prostate cancer-specific quality of life 2 and 3 years after radiotherapy to the prostate in a randomized dose-escalation trial of 70 versus 78 Gy conducted from 1993 to 1998. METHODS: Two years after completing radiotherapy, a questionnaire that assessed bladder, rectal, and sexual function was sent to 301 patients in the study. Three years after treatment, a second questionnaire was sent to the 175 patients with adequate follow-up. RESULTS: Three years after radiotherapy, urinary incontinence was reported by 35% of patients, but only 6% required the use of a pad or other protective device. Patients reported increased leakage with a full bladder (urge incontinence) between the 2 and 3-year questionnaires (42% versus 50%; P = 0.03). At 3 years, 33% of patients reported rectal bleeding compared with 47% at 2 years (P = 0.006). Patients in the 78-Gy arm reported more frequent bowel movements at 3 years and less change in bowel function at 2 years than patients in the 70-Gy arm. Before radiotherapy, 84% of patients reported erections adequate for intercourse at least a few times during the previous year. After 2 and 3 years, this had decreased to 49% and 41%, respectively (P <0.02). CONCLUSIONS: By patient-reported questionnaire, 78 Gy produced an increase in bowel movement frequency and no increase in bladder or sexual side effects at 3 years compared with 70 Gy. Comparing the results 2 and 3 years after radiotherapy, the symptoms of rectal bleeding had improved, erectile function had decreased, and urinary urge incontinence had increased.","Urology, 62(4): 707-713","USA",2003,"Any or unknown","Radiotherapy","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Complication"]
[406,"Litwin, M. S. and K. A. McGuigan (1999). \"Accuracy of recall in health-related quality-of-life assessment among men treated for prostate cancer.\" J Clin Oncol 17(9): 2882-2888.",null,"Litwin, M. S. and K. A. McGuigan","Accuracy of recall in health-related quality-of-life assessment among men treated for prostate cancer","PURPOSE: To determine the accuracy of patient recall of health-related quality of life (HRQOL) in men who have undergone radical prostatectomy for early-stage prostate cancer. PATIENTS AND METHODS: Patients enrolled onto a longitudinal, observational cohort study of HRQOL after radical prostatectomy for early-stage prostate cancer were asked to assess their baseline HRQOL before surgery. They were later asked to recall their baseline HRQOL at intervals of 7 to 37 months after surgery. The two views of baseline HRQOL (actual and recall) were compared. HRQOL was measured with established instruments (the RAND 12-Item Short-Form Health Survey and a validated short form of the University of California Los Angeles Prostate Cancer Index) that addressed impairment in the physical, mental, urinary, bowel, and sexual domains. RESULTS: Overall, recall was poor. Patients tended to remember their baseline HRQOL as being better than it actually was. This effect was particularly striking for urinary and sexual function. Greater education and younger age diminished this effect in some domains. The effect did not vary with time since surgery. CONCLUSION: Men undergoing radical prostatectomy for early-stage prostate cancer do not accurately recall their pretreatment HRQOL when asked several months or years later. This recall bias is constant throughout a period of 6 months to 3 years after surgery. By collecting data before treatment and observing subjects longitudinally, investigators can ensure that HRQOL changes are analyzed in the context of any impairment that may have been present at baseline. If a longitudinal study is not feasible, then great caution must be used if patients are asked to recall their pretreatment HRQOL.","J Clin Oncol, 17(9): 2882-2888","USA",1999,"Local","Surgery","UCLA-PCI,SF-12","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease,Utility"]
[407,"Litwin, M. S., et al. (1995). \"Quality-of-life outcomes in men treated for localized prostate cancer.\" Jama 273(2): 129-135.",null,"Litwin, M. S., et al.","Quality-of-life outcomes in men treated for localized prostate cancer","OBJECTIVE: To assess health-related quality of life (HRQOL) in men treated for clinically localized prostate cancer. DESIGN: A cross-sectional analysis of HRQOL after treatment with radical prostatectomy, pelvic irradiation, or observation alone for clinically localized prostatic adenocarcinoma, and in age-matched comparison patients. SETTING: A large managed care population in California. SUBJECTS: A total of 528 men, including 214 treated for clinically localized prostate cancer (41 with evidence of metastatic disease were excluded from this analysis) and 273 age-matched, ZIP code-matched comparison patients without prostate cancer. Cancer patients were analyzed in three treatment groups: radical prostatectomy (n = 98), primary pelvic irradiation (n = 56), and observation alone (n = 60). MAIN OUTCOME MEASURES: General HRQOL was measured with the RAND 36-Item Health Survey 1.0. Cancer-specific HRQOL was measured with the CAncer Rehabilitation Evaluation System-Short Form and the Functional Assessment of Cancer Therapy-General form. Disease-targeted quality of life was measured with a new instrument assessing function and bother in three organ systems: sexual, urinary, and bowel. RESULTS: No differences among treatment groups were seen in comparisons of general HRQOL: Significant differences among treatment groups were seen in both function and bother in the prostate-targeted measures of sexual, urinary, and bowel domains. When cancer patients were compared with men of similar age without prostate cancer, differences were seen in the sexual, urinary, and bowel function and bother but not in general HRQOL measures. Although cancer-free men were found not to have full potency or continence, prostate cancer patients treated with surgery or radiation reported significantly worse sexual, urinary, and bowel function than men without cancer. Men who had undergone nerve-sparing prostatectomy did not differ from those who had undergone standard prostatectomy, but the power to detect a difference was low. CONCLUSIONS: Although no differences were seen in general HRQOL, three disease-targeted domains were found to differ significantly among the treatment groups and comparison patients. Even after controlling for the sexual and urinary dysfunction experienced by older men without cancer, those receiving therapeutic interventions for their prostate cancer were found to have poorer disease-targeted HRQOL: We conclude that in addition to general HRQOL, disease-targeted measures must be used to assess outcomes of care in men treated for localized prostate cancer.","Jama, 273(2): 129-135","USA",1995,"Local","Surgery,Radiotherapy,Surveillance","SF-36,FACT-G,CARES-SF","Patient",null,"Case-control",null,null,null,null,null,null,null,null,"Treatment,Utility"]
[408,"Litwin, M. S., et al. (1997). \"Health related quality of life outcomes in patients treated for metastatic kidney cancer: a pilot study.\" J Urol 157(5): 1608-1612.",null,"Litwin, M. S., et al.","Health related quality of life outcomes in patients treated for metastatic kidney cancer: a pilot study","PURPOSE: We assessed health related quality of life in patients with advanced renal cell carcinoma treated with nephrectomy and tumor infiltrating lymphocyte therapy in combination with interleukin-2. MATERIALS AND METHODS: A total of 20 patients with advanced renal cell carcinoma who underwent nephrectomy and combination immunotherapy with tumor infiltrating lymphocytes and interleukin-2 completed a retrospective, cross-sectional health related quality of life instrument. Established reference populations with other chronic medical conditions, or breast, prostate or other cancers were used for comparison of health related quality of life scores. General health related quality of life was measured with a RAND 36-Item Health Survey 1.0. Cancer targeted quality of life was measured with the Cancer Rehabilitation Evaluation System-Short Form. Sociodemographic and co-morbidity variables were also collected. RESULTS: General health related quality of life in patients treated with tumor infiltrating lymphocytes and interleukin-2 was significantly better than that in heart failure patients on 1 of 8 scales but significantly worse than in the general population on 6 of 8 scales. General health related quality of life in the former patients was also significantly worse than in those with hypertension on 5 of 8 scales and significantly worse than in diabetics on 2 scales. Cancer targeted health related quality of life in patients given immunotherapy was significantly better than in men with prostate cancer on 1 of 5 scales, significantly better than in women with breast cancer on 2 of 5 scales and significantly better than patients with other cancers (nonbreast and nonprostate) on 3 of 5 scales. CONCLUSIONS: Patients undergoing nephrectomy and adjuvant tumor infiltrating lymphocytes plus interleukin-2 therapy for advanced renal cell carcinoma report better health related quality of life than those with other malignancies and better physical function than patients with congestive heart failure. However, health related quality of life is worse than in the general population and similar or worse than in patients with hypertension or type II diabetes. This surveyed population is selective and may represent the best responders among survivors of a highly toxic therapy. Nevertheless, quality and quantity of life should be addressed with patients when considering immunotherapy for metastatic kidney cancer.","J Urol, 157(5): 1608-1612","USA",1997,"Any or unknown","None","SF-36,CARES-SF","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Treatment,Utility"]
[409,"Litwin, M. S., et al. (1998). \"Differences in urologist and patient assessments of health related quality of life in men with prostate cancer: results of the CaPSURE database.\" J Urol 159(6): 1988-1992.",null,"Litwin, M. S., et al.","Differences in urologist and patient assessments of health related quality of life in men with prostate cancer: results of the CaPSURE database","PURPOSE: We determine whether urologists caring for men with prostate cancer accurately captured the nuances of quality of life, as disclosed by patients in validated, self-administered health related quality of life instruments. MATERIALS AND METHODS: We analyzed information on 2,252 patients 42 to 95 years old enrolled in CaPSURE, a large, observational cancer of the prostate strategic urological research endeavor database, in which men with all stages of prostate cancer are followed quarterly with standardized validated written surveys to assess clinical parameters, symptoms and health related quality of life. At each visit urologists recorded Karnofsky performance status rating and the presence or absence of various symptoms, such as fatigue, pain and dysfunction in the sexual, urinary and bowel domains. Within 30 days of the visit patients independently completed self-administered health related quality of life instruments, including the RAND 36-Item Health Survey and University of California, Los Angeles Prostate Cancer Index, in which scores of 80 to 100 and 0 to 79 were interpreted as absence of impairment and moderate to severe impairment, respectively. Using chi-square analysis we compared symptoms, as recorded by the urologist, with health related quality of life impairment in relevant domains, as reported by the patient. RESULTS: Significant differences (p < or = 0.002) were noted between physician and patient assessment of clinical domains, such as physical, sexual, urinary and bowel function, fatigue and bone pain. In all domains urologists underestimated patient symptoms, causing health related quality of life impairment. CONCLUSIONS: In men with early stage and advanced prostate cancer physician ratings of patient symptoms do not correlate well with patient self-assessments of health related quality of life. Hence, urologists should attempt to elucidate more completely the components of patient quality of life after the diagnosis and treatment of prostate cancer.","J Urol, 159(6): 1988-1992","USA",1998,"Any or unknown","Unclear","SF-36,UCLA-PCI","HCP,Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease,Utility"]
[410,"Litwin, M. S., et al. (1998). \"Quality-of-life outcomes in long-term survivors of advanced prostate cancer.\" Am J Clin Oncol 21(4): 327-332.",null,"Litwin, M. S., et al.","Quality-of-life outcomes in long-term survivors of advanced prostate cancer","The authors evaluate the temporal progression of health-related quality of life (HRQOL) in men treated hormonally with surgical or medical castration, as well as to see if either treatment would be associated with a greater impact on patients' quality of life. The authors assessed general and prostate-targeted HRQOL with two self-administered, validated instruments (the RAND 36-Item Health Survey and the UCLA Prostate Cancer Index) in a longitudinal, observational study of 63 men newly diagnosed with metastatic prostate cancer and treated with bilateral orchiectomy or combined androgen blockade with leuprolide and flutamide. Patients completed the two HRQOL instruments by mail at baseline and at 3- and 6-month intervals after initiation of treatment. Significant improvements were demonstrated in 10 of 14 HRQOL domains for all men during the first 12 months. These include all eight of the general HRQOL domains and the disease-specific domains that address bowel function. The authors identified no differences in any of the general or prostate-targeted HRQOL domains when comparing men who underwent orchiectomy versus combined androgen blockade. Patients with metastatic prostate cancer can be informed that general and prostate-specific HRQOL will be similar, regardless of whether they choose medical or surgical castration, and that health status will likely remain stable or improve during the initial months of treatment. Physicians must make patients aware of both the quantity and quality of life they can expect with advanced prostate cancer, and must actively involve them in their treatment decisions.","Am J Clin Oncol, 21(4): 327-332","USA",1998,"Metastatic","Surgery,Hormonal","SF-36,UCLA-PCI","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease,Utility"]
[411,"Litwin, M. S., et al. (1998). \"The UCLA Prostate Cancer Index: development, reliability, and validity of a health-related quality of life measure.\" Med Care 36(7): 1002-1012.",null,"Litwin, M. S., et al.","The UCLA Prostate Cancer Index: development, reliability, and validity of a health-related quality of life measure","OBJECTIVES: The need for accurate measures of health-related quality of life (HRQOL) in men treated for prostate cancer is of paramount importance because patients may survive for many years after their diagnosis. Hence, interest has increased in choosing treatments that optimize both the quality and quantity of life in patients with this disease. This study sought to develop and evaluate a self-administered, multiitem, disease-specific instrument to capture the health concerns central to the quality of life of men treated for early stage prostate cancer. METHODS: After focus group analysis and pilot testing, the instrument was tested with a large retrospective, cross-sectional survey. Exploratory factor analysis and multitrait scaling analysis were used to facilitate the formation of six scales containing 20 disease-targeted items that address impairment in the urinary, bowel, and sexual domains. The psychometric properties of the new scales were assessed by measuring test-retest reliability, internal consistency reliability, and construct validity. Performance on the new scales was compared with scores on other established cancer-related health-related quality of life instruments. Two hundred fifty-five long-term survivors of prostate cancer treatment and 273 age-matched and ZIP code-matched comparison subjects without prostate cancer from a large managed care population in California were studied. Mean age was 72.7 years. In addition to the new scales, the RAND 36-Item Health Survey (SF-36) was used as a generic core measure, and a cancer-related health-related quality of life instrument (the Cancer Rehabilitation System-Short Form) was used to provide construct validity. RESULTS: For the new scales, test-retest reliability ranged from 0.66 to 0.93, and internal consistency ranged from 0.65 to 0.93. Disease-targeted measures of function and bother in the three domains correlated substantially with one another. Scale scores correlated well with related, established scales. Men undergoing prostatectomy or pelvic irradiation demonstrated the expected differences in performance on the disease-specific health-related quality of life scales when compared with each other or with comparison subjects. Age was inversely related to sexual and bowel function. CONCLUSIONS: The UCLA Prostate Cancer Index performed well in this population of older men with and without prostate cancer. It demonstrated good psychometric properties and appeared to be well understood and easily completed. The high response among patients suggests that these men especially are interested in addressing both the general and disease-specific concerns that impact their daily quality of life.","Med Care, 36(7): 1002-1012","USA",1998,"Local","Unclear","SF-36,UCLA-PCI,CARES-SF","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease,Treatment,Utility"]
[412,"Litwin, M. S., et al. (1999). \"Recovery of health related quality of life in the year after radical prostatectomy: early experience.\" J Urol 161(2): 515-519.",null,"Litwin, M. S., et al.","Recovery of health related quality of life in the year after radical prostatectomy: early experience","PURPOSE: We determined the temporal course of patient return to baseline quality of life after treatment with radical prostatectomy for early stage prostate cancer. MATERIALS AND METHODS: After establishing a longitudinal observational database of men undergoing radical retropubic prostatectomy we used established, validated quality of life questionnaires (RAND 36-Item Health Survey and University of California, Los Angeles Prostate Cancer Index) to document changes in general and disease specific health related quality of life (HRQOL). We assessed 90 patients at baseline before surgery and then at 3-month intervals for 1 year postoperatively. Logistic regression was used to explore predictors of the return to baseline. RESULTS: After prostatectomy patients had a significant decrease in all domains of HRQOL. Return to baseline was rapid in the general and bowel domains with at least two-thirds to three-fourths of patients reaching pretreatment levels within 6 months of surgery. Return to baseline was slower in the urinary and sexual function domains with 61 and 31% of the men, respectively, reaching pretreatment levels by 1 year after surgery. Of those who reached baseline the average intervals for the bowel, sexual and urinary domains were 5, 6 and 7 months, respectively. Married and white patients were more likely to achieve a return to baseline HRQOL during year 1 postoperatively. However, education level was inversely associated with the likelihood of returning to baseline. CONCLUSIONS: During the year after radical prostatectomy for early stage prostate cancer patient quality of life steadily improved. By 3 months postoperatively 30 to 40% of the patients had already recovered baseline levels of physical, mental and social functioning, and by 6 months more than 70% had reached baseline in the general HRQOL domains. By 12 months after surgery 86 to 97% of the patients had returned to baseline levels in each domain. Each domain continued to improve throughout the year. For the patients who reached baseline general HRQOL during followup average recovery time was 5 to 6 months.","J Urol, 161(2): 515-519","USA",1999,"Local","Surgery","SF-36,UCLA-PCI","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease,Utility"]
[413,"Litwin, M. S., et al. (1999). \"Sexual function and bother after radical prostatectomy or radiation for prostate cancer: multivariate quality-of-life analysis from CaPSURE. Cancer of the Prostate Strategic Urologic Research Endeavor.\" Urology 54(3): 503-508.",null,"Litwin, M. S., et al.","Sexual function and bother after radical prostatectomy or radiation for prostate cancer: multivariate quality-of-life analysis from CaPSURE. Cancer of the Prostate Strategic Urologic Research Endeavor","OBJECTIVES: To measure the effect of treatment choice (pelvic irradiation [XRT] versus radical prostatectomy [RP] with or without nerve sparing) on sexual function and sexual bother during the first 2 years after treatment. METHODS: We studied sexual function and sexual bother in 438 men recently diagnosed with early-stage prostate cancer and treated with XRT or RP with or without nerve sparing. Outcomes were assessed with the University of California, Los Angeles Prostate Cancer Index, a validated health-related quality-of-life instrument that includes these two domains. To minimize the influence of other factors, we adjusted for age, comorbidity, general health, and previous treatment for erectile dysfunction. All subjects were drawn from CaPSURE, a national, longitudinal data base. RESULTS: Sexual function improved over time during the first year in all treatment groups; however, during the second year, sexual function began to decline in the XRT group. Older patients who received XRT showed substantial declines in sexual function throughout the 2 years, and older patients who underwent RP experienced a return of very low baseline sexual function. Sexual function was improved by the use of nerve-sparing procedures or erectile aids. Alterations in sexual bother were ameliorated by many factors, including age, general health perceptions, and sexual function. CONCLUSIONS: Patients undergoing XRT or RP with or without nerve sparing all showed comparable rates of improvement in sexual function during the first year after treatment for early-stage prostate cancer. However, in the second year after treatment, patients treated with XRT began to show declining sexual function; patients treated with RP did not.","Urology, 54(3): 503-508","USA",1999,"Local","Surgery,Radiotherapy","UCLA-PCI","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease"]
[414,"Litwin, M. S., et al. (2000). \"Urinary function and bother after radical prostatectomy or radiation for prostate cancer: a longitudinal, multivariate quality of life analysis from the Cancer of the Prostate Strategic Urologic Research Endeavor.\" J Urol 164(6): 1973-1977.",null,"Litwin, M. S., et al.","Urinary function and bother after radical prostatectomy or radiation for prostate cancer: a longitudinal, multivariate quality of life analysis from the Cancer of the Prostate Strategic Urologic Research Endeavor","PURPOSE: We measure the effect of time on urinary function and bother during the first 2 years following treatment for early stage prostate cancer. MATERIALS AND METHODS: We studied urinary function and bother in 564 men recently diagnosed with early stage prostate cancer and treated with radiotherapy or radical prostatectomy with or without nerve sparing. Outcomes were assessed with the UCLA Prostate Cancer Index, which is a validated, health related quality of life instrument that includes these 2 domains. To minimize the influence of other factors we adjusted for age, co-morbidity, general health, pad use, anticholinergics or procedures for urethral stricture. All subjects were drawn from the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE), which is a national longitudinal database. RESULTS: Urinary function improved with time during the first year after surgery but remained fairly constant during year 2. Urinary function remained stable throughout the 2 years after radiation. Urinary bother was worse after radiation throughout the 2 years, although it improved markedly by the end of year 1. Age, ethnicity and co-morbidity did not impact urinary function or bother but being married did have an advantage. CONCLUSIONS: Patients undergoing surgery or radiation showed different longitudinal profiles of urinary function and bother during the first 2 years after treatment.","J Urol, 164(6): 1973-1977","USA",2000,"Local","Surgery,Radiotherapy","UCLA-PCI","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease"]
[415,"Litwin, M. S., et al. (2001). \"Life after radical prostatectomy: a longitudinal study.\" J Urol 166(2): 587-592.",null,"Litwin, M. S., et al.","Life after radical prostatectomy: a longitudinal study","PURPOSE: We investigate the longitudinal recovery of quality of life after radical prostatectomy in men with localized prostate cancer. MATERIALS AND METHODS: We assessed the self-reported health related quality of life in 247 men undergoing radical prostatectomy for prostate cancer. Patients were assessed at baseline before surgery and postoperatively every 3 months for 1 year and then every 6 months for up to 48 months (median 30). We measured general and prostate specific health related quality of life with the RAND 36-Item Health Survey 1.0 SF-36 and University of California, Los Angeles Prostate Cancer Index. The Cox proportional hazards regression model was used to determine whether some patients were more likely than others to have a successful return to baseline functioning after treatment. RESULTS: In the SF-36 60% of patients reached baseline in all domains by 3 months. By 12 months, greater than 90% of patients reached baseline in all domains. Mean recovery time for these domains was about 4(1/2) months. The recovery of urinary function to baseline was 21% at 3, 56% at 12 and 63% at 30 months, respectively. About 80% of patients recovered to baseline urinary bother. In the urinary domains patients who recovered did so at an average of 7 to 8 months, and there was little additional recovery after 18 months. By 1 year postoperatively, approximately a third of patients reached baseline sexual function and about half recovered to baseline sexual bother. At 2 years postoperatively, sexual function and bother returned to baseline in 40% and 60% of patients, respectively. Mean recovery time was about 11 months for sexual function and about 9 months for sexual bother. There was little additional recovery in the sexual domains after 18 to 24 months. In the bowel domains more than two thirds of patients returned to baseline by 3 months, and greater than 90% recovered by 12 months, with a mean recovery of 4.8 months. Unmarried men were more likely than those married to regain baseline sexual function (p = 0.03) and urinary function (p = 0.07). Patients who were 65 years and older were more likely than those younger to return to baseline sexual bother (p = 0.03). There were trends that showed patients with higher incomes as well as those who were white were more likely to recover baseline scores for urinary function and the physical component summary. Another trend suggested that men with a higher education were less likely to regain urinary function (p = 0.08). CONCLUSIONS: Most quality of life recovery occurs early after radical prostatectomy, except in several domains, including urinary and sexual, which continue to improve even beyond 2 years postoperatively. Patients should be encouraged that recovery may continue for months or years after surgery.","J Urol, 166(2): 587-592","USA",2001,"Local","Surgery","SF-36,UCLA-PCI","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease,Utility"]
[416,"Litwin, M. S., et al. (2001). \"Quality of life before death for men with prostate cancer: results from the CaPSURE database.\" J Urol 165(3): 871-875.",null,"Litwin, M. S., et al.","Quality of life before death for men with prostate cancer: results from the CaPSURE database","PURPOSE: We examined changes in health related quality of life during the 12 months before death in men with prostate cancer. MATERIALS AND METHODS: We studied patients from CapSure, which is a longitudinal observational cohort of men with biopsy proved prostate cancer treated in community and academic urology practices across the United States. Of all men in the cohort who died while being followed for prostate cancer 131 who had submitted health related quality of life surveys during the 6 months before death were included in this analysis. Health related quality of life was measured with the RAND 36-Item Health Survey, an established validated instrument that comprises 4 physical and 4 mental domains. RESULTS: On univariate analysis all 8 domains of the 36-Item Health Survey substantially decreased in the final year of life. On multivariate analysis only physical function decreased more rapidly in men dying of prostate cancer compared to those dying of other cancer or benign causes. CONCLUSIONS: Quality of life begins a steady and inexorable decline in the final 12 months of life in men with prostate cancer. Increased attention to quality of life changes may provide new clinical opportunities to enhance quality of care in the final year of life in these men.","J Urol, 165(3): 871-875","USA",2001,"End of life","None","SF-36","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Utility"]
[417,"Litwin, M. S., et al. (2002). \"Mental health in men treated for early stage prostate carcinoma: a posttreatment, longitudinal quality of life analysis from the Cancer of the Prostate Strategic Urologic Research Endeavor.\" Cancer 95(1): 54-60.",null,"Litwin, M. S., et al.","Mental health in men treated for early stage prostate carcinoma: a posttreatment, longitudinal quality of life analysis from the Cancer of the Prostate Strategic Urologic Research Endeavor","BACKGROUND: The current study was conducted to assess posttreatment changes in the mental components of health related quality of life in prostate carcinoma patients during the two years following diagnosis and management with radical prostatectomy, pelvic irradiation, or watchful waiting. METHODS: The authors studied the mental domains of general health related quality of life in 452 men recently diagnosed with early stage prostate carcinoma and treated with radical prostatectomy, pelvic radiation, or watchful waiting. Outcomes were assessed with the RAND 36-Item Health Survey, a validated health-related quality of life instrument that includes four mental domains. To minimize the influence of potentially confounding factors, the authors adjusted for age, comorbidity, prostate specific antigen (PSA) at diagnosis, and biopsy Gleason score. All subjects were drawn from CaPSURE, a national, longitudinal cohort. RESULTS: By 6-12 months after treatment, the active treatment groups began to show differences in mental health and vitality. By 15 months, surgery and radiation patients scored differently in all four mental domains. Over time, the gaps between mental domain scores grew wider among the treatment groups, with surgery patients performing the best, radiation patients performing the worst, and watchful waiting patients falling in between. CONCLUSIONS: The mental health profiles differ for patients undergoing surgery, radiation, or watchful waiting for early stage prostate carcinoma. Men with more serious disease, as evidenced by higher PSA levels or more aggressive histology, tended to worry more about it. Older men performed better, while sicker men performed worse, even though the older men tended to be sicker.","Cancer, 95(1): 54-60","USA",2002,"Local","Surgery,Radiotherapy,Surveillance","SF-36","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Utility"]
[418,"Litwin, M. S., et al. (2003). \"Health-related quality of life in men with metastatic prostate cancer: the misleading effect of lead-time bias.\" BJU Int 91(1): 9-13.",null,"Litwin, M. S., et al.","Health-related quality of life in men with metastatic prostate cancer: the misleading effect of lead-time bias","OBJECTIVE: To ascertain whether the difference in health-related quality of life, which appears to be worse in men with metastatic prostate cancer when the metastases are noted at initial diagnosis than during follow-up after treatment for clinically localized disease, can be attributed to previous local control or to some form of measurement bias. PATIENTS AND METHODS: We analysed by univariate and multivariate methods 375 men with metastatic prostate cancer who were enrolled in CaPSURE, a national observational cohort of patients with prostate cancer treated in community and academic settings throughout the USA. In particular, we assessed whether group differences in health-related quality of life were explained by the timing of metastatic diagnosis in the course of their disease. Health-related quality of life was measured with the RAND 36-Item Health Survey (SF-36). RESULTS: After controlling for relevant covariates (age, comorbidity and ethnicity), multivariate models suggested that men whose metastases were noted at the time of initial diagnosis scored 5-15 points worse in all eight domains of the SF-36. CONCLUSION: Men who are diagnosed with metastatic prostate cancer during the follow-up after treatment for clinically localized disease report a better quality of life than those who are metastatic at the time of diagnosis, not because the primary treatment confers any benefit but because they are followed more closely over time and diagnosed with metastases earlier in the course of their disease. This apparent difference in quality of life is an effect of lead-time bias in the diagnosis of metastasis.","BJU Int, 91(1): 9-13","USA",2003,"Metastatic","Unclear","SF-36","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Utility"]
[419,"Litwin, M. S., et al. (2004). \"Bowel function and bother after treatment for early stage prostate cancer: a longitudinal quality of life analysis from CaPSURE.\" J Urol 172(2): 515-519.",null,"Litwin, M. S., et al.","Bowel function and bother after treatment for early stage prostate cancer: a longitudinal quality of life analysis from CaPSURE","PURPOSE: We measured bowel function and bowel bother longitudinally the first 2 years after treatment for early stage prostate cancer. MATERIALS AND METHODS: We studied bowel function and bother in 1,584 men recently diagnosed with early stage prostate cancer and followed for 2 years after radical prostatectomy, external beam radiation or brachytherapy. Principal outcomes were assessed with the UCLA Prostate Cancer Index, a validated instrument that includes these 2 domains. Multivariate analyses were conducted to ascertain significant predictors of bowel function and bother. Subjects were drawn from Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE, TAP Pharmaceutical Products, Inc., Lake Forest, Illinois), a national, longitudinal registry of men with prostate cancer. RESULTS: Men treated with external beam radiation or brachytherapy suffered worse bowel function and were more bothered by it than men treated surgically. After an initial period of posttreatment impairment, all 3 groups demonstrated improvement with time in both domains, although bowel bother persisted longer in men treated with external beam radiation. Surgery patients reached a steady state by 3 months, while those treated with external beam radiation or brachytherapy continued to improve for more than a year after treatment. Older men were more bothered by bowel dysfunction than younger men. Ethnicity, comorbidity and education did not affect either bowel function or bother. CONCLUSIONS: Patients undergoing surgery, external beam radiation or brachytherapy have different longitudinal profiles of bowel function and bother during the first 2 years after treatment. Bowel function and bother are worse after external beam radiation but they are also impaired after brachytherapy. Men choosing surgery experience transient impairment in the bowel domains. This information may be useful to patients making treatment decisions for early stage prostate cancer.","J Urol, 172(2): 515-519","USA",2004,"Local","Surgery,Radiotherapy,Brachytherapy","UCLA-PCI","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease"]
[420,"Livsey, J. E., et al. (2002). \"Scoring of treatment-related late effects in prostate cancer.\" Radiother Oncol 65(2): 109-121.",null,"Livsey, J. E., et al.","Scoring of treatment-related late effects in prostate cancer","BACKGROUND AND PURPOSE: To assess the correlation between different general and organ specific quality of life and morbidity scoring methods in a cohort of men treated with radical radiotherapy for prostate cancer. MATERIALS AND METHODS: Men who had been treated with radical radiotherapy (50 Gy in 16 fractions over 21 days) for localized prostate cancer more than 3 years previously and who had no evidence of recurrent disease were invited to take part in the study. A total of 101 of 135 invited patients agreed and completed LENT/SOMA, UCLA Prostate Cancer Index, and 36 item RAND Health survey questionnaires. RESULTS: The patients had comparable results with other published series with respect to the UCLA and SF-36 indices. There was significant correlation between the corresponding parts of the UCLA and LENT/SOMA scales (P<0.0005). However, for the same symptoms, a patient tended to score lower (worse) on the UCLA scale in comparison to LENT/SOMA. The relationship between the average LENT/SOMA score and maximum score was also not straightforward with each set of data revealing different information. CONCLUSIONS: The LENT/SOMA questions were, in the main, more wide-ranging and informative than the UCLA index. It is helpful to give both the overall and maximum LENT/SOMA scores to most efficiently use all of the data. There may need to be a further LENT/SOMA question to allow both symptoms of tenesmus and faecal urgency to be fully addressed.","Radiother Oncol, 65(2): 109-121","UK",2002,"Local","Radiotherapy","UCLA-PCI,SF-36,LENT-SOMA","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease,Treatment,Utility"]
[421,"Lloyd, A. J., et al. (2015). \"Health-Related Quality of Life and Health Utilities in Metastatic Castrate-Resistant Prostate Cancer: A Survey Capturing Experiences from a Diverse Sample of UK Patients.\" Value Health 18(8): 1152-1157.",null,"Lloyd, A. J., et al.","Health-Related Quality of Life and Health Utilities in Metastatic Castrate-Resistant Prostate Cancer: A Survey Capturing Experiences from a Diverse Sample of UK Patients","BACKGROUND: The collection of preference-based health outcomes data (or utility values) is required to support cost-effectiveness analyses. OBJECTIVE: This study aimed to collect health-related quality of life (HRQOL) data in men with metastatic castration-resistant prostate cancer (CRPC) stratified by disease states. METHODS: Men with metastatic CRPC were recruited via UK patient associations, patient panels, and specialist recruiters and classified into four subgroups reflecting disease state: asymptomatic/mildly symptomatic before chemotherapy, symptomatic before chemotherapy, receiving chemotherapy, and postchemotherapy. HRQOL data (including five-level EuroQol five-dimensional questionnaire [EQ-5D-5L], European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire [EORTC QLQ-C30], and 25-item prostate cancer-specific questionnaire module designed to supplement the EORTC QLQ-C30) along with background and medical history data were collected via an online survey. The EQ-5D-5L and the EORTC-8D (EORTC-8D is an 8 dimensional utility index scored from QLQ-C30 data) were both used to estimate utilities. RESULTS: Data were collected from a total sample of 163 men with metastatic CRPC. Utility values elicited by the EQ-5D-5L ranged from 0.830 for the asymptomatic/mildly symptomatic before chemotherapy disease state (95% confidence interval [CI] 0.795-0.865) to 0.625 for the symptomatic before chemotherapy disease state (95% CI 0.577-0.673). EORTC-8D utilities ranged from 0.856 (95% CI 0.831-0.882) to 0.697 (95% CI 0.664-0.731) for the same disease/treatment states. CONCLUSIONS: This online survey was designed to capture real-world HRQOL data describing men with CRPC. The study estimated utilities using two alternative methods, and the results show good agreement, suggesting that they are robust. This methodology offers a potentially higher quality alternative to vignette-based methods that are commonly used in oncology submissions.","Value Health, 18(8): 1152-1157","UK",2015,"Metastatic","Chemotherapy","EQ-5D,EORTC QLQ-C30,EORTC-8D,EORTC QLQ-PR25","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"General,Utility,Disease"]
[422,"Loblaw, A., et al. (2013). \"Prostate stereotactic ablative body radiotherapy using a standard linear accelerator: toxicity, biochemical, and pathological outcomes.\" Radiother Oncol 107(2): 153-158.",null,"Loblaw, A., et al.","Prostate stereotactic ablative body radiotherapy using a standard linear accelerator: toxicity, biochemical, and pathological outcomes","BACKGROUND AND PURPOSE: Biological dose escalation through stereotactic ablative radiotherapy (SABR) holds promise of improved patient convenience, system capacity and tumor control with decreased cost and side effects. The objectives are to report the toxicities, biochemical and pathologic outcomes of this prospective study. MATERIALS AND METHODS: A phase I/II study was performed where low risk localized prostate cancer received SABR 35 Gy in 5 fractions, once weekly on standard linear accelerators. Common Terminology Criteria for Adverse Events v3.0 and Radiation Therapy Oncology Group late morbidity scores were used to assess acute and late toxicities, respectively. Biochemical control (BC) was defined by the Phoenix definition. RESULTS: As of May 2012, 84 patients have completed treatment with a median follow-up of 55 months (range 13-68 months). Median age was 67 years and median PSA was 5.3 ng/ml. The following toxicities were observed: acute grade 3+: 0% gastrointestinal (GI), 1% genitourinary (GU), 0% fatigue; late grade 3+: 1% GI, 1% GU. Ninety-six percent were biopsy negative post-treatment. The 5-year BC was 98%. CONCLUSIONS: This novel technique employing standard linear accelerators to deliver an extreme hypofractionated schedule of radiotherapy is feasible, well tolerated and shows excellent pathologic and biochemical control.","Radiother Oncol, 107(2): 153-158","Canada",2013,"Local","Radiotherapy","CTCAE,RTOG-EORTC-SS","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Treatment"]
[423,"Lofters, A., et al. (2002). \"\"PSA-itis\": knowledge of serum prostate specific antigen and other causes of anxiety in men with metaststic prostate cancer.\" J Urol 168(6): 2516-2520.",null,"Lofters, A., et al.","PSA-itis: knowledge of serum prostate specific antigen and other causes of anxiety in men with metaststic prostate cancer","PURPOSE: High or increasing prostatic specific antigen (PSA) levels may be a source of anxiety in patients with metastatic prostate cancer. MATERIALS AND METHODS: Patients with metastatic prostate cancer completed questionnaires, including the Prostate Cancer Specific Quality of Life Instrument, Hospital Anxiety and Depression Scale, and a questionnaire to assess the impact of the knowledge of PSA levels on anxiety. These were completed at home more than 3 days before or after a clinic appointment and returned by mail. Patient medical history was obtained from the record. RESULTS: Of the 65 patients who consented to the study 52 returned the completed questionnaires. Median age was 70 years (range 55 to 86) and median time since diagnosis was 53 months. Of the patients 81% had hormone resistant disease. Most reported good overall quality of life with a median Prostate Cancer Specific Quality of Life Instrument score of 93 (maximum 100). Of the patients 77% indicated that PSA levels were one of the ways and 44% indicated they were the only way that they knew whether disease was progressing. When asked to rate preferences for treatment outcome, 25% of the men rated decreasing PSA and worse physical symptoms above increasing PSA and better physical symptoms. If measurement of PSA levels ceased, 52% of patients would believe that their doctor was giving up on them and only 1 would be relieved. Before receiving PSA results 76% reported some level of anxiety and 15% reported extreme anxiety. CONCLUSIONS: PSA related anxiety represents a substantial problem in patients with metastatic prostate cancer.","J Urol, 168(6): 2516-2520","Canada",2002,"Metastatic","None","HADS,PCSQLI","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Disease,Comorbidity"]
[424,"Lopez-Calderero, I., et al. (2017). \"Impact of locally advanced or metastatic prostate cancer on the quality of life.\" Actas Urol Esp 41(6): 368-375.",null,"Lopez-Calderero, I., et al.","Impact of locally advanced or metastatic prostate cancer on the quality of life","OBJECTIVE: The aim of this study was to assess the health-related quality of life of patients with prostate cancer in advanced phases to obtain additional information on the patients' health. The growing interest in understanding the patient's perspective and the scarcity of prospective studies of this population motivated this research study. MATERIAL AND METHODS: We present an observational study performed on 131 urology consultations, with a sample of 601 patients with locally advanced or metastatic prostate cancer, assessed during 2 visits: baseline and at 12 months. We collected demographic, clinical, quality-of-life (PROSQoLI and EuroQoL-5D-5L questionnaires) and anxiety/depression (HADS questionnaire) endpoints. RESULTS: The mean age (SD) was 73.8 (8.2) years, and 87.2% of the participants were retired or pensioners. Some 58.7% of the patients presented locally advanced prostate cancer. Urinary symptoms were the most common, decreasing significantly after one year (P<.05). Urinary problems and fatigue were the most affected measures, and pain/discomfort was the dimension present in most patients (65.3%). According to the linear regression model, asthenia and pain were 2 of the factors most closely related to a poorer quality of life. The presence of anxiety/depression was low. Finally, the health condition as assessed by the clinician was more positive than when assessed by the patients. CONCLUSIONS: This study broadens the scarce information on the quality of life of the population with advanced prostate cancer, information of use for the clinical management of these patients.","Actas Urol Esp, 41(6): 368-375","France,Spain",2017,"Advanced,Metastatic","None","HADS,PROSQoLI,EQ-5D","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease,Utility,Comorbidity"]
[425,"Loriot, Y., et al. (2015). \"Effect of enzalutamide on health-related quality of life, pain, and skeletal-related events in asymptomatic and minimally symptomatic, chemotherapy-naive patients with metastatic castration-resistant prostate cancer (PREVAIL): results from a randomised, phase 3 trial.\" Lancet Oncol 16(5): 509-521.",null,"Loriot, Y., et al.","Effect of enzalutamide on health-related quality of life, pain, and skeletal-related events in asymptomatic and minimally symptomatic, chemotherapy-naive patients with metastatic castration-resistant prostate cancer (PREVAIL): results from a randomised, phase 3 trial","BACKGROUND: Enzalutamide significantly increased overall survival and radiographic progression-free survival compared with placebo in the PREVAIL trial of asymptomatic and minimally symptomatic, chemotherapy-naive patients with metastatic castration-resistant prostate cancer. We report the effect of enzalutamide on health-related quality of life (HRQoL), pain, and skeletal-related events observed during this trial. METHODS: In this phase 3, double-blind trial, patients were randomly assigned (1:1) to receive enzalutamide 160 mg/day (n=872) or placebo (n=845) orally. HRQoL was assessed at baseline and during treatment using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) and EQ-5D questionnaires. Pain status was assessed at screening, baseline, week 13, and week 25 with the Brief Pain Inventory Short Form (BPI-SF). The primary analysis of HRQoL data used a mixed-effects model to test the difference between least square means change from baseline at week 61. We assessed change from baseline, percentage improvement, and time to deterioration in HRQoL and pain, the proportion of patients with a skeletal-related event, and time to first skeletal-related event. Analysis was done on the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT01212991. FINDINGS: Median treatment duration was 16.6 months (IQR 10.1-21.1) in the enzalutamide group and 4.6 months (2.8-9.7) in the placebo group. The mixed-effects model analyses showed significant treatment differences in change from baseline to week 61 with enzalutamide compared with placebo for most FACT-P endpoints and EQ-5D visual analogue scale. Median time to deterioration in FACT-P total score was 11.3 months (95% CI 11.1-13.9) in the enzalutamide group and 5.6 months (5.5-5.6) in the placebo groups (hazard ratio [HR] 0.62 [95% CI 0.54-0.72]; p<0.0001). A significantly greater proportion of patients in the enzalutamide group than in the placebo group reported clinically meaningful improvements in FACT-P total score (327 [40%] of 826 vs 181 [23%] of 790), in EQ-5D utility index (224 [28%] of 812 vs 99 [16%] of 623), and visual analogue scale (218 [27%] of 803 vs 106 of [18%] 603; all p<0.0001). Median time to progression in BPI-SF pain at its worst was 5.7 months (95% CI 5.6-5.7) in the enzalutamide group and 5.6 months (5.4-5.6) in the placebo group (HR 0.62 [95% CI 0.53-0.74]; p<0.0001). Progression of pain at its worst was less common in the enzalutamide group than in the placebo group at week 13 (220 [29%] of 769 vs 257 [42%] of 610; p<0.0001), but not at week 25 (225 [32%] of 705 vs 135 [38%] of 360; p=0.068). 278 (32%) of 872 patients in the enzalutamide group and 309 (37%) of 845 patients in the placebo group had experienced a skeletal-related event by data cutoff. Median time to first skeletal-related events in the enzalutamide group was 31.1 months (95% CI 29.5-not reached) and 31.3 months (95% CI 23.9-not reached) in the placebo group (HR 0.72 [95% CI 0.61-0.84]; p<0.0001). INTERPRETATION: In addition to improving overall survival relative to placebo, enzalutamide significantly improves patient-related outcomes and delays occurrence of first skeletal-related event in chemotherapy-naive men with metastatic castration-resistant prostate cancer. FUNDING: Astellas Pharma and Medivation.","Lancet Oncol, 16(5): 509-521","Germany,Italy,France,UK,USA,Spain,Norway,Netherlands,Belgium",2015,"Metastatic","Hormonal","FACT-P,EQ-5D,BPI","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,Symptom,Utility"]
[426,"LoRusso, P. M., et al. (2003). \"Improvements in quality of life and disease-related symptoms in phase I trials of the selective oral epidermal growth factor receptor tyrosine kinase inhibitor ZD1839 in non-small cell lung cancer and other solid tumors.\" Clin Cancer Res 9(6): 2040-2048.",null,"LoRusso, P. M., et al.","Improvements in quality of life and disease-related symptoms in phase I trials of the selective oral epidermal growth factor receptor tyrosine kinase inhibitor ZD1839 in non-small cell lung cancer and other solid tumors","PURPOSE: The feasibility and utility of assessing quality of life (QoL) and disease-related symptoms in patients with advanced cancer have been evaluated in two Phase I clinical trials of p.o. administered ZD1839 ('Iressa'), an epidermal growth factor receptor tyrosine kinase inhibitor, in patients with advanced cancer. EXPERIMENTAL DESIGN: Functional Assessment of Cancer Therapy (FACT) questionnaires, including disease-specific subscales for lung, head and neck, colorectal, prostate, and ovarian cancer, were completed by patients in two open-label, Phase I, escalating multiple-dose safety and tolerability trials. RESULTS: In 157 patients, 92% of whom had received prior therapy, compliance in returning FACT questionnaires was 87% (European/Australian trial) and 57% (United States trial). This did not appear to be influenced by dose level or tumor type. For patients with colorectal, prostate, or ovarian cancer, median QoL [FACT and Trial Outcome Index (TOI)] scores deteriorated over time. In contrast, for patients with non-small cell lung cancer (NSCLC) or head and neck cancer, median FACT and TOI scores did not deteriorate significantly, and in the United States trial, head and neck cancer scores improved significantly over time. In patients with NSCLC, symptom-related scores measured by the Lung Cancer Subscale of FACT-L appeared sensitive to clinical change. CONCLUSIONS: QoL (FACT-L) questionnaires were used successfully in the Phase I clinical trials of ZD1839. They appeared to be a sensitive tool to monitor clinical changes for the five tumor types in these trials and showed that ZD1839 has the potential to improve patients' QoL.","Clin Cancer Res, 9(6): 2040-2048","USA",2003,"Advanced","Gefitinib","FACT-P,TOI","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,Treatment"]
[427,"Lubeck, D. P., et al. (1997). \"Measurement of health-related quality of life in men with prostate cancer: the CaPSURE database.\" Qual Life Res 6(5): 385-392.",null,"Lubeck, D. P., et al.","Measurement of health-related quality of life in men with prostate cancer: the CaPSURE database","This paper reviews the reliability and validity of an instrument for assessing health-related quality of life (HRQOL) in CaPSURE (Cancer of the Prostate Strategic Urologic Research Endeavor), an observational database of men with biopsy-confirmed prostate cancer. The questionnaire includes the RAND 36 item Health Survey 1.0, the UCLA Prostate Cancer Index and items measuring self-esteem and the impact of prostate cancer in general and on the family. The reliability and validity of this instrument are reported for a group of 2,382 men enrolled in CaPSURE. Individuals complete HRQOL questionnaires at enrollment and quarterly thereafter. The subscales of the instrument resulted in a high internal-consistency reliability across all subscales (range = 0.75-0.94). The test-retest reliability was good with the exception of the comparative health item (intraclass correlation coefficient (ICC) = 0.55). The concurrent validity data included moderately strong associations with subscales of similar concepts and the ability to distinguish between patients who are known to be different--newly diagnosed (within 6 months) and patients diagnosed and treated an average of 3 years ago. Overall, this instrument demonstrated good reliability and validity and supported the need for incorporating HRQOL as a component of outcomes assessment in the management of patients with prostate cancer.","Qual Life Res, 6(5): 385-392","USA",1997,"Any or unknown","Unclear","UCLA-PCI,SF-36","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease,Utility"]
[428,"Lubeck, D. P., et al. (2000). \"An instrument to measure patient satisfaction with healthcare in an observational database: results of a validation study using data from CaPSURE.\" Am J Manag Care 6(1): 70-76.",null,"Lubeck, D. P., et al.","An instrument to measure patient satisfaction with healthcare in an observational database: results of a validation study using data from CaPSURE","OBJECTIVE: To validate a satisfaction measure for use in longitudinal, prospective studies of patient care. STUDY DESIGN: Patients with biopsy-confirmed prostate cancer (n = 228) who were enrolled in CaPSURE (Cancer of the Prostate Strategic Urologic Research Endeavor) completed a self-administered questionnaire that included a health-related quality-of-life and satisfaction measure. A subset of patients completed the questionnaire again within 30 days. METHODS: The satisfaction measure contained 6 individual subscales: overall satisfaction with care, contact with providers, confidence in providers, communication skills, humaneness, and a summary scale. Six items surveyed patients' willingness to participate in decision making (participatory style), and these were averaged into a single score. Variability, reliability, stability, and validity were evaluated. RESULTS: Responses to the items varied substantially. The overall satisfaction scale demonstrated good internal consistency reliability (Cronbach alpha = 0.82) and moderate test-retest reliability (0.62), and it could discriminate between groups of individuals expected to differ with regard to satisfaction (by age and disease stage). Subscale internal consistency reliability (0.37-0.54) and stability (0.38-0.63) were weaker, suggesting that only a single scale should be reported. The participatory scale performed poorly and could not be recommended for future use. CONCLUSION: The overall satisfaction measure developed for this study demonstrated good reliability and validity and should be useful in other population-based studies in conjunction with other outcome measures.","Am J Manag Care, 6(1): 70-76","USA",2000,"Any or unknown","Unclear","Unclear","Patient",null,"Validation",null,null,null,null,null,null,null,null,"General,Satisfaction"]
[429,"Lubeck, D. P., et al. (2001). \"The effect of androgen deprivation therapy on health-related quality of life in men with prostate cancer.\" Urology 58(2 Suppl 1): 94-100.",null,"Lubeck, D. P., et al.","The effect of androgen deprivation therapy on health-related quality of life in men with prostate cancer","Treatment for prostate cancer has a significant impact on health-related quality of life (HRQOL). We examined HRQOL in a cohort of men receiving androgen deprivation therapy (ADT) and a cohort who opted for surveillance. The cohort consisted of 1178 newly diagnosed patients from the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) database (a national longitudinal registry of patients with prostate cancer). General and disease-specific HRQOL outcomes were measured with validated instruments (the SF-36 and University of California at Los Angeles [UCLA] Prostate Cancer Index) at study entry and quarterly thereafter. Individuals were grouped by initial treatment: ADT, surveillance, radical prostatectomy, or radiation therapy. There were 106 men who selected surveillance, 167 men receiving ADT, 351 men treated by radical prostatectomy, and 75 men receiving radiation therapy in the first year after diagnosis. Mean age at diagnosis was 73 years of age, with surveillance patients the oldest and radical prostatectomy patients the youngest. Men receiving ADT reported poorer urinary and sexual function and a higher rate of urinary and sexual bother than patients selecting surveillance. ADT and surveillance HRQOL scores remained low (ie, poorer function) in the year after treatment, whereas men undergoing radical prostatectomy showed improvement in these scales. Patients who received ADT had reduced energy, poorer sexual and urinary function, and were more bothered by their urine and sexual function than patients undergoing other treatments, except surveillance. Longer follow-up time after start of ADT and surveillance is needed to discern the impact of comorbidities on HRQOL.","Urology, 58(2 Suppl 1): 94-100","USA",2001,"Any or unknown","Hormonal,Surveillance,Surgery,Radiotherapy","SF-36,UCLA-PCI","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease,Utility"]
[430,"Lucas, M. D., et al. (1995). \"Quality of life, sexual functioning and sex role identity after surgical orchidectomy in patients with prostatic cancer.\" Scand J Urol Nephrol 29(4): 497-500.",null,"Lucas, M. D., et al.","Quality of life, sexual functioning and sex role identity after surgical orchidectomy in patients with prostatic cancer","Surgical orchidectomy is a simple procedure with few physical side effects, low mortality, and cost effectiveness. Nevertheless, there can be negative sequelae such as sexual dysfunction, impaired quality of life, and poor body image. Although it is a frequent treatment approach for prostate cancer, it is not clear whether these sequelae are problematic for this patient group. It is possible that relief from painful metastases and the prolongation of life outweigh these negative factors. The present study investigated quality of life, sex-role identity, and sexual function in 15 patients with stage D prostate cancer, before and after surgery. Orchidectomy did not appear to affect quality of life, or sex-role identity. However, loss of sexual function did present as an area of concern. It was noted that 55% of premorbidly sexually active patients found this loss disturbing. These patients, premorbidly, appeared to have higher sex-role stereotypy.","Scand J Urol Nephrol, 29(4): 497-500","South Africa",1995,"Metastatic","Surgery","Unclear","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"General,Complication"]
[431,"Macaulay, M., et al. (2015). \"A trial of devices for urinary incontinence after treatment for prostate cancer.\" BJU Int 116(3): 432-442.",null,"Macaulay, M., et al.","A trial of devices for urinary incontinence after treatment for prostate cancer","OBJECTIVE: To compare the performance of three continence management devices and absorbent pads used by men with persistent urinary incontinence (>1 year) after treatment for prostate cancer. PATIENTS AND METHODS: Randomised, controlled trial of 56 men with 1-year follow-up. Three devices were tested for 3 weeks each: sheath drainage system, body-worn urinal (BWU) and penile clamp. Device and pad performance were assessed. Quality of life (QoL) was measured at baseline and follow-up with the King's Health Questionnaire. Stated (intended use) and revealed (actual use) preference for products were assessed. Value-for-money was gathered. RESULTS: Substantial and significant differences in performance were found. The sheath was rated as 'good' for extended use (e.g. golf and travel) when pad changing is difficult; for keeping skin dry, not leaking, not smelling and convenient for storage and travel. The BWU was generally rated worse than the sheath and was mainly used for similar activities but by men who could not use a sheath (e.g. retracted penis) and was not good for seated activities. The clamp was good for short vigorous activities like swimming/exercise; it was the most secure, least likely to leak, most discreet but almost all men described it as uncomfortable or painful. The pads were good for everyday activities and best for night-time use; most easy to use, comfortable when dry but most likely to leak and most uncomfortable when wet. There was a preference for having a mixture of products to meet daytime needs; around two-thirds of men were using a combination of pads and devices after testing compared with baseline. CONCLUSIONS: This is the first trial to systematically compare different continence management devices for men. Pads and devices have different strengths, which make them particularly suited to certain circumstances and activities. Most men prefer to use pads at night but would choose a mixture of pads and devices during the day. Device limitations were important but may be overcome by better design.","BJU Int, 116(3): 432-442","Canada",2015,"Any or unknown","Various","KHQ","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General"]
[432,"Machold, S., et al. (2009). \"Comparison of a 20-min pad test with the 1-hour pad test of the international continence society to evaluate post-prostatectomy incontinence.\" Urol Int 83(1): 27-32.",null,"Machold, S., et al.","Comparison of a 20-min pad test with the 1-hour pad test of the international continence society to evaluate post-prostatectomy incontinence","OBJECTIVES: Urinary incontinence is a hygienic and socially distressing problem for affected people and causes high healthcare costs. Objective standardized noninvasive quantification of urinary incontinence is highly important and, in addition, enables control of therapeutic efficacy. The aim of this prospective study was to evaluate the feasibility, accuracy and reproducibility of a standardized 20-min pad test to measure urinary incontinence after radical prostatectomy in comparison to the 1-hour pad-weighing test recommended by the International Continence Society (ICS). METHODS: We applied a standardized questionnaire, the ICS 1-hour pad test and a simplified 20-min pad test to evaluate subjective and objective post-prostatectomy urinary incontinence in 56 men. RESULTS: The technical feasibility of the 20-min pad test was excellent; the results correlated significantly with both the self-assessment via questionnaire (r = 0.63; p < 0.001) and the 1-hour pad test (ICS; r = 0.66; p < 0.001). Moreover, it was highly reliable (r = 0.74; p < 0.0005) with excellent patient acceptance. CONCLUSIONS: The 20-min pad test qualified as a reliable, cost-effective and noninvasive tool which can easily be applied in urologic or physiotherapeutic practice to assess post-prostatectomy urinary incontinence and to evaluate the success of therapeutic approaches.","Urol Int, 83(1): 27-32","Germany",2009,"Any or unknown","Surgery","Unclear","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Complication"]
[433,"Madalinska, J. B., et al. (2001). \"Health-related quality-of-life effects of radical prostatectomy and primary radiotherapy for screen-detected or clinically diagnosed localized prostate cancer.\" J Clin Oncol 19(6): 1619-1628.",null,"Madalinska, J. B., et al.","Health-related quality-of-life effects of radical prostatectomy and primary radiotherapy for screen-detected or clinically diagnosed localized prostate cancer","PURPOSE: The current study was undertaken within the framework of a screening trial to compare the health-related quality-of-life (HRQOL) outcomes of two primary treatment modalities for localized prostate cancer: radical prostatectomy and external-beam radiotherapy. PATIENTS AND METHODS: We conducted a prospective longitudinal cohort study among 278 patients with early screen-detected (59%) or clinically diagnosed (41%) prostate cancer using both generic and disease-specific HRQOL measures (SF-36, UCLA Prostate Cancer Index [urinary and bowel modules] and items relating to sexual functioning) at three points in time: t1 (baseline), t2 (6 months later), and t3 (12 months after t1). RESULTS: Questionnaires were completed by 88% to 93% of all initially enrolled patients. Patients referred for primary radiotherapy were significantly older than prostatectomy patients (63 v 68 years, P <.01). Analyses (adjusted for age and pretreatment level of functioning) revealed poorer levels of generic HRQOL after radiotherapy. Prostatectomy patients reported significantly higher (P <.01) posttreatment incidences of urinary incontinence (39% to 49%) and erectile dysfunction (80% to 91%) than radiotherapy patients (respectively, 6% to 7% and 41% to 55%). Bowel problems (urgency) affected 30% to 35% of the radiotherapy group versus 6% to 7% of the prostatectomy group (P <.01). Patients with screen-detected and clinically diagnosed cancer reported similar posttreatment HRQOL. CONCLUSION: Prostatectomy and radiotherapy differed in the type of HRQOL impairment. Because the HRQOL effects may be valued differently at the individual level, patients should be made fully aware of the potential benefits and adverse consequences of therapies for early prostate cancer. Differences in posttreatment HRQOL were not related to the method of cancer detection.","J Clin Oncol, 19(6): 1619-1628","Netherlands",2001,"Local","Surgery,Radiotherapy","SF-36,UCLA-PCI","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease,Utility"]
[434,"Mahal, B. A., et al. (2014). \"Use of a rectal spacer with low-dose-rate brachytherapy for treatment of prostate cancer in previously irradiated patients: Initial experience and short-term results.\" Brachytherapy 13(5): 442-449.",null,"Mahal, B. A., et al.","Use of a rectal spacer with low-dose-rate brachytherapy for treatment of prostate cancer in previously irradiated patients: Initial experience and short-term results","BACKGROUND: Salvage brachytherapy in patients with prior pelvic radiation carries a risk of rectal injury. Herein, we report our initial experience using a hydrogel spacer between the prostate and the rectum during salvage brachytherapy. METHODS AND MATERIALS: A total of 11 patients with prostate cancer and prior radiotherapy (5 prostate brachytherapy, 2 prostate external beam radiation therapy [EBRT], and 4 rectal cancer EBRT) received (125)I brachytherapy after attempted placement of 10cc of a diluted hydrogel spacer between the prostate and rectum. RESULTS: Spacing was achieved in 8 of the 11 (73%) patients but was not possible in 3 (1 prior brachytherapy and 2 prior EBRT) owing to fibrosis and adhesions. For the 8 patients in whom spacing was accomplished, the median space between the prostate and rectum was 10.9mm (prior EBRT) vs. 7.7mm (prior brachytherapy), p=0.048. Median followup was 15.7 months. One patient developed a prostato-rectal fistula requiring a diverting colostomy. The 16-month estimate of late Grade 3 or 4 gastrointestinal or genitourinary toxicity was 26%. One patient developed lymph node-positive recurrence. The 16-month prostate-specific antigen failure-free survival rate was 89%. Compared with baseline, Expanded Prostate Cancer Index Composite for Clinical Practice urinary quality of life (QoL) was significantly worse at 3 and 6 months but not significantly worse by 1 year. There were no significant changes throughout the study period in bowel or sexual QoL. CONCLUSION: Hydrogel spacer placements may be feasible in most patients with prior pelvic radiation. Further followup is needed to determine whether spacer placement will produce long-term improvements in toxicity or QoL.","Brachytherapy, 13(5): 442-449","USA",2014,"Any or unknown","Brachytherapy,Radiotherapy","EPIC","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease"]
[435,"Majumder, K., et al. (2014). \"Less satisfaction with information in patients with prostate cancer treated with surgery and salvage radiotherapy compared with patients treated with curative radiotherapy alone, despite similar health-related quality of life.\" Clin Genitourin Cancer 12(3): e71-82.",null,"Majumder, K., et al.","Less satisfaction with information in patients with prostate cancer treated with surgery and salvage radiotherapy compared with patients treated with curative radiotherapy alone, despite similar health-related quality of life","BACKGROUND: This study examined patient perception of information received, satisfaction with that information, and its relation to health-related quality of life (HRQoL) and clinical and demographic variables before, during, and after radiotherapy (RT) for localized prostate cancer. PATIENTS AND METHODS: In 2010, 2 questionnaires (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 [EORTC QLQ-C30] and EORTC QLQ information module [QLQ-INFO25]) were sent to 660 consecutive patients with prostate cancer who had undergone or were to undergo RT with curative intent between December 2006 and March 2010. RESULTS: The response rate was 92%. Although most patients (69%) were satisfied with the information they received, statistically significant differences were found for all but 2 EORTC QLQ-INFO25 variables, favoring those who were treated with RT alone compared with those treated with both prostatectomy and salvage RT. Statistically significant associations between all HRQoL variables and satisfaction with information were found; higher levels of satisfaction were associated with better functioning and lower levels of symptoms and problems. CONCLUSION: Satisfaction with the information received was studied in patients with prostate cancer with localized disease. Despite the fact that the majority of patients reported being satisfied with the information received, there is room for improvement, especially regarding \"the disease,\" \"other services,\" \"different places of care,\" and \"things you can do to help yourself.\" Patients treated with both prostatectomy and salvage RT reported significantly lower levels of satisfaction with information received and of having received significantly less information than did patients treated with RT alone.","Clin Genitourin Cancer, 12(3): e71-82","Sweden",2014,"Local","Surgery,Radiotherapy","EORTC QLQ-C30,EORTC-QLQ-INFO25","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"General,Knowledge"]
[436,"Majumder, K., et al. (2016). \"Higher sexual interest with androgen receptor inhibitor monotherapy than with castration plus an androgen receptor inhibitor in prostate cancer patients treated with curative radiotherapy, but otherwise small health-related quality of life differences: A randomised prospective 18-month follow-up study.\" Eur J Cancer 65: 43-51.",null,"Majumder, K., et al.","Higher sexual interest with androgen receptor inhibitor monotherapy than with castration plus an androgen receptor inhibitor in prostate cancer patients treated with curative radiotherapy, but otherwise small health-related quality of life differences: A randomised prospective 18-month follow-up study","PURPOSE: To prospectively study differences in health-related quality of life (HRQoL) in patients with localised/locally advanced prostate cancer (PC) treated with curative intended radiation therapy and randomised to androgen receptor inhibitor monotherapy treatment versus castration plus an androgen receptor inhibitor used continuously. Time to Prostate Specific Antigen (PSA) relapse, time to symptomatic metastasis and overall survival (OS) were also described for the two groups. PATIENTS AND METHODS: From 2005 to 2011, a total of 110 patients were randomised at a ratio of 1:1. HRQoL was assessed at six time points: before randomisation, before radiotherapy (RT) start and 9, 12, 15 and 18 months after randomisation, using the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) and EORTC QLQ-PR25. RESULTS: At the 3-month follow-up, statistically significant differences between the two groups were found for overall quality of life (p = 0.006), fatigue (p = 0.023), sexual interest (p < 0.001) and urinary problems (p = 0.036). Small clinical differences were noted for overall quality of life, role functioning, fatigue, pain, sleeping problems and urinary problems. At that assessment point, clinical differences between the groups were substantial regarding sexual interest and moderate regarding sexual functioning (the latter indicated only by patients reporting having sexual interest at baseline). All statistical and clinical differences favoured the androgen receptor inhibitor monotherapy arm. At 18 months after randomisation, statistically significant differences were found for cognitive functioning (p = 0.040) and sexual interest (p = 0.011), both favouring the androgen receptor inhibitor monotherapy arm. CONCLUSION: The results suggest that neo-adjuvant androgen receptor inhibitor monotherapy might be preferred compared to castration plus an androgen receptor inhibitor before curative intended RT in men with localised/locally advanced PC, with higher levels of HRQoL, especially concerning sexual interest. HRQoL differences over time were small. The observation time and study sample were too small for evaluating time to PSA progression and OS. Further studies are needed to confirm the results. The study was registered in, identification number NCT02382094.","Eur J Cancer, 65(43-51","Sweden",2016,"Advanced,Local","Hormonal,Radiotherapy,Surgery","EORTC QLQ-C30,EORTC QLQ-PR25","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,General"]
[437,"Malcolm, J. B., et al. (2010). \"Quality of life after open or robotic prostatectomy, cryoablation or brachytherapy for localized prostate cancer.\" J Urol 183(5): 1822-1828.",null,"Malcolm, J. B., et al.","Quality of life after open or robotic prostatectomy, cryoablation or brachytherapy for localized prostate cancer","PURPOSE: Health related quality of life concerns factor prominently in prostate cancer management. We describe health related quality of life impact and recovery profiles of 4 commonly used operative treatments for localized prostate cancer. MATERIALS AND METHODS: Beginning in February 2000 all patients treated with open radical prostatectomy, robot assisted laparoscopic prostatectomy, brachytherapy or cryotherapy were asked to complete the UCLA-PCI questionnaire before treatment, and at 3, 6, 12, 18, 24, 30 and 36 months after treatment. Outcomes were compared across treatment types with statistical analysis using univariate and multivariate models. RESULTS: A total of 785 patients treated between February 2000 and December 2008 were included in the analysis with a mean followup of 24 months. All health related quality of life domains were adversely affected by all treatments and recovery profiles varied significantly by treatment type. Overall urinary function and bother outcomes scored significantly higher after brachytherapy and cryotherapy compared to open radical prostatectomy and robotic assisted laparoscopic radical prostatectomy. Brachytherapy and cryotherapy had a 3-fold higher rate of return to baseline urinary function compared to open radical prostatectomy and robotic assisted laparoscopic radical prostatectomy. Sexual function and bother scores were highest after brachytherapy, with a 5-fold higher rate of return to baseline function compared to cryotherapy, open radical prostatectomy and robotic assisted laparoscopic radical prostatectomy. All 4 treatments were associated with relatively transient and less pronounced impact on bowel function and bother. CONCLUSIONS: In a study of sequential health related quality of life assessments brachytherapy and cryotherapy were associated with higher urinary function and bother scores compared to open radical prostatectomy and da Vinci prostatectomy. Brachytherapy was associated with higher sexual function and bother scores compared to open radical prostatectomy, robotic assisted laparoscopic radical prostatectomy and cryotherapy.","J Urol, 183(5): 1822-1828","USA",2010,"Local","Surgery,Radiotherapy,Brachytherapy,Various","UCLA-PCI","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease"]
[438,"Malmi, H., et al. (2010). \"Why do men opt out of prostate-cancer screening? Attitudes and perception among participants and non-participants of a screening trial.\" BJU Int 106(4): 472-477.",null,"Malmi, H., et al.","Why do men opt out of prostate-cancer screening? Attitudes and perception among participants and non-participants of a screening trial","OBJECTIVE: To evaluate attitudes to prostate cancer screening with prostate-specific antigen (PSA) of men who complied with offered screening and those who declined it within the Finnish randomized population-based screening trial, and to compare general health-related quality of life (HRQL) between participants and non-participants. SUBJECTS AND METHODS: Self-administered questionnaires were sent to 500 men randomized into the screening arm in 1996-99 within the Finnish component of the European Randomized Study on Screening for Prostate Cancer. A similar survey was conducted among 500 non-participants. RESULTS: Response proportions among the screening participants and non-participants were 59% and 28%, respectively. Current smoking was less frequent (P < 0.05) among the participants. In terms of attitude, the participants regarded the prostate cancer study as more important and the invitation letter as more informative than the non-participants (P < 0.001). There was no clear difference in worry about treatment consequences. The most commonly given reasons for not participating included previous PSA testing (41%), forgetting the invitation (51%), or not wanting to think of prostate cancer (39%) and regarding possible further diagnostic examinations as unpleasant (28%). The non-participants had a lower mental health score (P < 0.001) than the participants in the RAND-36 Survey. CONCLUSION: Most men who chose not to attend screening had a positive attitude, but did not participate due to practical reasons. However, two-thirds of the non-participants indicated a willingness to participate in the next screening round.","BJU Int, 106(4): 472-477","USA",2010,"At risk","Screening","Unclear","General population",null,"Clinical trial",null,null,null,null,null,null,null,null,"Views"]
[439,"Mason, M., et al. (2013). \"Neoadjuvant androgen deprivation therapy for prostate volume reduction, lower urinary tract symptom relief and quality of life improvement in men with intermediate- to high-risk prostate cancer: a randomised non-inferiority trial of degarelix versus goserelin plus bicalutamide.\" Clin Oncol (R Coll Radiol) 25(3): 190-196.",null,"Mason, M., et al.","Neoadjuvant androgen deprivation therapy for prostate volume reduction, lower urinary tract symptom relief and quality of life improvement in men with intermediate- to high-risk prostate cancer: a randomised non-inferiority trial of degarelix versus goserelin plus bicalutamide","AIMS: The treatment of intermediate- to high-risk prostate cancer with radical radiotherapy is usually in combination with neoadjuvant androgen deprivation therapy. The aim of the present trial was to investigate whether degarelix achieves comparable efficacy with that of goserelin plus bicalutamide as neoadjuvant therapy before radiotherapy. MATERIALS AND METHODS: The study was a randomised, parallel-arm, active-controlled, open-label trial in 244 men with a UICC prostate cancer TNM category T2b-T4, N0, M0, Gleason score >/=7, or prostate-specific antigen >/=10 ng/ml and a total prostate volume >30 ml, who were scheduled to undergo radical radiotherapy and in whom neoadjuvant androgen deprivation therapy was indicated. Eligible patients received treatment with either monthly degarelix (240/80 mg) or goserelin (3.6 mg) for 12 weeks, the latter patients also receiving bicalutamide (50 mg) for 17 days initially. The primary efficacy measure was the mean percentage reduction in total prostate volume from baseline at week 12 measured by transrectal ultrasound. The severity and relief of lower urinary tract symptoms were assessed by the International Prostate Symptom Score questionnaire. Quality of life was assessed by the eighth question of the International Prostate Symptom Score. About 50% of the patients had moderate to severe lower urinary tract symptoms at baseline. RESULTS: The total prostate volume decreased significantly from baseline to week 12 in both treatment groups, reaching -36.0 +/- 14.5% in degarelix-treated patients and -35.3 +/- 16.7% in goserelin-treated patients (adjusted difference: -0.3%; 95% confidence interval: -4.74; 4.14%). At the end of the therapy, more degarelix- than goserelin-treated patients reported International Prostate Symptom Score decreases of >/=3 points (37% versus 27%, P = 0.21). In addition, in patients with a baseline International Prostate Symptom Score of >/=13, the magnitude of the decrease was larger in degarelix- (n = 53) versus goserelin-treated patients (n = 17) (6.04 versus 3.41, P = 0.06). CONCLUSIONS: The efficacy of degarelix in terms of prostate shrinkage is non-inferior to that of goserelin plus bicalutamide. The added benefits of degarelix in terms of more pronounced lower urinary tract symptom relief in symptomatic patients could be the reflection of differences in the direct effects on extra-pituitary receptors in the lower urinary tract [Clinicaltrials.gov ID: NCT00833248].","Clin Oncol (R Coll Radiol), 25(3): 190-196","UK",2013,"Local,Advanced","Radiotherapy,Hormonal","IPSS","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease"]
[440,"Matthew, A. G., et al. (2007). \"Serial personal digital assistant data capture of health-related quality of life: a randomized controlled trial in a prostate cancer clinic.\" Health Qual Life Outcomes 5: 38.",null,"Matthew, A. G., et al.","Serial personal digital assistant data capture of health-related quality of life: a randomized controlled trial in a prostate cancer clinic","BACKGROUND: In clinical and research practice linked to prostate cancer treatment, frequent monitoring of patient health-related quality of life (HRQOL) is essential. Practical and analytic limitations of paper questionnaire data capture may be overcome with the use of self-administered personal digital assistant (PDA) data collection. The objective of this study was to assess the reliability, validity, and feasibility of using PDA in place of paper versions of the International Prostate Symptom Score (IPSS), the Patient Oriented Prostate Cancer Utility Survey (PORPUS), and the International Index of Erectile Function-5 (IIEF-5) in a prostate cancer clinic setting. METHODS: 152 participants were randomly assigned to one of three conditions: 1) paper followed by PDA survey; 2) PDA followed by paper survey; or 3) PDA followed by PDA survey. Evaluation included an assessment of data quality (internal consistency, test-retest reliability, response correlation, completeness of data), and feasibility (participation rates, time to completion, preference and difficulty/ease of using PDA). RESULTS: Internal consistency was similar for both PDA and paper applications. Test-retest reliability was confirmed for PDA repeated administration. Data from paper and PDA questionnaires were strongly correlated. Lower missed item rates were found in PDA administration. 82.8% of participants preferred using the PDA or had no preference. Mean difficulty/ease ratings indicated that participants found the PDA easy to use. Age did not significantly correlate with preference or difficulty. CONCLUSION: The results confirm the adaptability of the IPSS, IIEF-5, and the PORPUS to PDA administration. Similarly, the findings of this study support the feasibility of using PDA technology for HRQOL serial data capture in the prostate cancer patient population.","Health Qual Life Outcomes, 5(38","Canada",2007,"Any or unknown","Unclear","IPSS,PORPUS,IIEF-5","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease,Complication,Utility"]
[441,"Mazur, D. J. and J. F. Merz (1996). \"How older patients' treatment preferences are influenced by disclosures about therapeutic uncertainty: surgery versus expectant management for localized prostate cancer.\" J Am Geriatr Soc 44(8): 934-937.",null,"Mazur, D. J. and J. F. Merz","How older patients' treatment preferences are influenced by disclosures about therapeutic uncertainty: surgery versus expectant management for localized prostate cancer","OBJECTIVES: There is an ongoing debate about the proper management of localized prostate cancer in older men. We assessed whether older patients differ in their willingness to accept surgery versus expectant management for a hypothetical early stage, low grade, clinically localized prostate carcinoma, and whether patients' current levels or past history of urologic dysfunction (difficulties initiating urination, failing to empty the bladder, urinary dribbling, getting up at night to urinate, and frequency of sexual activity) influence their decisions. We assessed patients' willingness to choose surgery over expectant management by varying the expected survival benefit in years (ESBs-em) of surgery over expectant management. DESIGN: Structured interviews with a consecutive series of male patients. SETTING: A university-based Department of Veterans Affairs Medical Center. PATIENTS: One hundred forty-eight patients seen consecutively in General Medicine Clinic at the Department of Veterans Affairs Medical Center in Portland, Oregon, were enrolled in the study. Mean age of the patients was 66.3 years (SD = 10.3, range = 30-85); mean level of formal education was 12.6 years (SD = 2.7, range = 6-22). MEASUREMENTS: Patients were asked whether they would accept surgery or expectant management in one of 11 treatment comparisons. We varied the ESBs-em in 1-year increments from 0 years to 10 years. As described to patients, surgery carried a mortality risk at the time of treatment of 1 to 2%. Once any patient indicated a willingness to accept surgery at any of the treatment comparisons or if any patient reported preferring expectant management across all treatment comparisons, the elicitation procedure was stopped. All patients were asked to complete a urological and sexual functioning questionnaire to determine the presence of coexisting urological dysfunction and level of sexual activity both at present and in the past. RESULTS: Of the 148 patients enrolled in the study, 43.2% (64/148) preferred surgery with a zero expected life benefit over expectant management (ESBs-em = 0) and a 1 to 2% chance of dying within 1 month of surgery; 24.3% (36/148) rejected surgery as the expected life benefit of surgery was increased (0 < ESBs-em < or = 10 years); 26.4% (39/148) preferred expectant management even when there was a 10-year expected life benefit of surgery; 4.7% (7/148) preferred that their physician make the decision for them; and 1.4% (2/148) of patients reported that they preferred radiation therapy, an option that was not offered to them explicitly. Our results suggest that older patients are more likely to report a preference for expectant management (OR = 1.07). Further, our results suggest that patients who report current urinary dribbling (OR = 9.03) are much more likely to prefer expectant management but that this preference decreases with the amount of time they have had this problem. Similarly, we find that patients who have difficulty with starting urination are much more likely to prefer surgery (OR = 0.13), and this preference is also mediated by the number of years they have experienced this problem. Treatment choice was not associated with formal education, present health status, or the other urological symptoms we assessed. CONCLUSION: Our study in an older male veteran population showed preferences for a variety of options in prostate cancer. Although the majority of men preferred surgery, a significant number preferred expectant management. Our results show that preferences reflect patients' experiences with physical problems associated with disease and that these experiences need to be explored and considered by patients and their providers when making treatment decisions.","J Am Geriatr Soc, 44(8): 934-937","USA",1996,"Local","Radiotherapy,Surgery,Surveillance","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Complication"]
[442,"Mazzarello Moore, T. H., et al. (2015). \"Supportive care for men with prostate cancer: why are the trials not working? A systematic review and recommendations for future trials.\" Cancer Med 4(8): 1240-1251.",null,"Mazzarello Moore, T. H., et al.","Supportive care for men with prostate cancer: why are the trials not working? A systematic review and recommendations for future trials","Men with prostate cancer are likely to have a long illness and experience psychological distress for which supportive care may be helpful. This systematic review describes the evidence for effectiveness and cost-effectiveness of supportive care for men with prostate cancer, taking into account treatment pathway and components of interventions. MEDLINE, EMBASE, CINAHL, CENTRAL, and Psychinfo were searched from inception--July 2013 for randomized controlled trials and controlled trials. Two authors independently assessed risk of bias and extracted data. Twenty-six studies were included (2740 participants). Interventions were delivered pre and during (n = 12), short-term (n = 8), and longer term (18 months) (n = 5) after primary treatment. No interventions were delivered beyond this time. Few trials recruited ethnic minorities and none recruited men in same sex relationships. Intervention components included information, education, health professional discussion, homework, peer discussion, buddy support, cognitive behavioral therapy, cognitive restructuring, psychoeducation, Reiki and relaxation. Most interventions were delivered for 5-10 weeks. Risk of bias of trials was assessed as unclear for most domains due to lack of information. The majority of trials measuring quality of life and depression found no effect. Relatively few trials measured anxiety, coping skills and self-efficacy, and the majority found no effect. No cost data were available. Trials of supportive care for men with prostate cancer cover a range of interventions but are limited by population diversity, inconsistent measurement and reporting of outcomes, and inability to assess risk of bias. Recommendations on design and conduct of future trials are presented.","Cancer Med, 4(8): 1240-1251","International",2015,"Any or unknown","Various,Psychological","Unclear","Patient",null,"Systematic review",null,null,null,null,null,null,null,null,"General,Comorbidity"]
[443,"McBride, S. M., et al. (2012). \"Hypofractionated stereotactic body radiotherapy in low-risk prostate adenocarcinoma: preliminary results of a multi-institutional phase 1 feasibility trial.\" Cancer 118(15): 3681-3690.",null,"McBride, S. M., et al.","Hypofractionated stereotactic body radiotherapy in low-risk prostate adenocarcinoma: preliminary results of a multi-institutional phase 1 feasibility trial","BACKGROUND: Recent reports using extreme hypofractionated regimens in the treatment of low-risk prostate adenocarcinoma have been encouraging. Here, the authors report on their own multi-institutional experience with extreme hypofractionated stereotactic radiotherapy for early stage disease. METHODS: In total, at 4 centers, 45 patients with National Comprehensive Cancer Network-defined, low-risk prostate adenocarcinoma were enrolled in a phase 1, multi-institutional trial of hypofractionated radiosurgery with a proprietary radiosurgical device (CyberKnife). Thirty-four patients received 7.5 grays (Gy) delivered in 5 fractions, 9 patients received 7.25 Gy delivered in 5 fractions, and 2 patients received other regimens. The variables evaluated were biochemical progression-free survival (bPFS), prostate-specific antigen (PSA) bounce, and toxicities. Health-related quality of life was evaluated using the Sexual Health Inventory for Men (SHIM), American Urological Association (AUA), and Expanded Prostate Cancer Index Composite (EPIC) questionnaires. RESULTS: The median follow-up for surviving patients was 44.5 months (range, 0-62 months). The bPFS rate at 3 years was 97.7%. The median PSA declined from 4.9 ng/mL at diagnosis to 0.2 ng/mL at last follow-up, and the median percentage PSA decline at 12 months was 80%. Nine patients experienced at least 1 PSA bounce >/=0.4 ng/mL, and 4 patients experienced 2 PSA bounces. The median time to first PSA bounce was 11.6 months (range, 7.2-18.2 months), and the mean percentage PSA bounce was 1.07 ng/mL. There was 1 episode of late grade 3 urinary obstruction, and there were 2 episodes of late grade 3 proctitis. There was a significant late decline in SHIM and EPIC sexual scores and a small, late decline in the EPIC Bowel domain score. CONCLUSIONS: In a select population, extreme hypofractionation with stereotactic radiosurgery was safe and effective for the treatment of low-risk prostate adenocarcinoma.","Cancer, 118(15): 3681-3690","USA",2012,"Local","Radiotherapy","EPIC,SHIM,AUA-SI","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,Symptom"]
[444,"McCammon, K. A., et al. (1999). \"Comparative quality-of-life analysis after radical prostatectomy or external beam radiation for localized prostate cancer.\" Urology 54(3): 509-516.",null,"McCammon, K. A., et al.","Comparative quality-of-life analysis after radical prostatectomy or external beam radiation for localized prostate cancer","OBJECTIVES: To determine and compare quality-of-life (QOL) evaluations from patients who received external beam radiation therapy or radical prostatectomy for the treatment of localized prostate cancer, and to compare differences in QOL assessments for urinary and sexual function after radical prostatectomy as reported by patient and physician. METHODS: Two hundred three patients treated by radical prostatectomy and 257 patients treated by external beam irradiation, all beyond 12-month follow-up after therapy, responded to a QOL questionnaire. The difference in responses with regard to bladder, bowel, and sexual function, overall satisfaction with treatment, and choice of the same treatment were assessed. Satisfaction with and choice of the same treatment were also specifically assessed according to bowel and bladder function and current disease status. The medical records of patients treated by radical prostatectomy were reviewed by an independent data manager to record the physician's assessment of continence and sexual function for comparison with that patient's assessment as noted in the questionnaire. RESULTS: Problems with urinary continence were more frequent among patients treated by radical prostatectomy; problems with gastrointestinal function were more frequent after irradiation. Sexual dysfunction was similar in both groups, although surgical patients experienced a greater impact on sexual relationships. The physician estimates of urinary continence were more favorable than the patient-reported outcomes. However, the physician estimate of sexual function closely approximated that of the patient. Preservation of sexual function among patients who underwent nerve-sparing surgery was disappointingly low. Only for the response to the question dealing with difficulty in achieving an erection was there a statistically significant benefit for patients receiving nerve-sparing versus non-nerve-sparing procedures. Patient satisfaction with and choice of the same treatment varied according to function and current disease status. Patients who had incontinence or bowel dysfunction or had evidence of recurrent disease were statistically less likely to choose the same treatment again when compared with functional and disease-free counterparts. Because irradiated patients were on average 6 years older than surgical patients, responses were adjusted for age; adjustment for age did not alter results. CONCLUSIONS: QOL is determined by the treatment received, by the assessment source, and by the patient's function and disease status at the time of assessment. Prospective and longitudinal studies will more accurately quantify immediate and chronic alterations in QOL. Uniformity of evaluation through consolidation of QOL instruments will permit more accurate cross-series and cross-treatment comparisons.","Urology, 54(3): 509-516","USA",1999,"Local","Surgery,Radiotherapy","Unclear","HCP,Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"General,Complication"]
[445,"McGovern, P. M., et al. (2004). \"False-positive cancer screens and health-related quality of life.\" Cancer Nurs 27(5): 347-352.",null,"McGovern, P. M., et al.","False-positive cancer screens and health-related quality of life","By design, screening tests are imperfect-unresponsive to some cancers (false negatives) while occasionally raising suspicion of cancer where none exists (false positives). This pilot study describes patients' responses to having a false-positive screening test for cancer, and identifies screening effects on health-related quality of life (HRQoL). The pilot findings suggest issues important for incorporation in future evaluations of the impact of screening for prostate, lung, colon, or ovarian (PLCO) cancers. Seven focus groups were conducted to identify the nature and meaning of all phases of PLCO screening. Minnesota participants in the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial who had completed screening, with at least 1 false-positive screen, participated (N = 47). Participants' reactions to abnormal screens and diagnostic work-ups were primarily emotional (eg, anxiety and distress), not physical, and ultimately positive for the majority. Health distress and fear of cancer and death were the major negative aspects of HRQoL identified. These concepts are not typically included in generic HRQoL questionnaires like the SF-36, but are highly relevant to PLCO screening. Clinicians were regarded as underestimating the discomfort of follow-up diagnostic testing. However, relief and assurance appeared to eventually outweigh the negative emotions for most participants. Implications for oncology nurses include the need to consider the emotional consequences of screening in association with screen reliability and validity.","Cancer Nurs, 27(5): 347-352","USA",2004,"At risk","Screening","Interview","General population",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Views"]
[446,"McNaughton-Collins, M., et al. (2004). \"Health-related quality of life, satisfaction, and economic outcome measures in studies of prostate cancer screening and treatment, 1990-2000.\" J Natl Cancer Inst Monogr (33): 78-101.",null,"McNaughton-Collins, M., et al.","Health-related quality of life, satisfaction, and economic outcome measures in studies of prostate cancer screening and treatment, 1990-2000","Prostate cancer outcomes research incorporates a broad spectrum of endpoints, from clinical or intermediate endpoints, such as tumor shrinkage or patient compliance, to final endpoints, such as survival or disease-free survival. Three types of nontraditional endpoints that are of growing interest-health-related quality of life (QOL), satisfaction with care, and economic cost impact-hold the promise of improving our ability to understand the full burden of prostate cancer screening and treatment. In this article we review the last decade's published literature regarding the health-related QOL, satisfaction, and economic outcomes of prostate cancer screening and treatment to determine the \"state of the science\" of outcomes measurement. The focus is the enumeration of the types of outcome measurement used in the studies not the determination of the results of the studies. Studies were identified by searching Medline (1990-2000). Articles were included if they presented original data on any patient-centered outcome (including costs or survival alone) for men screened and treated for prostate cancer. Review papers were excluded unless they were quantitative syntheses of the results of other primary studies. Economic and decision analytic papers were included if they presented information on outcomes of real or hypothetical patient cohorts. Each retrieved article was reviewed by one of the authors. Included papers were assigned one primary, mutually exclusive study design. For the \"primary data\" studies, information was abstracted on care setting, dates of the study, sample size, racial distribution, age, tumor differentiation, tumor stage, survival, statistical power, and types of outcomes measures (QOL-generic, QOL-cancer specific, QOL-prostate cancer specific, satisfaction, costs, utilities, and other). For the \"economic and decision analytic\" papers, information was abstracted on stage of disease, age range, outcomes, costs, and whether utilities were measured. Of the 198 included papers, there were 161 primary data papers categorized as follows: randomized trial (n = 28), nonrandomized trial (n = 13), prospective or retrospective cohort study (n = 55), case-control study (n = 0), cross-sectional study (n = 63), and meta-analysis (n = 2). The remaining 37 papers were economic and decision analytic papers. Among the 149 primary data papers that contained patient outcome data, there were 42 standard instruments used, accounting for 44% (179 of 410) of the measures overall. Almost three-quarters (71%) of papers included one, two, or three outcomes measures of all types (standard and nonstandard); three papers included seven outcomes measures, and one paper included nine. Over the 11-year time period, there was a nonstatistically significant trend toward more frequent use of standardized QOL instruments and a statistically significant trend toward increased reporting of race (P = .003). Standardization of measurement of health-related QOL, satisfaction with care, and economic cost effect among men screened and treated for prostate cancer is needed. A core set of similar questions, both generic and disease-specific, should ideally be asked in every study, although investigators should be encouraged to include additional question sets as appropriate to individual studies to get a more complete picture of how patients screened and treated for this condition are doing over time.","J Natl Cancer Inst Monogr, 33): 78-101","International",2004,"At risk,Any or unknown","Screening,Unclear","Unclear","General population,Patient",null,"Systematic review",null,null,null,null,null,null,null,null,"General"]
[447,"McNaughton-Collins, M., et al. (2004). \"Psychological effects of a suspicious prostate cancer screening test followed by a benign biopsy result.\" Am J Med 117(10): 719-725.",null,"McNaughton-Collins, M., et al.","Psychological effects of a suspicious prostate cancer screening test followed by a benign biopsy result","PURPOSE: To evaluate the psychological implications of an apparently false-positive screening result for prostate cancer. METHODS: The sample comprised 167 men with a benign biopsy result in response to a suspicious screening test result (biopsy group) and 233 men with a normal prostate-specific antigen (PSA) test result (control group). The men responded to a questionnaire within about 6 weeks of their biopsy or PSA results. They were asked about demographic characteristics, medical history, psychological effects, biopsy experience, and prostate cancer knowledge. RESULTS: The survey response rate was 85% (400/471). The mean (+/- SD) age of respondents was 60 +/- 9 years (range, 40 to 88 years); 88% (n = 350) were white. Forty-nine percent (81/167) of men in the biopsy group reported having thought about prostate cancer either \"a lot\" or \"some of the time\", compared with 18% (42/230) in the control group (P < 0.001). In addition, 40% (67/167) in the biopsy group reported having worried \"a lot\" or \"some of the time\" that they may develop prostate cancer, compared with 8% (18/231) in the control group (P < 0.001). CONCLUSION: Men who underwent prostate biopsy more often reported having thought and worried about prostate cancer, despite having received a benign result. This underrecognized human cost of screening should be considered in the debate about the benefits and harms of prostate cancer screening.","Am J Med, 117(10): 719-725","USA",2004,"At risk","Screening","Unclear","General population",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Knowledge,Views"]
[448,"Melmed, G. Y., et al. (2002). \"Quality of life at the end of life: trends in patients with metastatic prostate cancer.\" Urology 59(1): 103-109.",null,"Melmed, G. Y., et al.","Quality of life at the end of life: trends in patients with metastatic prostate cancer","OBJECTIVES: To identify the rates of decline in health-related quality of life during the year before death in men with prostate cancer. METHODS: We studied men in a subset analysis within a longitudinal, observational cohort of patients with metastatic prostate cancer at the University of California, Los Angeles, Center for Health Sciences. The analysis included 23 patients who died and had submitted at least two health-related quality-of-life surveys in the final months before death. The outcomes were measured with the RAND 36-Item Health Survey, an established, validated instrument that includes physical and emotional domains. To gauge the effect of marital status, education, and income, we dichotomized these demographic variables. RESULTS: Most domains showed declines, many of them substantial. Patients who had a slower rate of decline in the physical domains tended to be married, better educated, and more affluent. We noted a trend toward a slower deterioration in the mental composite scores among patients who had less than a college degree and an annual household income of $30,000 or less. CONCLUSIONS: Patients dying of metastatic prostate cancer appear to experience declines in health-related quality of life during their final year of life. Further investigation may help identify specific patient characteristics associated with more rapid declines; this will help focus attention on enhancing patients' quality of life as death approaches.","Urology, 59(1): 103-109","USA",2002,"End of life","None","SF-36","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Utility"]
[449,"Menon, M., et al. (2005). \"Laparoscopic radical prostatectomy: conventional and robotic.\" Urology 66(5 Suppl): 101-104.",null,"Menon, M., et al.","Laparoscopic radical prostatectomy: conventional and robotic","By 2015, prostate cancer will become the most commonly diagnosed cancer in men. Radical prostatectomy reduces disease-specific mortality in patients with localized prostate cancer; however, the invasiveness of surgery and its resultant side effects cause many men to seek other treatments. In 2000, laparoscopic radical prostatectomy emerged as a minimally invasive alternative to open surgery; it has been refined recently by the addition of robotic technology. To examine the outcomes of robotic radical prostatectomy and compare them with those from open and conventional laparoscopic radical prostatectomy, we prospectively collected baseline demographic data on all patients undergoing surgery for prostate cancer over a 4-year period at our center. Urinary function and sexual function were evaluated using standardized criteria as well as a questionnaire preoperatively and at 1, 3, 6, 12, and 18 months after their procedure. Operative and postoperative outcomes were compared using values for open radical prostatectomy as the reference standard. A total of 100 men underwent open radical prostatectomy with conventional laparoscopic radical prostatectomy (n = 50) and robotic radical prostatectomy (n = 500). The odds ratios for operative times, blood loss, postoperative pain, complications, and median times to urinary continence and resumption of sexual activity all were lower for robotic than for open or laparoscopic radical prostatectomy. It appears safe to conclude that conventional laparoscopic radical prostatectomy is a reasonable alternative to open radical prostatectomy in the surgical treatment of patients with clinically localized prostate cancer. The incorporation of robotics may result in even better surgical outcomes than conventional laparoscopy. However, the surgical robot is expensive; few centers have access to the technology and even fewer have expertise in the technique. For robotic radical prostatectomy to become the standard of care for the treatment of localized prostate cancer will require economies of cost, dissemination of surgical expertise, and data from randomized trials.","Urology, 66(5 Suppl): 101-104","USA",2005,"Local","Surgery","Unclear","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Complication"]
[450,"Merrick, G. S., et al. (2000). \"Rectal function following prostate brachytherapy.\" Int J Radiat Oncol Biol Phys 48(3): 667-674.",null,"Merrick, G. S., et al.","Rectal function following prostate brachytherapy","PURPOSE: Quality of life following therapeutic intervention for carcinoma of the prostate gland has not been well documented. In particular, a paucity of data has been published regarding bowel function following prostate brachytherapy. This study evaluated late bowel function in 209 consecutive prostate brachytherapy patients via a one-time questionnaire administered 16-55 months postimplant. MATERIALS AND METHODS: Two hundred nineteen consecutive patients underwent permanent prostate brachytherapy from April 1995 through February 1998 using either (125)I or (103)Pd for clinical T1c-T3a carcinoma of the prostate gland. Of the 219 patients, 7 had expired. Of the remaining 212 patients (median follow-up, 28 months), each patient was mailed a self-administered questionnaire (10 questions) with a prestamped return envelope; 209 (98.6%) surveys were returned. Clinical parameters evaluated for bowel dysfunction included patient age, diabetes, hypertension, history of tobacco consumption, clinical T-stage, elapsed time since implant, and prostate ultrasound volume. Treatment parameters included utilization of neoadjuvant hormonal manipulation, utilization of moderate dose external beam radiation therapy prior to implantation, choice of isotope ((125)I vs. (103)Pd), rectal dose (average, median and maximum doses), total implanted seed strength, values of the minimum dose received by 90% of the prostate gland (D(90)), and the percent prostate volume receiving 100%, 150%, and 200% of the prescribed minimum peripheral dose (V(100), V(150) and V(200), respectively). Because detailed baseline bowel function was not available for these patients, a cross-sectional survey was performed in which 30 newly diagnosed prostate cancer patients of comparable demographics served as controls. RESULTS: The total rectal function scores for the brachytherapy and control patients were 4.3 and 1.6, respectively, out of a total 27 points (p < 0.001). Of the evaluated clinical parameters, only the preimplant number of bowel movements per day were correlated with the total survey score (p < 0.01). None of the treatment parameters were significantly correlated with the total survey score. Despite the fact that implantation with (103)Pd resulted in lower radiation doses to the rectum, the choice of isotope was not predictive of bowel function scores. A trend toward increased rectal scores was noted for older patients, and a nonsignificant improvement in rectal survey scores was noted with elapsed time from implantation. Only 19.2% (40/208) of the treatment group reported a worsening of bowel function following implantation. Patient perception of overall rectal quality of life, however, was inversely related to the utilization of external beam radiation therapy (p = 0.034). CONCLUSION: To date, no severe changes in late bowel function have been noted following prostate brachytherapy. Although the survey scores indicate bowel function is worse after an implant, the minor changes are not significant enough to bother most individuals. Less than 20% of patients reported that their bowel function was worse following prostate brachytherapy.","Int J Radiat Oncol Biol Phys, 48(3): 667-674","USA",2000,"Local,Advanced","Brachytherapy","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Complication"]
[451,"Merrick, G. S., et al. (2002). \"Erectile function after permanent prostate brachytherapy.\" Int J Radiat Oncol Biol Phys 52(4): 893-902.",null,"Merrick, G. S., et al.","Erectile function after permanent prostate brachytherapy","PURPOSE: To determine the incidence of potency preservation after permanent prostate brachytherapy using a validated patient-administered questionnaire and to evaluate the effect of multiple clinical and treatment parameters on penile erectile function. MATERIALS AND METHODS: Four hundred twenty-five patients underwent permanent prostate brachytherapy from April 1995 to October 1999. Two hundred nine patients who were potent before brachytherapy and who at the time of the survey were not receiving hormonal therapy were mailed the specific erectile questions of the International Index of Erectile Function (IIEF) questionnaire with a self-addressed stamped envelope. The questionnaire consisted of 5 questions, with a maximal score of 25. Of the 209 patients, 181 (87%) completed and returned the questionnaire. The mean and median follow-up was 40.4 +/- 14.9 and 40.6 months, respectively (range 19-75). Preimplant erectile function was assigned using a three-tiered scoring system (2 = erections always or nearly always sufficient for vaginal penetration; 1 = erections sufficient for vaginal penetration but considered suboptimal; 0 = the inability to obtain erections and/or erections inadequate for vaginal penetration). Postimplant potency was defined as an IIEF score >/=11. The clinical parameters evaluated for erectile function included patient age, preimplant potency, clinical T-stage, pretreatment prostate-specific antigen level, Gleason score, elapsed time after implantation, hypertension, diabetes mellitus, and tobacco consumption. Treatment parameters included radiation dose to the prostate gland, use of hormonal manipulation, use of supplemental external beam radiotherapy (EBRT), choice of isotope, prostate volume, and planning volume. The efficacy of sildenafil citrate in brachytherapy-induced erectile dysfunction (ED) was also evaluated. RESULTS: Pretreatment erectile function scores of 2 and 1 were assigned to 125 and 56 patients, respectively. With a 6-year follow-up, 39% of patients maintained potency after prostate brachytherapy, with a plateau on the potency preservation curve. Postimplant preservation of potency (IIEF >/=11) correlated with preimplant erectile function (50.4% vs. 13.2% for preimplant scores of 2 and 1, respectively, p <0.001), patient age (57.4%, 38.2%, and 21.9% for patients <60, 60-69, and >/=70 years old, respectively, p <0.004), use of supplemental EBRT (52.0% vs. 26.4% for patients without and with EBRT, p <0.001), and a history of diabetes mellitus (41.4% vs. 0% for patients without and with diabetes, respectively, p = 0.017). In multivariate analysis, clinical stage, radiation dose to the prostate gland, hormonal manipulation, choice of isotope, history of hypertension, and tobacco consumption had no effect on the ultimate preservation of potency. Only the preimplant potency score, use of supplemental EBRT, and diabetes maintained statistical significance. Sixty-two patients used sildenafil, with 53 (85%) reporting a favorable response. When potent patients were grouped with the ED patients who used sildenafil, the 6-year actuarial rate of potency preservation was 92%. Including the 70 impotent patients who never used sildenafil, the actuarial 6-year rate of potency preservation with and without pharmacologic support was 54% and 39%, respectively. CONCLUSION: Our results suggest that brachytherapy-induced ED is more common than previously reported and may be the result of obtaining patient information by means of a validated quality-of-life instrument by mail and not by personal interview. In multivariate analysis, only pretreatment potency, supplemental EBRT, and diabetes maintained statistical significance. Most patients with brachytherapy-induced ED responded favorably to sildenafil. Although the 6-year actuarial incidence of potency preservation was 39%, 52% of patients not receiving supplemental EBRT maintained potency. In addition, with pharmacologic support, 92% of patients maintained potency.","Int J Radiat Oncol Biol Phys, 52(4): 893-902","USA",2002,"Any or unknown","Brachytherapy","IIEF-5","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Complication"]
[452,"Merrick, G. S., et al. (2002). \"The importance of radiation doses to the penile bulb vs. crura in the development of postbrachytherapy erectile dysfunction.\" Int J Radiat Oncol Biol Phys 54(4): 1055-1062.",null,"Merrick, G. S., et al.","The importance of radiation doses to the penile bulb vs. crura in the development of postbrachytherapy erectile dysfunction","PURPOSE: Recent studies have implicated the proximal penis as a potential site-specific structure for radiation-related erectile dysfunction (ED). In this study, we evaluated by means of a validated patient-administered questionnaire whether radiation doses to the bulb of the penis and/or the proximal corporeal bodies were predictive for the development of brachytherapy-induced ED. METHODS AND MATERIALS: Thirty patients who underwent permanent prostate brachytherapy between April 1995 and October 1999 and developed brachytherapy-induced ED were paired with 30 similar men who maintained potency after implantation. None of the 60 patients received supplemental external beam radiation therapy, either before or after implantation. Potency was assessed by patient self-administration of the specific erectile questions of the International Index of Erectile Function. The questionnaire consisted of 5 questions with a maximum score of 25. Postimplant potency was defined as an International Index of Erectile Function score > or =11. Mean and median follow-up was 48.3 +/- 14.4 months and 48.0 months, respectively (range: 26.6-79.3 months). The bulb of the penis and the proximal crura were outlined at 0.5-cm intervals on the Day 0 postimplant CT scan. The radiation dose distribution to the bulb of the penis and adjacent crura was defined in terms of the minimum dose delivered to 25%, 50%, 70%, 75%, 90%, and 95% of the bulb (D(25), D(50), D(70), D(75), D(90), and D(95)). RESULTS: The radiation dose delivered to the bulb of the penis and the proximal crura in men with brachytherapy-induced ED was statistically greater for all evaluated dosimetric parameters (D(25), D(50), D(70), D(75), D(90), and D(95)). Stepwise linear regression analysis indicated that penile bulb dose parameter D(50), the postimplant prostate CT volume, and patient age at implant were predictive of postimplant ED, whereas the crura dose D(25) approached statistical significance. Seventy-five percent of the impotent men had a bulb D(25) >60% of prescribed minimum peripheral dose (mPD), whereas 80% of potent men had a bulb D(25) < or =60% mPD. Using the D(50) bulb parameter, 70% of ED men had a dose >40% mPD, whereas 90% of potent men had a dose < or =40% mPD. Similar cut points for D(25) and D(50) crura doses were 40% and 28% mPD. The crura D(25) cut point was exceeded by 50% of the ED patients and only 7% of the potent patients. CONCLUSION: This is the first study to evaluate potency preservation and radiation doses to the proximal penis by means of a validated patient-administered quality-of-life instrument. Our data confirm prior reports that radiation doses to the proximal penis are predictive of brachytherapy-induced ED. In a stepwise linear regression analysis, the strongest predictors of potency preservation were bulb D(50), postimplant prostate CT volume, and patient age. With Day 0 dosimetric evaluation, the penile bulb D(50) and D(25) should be maintained below 40% and 60% mPD, respectively, whereas the crura D(50) and D(25) should be maintained below 40% and 28% mPD, respectively, to maximize posttreatment potency.","Int J Radiat Oncol Biol Phys, 54(4): 1055-1062","USA",2002,"Any or unknown","Brachytherapy","IIEF-5","Patient",null,"Case-control",null,null,null,null,null,null,null,null,"Complication"]
[453,"Merrick, G. S., et al. (2003). \"Long-term urinary quality of life after permanent prostate brachytherapy.\" Int J Radiat Oncol Biol Phys 56(2): 454-461.",null,"Merrick, G. S., et al.","Long-term urinary quality of life after permanent prostate brachytherapy","PURPOSE: To evaluate late urinary function after permanent prostate brachytherapy using a validated, patient-administered quality-of-life instrument. METHODS AND MATERIALS: A total of 225 consecutive patients underwent prostate brachytherapy between April 1995 and March 1998. Of the 225 patients, 17 had died and 3 had been institutionalized secondary to Alzheimer's disease. Of the remaining 205 patients, each was mailed a self-administered questionnaire (the urinary function component of the Expanded Prostate Cancer Index [EPIC] and the International Prostate Symptom Score [IPSS]). Of the 205 surveys mailed, 195 (95.1%) were returned. The mean and median follow-up was 66.3 and 64.0 months, respectively. The clinical parameters evaluated included age, pretreatment prostate-specific antigen level, Gleason score, stage, risk group, prostate volume, presence of diabetes and hypertension, and tobacco consumption. The treatment parameters included the ultrasound planning volume, hormonal status, use of supplemental external beam radiotherapy, isotope, and follow-up. The dosimetric parameters included values of the minimal dose received by 90% of the prostate gland and the percentage of prostate volume receiving 100%, 150%, and 200% of the prescribed minimal peripheral dose. Because detailed baseline urinary function was not available, a cross-sectional survey was performed in which 51 newly diagnosed prostate cancer patients of comparable demographics served as controls. RESULTS: When the survey scores for the implant patients were compared with the control group, no significant differences in either the IPSS or function, bother, incontinence, or irritation/obstruction subscales of the urinary EPIC were discernible. In addition, no significant difference was observed between the implant and control groups when the EPIC and IPSS surveys were evaluated by each individual question. Of all the evaluated parameters, the use of tobacco was the best predictive variable for diminished quality of life. CONCLUSION: No significant difference was noted in the overall long-term urinary quality of life when brachytherapy patients were compared with a group of newly diagnosed prostate cancer patients of comparable demographics. Of all parameters evaluated, tobacco consumption was the single strongest predictor of late urinary function.","Int J Radiat Oncol Biol Phys, 56(2): 454-461","USA",2003,"Any or unknown","Brachytherapy","EPIC,IPSS","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Disease"]
[454,"Merrick, G. S., et al. (2004). \"Effect of transurethral resection on urinary quality of life after permanent prostate brachytherapy.\" Int J Radiat Oncol Biol Phys 58(1): 81-88.",null,"Merrick, G. S., et al.","Effect of transurethral resection on urinary quality of life after permanent prostate brachytherapy","PURPOSE: To determine the effect of transurethral resection on urinary function after permanent prostate brachytherapy using a validated, patient-administered, quality-of-life (QOL) instrument. METHODS AND MATERIALS: Twenty-seven consecutive brachytherapy patients with clinical T1b-T2b (1997 American Joint Commission on Cancer) prostate cancer and a history of either preimplant or postimplant transurethral resection of the prostate (TURP) were evaluated. Of the 27 patients, 1 continued to be catheter dependent and was excluded from analysis. Of the remaining 26 patients, each was mailed the urinary function component of the Expanded Prostate Cancer Index (EPIC) and the International Prostate Symptom Score (IPSS). Twenty-six surveys (100%) were returned. The mean and median follow-up was 44.8 and 39.8 months, respectively. The clinical, treatment, and dosimetric parameters evaluated included age, pretreatment prostate-specific antigen level, Gleason score, stage, risk group, prostate volume, presence of diabetes and hypertension, tobacco consumption, number of TURPs, number of grams resected, ultrasound planning volume, hormonal status, supplemental external beam radiotherapy, isotope, follow-up (in months), minimal dose received by 90% of the prostate gland, percentage of prostate volume receiving 100%, 150%, and 200% of the prescribed minimal peripheral dose, and the average and maximal urethral dose. Because baseline IPSSs, but not EPIC scores, were available, a cross-sectional survey was performed in which 51 newly diagnosed prostate cancer patients yet to receive any therapeutic intervention and 195 non-TURP brachytherapy patients served as controls. RESULTS: For all evaluated parameters, superior urinary scores were noted in the preimplant TURP group, with intermediate scores in the postimplant TURP patients and poor urinary QOL scores in the pre- and postimplant TURP patients. With time, the EPIC scores improved in the pre- and postimplant TURP cohorts. In multivariate linear regression analysis of the EPIC urinary summary score, the number of TURPs and supplemental external beam radiotherapy were the strongest predictors for diminished QOL. CONCLUSION: TURP results in diminished urinary QOL after brachytherapy. However, patients who underwent preimplant TURP had urinary QOL approaching that of non-TURP brachytherapy patients. Significant urinary dysfunction was noted in approximately one-half of patients who underwent postimplant TURP (especially pre- and postimplant TURP). Because most patients with brachytherapy-related urinary obstruction will eventually spontaneously void, TURP should be approached with extreme caution and only after substantial time has transpired.","Int J Radiat Oncol Biol Phys, 58(1): 81-88","USA",2004,"Local","Brachytherapy","EPIC,IPSS","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Disease"]
[455,"Merrick, G. S., et al. (2004). \"Influence of hormonal therapy on late rectal function after permanent prostate brachytherapy with or without supplemental external beam radiotherapy.\" Int J Radiat Oncol Biol Phys 58(1): 68-74.",null,"Merrick, G. S., et al.","Influence of hormonal therapy on late rectal function after permanent prostate brachytherapy with or without supplemental external beam radiotherapy","PURPOSE: Recent clinical studies have reported a relationship between the use of hormonal therapy and degradation in rectal function after external beam radiotherapy. Using a patient-administered quality-of-life instrument, we evaluated the effect of hormonal therapy on late rectal function after permanent prostate brachytherapy with or without supplemental external beam radiotherapy. METHODS AND MATERIALS: A total of 189 patients were mailed the Rectal Function Assessment Score (R-FAS), which consists of nine questions (score range 0-27, with higher scores indicative of poorer bowel function). Of the 189 surveys sent out, 187 (98.4%) were returned. Of the 187 patients, 149 (79.7%) were hormone naive, and 38 (20.3%) had received hormonal manipulation (median duration 4 months, range 3-36). The median follow-up for the entire group was 66.3 months. The effect of hormonal therapy on bowel function was evaluated by comparing the R-FAS scores across time, by each of the individual nine questions, and by means of a summary question evaluating the patient's perception of overall bowel function. The two groups were also evaluated in terms of clinical, treatment, and dosimetric parameters, including follow-up, age, Gleason score, clinical stage, pretreatment prostate-specific antigen level, number of pretreatment bowel movements/d, prostate volume, and rectal dosimetry. RESULTS: The two groups were well matched in all clinical, treatment, and dosimetric parameters, except the patients receiving hormonal therapy had a statistically shorter follow-up (63.9 vs. 69.4 months, p <0.001) and higher pretreatment prostate-specific antigen level (12.0 vs. 9.8 ng/mL, p = 0.024). The R-FAS scores for the hormone-naive and hormonally manipulated patients were comparable (3.76 vs. 4.55, p = 0.083). In terms of the nine individual R-FAS questions, no statistically significant difference was reported for any question when stratified by hormonal status, including rectal bleeding (p = 0.735). Only 12% and 13% of hormone-naive and hormonally manipulated patients, respectively, reported bowel function to be worse after implantation. With time, a trend for improvement in the R-FAS was noted in both cohorts. CONCLUSION: After permanent prostate brachytherapy, no statistically significant difference in bowel habits was discerned when stratified by hormonal status. In addition, only 12% of brachytherapy patients reported deterioration in bowel function after implantation.","Int J Radiat Oncol Biol Phys, 58(1): 68-74","USA",2004,"Any or unknown","Radiotherapy,Hormonal,Brachytherapy","R-FAS","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Complication"]
[456,"Metz, J. M., et al. (2003). \"A multi-institutional study of Internet utilization by radiation oncology patients.\" Int J Radiat Oncol Biol Phys 56(4): 1201-1205.",null,"Metz, J. M., et al.","A multi-institutional study of Internet utilization by radiation oncology patients","PURPOSE: Studies describing the use of the Internet by radiation oncology patients are lacking. This multi-institutional study of cancer patients presenting to academic (AC), community (CO), and veterans (VA) radiation oncology centers was designed to analyze the use of the Internet, demographic factors related to utilization, and barriers to access to the Internet. METHODS AND MATERIALS: A questionnaire evaluating the use of the Internet was administered to 921 consecutive patients presenting to radiation oncology centers at AC, CO, and VA medical centers. The study included 436 AC patients (47%), 284 CO patients (31%), and 201 VA patients (22%). A computer was available at home to 427 patients (46%), and 337 patients (37%) had E-mail access. The mean age of the patient population was 64 (range = 14-93). Males represented 70% of the patient population. The most common diagnoses included prostate cancer (33%), breast cancer (13%), and lung cancer (11%). RESULTS: Overall, 265/921 patients (29%) were using the Internet to find cancer-related information. The Internet was used by 42% of AC patients, 25% of CO patients, and only 5% of VA patients (p < 0.0001). A computer was available at home in 62% AC vs. 45% CO vs. 12% VA patients (p < 0.0001). Patients < 60 years were much more likely to use the Internet than older patients (p < 0.0001). Most of the Internet users considered the information either very reliable (22%) or somewhat reliable (70%). Unconventional medical therapies were purchased over the Internet by 12% of computer users. CONCLUSIONS: A significant number of cancer patients seen in radiation oncology departments at academic and community medical centers utilize the Internet to obtain information about cancer. Radiation oncologists must familiarize themselves with this resource because of the large number of patients using the Internet. Veterans lack the computerized access to this information and are thus underserved by this important resource.","Int J Radiat Oncol Biol Phys, 56(4): 1201-1205","USA",2003,"Any or unknown","Radiotherapy","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Knowledge,Views"]
[457,"Meulenbeld, H. J., et al. (2012). \"Randomised phase II/III study of docetaxel with or without risedronate in patients with metastatic Castration Resistant Prostate Cancer (CRPC), the Netherlands Prostate Study (NePro).\" Eur J Cancer 48(16): 2993-3000.",null,"Meulenbeld, H. J., et al.","Randomised phase II/III study of docetaxel with or without risedronate in patients with metastatic Castration Resistant Prostate Cancer (CRPC), the Netherlands Prostate Study (NePro)","BACKGROUND: This multicentre, randomised, open label, phase II/III study aimed to investigate the potential benefit of adding risedronate (R) to docetaxel (D) in patients with metastatic Castration Resistant Prostate Cancer (CRPC). PATIENTS AND METHODS: CRPC patients with bone metastasis were randomly assigned to receive D 75 mg/m(2) every 3 weeks and prednisone as first line chemotherapy, with or without R 30 mg oral once daily. The primary end-point was time to progression (TTP). A composite end-point of objective progression by RECIST criteria, PSA progression, or pain progression, whichever occurred first, was applied. The study had 80% power to detect an improvement of 30% in median TTP in the DR group (two-sided alpha=0.05). RESULTS: Five hundred and ninety-two men (301 D versus 291 DR) were randomised. TTP was 7.4 [D] versus 6.5 [DR] months (p=0.75). PSA and pain response rates were similar, 66.3% [D] versus 65.9% [DR] and 27.9% [D] versus 31.2% [DR], respectively. Median overall survival (OS) was 18.4 [D] versus 19.2 [DR] months (p=0.33). There were no differences in toxicity. CONCLUSION: The addition of the third generation bisphosphonate, risedronate, in the setting of effective first line docetaxel based chemotherapy did not increase efficacy, as indicated by the lack of improvement in TTP, OS, PSA- and pain response.","Eur J Cancer, 48(16): 2993-3000","Netherlands",2012,"Metastatic","Taxane,Bisphosphonate","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Symptom"]
[458,"Meyer, J. P., et al. (2003). \"The effect of erectile dysfunction on the quality of life of men after radical prostatectomy.\" BJU Int 92(9): 929-931.",null,"Meyer, J. P., et al.","The effect of erectile dysfunction on the quality of life of men after radical prostatectomy","OBJECTIVE: To report on the first use of a quality-of-life (QoL) measure specific for erectile dysfunction (ED), the 'ED effect on QoL' (ED-EQoL), to assess the effect of ED on QoL after radical prostatectomy (RP). PATIENTS AND METHODS: We retrospectively identified 89 patients who had undergone RP at one institution. Each was sent the ED-EQoL and a second questionnaire asking whether they had been counselled before RP about possible ED afterward. RESULTS: The response rate was 91% and the median time since RP 92 months; 76% of those who were potent before RP were impotent afterward. The overall results showed that the QoL of 72% of patients was moderately or severely affected. For each question, on average a third of the patients reported that their QoL was affected either 'quite a lot' or 'a great deal'. CONCLUSIONS: This study shows that ED after RP has a profound effect on QoL; it is therefore important when assessing ED to use an ED-specific QoL questionnaire such as the ED-EQoL to measure the psychosocial effect of ED, in addition to using an instrument such as the International Index of Erectile Function to measure the functional aspects of ED.","BJU Int, 92(9): 929-931","UK",2003,"Any or unknown","Surgery","ED-EQoL","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Complication"]
[459,"Miles, B. J., et al. (1999). \"Recall and attitudes in patients with prostate cancer.\" Urology 53(1): 169-174.",null,"Miles, B. J., et al.","Recall and attitudes in patients with prostate cancer","OBJECTIVES: To assess the ability of men with adenocarcinoma of the prostate to recall aspects of testing leading to their diagnosis, recall of the informed consent process, and their satisfaction with treatment and that treatment's impact on their lives. METHODS: A Gallup Organization telephone survey of a national sample of 421 men with known prostate cancer randomly selected from a pool of men identified during \"National Prostate Cancer Awareness Week\" was performed from November 1995 to January 1996. Men were queried about diagnostic tests performed to make the diagnosis of prostate cancer, reasons for being \"tested,\" sources of importance in helping men make an informed treatment decision, informed consent discussions, treatment satisfaction, treatment-related quality of life, and the quality of ongoing physicians' care. RESULTS: Patients' recall of procedures performed to diagnose prostate cancer is poor; less than 20% remember having a \"biopsy.\" More than 80% depended entirely on their attending urologist for informed consent and education about prostate cancer management. Forty percent sustained a complication as a result of their treatment, primarily impacting their sexual or urinary function. Ongoing follow-up care provided by physicians was reported as poor in the management of sexual or urinary problems by 50% and 33% of patients, respectively. CONCLUSIONS: Patients are generally satisfied with the care process for prostate cancer. However, the lack of patient recall for diagnostic procedures makes the adequacy of the current informed consent process questionable and suggests the need for increased efforts at improving patient education.","Urology, 53(1): 169-174","USA",1999,"Any or unknown","None","Interview","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Views"]
[460,"Miller, J., et al. (2007). \"Prospective evaluation of short-term impact and recovery of health related quality of life in men undergoing robotic assisted laparoscopic radical prostatectomy versus open radical prostatectomy.\" J Urol 178(3 Pt 1): 854-858; discussion 859.",null,"Miller, J., et al.","Prospective evaluation of short-term impact and recovery of health related quality of life in men undergoing robotic assisted laparoscopic radical prostatectomy versus open radical prostatectomy","PURPOSE: In the last few years there have been increasing claims that robotic assisted laparoscopic radical prostatectomy decreases short-term morbidity in patients undergoing surgical treatment for prostate cancer. However, there is surprisingly little objective evidence to support this point, which is often used to market the procedure to patients. To address this issue we prospectively evaluated patients undergoing open and robotic assisted laparoscopic radical prostatectomy at baseline and weekly through the postoperative period using a validated questionnaire. MATERIALS AND METHODS: A total of 162 men undergoing radical prostatectomy, including open radical prostatectomy in 120 and robotic assisted laparoscopic radical prostatectomy in 42, for clinically localized prostate cancer completed the SF-12, version 2 Physical and Mental Health Survey Acute Form preoperatively and each week postoperatively for 6 weeks. Physical and Mental Component Scores were calculated from the questionnaires at each time point. Comparisons between the 2 surgical approaches were made at each time point. RESULTS: No significant differences were seen between the open and robotic assisted laparoscopic radical prostatectomy groups with regard to patient age, clinical stage or preoperative prostate specific antigen. Mean surgical blood loss was significantly higher in the open group compared to that in the robotic assisted laparoscopic group. Physical Component Scores in the robotic assisted laparoscopic group were significantly higher than those in the open cohort beginning postoperative week 1 and extending through week 6. On statistical extrapolation Physical Component Scores returned to baseline between weeks 5 and 6 postoperatively in the robotic assisted laparoscopic group and between weeks 6 and 7 in the open group. Mental Component Score scores were not statistically different between the groups except preoperatively. CONCLUSIONS: This study helps prospectively define short-term health related quality of life in patients undergoing robotic assisted laparoscopic vs open radical prostatectomy. Higher physical scores were seen in the robotic assisted laparoscopic group than the open group beginning postoperative week 1 and continuing weekly throughout the 6-week study period. Physical Component Score scores returned to baseline sooner in the robotic assisted laparoscopic group than in the open group.","J Urol, 178(3 Pt 1): 854-858; discussion 859","USA",2007,"Local","Surgery","SF-12","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Utility"]
[461,"Miller, N. L., et al. (2003). \"Impact of a novel neoadjuvant and adjuvant hormone-deprivation approach on quality of life, voiding function, and sexual function after prostate brachytherapy.\" Cancer 97(5): 1203-1210.",null,"Miller, N. L., et al.","Impact of a novel neoadjuvant and adjuvant hormone-deprivation approach on quality of life, voiding function, and sexual function after prostate brachytherapy","BACKGROUND: Data demonstrate a benefit from neoadjuvant and adjuvant hormone-deprivation therapy with luteinizing hormone-releasing hormone agonists in patients who are treated with radiotherapy for localized prostate carcinoma; however, this approach has detrimental effects on quality of life (QOL). A cross-sectional study was undertaken to evaluate the impact on QOL, voiding function, and sexual function of an alternative hormone-deprivation approach. METHODS: Three hundred fifty patients with clinical T1c-T2b prostate carcinoma were treated from March 1997 to August 2000 either with palladium 103 brachytherapy (BTM) without hormone therapy or with 8 months of adjuvant and neoadjuvant hormone-deprivation therapy with an antiandrogen and finasteride (BTM+H), were mailed the Functional Assessment of Cancer Therapy (FACT) global well being QOL instrument (FACT-G), the American Urological Association symptom score (AUASS), and specific items addressing urinary control and sexual function from validated instruments. Differences between treatment groups were assessed as a function of time since treatment. RESULTS: Seventy-two percent of patients responded to the questionnaire. No differences in overall FACT-G scores, AUASS scores, or AUASS subscale scores between the BTM group and the BTM+H group were found. The BTM+H group initially had lower personal well being FACT-G subscale scores, more urinary incontinence, and lower odds of attaining an erection sufficient for intercourse initially, although these differences disappeared with longer follow-up. CONCLUSIONS: The use of neoadjuvant and adjuvant antiandrogen and finasteride with brachytherapy is associated with QOL equal to that of brachytherapy alone for the treatment of patients with localized prostate carcinoma, allowing the advantages of hormone manipulation in terms of tumor control without its downside.","Cancer, 97(5): 1203-1210","USA",2003,"Local","Brachytherapy,Hormonal","FACT-G,AUA-SI","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"General,Symptom"]
[462,"Mishra, S. I., et al. (2012). \"Exercise interventions on health-related quality of life for people with cancer during active treatment.\" Cochrane Database Syst Rev 8: Cd008465.",null,"Mishra, S. I., et al.","Exercise interventions on health-related quality of life for people with cancer during active treatment","BACKGROUND: People with cancer undergoing active treatment experience numerous disease- and treatment-related adverse outcomes and poorer health-related quality of life (HRQoL). Exercise interventions are hypothesized to alleviate these adverse outcomes. HRQoL and its domains are important measures of cancer survivorship, both during and after the end of active treatment for cancer. OBJECTIVES: To evaluate the effectiveness of exercise on overall HRQoL outcomes and specific HRQoL domains among adults with cancer during active treatment. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed MEDLINE, EMBASE, CINAHL, PsycINFO, PEDRO, LILACS, SIGLE, SportDiscus, OTSeeker, Sociological Abstracts from inception to November 2011 with no language or date restrictions. We also searched citations through Web of Science and Scopus, PubMed's related article feature, and several websites. We reviewed reference lists of included trials and other reviews in the field. SELECTION CRITERIA: We included all randomized controlled trials (RCTs) and quasi-randomized controlled clinical trials (CCTs) comparing exercise interventions with usual care or other type of non-exercise comparison intervention to maintain or enhance, or both, overall HRQoL or at least one distinct domain of HRQoL. Included trials tested exercise interventions that were initiated when adults with cancer were undergoing active cancer treatment or were scheduled to initiate treatment. DATA COLLECTION AND ANALYSIS: Five paired review authors independently extracted information on characteristics of included trials, data on effects of the intervention, and assessed risk of bias based on predefined criteria. Where possible, we performed meta-analyses for HRQoL and HRQoL domains for the reported difference between baseline values and follow-up values using standardized mean differences (SMDs) and a random-effects model by length of follow-up. We also reported the SMD at follow-up between the exercise and control groups. Because investigators used many different HRQoL and HRQoL domain instruments and often more than one for the same domain, we selected the more commonly used instrument to include in the SMD meta-analyses. We also report the mean difference for each type of instrument separately. MAIN RESULTS: We included 56 trials with 4826 participants randomized to an exercise (n = 2286) or comparison (n = 1985) group. Cancer diagnoses in trial participants included breast, prostate, gynecologic, hematologic, and other. Thirty-six trials were conducted among participants who were currently undergoing active treatment for their cancer, 10 trials were conducted among participants both during and post active cancer treatment, and the remaining 10 trials were conducted among participants scheduled for active cancer treatment. Mode of exercise intervention differed across trials and included walking by itself or in combination with cycling, resistance training, or strength training; resistance training; strength training; cycling; yoga; or Qigong. HRQoL and its domains were assessed using a wide range of measures.The results suggest that exercise interventions compared with control interventions have a positive impact on overall HRQoL and certain HRQoL domains. Exercise interventions resulted in improvements in: HRQoL from baseline to 12 weeks' follow-up (SMD 0.33; 95% CI 0.12 to 0.55) or when comparing difference in follow-up scores at 12 weeks (SMD 0.47; 95% CI 0.16 to 0.79); physical functioning from baseline to 12 weeks' follow-up (SMD 0.69; 95% CI 0.16 to 1.22) or 6 months (SMD 0.28; 95% CI 0.00 to 0.55); or when comparing differences in follow-up scores at 12 weeks (SMD 0.28; 95% CI 0.11 to 0.45) or 6 months (SMD 0.29; 95% CI 0.07 to 0.50); role function from baseline to 12 weeks' follow-up (SMD 0.48; 95% CI 0.07 to 0.90) or when comparing differences in follow-up scores at 12 weeks (SMD 0.17; 95% CI 0.00 to 0.34) or 6 months (SMD 0.32; 95% CI 0.03 to 0.61); and, in social functioning at 12 weeks' follow-up (SMD 0.54; 95% CI 0.03 to 1.05) or when comparing differences in follow-up scores at both 12 weeks (SMD 0.16; 95% CI 0.04 to 0.27) and 6 months (SMD 0.24; 95% CI 0.03 to 0.44). Further, exercise interventions resulted in a decrease in fatigue from baseline to 12 weeks' follow-up (SMD -0.38; 95% CI -0.57 to -0.18) or when comparing difference in follow-up scores at follow-up of 12 weeks (SMD -0.73; 95% CI -1.14 to -0.31). Since there is consistency of findings on both types of measures (change scores and difference in follow-up scores) there is greater confidence in the robustness of these findings.When examining exercise effects by subgroups, exercise interventions had significantly greater reduction in anxiety for survivors with breast cancer than those with other types of cancer. Further, there was greater reduction in depression, fatigue, and sleep disturbances, and improvement in HRQoL, emotional wellbeing (EWB), physical functioning, and role function for cancer survivors diagnosed with cancers other than breast cancer but not for breast cancer. There were also greater improvements in HRQoL and physical functioning, and reduction in anxiety, fatigue, and sleep disturbances when prescribed a moderate or vigorous versus a mild exercise program.Results of the review need to be interpreted cautiously owing to the risk of bias. All the trials reviewed were at high risk for performance bias. In addition, the majority of trials were at high risk for detection, attrition, and selection bias. AUTHORS' CONCLUSIONS: This systematic review indicates that exercise may have beneficial effects at varying follow-up periods on HRQoL and certain HRQoL domains including physical functioning, role function, social functioning, and fatigue. Positive effects of exercise interventions are more pronounced with moderate- or vigorous-intensity versus mild-intensity exercise programs. The positive results must be interpreted cautiously because of the heterogeneity of exercise programs tested and measures used to assess HRQoL and HRQoL domains, and the risk of bias in many trials. Further research is required to investigate how to sustain positive effects of exercise over time and to determine essential attributes of exercise (mode, intensity, frequency, duration, timing) by cancer type and cancer treatment for optimal effects on HRQoL and its domains.","Cochrane Database Syst Rev, 8(Cd008465","International",2012,"Any or unknown","Various","Unclear","Patient",null,"Systematic review",null,null,null,null,null,null,null,null,"General"]
[463,"Miyake, H., et al. (2016). \"Prospective assessment of time-dependent changes in quality of life of Japanese patients with prostate cancer following robot-assisted radical prostatectomy.\" J Robot Surg 10(3): 201-207.",null,"Miyake, H., et al.","Prospective assessment of time-dependent changes in quality of life of Japanese patients with prostate cancer following robot-assisted radical prostatectomy","The objective of this study was to characterize changes in the quality of life (QOL) of Japanese patients following robot-assisted radical prostatectomy (RARP). This study included 298 consecutive localized prostate cancer (PC) patients undergoing RARP. The health-related QOL and disease-specific QOL were assessed using The Medical Outcomes Study 8-Item Short Form (SF-8) and The Extended Prostate Cancer Index Composite (EPIC), respectively, before and 1, 3, 6, 12 and 24 months after RARP. At 1 month after RARP, four (physical function, role limitations because of physical health problems, social function and role limitations because of emotional problems) of the eight scores in SF-8 were significantly impaired compared with those of baseline scores. However, all eight scores on all postoperative assessments, except for at 1 month after RARP, showed no significant differences from baseline scores. Although there were no significant differences in the bowel function, bowel bother, sexual bother, hormonal function or hormonal bother between baseline and postoperative assessments of EPIC at all time points, the urinary function, urinary incontinence and sexual function scores at 1, 3 and 6 months after RARP were significantly inferior to those of baseline scores, and urinary bother and urinary irritation/obstruction scores at 1 month after RARP were significantly impaired compared with those of baseline scores. These findings suggest that the health-related QOL of Japanese PC patients undergoing RARP may not be markedly deteriorated following RARP; however, as for the disease-specific QOL, urinary and sexual functions, particularly those early after RARP, appeared to be significantly impaired.","J Robot Surg, 10(3): 201-207","Japan",2016,"Local","Surgery","EPIC,SF-8","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease,Utility"]
[464,"Moinpour, C. M., et al. (1998). \"Quality of life in advanced prostate cancer: results of a randomized therapeutic trial.\" J Natl Cancer Inst 90(20): 1537-1544.",null,"Moinpour, C. M., et al.","Quality of life in advanced prostate cancer: results of a randomized therapeutic trial","BACKGROUND: For patients with metastatic prostate cancer, treatment is primarily palliative, relying mainly on the suppression of systemic androgen hormone levels. To help document the achievement of palliation and to characterize positive and negative effects of treatment, we evaluated quality-of-life (QOL) parameters in patients with metastatic prostate cancer who were randomly assigned to two methods of androgen deprivation. METHODS: Patients (n = 739) with stage M1 (bone or soft tissue metastasis) prostate cancer were enrolled in a QOL protocol that was a companion to Southwest Oncology Group INT-0105, a randomized double-blind trial comparing treatment with bilateral orchiectomy (surgical castration) plus either flutamide or placebo. Patients completed a comprehensive battery of QOL questionnaires at random assignment to treatment and at 1, 3, and 6 months later. Data were collected on three treatment-specific symptoms (diarrhea, gas pain, and body image), on physical functioning, and on emotional functioning. All P values are two-sided. RESULTS: Questionnaire return rates for this study never dropped below 80%; only 2% of the patients did not submit baseline QOL assessments. Cross-sectional analyses (corrected for multiple testing) identified statistically significant differences that favored orchiectomy plus placebo for two of the five primary QOL parameters as follows: patients receiving flutamide reported more diarrhea at 3 months (P = .001) and worse emotional functioning at 3 and 6 months (both P<.003). Longitudinal analyses replicated these findings. Other analyzed QOL parameters favored the group receiving placebo but were not statistically significant after adjustment for multiple testing. CONCLUSIONS: We found a consistent pattern of better QOL outcomes at each follow-up assessment during the first 6 months of treatment for orchiectomized patients with metastatic prostate cancer who received placebo versus flutamide. Improvement over time was evident in both treatment groups but more so for patients receiving placebo.","J Natl Cancer Inst, 90(20): 1537-1544","USA",1998,"Metastatic","Hormonal,Surgery","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General,Symptom"]
[465,"Moinpour, C. M., et al. (2008). \"Health-related quality of life results in pathologic stage C prostate cancer from a Southwest Oncology Group trial comparing radical prostatectomy alone with radical prostatectomy plus radiation therapy.\" J Clin Oncol 26(1): 112-120.",null,"Moinpour, C. M., et al.","Health-related quality of life results in pathologic stage C prostate cancer from a Southwest Oncology Group trial comparing radical prostatectomy alone with radical prostatectomy plus radiation therapy","PURPOSE: To compare short- and long-term effects of adjuvant treatment versus observation after surgery on health-related quality of life (HRQL) of prostate cancer patients. PATIENTS AND METHODS: The Southwest Oncology Group (SWOG) intergroup trial compared radical prostatectomy (RP) plus observation versus RP plus adjuvant radiation therapy (RT). Two-hundred seventeen of 425 therapeutic trial patients were eligible and registered to the HRQL study. Patients completed the SWOG Quality of Life Questionnaire (emotional, physical, social, and role function; general symptom status; treatment/disease-specific symptoms; and global HRQL [GHRQL]) at baseline, 6 weeks, 6 months, and annually for 5 years. Prespecified outcomes were three genitourinary symptoms (bowel function tenderness, frequent urination, and erectile dysfunction [ED]) and measures of physical and emotional function. Adjustments were made for the baseline score. RESULTS: Patients receiving adjuvant RT reported worse bowel function (through approximately 2 years) and worse urinary function. There were no statistically significant differences for ED. GHRQL was initially worse for the RP+RT arm but improved over time and was better at the end of the period than the GHRQL reported for RP alone (treatment arm x time interaction, P = .0004). Symptom distress was significantly worse for the RP+RT arm compared with the RP alone arm, but the treatment arms did not differ with respect to other general measures of HRQL. CONCLUSION: The addition of RT to surgery resulted in more frequent urination, as well as early report of more bowel dysfunction, although bowel function differences disappeared over the 5-year period. The addition of RT did not negatively impact ED.","J Clin Oncol, 26(1): 112-120","USA",2008,"Advanced","Surgery,Radiotherapy","SWOG-QLQ","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General"]
[466,"Moinpour, C. M., et al. (2009). \"Chemotherapeutic impact on pain and global health-related quality of life in hormone-refractory prostate cancer: Dynamically Modified Outcomes (DYNAMO) analysis of a randomized controlled trial.\" Qual Life Res 18(2): 147-155.",null,"Moinpour, C. M., et al.","Chemotherapeutic impact on pain and global health-related quality of life in hormone-refractory prostate cancer: Dynamically Modified Outcomes (DYNAMO) analysis of a randomized controlled trial","PURPOSE: This paper applies the Dynamically Modified Outcomes (DYNAMO) model to a clinical trial of two chemotherapeutic regimens on global health-related quality of life (GHRQL) in hormone-refractory prostate cancer. METHODS: DYNAMO identifies the causal influences operating in a clinical trial and their mediation, moderation, and modulation by uncontrolled variables. The Southwest Oncology Group trial S9916 randomized assignment to mitoxantrone plus prednisone (M + P) versus docetaxel plus estramustine (D + E) treatments. In this application, we examine baseline-adjusted impacts of worst pain (McGill Pain Questionnaire) on GHRQL (EORTC Quality of Life Questionnaire-C30) at 10 weeks. RESULTS: The average treatment levels of pain did not differ, hence, the average mediated effect of treatment on GHRQL was zero. Nonetheless, M + P reduced the impact (the relational outcome) of pain on GHRQL by 54% relative to D + E. Individual variation in the relational outcome (modulation) was of the same magnitude as the average difference between the groups. Performance status moderated the direct effects of treatment, with D + E being more effective in good, but not poor, performance strata. CONCLUSIONS: The DYNAMO approach comprehensively accounted for treatment effects. Rather than a single average effect, there were three distinct treatment effects: one direct effect for each performance status level and a direct effect on the relationship between pain and GHRQL.","Qual Life Res, 18(2): 147-155","USA",2009,"Any or unknown","Taxane,Chemotherapy","EORTC QLQ-C30,MPQ","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General,Symptom"]
[467,"Moinpour, C. M., et al. (2000). \"Profile of men randomized to the prostate cancer prevention trial: baseline health-related quality of life, urinary and sexual functioning, and health behaviors.\" J Clin Oncol 18(9): 1942-1953.",null,"Moinpour, C. M., et al.","Profile of men randomized to the prostate cancer prevention trial: baseline health-related quality of life, urinary and sexual functioning, and health behaviors","PURPOSE: To describe men who agreed to be randomized to the Prostate Cancer Prevention Trial (PCPT), a 7-year, double-blind placebo-controlled study of the efficacy of finasteride in preventing prostate cancer. METHODS: Comprehensive health-related quality-of-life data are presented for 18,882 randomized PCPT participants. RESULTS: PCPT participants are highly educated, middle to upper income, and primarily white (92%). Participants reported healthy lifestyles. The mean American Urological Association Symptom Index score was well below the maximum entry score of less than 19; existing urinary symptoms were generally not bothersome. The scores for two sexual functioning scales could range from 0 to 100, with higher scores reflecting worse sexual functioning. The mean score for the Sexual Problem Scale was 19.2 out of 100, and the mean Sexual Activities Scale was 44.1 out of 100. Scores for seven of the eight Medical Outcomes Study 36-item Short-Form Health Survey scales (higher scores are better) were 10 to 20 points higher than those reported by a general population sample and differed minimally by race but not by age. Previously reported associations between sexual dysfunction and hypertension, diabetes, and depression were also observed. Men who never smoked reported less sexual dysfunction than did those who either had quit or still smoked. CONCLUSION: Individuals who are likely to enroll in primary prevention trials have a high socioeconomic status, healthy lifestyle behaviors, and better health than the general population. These data help oncologists design chemoprevention trials with respect to the selection of health-related quality-of-life assessments and recruitment strategies.","J Clin Oncol, 18(9): 1942-1953","USA",2000,"At risk","Various","AUA-SI,SF-36","General population",null,"Clinical trial",null,null,null,null,null,null,null,null,"Symptom,Utility"]
[468,"Moinpour, C. M., et al. (2012). \"Health-related quality-of-life findings for the prostate cancer prevention trial.\" J Natl Cancer Inst 104(18): 1373-1385.",null,"Moinpour, C. M., et al.","Health-related quality-of-life findings for the prostate cancer prevention trial","BACKGROUND: The Prostate Cancer Prevention Trial (PCPT)-a randomized placebo-controlled study of the efficacy of finasteride in preventing prostate cancer-offered the opportunity to prospectively study effects of finasteride and other covariates on the health-related quality of life of participants in a multiyear trial. METHODS: We assessed three health-related quality-of-life domains (measured with the Health Survey Short Form-36: Physical Functioning, Mental Health, and Vitality scales) via questionnaires completed by PCPT participants at enrollment (3 months before randomization), at 6 months after randomization, and annually for 7 years. Covariate data obtained at enrollment from patient-completed questionnaires were included in our model. Mixed-effects model analyses and a cross-sectional presentation at three time points began at 6 months after randomization. All statistical tests were two-sided. RESULTS: For the physical function outcome (n = 16 077), neither the finasteride main effect nor the finasteride interaction with time were statistically significant. The effects of finasteride on physical function were minor and accounted for less than a 1-point difference over time in Physical Functioning scores (mixed-effect estimate = 0.07, 95% confidence interval [CI] = -0.28 to 0.42, P = .71). Comorbidities such as congestive heart failure (estimate = -5.64, 95% CI = -7.96 to -3.32, P < .001), leg pain (estimate = -2.57, 95% CI = -3.04 to -2.10, P < .001), and diabetes (estimate = -1.31, 95% CI = -2.04 to -0.57, P < .001) had statistically significant negative effects on physical function, as did current smoking (estimate = -2.34, 95% CI = -2.97 to -1.71, P < .001) and time on study (estimate = -1.20, 95% CI = -1.36 to -1.03, P < .001). Finasteride did not have a statistically significant effect on the other two dependent variables, mental health and vitality, either in the mixed-effects analyses or in the cross-sectional analysis at any of the three time points. CONCLUSION: Finasteride did not negatively affect SF-36 Physical Functioning, Mental Health, or Vitality scores.","J Natl Cancer Inst, 104(18): 1373-1385","USA",2012,"At risk","Various","SF-36","General population",null,"Clinical trial",null,null,null,null,null,null,null,null,"Utility"]
[469,"Mold, J. W., et al. (1998). \"Outcomes of an insurance company-sponsored multichannel chemistry screening initiative.\" J Fam Pract 47(2): 110-117.",null,"Mold, J. W., et al.","Outcomes of an insurance company-sponsored multichannel chemistry screening initiative","BACKGROUND: The use of serum chemistry panels as screening tests has been studied in a variety of clinical and nonclinical settings. None of the studies, however, has attempted to carefully examine any potential harm done to participants, and none has measured the impact on health-related quality of life. METHODS: Consenting participants in an insurance company-sponsored screening initiative completed a questionnaire before and 6 months after having blood drawn for a 25-item chemistry panel and a lipid profile; for men older than 50, a prostate-specific antigen (PSA) test was also done. The prescreening questionnaire included demographic and health information. The postscreening questionnaire included questions about specific outcomes. Included in both questionnaires were single-item measures of self-rated health and self-rated worry about health, and the 17-item Duke Health Profile (DUKE), a measure of health-related quality of life. Various outcomes were examined, including the numbers of new diagnoses, numbers and types of new treatment recommendations, change in self-reported health and worry, and change in DUKE subscale scores. Participants who were potentially helped and those who were potentially harmed by the serum chemistry panels screening program were identified and further characterized. RESULTS: Of the 2249 subjects who satisfactorily completed both questionnaires, 2012 (89%) had at least one abnormal test result, but only 985 of these (49%) remembered having discussed their test results with a physician. A total of 342 individuals received new treatment advice. However, 29 (10%) of them indicated that they would be \"somewhat unlikely\" to \"very unlikely\" to follow it. Following the intervention questionnaire, there were statistically significant average decrements in the General Health, Physical Health, and Pain subscales of the DUKE for participants with abnormal results. Self-rated health status did not change but level of worry about health increased significantly. At least 250 (11%) subjects were potentially helped by the screening initiative, but at least 574 (26%) were potentially harmed by it. CONCLUSIONS: The use of serum chemistry panels as screening tests in nonclinical settings should probably be discouraged, since health-related quality of life is not improved and the intervention may harm more individuals than it benefits.","J Fam Pract, 47(2): 110-117","USA",1998,"At risk","Screening","DUKE","General population",null,"Cohort",null,null,null,null,null,null,null,null,"General"]
[470,"Mols, F., et al. (2009). \"Health-related quality of life in I-125 prostate brachytherapy patients treated with and without volume-reducing hormone therapy: results of a short-term prospective study.\" J Endourol 23(1): 153-159.",null,"Mols, F., et al.","Health-related quality of life in I-125 prostate brachytherapy patients treated with and without volume-reducing hormone therapy: results of a short-term prospective study","PURPOSE: This study describes the differences in short-term effects of health-related quality of life (HRQOL) in I-125 prostate brachytherapy patients who were treated with and without volume-reducing hormone therapy. PATIENTS AND METHODS: Prostate cancer patients (N = 312) filled out questionnaires on HRQOL (European Organization of Research and Treatment of Cancer Quality of Life Questionnaire [EORTC-QLQ]-C30 and EORTC-QLQ-PR25) before treatment and 6 weeks and 3 months after treatment. HRQOL was compared between the two groups: Patients who were receiving brachytherapy (n = 233) and patients who were receiving brachytherapy with volume-reducing hormone therapy (n = 79). Duration of androgen ablation was 9 months, starting 3 months before I-125 implantation. RESULTS: After treatment, patients reported significant and clinically relevant decreased scores on the following subscales: Global health status, role functioning, social functioning, pain, insomnia, bowel symptoms and functioning, and treatment-related functions, regardless of the therapy they received. Results showed that prostate cancer patients receiving brachytherapy with volume-reducing hormone therapy also experienced lower treatment-related functions and lower sexual function. Significant time by treatment interaction effects were found for treatment-related functions. The subscale treatment-related functions was the only scale that showed a difference over time, between treatments, and time by treatment. CONCLUSIONS: The differences in HRQOL between brachytherapy and brachytherapy with volume-reducing hormone therapy are small; they both decrease HRQOL and increase treatment-related problems. A long-term prospective study on long-term effects on HRQOL is needed to obtain a more comprehensive view of the consequences of a specific treatment modality over time. Our results can help to identify the problems patients face after brachytherapy with or without hormone therapy; these problems deserve additional attention during the period of recovery.","J Endourol, 23(1): 153-159","Netherlands",2009,"Any or unknown","Brachytherapy,Hormonal","EORTC QLQ-C30,EORTC QLQ-PR25","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,General"]
[471,"Moore, M. J., et al. (1994). \"Use of palliative end points to evaluate the effects of mitoxantrone and low-dose prednisone in patients with hormonally resistant prostate cancer.\" J Clin Oncol 12(4): 689-694.",null,"Moore, M. J., et al.","Use of palliative end points to evaluate the effects of mitoxantrone and low-dose prednisone in patients with hormonally resistant prostate cancer","PURPOSE: This phase II study was designed to assess the effects of mitoxantrone with prednisone in patients with metastatic prostate cancer who had progressed on hormonal therapy. The methods of assessment included quality-of-life analyses, pain indices, analgesic scores, and the National Prostatic Cancer Project (NPCP) criteria. PATIENTS AND METHODS: Patients received mitoxantrone 12 mg/m2 intravenously every 3 weeks plus prednisone 10 mg orally daily. All had a castrate serum testosterone and Eastern Cooperation Oncology Group (ECOG) performance status < or = 3, and had not received prior chemotherapy. Every 3 weeks, analgesic intake was scored, and a present pain intensity (PPI) record and visual analog scale (VAS) describing pain were collected. Every 6 weeks, the European Organization for Research and Treatment of Cancer (EORTC) core quality-of-life questionnaire plus a prostate-specific module were completed. A palliative response was defined as a decrease in analgesic score by > or = 50% or a decrease in PPI by > or = two integers without any increase in the other. RESULTS: Twenty-seven patients were entered onto the study. Nine of 25 (36%) assessable patients achieved a palliative response maintained for > or = two cycles (range, two to eight or more). Improvements in mean PPI and VAS pain scores after each cycle of therapy (P < .05) were seen. Quality-of-life analysis showed improvements in social and emotional functioning, and in pain and anorexia. Using NPCP criteria, one patient achieved a partial response (PR) and 12 had stable disease; one of seven patients with measurable disease had a PR. No serious nonhematologic toxicity was experienced, and there were no episodes of febrile neutropenia. CONCLUSION: Mitoxantrone with low-dose prednisone is a well-tolerated treatment regimen that has some beneficial effects on disease-related symptoms and quality of life for patients with advanced prostate cancer.","J Clin Oncol, 12(4): 689-694","Canada",1994,"Metastatic","Chemotherapy","VAS,EORTC QLQ-C30,EORTC QLQ-PR25,MPQ","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General,Disease,Symptom"]
[472,"Morgan, M. S., et al. (2016). \"An Assessment of Patient Comfort and Morbidity After Robot-Assisted Radical Prostatectomy with Suprapubic Tube Versus Urethral Catheter Drainage.\" J Endourol 30(3): 300-305.",null,"Morgan, M. S., et al.","An Assessment of Patient Comfort and Morbidity After Robot-Assisted Radical Prostatectomy with Suprapubic Tube Versus Urethral Catheter Drainage","OBJECTIVE: Robot-assisted laparoscopic prostatectomy (RALP) with suprapubic tube (SPT), compared to urethral catheter (UC) drainage, has been proposed to improve patient comfort and recovery. We sought to compare short-term outcomes for pain and morbidity after RALP with SPT vs UC drainage. METHODS: Between August 2012 and 2014, 159 men underwent a RALP and prospectively completed a questionnaire addressing postoperative pain and satisfaction. Group 1 (n = 94) underwent a RALP by one surgeon who placed a UC and removed it between postoperative day (POD) 7 and 10. Group 2 (n = 65) underwent a RALP by a different surgeon who placed an SPT and UC. On POD 1, the UC was removed. On POD 9, the SPT was capped and removed on POD 11 if the patient was voiding adequately. Preoperative and intraoperative data, complications, questionnaires, and patient-reported morbidity, including unplanned telephone calls and emergency department (ED) visits, were compared between groups. RESULTS: Patient characteristics were similar between groups. One week after surgery, the penile pain score was statistically significantly lower in Group 2 compared to Group 1 (56.9% and 79.8%, respectively, reported minimal-to-moderate pain, p = 0.003). Bladder spasms and overall pain were not significantly higher for Group 1 compared to Group 2 (p > 0.05). When asked \"How big a problem has your urine storage device been?,\" 20.2% of patients in Group 1 reported it as a \"moderate-to-big\" problem compared to 10.8% in Group 2 (p > 0.05). The number of catheter-related unplanned telephone encounters did not differ between the two groups (p = 0.7), however, although not statistically significant, 4.6% of patients in Group 2 presented to the ED with catheter-related issues (p = 0.07). CONCLUSION: SPT after RALP was associated with less penile pain compared to UC drainage, and modestly better patient satisfaction. There were no significant differences in bladder spasms, overall pain, and patient-reported morbidity between groups.","J Endourol, 30(3): 300-305","USA",2016,"Any or unknown","Surgery","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Symptom,Satisfaction"]
[473,"Morton, G. C., et al. (2011). \"Health-related quality of life after single-fraction high-dose-rate brachytherapy and hypofractionated external beam radiotherapy for prostate cancer.\" Int J Radiat Oncol Biol Phys 80(5): 1299-1305.",null,"Morton, G. C., et al.","Health-related quality of life after single-fraction high-dose-rate brachytherapy and hypofractionated external beam radiotherapy for prostate cancer","PURPOSE: To investigate the change in health-related quality of life for men after high-dose-rate brachytherapy and external beam radiotherapy for prostate cancer and the factors associated with this change. METHODS AND MATERIALS: Eligible patients had clinically localized intermediate-risk prostate cancer. The patients received high-dose-rate brachytherapy as a single 15-Gy implant, followed by external beam radiotherapy to 37.5 Gy in 15 fractions. The patients were monitored prospectively for toxicity (Common Terminology Criteria for Adverse Events, version 3.0) and health-related quality of life (Expanded Prostate Cancer Index Composite [EPIC]). The proportion of patients developing a clinically significant difference in the EPIC domain score (minimally important difference of >0.5 standard deviation) was determined and correlated with the baseline clinical and dosimetric factors. The study accrued 125 patients, with a median follow-up of 24 months. RESULTS: By 24 months, 23% had Grade 2 urinary toxicity and only 5% had Grade 2 bowel toxicity, with no Grade 3 toxicity. The proportion of patients reporting a significant decrease in EPIC urinary, bowel, sexual, and hormonal domain scores was 53%, 51%, 45%, and 40% at 12 months and 57%, 65%, 51%, and 30% at 24 months, respectively. The proportion with a >1 standard deviation decrease in the EPIC urinary, bowel, sexual, and hormonal domain scores was 38%, 36%, 24%, and 20% at 12 months and 46%, 48%, 19%, and 8% at 24 months, respectively. On multivariate analysis, the dose to 10% of the urethra was associated with a decreasing EPIC urinary domain score (p = .0089) and, less strongly (p = .0312) with a decreasing hormonal domain score. No association was found between the prostate volume, bladder dose, or high-dose volume and urinary health-related quality of life. A high baseline International Index of Erectile Function score was associated (p = .0019) with a decreasing sexual domain score. The optimal maximal dose to 10% of the urethra cutpoint for urinary health-related quality of life was 120% of the prescription dose. CONCLUSION: EPIC was a more sensitive tool for detecting the effects on function and bother than were the generic toxicity scales. The urethral dose had the strongest association with a deteriorating urinary quality of life.","Int J Radiat Oncol Biol Phys, 80(5): 1299-1305","Canada",2011,"Local","Radiotherapy,Brachytherapy","EPIC,CTCAE","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease,Treatment"]
[474,"Mottet, N., et al. (1998). \"Artificial urinary sphincter AMS 800 for urinary incontinence after radical prostatectomy: the French experience.\" Urol Int 60 Suppl 2: 25-29; discussion 35.",null,"Mottet, N., et al.","Artificial urinary sphincter AMS 800 for urinary incontinence after radical prostatectomy: the French experience","Post-radical prostatectomy urinary incontinence (PRP-UI) has a major negative impact on the patient's quality of life with the incidence accounting for over 30% on a patient questionnaire basis. In 1995 the French Urological Association started a prospective survey to investigate the efficacy and safety of the AMS 800 artificial urinary sphincter (AUS) in PRP-UI, and preliminary results are presented for the 103 men enrolled in the study in whom bulbar urethral cuff placement was used exclusively. Surgical revision was necessary in 22 patients (21%). Infection and erosion accounted for 12 non-mechanical revisions leading to complete removal of 6 AUS and to eventual replacement of 6 devices with new ones. Mechanical malfunction accounted for revision in l0 patients (9.7%). Fifty-nine patients (61.45%) reported no leakage for the 96 working devices. Twenty-seven patients (28%) wore no pads, 3 patients used 1 pad and 4 patients used 2 pads/day, and all these patients reported improvement, with only 3 patients (3%) having had more than 2 pads/day. Currently, no non-prosthetic procedure reliably affords such good objective results. Insertion of the AMS 800 AUS no doubt represents an attractive treatment modality available for male urinary incontinence following radical prostatectomy.","Urol Int, 60 Suppl 2(25-29; discussion 35","France",1998,"Any or unknown","Various,Surgery","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Complication"]
[475,"Mottet, N., et al. (2012). \"Intermittent hormonal therapy in the treatment of metastatic prostate cancer: a randomized trial.\" BJU Int 110(9): 1262-1269.",null,"Mottet, N., et al.","Intermittent hormonal therapy in the treatment of metastatic prostate cancer: a randomized trial","Study Type - Therapy (RCT) Level of Evidence 1b. What's known on the subject? and What does the study add? Intermittent androgen deprivation therapy (ADT) involves cycling ADT, allowing hormonal recovery during off-treatment periods. This could lead to a better quality of life during off-treatment periods and could delay progression to castration resistance. Safety and feasibility of intermittent ADT have been shown but tolerability and health-related quality of life improvement have been suggested but questioned by others. Results from randomized trials, including relapsing or mixed populations, have suggested intermittent ADT to be as effective as continuous ADT. In this study of only metastatic patients, no statistical difference in either overall survival or progression-free survival was shown between intermittent and continuous ADT and suggests that intermittent might be as safe as continuous castration. It could be an option in highly responding and well-informed metastatic patients even if no clear benefit in health-related quality of life was shown. This intermittent modality could be of interest in metastatic patients with significant treatment-induced side-effects. OBJECTIVE: * To compare intermittent androgen deprivation therapy (ADT) and continuous ADT after 6 months of induction of ADT in patients with metastatic prostate cancer (PCa). PATIENTS AND METHODS: * This is an open-label randomized multi-centre study conducted in 58 centres in Europe. * Patients with metastatic PCa and prostate-specific antigen (PSA) level >20 ng/mL at selection were randomized after 6 months of induction of ADT (leuprorelin and flutamide) if PSA level had decreased below 4 ng/mL. * Patients received either continuous or intermittent ADT. All patients were treated until signs of disease progression under treatment or until study end with a monthly central PSA determination and follow-up visits were performed every 3 months. * The primary endpoint was overall survival. Secondary endpoints included progression-free survival, health-related quality of life (QLQ C30 questionnaire) and safety criteria. RESULTS: * Of 383 selected patients, 173 had a PSA level below 4 ng/mL after 6 months of induction of ADT and were randomized. Median overall survival (52 vs 42 months, P= 0.75) and median progression-free survival (15.1 vs 20.7 months, P= 0.74) were not significantly different between continuous and intermittent ADT. * Although some differences in quality of life were observed, most of the functional and symptom scales showed no significant difference between the two groups. * Significantly fewer treatment-emergent adverse events occurred in the intermittent group (P= 0.042), with the incidence of headache and hot flushes also lower. CONCLUSIONS: * This first randomized trial comparing continuous with intermittent ADT in metastatic PCa suggests that intermittent ADT might be as safe as continuous ADT. * It could be an option in highly responding and well-informed patients even if no clear benefit in health-related quality of life was shown.","BJU Int, 110(9): 1262-1269","France",2012,"Metastatic","Hormonal","EORTC QLQ-C30","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General"]
[476,"Movsas, B., et al. (2014). \"Can electronic web-based technology improve quality of life data collection? Analysis of Radiation Therapy Oncology Group 0828.\" Pract Radiat Oncol 4(3): 187-191.",null,"Movsas, B., et al.","Can electronic web-based technology improve quality of life data collection? Analysis of Radiation Therapy Oncology Group 0828","PURPOSE: Missing data are a significant problem in clinical trials, particularly for quality of life (QOL), which cannot be obtained retrospectively. The purpose of this study was to evaluate the feasibility of an electronic web-based strategy for QOL data collection in a cooperative group radiation oncology trial setting. METHODS AND MATERIALS: Radiation Therapy Oncology Group (RTOG) 0828 was a prospective National Cancer Institute cooperative group companion study of RTOG-0415, a randomized study of conventional versus hypofractionated radiation. Forty-nine English-speaking patients with favorable risk prostate cancer who enrolled on RTOG-0415 consented to using web-based technology for completing QOL. In RTOG-0415, using paper forms, the 6-month QOL compliance rate was 52%. The purpose of RTOG-0828 was to test the feasibility of a web-based strategy with the goal of increasing the 6-month QOL completion rate by 25% (from 52% to 77%) for a relative improvement of ~50%. The web-based tool used in this study was VisionTree Optimal Care (VTOC; VisionTree Software, Inc, San Diego, CA), a Health-Insurance-Portability-Accountability-Act secure, online technology that allows real-time tracking and e-mail reminders. The primary endpoint was the 6-month compliance rate for the validated QOL instrument, Expanded Prostate Index Composite. RESULTS: The QOL completion rate at baseline was 98%. Compared with the prior 52% QOL completion rate at 6 months using paper forms, the QOL web-based completion rate at 6 months was 90% (2-sided P value < .001). At 12 months, the EPIC completion rate was 82% (compared with 36% using paper forms). CONCLUSIONS: This RTOG study suggests that a web-based strategy to collect QOL appears to be feasible in the cooperative group radiation oncology trial setting and is associated with an increase in the 6-month QOL compliance rate compared with the prior method of using paper forms. The RTOG plans to further test this strategy in a head-and-neck cancer trial across all participating RTOG sites.","Pract Radiat Oncol, 4(3): 187-191","USA,Canada",2014,"Any or unknown","Radiotherapy","EPIC","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease"]
[477,"Moyad, M. A., et al. (1999). \"Use of PC-SPES, a commercially available supplement for prostate cancer, in a patient with hormone-naive disease.\" Urology 54(2): 319-323; discussion 323-314.",null,"Moyad, M. A., et al.","Use of PC-SPES, a commercially available supplement for prostate cancer, in a patient with hormone-naive disease","OBJECTIVES: PC-SPES, an over-the-counter supplement, is actually a combination of eight different herbs. It is being used by patients to treat cancer of the prostate at different stages of the disease and has been commercially available since November 1996. It has been observed to dramatically decrease prostate-specific antigen (PSA) values in several patients; however, its out-of-pocket cost ($162 to $486/mo) and potential side effects must be weighed against its potential objective benefits. We reviewed its use in 1 patient. METHODS: A patient with clinically localized prostate cancer (T1c) with a PSA of 8.8 ng/mL, who decided to delay any conventional treatment, began treatment with 9 PC-SPES capsules/day. RESULTS: After 3 weeks, his PSA dropped to 1.4 ng/mL and after a total of 8 weeks, his PSA was less than 0.1 ng/mL (undetectable). He has continued on a maintenance dose of 6 capsules per day, decreasing to 4 capsules per day, with a continuing undetectable PSA. During this time the patient also experienced a number of strong estrogenic effects: loss of libido, erectile dysfunction, extreme breast enlargement and tenderness, reduction in overall body hair, pitting edema, and a significant drop in his lipoprotein (a) level (from 46 to 11 mg/dL). CONCLUSIONS: PC-SPES may provide additive advantages (or disadvantages) over prescribed hormonal treatments but must be compared with other hormonal and nonhormonal treatments in clinical trials with hormone-sensitive and -insensitive patients with prostate cancer to determine its future use or nonuse.","Urology, 54(2): 319-323; discussion 323-314","USA",1999,"Local","Various","Unclear","Patient",null,"Case study",null,null,null,null,null,null,null,null,"Treatment"]
[478,"Mulholland, T. L., et al. (2006). \"Urinary incontinence after radical retropubic prostatectomy is not related to patient body mass index.\" Prostate Cancer Prostatic Dis 9(2): 153-159.",null,"Mulholland, T. L., et al.","Urinary incontinence after radical retropubic prostatectomy is not related to patient body mass index","To determine if a relationship exists between patient body habitus and urinary incontinence after radical retropubic prostatectomy (RRP) for clinically localized prostate cancer. A questionnaire developed by combining parts of lower urinary tract symptom questionnaires concerning voiding symptoms after RRP was mailed to 268 consecutive patients who underwent RRP over a 2-year period. The interval between surgery and questionnaire administration was greater than 24 months for each patient. No interval was greater than 54 months. The questionnaire attempted to overcome the subjectivity of patient documented urinary incontinence by probing different aspects of each patient's voiding symptoms. Body mass index (BMI), obtained from preoperative anesthesia records, was used as the measurement for body habitus. Pearson correlations were used to determine relationships between BMI and responses and the independent t-test was used to determine differences between grouped responses and BMI. One hundred and eighty-two of 268 (68%) questionnaires were returned. No relationship was detected between BMI and patient estimates of urinary control, QOL relating to urinary symptoms, severity of stress incontinence, or use of protection (pad use). As well, no statistically significant relationship was found between BMI and a patient's willingness to undergo RRP again, based on his voiding symptoms, if given the choice. In conclusion, although patient body habitus may be related to other clinical outcomes following RRP, there does not appear to be a relationship of BMI to post-RRP urinary incontinence.","Prostate Cancer Prostatic Dis, 9(2): 153-159","USA",2006,"Local","Surgery","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Complication"]
[479,"Naccarato, A. M., et al. (2016). \"Psychotherapy and phosphodiesterase-5 inhibitor in early rehabilitation after radical prostatectomy: a prospective randomised controlled trial.\" Andrologia 48(10): 1183-1187.",null,"Naccarato, A. M., et al.","Psychotherapy and phosphodiesterase-5 inhibitor in early rehabilitation after radical prostatectomy: a prospective randomised controlled trial","The aim of this study was to evaluate the impact of group psychotherapy and the use of a phosphodiesterase-5 inhibitor (PDE-5i) in the early rehabilitation stage of patients with prostate cancer undergoing radical prostatectomy (RP). Fifty-six patients undergoing RP for prostate cancer were randomised into four groups, and 53 completed the protocol: Group 1 - control (n = 11), Group 2 - group psychotherapy (n = 16), Group 3 - lodenafil 80 mg/one tablet per week (n = 12) and Group 4 - group psychotherapy + lodenafil 80 mg/one tablet per week (n = 14). The groups were individually evaluated for erectile function (IIEF-5) and quality of life - QoL (SF-36) weekly, with two meetings held a week apart before the RP and 12 weekly meetings after surgery. The ages ranged from 39 to 76 years, average 61.84. There were no significant medication side effects. Only Group 4 showed improvement in intimacy with a partner and satisfaction with their sex life (P = 0.045 and P = 0.013 respectively), and with no significant worsening of the IIEF-5 (P = 0.250) reported. All groups showed worsening in the final result of the role limitations caused by physical problems (P = 0.009) and role limitations caused by emotional problems (P = 0.002) of the SF-36, but Group 4 had a significantly higher score for the role limitations caused by physical problems (P = 0.009) than the other groups. In conclusion, precocious integral treatment involving group psychotherapy and PDE-5i before and after RP led to less deterioration of erectile function and other domains related to physical aspects (SF-36), with improvement in intimacy with their partner and satisfaction in their sex life, being superior to single treatments.","Andrologia, 48(10): 1183-1187","Brazil",2016,"Any or unknown","Surgery,Psychological,PDEi","IIEF-5,SF-36","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Complication,Utility"]
[480,"Nag, S., et al. (2002). \"American Brachytherapy Society recommendations for reporting morbidity after prostate brachytherapy.\" Int J Radiat Oncol Biol Phys 54(2): 462-470.",null,"Nag, S., et al.","American Brachytherapy Society recommendations for reporting morbidity after prostate brachytherapy","PURPOSE: To standardize the reporting of brachytherapy-related prostate morbidity to guide ongoing clinical practice and future investigations. METHODS: Members of the American Brachytherapy Society (ABS) with expertise in prostate brachytherapy performed a literature review and, guided by their clinical experience, formulated specific recommendations for reporting on morbidity related to prostate brachytherapy. RESULTS: The ABS recommends using validated, patient-administered health-related quality-of-life instruments for the determination of baseline and follow-up data regarding bowel, urinary, and sexual function. Both actuarial and crude incidences should be reported, along with the temporal resolution of specific complications, and correlated with the doses to the normal tissues. The International Prostate Symptom Score is recommended to assess urinary morbidity, and any dysuria, gross hematuria, urinary retention, incontinence, or medication use should be quantified. Likewise, the \"Sexual Health Inventory for Men,\" which includes the specific erectile questions of the International Index of Erectile Function, is the preferred instrument for reporting sexual function, and the loss of sexual desire, incidence of hematospermia, painful orgasm (orgasmalgia), altered orgasm intensity, decreased ejaculatory volume, use of erectile aids, and use of hormones for androgen deprivation should be quantified. The ABS recommends adoption of the Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer acute and late radiation morbidity scoring scheme for reporting rectal morbidity and noting the incidence of rectal steroid, laser, or antidiarrheal use. CONCLUSION: It is important to focus on health-related quality-of-life issues in the treatment of prostate cancer, because the control rates are very similar between appropriate treatment modalities. The ABS recommends using the International Prostate Symptom Score, International Index of Erectile Function, and Radiation Therapy Oncology Group toxicity grading criteria for the determination of urinary, sexual, and bowel function, respectively. Additional parameters for reporting urinary, rectal, and sexual morbidities are presented. These morbidities should be correlated with the doses to the normal tissues. Some of these specific recommendations may be modified if and when new data become available.","Int J Radiat Oncol Biol Phys, 54(2): 462-470","USA",2002,"Any or unknown","Brachytherapy","IIEF-5,SHIM,RTOG-EORTC-SS","Patient",null,"Systematic review",null,null,null,null,null,null,null,null,"Treatment,Complication"]
[481,"Namiki, S., et al. (2003). \"Health-related quality of life after radical prostatectomy in Japanese men with localized prostate cancer.\" Int J Urol 10(12): 643-650.",null,"Namiki, S., et al.","Health-related quality of life after radical prostatectomy in Japanese men with localized prostate cancer","PURPOSE: We evaluated retrospectively health-related quality of life (HRQOL) after radical prostatectomy (RP) in Japanese men with localized prostate cancer. METHODS: The study was based on self-reported HRQOL of 280 patients. Patients were divided into seven groups: time 0 (T0), baseline before operation; T1, 1-3 months after RP; T2, 4-6 months after RP; T3, 7-12 months after RP; T4, 13-24 months after RP; T5, 25-36 months after RP; and T6, more than 36 months after RP. We measured the general and disease-specific HRQOL using the RAND 36-item Health Survey 1.0 (SF-36) and the University of California, Los Angeles Prostate Cancer Index (UCLA PCI). RESULTS: The general HRQOL of the postoperative groups was assessed by SF-36. The postoperative groups showed almost the same or higher scores than those of the baseline group. Urinary function scores decreased substantially after surgery. In contrast, there was no difference in urinary bother between the baseline and postoperative groups. Sexual function deteriorated substantially in all postoperative groups. Similarly, the sexual bother score significantly deteriorated after RP. The sexual bother score of men aged 65-years or younger was significantly worse than that of their counterparts in the T1-2 groups. CONCLUSION: Despite reports of problems with sexual activity and urinary continence, general HRQOL was mostly unaffected by RP. Although there was a substantial decrease in urinary function, recovery from urinary bother was rapid. Since the deterioration of sexual function was marked through the postoperative period, careful attention should be paid to this issue during preoperative counseling, especially for younger patients.","Int J Urol, 10(12): 643-650","Japan",2003,"Local","Surgery","SF-36,UCLA-PCI","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease,Utility"]
[482,"Namiki, S., et al. (2004). \"Health related quality of life in Japanese men after radical prostatectomy or radiation therapy for localized prostate cancer.\" Int J Urol 11(8): 619-627.",null,"Namiki, S., et al.","Health related quality of life in Japanese men after radical prostatectomy or radiation therapy for localized prostate cancer","BACKGROUND: We performed a retrospective survey of general and disease specific health-related quality of life (HRQOL) after radical prostatectomy (RP) and external beam radiotherapy (XRT) in Japanese men. METHODS: A total of 186 patients underwent RP and 78 underwent XRT for clinically localized prostate cancer between 2000 and 2002. We measured the general and disease specific HRQOL with the MOS 36-Item Health Survey and the University of California, Los Angeles Prostate Cancer Index, respectively. Each treatment group was further divided into four subgroups according to the time scale. RESULTS: Patients from the RP group were significantly younger than those from the XRT group. The tumor characteristics differed significantly in their distributions among the treatment groups. Patients undergoing XRT had low scores in most of the general measures of HRQOL just after treatment, but after 6 months there were no differences between the treatment groups, except for the physical domains. The RP group was associated with worse urinary function, whereas the XRT group had worse bowel function and bother during the first 6 months after treatment. Thereafter, however, urinary and bowel domain did not differ between the groups. Both groups reported poor sexual function, although the RP group scored lower sexual bother. CONCLUSION: The patients who underwent RP had significantly worse urinary and better bowel function than those treated with XRT. Both treatment groups had decrements in sexual function throughout the post-treatment period; careful attention should be paid to this side-effect in preoperative counselling, especially in younger patients, regardless of the primary treatments.","Int J Urol, 11(8): 619-627","Japan",2004,"Local","Surgery,Radiotherapy","SF-36,UCLA-PCI","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease,Utility"]
[483,"Namiki, S., et al. (2004). \"Recovery of health related quality of life after radical prostatectomy in japanese men: a longitudinal study.\" Int J Urol 11(9): 742-749.",null,"Namiki, S., et al.","Recovery of health related quality of life after radical prostatectomy in japanese men: a longitudinal study","BACKGROUND: We performed a longitudinal survey of health related quality of life (HRQOL) after radical retropubic prostatectomy (RP) in Japanese men with localized prostate cancer. METHODS: The present study started with self-reported HRQOL assessments provided by 72 patients who received only RP. The RAND 36-Item Health Survey and the University of California, Los Angeles Prostate Cancer Index were administered before and 3, 6 and 12 months after RP. RESULTS: Patients who underwent RP showed problems in some domains of general HRQOL, but these problems diminished over time. Urinary function declined substantially at 3 months and continued to recover at 6 and 12 months, but scored lower than the baseline. Urinary bother at 3 months had a significant decrease, but at six months it turned out to be the same as the baseline. The data of sexual function and bother showed a substantially lower score after RP. The sexual bother score of the younger men was significantly worse than that of the older men. Those who underwent nerve sparing procedures experienced significantly better recovery of urinary and sexual functions than the non-nerve sparing group. CONCLUSION: Despite reports of problems with sexuality and urinary continence, general HRQOL was mostly unaffected by RP after 6 months. Although there was a substantial decrease in urinary function, recovery from urinary bother was rapid. Deterioration of the sexual domain was remarkable throughout the postoperative period. Therefore, careful attention should be given to preoperative counseling, especially for younger patients.","Int J Urol, 11(9): 742-749","Japan",2004,"Local","Surgery","SF-36,UCLA-PCI","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease,Utility"]
[484,"Namiki, S., et al. (2005). \"An evaluation of urinary function after radical prostatectomy in Japanese men: concordance with definitions of urinary continence.\" BJU Int 95(4): 530-533.",null,"Namiki, S., et al.","An evaluation of urinary function after radical prostatectomy in Japanese men: concordance with definitions of urinary continence","OBJECTIVE: To determine how well various definitions of continence outcome after radical retropubic prostatectomy (RP) corresponded with each other, using published health-related quality-of-life (HRQoL) questionnaires. PATIENTS AND METHODS: In all, 198 patients undergoing RP alone were enrolled in a study between November 2000 and June 2003. The baseline interview was conducted before RP and 3, 6 and 12 months afterward. The disease-specific HRQoL was assessed using the University of California-Los Angeles Prostate Cancer Index; the correspondence among definitions of incontinence was investigated. RESULTS: The urinary function score substantially declined at 3 months, continued to recover at 6 and 12 months, but remained lower than at baseline (P < 0.001). The correspondence among definitions of continence varied widely; 97% of men who did not have urine leakage at all claimed to use no pads, but only 63% of those claiming no use of pads had no urine leakage at all. Interestingly, this concordance rate progressively changed from 46% at 3 months to 60% at 12 months, whereas it was 82% at baseline. CONCLUSIONS: Based on self-reported questionnaire data, different definitions of continence gave different results when applied to the same patients at the same time. The correspondence among definitions may vary with time after RP. No single question adequately assesses the urinary HRQoL outcome after treatment for prostate cancer.","BJU Int, 95(4): 530-533","Japan",2005,"Any or unknown","Surgery","UCLA-PCI","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease"]
[485,"Namiki, S., et al. (2006). \"Health-related quality of life after intensity modulated radiation therapy for localized prostate cancer: comparison with conventional and conformal radiotherapy.\" Jpn J Clin Oncol 36(4): 224-230.",null,"Namiki, S., et al.","Health-related quality of life after intensity modulated radiation therapy for localized prostate cancer: comparison with conventional and conformal radiotherapy","OBJECTIVE: No previous studies have reported the longitudinal health-related quality of life (HRQOL) for intensity modulated radiation therapy (IMRT). We compared HRQOL after IMRT with that after conventional and after conformal radiation therapy (XRT). METHODS: A total of 110 patients underwent XRT (34 patients underwent conventional radiation therapy and 76 underwent conformal radiation therapy) and 30 underwent IMRT for clinically localized prostate cancer between 2000 and 2002. We measured the general and disease-specific HRQOL using the Medical Outcomes Study 36-Item Health Survey and University of California, Los Angeles, Prostate Cancer Index, respectively. RESULTS: There were no significant differences in the preoperative characteristics and HRQOL scores of the two groups. Repeated measure analyses of variance revealed significantly different patterns of alteration in several general HRQOL domains between XRT and the IMRT groups. In the urinary domain, there was no difference in the alteration patterns between the two groups. The XRT group suffered worse bowel function at 3 and 6 months than the IMRT group (P < 0.05). In the XRT group, sexual function decreased at 3 months and remained substantially lower than the baseline level. However, the IMRT group showed no significant difference from the baseline level at any of the observation periods. At 18 months the XRT group showed worse sexual function than the IMRT group. CONCLUSION: The two approaches showed different longitudinal profiles regarding general and disease-specific HRQOL during the first 2 years after treatment. The IMRT approach produced little impairment in bowel and sexual function.","Jpn J Clin Oncol, 36(4): 224-230","Japan",2006,"Local","Radiotherapy","SF-36,UCLA-PCI","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,Utility"]
[486,"Namiki, S., et al. (2007). \"Impact of salvage therapy for biochemical recurrence on health-related quality of life following radical prostatectomy.\" Int J Urol 14(3): 186-191.",null,"Namiki, S., et al.","Impact of salvage therapy for biochemical recurrence on health-related quality of life following radical prostatectomy","OBJECTIVE: To determine the impact of salvage therapy for prostate-specific antigen (PSA) recurrence on the health-related quality of life (HRQOL) of patients after radical retropubic prostatectomy (RP). METHODS: Between January 2000 and December 2003, a total of 249 patients who underwent RP were available for 2-year follow up. Of the respondents, 203 men did not show evidence of recurrence (group A), and 46 men received salvage hormonal therapy and/or radiotherapy after RP because of a rise in PSA (group B). The general and prostate-target HRQOL was assessed with the Medical Outcomes Study 36-Item Short Form and University of California, Los Angeles Prostate Cancer Index, respectively. Patients completed the HRQOL instruments by mail at baseline and at 24 months after RP. RESULTS: All of the patients completed both questionnaires. At baseline no significant differences were found between the two groups in any of the HRQOL domains. There were significant improvements in mental health and social function for the patients without biochemical recurrence postoperatively. Repeated measure anova revealed significantly different patterns of alteration in several general HRQOL domains among the treatment groups. The urinary and bowel domains were equivalent between the two treatment groups at baseline and 24 months after RP. The patients treated with salvage hormonal therapy tended to show delayed recovery of sexual function. CONCLUSION: Using a self-administered questionnaire, biochemical recurrence following RP was found to impose a substantial burden in patients with localized prostate cancer.","Int J Urol, 14(3): 186-191","Japan",2007,"Any or unknown","Surgery,Hormonal,Radiotherapy","SF-36,UCLA-PCI","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease,Utility"]
[487,"Namiki, S., et al. (2007). \"Psychological distress in Japanese men with localized prostate cancer.\" Int J Urol 14(10): 924-929.",null,"Namiki, S., et al.","Psychological distress in Japanese men with localized prostate cancer","OBJECTIVE: To investigate: (i) the level of psychological distress; and (ii) the relationships between the level of psychological distress and general or disease-specific HRQOL of Japanese men with localized prostate cancer following surgery or radiotherapy. PATIENTS AND METHODS: The study was a retrospective cross-sectional survey of 253 men with localized prostate cancer treated with radical prostatectomy and 87 with external beam radiotherapy were collected. The measures used four questionnaires including: (i) the Medical Outcomes Study 36-Item Health Survey; (ii) The University of California, Los Angeles Prostate Cancer Index; (iii) International Prostate Symptom Score; and (iv) Hospital Anxiety and Depression Scale (HADS). RESULTS: Mean anxiety and depression scores were 4.0 and 4.7, respectively (standard deviation, 3.3 and 3.7). On the anxiety section of HADS, 291 patients (85%) scored 7 points or less; and on the depression scale, 183 (54%) patients scored 4 points or less. Those 'cases' (HADS total, >10) with psychological distress scored lower in all domains of the general and disease related health-related quality of life (HRQOL) than the 'non-cases' (HADS total, <or=10) except for sexual domains. Logistic regression modeling suggested that the men who tended to experience moderate to high distress suffered from worse urinary and bowel symptoms. CONCLUSION: Most patients who underwent radical prostatectomy or external beam radiotherapy for localized prostate cancer experienced low levels of psychological distress after treatment. However, men who were experiencing urinary and bowel symptoms tended to suffer from moderate to higher distress compared with men reporting no or fewer such symptoms.","Int J Urol, 14(10): 924-929","Japan",2007,"Local","Surgery,Radiotherapy","UCLA-PCI,HADS,IPSS,SF-36","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Disease,Comorbidity,Utility"]
[488,"Namiki, S., et al. (2009). \"Association of lower urinary tract symptoms with sexual dysfunction: a cross-cultural study between Japanese and American men with localized prostate cancer.\" BJU Int 104(8): 1071-1076.",null,"Namiki, S., et al.","Association of lower urinary tract symptoms with sexual dysfunction: a cross-cultural study between Japanese and American men with localized prostate cancer","OBJECTIVE: To assess the association of lower urinary tract symptoms (LUTS) with sexual function, and estimate the correlates of LUTS among Japanese and American men with localized prostate cancer. PATIENTS AND METHODS: In all, 343 Japanese men and 307 American men with prostate cancer were enrolled in the study. Sexual function and sexual bother were measured separately with the University of California-Los Angeles Prostate Cancer Index and obstructive/irritative voiding symptoms were measured with the American Urological Association Symptom Index (AUA SI). RESULTS: Japanese men had worse sexual function scores than the American men before treatment, whereas no differences were reported between Japanese and American men in sexual bother scores. Japanese and American men also did not differ meaningfully in AUA SI. However, those with moderate to severe LUTS reported significantly worse sexual bother scores than those with mild symptoms in both Japanese and American men (P = 0.004 and <0.001, respectively). The Japanese men were more likely to have LUTS than were American men (odds ratio 1.60, P = 0.029). Age and sexual function were highly associated with LUTS (odds ratio 1.35, P = 0.027; and 0.652, P = 0.001, respectively). The comorbidity count was independently associated with worse urinary symptoms (odds ratio 1.23, P = 0.015). CONCLUSIONS: We posit that cultural differences in the meaning or salience of sexual functioning, and the interpretation of the questionnaire in quality-of-life surveys, might explain the different profiles in the association of LUTS with sexual activity in Japanese and American men with localized prostate cancer.","BJU Int, 104(8): 1071-1076","Japan",2009,"Local","None","AUA-SI,UCLA-PCI","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Disease,Symptom"]
[489,"Namiki, S., et al. (2009). \"Distress and social dysfunction following prostate cancer treatment: a longitudinal cross-cultural comparison of Japanese and American men.\" Prostate Cancer Prostatic Dis 12(1): 67-71.",null,"Namiki, S., et al.","Distress and social dysfunction following prostate cancer treatment: a longitudinal cross-cultural comparison of Japanese and American men","We assessed the impact of bother with urinary and bowel dysfunction on social activities among men in Japan and the United States following primary therapy for localized prostate cancer. In paired longitudinal outcomes studies, we measured general and disease-specific health-related quality of life in 400 Japanese and 427 American men who underwent radical prostatectomy or brachytherapy for localized prostate cancer. Outcomes included the social function domain of the Medical Outcomes Study Short Form-36 and the University of California, Los Angeles Prostate Cancer Index, all of which are scored 0-100. Participants completed the questionnaires before and 1, 12 and 24 months after treatment. Among men who reported any urinary bother, Japanese men had slightly better urinary function than American men (84 vs 77, P<0.01). Before brachytherapy, urinary bother was weakly correlated with social function in both the countries; after brachytherapy, urinary bother was strongly correlated with social function in American but not Japanese men. After brachytherapy, bowel dysfunction had a stronger correlation with social function in American than Japanese men (P<0.05). The bother associated with urinary and bowel dysfunction after surgery or brachytherapy for prostate cancer has a greater impact on social function in American men than in Japanese men.","Prostate Cancer Prostatic Dis, 12(1): 67-71","USA",2009,"Local","Surgery,Brachytherapy","SF-36,UCLA-PCI","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease,Utility"]
[490,"Namiki, S., et al. (2010). \"Quality of life among elderly men treated for prostate cancer with either radical prostatectomy or external beam radiation therapy.\" J Cancer Res Clin Oncol 136(3): 379-386.",null,"Namiki, S., et al.","Quality of life among elderly men treated for prostate cancer with either radical prostatectomy or external beam radiation therapy","PURPOSE: We evaluated the changes of health-related quality of life (HRQOL) during the first 2 years after radical prostatectomy (RP) or external beam radiation therapy (EBRT) in elderly men (70 years old or older) treated for prostate cancer. PATIENTS AND METHODS: Between 2002 and 2005, a total of 319 elderly men who underwent RP or EBRT participated in our study. Patients completed the general and disease-specific HRQOL with the Short Form-36 (SF-36) and University of California, Los Angeles Prostate Cancer Index, respectively. The participants were asked to complete the questionnaire before and 3, 6, 12, 18 and 24 months after treatment. RESULTS: The RP group was younger and had more favorable tumor characteristics than the EBRT group. When compared with the EBRT group, the RP group had higher scores for several SF-36 subscales and sexual function, whereas other domains were comparable. In the EBRT group, there were no significant differences in the general HRQOL scores between the baseline and any of the observation periods. The RP group had a significantly worse urinary function and bother scores postoperatively than the EBRT group. The score for sexual function declined over the 24 months, but more so in the RP group. Similarly, sexual bother scores were significantly lower at each postoperative time point for the RP group. CONCLUSIONS: Both aggressive treatments can offer satisfactory functional outcomes from the perspective of HRQOL for selected elderly subjects with localized prostate cancer.","J Cancer Res Clin Oncol, 136(3): 379-386","Japan",2010,"Any or unknown","Surgery,Radiotherapy","SF-36,UCLA-PCI","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease,Utility"]
[491,"Naoe, M., et al. (2006). \"Pilot evaluation of selective serotonin reuptake inhibitor antidepressants in hot flash patients under androgen-deprivation therapy for prostate cancer.\" Prostate Cancer Prostatic Dis 9(3): 275-278.",null,"Naoe, M., et al.","Pilot evaluation of selective serotonin reuptake inhibitor antidepressants in hot flash patients under androgen-deprivation therapy for prostate cancer","PURPOSE: Hot flash (HF) is a common side effect in prostate cancer patient undergoing androgen-deprivation therapy (ADT). In this study, we evaluated the efficacy of paroxetine (selective serotonin reuptake inhibitors (SSRIs)) for HF. PATIENTS AND METHODS: In total, 10 men with prostate cancer under ADH who were suffering with HF entered this study. Self-report questionnaire was used for the evaluation. RESULTS: The average rating for HF frequency decreased (P=0.009) and HF severity decreased (P=0.0332) also, reported QOL score increased (P=0.0218). CONCLUSION: These preliminary data suggest that low dose (10 mg/day) of antidepressant paroxetine can be helpful in the treatment of HFs in patients under ADT for prostate cancer. Further controlled studies are needed to more fully evaluate the efficacy of the SSRIs.","Prostate Cancer Prostatic Dis, 9(3): 275-278","Japan",2006,"Any or unknown","Hormonal,Various","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Treatment"]
[492,"Nascimento, M., et al. (2014). \"Efficacy of synbiotics to reduce acute radiation proctitis symptoms and improve quality of life: a randomized, double-blind, placebo-controlled pilot trial.\" Int J Radiat Oncol Biol Phys 90(2): 289-295.",null,"Nascimento, M., et al.","Efficacy of synbiotics to reduce acute radiation proctitis symptoms and improve quality of life: a randomized, double-blind, placebo-controlled pilot trial","PURPOSE: To evaluate whether the daily intake of synbiotics interferes in radiation-induced acute proctitis symptoms and in quality of life in patients with prostate cancer. METHODS AND MATERIALS: Twenty patients who underwent 3-dimensional conformal radiation therapy for prostate cancer were randomized to intake either a synbiotic powder containing Lactobacillus reuteri 10(8) colony-forming units and 4.3 g of soluble fiber (Nestle) or placebo. The questionnaire EORTC QLQ-PRT23 was applied before the beginning of radiation therapy and in every week for the first 4 weeks of treatment. The sum of both the complete (proctitis symptoms plus quality of life) and partial (proctitis symptoms) scores of the EORTC QLQ-PRT23 (European Organization for Research and Treatment of Cancer Quality of Life Module for Proctitis-23 items) questionnaire were the main endpoints. RESULTS: This pilot study showed that the complete questionnaire score (median [range]) was higher in the second (23 [21-30] vs 26.5 [22-34], P<.05) and third (23 [21-32] vs 27.5 [24-33], P<.01) weeks in the placebo group. Proctitis symptoms were highest scored in the placebo group in both the second (19.5 [16-25]) and third (19 [17-24]) weeks than in the synbiotic group (week 2: 16.5 [15-20], P<.05; week 3: 17 [15-23], P<.01). In both scores the placebo group had a significantly higher result (P<.01) than the synbiotic group (repeated-measures analysis of variance). CONCLUSIONS: Synbiotics reduce proctitis symptoms and improve quality of life in radiation-induced acute proctitis during radiation therapy for prostate cancer.","Int J Radiat Oncol Biol Phys, 90(2): 289-295","Brazil",2014,"Any or unknown","Radiotherapy,Various","EORTC-QLQ-PRT23","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Complication"]
[493,"Naughton, C. K., et al. (2001). \"Impact of transrectal ultrasound guided prostate biopsy on quality of life: a prospective randomized trial comparing 6 versus 12 cores.\" J Urol 165(1): 100-103.",null,"Naughton, C. K., et al.","Impact of transrectal ultrasound guided prostate biopsy on quality of life: a prospective randomized trial comparing 6 versus 12 cores","PURPOSE: Recent studies advocating an increase in the number of cores of sextant transrectal ultrasound guided biopsy of the prostate to improve the cancer detection rate often have not addressed the impact on quality of life. We performed a prospective randomized trial comparing 6 to 12 prostate biopsy cores to determine the impact on the cancer detection rate, pain and morbidity, and quality of life. We report the impact on health related and screening specific quality of life in men undergoing 6 versus 12 core transrectal ultrasound guided prostate biopsy. MATERIALS AND METHODS: We prospectively randomized 244 men with a mean age plus or minus standard deviation of 65 +/- 8 years, serum total prostate specific antigen between 2.5 and 20.0 ng./ml., and/or digital rectal examination findings suspicious of cancer to undergo 6 or 12 core peripheral zone tissue biopsy. Of the men 71 (29%) were black. All patients completed a self-administered questionnaire before, and 2 questionnaires 2 and 4 weeks after the procedure. Health related quality of life was measured using 2 subscales (emotional well-being and role limitation due to physical health) of the short form 36-Item Health Survey. Screening specific quality of life was addressed by questions on the functional consequences of the procedure (return to daily activity, work-employment and sports-exercise). Health related and screening specific quality of life responses were compared in the groups. RESULTS: After controlling for cancer diagnosis, patient age, race, education, report of pain and baseline emotional well-being there was no significant difference in the mean change in emotional well-being scores at 2 and 4 weeks in the 6 and 12 core groups (p = 0.7 and 0.3, respectively). Similarly after controlling for these factors and baseline role limitation due to physical health there was no significant difference in the mean change in role limitation due to physical health scores at 2 and 4 weeks in the 2 groups (p = 0.3 and 0.5, respectively). There was no difference in the percent of men returning to routine daily activity (p = 0.6), work-employment (p = 0.5) or sports-exercise (p = 0.3) at 0 to 1, 2 to 3 and 4 to 7 days or longer than 1 week after the procedure in the groups. CONCLUSIONS: Doubling the sextant biopsy does not affect the quality of life in regard to emotional well-being, role limitation due to physical health, or return to routine daily activity, work-employment or sports-exercise.","J Urol, 165(1): 100-103","USA",2001,"At risk","Screening","SF-36","General population",null,"Clinical trial",null,null,null,null,null,null,null,null,"Utility"]
[494,"Navon, L. and A. Morag (2003). \"Advanced prostate cancer patients' relationships with their spouses following hormonal therapy.\" Eur J Oncol Nurs 7(2): 73-80; discussion 81-72.",null,"Navon, L. and A. Morag","Advanced prostate cancer patients' relationships with their spouses following hormonal therapy","The paper analyses the adverse impact of the hormonal therapy's side-effects on advanced prostate cancer patients' capacity for maintaining their pre-treatment spousal relationships, the pros and cons of their ways of coping with the difficulties involved, and the implications of these issues for oncology nursing interventions. In-depth interviews were conducted with 15 Israeli prostate cancer patients, and the data were processed according to the constant comparative analysis method. The findings show that partners' supportive attitude and patients' attempts to stage resilience led to pre-treatment relationships' maintenance, and that, accordingly, patients' rejection by their partners and resignation to this difficulty resulted in spousal ties' disruption. However, whereas the relationships' maintenance came at the cost of burdensome constant pretence, their disruption was eventually reconstructed by the patients in positive terms. These findings are analysed against the backdrop of the constraints imposed by the hormonal therapy on patients' general coping competence and ability to enjoy non-sexual activities, which impair their capability to solve their marital problems more effectively. They would thus benefit from training oncology nurses who specialize in the unique difficulties facing them and their partners, and from oncology nursing interventions that focus on relevant information provision and counselling.","Eur J Oncol Nurs, 7(2): 73-80; discussion 81-72","Israel",2003,"Advanced","Hormonal","Interview","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Social"]
[495,"Neumann, P. J., et al. (2012). \"Willingness-to-pay for predictive tests with no immediate treatment implications: a survey of US residents.\" Health Econ 21(3): 238-251.",null,"Neumann, P. J., et al.","Willingness-to-pay for predictive tests with no immediate treatment implications: a survey of US residents","We assessed how much, if anything, people would pay for a laboratory test that predicted their future disease status. A questionnaire was administered via an internet-based survey to a random sample of adult US respondents. Each respondent answered questions about two different scenarios, each of which specified: one of four randomly selected diseases (Alzheimer's, arthritis, breast cancer, or prostate cancer); an ex ante risk of developing the disease (randomly designated 10 or 25%); and test accuracy (randomly designated perfect or 'not perfectly accurate'). Willingness-to-pay (WTP) was elicited with a double-bounded, dichotomous-choice approach. Of 1463 respondents who completed the survey, most (70-88%, depending on the scenario) were inclined to take the test. Inclination to take the test was lower for Alzheimer's and higher for prostate cancer compared with arthritis, and rose somewhat with disease prevalence and for the perfect versus imperfect test [Correction made here after initial online publication.]. Median WTP varied from $109 for the imperfect arthritis test to $263 for the perfect prostate cancer test. Respondents' preferences for predictive testing, even in the absence of direct treatment consequences, reflected health and non-health related factors, and suggests that conventional cost-effectiveness analyses may underestimate the value of testing.","Health Econ, 21(3): 238-251","USA",2012,"At risk","Screening","WTP","General population",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Utility"]
[496,"Newton, F. J., et al. (2006). \"Disease-specific quality of life among patients with localized prostate cancer: an Australian perspective.\" BJU Int 97(6): 1179-1183.",null,"Newton, F. J., et al.","Disease-specific quality of life among patients with localized prostate cancer: an Australian perspective","OBJECTIVES: To examine differences in sexual, urinary and bowel function, and bother, in patients with prostate cancer after treatment with radical prostatectomy (RP) or external beam radiation (EBRT), compared to a convenience sample of men with no diagnosis of prostate cancer, as little is known about the disease-specific health-related quality of life (HRQoL) of men in Australia after treatment for clinically localized prostate cancer. PATIENTS AND METHODS: The study was a retrospective cross-sectional survey of 95 controls, 82 men with localized prostate cancer treated with RP and 39 with EBRT at > or = 2 years before data were collected. Disease-specific HRQoL was assessed using the University of California Los Angeles Prostate Cancer Index, a validated measure that includes six subscales addressing sexual, urinary and bowel symptoms, and level of bother associated with the symptoms. Univariate analyses were conducted to ascertain differences in disease-specific HRQoL among the three groups. To minimize the influence of other factors, age and comorbid medical conditions were included as covariates. RESULTS: Men treated with RP had more sexual and urinary symptoms (both P < 0.001) than those treated with EBRT, and more sexual bother (P < 0.001). Men treated with EBRT reported significantly worse bowel function (P = 0.02) and more bother (P < 0.001) with these symptoms than those who had RP. CONCLUSIONS: Except for bowel dysfunction and the bother associated with these symptoms, disease-specific HRQoL was generally worse after RP than EBRT.","BJU Int, 97(6): 1179-1183","Australia",2006,"Local","Surgery,Radiotherapy","UCLA-PCI","Patient,General population",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Disease"]
[497,"Nguyen, L. N., et al. (1998). \"Late effects after radiotherapy for prostate cancer in a randomized dose-response study: results of a self-assessment questionnaire.\" Urology 51(6): 991-997.",null,"Nguyen, L. N., et al.","Late effects after radiotherapy for prostate cancer in a randomized dose-response study: results of a self-assessment questionnaire","OBJECTIVES: To evaluate the late effects more than 2 years after radiotherapy using a patient-reported questionnaire in patients with prostate cancer enrolled in a randomized dose-response study comparing 70 Gy (conventional) and 78 Gy (conformal) radiotherapy (RT). METHODS: The first 112 patients in the study were sent questionnaires to evaluate late bladder, rectal, and sexual function. There were 101 evaluable responses, with 50 in the conventional (Conven-RT) arm and 51 in the conformal (3DCRT) arm. RESULTS: The overall rate of persistent incontinence was 29%, with 36% reporting urgency-related and 8% stress-related incontinence at some time after radiation. Use of a urinary protective device was required in 2%. The majority noticed leakage less than once per day (52%). In comparing the Conven-RT group with the 3DCRT group, similar incontinence rates were seen. However, fewer of those who received 3DCRT reported daily leakage of urine (33% versus 63%, P = 0.044). The majority (78%) of patients experienced no or mild change in bowel function after RT. Urgency of bowel movements (BMs) was of concern for 27% of patients; however, 90% reported their BMs were controlled without accidents, and 1% were taking antidiarrheal medications once a week or daily. The Conven-RT group had more moderate or major changes in bowel function than the 3DCRT group (34% versus 10%), more frequent BMs (47% versus 27%), and more urgent BMs (37% versus 18%) (P < or = 0.040 for all three comparisons). Hematochezia was uncommon, occurring once a week in 7% and daily in 4% of patients. Before RT, 80% of patients were potent, with erections adequate for intercourse at least a few times over the prior year. After RT, potency was decreased to 51%, with erections adequate for intercourse at least a few times since the completion of RT. CONCLUSIONS: The overall rates of significant complications were extremely low. Although 30% reported incontinence, relatively few patients (2%) required pads. This rate compares favorably with the 31% of patients requiring protection after radical prostatectomy reported previously. Despite the higher treatment doses in the 3DCRT arm, slightly fewer long-term bowel side effects were noted. These data indicate that 78 Gy may safely be delivered using the conformal RT boost treatment technique described.","Urology, 51(6): 991-997","USA",1998,"Any or unknown","Radiotherapy","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Complication"]
[498,"Nguyen, P. L., et al. (2009). \"Patient-reported quality of life after salvage brachytherapy for radio-recurrent prostate cancer: A prospective Phase II study.\" Brachytherapy 8(4): 345-352.",null,"Nguyen, P. L., et al.","Patient-reported quality of life after salvage brachytherapy for radio-recurrent prostate cancer: A prospective Phase II study","BACKGROUND: Patient-reported quality of life (QOL) after salvage brachytherapy for radiorecurrent prostate cancer has not been well-characterized prospectively. METHODS: We examined 25 men who recurred after primary radiotherapy for prostate cancer and received MRI-guided salvage brachytherapy as part of a prospective Phase II study. These patients received prospectively a validated patient-reported QOL questionnaire to fill out at baseline, as well as 3, 15, and 27 months after re-irradiation to determine the degree of sexual, bowel, and urinary dysfunction (maximum dysfunction score=100). RESULTS: On average, sexual function continued to decline with time, and patients had significantly worse sexual function scores at 27 months than baseline (p=0.01). Although bowel and urinary symptoms worsened acutely at 3 or 15 months, they showed on average some improvement by 27 months, and there were no significant differences between baseline and 27-month urinary or bowel scores. An interval to re-irradiation less than 4.5 years and prior brachytherapy were each associated significantly with the largest decrements in bowel function (p=0.035). CONCLUSION: Similar to the patterns seen in the de novo setting, patients who receive salvage brachytherapy report a worsening of bowel and urinary symptoms followed by some improvement by 27 months, while sexual function steadily declines over time. Interval to re-irradiation and type of prior radiation received may be used to counsel and optimize selection of men for salvage brachytherapy with regard to QOL endpoints.","Brachytherapy, 8(4): 345-352","USA",2009,"Recurrent","Radiotherapy,Brachytherapy","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Complication"]
[499,"Nguyen, P. L., et al. (2010). \"Rectal dose-volume histogram parameters are associated with long-term patient-reported gastrointestinal quality of life after conventional and high-dose radiation for prostate cancer: a subgroup analysis of a randomized trial.\" Int J Radiat Oncol Biol Phys 78(4): 1081-1085.",null,"Nguyen, P. L., et al.","Rectal dose-volume histogram parameters are associated with long-term patient-reported gastrointestinal quality of life after conventional and high-dose radiation for prostate cancer: a subgroup analysis of a randomized trial","PURPOSE: We examined whether rectal dose-volume histogram (DVH) parameters were associated with long-term patient-reported gastrointestinal (GI) quality of life (QOL) after conventional (70.2 GyE) or high-dose (79.2 GyE) radiation for prostate cancer. METHODS AND MATERIALS: Of 64 men with localized prostate cancer alive with a minimum 7-year follow-up after treatment as part of a randomized trial with either 70.2 GyE or 79.2 GyE of external beam radiation at Massachusetts General Hospital, 56 men (88%) returned a QOL questionnaire, and 50 of those men had DVH information. The DVH parameters of the anterior rectal wall were correlated with patient-reported long-term GI QOL using Pearson correlation and t tests. RESULTS: There was a trend toward an association between increased long-term GI dysfunction and higher V60 (p = 0.07), V65 (p = 0.06), V70 (p = 0.09), and V75 (p = 0.09). When dichotomized by their medians, a V60 > 54% (p = 0.04), V70 > 44% (p = 0.06), and V75 > 39% (p = 0.06) were associated with increased long-term GI dysfunction. There was no difference in long-term GI dysfunction between men on the conventional vs. high-dose arms (p = 0.49). CONCLUSIONS: Dose-volume histogram parameters of the anterior rectal wall were associated with long-term patient-reported GI QOL after prostate radiation, whereas the dose prescribed to the prostate was not, suggesting that DVH constraints, rather than total prescribed dose, may have the greatest impact on long-term bowel dysfunction, and therefore that continued dose escalation may be feasible if appropriate dose-volume constraints are met.","Int J Radiat Oncol Biol Phys, 78(4): 1081-1085","USA",2010,"Local","Radiotherapy","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Complication"]
[500,"Nielsen, O. S., et al. (1998). \"Randomized trial of single dose versus fractionated palliative radiotherapy of bone metastases.\" Radiother Oncol 47(3): 233-240.",null,"Nielsen, O. S., et al.","Randomized trial of single dose versus fractionated palliative radiotherapy of bone metastases","PURPOSE: Data in the literature suggest that for painful bone metastases a single dose is as effective as fractionated radiotherapy. In the present multicentre prospective trial, the effects of 8 Gy x1 and 5 Gy x4 were compared. PATIENTS AND METHODS: A total of 241 patients were randomized to 8 Gy (122 patients) or 20 Gy (119 patients). The primary tumour was in the breast in 39% of patients, in the prostate in 34% of patients, in the lung in 13% of patients and in other locations in 14% of patients. Outcome measures were pain relief as measured by VAS and in half of the patients also by a five-point categorical pain scale, global quality of life (QoL) and analgesic consumption. Evaluation was performed before and 4, 8, 12 and 20 weeks after treatment. RESULTS: A total of 239 patients were evaluable for response. The two groups did not differ with respect to age, sex, primary tumour, metastasis localization, analgesic consumption (type and dose), performance status, prior systemic treatment, degree of pain and QoL. The treatment was completed as planned in 98% of patients. The degree of pain relief did not differ between the two treatment groups. At 4 weeks the difference in pain relief was 6% (95% CI 7, 20%) and at 8 weeks the difference was 13% (95% CI 3, 28%). Neither was there any significant difference in the duration of pain relief, the number of new painful sites and the need for reirradiation and toxicity was minor. CONCLUSION: The present randomized study showed that a single fraction of 8 Gy was as effective as 5 Gy x4 in relieving pain from bone metastasis.","Radiother Oncol, 47(3): 233-240","Denmark",1998,"Metastatic","Radiotherapy","VAS","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Symptom"]
[501,"Nilsen, T. S., et al. (2015). \"Effects of strength training on body composition, physical functioning, and quality of life in prostate cancer patients during androgen deprivation therapy.\" Acta Oncol 54(10): 1805-1813.",null,"Nilsen, T. S., et al.","Effects of strength training on body composition, physical functioning, and quality of life in prostate cancer patients during androgen deprivation therapy","BACKGROUND: Androgen deprivation therapy (ADT) increases survival rates in prostate cancer (PCa) patients with locally advanced disease, but is associated with side effects that may impair daily function. Strength training may counteract several side effects of ADT, such as changes in body composition and physical functioning, which in turn may affect health-related quality of life (HRQOL). However, additional randomised controlled trials are needed to expand this knowledge. MATERIAL AND METHODS: Fifty-eight PCa patients on ADT were randomised to either 16 weeks of high-load strength training (n = 28) or usual care (n = 30). The primary outcome was change in total lean body mass (LBM) assessed by dual x-ray absorptiometry (DXA). Secondary outcomes were changes in regional LBM, fat mass, and areal bone mineral density (aBMD) measured by DXA; physical functioning assessed by 1-repetition maximum (1RM) tests, sit-to-stand test, stair climbing test and Shuttle walk test; and HRQOL as measured by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30. RESULTS AND CONCLUSION: No statistically significant effect of high-load strength training was demonstrated on total LBM (p = 0.16), but significant effects were found on LBM in the lower and upper extremities (0.49 kg, p < 0.01 and 0.15 kg, p < 0.05, respectively). Compared to usual care, high-load strength training showed no effect on fat mass, aBMD or HRQOL, but beneficial effects were observed in all 1RM tests, sit-to-stand test and stair climbing tests. Adherence to the training program was 88% for lower body exercises and 84% for upper body exercises. In summary, high-load strength training improved LBM in extremities and physical functioning, but had no effect on fat mass, aBMD, or HRQOL in PCa patients on ADT.","Acta Oncol, 54(10): 1805-1813","Norway,Canada",2015,"Advanced","Various,Hormonal","EORTC QLQ-C30","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General"]
[502,"Nilssen, S. R., et al. (2012). \"Does physiotherapist-guided pelvic floor muscle training increase the quality of life in patients after radical prostatectomy? A randomized clinical study.\" Scand J Urol Nephrol 46(6): 397-404.",null,"Nilssen, S. R., et al.","Does physiotherapist-guided pelvic floor muscle training increase the quality of life in patients after radical prostatectomy? A randomized clinical study","OBJECTIVE: The aim of this study was to study the effect of postoperative physiotherapist-guided pelvic floor muscle training (PFMT) on health-related quality of life (HRQoL) parameters in patients treated with radical prostatectomy (RP). MATERIAL AND METHODS: A prospective randomized controlled trial was conducted at St. Olavs Hospital, Trondheim University Hospital, Norway. Eighty-five men were randomized into two intervention groups (A and B). patients in group A (n = 42) were offered physiotherapist-guided PFMT (in groups or by DVD) once weekly throughout the first 12 months after RP, while those in group B (n = 43) trained on their own. HRQoL data were assessed using the University of California, Los Angeles Prostate Cancer Index (UCLA-PCI) and the Short Form-12 (SF-12) health survey. The physical component summary (PCS) and mental component summary (MCS) scores of the SF-12 plus the urinary, sexual and bowel function and bother of the UCLA-PCI make up the eight quality of life outcomes used in this study. Data were obtained preoperatively (baseline), 6 weeks, and 3, 6 and 12 months postoperatively. RESULTS: Eighty patients completed at least one follow-up assessment, 38 in group A and 42 in group B, giving a dropout rate of 5.9%. The overall response rates were 96% at baseline, 83% at 6 weeks, 90% at 3 months, 88% at 6 months and 68% at 12 months. No statistically significant difference in HRQoL was found between groups A and B. CONCLUSIONS: Even though physiotherapist-guided training of the pelvic floor muscles after RP improved postoperative urinary incontinence significantly compared to those patients receiving standard care/training, this was not reflected in better outcome in HRQoL parameters.","Scand J Urol Nephrol, 46(6): 397-404","Norway",2012,"Any or unknown","Surgery,Various","SF-12,UCLA-PCI","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,Utility"]
[503,"Nilsson, S., et al. (2016). \"Patient-reported quality-of-life analysis of radium-223 dichloride from the phase III ALSYMPCA study.\" Ann Oncol 27(5): 868-874.",null,"Nilsson, S., et al.","Patient-reported quality-of-life analysis of radium-223 dichloride from the phase III ALSYMPCA study","BACKGROUND: Radium-223 dichloride (radium-223), a first-in-class alpha-emitting radiopharmaceutical, is recommended in both pre- and post-docetaxel settings in patients with castration-resistant prostate cancer (CRPC) and symptomatic bone metastases based on overall survival benefit demonstrated in the phase III ALSYMPCA study. ALSYMPCA included prospective measurements of health-related quality of life (QOL) using two validated instruments: the general EuroQoL 5D (EQ-5D) and the disease-specific Functional Assessment of Cancer Therapy-Prostate (FACT-P). PATIENTS AND METHODS: Analyses were conducted to determine treatment effects of radium-223 plus standard of care (SOC) versus placebo plus SOC on QOL using FACT-P and EQ-5D. Outcomes assessed were percentage of patients experiencing improvement, percentage of patients experiencing worsening, and mean QOL scores during the study. RESULTS: Analyses were carried out on the intent-to-treat population of patients randomized to receive radium-223 (n = 614) or placebo (n = 307). The mean baseline EQ-5D utility and FACT-P total scores were similar between treatment groups. A significantly higher percentage of patients receiving radium-223 experienced meaningful improvement in EQ-5D utility score on treatment versus placebo {29.2% versus 18.5%, respectively; P = 0.004; odds ratio (OR) = 1.82 [95% confidence interval (CI) 1.21-2.74]}. Findings were similar for FACT-P total score [24.6% versus 16.1%, respectively; P = 0.020; OR = 1.70 (95% CI 1.08-2.65)]. A lower percentage of patients receiving radium-223 experienced meaningful worsening versus placebo measured by EQ-5D utility score and FACT-P total score. Prior docetaxel use and current bisphosphonate use did not affect these findings. Treatment was a significant predictor of EQ-5D utility score, with radium-223 associated with higher scores versus placebo (0.56 versus 0.50, respectively; P = 0.002). Findings were similar for FACT-P total score (99.08 versus 95.22, respectively; P = 0.004). CONCLUSIONS: QOL data from ALSYMPCA demonstrated that improved survival with radium-223 is accompanied by significant QOL benefits, including a higher percentage of patients with meaningful QOL improvement and a slower decline in QOL over time in patients with CRPC.","Ann Oncol, 27(5): 868-874","USA,UK",2016,"Metastatic","Radiotherapy","FACT-P,EQ-5D","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,Utility"]
[504,"Nishiyama, T., et al. (2004). \"Influence of hot flashes on quality of life in patients with prostate cancer treated with androgen deprivation therapy.\" Int J Urol 11(9): 735-741.",null,"Nishiyama, T., et al.","Influence of hot flashes on quality of life in patients with prostate cancer treated with androgen deprivation therapy","BACKGROUND: We surveyed patients with prostate cancer treated with androgen deprivation therapy to examine the influence of hot flashes on quality of life (QOL). METHODS: Fifty-five outpatients with prostate cancer (M0, 39; M1, 16) treated with androgen deprivation therapy (castration, 15; castration and antiandrogen, 40) were enrolled in this study. Mean duration of androgen deprivation therapy was 21 months (2-91 months). The patients were still being treated with androgen deprivation therapy at the time of the survey. The functional assessment of cancer therapy (FACT) was used as a QOL questionnaire for outpatients with prostate cancer treated with androgen deprivation therapy. Hot flash assessments were used to document the number and severity (mild, moderate, and severe) of daily hot flashes. The patients prescribed fluvoxamine maleate were reassessed for hot flashes 2 weeks after the prescription. RESULTS: Thirty-two of the 55 patients (58.2%) suffered from hot flashes. Hot flashes deteriorated the physical well-being subscale of QOL in patients with prostate cancer treated with androgen deprivation therapy (P = 0.043). There was a significant relationship between the desire to be treated for hot flashes and the hot flash assessments (P = 0.038). Fluvoxamine maleate was significantly effective in reducing hot flashes (P = 0.001). CONCLUSIONS: Hot flashes had adverse effects on the patients' physical status and deteriorated the patients' QOL. New treatment options such as fluvoxamine maleate might help simplify the often difficult management of hot flashes in patients with prostate cancer treated with androgen deprivation therapy.","Int J Urol, 11(9): 735-741","Japan",2004,"Any or unknown","Hormonal,Surgery","FACT-G","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Treatment"]
[505,"Noale, M., et al. (2017). \"Pros-IT CNR: an Italian prostate cancer monitoring project.\" Aging Clin Exp Res 29(2): 165-172.",null,"Noale, M., et al.","Pros-IT CNR: an Italian prostate cancer monitoring project","AIMS: The Pros-IT CNR project aims to monitor a sample of Italian males >/=18 years of age who have been diagnosed in the participating centers with incident prostate cancer, by analyzing their clinical features, treatment protocols and outcome results in relation to quality of life. METHODS: Pros-IT CNR is an observational, prospective, multicenter study. The National Research Council (CNR), Neuroscience Institute, Aging Branch (Padua) is the promoting center. Ninety-seven Italian centers located throughout Italy were involved. The field study began in September 1, 2014. Subjects eligible were diagnosed with biopsy-verified prostate cancer, naive. A sample size of 1500 patients was contemplated. A baseline assessment including anamnestic data, clinical history, risk factors, the initial diagnosis, cancer staging information and quality of life (Italian UCLA Prostate Cancer Index; SF-12 Scale) was completed. Six months after the initial diagnosis, a second assessment evaluating the patient's health status, the treatment carried out, and the quality of life will be made. A third assessment, evaluating the treatment follow-up and the quality of life, will be made 12 months after the initial diagnosis. The 4th, 5th, 6th and 7th assessments, similar to the third, will be completed 24, 36, 48 and 60 months after the initial diagnosis, respectively, and will include also a Food Frequency Questionnaire and the Physical Activity Scale for the Elderly. DISCUSSION: The study will provide information on patients' quality of life and its variations over time in relation to the treatments received for the prostate cancer.","Aging Clin Exp Res, 29(2): 165-172","Italy",2017,"Any or unknown","None","UCLA-PCI,SF-12","Patient",null,"Protocol",null,null,null,null,null,null,null,null,"Disease,Utility"]
[506,"Noguchi, M., et al. (2004). \"Early catheter removal 3 days after radical retropubic prostatectomy.\" Int J Urol 11(11): 983-988.",null,"Noguchi, M., et al.","Early catheter removal 3 days after radical retropubic prostatectomy","AIM: We investigated the feasibility and safety of the early removal of urethral catheters 3 days after radical retropubic prostatectomy. METHODS: Seventy consecutive patients underwent radical retropubic prostatectomy with the intent of early catheter removal on postoperative day (POD) 3. Catheter removal was based on postoperative cystograms performed on POD 2. Patients were analyzed using a validated prostate cancer specific questionnaire (University of California, Los Angeles Prostate Cancer Symptom Index) to determine quality of life outcomes. Multiple logistic regression analysis was also used to evaluate if any of the preoperative or intraoperative parameters were able to predict the success of early catheter removal after radical retropubic prostatectomy. RESULTS: The catheter was removed on POD 3 in 67 of 70 patients (97%) excluding three patients with moderate or severe extravasation on postoperative cystograms. Of the 67 patients, 53 (76%) were successful in early catheter removal, but the remaining 14 (24%) patients experienced urinary retention within 48 h and were treated with simple catheter replacement for 1 or 2 days. Two patients developed anastomotic strictures 3 and 4 months postoperatively, which were managed by dilation alone. Multiple logistic regression analysis showed that no leak during an intraoperative leak test was the only independent predictor of success for early catheter removal (P = 0.0069; odds ratio, 6.667; 95% confidence interval, 1.682-26.428). CONCLUSION: The present study revealed that early catheter removal 3 days after radical retropubic prostatectomy is feasible in patients who show a negative intraoperative leak test. Postoperative monitoring of more patients is needed to determine if the early catheter removal is widely applicable.","Int J Urol, 11(11): 983-988","Japan",2004,"Any or unknown","Surgery","UCLA-PCI","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease"]
[507,"Noldus, J., et al. (2002). \"Patient-reported sexual function after nerve-sparing radical retropubic prostatectomy.\" Eur Urol 42(2): 118-124.",null,"Noldus, J., et al.","Patient-reported sexual function after nerve-sparing radical retropubic prostatectomy","OBJECTIVE: Improved selection criteria have lead to an increasing number of nerve-sparing radical retropubic prostatectomies (RRP) in patients with clinically localised prostate cancer (PCA). Patient questionnaire based outcome analysis on post-operative erectile function after uni- or bilateral nerve-sparing RRP is described. METHODS: Between January 1992 and March 1999, 366 patients (mean age 62.5 years) underwent uni- or bilateral nerve-sparing RRP at our institution. Indication for nerve-sparing procedure was based on the results of a multivariate classification and regression tree analysis (CART). For evaluation of post-operative patient-reported rates of sexual and erectile function non-validated and validated questionnaires (IIEF 5) were administered after a follow-up of 12 months. Data of five operation periods were analysed. RESULTS: The unilateral procedure resulted in rates of 13-29% of erections sufficient for unassisted intercourse. Some degree of tumescence was reported by 37-73% of the remaining patients. Bilateral nerve-sparing procedures were almost exclusively performed in periods 3-5, only four patients of period 2 received the bilateral procedure. Here, rates of erections sufficient for intercourse were 25% (period 2), 61% (period 3), 50% (period 4), and 52% (period 5), respectively. Patients with grades 4 and 5 erections had IIEF scores of 19.2 and 20.2 and patients without rigidity or tumescence had scores of 5.7 and 7.0 after uni- and bilateral nerve-sparing procedure, respectively. Patients <60 years of age had better erections than those > or =60 (unilateral: 19% versus 13%, bilateral 45% versus 38%). CONCLUSION: Compared to a unilateral nerve-sparing procedure, the bilateral nerve-sparing technique revealed much better results inasmuch as about 50% of the patients reported recovery of erections sufficient for sexual intercourse without use of sexual aids.","Eur Urol, 42(2): 118-124","Germany",2002,"Local","Surgery","IIEF-5","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Complication"]
[508,"Norkus, D., et al. (2013). \"A randomized hypofractionation dose escalation trial for high risk prostate cancer patients: interim analysis of acute toxicity and quality of life in 124 patients.\" Radiat Oncol 8: 206.",null,"Norkus, D., et al.","A randomized hypofractionation dose escalation trial for high risk prostate cancer patients: interim analysis of acute toxicity and quality of life in 124 patients","BACKGROUND: The alpha/beta ratio for prostate cancer is postulated being in the range of 0.8 to 2.2 Gy, giving rise to the hypothesis that there may be a therapeutic advantage to hypofractionation. To do so, we carried out a randomized trial comparing hypofractionated and conventionally fractionated image-guided intensity modulated radiotherapy (IG-IMRT) in high-risk prostate cancer. Here, we report on acute toxicity and quality of life (QOL) for the first 124 randomized patients. METHODS: The trial compares 76 Gy in 38 fractions (5 fractions/week) (Arm 1) to 63 Gy in 20 fractions (4 fractions/week) (Arm 2) (IG-IMRT). Prophylactic pelvic lymph node irradiation with 46 Gy in 23 fractions sequentially (Arm 1) and 44 Gy in 20 fractions simultaneously (Arm 2) was applied. All patients had long term androgen deprivation therapy (ADT) started before RT. Both physician-rated acute toxicity and patient-reported QOL using EPIC questionnaire are described. RESULTS: There were no differences in overall maximum acute gastrointestinal (GI) or genitourinary (GU) toxicity. Compared to conventional fractionation (Arm 1), GI and GU toxicity both developed significantly earlier but also disappeared earlier in the Arm 2, reaching significant differences from Arm 1 at week 8 and 9. In multivariate analyses, only parameter shown to be related to increased acute Grade >/=1 GU toxicity was the study Arm 2 (p = 0.049). There were no statistically significant differences of mean EPIC scores in any domain and sub-scales. The clinically relevant decrease (CRD) in EPIC urinary domain was significantly higher in Arm 2 at month 1 with a faster recovery at month 3 as compared to Arm 1. CONCLUSIONS: Hypofractionation at 3.15 Gy per fraction to 63 Gy within 5 weeks was well tolerated. The GI and GU physician-rated acute toxicity both developed earlier but recovered faster using hypofractionation. There was a correlation between acute toxicity and bowel and urinary QOL outcomes. Longer follow-up is needed to determine the significance of these associations with late toxicity.","Radiat Oncol, 8(206","Lithuania",2013,"Any or unknown","Radiotherapy,Hormonal","EPIC","HCP,Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,Treatment"]
[509,"Nussbaum, N., et al. (2016). \"Patient experience in the treatment of metastatic castration-resistant prostate cancer: state of the science.\" Prostate Cancer Prostatic Dis 19(2): 111-121.",null,"Nussbaum, N., et al.","Patient experience in the treatment of metastatic castration-resistant prostate cancer: state of the science","BACKGROUND: Contemporary therapies for metastatic castration-resistant prostate cancer (mCRPC) have shown survival improvements, which do not account for patient experience and health-related quality of life (HRQoL). METHODS: This literature review included a search of MEDLINE for randomized clinical trials enrolling 50 patients with mCRPC and reporting on patient-reported outcomes (PROs) since 2010. RESULTS: Nineteen of 25 publications describing seven treatment regimens (10 clinical trials and nine associated secondary analyses) met the inclusion criteria and were critically appraised. The most commonly used measures were the Functional Assessment of Cancer Therapy-Prostate (n=5 trials) and Brief Pain Inventory Short Form (n=4 trials) questionnaires. The published data indicated that HRQoL and pain status augmented the clinical efficacy data by providing a better understanding of treatment impact in mCRPC. Abiraterone acetate and prednisone, enzalutamide, radium-223 dichloride and sipuleucel-T offered varying levels of HRQoL benefit and/or pain mitigation versus their respective comparators, whereas three treatments (mitoxantrone, estramustine phosphate and docetaxel, and cabazitaxel) had no meaningful impact on HRQoL or pain. The main limitation of the data were that the PROs utilized were not developed for use in mCRPC patients and hence may not have comprehensively captured symptoms important to this population. CONCLUSIONS: Recently published randomized clinical trials of new agents for mCRPC have captured elements of the patient experience while on treatment. Further research is required to standardize methods for measuring, quantifying and reporting on HRQoL and pain in patients with mCRPC in the clinical practice setting.","Prostate Cancer Prostatic Dis, 19(2): 111-121","International",2016,"Metastatic","Taxane,Chemotherapy,Brachytherapy,Abiraterone","FACT-P,BPI","Patient",null,"Systematic review",null,null,null,null,null,null,null,null,"Disease,Symptom"]
[510,"Nyarangi-Dix, J. N., et al. (2013). \"Impact of complete bladder neck preservation on urinary continence, quality of life and surgical margins after radical prostatectomy: a randomized, controlled, single blind trial.\" J Urol 189(3): 891-898.",null,"Nyarangi-Dix, J. N., et al.","Impact of complete bladder neck preservation on urinary continence, quality of life and surgical margins after radical prostatectomy: a randomized, controlled, single blind trial","PURPOSE: We investigated the influence of bladder neck preservation on urinary continence, quality of life and surgical margins after radical prostatectomy. MATERIALS AND METHODS: A total of 208 men who presented for radical prostatectomy were randomized to complete bladder neck preservation with subsequent urethro-urethral anastomosis or to no preservation as controls. Patients with failed bladder neck preservation were not included in study. We documented objective continence by the 24-hour pad test, social continence by the number of pads per day and quality of life outcomes by the validated Incontinence Quality of Life questionnaire in a single blind setting. Cancer resection was assessed by surgical margin status. RESULTS: At 0, 3, 6 and 12 months mean urine loss in the control vs the bladder neck preservation group was 713.3 vs 237.0, 49.6 vs 15.6, 44.4 vs 5.5 and 25.4 vs 3.1 gm, respectively (each p <0.001). At 3, 6 and 12 months in the control vs the preservation group the social continence rate was 55.3% vs 84.2% (p <0.001), 74.8% vs 89.5% (p = 0.05) and 81.4% vs 94.7% (p = 0.027), and the quality of life score was 80.4 vs 90.3 (p <0.001), 85.4 vs 91.7 (p = 0.016) and 86.0 vs 93.8 (p = 0.001), respectively. We noted significantly less urine loss, higher objective and social continence rates, and higher quality of life scores after complete bladder neck preservation at all followup points. On multiple logistic regression analysis complete bladder neck preservation was an independent positive predictor of continence. No significant difference was found in surgical margin status between the control and bladder neck preservation groups (12.5% vs 14.7%, p = 0.65). CONCLUSIONS: In what is to our knowledge the first prospective, randomized, controlled, single blind trial complete bladder neck preservation during radical prostatectomy was associated with a significantly higher urinary continence rate and increased patient satisfaction without compromising resection margins.","J Urol, 189(3): 891-898","Germany",2013,"Any or unknown","Surgery","I-QoL","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Complication"]
[511,"Nygard, R., et al. (2001). \"Goserelin (Zoladex) or orchiectomy in metastatic prostate cancer? A quality of life and cost-effectiveness analysis.\" Anticancer Res 21(1b): 781-788.",null,"Nygard, R., et al.","Goserelin (Zoladex) or orchiectomy in metastatic prostate cancer? A quality of life and cost-effectiveness analysis","BACKGROUND: We have today two treatment alternatives (orchiectomy or LHRH-analogue) in metastatic prostate cancer offering the same expectations of survival. This study documents the quality of life (QoL) and cost-effectiveness of these alternatives. PATIENTS AND METHODS: 65 consecutive patients treated at the University Hospital of Tromso (UHT), Norway, between 1994 and 1999 were registered. At evaluation, 45 patients (LHRH-analogue--15 patients, orchiectomy--30 patients) were alive and included in the QoL-study (EORTC QLQ C-30, QoL 15D). 45 patients were followed-up at the UHT and included in the cost-analysis. Costs were calculated for a 36-month interval and converted to British pounds (1 Pound = 13 NOK). A 5% d.r. was employed. RESULTS: The mean QoL (15D) was 76.4 (orchiectomy) and 72 (LHRH) (0-100 scale). Constipation, urinating problems, fatigue, pain and loss of sexual functioning were the dominant symptoms. The treatment costs per patient treated were 8,895 Pounds (orchiectomy) and 10,937 Pounds (LHRH-analogue). The crossover in cost was located at 25 months. A sensitivity analysis varying discount rate (0-10%), drug charges (25-50% off) and treatment time (12-18 months) did not alter the conclusion. CONCLUSION: Orchiectomy is the treatment of choice when life expectancy is more than two years.","Anticancer Res, 21(1b): 781-788","Norway",2001,"Metastatic","Hormonal,Surgery","EORTC QLQ-C30,15D","Patient",null,"Economic model",null,null,null,null,null,null,null,null,"General,Utility"]
[512,"O'Callaghan, M. E., et al. (2017). \"Patient-Reported Outcomes After Radiation Therapy in Men With Prostate Cancer: A Systematic Review of Prognostic Tool Accuracy and Validity.\" Int J Radiat Oncol Biol Phys 98(2): 318-337.",null,"O'Callaghan, M. E., et al.","Patient-Reported Outcomes After Radiation Therapy in Men With Prostate Cancer: A Systematic Review of Prognostic Tool Accuracy and Validity","PURPOSE: To identify, through a systematic review, all validated tools used for the prediction of patient-reported outcome measures (PROMs) in patients being treated with radiation therapy for prostate cancer, and provide a comparative summary of accuracy and generalizability. METHODS AND MATERIALS: PubMed and EMBASE were searched from July 2007. Title/abstract screening, full text review, and critical appraisal were undertaken by 2 reviewers, whereas data extraction was performed by a single reviewer. Eligible articles had to provide a summary measure of accuracy and undertake internal or external validation. Tools were recommended for clinical implementation if they had been externally validated and found to have accuracy >/=70%. RESULTS: The search strategy identified 3839 potential studies, of which 236 progressed to full text review and 22 were included. From these studies, 50 tools predicted gastrointestinal/rectal symptoms, 29 tools predicted genitourinary symptoms, 4 tools predicted erectile dysfunction, and no tools predicted quality of life. For patients treated with external beam radiation therapy, 3 tools could be recommended for the prediction of rectal toxicity, gastrointestinal toxicity, and erectile dysfunction. For patients treated with brachytherapy, 2 tools could be recommended for the prediction of urinary retention and erectile dysfunction. CONCLUSIONS: A large number of tools for the prediction of PROMs in prostate cancer patients treated with radiation therapy have been developed. Only a small minority are accurate and have been shown to be generalizable through external validation. This review provides an accessible catalogue of tools that are ready for clinical implementation as well as which should be prioritized for validation.","Int J Radiat Oncol Biol Phys, 98(2): 318-337","International",2017,"Any or unknown","Radiotherapy","Unclear","Patient",null,"Systematic review,Validation",null,null,null,null,null,null,null,null,"Complication"]
[513,"Oefelein, M. (2003). \"Health related quality of life using serum testosterone as the trigger to re-dose long acting depot luteinizing hormone-releasing hormone agonists in patients with prostate cancer.\" J Urol 169(1): 251-255.",null,"Oefelein, M.","Health related quality of life using serum testosterone as the trigger to re-dose long acting depot luteinizing hormone-releasing hormone agonists in patients with prostate cancer","PURPOSE: Health related quality of life was assessed in patients with prostate cancer on androgen suppression therapy re-dosed based on serum testosterone, and observations were confirmed regarding the safety, efficacy and cost per patient treated with this method of re-dosing luteinizing hormone-releasing hormone agonists. MATERIALS AND METHODS: The study comprised 22 patients with prostate cancer prospectively enrolled in a control-crossover designed trial of dosing depot luteinizing hormone-releasing hormone agonist based on serum testosterone. Health related quality of life using the Expanded Prostate Index Composite and SF-36 instruments was the primary outcome assessed. RESULTS: Median duration of castrate testosterone was 5.5 months (range 3.5 to 10). Longer durations of castrate testosterone significantly correlated with lower pretreatment serum testosterone and smaller body mass index. No significant change from nadir prostate specific antigen was observed during castrate duration. The yearly cost of care was significantly decreased using the method of re-dosing based on serum testosterone ($3,567.90 versus $7,135.80). Short-term overall health related quality of life and patient satisfaction were significantly improved over baseline measurements. However, by study completion overall health related quality of life was equivalent regardless of the dosing method. CONCLUSIONS: Patient assessed health related quality of life improved in the short term and the cost of care decreased with no loss in the quality of care or patient satisfaction using serum testosterone as the trigger to re-dose 10.8 mg. goserelin in patients with prostate cancer on androgen suppression therapy.","J Urol, 169(1): 251-255","USA",2003,"Any or unknown","Hormonal","SF-36,EPIC","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,Utility"]
[514,"Oefelein, M. G. (2004). \"Prospective predictors of urinary continence after anatomical radical retropubic prostatectomy: a multivariate analysis.\" World J Urol 22(4): 267-271.",null,"Oefelein, M. G.","Prospective predictors of urinary continence after anatomical radical retropubic prostatectomy: a multivariate analysis","The aim of this work was to evaluate variables that predict time to pad-free urinary continence after anatomical radical prostatectomy (ARP). Sixty consecutive prostate cancer patients who underwent ARP by one surgeon were studied. Pad-free urinary continence was prospectively determined by patient interviews and confirmed on physical examination and by the urinary domain of the Extended Prostate Inventory Composite (EPIC) Health Related Quality of Life questionnaire. A time-dependent Cox multivariate regression analysis was performed to determine which variables significantly correlated with time to pad-free urinary continence. Increasing prostate size (cc), increasing prostate urethral length (cm) and surgical technique (wide excision of the neuro-vascular bundle) correlated with a significantly (P<0.05) prolonged time to achieve pad-free urinary continence. In conclusion, prostate size and surgical technique were the most useful variables in predicting time to pad-free urinary continence after ARP.","World J Urol, 22(4): 267-271","USA",2004,"Any or unknown","Surgery","EPIC","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease"]
[515,"Okihara, K., et al. (2012). \"Quantitative evaluation of lower urinary tract symptoms using a visual analog scale in men undergoing permanent brachytherapy.\" Brachytherapy 11(4): 265-270.",null,"Okihara, K., et al.","Quantitative evaluation of lower urinary tract symptoms using a visual analog scale in men undergoing permanent brachytherapy","PURPOSE: A previous study showed that a visual analog scale (VAS) that measures quality of life (QOL) in relation to each of the seven items on the International Prostate Symptom Score (IPSS) was found to be significantly more able to identify a patient's chief complaint. The aim of this study was to assess the two questionnaires with special reference to the symptom that the patient most wants treated via the concomitant use of the IPSS and VAS after permanent brachytherapy (PBT). METHODS AND MATERIALS: A total of 156 men undergoing PBT were enrolled. The IPSS and VAS were evaluated at the preimplantation stage and at 1-3 months, 6-9 months, and 1 year after PBT. The correlations between the IPSS-QOL score and the total for the 14 symptoms questions included in the IPSS and VAS were statistically calculated. Multivariate analysis was used to investigate which factors could be used to predict the IPSS-QOL after PBT. RESULTS: The correlation coefficients between the IPSS-QOL score and the seven questions on the VAS were higher than those between the IPSS-QOL and the seven questions on the IPSS. Multivariate analysis showed that the strongest factor for determining IPSS-QOL at each time point was nocturia on the VAS. CONCLUSIONS: The VAS scale reflected the change in the patients' QOL more precisely than the IPSS, which examines the frequency of lower urinary tract symptoms. Nocturia plays a key role in determining QOL. VAS could be a promising tool for assessing satisfaction in patients with lower urinary tract symptoms after PBT.","Brachytherapy, 11(4): 265-270","Japan",2012,"Any or unknown","Brachytherapy","VAS,IPSS","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease"]
[516,"O'Leary, E., et al. (2015). \"Psychometric evaluation of the EORTC QLQ-PR25 questionnaire in assessing health-related quality of life in prostate cancer survivors: a curate's egg.\" Qual Life Res 24(9): 2219-2230.",null,"O'Leary, E., et al.","Psychometric evaluation of the EORTC QLQ-PR25 questionnaire in assessing health-related quality of life in prostate cancer survivors: a curate's egg","PURPOSE: The EORTC QLQ-PR25 was primarily developed to measure disease-specific health-related quality of life (HRQoL) of prostate cancer (PCa) patients undergoing active treatment. The growing number of cancer survivors has focussed interest on assessing survivors' HRQoL. We evaluated psychometric properties of the EORTC QLQ-PR25 questionnaire amongst PCa survivors. METHODS: A postal questionnaire, including the QLQ-PR25, was administered to 6559 PCa survivors 2-18 years post-diagnosis, identified through population-based cancer registries in Ireland; 3348 participated. The QLQ-PR25 has been suggested to have five multi-item subscales measuring urinary (US), bowel (BS) and hormone treatment-related symptoms (TS), sexual activity (SA) and sexual functioning (SF), and a single item measuring bother due to using incontinence aids (IA). Reliability analysis, divergent validity, discriminant validity (compared to EORTC QLQ-C30, DASS-21 and EuroQoL EQ-5D-5L), and exploratory and confirmatory factor analysis (EFA, CFA) were undertaken. RESULTS: The percentage of survivors completing QLQ-PR25 subscales was: US-79 %; IA-20 %; BS-83 %; TS-86 %; SA-87 %; and SF-26 %. Reliability was acceptable (Cronbach's alpha > 0.7) for three subscales (US, SA, SF). The instrument discriminated well between clinically distinct groups, especially those defined by primary treatment(s) and stage at diagnosis. The SA and SF subscales showed good discriminant validity compared to QLQ-C30, DASS-21 and EQ-5D-5L; other subscales did not. EFA reproduced a near fit to the proposed factor structure. CFA confirmed this. CONCLUSION: This is the largest ever QLQ-PR25 validation study. When used in PCa survivors, although the proposed factor structure was confirmed, some of the subscales (e.g. BS and TS) showed poor reliability, a lack of discriminant validity and moderate levels of item non-response.","Qual Life Res, 24(9): 2219-2230","Ireland",2015,"Survivors","None","EORTC QLQ-PR25,EORTC QLQ-C30,EQ-5D,DASS-21","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease,General,Comorbidity"]
[517,"Organ, M., et al. (2013). \"Intermittent LHRH therapy in the management of castrate-resistant prostate cancer (CRPCa): results of a multi-institutional randomized prospective clinical trial.\" Am J Clin Oncol 36(6): 601-605.",null,"Organ, M., et al.","Intermittent LHRH therapy in the management of castrate-resistant prostate cancer (CRPCa): results of a multi-institutional randomized prospective clinical trial","BACKGROUND: Patients who develop castration-resistant prostate cancer (CRPCa) typically continue on androgen deprivation therapy (ADT). Whether these patients need to remain on ADT has not been well studied. We conducted a multicenter randomized trial to compare an intermittent versus continuous approach to ADT in CRPCa patients. Overall survival, health-related quality of life (QOL), and cost were the main endpoints. METHODS: CRPCa patients were randomized 2:1 to intermittent or continuous luteinizing hormone-releasing hormone agonists (LHRHa). Patients were followed with clinical assessments, laboratory investigations, and QOL questionnaires (EORTC QLQ-C30 or PROSQOLI) every 2 months. If the serum testosterone rose above castrate levels (1.75 nmol/L), LHRHa were reinitiated. The study was designed to close if >50% of patients needed to restart ADT in the intermittent arm. RESULTS: Thirty-one patients were followed with a median follow-up of 26.8 months-18 in the intermittent arm and 13 in the continuous. Twelve of 18 patients on the intermittent arm were reinitiated on LHRHa at a median time of 17.9 months. There was no difference in overall or cancer-specific survival between the 2 arms. There was no statistically significant difference in QOL between the 2 arms at 0 and 12 months. The total mean costs at 24 months were significantly lower in the intermittent arm ($3135 vs. $8253 Canadian dollars, P=0.0167) compared with the continuous. The main limitation of this study is the small sample size. CONCLUSIONS: We have observed that intermittent ADT in patients with CRPCa, using a testosterone of >1.75 ngmol/L as a trigger to reinitiate LHRHa, results in a substantial cost savings with no negative impact on oncologic and QOL outcomes.","Am J Clin Oncol, 36(6): 601-605","Canada",2013,"Any or unknown","Hormonal","EORTC QLQ-C30,PROSQOLI","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,General"]
[518,"O'Shaughnessy, P. K., et al. (2013). \"Differences in self-reported outcomes of open prostatectomy patients and robotic prostatectomy patients in an international web-based survey.\" Eur J Oncol Nurs 17(6): 775-780.",null,"O'Shaughnessy, P. K., et al.","Differences in self-reported outcomes of open prostatectomy patients and robotic prostatectomy patients in an international web-based survey","OBJECTIVES: To compare patient reported outcomes between robotic assisted surgery and non-robotic assisted surgery. METHODS: This was an international web-based survey based on a qualitative research and literature review, an internet-based questionnaire was developed with approximately 70 items. The questionnaire included both closed and open-ended questions. RESULTS: Responses were received from 193 men of whom 86 had received either open (OP) or robotic (RALP) surgery. A statistically significant (p=0.027), ranked analysis of covariance was found demonstrating higher recent distress in the robotic (RALP) surgery group. Although not statistically significant, there was a pattern of men having robotic (RALP) surgery reporting fewer urinary and bowel problems, but having a greater rate of sexual dysfunction. CONCLUSIONS: Men who opt for robotic surgery may have higher expectations for robotic (RALP) surgery, when these expectations are not fully met they may be less likely to accept the consequences of this major cancer surgery. Information regarding surgical choice needs to be tailored to ensure that men diagnosed with prostate cancer are fully informed of not only short term surgical and physical outcomes such as erectile dysfunction and incontinence, but also of potential issues with regards to masculinity, lifestyle and sexual health.","Eur J Oncol Nurs, 17(6): 775-780","Australia",2013,"Any or unknown","Surgery","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Complication"]
[519,"Osoba, D., et al. (1999). \"Health-related quality of life in men with metastatic prostate cancer treated with prednisone alone or mitoxantrone and prednisone.\" J Clin Oncol 17(6): 1654-1663.",null,"Osoba, D., et al.","Health-related quality of life in men with metastatic prostate cancer treated with prednisone alone or mitoxantrone and prednisone","PURPOSE: A combination of mitoxantrone plus prednisone is preferable to prednisone alone for reduction of pain in men with metastatic, hormone-resistant, prostate cancer. The purpose of this study was to assess the effects of these treatments on health-related quality of life (HQL). PATIENTS AND METHODS: Men with metastatic prostate cancer (n = 161) were randomized to receive either daily prednisone alone or mitoxantrone (every 3 weeks) plus prednisone. Those who received prednisone alone could have mitoxantrone added after 6 weeks if there was no improvement in pain. HQL was assessed before treatment initiation and then every 3 weeks using the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire C30 (EORTC QLQ-C30) and the Quality of Life Module-Prostate 14 (QOLM-P14), a trial-specific module developed for this study. An intent-to-treat analysis was used to determine the mean duration of HQL improvement and differences in improvement duration between groups of patients. RESULTS: At 6 weeks, both groups showed improvement in several HQL domains, and only physical functioning and pain were better in the mitoxantrone-plus-prednisone group than in the prednisone-alone group. After 6 weeks, patients taking prednisone showed no improvement in HQL scores, whereas those taking mitoxantrone plus prednisone showed significant improvements in global quality of life (P =.009), four functioning domains, and nine symptoms (.001 < P <. 01), and the improvement (> 10 units on a scale of 0 to100) lasted longer than in the prednisone-alone group (.004 < P <.05). The addition of mitoxantrone to prednisone after failure of prednisone alone was associated with improvements in pain, pain impact, pain relief, insomnia, and global quality of life (.001 < P <.003). CONCLUSION: Treatment with mitoxantrone plus prednisone was associated with greater and longer-lasting improvement in several HQL domains and symptoms than treatment with prednisone alone.","J Clin Oncol, 17(6): 1654-1663","Canada",1999,"Metastatic","Chemotherapy","EORTC QLQ-C30,QOLM-P14","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,General"]
[520,"Ott, C. and M. K. Fulton (2005). \"Osteoporosis risk and interest in strength training in men receiving androgen ablation therapy for locally advanced prostate cancer.\" J Am Acad Nurse Pract 17(3): 113-122.",null,"Ott, C. and M. K. Fulton","Osteoporosis risk and interest in strength training in men receiving androgen ablation therapy for locally advanced prostate cancer","PURPOSE: The overall purpose of this preliminary study to a clinical trial is to explore the feasibility of recruiting men receiving androgen ablation therapy (AAT) for locally advanced prostate cancer to a future strength training study for the prevention of osteoporosis. The threefold specific purpose of this comparative and correlational study is to (a) describe the prevalence of risk factors for osteoporosis, (b) compare functional status and symptom distress between those interested and not interested in a future strength training study, and (c) examine relationships among self-efficacy for strength training, functional status, symptom distress, years since cancer diagnosis, and cumulative dose of AAT in this at-risk population. METHOD: Data were obtained from 40 Caucasian men (mean age = 75.8 years) with locally advanced prostate cancer, capable of self-care, and receiving AAT. The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ) EORTC QLQ-C30 and EORTC QLQ-PR25 (prostate cancer specific) were used to measure functional status and symptom distress. A 6-item, investigator-developed questionnaire was used to measure self-efficacy for learning and overcoming barriers to strength training. CONCLUSIONS: The majority of these men had multiple risk factors for osteoporosis, in addition to receiving AAT, and had not completed bone mineral density (BMD) testing. A high percentage (67.5%) expressed interest in a future strength training protocol for osteoporosis prevention; functional status and symptom distress did not appear to influence this interest. Several aspects of functional status and symptom distress were significantly related to self-efficacy for learning and overcoming barriers to strength training. Years since cancer diagnosis and cumulative dose of AAT were not significantly related to self-efficacy for strength training, but age was related. This study informs a planned future experimental study by establishing the recruitment potential and the decreased likelihood of symptom distress interfering with self-efficacy for participation in strength training. IMPLICATIONS FOR PRACTICE: Advanced practice nurses should complete assessments for osteoporosis risk factors, monitor height loss, order BMD testing and bone enhancing medications, and discuss lifestyle modifications including strength training to improve bone health in men receiving AAT for prostate cancer.","J Am Acad Nurse Pract, 17(3): 113-122","USA",2005,"Advanced","Hormonal","EORTC QLQ-C30,EORTC QLQ-PR25","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Disease,General"]
[521,"Pannek, J., et al. (1997). \"Quality of life of patients with renal cell carcinoma or prostate cancer after radical surgery.\" Int Urol Nephrol 29(6): 637-643.",null,"Pannek, J., et al.","Quality of life of patients with renal cell carcinoma or prostate cancer after radical surgery","OBJECTIVES: To study the impact of radical tumour surgery in prostate and renal cell cancer patients on quality of life (QOL). METHODS: In 38 male patients suffering from organ-confined prostate or renal cell cancer, a prospective study was performed. For the evaluation of QOL, we used the EMPK (Erfassung multipler psychischer Konstrukte). Urologic symptoms were evaluated with a specially designed symptom score. The test instrument was filled out the day before surgery and one year after operation. RESULTS: The EMPK was able to detect and describe significant changes in certain aspects of QOL in renal cell cancer and prostate cancer patients. Moreover, there seems to be a difference between the two groups. A direct relation between QOL and the different quality and quantity of operation-related symptoms, however, could not be proven. CONCLUSIONS: In this pilot study, radical surgical therapy did not significantly change QOL in prostate cancer patients, but seemed to have a positive influence on the QOL of renal cell cancer patients.","Int Urol Nephrol, 29(6): 637-643","Germany",1997,"Any or unknown","Surgery","EMPK","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"General"]
[522,"Papatheofanis, F. J., et al. (2009). \"Improvement in sensory pain rating after palliative systemic radionuclide therapy in patients with advanced prostate cancer.\" Am J Ther 16(2): 127-132.",null,"Papatheofanis, F. J., et al.","Improvement in sensory pain rating after palliative systemic radionuclide therapy in patients with advanced prostate cancer","This study assessed whether baseline and short-term patient-reported quality of life (QOL) differs in patients with symptomatic metastatic prostate cancer undergoing palliative management using opioids, nonsteroidal anti-inflammatory agents (NSAIDs), (89)strontium chloride ((89)Sr), and samarium-lexidronam ((153)Sm). Males were grouped according to primary palliative intervention: opioids (n = 40), NSAIDs (n = 40), (89)Sr chloride (n = 25), and (153)Sm (n = 25). The short form of the self-administered McGill Pain Questionnaire was used to measure QOL at baseline, 4 and 8 weeks after initiation of treatment. Clinical data were collected from patients' medical records. Statistical analyses were conducted using descriptive methods and the Student t test. A significant increase in the sensory pain rating was observed in the patients treated by NSAIDs ([upward arrow]21%) and (89)Sr ([upward arrow]46%), whereas those treated by opioids ([downward arrow]27%) and (153)Sm ([downward arrow]27%) demonstrated a significant (P < 0.05) decrease in this subscore. There was a longitudinal decrease in QOL over time in patients treated by NSAIDs and (89)Sr as measured by the total pain rating score, whereas those treated with the other agents experienced improved QOL. This study demonstrates improvement in QOL achieved using (153)Sm, which is comparable to that achieved with the use of opioids during this observation interval.","Am J Ther, 16(2): 127-132","USA",2009,"Metastatic","Palliative care","MPQ","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Symptom"]
[523,"Park, J., et al. (2013). \"Cross-cultural application of the Korean version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for patients with prostate cancer - EORTC QLQ-PR25.\" Oncology 85(5): 299-305.",null,"Park, J., et al.","Cross-cultural application of the Korean version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for patients with prostate cancer - EORTC QLQ-PR25","OBJECTIVE: We evaluated the psychometric properties of the Korean version of the European Organization for Research and Treatment of Cancer QLQ-PR25 when applied to Korean prostate cancer (PC) patients. METHODS: A total of 172 patients who underwent curative radical prostatectomy (RP) with or without adjuvant androgen deprivation therapy were asked to complete the Korean version of the EORTC QLQ-C30 and PR25 questionnaires 3 times (before and 3 and 6 months after RP). Psychometric evaluation of the questionnaire was conducted. RESULTS: Multitrait scaling analysis showed satisfactory construct validity in most scales except for bowel symptoms and hormonal treatment-related symptoms. Internal consistency tested by Cronbach's alpha coefficient met the 0.70 criterion for the urinary symptom, sexual activity and sexual functioning scales at the all 3 time points. Known-group comparison analyses showed better quality-of-life (QOL) scores in patients with higher performance status, and higher hormonal treatment-related symptom scores in patients on hormonal treatment. Responsiveness to changes was in line with clinical implications over time after RP. CONCLUSIONS: Our results show that the EORTC QLQ-PR25 questionnaire has adequate levels in cross-cultural validity. The Korean version of the EORTC QLQ-PR25 is a generally reliable and robust instrument for the assessment of various QOL aspects that can be self-administered to Korean PC patients undergoing RP.","Oncology, 85(5): 299-305","Korea",2013,"Any or unknown","Surgery,Hormonal","EORTC QLQ-C30,EORTC QLQ-PR25","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease,General"]
[524,"Park, S. W., et al. (2012). \"Recovery of overall exercise ability, quality of life, and continence after 12-week combined exercise intervention in elderly patients who underwent radical prostatectomy: a randomized controlled study.\" Urology 80(2): 299-305.",null,"Park, S. W., et al.","Recovery of overall exercise ability, quality of life, and continence after 12-week combined exercise intervention in elderly patients who underwent radical prostatectomy: a randomized controlled study","OBJECTIVE: To examine the changes from a combined exercise intervention after radical prostatectomy (RP) in elderly patients with prostate cancer, because randomized controlled trials addressing exercise intervention after RP have been lacking. METHODS: From May 2009 to May 2010, all patients who underwent laparoscopic RP were assessed for eligibility. A total of 66 patients were randomized to an exercise or a control group. The exercise group received a combined exercise intervention (resistance, flexibility, and Kegel exercises) twice a week for 12 weeks, and the control group received only Kegel exercises. The primary outcome was physical function, and the secondary outcomes were continence status and quality of life after the exercise intervention. RESULTS: A total of 49 patients completed follow-up to the end of study. After the 12-week exercise intervention, except for grip strength, all physical functions were better in the exercise group than in the control group. The 24-hour pad test results (12.2 g in the exercise group, 46.2 g in the control group) and continence rate (73.1% in exercise group, 43.5% in the control group) recovered more promptly in the exercise group. On a questionnaire study using the International Consultation on Incontinence questionnaire, Beck Depression Inventory, and Medical Outcomes Study 36-item short-form health survey, only the exercise group showed improvement at the last follow-up visit. CONCLUSION: A 12-week combined exercise intervention after RP results in improvement of physical function, continence rate, and quality of life. These results could help with prompt recovery of daily activities.","Urology, 80(2): 299-305","Korea",2012,"Any or unknown","Surgery,Various","ICIQ,BDI,SF-36","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Complication,Comorbidity,Utility"]
[525,"Parker, C. C., et al. (2013). \"A randomized, double-blind, dose-finding, multicenter, phase 2 study of radium chloride (Ra 223) in patients with bone metastases and castration-resistant prostate cancer.\" Eur Urol 63(2): 189-197.",null,"Parker, C. C., et al.","A randomized, double-blind, dose-finding, multicenter, phase 2 study of radium chloride (Ra 223) in patients with bone metastases and castration-resistant prostate cancer","BACKGROUND: Patients with castration-resistant prostate cancer (CRPC) and bone metastases have an unmet clinical need for effective treatments that improve quality of life and survival with a favorable safety profile. OBJECTIVE: To prospectively evaluate the efficacy and safety of three different doses of radium chloride (Ra 223) in patients with CRPC and bone metastases. DESIGN, SETTING, AND PARTICIPANTS: In this phase 2 double-blind multicenter study, 122 patients were randomized to receive three injections of Ra 223 at 6-wk intervals, at doses of 25 kBq/kg (n=41), 50 kBq/kg (n=39), or 80 kBq/kg (n=42). The study compared the proportion of patients in each dose group who had a confirmed decrease of >/= 50% in baseline prostate-specific antigen (PSA) levels. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Efficacy was evaluated using blood samples to measure PSA and other tumor markers, recorded skeletal-related events, and pain assessments. Safety was evaluated using adverse events (AEs), physical examination, and clinical laboratory tests. The Jonckheere-Terpstra test assessed trends between groups. RESULTS AND LIMITATIONS: The study met its primary end point with a statistically significant dose-response relationship in confirmed >/= 50% PSA declines for no patients (0%) in the 25-kBq/kg dose group, two patients (6%) in the 50-kBq/kg dose group, and five patients (13%) in the 80-kBq/kg dose group (p=0.0297). A >/= 50% decrease in bone alkaline phosphatase levels was identified in six patients (16%), 24 patients (67%), and 25 patients (66%) in the 25-, 50-, and 80-kBq/kg dose groups, respectively (p<0.0001). The most common treatment-related AEs (>/= 10%) occurring up to week 24 across all dose groups were diarrhea (21%), nausea (16%), and anemia (14%). No difference in incidence of hematologic events was seen among dose groups. Potential limitations include small patient numbers and differences among dose groups at baseline. CONCLUSIONS: Ra 223 had a dose-dependent effect on serum markers of CRPC activity, suggesting that control of bone disease with Ra 223 may affect cancer-related outcomes. Ra 223 was well tolerated at all doses. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00337155.","Eur Urol, 63(2): 189-197","UK",2013,"Metastatic","Radiotherapy","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Symptom"]
[526,"Parker, P. A., et al. (2009). \"The effects of a presurgical stress management intervention for men with prostate cancer undergoing radical prostatectomy.\" J Clin Oncol 27(19): 3169-3176.",null,"Parker, P. A., et al.","The effects of a presurgical stress management intervention for men with prostate cancer undergoing radical prostatectomy","PURPOSE This study assessed the short-term and long-term efficacy of a presurgical stress management intervention at reducing mood disturbance and improving quality of life (QOL) in men undergoing radical prostatectomy (RP) for prostate cancer. PATIENTS AND METHODS One hundred fifty-nine men were randomly assigned to a two-session (plus two boosters) presurgical stress management intervention (SM), a two-session (plus two boosters) supportive attention group (SA), or a standard care group (SC). Assessments occurred 1 month before surgery; 1 week before surgery; the morning of surgery; 6 weeks after surgery, and 6 and 12 months after surgery. Results Results indicated significant group differences in mood disturbance before surgery (P = .02), such that men in the SM group had significantly less mood disturbance than men in the SC group (P = .006), with no significant differences between the SM and SA or SA and SC groups. In the year after surgery, there were significant group differences on Medical Outcomes Study 36-item short form survey (SF-36) physical component summary (PCS) scores (P = .004); men in the SM group had significantly higher PCS scores than men in the SC group (P = .0009), and there were no significant differences between the SM and SA or SA and SC groups. There were no group effects on prostate-specific QOL or SF-36 mental health scores. CONCLUSION These findings demonstrate the efficacy of a brief presurgical stress management intervention in improving some short-term and long-term outcomes. If these results are replicated, it may be a useful adjunct to standard care for men with prostate cancer undergoing surgery.","J Clin Oncol, 27(19): 3169-3176","USA",2009,"Any or unknown","Surgery,Psychological","SF-36","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Utility"]
[527,"Partin, M. R., et al. (2004). \"Randomized trial examining the effect of two prostate cancer screening educational interventions on patient knowledge, preferences, and behaviors.\" J Gen Intern Med 19(8): 835-842.",null,"Partin, M. R., et al.","Randomized trial examining the effect of two prostate cancer screening educational interventions on patient knowledge, preferences, and behaviors","OBJECTIVE: To assess the effect of video and pamphlet interventions on patient prostate cancer (CaP) screening knowledge, decision-making participation, preferences, and behaviors. DESIGN: Randomized, controlled trial. SETTING: Four midwestern Veterans Affairs medical facilities. PATIENTS/PARTICIPANTS: One thousand, one hundred fifty-two male veterans age 50 and older with primary care appointments at participating facilities were randomized and 893 completed follow-up. INTERVENTIONS: Patients were randomized to mailed pamphlet, mailed video, or usual care/control. MEASUREMENTS AND MAIN RESULTS: Outcomes assessed by phone survey 2 weeks postintervention included a 10-item knowledge index; correct responses to questions on CaP natural history, treatment efficacy, the prostate-specific antigen (PSA)'s predictive value, and expert disagreement about the PSA; whether screening was discussed with provider; screening preferences; and PSA testing rates. Mean knowledge index scores were higher for video (7.44; P = .001) and pamphlet (7.26; P = .03) subjects versus controls (6.90). Video and pamphlet subjects reported significantly higher percentages of correct responses relative to controls to questions on CaP natural history (63%, 63%, and 54%, respectively); treatment efficacy (19%, 20%, and 5%), and expert disagreement (28%, 19%, and 8%), but not PSA accuracy (28%, 22%, and 22%). Pamphlet subjects were more likely than controls to discuss screening with their provider (41% vs 32%; P = .03) but video subjects were not (35%; P = .33). Video and pamphlet subjects were less likely to intend to have a PSA, relative to controls (63%, 65%, and 74%, respectively). PSA testing rates did not differ significantly across groups. CONCLUSIONS: Mailed interventions enhance patient knowledge and self-reported participation in decision making, and alter screening preferences. The pamphlet and video interventions evaluated are comparable in effectiveness. The lower-cost pamphlet approach is an attractive option for clinics with limited resources.","J Gen Intern Med, 19(8): 835-842","USA",2004,"At risk","Various,Screening","Interview","General population",null,"Clinical trial",null,null,null,null,null,null,null,null,"Knowledge"]
[528,"Pastore, A. L., et al. (2014). \"Are early continence recovery and oncologic outcomes influenced by use of different devices in prostatic apex dissection during laparoscopic radical prostatectomy?\" J Endourol 28(11): 1313-1319.",null,"Pastore, A. L., et al.","Are early continence recovery and oncologic outcomes influenced by use of different devices in prostatic apex dissection during laparoscopic radical prostatectomy?","BACKGROUND AND PURPOSE: Treatment of patients with prostate cancer has evolved considerably in the last decade, especially in terms of minimization of the negative impacts on erectile function and continence to ensure good quality of life for treated patients. New surgical devices, such as dissectors and hemostatic scalpels, allow precise definition of the surgical field with finer dissection of the anatomic structures, with subsequent reductions in operative times and better oncologic and functional outcomes. Although monopolar scissors (MS) are still widely used, radiofrequency (RF) and ultrasound (US) scalpels have been introduced recently in laparoscopic radical prostatectomy (LRP). Despite the widespread use of these scalpels, however, few studies have compared these devices in terms of oncologic and functional outcomes after radical prostatectomy. The present study aimed to prospectively assess the impact of MS, RF, and US scalpels on margin status at apex, and recovery of urinary continence and erectile function in patients undergoing extraperitoneal LRP. PATIENTS AND METHODS: A total of 150 men were prospectively enrolled between September 2009 and April 2013 and postoperatively evaluated for continence and clinical factors. RESULTS: There were no differences in terms of operative times (P=0.9433), blood loss (P=0.9681), apical margin positivity (P=0.3965) or postoperative hospital stay (P=0.9257) among the groups. Moreover, no differences in the functional outcome scores, as evaluated by the International Consultation on Incontinence self-administered Questionnaire, at 1, 3, and 6 months postsurgery were observed. CONCLUSION: Our study represents the first evaluation of continence recovery in LRP with respect to different devices used for prostatic apex dissection. We found that the oncologic, functional, and operative outcomes were similar between these different devices during LRP, with no scalpel demonstrating superiority in continence recovery.","J Endourol, 28(11): 1313-1319","Italy",2014,"Any or unknown","Surgery,Various","ICIQ","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Complication"]
[529,"Patel, V. R., et al. (2005). \"Robotic radical prostatectomy in the community setting--the learning curve and beyond: initial 200 cases.\" J Urol 174(1): 269-272.",null,"Patel, V. R., et al.","Robotic radical prostatectomy in the community setting--the learning curve and beyond: initial 200 cases","PURPOSE: The introduction of robotic assistance has the potential to improve surgical outcomes and reduce the steep learning curve associated with conventional laparoscopic radical prostatectomy. We report on our experience with robotic radical prostatectomy in the community setting. MATERIALS AND METHODS: A total of 200 patients underwent robotic radical prostatectomy during 18 months. Prospective data collection included a quality of life (Expanded Prostate Cancer Index Composite) questionnaire, basic demographics, prostate specific antigen (PSA), clinical stage and Gleason grade. Operative outcome measures included operative time, estimated blood loss and complications. Postoperative outcome measures included hospital stay, catheter time, pathology, PSA and return of continence. RESULTS: Average operative time was 141 minutes with an estimated blood loss of 75 cc. The intraoperative complication rate was 1% with no mortality, reexploration or transfusion. Of the patients 95% were discharged home on postoperative day 1 (1 to 3) with hematocrit averaging 34.5 (range 25 to 45). The average difference in preoperative and postoperative hematocrit was 3 points (range -2 to 15). Average catheter time was 7.2 days (range 5 to 15). The positive margin rate was 10.5% for the entire series, 5.7% for T2 tumors, 28.5% (T3a), 20% (T3b) and 33% (T4a). Of the patients 95% had undetectable PSA (less than 0.1 ng/ml) at average followup of 9.7 months. Continence at 1, 3, 6, 9 and 12 months was 47%, 78%, 89%, 92% and 98%, respectively. CONCLUSIONS: Our initial experience with robotic radical prostatectomy is promising. The learning curve was approximately 20 to 25 cases. With a structured methodical approach we were able to implement robotics safely and effectively into our community practice with minimal patient morbidity, and good oncological and functional outcomes.","J Urol, 174(1): 269-272","USA",2005,"Local,Advanced","Surgery","EPIC","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease"]
[530,"Patterson, R. E., et al. (2002). \"Types of alternative medicine used by patients with breast, colon, or prostate cancer: predictors, motives, and costs.\" J Altern Complement Med 8(4): 477-485.",null,"Patterson, R. E., et al.","Types of alternative medicine used by patients with breast, colon, or prostate cancer: predictors, motives, and costs","OBJECTIVE: Assess predictors and costs of various types of alternative medicine used by adult patients with cancer. DESIGN, LOCATION, SUBJECTS: Telephone survey of 356 patients with colon, breast, or prostate cancer identified from the population-based Cancer Surveillance System of western Washington. RESULTS: Overall, 70.2% of patients used at least one type of alternative medicine, with 16.6% seeing alternative providers, 19.1% using mental/other therapy, and 64.6% taking dietary supplements. Compared to males, females were five times more likely to see an alternative provider and about twice as likely to use mental therapies or supplements (p < 0.05 for all). Older patients were less likely to use mental/other therapy. Higher education (but not income) was associated with use of all types of alternative medicine. Patients with multiple medical treatments were two times more likely to take dietary supplements compared to patients having only surgery (p < 0.01). Varying by the type of alternative therapy, 83%-97% of patients reported that they used alternative medicine for general health and well-being while 8% to 56% reported use for treatment of cancer. Almost all patients reported that the alternative therapy improved their well-being. Expenditures for alternative medicine averaged $68 per user per year, but ranged from $4 to $14,659. CONCLUSIONS: Given the high prevalence of use and that patients believed that alternative medicine improved their well-being, clinicians should show an open mind toward these treatment choices and encourage frank discussion. Familiarity and some knowledge regarding use of alternative medicine is important in cases where interactions between conventional and alternative medicine may occur. It is also important to identify potential patient needs for mental health support beyond conventional care and support patients who want to make healthful lifestyle changes. Longitudinal investigations are urgently needed to investigate associations of alternative medicine use with survival and quality of life in patients with cancer.","J Altern Complement Med, 8(4): 477-485","USA",2002,"Any or unknown","Various","Interview","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"General"]
[531,"Pearce, A., et al. (2006). \"Effect of combined treatment with salvage radiotherapy plus androgen suppression on quality of life in patients with recurrent prostate cancer after radical prostatectomy.\" Int J Radiat Oncol Biol Phys 65(1): 78-83.",null,"Pearce, A., et al.","Effect of combined treatment with salvage radiotherapy plus androgen suppression on quality of life in patients with recurrent prostate cancer after radical prostatectomy","PURPOSE: To examine the effect of salvage radiotherapy (RT) plus 2-year androgen suppression (AS) on quality of life (QOL). METHODS AND MATERIALS: A total of 74 patients with biopsy-proven local recurrence or PSA relapse after radical prostatectomy were treated with salvage RT plus 2-year AS, as per a phase II study. Quality of life was prospectively assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-Item Version 3.0 with the added prostate cancer-specific module at baseline and predefined follow-up visits. RESULTS: Patients experienced a significant increase in bowel dysfunction (23%) by the end of RT (p < 0.0001). This bowel dysfunction improved after RT but remained slightly elevated (5-10%) throughout the 2-year AS period. This extent of residual bowel dysfunction would be considered of minimal clinical importance. A similar, but less pronounced, pattern of change did occur for urinary dysfunction. Erectile function showed no change during RT, but had an abrupt decline (10%) with initiation of AS that was of moderate clinical significance (p < 0.01). None of the other QOL domains demonstrated a persistent, significant change from baseline that would be considered of major clinical significance. CONCLUSION: The combined treatment with salvage RT plus 2-year AS had relatively minor long-term effects on QOL.","Int J Radiat Oncol Biol Phys, 65(1): 78-83","Canada",2006,"Recurrent","Surgery,Radiotherapy,Hormonal","EORTC QLQ-C30,EORTC QLQ-PR25","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,General"]
[532,"Pearse, M., et al. (2014). \"A Phase III trial to investigate the timing of radiotherapy for prostate cancer with high-risk features: background and rationale of the Radiotherapy -- Adjuvant Versus Early Salvage (RAVES) trial.\" BJU Int 113 Suppl 2: 7-12.",null,"Pearse, M., et al.","A Phase III trial to investigate the timing of radiotherapy for prostate cancer with high-risk features: background and rationale of the Radiotherapy -- Adjuvant Versus Early Salvage (RAVES) trial","OBJECTIVES: To test the hypothesis that observation with early salvage radiotherapy (SRT) is not inferior to 'standard' treatment with adjuvant RT (ART) with respect to biochemical failure in patients with pT3 disease and/or positive surgical margins (SMs) after radical prostatectomy (RP). To compare the following secondary endpoints between the two arms: patient-reported outcomes, adverse events, biochemical failure-free survival, overall survival, disease-specific survival, time to distant failure, time to local failure, cost utility analysis, quality adjusted life years and time to androgen deprivation. PATIENTS AND METHODS: The Radiotherapy - Adjuvant Versus Early Salvage (RAVES) trial is a phase III multicentre randomised controlled trial led by the Trans Tasman Radiation Oncology Group (TROG), in collaboration with the Urological Society of Australia and New Zealand (USANZ), and the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP). In all, 470 patients are planned to be randomised 1:1 to either ART commenced at </=4 months of RP (standard of care) or close observation with early SRT triggered by a PSA level of >0.20 ng/mL (experimental arm). Eligible patients have had a RP for adenocarcinoma of the prostate with at least one of the following risk factors: positive SMs +/- extraprostatic extension +/- seminal vesicle involvement. The postoperative PSA level must be </=0.10 ng/mL. Rigorous investigator credentialing and a quality assurance programme are designed to promote consistent RT delivery among patients. RESULTS: Trial is currently underway, with 258 patients randomised as of 31 October 2013. International collaborations have developed, including a planned meta-analysis to be undertaken with the UK Medical Research Council/National Cancer Institute of Canada Clinical Trials Group RADICALS (Radiotherapy and Androgen Deprivation In Combination with Local Surgery) trial and an innovative psycho-oncology sub-study to investigate a patient decision aid resource. CONCLUSION: On the current evidence available, it remains unclear if ART is equivalent or superior to observation with early SRT.","BJU Int, 113 Suppl 2(7-12","New Zealand",2014,"Advanced","Radiotherapy","Unclear","Patient",null,"Protocol",null,null,null,null,null,null,null,null,"Unclear"]
[533,"Pedersen, K. V., et al. (1990). \"Screening for carcinoma of the prostate by digital rectal examination in a randomly selected population.\" Bmj 300(6731): 1041-1044.",null,"Pedersen, K. V., et al.","Screening for carcinoma of the prostate by digital rectal examination in a randomly selected population","OBJECTIVE: To study the acceptability, costs, psychosocial consequences, and organisation of screening for carcinoma of the prostate. DESIGN: A randomly selected population was personally invited for digital rectal examination by a urologist and a general practitioner. Further examinations were performed if induration was felt. Each man completed a questionnaire on his response to the examination. SETTING: General practices in the area of Norrkoping. PATIENTS: 1494 Men aged 50-69 randomly selected from a population of 9026. MAIN OUTCOME MEASURE: Prostates having a firm nodular consistency. RESULTS: Carcinoma of the prostate was suspected in 45 of 1163 patients examined; in 10 by the general practitioners, in 10 by the urologists, and in 25 by both. Forty four men had a fine needle aspiration biopsy, and carcinomas were found in 13 cases. Of these, one had been suspected by the general practitioner, four by urologists, and eight by both. The cost for each man was 11.60 pounds, and the cost for each case of carcinoma detected and treated by potentially curative methods was 2477 pounds. Of the 13 men with carcinoma, 10 underwent radical prostatectomy and one radiotherapy. One man had advanced disease and was given endocrine treatment, another was not treated. Only 193 men felt distress during the initial examination. Of the 44 men who had an aspiration biopsy, 25 experienced anxiety. CONCLUSIONS: Screening for carcinoma of the prostate by a urologist or a general practitioner using digital rectal examination is a cost effective method of early diagnosis. Whether such screening leads to prolonged survival, however, remains doubtful.","Bmj, 300(6731): 1041-1044","Sweden",1990,"At risk","Screening","Unclear","General population",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Views"]
[534,"Penson, D. F., et al. (2001). \"The association between socioeconomic status, health insurance coverage, and quality of life in men with prostate cancer.\" J Clin Epidemiol 54(4): 350-358.",null,"Penson, D. F., et al.","The association between socioeconomic status, health insurance coverage, and quality of life in men with prostate cancer","The objective of this study was to examine the effect of socioeconomic status and insurance status on health-related quality of life (HRQOL) outcomes in men with prostate cancer. The design was a retrospective cohort study using multiple sites, including both academic and private practice settings. A cohort of 860 men with newly diagnosed, biopsy-proven prostate cancer of any stage was identified within CaPSURE, a longitudinal disease registry of prostate cancer patients. HRQOL was assessed with validated instruments, including the RAND 36-item Health Survey (SF-36) and the UCLA Prostate Cancer Index. Covariates included insurance status, education level, annual income, age, stage, comorbidity, Gleason grade, baseline PSA, marital status, ethnicity and primary treatment. HRQOL measurements were taken at 3-6-month intervals. Analysis of covariance was used to determine the effect of SES and insurance status on the HRQOL domains at baseline and over time. Patients with lower annual income had significantly lower baseline HRQOL scores in the all of the domains of the SF-36 and four of eight disease-specific HRQOL domains. No relationship was seen between annual income and HRQOL outcomes over time. Conversely, health insurance status was associated with HRQOL over time, but not at baseline. Health insurance status appears to have a unique effect on general HRQOL outcomes in men after treatment for prostate cancer. This study confirms the commonly held belief that patients of lower SES tend to have worse quality of life at baseline and following treatment for their disease. These findings have important ramifications for clinicians, researchers and policy makers.","J Clin Epidemiol, 54(4): 350-358","USA",2001,"Any or unknown","Unclear","SF-36,UCLA-PCI","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease,Utility,Costs"]
[535,"Penson, D. F., et al. (2003). \"General quality of life 2 years following treatment for prostate cancer: what influences outcomes? Results from the prostate cancer outcomes study.\" J Clin Oncol 21(6): 1147-1154.",null,"Penson, D. F., et al.","General quality of life 2 years following treatment for prostate cancer: what influences outcomes? Results from the prostate cancer outcomes study","PURPOSE: The goal of this study was to determine the relationship between primary treatment, urinary dysfunction, sexual dysfunction, and general health-related quality of life (HRQOL) in prostate cancer. METHODS: A sample of men with newly diagnosed prostate cancer between 1994 and 1995 was randomly selected from six population-based Surveillance, Epidemiology, and End Results registries. A baseline survey was completed by 2,306 men within 6 to 12 months of diagnosis, and these men also completed a follow-up HRQOL survey 2 years after diagnosis. Logistic regression models were used to determine whether primary treatment, urinary dysfunction, and sexual dysfunction were independently associated with general HRQOL outcomes approximately 2 years after diagnosis as measured by the Medical Outcomes Study 36-item Short Form Health Survey. The magnitude of this effect was estimated using least square means models. RESULTS: After adjustment for potential confounders, primary treatment was not associated with 2-year general HRQOL outcomes in men with prostate cancer. Urinary function and bother were independently associated with worse general HRQOL in all domains. Sexual function and bother were also independently associated with worse general HRQOL, although the relationship was not as strong as in the urinary domains. CONCLUSION: Primary treatment is not associated with 2-year general HRQOL outcomes in prostate cancer. Although both sexual and urinary function and bother are associated with quality of life, men who are more bothered by their urination or impotence are more likely to report worse quality of life. This implies that future research should be directed toward finding ways to improve treatment-related outcomes or help patients better cope with their posttreatment urinary or sexual dysfunction.","J Clin Oncol, 21(6): 1147-1154","USA",2003,"Any or unknown","Unclear","SF-36","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Utility"]
[536,"Perkins, J. J., et al. (1998). \"An exploration of screening practices for prostate cancer and the associated community expenditure.\" Br J Urol 82(4): 524-529.",null,"Perkins, J. J., et al.","An exploration of screening practices for prostate cancer and the associated community expenditure","OBJECTIVES: To determine: (i) the prevalence, reasons for, and demographic and psychosocial predictors of prostate cancer screening among a randomly selected sample of men; and (ii) to estimate the community expenditure involved in the screening of asymptomatic men. SUBJECTS AND METHODS: A random sample of men aged 40-79 years was selected from the State Electoral Register of New South Wales, Australia, and asked to complete a computer-assisted telephone interview. The questions determined their demographic characteristics, their subjective health rating compared with others of the same age (5-point scale), the prevalence and reasons for any screening for prostate cancer ('ever screened' and 'screened within the last 12 months'), whether they had undergone a digital rectal examination (DRE), a blood test for prostate-specific antigen (PSA) or transrectal ultrasonography (TRUS), and the prevalence of urinary symptoms. Those who had been screened were then asked to nominate the single most important factor in the decision to undergo prostate cancer screening. To estimate community expenditure, the costs for prostate cancer screening were estimated by applying Medicare schedule charges to the screening and subsequent diagnostic tests performed. Two scenarios were developed to estimate costs: the first used guidelines which do not recommend the use of routine screening for all asymptomatic men, and the second was based on guidelines where the routine use of PSA or TRUS as part of a periodic health examination is not recommended, but the use of DRE in asymptomatic men aged 50-70 years is. RESULTS: Of the 551 eligible participants, 86% completed the interview; 44% of participants reported that they had 'ever' been screened, whilst 23% had been screened in the year before the study. Among those who had been screened, the reason reported most often for screening, apart from symptoms and family history, was the doctor's recommendation after a medical assessment of their prostate cancer risk status. Screening status was predicted both by the age of the man and his symptom score. As a result, the community expenditure in New South Wales for screening among asymptomatic men was estimated to be A$6.4 million and A$5.2 million for the first and second scenarios, respectively. CONCLUSIONS: The results of this study suggest that, despite the recommendations of primary bodies that asymptomatic men not be screened for prostate cancer, screening is occurring at a high level and with significant costs to the healthcare system.","Br J Urol, 82(4): 524-529","Australia",1998,"At risk","Screening","Interview","General population",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Views"]
[537,"Petersen, S. E., et al. (2014). \"Development and validation of a scoring system for late anorectal side-effects in patients treated with radiotherapy for prostate cancer.\" Radiother Oncol 111(1): 94-99.",null,"Petersen, S. E., et al.","Development and validation of a scoring system for late anorectal side-effects in patients treated with radiotherapy for prostate cancer","PURPOSE: To develop and validate a scoring system for evaluation of long term anorectal dysfunction following radiotherapy for prostate cancer. MATERIALS AND METHODS: Patients treated for prostate cancer with radiotherapy filled in questionnaires on anorectal function and quality of life. Items for the condensed anorectal dysfunction score (RT-ARD) were identified and weighted by binomial regression analysis. The score was tested in a separate patient material by receiver operating characteristic (ROC) analysis and correlations to quality of life domains. RESULTS: A total of 309 patients participated in the study. The items selected were \"incontinence for solid stool\", \"ability to defer defecation\", \"unproductive call to stool\", \"clustering of stool\", and \"mucus in stool.\" Patients were grouped into three categories according to the RT-ARD score; 0-8 (no RT-ARD), 9-23 (minor RT-ARD), 24-45 (major RT-ARD). ROC analyses revealed high sensitivity (91%) and specificity (85%) for major RT-ARD. The prediction model demonstrated a perfect fit in 60%, moderate fit in 36% and no fit in 4%. There was good correlation between the RT-ARD score and quality of life. CONCLUSIONS: The RT-ARD score is a validated and simple instrument for evaluation of anorectal dysfunction following radiotherapy for prostate cancer, and the RT-ARD score correlates to the patient's quality of life.","Radiother Oncol, 111(1): 94-99","Denmark",2014,"Any or unknown","Radiotherapy","RT-ARD","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Complication"]
[538,"Petrylak, D. P., et al. (2004). \"Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer.\" N Engl J Med 351(15): 1513-1520.",null,"Petrylak, D. P., et al.","Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer","BACKGROUND: Mitoxantrone-based chemotherapy palliates pain without extending survival in men with progressive androgen-independent prostate cancer. We compared docetaxel plus estramustine with mitoxantrone plus prednisone in men with metastatic, hormone-independent prostate cancer. METHODS: We randomly assigned 770 men to one of two treatments, each given in 21-day cycles: 280 mg of estramustine three times daily on days 1 through 5, 60 mg of docetaxel per square meter of body-surface area on day 2, and 60 mg of dexamethasone in three divided doses before docetaxel, or 12 mg of mitoxantrone per square meter on day 1 plus 5 mg of prednisone twice daily. The primary end point was overall survival; secondary end points were progression-free survival, objective response rates, and post-treatment declines of at least 50 percent in serum prostate-specific antigen (PSA) levels. RESULTS: Of 674 eligible patients, 338 were assigned to receive docetaxel and estramustine and 336 to receive mitoxantrone and prednisone. In an intention-to-treat analysis, the median overall survival was longer in the group given docetaxel and estramustine than in the group given mitoxantrone and prednisone (17.5 months vs. 15.6 months, P=0.02 by the log-rank test), and the corresponding hazard ratio for death was 0.80 (95 percent confidence interval, 0.67 to 0.97). The median time to progression was 6.3 months in the group given docetaxel and estramustine and 3.2 months in the group given mitoxantrone and prednisone (P<0.001 by the log-rank test). PSA declines of at least 50 percent occurred in 50 percent and 27 percent of patients, respectively (P<0.001), and objective tumor responses were observed in 17 percent and 11 percent of patients with bidimensionally measurable disease, respectively (P=0.30). Grade 3 or 4 neutropenic fevers (P=0.01), nausea and vomiting (P<0.001), and cardiovascular events (P=0.001) were more common among patients receiving docetaxel and estramustine than among those receiving mitoxantrone and prednisone. Pain relief was similar in both groups. CONCLUSIONS: The improvement in median survival of nearly two months with docetaxel and estramustine, as compared with mitoxantrone and prednisone, provides support for this approach in men with metastatic, androgen-independent prostate cancer.","N Engl J Med, 351(15): 1513-1520","USA",2004,"Metastatic","Taxane,Chemotherapy","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Symptom"]
[539,"Pettersson, A., et al. (2012). \"Effects of a dietary intervention on acute gastrointestinal side effects and other aspects of health-related quality of life: a randomized controlled trial in prostate cancer patients undergoing radiotherapy.\" Radiother Oncol 103(3): 333-340.",null,"Pettersson, A., et al.","Effects of a dietary intervention on acute gastrointestinal side effects and other aspects of health-related quality of life: a randomized controlled trial in prostate cancer patients undergoing radiotherapy","PURPOSE: To study the effect of a dietary intervention on acute gastrointestinal side effects and other aspects of health-related quality of life (HRQOL) in prostate cancer patients referred to radiotherapy. MATERIALS AND METHODS: A total of 130 patients were randomly assigned to one of two groups: an intervention group (IG, n=64), instructed to reduce their intake of insoluble dietary fibres and lactose, a standard care group (SC, n=66), instructed to continue their normal diet. Gastrointestinal side effects and other aspects of HRQOL were evaluated from baseline up to 2 months after completed radiotherapy, using the EORTC QLQ-C30 and QLQ-PR25 and the study-specific Gastrointestinal Side Effects Questionnaire (GISEQ). A scale indicating adherence to dietary instructions was developed from a Food Frequency Questionnaire (FFQ), with lower scores representing better compliance. Descriptive and inferential statistical analyses were conducted. RESULTS: There was an interaction effect between randomization and time in the FFQ Scores (p<0.001), indicating that both groups followed their assigned dietary instructions. The dietary intervention had no effect on gastrointestinal side effects or other aspects of HRQOL. During radiotherapy, the percentage of patients with bowel symptoms and bloated abdomen was lower in IG compared to SC, but the between-group differences were not statistically significant. During radiotherapy, the percentage of patients with bowel symptoms, urinary symptoms, pain, fatigue and diminished physical and role functioning increased in both groups. CONCLUSIONS: The dietary intervention had no effect on gastrointestinal side effects or other aspects of HRQOL. The tendency towards lower prevalence of bowel symptoms in IG may indicate some positive effect of the dietary intervention, but methodological refinements, clearer results and longer follow-up are needed before the value of diet change can be established with certainty.","Radiother Oncol, 103(3): 333-340","Sweden",2012,"Any or unknown","Various,Radiotherapy","EORTC QLQ-C30,EORTC QLQ-PR25,GISEQ,FFQ","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,General,Complication,Treatment"]
[540,"Pickard, A. S., et al. (2009). \"Proxy assessment of health-related quality of life in african american and white respondents with prostate cancer: perspective matters.\" Med Care 47(2): 176-183.",null,"Pickard, A. S., et al.","Proxy assessment of health-related quality of life in african american and white respondents with prostate cancer: perspective matters","OBJECTIVES: An emerging issue in the proxy literature is whether specifying different proxy viewpoints contributes to different health-related quality of life (HRQL) assessments, and if so, how might each perspective be informative in medical decision making. The aims of this study were to determine if informal caregiver assessments of patients with prostate cancer differed when prompted from both the patient perspective (proxy-patient) and their own viewpoint (proxy-proxy), and to identify factors associated with differences in proxy perspectives (ie, the intraproxy gap). RESEARCH DESIGN AND METHODS: Using a cross-sectional design, prostate cancer patients and their informal caregivers were recruited from urology clinics in the Jesse Brown Veterans Affairs Healthcare System in Chicago. Dyads assessed HRQL using the EQ-5D visual analog scale (VAS) and EORTC QLQ-C30. RESULTS: Of 87 dyads, most caregivers were female (83%) and were spouses/partners (58%). Mean difference scores between proxy-patient and proxy-proxy perspectives were statistically significant for QLQ-C30 physical and emotional functioning, and VAS (all P < 0.05), with the proxy-patient perspective closer to patient self-report. Emotional functioning had the largest difference, mean 6.0 (SD 12.8), an effect size = 0.47. Factors weakly correlated with the intraproxy gap included relationship (spouse) and proxy gender for role functioning, and health literacy (limited/functional) for physical functioning (all P < 0.05, 0.20 < r < 0.35). CONCLUSIONS: Meaningful differences between proxy-patient and proxy-proxy perspectives on mental health were consistent with a conceptual framework for understanding proxy perspectives. Prompting different proxy viewpoints on patient health could help clinicians identify patients who may benefit from clinical intervention.","Med Care, 47(2): 176-183","USA",2009,"Any or unknown","None","EQ-5D,EORTC QLQ-C30","Caregiver,Patient",null,"Validation",null,null,null,null,null,null,null,null,"General,Disease"]
[541,"Pietrow, P. K., et al. (2001). \"Health related quality of life assessment after radical prostatectomy in men with prostate specific antigen only recurrence.\" J Urol 166(6): 2286-2290.",null,"Pietrow, P. K., et al.","Health related quality of life assessment after radical prostatectomy in men with prostate specific antigen only recurrence","PURPOSE: The health related quality of life assessment is becoming increasingly important among patients with prostate cancer. Meanwhile, treatment of patients with increasing prostate specific antigen (PSA) after radical retropubic prostatectomy remains controversial. We attempt to define the impact of PSA recurrence on the health related quality of life of patients after radical retropubic prostatectomy. MATERIALS AND METHODS: Of 604 consecutive patients who underwent radical retropubic prostatectomy between March 1991 and September 1998, 510 (84%) were available for followup. Each patient was mailed the RAND 36-Item Health Survey and University of California, Los Angeles, Prostate Cancer Index questionnaire. A total of 348 (70%) questionnaires were returned. Health related quality of life scores were then compared between patients with and without PSA recurrence. A multivariate analysis was also performed to elucidate further the cause of differences between the groups. RESULTS: Overall, 88 (25%) patients had PSA recurrence. In regard to health related quality of life there were small (less than 10%) but statistically significant differences in 2 of 4 physical health domains (RAND 36-Item Health Survey). There was a significant decrease in only 1 category of the mental health domain for patients with PSA recurrence. Only sexual function was statistically lower on the University of California, Los Angeles, Prostate Cancer Index. This result reflects the lower incidence of nerve sparing in these patients, as confirmed by the multivariate analysis. Overall patient satisfaction was similar between those with and without PSA recurrence (76% and 79%, respectively). CONCLUSIONS: Our study demonstrates small health related quality of life differences in patients with biochemical PSA recurrence versus those without. These findings provide a baseline assessment of general and disease specific health related quality of life domains among these patients. Future studies should focus on differences in the measure of cancer anxiety before and after administration of adjuvant therapy in these asymptomatic patients.","J Urol, 166(6): 2286-2290","USA",2001,"Recurrent","Surgery","SF-36,UCLA-PCI","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Disease,Utility"]
[542,"Pinkawa, M., et al. (2009). \"Health-related quality of life after permanent I-125 brachytherapy and conformal external beam radiotherapy for prostate cancer--a matched-pair comparison.\" Radiother Oncol 91(2): 225-231.",null,"Pinkawa, M., et al.","Health-related quality of life after permanent I-125 brachytherapy and conformal external beam radiotherapy for prostate cancer--a matched-pair comparison","BACKGROUND AND PURPOSE: The aim of the study was to compare quality of life after permanent I-125 brachytherapy (BT) and external beam radiotherapy (EBRT) for prostate cancer. MATERIALS AND METHODS: A group of 104 patients (52 in each group) have been surveyed prospectively before EBRT/BT (time A), at the last day of EBRT (70.2-72.0 Gy) or one month after BT (time B), and a median time of 16 months after EBRT/BT (time C) using a validated questionnaire (Expanded Prostate Cancer Index Composite). Pairs were matched according to the following criteria: age +/-5 years, prostate volume +/-10 cc, use of antiandrogens, and erectile function. RESULTS: Urinary function/bother scores decreased significantly more after BT both at time B and time C. Bowel function/bother scores tended to be higher after BT, with a lower percentage of patients with painful bowel movements (BT: 12%/27%/15%; EBRT: 19%/52%/35% at time A/B/C; p<0.05 for differences at times B/C) and rectal bleeding (BT: 12%/12%/12%; EBRT: 8%/14%/17%). No difference concerning erectile dysfunction was found (67% vs. 61% with preserved erections firm enough for intercourse after BT vs. EBRT at time C). CONCLUSIONS: BT was associated with higher urinary, but lower rectal toxicity. The risk of treatment-associated erectile dysfunction did not differ between these methods.","Radiother Oncol, 91(2): 225-231","Germany",2009,"Any or unknown","Radiotherapy,Brachytherapy","EPIC","Patient",null,"Case-control",null,null,null,null,null,null,null,null,"Disease"]
[543,"Pinkawa, M., et al. (2009). \"Impact of the target volume (prostate alone vs. prostate with seminal vesicles) and fraction dose (1.8 Gy vs. 2.0 Gy) on quality of life changes after external-beam radiotherapy for prostate cancer.\" Strahlenther Onkol 185(11): 724-730.",null,"Pinkawa, M., et al.","Impact of the target volume (prostate alone vs. prostate with seminal vesicles) and fraction dose (1.8 Gy vs. 2.0 Gy) on quality of life changes after external-beam radiotherapy for prostate cancer","PURPOSE: To evaluate the impact of the clinical target volume (CTV) and fraction dose on quality of life (QoL) after external-beam radiotherapy (EBRT) for prostate cancer. PATIENTS AND METHODS: A group of 283 patients has been surveyed prospectively before, at the last day, at a median time of 2 months and 15 months after EBRT (70.2-72 Gy) using a validated questionnaire (Expanded Prostate Cancer Index Composite). EBRT of prostate alone (P, n = 70) versus prostate with seminal vesicles (PS, n = 213) was compared. Differences of fraction doses (1.8 Gy, n = 80, vs. 2.0 Gy, n = 69) have been evaluated in the patient group receiving a total dose of 72 Gy. RESULTS: Significantly higher bladder and rectum volumes were found at all dose levels for the patients with PS versus P within the CTV (p < 0.001). Similar volumes resulted in the groups with different fraction doses. Paradoxically, bowel function scores decreased significantly less 2 and 15 months after EBRT of PS versus P. 2 months after EBRT, patients with a fraction dose of 2.0 Gy versus 1.8 Gy reported pain with urination (> or = once a day in 12% vs. 3%; p = 0.04) and painful bowel movements (> or = rarely in 46% vs. 29%; p = 0.05) more frequently. No long-term differences were found. CONCLUSION: The risk of adverse QoL changes after EBRT for prostate cancer cannot be derived from the dose-volume histogram alone. Seminal vesicles can be included in the CTV up to a moderate total dose without adverse effects on QoL. Apart from a longer recovery period, higher fraction doses were not associated with higher toxicity.","Strahlenther Onkol, 185(11): 724-730","Germany",2009,"Any or unknown","Radiotherapy","EPIC","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease"]
[544,"Pinkawa, M., et al. (2009). \"Neoadjuvant hormonal therapy and external-beam radiotherapy versus external-beam irradiation alone for prostate cancer. A quality-of-life analysis.\" Strahlenther Onkol 185(2): 101-108.",null,"Pinkawa, M., et al.","Neoadjuvant hormonal therapy and external-beam radiotherapy versus external-beam irradiation alone for prostate cancer. A quality-of-life analysis","PURPOSE: To evaluate the impact of neoadjuvant hormonal therapy (NHT) on quality of life after external-beam radiotherapy (EBRT) for prostate cancer. PATIENTS AND METHODS: A group of 170 patients (85 with and 85 without NHT) has been surveyed prospectively before EBRT (70.2-72 Gy), at the last day of EBRT, a median time of 2 months and 15 months after EBRT using a validated questionnaire (Expanded Prostate Cancer Index Composite). Pairs with and without NHT (median treatment time of 3.5 months before EBRT) were matched according to the respective planning target volume and prostate volume. RESULTS: Before EBRT, significantly lower urinary function/bother, sexual function and hormonal function/bother scores were found for patients with NHT. More than 1 year after EBRT, only sexual function scores remained lower. In a multivariate analysis, NHT and adjuvant hormonal therapy (HT) versus NHT only (hazard ratio 14; 95% confidence interval 2.7-183; p = 0.02) and luteinizing hormone-releasing hormone (LHRH) agonists versus antiandrogens (hazard ratio 3.6; 95% confidence interval 1.1-12; p = 0.04) proved to be independent risk factors for long-term erectile dysfunction (no or very poor ability to have an erection). CONCLUSION: With the exception of sexual function (additional adjuvant HT and application of LHRH analog independently adverse), short-term NHT was not found to decrease quality of life after EBRT for prostate cancer.","Strahlenther Onkol, 185(2): 101-108","Germany",2009,"Any or unknown","Hormonal,Radiotherapy","EPIC","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease"]
[545,"Pinkawa, M., et al. (2010). \"Rectal morbidity after permanent interstitial brachytherapy for prostate cancer--impact of day 1 vs. day 30 computed tomography-based postimplant dosimetry.\" Brachytherapy 9(1): 1-7.",null,"Pinkawa, M., et al.","Rectal morbidity after permanent interstitial brachytherapy for prostate cancer--impact of day 1 vs. day 30 computed tomography-based postimplant dosimetry","PURPOSE: The aim of the study was to evaluate bowel quality-of-life changes after prostate brachytherapy and the impact of Day 1 vs. Day 30 postimplant dosimetry. METHODS AND MATERIALS: In 61 patients, computed tomography (CT) scans were performed at Days 1 and 30 after (125)I brachytherapy. The patients have been surveyed prospectively before (time A), 1 month (time B), and >1 year after treatment (time C) using a validated questionnaire (Expanded Prostate Cancer Index Composite). Different parameters were tested for their predictive value on bowel quality-of-life changes (bowel bother score decrease >20 points at time B=BB20; bowel bother score decrease >10 points at time C=BC10), including seed displacements. RESULTS: Mean bowel function/bother score decreased 13/13 points at time B (p<0.01) and 1/4 points at time C (change not significant). BB20 and BC10 were found in 25% and 20% of patients, respectively. Bowel bother score declines at time B correlated well with declines at time C (r=0.53; p<0.01). Prostate volume before implantation and the number of seeds per cubic centimeters were found to be predictive for BB20 and BC10. Smaller rectal wall volumes covered by the 60-100% isodoses at Day 1 were (paradoxically) found to be significantly predictive for BC10. Larger posterior seed displacements between Days 1 and 30 were significantly associated with BB20. CONCLUSIONS: Quality-of-life scores have not been found to change significantly >1 year after brachytherapy. Larger rectal wall volumes within higher isodoses at Day 1 or 30 were not found to be predisposing for adverse quality-of-life changes.","Brachytherapy, 9(1): 1-7","Germany",2010,"Any or unknown","Brachytherapy","EPIC","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease"]
[546,"Pinkawa, M., et al. (2011). \"Combination of dose escalation with technological advances (intensity-modulated and image-guided radiotherapy) is not associated with increased morbidity for patients with prostate cancer.\" Strahlenther Onkol 187(8): 479-484.",null,"Pinkawa, M., et al.","Combination of dose escalation with technological advances (intensity-modulated and image-guided radiotherapy) is not associated with increased morbidity for patients with prostate cancer","PURPOSE: The aim was to evaluate treatment-related morbidity after intensity-modulated (IMRT) and image-guided (IGRT) radiotherapy with a total dose of 76 Gy in comparison to conventional conformal radiotherapy (3DCRT) up to 70.2-72 Gy for patients with prostate cancer. PATIENTS AND METHODS: All patients were prospectively surveyed prior to, on the last day, as well as after a median time of 2 and 16 months after RT using a validated questionnaire (Expanded Prostate Cancer Index Composite). Criteria for the 78 matched pairs after IMRT vs. 3DCRT were patient age, use of antiandrogens, treatment volume (+/- whole pelvis), prognostic risk group, and urinary/bowel/sexual quality of life (QoL) before treatment. RESULTS: QoL changes after dose-escalated IMRT were found to be similar to QoL changes after 3DCRT in all domains. Only sexual function scores more than 1 year after RT decreased slightly more after 3DCRT in comparison to IMRT (mean 9 vs. 6 points; p = 0.04), with erections firm enough for intercourse in 14% vs. 30% (p = 0.03). Painful bowel movements were reported more frequently after 3DCRT vs. IMRT 2 months after treatment (>/= once a day in 10% vs. 1%; p = 0.03), but a tendency for higher rectal bleeding rates was found after IMRT vs. 3DCRT more than 1 year after RT (>/= rarely in 20% vs. 9%; p = 0.06). CONCLUSION: Combination of dose escalation with technological advances (IMRT and IGRT) is not associated with increased morbidity for patients with prostate cancer.","Strahlenther Onkol, 187(8): 479-484","Germany",2011,"Any or unknown","Radiotherapy","EPIC","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease"]
[547,"Pinkawa, M., et al. (2012). \"Quality of life after intensity-modulated radiotherapy for prostate cancer with a hydrogel spacer. Matched-pair analysis.\" Strahlenther Onkol 188(10): 917-925.",null,"Pinkawa, M., et al.","Quality of life after intensity-modulated radiotherapy for prostate cancer with a hydrogel spacer. Matched-pair analysis","BACKGROUND: Hydrogel spacer is an innovative method to protect the rectal wall during prostate cancer radiotherapy. Clinical effects are not well known. METHODS: Patients have been surveyed before, at the last day, and 2-3 months after radiotherapy using a validated questionnaire (Expanded Prostate Cancer Index Composite). Median dose to the prostate in the spacer subgroup (SP) was 78 Gy in 2 Gy fractions. The results were independently compared with two matched-pair subgroups (treated conventionally without spacer): 3D conformal 70.2 Gy in 1.8 Gy fractions (3DCRT) and intensity-modulated radiotherapy (IMRT) 76 Gy in 2 Gy fractions. There were 28 patients in each of the three groups. RESULTS: Baseline mean bowel bother scores were 96 points in all subgroups. Similar mean changes (SP 16, 3DCRT 14, IMRT 17 points) were observed at the end of radiotherapy. The smallest difference resulted in the spacer subgroup 2-3 months after radiotherapy (SP 2, 3DCRT 8, IMRT 6 points). Bowel bother scores were only significantly different in comparison to baseline levels in the spacer subgroup. The percentage of patients reporting moderate/big bother with specific symptoms did not increase for any item (urgency, frequency, diarrhoea, incontinence, bloody stools, pain). CONCLUSION: Moderate bowel quality-of-life changes can be expected during radiotherapy irrespective of spacer application or total dose. Advantages with a spacer can be expected a few weeks after treatment.","Strahlenther Onkol, 188(10): 917-925","Germany",2012,"Any or unknown","Radiotherapy,Various","EPIC","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease"]
[548,"Pinkawa, M., et al. (2014). \"Transurethral resection of the prostate after radiotherapy for prostate cancer: impact on quality of life.\" Int J Urol 21(9): 899-903.",null,"Pinkawa, M., et al.","Transurethral resection of the prostate after radiotherapy for prostate cancer: impact on quality of life","OBJECTIVES: To evaluate the impact of transurethral resection of the prostate on quality of life after radiotherapy for prostate cancer. METHODS: A group of 49 consecutive patients with and 487 without prior transurethral resection of the prostate responded to the Expanded Prostate Cancer Index Composite questionnaire before, on the last day, and a median time of 2 months and 16 months after external beam radiotherapy (70-78 Gy). A matched-pair analysis was used to avoid the influence of treatment-associated confounding factors, including dose, treatment volume and hormonal therapy. RESULTS: Significantly smaller acute urinary score changes relative to baseline levels resulted with versus without prior transurethral resection of the prostate (mean function/bother score decrease of 3/6 vs 18/21 points at the end of radiotherapy; P < 0.01), affecting urinary incontinence (pads to control urinary leakage in 4% vs 24%; P = 0.03) and irritative/obstructive symptoms (big/moderate problem with weak urinary stream in 11% vs 37%; P = 0.02). As opposed to acute changes, transurethral resection of the prostate was a significant predisposing factor for a long-term urinary function score decrease >10 points (20% vs 6% of patients with vs without prior resection; P = 0.04). Urinary incontinence risk was higher for patients with a longer time from resection to radiotherapy. CONCLUSIONS: Transurethral resection of the prostate significantly affects acute (considerably fewer symptoms) and long-term (relevant toxicity in some cases) urinary quality of life after radiotherapy for prostate cancer.","Int J Urol, 21(9): 899-903","Germany",2014,"Any or unknown","Radiotherapy,Surgery","EPIC","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease"]
[549,"Pinkawa, M., et al. (2017). \"Hydrogel injection reduces rectal toxicity after radiotherapy for localized prostate cancer.\" Strahlenther Onkol 193(1): 22-28.",null,"Pinkawa, M., et al.","Hydrogel injection reduces rectal toxicity after radiotherapy for localized prostate cancer","PURPOSE: Injection of a hydrogel spacer before prostate cancer radiotherapy (RT) is known to reduce the dose to the rectal wall. Clinical results from the patient's perspective are needed to better assess a possible benefit. METHODS: A group of 167 consecutive patients who received prostate RT during the years 2010 to 2013 with 2Gy fractions up to 76 Gy (without hydrogel, n = 66) or 76-80 Gy (with hydrogel, n = 101) were included. The numbers of interventions resulting from bowel problems during the first 2 years after RT were compared. Patients were surveyed prospectively before RT, at the last day of RT, and at a median of 2 and 17 months after RT using a validated questionnaire (Expanded Prostate Cancer Index Composite). RESULTS: Baseline patient characteristics were well balanced. Treatment for bowel symptoms (0 vs. 11 %; p < 0.01) and endoscopic examinations (3 vs. 19 %; p < 0.01) were performed less frequently with a spacer. Mean bowel function scores did not change for patients with a spacer in contrast to patients without a spacer (mean decrease of 5 points) >1 year after RT in comparison to baseline, with 0 vs. 12 % reporting a new moderate/big problem with passing stools (p < 0.01). Statistically significant differences were found for the items \"loose stools\", \"bloody stools\", \"painful bowel movements\" and \"frequency of bowel movements\". CONCLUSION: Spacer injection is associated with a significant benefit for patients after prostate cancer RT.","Strahlenther Onkol, 193(1): 22-28","Germany",2017,"Local","Radiotherapy,Various","EPIC","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease"]
[550,"Pistevou-Gombaki, K., et al. (2003). \"Octreotide for palliative treatment of hepatic metastases from non-neuroendocrine primary tumours: evaluation of quality of life using the EORTC QLQ-C30 questionnaire.\" Palliat Med 17(3): 257-262.",null,"Pistevou-Gombaki, K., et al.","Octreotide for palliative treatment of hepatic metastases from non-neuroendocrine primary tumours: evaluation of quality of life using the EORTC QLQ-C30 questionnaire","BACKGROUND AND AIM: While octreotide has been used in palliative treatment of hepatocellular carcinoma and neuroendocrine tumours with good results, little is known about the possible role of this in palliative treatment of hepatic metastases. MATERIAL AND METHODS: We present our experience from the use of octreotide in palliative treatment of symptomatic liver metastases in 16 patients (11 males, five females, age ranged 43-69 years) with proven hepatic metastases from different primary tumours (six with non-small lung cancer, four with colon carcinoma, two with primary pancreatic head carcinoma, two with prostate cancer and two with adenocarcinoma of the stomach). All patients were administered 20 mg long-acting octreotide IM (octreotide LAR) once the first day, octreotide SC 0.5 mg three times daily on days 2-14 and then 20 mg long-acting octreotide IM every month. Quality of life was assessed by using the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30). Tumour response was evaluated by using ultrasonography. RESULTS: One month after baseline, octreotide resulted in significant (P < 0.01, Wilcoxon test) improvement and stabilization of all major related EORTC QLQ-C30 parameters such as global quality of life, pain, fatigue, insomnia, appetite loss as well as physical, emotional, cognitive, social and role functioning. Except for mild hyperglycaemia in six out of 16 patients and mild gastrointestinal complications in one patient, no other severe side effect due to octreotide was reported. Two patients died two months after the initiation of the study due to generalized metastatic disease, while the remaining 14 patients were still alive seven months after the initiation of the study. The hepatic metastases were stabilized and no new lesions were detected by ultrasonography. CONCLUSIONS: Although further studies are warranted, we consider the use of octreotide a good alternative in palliative treatment of symptomatic liver metastases in patients with end-stage malignant disease.","Palliat Med, 17(3): 257-262","Greece",2003,"Metastatic","Various","EORTC QLQ-C30","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General"]
[551,"Pommier, P., et al. (2007). \"Is there a role for pelvic irradiation in localized prostate adenocarcinoma? Preliminary results of GETUG-01.\" J Clin Oncol 25(34): 5366-5373.",null,"Pommier, P., et al.","Is there a role for pelvic irradiation in localized prostate adenocarcinoma? Preliminary results of GETUG-01","PURPOSE: To assess the benefit and toxicity and quality-of-life (QOL) outcomes of pelvic nodes irradiation in nonmetastatic prostate carcinoma patients. PATIENTS AND METHODS: Between December 1998 and June 2004, 444 patients with T1b-T3, N0 pNx, M0 prostate carcinoma were randomly assigned to either pelvic and prostate radiotherapy or prostate radiotherapy only. Patients were stratified according to the prognostic factor of lymph node involvement (LNI). Short-term 6-month neoadjuvant and concomitant hormonal therapy was allowed only for patients in the high-risk group. The pelvic dose was 46 Gy. The total dose recommended to the prostate was changed during the course of the study from 66 Gy to 70 Gy. Criteria for progression-free survival (PFS) included biologic prostate-specific antigen recurrences or a local or metastatic evolution. Acute and late toxicities were recorded according to the Radiation Therapy Oncology Group and Late Effects in Normal Tissues Subjective, Objective, Management, and Analytic scales, respectively. The QOL outcome was recorded with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30, the International Prostatic Symptom Score, and the Sexual Function Index scales. RESULTS: With a 42.1-month median follow-up time, the 5-year PFS and overall survival were similar in the two treatment arms for the whole series and for each stratified group. On multivariate analysis, low LNI risk and hormonal therapy were statistically associated with increased PFS. However, subgroup analyses based on these factors did not show any benefit for pelvic irradiation. There were no significant differences in acute and late digestive toxicities and in QOL outcomes. CONCLUSION: Pelvic node irradiation was well tolerated but did not improve PFS.","J Clin Oncol, 25(34): 5366-5373","France",2007,"Advanced,Local","Radiotherapy","RTOG-EORTC-SS,LENT-SOMA,EORTC QLQ-C30,IPSS,SFI","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General,Disease,Treatment,Complication"]
[552,"Ponholzer, A., et al. (2003). \"Frequent use of complementary medicine by prostate cancer patients.\" Eur Urol 43(6): 604-608.",null,"Ponholzer, A., et al.","Frequent use of complementary medicine by prostate cancer patients","OBJECTIVES: To assess the use of complementary and alternative medicine (CAM) by prostate cancer patients and to characterize CAM-users in this population. METHODS: Prostate cancer patients who underwent routine follow-up at urological practices completed an anonymous, self-administered questionnaire on lower urinary tract function, sexuality, quality of life and use of CAM. All patients with biopsy proven cancer irrespective of age, stage and therapy were eligible. RESULTS: 822 men (69+/-8.5 years; range: 45-95) entered this survey. 245 men (29.8%) used at least one form of CAM, most frequent forms were fat-reduced diet (13.3%), selenium (10.8%) and vitamin E (9.3%). CAM-users did not differ regarding age (68.6 vs. 69.2 years), time interval between diagnosis and current evaluation (4.4 vs. 3.8 years) and PSA at diagnosis (24.9 vs. 18.5 ng/ml) from non-users. CAM-use was dependent on primary therapy (radical prostatectomy: 23.3%, radiotherapy: 31.6%, endocrine therapy: 38.8%) and disease progression. CAM-users were generally less satisfied with their treatment and rated health status and quality of life lower than those not using CAM (all p<0.001). CONCLUSIONS: CAM is used by almost 1/3 of prostate cancer patients in Austria, particularly by those with disease progression, impaired quality of life and treatment satisfaction. Urologists have to be aware of this fact and require a detailed knowledge on this issue to provide objective and evidence-based information.","Eur Urol, 43(6): 604-608","Austria",2003,"Any or unknown","Various","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"General,Complication"]
[553,"Ponholzer, A., et al. (2006). \"Lower urinary tract symptoms, urinary incontinence, sexual function and quality of life after radical prostatectomy and external beam radiation therapy: real life experience in Austria.\" World J Urol 24(3): 325-330.",null,"Ponholzer, A., et al.","Lower urinary tract symptoms, urinary incontinence, sexual function and quality of life after radical prostatectomy and external beam radiation therapy: real life experience in Austria","The objective of this study was to assess lower urinary tract symptoms (LUTS), urinary incontinence (UI), erectile dysfunction (ED) and quality of life after radical prostatectomy (RPE) and external beam radiation therapy (EBRT) in a \"real-life\" setting. A consecutive series of patients undergoing routine follow-up after RPE and EBRT at 28 Austrian institutions were analyzed. Men who received adjuvant therapy were excluded. All patients completed a questionnaire on (a) LUTS and UI, (b) sexual function and (c) quality of life. A total of 364 patients following RPE and 82 after EBRT entered this study and were compared in a matched pair analysis (1:1) based on age, PSA at diagnosis and follow-up (RPE: n=82; EBRT: n=82). Mean time-interval between treatment and current investigation was 4.6 years for RPE and 4.4 years for EBRT (n.s.). UI was reported by 41.3% after RPE and 18.8% after EBRT (P=0.001). Urgency was more frequent after EBRT, this difference, however, did not reach statistical significance. Moderate to severe ED (IIEF-5, <17) was present in 80.0% after RPE and in 80.8% after EBRT (n.s.). On a ten-point scale, RPE-patients rated their quality of life higher (7.3) than after EBRT (6.7) (P=0.01). In this \"real-life\" setting, RPE and EBRT had significant, yet divergent effects on LUTS, UI and sexual function. The respective numbers were substantially higher than those usually reported by physician-directed studies and centers of excellence.","World J Urol, 24(3): 325-330","Austria",2006,"Any or unknown","Surgery,Radiotherapy","IIEF-5","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"General,Complication"]
[554,"Portenoy, R. K., et al. (1994). \"Symptom prevalence, characteristics and distress in a cancer population.\" Qual Life Res 3(3): 183-189.",null,"Portenoy, R. K., et al.","Symptom prevalence, characteristics and distress in a cancer population","Despite the importance of symptom control in the cancer population, few studies have systematically assessed the prevalence and characteristics of symptoms or the interactions between various symptom characteristics and other factors related to quality of life (QOL). As part of a validation study of a new symptom assessment instrument, inpatients and outpatients with prostate, colon, breast or ovarian cancer were evaluated using the Memorial Symptom Assessment Scale and other measures of psychological condition, performance status, symptom distress and overall quality of life. The mean age of the 243 evaluable patients was 55.5 years (range 23-86 years); over 60% were women and almost two-thirds had metastatic disease. The Karnofsky Performance Status (KPS) score was < or = 80 in 49.8% and 123 were inpatients at the time of assessment. Across tumour types, 40-80% experienced lack of energy, pain, feeling drowsy, dry mouth, insomnia, or symptoms indicative of psychological distress. Although symptom characteristics were variable, the proportion of patients who described a symptom as relatively intense or frequent always exceeded the proportion who reported it as highly distressing. The mean (+/- SD range) number of symptoms per patient was 11.5 +/- 6.0 (0-25); inpatients had more symptoms than outpatients (13.5 +/- 5.4 vs. 9.7 +/- 6.0, p < 0.002) and those with KPS < or = 80 had more symptoms than those with KPS > 80 (14.8 +/- 5.5 vs. 9.2 +/- 4.9, p < 0.0001).(ABSTRACT TRUNCATED AT 250 WORDS)","Qual Life Res, 3(3): 183-189","USA",1994,"Any or unknown","None","MSAS","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Symptom"]
[555,"Portenoy, R. K., et al. (1994). \"The Memorial Symptom Assessment Scale: an instrument for the evaluation of symptom prevalence, characteristics and distress.\" Eur J Cancer 30a(9): 1326-1336.",null,"Portenoy, R. K., et al.","The Memorial Symptom Assessment Scale: an instrument for the evaluation of symptom prevalence, characteristics and distress","The Memorial Symptom Assessment Scale (MSAS) is a new patient-rated instrument that was developed to provide multidimensional information about a diverse group of common symptoms. This study evaluated the reliability and validity of the MSAS in the cancer population. Randomly selected inpatients and outpatients (n = 246) with prostate, colon, breast or ovarian cancer were assessed using the MSAS and a battery of measures that independently evaluate phenomena related to quality of life. Symptom prevalence in the 218 evaluable patients ranged from 73.9% for lack of energy to 10.6% for difficulty swallowing. Based on a content analysis, three symptoms were deleted and two were added; the revised scale evaluates 32 physical and psychological symptoms. A factor analysis of variance yielded two factors that distinguished three major symptom groups and several subgroups. The major groups comprised psychological symptoms (PSYCH), high prevalence physical symptoms (PHYS H), and low prevalence physical symptoms (PHYS L). Internal consistency was high in the PHYS H and PSYCH groups (Cronback alpha coefficients of 0.88 and 0.83, respectively), and moderate in the PHYS L group (alpha = 0.58). Although the severity, frequency and distress dimensions were highly intercorrelated, canonical correlations and other analyses demonstrated that multidimensional assessment (frequency and distress) augments information about the impact of symptoms. High correlations with clinical status and quality of life measures support the validity of the MSAS and indicate the utility of several subscale scores, including PSYCH, PHYS, and a brief Global Distress Index. The MSAS is a reliable and valid instrument for the assessment of symptom prevalence, characteristics and distress. It provides a method for comprehensive symptom assessment that may be useful when information about symptoms is desirable, such as clinical trials that incorporate quality of life measures or studies of symptom epidemiology.","Eur J Cancer, 30a(9): 1326-1336","USA",1994,"Any or unknown","None","MSAS","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Symptom"]
[556,"Prezioso, D., et al. (2007). \"Quality of life evaluation by the EORTC QLQ-C30 questionnaire in patients treated with hormonal treatment in Italy. A QuABIOS group study.\" Arch Ital Urol Androl 79(3): 99-103.",null,"Prezioso, D., et al.","Quality of life evaluation by the EORTC QLQ-C30 questionnaire in patients treated with hormonal treatment in Italy. A QuABIOS group study","OBJECTIVES: An observational study was planned by the QuABIOS group, to survey the hormonal treatment administered to prostate cancer patients in Italy within a time window of 12 months. We report here a prospective quality of life (QOL) evaluation over time and by hormonal treatment modalities. METHODS: Patients with diagnosis of prostate cancer and treated with hormonal therapy were eligible for this study. The EORTC QLQ-C30 v.3 questionnaire was administered at enrolment, after 6 months and after 12 months from enrolment. RESULTS: 587 patients were enrolled by 33 urological centers. When 1518 visits were considered together independently of time, antiandrogen monotherapy was associated with a significantly better QOL than LHRH-analogue containing treatment modalities in almost all functional scales; cyproterone acetate demonstrated a better physical function and general health status than bicalutamide. When QOL was analyzed in a prospective 12-month window, a worsening of physical function and general health status was observed, notwithstanding, antiandrogens remained significantly associated to a better QOL than LHRH-analogue therapies also over time: a favourable physical function and general health status appeared again to be related to cyproterone acetate than bicalutamide. CONCLUSIONS: Androgen deprivation therapy is associated with decline in QOL, particularly in the domains of physical function, energy, and general health status. This survey demonstrated that antiandrogens had a better QOL profile than LHRH-analogue containing therapies;furthermore, a more favourable tolerability for cyproterone acetate as compared to bicalutamide is suggested.","Arch Ital Urol Androl, 79(3): 99-103","Italy",2007,"Any or unknown","Hormonal","EORTC QLQ-C30","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"General"]
[557,"Protopapa, E., et al. (2017). \"Patient-reported outcome (PRO) questionnaires for men who have radical surgery for prostate cancer: a conceptual review of existing instruments.\" BJU Int 120(4): 468-481.",null,"Protopapa, E., et al.","Patient-reported outcome (PRO) questionnaires for men who have radical surgery for prostate cancer: a conceptual review of existing instruments","To critically review conceptual frameworks for available patient-reported outcome (PRO) questionnaires in men having radical prostatectomy (RP), psychometrically evaluate each questionnaire, and identify whether each is appropriate for use at the level of the individual patient. We searched PubMed, the Reports and Publications database of the University of Oxford Patient-Reported Outcomes Measurement Group and the website of the International Consortium for Health Outcomes Measurement (ICHOM) for psychometric reviews of prostate cancer-specific PRO questionnaires. From these we identified relevant questionnaires and critically appraised the conceptual content, guided by the Wilson and Cleary framework and psychometric properties, using well established criteria. The searches found four reviews and one recommendation paper. We identified seven prostate cancer-specific PROs: the Expanded Prostate Cancer Index Composite-26 (EPIC-26), Expanded Prostate Cancer Index Composite-50 (EPIC-50), University of California-Los Angeles Prostate Cancer Index (UCLA-PCI), Functional Assessment of Cancer Therapy - Prostate Cancer Subscale (FACT-P PCS), European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - prostate specific 25-item (EORTC QLQ-PR25), Prostate Cancer - Quality of Life (PC-QoL), and Symptom Tracking and Reporting (STAR). Six out of seven measures purported to measure health-related quality of life (HRQL), but items focused strongly on urinary and sexual symptoms/functioning. The remaining questionnaire (STAR) claimed to assess functional recovery after RP. The psychometric evidence for these questionnaires was incomplete and variable in quality; none had evidence that they were appropriate for use with individual patients. Several questionnaires provide the basis of measures of urinary and/or sexual symptoms/functioning. Further work should explore other aspects of HRQL that are important for men having RP. Further psychometric work is also needed to determine whether they can be used at the individual level.","BJU Int, 120(4): 468-481","International",2017,"Any or unknown","Surgery","EPIC,UCLA-PCI,FACT-P,EORTC QLQ-PR25,PC-QoL,STAR","Patient",null,"Systematic review",null,null,null,null,null,null,null,null,"Disease,Symptom"]
[558,"Punnen, S., et al. (2012). \"Among potent men post radical prostatectomy, does the need for phosphodiesterase inhibitors have an impact on sexual bother scores?\" BJU Int 109(10): 1520-1524.",null,"Punnen, S., et al.","Among potent men post radical prostatectomy, does the need for phosphodiesterase inhibitors have an impact on sexual bother scores?","Study Type - Therapy (case series) Level of Evidence 4. What's known on the subject? and What does the study add? Although phosphodiesterase inhibitor use post radical prostatectomy improves potency, little is known about its affects on sexual bother. We found no difference in sexual bother scores between patients who use and do not use phosphodiesterase inhibitors. This suggests that the current definition of potency, inclusive of medication use, is valid with respect to sexual bother. OBJECTIVE: To determine whether the current definition of potency, inclusive of phosphodiesterase inhibitor (PDEi) use, is valid with respect to sexual bother (SB). This will be assessed by characterizing the effect of PDEi use on SB scores in men who are potent post radical prostatectomy. PATIENTS AND METHODS: The study population consisted of patients who were potent both before and after radical prostatectomy, with at least 2 years of follow-up. Disease-specific quality of life data were evaluated by the University of California, Los Angeles, Prostate Cancer Index (PCI) survey. The relationships between changes in sexual function (SF) and SB and use of PDEi over time were evaluated by mixed model analysis controlling for age, clinical risk group, marital status, and time of PCI assessment. RESULTS: Of the 246 patients who met the study criteria, 39% reported PDEi use at some point after treatment. PDEi use was not associated with improved SF (P= 0.81). Furthermore, PDEi use was not associated with a change in SB (P= 0.36). Both SF and SB were significantly associated with time of assessment and age, and SF and SB each improved over time. In addition, SB was significantly associated with marital status. CONCLUSIONS: In this analysis, there was no difference in SF scores between men who were potent with or without the use of PDEi. Furthermore, there was no difference in SB scores between men who were potent with or without the use of PDEi. This suggests that the current, inclusive, definition of potency is valid with respect to SB.","BJU Int, 109(10): 1520-1524","USA",2012,"Any or unknown","Surgery,PDEi","UCLA-PCI","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease"]
[559,"Purohit, O. P., et al. (1994). \"High-dose intravenous pamidronate for metastatic bone pain.\" Br J Cancer 70(3): 554-558.",null,"Purohit, O. P., et al.","High-dose intravenous pamidronate for metastatic bone pain","The bisphosphonates are able to relieve pain from metastatic bone disease and, when given intravenously, may promote bone healing of lytic metastases. In this study, the aim was to assess the acute effects of a single 'high-dose' intravenous treatment with pamidronate on pain, mobility, analgesic consumption and quality of life (QOL). Thirty-four normocalcaemic patients with painful progressing bone metastases (22 from breast, five prostate and seven others) received a single intravenous infusion of 120 mg of pamidronate as palliative therapy. No other systemic therapy or drugs known to influence bone metabolism were administered during the study. Patients' subjective response to treatment was assessed weekly with a pain questionnaire recording a composite of pain intensity, mobility, performance status and analgesic consumption. In addition, patients completed the Rotterdam Symptom Check List (RSCL) for measurement of QOL and a mobility questionnaire. The mean reduction in the pain questionnaire score (recorded on at least two occasions) was 25% [standard error (s.e.) 3%, range 0-75%]. Twenty patients (59%) showed a > or = 20% improvement and were classified as responders. The median duration of symptomatic response was 12 (range 4-24 +) weeks. The responding patients showed a reduction in RSCL score (improvement in QOL) from 35% before treatment to 27% at 6 weeks, but no significant improvement was noted in non-responders. Twenty-one patients were retreated with pamidronate when their symptoms deteriorated again. Eight out of 15 responders showed a second reduction in pain score of > or = 20%, but this was not seen in any of the six non-responders. Five patients have remained well with no additional treatment for their disease other than repeat infusions of pamidronate every 3-6 months. Treatment was well tolerated. Eight (24%) experienced fever after the first treatment only, and four had asymptomatic, biochemical evidence of hypocalcaemia. The acute inhibition of osteoclastic bone resorption induced by a single high-dose treatment with pamidronate can provide useful palliation for patients with bone metastases. Responding patients may be retreated as symptoms dictate to good effect. We are currently running a phase III double-blind trial with high-dose pamidronate for progressive painful metastatic bone disease to exclude any placebo effect and observer bias.","Br J Cancer, 70(3): 554-558","UK",1994,"Metastatic","Bisphosphonate","RSCL","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Symptom"]
[560,"Quattrone, C., et al. (2015). \"Retropubic, laparoscopic and mini-laparoscopic radical prostatectomy: a prospective assessment of patient scar satisfaction.\" World J Urol 33(8): 1181-1187.",null,"Quattrone, C., et al.","Retropubic, laparoscopic and mini-laparoscopic radical prostatectomy: a prospective assessment of patient scar satisfaction","PURPOSE: To compare patient scar satisfaction after retropubic, standard laparoscopic, mini-laparoscopic (ML) and open radical prostatectomy (RP). METHODS: Patients undergoing RP for a diagnosis of localized prostate cancer at a single academic hospital between September 2012 and December 2013 were enrolled in this prospective nonrandomized study. The patients were included in three study arms: open surgery, VLP and ML. A skin stapler was used for surgical wound closure in all cases. Demographic and main surgical outcomes, including perioperative complications, were analyzed. Surgical scar satisfaction was measured using the Patient and Observer Scar Assessment Questionnaire (POSAS) and the two Body Image Questionnaire (BIQ) scales, respectively, recorded at skin clips removal and either at 6 months after surgery. RESULTS: Overall, 32 patients were enrolled and completed the 6 month of follow-up. At clips removal, laparoscopic approaches offered better scar result than open surgery according to the POSAS. However, at 6 months, no differences were detected between VLP and open, whereas ML was still associated with a better scar outcome (p = 0.001). This finding was also confirmed by both BIQ scales, including the body image score (ML 9.8 +/- 1.69, open 15.73 +/- 3.47, VLP 13.27 +/- 3.64; p = 0.001) and the cosmetic score (ML 16.6 +/- 4.12, open 10 +/- 1.9, LP 12.91 +/- 3.59; p = 0.001). Small sample size and lack of randomization represent the main limitations of this study. CONCLUSIONS: ML RP offers a better cosmetic outcome when compared to both open and standard laparoscopic RP, representing a step toward minimal surgical scar. The impact of scar outcome on RP patients' quality of life remains to be determined.","World J Urol, 33(8): 1181-1187","Italy",2015,"Local","Surgery","BIS,POSAS","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General,Satisfaction"]
[561,"Quon, H., et al. (2012). \"Quality of life after hypofractionated concomitant intensity-modulated radiotherapy boost for high-risk prostate cancer.\" Int J Radiat Oncol Biol Phys 83(2): 617-623.",null,"Quon, H., et al.","Quality of life after hypofractionated concomitant intensity-modulated radiotherapy boost for high-risk prostate cancer","PURPOSE: To evaluate the change in health-related quality of life (QOL) of patients with high-risk prostate cancer treated using hypofractionated radiotherapy combined with long-term androgen deprivation therapy. METHODS AND MATERIALS: A prospective Phase I-II study enrolled patients with any of the following: clinical Stage T3 disease, prostate-specific antigen level >/=20 ng/mL, or Gleason score 8-10. Radiotherapy consisted of 45 Gy (1.8 Gy per fraction) to the pelvic lymph nodes with a concomitant 22.5 Gy intensity-modulated radiotherapy boost to the prostate, for a total of 67.5 Gy (2.7 Gy per fraction) in 25 fractions over 5 weeks. Daily image guidance was performed using three gold seed fiducials. Quality of life was measured using the Expanded Prostate Cancer Index Composite (EPIC), a validated tool that assesses four primary domains (urinary, bowel, sexual, and hormonal). RESULTS: From 2004 to 2007, 97 patients were treated. Median follow-up was 39 months. Compared with baseline, at 24 months there was no statistically significant change in the mean urinary domain score (p = 0.99), whereas there were decreases in the bowel (p < 0.01), sexual (p < 0.01), and hormonal (p < 0.01) domains. The proportion of patients reporting a clinically significant difference in EPIC urinary, bowel, sexual, and hormonal scores at 24 months was 27%, 31%, 55%, and 60%, respectively. However, moderate and severe distress related to these symptoms was minimal, with increases of only 3% and 5% in the urinary and bowel domains, respectively. CONCLUSIONS: Hypofractionated radiotherapy combined with long-term androgen deprivation therapy was well tolerated. Although there were modest rates of clinically significant patient-reported urinary and bowel toxicity, most of this caused only mild distress, and moderate and severe effects on QOL were limited. Additional follow-up is ongoing to characterize long-term QOL.","Int J Radiat Oncol Biol Phys, 83(2): 617-623","Canada",2012,"Advanced","Radiotherapy,Hormonal","EPIC","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease"]
[562,"Rago, R. P., et al. (2003). \"Safety and efficacy of the MDR inhibitor Incel (biricodar, VX-710) in combination with mitoxantrone and prednisone in hormone-refractory prostate cancer.\" Cancer Chemother Pharmacol 51(4): 297-305.",null,"Rago, R. P., et al.","Safety and efficacy of the MDR inhibitor Incel (biricodar, VX-710) in combination with mitoxantrone and prednisone in hormone-refractory prostate cancer","PURPOSE: VX-710 (biricodar, Incel) restores drug sensitivity to cells expressing P-glycoprotein (P-gp) and multidrug resistance-associated protein (MRP1). MRP1 is expressed in a high proportion of prostate tumors while P-gp expression is variable. Since mitoxantrone (M) and prednisone (P) are substrates for MDR transporters, we initiated a study to evaluate the safety, pharmacokinetics, and efficacy of VX-710 plus M/P in patients with hormone-refractory prostate cancer (HRPC). PATIENTS AND METHODS: Eligible patients had progressive HRPC (defined as new lesions, new disease-related pain, or 50% increase in PSA within 6 weeks of entry), testosterone <30 ng/ml, no prior chemotherapy, ECOG performance status of 0-3, and adequate organ function. Patients received VX-710 (120 mg/m(2) per h) as a 72-h continuous intravenous infusion with intravenous bolus mitoxantrone (12 mg/m(2)) administered 4 h after VX-710 was started and prednisone (5 mg twice daily) administered throughout the study treatment. Endpoints included serum PSA response, PSA response duration, time to PSA progression, pain reduction, and quality of life measures. RESULTS: Enrolled in the study were 40 patients and 184 courses of VX-710 plus M/P were administered. Intensive pharmacokinetics, which were performed on six patients who received one cycle of M/P alone, followed by VX-710 plus M/P for all other cycles, showed that VX-710 did not alter mitoxantrone clearance. VX-710 blood concentration at the time of mitoxantrone administration averaged 4.52 microg/ml. VX-710 plus M/P was well tolerated. Transient nausea/vomiting and mild neutropenia were the principal treatment toxicities. Five patients experienced an uncomplicated febrile neutropenic episode (12%), three had severe nausea/vomiting, and two experienced transient moderate to severe ataxia. Of the 40 patients, 12 (30%, 95% confidence interval 16-44%) had a reduction in PSA of >/=50% and 9 of the 12 patients (23% overall, 95% CI 10-35%) achieved a reduction in PSA of >/=80% that was sustained for the duration of treatment with M/P plus VX-710. The median time to PSA progression was 41 weeks (95% CI 34-68 weeks). Of the 40 patients, 15 completed treatment with stable disease and 13 had progressive disease with increasing serum PSA during study treatment. Median survival was 48 weeks for the intent-to-treat population of 40 patients. CONCLUSIONS: The addition of VX-710 to M/P therapy did not appear to increase the proportion of patients with significant serum PSA reductions compared to M/P alone. However, the duration of PSA response observed for the 12 PSA responders suggests that MDR inhibition may benefit some patients with HRPC. In addition to MRP1 or P-gp expression, other mechanisms of drug resistance are probably associated with the relative insensitivity of HRPC to cytotoxic therapy.","Cancer Chemother Pharmacol, 51(4): 297-305","USA",2003,"Any or unknown","Chemotherapy","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General,Symptom"]
[563,"Ramachandra, P., et al. (2009). \"A brief self-administered psychological intervention to improve well-being in patients with cancer: results from a feasibility study.\" Psychooncology 18(12): 1323-1326.",null,"Ramachandra, P., et al.","A brief self-administered psychological intervention to improve well-being in patients with cancer: results from a feasibility study","BACKGROUND: Patients with cancer have relatively high rates of anxiety and distress, adversely affecting their well-being and quality of life. Recent studies indicate that addressing these symptoms could result in better response to cancer treatment. Researchers have found that interventions that focus on increasing mental awareness and the frequency of positive experiences may have a greater impact on reducing psychological morbidity and increasing quality of life than interventions that target relief of psychological symptoms. AIM: To develop and test a brief, easy to use intervention that could improve well-being and quality of life in cancer patients. METHODS: We developed a simple well-being intervention that made few demands on patient time and required little training resource. Participants were randomly assigned to an intervention group or a deferred entry group. Measures of anxiety, depression, well-being and quality of life were administered at baseline and at follow-ups. RESULTS: Twenty-two women with metastatic breast cancer and 24 men with metastatic prostate cancer were recruited from oncology clinics. Thirteen women and 14 men completed the study. Both qualitative and quantitative data showed that the intervention was acceptable to users. There was statistically significant improvement in quality of life scores on WHOQOL-BREF post-intervention (p=0.046). Compliance with the intervention was good. CONCLUSIONS: This brief well-being intervention appears to be a promising technique for improving quality of life of cancer patients, without making undue demands on staff resources or patient time. If further studies confirm its effectiveness, it could prove to be a cost-effective intervention.","Psychooncology, 18(12): 1323-1326","UK",2009,"Metastatic","Psychological","WHOQOL-BREF","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General"]
[564,"Ramsay, C. R., et al. (2015). \"Ablative therapy for people with localised prostate cancer: a systematic review and economic evaluation.\" Health Technol Assess 19(49): 1-490.",null,"Ramsay, C. R., et al.","Ablative therapy for people with localised prostate cancer: a systematic review and economic evaluation","BACKGROUND: For people with localised prostate cancer, active treatments are effective but have significant side effects. Minimally invasive treatments that destroy (or ablate) either the entire gland or the part of the prostate with cancer may be as effective and cause less side effects at an acceptable cost. Such therapies include cryotherapy, high-intensity focused ultrasound (HIFU) and brachytherapy, among others. OBJECTIVES: This study aimed to determine the relative clinical effectiveness and cost-effectiveness of ablative therapies compared with radical prostatectomy (RP), external beam radiotherapy (EBRT) and active surveillance (AS) for primary treatment of localised prostate cancer, and compared with RP for salvage treatment of localised prostate cancer which has recurred after initial treatment with EBRT. DATA SOURCES: MEDLINE (1946 to March week 3, 2013), MEDLINE In-Process & Other Non-Indexed Citations (29 March 2013), EMBASE (1974 to week 13, 2013), Bioscience Information Service (BIOSIS) (1956 to 1 April 2013), Science Citation Index (1970 to 1 April 2013), Cochrane Central Register of Controlled Trials (CENTRAL) (issue 3, 2013), Cochrane Database of Systematic Reviews (CDSR) (issue 3, 2013), Database of Abstracts of Reviews of Effects (DARE) (inception to March 2013) and Health Technology Assessment (HTA) (inception to March 2013) databases were searched. Costs were obtained from NHS sources. REVIEW METHODS: Evidence was drawn from randomised controlled trials (RCTs) and non-RCTs, and from case series for the ablative procedures only, in people with localised prostate cancer. For primary therapy, the ablative therapies were cryotherapy, HIFU, brachytherapy and other ablative therapies. The comparators were AS, RP and EBRT. For salvage therapy, the ablative therapies were cryotherapy and HIFU. The comparator was RP. Outcomes were cancer related, adverse effects (functional and procedural) and quality of life. Two reviewers extracted data and carried out quality assessment. Meta-analysis used a Bayesian indirect mixed-treatment comparison. Data were incorporated into an individual simulation Markov model to estimate cost-effectiveness. RESULTS: The searches identified 121 studies for inclusion in the review of patients undergoing primary treatment and nine studies for the review of salvage treatment. Cryotherapy [3995 patients; 14 case series, 1 RCT and 4 non-randomised comparative studies (NRCSs)], HIFU (4000 patients; 20 case series, 1 NRCS) and brachytherapy (26,129 patients; 2 RCTs, 38 NRCSs) studies provided limited data for meta-analyses. All studies were considered at high risk of bias. There was no robust evidence that mortality (4-year survival 93% for cryotherapy, 99% for HIFU, 91% for EBRT) or other cancer-specific outcomes differed between treatments. For functional and quality-of-life outcomes, the paucity of data prevented any definitive conclusions from being made, although data on incontinence rates and erectile dysfunction for all ablative procedures were generally numerically lower than for non-ablative procedures. The safety profiles were comparable with existing treatments. Studies reporting the use of focal cryotherapy suggested that incontinence rates may be better than for whole-gland treatment. Data on AS, salvage treatment and other ablative therapies were too limited. The cost-effectiveness analysis confirmed the uncertainty from the clinical review and that there is no technology which appears superior, on the basis of current evidence, in terms of average cost-effectiveness. The probabilistic sensitivity analyses suggest that a number of ablative techniques are worthy of further research. LIMITATIONS: The main limitations were the quantity and quality of the data available on cancer-related outcomes and dysfunction. CONCLUSIONS: The findings indicate that there is insufficient evidence to form any clear recommendations on the use of ablative therapies in order to influence current clinical practice. Research efforts in the use of ablative therapies in the management of prostate cancer should now be concentrated on the performance of RCTs and the generation of standardised outcomes. STUDY REGISTRATION: This study is registered as PROSPERO CRD42012002461. FUNDING: The National Institute for Health Research Health Technology Assessment programme.","Health Technol Assess, 19(49): 1-490","International",2015,"Local","Surgery,Radiotherapy,Surveillance,HIFU,Brachytherapy,Various","Unclear","Patient",null,"Systematic review",null,null,null,null,null,null,null,null,"Complication"]
[565,"Ravasco, P., et al. (2003). \"Does nutrition influence quality of life in cancer patients undergoing radiotherapy?\" Radiother Oncol 67(2): 213-220.",null,"Ravasco, P., et al.","Does nutrition influence quality of life in cancer patients undergoing radiotherapy?","PURPOSE: To investigate in cancer patients referred for radiotherapy (RT): (1) quality of life (QoL), nutritional status and nutrient intake, at the onset and at the end of RT; (2) whether individualised nutritional counselling, despite symptoms, was able to enhance nutrient intake over time and whether the latter influenced the patient's QoL; and (3) which symptoms may anticipate poorer QoL and/or reduced nutritional intake. MATERIAL AND METHODS: One hundred and twenty-five patients with tumours of the head-neck/gastrointestinal tract (high-risk: HR), prostate, breast, lung, brain, gallbladder, uterus (low-risk: LR) were evaluated before and at the end of RT. Nutritional status was evaluated by Ottery's Subjective Global Assessment, nutritional intake by a 24-h recall food questionnaire and QoL by two instruments: EUROQOL and the European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30. RESULTS: Baseline malnutrition was prevalent in HR vs. LR (P=0.02); nutritional intake was associated with nutritional status (P=0.007); the latter did not change significantly during RT. In LR, baseline energy intake was higher than EER (P=0.001), and higher than HR' intake (P=0.002); the latter increased (P<0.03), in spite of symptom increase anew and/or in severity (P=0.0001). According to both instruments, QoL was always better in LR vs. HR (P=0.01); at the end of RT, QoL improvement in HR was correlated with increased nutritional intake (P=0.001), both remained stable in LR. CONCLUSIONS: Individualised nutritional counselling accounting for nutritional status and clinical condition, was able to improve nutritional intake and patients' QoL, despite self-reported symptoms.","Radiother Oncol, 67(2): 213-220","Portugal",2003,"Any or unknown","Radiotherapy,Various","EORTC QLQ-C30,EQ-5D,OSGA,FFQ","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"General,Utility"]
[566,"Reddy, S. M., et al. (1997). \"Patient self-assessment of complications and quality of life after conformal neutron and photon irradiation for localized prostate cancer.\" Radiat Oncol Investig 5(5): 252-256.",null,"Reddy, S. M., et al.","Patient self-assessment of complications and quality of life after conformal neutron and photon irradiation for localized prostate cancer","Although neutron irradiation for prostate cancer has been associated with significant morbidity, pilot data in patients with early stage disease suggested that conformal neutron and photon irradiation was well tolerated without severe complications. A self-assessment questionnaire was mailed to the first 83 patients treated with conformal neutron and photon irradiation to objectively evaluate the impact on quality of life of this regimen. In total, 75 patients (90%) returned the completed questionnaire. These patients had received either 9 neutron Gy (N Gy) plus 38 photon Gy (50 patients) or 10 N Gy plus 38 photon Gy (33 patients) for stage T1/T2 N0 M0 prostate cancer (Gleason score < or = 7). The irradiated volume included the prostate and seminal vesicles with a 1.5 cm margin. Neutrons were delivered as a boost to the prostate only with a non-axial four field beam arrangement. Approximately 50% of the dose to the prostate was from neutron irradiation. Follow-up ranged from 6 to 25 months (median 13 months). The questionnaire used was a validated quality of life instrument used previously in patients treated with surgery or radiation. Prior to irradiation, 29% of patients reported urinary symptoms and 11% had prostate surgery (TURP). At follow-up, 23% reported persistent urinary symptoms. Of these, 21% dripped a few drops of urine, 3% used pads but none leaked > 1 tablespoon/day. One patient underwent surgery to dilate a urethral stricture. Although 55% of patients had gastrointestinal symptoms during radiation therapy, only 26% had persistent symptoms at the time of questioning. These included minor rectal bleeding in 20% and significant hematochezia in 3%. Of the 85% of patients able to obtain full or partial erections prior to irradiation, 87% maintained their potency. Fifteen percent sought treatment for impotence. Overall, at last follow-up, 84% felt little or no physical discomfort, 91% were very satisfied with their treatment, and 97% would choose radiation therapy again. This patient self-assessment questionnaire confirmed that this regimen of conformal neutron and photon irradiation resulted in levels of chronic toxicity acceptable to the patient.","Radiat Oncol Investig, 5(5): 252-256","USA",1997,"Local","Radiotherapy","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"General,Complication"]
[567,"Rees, J., et al. (2005). \"The measurement of response shift in patients with advanced prostate cancer and their partners.\" Health Qual Life Outcomes 3: 21.",null,"Rees, J., et al.","The measurement of response shift in patients with advanced prostate cancer and their partners","BACKGROUND: There is increasing evidence to support the phenomenon of response shift (RS) in quality of life (QoL) studies, with many current QoL measures failing to allow for this. If significant response shift occurs amongst prostate cancer patients, it will be necessary to allow for this in the design of future clinical research and to reassess the conclusions of previous studies that have not allowed for this source of bias. This study therefore aimed to assess the presence of RS and psychosocial morbidity in patients with advanced prostate cancer and their partners. METHODS: 55 consecutive advanced prostate cancer patients and their partners completed the Prostate Cancer Patient & Partner questionnaire (PPP), shortly after diagnosis and again at 3 months and 6 months. At the follow-up visits, both patients and partners also completed a then-test in order to assess RS. RESULTS: Partners consistently showed greater psychological morbidity than patients in relation to the prostate cancer. This was most marked on the General Cancer Distress (GCD) subscale (p < 0.001, paired t-test), and regarding worries about treatment (p = 0.01). Significant RS was identified in partners and patients by the use of the then-test technique, particularly on the GCD subscale, the concerns about treatment and the concerns about urinary symptoms items. CONCLUSION: These results suggest the presence of RS in patients with advanced prostate cancer and their partners, with higher levels of psychosocial morbidity noted amongst partners. This is the first study to identify RS in partners and calls into question the interpretation of all studies assessing changes in QoL that fail to allow for this phenomenon.","Health Qual Life Outcomes, 3(21","UK",2005,"Advanced","Unclear","PPP","Patient,Caregiver",null,"Cohort",null,null,null,null,null,null,null,null,"Disease"]
[568,"Reeve, B. B., et al. (2009). \"Impact of cancer on health-related quality of life of older Americans.\" J Natl Cancer Inst 101(12): 860-868.",null,"Reeve, B. B., et al.","Impact of cancer on health-related quality of life of older Americans","BACKGROUND: The impact of cancer on health-related quality of life (HRQOL) is poorly understood because of the lack of baseline HRQOL status before cancer diagnosis. To our knowledge, this is the first population-based study to quantify the nature and extent of HRQOL changes from before to after cancer diagnosis for nine types of cancer patients and to compare their health with individuals without cancer. METHODS: The Surveillance, Epidemiology, and End Results cancer registry data were linked with the Medicare Health Outcomes Survey (MHOS) data; data were collected from Medicare beneficiaries who were aged 65 years and older from 1998 through 2003. Cancer patients (n = 1432; with prostate, breast, colorectal, lung, bladder, endometrial, or kidney cancers; melanoma; or non-Hodgkin lymphoma [NHL]) were selected whose first cancer diagnosis occurred between their baseline and follow-up MHOS assessments. Control subjects without cancer (n = 7160) were matched to cancer patients by use of propensity scores that were estimated from demographics and comorbid medical conditions. Analysis of covariance models were used to estimate changes in HRQOL as assessed with the Medical Outcomes Study Short Form-36 survey (mean score = 50, SD = 10). All statistical tests were two-sided. RESULTS: Patients with all cancer types (except melanoma and endometrial cancer) reported statistically significant declines in physical health (mean scores: prostate cancer = -3.4, 95% confidence interval [CI] = -2.5 to -4.2; breast cancer = -3.5, 95% CI = -2.5 to -4.5; bladder cancer = -4.3, 95% CI = -2.5 to -6.1; colorectal cancer = -4.4, 95% CI = -3.3 to -5.5; kidney cancer = -5.7, 95% CI = -3.2 to -8.2; NHL = -6.7, 95% CI = -4.4 to -9.1; and lung cancer = -7.5, 95% CI = -5.9 to -9.2) compared with the control subjects (mean score = -1.8, 95% CI = -1.6 to -2.0) (all P < .05). However, only lung (mean score = -5.4, 95% CI = -3.5 to -7.2), colorectal (mean score = -3.5, 95% CI = -2.2 to -4.7), and prostate (mean score = -2.8, 95% CI = -1.8 to -3.7) cancer patients showed statistically significant decreases in mental health relative to the mean change of the control subjects (mean score = -1.2, 95% CI = -0.9 to -1.4) (all P < .05). CONCLUSION: These findings provide validation of the specific deleterious effects of cancer on HRQOL and an evidence base for future research and clinical interventions aimed at understanding and remediating these effects.","J Natl Cancer Inst, 101(12): 860-868","USA",2009,"Any or unknown","None","SF-36","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Utility"]
[569,"Register, S. P., et al. (2013). \"An MRI-based dose--reponse analysis of urinary sphincter dose and urinary morbidity after brachytherapy for prostate cancer in a phase II prospective trial.\" Brachytherapy 12(3): 210-216.",null,"Register, S. P., et al.","An MRI-based dose--reponse analysis of urinary sphincter dose and urinary morbidity after brachytherapy for prostate cancer in a phase II prospective trial","PURPOSE: To compare dose-volume histogram variables for the internal and external urinary sphincters (IUS/EUS) with urinary quality of life after prostate brachytherapy. METHODS AND MATERIALS: Subjects were 42 consecutive men from a prospective study of brachytherapy as monotherapy with (125)I for intermediate-risk localized prostate cancer. No patient received hormonal therapy. Preplanning constraints included prostate V100 higher than 95%, V150 lower than 60%, and V200 lower than 20% and rectal R100 less than 1cm(3). Patients completed the Expanded Prostate Cancer Index Composite quality-of-life questionnaire before and at 1, 4, 8, and 12 months after implantation, and urinary domain scores were analyzed. All structures including the IUS and EUS were contoured on T2-weighted MRI at day 30, and doses received were calculated from identification of seeds on CT. Spearman's (nonparametric) rank correlation coefficient (rho) was used for statistical analyses. RESULTS: Overall urinary morbidity was worst at 1 month after the implant. Urinary function declined when the IUS V285 was 0.4% (rho=-0.32, p=0.04); bother worsened when the IUS V35 was 99% (rho=-0.31, p=0.05) or the EUS V240 was 63% (rho=-0.31, p=0.05); irritation increased when the IUS V35 was 95% (rho=-0.37, p=0.02) and the EUS V265 was 24% (rho=-0.32, p=0.04); and urgency worsened when the IUS V35 was 99.5% (rho=-0.38, p=0.02). Incontinence did not correlate with EUS or IUS dose. CONCLUSIONS: Doses to the IUS and EUS on MRI/CT predicted worse urinary function, with greater bother, irritative symptoms, and urgency. Incorporating MRI-based dose-volume histogram analysis into the treatment planning process may reduce acute urinary morbidity after brachytherapy.","Brachytherapy, 12(3): 210-216","USA",2013,"Local","Brachytherapy","EPIC","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease"]
[570,"Rehman, J., et al. (2004). \"Laparoscopic radical prostatectomy: Washington University initial experience and prospective evaluation of quality of life.\" J Endourol 18(3): 277-287.",null,"Rehman, J., et al.","Laparoscopic radical prostatectomy: Washington University initial experience and prospective evaluation of quality of life","BACKGROUND AND PURPOSE: The laparoscopic approach to radical prostatectomy offers an alternative to the open surgical procedure with less morbidity. We prospectively collected data including a validated quality-of-life questionnaires on our first 38 laparoscopic radical prostatectomies (LRPs). The first 10 patients (group 1), second 10 patients (group II), and the most recent 18 patients (group III) were examined separately to study the learning curve for this procedure. In addition, we determined the pattern of recovery of urinary continence, potency, and quality of life. PATIENTS AND METHODS: Between July 1999 and July 2002, 38 consecutive transperitoneal laparoscopic radical prostatectomies were performed for clinically localized prostate carcinoma. Patients completed quality-of-life questionnaires (Rand 36 Health Survey) before surgery as well as at 1, 3, 6, and 12 months and every 6 months thereafter. The patients were also interviewed by an individual not directly involved in patient care. RESULTS: One patient (the second in our experience) was converted to the open approach because of failure to progress. The average operating time for the whole series was 423 +/- 137.6 minutes (range 215-825 minutes), the last 10 procedures taking 305 +/- 63 minutes (range 215-420 minutes). Complications consisted of one case each of intraoperative bladder injury, transient superficial peroneal nerve palsy, pulmonary embolism, and bladder neck obstruction. The bladder injury was closed laparoscopically without further complication. Bladder neck obstruction was secondary to a bladder wall fold that was treated with transurethral resection 14 months after surgery with good results. Four patients in group 1 had minor anastomotic leaks, while only one patient after that had a leak (group III). Four patients required transfusion, two intraoperatively and two postoperatively. In group III, the urethral catheter remained in place for an average of 8 days (range 6-10 days). With a mean follow-up of 22.8 months (range 9-43 months), 84.8% of the patients had perfect urinary control. Postoperatively, 9 patients (27%) were fully continent on removal of the Foley catheter. At 1, 3, 6, and 9 months postoperatively, diurnal urinary control was reported by 30.3%, 48%, 72.7%, and 84.8% of the patients, respectively. One patient needed an artificial urinary sphincter. Among the incontinent patients, 24.2% had urinary urgency, and one third of these patients reported urge incontinence. CONCLUSIONS: Laparoscopic prostatectomy is a reproducible technique with a steep learning curve. Operating times and the incidence of anastomotic leaks and urinary incontinence decrease significantly after the initial 10 patients.","J Endourol, 18(3): 277-287","USA",2004,"Local","Surgery","SF-36","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Utility"]
[571,"Reidunsdatter, R. J., et al. (2010). \"Validation of the intestinal part of the prostate cancer questionnaire \"QUFW94\": psychometric properties, responsiveness, and content validity.\" Int J Radiat Oncol Biol Phys 77(3): 793-804.",null,"Reidunsdatter, R. J., et al.","Validation of the intestinal part of the prostate cancer questionnaire \"QUFW94\": psychometric properties, responsiveness, and content validity","PURPOSE: Several treatment options are available for patients with prostate cancer. Applicable and valid self-assessment instruments for assessing health-related quality of life (HRQOL) are of paramount importance. The aim of this study was to explore the validity and responsiveness of the intestinal part of the prostate cancer-specific questionnaire QUFW94. METHODS AND MATERIALS: The content of the intestinal part of QUFW94 was examined by evaluation of experienced clinicians and reviewing the literature. The psychometric properties and responsiveness were assessed by analyzing HRQOL data from the randomized study Scandinavian Prostate Cancer Group 7 (SPCG)/Swedish Association for Urological Oncology 3 (SFUO). Subscales were constructed by means of exploratory factor analyses. Internal consistency was assessed by Cronbach's alpha. Responsiveness was investigated by comparing baseline scores with the 4-year posttreatment follow-up. RESULTS: The content validity was found acceptable, but some amendments were proposed. The factor analyses revealed two symptom scales. The first scale comprised five items regarding general stool problems, frequency, incontinence, need to plan toilet visits, and daily activity. Cronbach's alpha at 0.83 indicated acceptable homogeneity. The second scale was less consistent with a Cronbach's alpha at 0.55. The overall responsiveness was found to be very satisfactory. CONCLUSION: Two scales were identified in the bowel dimension of the QUFW94; the first one had good internal consistency. The responsiveness was excellent, and some modifications are suggested to strengthen the content validity.","Int J Radiat Oncol Biol Phys, 77(3): 793-804","Norway",2010,"Any or unknown","Unclear","QUFW94","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease"]
[572,"Reis, F., et al. (2004). \"The impact of prostatectomy and brachytherapy in patients with localized prostate cancer.\" Int Urol Nephrol 36(2): 187-190.",null,"Reis, F., et al.","The impact of prostatectomy and brachytherapy in patients with localized prostate cancer","PURPOSE: to compare urinary incontinence and erectile dysfunction symptoms reflecting quality of life and the willingness to undergo treatment again in patients treated by radical retropubic prostatectomy and low dose radiation (LDR) brachytherapy. MATERIALS AND METHODS: from July 1992 to November 2001, 158 patients with clinical localized prostate cancer were treated by radical retropubic prostatectomy with or without nerve sparring or LDR brachytherapy. To all the 158 patients we mailed a self-reporting questionnaire with 5 questions to access sexual function, 4 questions for urinary continence, and 2 for the satisfaction with the treatment and willingness to undergo treatment again. Patients had no form of adjuvant radiation therapy, or neoadjuvant or adjuvant androgen suppression therapy. A total of 56 patients (43%), 34 of the prostatectomy and 22 patients of the brachytherapy group answered the questionnaire. Questionnaire results were independently analyzed by someone else not involved with patients' treatment. RESULTS: patients self-reported some degree of erectile dysfunction in 84.8% (p = 0.01) in the group treated by prostatectomy and 23.07% (p = 0.86) in the brachytherapy group. Urinary incontinence occurred in 17.6% in the group treated by prostatectomy (p = 0.01) and in 9.5% (p = 0.52) in the brachytherapy group. Urinary incontinence and impotence significantly affected treatment satisfaction. However, considering satisfaction with the treatment and willingness to undergo treatment again, 88.2% of patients would elect surgery again and 95.5% brachytherapy again.","Int Urol Nephrol, 36(2): 187-190","Brazil",2004,"Local","Surgery,Brachytherapy","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Complication,Satisfaction"]
[573,"Richard, P. O., et al. (2015). \"Phase II, randomised, double-blind, placebo-controlled trial of methylphenidate for reduction of fatigue levels in patients with prostate cancer receiving LHRH-agonist therapy.\" BJU Int 116(5): 744-752.",null,"Richard, P. O., et al.","Phase II, randomised, double-blind, placebo-controlled trial of methylphenidate for reduction of fatigue levels in patients with prostate cancer receiving LHRH-agonist therapy","OBJECTIVES: To investigate whether methylphenidate can alleviate fatigue, as measured by the Functional Assessment of Cancer Therapy: Fatigue subscale, in men with prostate cancer (PCa) treated with a luteinizing hormone-releasing hormone (LHRH) for a minimum of 6 months, and to assess changes in global fatigue and quality of life (QoL) as measured by the Bruera Global Fatigue Severity Scale (BFS) and the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36), respectively. PARTICIPANTS AND METHODS: We performed a single-centre, randomised, double-blind, placebo-controlled trial with the aim of recruiting 128 participants. Men treated with a LHRH agonist for PCa were screened between February 2008 and June 2012 for fatigue at our outpatient clinics using the BFS. Participants were randomised to receive either 10 mg daily of methylphenidate or placebo. Change in fatigue levels and in SF-36 scores between both groups were compared using linear regression, adjusted for baseline scores. RESULTS: The study was closed prematurely because of poor accrual. Of the 790 subjects screened, 24 men were randomised to methylphenidate or placebo (12 per group). After 10 weeks, the improvement in mean [sd] fatigue score was greater in the methylphenidate than in the placebo arm (+7.7 [7.7] vs +1.4 [7.6]; P = 0.022). The within-group analysis showed a significant improvement in fatigue scores in the methylphenidate arm (P = 0.008) but not in the placebo arm (P = 0.82). The use of methylphenidate also resulted in a significantly greater improvement in QoL as measured by the physical and mental component summary scores than did the use of placebo (P = 0.04 for both component scores). CONCLUSIONS: Our findings support the beneficial effect of methylphenidate on fatigue and QoL among men with LHRH-induced fatigue. Clinicians should be aware of these benefits and should consider discussing these findings with patients who have high levels of fatigue.","BJU Int, 116(5): 744-752","Canada",2015,"Any or unknown","Hormonal,Various","FACT-F,SF-36,BFS","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Symptom,Utility"]
[574,"Riley, B. B., et al. (1998). \"Types of spiritual well-being among persons with chronic illness: their relation to various forms of quality of life.\" Arch Phys Med Rehabil 79(3): 258-264.",null,"Riley, B. B., et al.","Types of spiritual well-being among persons with chronic illness: their relation to various forms of quality of life","OBJECTIVES: Derive a spiritual well-being classification and thereby enhance understanding of the relation between spiritual well-being, quality of life (QOL), and health among persons with chronic illness or disability. DESIGN: Cluster analyses were performed to develop a spiritual well-being classification. Analysis of variance was used to compare cluster groups on various dimensions of QOL. SETTING: Part of a larger QOL study conducted at a midwestern medical center. PATIENTS: A convenience sample of 216 inpatients: amputation (n = 74), postpolio (n = 37), spinal cord injury (n = 34), breast cancer (n = 36), and prostate cancer (n = 35). Minors were excluded from the study. MAIN OUTCOME MEASURES: Spiritual Well-Being Scale (SWBS), Functional Assessment of Cancer Therapy (FACT), Functional Living Index-Cancer (FLIC), Sickness Impact Profile (SIP), Medical Outcome Survey-Short Form (SF-36), and the Satisfaction With Life Scale (SWLS). RESULTS: Three types of spiritual well-being were identified: religious (n = 146), existential (n = 37), and nonspiritual (n = 30). Significant cluster differences (p < .03 to p < .001) were observed across all QOL domains and life satisfaction. Compared with the other cluster groups, the nonspiritual group reported significantly lower levels of QOL and life satisfaction and the highest proportion of health status change with respect to both improvement and decline in health. CONCLUSIONS: Three types of spiritual well-being were empirically identified in this sample. Subtypes differed significantly with respect to various aspects of QOL. Further research is needed to validate this classification and to determine if type of spiritual well-being has a causal effect on treatment outcome or on the recovery process.","Arch Phys Med Rehabil, 79(3): 258-264","USA",1998,"Any or unknown","None","FACT-G,FLIC,SIP,SF-36,SWLS,SWBS","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"General,Utility"]
[575,"Rnic, K., et al. (2013). \"Measuring symptoms in localized prostate cancer: a systematic review of assessment instruments.\" Prostate Cancer Prostatic Dis 16(2): 111-122.",null,"Rnic, K., et al.","Measuring symptoms in localized prostate cancer: a systematic review of assessment instruments","It is critical for prostate cancer researchers and clinicians to have access to comprehensive, sensitive and simple-to-use symptom measures that allow them to understand and quantify the subjective patient experience. The purpose of the current review is to provide a comprehensive review, detailed tool descriptions and objectively defined quality criteria to facilitate tool choices for patients with localized prostate cancer. Using a systematic web-based literature search, we found n=29 prostate symptom measures described in n=35 validation studies. To be recommended, tools needed to meet four criteria: broad domain coverage, ability to differentiate objective and subjective experience, good internal consistency and validation in at least two populations and/or having achieved two types of validations. Of the 29 tools reviewed, n=7 meet our criteria for recommendation, and three in particular (the EPIC-26 (Expanded Prostate Cancer Index Composite)-26, PC-QOL (Prostate Cancer-Quality of Life) and the UCLA-PCI (UCLA Prostate Cancer Index)) showed the strongest psychometrics. There is a reasonable number of measures to choose from that meet criteria for good psychometrics.","Prostate Cancer Prostatic Dis, 16(2): 111-122","International",2013,"Local","None","EPIC,PC-QOL,UCLA-PCI","Patient",null,"Systematic review,Validation",null,null,null,null,null,null,null,null,"Disease"]
[576,"Roach, M., 3rd, et al. (1996). \"A pilot survey of sexual function and quality of life following 3D conformal radiotherapy for clinically localized prostate cancer.\" Int J Radiat Oncol Biol Phys 35(5): 869-874.",null,"Roach, M., 3rd, et al.","A pilot survey of sexual function and quality of life following 3D conformal radiotherapy for clinically localized prostate cancer","PURPOSE: To assess the impact of high dose three-dimensional conformal radiotherapy (3D CRT) for prostate cancer on the sexual function-related quality of life of patients and their partners. METHODS AND MATERIALS: Sixty of 124 consecutive patients (median age 72.3 years) treated with 3D CRT for localized prostate cancer were surveyed and reported being potent prior to treatment. The answers to survey questions assessing the impact of quality of life related to sexual function from these 60 patients and their partners forms the basis for this retrospective analysis. RESULTS: Following 3D CRT, 37 of 60 patients (62%) retained sexual function sufficient for intercourse. Intercourse at least once per month was reduced from 71 to 40%, whereas intercourse less than once per year increased from 12 to 35%. Following treatment, 25% of patients reported that the change in sexual dysfunction negatively affected their relationship or resulted in poor self-esteem. This outcome was associated with impotence following treatment (p < 0.01). Patients who had partners and satisfactory sexual function appeared to be at a higher risk of having a negatively affected relationship or losing self-esteem if they become impotent (p < 0.05). Partners of patients who reported a negatively affected relationship or loss of self-esteem appear to be less likely to return the survey instrument used (p = 0.02). CONCLUSIONS: More work is needed to evaluate the impact of radiotherapy and other treatments on the quality of life of patients and their partners to allow adequate informed consent to be given.","Int J Radiat Oncol Biol Phys, 35(5): 869-874","USA",1996,"Local","Radiotherapy","Unclear","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Complication"]
[577,"Robertson, J. M., et al. (2014). \"Exploring the feasibility and acceptability of couple-based psychosexual support following prostate cancer surgery: study protocol for a pilot randomised controlled trial.\" Trials 15: 183.",null,"Robertson, J. M., et al.","Exploring the feasibility and acceptability of couple-based psychosexual support following prostate cancer surgery: study protocol for a pilot randomised controlled trial","BACKGROUND: Men who undergo surgery for prostate cancer frequently experience significant side-effects including urinary and sexual dysfunction. These difficulties can lead to anxiety, depression and reduced quality of life. Many partners also experience psychological distress. An additional impact can be on the couple relationship, with changes to intimacy, and unmet psychosexual supportive needs in relation to sexual recovery and rehabilitation. The aim of this exploratory randomised controlled trial pilot study is to determine the feasibility and acceptability of a novel family-relational-psychosexual intervention to support intimacy and reduce distress among couples following prostate cancer surgery and to estimate the efficacy of this intervention. METHODS/DESIGN: The intervention will comprise six sessions of psychosexual and relationship support delivered by experienced couple-support practitioners. Specialist training in delivering the intervention will be provided to practitioners and they will be guided by a detailed treatment manual based on systemic principles. Sixty-eight couples will be randomised to receive either the intervention or standard care (comprising usual follow-up hospital appointments). A pre-test, post-test design will be used to test the feasibility of the intervention (baseline, end of intervention and six-month follow-up) and its acceptability to couples and healthcare professionals (qualitative interviews). Both individual and relational outcome measures will assess sexual functioning, anxiety and depression, couple relationship, use of health services and erectile dysfunction medication/technologies. An economic analysis will estimate population costs of the intervention, compared to usual care, using simple modelling to evaluate the affordability of the intervention. DISCUSSION: Given the increasing incidence and survival of post-operative men with prostate cancer, it is timely and appropriate to determine the feasibility of a definitive trial through a pilot randomised controlled trial of a family-relational-psychosexual intervention for couples. The study will provide evidence about the components of a couple-based intervention, its acceptability to patients and healthcare professionals, and its influence on sexual and relational functioning. Data from this study will be used to calculate sample sizes required for any definitive trial. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01842438.Registration date: 24 April 2013; Randomisation of first patient: 13 May 2013.","Trials, 15(183","UK",2014,"Any or unknown","Psychological,Surgery","Interview","Patient",null,"Protocol",null,null,null,null,null,null,null,null,"Complication"]
[578,"Robinson, J. P., et al. (2007). \"Psychometric properties of the Male Urogenital Distress Inventory (MUDI) and Male Urinary Symptom Impact Questionnaire (MUSIQ) in patients following radical prostatectomy.\" Urol Nurs 27(6): 512-518.",null,"Robinson, J. P., et al.","Psychometric properties of the Male Urogenital Distress Inventory (MUDI) and Male Urinary Symptom Impact Questionnaire (MUSIQ) in patients following radical prostatectomy","INTRODUCTION: Research instruments can be used to assess the impact of lower urinary tract symptoms on health-related quality of life. Evaluating the reliability, validity, and sensitivity of two of these instruments provides evidence concerning their readiness for use in research and clinical settings. OBJECTIVE: The researchers evaluated psychometric properties of the Male Urogenital Distress Inventory and Male Urinary Symptom Impact Questionnaire in men suffering from lower urinary tract symptoms following radical prostatectomy. METHOD: The internal consistency reliability, concurrent validity, construct validity, and sensitivity of both instruments were evaluated in a cohort of men who participated in a larger study of nursing's impact on quality of life post-prostatectomy. RESULTS: The reliability, validity, and sensitivity of both instruments were supported in this population. CONCLUSIONS: Initial support is provided for use of the instruments to measure the effect of interventions for lower urinary tract symptoms and urine leakage on health-related quality of life during the first 6 months of recovery from radical prostatectomy; however, further research with a larger and more diverse sample is needed prior to using the instruments in clinical settings.","Urol Nurs, 27(6): 512-518","USA",2007,"Any or unknown","Surgery","MUDI,MUSIQ","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Complication"]
[579,"Robinson, J. W., et al. (2002). \"Quality of life and sexuality of men with prostate cancer 3 years after cryosurgery.\" Urology 60(2 Suppl 1): 12-18.",null,"Robinson, J. W., et al.","Quality of life and sexuality of men with prostate cancer 3 years after cryosurgery","The current study was designed to describe the long-term life quality and sexuality of men enrolled in a phase 2 clinical trial of cryosurgery for the treatment of localized prostate cancer. A total of 75 men were administered the Functional Assessment of Cancer Treatment-Prostate (FACT-P) before treatment and after treatment at 6 weeks, and at 3, 6, 12, 24, and 36 months. Additionally, these men completed a Sexuality Follow-Up Questionnaire (SFQ) 3 years after cryosurgery. By 12 months after cryosurgery, most FACT-P subscales had returned to pretreatment levels. Quality of life remained stable over the subsequent 2 years. The only exception to this general trend was persistent impairment in measures of social/family well-being. At 36 months, 13% (5 of 38) of patients had regained erectile functioning, and an additional 34% (13 of 38) of patients were sexually active with the help of aids. The 3-year quality-of-life outcomes support the renewed interest in cryosurgery. No late complications were observed. Whereas improvements in erectile function were observed between years 1 and 3 for some patients, most continue to experience erectile dysfunction. For these patients, aids are an important adjunct to the treatment of their erectile dysfunction.","Urology, 60(2 Suppl 1): 12-18","Canada",2002,"Local","Various","FACT-P,SFQ","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,Complication"]
[580,"Rodda, S., et al. (2017). \"ASCENDE-RT: An Analysis of Health-Related Quality of Life for a Randomized Trial Comparing Low-Dose-Rate Brachytherapy Boost With Dose-Escalated External Beam Boost for High- and Intermediate-Risk Prostate Cancer.\" Int J Radiat Oncol Biol Phys 98(3): 581-589.",null,"Rodda, S., et al.","ASCENDE-RT: An Analysis of Health-Related Quality of Life for a Randomized Trial Comparing Low-Dose-Rate Brachytherapy Boost With Dose-Escalated External Beam Boost for High- and Intermediate-Risk Prostate Cancer","PURPOSE: To report the patient-reported health-related quality of life (HR-QoL) outcomes for a multicenter randomized trial evaluating the safety and efficacy of 2 different techniques for dose escalation. METHODS AND MATERIALS: A total of 357 men with intermediate- and high-risk prostate cancer were stratified by risk group and randomized (1:1) to either a dose-escalated external beam (DE-EBRT) boost (n=177) or a low-dose-rate prostate brachytherapy (LDR-PB) boost (n=180) as part of combined modality therapy. The HR-QoL was assessed using the SF36v2 questionnaire, with additional scales for urinary, bowel, and sexual function. Date of starting androgen deprivation therapy was considered time zero, the median follow-up of 6 years. Scales were scored from 0 to 100; a decline in a mean score >/=10 compared with baseline was considered a clinically significant decline. This was an intent-to-treat analysis. RESULTS: Mean domain scores at baseline were well balanced between the 2 treatment arms. A clinically significant decline in mean scores in both the arms compared with baseline was noted for role physical (DE-EBRT [-11.4] and LDR-PB [-15.3]) and sexual function scale (DE-EBRT [-15.1] and LDR-PB [-19.2]). There was a significantly larger drop in mean scores in the LDR-PB group compared with the DE-EBRT group for physical function (-15.3 vs -6.9; P=.03), urinary function (-3.6 vs -0.5; P=.04). CONCLUSION: At 6 years' follow up, there were no significant differences in mean scores in 9 of 11 scales compared with baseline in both arms. A clinically significant decline in mean scores was noted in both arms for role physical and sexual function scales. There was a statistically significant decline in physical function and urinary function scales in the LDR-PB arm compared with the DE-EBRT arm.","Int J Radiat Oncol Biol Phys, 98(3): 581-589","Canada",2017,"Any or unknown","Radiotherapy,Brachytherapy","SF-36","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Utility"]
[581,"Rodrigues, G., et al. (2004). \"The relationship of changes in EORTC QLQ-C30 scores to ratings on the Subjective Significance Questionnaire in men with localized prostate cancer.\" Qual Life Res 13(7): 1235-1246.",null,"Rodrigues, G., et al.","The relationship of changes in EORTC QLQ-C30 scores to ratings on the Subjective Significance Questionnaire in men with localized prostate cancer","PURPOSE: To examine the relationship between changes in health-related quality-of-life (HRQOL) on the EORTC Quality of Life Questionnaire (QLQ-C30), and patients' perceptions of HRQOL changes as measured by the Subjective Significance Questionnaire (SSQ). PATIENTS AND METHODS: A total of 101 patients completed the QLQ-C30 on weeks 1, 4 and 7 of radical external-beam radiation therapy (RT) for localized cancer of the prostate. Patients rated their change in physical functioning, emotional functioning, social functioning, and overall/global quality of life (QOL) by completing a seven-category SSQ at weeks 4 and 7. The association between changes in the QLQ-C30 change and the corresponding SSQ ratings were determined by calculation of mean change scores for each SSQ category and by Spearman rank correlation coefficient analysis. RESULTS: Patients' completion of the QLQ-C30 and SSQ exceeded 95%. Statistically significant changes in fatigue, pain, appetite, diarrhea, and global QOL scores were detected during RT. For patients reporting 'a little' change in global QOL on the SSQ, absolute mean QLQ-C30 change scores ranged between 0 to 15 points with 12/16 mean change scores between 2.5 and 8.5 points. In the entire study sample, correlations between SSQ patient ratings and QLQ-C30 change scores were lower than previously reported, ranging between 0.15 and 0.24 for the four different domains, but were higher when QOL scores producing ceiling effects were omitted. CONCLUSION: The SSQ and QLQ-C30 may measure related concepts that could assist in the interpretation of changes in scores and in the calibration of the QLQ-C30. However, the nature of this relationship could not be elucidated in this data set because of a lack of variance in HRQOL scores in the study sample. Further investigation should be carried out in study samples with sufficient variance to allow more robust conclusions.","Qual Life Res, 13(7): 1235-1246","UK",2004,"Local","Radiotherapy","EORTC QLQ-C30,SSQ","Patient",null,"Validation",null,null,null,null,null,null,null,null,"General"]
[582,"Rodrigues, G., et al. (2007). \"Psychometric properties of a prostate cancer radiation late toxicity questionnaire.\" Health Qual Life Outcomes 5: 29.",null,"Rodrigues, G., et al.","Psychometric properties of a prostate cancer radiation late toxicity questionnaire","BACKGROUND: To construct a short prostate cancer radiation late toxicity (PCRT) questionnaire with health-related quality-of-life (HRQoL) domains. METHODS: The PCRT was developed by item generation, questionnaire construction (n = 7 experts, n = 8 focus group patients), pilot testing (n = 37), item reduction (n = 100), reliability testing (n = 237), and validity testing (n = 274). RESULTS: Reliability of the three item-reduced subscales demonstrated intraclass correlation coefficients (CC) of 0.811 (GU), 0.842 (GI), and 0.740 (sexual). Discriminant validity demonstrated Pearson CC of 0.449 (GU-GI), 0.200 (sexual-GU), and 0.09 (sexual-GI). Content validity correlations between PCRT-PCQoL were 0.35-0.78, PCRT-FACT-G(c) were 0.19-0.39, and PCRT-SF-36(R) were 0.03-0.34. CONCLUSION: We successfully generated a PCRT HRQoL questionnaire including subscales with very good psychometric properties.","Health Qual Life Outcomes, 5(29","Canada",2007,"Any or unknown","Radiotherapy","PCRT,FACT-G,SF-36,PC-QoL","Patient",null,"Validation,Mapping to utility",null,null,null,null,null,null,null,null,"Treatment,Utility,Disease"]
[583,"Rodrigues, G., et al. (2011). \"Cross validation of the prostate cancer radiotherapy late toxicity (PCRT) questionnaire with the expanded prostate cancer index composite (EPIC) instrument.\" Can J Urol 18(4): 5802-5810.",null,"Rodrigues, G., et al.","Cross validation of the prostate cancer radiotherapy late toxicity (PCRT) questionnaire with the expanded prostate cancer index composite (EPIC) instrument","INTRODUCTION: A 29-item prostate cancer radiotherapy (PCRT) questionnaire with genitourinary (GU), gastrointestinal (GI), and sexual (S) domains has been previously validated for the assessment of late toxicity health-related quality of life (HRQoL) effects. The study objective was to cross-validate the PCRT domains versus the expanded prostate cancer index composite (EPIC) questionnaire urinary (U), bowel (B), hormonal (H), and S subscales. METHODS AND MATERIALS: A single-institution cross-sectional PCRT patient cohort was surveyed. Descriptive and intra- and inter-class correlation coefficient statistics for the various EPIC and PCRT HRQoL domain scores were generated. Univariable and multivariable Cox and logistic regressions were performed depending on the HRQoL endpoint being assessed. RESULTS: A total of 189/276 patients (68%) completed questionnaires with EPIC and PCRT missing data rates of 9% and 4%, respectively. Mean age was 75.8 years (SD 5.5) and the mean time of questionnaire completion after radiotherapy was 852 days (range 212-1454 days). Mean EPIC urinary (85.1 SD 12.9), bowel (84.1 SD 15.8), sexual (21.8 SD 20.7), and hormonal (85.3 SD 13.7) as well as PCRT genitourinary (66.1 SD 15.3), gastrointestinal (83.6 SD 14.3), and sexual (39.4 SD 21.6) domain scores were calculated. Intraclass correlation coefficients comparing corresponding EPIC/PCRT domains ranged from 0.50-0.88. Interclass correlation coefficients for non-corresponding EPIC/PCRT domains ranged from 0.16-0.43 and 0.23-0.30, respectively. EPIC B/U, PCRT GI/GU and PCRT S required arcsin square root transformation and EPIC S/H domains required dichotomous transformations prior to univariable/multivariable analyses. Multivariable analysis demonstrated novel associations between predictive variables and HRQoL domains including between the PTV-bladder overlap volume and PCRT GU score. CONCLUSIONS: The PCRT is a compact, valid, and HRQoL instrument with very high questionnaire compliance rates and similar statistical properties to the EPIC instrument. However, dichotomization of the PRCT S data was not required which suggests some potential statistical advantage to the PCRT.","Can J Urol, 18(4): 5802-5810","Canada",2011,"Any or unknown","Radiotherapy","PCRT,EPIC","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease,Treatment"]
[584,"Rondorf-Klym, L. M. and J. Colling (2003). \"Quality of life after radical prostatectomy.\" Oncol Nurs Forum 30(2): E24-32.",null,"Rondorf-Klym, L. M. and J. Colling","Quality of life after radical prostatectomy","PURPOSE/OBJECTIVES: To examine physical and psychosocial factors that affect the quality of life (QOL) for men 12-24 months after radical prostatectomy treatment for prostate cancer. DESIGN: Cross-sectional survey. SETTING: An entire population from one tumor registry. SAMPLE: Of the 132 men meeting inclusion criteria, 97 men responded, with 91 meeting analysis requirements. Analysis was completed on the Caucasian sample (n = 88) with a mean age of 66 years. Most men were married, lived with a spouse or partner, and had a high level of education. METHODS: A survey was developed to assess men 12-24 months prostatectomy. The tumor registry mailed the survey, which was completed at home, and participants returned it in a prestamped, addressed envelope. MAIN RESEARCH VARIABLES: Major hypotheses in the causal model were that age, sexual function, urinary function, and sexual appraisal would only have indirect effects on QOL, whereas urinary function appraisal, self-esteem, anger suppression, perceived social support, depression, and health locus of control would directly affect QOL. FINDINGS: As analyzed by path analytic techniques, the hypothesized causal model explained 72% variance in the QOL variable. Perceived social support, self-esteem, and health locus of control were significant predictors of QOL. Urinary function appraisal contributed indirectly through health locus of control. Contrary to the hypotheses, anger suppression and depression were not significant predictors of QOL. CONCLUSIONS: After radical prostatectomy for prostate cancer, perceived social support, self-esteem, and health locus of control may influence men's QOL. Future research is needed to increase understanding about the adaptation trajectory of men's response to the impact of prostate cancer. IMPLICATIONS FOR NURSING: Nurses can help patients by providing a thorough assessment of each patient's values that may affect QOL before any intervention begins, using research-based evidence regarding potential side effects of interventions, clear and concise information from a variety of sources that addresses the possible concerns of men and their spouses, and focused counseling that addresses patient-specific problems.","Oncol Nurs Forum, 30(2): E24-32","USA",2003,"Any or unknown","Surgery","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"General,Complication"]
[585,"Rosario, D. J., et al. (2012). \"Short term outcomes of prostate biopsy in men tested for cancer by prostate specific antigen: prospective evaluation within ProtecT study.\" Bmj 344: d7894.",null,"Rosario, D. J., et al.","Short term outcomes of prostate biopsy in men tested for cancer by prostate specific antigen: prospective evaluation within ProtecT study","OBJECTIVES: To measure the effect of the adverse events within 35 days of transrectal ultrasound guided biopsy from the perspective of asymptomatic men having prostate specific antigen (PSA) testing; to assess early attitude to re-biopsy; to estimate healthcare resource use associated with adverse events due to biopsy; and to develop a classification scheme for reporting adverse events after prostate biopsy. DESIGN: Prospective cohort study (Prostate Biopsy Effects: ProBE) nested within Prostate Testing for Cancer and Treatment (ProtecT) study. Participants Between 1999 and 2008, 227,000 community dwelling men aged 50-69 years were identified at 352 practices and invited to counselling about PSA testing. 111,148 attended a nurse led clinic in the community, and 10,297 with PSA concentrations of 3-20 ng/mL were offered biopsy within ProtecT. Between February 2006 and May 2008, 1147/1753 (65%) eligible men (mean age 62.1 years, mean PSA 5.4 ng/mL) having 10 core transrectal ultrasound guided biopsy under antibiotic cover in the context of ProtecT were recruited to the ProBE study. OUTCOME MEASURES: Purpose designed questionnaire administered at biopsy and 7 and 35 days after the procedure to measure frequency and effect of symptoms related to pain, infection, and bleeding; patients' attitude to repeat biopsy assessed immediately after biopsy and 7 days later; participants' healthcare resource use within 35 days of biopsy evaluated by questionnaire, telephone follow-up, and medical note review; each man's adverse event profile graded according to symptoms and healthcare use. RESULTS: Pain was reported by 429/984 (43.6%), fever by 172/985 (17.5%), haematuria by 642/976 (65.8%), haematochezia by 356/967 (36.8%), and haemoejaculate by 605/653 (92.6%) men during the 35 days after biopsy. Fewer men rated these symptoms as a major/moderate problem-71/977 (7.3%) for pain, 54/981 (5.5%) for fever, 59/958 (6.2%) for haematuria, 24/951 (2.5%) for haematochezia, and 172/646 (26.6%) for haemoejaculate. Immediately after biopsy, 124/1142 (10.9%, 95% confidence interval 9.2 to 12.8) men reported that they would consider further biopsy a major or moderate problem: seven days after biopsy, this proportion had increased to 213/1085 (19.6%, 17.4% to 22.1%). A negative attitude to repeat biopsy was associated with unfavourable experience after the first biopsy, particularly pain at biopsy (odds ratio 8.2, P<0.001) and symptoms related to infection (7.9, P<0.001) and bleeding (4.2, P<0.001); differences were evident between centres (P<0.001). 119/1147 (10.4%, 8.7% to 12.3%) men reported consultation with a healthcare professional (usually their general practitioner), most commonly for infective symptoms. Complete data for all index symptoms at all time points were available in 851 participants. Symptoms and healthcare use could be used to grade these men as follows: grade 0 (no symptoms/contact) 18 (2.1%, 1.3% to 3.3%); grade 1 (minor problem/no contact) 550 (64.6%, 61.4% to 67.8%); grade 2 (moderate/major problem or contact) 271 (31.8%, 28.8% to 35.1%); grade 3 (hospital admission) 12 (1.4%, 0.8% to 2.4%); and grade 4 (death) 0. Grade of adverse event was associated with an unfavourable attitude to repeat biopsy (Kendall's tau-b ordinal by ordinal 0.29, P<0.001). CONCLUSION: This study with a high response rate of 89% at 35 days in men undergoing biopsy in the context of a randomised controlled trial has shown that although prostate biopsy is well tolerated by most men, it is associated with significant symptoms in a minority and affects attitudes to repeat biopsy and primary care resource use. These findings will inform men who seek PSA testing for detection of prostate cancer and assist their physicians during counselling about the potential risks and effect of biopsy. Variability in the adverse event profile between centres suggests that patients' outcomes could be improved and healthcare use reduced with more effective administration of local anaesthetic and antibiotics. Trial registration Current Controlled Trials ISRCTN20141297.","Bmj, 344(d7894","UK",2012,"At risk","Screening","Unclear","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Complication"]
[586,"Ross, P. L., et al. (2003). \"Paper standard gamble: a paper-based measure of standard gamble utility for current health.\" Int J Technol Assess Health Care 19(1): 135-147.",null,"Ross, P. L., et al.","Paper standard gamble: a paper-based measure of standard gamble utility for current health","OBJECTIVES: To develop and validate a paper-based instrument that is simple to administer and produces a reliable estimate of patient standard gamble (SG) utilities for current health status. METHODS: A 1-page paper questionnaire instrument, paper standard gamble (PSG), was designed to estimate SG utilities. We performed two studies to assess the validity of PSG. First we compared PSG and SG utilities for current health in patients with prostate cancer. They randomly received either PSG followed by SG or vice versa, always with an intervening SF-12. In the second validity study, we assessed the test-retest reliability of PSG by administering it to prostate cancer patients twice, at least 2 weeks apart. RESULTS: In the first study, utilities were assessed in 64 men (32 per SG/PSG order group). A paired-comparison t test suggested no difference between SG and PSG (mean difference = -0.007; 95% confidence interval (Cl), -0.022 to 0.008). The concordance correlation coefficient was 0.92 (95% Cl, 0.79 to 0.99). In the second study, test and retest PSGs were available for 184 patients. The concordance correlation coefficient was 0.88 (95% Cl, 0.73 to 0.94). CONCLUSIONS: These data suggest that PSG may serve as a reliable substitute for SG when current health utility is of interest. PSG may have particular advantages for acquisition of health-related quality-of-life data in longitudinal studies.","Int J Technol Assess Health Care, 19(1): 135-147","USA",2003,"Any or unknown","None","SF-12,SG","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Utility"]
[587,"Rossetti, S. R. and C. Terrone (1996). \"Quality of life in prostate cancer patients.\" Eur Urol 30 Suppl 1: 44-48; discussion 49.",null,"Rossetti, S. R. and C. Terrone","Quality of life in prostate cancer patients","INTRODUCTION: Quality of life (QL) assessment should be an essential part of clinical practice and should also be included in every clinical trial of prostate cancer. The term QL describes a person's overall well-being comprising not only physical functioning but also psychological and social dimensions. It is important to remember that QL can be affected by the disease as well as by the therapeutic treatment adopted. OBJECTIVES: To measure the impact on QL in 161 patients treated by radical prostatectomy performed from January 1980 to June 1995. To describe the QL results from a national epidemiological study on prostate cancer, and to review the assessment of QL in this setting. CONCLUSIONS: We found radical prostatectomy to have minimal overall impact on QL in patients informed of, and involved with all therapeutic decisions. Maintenance of sexual activity was considered to be of less importance than the attempt to cure the disease. The best method of assessment remains unclear but, minimally, a general questionnaire supplemented by specific questions on urinary-sexual symptoms should be administered at follow-up.","Eur Urol, 30 Suppl 1(44-48; discussion 49","Italy",1996,"Any or unknown","Surgery","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"General"]
[588,"Rubio-Briones, J., et al. (2016). \"Preliminary results of the Spanish Association of Urology National Registry in Active Surveillance for prostate cancer.\" Actas Urol Esp 40(1): 3-10.",null,"Rubio-Briones, J., et al.","Preliminary results of the Spanish Association of Urology National Registry in Active Surveillance for prostate cancer","OBJECTIVES: To present a National Registry of patients with prostate cancer as monitored through active surveillance, with the intention of testing the hypothesis that cancer-specific mortality in very low-risk and low-risk patients is less than 5% at 15 years. MATERIAL AND METHODS: A multicentre observational study (AEU-PIEM/2014/0001) sponsored by the Spanish Association of Urology was conducted using their platform for multicentre studies. The clinical-pathological inclusion criteria were as follows: cT1a-cT3a, PSA </= 20 ng/ml, initial minimum biopsy of 10 cores, number of affected cores </= 3, 1st Gleason score of 3 and 2nd Gleason score </= 4 and a known prostate volume (in cc). A unified follow-up was not established for all recruiting centres; however, a survey was conducted that reflects the follow-up characteristics based on a number of tangible parameters that allow for their comparison. With the same philosophy of flexibility, the use of certain biomarkers and multiparametric MRI was not considered necessary for inclusion. RESULTS: We describe the Registry's characteristics and possibilities, as well as the preliminary results from the 324 patients included in its first 5 months of operation in the 15 recruiting centres. We also report the clinical-pathological variables, biomarkers, radiodiagnosis technique and quality-of-life questionnaires considered for the database, as well as the possibilities for indefinite follow-up, remaining open to any active treatment recognized in clinical guidelines. CONCLUSIONS: The AEU-PIEM/2014/0001 represents an extremely useful tool for all Spanish urologists for multicentre clinical research. The registry will undoubtedly enable the dissemination of active surveillance of our patients in a more coordinated manner, thus maintaining the advantages of optimised opportunistic screening for prostate cancer without resulting in overtreatment.","Actas Urol Esp, 40(1): 3-10","Spain",2016,"Local,Advanced","Surveillance","Unclear","Patient",null,"Protocol",null,null,null,null,null,null,null,null,"General"]
[589,"Ruiz-Deya, G., et al. (2001). \"Outpatient radical prostatectomy: impact of standard perineal approach on patient outcome.\" J Urol 166(2): 581-586.",null,"Ruiz-Deya, G., et al.","Outpatient radical prostatectomy: impact of standard perineal approach on patient outcome","PURPOSE: As managed care becomes more prevalent, urologists must critically evaluate the economic aspect of and patient satisfaction with urological practice patterns. We have previously reported the advantages of radical perineal prostatectomy, which decreases hospitalization and morbidity, and provides a more rapid return to normal activity, translating into cost savings. We have since evaluated the satisfaction of patients who underwent outpatient radical prostatectomy with and without laparoscopic pelvic lymph node dissection. MATERIALS AND METHODS: We evaluated the charts of 250 consecutive patients who underwent outpatient radical perineal prostatectomy with less than 24 hours of hospitalization from 1992 to 1997. Complications, pain management, blood transfusion, and bowel and urinary dysfunction were assessed. Validated quality of life questionnaires were mailed to 200 patients several months postoperatively and a 62% response rate was achieved. RESULTS: Mean followup in the series was 30 months. In the perioperative period there were rectal perforation in less than 2% of patients, anastomotic stricture in 3%, perineal fistula in 0.4% and blood transfusion in 11%. Some problems with bowel movements immediately after the procedure, such as diarrhea, constipation or soiled underwear, developed in 17% of patients, of whom up to 20% had had some bowel dysfunction before surgery. In the majority bowel problems resolved in an average of 7.3 weeks. Persistent new onset bowel trouble developed in 9 of the 124 patients (7%). The questionnaire demonstrated persistent significant urinary incontinence in 8 cases (7%). Nerve sparing was attempted in 54 patients, including 22 (41%) who achieve erection sufficient for vaginal penetration and are satisfied with sexual function. Of the patients 17% reported problems after hospital discharge that were mostly related to Foley catheter management. Overall 94.8% of patients were satisfied with treatment. Physical and social/family well-being appeared to be excellent according to the questionnaire. Only 12% of patients would have preferred longer hospitalization. The preferred method of pain control was nonsteroidal anti-inflammatory drugs. CONCLUSIONS: Radical perineal prostatectomy is a low morbidity alternative for localized prostate cancer. Outpatient radical perineal prostatectomy may be performed with good patient satisfaction and safety. There appear to be few bowel problems after long-term followup.","J Urol, 166(2): 581-586","USA",2001,"Any or unknown","Surgery","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Complication,Satisfaction"]
[590,"Ruland, C. M., et al. (2013). \"Effects of an internet support system to assist cancer patients in reducing symptom distress: a randomized controlled trial.\" Cancer Nurs 36(1): 6-17.",null,"Ruland, C. M., et al.","Effects of an internet support system to assist cancer patients in reducing symptom distress: a randomized controlled trial","BACKGROUND: Cancer patients experience many physical and psychosocial problems for which they need support. WebChoice is an Internet-based, interactive health communication application that allows cancer patients to monitor their symptoms and problems, provides individually tailored information and self-management support, e-communication with expert cancer nurses, and an e-forum for group discussion with other patients. OBJECTIVE: The objective of this study was to examine the effects of WebChoice on symptom distress (primary outcome), depression, self-efficacy, health-related quality of life, and social support (secondary outcomes). METHODS: In this 1-year repeated-measures randomized controlled trial, 325 breast and prostate cancer patients were randomized into 1 experimental group with access to WebChoice and 1 control group who received URLs of publicly available cancer Web sites. RESULTS: Group differences on symptom distress were significant only for the global symptom distress index on the Memorial Symptom Assessment Scale (slope estimate, -0.052 [95% confidence interval, -0.101 to -0.004]; t = 4.42; P = .037). There were no significant group differences on secondary outcomes. Additional analyses showed significant within-group improvements in depression in the experimental group only. In the control group, self-efficacy and health-related quality of life deteriorated significantly over time. CONCLUSION: This randomized controlled trial is one of the first to evaluate effects of an interactive health communication application to support cancer patients in illness management on symptoms. Although only 1 hypothesis was partially supported, the combined results show a clear trend toward better scores in the intervention group on most outcome measures. IMPLICATIONS FOR PRACTICE: If findings can be supported with additional research, WebChoice may become an important tool to support nursing care that can equip cancer patients to better manage their illness.","Cancer Nurs, 36(1): 6-17","Norway",2013,"Any or unknown","Various","MSAS","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Symptom"]
[591,"Sadetsky, N., et al. (2008). \"Insurance and quality of life in men with prostate cancer: data from the Cancer of the Prostate Strategic Urological Research Endeavor.\" BJU Int 101(6): 691-697.",null,"Sadetsky, N., et al.","Insurance and quality of life in men with prostate cancer: data from the Cancer of the Prostate Strategic Urological Research Endeavor","OBJECTIVE: To evaluate the effect of medical insurance coverage on health-related quality of life (HRQoL) outcomes in men newly diagnosed with prostate cancer, as insurance status has been shown to be related to clinical presentation, and types of treatments received for localized prostate cancer, but the relationship of insurance and QoL has not been explored sufficiently. PATIENTS AND METHODS: Data from the Cancer of the Prostate Strategic Urological Research Endeavor (CaPSURE), a national longitudinal database registry of men with prostate cancer, were used for this study. Men who were newly diagnosed at entry to CaPSURE and completed one questionnaire before treatment, and one or more afterwards, were included. Insurance groups specific to age distribution of the study population were assessed, i.e. Medicare, preferred provider organizations (PPOs), health maintenance organizations (HMOs), fee for service (FFS), and the Veterans Administration (VA) for the younger group, and Medicare only, Medicare plus supplement (+S), and HMO/PPO for the older group. Associations between patients' clinical and sociodemographic characteristics and insurance status were evaluated by chi-square and analysis of variance. Relationships between insurance status and HRQoL outcomes over time were evaluated by multivariate mixed model. RESULTS: Of 2258 men who met the study criteria, 1259 were younger and 999 were older than 65 years. More than half of the younger patients belonged to an HMO or PPO (42.2% and 32.5%, respectively), with the remainder distributed between Medicare, FFS and VA. In the older group most men belonged to Medicare only and the Medicare +S groups (22.4% and 58.8%, respectively). There was greater variation in clinical risk categories at presentation by insurance groups in the younger group. In the multivariate analysis, insurance status was significantly associated with changes in most HRQoL outcomes over time in the younger group, while in the older patients the effect of insurance diminished. Men in the VA and Medicare systems had lower scores at baseline and a steeper decline in Physical Function, Role Physical, Role Emotional, Social Function, Bodily Pain, Vitality, and General Health domains over time, controlling for type of initial treatment received, timing of HRQoL assessment, number of comorbidities, clinical risk at presentation, and income. CONCLUSION: Insurance was independently related to changes in a wide range of HRQoL outcomes in men aged <65 years treated for prostate cancer. With the latest advances in early diagnosis and treatment of prostate cancer, clinicians and researchers should be aware of the specific groups of patients who are more vulnerable to the adverse effects of treatment and subsequent decline in functioning. The present findings could provide important tools for understanding the process of recovery after treatment for prostate cancer, and identifying needs for specific services.","BJU Int, 101(6): 691-697","USA",2008,"Local","Unclear","Unclear","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"General"]
[592,"Saigal, C. S., et al. (2001). \"Predictors of utilities for health states in early stage prostate cancer.\" J Urol 166(3): 942-946.",null,"Saigal, C. S., et al.","Predictors of utilities for health states in early stage prostate cancer","PURPOSE: When faced with treatment choices for early stage prostate cancer, patients must balance the survival benefit of a treatment with its morbidity. Little is known about how patients balance these trade-offs. To further our understanding of patient decision making we assessed patient utilities for prostate cancer treatment related morbidities. We determined whether patient utilities were predicted by sociodemographic characteristics or baseline genitourinary function. MATERIALS AND METHODS: We evaluated 401 men undergoing prostate needle biopsy for suspicion of prostate cancer at university, Veterans Affairs and public hospitals. Study design included a prospective cross-sectional cohort with correlation and multivariate analysis. Subjects were studied with 2 established health related quality of life instruments. Patient utilities were assessed with an interactive software application. RESULTS: On multivariate analysis utility for current general health was a significant predictor of utilities for treatment related morbidities. Surprisingly baseline urinary, sexual and bowel function scores did not correlate well with respective utilities for potential incontinence, impotence or radiation proctitis. In other words, men with good and imperfect baseline function were equally willing to risk impairment to preserve life. CONCLUSIONS: Men who perceived that general health was better appear to place higher value on quantity of life, while those who already are suffering from poor general health place higher value on quality of life. Ethnicity appears to modify some effects of other variables on patient preference. Utility assessment provides a quantitative tool to aid physicians in counseling patients when making treatment decisions for localized prostate cancer.","J Urol, 166(3): 942-946","USA",2001,"Local","Unclear","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Utility"]
[593,"Sakai, H., et al. (2009). \"Hot flashes during androgen deprivation therapy with luteinizing hormone-releasing hormone agonist combined with steroidal or nonsteroidal antiandrogen for prostate cancer.\" Urology 73(3): 635-640.",null,"Sakai, H., et al.","Hot flashes during androgen deprivation therapy with luteinizing hormone-releasing hormone agonist combined with steroidal or nonsteroidal antiandrogen for prostate cancer","OBJECTIVES: To investigate hot flashes and quality of life during combined androgen blockade (CAB) therapy using steroidal or nonsteroidal antiandrogens. METHODS: A total of 151 patients with prostate cancer, who were enrolled into this study from May 2001 to June 2003, were randomized to receive CAB therapy using a luteinizing hormone-releasing hormone agonist (leuprorelin) combined with a steroidal antiandrogen (chlormadinone) or a nonsteroidal antiandrogen (bicalutamide). The incidence of, frequency of, and distress due to hot flashes were evaluated with a self-administered questionnaire during a 2-year period. The general and disease-specific quality-of-life outcomes were also measured using the Functional Assessment of Cancer Therapy-Prostate questionnaire. RESULTS: Data were available for analysis from 124 patients. Although the incidence of hot flashes largely tended to be greater in the bicalutamide group than in the chlormadinone group, no significant difference was noted in the cumulative incidence of hot flashes at 2 years. The median frequency of hot flashes daily was 1.3 and 2.2 for warmth/flushing (P = .16) and 1.0 and 3.6 for sweating (P = .021) in the chlormadinone and bicalutamide groups, respectively. Patients in the chlormadinone group were significantly less likely to be distressed by warmth/flushing (odds ratio 0.47, P < .001) and sweating (odds ratio 0.61, P = .01) than were those in the bicalutamide group. The Functional Assessment of Cancer Therapy-Prostate scores over time showed no intergroup differences. CONCLUSIONS: Our results suggest that CAB using a steroidal antiandrogen such as chlormadinone might induce fewer and less-distressing hot flashes than CAB with bicalutamide.","Urology, 73(3): 635-640","Japan",2009,"Any or unknown","Hormonal","FACT-P","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease"]
[594,"Salonen, A. J., et al. (2013). \"Advanced prostate cancer treated with intermittent or continuous androgen deprivation in the randomised FinnProstate Study VII: quality of life and adverse effects.\" Eur Urol 63(1): 111-120.",null,"Salonen, A. J., et al.","Advanced prostate cancer treated with intermittent or continuous androgen deprivation in the randomised FinnProstate Study VII: quality of life and adverse effects","BACKGROUND: Intermittent dosing may reduce the adverse events (AEs) of androgen-deprivation therapy (ADT). OBJECTIVE: To compare intermittent androgen deprivation (IAD) and continuous androgen deprivation (CAD) with regard to health-related quality of life (QoL). DESIGN, SETTING, AND PARTICIPANTS: A total of 852 men with advanced prostate cancer (PCa) were enrolled to receive goserelin acetate 3.6 mg every 28 d for 24 wk. A total of 554 patients whose prostate-specific antigen (PSA) decreased to <10 ng/ml or by >/=50% (<20 ng/ml at baseline) were randomised to IAD or CAD. INTERVENTION: In the IAD arm, ADT was resumed for at least 24 wk whenever PSA increased >20 ng/ml or above baseline. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: QoL was monitored with a validated Cleary 30-item questionnaire and analysed by the Mann-Whitney U test, 0.5 standard deviation rule, and repeated measures analysis of variance. AEs and adverse drug reactions (ADRs) were analysed by the chi-square test. RESULTS AND LIMITATIONS: Median follow-up was 65 mo. Significant differences in QoL emerged in activity limitation, physical capacity, and sexual functioning, favouring IAD. No significant differences emerged in the prevalence of AEs: 87 patients in the IAD arm (31.8%) and 95 in the CAD arm (33.9%) had cardiovascular (CV) AEs (p=0.59), with 25 (9.1%) and 29 (10.4%) withdrawn (p=0.62), and 21 (7.7%) and 24 (8.6%) dying because of a CV event (p=0.70), respectively; bone fractures occurred in 19 (6.9%) and 15 (5.4%) patients (p=0.44), respectively. Hot flushes or night sweats were the most common ADRs (47.1% vs 50.4%; p=0.44). Erectile dysfunction (15.7% vs 7.9%; p=0.042) and depressed mood (2.2 vs 0%; p=0.032) were more common in the IAD arm. CONCLUSIONS: IAD showed benefits in the treatment of advanced PCa with respect to QoL. The prevalence of AEs was not significantly lower with IAD. TRIAL REGISTRATION: ClinicalTrials.gov, NCT00293670.","Eur Urol, 63(1): 111-120","Finland",2013,"Advanced","Hormonal","Cleary-30","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General"]
[595,"Sammon, J., et al. (2011). \"Robotic radical prostatectomy: a critical analysis of surgical quality.\" Curr Opin Urol 21(3): 195-199.",null,"Sammon, J., et al.","Robotic radical prostatectomy: a critical analysis of surgical quality","PURPOSE OF REVIEW: To review the ways in which the quality of radical prostatectomy and robot-assisted radical prostatectomy have been assessed, including quality-of-life (QoL) assessment, combined outcomes reporting, and patient utilities. RECENT FINDINGS: Superlative survival expectations following radical prostatectomy have shifted the paradigm of assessing surgical quality toward the prospective evaluation of QoL outcomes and combined outcomes reporting. Several high quality multi-institutional studies have compared QoL outcomes between the common treatment modalities for prostate cancer. Single-institution combined outcomes 'Trifecta' studies provide a convenient presentation of outcomes most important to the surgeon but have many associated limitations. The assessment of patient preferences for treatment outcomes is an underexplored area within the urologic literature and can provide an insight into a patient's perception of surgical quality as seen in a pilot study performed at our institution. SUMMARY: Advances in the use of validated QoL instruments allow patients and clinicians to select treatment based on the perceived risk of adverse QoL impact but do not provide an insight into what the individual patient considers important. Combined outcomes reports also fail to address key patient concerns. A phenomenologic assessment of robot-assisted radical prostatectomy surgical quality does not exist, but will be necessary to properly evaluate surgical quality.","Curr Opin Urol, 21(3): 195-199","USA",2011,"Any or unknown","Surgery","Unclear","Patient",null,"Narrative review",null,null,null,null,null,null,null,null,"General"]
[596,"Sampurno, F., et al. (2016). \"Comparison of Patient-Reported Quality-of-Life and Complications in Men With Prostate Cancer, Between Two Modes of Administration.\" Clin Genitourin Cancer 14(4): 284-289.",null,"Sampurno, F., et al.","Comparison of Patient-Reported Quality-of-Life and Complications in Men With Prostate Cancer, Between Two Modes of Administration","INTRODUCTION: Our purpose was to: (1) assess the level of consistency between the quality-of-life (QOL) scores of men with prostate cancer for urinary/bowel/sexual bother, collected via telephone versus self-administered survey; (2) determine factors associated with variation in level of agreement; and (3) assess the efficacy of telephone interview as a mode of administration against the \"gold standard\" tool, EPIC-26. METHODS: Cohen's Kappa coefficients were calculated to investigate test-retest reliability across modes of administration. Logistic regression models explored patients' characteristics associated with the magnitude of urinary/bowel/sexual problem. Sensitivities and specificities of the telephone mode in reference to \"gold standard\" were further measured. RESULTS: From 221 men who agreed to participate in the study, 168 (76.0%) returned completed surveys. Kappa-linear model resulted in a moderate agreement across the urinary/bowel/sexual bother scores for both modes of administration; with greatest concordance recorded for bowel bother (90%). Patient's age (<75 years), disease risk, and active treatment type determined a moderate-to-good level of agreement between administration modalities with a Kappa varying between 0.44 and 0.73; chi(2), 8.18; P = .042. Sensitivity tests revealed that 68% of men with a moderate/big problem during the phone interviews would respond to suffering from a moderate/big sexual problem. CONCLUSION: Results of this pilot study revealed that QOL outcomes from this registry will likely underestimate the true bother experienced by men. More research is required to determine the differences between self-administered and telephone interviews in men with prostate cancer.","Clin Genitourin Cancer, 14(4): 284-289","Australia",2016,"Any or unknown","None","EPIC","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease"]
[597,"Sanchez-Ortiz, R. F., et al. (2000). \"Erectile function and quality of life after interstitial radiation therapy for prostate cancer.\" Int J Impot Res 12 Suppl 3: S18-24.",null,"Sanchez-Ortiz, R. F., et al.","Erectile function and quality of life after interstitial radiation therapy for prostate cancer","Few studies have evaluated erectile function after interstitial radiation therapy for localized prostate cancer. Using a validated quality of life questionnaire, we assessed post-treatment erectile function and its relationship to treatment satisfaction and quality of life. We retrospectively reviewed the records of 171 consecutive patients who underwent Pd-103 or I-125 brachytherapy for prostate cancer between December 1992 and June 1998. Seventy percent of patients received neoadjuvant androgen deprivation therapy. All patients were mailed a validated questionnaire assessing sexual function and overall quality of life (UCLA Prostate Cancer Index and SF-36). Sixty-seven percent of all questionnaires were available for evaluation (114/171). The mean age was 69.1 y with a mean follow-up of 23 months (range 4-72, median 24). Seventy-one percent of patients (81/114) had pre-treatment erections sufficient for sustained vaginal penetration. Of these patients, potency was maintained in 49% of men (40/81). An additional 26% had erections firm enough for foreplay but not penetration (21/81). Erectile dysfunction rates were significantly lower in younger patients (48%) vs older patients (55%). There was no difference in post-treatment potency between men who received neoadjuvant hormonal therapy and those who did not (P>0.05). In addition, there were no differences in physical function (86, scale 0-100), general health perception (78), emotional well-being (83), energy/fatigue (74), and overall satisfaction (84) between men with erectile dysfunction and those without. In summary, two years following brachytherapy 25% of patients complained of complete (20/81) or partial (26%, 21/81) erectile dysfunction, for an overall rate of 51% (41/81). Short-term neoadjuvant hormonal therapy (<3-6 months) did not increase the likelihood of post-treatment erectile dysfunction. Interestingly, overall satisfaction rates among brachytherapy patients were high (84/100) and surprisingly did not correlate with post-treatment sexual function.","Int J Impot Res, 12 Suppl 3(S18-24","USA",2000,"Local","Brachytherapy,Hormonal","UCLA-PCI,SF-36","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Disease,Utility"]
[598,"Sandblom, G., et al. (2001). \"Pain and health-related quality of life in a geographically defined population of men with prostate cancer.\" Br J Cancer 85(4): 497-503.",null,"Sandblom, G., et al.","Pain and health-related quality of life in a geographically defined population of men with prostate cancer","In order to provide baseline data on pain and health-related quality of life, to explore factors predicting pain and reduced quality of life, and to find potentially undertreated cases in men with prostate cancer, we undertook a population-based questionnaire study. The questionnaire, which included the EuroQo1 instrument, the Brief Pain Inventory form and 8 specially designed questions, was sent to all men with prostate cancer in the county of Ostergotland, Sweden. Of the 1442 men included in the study, 1243 responded to the questionnaire. Altogether 42% had perceived pain during the previous week and 26% stated their quality of life to be 50% or lower on a visual analogue scale. A high rating of health care availability and short time since diagnosis were found to significantly predict lower ratings of pain (P< 0.05). Pain was found to be a significant predictive factor for decreased quality of life together with high age, low rating of health care availability and palliative treatment (P< 0.05). In conclusion, assessment and treatment of pain is essential for a good quality of life in men with prostate cancer. The monitoring of prostate cancer patients should be individualized to fit the demands of the groups with the greatest need for support.","Br J Cancer, 85(4): 497-503","Sweden",2001,"Any or unknown","None","EQ-5D,BPI,VAS","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Symptom,Utility"]
[599,"Sandblom, G., et al. (2004). \"A population-based study of pain and quality of life during the year before death in men with prostate cancer.\" Br J Cancer 90(6): 1163-1168.",null,"Sandblom, G., et al.","A population-based study of pain and quality of life during the year before death in men with prostate cancer","In order to explore how health-related quality of life changes towards the end of life, a questionnaire including the EuroQOl form and the Brief Pain Inventory form was sent to all men with prostate cancer in the county of Ostergotland, Sweden, in September 1999. Responders who had died prior to 1 January 2001 were later identified retrospectively. Of the 1442 men who received the questionnaire, 1243 responded (86.2%). In the group of responders, 167 had died within the study period, 66 of prostate cancer. In multivariate analysis, pain as well as death within the period of study were found to predict decreased quality of life significantly. Of those who died of prostate cancer, 29.0% had rated their worst pain the previous week as severe. The same figure for those still alive was 10.5%. On a visual analogue scale (range 0-100), the mean rating of quality of life for those who subsequently died of prostate cancer was 54.0 (95% confidence interval +/-5.2) and those still alive was 70.0 (+/-1.2). In conclusion, health-related quality of life gradually declines during the last year of life in men with prostate cancer. This decline may partly be avoided by an optimised pain management.","Br J Cancer, 90(6): 1163-1168","Sweden",2004,"End of life","None","EQ-5D,BPI,VAS","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Symptom,Utility"]
[600,"Sato, K., et al. (2003). \"Total cystoprostatectomy in the treatment of locally advanced prostate carcinoma.\" Aktuelle Urol 34(4): 259-261.",null,"Sato, K., et al.","Total cystoprostatectomy in the treatment of locally advanced prostate carcinoma","OBJECTIVE: Locally advanced prostate carcinoma frequently causes lower urinary tract symptoms and is a clinical challenge when radiation and/or hormone therapy fail. We investigated whether cystoprostatectomy with urinary diversion benefits patients with locally advanced prostate carcinoma in terms of quality of life and prognostic outcome. PATIENTS AND METHODS: Between 1989 and 2001, we performed 15 cystoprostatectomies for stage C-D1 prostate carcinoma with bladder neck involvement. Of these patients, 5 underwent ileal conduit, 8 rectal bladder, 1 Koch pouch, and 1 ureterocutaneostomy. All the patients received neoadjuvant and/or adjuvant hormonal therapy. In the same period, 28 patients underwent retropubic prostatectomies and 15 patients received hormone therapy alone for stage C-Dl disease. These patients were included as references. RESULTS: Lower urinary tract symptoms caused by bladder involvement were controlled well until the end of follow-up for all the patients in the cystoprostatectomy group. There was no statistically significant difference in QOL score assessed with the EORTC QLQ-C30 questionnaire between the prostatectomy group and the cystoprostatectomy group, while that in the hormone therapy group was lower than those in the surgery groups. There was no statistically significant difference in 5-year PSA-relapse-free survival among cystoprostatectomy, prostatectomy, and hormone therapy groups. Patients in the hormone therapy group died earlier than those in the prostatectomy group (p = 0.02), while those in the cystoprostatectomy group did not. CONCLUSION: These results suggest that total cystoprostatectomy with urinary diversion is a valid option, in terms of disease control and QOL, for prostate cancer patients whose tumor is infiltrating into the bladder.","Aktuelle Urol, 34(4): 259-261","Japan",2003,"Advanced","Surgery,Hormonal","EORTC QLQ-C30","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"General"]
[601,"Sato, N., et al. (2004). \"Intermittent androgen suppression for locally advanced and metastatic prostate cancer: preliminary report of a prospective multicenter study.\" Urology 64(2): 341-345.",null,"Sato, N., et al.","Intermittent androgen suppression for locally advanced and metastatic prostate cancer: preliminary report of a prospective multicenter study","OBJECTIVES: To clarify the effect of intermittent androgen suppression on the time to androgen-independent progression and changes in quality of life (QOL). METHODS: Patients with locally advanced or metastatic prostate cancer were treated with a combination of leuprolide acetate and flutamide for 36 weeks. When the serum prostate-specific antigen (PSA) levels at 24 and 32 weeks were less than 4.0 ng/mL, treatment was withheld until the PSA level reached 15 ng/mL or the pretreatment level. This cycle of on-treatment and off-treatment was repeated until PSA failure (three consecutive increases in PSA level greater than 4.0 ng/mL during the on-treatment period) or symptomatic progression was observed. Changes in QOL were assessed by a self-assessment questionnaire. RESULTS: Forty-nine patients (26 with T3N0M0, 8 with T2-T3N1M0, 2 with T4N0M0, and 13 with T2-T3N0M1) were enrolled. The mean follow-up period was 136.5 weeks. Thirty-one patients finished cycle 1, six finished cycle 2, and three finished cycle 3. The mean off-treatment duration in cycles 1, 2, and 3 was 46.1, 36.9, and 23.3 weeks, respectively. In the off-treatment period, statistically significant improvements in the QOL score were observed in the categories of potency (11.4 versus 2.4) and social/family well-being (20.3 versus 16.1) compared with those in the on-treatment period. PSA failure occurred in 6 patients (3 with T3N0M0 and 3 with T2-T3N1M0), and all patients were alive at last follow-up. CONCLUSIONS: Our interim analysis indicated that QOL is remarkably improved during the off-treatment period. Intermittent androgen suppression would be a viable option for treatment of advanced prostate cancer, although a randomized controlled study is required to determine whether intermittent androgen suppression prolongs the time to androgen-independent cancer. We will continue follow-up in this study to a minimum of 3 years.","Urology, 64(2): 341-345","Japan",2004,"Advanced,Metastatic","Hormonal","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General"]
[602,"Scalliet, P. G., et al. (2004). \"Retrospective analysis of results of p(65)+Be neutron therapy for treatment of prostate adenocarcinoma at the cyclotron of Louvain-la-Leuve. Part II: Side effects and their influence on quality of life measured with QLQ-C30 of EORTC.\" Int J Radiat Oncol Biol Phys 58(5): 1549-1561.",null,"Scalliet, P. G., et al.","Retrospective analysis of results of p(65)+Be neutron therapy for treatment of prostate adenocarcinoma at the cyclotron of Louvain-la-Leuve. Part II: Side effects and their influence on quality of life measured with QLQ-C30 of EORTC","PURPOSE: Between 1978 and 1998, 533 prostate adenocarcinoma patients were treated with mixed photon-neutron radiotherapy. We report on a retrospective series of patients for whom the side effects of the treatment and their impact on quality of life were assessed by a mailed questionnaire. METHODS AND MATERIALS: The European Organization for Research and Treatment of Cancer quality-of-life core questionnaire and a prostate-specific questionnaire were used. Between 1990 and 1996, 308 consecutive patients were treated. Two protocols were used: pelvic fields (50 Gy equivalent photons, 2 Gy/fraction) followed by a prostate boost (66 Gy) or prostate alone. The neutron/photon ratio varied. The questionnaire was mailed to 262 patients presumed to be alive. RESULTS: Of the 262 patients, 230 replied. Of the 230 patients, 73% had no trouble doing strenuous activities and 4% had trouble with taking a short walk. The overall physical condition and quality-of-life questions received a mean score of 5.2 and 5.3 on a 7-point scale, respectively. Twenty-two percent had bowel movements at least four times daily, and 6% did so six times or more. Retaining stool was a problem in 26%, and only 38% reported full continence; 17% urinated four times or more nightly. Urinary incontinence was scored as \"quite a bit\" or \"very much\" in 11% and 5%, respectively. Hematuria and dysuria (pain) were reported by 7% and 16%, respectively, mainly as moderate. Only 28% reported easy erections, but 75% judged the sexual change acceptable. A greater neutron/photon ratio was significantly associated with more bowel problems (p = 0.003). CONCLUSION: Mixed photon-neutron therapy for prostate cancer was associated with significant patient-reported side effects. Their significant effect on patients' quality of life is described.","Int J Radiat Oncol Biol Phys, 58(5): 1549-1561","Belgium",2004,"Any or unknown","Radiotherapy","EORTC QLQ-C30,EORTC QLQ-PR25","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Disease,General"]
[603,"Schaake, W., et al. (2014). \"The impact of gastrointestinal and genitourinary toxicity on health related quality of life among irradiated prostate cancer patients.\" Radiother Oncol 110(2): 284-290.",null,"Schaake, W., et al.","The impact of gastrointestinal and genitourinary toxicity on health related quality of life among irradiated prostate cancer patients","PURPOSE: To determine the impact of late radiation-induced toxicity on health-related quality of life (HRQoL) among patients with prostate cancer. PATIENTS AND METHODS: The study sample was composed of 227 patients, treated with external beam radiotherapy. Common Terminology Criteria for Adverse Events version 3.0 were used to grade late genitourinary and gastrointestinal toxicity. The European Organization for Research and Treatment of Cancer Quality of life Questionnaire C30 (EORTC QLQ-C30) was used to assess HRQoL at baseline, and 6, 12 and 24 months after completion of radiotherapy. Statistical analysis was performed using a multivariate analysis of variance (MANOVA). RESULTS: Urinary incontinence and rectal discomfort significantly affected HRQoL. The impact of urinary incontinence on HRQoL was most pronounced 6 months after radiotherapy and gradually decreased over time. The impact of rectal discomfort on HRQoL was predominant at 6 months after radiotherapy, decreased at 12 months and increased again 2 years after radiotherapy. No significant impact on HRQoL was observed for any of the other toxicity endpoints, or non-toxicity related factors such as hormonal therapy, radiotherapy technique or age. CONCLUSION: Urinary incontinence and rectal discomfort have a significant impact on HRQoL. Prevention of these side effects may likely improve quality of life of prostate cancer patients after completion of treatment.","Radiother Oncol, 110(2): 284-290","Netherlands",2014,"Any or unknown","Radiotherapy","EORTC QLQ-C30,CTCAE","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General,Treatment"]
[604,"Schafer, J. W., et al. (2008). \"Long-term health-related quality-of-life outcomes after permanent prostate brachytherapy.\" Onkologie 31(11): 599-603.",null,"Schafer, J. W., et al.","Long-term health-related quality-of-life outcomes after permanent prostate brachytherapy","BACKGROUND: We evaluated the long-term health-related quality of life (HRQoL) after modern prostate brachytherapy (PB). PATIENTS AND METHODS: The European Organization for Research and Treatment of Cancer (EORTC) prostate cancer quality-of-life questionnaire, QLQ-PR25, and the modified International Continence Society (ICS) male questionnaire were sent to 296 men treated with PB at the University Medical Center Mannheim. To evaluate the influence of age, we subclassified two groups: group 1 <65 years, group 2 > or =65 years. 258 of the 296 patients were alive at the time of assessment. Of 238 questionnaires (92% response rate), 231 were suitable for analysis. Median follow-up was 51 months. RESULTS: Of group 1 77.8% and of group 2 73.4% of the men were in good, very good or excellent health. There was a low rate of moderate (10.4%) or strong (1.0%) symptoms regarding urinary functioning. Stress incontinence was uncommon. Only 28.2% reported moderate or strong (up to 17.6%) symptoms regarding sexual functioning. In group 1 48.6% and in group 2 25.0% of patients reported no or minor erectile dysfunction (p < 0.007). There was no severe overall rectal dysfunction (<2%). CONCLUSION: Our data substantiate the favorable long-term HRQoL outcomes associated with modern PB techniques. Significant age differences were observed in sexual symptoms and less pronounced age differences in urinary symptoms. We found a low rate of urinary symptoms and no evidence of severe rectal dysfunction.","Onkologie, 31(11): 599-603","Germany",2008,"Any or unknown","Brachytherapy","EORTC QLQ-PR25,ICSQ","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Disease,Complication"]
[605,"Schapira, M. M., et al. (2001). \"Effect of treatment on quality of life among men with clinically localized prostate cancer.\" Med Care 39(3): 243-253.",null,"Schapira, M. M., et al.","Effect of treatment on quality of life among men with clinically localized prostate cancer","BACKGROUND: Quality-of-life outcomes are an important consideration for patients evaluating therapeutic options for localized prostate cancer. OBJECTIVES: The objective of this study was to describe the effect of treatment choice on change in health-related quality of life (HRQOL) among men with clinically localized prostate cancer. RESEARCH DESIGN: This was a prospective observational study. SUBJECTS: The study subjects were 122 men with clinically localized adenocarcinoma of the prostate. Forty-two subjects (34%) underwent radical prostatectomy, 51 (42%) underwent radiation therapy, and 29 (24%) were followed with expectant management. MEASURES: The University of California at Los Angeles Prostate Cancer Quality of Life Inde- and the Medical Outcomes Study Short Form-36 were administered before and 3 and 12 months after initial treatment. The study used an analysis of covariance model adjusted for baseline differences in clinical and demographic factors. RESULTS: Men who underwent radical prostatectomy experienced significant declines in urinary and sexual function and bother that persisted at 12 months after treatment. Men treated with radiation therapy experienced smaller but significant declines in sexual function and a decline in social function. Expectant management patients did not have a significant change in disease-targeted or generic HRQOL domains. Differential rates of change in urinary and sexual function between treatment groups persisted after adjustment for differences in pretreatment clinical and demographic factors. CONCLUSIONS: Men undergoing radical prostatectomy have substantial declines in urinary and sexual function, and men undergoing radiotherapy have declines in sexual function. Men undergoing expectant management have no change in disease-specific or general HRQOL in the first year after treatment.","Med Care, 39(3): 243-253","USA",2001,"Local","Surgery,Radiotherapy,Surveillance","SF-36,UCLA-PCI","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease,Utility"]
[606,"Schellhammer, P., et al. (1995). \"A controlled trial of bicalutamide versus flutamide, each in combination with luteinizing hormone-releasing hormone analogue therapy, in patients with advanced prostate cancer. Casodex Combination Study Group.\" Urology 45(5): 745-752.",null,"Schellhammer, P., et al.","A controlled trial of bicalutamide versus flutamide, each in combination with luteinizing hormone-releasing hormone analogue therapy, in patients with advanced prostate cancer. Casodex Combination Study Group","OBJECTIVES: To compare the efficacy and safety of bicalutamide and flutamide, each used in combination with luteinizing hormone-releasing analogue (LHRH-A) therapy, in patients with untreated metastatic (Stage D2) prostate cancer. METHODS: Randomized, double-blind (for antiandrogen therapy), multicenter study with a 2 x 2 factorial design. Eight hundred thirteen patients were allocated 1:1 to bicalutamide (50 mg once daily) and flutamide (250 mg three times daily) and 2:1 to goserelin acetate (3.6 mg every 28 days) and leuprolide acetate (7.5 mg every 28 days). RESULTS: With a median duration of follow-up of 49 weeks, time to treatment failure, the primary endpoint, was significantly (P = 0.005) better for the bicalutamide plus LHRH-A group than for the flutamide plus LHRH-A group. Patients in the flutamide plus LHRH-A group were 34% more likely to fail treatment over the given time period, as indicated by the hazard ratio of 0.749 (95% confidence interval, 0.61 to 0.92) for bicalutamide plus LHRH-A to flutamide plus LHRH-A. Results for secondary endpoints (survival, quality of life, and subjective response) were similar between groups. Diarrhea occurred in 24% of patients in the flutamide plus LHRH-A group, compared with 10% of patients in the bicalutamide plus LHRH-A group (P < 0.001). CONCLUSIONS: In patients with metastatic prostate cancer, bicalutamide plus LHRH-A is well tolerated and provides superior efficacy to flutamide plus LHRH-A with respect to time to treatment failure. Assessment of the effects of these regimens on longer term survival requires additional time for follow-up.","Urology, 45(5): 745-752","USA",1995,"Metastatic","Hormonal","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General"]
[607,"Schlenk, E. A., et al. (1998). \"Health-related quality of life in chronic disorders: a comparison across studies using the MOS SF-36.\" Qual Life Res 7(1): 57-65.",null,"Schlenk, E. A., et al.","Health-related quality of life in chronic disorders: a comparison across studies using the MOS SF-36","The purpose of this report is to examine health-related quality of life (HRQoL) as measured by the Medical Outcomes Study Short Form-36, across patient populations with chronic disorders and to compare quality of life (QoL) in these subjects with normative data on healthy persons. Six studies, within the Center for Research in Chronic Disorders at the University of Pittsburgh School of Nursing, in patients with urinary incontinence, prostate cancer, chronic obstructive pulmonary disease (COPD), acquired immune deficiency syndrome (AIDS), fibromyalgia and hyperlipidaemia provided the data for analysis. The results demonstrated that not only did the prostate cancer and hyperlipidaemia patients have the highest QoL across the chronic disorders, but their QoL was comparable to normative data on healthy persons. Homebound, elderly, incontinent patients had the lowest QoL for physical functioning, whereas patients hospitalized with AIDS had the lowest QoL in general health and social functioning. Patients with COPD had the lowest QoL in role-physical, role-emotional and mental health. Patients with fibromyalgia had the lowest QoL in bodily pain and vitality. Compared to normative data, patients with urinary incontinence, COPD, AIDS and fibromyalgia generally had lower QoL. Prostate cancer and hyperlipidaemia patients had QoL comparable to normative data. Compared to normative data, patients with urinary incontinence, COPD, AIDS and fibromyalgia had more variability for role-emotional. AIDS patients had more variability on physical functioning, bodily pain and social functioning compared to the normative data. These data suggest that patients with various chronic disorders may have QoL that is lower in most domains compared to a healthy population. However, there may be differences in the domains affected as well as the extent of variation across specific chronic disorders.","Qual Life Res, 7(1): 57-65","USA",1998,"Any or unknown","None","SF-36","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Utility"]
[608,"Schmid, S., et al. (2015). \"Assessment of anticancer-treatment outcome in patients with metastatic castration-resistant prostate cancer-going beyond PSA and imaging, a systematic literature review.\" Ann Oncol 26(11): 2221-2247.",null,"Schmid, S., et al.","Assessment of anticancer-treatment outcome in patients with metastatic castration-resistant prostate cancer-going beyond PSA and imaging, a systematic literature review","BACKGROUND: In the past years, there has been significant progress in anticancer drug development for patients with metastatic castration-resistant prostate cancer (CRPC). However, the current instruments to assess clinical treatment response have limitations and may not sufficiently reflect patient benefit. Our objective was to systematically identify tools to evaluate both patient benefit and clinical anticancer-treatment response as basis for an international consensus process and development of a specific pragmatic instrument for men with CRPC. METHODS: PubMed, Embase and CINAHL were searched to identify currently available tools to assess anticancer-treatment benefit, other than standard imaging procedures and prostate-specific antigen measurements, namely quality of life (QoL), detailed pain assessment, physical function and objective measures of other complex cancer-related syndromes in patients with CRPC. Additionally, all CRPC phase III trials published in the last 5 years were reviewed as well as studies using physical function tools in a general cancer population. The PRIMSA statement was followed for the systematic review process. RESULTS: The search generated 1096 hits, 185 full-text papers were screened and finally 73 publications were included. Additional 89 publications were included by hand-search. We identified a total of 98 tools used in CRPC trials and grouped these into three categories: 22 tools assessing QoL domains and subgroups, 47 tools for pain assessment and 29 tools for objective measures, mainly physical function and assessment of skeletal disease burden. CONCLUSION: A wide variety of assessment tools and also efforts to standardize and harmonize patient-reported outcomes and pain assessment were identified. However, the specific needs of the increasing CRPC population living longer with their incurable cancer are insufficiently captured and objective physical outcome measures are under-represented. In the age of new anticancer drug targets and principles, new methods to monitor patient relevant outcomes of antineoplastic therapy are of utmost importance.","Ann Oncol, 26(11): 2221-2247","International",2015,"Metastatic","Unclear","Unclear","Patient",null,"Systematic review",null,null,null,null,null,null,null,null,"General,Symptom"]
[609,"Schmidt, S., et al. (2014). \"Assessing quality of life in patients with prostate cancer: a systematic and standardized comparison of available instruments.\" Qual Life Res 23(8): 2169-2181.",null,"Schmidt, S., et al.","Assessing quality of life in patients with prostate cancer: a systematic and standardized comparison of available instruments","PURPOSE: The objective was to obtain a standardized evaluation of available prostate cancer-specific quality of life instruments used in patients with early-stage disease. METHODS: We carried out systematic literature reviews in the PubMed database to identify manuscripts which contained information regarding either the development process or metric properties of prostate cancer-specific quality of life instruments. Each instrument was evaluated by two experts, independently, using the Evaluating Measures of Patient-Reported Outcomes (EMPRO) tool. An overall and seven attribute-specific EMPRO scores were calculated (range 0-100, worst to best): measurement model, reliability, validity, responsiveness, interpretability, burden and alternative forms. RESULTS: Eight instruments and 57 manuscripts (2-15 per instrument) were identified. The Expanded Prostate Cancer Index Composite (EPIC) was the best rated (overall EMPRO score 83.1 points). Good results were also obtained by University of California Los Angeles-Prostate Cancer Index (UCLA-PCI), Patient-Oriented Prostate Utility Scale (PORPUS) and Prostate Cancer Quality of Life Instrument (PC-QoL) with 77.3, 70.5 and 64.8 points, respectively. These four instruments passed with distinction the validity and responsiveness evaluation. Insufficient reliability results were observed for UCLA-PCI and PORPUS. CONCLUSIONS: Current evidence supports the choice of EPIC, PORPUS or PC-QoL. Attribute-specific EMPRO results facilitate selecting the adequate instrument for every purpose. For longitudinal studies or clinical trials, where responsiveness is the priority, EPIC or PC-QoL should be considered. We recommend the PORPUS for economic evaluations because it allows cost-utility analysis, and EPIC short versions to minimize administration burden.","Qual Life Res, 23(8): 2169-2181","Spain",2014,"Local","None","EPIC,PORPUS,PC-QoL,UCLA-PCI","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease,Utility"]
[610,"Schofield, P., et al. (2016). \"Nurse-led group consultation intervention reduces depressive symptoms in men with localised prostate cancer: a cluster randomised controlled trial.\" BMC Cancer 16: 637.",null,"Schofield, P., et al.","Nurse-led group consultation intervention reduces depressive symptoms in men with localised prostate cancer: a cluster randomised controlled trial","BACKGROUND: Radiotherapy for localised prostate cancer has many known and distressing side effects. The efficacy of group interventions for reducing psychological morbidity is lacking. This study investigated the relative benefits of a group nurse-led intervention on psychological morbidity, unmet needs, treatment-related concerns and prostate cancer-specific quality of life in men receiving curative intent radiotherapy for prostate cancer. METHODS: This phase III, two-arm cluster randomised controlled trial included 331 men (consent rate: 72 %; attrition: 5 %) randomised to the intervention (n = 166) or usual care (n = 165). The intervention comprised four group and one individual consultation all delivered by specialist uro-oncology nurses. Primary outcomes were anxious and depressive symptoms as assessed by the Hospital Anxiety and Depression Scale. Unmet needs were assessed with the Supportive Care Needs Survey-SF34 Revised, treatment-related concerns with the Cancer Treatment Scale and quality of life with the Expanded Prostate Cancer Index -26. Assessments occurred before, at the end of and 6 months post-radiotherapy. Primary outcome analysis was by intention-to-treat and performed by fitting a linear mixed model to each outcome separately using all observed data. RESULTS: Mixed models analysis indicated that group consultations had a significant beneficial effect on one of two primary endpoints, depressive symptoms (p = 0.009), and one of twelve secondary endpoints, procedural concerns related to cancer treatment (p = 0.049). Group consultations did not have a significant beneficial effect on generalised anxiety, unmet needs and prostate cancer-specific quality of life. CONCLUSIONS: Compared with individual consultations offered as part of usual care, the intervention provides a means of delivering patient education and is associated with modest reductions in depressive symptoms and procedural concerns. Future work should seek to confirm the clinical feasibility and cost-effectiveness of group interventions. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ANZCTRN012606000184572 . 1 March 2006.","BMC Cancer, 16(637","Australia",2016,"Local","Various,Radiotherapy","HADS,EPIC,SCN-SF34,CTS","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,Comorbidity,Treatment,Social"]
[611,"Schroder, F. H., et al. (2000). \"Prostate cancer treated by anti-androgens: is sexual function preserved? EORTC Genitourinary Group. European Organization for Research and Treatment of Cancer.\" Br J Cancer 82(2): 283-290.",null,"Schroder, F. H., et al.","Prostate cancer treated by anti-androgens: is sexual function preserved? EORTC Genitourinary Group. European Organization for Research and Treatment of Cancer","This paper reports on results of the EORTC protocol 30892, an open, prospective, randomized study of 310 patients with previously untreated metastatic prostate cancer with favourable prognostic factors who were treated by either flutamide (FLU) or cyproterone acetate (CPA) monotherapy. The final analysis with regard to the main end points, time to progression and survival are still pending. Final results related to the evaluation of sexual functioning prior to and under treatment are reported here. Of 310 randomized patients 294 were eligible for evaluation within this side study. The median age was 71 years (range 48-85). Potential risk factors related to age, general health and prostate cancer were evaluated. For evaluation of sexual functions a five-item questionnaire was used which was administered by the investigator. The protocol allowed time dependent observations at 3-monthly follow-up visits. Sexual functioning was dependent on age but not on prostate cancer-related parameters. Sexual functions at entry were similar within the two treatment groups, spontaneous (nightly) erections and sexual activity were seen in 43-51% and 29-35% of cases. Under treatment, sexual functions under FLU and CPA declined slowly with median times of 12.9 and 5.8 months versus 13.7 and 8.9 months respectively for spontaneous erections and sexual activity. Eventually, with an average observation time in excess of 2 years, loss of spontaneous erections and of sexual activity occurred in 80% versus 92% and in 78% versus 88% of men under FLU versus CPA treatment respectively. None of these differences reached statistical significance. Maintenance of potency under treatment with FLU as reported in the literature is not confirmed in this study. However, loss of sexual functions under monotherapy with both antiandrogens is slow and 10-20% of men retain sexual activity after 2-6 years of treatment. This observation can be exploited in new treatment schemes and is likely to lead to improved quality of life. The advantage of FLU in time and total preservation of sexual functions is statistically not significant and must be balanced against the side effects of FLU and other pure antiandrogens, which may exceed those of CPA especially with respect to gynaecomastia. Hepatic toxicity may limit the long-term use of both drugs.","Br J Cancer, 82(2): 283-290","Netherlands",2000,"Metastatic","Hormonal","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Complication"]
[612,"Schulman, C., et al. (2016). \"Intermittent Versus Continuous Androgen Deprivation Therapy in Patients with Relapsing or Locally Advanced Prostate Cancer: A Phase 3b Randomised Study (ICELAND).\" Eur Urol 69(4): 720-727.",null,"Schulman, C., et al.","Intermittent Versus Continuous Androgen Deprivation Therapy in Patients with Relapsing or Locally Advanced Prostate Cancer: A Phase 3b Randomised Study (ICELAND)","BACKGROUND: Intermittent androgen deprivation (IAD) has received increasing attention; however, the current literature is still limited, especially in nonmetastatic prostate cancer (PCa), and the relative efficacy and safety benefits of IAD versus continuous androgen deprivation (CAD) remain unclear. OBJECTIVE: To add to the knowledge base regarding efficacy and potential benefits, including reduced side effects and improved quality of life (QoL), of IAD versus CAD in patients with nonmetastatic relapsing or locally advanced PCa. DESIGN, SETTING, AND PARTICIPANTS: A 42-mo phase 3b open-label randomised study in 933 patients from 20 European countries. INTERVENTION: Following a 6-mo induction with leuprorelin acetate (Eligard) 22.5mg 3-mo depot, patients were randomised to CAD or IAD with leuprorelin for 36 mo. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary end point was time to prostate-specific antigen (PSA) progression while receiving luteinising hormone-releasing hormone agonist, defined as three consecutive increasing PSA values >/= 4 ng/ml >/= 2 wk apart. Secondary end points included PSA progression-free survival (PFS), overall survival (OS), testosterone levels, performance status, and QoL. RESULTS AND LIMITATIONS: A total of 933 patients entered the induction phase; 701 were randomised. The median number of injections administered after randomisation was 12 (range: 1-12) for the CAD group and 3 (range: 1-10) for the IAD group. There were no statistically significant or clinically relevant differences between the groups for time to PSA progression, PSA PFS, OS, mean PSA levels over time, or QoL. A similar number of adverse events was observed in each group; the most common were hot flushes and hypertension. Study limitations include the open-label design and absence of formal testosterone recovery assessment. CONCLUSIONS: IAD and CAD demonstrated similar efficacy, tolerability, and QoL in men with nonmetastatic PCa. The principal benefit of IAD compared with CAD is a potential cost reduction with comparable OS rates. There are no apparent QoL benefits. PATIENT SUMMARY: This randomised trial showed that both intermittent and continuous hormone therapy had similar efficacy, tolerability, and quality-of-life profiles in patients with relapsing M0 or locally advanced prostate cancer. Intermittent therapy may be a valid option for selected patients. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT00378690.","Eur Urol, 69(4): 720-727","Europe",2016,"Advanced,Refractory","Hormonal","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General,Treatment"]
[613,"Schweizer, M. T., et al. (2016). \"Bipolar Androgen Therapy for Men With Androgen Ablation Naive Prostate Cancer: Results From the Phase II BATMAN Study.\" Prostate 76(13): 1218-1226.",null,"Schweizer, M. T., et al.","Bipolar Androgen Therapy for Men With Androgen Ablation Naive Prostate Cancer: Results From the Phase II BATMAN Study","BACKGROUND: We have previously documented a paradoxical anti-tumor effect when castration-resistant prostate cancer patients were treated with intermittent, high-dose testosterone (i.e., Bipolar Androgen Therapy; BAT). Because, an adaptive increase in androgen receptor expression following chronic androgen deprivation therapy (ADT) may underlie this effect, we tested whether men with hormone-sensitive (HS) prostate cancer (PC) would also respond to BAT if given following a 6-month ADT lead-in. METHODS: Asymptomatic HS PC patients with low metastatic burden or non-metastatic biochemically recurrent disease were enrolled. Following 6-month of ADT, those with a PSA <4 ng/ml went on to receive alternating 3-month cycles of BAT and ADT. BAT was administered as intramuscular testosterone (T) cypionate or enanthate 400 mg on Days (D) 1, 29, and 57. ADT was continued throughout the study to allow rapid cycling from near castrate to supraphysiologic range T following T injections. The primary endpoint was the percent of patients with a PSA <4 ng/ml after 18 months. Secondary endpoints included radiographic response and quality of life (QoL). RESULTS: Twenty-nine of 33 patients received BAT following the ADT lead-in. The primary endpoint was met, with 17/29 men (59%, 90% confidence interval: 42-74%) having a PSA <4 ng/ml at 18 months. Ten patients receiving BAT had RECIST evaluable disease, and eight (80%) objective responses were observed (four complete; four partial). Three patients progressed per RECIST criteria and three had unconfirmed progression on bone scan. Men treated with 6-month of ADT had improved QoL following the first cycle of BAT as measured by the SF-36, FACT-P, and IIEF surveys. CONCLUSIONS: BAT demonstrated preliminary efficacy in men with HS PC following 6-month of ADT. BAT may improve QoL in men treated with ADT. Prostate 76:1218-1226, 2016. (c) 2016 Wiley Periodicals, Inc.","Prostate, 76(13): 1218-1226","USA",2016,"Any or unknown","Hormonal","SF-36,FACT-P,IIEF-5","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,Complication,Utility"]
[614,"Sciarra, A., et al. (2013). \"Intermittent androgen-deprivation therapy in prostate cancer: a critical review focused on phase 3 trials.\" Eur Urol 64(5): 722-730.",null,"Sciarra, A., et al.","Intermittent androgen-deprivation therapy in prostate cancer: a critical review focused on phase 3 trials","CONTEXT: Intermittent androgen deprivation (IAD) in prostate cancer (PCa) patients has been proposed to delay development of castration resistance and to reduce the side effects and costs of androgen deprivation therapy (ADT). OBJECTIVE: This review analyzes (1) the oncologic and quality of life (QoL) results from randomized phase 3 trials comparing IAD and continuous ADT and (2) the prognostic parameters for IAD. EVIDENCE ACQUISITION: We searched the Medline and Cochrane Library databases (primary fields: prostate neoplasm and intermittent androgen deprivation; secondary fields: randomized trials, survival, quality of life, predictors) without language restriction. EVIDENCE SYNTHESIS: We found seven extensively described phase 3 trials randomizing 4675 patients to IAD versus continuous ADT. Other randomized trials investigating IAD have been performed, but available data are limited and have been published only in preliminary fashion. In all seven trials, patients spent most of their time on, rather than off, ADT. The induction periods ranged from 3 mo to 8 mo; in all but one trial, the PSA level designated for ADT discontinuation was <4 ng/ml. Mean follow-up ranged from 40-108 mo. Collectively, these trials support the concept that, mainly in metastatic cases, IAD can produce oncologic results similar to continuous ADT. In terms of overall survival, the hazard ratios for IAD and continuous ADT were very similar (range: 0.98-1.08). The QoL benefit of IAD appears to be modest at best. With IAD, QoL is likely influenced by the duration of the off-treatment periods and by the rate of testosterone recovery. CONCLUSIONS: The evidence indicates that IAD is not inferior to continuous ADT. Data are insufficient to determine whether IAD is able to prevent the long-term complications of ADT. More comparative analysis focused on QoL is warranted.","Eur Urol, 64(5): 722-730","International",2013,"Any or unknown","Hormonal","Unclear","Patient",null,"Systematic review",null,null,null,null,null,null,null,null,"General"]
[615,"Scorsetti, M., et al. (2014). \"Stereotactic body radiotherapy with flattening filter-free beams for prostate cancer: assessment of patient-reported quality of life.\" J Cancer Res Clin Oncol 140(10): 1795-1800.",null,"Scorsetti, M., et al.","Stereotactic body radiotherapy with flattening filter-free beams for prostate cancer: assessment of patient-reported quality of life","PURPOSE: Stereotactic body radiotherapy (SBRT) is an emerging treatment approach reported as safe and effective strategy for low- and intermediate-risk prostate cancer patients. End point of the current study is to appraise the patient-reported quality of life according to the expanded prostate cancer index composite (EPIC) questionnaire. METHODS: In the framework of a prospective mono-institutional phase II trial, EPIC questionnaire was dispensed (up to 1 year after treatment) to a cohort of 46 patients of 72 treated with 5 fractions of 7 Gy each to the prostate. SBRT was delivered with RapidArc VMAT with 10 MV flattening filter-free photon beams. RESULTS: Median follow-up of patients was 14.5 months (range: 6-23). Acute rectal toxicity was mild (only 23/72 cases with G1-2 and no G3-4) as well as urinary (50/72 G1-2 and no G3-4). At the moment, four cases of G1 late rectal toxicity and 22 cases of G1 urinary (1 of G2) were reported. Urinary, rectal, sexual, and hormonal scores resulted stable over time: 1 year scores resulted, respectively, in -0.3, +2.8, -1.7, and -2.8 % variations with respect to baseline. No significant differences were observed also when data were stratified according to functional and bother sub-scales. CONCLUSIONS: Stereotactic body radiotherapy (SBRT) treatment of prostate with RapidArc and high-intensity photon beams resulted to be well tolerated by patients with mild toxicity profiles and good patient-reported quality of life perception for the first year after treatment. Longer follow-up in the trial cohort is in progress.","J Cancer Res Clin Oncol, 140(10): 1795-1800","Italy",2014,"Any or unknown","Radiotherapy","EPIC","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease"]
[616,"Sebrow, D., et al. (2012). \"Monitoring validated quality of life outcomes after prostatectomy: initial description of novel online questionnaire.\" Urology 79(2): 314-319.",null,"Sebrow, D., et al.","Monitoring validated quality of life outcomes after prostatectomy: initial description of novel online questionnaire","OBJECTIVES: To describe a novel, low-cost, online health-related quality of life (HRQOL) survey that allows for automated follow-up and convenient access for patients in geographically diverse locations. Clinicians and investigators have been encouraged to use validated HRQOL instruments when reporting outcomes after radical prostatectomy. METHODS: The institutional review board approved our protocol and the use of a secure web site (http://www.SurveyMonkey.com) to send patients a collection of validated postprostatectomy HRQOL instruments by electronic mail. To assess compliance with the electronic mail format, a pilot study of cross-sectional surveys was sent to patients who presented for follow-up after robotic-assisted laparoscopic prostatectomy. The response data were transmitted in secure fashion in compliance with the Health Insurance Portability and Accountability Act. RESULTS: After providing written informed consent, 514 patients who presented for follow-up after robotic-assisted laparoscopic prostatectomy from March 2010 to February 2011 were sent the online survey. A total of 293 patients (57%) responded, with an average age of 60 years and a median interval from surgery of 12 months. Of the respondents, 75% completed the survey within 4 days of receiving the electronic mail, with a median completion time of 15 minutes. The total survey administration costs were limited to the web site's $200 annual fee-for-service. CONCLUSIONS: An online survey can be a low-cost, efficient, and confidential modality for assessing validated HRQOL outcomes in patients who undergo treatment of localized prostate cancer. This method could be especially useful for those who cannot return for follow-up because of geographic reasons.","Urology, 79(2): 314-319","USA",2012,"Any or unknown","Surgery","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"General"]
[617,"See, D., et al. (2002). \"Increased tumor necrosis factor alpha (TNF-alpha) and natural killer cell (NK) function using an integrative approach in late stage cancers.\" Immunol Invest 31(2): 137-153.",null,"See, D., et al.","Increased tumor necrosis factor alpha (TNF-alpha) and natural killer cell (NK) function using an integrative approach in late stage cancers","Natural products may increase cytotoxic activity of Natural Killer Cells (NK) Tumor Necrosis Factor alpha (TNF-alpha) while decreasing DNA damage in patients with late-stage cancer. Pilot studies have suggested that a combination of Nutraceuticals can raise NK cell function and TNF-alpha alpha activity and result in improved clinical outcomes in patients with late stage cancer. The objective of the study is to determine if Nutraceuticals can significantly raise NK function and TNF levels in patients with late stage cancer. After informed consent was obtained, 20 patients with stage IV, end-stage cancer were evaluated (one bladder, five breast, two prostate, one neuroblastoma, two non-small cell lung, three colon, 1 mesothelioma, two lymphoma, one ovarian, one gastric, one osteosarcoma). Transfer Factor Plus (TFP+, 3 tablets 3 times per day), IMUPlus (non denatured milk whey protein, 40 gm/day); Intravenous (50 to 100 gm/day) and oral (1-2 gm/day) ascorbic acid; Agaricus Blazeii Murill teas (10 gm/day); Immune Modulator Mix (a combination of vitamin, minerals, antioxidants and immune-enhancing natural products); nitrogenated soy extract (high levels of genistein and dadzein) and Andrographis Paniculata (500 mg twice, daily) were used. Baseline NK function by standard 4 h 51Cr release assay and TNF alpha and receptor levels were measured by ELISA from resting and phytohemagglutinin (PHA) stimulated adherent and non-adherent Peripheral Blood Mononuclear Cell (PBMC). Total mercaptans and glutathione in plasma were taken and compared to levels measured 6 months later. Complete blood counts and chemistry panels were routinely monitored. As of a mean of 6 months, 16/20 patients were still alive. The 16 survivors had significantly higher NK function than baseline (p < .01 for each) and TNF-alpha levels in all four cell populations studied (p < .01 for each). Total mercaptans (p < .01) and TNF-alpha receptor levels were significantly reduced (p < .01). It was also observed that hemoglobin, hematocrit and glutathione levels were significantly elevated. The only toxicity noted was occasional diarrhea and nausea. The quality of life improved for all survivors by SF-36 form evaluation. An aggressive combination of immunoactive Nutraceuticals was effective in significantly increasing NK function, other immune parameters and hemoglobin from PBMC or plasma in patients with late stage cancers. Nutraceutical combinations may be effective in late stage cancers. Clinical outcomes evaluations are ongoing.","Immunol Invest, 31(2): 137-153","USA",2002,"Metastatic","Various","SF-36","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Utility"]
[618,"Seidenfeld, J., et al. (1999). \"Relative effectiveness and cost-effectiveness of methods of androgen suppression in the treatment of advanced prostate cancer.\" Evid Rep Technol Assess (Summ) (4): i-x, 1-246, I241-236, passim.",null,"Seidenfeld, J., et al.","Relative effectiveness and cost-effectiveness of methods of androgen suppression in the treatment of advanced prostate cancer","OBJECTIVES: With 184,500 new cases and 39,200 deaths anticipated in 1998, prostate cancer is second only to lung cancer in cancer mortality for men. This report is a systematic review of the evidence from randomized controlled trials on the relative effectiveness of alternative strategies for androgen suppression as treatment of advanced prostate cancer. Three key issues are addressed: (1) the relative effectiveness of the available methods for monotherapy (orchiectomy, luteinizing hormone-releasing hormone [LHRH] agonists, and antiandrogens), (2) the effectiveness of combined androgen blockade compared to monotherapy, and (3) the effectiveness of immediate androgen suppression compared to androgen suppression deferred until clinical progression. Outcomes of interest are overall, cancer-specific, and progression-free survival; time to treatment failure; adverse effects; and quality of life. Two supplementary analyses were conducted for each key question: (1) meta-analysis of overall survival at 2 years (questions 1 and 2) and 5 years (questions 2 and 3), and (2) cost-effectiveness analysis. SEARCH STRATEGY: The MEDLINE, CANCERLIT, and EMBASE databases were searched from 1966 to March 1998, and Current Contents to August 24, 1998, for the terms: leuprolide (Lupron); goserelin (Zoladex); buserelin (Suprefact); flutamide (Eulexin); nilutamide (Anandron, Nilandron); bicalutamide (Casodex); cyproterone acetate (Androcur); diethylstilbestrol (DES); and orchiectomy (castration, orchidectomy). The search was then limited to human studies indexed under the MeSH term \"prostatic neoplasms\" and by the UK Cochrane Center search strategy for randomized controlled trials. Total yield was 1,477 references. SELECTION CRITERIA: We Reports of efficacy outcomes were limited to randomized controlled trials. Phase II studies that reported on withdrawals from therapy and all studies reporting on quality of life were also included. DATA COLLECTION AND ANALYSIS: The systematic review used a prospectively designed protocol conducted by two independent reviewers, with disagreements resolved by consensus. The meta-analysis combined data on overall survival using a random effects model. The cost-effectiveness analysis used a decision analysis model of advanced prostate cancer with health states and transitions derived from the literature and estimates of effectiveness derived from the meta-analysis. The cost-effectiveness analysis is conducted from a societal perspective, consistent with the guidelines of the U.S. Public Health Service Panel on Cost-Effectiveness in Health and Medicine. MAIN RESULTS: Survival after treatment with an LHRH agonist is equivalent to survival after orchiectomy. The available LHRH agonists are equally effective, and no LHRH agonist is superior to the other when adverse effects are considered. Survival may be somewhat lower with use of a nonsteroidal antiandrogen. There is no statistically significant difference in survival at 2 years between patients treated with combined androgen blockade or monotherapy. Meta-analysis of the limited data available shows a statistically significant difference in survival at 5 years that favors combined androgen blockade. However, the magnitude of this difference is of questionable clinical significance. For the subgroup of patients with good prognosis, there is no statistically significant difference in survival. Adverse effects leading to withdrawal from therapy occurred more often with combined androgen blockade. No evidence is yet available from randomized controlled trials of androgen suppression initiated at prostate-specific antigen (PSA) rise after definitive therapy for clinically localized disease. For patients who are newly diagnosed with locally advanced or asymptomatic metastatic disease, the evidence is insufficient to determine whether primary androgen suppression initiated at diagnosis improves outcomes. (ABSTRACT TRUNCATED)","Evid Rep Technol Assess (Summ), 4): i-x, 1-246, I241-236, passim","USA",1999,"Advanced","Hormonal,Surgery","Unclear","Patient",null,"Systematic review,Economic model",null,null,null,null,null,null,null,null,"Utility"]
[619,"Selek, U., et al. (2004). \"Erectile dysfunction and radiation dose to penile base structures: a lack of correlation.\" Int J Radiat Oncol Biol Phys 59(4): 1039-1046.",null,"Selek, U., et al.","Erectile dysfunction and radiation dose to penile base structures: a lack of correlation","PURPOSE: To evaluate the relationship between the dose and volume of radiation to proximal penile structures and the development of erectile dysfunction after external beam radiotherapy (RT) for localized prostate adenocarcinoma. METHODS AND MATERIALS: The study cohort comprised 28 patients who were enrolled our in-house three-dimensional conformal RT dose escalation protocol. The patients were treated to 78 Gy between 1995 and 1998. This protocol included a planned quality-of-life questionnaire to assess sexual function 2 years after completing RT. All the study patients were potent before RT. The median follow-up was 66 months (range 39-95). Penile base contents were outlined retrospectively in restored treatment plans. The dose-volume histograms (DVHs) for the corpus spongiosum (penile bulb), corpora cavernosum and crura, and total penile structure (corpus spongiosum plus corpora cavernosum and crura) were calculated. Statistical significance was defined as p < 0.05. The Bonferroni correction was used to adjust for multiple comparisons. Power calculations showed that our study sample would detect radiation- induced impotence with a very high power. We also estimated that a relatively small difference of 10-15% in the DVHs between the potent and impotent patients could be detected. RESULTS: At 2 years after RT, 10 patients (35.7%) reported new-onset erectile dysfunction and were unable to attain firm enough erections to have intercourse. Only hypertension was observed to affect erectile dysfunction after external beam RT. We found no statistically significant correlation among age, diabetes, or heavy alcohol consumption and post-RT potency. The mean radiation dose +/- standard deviation delivered to the corpus spongiosum, corpora cavernosa and crura, and total penile structure was, respectively, 42.2 +/- 8.4 Gy, 36.3 +/- 8.0 Gy, and 38.2 +/- 7.5 Gy. t test comparisons were performed between DVHs of post-RT potent and impotent patients on multiple cutpoints. No dose-volume effect was found. Analysis of the DVHs when the patients were subdivided into normotensive and hypertensive groups also showed no dose-volume response. CONCLUSION: Our analysis did not show statistically significant correlations between potency preservation and radiation dose to the proximal penis. The entire etiology of radiation- induced erectile dysfunction remains unclear and further research is needed.","Int J Radiat Oncol Biol Phys, 59(4): 1039-1046","USA",2004,"Local","Radiotherapy","Unclear","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Complication"]
[620,"Selli, C., et al. (2004). \"Role of bladder neck preservation in urinary continence following radical retropubic prostatectomy.\" Scand J Urol Nephrol 38(1): 32-37.",null,"Selli, C., et al.","Role of bladder neck preservation in urinary continence following radical retropubic prostatectomy","OBJECTIVE: To report our experience of the influence of bladder neck preservation on patient continence. MATERIAL AND METHODS: Radical retropubic prostatectomy with bladder neck preservation was performed in 131 patients (age range 48-73 years; mean 64.5 years). Urinary continence was evaluated using a validated questionnaire at follow-up visits and telephone interviews. All patients reporting incontinence were studied using a pad test and urodynamics. RESULTS: After a mean follow-up period of 21.7 months (range 4-47 months), 115 patients were continent (87%) and 16 incontinent. According to the International Continence Society criteria, three had severe, three moderate and 10 mild incontinence. Urodynamics revealed sphincter deficiency in 15 cases, which was associated with decreased bladder compliance in four, while decreased compliance was the only abnormality in one. Continence was recovered 0-27 months after surgery (mean 3.2 months): 40% of men were continent within the first month and 74% within the third. Histopathology revealed positive margins in 30/131 patients (22%), but exclusively at the bladder neck level in only seven (5%), and two also had positive nodes. Six patients (4.5%) presented bladder neck stenosis requiring transurethral incision. No statistically significant differences were found between the ages of continent and incontinent men or between the time to continence recovery with two different techniques of retropubic hemostasis; however, use of a nerve-sparing technique significantly reduced the time to continence recovery. CONCLUSIONS: Bladder neck preservation during radical retropubic prostatectomy does not improve the long-term results of urinary continence but does contribute substantially to its earlier recovery, thus improving the quality of life. With proper patient selection the risk of positive margins at the bladder neck level only is reasonably low.","Scand J Urol Nephrol, 38(1): 32-37","Italy",2004,"Any or unknown","Surgery","ICSQ","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Complication"]
[621,"Seo, P. H., et al. (2004). \"Assessing a prostate cancer brachytherapy technique using early patient-reported symptoms: a potential early indicator for technology assessment?\" Clin Prostate Cancer 3(1): 38-42.",null,"Seo, P. H., et al.","Assessing a prostate cancer brachytherapy technique using early patient-reported symptoms: a potential early indicator for technology assessment?","Brachytherapy for early prostate cancer can cause long-term urinary, bowel, and sexual dysfunction. Modifying technique may mitigate complications, but definitive outcome assessment requires long-term follow-up. Although radiation dose plausibly mediates all treatment-related toxicity, short-term symptoms may indicate long-term outcomes. We sought an early indication of whether a modified brachytherapy technique successfully decreased toxicity in the anticipated direction by assessing changes in symptoms and symptom distress 3 months after treatment. In a prospective study of clinically localized prostate cancer using a validated, patient-reported questionnaire, we assessed 85 men, whose primary treatment was brachytherapy alone, prior to treatment and 3 months after the procedure. Twenty-two men received standard ultrasound-guided brachytherapy (SB), and 63 men received magnetic resonance imaging-guided brachytherapy (MB), a technique intended to decrease urinary toxicity by reducing urethral irradiation. Patient age and other sociodemographic variables were similar in the 2 groups. The MB group experienced a greater increase in urinary obstruction/irritation symptoms (P = 0.02) and sexual function distress, but not sexual dysfunction (P = 0.22), whereas the SB group reported a smaller increase in bowel symptoms (P = 0.04) and bowel distress (P = 0.02). We found reduced short-term urinary obstruction/irritation and increased bowel problems after MB consistent with the hypothesized effects of the modified technique, although no obvious mechanism explains the decreased sexual function distress in MB patients. Whether these short-term changes predict long-term outcome differences will require much longer follow-up. However, these results suggest that measuring early symptoms may indicate whether an altered brachytherapy treatment technique has intended favorable consequences, potentially accelerating technology assessment.","Clin Prostate Cancer, 3(1): 38-42","USA",2004,"Local","Brachytherapy","Unclear","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Complication"]
[622,"Shaikh, T., et al. (2017). \"Long-Term Patient-Reported Outcomes From a Phase 3 Randomized Prospective Trial of Conventional Versus Hypofractionated Radiation Therapy for Localized Prostate Cancer.\" Int J Radiat Oncol Biol Phys 97(4): 722-731.",null,"Shaikh, T., et al.","Long-Term Patient-Reported Outcomes From a Phase 3 Randomized Prospective Trial of Conventional Versus Hypofractionated Radiation Therapy for Localized Prostate Cancer","PURPOSE: To assess the long-term quality of life (QoL) outcomes from a phase 3 trial comparing 2 modes of intensity modulated radiation therapy (IMRT): conventional IMRT (CIMRT) versus hypofractionated IMRT (HIMRT) in patients with localized prostate cancer. METHODS AND MATERIALS: Between 2002 and 2006, 303 men with low-risk to high-risk prostate cancer were randomized to 76 Gy in 38 fractions (CIMRT) versus 70.2 Gy in 26 fractions (HIMRT). QoL was compared by use of the Expanded Prostate Cancer Index Composite (EPIC), the International Prostate Symptom Score (IPSS), and EuroQoL (EQ5D) questionnaires. The primary outcome of the QoL analysis was a minimum clinically important difference defined as a 0.5 standard deviation change from baseline for each respective QoL parameter. Treatment effects were evaluated with the use of logistic mixed effects regression models. RESULTS: A total of 286, 299, and 218 patients had baseline EPIC, IPSS, or EQ5D data available and were included in the analysis. Overall, there was no statistically significant difference between the 2 treatment arms in terms of EPIC, IPSS, or EQ5D scores over time, although there was a trend toward lower EPIC urinary incontinence scores in the HIMRT arm. More patients in the HIMRT arm had a lower EPIC urinary incontinence score relative to baseline versus patients in the CIMRT arm with long-term follow-up. On multivariable analysis, there was no association between radiation fractionation scheme and any QoL parameter. When other clinical factors were examined, lymph node radiation was associated with worse EPIC hormonal scores versus patients receiving no lymph node radiation. In general, QoL outcomes were generally stable over time, with the exception of EPIC hormonal and EQ5D scores. CONCLUSIONS: In this randomized prospective study, there were stable QoL changes in patients receiving HIMRT or CIMRT. Our results add to the growing body of literature suggesting that HIMRT may be an acceptable treatment modality in clinically localized prostate cancer.","Int J Radiat Oncol Biol Phys, 97(4): 722-731","USA",2017,"Local","Radiotherapy","EPIC,IPSS,EQ-5D","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,Utility"]
[623,"Shamash, J., et al. (2011). \"A multi-centre randomised phase III trial of Dexamethasone vs Dexamethasone and diethylstilbestrol in castration-resistant prostate cancer: immediate vs deferred Diethylstilbestrol.\" Br J Cancer 104(4): 620-628.",null,"Shamash, J., et al.","A multi-centre randomised phase III trial of Dexamethasone vs Dexamethasone and diethylstilbestrol in castration-resistant prostate cancer: immediate vs deferred Diethylstilbestrol","BACKGROUND: The role of further hormone therapy in castration-resistant prostate cancer (CRPC) remains unclear. We performed a multi-centre randomised phase III study comparing the use of Dexamethasone, Aspirin, and immediate addition of Diethylstilbestrol (DAiS) vs Dexamethasone, Aspirin, and deferred (until disease progression) addition of Diethylstilbestrol (DAdS). METHODS: From 2001 to 2008, 270 men with chemotherapy-naive CRPC were randomly assigned, in a 1 : 1 ratio, to receive either DAiS or DAdS. They were stratified for performance status, presence of bone metastases, and previous normalisation of prostate-specific antigen (PSA) to androgen deprivation. The study end points were the proportion of patients achieving a 50% PSA response, progression-free survival (PFS), overall survival, and quality of life. Intention-to-treat analysis was carried out. The effect of treatment was studied first by Kaplan-Meier curves and log-rank test, and finally through multivariable stratified Cox's proportional hazards model adjusting for the effects of possible baseline prognostic factors. Quality of life was analysed using multivariate analysis of variance. RESULTS: At study entry, the median age was 76 years (inter-quartile range: 70-80 years), the median PSA was 79 ng ml(-1), and 76% of the cohort had metastatic disease. The response rates for DAiS (68%) and DAdS (64%) were not significantly different (P=0.49). Similar to the response rate, neither the PFS (median=8.1 months for both arms) nor the overall survival (19.4 vs 18.8 months) differed significantly between the DAiS and DAdS groups (P>0.20). However, the response rate for the DAiS (68%) was significantly higher than the response rate of DA (before adding Diethylstilbestrol) (50%) (P=0.002). Similarly, the median time to progression for DAiS (8.6 months) was significantly longer than that of DA (4.5 months) (P<0.001). Multivariable analysis showed that patients with previous haemoglobin >/=11 g dl(-1) decreased the risk of death significantly (hazard ratio: 0.44, 95% CI: 0.25-0.77). Patients treated with previous anti-androgens alone had more than 5 times more risk of death compared with patients treated with gonadorelin analogues throughout their castration-sensitive phase. Treatment sequencing did not affect the quality of life but pre-treatment performance status did. The incidence of veno-thromboembolic events was 22% (n=28) in DAiS and 11% (n=14) in the DA arm (P=0.02). Painful gynaecomastia occurred in only 1% on DA, whereas in 40% on DAiS (P=0.001). CONCLUSION: Dexamethasone and immediate Diethylstilbestrol resulted in neither higher PSA response rate nor higher PFS compared with Dexamethasone with deferred Diethylstilbestrol. There was no suggestion of significantly improved overall survival or quality of life. Given the significantly higher toxicity of Diethylstilbestrol, deferring Diethylstilbestrol until failure of Dexamethasone is the preferred strategy when using these agents in CRPC.","Br J Cancer, 104(4): 620-628","UK",2011,"Any or unknown","Hormonal","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General"]
[624,"Sharma, P., et al. (2016). \"Evaluation of point-of-care PRO assessment in clinic settings: integration, parallel-forms reliability, and patient acceptability of electronic QOL measures during clinic visits.\" Qual Life Res 25(3): 575-583.",null,"Sharma, P., et al.","Evaluation of point-of-care PRO assessment in clinic settings: integration, parallel-forms reliability, and patient acceptability of electronic QOL measures during clinic visits","PURPOSE: Assessment of patient-reported outcomes (PROs), such as health-related quality of life, has become an important component of healthcare that measures the impact of disease and medical treatment on patient health. Collecting PROs during point-of-care assessments and integrating them into the clinical setting, however, remains challenging. The objective of this pilot study was to evaluate the reliability, usability, and acceptability of point-of-care electronic PRO assessments implemented in a prostate cancer clinic. METHODS: Fifty subjects completed paper-pencil and computerized formats of the Expanded Prostate Cancer Index Composite (EPIC), a validated, condition-specific QOL instrument, at separate times before treatment. Parallel-forms reliability was evaluated by comparing mean scores, variations in response distribution, and correlations between administration formats. Correlation coefficients of at least 0.70 were used for reliability testing. Differences between administration forms, indicating potential bias, were compared using the signed-rank test. A 6-item acceptability scale was also used to evaluate patient acceptability and satisfaction with the electronic format. RESULTS: Mean scores and standard deviations were similar between the paper-pencil and electronic forms across all EPIC instrument domains, and no assessment bias was found. Each EPIC domain demonstrated a high reliability between administration formats (correlation coefficients: 0.70-0.98). The majority (>90 %) of respondents found that the computerized QOL format was user friendly and simple to use. CONCLUSIONS: Point-of-care computerized QOL assessments were reliable and acceptable to patients in this study, supporting the feasibility of PRO integration at the point-of-care in clinical settings.","Qual Life Res, 25(3): 575-583","USA",2016,"Any or unknown","None","EPIC","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease"]
[625,"Sharp, L. K., et al. (1999). \"Quality of life in low-income patients with metastatic prostate cancer: divergent and convergent validity of three instruments.\" Qual Life Res 8(5): 461-470.",null,"Sharp, L. K., et al.","Quality of life in low-income patients with metastatic prostate cancer: divergent and convergent validity of three instruments","Few studies have evaluated Quality Of Life (QOL) among low-income patients with cancer. Information is needed about the feasibility and psychometric characteristics of QOL instruments in these populations. The purpose of this study was to examine the convergent and discriminant relationships between scales of three QOL instruments: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC), Functional Assessment of Cancer Therapy--General (FACT), and Quality of Life Index (QLI). Participants included 110 men with metastatic prostate cancer of whom 94% were low income and 62% were African-American. Interviewers administered the questionnaires. Cronbach alpha internal consistency reliabilities were 0.57 to 0.90 for the EORTC, 0.65 to 0.86 for the FACT, and 0.63 for the QLI. Convergent validity was supported for the EORTC and FACT scales measuring emotional, physical, and role/functional dimensions (r = 0.54 to 0.72), but not on scales measuring social function (r = 0.12). Divergent validity was supported between dissimilar scales (r = 0.14 to 0.38). Analysis with receiver operating characteristics curves provided empirical support for the EORTC and FACT as multidimensional measures. These findings suggest that, even in busy clinical settings with low literacy patients, interviewer-administered EORTC and FACT QOL instruments can provide valid and reliable information.","Qual Life Res, 8(5): 461-470","USA",1999,"Metastatic","None","EORTC QLQ-C30,FACT-G,QLI","Patient",null,"Validation",null,null,null,null,null,null,null,null,"General,Treatment"]
[626,"Shelfo, S. W., et al. (1998). \"Update on bladder neck preservation during radical retropubic prostatectomy: impact on pathologic outcome, anastomotic strictures, and continence.\" Urology 51(1): 73-78.",null,"Shelfo, S. W., et al.","Update on bladder neck preservation during radical retropubic prostatectomy: impact on pathologic outcome, anastomotic strictures, and continence","OBJECTIVES: To preserve the bladder neck during radical prostatectomy in an attempt to maintain continence and decrease the incidence of anastomotic stricture without compromising the removal of cancer. METHODS: A retrospective analysis of 365 consecutive radical prostatectomies performed from December 1991 through January 1997 was carried out. The records were reviewed in regard to the pathology of the prostate. In addition, the incidence of anastomotic strictures was determined. Urinary function and continence was evaluated in 195 patients by a quality of life questionnaire. RESULTS: (1) Pathology: positive margins were found in 119 patients (32%). The bladder neck margin was positive in 27 (7%), but the bladder neck was the only positive margin in only 2 patients (0.5%). The mean Gleason score for patients with negative margins was 6.4, for those with positive margins 7.2, and for all those with bladder neck margin positive 7.7. The mean Gleason score for the 2 patients with a solitary positive margin at the bladder neck was 9.0. Of patients with a Gleason score less than 7, 81% had a negative margin, 19% had a positive margin, and 1% had tumor at the bladder neck. Of patients with a Gleason score 7 or more, 58% had a negative margin, 42% had a positive margin, and 11% had a positive bladder neck. Patients with a prostate-specific antigen value of less than 10 ng/mL were more likely to have a favorable pathology. (2) Anastomotic stricture: an anastomotic stricture occurred in 5 patients (1%). Three had a previous transurethral resection of the prostate (TURP) and therefore bladder neck preservation was not possible. (3) Urinary function: 88% of all responders did not wear pads 6 months or more after surgery. Seventy percent of patients did not wear pads less than 6 months after surgery. Ninety percent of patients believed that urinary function did not limit social, physical, or occupational activities. CONCLUSIONS: We believe that bladder neck preservation during radical prostatectomy does not compromise surgical margins. The incidence of anastomotic strictures is less than 1% in patients who have not had a previous TURP. The quality of life questionnaire indicates a high level of continence that may be related in part to preservation of the bladder neck.","Urology, 51(1): 73-78","USA",1998,"Any or unknown","Surgery","Unclear","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Complication"]
[627,"Sherman, E. J., et al. (2001). \"The Collection of Indirect and Nonmedical Direct Costs (COIN) form: a new tool for collecting the invisible costs of androgen independent prostate carcinoma.\" Cancer 91(4): 841-853.",null,"Sherman, E. J., et al.","The Collection of Indirect and Nonmedical Direct Costs (COIN) form: a new tool for collecting the invisible costs of androgen independent prostate carcinoma","BACKGROUND: There are limited data available regarding the cost of care in patients with androgen independent prostate carcinoma (AIPC), and there are no data on the impact of direct nonmedical and indirect costs (DNM/IC). This lack of data, along with the feasibility of collecting DNM/IC, was examined in patients with AIPC who took part in a randomized trial using a newly developed questionnaire, the Collection of Indirect and Nonmedical Direct Costs (COIN) form. METHODS: Patients with AIPC were randomized to one of three treatment arms: 1) strontium only (strontium 4 Mci in Week 1 and Week 12) (STRONT); 2) vinblastine 4 mg/m(2) per week for 3 weeks then 1 week off and estramustine, 10 mg/kg per day (CHEMO); or 3) a combination of treatments outlined in the arms for CHEMO and STRONT (CHEMO/STRONT). Direct medical costs were collected through the hospital billing system. DNM/IC data were obtained prospectively using the COIN form. Cost data were analyzed for a period of 6 months. RESULTS: Twenty-nine patients were randomized, after which the protocol was closed because of poor accrual. The median survival of the patients was 22.3 months. The mean and median total costs for the 20 of 29 patients with complete cost information were $12,647 and $11,257 over 6 months, respectively. DNM/IC represented 11% of the total cost (range, from < 1% to 42%); in 20% of participating individuals, these costs accounted for 35-42% of total costs. Failure to collect complete cost information was due to early death, administrative difficulties, and loss to follow-up. CONCLUSIONS: In this pilot project, the collection of these cost data using the COIN form was feasible and practical and was limited primarily by logistic, not form specific, issues. DNM/IC were found to be a significant proportion of total costs (up to 42%) in selected patients, and this information proved to be a useful addition to the cost analysis. Approximately 98 patients would be required to detect a 20% difference in total costs between arms in a properly powered, randomized trial. Considering the potentially significant impact on total costs, DNM/IC data should be included in future cost-analysis studies of patients with AIPC and other diseases.","Cancer, 91(4): 841-853","USA",2001,"Any or unknown","None","COIN","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Costs"]
[628,"Shim, M., et al. (2015). \"The therapeutic effect of solifenacin succinate on the recovery from voiding dysfunction after radical prostatectomy in men with clinically localized prostate cancer: a prospective, randomized, controlled study.\" Urology 85(5): 1123-1129.",null,"Shim, M., et al.","The therapeutic effect of solifenacin succinate on the recovery from voiding dysfunction after radical prostatectomy in men with clinically localized prostate cancer: a prospective, randomized, controlled study","OBJECTIVE: To evaluate whether anticholinergic medication contributes to early recovery of continence and improvement of other voiding symptoms after radical prostatectomy (RP). PATIENTS AND METHODS: A total of 78 patients with clinically localized prostate cancer who had incontinence at 1 week after RP were enrolled prospectively. The patients were allocated to one of the 2 groups: group 1 (alpha-adrenergic agonist [midodrine] plus an anticholinergic [solifenacin]) or group 2 (alpha-adrenergic agonist only). A urodynamic study and the International Continence Society male Short Form questionnaire were completed preoperatively and 4 months after RP. One-hour pad test and 3-day frequency volume chart at 1 and 4 months after medication were also analyzed. RESULTS: The rate of continence, defined as being pad free, did not differ between the groups at 4 months (both 71.8%; P >.05). However, the decreased value of mean weight of daily pads worn by groups 1 and 2 were 51.5 vs 11.7 g, respectively (P = .005). The incontinence (P = .008) and quality of life (P = .044) subscale scores significantly worsened in group 2, whereas they remained unchanged in group 1. Maximal detrusor pressure and maximal urethral closure pressure significantly decreased in both groups, whereas maximal cystometric capacity increased significantly in group 1 only (290.8-332.0 cm H2O; P <.001). CONCLUSION: Anticholinergics may facilitate early recovery from incontinence and prevent worsening of quality of life, which might be attributed to increased cystometric capacity after their use.","Urology, 85(5): 1123-1129","Korea",2015,"Local","Surgery,Various","ISCQ","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Complication"]
[629,"Shrader-Bogen, C. L., et al. (1997). \"Quality of life and treatment outcomes: prostate carcinoma patients' perspectives after prostatectomy or radiation therapy.\" Cancer 79(10): 1977-1986.",null,"Shrader-Bogen, C. L., et al.","Quality of life and treatment outcomes: prostate carcinoma patients' perspectives after prostatectomy or radiation therapy","BACKGROUND: Of the estimated 317,000 men in the United States diagnosed with prostate carcinoma in 1996, 57% will have localized disease, and their 5-year relative survival rate will be 98%. Limited information exists on patient-reported quality of life (QOL) and the incidence and severity of treatment-related side effects. The purpose of this study was to identify and compare patients' self-reported QOL and treatment side effects 1-5 years after radical prostatectomy or radiotherapy. METHODS: Data collection for this cross-sectional study included a mailed, self-administered survey with three parts: a demographic survey, the Functional Assessment of Cancer Therapy-General (FACT-G), and a newly developed Prostate Cancer Treatment Outcome Questionnaire (PCTO-Q). The FACT-G measured the effect of prostate carcinoma on overall QOL in the two treatment groups. The PCTO-Q assessed the patients' perceptions of the incidence and severity of specific changes in bowel, urinary, and sexual functions. The test-retest reliability of the PCTO-Q in a pilot study was 91.2%. RESULTS: Two hundred seventy-four eligible men completed the questionnaires; 132 (48%) reported having undergone prostatectomy and 142 (52%) reported having undergone radiotherapy. After age adjustment, the radiotherapy group reported more bowel dysfunction (P = 0.001), whereas the prostatectomy group reported more urinary problems (P = 0.03) and more sexual dysfunction (P = 0.001). Scores for the FACT-G were similar in the two treatment groups. CONCLUSIONS: Men undergoing treatment for clinically localized prostate carcinoma continue to experience difficulty long after treatment. In this study, the prostatectomy group fared worse in regard to sexual and urinary functions, whereas the radiotherapy group experienced more bowel dysfunction. Survivor-reported QOL and treatment outcomes can assist physicians in counseling patients in the selection of the preferred course of treatment.","Cancer, 79(10): 1977-1986","USA",1997,"Local","Surgery,Radiotherapy","FACT-G,PCTO-Q","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Treatment"]
[630,"Simard, S. and J. Savard (2009). \"Fear of Cancer Recurrence Inventory: development and initial validation of a multidimensional measure of fear of cancer recurrence.\" Support Care Cancer 17(3): 241-251.",null,"Simard, S. and J. Savard","Fear of Cancer Recurrence Inventory: development and initial validation of a multidimensional measure of fear of cancer recurrence","BACKGROUND: Despite the fact that the fear of cancer recurrence is to varying degrees almost universal in cancer survivors, there is a lack of validated multidimensional instruments to evaluate this issue specifically. PURPOSE: The goal of this study was to develop and empirically validate a multidimensional self-report scale for assessing the fear of cancer recurrence, the Fear of Cancer Recurrence Inventory (FCRI). METHODS: A provincial medical databank was used to randomly select a pool of 1,704 French-Canadian patients who had been treated for breast, prostate, lung, and colorectal cancer within the past 10 years. Of these, 300 patients were asked to complete the FCRI on two occasions. RESULTS: The factorial analysis conducted on the final 42-item scale revealed a seven-component solution (64% of the variance) including the following factors: triggers, severity, psychological distress, coping strategies, functioning impairments, insight, and reassurance. The results also supported the internal consistency (alpha = 0.95) and the temporal stability (r = 0.89) of the FCRI, as well as its construct validity with other self-report scales assessing fear of cancer recurrence (r = 0.68 to 0.77) or related constructs such as psychological distress (r = 0.43 to 0.77) and quality of life (r = -0.20 to -0.36). CONCLUSIONS: This study suggests that the French-Canadian version of the FCRI is a reliable and valid instrument for evaluating the multidimensional aspects of the fear of cancer recurrence.","Support Care Cancer, 17(3): 241-251","Canada",2009,"Survivors","None","FCRI","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease"]
[631,"Sini, C., et al. (2017). \"Patient-reported intestinal toxicity from whole pelvis intensity-modulated radiotherapy: First quantification of bowel dose-volume effects.\" Radiother Oncol 124(2): 296-301.",null,"Sini, C., et al.","Patient-reported intestinal toxicity from whole pelvis intensity-modulated radiotherapy: First quantification of bowel dose-volume effects","BACKGROUND AND PURPOSE: Intestinal toxicity is commonly experienced during whole-pelvis intensity-modulated radiotherapy (WPRT) for prostate cancer. The aim of the current study was to assess bowel dose-volume relationships for acute patient-reported intestinal symptoms of patients treated with WPRT for prostate cancer. MATERIALS AND METHODS: Complete data of 206 patients were available; the median dose to pelvic nodes was 51.8Gy (range 50.4-54.4, 1.7-2Gy/fr). Intestinal symptoms were assessed as changes in the Inflammatory Bowel Disease Questionnaire scores relative to the Bowel Domain (IBDQ-B) between baseline and radiotherapy mid-point/end. The 25th percentiles of the most severe worsening from baseline (DeltaIBDQ-B) were set as end-points. The impact of bowel loops and sigmoid colon dose-volume/surface parameters as well as selected clinical parameters were investigated using multivariate logistic regression. RESULTS: Analyses were focused on the four questions showing a median DeltaIBDQ-B>0. No dose volume/surface parameters were predictive, other than DeltaIBDQ5>/=3 (loose stools): when grouping patients according to bowel DVHs (high risk: V20>470cc, V30>245cc, V42>110cc; low risk: all the remaining patients), a two-variable model including high-risk DVH-shape (OR: 9.3) and age (protective, OR: 0.94) was assessed. The model showed good calibration (slope: 1.003, R(2)=0.92) and was found to be robust after bootstrap-based internal validation. CONCLUSIONS: Constraining the bowel loops may reduce the risk of loose stools. The risk is higher for younger patients.","Radiother Oncol, 124(2): 296-301","Italy",2017,"Any or unknown","Radiotherapy","IBDQ","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Complication"]
[632,"Siston, A. K., et al. (2003). \"Quality of life after a diagnosis of prostate cancer among men of lower socioeconomic status: results from the Veterans Affairs Cancer of the Prostate Outcomes Study.\" Urology 61(1): 172-178.",null,"Siston, A. K., et al.","Quality of life after a diagnosis of prostate cancer among men of lower socioeconomic status: results from the Veterans Affairs Cancer of the Prostate Outcomes Study","OBJECTIVES: To evaluate prospectively the health-related and disease-specific quality of life (QOL) at diagnosis and during the first year thereafter for patients with newly diagnosed prostate cancer who received care at Veterans Affairs Medical Centers. METHODS: Interviewers administered the European Organization for Research and Treatment of Cancer-QOL Questionnaire, a valid and reliable measure of health status, to 140 patients with prostate cancer at baseline (at diagnosis, before the initiation of treatment) and at 3 and 12 months thereafter at five Veterans Affairs Medical Centers. The mean changes from baseline values were analyzed statistically for patients with localized disease stratified by treatment group and separately for patients with metastatic disease. RESULTS: Among the 98 men with localized prostate cancer, significant disease-specific QOL changes noted at 3 and 12 months included worsening of urinary and sexual function among men treated with radical prostatectomy or radiotherapy and worsening of urinary function among those who opted for watchful waiting (each P <0.05). Among the 42 men with metastatic prostate cancer, significant decrements in role and social and sexual function were noted at 3 months, but had resolved on average by 12 months of follow-up. CONCLUSIONS: At 12 months, disease-specific QOL decrements persisted for patients with localized disease, but for patients with metastatic disease, disease-specific QOL appeared to return to near baseline (at diagnosis, before treatment initiation) function. Our study, among the first to assess the QOL at baseline before treatment, provides meaningful information on general treatment effects, which are directly relevant to clinicians when discussing treatment options with patients.","Urology, 61(1): 172-178","USA",2003,"Local,Metastatic","Surgery,Radiotherapy,Surveillance","EORTC QLQ-C30","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"General"]
[633,"Skaltsa, K., et al. (2014). \"Mapping the FACT-P to the preference-based EQ-5D questionnaire in metastatic castration-resistant prostate cancer.\" Value Health 17(2): 238-244.",null,"Skaltsa, K., et al.","Mapping the FACT-P to the preference-based EQ-5D questionnaire in metastatic castration-resistant prostate cancer","OBJECTIVES: To develop a mapping algorithm for estimating EuroQol five-dimensional (EQ-5D) questionnaire values from the prostate cancer-specific health-related quality-of-life (HRQOL) instrument Functional Assessment of Cancer Therapy-Prostate (FACT-P) instrument. METHODS: The EQ-5D questionnaire and FACT-P instrument data were collected for a subset of patients with metastatic castration-resistant prostate cancer in a multicenter, randomized, double-blind, placebo-controlled phase 3 trial. We compared three statistical techniques to estimate patients' EQ-5D questionnaire index scores determined by using the UK tariff: 1) generalized estimating equations, 2) two-part model combining logistic regression and generalized estimating equation, and 3) separate mapping algorithms for patients with poor health defined as a FACT-P score of 76 or less (group-specific model). Four different sets of explanatory variables were compared. The models were cross-validated by using a 10-fold in-sample cross-validation. RESULTS: Values for both instruments were available for 236 patients with metastatic castration-resistant prostate cancer. The group-specific model including the FACT-P subscale scores and baseline variables had the best predictive performance with R(2) 0.718, root mean square error 0.162, and mean absolute error 0.117. The two-part model and the generalized estimating equation model including the FACT-P subdomain scores and baseline variables also had good predictive performance. CONCLUSIONS: The developed algorithms for mapping the FACT-P instrument to the EQ-5D questionnaire enable the estimation of preference-based health-related quality-of-life scores for use in cost-effectiveness analyses when directly elicited EQ-5D questionnaire data are missing.","Value Health, 17(2): 238-244","Netherlands",2014,"Metastatic","Unclear","EQ-5D,FACT-P","Patient",null,"Mapping to utility",null,null,null,null,null,null,null,null,"Disease,Utility"]
[634,"Skolarus, T. A., et al. (2012). \"Monitoring quality of life among prostate cancer survivors: the feasibility of automated telephone assessment.\" Urology 80(5): 1021-1026.",null,"Skolarus, T. A., et al.","Monitoring quality of life among prostate cancer survivors: the feasibility of automated telephone assessment","OBJECTIVE: To examine the feasibility of using automated interactive voice response calls to assess prostate cancer survivor quality of life (QOL). In light of an increasing focus on patient-centered outcomes, innovative and efficient approaches to monitor QOL among prostate cancer survivors are increasingly valuable. METHODS: Forty prostate cancer survivors less than 1 year post-treatment were enrolled at a university-based cancer center clinic from July through August 2011. We adapted the Expanded Prostate Cancer Index Composite (EPIC) survey, a prostate cancer-specific QOL instrument, for use via personal telephone with interactive voice response. We compared written vs interactive voice response EPIC scores across urinary, sexual, bowel, and vitality domains. RESULTS: The median age of respondents was 63 years (range, 41-76 years) and the majority had undergone surgery (97.5%). The entire interactive voice response call was completed by 35 participants (87.5%). Over half of all interactive voice response calls were answered after 2 attempts with a median length of 11.3 minutes. On average, interactive voice response EPIC scores were slightly lower than written scores (-2.1 bowel, P = .05; -4.6 urinary incontinence, P < .01). Test-retest reliability was very high for urinary incontinence (r = .97) and sexual function domains (r = .96). Although mean scores were similar for other domains, their distributions had significant ceiling effects limiting our reliability measure interpretation. CONCLUSION: Automated interactive voice response calls are a feasible strategy for assessing prostate cancer survivor QOL. Interactive voice response could provide a low cost, sustainable, and systematic approach to measuring patient-centered outcomes, conducting comparative effectiveness research, and monitoring the quality of prostate cancer care.","Urology, 80(5): 1021-1026","USA",2012,"Survivors","None","EPIC","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Disease"]
[635,"Small, E. J., et al. (2000). \"Suramin therapy for patients with symptomatic hormone-refractory prostate cancer: results of a randomized phase III trial comparing suramin plus hydrocortisone to placebo plus hydrocortisone.\" J Clin Oncol 18(7): 1440-1450.",null,"Small, E. J., et al.","Suramin therapy for patients with symptomatic hormone-refractory prostate cancer: results of a randomized phase III trial comparing suramin plus hydrocortisone to placebo plus hydrocortisone","PURPOSE: Suramin is a novel agent that has demonstrated preliminary evidence of antitumor activity in hormone-refractory prostate cancer (HRPC). A prospective randomized clinical trial was designed to evaluate pain and opioid analgesic intake as surrogates for antitumor response in HRPC patients with significant, opioid analgesic-dependent pain. PATIENTS AND METHODS: A double-blind, placebo-controlled trial randomized patients to receive a 78-day, outpatient regimen of either suramin plus hydrocortisone (HC, 40 mg/d) or placebo plus HC. Treatment assignment was unblinded when either disease progression or dose-limiting toxicity occurred; placebo patients were allowed to cross-over to open-label suramin plus HC. In addition to pain and opioid analgesic intake, prostate-specific antigen (PSA) response, time to disease progression, quality of life, performance status, and survival were compared. RESULTS: Overall mean reductions in combined pain and opioid analgesic intake were greater for suramin plus HC (rank sum P =.0001). Pain response was achieved in a higher proportion of patients receiving suramin than placebo (43% v 28%; P =.001), and duration of response was longer for suramin responders (median, 240 v 69 days; P =.0027). Time to disease progression was longer (relative risk = 1.5; 95% confidence interval, 1.2 to 1.9) and the proportion of patients with a greater than 50% decline in PSA was higher (33% v 16%; P =.01) in patients who received suramin. Neither quality of life nor performance status was decreased by suramin treatment, and overall survival was similar. Most adverse events were of mild or moderate intensity and were easily managed medically. CONCLUSION: Outpatient treatment with suramin plus HC is well tolerated and provides moderate palliative benefit and delay in disease progression for patients with symptomatic HRPC.","J Clin Oncol, 18(7): 1440-1450","USA",2000,"Any or unknown","Various","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General"]
[636,"Smith, D. S., et al. (2000). \"Quality-of-life outcomes for men with prostate carcinoma detected by screening.\" Cancer 88(6): 1454-1463.",null,"Smith, D. S., et al.","Quality-of-life outcomes for men with prostate carcinoma detected by screening","BACKGROUND: There is limited information on outcomes of prostate carcinoma treatments given to screened patient populations for whom cancer is usually detected at an earlier stage. METHODS: The authors conducted a cross-sectional evaluation of quality-of-life outcomes for men with prostate carcinoma detected in screening studies at a university center. Of 2234 men diagnosed with prostate carcinoma between 1989 and 1997, 74% responded to the questionnaire. Primary management included radical prostatectomy (76%), radiotherapy (11%), observation (7%), hormonal therapy (4%), and cryoablation (2%). Main outcome measures included validated measurements of quality of life, urinary and sexual functioning, and bother (36-item RAND Health Survey, UCLA Prostate Cancer Index). RESULTS: After controlling for demographic factors, differences among treatment groups were found for all general quality-of-life outcomes, with increased impairment in men who underwent hormonal therapy (all P values <0.05). Urinary and sexual function and bother were also significantly related to treatment. However, among men followed for > or =12 months, only 9% reported a moderate or major problem with urinary control. Sexual functioning was a moderate or major problem following treatment for 58% treated with prostatectomy, 48% treated with radiotherapy, 64% treated with hormonal therapy, 45% treated with cryoablation, and 30% managed with observation. Approximately one-third of the men younger than 70 years who underwent radical prostatectomy maintained adequate sexual functioning posttreatment. CONCLUSIONS: Up to 6 years after diagnosis, the majority of men with prostate carcinoma detected by screening were bothered by their current sexual function, regardless of treatment. In contrast, most men were not bothered by their current urinary function.","Cancer, 88(6): 1454-1463","USA",2000,"Any or unknown","Surgery,Radiotherapy,Surveillance,Hormonal,Various","UCLA-PCI,SF-36","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Disease,Utility"]
[637,"Smith, D. S., et al. (2002). \"Patient preferences for outcomes associated with surgical management of prostate cancer.\" J Urol 167(5): 2117-2122.",null,"Smith, D. S., et al.","Patient preferences for outcomes associated with surgical management of prostate cancer","PURPOSE: We used utility assessment to evaluate patient preferences for current urinary and sexual function after radical prostatectomy. MATERIALS AND METHODS: We measured preferences in 209 community volunteers enrolled in a prostate cancer screening study who underwent radical prostatectomy between 1994 and 1998. We compared preferences in 3 outcome groups, namely men bothered by current urinary and sexual functioning, only bothered by current sexual functioning and not bothered by current sexual or urinary functioning. Preferences were assessed via a computer based interview using time trade-off and standard gamble methods. Current functioning was assessed via a standardized questionnaire. RESULTS: Median time trade-off and standard gamble utilities were high at 0.9 across outcome groups, indicating that men were not willing to give up many remaining life years (10% of remaining life expectancy) with current functioning to achieve ideal functioning. However, mean time trade-off and standard gamble scores significantly decreased as the burden increased in men bothered by current sexual and urinary function (0.77 and 0.82), bothered by current sexual function only (0.87 and 0.89) and not bothered by sexual or urinary function (0.92 and 0.96, respectively). CONCLUSIONS: Health related quality of life was generally good in this observational study of patients treated for prostate cancer with radical prostatectomy. In addition, those bothered by urinary and/or sexual function would not be willing to trade much of the remaining life span to achieve perfect functioning. However, the perception of side effects was bothersome enough in some men to warrant appropriate patient counseling regarding the potential risks and benefits.","J Urol, 167(5): 2117-2122","USA",2002,"Any or unknown","Surgery","TTO,SG","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Utility"]
[638,"Smith, R. P., et al. (2003). \"Internet use by patients with prostate cancer undergoing radiotherapy.\" Urology 62(2): 273-277.",null,"Smith, R. P., et al.","Internet use by patients with prostate cancer undergoing radiotherapy","OBJECTIVES: To analyze the amount of Internet use, type of Internet use, and factors that predict Internet use by patients with prostate cancer. METHODS: A questionnaire evaluating the use of the Internet was given to 295 patients undergoing radiotherapy for prostate cancer in three different settings: an academic center (AC), a Veterans Affairs center (VA), and a community hospital. The study included 171 AC patients (58%), 104 VA patients (35%), and 20 community hospital patients (7%). RESULTS: The response rate to the questionnaire was greater than 99%. Overall, 128 (43%) of 295 patients had a home computer. This differed among the institutions, with 64% of AC patients and only 5% of VA patients having a home computer (P <0.0001). Overall, 94 (32%) of 295 patients used the Internet to access cancer information, with 48% of AC patients and 8% of VA patients using the Internet (P <0.0001). Seventeen percent of black patients (n = 113) had a home computer compared with 62% of white patients (n = 175; P <0.0001). Equal access to computers did not influence Internet use because, among those patients who had access to computers, black patients used the Internet less than did white patients (32% versus 61%, P <0.0001). Men 65 years of age or younger were more likely to use the Internet (45%) than those older than 65 years (28%; P = 0.004). Patients used many sites to access different types of information. CONCLUSIONS: A significant number of patients with prostate cancer access the Internet to obtain cancer information. Urologists and radiation oncologists should be familiar with this important resource to help patients access appropriate material.","Urology, 62(2): 273-277","USA",2003,"Any or unknown","Radiotherapy","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Knowledge"]
[639,"Sneeuw, K. C., et al. (2001). \"Comparison of patient and spouse assessments of health related quality of life in men with metastatic prostate cancer.\" J Urol 165(2): 478-482.",null,"Sneeuw, K. C., et al.","Comparison of patient and spouse assessments of health related quality of life in men with metastatic prostate cancer","PURPOSE: We examined the extent of agreement in health related quality of life ratings provided by patients with metastatic prostate cancer and their spouses. This agreement is important for determining the feasibility of using spouses as potential proxy raters in quality of life studies in this patient population. MATERIALS AND METHODS: The study sample consisted of 72 pairs of patients with metastatic prostate cancer in remission or progression and their spouses. Patients and spouses independently completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 and a prostate cancer specific questionnaire module. Together the 2 questionnaires assess a wide range of symptoms and functional limitations for a total of 21 quality of life outcomes. RESULTS: For 5 of the 21 patient-proxy comparisons we noted systematic differences in the mean score with spouses rating more impairment in patients than patients indicated. Most patient-proxy correlations were 0.40 to 0.75, indicating moderate to good agreement in patient and spouse ratings. A low patient-proxy correlation of less than 0.40 was noted only for the 2 measures of sexual function. CONCLUSIONS: Our findings suggest that the spouses of men with metastatic prostate cancer evaluate with a fair degree of accuracy how patients experience physical and psychosocial functioning, symptoms and overall quality of life. However, caution should be exercised when relying on proxy raters for assessing sexual functioning and satisfaction.","J Urol, 165(2): 478-482","Netherlands",2001,"Metastatic","None","EORTC QLQ-C30,EORTC QLQ-PR25","Patient,Caregiver",null,"Validation",null,null,null,null,null,null,null,null,"Disease,General"]
[640,"So, W. K., et al. (2013). \"Comparison of health-related quality of life and emotional distress among Chinese cancer survivors.\" Int J Nurs Pract 19(3): 306-317.",null,"So, W. K., et al.","Comparison of health-related quality of life and emotional distress among Chinese cancer survivors","The purpose of this study is to compare health-related quality of life (HRQoL) and emotional distress among diverse cancer survivors who had completed all treatment within the previous year. A convenience sample of 353 cancers survivors (lung, head and neck, breast and prostate cancers) were recruited to complete a survey, which consisted of (i) Hospital Anxiety and Depression Scales; (ii) Chinese version of the Functional Assessment of Cancer Therapy-General version; and (iii) demographic and clinical data. The HRQoL scores were similar among the four types of survivors. Mild anxiety and depression levels were reported, but no significant difference was noted. Younger females with financial burdens and uncertain prognosis were particularly associated with HRQoL and emotional distress. Further studies are essential to identify specific problems that cancer patients experience after cancer diagnosis that might lead to the early detection of those most at risk of ongoing problems.","Int J Nurs Pract, 19(3): 306-317","China",2013,"Survivors","None","HADS,FACT-G","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Comorbidity,Treatment"]
[641,"Soderdahl, D. W., et al. (2005). \"Prospective longitudinal comparative study of health-related quality of life in patients undergoing invasive treatments for localized prostate cancer.\" J Endourol 19(3): 318-326.",null,"Soderdahl, D. W., et al.","Prospective longitudinal comparative study of health-related quality of life in patients undergoing invasive treatments for localized prostate cancer","BACKGROUND AND PURPOSE: Health-related quality of life (QoL) concerns are important for patients selecting treatment options for clinically localized prostate cancer and are critical in evaluating outcomes. We report pretreatment and post-treatment general and disease-specific QoL for the following invasive interventions: open radical prostatectomy (ORP), laparoscopic radical prostatectomy (LRP), and palladium-103 ((103)Pd) brachytherapy. PATIENTS AND METHODS: We performed a prospective longitudinal survey of 452 patients with newly diagnosed prostate cancer treated at a single medical center between 2001 and 2003. An Institutional Review Board-approved questionnaire comprised of validated QoL instruments was sent to patients scheduled to undergo ORP (N = 186), LRP (N = 116), or brachytherapy (N = 150). The same questionnaire was sent out 1, 3, 6, 9, and 12 months after therapy. Comparisons were made between the groups to determine if the choice of therapy resulted in differences in QoL. RESULTS: General QoL scores were minimally affected by the choices; however, the disease-specific domains of bowel, urinary, and sexual function were adversely affected by all modalities. The ORP and LRP groups were similar among disease-specific domains and received lower post-treatment urinary and sexual scores than the (103)Pd patients. At 12 months, 38% of ORP and 46% of LRP patients had returned to baseline urinary function compared with 75% of (103)Pd patients. At 12 months, 63% of (103)Pd patients had returned to baseline sexual function compared with 19% of both the LRP and ORP patients. CONCLUSIONS: Invasive treatments for localized prostate cancer have little impact on general QoL but significantly affect disease-specific domains. Both ORP and LRP have a greater initial negative impact on urinary and sexual function than (103)Pd. The differences among the treatments with regard to QoL provide information to patients faced with choosing a treatment.","J Endourol, 19(3): 318-326","USA",2005,"Local","Surgery,Brachytherapy","Unclear","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"General"]
[642,"Solberg, A., et al. (2011). \"Side-effects of post-treatment biopsies in prostate cancer patients treated with endocrine therapy alone or combined with radical radiotherapy in the Scandinavian Prostate Cancer Group-7 randomized trial.\" Scand J Urol Nephrol 45(4): 233-238.",null,"Solberg, A., et al.","Side-effects of post-treatment biopsies in prostate cancer patients treated with endocrine therapy alone or combined with radical radiotherapy in the Scandinavian Prostate Cancer Group-7 randomized trial","OBJECTIVE: Post-treatment prostate biopsy side-effects were evaluated in patients with locally advanced prostate cancer on endocrine therapy alone or combined with radiotherapy in the Scandinavian Prostate Cancer Group-7 randomized trial. MATERIAL AND METHODS: One-hundred and twenty patients underwent transrectalultrasound-guided biopsy, and were requested to complete a questionnaire on side-effects occurring within 7 days' follow-up. RESULTS: The questionnaire was returned by 109 patients (91%) (endocrine therapy only 52%, combined endocrine therapy and radiotherapy 48%). Previous therapy had no significant influence on pain, urinary flow, haematuria or haematospermia. Pain at biopsy was reported in 63% (mild, 57%; moderate, 5.6%; severe, one patient) and pain at follow-up in 31% (mild, 27%; moderate, four patients). Haematuria (mean duration 2.2 days) was reported in 41%, and reduced urinary flow in 20% (mild, 18%; severe: four patients; no patient had urinary retention). Haematospermia was scarce. No patient reported urinary tract infection. Rectal bleeding occurred in 18% in the endocrine and 35% in the combined therapy group (p = 0.047), with a mean duration of 1.6 and 2.2 days, respectively (p = 0.031). In logistic regression analysis, a trend towards increased rectal bleeding was found in patients on combined endocrine therapy and radiotherapy (odds ratio 2.4, p = 0.050). CONCLUSION: Patient-reported post-treatment prostate biopsy side-effects were mild and self-limiting.","Scand J Urol Nephrol, 45(4): 233-238","Norway",2011,"Advanced","Radiotherapy,Hormonal","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Treatment"]
[643,"Sommers, S. D. and S. D. Ramsey (1999). \"A review of quality-of-life evaluations in prostate cancer.\" Pharmacoeconomics 16(2): 127-140.",null,"Sommers, S. D. and S. D. Ramsey","A review of quality-of-life evaluations in prostate cancer","Prostate cancer is a highly prevalent malignancy in older men. Because the disease and its treatments have the potential to cause substantial morbidity in affected individuals, prostate cancer has been the subject of great interest for quality-of-life (QOL) researchers. In this article, we review published QOL studies that have focused on individuals with prostate cancer. Generic survey instruments have generally been found to be insensitive to changes in health-related quality of life (HR-QOL) related to prostate cancer and its treatments. Domain-specific survey instruments (such as those focusing on sexual function) have been more sensitive, but fail to capture all relevant impacts. At least 9 disease-specific instruments have been developed to measure the HR-QOL impact of prostate cancer. These instruments generally focus on specific symptoms related to the disease and its treatment--urinary function, bowel function, sexual function, physical function, psychological function and pain--however, the domains covered are not consistent from instrument to instrument, and the domains of emphasis within each instrument are rarely the same. In addition, no single instrument has been applied to all major therapies for prostate cancer across men at different ages and stages of disease. Finally, HR-QOL evaluations in some patient groups, such as those with advanced disease, have received relatively little attention to date. As a result of the proliferation of prostate cancer-specific survey instruments and inconsistencies in their design and application, decision-makers face great difficulties evaluating HR-QOL across disease stages and comparing the HR-QOL impacts of alternative therapies, including conservative management ('watchful waiting'). In order for these tools to be useful for patient management and policy-making, coordination of instrument development efforts with the goal of consolidating the number of measures used is urgently needed.","Pharmacoeconomics, 16(2): 127-140","USA",1999,"Any or unknown","None","Unclear","Patient",null,"Narrative review",null,null,null,null,null,null,null,null,"Unclear"]
[644,"Sonn, G. A., et al. (2013). \"Differing perceptions of quality of life in patients with prostate cancer and their doctors.\" J Urol 189(1 Suppl): S59-65; discussion S65.",null,"Sonn, G. A., et al.","Differing perceptions of quality of life in patients with prostate cancer and their doctors","PURPOSE: As the number of prostate cancer survivors increases, urologists must recognize their quality of life impairment. In the past physician ratings of patient symptoms did not correlate with patient self-assessments. We determined if urologists have improved their reporting of patient health related quality of life. We also investigated if urologists assessed health related quality of life more accurately in the short or long term. MATERIALS AND METHODS: We identified 1,366 men from CaPSURE, a national, prospective cohort, who had undergone prostatectomy, brachytherapy or external beam radiation therapy. At each visit urologists assessed fatigue, pain, and sexual, urinary and bowel dysfunction. Participants independently completed the SF-36 and the UCLA-PCI. We contrasted the frequency of impairment reported by physicians and participants in select health related quality of life domains in the short (less than 1 year) and long (greater than 2 years) term. We also compared physician-patient concordance between the periods 1995 to 2000 and 2001 to 2007. RESULTS: In short-term and long-term followup, and for the 1995 to 2000 and 2001 to 2007 cohorts, physician and participant assessments differed in all analyzed domains. Urologists noted impairment in urinary and sexual function more often than fatigue or pain. Disagreement between physician and participant ratings did not vary dramatically from short-term to long-term followup, or from the earlier to the later cohort. CONCLUSIONS: In men treated for localized prostate cancer physician ratings of symptoms do not correlate well with patient self-assessments of health related quality of life. Physician reporting did not improve over time. It is increasingly important to recognize and address impairments in quality of life from prostate cancer and its treatment.","J Urol, 189(1 Suppl): S59-65; discussion S65","USA",2013,"Any or unknown","Surgery,Radiotherapy,Brachytherapy","SF-36,UCLA-PCI","HCP,Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease,Utility"]
[645,"Souchek, J., et al. (2000). \"A trial for comparing methods for eliciting treatment preferences from men with advanced prostate cancer: results from the initial visit.\" Med Care 38(10): 1040-1050.",null,"Souchek, J., et al.","A trial for comparing methods for eliciting treatment preferences from men with advanced prostate cancer: results from the initial visit","OBJECTIVE: The objective of this study was to evaluate the convergent validity of 3 types of utility measures: standard gamble, time tradeoff, and rating scale. RESEARCH DESIGN: A prospective cohort of 120 men with advanced prostate cancer were first asked to rank order 8 health states, and then utility values were obtained from each participant for each of the 8 health states through 2 of the 3 techniques evaluated (standard gamble, time tradeoff and rating scale). Participants were randomly assigned to 1 of 3 possible pairs of techniques. The validity of the 3 methods, as measured by the convergence and raw score differences of the techniques, was assessed with ANOVA. The ability of the techniques to differentiate health states was determined. The inconsistencies between rankings and utility values were also measured. Proportions of illogical utility responses were assessed as the percent of times when states with more symptoms were given higher or equal utility values than states with fewer symptoms. RESULTS: There were significant differences in raw scores between techniques, but the values were correlated across health states. Utility values were often inconsistent with the rank order of health states. In addition, utility assessment did not differentiate the health states as well as the rank order. Furthermore, utility values were often illogical in that states with more symptoms received equal or higher utility values than states with fewer symptoms. CONCLUSIONS: Use of the utility techniques in cost-effectiveness analysis and decision making has been widely recommended. The results of this study raise serious questions as to the validity and usefulness of the measures.","Med Care, 38(10): 1040-1050","USA",2000,"Advanced","None","SG,TTO,RatingS","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Utility"]
[646,"Soumarova, R., et al. (2006). \"Acute toxicity of conformal high dose interstitial brachytherapy boost in prostate cancer.\" Neoplasma 53(5): 410-417.",null,"Soumarova, R., et al.","Acute toxicity of conformal high dose interstitial brachytherapy boost in prostate cancer","Over the past few years, brachytherapy has become more and more common in the treatment of prostate cancer, largely thanks to the reduced amount of acute and chronic side effects. At the same time, brachytherapy also allows dose escalation, resulting in significant improvements in the treatment results. From August 2004 to June 2005, we irradiated 40 patients suffering from T1c-T3a prostate cancer. All of the patients underwent external beam radiotherapy with a median dose of 45-50.4 Gy and a conformal high dose interstitial brachytherapy boost (two fractions, 8 Gy per fraction). The patients were divided into three groups: low risk of recurrence (11 patients - 27.5%), intermediate risk (14 patients - 35%) and high risk (15 patients - 37.5%). The medium age of the patients was 68.7 years (between 55 and 77). Hormonal treatment was carried out 17 patients (42.5%). We evaluated the quality of each implantation, including the maximum urethral and rectal dose. The calculated doses were compared with measurements by in vivo dosimetry. Acute toxicity was evaluated in all of the patients according to the Radiation Therapy Oncology Group (RTOG) scale. Each of the patients completed an International Prostatic Symptom Score (IPSS) questionnaire. Acute genitourinary morbidity grade 1 was recorded in 37.5% of patients; grade 2 in 15% of patients. Urine retention in one of the patients resulted in the need to perform an epicystostomy. According to the IPSS score, the majority of patients (90%) experienced an improvement in symptoms related to quality of life. Grade 1 acute gastrointestinal toxicity was recorded in 40% of the patients. Grades 2-4 were not recorded. Here, we show that the combination of external beam radiotherapy and high dose rate (HDR) brachytherapy in the treatment of early prostate cancer to be feasible and well tolerated. Acute toxicity was low and scarcely influenced the quality of life. Among the risk factors of genitourinary toxicity was the volume of the prostate. For gastrointestinal toxicity, risk factors included the combination of HDR brachytherapy and external beam radiotherapy to the pelvis, as well as hormonal treatment.","Neoplasma, 53(5): 410-417","Czech Republic",2006,"Local,Advanced","Radiotherapy,Brachytherapy","IPSS,RTOG-EORTC-SS","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,Treatment"]
[647,"Staff, I., et al. (2003). \"Disease-specific symptoms and general quality of life of patients with prostate carcinoma before and after primary three-dimensional conformal radiotherapy.\" Cancer 98(11): 2335-2343.",null,"Staff, I., et al.","Disease-specific symptoms and general quality of life of patients with prostate carcinoma before and after primary three-dimensional conformal radiotherapy","BACKGROUND: Approximately 189,000 men are diagnosed with prostate carcinoma each year and more than 1 million are living with the disease. Good prognoses and undesirable sequelae accompany each of several available primary and adjuvant treatment options. The current study explored the effects of primary three-dimensional conformal radiotherapy with or without neoadjuvant hormonal therapy on urinary, bowel, and sexual symptoms and health-related quality of life (HRQOL). METHODS: A prospective, repeated-measures design study included 100 patients. Data from the Medical Outcomes Study Short Form Health Survey (a measure of general HRQOL) and a 12-item symptom questionnaire were collected before the start of radiotherapy, approximately 1-3 months after completion of treatment, and again approximately 5-10 months after completion of treatment for follow-up. RESULTS: Patients reported few urinary symptoms after treatment. Bowel frequency and urgency were reported more frequently posttreatment and at follow-up. Erectile difficulties, which were common pretreatment, were reported with increased frequency posttreatment and at follow-up. General HRQOL scores were higher than age-related general population norms for men at all three data collection times, but there were significant losses posttreatment for patients' physical functioning and vitality. At the 5-10-month follow-up, physical functioning remained lower but vitality scores regained some of the losses. A more extended follow-up is needed. Neoadjuvant therapy, which was received before the pretreatment data collection, had a deleterious effect on erectile functioning but no interactive effects with the radiotherapy on symptoms or HRQOL. CONCLUSIONS: Although patients with a diagnosis of prostate carcinoma experienced increased bowel and sexual dysfunction and decreased vitality after radiotherapy, their HRQOL scores remained at or above age-related general population norms.","Cancer, 98(11): 2335-2343","USA",2003,"Any or unknown","Radiotherapy,Hormonal","SF-36","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Utility,Symptom"]
[648,"Stafford, R. S. and P. L. Cyr (1997). \"The impact of cancer on the physical function of the elderly and their utilization of health care.\" Cancer 80(10): 1973-1980.",null,"Stafford, R. S. and P. L. Cyr","The impact of cancer on the physical function of the elderly and their utilization of health care","BACKGROUND: Controversy about whether cancer has an independent impact on patient quality of life led the authors to evaluate the effects of cancer on a range of quality-of-life and health care utilization measures within an elderly population. METHODS: The authors analyzed a nationally representative sample of 9745 elderly community-based Medicare beneficiaries sampled in the 1991 Medicare Current Beneficiary Survey. Of these, 1647 reported being diagnosed by a physician as having a malignancy that was not of the skin. Multiple logistic regression was used to identify the independent predictors of functional limitation, poor health status, health care utilization, and patient satisfaction with medical care. RESULTS: Cancer was reported by 17% of the elderly. Individuals with cancer reported poorer health, more limitations of the activities of daily living (ADLs) and the instrumental activities of daily living (IADLs), and greater health care utilization than individuals without cancer. For individuals with cancer, difficulty walking (38%) and getting out of a chair (21%) were the most commonly reported ADL limitations, whereas difficulty completing heavy housework (34%) and shopping (17%) were the most common IADL limitations. Carcinomas of the lung, prostate, and colon independently predicted poorer health status. Lung carcinoma was independently associated with more ADL limitations. Lung, bladder, and prostate carcinomas predicted increased health care utilization. Overall, cancer patients were at least as satisfied with their medical care as those without cancer. CONCLUSIONS: Cancer increased the use of health care resources and modestly reduced physical function. By identifying specific connections between cancer and physical function, these findings have implications for improving cancer care.","Cancer, 80(10): 1973-1980","USA",1997,"Any or unknown","None","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Satisfaction,General"]
[649,"Stanciu, M. A., et al. (2015). \"A pilot randomised controlled trial of personalised care after treatment for prostate cancer (TOPCAT-P): nurse-led holistic-needs assessment and individualised psychoeducational intervention: study protocol.\" BMJ Open 5(6): e008470.",null,"Stanciu, M. A., et al.","A pilot randomised controlled trial of personalised care after treatment for prostate cancer (TOPCAT-P): nurse-led holistic-needs assessment and individualised psychoeducational intervention: study protocol","INTRODUCTION: Prostate cancer is common and the incidence is increasing, but more men are living longer after diagnosis, and die with their disease rather than of it. Nonetheless, specific and substantial physical, sexual, emotional and mental health problems often lead to a poor quality of life. Urology services increasingly struggle to cope with the demands of follow-up care, and primary care is likely to play the central role in long-term follow-up. The present phase II trial will evaluate the feasibility and acceptability of a nurse-led, person-centred psychoeducational intervention, delivered in community or primary care settings. METHODS AND ANALYSIS: Prostate cancer survivors diagnosed in the past 9-48 months and currently biochemically stable will be identified from hospital records by their treating clinician. Eligible men would have either completed radical treatment, or would be followed up with prostate specific antigen monitoring and symptom reporting. We will recruit 120 patients who will be randomised to receive either an augmented form of usual care, or an additional nurse-led intervention for a period of 36 weeks. Following the health policy in Wales, the intervention is offered by a key worker, is promoting prudent healthcare and is using a holistic needs assessment. Outcome measures will assess physical symptoms, psychological well-being, confidence in managing own health and quality of life. Healthcare service use will be measured over 36 weeks. Feedback interviews with patients and clinicians will further inform the acceptability of the intervention. Recruitment, attrition, questionnaire completion rates and outcome measures variability will be assessed, and results will inform the design of a future phase III trial and accompanying economic evaluation. ETHICS AND DISSEMINATION: Ethics approval was granted by Bangor University and North Wales REC (13/WA/0291). Results will be reported in peer-reviewed publications, at scientific conferences, and directly through national cancer and primary care networks. TRIAL REGISTRATION NUMBER: ISRCTN 34516019.","BMJ Open, 5(6): e008470","UK",2015,"Survivors","Various,Psychological","Unclear","Patient",null,"Protocol",null,null,null,null,null,null,null,null,"General,Symptom"]
[650,"Steenland, E., et al. (1999). \"The effect of a single fraction compared to multiple fractions on painful bone metastases: a global analysis of the Dutch Bone Metastasis Study.\" Radiother Oncol 52(2): 101-109.",null,"Steenland, E., et al.","The effect of a single fraction compared to multiple fractions on painful bone metastases: a global analysis of the Dutch Bone Metastasis Study","PURPOSE: To answer the question whether a single fraction of radiotherapy that is considered more convenient to the patient is as effective as a dose of multiple fractions for palliation of painful bone metastases. PATIENTS: 1171 patients were randomised to receive either 8 Gy x 1 (n = 585) or 4 Gy x 6 (n = 586). The primary tumour was in the breast in 39% of the patients, in the prostate in 23%, in the lung in 25% and in other locations in 13%. Bone metastases were located in the spine (30%), pelvis (36%), femur (10%), ribs (8%), humerus (6%) and other sites (10%). METHOD: Questionnaires were mailed to collect information on pain, analgesics consumption, quality of life and side effects during treatment. The main endpoint was pain measured on a pain scale from 0 (no pain at all) to 10 (worst imaginable pain). Costs per treatment schedule were estimated. RESULTS: On average, patients participated in the study for 4 months. Median survival was 7 months. Response was defined as a decrease of at least two points as compared to the initial pain score. The difference in response between the two treatment groups proved not significant and stayed well within the margin of 10%. Overall, 71% experienced a response at some time during the first year. An analysis of repeated measures confirmed that the two treatment schedules were equivalent in terms of palliation. With regard to pain medication, quality of life and side effects no differences between the two treatment groups were found. The total number of retreatments was 188 (16%). This number was 147 (25%) in the 8 Gy x 1 irradiation group and 41 (7%) in the 4 Gy x 6 group. It was shown that the level of pain was an important reason to retreat. There were also indications that doctors were more willing to retreat patients in the single fraction group because time to retreatment was substantially shorter in this group and the preceding pain score was lower. Unexpectedly, more pathological fractures were observed in the single fraction group, but the absolute percentage was low. In a cost-analysis, the costs of the 4 Gy x 6 and the 8 Gy x 1 treatment schedules were calculated at 2305 and 1734 Euro respectively. Including the costs of retreatment reduced this 25% cost difference to only 8%. The saving of radiotherapy capacity, however, was considered the major economic advantage of the single dose schedule. CONCLUSION: The global analysis of the Dutch study indicates the equality of a single fraction as compared to a 6 fraction treatment in patients with painful bone metastases provided that 4 times more retreatments are accepted in the single dose group. This equality is also shown in long term survivors. A more detailed analysis of the study is in progress.","Radiother Oncol, 52(2): 101-109","Netherlands",1999,"Metastatic","Radiotherapy","NPS","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Symptom"]
[651,"Steineck, G., et al. (2002). \"Quality of life after radical prostatectomy or watchful waiting.\" N Engl J Med 347(11): 790-796.",null,"Steineck, G., et al.","Quality of life after radical prostatectomy or watchful waiting","BACKGROUND: We evaluated symptoms and self-assessments of quality of life in men with localized prostate cancer who participated in a randomized comparison between radical prostatectomy and watchful waiting. METHODS: Between 1989 and 1999, a group of Swedish urologists randomly assigned men with localized prostate cancer to radical prostatectomy or watchful waiting. In this follow-up study, we obtained information from 326 of 376 eligible men (87 percent) concerning certain symptoms, symptom-induced distress, well-being, and the subjective assessment of quality of life by means of a mailed questionnaire. RESULTS: Erectile dysfunction (80 percent vs. 45 percent) and urinary leakage (49 percent vs. 21 percent) were more common after radical prostatectomy, whereas urinary obstruction (e.g., 28 percent vs. 44 percent for weak urinary stream) was less common. Bowel function, the prevalence of anxiety, the prevalence of depression, well-being, and the subjective quality of life were similar in the two groups. CONCLUSIONS: The assignment of patients to watchful waiting or radical prostatectomy entails different risks of erectile dysfunction, urinary leakage, and urinary obstruction, but on average, the choice has little if any influence on well-being or the subjective quality of life after a mean follow-up of four years.","N Engl J Med, 347(11): 790-796","Sweden",2002,"Local","Surgery,Surveillance","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General,Symptom"]
[652,"Stephens, R. J., et al. (2007). \"The quality of life of men with locally advanced prostate cancer during neoadjuvant hormone therapy: data from the Medical Research Council RT01 trial (ISRCTN 47772397).\" BJU Int 99(2): 301-310.",null,"Stephens, R. J., et al.","The quality of life of men with locally advanced prostate cancer during neoadjuvant hormone therapy: data from the Medical Research Council RT01 trial (ISRCTN 47772397)","OBJECTIVE: To explore patients' quality of life (QoL) during neoadjuvant hormone therapy (HT) using data from the Medical Research Council RT01 trial of standard- (64 Gy/32-fraction) and high- (74 Gy/37-fraction) dose radiotherapy (RT, both given conformally). PATIENTS AND METHODS: Of the 843 patients randomized to the RT01 trial, 316 completed the Functional Assessment Of Cancer Therapy core questionnaire with its additional prostate subscale, and the Short Form-36 Health Survey questionnaire with the University of California-Los Angeles Prostate Cancer Index before HT and again before starting RT. Three predefined QoL hypotheses were generated to focus the analyses. RESULTS: For the three primary QoL analyses there was evidence that sexual functioning deteriorated, urinary function did not change, and there was a slight decline in physical well-being after > or = 3 months of HT. Sensitivity analyses confirmed these findings. Exploratory analyses also suggested that role functioning deteriorated, sleep was more disturbed, and there was an increase in fatigue. However, overall QoL was not reported to be affected and patients indicated an improvement in attitude and satisfaction with treatment. CONCLUSIONS: In this group of men, many of whom reported reduced sexual functioning before treatment, the additional decline during HT seemed to be generally accepted as the price to pay for an appropriate cancer treatment. Nevertheless, these changes need to be discussed with patients before HT is commenced.","BJU Int, 99(2): 301-310","UK",2007,"Advanced","Hormonal,Radiotherapy","SF-36,UCLA-PCI,FACT-G,FACT-P","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,Treatment,Utility"]
[653,"Stewart, S. T., et al. (2005). \"Utilities for prostate cancer health states in men aged 60 and older.\" Med Care 43(4): 347-355.",null,"Stewart, S. T., et al.","Utilities for prostate cancer health states in men aged 60 and older","PURPOSE: We sought to measure utilities for prostate cancer health states in older men. METHODS: A total of 162 men aged 60 years or older (52% of whom had been diagnosed with prostate cancer) provided standard gamble utilities for 19 health states associated with prostate cancer or its treatment using an interactive, computer-based utility assessment program. Demographics and experience with specific health states were examined as predictors of ratings using ordinary least squares regression analysis. RESULTS: Mean utilities ranged from 0.67 to 0.84 for living with symptom-free cancer under conservative management (\"watchful waiting\") and from 0.71 to 0.89 for symptoms occurring with treatment (prostatectomy, radiation, and hormone ablation). For long-term treatment complications, bowel problems (0.71) were rated as significantly worse than impotence (0.89), urinary difficulty (0.88), or urinary incontinence (0.83). Combinations of these conditions were rated as significantly worse than individual component states. Men who had experienced impotence or urinary incontinence rated these states as slightly better than men who had not experienced the specific problems. CONCLUSIONS: Both \"watchful waiting\" and treatment complications from prostate cancer treatments can have large impacts on quality of life. Mean ratings are important for use in policy-making and cost-effectiveness analyses. Variation in ratings across patients suggests that mean scores do not reflect individual preferences and that shared decision-making may be best for clinical decisions.","Med Care, 43(4): 347-355","USA",2005,"Any or unknown","Hormonal,Radiotherapy,Surgery","SG","Patient,General population",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Utility"]
[654,"Stier, D. M., et al. (1999). \"Quantifying comorbidity in a disease-specific cohort: adaptation of the total illness burden index to prostate cancer.\" Urology 54(3): 424-429.",null,"Stier, D. M., et al.","Quantifying comorbidity in a disease-specific cohort: adaptation of the total illness burden index to prostate cancer","OBJECTIVES: Numerous studies have demonstrated the importance of comorbid illness when analyzing medical outcomes. The purpose of this study was to adapt a generic comorbidity index, the Total Illness Burden Index (TIBI), for use in men with prostate cancer, and to evaluate the usefulness of the new instrument in adjusting for the impact of comorbidity on functional outcomes in a prostate cancer cohort. METHODS: The TIBI uses patients' self-report of symptoms and diagnoses to determine not only the presence but also the severity of comorbidities in each of 16 body system domains. To create the TIBI-P (prostate cancer modification), some domains were added and others were modified according to clinical criteria. The TIBI-P was completed by 1638 men with prostate cancer followed up longitudinally in 29 urology practices in the United States. TIBI-P scores were calculated for each patient and analyzed with scores on the SF-36 quality-of-life questionnaire and with patient report of days confined to bed. RESULTS: After adjusting for age and income, lower SF-36 scale scores and increases in confinement to bed were associated with a greater burden of comorbid illness as measured by the TIBI-P, independent of the extent of prostate cancer. The TIBI-P explained 24% of the variance in the SF-36 physical functioning domain score. CONCLUSIONS: The TIBI-P is a powerful measure of the impact of comorbid illness on the quality of life and functioning among patients with prostate cancer. This index may prove valuable in research on clinical and economic outcomes of prostate cancer.","Urology, 54(3): 424-429","USA",1999,"Any or unknown","None","SF-36,TIBI-P","Patient",null,"Mapping to utility,Validation",null,null,null,null,null,null,null,null,"Comorbidity,Utility"]
[655,"Stockler, M. R., et al. (1998). \"Responsiveness to change in health-related quality of life in a randomized clinical trial: a comparison of the Prostate Cancer Specific Quality of Life Instrument (PROSQOLI) with analogous scales from the EORTC QLQ-C30 and a trial specific module. European Organization for Research and Treatment of Cancer.\" J Clin Epidemiol 51(2): 137-145.",null,"Stockler, M. R., et al.","Responsiveness to change in health-related quality of life in a randomized clinical trial: a comparison of the Prostate Cancer Specific Quality of Life Instrument (PROSQOLI) with analogous scales from the EORTC QLQ-C30 and a trial specific module. European Organization for Research and Treatment of Cancer","INTRODUCTION: The Prostate Cancer Specific Quality of Life Instrument (PROSQOLI) was developed to be a pragmatic outcome measure for clinical trials in symptomatic men with advanced hormone-resistant prostate cancer. DESIGN AND SETTING: A comparative assessment of responsiveness was made with longitudinal data from a positive multicenter randomized trial of palliative chemotherapy in 161 symptomatic men with advanced hormone-resistant prostate cancer. INSTRUMENTS: The PROSQOLI, the European Organisation for Research and Treatment of Cancer (EORTC) core quality of life questionnaire (QLQ-C30), and a specific quality of life module for advanced prostate cancer [QLM-P14] were administered every 3 weeks while patients received their allocated treatment. FINDINGS: Sixteen of the 19 health-related quality of life (HRQL) scales demonstrated improvements in palliative responders. All three pain scales detected a beneficial effect of palliative chemotherapy. The relative efficiency statistics favored the PROSQOLI for physical symptoms and physical function but the QLQ-C30 for emotional function, social function, and global perceptions. The PROSQOLI linear analog scale was the most responsive measure of pain. Bootstrap confidence intervals for the relative efficiency statistics were wide. CONCLUSIONS: Both the PROSQOLI and the analogous scales from the QLQ-C30 were responsive to improvements in HRQL. Differences between the instruments were generally subtle. The PROSQOLI is a short, simple, responsive measure of HRQL in men receiving systemic treatment for advanced hormone-resistant prostate cancer.","J Clin Epidemiol, 51(2): 137-145","Canada",1998,"Advanced","Chemotherapy,Palliative care","EORTC QLQ-C30,PROSQoLI,QOLM-P14","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease,General"]
[656,"Stockler, M. R., et al. (1999). \"Convergent discriminitive, and predictive validity of the Prostate Cancer Specific Quality of Life Instrument (PROSQOLI) assessment and comparison with analogous scales from the EORTC QLQ-C30 and a trial-specific module. European Organisation for Research and Treatment of Cancer. Core Quality of Life Questionnaire.\" J Clin Epidemiol 52(7): 653-666.",null,"Stockler, M. R., et al.","Convergent discriminitive, and predictive validity of the Prostate Cancer Specific Quality of Life Instrument (PROSQOLI) assessment and comparison with analogous scales from the EORTC QLQ-C30 and a trial-specific module. European Organisation for Research and Treatment of Cancer. Core Quality of Life Questionnaire","The Prostate Cancer Specific Quality of Life Instrument (PROSQOLI) is a measure of health-related quality of life (HRQL) that was designed to be an outcome measure for clinical trials in advanced hormone-resistant prostate cancer. The cross-sectional validity of the PROSQOLI was assessed using baseline data from a randomized trial in which HRQL was also assessed with the European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) and a trial-specific quality of life module (QLM-P14). Convergent validity was assessed with the multitrait-multimethod matrix approach; discriminative validity was assessed according to conventional clinical criteria; and predictive validity was assessed by the ability to predict survival duration. These assessments provided strong support for the validity of all PROSQOLI scales except those for family/marriage relationships and passing urine; modifications of these two scales are under evaluation. The strength, consistency, and independence of the prognostic information provided by the HRQL scales were striking. Differences between the instruments were generally subtle. These data support validity of the PROSQOLI and the analogous scales from the QLQ-C30 and QLM-P14 in symptomatic men with advanced hormone resistant prostate cancer. The PROSQOLI is a short, simple, and valid measure of HRQL in this setting.","J Clin Epidemiol, 52(7): 653-666","Canada",1999,"Advanced","Unclear","EORTC QLQ-C30,QOLM-P14,PROSQoLI","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease,General"]
[657,"Stone, P., et al. (2001). \"Fatigue in patients with cancers of the breast or prostate undergoing radical radiotherapy.\" J Pain Symptom Manage 22(6): 1007-1015.",null,"Stone, P., et al.","Fatigue in patients with cancers of the breast or prostate undergoing radical radiotherapy","To determine the prevalence, severity, and correlates of fatigue among patients with cancers of the prostate or breast receiving high dose radiotherapy with curative intent, a prospective, questionnaire-based study evaluated a convenience sample of 62 patients who were about to start a course of radiotherapy. Patients were assessed immediately prior to treatment, and again within a week of finishing. Fatigue was assessed using the Fatigue Severity Scale (FSS) and the Bidimensional Fatigue Scale (BFS). Quality of life was assessed using the European Organisation for Research and Treatment of Cancer 30-item Quality of Life Questionnaire (EORTC QLQc30). Psychological distress was assessed using the Hospital Anxiety and Depression Scale (HADS). Personality Traits were assessed using the Eysenck Personality Inventory (EPI). Fatigue severity increased significantly on 3 out of the 5 assessment instruments used. Radiotherapy was associated with a decline in global quality of life, role, cognitive and social functioning, and an increase in nausea/vomiting, pain, insomnia, diarrhea, and financial difficulty. At baseline, 39% of the variation in fatigue scores among the patients could be explained by a combination of measures of their global quality of life and physical functioning. A combination of fatigue and anxiety scores at baseline was able to predict 54% of the variation in fatigue scores at the completion of radiotherapy. These data indicate that fatigue is a significant problem for patients receiving radical radiotherapy, although its severity is relatively modest.","J Pain Symptom Manage, 22(6): 1007-1015","UK",2001,"Any or unknown","Radiotherapy","EORTC QLQ-C30,HADS,FSS,EPInv,BiFS","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"General,Comorbidity,Symptom"]
[658,"Sullivan, P. W., et al. (2007). \"Quality of life findings from a multicenter, multinational, observational study of patients with metastatic hormone-refractory prostate cancer.\" Qual Life Res 16(4): 571-575.",null,"Sullivan, P. W., et al.","Quality of life findings from a multicenter, multinational, observational study of patients with metastatic hormone-refractory prostate cancer","BACKGROUND: The assessment of health-related quality of life (HRQL) for patients with hormone-refractory prostate cancer (HRPC) is of paramount importance because new treatments have a modest impact on survival but side effects of treatment and disease symptoms can significantly impact HRQL. METHODS: This was an observational, non-interventional, multi-center, multi-national cohort study of patients with metastatic HRPC. Health-related quality of life was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C30), the Functional Assessment of Cancer Therapy-Prostate (FACT-P) and the EQ-5D index. Mean changes from baseline to month 3, 6, and 9 were computed and tested using paired t-tests. RESULTS: FACT-P PCS, EQ-5D index and 10 of 14 EORTC domains were statistically significantly lower (P < 0.05) than the baseline scores at the 3, 6 and 9 month visits. The domains that did not reach statistical significance were cognitive functioning, insomnia, diarrhea and financial difficulties. CONCLUSIONS: These data demonstrate that patients with metastatic HRPC experience rapid, significant deterioration in HRQL, highlighting the need for effective palliative therapy for men with HRPC.","Qual Life Res, 16(4): 571-575","USA",2007,"Metastatic","None","EORTC QLQ-C30,FACT-P,EQ-5D","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"General,Disease,Utility"]
[659,"Sundberg, K., et al. (2015). \"Feasibility of an interactive ICT-platform for early assessment and management of patient-reported symptoms during radiotherapy for prostate cancer.\" Eur J Oncol Nurs 19(5): 523-528.",null,"Sundberg, K., et al.","Feasibility of an interactive ICT-platform for early assessment and management of patient-reported symptoms during radiotherapy for prostate cancer","PURPOSE: The aim of this study was to test the feasibility and acceptability of an Information and Communication Technology platform for assessing and managing patient reported symptoms during radiotherapy for prostate cancer. METHODS: In cooperation with a health management company, using a patient experience co-design, we developed the platform operated by an interactive application for reporting and managing symptoms in real time. Nine patients diagnosed with prostate cancer and receiving radiotherapy were recruited from two university hospitals in Sweden. Evidence-based symptoms and related self-care advice specific to prostate cancer were implemented in the application based on a literature review and interviews with patients and health care professionals. In the test of the platform the patients reported symptoms, via a mobile phone, daily for two weeks and were afterwards interviewed about their experiences. RESULTS: Overall, the patients found the symptom questionnaire and the self-care advice relevant and the application user friendly. The alert system was activated on several occasions when the symptoms were severe leading to a nurse contact and support so the patients felt safe and well cared for. CONCLUSIONS: The platform enabled increased patient involvement and facilitated symptom assessment and communication between the patient and the health care provider. The study's results support further development of the platform, as well as tests in full-scale studies and in other populations.","Eur J Oncol Nurs, 19(5): 523-528","Sweden",2015,"Any or unknown","Radiotherapy","Unclear","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Symptom"]
[660,"Syndikus, I., et al. (2010). \"Late gastrointestinal toxicity after dose-escalated conformal radiotherapy for early prostate cancer: results from the UK Medical Research Council RT01 trial (ISRCTN47772397).\" Int J Radiat Oncol Biol Phys 77(3): 773-783.",null,"Syndikus, I., et al.","Late gastrointestinal toxicity after dose-escalated conformal radiotherapy for early prostate cancer: results from the UK Medical Research Council RT01 trial (ISRCTN47772397)","PURPOSE: In men with localized prostate cancer, dose-escalated conformal radiotherapy (CFRT) improves efficacy outcomes at the cost of increased toxicity. We present a detailed analysis to provide further information about the incidence and prevalence of late gastrointestinal side effects. METHODS AND MATERIALS: The UK Medical Research Council RT01 trial included 843 men with localized prostate cancer, who were treated for 6 months with neoadjuvant radiotherapy and were randomly assigned to either 64-Gy or 74-Gy CFRT. Toxicity was evaluated before CFRT and during long-term follow-up using Radiation Therapy Oncology Group (RTOG) grading, the Late Effects on Normal Tissue: Subjective, Objective, Management (LENT/SOM) scale, and Royal Marsden Hospital assessment scores. Patients regularly completed Functional Assessment of Cancer Therapy--Prostate (FACT-P) and University of California, Los Angeles, Prostate Cancer Index (UCLA-PCI) questionnaires. RESULTS: In the dose-escalated group, the hazard ratio (HR) for rectal bleeding (LENT/SOM grade >or=2) was 1.55 (95% CI, 1.17-2.04); for diarrhea (LENT/SOM grade >or=2), the HR was 1.79 (95% CI, 1.10-2.94); and for proctitis (RTOG grade >or=2), the HR was 1.64 (95% CI, 1.20-2.25). Compared to baseline scores, the prevalence of moderate and severe toxicities generally increased up to 3 years and than lessened. At 5 years, the cumulative incidence of patient-reported severe bowel problems was 6% vs. 8% (standard vs. escalated, respectively) and severe distress was 4% vs. 5%, respectively. CONCLUSIONS: There is a statistically significant increased risk of various adverse gastrointestinal events with dose-escalated CFRT. This remains at clinically acceptable levels, and overall prevalence ultimately decreases with duration of follow-up.","Int J Radiat Oncol Biol Phys, 77(3): 773-783","UK",2010,"Local","Radiotherapy","FACT-P,UCLA-PCI,RTOG-EORTC-SS,LENT-SOMA,RMS","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,Treatment"]
[661,"Szymanski, K. M., et al. (2010). \"Development and validation of an abbreviated version of the expanded prostate cancer index composite instrument for measuring health-related quality of life among prostate cancer survivors.\" Urology 76(5): 1245-1250.",null,"Szymanski, K. M., et al.","Development and validation of an abbreviated version of the expanded prostate cancer index composite instrument for measuring health-related quality of life among prostate cancer survivors","OBJECTIVES: Widespread implementation of health-related quality-of-life (HRQOL) measurement in prostate cancer practice and research requires concise instruments. With 50 questions, the full-length Expanded Prostate Cancer Index Composite (EPIC) is cumbersome to administer outside of studies focusing exclusively on HRQOL. To facilitate HRQOL measurement in a broad range of prostate cancer research and practice settings, we developed and validated an abbreviated version of the EPIC. METHODS: The 50 questions that constitute the full-length EPIC-50 were evaluated to identify the items suitable for elimination while retaining the ability to measure the 5 prostate cancer-specific HRQOL domains of the EPIC-50. The resulting abbreviated version (EPIC-26) was validated using question responses from 252 subjects who had undergone brachytherapy, external beam radiotherapy, or prostatectomy for prostate cancer. The EPIC-26 internal consistency was measured by Cronbach's alpha coefficient and reliability using test-retest correlation. RESULTS: Using the high item-scale correlations, clinically relevant content, and preservation of domain psychometrics, 26 items were retained in the EPIC-26 from the 50 questions in the full-length EPIC-50. A high correlation was observed between the EPIC-50 and EPIC-26 versions for the urinary incontinence, urinary irritation/obstruction, bowel, sexual, and vitality/hormonal domain scores (all r >/= 0.96). The correlations between the different domains were low, confirming that EPIC-26 retained the ability to discern the 5 distinct HRQOL domains. The internal consistency and test-retest reliability for EPIC-26 (Cronbach's alpha >/= 0.70 and r >/= 0.69, respectively for all 5 HRQOL domains) supported its validity. CONCLUSIONS: EPIC-26 is a brief, valid, and reliable subjective measure of health quality among patients with prostate cancer and is suitable for measuring the HRQOL among patients undergoing treatment of early-stage prostate cancer.","Urology, 76(5): 1245-1250","Canada",2010,"Survivors","Surgery,Radiotherapy,Brachytherapy","EPIC","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease"]
[662,"Talcott, J. A., et al. (1997). \"Patient-reported impotence and incontinence after nerve-sparing radical prostatectomy.\" J Natl Cancer Inst 89(15): 1117-1123.",null,"Talcott, J. A., et al.","Patient-reported impotence and incontinence after nerve-sparing radical prostatectomy","BACKGROUND: The age-adjusted rate of radical prostatectomy, the most common treatment of early (nonmetastatic) prostate cancer, increased almost sixfold between 1984 and 1990. This increase was due in part to reported improvements in postoperative sexual potency after the use of newly developed \"nerve-sparing\" procedures. However, published estimates from physicians of impotence following various types of radical prostatectomy may be low, since not all patients may report treatment-related complications accurately and completely to their doctors. In contrast, direct surveys of patients indicate much higher rates of postoperative sexual and urinary dysfunction. One problem with most physician and patient surveys is that they have been performed retrospectively, and pretreatment impotence and incontinence prevalent in older men cannot be assessed accurately in retrospective studies. PURPOSE: This study was initiated in a cohort of men before they underwent radical prostatectomy to assess treatment-related effects on impotence and incontinence. METHODS: The study population consisted of 94 men enrolled in a cohort study of treatment for early prostate cancer. The patients completed questionnaires about sexual and urinary functions before surgery and at 3 and 12 months after surgery and had adequate information to assess the type of surgical technique used (non-nerve-sparing, unilateral nerve-sparing, or bilateral nerve-sparing). Because items assessing sexual function were inadvertently omitted from the questionnaire in the initial months of the study, information on sexual function for all time periods was available for only 49 men. RESULTS: Compared with men who had not been treated with a nerve-sparing procedure, men who underwent nerve-sparing radical prostatectomy, particularly of the bilateral type, were younger and had better prognostic features, indicating less advanced cancers. Before surgery, nine (75%) of 12 men not treated with a nerve-sparing procedure reported erections that were usually inadequate for sexual intercourse compared with six (33%) of 18 men and one (5%) of 19 men who underwent unilateral and bilateral nerve-sparing prostatectomies, respectively. At 12 months after surgery, most men reported inadequate erections, including 15 (79%) of the 19 men who had bilateral nerve-sparing surgery; unilateral nerve preservation provided no apparent benefit. In general, nerve-sparing surgery was associated with more use of absorbent pads at 3 and 12 months following treatment, and this approach was associated with substantial urinary incontinence at 3 months but not at 12 months following surgery. CONCLUSIONS: Nerve-sparing prostatectomy, particularly when performed unilaterally, improves postoperative sexual function to a lesser extent than previously reported. Because men with preoperative impotence and more advanced cancers receive nerve-sparing surgery less often, some of the previously reported benefit of nerve preservation may be the result of patient selection and not of the technique per se.","J Natl Cancer Inst, 89(15): 1117-1123","USA",1997,"Local","Surgery","Unclear","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Complication"]
[663,"Talcott, J. A., et al. (2010). \"Patient-reported long-term outcomes after conventional and high-dose combined proton and photon radiation for early prostate cancer.\" Jama 303(11): 1046-1053.",null,"Talcott, J. A., et al.","Patient-reported long-term outcomes after conventional and high-dose combined proton and photon radiation for early prostate cancer","CONTEXT: Increased radiation doses improve prostate cancer control but also increase toxicity to adjacent normal tissue. Proton radiation may attenuate adverse effects. OBJECTIVE: To determine long-term, patient-reported, dose-related toxicity. DESIGN, SETTING, AND PATIENTS: We performed a post hoc cross-sectional survey of surviving participants in the Proton Radiation Oncology Group (PROG) 9509--a randomized trial comparing 70.2 Gy vs 79.2 Gy of combined photon and proton radiation for 393 men with clinically localized prostate cancer (stage T1b-T2b, prostate-specific antigen <15 ng/mL, and no radiographic evidence of metastasis). The estimated 10-year biochemical progression rate for patients receiving standard dose was 32% (95% confidence interval, 26%-39%) compared with 17% (95% confidence interval, 11%-23%) for patients receiving high dose (P < .001). We surveyed 280 of the surviving 337 patients (83%) from April 2007 to September 2008. MAIN OUTCOME MEASURES: Prostate Cancer Symptom Indices, a validated measure of urinary incontinence, urinary obstruction and irritation, bowel problems, and sexual dysfunction, and related quality-of-life instruments. RESULTS: At a median of 9.4 years after treatment (range, 7.4-12.1 years), participants' demographic and clinical characteristics were similar. Patient-reported outcomes were reported as mean (SD) scale score for standard dose vs high dose: urinary obstruction/irritation (23.3 [13.7] vs 24.6 [14.0]; P = .36), urinary incontinence (10.6 [17.7] vs 9.7 [15.8]; P = .99), bowel problems (7.7 [7.8] vs 7.9 [9.1]; P = .70), sexual dysfunction (68.2 [34.6] vs 65.9 [34.7]; P = .65), and most other outcomes were also similar, although patients receiving standard dose whose cancers had more often progressed expressed less confidence that their cancers were under control (mean [SD] scale score for standard dose, 76.0 [25.4] vs high dose, 86.2 [17.9]; P < .001). Many patients characterized their urinary and bowel function as normal despite reporting symptoms that, for other prostate cancer patients before and early after cancer treatment, caused substantial distress. CONCLUSION: Among men with clinically localized prostate cancer, treatment with higher-dose radiation compared with standard dose was not associated with an increase in patient-reported prostate cancer symptoms after a median of 9.4 years.","Jama, 303(11): 1046-1053","USA",2010,"Local","Radiotherapy","PCSI","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Symptom"]
[664,"Talcott, J. A., et al. (2014). \"Using patient-reported outcomes to assess and improve prostate cancer brachytherapy.\" BJU Int 114(4): 511-516.",null,"Talcott, J. A., et al.","Using patient-reported outcomes to assess and improve prostate cancer brachytherapy","OBJECTIVE: To describe a successful quality improvement process that arose from unexpected differences in control groups' short-term patient-reported outcomes (PROs) within a comparative effectiveness study of a prostate brachytherapy technique intended to reduce urinary morbidity. PATIENTS AND METHODS: Patients planning prostate brachytherapy at one of three institutions were enrolled in a prospective cohort study. Patients were surveyed using a validated instrument to assess treatment-related toxicity before treatment and at pre-specified intervals. Unexpectedly, urinary PROs were worse in one of two standard brachytherapy technique control populations (US-BT1 and US-BT2 ). Therefore, we collaboratively reviewed treatment procedures, identified a discrepancy in technique, made a corrective modification, and evaluated the change. RESULTS: The patient groups were demographically and clinically similar. In the first preliminary analysis, US-BT2 patients reported significantly more short-term post-treatment urinary symptoms than US-BT1 patients. The study's treating physicians reviewed the US-BT1 and US-BT2 treatment protocols and found that they differed in whether they used an indwelling urinary catheter. After adopting the US-BT1 approach, short-term urinary morbidity in US-BT2 patients decreased significantly. Brachytherapy procedures were otherwise unchanged. CONCLUSION: Many procedures in cancer treatments are not evaluated, resulting in practice variation and suboptimal outcomes. Patients, the primary medical consumers, provide little direct input in evaluations of their care. We used PROs, a sensitive and valid measure of treatment-related toxicity, for quality assessment and quality improvement (QA/QI) of prostate brachytherapy. This serendipitous patient-centred QA/QI process may be a useful model for empirically evaluating complex cancer treatment procedures and for screening for substandard care.","BJU Int, 114(4): 511-516","USA",2014,"Any or unknown","Brachytherapy","Unclear","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Treatment"]
[665,"Tannock, I. F., et al. (1996). \"Chemotherapy with mitoxantrone plus prednisone or prednisone alone for symptomatic hormone-resistant prostate cancer: a Canadian randomized trial with palliative end points.\" J Clin Oncol 14(6): 1756-1764.",null,"Tannock, I. F., et al.","Chemotherapy with mitoxantrone plus prednisone or prednisone alone for symptomatic hormone-resistant prostate cancer: a Canadian randomized trial with palliative end points","PURPOSE: To investigate the benefit of chemotherapy in patients with symptomatic hormone-resistant prostate cancer using relevant end points of palliation in a randomized controlled trial. PATIENTS AND METHODS: We randomized 161 hormone-refractory patients with pain to receive mitoxantrone plus prednisone or prednisone alone (10 mg daily). Nonresponding patients on prednisone could receive mitoxantrone subsequently. The primary end point was a palliative response defined as a 2-point decrease in pain as assessed by a 6-point pain scale completed by patients (or complete loss of pain if initially 1 +) without an increase in analgesic medication and maintained for two consecutive evaluations at least 3 weeks apart. Secondary end points were a decrease of > or = 50% in use of analgesic medication without an increase in pain, duration of response, and survival. Health-related quality of life was evaluated with a series of linear analog self-assessment scales (LASA and the Prostate Cancer-Specific Quality-of-Life Instrument [PROSQOLI]), the core questionnaire of the European Organization for Research and Treatment of Cancer (EORTC), and a disease-specific module. RESULTS: Palliative response was observed in 23 of 80 patients (29%; 95% confidence interval, 19% to 40%) who received mitoxantrone plus prednisone, and in 10 of 81 patients (12%; 95% confidence interval, 6% to 22%) who received prednisone alone (P = .01). An additional seven patients in each group reduced analgesic medication > or = 50% without an increase in pain. The duration of palliation was longer in patients who received chemotherapy (median, 43 and 18 weeks; P < .0001, log-rank). Eleven of 50 patients randomized to prednisone treatment responded after addition of mitoxantrone. There was no difference in overall survival. Treatment was well tolerated, except for five episodes of possible cardiac toxicity in 130 patients who received mitoxantrone. Most responding patients had an improvement in quality-of-life scales and a decrease in serum prostate-specific antigen (PSA) level. CONCLUSION: Chemotherapy with mitoxantrone and prednisone provides palliation for some patients with symptomatic hormone-resistant prostate cancer.","J Clin Oncol, 14(6): 1756-1764","Canada",1996,"Any or unknown","Chemotherapy","PROSQoLI,EORTC QLQ-C30,NPS,LASA","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,General,Symptom"]
[666,"Tannock, I. F., et al. (2004). \"Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer.\" N Engl J Med 351(15): 1502-1512.",null,"Tannock, I. F., et al.","Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer","BACKGROUND: Mitoxantrone plus prednisone reduces pain and improves the quality of life in men with advanced, hormone-refractory prostate cancer, but it does not improve survival. We compared such treatment with docetaxel plus prednisone in men with this disease. METHODS: From March 2000 through June 2002, 1006 men with metastatic hormone-refractory prostate cancer received 5 mg of prednisone twice daily and were randomly assigned to receive 12 mg of mitoxantrone per square meter of body-surface area every three weeks, 75 mg of docetaxel per square meter every three weeks, or 30 mg of docetaxel per square meter weekly for five of every six weeks. The primary end point was overall survival. Secondary end points were pain, prostate-specific antigen (PSA) levels, and the quality of life. All statistical comparisons were against mitoxantrone. RESULTS: As compared with the men in the mitoxantrone group, men in the group given docetaxel every three weeks had a hazard ratio for death of 0.76 (95 percent confidence interval, 0.62 to 0.94; P=0.009 by the stratified log-rank test) and those given weekly docetaxel had a hazard ratio for death of 0.91 (95 percent confidence interval, 0.75 to 1.11; P=0.36). The median survival was 16.5 months in the mitoxantrone group, 18.9 months in the group given docetaxel every 3 weeks, and 17.4 months in the group given weekly docetaxel. Among these three groups, 32 percent, 45 percent, and 48 percent of men, respectively, had at least a 50 percent decrease in the serum PSA level (P<0.001 for both comparisons with mitoxantrone); 22 percent, 35 percent (P=0.01), and 31 percent (P=0.08) had predefined reductions in pain; and 13 percent, 22 percent (P=0.009), and 23 percent (P=0.005) had improvements in the quality of life. Adverse events were also more common in the groups that received docetaxel. CONCLUSIONS: When given with prednisone, treatment with docetaxel every three weeks led to superior survival and improved rates of response in terms of pain, serum PSA level, and quality of life, as compared with mitoxantrone plus prednisone.","N Engl J Med, 351(15): 1502-1512","Canada",2004,"Metastatic","Taxane,Chemotherapy","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General,Symptom"]
[667,"Tannock, I., et al. (1989). \"Treatment of metastatic prostatic cancer with low-dose prednisone: evaluation of pain and quality of life as pragmatic indices of response.\" J Clin Oncol 7(5): 590-597.",null,"Tannock, I., et al.","Treatment of metastatic prostatic cancer with low-dose prednisone: evaluation of pain and quality of life as pragmatic indices of response","Thirty-seven men with symptomatic bone metastases from prostate cancer that had progressed following earlier treatment with estrogens and/or orchidectomy were treated with low-dose prednisone (7.5 to 10 mg daily). The rationale for this treatment was that some patients might still have hormone-sensitive disease that was stimulated by weak androgens of adrenal origin, and that these androgens could be suppressed by prednisone through its negative feedback on secretion of adrenocorticotrophic hormone (ACTH). Response to treatment was assessed by requirement for analgesics, by the McGill-Melzack pain questionnaire, and by a series of 17 linear analog self-assessment (LASA) scales relating to pain and to various aspects of quality of life. Fourteen patients (38%) had improvement in indices used to assess pain at 1 month after starting prednisone, and seven patients (19%) maintained this improvement for 3 to 30 months (median, 4 months). Reduction in pain was associated with improvement in other dimensions of quality of life, and in the scale for overall well-being. Prednisone treatment led to a decrease in the concentration of serum testosterone in seven of nine patients where it was not initially suppressed below 2 nmol/L, and caused a decrease in serum levels of androstenedione and dehydroepiandrosterone sulfate in more than 50% of patients. Symptomatic response was associated with a decrease in serum concentration of adrenal androgens. We conclude that (1) low-dose prednisone may cause useful relief of pain in some patients with advanced prostatic cancer; (2) relief of pain was associated with suppression of adrenal androgens; and (3) measures of pain and quality of life can be used to assess possible benefits of systemic therapy in patients with metastatic prostate cancer.","J Clin Oncol, 7(5): 590-597","Canada",1989,"Metastatic","Hormonal","LASA,MPQ","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"General,Symptom"]
[668,"Tate, D. G., et al. (1997). \"Quality of life issues among women with physical disabilities or breast cancer.\" Arch Phys Med Rehabil 78(12 Suppl 5): S18-25.",null,"Tate, D. G., et al.","Quality of life issues among women with physical disabilities or breast cancer","OBJECTIVE: The purpose of this study was to assess quality of life (QOL) and life satisfaction among women with physical disabilities or breast cancer, and to identify factors predictive of QOL and life satisfaction for women and men. QOL and life satisfaction differences were examined between women and men with physical disabilities and cancer, and between women with traumatic and chronic physical conditions. DESIGN: A cross-sectional design employing several QOL and life satisfaction measures was used. SAMPLE: Two hundred sixteen outpatient subjects (99 women, 117 men) with physical disabilities or cancer were studied. INSTRUMENTS: The Health Status Questionnaire-Short-Form 36 (SF-36), Functional Assessment of Cancer Therapy (FACT), Functional Living Index-Cancer (FLIC), and the Satisfaction With Life Scale (SWLS). RESULTS: Women with traumatic conditions (amputation, spinal cord injury) reported poorer physical functioning and well-being, whereas women in the chronic (postpolio, breast cancer) group reported poorer health status. No significant gender differences were found with respect to QOL or life satisfaction. Whereas functional and emotional well-being were the strongest predictors of overall QOL for both men and women, self-perceived general health significantly predicted QOL for women (p < .05) and social well-being significantly predicted QOL for men (p < .01). Among men, life satisfaction was best predicted by marital status (p < .05), general health (p < .05), and social well-being (p < .01). The resulting QOL models had adjusted R2 values of .77 and .76 for women and men, respectively. Among women with traumatic conditions, functional well-being best predicted QOL (p < .01). Life satisfaction for women with chronic conditions was best predicted by age, education, and spiritual well-being. CONCLUSION: QOL as measured by the impact of illness on an individual is best predicted by physical and functional well-being. Satisfaction with one's life was best predicted by functional ability. Although functional and physical ability were the best predictors for both QOL and life satisfaction, social functioning made significant and substantive contributions to these constructs. Spinal cord injury had the most impact on physical functioning, whereas prostate cancer had the least. Psychosocial functioning was most affected by amputation and least affected by prostate cancer.","Arch Phys Med Rehabil, 78(12 Suppl 5): S18-25","USA",1997,"Any or unknown","None","SF-36,FACT-G,FLIC,SWLS","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"General,Treatment,Utility"]
[669,"Taussky, D., et al. (2003). \"Patient-reported toxicity correlated to dose-volume histograms of the rectum in radiotherapy of the prostate.\" Am J Clin Oncol 26(5): e144-149.",null,"Taussky, D., et al.","Patient-reported toxicity correlated to dose-volume histograms of the rectum in radiotherapy of the prostate","We studied 73 patients treated with 3-dimensional conformal radiotherapy for prostate cancer to determine whether there is a correlation between dose per volume to either the whole rectum, rectal wall, rectal surface, or anal canal and the development of late rectal complications measured with prostate-specific quality-of-life (QOL) questionnaires. Given doses were 66.6 to 72 Gy. The prostate cancer modules used were the UCLA-Prostate Cancer Index module (UCLA-PCI) (5 questions), the Functional Assessment of Cancer Therapy-Prostate module (FACT-P) (1 question), and the European Organization for Research and Treatment of Cancer prostate cancer module (EORTC QLQ-PR25) (4 questions). A Spearman correlation analysis between the total toxicity score and the dose-volume histograms (DVHs) was performed. All statistical tests were 2-sided. Sixty-five (89%) patients returned the questionnaire, and 18 (28%) underwent endoscopy for rectal bleeding. We found that only patients who had had an endoscopy showed a correlation between rectal toxicity and dose per volume, as compared with the other patients who showed none. Correlation between rectal toxicity and dose per volume for all 4 structures was stronger for higher doses. For 70 Gy, all contours, except the anal canal, showed a significant dose-volume correlation. Our results indicate that only in cases of pronounced rectal toxicity is there a dose-volume correlation, especially for doses of 70 Gy or more. DVHs of the whole rectum, wall, or surface, but not the anal canal, are all equivalent in predicting late rectal toxicity.","Am J Clin Oncol, 26(5): e144-149","Switzerland",2003,"Any or unknown","Radiotherapy","FACT-P,EORTC QLQ-PR25,UCLA-PCI","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Disease"]
[670,"Tefilli, M. V., et al. (1998). \"Quality of life in patients undergoing salvage procedures for locally recurrent prostate cancer.\" J Surg Oncol 69(3): 156-161.",null,"Tefilli, M. V., et al.","Quality of life in patients undergoing salvage procedures for locally recurrent prostate cancer","BACKGROUND AND OBJECTIVES: As patients are being treated for prostate cancer at a younger age, a significant number of them will ultimately fail the primary treatment and will be candidates for potentially curative salvage therapy. The purpose of this study was to evaluate the impact of salvage therapy for locally recurrent prostate cancer upon the patients' quality of life. METHODS: A cohort of 68 men with locally recurrent prostate cancer undergoing salvage treatment was included in this analysis. Data were collected for the study by mailing the subjects a self-administered questionnaire that included a General Functional Assessment of Cancer Therapy (FACT-G) and a Prostate Cancer Treatment Outcome Questionnaire (FACT-P). Group comparisons were conducted using one-way analysis of variance (ANOVA). RESULTS: Overall, 50% and 88.6% of patients were free of biochemical recurrence in the salvage surgery (SS) and salvage radiotherapy (SRt) group, respectively (P=0.4). The physical well-being (PWB) subscale of FACT-G was significantly higher for the SRt patients (P=0.008). Using the Trial Outcome Index Prostate subscale, the Trial Outcome Index Incontinence Urinary scores, and the Functional Assessment of Incontinence Therapy-Urinary score group comparisons, patients in the SRt group had a higher quality of life than patients in the SS group (P=0.038, P=0.001, and P=0.001, respectively). CONCLUSIONS: In the current study, patients with clinically localized prostate cancer who are at high risk for local disease recurrence may have a trend toward better disease-free survival and a better urinary continence rates if the primary treatment is radical prostatectomy rather than radiation therapy.","J Surg Oncol, 69(3): 156-161","USA",1998,"Recurrent","Surgery,Radiotherapy","FACT-G,FACT-P,TOI,FAIT-U","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Treatment,Disease,Complication"]
[671,"Templeton, H. and V. Coates (2004). \"Evaluation of an evidence-based education package for men with prostate cancer on hormonal manipulation therapy.\" Patient Educ Couns 55(1): 55-61.",null,"Templeton, H. and V. Coates","Evaluation of an evidence-based education package for men with prostate cancer on hormonal manipulation therapy","Prostate cancer has become a public health problem worldwide with considerable social and economic consequences. Many men have extraprostatic spread at diagnosis, and treatment usually involves hormonal manipulation therapy, which can challenge the stereotypical male image. It is often assumed that merely the provision of educational material for patients in an accessible form is sufficient to address informational needs. However, with the increasing emphasis on evidence-based practice, an essential element of the patient education process is evaluation of the impact of educational interventions. In this study, a randomised controlled trial was used to evaluate the effect of an evidence-based education package on the knowledge of disease and treatment, quality of life, coping and satisfaction of a sample (n=55) of men with prostate cancer on hormonal manipulation therapy in the UK. The men were randomly assigned to experimental (n=28) and control group (n=27). Established instruments with satisfactory reliability and validity were used to measure the dependent variables. The independent variable, namely the education package, had been developed following the results of a previous study, which assessed the informational needs of this client group. This package consisted of an information booklet supplemented by the verbal teaching of a urology nurse. Results demonstrated that delivery of the education package had a significant effect on knowledge, quality of life and satisfaction with care, but not on coping. This study has contributed to the evidence-base for practice in urological nursing. This education package should become a routine, and not merely incidental aspect of care for this client group.","Patient Educ Couns, 55(1): 55-61","UK",2004,"Any or unknown","Hormonal,Various","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General,Knowledge"]
[672,"Thiel, D. D., et al. (2015). \"Comparison of patient-reported quality of life outcome questionnaire response rates between patients treated surgically for renal cell carcinoma and prostate carcinoma.\" BMC Urol 15: 58.",null,"Thiel, D. D., et al.","Comparison of patient-reported quality of life outcome questionnaire response rates between patients treated surgically for renal cell carcinoma and prostate carcinoma","BACKGROUND: We sought to examine differences in response rates to quality of life (QoL) surveys in patients treated surgically for renal cell carcinoma (RCC) and prostate cancer (PCa) and to analyze factors associated with non-response of the surveys. METHODS: Patients who underwent surgery for RCC or PCa between 2006 and 2012 were offered enrollment in respective prospective cancer registries that included baseline and annual QoL assessments. We identified 201 RCC patients and 616 PCa patients who completed a baseline QoL survey and were mailed annual QoL surveys [RCC: SF-36, FACT-G (73 questions), PCa: EPIC, IIEF, Max-PC (80 questions)]. We compared patient characteristics between responders and non-responders using a Wilcoxon rank-sum test for continuous variables and a Fisher's Exact test for categorical variables. RESULTS: The overall response rates for the PCa and RCC groups were 63 and 48% (p < 0.001), respectively. This difference in response rates remained when we limited analysis to only those with early stage disease (pT2 for PCa and pT1 RCC, 62% vs. 52%; p = 0.03). PCa characteristics associated with response included older age (64.1 vs 62.6 years, p = 0.032) and robotic versus open surgery (56% vs 44%; p = 0.009). There were no characteristics that were associated with response in RCC patients. CONCLUSIONS: Surgically treated PCa patients have higher QoL mail-based survey response rates compared to patients treated surgically for RCC. This difference holds true for clinically localized cancers as well.","BMC Urol, 15(58","USA",2015,"Any or unknown","Surgery","EPIC,IIEF-5,MASPC","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease,Comorbidity,Complication"]
[673,"Thong, M. S., et al. (2010). \"Prostate cancer survivors who would be eligible for active surveillance but were either treated with radiotherapy or managed expectantly: comparisons on long-term quality of life and symptom burden.\" BJU Int 105(5): 652-658.",null,"Thong, M. S., et al.","Prostate cancer survivors who would be eligible for active surveillance but were either treated with radiotherapy or managed expectantly: comparisons on long-term quality of life and symptom burden","OBJECTIVE: To assess and identify factors associated with the long-term health-related quality of life (HRQL) of prostate cancer survivors managed expectantly, as patients with low-risk prostate cancer can be managed with active surveillance (AS), but research on associated long-term HRQL is scarce. PATIENTS AND METHODS: From the population-based Eindhoven Cancer Registry, 71 men managed with AS were matched with 71 survivors who had similar demographic and clinical characteristics but treated with external beam radiotherapy (RT). All were diagnosed between 1994 and 1998. HRQL data were collected 5-10 years after diagnosis. Patients completed generic- (Short Form-36) and cancer-specific (Quality of Life - Cancer Survivors) HRQL instruments, and symptom burden (Expanded Prostate Cancer Index, Sexual Activity) questionnaires. RESULTS: Patients on AS were comparable to those treated with RT for most generic- and disease-specific HRQL dimensions. Patients treated with RT had poorer mean (sd) bowel function scores, of 87.1 (13.1) vs 92.8 (10.7) (P < 0.001), more bother with bowel function, at 85.0 (16.4) vs 93.7 (10.1) (P < 0.001), and more problems with getting an erection (68% vs 47%, P = 0.005). Multivariate regression analyses (corrected for comorbidity and clinical disease progression) indicated that the management strategy independently predicted differences in physical functioning, bodily pain, spiritual and total well-being, and bowel function and bowel bother. CONCLUSIONS: Patients managed expectantly at initial diagnosis (AS) have comparable HRQL and a lower symptom burden than patients treated with RT up to 10 years after the diagnosis.","BJU Int, 105(5): 652-658","Netherlands",2010,"Survivors","Radiotherapy,Surveillance","SF-36,EPIC,SActQ,QOL-CS","Patient",null,"Case-control",null,null,null,null,null,null,null,null,"Disease,Complication,Utility"]
[674,"Thorsteinsdottir, T., et al. (2011). \"LAPPRO: a prospective multicentre comparative study of robot-assisted laparoscopic and retropubic radical prostatectomy for prostate cancer.\" Scand J Urol Nephrol 45(2): 102-112.",null,"Thorsteinsdottir, T., et al.","LAPPRO: a prospective multicentre comparative study of robot-assisted laparoscopic and retropubic radical prostatectomy for prostate cancer","OBJECTIVE: This study describes the study design and procedures for a prospective, non-randomized trial comparing open retropubic and robot-assisted laparoscopic radical prostatectomy regarding functional and oncological outcomes. MATERIAL AND METHODS: The aim was to achieve a detailed prospective registration of symptoms experienced by patients using validated questionnaires in addition to documentation of surgical details, clinical examinations, medical facts and resource use. Four patient questionnaires and six case-report forms were especially designed to collect data before, during and after surgery with a follow-up time of 2 years. The primary endpoint is urinary leakage 1 year after surgery. Secondary endpoints include erectile dysfunction, oncological outcome, quality of life and cost-effectiveness at 3, 12 and 24 months after surgery. RESULTS: The study started in September 2008 with accrual continuing to October 2011. Twelve urological departments in Sweden well established in performing radical prostatectomy are participating. Personal contact with the participating departments and patients was established to ascertain a high response rate. To reach 80% statistical power to detect a difference of 5 absolute per cent in incidence of urinary leakage, 700 men in the retropubic group and 1400 in the robotic group are needed. CONCLUSIONS: The Swedish healthcare context is well suited to performing multicentre long-term prospective clinical trials. The similar care protocols and congruent specialist training are particularly favourable. The LAPPRO trial aims to compare the two surgical techniques in aspects of short- and long-term functional and oncological outcome, cost effectiveness and quality of life, supplying new knowledge to support future decisions in treatment strategies for prostate cancer.","Scand J Urol Nephrol, 45(2): 102-112","Sweden",2011,"Any or unknown","Surgery","Unclear","Patient",null,"Protocol",null,null,null,null,null,null,null,null,"General,Complication"]
[675,"Thrasher, J. B., et al. (2000). \"Comparative study of the clinical efficacy of two dosing regimens of flutamide.\" Mol Urol 4(3): 259-263;discussion 265.",null,"Thrasher, J. B., et al.","Comparative study of the clinical efficacy of two dosing regimens of flutamide","PURPOSE: We performed a randomized trial to compare the efficacy and toxicity of a new dose of flutamide (500 mg QD) with the currently recommended dose (250 mg q8h) in the treatment of advanced prostate cancer. The primary endpoints were percent of patients having normalization of prostate specific antigen (PSA), time to normalization, and percent change from baseline. Secondary endpoints were quality of life and toxicity. PATIENTS: Altogether, 440 men aged 46 to 94 years (mean 71 years) with confirmed stage M(1) disease, documented PSA rise >0.2 ng/mL, ECOG status 0 to 2, no second neoplasm, no liver function tests > or = 1.5-fold normal values, and no previous treatment for metastatic disease were entered in the trial. RESULTS: The PSA normalized by week 12 in 71% of the patients receiving 500-mg dose and 75% of those receiving the standard dose. The percent change in PSA was 89% and 96%, respectively. The treatment groups were not significantly different with respect to the incidence of adverse events: 71% v 68% in the 500-mg and 250-mg arms, respectively (P = 0.337). CONCLUSIONS: When combined with castration, 500 mg of flutamide appears to be equally effective in lowering serum PSA and is not significantly more toxic than conventional dosing. The use of 500 mg QD instead of the standard 250 mg q8h would result in a cost savings of 30%.","Mol Urol, 4(3): 259-263;discussion 265","USA",2000,"Advanced","Hormonal","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General,Treatment"]
[676,"Tienforti, D., et al. (2012). \"Efficacy of an assisted low-intensity programme of perioperative pelvic floor muscle training in improving the recovery of continence after radical prostatectomy: a randomized controlled trial.\" BJU Int 110(7): 1004-1010.",null,"Tienforti, D., et al.","Efficacy of an assisted low-intensity programme of perioperative pelvic floor muscle training in improving the recovery of continence after radical prostatectomy: a randomized controlled trial","Study Type - Therapy (RCT) Level of Evidence 1b. What's known on the subject? and What does the study add? Peri-operative pelvic floor muscle training reduces urinary incontinence for men undergoing radical prostatectomy (RP). A preoperative biofeedback session, combined with postoperative pelvic floor muscle training, and assisted sessions on a monthly basis only, is an effective low-intensity programme to improve recovery of continence in patients undergoing RP. OBJECTIVE: To evaluate the efficacy of preoperative biofeedback (BFB) combined with an assisted low-intensity programme of postoperative perineal physiokinesitherapy in reducing the incidence, duration and severity of urinary incontinence (UI) in patients undergoing radical prostatectomy (RP). PATIENTS AND METHODS: A prospective, single-centre, randomized controlled clinical study was designed. * The intervention group received a training session with BFB, supervised oral and written instructions on Kegel exercises and a structured programme of postoperative exercises on the day before open RP. After RP, patients received control visits, including a session of BFB, at monthly intervals only. * The control group received, after catheter removal, only oral and written instructions on Kegel exercises to be performed at home. Patients received control visits at 1, 3 and 6 months after catheter removal. * At each visit the number of incontinence episodes, the number of pads used and patient-reported outcome measures (International Consultation on Incontinence Questionnaire on Urinary Incontinence [ICIQ-UI], [ICIQ]-Overactive Bladder [OAB], University of California, Los Angeles-Prostate Cancer Index [UCLA-PCI], International Prostate Symptom Score-Quality of Life [IPSS-QoL]) were assessed in both groups. All patients were followed-up for a period of at least 6 months after catheter removal. * The primary outcome was the recovery of continence, strictly defined as a ICIQ-UI score of zero. RESULTS: Overall, 34 consecutive patients were eligible and 32 were available for the final analysis: 16 patients for each study group. The two groups were homogeneous for all pre- and intraoperative features examined. * In the intervention group, continence had been achieved by six, eight and 10 patients at 1-, 3- and 6-month follow-ups, respectively, vs no patients (P= 0.02), one patient (P= 0.01) and one patient (P= 0.002) in the control group at each follow-up, respectively. * The analysis of the UCLA-PCI and ICIQ-OAB scores, the number of incontinence episodes per week and the number of pads per week showed significant differences in favour of patients in the intervention group at 3 and 6 months. * Patients in the intervention group reported better IPSS-QoL scores at all follow-up times but the difference did not reach statistical significance. CONCLUSIONS: Preoperative BFB combined with a postoperative programme of perineal physiokinesitherapy and assisted sessions on a monthly basis only, is a treatment strategy significantly more effective than the standard care in improving recovery of continence in patients undergoing RP. * The impact on QoL appeared less evident, although a trend for a better QoL was observed in the intervention group.","BJU Int, 110(7): 1004-1010","Italy",2012,"Any or unknown","Surgery,Various","IPSS, ICIQ,UCLA-PCI","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,Complication"]
[677,"Torvinen, S., et al. (2016). \"USE OF PATIENT ASSESSED HEALTH-RELATED QUALITY OF LIFE INSTRUMENTS IN PROSTATE CANCER RESEARCH: A SYSTEMATIC REVIEW OF THE LITERATURE 2002-15.\" Int J Technol Assess Health Care 32(3): 97-106.",null,"Torvinen, S., et al.","USE OF PATIENT ASSESSED HEALTH-RELATED QUALITY OF LIFE INSTRUMENTS IN PROSTATE CANCER RESEARCH: A SYSTEMATIC REVIEW OF THE LITERATURE 2002-15","OBJECTIVES: The objectives of this study were to identify and qualitatively describe, in a systematic literature review, published studies that collected prostate cancer patients' health-related quality of life (HRQoL) estimates by using validated, generic instruments. METHODS: Systematic searches of the literature were made using the Medline, Cochrane Library, PsycINFO, and CINAHL electronic databases from 2002 to 2015. RESULTS: The search identified 2,171 references, of which 237 were obtained for full-text assessment; thirty-three of these articles were deemed relevant and included in the systematic review. An indirect valuation method was used in 73 percent (n = 24) of the studies. The most commonly used HRQoL instrument with an indirect valuation method was the EuroQol (EQ-5D; n = 21), and the second most common was the 15D (n = 5). A direct valuation method was used in 48 percent (n = 16) of the studies. Of these, the Visual Analogue Scale (VAS) was the most often used (n = 10), followed by the Time-Trade-Off (n = 6). HRQoL scores varied in localized and early stage disease between 0.63 and 0.91, and in advanced or metastatic disease stage between 0.50 and 0.87. There was also variance in the HRQoL instruments and study methods used, which explains the large variance in HRQoL scores between the various disease stages. CONCLUSIONS: Although utility and quality-adjusted life-years gained are considered important measures of effectiveness in health care, the number of studies in which utilities of prostate cancer patients have been estimated using generic HRQoL instruments, based on either direct or indirect measurement of HRQoL, is fairly small.","Int J Technol Assess Health Care, 32(3): 97-106","International",2016,"Any or unknown","None","EQ-5D,VAS,TTO,15D","Patient",null,"Systematic review",null,null,null,null,null,null,null,null,"Utility"]
[678,"Touijer, K., et al. (2008). \"Comprehensive prospective comparative analysis of outcomes between open and laparoscopic radical prostatectomy conducted in 2003 to 2005.\" J Urol 179(5): 1811-1817; discussion 1817.",null,"Touijer, K., et al.","Comprehensive prospective comparative analysis of outcomes between open and laparoscopic radical prostatectomy conducted in 2003 to 2005","PURPOSE: In a nonrandomized prospective fashion we compared the oncological, functional and morbidity outcomes after laparoscopic and retropubic radical prostatectomy. MATERIALS AND METHODS: Between January 2003 and December 2005 a total of 1,430 consecutive men with clinically localized prostate cancer underwent radical prostatectomy, laparoscopic in 612 and retropubic in 818. The surgical approach was selected by the patient. Preoperative staging, respective surgical techniques, pathological examination and followup were uniform. Functional outcome was measured by patient completed health related quality of life questionnaire. RESULTS: Positive surgical margin rates (11%) and freedom from progression (median followup 18 months) were comparable between laparoscopic and retropubic radical prostatectomy (HR 0.99 for laparoscopic vs retropubic radical prostatectomy, p = 0.9). We found no significant association between operation type and time to postoperative potency (HR 1.04 for laparoscopic vs retropubic radical prostatectomy; 95% CI 0.74, 1.46; p = 0.8). Patients who underwent laparoscopic radical prostatectomy were less likely to become continent than those treated with retropubic radical prostatectomy (HR 0.56 for laparoscopic vs retropubic radical prostatectomy; 95% CI 0.44, 0.70; p <0.0005). Laparoscopic radical prostatectomy was associated with less blood loss (mean ml +/- SD 315 +/- 186 vs 1,267 +/- 660) and lower overall transfusion rate (3% vs 49%). No significant difference was noted in cardiovascular, thromboembolic and urinary complications. Emergency room visits and readmissions were higher after laparoscopic radical prostatectomy (15% vs 11% and 4.6% vs 1.2%, respectively). CONCLUSIONS: At our institution and during the study period laparoscopic radical prostatectomy and retropubic radical prostatectomy provided comparable oncological efficacy. Laparoscopic radical prostatectomy was associated with less blood loss and a lower transfusion rate, and higher postoperative hospital visits and readmission rate. While the recovery of potency was equivalent, that of continence was superior after retropubic radical prostatectomy.","J Urol, 179(5): 1811-1817; discussion 1817","USA",2008,"Local","Surgery","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General"]
[679,"Turini, M., et al. (2003). \"Quality of life and economic considerations in the management of prostate cancer.\" Pharmacoeconomics 21(8): 527-541.",null,"Turini, M., et al.","Quality of life and economic considerations in the management of prostate cancer","The purpose of this article was to provide an overview of the morbidity and mortality of prostate cancer, QOL issues and the economic impact of the disease. We searched Medline (from 1990 onwards) for all studies dealing with prostate cancer epidemiology, treatment, screening and staging, and critically reviewed the most relevant articles, focusing on pharmacoeconomic issues. Prostate cancer is the most common cancer in men. In the US, new estimated cases of prostate cancer represented 14.8% of all new cancer cases for 2000, with estimated deaths from prostate cancer comprising 5.8% of all deaths from cancer. Current options for prostate cancer management include radical prostatectomy, cryosurgery, radiotherapy, hormone therapy and watchful waiting. Many of the long-term effects of treatment, such as urinary incontinence, impotence and radiation-induced proctitis, have a large impact on patients' quality of life and, in some patients, may offset the clinical benefits. Regulatory bodies and managed care organisations are assigning increasing importance to the evaluation of QOL benefits as an independent clinical endpoint and a measure of patient satisfaction. Several screening programmes for early detection of prostate cancer, mostly based on prostate-specific antigen (PSA) measurement or digital rectal examination, have been proposed, but their routine implementation in all asymptomatic elderly men has been questioned. There is still no definite proof that patient outcomes are improved by extensive PSA screening. Furthermore, the total cost of a screening programme is difficult to define since it extends well beyond the initial test. Several instruments are used for QOL assessment in prostate cancer, some of which have been specifically developed for, or adapted to, patients with this disease, such as the Functional Assessment Cancer Therapy (FACT) tool, Prostate Cancer Treatment Outcome Questionnaire (PCTO-Q) and Prostate Cancer Specific Quality of Life Instrument (PROSQOLI). More than 50% of treatment costs for prostate cancer are accrued during the patient's last year of life, and total initial care costs decrease with increasing age. In the US, initial average inpatient costs were estimated at $US 2253, in 1995, for men aged > or =80 years, compared with $US 4540 for men aged 35-64 years. In recent years, treatments based on combined modalities (i.e. radiotherapy/prostatectomy plus hormonal therapies) have emerged. Although cost-effectiveness analyses of various treatment options have been attempted, the strength of their conclusions appears to be limited by the lack of homogeneous literature data on the effects of such interventions on survival and morbidity.","Pharmacoeconomics, 21(8): 527-541","International",2003,"Any or unknown","Surgery,Radiotherapy,Hormonal,Surveillance","FACT-G,PCTO-Q,PROSQoLI","Patient",null,"Systematic review",null,null,null,null,null,null,null,null,"General,Disease,Treatment"]
[680,"Turner, S. L., et al. (2001). \"Less pain does equal better quality of life following strontium-89 therapy for metastatic prostate cancer.\" Br J Cancer 84(3): 297-302.",null,"Turner, S. L., et al.","Less pain does equal better quality of life following strontium-89 therapy for metastatic prostate cancer","93 patients with hormone refractory metastatic prostate cancer were entered on a prospective study to measure reduction in pain and changes in quality of life (QoL) after the administration of 150 MegaBequerel (MBq) Strontium-89 (Sr-89). QoL was assessed using a validated instrument, the Functional Living Index - Cancer (FLIC) questionnaire. Pain response was measured using the Radiation Therapy Oncology Group scoring system. Overall there was limited QoL improvement over 3 months following Sr-89. However, in the 53 patients (63%) achieving pain responses, QoL did significantly improve within 6 weeks of receiving Sr-89 compared to patients with stable or worsening bone pain, and this was independent of other parameters that might influence QoL outcomes, such as performance status, baseline PSA and extent of skeletal disease (P = 0.004). PSA 'response' occurred in 30 patients (37%) over 4 months after Sr-89. This did not appear to correlate with clinical improvement. This study supports the presumption that improvement in pain following Sr-89 is accompanied by better QoL. The lack of correlation of PSA response and clinical parameters indicates that in the palliative setting, PSA may not provide a useful surrogate for treatment outcome.","Br J Cancer, 84(3): 297-302","Australia",2001,"Metastatic","Brachytherapy","FLIC,RTOG-EORTC-SS","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"General,Treatment"]
[681,"Tyrrell, C. J. (1994). \"Tolerability and quality of life aspects with the anti-androgen Casodex (ICI 176,334) as monotherapy for prostate cancer. International Casodex Investigators.\" Eur Urol 26 Suppl 1: 15-19.",null,"Tyrrell, C. J.","Tolerability and quality of life aspects with the anti-androgen Casodex (ICI 176,334) as monotherapy for prostate cancer. International Casodex Investigators","Over 3,000 men, the majority of whom were patients with prostate cancer, were treated with Casodex (ICI 176,334), an oral anti-androgen, at doses ranging from 10 to 200 mg daily, corresponding to a total exposure to the drug of over 1,500 patient-years. Over this period, the tolerability of Casodex and its effect on quality of life were closely studied. Information on tolerability is presented from three large randomized trials of Casodex, 50 mg/day, in patients with prostate cancer, two large randomized trials of Casodex, 150 mg/day, in patients with prostate cancer and three double-blind, placebo-controlled trials of Casodex, 50 mg/day, in patients with benign prostatic hyperplasia (BPH). Information on quality of life and assessment of sexual functioning is presented from the trials using Casodex, 50 mg/day, for both prostate cancer and BPH. The most commonly reported adverse events were those that would be expected with an anti-androgen (i.e. breast tenderness, gynaecomastia and hot flushes). Overall, Casodex was well tolerated; there were no reports of light/dark adaptation problems or pulmonary fibrosis, and only one case of alcohol intolerance, which was not considered by the investigator to be treatment related. Only 0.3% of patients in the whole trial programme had to be withdrawn because of changes in liver function, and there were no clinically significant changes in mean liver function tests. Although there were no consistent differences between treatments for other aspects of quality of life, there was evidence of benefit from treatment with Casodex in maintaining both sexual interest and functioning.","Eur Urol, 26 Suppl 1(15-19","UK",1994,"Any or unknown","Hormonal","Unclear","Patient",null,"Narrative review",null,null,null,null,null,null,null,null,"General,Treatment"]
[682,"Tyrrell, C. J., et al. (1998). \"A randomised comparison of 'Casodex' (bicalutamide) 150 mg monotherapy versus castration in the treatment of metastatic and locally advanced prostate cancer.\" Eur Urol 33(5): 447-456.",null,"Tyrrell, C. J., et al.","A randomised comparison of 'Casodex' (bicalutamide) 150 mg monotherapy versus castration in the treatment of metastatic and locally advanced prostate cancer","OBJECTIVES: To evaluate the efficacy and tolerability of 'Casodex' monotherapy (150 mg daily) for metastatic and locally advanced prostate cancer. METHODS: A total of 1,453 patients with either confirmed metastatic disease (M1), or T3/T4 non-metastatic disease with elevated prostate-specific antigen (M0) were recruited into one of two identical, multicentre, randomised studies to compare 'Casodex' 150 mg/day with castration. The protocols allowed for combined analysis. RESULTS: At a median follow-up period of approximately 100 weeks for both studies, 'Casodex' 150 mg was found to be less effective than castration in patients with metastatic disease (M1) at entry (hazard ratio of 1.30 for time to death) with a difference in median survival of 6 weeks. In symptomatic M1 patients, 'Casodex' was associated with a statistically significant improvement in subjective response (70%) compared with castration (58%). Analysis of a validated quality-of-life questionnaire proved an advantage for 'Casodex' in sexual interest and physical capacity. 'Casodex' had a substantially lower incidence of hot flushes compared to castration (6-13% compared with 39-44%) and the most commonly reported adverse events were those expected for a potent antiandrogen. However, in patients with M0 disease at entry, the data are still immature with only 13% of M0 patients having died. An initial analysis of this immature data has suggested that the results in these patients may be different to those obtained in patients with M1 disease. A further survival analysis in patients with M0 disease is therefore planned when the data are more mature. CONCLUSIONS: 'Casodex' 150 mg is less effective than castration in patients with M1 disease. However, 'Casodex' has shown a benefit in terms of quality of life and subjective response when compared to castration and has an acceptable tolerability profile. Thus 'Casodex' 150 mg monotherapy is an option for patients with M1 prostate cancer for whom surgical or medical castration is not indicated or is not acceptable.","Eur Urol, 33(5): 447-456","UK",1998,"Advanced,Metastatic","Hormonal,Surgery","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General,Complication"]
[683,"Uchida, T., et al. (2005). \"Transrectal high-intensity focused ultrasound in the treatment of localized prostate cancer: a multicenter study.\" Hinyokika Kiyo 51(10): 651-658.",null,"Uchida, T., et al.","Transrectal high-intensity focused ultrasound in the treatment of localized prostate cancer: a multicenter study","We report a multicenter trial with transrectal high-intensity focused ultrasound (HIFU) in the treatment of localized prostate cancer. A total of 72 consecutive patients with stage T1c-2NOM0 prostate cancer were treated using the Sonablate 500TM HIFU device (Focus Surgery, Indianapolis, USA). Biochemical recurrence was defined according to the criteria recommended by the American Society for Therapeutic Radiology and Oncology Consensus Panel. The median age and prostate specific antigen (PSA) level were 72 years and 8.10 ng/ml, respectively. The median follow-up period for all patients was 14.0 months. Biochemical disease-free survival rates in all patients at 1 and 2 years were 78% and 76%, respectively. Biochemical disease-free survival rates in patients with stage T1c, T2a and T2b groups at 2 years were 89, 67% and 40% (p = 0.0817). Biochemical disease-free survival rates in patients with Gleason scores of 2-4, 5-7 and 8-10 at 2 years were 88, 72% and 80% (p = 0.6539). Biochemical disease-free survival rates in patients with serum PSA of less than 10 ng/ml and 10-20 ng/ml were 75% and 78% (p = 0.6152). No viable tumor cells were noted in 68% of patients by postoperative prostate needle biopsy. Prostatic volume was decreased from 24.2 ml to 14.0 ml at 6 months after HIFU (p < 0.01). No statistically significant differences were noted in International Prostate Symptom Score, maximum urinary flow rate and quality of life analysis with Functional Assessment of Cancer Therapy. HIFU therapy appears to be minimally invasive, efficacious and safe for patients with localized prostate cancer with pretreatment PSA levels less than 20 ng/ml.","Hinyokika Kiyo, 51(10): 651-658","Japan",2005,"Local","HIFU","FACT-G,IPSS","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Treatment,Disease"]
[684,"Vainshtein, J., et al. (2012). \"Randomized phase II trial of urethral sparing intensity modulated radiation therapy in low-risk prostate cancer: implications for focal therapy.\" Radiat Oncol 7: 82.",null,"Vainshtein, J., et al.","Randomized phase II trial of urethral sparing intensity modulated radiation therapy in low-risk prostate cancer: implications for focal therapy","BACKGROUND: Low-risk prostate cancer (PCa) patients have excellent outcomes, with treatment modality often selected by perceived effects on quality of life. Acute urinary symptoms are common during external beam radiotherapy (EBRT), while chronic symptoms have been linked to urethral dose. Since most low-risk PCa occurs in the peripheral zone (PZ), we hypothesized that EBRT using urethral sparing intensity modulated radiation therapy (US-IMRT) could improve urinary health-related quality of life (HRQOL) while maintaining high rates of PCa control. METHODS: Patients with National Comprehensive Cancer Network (NCCN) defined low-risk PCa with no visible lesion within 5 mm of the prostatic urethra on MRI were randomized to US-IMRT or standard (S-) IMRT. Prescription dose was 75.6 Gy in 41 fractions to the PZ + 3-5 mm for US-IMRT and to the prostate + 3 mm for S-IMRT. For US-IMRT, mean proximal and distal urethral doses were limited to 65 Gy and 74 Gy, respectively. HRQOL was assessed using the Expanded Prostate Cancer Index (EPIC) Quality of Life questionnaire. The primary endpoint was change in urinary HRQOL at 3 months. RESULTS: From June 2004 to November 2006, 16 patients were randomized, after which a futility analysis concluded that continued accrual was unlikely to demonstrate a difference in the primary endpoint. Mean change in EPIC urinary HRQOL at 3 months was -0.5 +/- 11.2 in the US-IMRT arm and +3.9 +/- 15.3 in the S-IMRT arm (p = 0.52). Median PSA nadir was higher in the US-IMRT arm (1.46 vs. 0.78, p = 0.05). At 4.7 years median follow-up, three US-IMRT and no S-IMRT patients experienced PSA failure (p = 0.06; HR 8.8, 95% CI 0.9-86). Two out of 3 patients with PSA failure had biopsy-proven local failure, both located contralateral to the original site of disease. CONCLUSIONS: Compared with S-IMRT, US-IMRT failed to improve urinary HRQOL and resulted in higher PSA nadir and inferior biochemical control. The high rate of PSA failure and contralateral local failures in US-IMRT patients, despite careful selection of MRI-screened low-risk patients, serve as a cautionary tale for focal PCa treatments.","Radiat Oncol, 7(82","USA",2012,"Local","Radiotherapy","EPIC","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease"]
[685,"Valdimarsdottir, U., et al. (2002). \"The unrecognised cost of cancer patients' unrelieved symptoms:a nationwide follow-up of their surviving partners.\" Br J Cancer 86(10): 1540-1545.",null,"Valdimarsdottir, U., et al.","The unrecognised cost of cancer patients' unrelieved symptoms:a nationwide follow-up of their surviving partners","We investigated if a cancer patient's unrelieved symptoms during the last 3 months of life increase the risk of long-term psychological morbidity of the surviving partner. All women (n=506) living in Sweden under 80 years of age, who lost their husband/partner owing to cancer of the prostate in 1996 or of the urinary bladder in 1995 or 1996 were asked to answer an anonymous postal questionnaire, 2-4 years after their loss. The widows' psychological morbidity was associated with the patient's unrelieved mental symptoms. When the patient was perceived to have been very anxious during last three months of life (compared to no observed symptoms) the relative risks for the widows' psychological morbidity were: 2.5 (1.4-4.3) for depression and 3.4 (1.4-8.2) for anxiety. When comparing reports of the patient's pain (much vs no), the relative risks were 0.8 (0.5-1.2) for widowhood depression, and 0.8 (0.4-1.7) for widowhood anxiety. The patients were found to have had adequate access to physical pain control but poor access to psychological symptom control. Efficiency in diagnosing and treating psychological complications of terminally ill cancer patients may not only improve their quality of life but possibly also prevent long-term psychological morbidity of their surviving partners.","Br J Cancer, 86(10): 1540-1545","Sweden",2002,"End of life","None","Unclear","Caregiver",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Comorbidity"]
[686,"van Andel, G. and K. H. Kurth (2003). \"The impact of androgen deprivation therapy on health related quality of life in asymptomatic men with lymph node positive prostate cancer.\" Eur Urol 44(2): 209-214.",null,"van Andel, G. and K. H. Kurth","The impact of androgen deprivation therapy on health related quality of life in asymptomatic men with lymph node positive prostate cancer","PURPOSE: To evaluate the impact of androgen deprivation on health related quality of life (HRQOL) in patients with asymptomatic lymph node positive prostatic carcinoma (LPPC). MATERIALS AND METHODS: HRQOL domains were measured, using standard instruments in 91 patients with histologically proven LPPC. Most patients were randomized for immediate or deferred hormonal treatment until progression was observed. For analyses concerning the time to progression and survival the Kaplan-Meier method was used. RESULTS: Patients treated with androgen deprivation showed a significantly worse sexual, emotional, and physical function, experienced more hot flushes and a worse overall HRQOL, compared with patients receiving no therapy. Time to progression was significantly shorter in the deferred treated patients in comparison with the immediately treated patients (33 vs. 62 months, p<0.001). No significant differences were found with respect to the duration of survival. CONCLUSION: Hormonally treated patients with asymptomatic LPPC have a worse HRQOL compared with patients receiving no therapy. The duration of survival was similar, whether patients received immediate or deferred hormonal treatment. Nowadays, with patients' preferences playing an increasingly important role in therapeutic decision making, physicians should be aware of this negative impact and ought to inform the patients on this.","Eur Urol, 44(2): 209-214","Netherlands",2003,"Advanced","Hormonal","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General,Complication"]
[687,"van Andel, G., et al. (1997). \"Quality of life in patients with prostatic carcinoma: a review and results of a study in N+ disease. Prostate-specific antigen as predictor of quality of life.\" Urol Res 25 Suppl 2: S79-88.",null,"van Andel, G., et al.","Quality of life in patients with prostatic carcinoma: a review and results of a study in N+ disease. Prostate-specific antigen as predictor of quality of life","Clinical evaluation in oncology has typically focused on outcome indicators, while less attention has been paid to how treatment affects quality of life (QOL) of the patient. In this article some general aspects of quality of life are discussed, a short review of published data on QOL in patients with prostate cancer is given and results of a QOL study executed by the authors on patients with lymph node positive prostatic cancer are presented. The purpose of the study was to examine the impact of immediate or delayed treatment (after objective progression) in patients with prostatic carcinoma (T1-3 N1-3 M0) on quality of life parameters. To this end an extended questionnaire was constructed. Fifty-five patients participated. Assessment was performed twice, in 1994 and 1995. The comparison between patients with and patients without treatment showed in 1994 as well as in 1995 significant differences for hormonal treatment side effects such as sexual functioning and hot flushes, all of which were experienced more frequently by treated patients. In 1994 the treated patients experienced more psychological distress while in 1995 they showed worse physical function, less energy and more fatigue when compared to patients under surveillance. The premise that active treatment would improve the psychological quality of life was not sustained. In addition global health status and quality of life were identified as independent factors for progression in untreated patients with lymph node positive prostate cancer. Finally, an increase in prostate-specific antigen (PSA) in hormonally treated patients not only indicated hormonal escape but also a decrease in QOL.","Urol Res, 25 Suppl 2(S79-88","Netherlands",1997,"Advanced","None","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Complication"]
[688,"van Andel, G., et al. (2000). \"Quality of life assessment in patients with hormone-resistant prostate cancer treated with epirubicin or with epirubicin plus medroxy progesterone acetate - is it feasible?\" Eur Urol 38(3): 259-264.",null,"van Andel, G., et al.","Quality of life assessment in patients with hormone-resistant prostate cancer treated with epirubicin or with epirubicin plus medroxy progesterone acetate - is it feasible?","OBJECTIVES: The optimal palliative treatment in patients with advanced hormone-resistant prostate cancer (AHRPC) is still under investigation. We studied the effect of epirubicin, alone or combined with medroxy progesterone acetate (MPA), in this particular patient group. The aim of the study was to investigate the feasibility of quality of life (QOL) measurement and to ascertain whether MPA added to epirubicin produces a better QOL than epirubicin alone. METHODS: Of 28 randomized patients with symptomatic AHRPC, 26 were eligible for the study. Fourteen of them received epirubicin (100 mg/m(2) i.v.) every 3 weeks in combination with an oral dose of 500 mg of MPA twice daily. Twelve patients received epirubicin alone. For the QOL assessment, the Rotterdam Symptom Checkliste was used. Toxic side effects of chemotherapy were assed by the WHO criteria. Subjective responses included performance status and pain score. RESULTS: Compliance in completing QOL questionnaires was high (87.5%). In none of the QOL domains studied did any of the patients, irrespective of their treatment, experience an improvement in their QOL. Moreover, after 12 and 24 weeks, patients in both treatment arms experienced a significant worsening of physical symptom distress when compared to study entry. Toxicity was moderate to severe. A biochemical response (drop in prostate-specific antigen of more than 50%) was observed in 5 out of 26 patients (19.1%) and a subjective response in 7 out of 26 patients (26.9%). The median survival for all patients was 30 weeks. There was no statistically significant difference between the two arms. Performance status and the global QOL as judged by the patients themselves were associated with the duration of survival. No relation was found between the initial observed subjective response and survival. CONCLUSIONS: The feasibility of measuring QOL in patients with symptomatic AHRPC is demonstrated in the present study. Subjective and biochemical responses were observed in both treatment arms, but these were not translatable as improved measured QOL domains.","Eur Urol, 38(3): 259-264","Netherlands",2000,"Advanced","Chemotherapy,Palliative care","RSCL","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Symptom"]
[689,"van Andel, G., et al. (2003). \"A randomized study comparing epirubicin in a 4-weekly versus a weekly intravenous regimen in patients with metastatic, hormone resistant, prostatic carcinoma: effects on health related quality of life.\" World J Urol 21(3): 177-182.",null,"van Andel, G., et al.","A randomized study comparing epirubicin in a 4-weekly versus a weekly intravenous regimen in patients with metastatic, hormone resistant, prostatic carcinoma: effects on health related quality of life","The treatment of hormone resistant prostate cancer) with epirubicin 25 mg/m(2)(Epi25) on a weekly intravenous regimen may be better in terms of health related quality of life (HRQOL) than with 100 mg/m(2)(Epi100) on a 4-weekly regimen. A total of 79 patients who filled out the EORTC-QLQ-C30 questionnaire for the assessment of HRQOL could be evaluated. Compared with the baseline, no changes in HRQOL function scales or significant changes in the following HRQOL symptom scales were found. The Epi25 group reported less pain during the first 3 months and the Epi100 group more dyspnoea after 4 weeks and less pain and less insomnia but more loss of appetite after 8 weeks. In both groups, toxicity was comparable, except for World Health Organisation grade II-III alopecia occurring in 82% in the Epi100 versus 31% in the Epi25 group. There were no significant differences between groups in response rates and survival. In this study, HRQOL was not improved which is in line with other studies using only epirubicine. Epirubicin as single agent therapy should not be used in future treatment of patients with HRPC.","World J Urol, 21(3): 177-182","Netherlands",2003,"Metastatic","Chemotherapy","EORTC QLQ-C30","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General"]
[690,"Van Andel, G., et al. (2003). \"Health-related quality of life and psychosocial factors in patients with prostate cancer scheduled for radical prostatectomy or external radiation therapy.\" BJU Int 92(3): 217-222.",null,"Van Andel, G., et al.","Health-related quality of life and psychosocial factors in patients with prostate cancer scheduled for radical prostatectomy or external radiation therapy","OBJECTIVE: To assess whether baseline health-related quality of life (HRQOL) and psychosocial profiles differ in patients with prostate cancer scheduled for radical prostatectomy (RP) or external radiation therapy (ERT), as there is evidence that HRQOL is influenced by psychosocial factors (PFs), so that any variation at baseline should be considered when comparing the effect of therapy on HRQOL. PATIENTS AND METHODS: Before receiving therapy, HRQOL and PFs were assessed in 65 patients scheduled for RP and in 73 scheduled for ERT. To measure HRQOL (generic and disease-specific) and PFs, an extended questionnaire was constructed, using validated and standardized instruments. Clinical data were collected from patients' medical records. Comparisons adjusted for age and socio-economic status (SES) were analysed using Student's t-test and univariate analyses of variance and covariance. RESULTS: Patients scheduled for ERT were 7.9 years older and had a lower SES (both P < 0.001), more often had stage T3 and T4 disease, had poorer histopathological differentiation and higher levels of prostate-specific antigen (all P < 0.01). They also reported a worse physical, role, cognitive and social function, more fatigue, more pain, a lower overall HRQOL and worse sexual function than patients scheduled for RP. There were no differences in urinary and bowel function, nor in the PFs assessed. CONCLUSION: The baseline HRQOL profile of patients scheduled for RP is better than in those scheduled for ERT. These results are in line with those from the few other studies on this subject. Knowing the impact of RP and ERT on HRQOL should therefore be based mainly on longitudinal studies including baseline measures, the analyses of which should be adjusted for age and SES. In the present small study, baseline PFs did not differ between the treatments.","BJU Int, 92(3): 217-222","Netherlands",2003,"Any or unknown","Surgery,Radiotherapy","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"General,Disease"]
[691,"van Andel, G., et al. (2004). \"A prospective longitudinal study comparing the impact of external radiation therapy with radical prostatectomy on health related quality of life (HRQOL) in prostate cancer patients.\" Prostate 58(4): 354-365.",null,"van Andel, G., et al.","A prospective longitudinal study comparing the impact of external radiation therapy with radical prostatectomy on health related quality of life (HRQOL) in prostate cancer patients","BACKGROUND: The objective of the present study is to compare the impact on the general and disease-specific health related quality of life (HRQOL) of external radiation therapy (ERT) with radical prostatectomy (RP) in patients with localized prostate cancer, and to explore which factors, and to what extent, contribute to the assessed changes in HRQOL. METHODS: One hundred and thirty eight patients participated in this prospective longitudinal study. They completed before treatment (T0) and after 12 months (T1) a questionnaire constructed of validated instruments, measuring HRQOL and several psychosocial factors (PF). Among other things, multiple regression analyses including all baseline characteristics, HRQOL and PF were executed in order to meet the objectives. RESULTS: RP patients showed significantly more improvement in their emotional function, while they reported more incontinence and a worse sexual function. There was significantly more improvement in the overall HRQOL of ERT patients, while the changes in the gastrointestinal function of these patients were significantly worse. Only the differences with respect to incontinence can be attributed to the treatment itself. Almost all HRQOL change scores are primarily influenced by their own baseline score. The influence of other factors, like age, socioeconomic status, and several PF, is limited. CONCLUSIONS: The impact on HRQOL of ERT is similar to that of RP, except for incontinence. RP patients suffer more from incontinence than ERT patients. Changes in the assessed HRQOL are mainly influenced by the pre-treatment HRQOL scores.","Prostate, 58(4): 354-365","Netherlands",2004,"Local","Surgery,Radiotherapy","Unclear","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"General,Disease"]
[692,"van Andel, G., et al. (2008). \"An international field study of the EORTC QLQ-PR25: a questionnaire for assessing the health-related quality of life of patients with prostate cancer.\" Eur J Cancer 44(16): 2418-2424.",null,"van Andel, G., et al.","An international field study of the EORTC QLQ-PR25: a questionnaire for assessing the health-related quality of life of patients with prostate cancer","AIM: To evaluate the psychometrics of the EORTC QLQ-PR25, a questionnaire assessing the health-related quality of life of prostate cancer patients. METHODS: The QLQ-PR25 and the QLQ-C30 were administered to 642 prostate cancer patients from 13 countries treated with curative or palliative intent. The QLQ-PR25 assesses urinary, bowel and sexual symptoms and functioning, and the side-effects of hormonal treatment. RESULTS: Five hundred and nine patients were available for the final analysis. Multitrait scaling analyses confirmed the hypothesised scale structure of the QLQ-PR25. Internal consistency reliability was good (coefficient alpha=0.70-0.86) for the urinary symptoms and sexual function scales, but lower for the bowel function and side-effects of hormonal treatment scales (alpha<0.70). The module discriminated clearly between clinically distinct patient subgroups, and was responsive to changes in health status over time. CONCLUSION: In general, the QLQ-PR25 demonstrates acceptable psychometric properties and clinical validity. Some caution should be used in interpreting the bowel function and side-effects of hormonal therapy scales; results can be reported at the individual item and scale level.","Eur J Cancer, 44(16): 2418-2424","Netherlands",2008,"Any or unknown","Hormonal","EORTC QLQ-PR25,EORTC QLQ-C30","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease,General"]
[693,"van Brussel, J. P., et al. (2000). \"A phase II study of temozolomide in hormone-refractory prostate cancer.\" Cancer Chemother Pharmacol 45(6): 509-512.",null,"van Brussel, J. P., et al.","A phase II study of temozolomide in hormone-refractory prostate cancer","INTRODUCTION: Hormone-refractory disseminated prostate cancer is a major oncological problem. Preclinical studies with temozolomide, an oral alkylating agent, in prostate cancer have shown encouraging results. In phase I studies the safety of temozolomide in non-prostate cancer patients has been demonstrated. Based on these results, a phase II study of temozolomide in patients with metastatic disease who had developed progressive symptomatic disease while on antiandrogen therapy, was initiated. METHODS: A group of 18 patients started a 5-day temozolomide regimen, with a 28-day treatment cycle. Response parameters (prostate-specific antigen, bone scan, quality of life questionnaire) and toxicity (common toxicity criteria for international studies) were recorded at regular intervals. RESULTS: Of the 18 patients, 16 were evaluable by completing two or three cycles. All patients developed progressive disease within two cycles, except one who had progressive disease at the end of cycle 3. Of the 16 evaluable patients, 11 developed new bone metastases (bone scan), 1 developed lung metastases, 4 had progressive disease as reflected by a 25% increase in serum PSA together with subjective progression, and 7 and 5 had progressive disease as reflected by decreased quality of life and increased pain score, respectively. Toxicity was limited to nausea and vomiting, which was effectively treated with antiemetic medication, and anemia and thrombocytopenia, which returned to normal values within 1 week. DISCUSSION: Treatment with temozolomide was generally well tolerated, with occasionally moderate toxicity. As all patients developed progressive disease the results are rather discouraging. Temozolomide is ineffective for the treatment of patients with symptomatic progressive hormone-refractory prostate cancer.","Cancer Chemother Pharmacol, 45(6): 509-512","Netherlands",2000,"Metastatic","Chemotherapy","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General"]
[694,"van Dis, F. W., et al. (2006). \"A validation study of the Dutch version of the Quality of Life-Cancer Survivor (QOL-CS) questionnaire in a group of prostate cancer survivors.\" Qual Life Res 15(10): 1607-1612.",null,"van Dis, F. W., et al.","A validation study of the Dutch version of the Quality of Life-Cancer Survivor (QOL-CS) questionnaire in a group of prostate cancer survivors","The primary objective of this study was to validate the Dutch version of the Quality of Life-Cancer Survivor (QOL-CS) questionnaire using a group of Dutch prostate cancer survivors. The QOL-CS was specifically designed to measure the quality of life of long-term cancer survivors. We performed a population-based, cohort study of 784 prostate cancer survivors who were diagnosed with prostate cancer between 1994 and 1998. To determine the test-retest reliability, second questionnaires were sent to 109 participants, of whom 103 (94%) returned the forms. The quality of life in Dutch long-term prostate cancer survivors was adequately measured by the physical, psychological and social well-being subscale and can be used in order to measure the specific aspects of quality of life important to cancer survivors. However, as the subscale spiritual well-being showed a low internal consistency, which could be related to cultural background, it seems to be appropriate to evaluate the validity and reliability of the QOL-CS in other cultural settings.","Qual Life Res, 15(10): 1607-1612","Netherlands",2006,"Survivors","None","QOL-CS","Patient",null,"Validation",null,null,null,null,null,null,null,null,"General"]
[695,"van Gysen, K. L., et al. (2013). \"Health-related quality of life using intensity-modulated radiation therapy for post-prostatectomy radiotherapy.\" J Med Imaging Radiat Oncol 57(1): 89-96.",null,"van Gysen, K. L., et al.","Health-related quality of life using intensity-modulated radiation therapy for post-prostatectomy radiotherapy","INTRODUCTION: Post-prostatectomy radiotherapy (PPRT) with intensity-modulated radiation therapy (IMRT) has the potential to decrease toxicity by reducing dose to surrounding structures. We assessed its impact on health-related quality of life (HRQoL). METHODS: PPRT patients were enrolled in a prospective HRQoL database. To be eligible, patients were required to be treated with IMRT and have a minimum of 15-month follow up. HRQoL was assessed at baseline, 3, 9 and 15-24 months using the Expanded Prostate Cancer Index Composite questionnaire. Higher scores reflected better HRQoL. Results were analysed as both population means and as individual scores where a moderate change was 10-20 points and a substantial change was >20 points. RESULTS: There were 64 patients eligible and 83% of the cohort received salvage radiotherapy. Prescribed dose was 64 Gy in 32 fractions for adjuvant and 66 Gy in 33 fractions for salvage IMRT. Mean function scores for urinary, bowel and sexual domains were similar at baseline and 15 months (83.5, 94.2 and 16.9 vs. 82.2, 93.1 and 14.3, respectively). Mean global physical functioning (51.0 vs. 48.1) and mental functioning (51.6 vs. 54.2) showed no difference over time. Individual patient scores by 2 years showed a >20-point deterioration in urinary (12.5%), bowel (1.6%), sexual function (9.4%), physical functioning (3.1%) and mental functioning (1.6%). CONCLUSION: This report on HRQoL following post-prostatectomy IMRT demonstrates no variation in mean scores in any domain and only 1.6% of patients reporting a greater than 20-point deterioration between baseline and 15-24 months in bowel function.","J Med Imaging Radiat Oncol, 57(1): 89-96","Australia",2013,"Any or unknown","Surgery,Radiotherapy","EPIC","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease"]
[696,"van Leeuwen, M., et al. (2014). \"Recruiting long-term survivors of European Organisation for Research and Treatment of Cancer phase III clinical trials into quality of life studies: challenges and opportunities.\" Eur J Cancer 50(11): 1957-1963.",null,"van Leeuwen, M., et al.","Recruiting long-term survivors of European Organisation for Research and Treatment of Cancer phase III clinical trials into quality of life studies: challenges and opportunities","OBJECTIVES: In this pilot study we evaluated the feasibility of and methods for assessing the quality of life of long term survivors of European Organisation for Research and Treatment of Cancer (EORTC) phase III clinical trials. Here we report the results pertaining to the feasibility of conducting such research. METHODS: In this cross-sectional study, we recruited long-term, disease-free survivors from two mature EORTC clinical trials in testicular and prostate cancer from centres in Northern and Southern Europe, and the United Kingdom (UK). RESULTS: A number of challenges were encountered in recruiting participating centres, obtaining medical ethical approval and in recruiting survivors and collecting the health-related quality of life (HRQoL) data in a timely manner. The efficiency with which the study could be conducted varied widely across centres and countries. Time to obtain medical ethical approval for the study ranged from 1.5 to 25 months. We encountered most problems with ethical approval in the UK, Italy and Belgium. In most cases, data collection was completed within 3 months (range 10 weeks-1 year). Completed questionnaires were obtained from 68% and 56%, respectively, of the testicular and prostate cancer survivors who were approached. CONCLUSIONS: HRQoL research among long-term survivors of EORTC phase III clinical trials is possible, but the process of ethical approval and data collection is a lengthy one. To minimise many of the logistical problems, long-term follow-up of patients should be an integral part of future clinical trials. Moreover, regulations governing medical ethical approval for clinical research within the EU should be carefully evaluated to facilitate long-term follow-up of cancer survivors in Europe.","Eur J Cancer, 50(11): 1957-1963","Netherlands,France,Italy,Austria,Belgium,UK,Norway",2014,"Survivors","None","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"General"]
[697,"van Leeuwen, M., et al. (2017). \"International evaluation of the psychometrics of health-related quality of life questionnaires for use among long-term survivors of testicular and prostate cancer.\" Health Qual Life Outcomes 15(1): 97.",null,"van Leeuwen, M., et al.","International evaluation of the psychometrics of health-related quality of life questionnaires for use among long-term survivors of testicular and prostate cancer","BACKGROUND: Understanding of the physical, functional and psychosocial health problems and needs of cancer survivors requires cross-national and cross-cultural standardization of health-related quality of life (HRQoL) questionnaires that capture the full range of issues relevant to cancer survivors. To our knowledge, only one study has investigated in a comprehensive way whether a questionnaire used to evaluate HRQoL in cancer patients under active treatment is also reliable and valid when used among (long-term) cancer survivors. In this study we evaluated, in an international context, the psychometrics of HRQoL questionnaires for use among long-term, disease-free, survivors of testicular and prostate cancer. METHODS: In this cross-sectional study, we recruited long-term survivors of testicular and prostate cancer from Northern and Southern Europe and from the United Kingdom who had participated in two phase III EORTC clinical trials. Participants completed the SF-36 Health Survey, the EORTC QLQ-C30 questionnaire, the QLQ-PR25 (for prostate cancer) or the QLQ-TC26 (for testicular cancer) questionnaires, and the Impact of Cancer questionnaire. Testicular cancer survivors also completed subscales from the Nordic Questionnaire for Monitoring the Age Diverse Workforce. RESULTS: Two hundred forty-two men (66% response rate) were recruited into the study. The average time since treatment was more than 10 years. Overall, there were few missing questionnaire data, although scales related to sexuality, satisfaction with care and relationship concerns of men without partners were missing in more than 10% of cases. Debriefing showed that in general the questionnaires were accepted well. Many of the survivors scored at the upper extremes of the questionnaires, resulting in floor and ceiling effects in 64% of the scales. All of the questionnaires investigated met the threshold of 0.70 for group level reliability, with the exception of the QLQ-TC26 (mean reliability .64) and the QLQ-PR25 (mean reliability .69). The questionnaires were able to discriminate clearly between patients with and without comorbid conditions. CONCLUSIONS: The currently available HRQoL questionnaires exhibit acceptable psychometric properties and were well received by patients, but additional efforts are needed to ensure that the full range of survivor-specific issues is assessed.","Health Qual Life Outcomes, 15(1): 97","Netherlands,Italy,France,Norway,Austria,Belgium",2017,"Survivors","Unclear","SF-36,EORTC QLQ-C30,EORTC QLQ-PR25","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease,General,Utility"]
[698,"Van Vulpen, M., et al. (2003). \"A prospective quality of life study in patients with locally advanced prostate cancer, treated with radiotherapy with or without regional or interstitial hyperthermia.\" Int J Hyperthermia 19(4): 402-413.",null,"Van Vulpen, M., et al.","A prospective quality of life study in patients with locally advanced prostate cancer, treated with radiotherapy with or without regional or interstitial hyperthermia","INTRODUCTION: The aim of this prospective study was to describe quality of life (QoL) in patients with locally advanced prostate carcinoma treated with conventional radiotherapy and to evaluate the influence of adding regional or interstitial hyperthermia. MATERIALS AND METHODS: All patients were irradiated using a CT-planned conventional three field technique, administering 70 Gy to prostate and vesicles. In two different phase I studies, hyperthermia was added to the radiotherapy. Twelve patients were treated with one interstitial hyperthermia treatment, lasting 60 min. Fourteen patients have been treated with five regional hyperthermia treatments, lasting 75 min each. In both hyperthermia studies, the body, bladder and rectum temperatures remained below safety limits. Patients treated with radiotherapy alone (n = 58) or combined with regional (n = 8) or interstitial hyperthermia (n = 12) completed the European Organization for Research and Treatment of Cancer (EORTC) core questionnaire (C30 + 3), the EORTC prostate cancer module (PR25) and the Rand 36 health survey before treatment and 1 and 6 months after completion of treatment. Analysis of Variance (ANOVA) for repeated measurements has been performed to describe the data. RESULTS: All patient groups were comparable concerning patient characteristics. No significant interaction or difference in QoL has been noticed between the two hyperthermia patient groups and the patient group without hyperthermia. Therefore, all groups were analysed together (n = 78) to detect QoL changes in time. A deterioration of QoL has been measured from baseline to 1 month after treatment. Fatigue, pain, urinary symptoms, bowel symptoms and financial difficulties increased significantly. Social, physical and role functioning worsened significantly. No differences in QoL were measured 6 months after treatment compared to the baseline measurement, except for a decrease in sexual activity. CONCLUSIONS: After radiotherapy with or without hyperthermia only a temporary deterioration of QoL occurs, concerning social, psychological and disease related symptoms. Additional hyperthermia does not seem to decrease QoL.","Int J Hyperthermia, 19(4): 402-413","Netherlands",2003,"Advanced","Radiotherapy,Various","EORTC QLQ-C30,EORTC QLQ-PR25,SF-36","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,General,Utility"]
[699,"Vandecasteele, K., et al. (2012). \"Evaluation of the efficacy and safety of Salvia officinalis in controlling hot flashes in prostate cancer patients treated with androgen deprivation.\" Phytother Res 26(2): 208-213.",null,"Vandecasteele, K., et al.","Evaluation of the efficacy and safety of Salvia officinalis in controlling hot flashes in prostate cancer patients treated with androgen deprivation","The purpose of this pilot study was to evaluate the efficacy and safety of Salvia officinalis in controlling hot flashes in prostate cancer patients treated with androgen deprivation therapy (ADT). Ten patients experiencing hot flashes were included in a single-centre prospective pilot study. Treatment consisted of 150 mg of Salvia officinalis extract taken orally three times daily. A diary questionnaire scoring hot flashes, subjective side effects and quality of life (QOL) had to be completed. Clinical examination was performed at every visit and the concentration of ADT-linked hormones, haemoglobin and cholesterol was measured before, during and after ending treatment. Before the start of treatment, a 1 week baseline registration was performed. An analysis of variance with time of measurement as a within-subject factor was performed. When analysing the hot flashes score, one patient was excluded due to insufficient diary notes. The mean weekly score declined from 112 (SD = 71) at baseline to 59 (SD = 54) at the end of treatment (p = 0.002). Hot flashes diminished significantly from the first week up to and including week 3. This was maintained during treatment. There was no effect on QOL. There were no side effects. It is concluded that Salvia officinalis is efficient and safe in the treatment hot flashes, without improving QOL.","Phytother Res, 26(2): 208-213","Belgium",2012,"Any or unknown","Hormonal,Various","Diary","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General,Symptom"]
[700,"Vasarainen, H., et al. (2013). \"Effects of prostate cancer screening on health-related quality of life: results of the Finnish arm of the European randomized screening trial (ERSPC).\" Acta Oncol 52(8): 1615-1621.",null,"Vasarainen, H., et al.","Effects of prostate cancer screening on health-related quality of life: results of the Finnish arm of the European randomized screening trial (ERSPC)","BACKGROUND: As prostate cancer (PC) mortality reduction results are not unequivocal, a special emphasis has to be put on other aspects of the prostate-specific antigen (PSA) screening, including effects on quality of life. In the present study we describe the short-term effects of various phases of PC screening on health-related quality of life (HRQL). MATERIAL AND METHODS: The study participants were randomized into the screening arm within the Finnish component of the European Randomized Study on Screening for Prostate Cancer (ERSPC). The RAND 36-Item Health Survey on HRQL and questionnaires on sociodemographic and behavioral factors were delivered to participants at various phases of the first screening round: 1) 500 participants at invitation; 2) 500 after screening; 3) 500 after obtaining the PSA result; 4) to 300 participants after undergoing digital rectal examination (DRE) (but prior to being informed of its result); and 5) approximately 300 after prostate biopsy. At each stage, a new sample of participants was recruited. RESULTS: Response rates were 59% at invitation, 77% after PSA blood test, 54% after PSA result and 69% after DRE. The men recruited at each stage were comparable in respect to socioeconomic variables. The HRQL scores in RAND-36 subscales showed little variation in the different phases of the screening process. Compared with the previous phase, the social function score was slightly lower after obtaining the PSA result than after blood test, the emotional role score lower after DRE than after PSA result and the pain-related score lower after DRE than after TRUS and biopsy. The screening participants were comparable to the general population as their HRQL scores were similar to an age-stratified general Finnish male population. CONCLUSION: Short-term HRQL effects of prostate cancer screening appear minor and transient.","Acta Oncol, 52(8): 1615-1621","Finland",2013,"At risk","Screening","SF-36","General population",null,"Clinical trial",null,null,null,null,null,null,null,null,"Utility"]
[701,"Verma, V., et al. (2018). \"Quality of Life and Patient-Reported Outcomes Following Proton Radiation Therapy: A Systematic Review.\" J Natl Cancer Inst 110(4).",null,"Verma, V., et al.","Quality of Life and Patient-Reported Outcomes Following Proton Radiation Therapy: A Systematic Review","Background: As costs of cancer care rise, the importance of documenting value in oncology increases. Proton beam radiotherapy (PBT) has the potential to reduce toxicities in cancer patients, but is relatively expensive and unproven. Evaluating quality of life (QOL) and patient-reported outcomes (PROs) is essential to establishing PBT's \"value\" in oncologic therapy. The goal of this systematic review was to assess QOL and PROs in patients treated with PBT. Methods: Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)-guided systematic searches were conducted. The PubMed search engine was the primary data source, along with publications found from references of selected articles, and articles known to the authors published through 2017. Seventeen original investigations were found to have sufficient focus and relevance to be incorporated into the systematic review. Results: Studies of skull base (n = 1), brain (n = 1), head/neck (n = 1), lung (n = 1), breast (n = 2), prostate (n = 8), and pediatric (n = 3) malignancies treated with PBT that met eligibility criteria were included. QOL did not deteriorate during PBT for skull base and after PBT for brain tumors, respectively. PROs were higher for PBT than photon-based radiotherapy for both head/neck and lung cancer. Patient-reported breast cosmesis was appropriate after PBT and comparable to photon modalities. PBT in various settings of prostate cancer displayed an expected post-therapy decline; one study showed improved PROs (rectal urgency, bowel frequency) for PBT, and two others showed PROs/QOL comparable with other modalities. Pediatric studies demonstrated improvements in QOL during therapy, with additional increases thereafter. Conclusions: Based on limited data, PBT provides favorable QOL/PRO profiles for select brain, head/neck, lung, and pediatric cancers; measures for prostate and breast cancers were more modest. These results have implications for cost-effective cancer care and prudently designed QOL evaluation in ongoing trials, which are discussed. Future data could substantially change the conclusions of this review.","J Natl Cancer Inst, 110(4): ","International",2018,"Any or unknown","Radiotherapy","Unclear","Patient",null,"Systematic review",null,null,null,null,null,null,null,null,"Complication"]
[702,"Vickers, A. J., et al. (2010). \"Validation study of a web-based assessment of functional recovery after radical prostatectomy.\" Health Qual Life Outcomes 8: 82.",null,"Vickers, A. J., et al.","Validation study of a web-based assessment of functional recovery after radical prostatectomy","BACKGROUND: Good clinical care of prostate cancer patients after radical prostatectomy depends on careful assessment of post-operative morbidities, yet physicians do not always judge patient symptoms accurately. Logistical problems associated with using paper questionnaire limit their use in the clinic. We have implemented a web-interface (\"STAR\") for patient-reported outcomes after radical prostatectomy. METHODS: We analyzed data on the first 9 months of clinical implementation to evaluate the validity of the STAR questionnaire to assess functional outcomes following radical prostatectomy. We assessed response rate, internal consistency within domains, and the association between survey responses and known predictors of sexual and urinary function, including age, time from surgery, nerve sparing status and co-morbidities. RESULTS: Of 1581 men sent an invitation to complete the instrument online, 1235 responded for a response rate of 78%. Cronbach's alpha was 0.84, 0.86 and 0.97 for bowel, urinary and sexual function respectively. All known predictors of sexual and urinary function were significantly associated with survey responses in the hypothesized direction. CONCLUSIONS: We have found that web-based assessment of functional recovery after radical prostatectomy is practical and feasible. The instrument demonstrated excellent psychometric properties, suggested that validity is maintained when questions are transferred from paper to electronic format and when patients give responses that they know will be seen by their doctor and added to their clinic record. As such, our system allows ready implementation of patient-reported outcomes into routine clinical practice.","Health Qual Life Outcomes, 8(82","USA",2010,"Any or unknown","Surgery","STAR","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Symptom"]
[703,"Vieira, I., et al. (2014). \"Prostate cancer follow-up needs: do patients and professionals agree?\" Br J Nurs 23(9): S12, s14-19.",null,"Vieira, I., et al.","Prostate cancer follow-up needs: do patients and professionals agree?","BACKGROUND: With recent changes in the economy and the drive for cost-effective health care, current practices in the NHS need to be reviewed and revised. In light of this, the aim of this study is to investigate the perceived benefits of routine follow-up of patients with prostate cancer and to examine perceptions of prostate cancer patients and health professionals about who should follow-up patients and where and when this should take place. METHODS: A service evaluation was carried out on a sample of patients receiving follow-up assessment following radical treatment for prostate cancer and health professionals in a specialist cancer urology unit in an acute NHS trust in south-east England. Data were collected through patient (n=47) and health professional (n=17) questionnaires and through a group discussion with a sample of patients (n=52). RESULTS: There was agreement between patients and professionals that the main purpose of follow-up consultation was to review the prostate-specific antigen (PSA) blood test and assess urinary symptoms. The majority of patients and professionals wanted follow-up in the hospital with face-to-face consultation. There was general agreement that assessments should be carried out every six months. An overwhelming majority of patients (95%) felt that it was important to have easy access to the urology cancer nurses and doctors. CONCLUSION: Patients want to maintain the traditional model of hospital based follow-up in specialist urology cancer clinics. However, this approach is not economically sustainable. If this is to change we need to work with our patients to develop a service that meets their needs. For a new approach to follow-up to meet the needs of patients, they need to be confident that they have access to expert advice and support, and are assured of referral back to the urology team if required. Nurses are ideally placed to play a key role in the development of such a service.","Br J Nurs, 23(9): S12, s14-19","UK",2014,"Any or unknown","None","Unclear","Patient,HCP",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Views"]
[704,"Viers, B. R., et al. (2015). \"Efficiency, satisfaction, and costs for remote video visits following radical prostatectomy: a randomized controlled trial.\" Eur Urol 68(4): 729-735.",null,"Viers, B. R., et al.","Efficiency, satisfaction, and costs for remote video visits following radical prostatectomy: a randomized controlled trial","BACKGROUND: Telemedicine in an ambulatory surgical population remains incompletely evaluated. OBJECTIVE: To investigate patient encounters in the outpatient setting using video visit (VV) technology compared to traditional office visits (OVs). DESIGN, SETTING, AND PARTICIPANTS: From June 2013 to March 2014, 55 prescreened men with a history of prostate cancer were prospectively randomized. VVs, with the patient at home or at work, were included in the outpatient clinic calendar of urologists. INTERVENTION: Remote VV versus traditional OV. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: An equivalence analysis was used to assess the primary outcome, visit efficiency as measured by time studies. Secondary outcomes were patient/provider satisfaction and costs. RESULTS AND LIMITATIONS: There were 28 VVs and 27 OVs. VVs were equivalent in efficiency to relative to OVs, as measured by patient-provider face time (mean 14.5 vs 14.3min; p=0.96), patient wait time (18.4 vs 13.0min; p=0.20), and total time devoted to care (17.9 vs 17.8min; p=0.97). There were no significant differences in patient perception of visit confidentiality, efficiency, education quality, or overall satisfaction. VVs incurred lower costs, including distance traveled (median 0 vs 95 miles), travel time (0 vs 95min), missed work (0 vs 1 d), and money spent on travel ($0 vs $48; all p<0.0001). There was a high level of urologist satisfaction for both VVs (88%) and OVs (90%). The major limitation was sample size. CONCLUSIONS: VV in the ambulatory postprostatectomy setting may have a future role in health care delivery models. We found equivalent efficiency, similar satisfaction, but significantly reduced patient costs for VV compared to OV. Further prospective analyses are warranted. PATIENT SUMMARY: Among men with surgically treated prostate cancer, we evaluated the utility of remote video visits compared to office visits for outpatient consultation with a urologist. Video visits were associated with equivalent efficiency, similar satisfaction, and significantly lower patient costs when compared to office visits. We conclude that video visits may have a future role in health care delivery models.","Eur Urol, 68(4): 729-735","USA",2015,"Any or unknown","Surgery,Various","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Satisfaction,Costs"]
[705,"Visser, A., et al. (2003). \"Changes in health-related quality of life of men with prostate cancer 3 months after diagnosis: the role of psychosocial factors and comparisment with benign prostate hyperplasia patients.\" Patient Educ Couns 49(3): 225-232.",null,"Visser, A., et al.","Changes in health-related quality of life of men with prostate cancer 3 months after diagnosis: the role of psychosocial factors and comparisment with benign prostate hyperplasia patients","The objective of the pilot study is to measure the changes in health-related quality of life (HRQOL, general and prostate specific) 3 months after the disease has been diagnosed in men with prostate cancer. The results are compared with benign prostate hyperplasia (BPH) patients. Also the influence of psychosocial factors (distress, coping and social support) on the experienced changes in health-related quality of life is studied for both patient groups. The sample consists of 61 patients who filled in the questionnaire before the diagnosis was know to them and after 3 months (38 benign prostate hyperplasia and 23 prostate cancer patients). The measures consist of: quality of life, micturation symptoms, sexual functioning, coping style, psychological distress, life events, social support, social desirability, and health behavior. The results show a decrease in quality of life for prostate cancer patient after three moments, while the quality of life measure for BPH patients are stable over time. For both patient groups, the psychosocial factors do not change after 3 months. The psychosocial factors contribute only marginal to the changes in quality of life. Conclusions are drawn concerning the need and the content of psychosocial support and education for prostate cancer patients.","Patient Educ Couns, 49(3): 225-232","Netherlands",2003,"Any or unknown","None","Unclear","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"General,Symptom,Social,Comorbidity"]
[706,"Voerman, B., et al. (2006). \"Health-related quality of life in Dutch men with prostate cancer.\" J Psychosoc Oncol 24(2): 49-64.",null,"Voerman, B., et al.","Health-related quality of life in Dutch men with prostate cancer","Prostate cancer is the most prevalent solid malignancy in men in the Netherlands. With regard to treatment, the focus of attention has shifted in the last decade from pure survival rates to health-related quality of life. HRQOL is affected differently by different treatments. The objective of this study is to assess the HRQOL related to treatment regime and time since diagnosis in Dutch men with prostate cancer. We conducted a cross-sectional study among 238 men with prostate cancer in a heterogeneous sample who filled in a general health-related quality-of-life measure (EORTC-QLQ-C30) and a prostate cancer specific quality-of-life instrument (the EORTC-QLQ-PR25) and a Joy-of-Life questionnaire. Men on hormonal treatment are doing worse compared with other treatments with respect to physical functioning, role functioning, fatigue, pain and sexual functioning. No differences were found between radical prostatectomy and radiation therapy on any of the HRQOL dimensions nor for time since diagnosis. In hormonal therapy, men who are diagnosed longer than two years ago report a worse cognitive functioning and more burdens from urinary problems.","J Psychosoc Oncol, 24(2): 49-64","Netherlands",2006,"Any or unknown","Surgery,Radiotherapy,Hormonal","EORTC QLQ-C30,EORTC QLQ-PR25,JOL","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Disease,General"]
[707,"Volk, R. J., et al. (2004). \"Preferences of husbands and wives for outcomes of prostate cancer screening and treatment.\" J Gen Intern Med 19(4): 339-348.",null,"Volk, R. J., et al.","Preferences of husbands and wives for outcomes of prostate cancer screening and treatment","OBJECTIVE: To explore the preferences of male primary care patients and their spouses for the outcomes of prostate cancer screening and treatment, and quality of life with metastatic prostate cancer. DESIGN: Cross-sectional design. SETTING: Primary care clinics in Galveston County, Texas. PATIENTS: One hundred sixty-eight couples in which the husband was a primary care patient and a candidate for prostate cancer screening. MEASUREMENTS AND MAIN RESULTS: Preferences were measured as utilities for treatment outcomes and quality of life with metastatic disease by the time trade-off method for the husband and the wife individually and then conjointly for the couple. For each health state considered, husbands associated lower utilities for the health states than did their wives. Couples' utilities fell between those of husbands and wives (all comparisons were significant at P <.01). For partial and complete impotence and mild-to-moderate incontinence, the median utility value for the wives was 1.0, indicating that most wives did not associate disutility with their husbands having to experience these treatment complications. CONCLUSIONS: Male primary care patients who are candidates for prostate cancer screening evaluate the outcomes of prostate cancer treatment and life with advanced prostate cancer as being far worse than do their wives. Because the choice between quantity and quality of life is a highly individualistic one, both the patient and his partner should be involved in making decisions about prostate cancer screening. J","J Gen Intern Med, 19(4): 339-348","USA",2004,"At risk","Screening","TTO","Patient,Caregiver",null,"Validation",null,null,null,null,null,null,null,null,"Utility"]
[708,"Vordermark, D., et al. (2006). \"3-D conformal treatment of prostate cancer to 74 Gy vs. high-dose-rate brachytherapy boost: a cross-sectional quality-of-life survey.\" Acta Oncol 45(6): 708-716.",null,"Vordermark, D., et al.","3-D conformal treatment of prostate cancer to 74 Gy vs. high-dose-rate brachytherapy boost: a cross-sectional quality-of-life survey","The effects of two modalities of dose-escalated radiotherapy on health-related quality of life (HRQOL) were compared. Forty-one consecutive patients were treated with a 3-D conformal (3-DC) boost to 74 Gy, and 43 with high-dose rate (HDR) brachytherapy boost (2x9 Gy), following 3-D conformal treatment to 46 Gy. Median age was 70 years in both groups, median initial PSA was 7.9 microg/l in 3-DC boost patients and 8.1 microg/l in HDR boost patients. Stage was <or=T2 in 66% and 67% and Gleason score was >or=7 in 52% and 47%, respectively. HRQOL was assessed cross-sectionally using EORTC QLQ-C30 and organ-specific PR25 modules 3--32 (median 19) and 4--25 (median 14) months after treatment, respectively. Questionnaires were completed by 93% and 97% of patients, respectively. Diarrhea and insomnia scores were significantly increased in both groups. In the PR25 module, scores of 3-DC boost and HDR boost patients for urinary, bowel and treatment-related symptoms were similar. Among responders, 34% of 3-DC boost patients and 86% of HDR boost patients had severe erectile problems. Dose escalation in prostate cancer by either 3-DC boost to 74 Gy or HDR brachytherapy boost appears to result in similar HRQOL profiles.","Acta Oncol, 45(6): 708-716","Germany",2006,"Any or unknown","Radiotherapy,Brachytherapy","EORTC QLQ-C30,EORTC QLQ-PR25","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Disease,General"]
[709,"Wahlgren, T., et al. (2004). \"Health-related quality of life in men after treatment of localized prostate cancer with external beam radiotherapy combined with (192)ir brachytherapy: a prospective study of 93 cases using the EORTC questionnaires QLQ-C30 and QLQ-PR25.\" Int J Radiat Oncol Biol Phys 60(1): 51-59.",null,"Wahlgren, T., et al.","Health-related quality of life in men after treatment of localized prostate cancer with external beam radiotherapy combined with (192)ir brachytherapy: a prospective study of 93 cases using the EORTC questionnaires QLQ-C30 and QLQ-PR25","PURPOSE: To describe prospectively the long-term health-related quality of life (HRQOL) and treatment-related symptoms in patients with localized prostate cancer treated with neoadjuvant androgen deprivation therapy and radical radiotherapy (RT), including external beam RT and iridium high-dose-rate brachytherapy, and to compare them with age-matched normative data. METHODS AND MATERIALS: A total of 93 patients with T1-T3a tumors consecutively treated with definitive RT at our institution completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ)-C30 and QLQ-prostate specific 25-item (PR25) module twice at an 18-month interval 0-18 months after RT. Subgroups were analyzed regarding acute and late effects on symptoms and quality of life. RESULTS: The main analysis included 80 patients who were disease free at the final assessment. The levels of HRQOL were generally high, did not change over time, and were comparable to the normative data. Symptom development (urinary, bowel, and sexual) correlated well with the known acute and late effects of radical RT and neoadjuvant androgen deprivation therapy. CONCLUSION: Combining external beam RT and HDR brachytherapy when treating prostate cancer did not appear to impair HRQOL and was comparable to that of other brachytherapy methods. The negative contribution from late neoadjuvant androgen deprivation therapy on symptom development seemed to be substantial but mostly transitory. Additional research is needed to determine the long-term HRQOL (3-5 years), and interventional randomized studies are suggested.","Int J Radiat Oncol Biol Phys, 60(1): 51-59","Sweden",2004,"Local","Radiotherapy,Brachytherapy","EORTC QLQ-C30,EORTC QLQ-PR25","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease,General"]
[710,"Wakatsuki, M., et al. (2008). \"Quality of life in men treated with carbon ion therapy for prostate cancer.\" Int J Radiat Oncol Biol Phys 72(4): 1010-1015.",null,"Wakatsuki, M., et al.","Quality of life in men treated with carbon ion therapy for prostate cancer","PURPOSE: To prospectively assess patient quality of life (QOL) after carbon ion radiotherapy (C-ion RT) for prostate cancer, using established questionnaires. METHODS AND MATERIAL: The subjects were 150 patients who underwent C-ion RT. Of these, 25 patients with low-risk prostate cancer received C-ion RT alone, whereas the remaining 125 patients with a high-risk tumor also received androgen deprivation therapy. Quality of life was assessed using the self-administered Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire in all patients three times. In addition, the University of California-Los Angeles Prostate Cancer Index (UCLA-PCI) was conducted in the low-risk patients. RESULTS: The FACT-General (FACT-G) and FACT-P scores at 12 months after treatment averaged over all 150 patients showed no significant change compared with those before C-ion RT. In FACT-P subscales, emotional well-being increased significantly just after and 12 months after treatment. In contrast, physical well-being (PWB) and social/family well-being (S/FWB) decreased significantly at 12 months, whereas the prostate cancer subscale (PCS) decreased significantly just after treatment. Average scores for FACT-G, FACT-P, PWB, S/FWB, and PCS for the 125 patients receiving hormone therapy showed substantial detrimental changes at 12 months. In contrast, those of the 25 low-risk patients who had no hormone therapy showed no significant change. Similarly no significant change in the average of the UCLA-PCI scores in the low-risk patients was seen at 12 months. CONCLUSIONS: Average QOL parameters reported by patients with localized prostate cancer treated with C-ion RT, in the absence of hormone therapy, showed no significant decrease 12 months after C-ion RT.","Int J Radiat Oncol Biol Phys, 72(4): 1010-1015","Japan",2008,"Any or unknown","Radiotherapy,Hormonal","FACT-P,FACT-G,UCLA-PCI","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,Treatment"]
[711,"Waldmann, A., et al. (2009). \"Measuring prostate-specific quality of life in prostate cancer patients scheduled for radiotherapy or radical prostatectomy and reference men in Germany and Canada using the Patient Oriented Prostate Utility Scale-Psychometric (PORPUS-P).\" BMC Cancer 9: 295.",null,"Waldmann, A., et al.","Measuring prostate-specific quality of life in prostate cancer patients scheduled for radiotherapy or radical prostatectomy and reference men in Germany and Canada using the Patient Oriented Prostate Utility Scale-Psychometric (PORPUS-P)","BACKGROUND: The PORPUS-P is a short questionnaire for measuring prostate-specific quality of life (QoL), which was designed in Canada for use in prostate cancer (PC) patients. We aimed to generate a German version and compare PORPUS-P scores of German reference men from the general population, and German and Canadian patients with newly diagnosed PC who were scheduled to receive radical prostatectomy (RP) or radiotherapy (RT). METHODS: The study sample consisted of 988 reference men, 121 German and 66 Canadian PC patients scheduled for RT, and 371 German and 68 Canadian PC patients scheduled for RP. All men completed the PORPUS-P (German postal questionnaire, Canada personal interview). Data were gathered from PC patients before the start of therapy. RESULTS: Canadian patients were better educated than the German patients, and fewer were retired. Patients scheduled to receive RT were older and more were retired. German RT patients had lower D'Amico risk scores and pre-treatment Gleason scores than RP patients, and Canadian RT patients had higher pre-treatment PSA than RP patients. Urinary and sexual dysfunction were seen in PC patients (especially RT patients), but were also common in the German reference men. Crude mean PORPUS-P scores differed statistically significant between German RT and RP and Canadian RP and RT patients, with RT patients having higher QoL scores. The differences in age-adjusted mean PORPUS-P scores between reference men and RP patients were not clinically significant, while RT patients had (clinically) significantly lower scores than the reference men. CONCLUSION: The German translation of the PORPUS-P appears to be a short and feasible tool for assessing prostate-specific QoL. Although we found a similar response pattern, Canadian and German PC patients scheduled to receive RT or RP rated their pre-treatment quality of life on different levels, which reveals the need for national reference data. Problems in several QoL domains exist before treatment, and differ between PC patients scheduled for RT and RP.","BMC Cancer, 9(295","Germany,Canada",2009,"Any or unknown","Surgery,Radiotherapy","PORPUS","Patient,General population",null,"Validation",null,null,null,null,null,null,null,null,"Utility"]
[712,"Wallace, M. (2003). \"Uncertainty and quality of life of older men who undergo watchful waiting for prostate cancer.\" Oncol Nurs Forum 30(2): 303-309.",null,"Wallace, M.","Uncertainty and quality of life of older men who undergo watchful waiting for prostate cancer","PURPOSE/OBJECTIVES: To explore uncertainty, anxiety, and the personal manner in which uncertainty is understood, and explain the health-related and affective quality of life (QOL) of men who undergo watchful waiting for prostate cancer. DESIGN: Descriptive, quantitative, survey approach. SETTING: United States. SAMPLE: A national sample of 21 men diagnosed with prostate cancer (mean age = 76 years) who had elected to receive no treatment for their disease. METHODS: 19 subjects who met the criteria contacted the researcher and completed the mailed questionnaire. MAIN RESEARCH VARIABLES: Uncertainty and QOL. FINDINGS: Moderate yet significant relationships were found between each of the independent variables. Significant relationships were found among uncertainty, anxiety, and the perception of danger (a dimension of QOL). Using hierarchical multiple regression, a model was built to explain 60% of the variance in this QOL dimension. CONCLUSIONS: This study supports that men who undergo watchful waiting are uncertain and that this uncertainty results in their perception of danger and influences their affective health-functioning QOL. This study lends further support for the Uncertainty in Illness Model in the watchful waiting population. IMPLICATIONS FOR NURSING: The findings of this study imply that increased teaching and patient care management regarding watchful waiting are needed both before and after the treatment decision has been made. This study provides the framework for further study on interventions to improve the QOL of this population.","Oncol Nurs Forum, 30(2): 303-309","USA",2003,"Local","Surveillance","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"General"]
[713,"Wallerstedt, A., et al. (2015). \"Short-term results after robot-assisted laparoscopic radical prostatectomy compared to open radical prostatectomy.\" Eur Urol 67(4): 660-670.",null,"Wallerstedt, A., et al.","Short-term results after robot-assisted laparoscopic radical prostatectomy compared to open radical prostatectomy","BACKGROUND: Robot-assisted laparoscopic radical prostatectomy has become a widespread technique despite a lack of randomised trials showing its superiority over open radical prostatectomy. OBJECTIVE: To compare in-hospital characteristics and patient-reported outcomes at 3 mo between robot-assisted laparoscopic and open retropubic radical prostatectomy. DESIGN, SETTING, AND PARTICIPANTS: A prospective, controlled trial was performed of all men who underwent radical prostatectomy at 14 participating centres. Validated patient questionnaires were collected at baseline and after 3 mo by independent health-care researchers. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The difference in outcome between the two treatment groups were analysed using logistic regression analysis, with adjustment for identified confounders. RESULTS AND LIMITATIONS: Questionnaires were received from 2506 (95%) patients. The robot-assisted surgery group had less perioperative bleeding (185 vs 683 ml, p<0.001) and shorter hospital stay (3.3 vs 4.1 d, p<0.001) than the open surgery group. Operating time was shorter with the open technique (103 vs 175 min, p<0.001) compared with the robot-assisted technique. Reoperation during initial hospital stay was more frequent after open surgery after adjusting for tumour characteristics and lymph node dissection (1.6% vs 0.7%, odds ratio [OR] 0.31, 95% confidence interval [CI 95%] 0.11-0.90). Men who underwent open surgery were more likely to seek healthcare (for one or more of 22 specified disorders identified prestudy) compared to men in the robot-assisted surgery group (p=0.03). It was more common to seek healthcare for cardiovascular reasons in the open surgery group than in the robot-assisted surgery group, after adjusting for nontumour and tumour-specific confounders, (7.9% vs 5.8%, OR 0.63, CI 95% 0.42-0.94). The readmittance rate was not statistically different between the groups. A limitation of the study is the lack of a standardised tool for the assessment of the adverse events. CONCLUSIONS: This large prospective study confirms previous findings that robot-assisted laparoscopic radical prostatectomy is a safe procedure with some short-term advantages compared to open surgery. Whether these advantages also include long-term morbidity and are related to acceptable costs remain to be studied. PATIENT SUMMARY: We compare patient-reported outcomes between two commonly used surgical techniques. Our results show that the choice of surgical technique may influence short-term outcomes.","Eur Urol, 67(4): 660-670","Sweden,Iceland",2015,"Any or unknown","Surgery","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Costs"]
[714,"Wallner, K. (2002). \"Prostate brachytherapy under local anesthesia; lessons from the first 600 patients.\" Brachytherapy 1(3): 145-148.",null,"Wallner, K.","Prostate brachytherapy under local anesthesia; lessons from the first 600 patients","PURPOSE: Local anesthesia for prostate brachytherapy was instituted at the Puget Sound Veterans Hospital in 1999, peforming the procedure in our own department without anesthesia personnel in attendance. MATERIALS AND METHODS: The patient is brought into the simulator suite in the radiation oncology department, an i.v. line is started, a cardiac monitor attached, and a urinary catheter is inserted. He is then placed in the lithotomy position, using stirrups attached to the simulator table. A 6-8 cm patch of perineal skin and subcutaneous tissue is anesthetized by local infiltration of 1% lidocaine. The transrectal ultrasound (TRUS) probe is then inserted and positioned to reproduce the planning images. A 3.0 inch 22-gauge spinal needle is used to inject lidocaine up to the prostatic apex, in a pattern around the periphery of the prostate. Once the pelvic floor and prostatic apex are anesthetized, a 7.0-inch, 22-gauge spinal needle is inserted through an 18-gauge 3 inch spinal needle into the peripheral planned needle tracks, monitored by TRUS. As the needles are advanced to the prostatic base, about 1.0 cc of lidocaine solution is injected in the intraprostatic track. A total of 200 to 500 mg of lidocaine is used. RESULTS: As of December 2000, more than 600 patients have received implants under local anesthesia at Seattle, WA. Patients tolerate brachytherapy under local anesthesia surprisingly well. Post-implant CT-defined target coverage has ranged from 80% to 95%, well within published criteria for technical adequacy. Patients' typical implant pain score is 3, on a scale of 0-10. After a series of patient acceptance quality studies, we have abandoned the routine use of sedation, and relied instead on local lidocaine infiltration alone. CONCLUSION: In addition to a high degree of patient satisfaction, performing implants under local anesthesia allows for phenomenal logistical efficiencies and cost advantages.","Brachytherapy, 1(3): 145-148","USA",2002,"Any or unknown","Brachytherapy","NPS","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Symptom"]
[715,"Walsh, P. C., et al. (2000). \"Patient-reported urinary continence and sexual function after anatomic radical prostatectomy.\" Urology 55(1): 58-61.",null,"Walsh, P. C., et al.","Patient-reported urinary continence and sexual function after anatomic radical prostatectomy","OBJECTIVES: After radical prostatectomy, the rates for recovery of urinary continence and sexual function reported by experienced surgeons are much higher than the patient-reported outcomes from other centers. It is uncertain whether this represents differences in surgical technique or in the collection of data. This study was performed to determine patient-reported rates of continence and potency after radical prostatectomy performed by an experienced surgeon at a high-volume referral center for the treatment of localized prostate cancer. METHODS: Sixty-four men with localized prostate cancer who were potent preoperatively and who had sexual partners underwent anatomic radical prostatectomy between March 1997 and January 1998. A validated disease-targeted quality-of-life survey that assesses function and bother in two organ systems (urinary and sexual) was administered preoperatively and at 3, 6, 12, and 18 months postoperatively. RESULTS: Urinary continence, which was defined as wearing no pads, gradually improved during the first 12 months after surgery, and at 1 2 and 18 months, 93% of the patients were dry. Throughout the study, 93% to 98% of the patients characterized their urinary bother as none or small. Potency, defined as the ability to have unassisted intercourse with or without the use of sildenafil, improved gradually, and by 18 months, 86% of patients were potent and 84% considered sexual bother as none or small. Although one third of patients at 18 months were using sildenafil intermittently, only 2 patients were not able to have intercourse without its use. CONCLUSIONS: Patient-reported rates of continence and potency after radical prostatectomy performed by an experienced surgeon are high.","Urology, 55(1): 58-61","USA",2000,"Local","Surgery","Unclear","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"General"]
[716,"Wang, H., et al. (2000). \"Self-assessed health-related quality of life in men who have completed radiotherapy for prostate cancer: instrument validation and its relation to patient-assessed bother of symptoms.\" Int J Cancer 90(3): 163-172.",null,"Wang, H., et al.","Self-assessed health-related quality of life in men who have completed radiotherapy for prostate cancer: instrument validation and its relation to patient-assessed bother of symptoms","The purpose of this study was to develop a psychometrically reliable and valid questionnaire to assess the disease-specific dimensions of health-related quality of life (HRQOL) in the urinary function (UF), bowel function (BF), and sexual function (SF) domains of prostate cancer (PCa) patients treated with radiation therapy. Patients were given a six-page questionnaire using Likert-type questions assessing three HRQOL dimensions during their follow-up visits after completing radiotherapy. Scales created from an earlier study were utilized and tested for reliability and validity. In addition, we assessed the relationship between these dimensions and the degree to which a decreased HRQOL increases the degree to which patients feel bothered about their symptoms. There are two scales within each dimension: BF, Urgency and Daily Living; UF, Urgency and Weakness of Stream; SF, Interest/Satisfaction and Impotence. Internal-consistency reliability coefficients (Cronbach's alpha) for the proposed scales range from 0.48 to 0.92, and all item-scale correlations and divergence correlations validate the use of the scales, ranging from 0.49 to 0.89. The validity of these scales is also confirmed by the rising median scores with rising reported levels of patient-perceived \"bother.\" The different dimensions have differing quantitative influences on patients. We have developed a prostate-specific HRQOL instrument that is an adequate and suitable tool for measuring HRQOL along three distinct dimensions for patients who have completed radiotherapy for PCa. Psychometric standards for reliability and validity were met for the proposed scales. Moreover, positive correlations were found between these dimensions and how bothered patients were by their symptoms, suggesting important relationships that should be followed in PCa patients after radiotherapy. Certain scales have strong influences on patient-perceived \"bothersomeness\" of symptoms, such as loss of control of BF, urgency of BF, urgency of urination, and level of interest/satisfaction in sex. Compared to our earlier study on patients being treated with radiotherapy for PCa, this study produced very similar results. With some modification, the same questionnaire could be used for both groups of patients. Int. J. Cancer (Radiat. Oncol. Invest.) 90, 163-172 (2000).","Int J Cancer, 90(3): 163-172","USA",2000,"Any or unknown","Radiotherapy","Unclear","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Symptom,Complication"]
[717,"Watkins-Bruner, D., et al. (1995). \"RTOG's first quality of life study--RTOG 90-20: a phase II trial of external beam radiation with etanidazole for locally advanced prostate cancer.\" Int J Radiat Oncol Biol Phys 33(4): 901-906.",null,"Watkins-Bruner, D., et al.","RTOG's first quality of life study--RTOG 90-20: a phase II trial of external beam radiation with etanidazole for locally advanced prostate cancer","PURPOSE: To assess institutional and patient compliance with quality of life (QL) instruments in RTOG clinical trials. To assess feasibility of using the Functional Assessment Cancer Therapy (FACT), Sexual Adjustment Questionnaire (SAQ), and Changes in Urinary Function (CUF) QL instruments in a prostate clinical trial and to compare patient self-report of symptoms to medical professional ratings of the same symptoms using the RTOG acute toxicity rating scales. METHODS AND MATERIALS: Three self-assessment QL instruments, the FACT, the SAQ, and CUF, were to be administered to patients on a Phase II locally advanced prostate trial at specified time points. Specific instructions for both data managers and for patients on when, how, and why to fill out the questionnaires were included. RESULTS: Sixty-seven percent (24 out of 36) of patients accrued to RTOG 90-20 completed both the initial FACT and SAQ. Eighty-five percent completed FACT at end of RT and 73% at 3 months. Eighty-one percent completed SAQ at end of treatment, while 69% completed this form at 3 months. Compliance drops off thereafter. Seventy-five percent of patients who had their symptom of dysuria rated by a medical professional as 0 on the RTOG toxicity rating scale self-reported the same. Only 56% of patient self-reports on FACT regarding diarrhea were in agreement with the medical professional's RTOG rating of 0 toxicity. The measures were determined to be in moderate agreement when the patient evaluated a symptom as a 1 on the FACT and the medical professional rated the same symptom as a 0 on the RTOG toxicity rating scale. There was moderate agreement in 13% of patients with dysuria and 31% of patients with diarrhea. Low agreement occurred when the patient evaluated a symptom as a 2 or 3 on the FACT and the medical professional rated the same symptom as a 0 on the RTOG scale. Low agreement occurred in 13% of both patients reporting dysuria and diarrhea. Differences between how medical professionals and patients were able to rate erectile function make direct comparisons difficult, but the trend towards significant discrepancies is still noteworthy. CONCLUSIONS: Quality of life assessments are necessary and attainable in RTOG clinical trials. Compliance rates for both institutional and patient participation were acceptable at initial and 3 month follow-up. Reasons for noncompliance were predominantly institution related and not patient related. Strategies to address both institution and patient compliance have been developed and implemented within the RTOG. Serious disagreement between patient self-reports of symptoms on the FACT QL scale and medical professional ratings on the RTOG acute toxicity rating scales of the same symptoms was 13% at 3 months follow-up. This warrants continued use of QL self-assessments in clinical trials.","Int J Radiat Oncol Biol Phys, 33(4): 901-906","USA",1995,"Advanced","Radiotherapy,Various","FACT-G,SAQ,CUF","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Treatment,Complication,Symptom"]
[718,"Watson, E., et al. (2006). \"Informed decision making and prostate specific antigen (PSA) testing for prostate cancer: a randomised controlled trial exploring the impact of a brief patient decision aid on men's knowledge, attitudes and intention to be tested.\" Patient Educ Couns 63(3): 367-379.",null,"Watson, E., et al.","Informed decision making and prostate specific antigen (PSA) testing for prostate cancer: a randomised controlled trial exploring the impact of a brief patient decision aid on men's knowledge, attitudes and intention to be tested","OBJECTIVE: To examine the impact of a brief patient decision aid (pDA) on men's knowledge, attitudes and intention to have a prostate specific antigen (PSA) test. To explore the important predictors of intention to be tested in men who received the brief pDA. METHODS: A brief pDA designed to facilitate informed decision-making for men considering PSA testing was developed for the NHS Prostate Cancer Risk Management Programme. Men aged 40-75 years selected from 11 General Practices in England and Wales were randomised to receive either a mailed copy of the brief pDA and a questionnaire (intervention group), or a questionnaire alone (control group). The questionnaire assessed knowledge, attitudes, perceived risk and intention to have a PSA test and, for the intervention group, their perceptions of the brief pDA. RESULTS: Nine hundred and ninety of the men who were eligible for the study returned completed questionnaires (response rate=54%). Men who received the brief pDA had significantly higher knowledge scores (p<0.0001) and less positive attitudes (p<0.0001) regarding PSA testing than men in the control group. There was no significant difference between the two groups in intention to be tested within the next 12 months. 87% of men found the brief pDA was easy to read, 94% considered it contained about the right amount of detail and 94% felt the information was presented in a balanced way. Multivariate analysis identified perceived risk (p<0.0001), perceived benefits of PSA testing (p<0.0001), knowledge (p=0.004), attitude (p=0.007) and age (p=0.01) as the most important independent predictors of intention to be tested amongst men in the intervention group. CONCLUSION: The brief pDA was shown to dramatically increase men's knowledge of the benefits and risks of the PSA test. Men who received the brief pDA were significantly less positive about the PSA test, although there was no difference between the two groups regarding their intention to be tested within the next year. PRACTICE IMPLICATIONS: This brief pDA could serve as an acceptable and low cost adjunct to counselling by the General Practitioner (GP), and should promote informed decision making regarding the PSA test. Further research is required to ascertain the utility of the decision aid during the consultation.","Patient Educ Couns, 63(3): 367-379","UK",2006,"At risk","Various,Screening","Unclear","General population",null,"Clinical trial",null,null,null,null,null,null,null,null,"Knowledge"]
[719,"Watts, S., et al. (2015). \"A quantitative analysis of the prevalence of clinical depression and anxiety in patients with prostate cancer undergoing active surveillance.\" BMJ Open 5(5): e006674.",null,"Watts, S., et al.","A quantitative analysis of the prevalence of clinical depression and anxiety in patients with prostate cancer undergoing active surveillance","OBJECTIVE: To quantitatively determine the prevalence of anxiety and depression in men on active surveillance (AS). DESIGN: Cross-sectional questionnaire survey. SETTING: Secondary care prostate cancer (PCa) clinics across South, Central and Western England. PARTICIPANTS: 313 men from a total sample of 426 with a histological diagnosis of PCa currently managed with AS were identified from seven UK urology departments. The mean age of respondents was 70 (51-86) years with the majority (76%) being married or in civil partnerships. 94% of responders were of white British ethnicity. PRIMARY OUTCOME MEASURES: The prevalence of clinically meaningful depression and anxiety as assessed by the Hospital Anxiety and Depression Scale (HADS; score >/=8/21). SECONDARY OUTCOME MEASURES: Patient demographic data (age, employment, relationship, ethnic and educational status). Each demographic variable was cross-tabulated against patients identified as depressed or anxious to allow for the identification of variables that were significantly associated with depression and anxiety. In order to determine predictors for depression and anxiety among the demographic variables, logistic regression analyses were conducted, with p<0.05 considered as indicating statistical significance. RESULTS: The prevalence of clinical anxiety and depression as determined via the HADS (HADS >/=8) was 23% (n=73) and 12.5% (n=39), respectively. Published data from men in the general population of similar age has shown prevalence rates of 8% and 6%, respectively, indicating a twofold increase in depression and a threefold increase in anxiety among AS patients. Our findings also suggest that AS patients experience substantially greater levels of anxiety than patients with PCa treated radically. The only demographic predictor for anxiety or depression was divorce. CONCLUSIONS: Patients with PCa managed with AS experienced substantially higher rates of anxiety and depression than that expected in the general population. Strategies to address this are needed to improve the management of this population and their quality of life.","BMJ Open, 5(5): e006674","UK",2015,"Any or unknown","Surveillance","HADS","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Comorbidity"]
[720,"Wei, J. T. and J. E. Montie (2000). \"Comparison of patients' and physicians' rating of urinary incontinence following radical prostatectomy.\" Semin Urol Oncol 18(1): 76-80.",null,"Wei, J. T. and J. E. Montie","Comparison of patients' and physicians' rating of urinary incontinence following radical prostatectomy","One of the most important endpoints following a radical prostatectomy focuses on the recovery of urinary continence; however, the reported incontinence rates have been quite variable. In men with prostate cancer, it has been found that the physician's assessment of a patient's symptom does not correlate with the patient's own assessment. To further explore the differences in the reported outcomes between physicians and patients, we evaluated the assessment of urinary incontinence in a cohort of men undergoing radical prostatectomy. A total of 145 individuals completed a brief urinary continence questionnaire postoperatively at the 1-year anniversary of their operation and also had the physicians' assessment of incontinence documented in the medical record. Patient-reported incontinence rates varied from 13% to 65% depending on the definition of incontinence applied and the greatest agreement was seen when the physicians' assessment of incontinence was compared with the patient's report of pad use and urinary bother. These comparisons resulted in only moderate to good levels of agreement, which suggests that a more reliable and accurate means to evaluate urinary incontinence following radical prostatectomy needs to be developed.","Semin Urol Oncol, 18(1): 76-80","USA",2000,"Any or unknown","Surgery","Unclear","HCP,Patient",null,"Validation",null,null,null,null,null,null,null,null,"Complication"]
[721,"Wei, J. T., et al. (2000). \"Development and validation of the expanded prostate cancer index composite (EPIC) for comprehensive assessment of health-related quality of life in men with prostate cancer.\" Urology 56(6): 899-905.",null,"Wei, J. T., et al.","Development and validation of the expanded prostate cancer index composite (EPIC) for comprehensive assessment of health-related quality of life in men with prostate cancer","OBJECTIVES: Health-related quality of life (HRQOL) is an increasingly important endpoint in prostate cancer care. However, pivotal issues that are not fully assessed in existing HRQOL instruments include irritative urinary symptoms, hormonal symptoms, and multi-item scores quantifying bother between urinary, sexual, bowel, and hormonal domains. We sought to develop a novel instrument to facilitate more comprehensive assessment of prostate cancer-related HRQOL. METHODS: Instrument development was based on advice from an expert panel and prostate cancer patients, which led to expanding the 20-item University of California-Los Angeles Prostate Cancer Index (UCLA-PCI) to the 50-item Expanded Prostate Index Composite (EPIC). Summary and subscale scores were derived by content and factor analyses. Reliability and validity were assessed by test-retest correlation, Cronbach's alpha coefficient, interscale correlation, and EPIC correlation with other validated instruments. RESULTS: Test-retest reliability and internal consistency were high for EPIC urinary, bowel, sexual, and hormonal domain summary scores (each r >/=0.80 and Cronbach's alpha >/=0.82) and for most domain-specific subscales. Correlations between function and bother subscales within domains were high (r >0.60). Correlations between different primary domains were consistently lower, indicating that these domains assess distinct HRQOL components. EPIC domains had weak to modest correlations with the Medical Outcomes Study 12-item Short-Form Health Survey (SF-12), indicating rationale for their concurrent use. Moderate agreement was observed between EPIC domains relevant to the Functional Assessment of Cancer Therapy Prostate module (FACT-P) and the American Urological Association Symptom Index (AUA-SI), providing criterion validity without excessive overlap. CONCLUSIONS: EPIC is a robust prostate cancer HRQOL instrument that complements prior instruments by measuring a broad spectrum of urinary, bowel, sexual, and hormonal symptoms, thereby providing a unique tool for comprehensive assessment of HRQOL issues important in contemporary prostate cancer management.","Urology, 56(6): 899-905","USA",2000,"Any or unknown","None","EPIC,SF-12,FACT-P,AUA-SI","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease,Utility,Symptom"]
[722,"Wei, J. T., et al. (2000). \"Prospective assessment of patient reported urinary continence after radical prostatectomy.\" J Urol 164(3 Pt 1): 744-748.",null,"Wei, J. T., et al.","Prospective assessment of patient reported urinary continence after radical prostatectomy","PURPOSE: Reported urinary continence rates after radical prostatectomy vary. Although modifications of radical prostatectomy meant to improve outcome, such as nerve sparing or bladder neck preservation, are in widespread use, to our knowledge evidence to support these practices based on patient report is scant. We evaluated the potential effects of nerve sparing and bladder neck preservation on urinary continence after radical prostatectomy, and assessed the impact of various urinary continence definitions on the observed outcome. MATERIALS AND METHODS: We prospectively evaluated a cohort of men with prostate cancer who elected surgery with and without nerve sparing, and bladder neck preservation as primary therapy. A total of 482 men completed a brief urinary continence questionnaire preoperatively and postoperatively at a median followup of 18 months. Urinary continence was followed prospectively using the questionnaire and patient reported urinary continence recovery was based on 3 definitions of continence. RESULTS: Median time to continence recovery based on patient reporting was significantly shorter in the nerve sparing than in the nonnerve sparing group when continence was defined as no urinary leakage (5.3 versus 10.9 months, p <0.01). A multivariate model controlling for baseline factors revealed that significant predictors of continence outcome were preoperative continence, patient age, nerve sparing and the interaction of nerve sparing with age (p <0.05). The definition of urinary continence also affected outcome. CONCLUSIONS: The nerve sparing technique of radical prostatectomy was associated with improved recovery of urinary continence in an age dependent manner, whereas bladder neck preservation was not beneficial. Patient age and the sensitivity of the incontinence definitions, as reflected by the associated variable rates of preoperative baseline incontinence, are significant contexts for interpreting urinary function data after radical prostatectomy. These factors may partially explain the variation in continence rates in the literature.","J Urol, 164(3 Pt 1): 744-748","USA",2000,"Any or unknown","Surgery","Unclear","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Complication"]
[723,"Wei, J. T., et al. (2002). \"Comprehensive comparison of health-related quality of life after contemporary therapies for localized prostate cancer.\" J Clin Oncol 20(2): 557-566.",null,"Wei, J. T., et al.","Comprehensive comparison of health-related quality of life after contemporary therapies for localized prostate cancer","PURPOSE: Health-related quality-of-life (HRQOL) concerns are pivotal in choosing prostate cancer therapy. However, concurrent HRQOL comparison between brachytherapy, external radiation, radical prostatectomy, and controls is hitherto lacking. HRQOL effects of hormonal adjuvants and of cancer control after therapy also lack prior characterization. PATIENTS AND METHODS: A cross-sectional survey was administered to patients who underwent brachytherapy, external-beam radiation, or radical prostatectomy during 4 years at an academic medical center and to age-matched controls. HRQOL among controls was compared with therapy groups. Comparison between therapy groups was performed using regression models to control covariates. HRQOL effects of cancer progression were evaluated. RESULTS: One thousand fourteen subjects participated. Compared with controls, each therapy group reported bothersome sexual dysfunction; radical prostatectomy was associated with adverse urinary HRQOL; external-beam radiation was associated with adverse bowel HRQOL; and brachytherapy was associated with adverse urinary, bowel, and sexual HRQOL (P < or =.0002 for each). Hormonal adjuvant symptoms were associated with significant impairment (P <.002). More than 1 year after therapy, several HRQOL outcomes were less favorable among subjects after brachytherapy than after external radiation or radical prostatectomy. Progression-free subjects reported better sexual and hormonal HRQOL than subjects with increasing prostate-specific antigen (P <.0001). CONCLUSION: Long-term HRQOL after prostate brachytherapy showed no benefit relative to radical prostatectomy or external-beam radiation and may be less favorable in some domains. Hormonal adjuvants can be associated with significant impairment. Progression-free survival is associated with HRQOL benefits. These findings facilitate patient counseling regarding HRQOL expectations and highlight the need for prospective studies sensitive to urinary irritative and hormonal concerns in addition to incontinence, sexual, and bowel HRQOL domains.","J Clin Oncol, 20(2): 557-566","USA",2002,"Local","Surgery,Radiotherapy,Brachytherapy","Unclear","Patient",null,"Case-control",null,null,null,null,null,null,null,null,"Complication"]
[724,"Weinfurt, K. P., et al. (2005). \"The significance of skeletal-related events for the health-related quality of life of patients with metastatic prostate cancer.\" Ann Oncol 16(4): 579-584.",null,"Weinfurt, K. P., et al.","The significance of skeletal-related events for the health-related quality of life of patients with metastatic prostate cancer","BACKGROUND: We examined the clinical relevance of skeletal-related events (SREs) for health state preferences, pain and health-related quality of life in patients with advanced prostate cancer and a history of bone metastases. PATIENTS AND METHODS: Data were from a clinical trial of zoledronic acid versus placebo in the treatment of SREs associated with advanced prostate cancer metastatic to bone. Patients (n=248) were included if they experienced an SRE during the study. Outcome measures were assessed at fixed intervals. We used mixed-effects models to estimate changes in outcomes after each patient's first SRE. RESULTS: There were clinically meaningful and statistically significant declines in physical well-being after: radiation and pathologic fractures; functional well-being after radiation; and emotional well-being after radiation and pathologic fractures. There also were meaningful and significant declines in preference and utility scores after radiation and fracture. Pain intensity declined after radiation, but not after other SREs; no other pain measure changed substantively. CONCLUSIONS: SREs have important and significant effects on measures of health-related quality of life in men with prostate cancer. Treatments that prevent SREs may not demonstrate corresponding effects on outcomes if the effects of SREs occur between scheduled outcome assessments. Implications for trial design are discussed.","Ann Oncol, 16(4): 579-584","USA",2005,"Metastatic","Bisphosphonate","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Utility"]
[725,"Weinrich, S. P., et al. (1998). \"The impact of prostate cancer knowledge on cancer screening.\" Oncol Nurs Forum 25(3): 527-534.",null,"Weinrich, S. P., et al.","The impact of prostate cancer knowledge on cancer screening","PURPOSE/OBJECTIVES: To test the effect of knowledge on participation in prostate cancer screening. DESIGN: Quasi-experimental design; PRECEDE framework. SAMPLE: 319 men, 82% African American. METHODS: Prostate cancer knowledge was measured with a Prostate Cancer Knowledge Questionnaire prior to a community-based educational program. Men were referred to their personal physicians for a free prostate cancer screening. Results were sent to the Prostate Cancer Project. MAIN RESEARCH VARIABLES: Prostate cancer knowledge and participation in free prostate screening with a digital rectal examination and prostate specific antigen. FINDINGS: Prostate cancer knowledge was a predictor in participation in screening (p = 0.05). IMPLICATIONS FOR NURSING PRACTICE: Nurses need to target educational interventions for African American men, who have the highest incidence of and mortality rates for prostate cancer, to significantly reduce mortality rates. This study documented the importance of providing educational programs to increase participation in prostate cancer screening.","Oncol Nurs Forum, 25(3): 527-534","USA",1998,"At risk","Screening","PCKQ","General population",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Knowledge"]
[726,"Weitzner, M. A., et al. (1999). \"The Caregiver Quality of Life Index-Cancer (CQOLC) scale: development and validation of an instrument to measure quality of life of the family caregiver of patients with cancer.\" Qual Life Res 8(1-2): 55-63.",null,"Weitzner, M. A., et al.","The Caregiver Quality of Life Index-Cancer (CQOLC) scale: development and validation of an instrument to measure quality of life of the family caregiver of patients with cancer","Family caregivers have become increasingly responsible for providing home care for cancer patients. Research has documented the distress of family caregivers; however, little has been done to evaluate the broader impact of caregiving on quality of life (QoL). The objectives of this study were to evaluate the reliability and validity of the Caregiver Quality of Life Index-Cancer (CQOLC), a new self-report instrument. Two hundred and sixty-three family caregivers of patients with lung, breast or prostate neoplasms participated. Test-retest reliability was 0.95 and internal consistency was 0.91. As expected, there were moderate correlations with overall mental health (r = 0.64), emotional distress (r = -0.50 to -0.52), burden (r = -0.65) and patient's performance status (r = -0.47) and low correlations with overall physical health (r = 0.13), social support (r = 0.22) and social desirability (r = 0.08). These results show that increased overall mental health is associated with better QoL, while more emotional distress and worsening patient performance status are associated with poorer QoL. Thus, the CQOLC appears to possess adequate validity, test-retest reliability and internal consistency. Future directions include further evaluation of sensitivity to change and factor analysis to determine the principal health-related QoL domains evaluated by the CQOLC.","Qual Life Res, 8(1-2): 55-63","USA",1999,"Any or unknown","None","CQOLC","Caregiver",null,"Validation",null,null,null,null,null,null,null,null,"Carer"]
[727,"Westhoff, P. G., et al. (2014). \"An easy tool to predict survival in patients receiving radiation therapy for painful bone metastases.\" Int J Radiat Oncol Biol Phys 90(4): 739-747.",null,"Westhoff, P. G., et al.","An easy tool to predict survival in patients receiving radiation therapy for painful bone metastases","PURPOSE: Patients with bone metastases have a widely varying survival. A reliable estimation of survival is needed for appropriate treatment strategies. Our goal was to assess the value of simple prognostic factors, namely, patient and tumor characteristics, Karnofsky performance status (KPS), and patient-reported scores of pain and quality of life, to predict survival in patients with painful bone metastases. METHODS AND MATERIALS: In the Dutch Bone Metastasis Study, 1157 patients were treated with radiation therapy for painful bone metastases. At randomization, physicians determined the KPS; patients rated general health on a visual analogue scale (VAS-gh), valuation of life on a verbal rating scale (VRS-vl) and pain intensity. To assess the predictive value of the variables, we used multivariate Cox proportional hazard analyses and C-statistics for discriminative value. Of the final model, calibration was assessed. External validation was performed on a dataset of 934 patients who were treated with radiation therapy for vertebral metastases. RESULTS: Patients had mainly breast (39%), prostate (23%), or lung cancer (25%). After a maximum of 142 weeks' follow-up, 74% of patients had died. The best predictive model included sex, primary tumor, visceral metastases, KPS, VAS-gh, and VRS-vl (C-statistic = 0.72, 95% CI = 0.70-0.74). A reduced model, with only KPS and primary tumor, showed comparable discriminative capacity (C-statistic = 0.71, 95% CI = 0.69-0.72). External validation showed a C-statistic of 0.72 (95% CI = 0.70-0.73). Calibration of the derivation and the validation dataset showed underestimation of survival. CONCLUSION: In predicting survival in patients with painful bone metastases, KPS combined with primary tumor was comparable to a more complex model. Considering the amount of variables in complex models and the additional burden on patients, the simple model is preferred for daily use. In addition, a risk table for survival is provided.","Int J Radiat Oncol Biol Phys, 90(4): 739-747","Netherlands",2014,"Metastatic","Radiotherapy","VAS,VRS","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"General"]
[728,"Westhoff, P. G., et al. (2015). \"Quality of Life in Relation to Pain Response to Radiation Therapy for Painful Bone Metastases.\" Int J Radiat Oncol Biol Phys 93(3): 694-701.",null,"Westhoff, P. G., et al.","Quality of Life in Relation to Pain Response to Radiation Therapy for Painful Bone Metastases","PURPOSE: To study quality of life (QoL) in responders and nonresponders after radiation therapy for painful bone metastases; and to identify factors predictive for a pain response. PATIENTS AND METHODS: The prospectively collected data of 956 patients with breast, prostate, and lung cancer within the Dutch Bone Metastasis Study were used. These patients, irradiated for painful bone metastases, rated pain, QoL, and overall health at baseline and weekly afterward for 12 weeks. Using generalized estimating equations analysis, the course of QoL was studied, adjusted for primary tumor. To identify predictive variables, proportional hazard analyses were performed, taking into account death as a competing risk, and C-statistics were calculated for discriminative value. RESULTS: In total, 722 patients (76%) responded to radiation therapy. During follow-up, responders had a better QoL in all domains compared with nonresponders. Patients with breast or prostate cancer had a better QoL than patients with lung cancer. In multivariate analysis, baseline predictors for a pain response were breast or prostate cancer as primary tumor, younger age, good performance status, absence of visceral metastases, and using opioids. The discriminative ability of the model was low (C-statistic: 0.56). CONCLUSIONS: Responding patients show a better QoL after radiation therapy for painful bone metastases than nonresponders. Our model did not have enough discriminative power to predict which patients are likely to respond to radiation therapy. Therefore, radiation therapy should be offered to all patients with painful bone metastases, aiming to decrease pain and improve QoL.","Int J Radiat Oncol Biol Phys, 93(3): 694-701","Netherlands",2015,"Metastatic","Radiotherapy","Unclear","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"General,Symptom"]
[729,"Wheat, J. C., et al. (2009). \"Clinical interpretation of the Expanded Prostate Cancer Index Composite-Short Form sexual summary score.\" J Urol 182(6): 2844-2849.",null,"Wheat, J. C., et al.","Clinical interpretation of the Expanded Prostate Cancer Index Composite-Short Form sexual summary score","PURPOSE: The Expanded Prostate Cancer Index Composite is a validated health related quality of life instrument that is commonly administered after prostate cancer treatment. We classified Expanded Prostate Cancer Index Composite-Short Form sexual summary scores into clinically meaningful groups. MATERIALS AND METHODS: A development cohort of 561 patients undergoing radical prostatectomy was used to define sexual summary groups by correlation with their responses on the Sexual Health Inventory for Men. A separate validation cohort of 430 patients was used to compare Expanded Prostate Cancer Index Composite-Long Form sexual bother scores among these sexual summary groups. RESULTS: A sexual summary group score of 0 to 33, 34 to 45, 46 to 60, 61 to 75 and greater than 75 correlated with Sexual Health Inventory for Men groups of severe--1 to 7, moderate--8 to 11, mild/moderate--12 to 16, mild--17 to 21 and no erectile dysfunction--22 to 25, respectively. In the validation group mean sexual bother scores in each of the 5 sexual summary groups were significantly different from each other after controlling for patient age, stage, hormone treatment, marital status and nerve sparing (p <0.0001). CONCLUSIONS: Expanded Prostate Cancer Index Composite-Short Form sexual summary scores can be categorized into 5 groups for which excellent correlation is found with similar validated groups based on the Sexual Health Inventory for Men. Also, sexual bother scores are significantly different among the groups, showing that they represent discrete, clinically relevant cutoffs. This will help patients and physicians interpret Expanded Prostate Cancer Index Composite scores and help define potency for comparison among various prostate cancer treatments.","J Urol, 182(6): 2844-2849","USA",2009,"Any or unknown","Surgery,Hormonal","EPIC,SHIM","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease,Complication"]
[730,"Widmark, A., et al. (2003). \"Does prophylactic breast irradiation prevent antiandrogen-induced gynecomastia? Evaluation of 253 patients in the randomized Scandinavian trial SPCG-7/SFUO-3.\" Urology 61(1): 145-151.",null,"Widmark, A., et al.","Does prophylactic breast irradiation prevent antiandrogen-induced gynecomastia? Evaluation of 253 patients in the randomized Scandinavian trial SPCG-7/SFUO-3","OBJECTIVES: To examine the development of antiandrogen-induced gynecomastia and breast tenderness in the first 253 patients in a randomized Scandinavian trial (SPCG-7/SFUO-3) with a 12-month complete follow-up evaluation performed by both doctors and patients. METHODS: In this study, the treating doctor and patient decided whether prophylactic irradiation (RT) of the breast should be given to prevent antiandrogen-induced gynecomastia. At each visit, the doctor evaluated the occurrence of gynecomastia and breast tenderness. Questions about gynecomastia and breast tenderness were also included in the study quality-of-life questionnaire (Prostate Cancer Symptom Scale). RESULTS: Mammary RT with mostly single fraction (12 to 15 Gy) electrons was given to 174 (69%) of the 253 evaluated patients. At the 1-year follow-up visit, the doctor evaluations indicated some form of gynecomastia in 71% and 28% (P <0.001) of the nonirradiated (no-RT) and irradiated (RT) patients, respectively. The patient evaluations at 1 year showed some form of breast enlargement in 78% and 44% (P <0.001) of the no-RT and RT patients, respectively. The doctors reported some form of breast tenderness at 1 year in 75% and 43% (P <0.001) of the no-RT and RT patients, respectively. The patient evaluations of breast tenderness show an expected significant increase in the RT arm at the 3-month follow-up, which was probably due to skin reactions. At 1 year, significantly more patients who marked \"very much\" on the Prostate Cancer Symptom Scale were seen in the no-RT group. A weak correlation between the doctors' and patients' detection of breast problems was observed. CONCLUSIONS: The results show that, with high significance, prophylactic RT of the breast decreases the risk of antiandrogen-induced gynecomastia and breast tenderness.","Urology, 61(1): 145-151","Sweden",2003,"Any or unknown","Radiotherapy,Hormonal","PCSI","HCP,Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Symptom"]
[731,"Wiegner, E. A. and C. R. King (2010). \"Sexual function after stereotactic body radiotherapy for prostate cancer: results of a prospective clinical trial.\" Int J Radiat Oncol Biol Phys 78(2): 442-448.",null,"Wiegner, E. A. and C. R. King","Sexual function after stereotactic body radiotherapy for prostate cancer: results of a prospective clinical trial","PURPOSE: To study the sexual quality of life for prostate cancer patients after stereotactic body radiotherapy (SBRT). METHODS AND MATERIALS: Using the Expanded Prostate Cancer Index Composite (EPIC)-validated quality-of-life questionnaire, the sexual function of 32 consecutive patients who received prostate SBRT in a prospective Phase II clinical trial were analyzed at baseline, and at median times of 4, 12, 20, and 50 months after treatment. SBRT consisted of 36.25 Gy in five fractions of 7.25 Gy using the Cyberknife. No androgen deprivation therapy was given. The use of erectile dysfunction (ED) medications was monitored. A comprehensive literature review for radiotherapy-alone modalities based on patient self-reported questionnaires served as historical comparison. RESULTS: Median age at treatment was 67.5 years, and median follow-up was 35.5 months (minimum 12 months). The mean EPIC sexual domain summary score, sexual function score, and sexual bother score decreased by 45%, 49%, and 25% respectively at 50 months follow-up. These differences reached clinical relevance by 20 months after treatment. Baseline ED rate was 38% and increased to 71% after treatment (p = 0.024). Use of ED medications was 3% at baseline and progressed to 25%. For patients aged <70 years at follow-up, 60% maintained satisfactory erectile function after treatment compared with only 12% aged >/=70 years (p = 0.008). Penile bulb dose was not associated with ED. CONCLUSIONS: The rates of ED after treatment appear comparable to those reported for other modalities of radiotherapy. Given the modest size of this study and the uncertainties in the physiology of radiotherapy-related ED, these results merit further investigations.","Int J Radiat Oncol Biol Phys, 78(2): 442-448","USA",2010,"Any or unknown","Radiotherapy","EPIC","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease"]
[732,"Wilkins, A., et al. (2015). \"Hypofractionated radiotherapy versus conventionally fractionated radiotherapy for patients with intermediate-risk localised prostate cancer: 2-year patient-reported outcomes of the randomised, non-inferiority, phase 3 CHHiP trial.\" Lancet Oncol 16(16): 1605-1616.",null,"Wilkins, A., et al.","Hypofractionated radiotherapy versus conventionally fractionated radiotherapy for patients with intermediate-risk localised prostate cancer: 2-year patient-reported outcomes of the randomised, non-inferiority, phase 3 CHHiP trial","BACKGROUND: Patient-reported outcomes (PROs) might detect more toxic effects of radiotherapy than do clinician-reported outcomes. We did a quality of life (QoL) substudy to assess PROs up to 24 months after conventionally fractionated or hypofractionated radiotherapy in the Conventional or Hypofractionated High Dose Intensity Modulated Radiotherapy in Prostate Cancer (CHHiP) trial. METHODS: The CHHiP trial is a randomised, non-inferiority phase 3 trial done in 71 centres, of which 57 UK hospitals took part in the QoL substudy. Men with localised prostate cancer who were undergoing radiotherapy were eligible for trial entry if they had histologically confirmed T1b-T3aN0M0 prostate cancer, an estimated risk of seminal vesicle involvement less than 30%, prostate-specific antigen concentration less than 30 ng/mL, and a WHO performance status of 0 or 1. Participants were randomly assigned (1:1:1) to receive a standard fractionation schedule of 74 Gy in 37 fractions or one of two hypofractionated schedules: 60 Gy in 20 fractions or 57 Gy in 19 fractions. Randomisation was done with computer-generated permuted block sizes of six and nine, stratified by centre and National Comprehensive Cancer Network (NCCN) risk group. Treatment allocation was not masked. UCLA Prostate Cancer Index (UCLA-PCI), including Short Form (SF)-36 and Functional Assessment of Cancer Therapy-Prostate (FACT-P), or Expanded Prostate Cancer Index Composite (EPIC) and SF-12 quality-of-life questionnaires were completed at baseline, pre-radiotherapy, 10 weeks post-radiotherapy, and 6, 12, 18, and 24 months post-radiotherapy. The CHHiP trial completed accrual on June 16, 2011, and the QoL substudy was closed to further recruitment on Nov 1, 2009. Analysis was on an intention-to-treat basis. The primary endpoint of the QoL substudy was overall bowel bother and comparisons between fractionation groups were done at 24 months post-radiotherapy. The CHHiP trial is registered with ISRCTN registry, number ISRCTN97182923. FINDINGS: 2100 participants in the CHHiP trial consented to be included in the QoL substudy: 696 assigned to the 74 Gy schedule, 698 assigned to the 60 Gy schedule, and 706 assigned to the 57 Gy schedule. Of these individuals, 1659 (79%) provided data pre-radiotherapy and 1444 (69%) provided data at 24 months after radiotherapy. Median follow-up was 50.0 months (IQR 38.4-64.2) on April 9, 2014, which was the most recent follow-up measurement of all data collected before the QoL data were analysed in September, 2014. Comparison of 74 Gy in 37 fractions, 60 Gy in 20 fractions, and 57 Gy in 19 fractions groups at 2 years showed no overall bowel bother in 269 (66%), 266 (65%), and 282 (65%) men; very small bother in 92 (22%), 91 (22%), and 93 (21%) men; small bother in 26 (6%), 28 (7%), and 38 (9%) men; moderate bother in 19 (5%), 23 (6%), and 21 (5%) men, and severe bother in four (<1%), three (<1%) and three (<1%) men respectively (74 Gy vs 60 Gy, ptrend=0.64, 74 Gy vs 57 Gy, ptrend=0.59). We saw no differences between treatment groups in change of bowel bother score from baseline or pre-radiotherapy to 24 months. INTERPRETATION: The incidence of patient-reported bowel symptoms was low and similar between patients in the 74 Gy control group and the hypofractionated groups up to 24 months after radiotherapy. If efficacy outcomes from CHHiP show non-inferiority for hypofractionated treatments, these findings will add to the growing evidence for moderately hypofractionated radiotherapy schedules becoming the standard treatment for localised prostate cancer. FUNDING: Cancer Research UK, Department of Health, and the National Institute for Health Research Cancer Research Network.","Lancet Oncol, 16(16): 1605-1616","UK",2015,"Local","Radiotherapy","UCLA-PCI,SF-36,FACT-P,EPIC,SF-12","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,Utility"]
[733,"Wilkinson, S., et al. (2002). \"Attitudes and use of complementary medicine in men with prostate cancer.\" J Urol 168(6): 2505-2509.",null,"Wilkinson, S., et al.","Attitudes and use of complementary medicine in men with prostate cancer","PURPOSE: Patients with cancer are increasingly incorporating complementary therapies into the overall treatment. We determine the prevalence and patterns of use of complementary therapies among patients with prostate cancer. MATERIALS AND METHODS: Patients attending 6 urology institutions for prostate cancer management completed a self-administered questionnaire on complementary therapy. All men diagnosed with prostate cancer were eligible, regardless of age, stage of disease or treatment. RESULTS: A total of 1,099 patients returned the questionnaire. The overall response rate was 78.5%. Complementary therapies had previously been or were currently being used by 23.5% (258) and 18.2% (200) of patients, respectively. Higher levels of education and income were associated with greater use of complementary therapy (p <0.002 by logistic regression). Patients with progressive disease or those primarily treated with hormones were most likely to use complementary therapy. Among the patients using complementary therapy 90% believed that it would help them live longer and improve quality of life, 60% believed it would relieve symptoms and 47% expected it to cure disease. CONCLUSIONS: Complementary therapies are used by a large number of patients with prostate cancer, particularly those with progressive disease or who have undergone multiple treatments. Health care providers need to recognize this growing pattern of use of complementary therapy. Among patients who use complementary therapy the perception of benefit is much greater than that supported by scientific data. Future research should aim to unravel the complex psychosocial dynamics that influence the decision to use complementary therapy by men with prostate cancer and to educate patients about the efficacy of such therapies.","J Urol, 168(6): 2505-2509","USA",2002,"Any or unknown","Various","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Views"]
[734,"Willis, D. L., et al. (2012). \"Comparison of outcomes between pure laparoscopic vs robot-assisted laparoscopic radical prostatectomy: a study of comparative effectiveness based upon validated quality of life outcomes.\" BJU Int 109(6): 898-905.",null,"Willis, D. L., et al.","Comparison of outcomes between pure laparoscopic vs robot-assisted laparoscopic radical prostatectomy: a study of comparative effectiveness based upon validated quality of life outcomes","OBJECTIVE: To compare perioperative, oncological and functional outcomes of laparoscopic radical prostatectomy (LRP) and robot-assisted laparoscopic radical prostatectomy (RALP) with emphasis on health-related quality of life (HRQOL) data as few studies exist. PATIENTS AND METHODS: Patients underwent RALP or LRP by a single, fellowship trained surgeon with a standard clinical care pathway. HRQOL data using the Expanded Prostate Cancer Index Composite (EPIC) were collected at 0, 3, 6 and 12 months after 175 consecutive LRP and 174 RALP procedures. Urinary and sexual function outcomes were compared using two methods: (1) EPIC summary/subscale analyses described as percent return to baseline function and (2) traditional single-question analysis. RESULTS: The two groups were statistically similar with respect to demographics, clinical stage, perioperative outcomes, stage-specific surgical margin rates, and baseline urinary and sexual function scores. There was no statistical difference in postoperative urinary function between RALP and LRP using EPIC or single-question analyses at 3, 6 and 12 months. EPIC questionnaire data showed a greater return to baseline sexual function over time (mixed model analysis) in RALP than in LRP patients who had a bilateral nerve sparing procedure (Sexual Summary Score, P= 0.005; Sexual Function and Bother Subscales, P= 0.007). Using EPIC, RALP patients receiving a bilateral nerve sparing procedure showed improved percent return to baseline potency at 3 and 6 months (P < 0.025) compared with LRP patients, but had similar outcomes at 12 months (73.7% vs 66.2%, P= 0.3). Single-question analysis suggested improved potency after RALP compared with LRP, with a greater percentage of RALP patients reporting successful sexual intercourse in the past 4 weeks (87.5% vs 66.7% at 12 months, P= 0.06). CONCLUSIONS: When comparing surgical techniques, RALP and LRP groups showed statistically similar postoperative urinary function outcomes. RALP patients had an earlier return of sexual function when compared with LRP patients after a bilateral nerve sparing procedure.","BJU Int, 109(6): 898-905","USA",2012,"Any or unknown","Surgery","EPIC","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease"]
[735,"Wilson, K. A., et al. (2000). \"Perception of quality of life by patients, partners and treating physicians.\" Qual Life Res 9(9): 1041-1052.",null,"Wilson, K. A., et al.","Perception of quality of life by patients, partners and treating physicians","The objective of the study was to determine possible differences in perception of quality of life (QoL) between patients with metastatic breast or prostate cancer, their partners, and the treating physician. Patients with metastatic breast cancer (n = 71), and metastatic prostate cancer (n = 29), a partner, and the physician each completed the same QoL questionnaire indicating how they perceived the patient's QoL. The European organization for research and treatment of cancer (EORTC) QLQ-C30 questionnaire was used to assess patients with breast cancer and the modified prostate cancer specific quality of life instrument (PROSQOLI) for patients with prostate cancer. There was reasonable agreement in mean scores between patients, and physicians or partners, for many domains of QoL; however, there was substantial discordance between scores when considering individual patients. For patients with metastatic breast cancer, physicians systematically underestimated overall QoL (p = 0.0002), social functioning (p = 0.001), and role functioning (p = 0.008), while partners showed better agreement. With prostate cancer physicians tended to underestimate pain, while mean scores for spouses were more concordant. There is substantial variability between ratings of QoL by physicians or partners, as compared to patient ratings. Medical decisions should be based on information about QoL provided by patients using validated methods.","Qual Life Res, 9(9): 1041-1052","Canada",2000,"Metastatic","Unclear","PROSQoLI","HCP,Patient,Caregiver",null,"Validation",null,null,null,null,null,null,null,null,"Disease"]
[736,"Wilt, T. J. and M. K. Brawer (1994). \"The Prostate Cancer Intervention Versus Observation Trial: a randomized trial comparing radical prostatectomy versus expectant management for the treatment of clinically localized prostate cancer.\" J Urol 152(5 Pt 2): 1910-1914.",null,"Wilt, T. J. and M. K. Brawer","The Prostate Cancer Intervention Versus Observation Trial: a randomized trial comparing radical prostatectomy versus expectant management for the treatment of clinically localized prostate cancer","The Prostate Cancer Intervention Versus Observation Trial (PIVOT) is a randomized controlled trial sponsored by the Department of Veterans Affairs and the National Cancer Institute. PIVOT will enroll 2,000 participants from at least 80 Veterans Administration and National Cancer Institute medical centers. The purpose of PIVOT is to determine which of 2 strategies is superior for managing clinically localized prostate cancer (stage T1/T2NXM0) of all histological grades. Patients less than 75 years old will be randomized to either radical prostatectomy with early intervention for disease persistence/recurrence or expectant management with palliative therapy reserved for symptomatic or metastatic disease progression. Participants will be excluded if they have received prior therapy for prostate cancer (except transurethral resection of the prostate) or are judged not to be candidates for radical prostectomy. All patients with newly diagnosed prostate cancer will be recorded on the PIVOT screening log. Registry information will include patient age, race, prostate specific antigen level, clinical stage, histological tumor grade, initial therapy, and vital status. Patients meeting eligibility criteria will watch an information and randomization video tape developed for PIVOT. Participants will be randomized over a 3-year period and followed for a minimum of 12 years. Data collected at followup will include urological symptoms, disease and treatment related morbidity, and disease specific and overall quality of life. Evidence of symptomatic or asymptomatic disease persistence, recurrence or progression will be measured by questionnaire, physical examination, digital rectal examination, prostate specific antigen and annual bone scan. The primary study end point will be all cause mortality. Secondary outcomes will include prostate cancer and treatment specific morbidity and mortality rates, health status, predictors of disease specific outcomes and cost-effectiveness. PIVOT will provide a 90% power to detect a 15% relative decrease in all cause mortality and a 35% relative decrease in prostate cancer specific mortality rate by either treatment strategy.","J Urol, 152(5 Pt 2): 1910-1914","USA",1994,"Local","Surgery,Surveillance","Unclear","Patient",null,"Protocol",null,null,null,null,null,null,null,null,"Symptom"]
[737,"Winters-Stone, K. M., et al. (2016). \"Benefits of partnered strength training for prostate cancer survivors and spouses: results from a randomized controlled trial of the Exercising Together project.\" J Cancer Surviv 10(4): 633-644.",null,"Winters-Stone, K. M., et al.","Benefits of partnered strength training for prostate cancer survivors and spouses: results from a randomized controlled trial of the Exercising Together project","BACKGROUND: Prostate cancer can negatively impact quality of life of the patient and his spouse caregiver, but interventions rarely target the health of both partners simultaneously. We tested the feasibility and preliminary efficacy of a partnered strength training program on the physical and mental health of prostate cancer survivors (PCS) and spouse caregivers. METHODS: Sixty-four couples were randomly assigned to 6 months of partnered strength training (Exercising Together, N = 32) or usual care (UC, N = 32). Objective measures included body composition (lean, fat and trunk fat mass (kg), and % body fat) by DXA, upper and lower body muscle strength by 1-repetition maximum, and physical function by the physical performance battery (PPB). Self-reported measures included the physical and mental health summary scales and physical function and fatigue subscales of the SF-36 and physical activity with the CHAMPS questionnaire. RESULTS: Couple retention rates were 100 % for Exercising Together and 84 % for UC. Median attendance of couples to Exercising Together sessions was 75 %. Men in Exercising Together became stronger in the upper body (p < 0.01) and more physically active (p < 0.01) than UC. Women in Exercising Together increased muscle mass (p = 0.05) and improved upper (p < 0.01) and lower body (p < 0.01) strength and PPB scores (p = 0.01) more than UC. CONCLUSIONS: Exercising Together is a novel couples-based approach to exercise that was feasible and improved several health outcomes for both PCS and their spouses. IMPLICATIONS FOR CANCER SURVIVORS: A couples-based approach should be considered in cancer survivorship programs so that outcomes can mutually benefit both partners. TRIAL REGISTRATION: ClinicalTrials.gov NCT00954044.","J Cancer Surviv, 10(4): 633-644","USA",2016,"Survivors","Various","SF-36,CHAMPS","Patient,Caregiver",null,"Clinical trial",null,null,null,null,null,null,null,null,"Utility,General"]
[738,"Wiygul, J. B., et al. (2005). \"Early patient self-assessed outcomes of nerve-sparing radical perineal prostatectomy.\" Urology 66(3): 582-586.",null,"Wiygul, J. B., et al.","Early patient self-assessed outcomes of nerve-sparing radical perineal prostatectomy","OBJECTIVES: To compare the early recovery of erectile function and urinary continence in patients undergoing nerve-sparing and non-nerve-sparing radical perineal prostatectomy (RPP) using a validated patient self-assessment instrument. METHODS: Eighty-eight patients who underwent RPP by a single surgeon between January 2002 and July 2003 were given a validated patient self-assessment questionnaire, the Expanded Prostate Cancer Index Composite, preoperatively and subsequently at 3- to 6-month intervals. Of the 88 patients, 40 underwent non-nerve-sparing and 48 nerve-sparing RPP. The time to recover erectile function and urinary continence, as well as sexual and urinary health-related quality of life was analyzed using the Kaplan-Meier method and a multivariate Cox proportional hazards model. RESULTS: Nerve-sparing RPP was a predictor of the time to recover erections sufficient for intercourse (P = 0.013). In a multivariate regression model adjusting for baseline erectile function, age, and prostate size, preservation of the neurovascular bundle (P = 0.007) was an independent predictor of the time to recover erectile function sufficient for intercourse (hazard ratio 5.3; 95% confidence interval 1.2 to 23.1). The median time to recover urinary continence, defined as no pad use, was 4.7 months in the nerve-sparing group compared with 5.6 months in the non-nerve-sparing group (P = 0.021). In multivariate analysis, nerve-sparing status was an independent predictor (P = 0.003) of an earlier recovery of continence (hazard ratio 2.2; 95% confidence interval 1.3 to 3.6). CONCLUSIONS: Patient self-assessed outcomes support a benefit of nerve-sparing RPP for the postoperative recovery of erectile function and urinary continence. Future studies with larger patient numbers and longer follow-up are necessary to validate these findings.","Urology, 66(3): 582-586","USA",2005,"Any or unknown","Surgery","EPIC","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease"]
[739,"Wong, C. K., et al. (2015). \"Psychometric properties of Functional Assessment of Cancer Therapy-Prostate (FACT-P) in Chinese patients with prostate cancer.\" Qual Life Res 24(10): 2397-2402.",null,"Wong, C. K., et al.","Psychometric properties of Functional Assessment of Cancer Therapy-Prostate (FACT-P) in Chinese patients with prostate cancer","PURPOSE: The aim of the study was to assess the validity, reliability and sensitivity of the FACT-P (version 4) in Chinese males with prostate cancer. METHODS: Construct validity was assessed using Spearman's correlation test against the 12-item Short Form Health Survey (SF-12v2). Internal consistency and test-retest reliability were assessed using Cronbach's alpha coefficient and intra-class correlation coefficient, respectively. Sensitivity was determined by performing known-group comparisons by independent t test. RESULTS: FACT-P subscale scores had a moderate correlation with the corresponding SF-12v2 domain score that conceptually measures the similar construct providing evidence for adequate construct validity. Internal consistency was acceptable (alpha: 0.687-0.900) for all subscales aside from the Prostate Cancer Subscale (alpha: 0.505) and Trial Outcome Index (alpha: 0.562). FACT-P subscale and total scores showed good test-retest reliability (range 0.753-0.913). All total scales and most of the subscales were sensitive in detecting differences between patients with different levels of functional impairment but not different cancer stages or levels of prostate-specific antigen. CONCLUSIONS: The measure is a valid and reliable measure to assess the health-related quality of life of Chinese males with prostate cancer. The FACT-P is sensitive to detect difference between patients with varying functional status.","Qual Life Res, 24(10): 2397-2402","China",2015,"Any or unknown","None","SF-12,FACT-P","Patient",null,"Validation,Mapping to utility",null,null,null,null,null,null,null,null,"Disease,Utility"]
[740,"Woolsey, J., et al. (2004). \"Prospective outcomes associated with migration from preoperative to intraoperative planned brachytherapy: a single center report.\" J Urol 172(6 Pt 2): 2528-2531.",null,"Woolsey, J., et al.","Prospective outcomes associated with migration from preoperative to intraoperative planned brachytherapy: a single center report","PURPOSE: Brachytherapy (BT) for prostate cancer can be performed with either preoperative (PO) or intraoperative (IO) planned dosimetry. Potential benefits of intraoperative include fewer procedures for the patient, cost savings and improved accuracy of seed implantation leading to improved tumor control and urinary side effect profile. We report our experience with transition to IO planned BT after performing more than 600 PO planned implants since 1997. MATERIALS AND METHODS: From September 2001 to February 2003, 46 consecutive patients with T1-3N0M0 adenocarcinoma of the prostate underwent BT. IO dosimetry was performed in 23 patients, while PO dosimetry was used in 23 immediately before changing to IO. American Urological Association (AUA) symptom index questionnaires were administered preoperatively and postoperatively. All patients underwent postoperative dosimetry by computerized tomography. Total, irritative and obstructive AUA scores were compared in the 2 groups using analysis of covariance. Models were adjusted for pretreatment variables of symptom scores, type of procedure and time since procedure. RESULTS: Median followup was 47 and 45 days for PO and IO dosimetry, respectively. No differences were observed in seed, needle numbers or prostate size in the 2 groups. Average operative times were higher (47 vs 79 minutes, p <0.01) in the IO group but they decreased to nearly the same levels as PO implants in the first 23 cases so treated. Slopes of operative time over date of procedure differed significantly between methods (p <0.01). Comparing PO to IO dosimetry adjusted estimate of difference was -1.96 for total (95% CI -6.4, 2.5), -0.48 for obstructive (95% CI -3.3, 2.3) and -1.78 for irritative (95% CI -3.9, 0.31) AUA score. These differences were neither statistically nor clinically significant. CONCLUSIONS: Our experience indicates that intraoperative planned BT is easily implemented in clinical practice as a result of a short learning curve. In addition, the approach is not associated with any changes in early postoperative voiding symptoms and, due to only marginally longer operative times, may have a cost advantage by eliminating the preplanning visit and ultrasound.","J Urol, 172(6 Pt 2): 2528-2531","USA",2004,"Local,Advanced","Brachytherapy","AUA-SI","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Symptom"]
[741,"Wu, A. W., et al. (2016). \"Improving an electronic system for measuring PROs in routine oncology practice.\" J Cancer Surviv 10(3): 573-582.",null,"Wu, A. W., et al.","Improving an electronic system for measuring PROs in routine oncology practice","PURPOSE: Our aim was to study how patients and their clinicians evaluated the usability of PatientViewpoint, a webtool designed to allow patient-reported outcome (PRO) measures to be used in clinical practice. METHODS: As part of a two-round quality improvement study, breast and prostate cancer patients and their medical and radiation oncology clinicians completed semi-structured interviews about their use of PatientViewpoint. The patient interview addressed different phases of the PRO completion workflow: reminders, completing the survey, and viewing the results. The clinician interviews asked about use of PatientViewpoint, integration with the clinical workflow, barriers to use, and helpful and desired features. Responses were recorded, categorized, and reviewed. After both rounds of interviews, modifications were made to PatientViewpoint. RESULTS: Across the two rounds, 42 unique patients (n = 19 in round 1, n = 23 in round 2) and 12 clinicians (all in both rounds) completed interviews. For patients, median age was 65, 81 % were white, 69 % were college graduates, 80 % had performance status of 0, 69 % had loco-regional disease, and 81 % were regular computer users. In the quality improvement interviews, patients identified numerous strengths of the system, including its ability to flag issues for discussion with their provider. Comments included confusion about how scores were presented and that the value of the system was diminished if the doctor did not look at the results. Requests included tailoring questions to be applicable to the individual and providing more explanation about the score meaning, including having higher scores consistently indicating either better or worse status. Clinicians also provided primarily positive feedback about the system, finding it helpful in some cases, and confirmatory in others. Their primary concern was with impact on their workflow. CONCLUSIONS: Systematically collected feedback from patients and clinicians was useful to identify ways to improve a system to incorporate PRO measures into oncology practice. The findings and evaluation methods should be useful to others in efforts to integrate PRO assessments into ambulatory care. IMPLICATIONS FOR CANCER SURVIVORS: Systems to routinely collect patient-reported information can be incorporated into oncology practices and provide useful information that promote patient and clinician partnership to improve the quality of care.","J Cancer Surviv, 10(3): 573-582","USA",2016,"Any or unknown","None","PVP","Patient",null,"Validation",null,null,null,null,null,null,null,null,"General"]
[742,"Wu, E. Q., et al. (2007). \"Mapping FACT-P and EORTC QLQ-C30 to patient health status measured by EQ-5D in metastatic hormone-refractory prostate cancer patients.\" Value Health 10(5): 408-414.",null,"Wu, E. Q., et al.","Mapping FACT-P and EORTC QLQ-C30 to patient health status measured by EQ-5D in metastatic hormone-refractory prostate cancer patients","OBJECTIVES: To construct and validate a prediction model of preference-adjusted health status (EQ-5D) for metastatic hormone-refractory prostate cancer (HRPCA) patients using cancer-specific health-related quality of life (HRQoL) measures. METHODS: Data were obtained from a multicenter, multinational observational study of metastatic HRPCA patients conducted during 2002 to 2004. In addition to clinical and resource utilization, preference-adjusted health status (EQ-5D) and HRQoL (Functional Assessment of Cancer Therapy-Prostate [FACT-P] and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30]) data were collected. Predictive validity of ordinary least square (OLS) and median regressions of various model specifications were tested using cross-validation samples. The selected specification was then further refined and tested for alternative model specifications and restrictions. RESULTS: OLS regression with both HRQoL measures as individual components and patient demographics was the best-performing model. It explained 58.2% of the observed EQ-5D variation in the validation sample. A model including only the prostate cancer-specific HRQoL measure, FACT-P, explained 53.5% of the observed EQ-5D variation. CONCLUSIONS: The models developed have good predictive validity. These algorithms enable researchers to translate cancer-specific HRQoL measures to preference-adjusted health status in metastatic HRPCA patients. The findings will help perform health status adjustments in cost-utility analyses.","Value Health, 10(5): 408-414","USA",2007,"Metastatic","None","EQ-5D,FACT-P,EORTC QLQ-C30","Patient",null,"Mapping to utility",null,null,null,null,null,null,null,null,"Disease,General,Utility"]
[743,"Wust, P., et al. (2004). \"Clinical and physical determinants for toxicity of 125-I seed prostate brachytherapy.\" Radiother Oncol 73(1): 39-48.",null,"Wust, P., et al.","Clinical and physical determinants for toxicity of 125-I seed prostate brachytherapy","BACKGROUND AND PURPOSE: To assess acute as well as long-term toxicity after permanent prostate seed implantation. To find predictive clinical or dosimetric factors for side effects in order to work out strategies for improvement. PATIENTS AND METHODS: A group of 174 patients with localised prostate cancer was treated with permanent seed implantation between 1999 and 2001, either alone (140 patients) or in combination with external radiotherapy (34 patients). For the majority (114/174, i.e. 66%) a CT was performed four weeks after implantation and analysed in the planning system VariSeed. In the postimplant analysis, dosimetric descriptors (doses, volumes) were determined for the prostate and rectum and compared with the intraoperative values. In addition, a questionnaire was sent to all patients to assess and quantify acute and chronic toxicity (urinary, rectal, sexual) and the impact on subjective acceptance and quality of life (return rate of questionnaires 83%). The derived score changes were correlated with clinical and dosimetric factors. RESULTS: In the mono-brachytherapy group 14% (16/140) required a bladder catheter, of them 8% (9/140) with a manifest urinary obstruction. Long-term rectal toxicity (<5%) and impairment of potency (<30%) are moderate and obviously below other treatment options. Urinary toxicity is dominant with an overall long-term dysuria up to 30% (at a mean observation interval of ten months), and a significant trend to decline with follow-up time. Conversely, the erectile function tends to deteriorate with follow-up time. Nevertheless, quality of life is not significantly reduced and acceptance is high. Our analysis suggests that the main factor for urinary toxicity and impaired erectile function is the dose load to larger portions of the prostate (D(50)>240 Gy), which appears to be attributed to unnecessarily high numbers of seeds (for a fixed activity per seed) and needles. The rectal toxicity is correlated with the high dose regions in the rectum (>/=145 Gy). Urinary toxicity is lower for combined-brachytherapy, while rectal toxicity and impairment of potency are slightly higher. CONCLUSIONS: Toxicity spectrum and quality of life after permanent seed implantation for early prostate cancer are acceptable for nearly all patients (98%). To further improve tolerance we should attempt to achieve a better dose homogeneity, i.e. by reducing D(50). Therefore, special attention should be given to D(50) during the real-time planning process. The necessity of more homogeneous dose distributions might imply a reduction of the activity per seed, e.g. from 0.7 mCi down to 0.6 mCi.","Radiother Oncol, 73(1): 39-48","Germany",2004,"Local","Brachytherapy","Unclear","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Treatment"]
[744,"Yamamoto, S., et al. (2014). \"Longitudinal change in health-related quality of life after intensity-modulated radiation monotherapy for clinically localized prostate cancer.\" Qual Life Res 23(5): 1641-1650.",null,"Yamamoto, S., et al.","Longitudinal change in health-related quality of life after intensity-modulated radiation monotherapy for clinically localized prostate cancer","PURPOSE: The purpose of the study is to assess longitudinal changes in general and disease-specific health-related quality-of-life (HRQOL) indices after intensity-modulated radiotherapy (IMRT) monotherapy for patients with localized prostate cancer (PCA). METHODS: Between 2006 and 2010, 91 patients with localized PCA underwent IMRT monotherapy and were enrolled into this prospective study. At baseline, and at 3, 6, 12, and 24 months after IMRT, the general and prostate-specific HRQOL were estimated using physical (PCS) and mental component summaries (MCS) calculated using the Medical Outcomes Study 8-Item Short Form Health Survey and Expanded Prostate Cancer Index Composite (EPIC). RESULTS: For 2 years, there were no significant changes in EPIC scores in all subscales of urinary domain, hormonal function, and bother. Bowel and sexual function scores decreased after IMRT and did not return to those at baseline (p = 0.006 and < 0.001, respectively). PCS began to decrease at 3 months after IMRT and then returned to the baseline score at 24 months. In contrast, the MCS score began to significantly increase after IMRT, and thereafter the score remained constant until 24 months (p < 0.001). On multivariate logistic regression analysis, urinary (p = 0.003) and sexual functions (p = 0.0005) at baseline were identified as significant predictors of EPIC urinary irritative/obstructive score and sexual function at 24 months after IMRT. CONCLUSION: Urinary function, including irritative/obstruction symptoms and hormonal function, was not affected by IMRT. However, bowel and sexual function decreased after IMRT. These findings will provide important information for PCA patients considering IMRT.","Qual Life Res, 23(5): 1641-1650","Japan",2014,"Local","Radiotherapy","EPIC,SF-8","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease,Utility"]
[745,"Yanez, B., et al. (2015). \"Feasibility, acceptability, and preliminary efficacy of a technology-assisted psychosocial intervention for racially diverse men with advanced prostate cancer.\" Cancer 121(24): 4407-4415.",null,"Yanez, B., et al.","Feasibility, acceptability, and preliminary efficacy of a technology-assisted psychosocial intervention for racially diverse men with advanced prostate cancer","BACKGROUND: The utility of psychosocial interventions in reducing symptom burden and improving health-related quality of life (HRQOL) for men with localized prostate cancer has been demonstrated. However, studies have yet to demonstrate the efficacy of interventions in advanced prostate cancer (APC). This study examined the feasibility, acceptability, and preliminary efficacy of a technology-assisted, 10-week, group-based psychosocial intervention for diverse men with APC. METHODS: The participants were 74 men (mean age, 68.84 years; non-Hispanic white, 57%; black, 40.5%) who were randomized to a cognitive-behavioral stress management (CBSM) treatment or health promotion (HP) attention-control condition. The participants were assessed at the baseline, weekly throughout the 10-week program, and 6 months after the baseline. Outcomes were assessed with the Patient-Reported Outcomes Measurement Information System along with established measures of HRQOL, CBSM intervention targets (eg, relaxation skills), and patient-reported acceptability. RESULTS: Feasibility was demonstrated through good retention rates (>85%) and acceptable average attendance rates (>70%), and acceptability was demonstrated through very favorable weekly session evaluations (mean score, 4/5) and exit surveys (mean score, 3.6/4). Men randomized to the CBSM condition reported significant reductions (P < .05) in depressive symptoms and improvements in relaxation self-efficacy (P < .05) at the 6-month follow-up. CBSM participants reported trends for improvement in distress and functional well-being (P < .08) in comparison with those in the HP condition. Effect sizes ranged from medium (0.54) to large (1.87) and, in some instances, were clinically meaningful. CONCLUSIONS: Technology-based CBSM interventions among diverse men with APC may be feasible, acceptable, and efficacious.","Cancer, 121(24): 4407-4415","USA",2015,"Advanced","Psychological","PROMIS","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Symptom,General"]
[746,"Yarbro, C. H. and C. E. Ferrans (1998). \"Quality of life of patients with prostate cancer treated with surgery or radiation therapy.\" Oncol Nurs Forum 25(4): 685-693.",null,"Yarbro, C. H. and C. E. Ferrans","Quality of life of patients with prostate cancer treated with surgery or radiation therapy","PURPOSE/OBJECTIVES: To compare the quality-of-life (QOL) perceptions of men treated for prostate cancer with surgery to those of men treated for prostate cancer with radiation therapy. DESIGN: A two-group descriptive study. SETTING: Midwestern community cancer center and teaching hospital. SAMPLE: The study group consisted of 121 men: 68 treated by radical prostatectomy and 53 treated with radiation therapy. METHODS: Mailed survey using the Quality of Life Index (QLI) Cancer Version and the University of California at Los Angeles Prostate Cancer Index. MAIN RESEARCH VARIABLES: QOL; level of urinary, bowel, and sexual function; impact of dysfunction on patients' lives. FINDINGS: No significant differences were found between the groups in QLI scores, but significant differences were found in urinary, bowel, and sexual function. Urinary function was superior in the radiation therapy group (p = 0.0002). Patients who had undergone surgery were more likely to leak urine every day (p < 0.001). Only 6% of patients who had undergone radiation therapy needed to use pads or diapers as compared to 32% of patients who had undergone surgery. Bowel function was better in the surgery group (p = 0.05). Both groups reported poor sexual function, although it was worse in the surgery group (p = 0.009). CONCLUSIONS: The patients who were treated with surgery had significantly worse urinary and sexual function and better bowel function than those treated with radiation therapy. QOL scores were consistent with these findings, although they did not differ significantly between groups. IMPLICATIONS FOR NURSING PRACTICE: This information on the problems of survivors of prostate cancer after surgery and radiation therapy and the effects of therapy on QOL will assist nurses in providing patient education, emotional support, and rehabilitative interventions.","Oncol Nurs Forum, 25(4): 685-693","USA",1998,"Any or unknown","Surgery,Radiotherapy","QLI,UCLA-PCI","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Disease,General"]
[747,"Yaxley, J. W., et al. (2016). \"Robot-assisted laparoscopic prostatectomy versus open radical retropubic prostatectomy: early outcomes from a randomised controlled phase 3 study.\" Lancet 388(10049): 1057-1066.",null,"Yaxley, J. W., et al.","Robot-assisted laparoscopic prostatectomy versus open radical retropubic prostatectomy: early outcomes from a randomised controlled phase 3 study","The absence of trial data comparing robot-assisted laparoscopic prostatectomy and open radical retropubic prostatectomy is a crucial knowledge gap in uro-oncology. We aimed to compare these two approaches in terms of functional and oncological outcomes and report the early postoperative outcomes at 12 weeks. In this randomised controlled phase 3 study, men who had newly diagnosed clinically localised prostate cancer and who had chosen surgery as their treatment approach, were able to read and speak English, had no previous history of head injury, dementia, or psychiatric illness or no other concurrent cancer, had an estimated life expectancy of 10 years or more, and were aged between 35 years and 70 years were eligible and recruited from the Royal Brisbane and Women's Hospital (Brisbane, QLD). Participants were randomly assigned (1:1) to receive either robot-assisted laparoscopic prostatectomy or radical retropubic prostatectomy. Randomisation was computer generated and occurred in blocks of ten. This was an open trial; however, study investigators involved in data analysis were masked to each patient's condition. Further, a masked central pathologist reviewed the biopsy and radical prostatectomy specimens. Primary outcomes were urinary function (urinary domain of EPIC) and sexual function (sexual domain of EPIC and IIEF) at 6 weeks, 12 weeks, and 24 months and oncological outcome (positive surgical margin status and biochemical and imaging evidence of progression at 24 months). The trial was powered to assess health-related and domain-specific quality of life outcomes over 24 months. We report here the early outcomes at 6 weeks and 12 weeks. The per-protocol populations were included in the primary and safety analyses. This trial was registered with the Australian New Zealand Clinical Trials Registry (ANZCTR), number ACTRN12611000661976. Between Aug 23, 2010, and Nov 25, 2014, 326 men were enrolled, of whom 163 were randomly assigned to radical retropubic prostatectomy and 163 to robot-assisted laparoscopic prostatectomy. 18 withdrew (12 assigned to radical retropubic prostatectomy and six assigned to robot-assisted laparoscopic prostatectomy); thus, 151 in the radical retropubic prostatectomy group proceeded to surgery and 157 in the robot-assisted laparoscopic prostatectomy group. 121 assigned to radical retropubic prostatectomy completed the 12 week questionnaire versus 131 assigned to robot-assisted laparoscopic prostatectomy. Urinary function scores did not differ significantly between the radical retropubic prostatectomy group and robot-assisted laparoscopic prostatectomy group at 6 weeks post-surgery (74.50 vs 71.10; p=0.09) or 12 weeks post-surgery (83.80 vs 82.50; p=0.48). Sexual function scores did not differ significantly between the radical retropubic prostatectomy group and robot-assisted laparoscopic prostatectomy group at 6 weeks post-surgery (30.70 vs 32.70; p=0.45) or 12 weeks post-surgery (35.00 vs 38.90; p=0.18). Equivalence testing on the difference between the proportion of positive surgical margins between the two groups (15 [10%] in the radical retropubic prostatectomy group vs 23 [15%] in the robot-assisted laparoscopic prostatectomy group) showed that equality between the two techniques could not be established based on a 90% CI with a Delta of 10%. However, a superiority test showed that the two proportions were not significantly different (p=0.21). 14 patients (9%) in the radical retropubic prostatectomy group versus six (4%) in the robot-assisted laparoscopic prostatectomy group had postoperative complications (p=0.052). 12 (8%) men receiving radical retropubic prostatectomy and three (2%) men receiving robot-assisted laparoscopic prostatectomy experienced intraoperative adverse events. These two techniques yield similar functional outcomes at 12 weeks. Longer term follow-up is needed. In the interim, we encourage patients to choose an experienced surgeon they trust and with whom they have rapport, rather than a specific surgical approach. Cancer Council Queensland.","Lancet, 388(10049): 1057-1066","Australia",2016,"Local","Surgery","EPIC,IIEF-5","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,Comp-lication"]
[748,"Yoshimura, K., et al. (2003). \"Neoadjuvant flutamide monotherapy for locally confined prostate cancer.\" Int J Urol 10(4): 190-195.",null,"Yoshimura, K., et al.","Neoadjuvant flutamide monotherapy for locally confined prostate cancer","BACKGROUND: We compared the clinical effects and impact on quality of life (QOL) of patients who received a 3-month course of flutamide monotherapy before radical prostatectomy with those who received a 3-month course of luteinizing hormone-releasing hormone (LHRH) agonist monotherapy. METHODS: Thirty-seven patients with non-metastatic prostate cancer were enrolled in this study (19, flutamide; 18, LHRH agonist). The rates of change of serum prostate-specific antigen (PSA) and testosterone levels, downsizing of prostate volume, the rate of organ confined disease, adverse effects and perioperative scores measured using the European Organization for Research and Treatment of Cancer Prostate Cancer Quality of Life Questionnaire (EORTC-P) and the Sapporo Medical University Sexual Function Questionnaire (SMUF) were analyzed. RESULTS: At radical prostatectomy, pathological variables were not significantly different in the two groups. Serum testosterone level was significantly higher (mean 359.2 compared to 10.5, P < 0.001), complete response rate of PSA (13% compared to 57%, P = 0.028) and rate of downsizing of prostate volume (mean, -17.7% compared to -35.4%, P = 0.038) were significantly lower in the flutamide group than in the LHRH group. After neoadjuvant hormone therapy, the scores on the sexual problem domain of EORTC-P (P = 0.033) and sexual desire score of SMUF (P = 0.021) were significantly higher in the flutamide group than in the LHRH group. At a median follow-up of 34 months after prostatectomy, biochemical failure-free survival rate in the flutamide group did not differ from that in the LHRH group. CONCLUSION: This study suggests that flutamide monotherapy can be an acceptable modality as an option for neoadjuvant hormone therapy.","Int J Urol, 10(4): 190-195","Japan",2003,"Local","Surgery,Hormonal","EORTC QLQ-PR25,SFQ","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,Complication"]
[749,"Yoshimura, K., et al. (2003). \"Use of complementary and alternative medicine by patients with localized prostate carcinoma: study at a single institute in Japan.\" Int J Clin Oncol 8(1): 26-30.",null,"Yoshimura, K., et al.","Use of complementary and alternative medicine by patients with localized prostate carcinoma: study at a single institute in Japan","BACKGROUND: The use of complementary/alternative medicine (CAM) has recently received considerable attention throughout the world. We evaluated the prevalence and predictors of CAM use among Japanese patients with localized prostate cancer. METHODS: A total of 177 patients with localized prostate carcinoma underwent radical retropubic prostatecotomy or external beam radiation therapy between January 1994 and January 2001. Of them, 138 (78%) answered a self-administered questionnaire on CAM use and were eligible for this study. The overall prevalence, types of CAM used, and costs of CAM were assessed. The effects of age, prostate-specific antigen (PSA) level, clinical stage, pretreatment Gleason score, patients' income, patients' final educational status, and general health-related quality of life at baseline and 1 year after treatment, as estimated using the European Organization for Research and Treatment of Cancer Prostate Cancer Quality of Life Questionnaire on the prevalence of CAM use, were evaluated. RESULTS: Twenty-seven patients (20%) had once used or had been using some types of CAM. Herbal medicine and vitamins were the most common types of CAM used. Preoperative Gleason score was significantly associated with CAM use, as determined by the chi(2) test ( P = 0.0198), and PSA level and posttreatment physical function domain were marginally associated with CAM use, as determined by the Mann-Whitney U-test ( P = 0.0734 and P = 0.0597, respectively). Patient age, income, and final educational status had no impact on CAM use. CONCLUSION: A relatively small proportion of Japanese patients with localized prostate cancer have tried CAM compared with the proportions of patients described in previous reports from Western countries.","Int J Clin Oncol, 8(1): 26-30","Japan",2003,"Local","Surgery,Radiotherapy,Various","EORTC QLQ-PR25","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Disease"]
[750,"Yoshimura, K., et al. (2004). \"A 3-y prospective study of health-related and disease-specific quality of life in patients with nonmetastatic prostate cancer treated with radical prostatectomy or external beam radiotherapy.\" Prostate Cancer Prostatic Dis 7(2): 144-151.",null,"Yoshimura, K., et al.","A 3-y prospective study of health-related and disease-specific quality of life in patients with nonmetastatic prostate cancer treated with radical prostatectomy or external beam radiotherapy","We assessed the longitudinal alteration of the quality of life (QOL) of patients with localized prostate cancer after radical prostatectomy or hormonoradiotherapy during 3-y follow-up. In addition, we examined the impact on QOL of initiation of second treatment after failure of primary treatment. In all, 135 patients with localized prostate cancer who underwent radical retropubic prostatectomy (RP) (N=84) or external beam radiotherapy with neoadjuvant hormone (XRT) (N=51) at our institute and who had a minimum follow-up of 3 y were included in this study. Data were collected prospectively, at baseline, at 3 months after treatment, at 1 y, and annually thereafter. QOL, generic and disease-targeted was evaluated using the European Organization for Research and Treatment of Cancer Prostate Cancer QOL Questionnaire, the Sapporo Medical University Sexual Function Questionnaire, the International Prostate Symptom Index Quality of Life Score and similar questions regarding bowel function. Repeated-measures ANOVA revealed significantly different patterns of alteration in the domains of QOL, with the exception of several domains, between the RP and XRT groups. Rapid decline of sexual function and increase in sexual bothersomeness were followed by slight amelioration throughout follow-up in the RP group, and did not change thereafter in the XRT group. Overall satisfaction with urinary condition significantly improved after treatment and that with bowel condition was stable during follow-up in both of the groups. Failure of primary treatment and initiation of salvage treatment had no impact on QOL. This prospective study revealed longitudinal alteration of QOL status of patients undergoing treatment for localized prostate cancer, but did not yield any conclusions regarding effect of treatment failure and second treatment on QOL due to small sample size. It should be noted that different instruments for assessment of QOL can generate different outcomes.","Prostate Cancer Prostatic Dis, 7(2): 144-151","Japan",2004,"Local","Surgery,Radiotherapy,Hormonal","EORTC QLQ-PR25,SMUF,IPSS","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease,Complication"]
[751,"Yoshimura, K., et al. (2005). \"Use of complementary and alternative medicine by patients with urologic cancer: a prospective study at a single Japanese institution.\" Support Care Cancer 13(9): 685-690.",null,"Yoshimura, K., et al.","Use of complementary and alternative medicine by patients with urologic cancer: a prospective study at a single Japanese institution","OBJECTIVES: We prospectively evaluated the prevalence and predictors of complementary medicine (CAM) use among Japanese patients with urologic cancer 1 year after diagnosis. PATIENTS AND METHODS: A total of 349 patients with newly diagnosed urologic cancer answered a self-administered questionnaire on CAM use 1 year after diagnosis. General-health-related quality of life (GHQL) of the patients was also assessed at diagnosis and 1 year after diagnosis using the Medical Outcome Study Short Form-36 (SF-36). The overall prevalence, types of CAM used, and costs of CAM were assessed. The effects of several variables including GHQL at baseline and 1 year after treatment on the prevalence of use of CAM were evaluated. RESULTS: A total of 164 respondents (47%) admitted using some type of CAM, of which 73 (45%) had used multiple types. \"Health food,\" in particular extract from Agaricus blazei, was the most common type of CAM used. CAM users had significantly lower scores for social function, general health perception, and vitality domains than CAM non-users 1 year after diagnosis. This tendency was more marked in users of multiple types of CAM. CONCLUSIONS: \"Health food,\" including extract from A. blazei, was the most commonly used CAM in Japan. The prevalence of CAM use did not differ between patients with prostate cancer and those with urologic cancer other than prostate cancer. CAM users, especially those who used multiple types of CAM, had lower GHQL scores than non-users of CAM.","Support Care Cancer, 13(9): 685-690","Japan",2005,"Any or unknown","Various","SF-36","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Utility"]
[752,"Yoshimura, K., et al. (2007). \"Health-related quality-of-life after external beam radiation therapy for localized prostate cancer: intensity-modulated radiation therapy versus conformal radiation therapy.\" Prostate Cancer Prostatic Dis 10(3): 288-292.",null,"Yoshimura, K., et al.","Health-related quality-of-life after external beam radiation therapy for localized prostate cancer: intensity-modulated radiation therapy versus conformal radiation therapy","We compared health-related quality-of-life (HRQL) after intensity-modulated radiotherapy (IMRT) with statuses obtained after old and new protocols of three-dimensional conformal radiation therapy (3DCRT) for localized prostate cancer. We measured the general and disease specific HRQL using the MOS 36-Item Health Survey (SF-36), and the University of California, Los Angeles Prostate Cancer Index (UCLA PCI), respectively. IMRT resulted in similar profiles of general and disease-specific HRQL to two other methods within the first year after treatment. Moreover, IMRT gave rise to comparable urinary, intestinal and sexual side effects despite the high dose of radiation applied.","Prostate Cancer Prostatic Dis, 10(3): 288-292","Japan",2007,"Local","Radiotherapy","SF-36,UCLA-PCI","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Disease,utility"]
[753,"You, D., et al. (2010). \"Impacts of leuprolide acetate on quality of life in patients with prostate cancer: a prospective multicenter study.\" Scand J Urol Nephrol 44(6): 399-405.",null,"You, D., et al.","Impacts of leuprolide acetate on quality of life in patients with prostate cancer: a prospective multicenter study","OBJECTIVE: To investigate the impacts of leuprolide acetate on the quality of life (QoL) of patients with prostate cancer. MATERIAL AND METHODS: A total of 104 patients was enrolled in this prospective multicenter study. All patients received subcutaneous injections of 3.75 mg leuprolide acetate at 4 week intervals for a total of 12 weeks. QoL was assessed before treatment and at 12 weeks using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and an accompanying prostate cancer-specific module (QLQ-PR25). RESULTS: Eighty-nine of 104 patients (85.6%) completed the 12 week study. Eighty-six of 89 patients (96.6%) achieved and maintained medical castration. The results of the EORTC QLQ-C30 indicated that patients experienced an improvement in global health status/QoL (p < 0.001), despite a deterioration in physical and role functioning (p = 0.012 and p = 0.007, respectively). The symptom scales indicated a statistically significant improvement in appetite (p = 0.003). The results of the QLQ-PR25 revealed that patients experienced an increase in hot flushes (p < 0.001) and erection problems and uncomfortable sexual intimacy among the sexual functioning items (p = 0.030 and p = 0.023, respectively), but day-time urinary frequency was improved (p = 0.004). CONCLUSION: The results of this prospective study indicate that leuprolide acetate treatment was accompanied by improvements in global health status/QoL, despite a deterioration in physical, role and sexual function.","Scand J Urol Nephrol, 44(6): 399-405","South Korea",2010,"Any or unknown","Hormonal","EORTC QLQ-C30,EORTC QLQ-PR25","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,General"]
[754,"Young, M. D., et al. (2003). \"Urinary continence and quality of life in the first year after radical perineal prostatectomy.\" J Urol 170(6 Pt 1): 2374-2378.",null,"Young, M. D., et al.","Urinary continence and quality of life in the first year after radical perineal prostatectomy","PURPOSE: We attempt to characterize the return of urinary continence and urinary domain related quality of life objectively after radical perineal prostatectomy (RPP). MATERIALS AND METHODS: A total of 92 RPP candidates were prospectively enrolled in a quality of life (QOL) survey using a validated assessment tool and evaluated before surgery, and then after surgery at 1 month and subsequent 3-month intervals. The time to regain continence based on 3 different definitions and the time to recover baseline urinary domain related QOL was calculated. RESULTS: Median time to regain continence after RPP ranged from 3.0 to 3.3 months depending on the definition of continence. Median time for patients to regain continence depending on age (younger than 55, 55 to 64 and older than 64) and medical comorbidities (none, 1 and 2 or more) varied between 1.4 +/- 0.3, 3.0 +/- 0.9 and 3.3 +/- 0.4 months, respectively (p = 0.028), and 1.4 +/- 0.2, 3.3 +/- 0.2 and 3.5 +/- 2.6 months, respectively (p = 0.009). Twelve months after RPP 84%, 66% and 82% of patients regained individual baseline urinary summary, function and bother scores, respectively. Postoperative radiation (XRT) represented the only independent predictor of the time to recover baseline urinary domain summary scores in a multivariate analysis (p = 0.042) with a median delay in the XRT (10 patients) and nonXRT group (82 patients) of 8.0 and 6.7 months, respectively. CONCLUSIONS: Based on self-reported questionnaire data, a majority of patients regain urinary continence and urinary domain related QOL within 12 months after RPP. The time course of recovery from radical prostatectomy represents an important outcome criterion that should be shared with patients considering treatment options.","J Urol, 170(6 Pt 1): 2374-2378","USA",2003,"Any or unknown","Surgery","Unclear","Patient",null,"Cohort",null,null,null,null,null,null,null,null,"Complication"]
[755,"Yount, S., et al. (2003). \"Brief assessment of priority symptoms in hormone refractory prostate cancer: the FACT Advanced Prostate Symptom Index (FAPSI).\" Health Qual Life Outcomes 1: 69.",null,"Yount, S., et al.","Brief assessment of priority symptoms in hormone refractory prostate cancer: the FACT Advanced Prostate Symptom Index (FAPSI)","BACKGROUND: The objective of this study was to construct and validate a brief, clinically-relevant symptom index for advanced prostate cancer. METHODS: Questions were extracted from a commonly-used multi-dimensional cancer quality of life instrument with prostate-specific items, the Functional Assessment of Cancer Therapy-Prostate (FACT-P). Surveys of disease-related symptoms were presented to an international sample of 44 expert physicians. Each expert narrowed the list to no more than five of the most important symptoms or concerns to monitor when assessing the value of treatment for advanced prostate cancer. Symptoms/concerns endorsed at a frequency greater than chance probability (17%) were retained for the symptom index and called the FACT Advanced Prostate Symptom Index-8 (FAPSI-8): pain (three items), fatigue, weight loss, urinary difficulties (two items), and concern about the condition becoming worse. The FAPSI-8 was validated using data from a clinical trial of 288 men being treated for hormone refractory prostate cancer. RESULTS: The FAPSI-8 showed good internal consistency (r = 0.67-0.80); association with existing FACT scales (e.g., FACT-P, Physical Well-being, Functional Well-being; r = 0.44-0.85, p <.0001), responsiveness to clinical change (Guyatt's Responsiveness statistic = 1.29), and ability to differentiate patients by performance status (p <.0001). A six-item alternate version of the FAPSI was also evaluated with comparable results. CONCLUSIONS: This project produced a reliable and valid list of the eight most important clinician-rated targets of drug therapy for advanced prostate cancer. These questions perform comparably to the longer derivative questionnaire. Examination of patient agreement with this priority list and the extent to which changes in these 8 targets are related to meaningful clinical benefit to the patient are important next steps for future research.","Health Qual Life Outcomes, 1(69","USA",2003,"Advanced","None","FACT-P,FAPSI-8","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease,Symptom"]
[756,"Zebrack, B. J., et al. (2006). \"Assessing the impact of cancer: development of a new instrument for long-term survivors.\" Psychooncology 15(5): 407-421.",null,"Zebrack, B. J., et al.","Assessing the impact of cancer: development of a new instrument for long-term survivors","OBJECTIVE: To develop and evaluate a new instrument that measures aspects of long-term survivorship not measured by existing tools. METHODS: In qualitative interviews, 47 long-term cancer survivors (LTS) detailed ways that cancer has impacted their lives. Content analysis resulted in the creation of 325 candidate items for inclusion in a new Impact of Cancer (IOC) instrument. Following expert review, item reduction and pilot testing, 81 items were administered with other established health status and quality of life (QOL) instruments to 193 LTS of breast, prostate, colorectal cancers and lymphoma. Internal consistency reliability and validity of newly-derived scales was assessed. RESULTS: Factor analysis of items using a priori QOL domains resulted in the derivation of ten new and specific subscales: Health Awareness, Body Changes, Health Worries, Positive and Negative Self-Evaluation, Positive and Negative Life Outlook, Social Life Interferences, Relationships, and Meaning of Cancer. Internal consistency measurements for these subscales ranged from 0.67 to 0.89. Expected associations within and among the IOC subscales and standardized measures of health status and QOL were observed, as were some unexpected findings. CONCLUSIONS: Psychometric analysis indicated that this initial version of the Impact of Cancer instrument measures distinct and relevant constructs for LTS. Future work is necessary to confirm the factor structure, responsiveness and further validation of the instrument.","Psychooncology, 15(5): 407-421","USA",2006,"Survivors","None","IOC","Patient",null,"Validation",null,null,null,null,null,null,null,null,"Disease"]
[757,"Zeliadt, S. B., et al. (2013). \"A preliminary exploration of the feasibility of offering men information about potential prostate cancer treatment options before they know their biopsy results.\" BMC Med Inform Decis Mak 13: 19.",null,"Zeliadt, S. B., et al.","A preliminary exploration of the feasibility of offering men information about potential prostate cancer treatment options before they know their biopsy results","BACKGROUND: A small pre-test study was conducted to ascertain potential harm and anxiety associated with distributing information about possible cancer treatment options at the time of biopsy, prior to knowledge about a definitive cancer diagnosis. Priming men about the availability of multiple options before they have a confirmed diagnosis may be an opportunity to engage patients in more informed decision-making. METHODS: Men with an elevated PSA test or suspicious Digital Rectal Examination (DRE) who were referred to a urology clinic for a biopsy were randomized to receive either the clinic's usual care (UC) biopsy instruction sheet (n = 11) or a pre-biopsy educational (ED) packet containing the biopsy instruction sheet along with a booklet about the biopsy procedure and a prostate cancer treatment decision aid originally written for newly diagnosed men that described in detail possible treatment options (n = 18). RESULTS: A total of 62% of men who were approached agreed to be randomized, and 83% of the ED group confirmed they used the materials. Anxiety scores were similar for both groups while awaiting the biopsy procedure, with anxiety scores trending lower in the ED group: 41.2 on a prostate-specific anxiety instrument compared to 51.7 in the UC group (p = 0.13). ED participants reported better overall quality of life while awaiting biopsy compared to the UC group (76.4 vs. 48.5, p = 0.01). The small number of men in the ED group who went on to be diagnosed with cancer reported being better informed about the risks and side effects of each option compared to men diagnosed with cancer in the UC group (p = 0.07). In qualitative discussions, men generally reported they found the pre-biopsy materials to be helpful and indicated having information about possible treatment options reduced their anxiety. However, 2 of 18 men reported they did not want to think about treatment options until after they knew their biopsy results. CONCLUSIONS: In this small sample offering pre-biopsy education about potential treatment options was generally well received by patients, appeared to be beneficial to men who went on to be diagnosed, and did not appear to increase anxiety unnecessarily among those who had a negative biopsy.","BMC Med Inform Decis Mak, 13(19","USA",2013,"At risk","Screening","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Comorbidity"]
[758,"Zenger, M., et al. (2009). \"Health-related quality of life of prostate cancer patients compared to the general German population: age-specific results.\" Urol Int 83(2): 166-170.",null,"Zenger, M., et al.","Health-related quality of life of prostate cancer patients compared to the general German population: age-specific results","OBJECTIVE: The objective of this study was to examine the age-specific health-related quality of life (HRQOL) of prostate cancer patients (PCPs). PATIENTS AND METHODS: 387 PCPs were asked to self-assess their HRQOL with the EORTC QLQ-C30 questionnaire. Patients' data were compared with those of the general German population. RESULTS: The reported global health/QOL scores of the study group and the general German population are nearly equal. However, most of the subdomains of HRQOL are negatively affected in PCPs, especially in younger patients (<or=59 years). CONCLUSION: Medical professionals should pay more attention to the emotional burden of PCPs, because their stress and strains during the time before treatment have a rather more emotional than physical character.","Urol Int, 83(2): 166-170","Germany",2009,"Any or unknown","None","EORTC QLQ-C30","Patient,General population",null,"Cross-sectional",null,null,null,null,null,null,null,null,"General"]
[759,"Zhang, A. Y. and A. Z. Fu (2016). \"Cost-effectiveness of a behavioral intervention for persistent urinary incontinence in prostate cancer patients.\" Psychooncology 25(4): 421-427.",null,"Zhang, A. Y. and A. Z. Fu","Cost-effectiveness of a behavioral intervention for persistent urinary incontinence in prostate cancer patients","OBJECTIVE: The aim of this study was to evaluate the cost-effectiveness of a behavioral intervention for urinary incontinence of prostate cancer patients. Study subjects were either participating in or eligible but declined (i.e., nonparticipating) the active intervention study. METHODS: The intervention-participating subjects were randomized into three groups, including two intervention groups (support and telephone groups) and a usual care reference group. Intervention-nonparticipating subjects were concurrently enrolled. Intervention effectiveness was assessed on the EQ-5D measure. The costs included direct healthcare cost from medical billing data, patient out-of-pocket expense, caregiver expense, patient loss-of-work cost, and intervention cost. We calculated incremental cost-effectiveness ratios (ICERs) from societal, provider, and patient perspectives. RESULTS: Two hundred and sixty-seven intervention-participating and 69 intervention-nonparticipating post-cancer treatment patients were included. The support and telephone groups, but not the usual care group, had significantly higher EQ-5D index scores (0.054, p = 0.033, and 0.057, p = 0.026, respectively) than the intervention-nonparticipating group at month 6. Within 6 months, intervention cost per subject was $252 and $484, respectively, for providers, and $564 and $203, respectively, for the support and phone group subjects. The final ICERs were $16,759 per quality-adjusted life year (QALY) and $12,561/QALY for support and telephone groups, compared with those of the intervention-nonparticipating group. These ICERs are much smaller than $50,000/QALY, the consensus threshold to determine cost-effectiveness for society. CONCLUSIONS: The study interventions are cost-effective in consideration of eligible patients who declined the interventions. The interventions can provide meaningful outcome improvement on urinary continence at a low cost. This evidence provides critical information for future health policy decision-making of healthcare providers and payers.","Psychooncology, 25(4): 421-427","USA",2016,"Any or unknown","Psychological","EQ-5D","Patient",null,"Economic model",null,null,null,null,null,null,null,null,"Utility"]
[760,"Zhou, T., et al. (2015). \"A multicenter, randomized clinical trial comparing the three-weekly docetaxel regimen plus prednisone versus mitoxantone plus prednisone for Chinese patients with metastatic castration refractory prostate cancer.\" PLoS One 10(1): e0117002.",null,"Zhou, T., et al.","A multicenter, randomized clinical trial comparing the three-weekly docetaxel regimen plus prednisone versus mitoxantone plus prednisone for Chinese patients with metastatic castration refractory prostate cancer","PURPOSE: To explore the feasibility and efficacy of docetaxel plus prednisone for Chinese population with metastatic castration refractory prostate cancer (mCRPC). PATIENTS AND METHODS: A total of 228 patients recruited from 15 centers were randomized to receive 10 cycles of D3P arm (docetaxel: 75 mg/m2, intravenous infusion, every three weeks; Prednisone 10mg orally given daily) or M3P arm (mitoxantrone: 12 mg/m2, intravenous infusion, every three weeks; Prednisone 10mg orally given daily). Primary end point was overall survival, and secondary end points were events progression-free survival (PFS), response rate, response duration. Quality of life (QoL) was also assessed in both treatment groups. RESULTS: The median overall survival was 21.88 months in D3P arm and 13.67 months in M3P arm (P = 0.0011, hazard ratio = 0.63, 95% confidence interval, 0.46-0.86). Subgroup analysis was consistent with the results of overall analysis. Events progression-free survival (pain, PSA, tumor and disease) were significantly improved in D3P arm compared with M3P arm. PSA response rate was 35.11% for patients treated by D3P arm and 19.39% for M3P arm (P = 0.0155). Pain response rate was higher in D3P arm (61.11%, P = 0.0011) than in M3P (23.08%) arm. No statistical differences were found between D3P arm and M3P arm for QoL, tumor response rate and response duration of PSA and pain. The tolerability and overall safety of D3P arm were generally comparable to that of M3P arm. CONCLUSIONS: Compared with M3P arm, D3P arm significantly prolonged overall survival for the Chinese patients with mCRPC and improved the response rate for PSA and pain. TRIAL REGISTRATION: clinicaltrials.gov NCT00436839.","PLoS One, 10(1): e0117002","China",2015,"Metastatic","Taxane,Chemotherapy","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"General"]
[761,"Zimmermann, M., et al. (2016). \"Prospective Phase II Trial of Once-weekly Hypofractionated Radiation Therapy for Low-risk Adenocarcinoma of the Prostate: Late Toxicities and Outcomes.\" Clin Oncol (R Coll Radiol) 28(6): 386-392.",null,"Zimmermann, M., et al.","Prospective Phase II Trial of Once-weekly Hypofractionated Radiation Therapy for Low-risk Adenocarcinoma of the Prostate: Late Toxicities and Outcomes","AIMS: To report the long-term toxicities and sexual quality of life of a once-weekly hypofractionated radiation therapy schedule for low-risk prostate cancer. MATERIALS AND METHODS: A multi-institutional phase II trial was conducted, using a three-dimensional conformal radiation therapy (3D-CRT) approach for low-risk prostate cancer (T1a-T2a, Gleason </= 6 and prostate-specific antigen </= 10 ng/ml). Forty-five Gray (Gy) were delivered in nine fractions of 5 Gy given on a weekly basis. Acute and late genitourinary and gastrointestinal toxicities were graded according to the Radiation Therapy Oncology Group toxicity scale. Sexual function and sexual bother were assessed with the Expanded Prostate Cancer Index Composite (EPIC) questionnaire. RESULTS: Between March 2006 and August 2008, 80 patients were treated, with a median age of 69 years (interquartile range 64-72). The median follow-up was 83 months (interquartile range 73-85 months). At 7 years, overall survival was 88%. No patients died of prostate cancer. Cumulative grade >/=2 genitourinary and gastrointestinal late toxicity was reported for 31.3% and 30% of our patients, respectively. Cumulative grade >/=3 genitourinary and gastrointestinal late toxicity was seen in 3.8% and 12.5% of cases, respectively. Late genitourinary grade 2 toxicity was correlated with the occurrence of acute genitourinary grade 2 toxicity (P = 0.006). The occurrence of late gastrointestinal toxicity was not correlated with acute gastrointestinal toxicity. Pre-treatment EPIC sexual function was low (37.5%) and the mean EPIC sexual function score at 7 years after treatment was 14%. On the other hand, pre-treatment EPIC sexual bother reached 80.5%, meaning little bother, and remained stable during follow-up. CONCLUSIONS: Once-weekly 3D-CRT leads to excellent biochemical disease-free survival and acceptable toxicities. Pre-treatment EPIC sexual function dropped by 42% at 5 years of follow-up. This functional deficit did not bother patients, possibly due to the already low sexual function at baseline.","Clin Oncol (R Coll Radiol), 28(6): 386-392","Canada",2016,"Local","Radiotherapy","EPIC,RTOG-EORTC-SS","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Disease,Treatment"]
[762,"Zorn, K. C., et al. (2012). \"Prospective randomized trial of barbed polyglyconate suture to facilitate vesico-urethral anastomosis during robot-assisted radical prostatectomy: time reduction and cost benefit.\" BJU Int 109(10): 1526-1532.",null,"Zorn, K. C., et al.","Prospective randomized trial of barbed polyglyconate suture to facilitate vesico-urethral anastomosis during robot-assisted radical prostatectomy: time reduction and cost benefit","Study Type - RCT (randomized trial) Level of Evidence 2b. What's known on the subject? and What does the study add? In a previous randomized controlled trial, barbed polyglyconate suture for vesico-urethral anastomosis was associated with more frequent cystogram leaks, longer mean catheterization times and greater suture costs per case. In the current randomized controlled trial, we show that barbed polyglyconate suture is associated with decreased anastomosis time, decreased need to readjust suture tension, cost reduction, and equal continence and early/late urinary complication rates. OBJECTIVE: To examine the effectiveness of barbed polyglyconate suture (V-Loc 180; Covidien, Mansfield, MA, USA) compared with standard monofilament for posterior reconstruction (PR) and vesico-urethral anastomosis (VUA) during robot-assisted radical prostatectomy (RARP). PATIENTS AND METHODS: A prospective randomized controlled trial was conducted in 70 consecutive RARP cases by a single surgeon (K.C.Z.). Standard VUA was performed using three 4-0 poliglecaprone 25 (Monocryl; Ethicon Endosurgery, Cincinnati, OH, USA) sutures secured with absorbable suture clips (LapraTy, Ethicon; one single 6-inch [15.2 cm] for PR and two attached 6-inch [15.2 cm] for VUA). Barbed suture VUA was performed using two 3-0 6-inch (15.2 cm) barbed polyglyconate sutures. Time to complete the suture set-up by the nursing team, anastomosis time and need to adjust suture tension were recorded. Suture-related complications, validated-questionnaire continence and cost were also examined. RESULTS: Compared with a conventional reconstruction technique, there was a significant reduction in mean nurse set-up time (31 vs. 294 s; P < 0.01) and reconstruction time (13.1 vs. 20.8 min; P < 0.01) for the barbed suture technique. Need to readjust suture tension or to place additional suture clips for watertight closure was greater in the standard monofilament group than in the barbed suture group (6% vs. 24%; P= 0.03). * A cost reduction was recorded at our institution (48.05 vs. 70.25 $CAN) with the barbed suture technique. * With a mean follow-up of 6.2 months, no delayed anastomotic leak or bladder neck contracture was observed in either group. * Pad-free continence outcomes for the monofilament suture vs the barbed suture groups at 1 (64 vs. 69%, P= 0.6), 3 (76 vs. 81%, P= 0.5) and 6 months (88 vs. 92%, P= 0.7) were similar. CONCLUSIONS: * Compared with standard monofilament suture, the unidirectional barbed polyglyconate suture appears to provide safe, efficient and cost-effective PR and VUA during RARP. * Use of the interlocked barbed polyglyconate suture technique prevents slippage, precluding the need for assistance, knot-tying and constant reassessment of anastomosis integrity.","BJU Int, 109(10): 1526-1532","Canada",2012,"Any or unknown","Surgery","Unclear","Patient",null,"Clinical trial",null,null,null,null,null,null,null,null,"Complication"]
[763,"Zuber, S., et al. (2015). \"Iodine-125 seed brachytherapy for early stage prostate cancer: a single-institution review.\" Radiat Oncol 10: 49.",null,"Zuber, S., et al.","Iodine-125 seed brachytherapy for early stage prostate cancer: a single-institution review","PURPOSE: We are reporting the five-year biochemical control, toxicity profile and dosimetric parameters using iodine-125 low dose rate brachytherapy (BT) as monotherapy for early stage prostate cancer at a single institution. MATERIAL AND METHODS: Between April 2006 and December 2010, 169 men with early stage prostate cancer were treated with BT. Biochemical failure was defined using the Phoenix definition (nadir + 2 ng/mL). Treatment-related morbidities, including urinary, rectal and sexual function, were measured, applying the International Prostate Symptom Score (IPSS), the 7-grade Quality of Life Scale (QoL) and medical status, the International Consultation on Incontinence Modular Questionnaire (ICIQ), the International Index of Erectile Function (IIEF-5) and the Common Terminology Criteria for Adverse Events (CTCAE v4.03). Seed migration and loss, dosimetric parameters and learning effects were also analyzed. RESULTS: Medium follow-up time was 50 months (range, 1-85 months). The five-year biochemical failure rate was 7%. Acute proctitis rates were 19% (grade 1) and 1% (grade 2), respectively. The overall incidence of incontinence was 19% (mild), 16% (moderate) and < 1% (severe). An increase in IPSS >/= 5 points was detected in 59% of patients, with 38% regaining their baseline. Seed dislocation was found in 24% of patients and correlated with D90 and V100. A learning curve was found for seed migration, D90 and V100. QoL correlated with the general health condition of patient, incontinence symptoms and IPSS. CONCLUSIONS: BT for early stage prostate cancer offers excellent five-year biochemical control with low toxicities. QoL aspects are favorable. A learning curve was detected for procedural aspects but its impact on patient relevant endpoints remains inconclusive.","Radiat Oncol, 10(49","Germany,UK,Switzerland",2015,"Local","Brachytherapy","IPSS,IIEF-5,ICIQ,CTCAE,QOL-7","Patient",null,"Cross-sectional",null,null,null,null,null,null,null,null,"Disease,Complication,Treatment,General"]

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[]
["Acronym","Full name","Type of PRO tool (if relevant)"]
["15D",null,"Utility"]
["ABC","Activities-specific Balance Confidence Scal","Symptom"]
["AUA-SI","American Urological Association Symptom Index","Symptom"]
["BAI","Beck Anxiety Inventory","Comorbidity"]
["BDI","Beck Depression Inventory","Comorbidity"]
["BFS","Bruera Global Fatigue Severity Scale ","Symptom"]
["BHS","Beck Hopelessness Scale","Comorbidity"]
["BiFS","Bidimensional Fatigue Scale","Symptom"]
["BIS","Body Image Scale","General"]
["BPI","Brief Pain Inventory","Symptom"]
["BSFI","Brief Sexual Function Inventory","Complication"]
["BSI","Brief Symptom Inventory","Symptom"]
["BSP-PC","Bononian Satisfaction Profile-Prostate Cancer","Treatment"]
["CARDI","Colon and Ano-Rectal Distress Inventory","Complication"]
["CARES-SF","Cancer Rehabilitation Evaluation System Short Form","Treatment"]
["CARIQ","Colon and Ano-Rectal Impact Questionnaire","Complication"]
["CAVIPRES-30","Prostate cancer-specific instrument","Disease"]
["CCCI","Coping with Cancer Instrument ","General"]
["CCFIS","Cleveland Clinic Fecal Incontinence Score","Complication"]
["CES-D","Center for Epidemiological Studies-Depression Scale","Comorbidity"]
["CHAMPS","Community Healthy Activities Model Program for Seniors","General"]
["CHIPS","Coping with Health Injuries and Problems Scale","General"]
["CILFS","Cancer Interference with Life and Family Scale","Carer"]
["Cleary-30","Cleary 30-item questionnaire","General"]
["CLSS","Core Lower Urinary Tract Symptom Score","Symptom"]
["COIN","Collection of Indirect and Nonmedical Direct Costs","Costs"]
["COPM","Canadian Occupational Performance Measure","Work"]
["CPQ","Cologne Patient Questionnaire","General"]
["CQOLC"," Caregiver Quality of Life Index-Cancer","Carer"]
["CSQ-8","Customer Satisfaction Questionnaire","Treatment"]
["CTCAE","Common Terminology Criteria for Adverse Events","Treatment"]
["CTS","Cancer Treatment Scale","Treatment"]
["CUF","Changes in Urinary Function","Symptom"]
["DASS-21"," Depression, Anxiety and Stress Scale","Comorbidity"]
["DUKE","Duke Health Profile","General"]
["ED-EQoL","Erectile Dysfunction effect on QoL","Complication"]
["EMPK","Erfassung multipler psychischer Konstrukte","General"]
["EORTC QLQ-C30","European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30","General"]
["EORTC QLQ-INFO25","European Organisation for Research and Treatment of Cancer Information Module","Knowledge"]
["EORTC QLQ-PR25","European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Prostate","Disease"]
["EORTC QLQ-PRT23","European Organization for Research and Treatment of Cancer Quality of Life -Proctitis","Complication"]
["EORTC-8D","European Organization for Research and Treatment of Cancer Utility index","Utility"]
["EPIC","Expanded Prostate Cancer Index Composite","Disease"]
["EPInv","Eysenck Personality Inventory","General"]
["EQ-5D","EuroQol Quality of Life (includes EQ-VAS)","Utility"]
["ESAS","Edmonton Symptom Assessment Scale","Symptom"]
["FACIT-F","Functional Assessment of Chronic Illness Therapy - Fatigue Scale","Symptom"]
["FACT-F","Functional Assessment of Cancer Therapy: Fatigue ","Symptom"]
["FACT-G","Functional Assessment of Cancer Therapy-General","Treatment"]
["FACT-P","Functional Assessment of Cancer Therapy-Prostate","Disease"]
["FACT-TOI","Functional Assessment of Cancer Therapy-Treatment Outcome Index","Treatment"]
["FAIT-U","Functional Assessment of Incontinence Therapy-Urinary","Complication"]
["FAPSI-8","FACT Advanced Prostate Symptom Index-8","Symptom"]
["FCRI","Fear of Cancer Recurrence Inventory","Disease"]
["FFQ","Food Frequency Questionnaire","General"]
["FLIC","Functional Living Index-Cancer","General"]
["FSS","Fatigue Severity Scale","Symptom"]
["GHI","General Health Index","General"]
["GISEQ","Gastrointestinal Side Effects Questionnaire","Treatment"]
["HADS","Hospital Anxiety and Depression Scale","Comorbidity"]
["HCP","Healthcare professional"]
["HIFU","High intensity focused ultrasound"]
["HSC","Hopkins Symptom Checklist","Symptom"]
["HSQ","Health Status Questionnaire ","General"]
["HUI","Health Utility Index","Utility"]
["IBDQ","Inflammatory Bowel Disease Questionnaire","Complication"]
["ICIQ","International Consultation on Incontinence Modular Questionnaire","Complication"]
["ICI-SF","IPSS bother score and incontinence questionnaire","Complication"]
["ICSQ","International Continence Society Questionnaire","Complication"]
["IES","Impact of Event Scale","Disease"]
["IIEF","International Index of Erectile Function-5","Complication"]
["IIQ","Incontinence Impact Questionnaire","Complication"]
["IOC","Impact of Cancer","Disease"]
["IPAQ","International Physical Activity Questionnaire","General"]
["IPSS","International Prostate Symptom Score","Disease"]
["I-QoL","Incontinence Quality of Life Instrument","Complication"]
["IQOL","International Quality of Life Score","General"]
["IRLE","Inventory of Recent Life Experiences","General"]
["ISvI","Insomnia Severity Index","Symptom"]
["ISyI","Incontinence Symptom Index ","Complication"]
["JOL","Joy-Of-Life Questionnaire","General"]
["KHQ","King's Health Questionnaire","General"]
["KUJ","Knowledge of cancer, Understanding treatment choices and Judgement of survival scale","Disease"]
["LASA","Linear analog self-assessment scale","General"]
["LENT-SOMA","Late Effects in Normal Tissues-Subjective, Objective, Management and Analytic scales","Treatment"]
["MASPC","Memorial Anxiety Scale for Prostate Cancer","Comorbidity"]
["MFI","Multidimensional Fatigue Inventory","Symptom"]
["MHI","Mental Health Index","Comorbidity"]
["MMAC","Mini-Mental Adjustment to Cancer","Disease"]
["MOS-MHI","MOS Mental Health Index","Comorbidity"]
["MOS-SP","MOS Sexual Problems ","Complication"]
["MOS-SSS","Medical Outcomes Study Social Support Survey","Social"]
["MPQ-PPI","McGill Pain Questionnaire Present Pain Intensity","Symptom"]
["MSAS","Memorial Symptom Assessment Scale","Symptom"]
["MUDI","Male Urogenital Distress Inventory","Complication"]
["MUSIQ"," Male Urinary Symptom Impact Questionnaire","Complication"]
["MYCWB","Measure Yourself Concerns and Well-Being","General"]
["NHP","Nottingham Health Profile ","General"]
["NPS","Numeric Pain Scale","Symptom"]
["OSGA","Ottery's Subjective Global Assessment","General"]
["PAIS","Psychological Adjustment to Illness Self-report Scale","General"]
["PBQ","Prostate Brachytherapy Questionnaire","Treatment"]
["PCIn","Prostate Cancer Index ","Disease"]
["PCKQ","Prostate Cancer Knowledge Questionnaire","Knowledge"]
["PC-QoL","Prostate cancer- Quality of Life","Disease"]
["PCRT-PCQoL","Prostate Cancer Radiotherapy Quality of Life Questionnaire","Treatment"]
["PCSI","Prostate Cancer Symptom Indices","Symptom"]
["PCSQLI","Prostate Cancer Specific Quality of Life Instrument","Disease"]
["PCTO-Q","Prostate Cancer Treatment Outcome Questionnaire","Treatment"]
["PDEi","Phosphodiesterase inhibitors"]
["PGI-I","Patient Global Impression of Improvement","Treatment"]
["PHQ-9","Patient Health Questionnaire","Comorbidity"]
["POMS","Profile of Mood States","Comorbidity"]
["PORPUS","Patient-Oriented Prostate Utility Scale","Disease"]
["PORT","Prostate Outcomes Research Team prostate cancer treatment complication profile","Treatment"]
["POSAS","Patient and Observer Scar Assessment Questionnair","Treatment"]
["PPB","Physical Performance Battery","Symptom"]
["PPP","Prostate Cancer Patient & Partner questionnaire","Disease"]
["PROMIS","Patient Reported Outcome Measurement Information System (PROMIS) Cancer Fatigue Short Form","Symptom"]
["PROSQoLI ","Prostate cancer Quality of Life ","Disease"]
["PSM-G","Prostate-specific instrument","Disease"]
["PcSS"," Perceived Stress Scale","General"]
["PSSR","Prostate Symptom Self-Report","Disease"]
["PVP","PatientViewpoint","General"]
["QLACS","Quality of Life in Adult Cancer Survivors","General"]
["QLI","Quality of Life Index","General"]
["QOL-CS","Quality of Life - Cancer Survivor","General"]
["QOLM-P14","Quality of Life Module-Prostate 14","Disease"]
["QUFW94","Prostate cancer specific symptom questionnaire","Disease"]
["QWB","Quality of Well-Being Scale","Utility"]
["R-FAS","Rectal Function Assessment Score","Complication"]
["RMS","Royal Marsden Scale","Treatment"]
["RatingS","Rating Scale","Utility"]
["RSCL","Rotterdam Symptom Checklist","Symptom"]
["RT-ARD","Condensed Anorectal Dysfunction Score","Complication"]
["RTOG-EORTC-SS","Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer scoring schema","Complication"]
["SActQ","Sexual Activities Module","Complication"]
["SActQ"," Sexual Activity questionnaire","Complication"]
["SAQ","Sexual Adjustment Questionnaire","Complication"]
["SCL-90","Symptom Checklist-90","Symptom"]
["SCN-SF34","Supportive Care Needs Survey-SF34 Revised","Social"]
["SCPQ","Support Care Preferences Questionnaire","Social"]
["SF-12","Medical Outcomes Study Short Form Health Survey-12","Utility"]
["SF-36","Medical Outcomes Study Short Form Health Survey SF-36","Utility"]
["SF-8","Medical Outcome Study 8-Item Short-Form Health Survey","Utility"]
["SFI","Sexual function Index","Complication"]
["SFQ","Sapporo Medical University Sexual Function Questionnaire","Complication"]
["SG","Standard Gamble","Utility"]
["SHIM","Sexual Health Inventory for Men","Complication"]
["SIP","Sickness Impact Profile","General"]
["SOC","Sense of Coherence ","General"]
["SQLU","Selby's QL Uniscale","General"]
["SSQ","Subjective Significance Questionnaire","General"]
["STAI","State-Trait Anxiety Inventory","Comorbidity"]
["STAR","Symptom Tracking and Reporting","Symptom"]
["SUPPH","Strategies Used by Patients to Promote Health","General"]
["SWBS","Spiritual Well-Being Scale","General"]
["SWLS","Satisfaction With Life Scale","General"]
["SWOG-QLQ","Southwest Oncology Group Quality of Life Questionnaire","General"]
["TIBI-P","Total Illness Burden Index-Prostate","Comorbidity"]
["TOI","Trial Outcome Index","Treatment"]
["TTO","Time Trade-Off","Utility"]
["UCLA-PCI","UCLA Prostate Cancer Index","Disease"]
["UCLA-SFS","University of California-Los Angeles Sexual Functioning Scale","Complication"]
["UFQ-RP","Urinary Function Questionnaire for men after RP","Complication"]
["U-Titer","U-Titer","Utility"]
["UWIN","Urgency, weak stream, incomplete emptying and nocturia","Complication"]
["VAS","Visual analogue scale","General"]
["VRS","Verbal Rating Scale","General"]
["WHO-Pain","WHO Pain Score","Symptom"]
["WHO-PS","WHO Performance Status","General"]
["WHOQOL-BREF","World Health Organization Quality of Life scale-BREF","General"]
["WHOQOL-OLD","World Health Organization Quality of Life scale for the elderly","General"]
["WOC","Ways of Coping Scale ","General"]
["WSFQ"," Watt's Sexual Function Questionnaire","Complication"]
["WTP","Willingness to Pay","Utility"]

{"sheet":"Mapper","index":3,"n_rows":613,"n_cols":11,"rows_kept":613,"cut":false,"hidden":false,"merged":[[22,1,22,6]]}
[]
[]
[null,"1. Select the first category to be included in the",null,null,null,null,null,null,null,null,"Count"]
[null," Evidence Map. This will show as a series of rows",null,null,null,null,null,null,null,"Unallocated",0]
[null,"in the Map",null,null,null,null,null,null,null,"15D",2]
[null,"First dimension",null,null,null,null,null,null,null,"ABC",1]
[null,4,{"$f":"OFFSET(C531,B7,0)","v":"PRO tools"},null,{"$f":"COUNTA(J4:J503)","v":184},null,null,null,null,"AUA-SI",18]
[null,null,null,null,null,null,null,null,null,"BAI",1]
[null,null,null,null,null,null,null,null,null,"BDI",2]
[null,"2. Then select the second category to be shown ",null,null,null,null,null,null,null,"BFS",1]
[null,"as the columns of the Map, or leave blank",null,null,null,null,null,null,null,"BHS",1]
[null,"Second dimension",null,null,null,null,null,null,null,"BIS",1]
[null,9,{"$f":"OFFSET(C531,B13,0)","v":"None"},null,{"$f":"COUNTA(K3:PZ3)","v":1},null,null,null,null,"BPI",11]
[null,null,null,null,null,null,null,null,null,"BSFI",3]
[null,"3. Click on a cell in the Map, then click the Show",null,null,null,null,null,null,null,"BSI",2]
[null,"Citation button below to see the relevant",null,null,null,null,null,null,null,"BSP-PC",1]
[null,"citations for that cell ",null,null,null,null,null,null,null,"BiFS",1]
[null,null,null,null,null,null,null,null,null,"CARDI",1]
[null,null,null,null,null,null,null,null,null,"CARES-SF",6]
[null,"Row",{"$f":"IF(AND(selectedRow>3,selectedRow<(4+E7)),OFFSET(tableLoc,(selectedRow-3),0),\"\")","v":""},null,null,null,null," ",null,"CARIQ",1]
[null,"Column",{"$f":"IF(AND(selectedColumn>10,selectedColumn<(11+columnCount)),OFFSET(tableLoc,0,(selectedColumn-10)),\"\")","v":""},null,null,null,null," ",null,"CAVIPRES-30",1]
[null,null,null,null,null,null,null,null,null,"CCCI",1]
[null,"See abbreviations",null,null,null,null,null,null,null,"CCFIS",1]
[null,null,null,null,null,null,null,null,null,"CES-D",1]
[null,null,null,null,null,null,null,null,null,"CHAMPS",2]
[null,null,null,null,null,null,null,null,null,"CHIPS",1]
[null,null,null,null,null,null,null,null,null,"CILFS",1]
[null,null,null,null,null,null,null,null,null,"CLSS",1]
[null,null,null,null,null,null,null,null,null,"COIN",1]
[null,null,null,null,null,null,null,null,null,"COPM",1]
[null,null,null,null,null,null,null,null,null,"CPQ",2]
[null,null,null,null,null,null,null,null,null,"CQOLC",1]
[null,null,null,null,null,null,null,null,null,"CSQ-8",2]
[null,null,null,null,null,null,null,null,null,"CTCAE",13]
[null,null,null,null,null,null,null,null,null,"CTS",1]
[null,null,null,null,null,null,null,null,null,"CUF",1]
[null,null,null,null,null,null,null,null,null,"Cleary-30",1]
[null,null,null,null,null,null,null,null,null,"DASS-21",2]
[null,null,null,null,null,null,null,null,null,"DUKE",1]
[null,null,null,null,null,null,null,null,null,"Diary",5]
[null,null,null,null,null,null,null,null,null,"ED-EQoL",1]
[null,null,null,null,null,null,null,null,null,"EMPK",1]
[null,null,null,null,null,null,null,null,null,"EORTC QLQ-C30",101]
[null,null,null,null,null,null,null,null,null,"EORTC QLQ-PR25",47]
[null,null,null,null,null,null,null,null,null,"EORTC-8D",1]
[null,null,null,null,null,null,null,null,null,"EORTC-QLQ-INFO25",1]
[null,null,null,null,null,null,null,null,null,"EORTC-QLQ-PRT23",1]
[null,null,null,null,null,null,null,null,null,"EORTC-QOL-C30",1]
[null,null,null,null,null,null,null,null,null,"EPIC",87]
[null,null,null,null,null,null,null,null,null,"EPInv",1]
[null,null,null,null,null,null,null,null,null,"EQ-5D",31]
[null,null,null,null,null,null,null,null,null,"ESAS",1]
[null,null,null,null,null,null,null,null,null,"FACIT-F",1]
[null,null,"Dates",null,null,null,null,null,null,"FACT-F",1]
[null,null,"None",null,null,null,null,null,null,"FACT-G",27]
[null,null,null,null,null,null,null,null,null,"FACT-P",49]
[null,null,null,null,null,null,null,null,null,"FACT-TOI",1]
[null,null,null,null,null,null,null,null,null,"FAIT-U",1]
[null,null,null,null,null,null,null,null,null,"FAPSI-8",1]
[null,null,null,null,null,null,null,null,null,"FCRI",1]
[null,null,null,null,null,null,null,null,null,"FFQ",2]
[null,null,null,null,null,null,null,null,null,"FLIC",5]
[null,null,null,null,null,null,null,null,null,"FSS",1]
[null,null,null,null,null,null,null,null,null,"GHI",1]
[null,null,null,null,null,null,null,null,null,"GISEQ",1]
[null,null,null,null,null,null,null,null,null,"HADS",15]
[null,null,null,null,null,null,null,null,null,"HSC",1]
[null,null,null,null,null,null,null,null,null,"HSQ",1]
[null,null,null,null,null,null,null,null,null,"HUI",4]
[null,null,null,null,null,null,null,null,null,"I-QoL",2]
[null,null,null,null,null,null,null,null,null,"IBDQ",1]
[null,null,null,null,null,null,null,null,null,"ICI-SF",1]
[null,null,null,null,null,null,null,null,null,"ICIQ",11]
[null,null,null,null,null,null,null,null,null,"ICSQ",6]
[null,null,null,null,null,null,null,null,null,"IES",2]
[null,null,null,null,null,null,null,null,null,"IIEF-5",27]
[null,null,null,null,null,null,null,null,null,"IIQ",1]
[null,null,null,null,null,null,null,null,null,"IOC",1]
[null,null,null,null,null,null,null,null,null,"IPAQ",1]
[null,null,null,null,null,null,null,null,null,"IPSS",35]
[null,null,null,null,null,null,null,null,null,"IQOL",1]
[null,null,null,null,null,null,null,null,null,"IRLE",1]
[null,null,null,null,null,null,null,null,null,"ISCQ",1]
[null,null,null,null,null,null,null,null,null,"ISvI",1]
[null,null,null,null,null,null,null,null,null,"ISyI",1]
[null,null,null,null,null,null,null,null,null,"Interview",9]
[null,null,null,null,null,null,null,null,null,"JOL",1]
[null,null,null,null,null,null,null,null,null,"KHQ",1]
[null,null,null,null,null,null,null,null,null,"KUJ",1]
[null,null,null,null,null,null,null,null,null,"LASA",2]
[null,null,null,null,null,null,null,null,null,"LENT-SOMA",9]
[null,null,null,null,null,null,null,null,null,"Likert scale",3]
[null,null,null,null,null,null,null,null,null,"MAS",2]
[null,null,null,null,null,null,null,null,null,"MASPC",1]
[null,null,null,null,null,null,null,null,null,"MFI",1]
[null,null,null,null,null,null,null,null,null,"MHI",2]
[null,null,null,null,null,null,null,null,null,"MMAC",1]
[null,null,null,null,null,null,null,null,null,"MOS-MHI",1]
[null,null,null,null,null,null,null,null,null,"MOS-SP",1]
[null,null,null,null,null,null,null,null,null,"MOS-SSS",1]
[null,null,null,null,null,null,null,null,null,"MPI",1]
[null,null,null,null,null,null,null,null,null,"MPQ",7]
[null,null,null,null,null,null,null,null,null,"MSAS",5]
[null,null,null,null,null,null,null,null,null,"MUDI",1]
[null,null,null,null,null,null,null,null,null,"MUSIQ",1]
[null,null,null,null,null,null,null,null,null,"MYCWB",1]
[null,null,null,null,null,null,null,null,null,"NHP",2]
[null,null,null,null,null,null,null,null,null,"NPS",5]
[null,null,null,null,null,null,null,null,null,"OSGA",1]
[null,null,null,null,null,null,null,null,null,"PAIS",2]
[null,null,null,null,null,null,null,null,null,"PBQ",1]
[null,null,null,null,null,null,null,null,null,"PC-QoL",4]
[null,null,null,null,null,null,null,null,null,"PCIn",1]
[null,null,null,null,null,null,null,null,null,"PCKQ",1]
[null,null,null,null,null,null,null,null,null,"PCRT",2]
[null,null,null,null,null,null,null,null,null,"PCSI",5]
[null,null,null,null,null,null,null,null,null,"PCSQLI",1]
[null,null,null,null,null,null,null,null,null,"PCTO-Q",2]
[null,null,null,null,null,null,null,null,null,"PGI-I",1]
[null,null,null,null,null,null,null,null,null,"PHQ-9",1]
[null,null,null,null,null,null,null,null,null,"POMS",5]
[null,null,null,null,null,null,null,null,null,"PORPUS",9]
[null,null,null,null,null,null,null,null,null,"PORT",1]
[null,null,null,null,null,null,null,null,null,"POSAS",1]
[null,null,null,null,null,null,null,null,null,"PPB",1]
[null,null,null,null,null,null,null,null,null,"PPP",1]
[null,null,null,null,null,null,null,null,null,"PROMIS",3]
[null,null,null,null,null,null,null,null,null,"PROSQoLI",9]
[null,null,null,null,null,null,null,null,null,"PSM-G",1]
[null,null,null,null,null,null,null,null,null,"PSSR",1]
[null,null,null,null,null,null,null,null,null,"PVP",1]
[null,null,null,null,null,null,null,null,null,"PcSS",2]
[null,null,null,null,null,null,null,null,null,"QLACS",1]
[null,null,null,null,null,null,null,null,null,"QLI",4]
[null,null,null,null,null,null,null,null,null,"QOL-7",1]
[null,null,null,null,null,null,null,null,null,"QOL-CS",2]
[null,null,null,null,null,null,null,null,null,"QOLM-P14",3]
[null,null,null,null,null,null,null,null,null,"QUFW94",3]
[null,null,null,null,null,null,null,null,null,"QWB",3]
[null,null,null,null,null,null,null,null,null,"R-FAS",1]
[null,null,null,null,null,null,null,null,null,"RMS",2]
[null,null,null,null,null,null,null,null,null,"RSCL",3]
[null,null,null,null,null,null,null,null,null,"RT-ARD",1]
[null,null,null,null,null,null,null,null,null,"RTOG-EORTC-SS",17]
[null,null,null,null,null,null,null,null,null,"RatingS",2]
[null,null,null,null,null,null,null,null,null,"SAQ",2]
[null,null,null,null,null,null,null,null,null,"SAc",2]
[null,null,null,null,null,null,null,null,null,"SActQ",1]
[null,null,null,null,null,null,null,null,null,"SCL-90",1]
[null,null,null,null,null,null,null,null,null,"SCN-SF34",2]
[null,null,null,null,null,null,null,null,null,"SCPQ",1]
[null,null,null,null,null,null,null,null,null,"SF-12",21]
[null,null,null,null,null,null,null,null,null,"SF-36",120]
[null,null,null,null,null,null,null,null,null,"SF-8",7]
[null,null,null,null,null,null,null,null,null,"SFI",4]
[null,null,null,null,null,null,null,null,null,"SFQ",3]
[null,null,null,null,null,null,null,null,null,"SG",7]
[null,null,null,null,null,null,null,null,null,"SHIM",5]
[null,null,null,null,null,null,null,null,null,"SIP",1]
[null,null,null,null,null,null,null,null,null,"SMUF",2]
[null,null,null,null,null,null,null,null,null,"SOC",2]
[null,null,null,null,null,null,null,null,null,"SQLU",1]
[null,null,null,null,null,null,null,null,null,"SSQ",1]
[null,null,null,null,null,null,null,null,null,"STAI",1]
[null,null,null,null,null,null,null,null,null,"STAR",2]
[null,null,null,null,null,null,null,null,null,"SUPPH",1]
[null,null,null,null,null,null,null,null,null,"SWBS",1]
[null,null,null,null,null,null,null,null,null,"SWLS",2]
[null,null,null,null,null,null,null,null,null,"SWOG-QLQ",1]
[null,null,null,null,null,null,null,null,null,"TIBI-P",1]
[null,null,null,null,null,null,null,null,null,"TOI",3]
[null,null,null,null,null,null,null,null,null,"TTO",16]
[null,null,null,null,null,null,null,null,null,"U-Titer",1]
[null,null,null,null,null,null,null,null,null,"UCLA-PCI",93]
[null,null,null,null,null,null,null,null,null,"UCLA-SFS",1]
[null,null,null,null,null,null,null,null,null,"UFQ-RP",2]
[null,null,null,null,null,null,null,null,null,"UWIN",1]
[null,null,null,null,null,null,null,null,null,"Unclear",211]
[null,null,null,null,null,null,null,null,null,"VAS",21]
[null,null,null,null,null,null,null,null,null,"VRS",1]
[null,null,null,null,null,null,null,null,null,"WHO-PS",1]
[null,null,null,null,null,null,null,null,null,"WHO-Pain",1]
[null,null,null,null,null,null,null,null,null,"WHOQOL-BREF",4]
[null,null,null,null,null,null,null,null,null,"WHOQOL-OLD",1]
[null,null,null,null,null,null,null,null,null,"WOC",1]
[null,null,null,null,null,null,null,null,null,"WSFQ",1]
[null,null,null,null,null,null,null,null,null,"WTP",2]
[]
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[]
[null,"Locations",{"$f":"COUNTA(C532:C545)","v":9}]
[1,"Locations","Locations"]
[2,"Interventions","Interventions"]
[3,"Diseases","Diseases"]
[4,{"$f":"INDEX(domainList,A535)","v":"PRO tools"},"PRO tools"]
[5,{"$f":"INDEX(domainList,A536)","v":"subPopulations"},"subPopulations"]
[6,{"$f":"INDEX(domainList,A537)","v":"Study types"},"Study methodologies"]
[7,{"$f":"INDEX(domainList,A538)","v":"Study methodologies"},"Type of PRO tool"]
[1,{"$f":"INDEX(customList,A539)","v":"Type of PRO tool"},"Dates"]
[2,{"$f":"INDEX(customList,A540)","v":"C2"},"None"]
[3,{"$f":"INDEX(customList,A541)","v":"C3"}]
[4,{"$f":"INDEX(customList,A542)","v":"C4"}]
[5,{"$f":"INDEX(customList,A543)","v":"C5"}]
[null,"Dates"]
[null,"None"]
[]
[]
[]
[]
[]
[]
[]
[]
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[1,"Abbott,R. R.,et al. (1998). \"A comparison of prostate knowledge of African-American and Caucasian men: changes from prescreening baseline to postintervention.\" Cancer J Sci Am 4(3): 175-177.",null,"Abbott,R. R.,et al.","A comparison of prostate knowledge of African-American and Caucasian men: changes from prescreening baseline to postintervention","PURPOSE: This study was undertaken to determine if a community screening program designed to overcome key barriers (lack of awareness,cost of program,ease of access to care) could successfully impact on African-American males' knowledge,attitudes,and behaviors regarding prostate cancer screening. The focus of this report is knowledge. To date,there are no reported studies that examine differences in knowledge from a prescreening baseline to a postintervention level for minority participants. PATIENTS AND METHODS: A total of 944 men were enrolled in the study in a 20-month period. Prostate screening and education were offered as a new service at an existing senior health clinic. In addition,mass screenings were offered approximately monthly at various locations in the community (including senior community centers,senior apartment complexes,and some public housing projects). Screening included both the digital rectal examination and the prostate specific antigen test. A brief questionnaire was administered during client intake (the pretest) and repeated after the education and screening participation (the posttest). Test items targeted three constructs: (1) etiology,(2) risk status,and (3) clinical factors. RESULTS: The largest difference on pretest scores between the racial groups resulted from clinical factor knowledge. African-American men were significantly less likely than Caucasian men to correctly identify early symptoms of prostate cancer and the basic components of a prostate checkup. Although scores were initially significantly lower for African-American participants,these differences were not evident after program involvement. There was a significant increase in knowledge level for all men when comparing pretest and posttest scores. Significant improvement was noted for each test item,with the exception of one key item. Even after participation in the program,African-American men were still more likely to believe that \"pain\" was the first symptom of prostate cancer. DISCUSSION: An item-by-item analysis revealed that there was only one test item in which program participation did not \"correct\" knowledge. African-American men were still more likely to believe that pain was the first symptom that would alert them to the presence of cancer. The screening program included information (both printed and oral content) that emphasized the importance of routine screening to detect cancer at an early stage,because most men would experience no symptoms. The only other reported study that examined knowledge documented similar findings with respect to an understanding of symptomology. These findings can be used to direct or guide the educational component of future screening programs that hope to target African-American men.","Cancer J Sci Am,4(3): 175-177","USA",1998,"At risk","None","Unclear","Patient",null,"Cross-sectional","USA","Patient","At risk","None",null,"Cross-sectional","Unclear","1960:1999","Knowledge"]
[2,"Ahles,T. A.,et al. (2004). \"Quality of life impact of three different doses of suramin in patients with metastatic hormone-refractory prostate carcinoma: results of Intergroup O159/Cancer and Leukemia Group B 9480.\" Cancer 101(10): 2202-2208.",null,"Ahles,T. A.,et al.","Quality of life impact of three different doses of suramin in patients with metastatic hormone-refractory prostate carcinoma: results of Intergroup O159/Cancer and Leukemia Group B 9480","BACKGROUND: Research has suggested that men with hormone-refractory prostate carcinoma have a lower quality of life (QOL) compared with men who have hormone-sensitive prostate carcinoma and that quality of life (QOL) steadily declines over the last year of life for men with prostate carcinoma. The primary purpose of the current study was to evaluate whether there was evidence of palliative effects associated with suramin at any of the three doses administered in the original clinical trial. METHODS: Patients with histologically confirmed advanced hormone-refractory adenocarcinoma of the prostate were randomized to receive suramin at a low dose (n = 129; median age,69 years),an intermediate dose (n = 129; median age,71 years),or a high dose (n = 127; median age,70 years) as part of the Intergroup 0159/Cancer and Leukemia Group B 9480 trial. Patients completed a battery of assessment tools,including the Functional Assessment of Cancer Therapy (FACT)-Prostate,the Center for Epidemiological Studies-Depression Scale (CES-D),the Brief Pain Inventory,and an opioid medication log,at baseline,on Day 1 of the sixth week of active therapy,during the second week after treatment termination,and 3 months after administration of the final suramin dose. RESULTS: Patients who received low-dose suramin reported improvement in QOL (FACT-General: P < 0.01; FACT-Treatment Outcome Index: P < 0.01) and decreased levels of depression (CES-D: P < 0.0006) during treatment compared with patients in the intermediate- and high-dose arms. After treatment,all groups experienced equal decreases in FACT and CES-D scores. CONCLUSIONS: The pattern of results suggests that the lowest dose of suramin administered had a palliative effect in terms of improvement in QOL and decreased levels of depression and that this effect was lost once suramin was discontinued.","Cancer,101(10): 2202-2208","USA",2004,"Advanced,Metastatic","Various","FACT-P,CES-D,BPI,FACT-G,FACT-TOI","Patient",null,"Clinical trial","USA","Patient","Advanced,Metastatic","Various",null,"Clinical trial","FACT-P,CES-D,BPI,FACT-G,FACT-TOI","2000:2004","Disease,Comorbidity,Treatment,Symptom"]
[3,"Ahmad,I. U.,et al. (2010). \"Soy isoflavones in conjunction with radiation therapy in patients with prostate cancer.\" Nutr Cancer 62(7): 996-1000.",null,"Ahmad,I. U.,et al.","Soy isoflavones in conjunction with radiation therapy in patients with prostate cancer","Soy isoflavones sensitize prostate cancer cells to radiation therapy by inhibiting cell survival pathways activated by radiation. At the same time,soy isoflavones have significant antioxidant and anti-inflammatory activity,which may help prevent the side effects of radiation. Therefore,we hypothesized that soy isoflavones could be useful when given in conjunction with curative radiation therapy in patients with localized prostate cancer. In addition to enhancing the efficacy of radiation therapy,soy isoflavones could prevent the adverse effects of radiation. We conducted a pilot study to investigate the effects of soy isoflavone supplementation on acute and subacute toxicity (</=6 mo) of external beam radiation therapy in patients with localized prostate cancer. Forty-two patients with prostate cancer were randomly assigned to receive 200 mg soy isoflavone (Group 1) or placebo (Group 2) daily for 6 mo beginning with the first day of radiation therapy,which was administered in 1.8 to 2.5 Gy fractions for a total of 73.8 to 77.5 Gy. Adverse effects of radiation therapy on bladder,bowel,and sexual function were assessed by a self-administered quality of life questionnaire at 3 and 6 mo. Only 26 and 27 patients returned completed questionnaires at 3 and 6 mo,respectively. At each time point,urinary,bowel,and sexual adverse symptoms induced by radiation therapy were decreased in the soy isoflavone group compared to placebo group. At 3 mo,soy-treated patients had less urinary incontinence,less urgency,and better erectile function as compared to the placebo group. At 6 mo,the symptoms in soy-treated patients were further improved as compared to the placebo group. These patients had less dripping/leakage of urine (7.7% in Group 1 vs. 28.4% in Group 2),less rectal cramping/diarrhea (7.7% vs. 21.4%),and less pain with bowel movements (0% vs. 14.8%) than placebo-treated patients. There was also a higher overall ability to have erections (77% vs. 57.1%). The results suggest that soy isoflavones taken in conjunction with radiation therapy could reduce the urinary,intestinal,and sexual adverse effects in patients with prostate cancer.","Nutr Cancer,62(7): 996-1000","USA",2010,"Local","Radiotherapy,Various","Unclear","Patient",null,"Clinical trial","USA","Patient","Local","Radiotherapy,Various",null,"Clinical trial","Unclear","2010:2014","Complication"]
[4,"Ahmed,H. U.,et al. (2011). \"Focal therapy for localized prostate cancer: a phase I/II trial.\" J Urol 185(4): 1246-1254.",null,"Ahmed,H. U.,et al.","Focal therapy for localized prostate cancer: a phase I/II trial","PURPOSE: Men with localized prostate cancer currently face a number of treatment options that treat the entire prostate. These can cause significant sexual and urinary side effects. Focal therapy offers a novel strategy that targets the cancer rather than the prostate in an attempt to preserve tissue and function. MATERIALS AND METHODS: A prospective,ethics committee approved trial was conducted to determine the side effects of focal therapy using high intensity focused ultrasound. Multiparametric magnetic resonance imaging (T2-weighted,dynamic contrast enhanced,diffusion-weighted) and template transperineal prostate mapping biopsies were used to identify unilateral disease. Genitourinary side effects and quality of life outcomes were assessed using validated questionnaires. Posttreatment biopsies were performed at 6 months and followup was completed to 12 months. RESULTS: A total of 20 men underwent high intensity focused ultrasound hemiablation. Mean age was 60.4 years (SD 5.4,range 50 to 70) with mean prostate specific antigen 7.3 ng/ml (SD 2.8,range 3.4 to 11.8). Of the men 25% had low risk and 75% had intermediate risk cancer. Return of erections sufficient for penetrative sex occurred in 95% of men (19 of 20). In addition,90% of men (18 of 20) were pad-free,leak-free continent while 95% were pad-free. Mean prostate specific antigen decreased 80% to 1.5 ng/ml (SD 1.3) at 12 months. Of the men 89% (17 of 19,1 refused biopsy) had no histological evidence of any cancer,and none had histological evidence of high volume or Gleason 7 or greater cancer in the treated lobe. In addition,89% of men achieved the trifecta status of pad-free,leak-free continence,erections sufficient for intercourse and cancer control at 12 months. CONCLUSIONS: Our results appear sufficiently promising to support the further evaluation of focal therapy as a strategy to decrease some of the harms and costs associated with standard whole gland treatments.","J Urol,185(4): 1246-1254","UK",2011,"Local","HIFU","Unclear","Patient",null,"Clinical trial","UK","Patient","Local","HIFU",null,"Clinical trial","Unclear","2010:2014","Complication,General"]
[5,"Ahmed,H. U.,et al. (2012). \"Focal salvage therapy for localized prostate cancer recurrence after external beam radiotherapy: a pilot study.\" Cancer 118(17): 4148-4155.",null,"Ahmed,H. U.,et al.","Focal salvage therapy for localized prostate cancer recurrence after external beam radiotherapy: a pilot study","BACKGROUND: The objective of this study was to evaluate the safety,feasibility,side-effect profile,and proof of concept for focal salvage therapy using high-intensity focused ultrasound (HIFU). METHODS: A registry-based analysis was conducted between 2004 and 2009 of 430 patients who underwent HIFU. Thirty-nine patients received focal salvage therapy for localized recurrence after external beam radiotherapy. Multiparametric magnetic resonance imaging studies combined with transperineal template prostate mapping biopsies or transrectal biopsies were used to localize disease. Validated questionnaires were used to assess functional outcomes. Biochemical failure was defined by using both Phoenix criteria (prostate-specific antigen [PSA] nadir plus 2 ng/mL) and Stuttgart criteria (PSA nadir plus 1.2 ng/mL). RESULTS: The mean pre-HIFU PSA level was 4.6 ng/mL. The median follow-up was 17 months (interquartile range,10-29 months). International Index of Erectile Function-5 scores decreased from a median +/- standard deviation (SD) of 18 +/- 16 to 13 +/- 21 at 6 months,demonstrating worsening function. Scores on the University of California Los Angeles-Expanded Prostate Cancer Index Composite Urinary domain indicate that pad-free,leak-free continence status was 64%,and the pad-free rate was 87.2% at last follow-up. One rectourethral fistula occurred and spontaneously resolved with urinary and bowel diversion. The actuarial progression-free survival rate (including PSA nonresponders) was 69% at 1 year and 49% at 2 years according to Phoenix criteria. Excluding PSA nonresponders,these rates were 74% and 58%,respectively (Phoenix criteria). CONCLUSIONS: The results from this study indicated that focal salvage therapy is a potential strategy for localized recurrence after radiotherapy that may reduce the harms resulting from whole-gland salvage therapies.","Cancer,118(17): 4148-4155","UK",2012,"Recurrent","HIFU","IIEF-5,EPIC","Patient",null,"Cohort","UK","Patient","Recurrent","HIFU",null,"Cohort","IIEF-5,EPIC","2010:2014","Disease,Complication"]
[6,"Akakura,K.,et al. (1999). \"Long-term results of a randomized trial for the treatment of Stages B2 and C prostate cancer: radical prostatectomy versus external beam radiation therapy with a common endocrine therapy in both modalities.\" Urology 54(2): 313-318.",null,"Akakura,K.,et al.","Long-term results of a randomized trial for the treatment of Stages B2 and C prostate cancer: radical prostatectomy versus external beam radiation therapy with a common endocrine therapy in both modalities","OBJECTIVES: To improve the treatment of locally advanced prostate cancer (Stages B2 and C),a prospective randomized trial was conducted to compare radical prostatectomy versus external beam radiotherapy with the combination of endocrine therapy in both modalities. METHODS: One hundred patients were enrolled and 95 were evaluated. Forty-six patients underwent radical prostatectomy with pelvic lymph node dissection,and 49 were treated with radiation by linear accelerator with 40 to 50 Gy to the whole pelvis and a 20-Gy boost to the prostatic area. For all patients,endocrine therapy was initiated 8 weeks before surgery or radiation,and continued thereafter. The living patients were asked to respond to a quality-of-life questionnaire. RESULTS: The follow-up period ranged from 6.0 to 94.4 months (median 58.5). The progression-free and cause-specific survival rates at 5 years were 90.5% and 96.6% in the surgery group and 81.2% and 84.6% in the radiation group,respectively. The surgery group had better progression-free and cause-specific survival rates (P = 0.044 and 0.024,respectively). More patients in the surgery group complained of urinary incontinence. The questionnaire revealed that quality of life was less disturbed in the radiation group. CONCLUSIONS: Radical prostatectomy combined with endocrine therapy may contribute to the survival benefit of patients with locally advanced prostate cancer. External beam radiotherapy in combination with endocrine therapy can be used in selected patients because of its low morbidity.","Urology,54(2): 313-318","Japan",1999,"Advanced","Surgery,Radiotherapy,Hormonal","Unclear","Patient",null,"Clinical trial","Japan","Patient","Advanced","Surgery,Radiotherapy,Hormonal",null,"Clinical trial","Unclear","1960:1999","Complication,General"]
[7,"Akaza,H.,et al. (2004). \"The 3rd Conference on Asian Trends in Prostate Cancer Hormone Therapy.\" Gan To Kagaku Ryoho 31(8): 1285-1295.",null,"Akaza,H.,et al.","The 3rd Conference on Asian Trends in Prostate Cancer Hormone Therapy","From its inception in 2001,the Conference on Asian Trends in Prostate Cancer Hormone Therapy has served as an annual forum for Asian urologists to compare data on prostate cancer and to discuss issues regarding the use of hormone therapy. The 3rd conference,held in Tokyo in December 2003,began with participants from China,Indonesia,Japan,Korea,Singapore,and Taiwan presenting QOL data deriving from a survey of patients with prostate cancer. For this purpose,each country translated the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire into its own language. Although the surveys conducted in each country included a heterogeneous cohort of patients and gave very mixed results,the trial of FACT-P in Asian countries seemed propitious and in future may provide insights that could prove beneficial to patients. Day 2 of the conference included 2 discussions,focusing on the most appropriate number of biopsy cores and the implementation of prospective trials involving the collaboration of Asian countries,respectively. In the latter discussion,although a varied assortment of proposals were put forth,the participants generally agreed that any collaborative study must be a prospective outcome study conducted in a relatively short time not exceeding 2-3 years,and that patient registration should be done using the Internet.","Gan To Kagaku Ryoho,31(8): 1285-1295","Japan,China,Indonesia,Korea,Singapore,Taiwan",2004,"Any or unknown","None","FACT-P","Patient",null,"Narrative review","Japan,China,Indonesia,Korea,Singapore,Taiwan","Patient","Any or unknown","None",null,"Narrative review","FACT-P","2000:2004","Disease"]
[8,"Albertsen,P. C.,et al. (1997). \"Health-related quality of life among patients with metastatic prostate cancer.\" Urology 49(2): 207-216; discussion 216-207.",null,"Albertsen,P. C.,et al.","Health-related quality of life among patients with metastatic prostate cancer","OBJECTIVES: To assess and compare the quality of life of men with advanced prostate cancer who are in remission receiving treatment with a luteinizing hormone-releasing hormone (LHRH) agonist and flutamide or who are in progression. METHODS: We conducted a cross-sectional survey to measure health-related quality of life in a cohort of 113 patients with metastatic prostate cancer,60 in remission and 53 with disease progression,using a battery of questionnaires,including the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30,the Medical Outcomes Study Short Form Health Survey SF-36,and a prostate cancer-specific module. RESULTS: Patients in remission receiving an LHRH agonist and flutamide reported a significantly better quality of life compared with patients with disease progression (P < 0.011). Men with hormone-sensitive cancer had significantly less bodily pain,more vitality,more social interactions,and better mental health than patients with hormone-resistant disease. No differences were noted between the two groups concerning treatment-related problems such as diarrhea,constipation,urinary symptoms,sexual function,sexual satisfaction or hot flashes,although men in remission tended to rate each of these items more favorably than did men with disease progression. Men in remission have a health-related quality of life that is similar to an equivalent norm for men in the United States general population as compared with men with disease progression,who demonstrate significant compromise in all domains measured. CONCLUSIONS: Patients in remission receiving an LHRH agonist and flutamide have a quality of life that is indistinguishable from a matched male population without prostate cancer and a quality of life significantly better than that of men with androgen-resistant disease. Among patients who respond to total androgen ablation,flutamide and an LHRH agonist provide significant,measurable benefits to recipients independent of any possible improvement in longevity.","Urology,49(2): 207-216; discussion 216-207","USA",1997,"Metastatic","Hormonal","EORTC QLQ-C30,SF-36","Patient",null,"Cross-sectional","USA","Patient","Metastatic","Hormonal",null,"Cross-sectional","EORTC QLQ-C30,SF-36","1960:1999","Disease,General,Utility"]
[9,"Albertsen,P. C.,et al. (1998). \"Assessment of patient preferences among men with prostate cancer.\" J Urol 159(1): 158-163.",null,"Albertsen,P. C.,et al.","Assessment of patient preferences among men with prostate cancer","PURPOSE: We developed a self-administered paper based instrument to assess patient preferences quantified as utilities for common outcomes associated with the management of prostate cancer. MATERIALS AND METHODS: A total of 50 patients was invited to test a self-administered paper based instrument designed to assess preferences for health outcomes associated with the management of localized prostate cancer. The 50 patients were selected from a group of 625 randomly identified men with prostate cancer who responded to a survey instrument designed to assess health related quality of life. The 50 patients selected for this pilot project were chosen because of the wide range of responses to the quality of life survey. Patient utilities were assessed for the 5 health states of overall quality of life,problems related to prostate cancer,and problems related to urinary,bowel and sexual dysfunction. RESULTS: Patients were able to complete the assigned tasks. The self-administered instrument had high test-retest reliability. In addition results obtained from this instrument showed a correlation with results obtained from assessments using other instruments,including an analog scale,a computer based system known as U-Titer,a quality of life survey and the Health Utility Index:3. CONCLUSIONS: A self-administered paper based instrument can be used to assess patient utilities for health states associated with prostate cancer management. Results from the instrument tested appear to be reliable and valid,and are comparable to those obtained from other assessment techniques. A self-administered paper based instrument has distinct advantages when conducting large survey studies because it can be incorporated at relatively low cost.","J Urol,159(1): 158-163","USA",1998,"Any or unknown","None","HUI,VAS,U-Titer","Patient",null,"Cross-sectional","USA","Patient","Any or unknown","None",null,"Cross-sectional","HUI,VAS,U-Titer","1960:1999","Utility"]
[10,"Alibhai,S. M.,et al. (2010). \"Impact of androgen-deprivation therapy on physical function and quality of life in men with nonmetastatic prostate cancer.\" J Clin Oncol 28(34): 5038-5045.",null,"Alibhai,S. M.,et al.","Impact of androgen-deprivation therapy on physical function and quality of life in men with nonmetastatic prostate cancer","PURPOSE: This prospective longitudinal study evaluated the effect of androgen deprivation therapy (ADT) on objective and self-reported physical function. PATIENTS AND METHODS: Men with nonmetastatic prostate cancer (PC) starting continuous ADT were enrolled in this matched cohort study. Physical function was assessed with the 6-minute walk test (6MWT),grip strength,and the timed-up-and-go (TUG) test,representing endurance and upper and lower extremity strength,respectively. Quality of life (QOL) was measured with the Medical Outcomes Study Short-Form 36 (SF-36) questionnaire. Subjects were assessed at baseline,3,6,and 12 months. Two control groups (PC without ADT; no PC),matched on age,education,and baseline function were enrolled. Mixed effects regression models were fitted,adjusting for baseline covariates. RESULTS: We enrolled 87 patients on ADT,86 PC controls,and 86 healthy controls; groups were similar in age (mean,69.1 years; range,50 to 87) and physical function. The 6MWT distance remained stable in the ADT group (P = .96) but improved in both control groups (P < .05). Grip strength declined in the ADT group (P = .04),remained stable in PC controls (P = .31),and improved in healthy controls (P = .008). TUG scores remained stable over time and across groups (P > .10). The SF-36 physical function summary score declined in the ADT group (P < .001),but increased in both control groups (P < .001). Negative effects on outcomes were observed within 3 months of starting ADT and were generally independent of age. CONCLUSION: Endurance,upper extremity strength,and physical components of QOL are affected within 3 months of starting ADT. Up-front exercise interventions to counteract these losses are warranted.","J Clin Oncol,28(34): 5038-5045","Canada",2010,"Advanced,Local","Hormonal","SF-36","Patient",null,"Case-control","Canada","Patient","Advanced,Local","Hormonal",null,"Case-control","SF-36","2010:2014","Utility"]
[11,"Alibhai,S. M.,et al. (2015). \"A phase II RCT and economic analysis of three exercise delivery methods in men with prostate cancer on androgen deprivation therapy.\" BMC Cancer 15: 312.",null,"Alibhai,S. M.,et al.","A phase II RCT and economic analysis of three exercise delivery methods in men with prostate cancer on androgen deprivation therapy","BACKGROUND: Androgen deprivation therapy is commonly used to treat prostate cancer,the most common visceral cancer in men. However,various side effects often worsen physical functioning and reduce well-being among men on this treatment. Based on existing evidence,both resistance and aerobic training provide benefits for this population yet adherence rates are often low. The method of exercise delivery (supervised in-center or home-based) may be important,yet few studies have compared different models. Additionally,long-term exercise adherence is critical to achieve sustained benefits but long-term adherence data and predictors of adherence are lacking. The primary aim of this phase II,non-inferiority randomized controlled trial is to determine whether three exercise training delivery models are equivalent in terms of benefits in quality of life and physical fitness in this population. Secondary aims include examination of long-term adherence and cost-effectiveness. DESIGN: Men diagnosed with prostate cancer,starting or continuing on androgen deprivation therapy for at least 6 months,fluent in English,and living close to one of two experienced Canadian study centers are eligible. Participants complete five assessments over one year,including a fitness assessment and self-report questionnaires. Socio-demographic and clinical data collection occur at baseline,bone mineral density testing at two time points,and blood work is performed at three time points. Participants are randomized in a 1:1:1 fashion to supervised personal training,supervised group training,or home-based smartphone- and health coach-supported training. Each participant receives a detailed exercise manual,including illustrations of exercises and safety precautions. Participants are asked to complete 4 to 5 exercise sessions per week,incorporating aerobic,resistance and flexibility training. Participant intensity levels will be monitored. The intervention duration is 6 months,with 6 months additional follow-up. Outcomes include: body composition,fitness testing,quality of life and fatigue,biological outcomes,and program adherence. Cost information will be obtained using patient diary-based self-report. DISCUSSION: The goals of this study are to gain a better understanding of health benefits and costs associated with commonly used yet currently not compared exercise delivery models as well as an increased understanding of adherence to exercise. TRIAL REGISTRATION: The trial has been registered at clinicaltrials.gov (Registration # NCT02046837),registered January 20(th),2014.","BMC Cancer,15(312","Canada",2015,"Any or unknown","Various,Hormonal","Unclear","Patient",null,"Protocol","Canada","Patient","Any or unknown","Various,Hormonal",null,"Protocol","Unclear","2015:2018","Unclear"]
[12,"Al-Mamgani,A.,et al. (2011). \"Dose escalation and quality of life in patients with localized prostate cancer treated with radiotherapy: long-term results of the Dutch randomized dose-escalation trial (CKTO 96-10 trial).\" Int J Radiat Oncol Biol Phys 79(4): 1004-1012.",null,"Al-Mamgani,A.,et al.","Dose escalation and quality of life in patients with localized prostate cancer treated with radiotherapy: long-term results of the Dutch randomized dose-escalation trial (CKTO 96-10 trial)","PURPOSE: To assess the impact of dose escalation of radiotherapy on quality of life (QoL) in prostate cancer patients. PATIENTS AND METHODS: Three hundred prostate cancer patients participating in the Dutch randomized trial (CKTO 69-10) comparing 68 Gy with 78 Gy were the subject of this analysis. These patients filled out the SF-36 QoL questionnaire before radiotherapy (baseline) and 6,12,24,and 36 months thereafter. Changes in QoL over time of >/=10 points were considered clinically relevant. Repeated-measures regression analyses were applied to estimate and test the QoL changes over time,the differences between the two arms,and for association with a number of covariates. RESULTS: At 3-year follow-up,the summary score physical health was 73.2 for the 68-Gy arm vs. 71.6 for the 78-Gy arm (p = 0.81),and the summary score mental health was 76.7 for the 68-Gy arm vs. 76.1 for the 78-Gy arm (p = 0.97). Statistically significant (p < 0.01) deterioration in QoL scores over time was registered in both arms in six scales. The deterioration over time was more pronounced in the high-dose arm for most scales. However,clinically relevant deterioration (>10 points) was seen for only two scales. None of the tested covariates were significantly correlated with QoL scores. CONCLUSION: Dose escalation did not result in significant deterioration of QoL in prostate cancer patients. In both randomization arms,statistically significant decreases in QoL scores over time were seen in six scales. The deterioration of QoL was more pronounced in the physical than in the mental health domain and in some scales more in the high- than in the low-dose arm,but the differences between arms were not statistically significant.","Int J Radiat Oncol Biol Phys,79(4): 1004-1012","Netherlands",2011,"Local","Radiotherapy","SF-36","Patient",null,"Clinical trial","Netherlands","Patient","Local","Radiotherapy",null,"Clinical trial","SF-36","2010:2014","Utility"]
[13,"Altwein,J.,et al. (1997). \"How is quality of life in prostate cancer patients influenced by modern treatment? The Wallenberg Symposium.\" Urology 49(4A Suppl): 66-76.",null,"Altwein,J.,et al.","How is quality of life in prostate cancer patients influenced by modern treatment? The Wallenberg Symposium","OBJECTIVES: To identify complications of various forms of treatments for prostate cancer and their influence on patients' quality of life with the ultimate goal of suggesting a Quality of Life Questionnaire specific for prostate cancer for further validation. METHODS: The literature was screened for reports on the more common complications following various forms of therapy for prostate cancer. Frequencies were summarized. The scarce literature reporting on quality of life in prostate cancer was reviewed and conflicting data were discussed and reassessed. Suggested questionnaires used in other studies were critically scrutinized and the various questions recorded. RESULTS: Following radical surgery,impotence and incontinence were the most common complications reducing patients' quality of life. The literature was not uniform with regard to whether loss of sexual function was regarded as a worse complication than loss of urinary control. Following radiotherapy,intestinal problems and sexual dysfunction were the dominating side effects. Quality of life was best preserved in surveillance-only series. Following endocrine therapy,not only impotence and hot flushes were focused upon,but also mental dysfunction and intestinal dysfunction from nonsteroidal antiandrogens,additionally,the importance of effective palliation was highlighted. A Quality of Life Questionnaire should contain general domains relevant to cancer patients,cancer-specific questions,and prostate-cancer-specific questions. The latter group includes: worry for prostate cancer and its prognosis,bone/pelvic pain,lower urinary tract symptoms,urinary incontinence,urinary diversion,bowel function,sexual function,endocrine effects,and satisfaction with medical care for prostate cancer. CONCLUSIONS: A modern trial of prostate cancer treatment should be regarded as insufficient without including a validated Quality of Life Questionnaire.","Urology,49(4A Suppl): 66-76","Germany",1997,"Any or unknown","Unclear","Unclear","Patient",null,"Systematic review","Germany","Patient","Any or unknown","Unclear",null,"Systematic review","Unclear","1960:1999","Complication,General"]
[14,"Alvarez-Maestro,M.,et al. (2014). \"Evaluation of the clinical usefulness of a health-related quality of life questionnaire in patients with prostate cancer.\" Actas Urol Esp 38(10): 669-677.",null,"Alvarez-Maestro,M.,et al.","Evaluation of the clinical usefulness of a health-related quality of life questionnaire in patients with prostate cancer","OBJECTIVES: The PROSQoLI questionnaire evaluates health related quality of life in patients with advanced prostate cancer. Although its utility in different clinical settings has never been assessed,its brevity and good measurement properties make its use recommendable in clinical practice. The objective is to evaluate the clinical usefulness of PROSQoLI in clinical treatment decision-making in patients with prostate cancer. MATERIALS AND METHODS: An observational,prospective longitudinal and multi-center study conducted in different Spanish centers. Sociodemographic and clinical data of patients and researchers were collected. Each patient fulfilled PROSQoLI questionnaire in each visit. Besides,physicians answered a survey about clinical usefulness of PROSQoLI questionnaire. RESULTS: The mean age of patients was 74.7 (7.4) years (standard deviation) and of researchers 51.8 (9.7) years. The usefulness in clinical decision-making was considered high by 66.1% of physicians; regarding questionnaire characteristics 71.3% of physicians considered it highly useful and 73.4% of them regarding doctor-patient communication. CONCLUSIONS: The use of health-related quality of life questionnaires improves doctor-patient communication. It is demonstrated that PROSQoLI can be an additional tool in clinical decision-making as well as a means of facilitating doctor-patient communication.","Actas Urol Esp,38(10): 669-677","Spain",2014,"Any or unknown","None","PROSQoLI","Patient",null,"Cohort","Spain","Patient","Any or unknown","None",null,"Cohort","PROSQoLI","2010:2014","Disease"]
[15,"Alves,E.,et al. (2013). \"Validation of the Brazilian version of the Expanded Prostate Cancer Index Composite (EPIC) for patients submitted to radical prostatectomy.\" Int Braz J Urol 39(3): 344-352.",null,"Alves,E.,et al.","Validation of the Brazilian version of the Expanded Prostate Cancer Index Composite (EPIC) for patients submitted to radical prostatectomy","OBJECTIVES: Validation of the Expanded Prostate Cancer Index Composite (EPIC) questionnaire translated to Portuguese. This is an evaluation tool of the effects of treatment on quality of life of patients with prostate cancer. MATERIALS AND METHODS: In order to translate and validate,several recommended methodological techniques in the literature were included: initial translation,synthesis of translation,board committee review and back translation. Sample included 40 patients with localized prostate cancer submitted to surgical retropubic radical prostatectomy from 2008 to 2010. RESULTS: The internal consistency analysis of the scales of the questionnaire resulted in alpha Cronbach coefficients \"very good\" (> 0.9) and \"good\" (> 0.8) to 8 of 14 domains. The higher coefficients (0.94) were assigned to sexual score,subscales incontinence and sexual function. Post-operatory follow-up ranged from 3 to 35 months,median 18.7 months. CONCLUSIONS: The Brazilian version of EPIC is reliable and valid,and is a useful tool to evaluate the impact of retropubic radical prostatectomy on quality of life of Brazilian patients with localized prostate cancer,in national and internationals studies.","Int Braz J Urol,39(3): 344-352","Brazil",2013,"Local","Surgery","EPIC","Patient",null,"Validation","Brazil","Patient","Local","Surgery",null,"Validation","EPIC","2010:2014","Disease"]
[16,"Ames,S. C.,et al. (2011). \"A pilot investigation of a multidisciplinary quality of life intervention for men with biochemical recurrence of prostate cancer.\" Psychooncology 20(4): 435-440.",null,"Ames,S. C.,et al.","A pilot investigation of a multidisciplinary quality of life intervention for men with biochemical recurrence of prostate cancer","OBJECTIVE: This pilot project evaluated the acceptability and estimated the effect size of a tailored multidisciplinary quality of life (MQOL) intervention for men who have biochemical recurrence of prostate cancer. METHODS: Participants included 57 men with localized prostate cancer with biochemical recurrence (Median=76 years; 89% White). Participants were randomized to wait list control which offered the intervention upon conclusion of the study (n=27) or to an eight-session group-based,MQOL (n=30) intervention. Assessments were completed at baseline,end of treatment,and 6 months post-treatment. RESULTS: MQOL was acceptable as indicated by favorable participant retention (100% retained),treatment compliance (97% attended > 6 treatment sessions),and high ratings of helpfulness (80% rated helpfulness > 4 on 5-point scale). MQOL had a favorable impact on the mental health composite score of the Short Form-36 at the end of treatment but not at 6 months (effect size=0.52 and -0.04); health-related QOL as measured by the Functional Assessment of Cancer Therapy-Prostate at the end of treatment and 6 months (effect size=0.14 and 0.10); and prostate cancer specific anxiety as measured by the Memorial Anxiety Scale for Prostate Cancer at the end of treatment and 6 months (effect size=0.45 and 0.23). CONCLUSIONS: This pilot project provides preliminary data supporting the premise that a tailored behaviorally based MQOL intervention for men with biochemical recurrence of prostate cancer is acceptable to men and might reduce prostate cancer specific anxiety and enhance QOL. Further research examining the efficacy of this intervention in a larger randomized trial is warranted.","Psychooncology,20(4): 435-440","USA",2011,"Local","Psychological","FACT-P,SF-36,MAS","Patient",null,"Clinical trial","USA","Patient","Local","Psychological",null,"Clinical trial","FACT-P,SF-36,MAS","2010:2014","Disease,Comorbidity,Utility"]
[17,"Anandadas,C. N.,et al. (2011). \"Early prostate cancer--which treatment do men prefer and why?\" BJU Int 107(11): 1762-1768.",null,"Anandadas,C. N.,et al.","Early prostate cancer--which treatment do men prefer and why?","STUDY TYPE: Preference (prospective cohort). LEVEL OF EVIDENCE: 1b. What's known on the subject? and What does the study add? In general the literature suggests that there is a need for improvement in aiding men diagnosed with early prostate cancer in their decision making about treatment options and that our understanding of this process is inadequate. There is limited data analyzing the reasons why these men decide between potentially curative or observational treatments and data evaluating patients' views before and after definitive therapy are scarce. This study begins the process of understanding the reasons underlying a patient's final treatment decision. Being a prospective study,it looks at the thought processes of these men before treatment during the time the decision is made. It also documents how satisfied patients are with their choice after their treatment and whether they would choose the same treatment again. OBJECTIVE: To identify the reasons for patients with localised prostate cancer choosing between treatments and the relationship of procedure type to patient satisfaction post-treatment. PATIENTS AND METHODS: 768 men with prostate cancer (stage T1/2,Gleason</=7,PSA<20 ug/L) chose between four treatments: radical prostatectomy,brachytherapy,conformal radiotherapy and active surveillance. Prior to choosing,patients were counselled by a urological surgeon,clinical (radiation) oncologist and uro-oncology specialist nurse. Pre-treatment reasons for choice were recorded. Post-treatment satisfaction was examined via postal questionnaire. RESULTS: Of the 768 patients,305 (40%) chose surgery,237 (31%) conformal beam radiotherapy,165 (21%) brachytherapy and 61 (8%) active surveillance. Sixty percent of men who opted for radical prostatectomy were motivated by the need for physical removal of the cancer. Conformal radiotherapy was mainly chosen by patients who feared other treatments (n=63,27%). Most men chose brachytherapy because it was more convenient for their lifestyle (n=64,39%). Active surveillance was chosen by patients for more varied reasons. Post-treatment satisfaction was assessed in a subgroup who took part in the QOL aspect of this study. Of the respondents to the questionnaire,212(87.6%) stated that they were satisfied/extremely satisfied with their choice and 171(92.9%) indicated they would choose the same treatment again. CONCLUSION: Men with early prostate cancer have clear reasons for making decisions about treatment. Overall,patients were satisfied with the treatment and indicated that despite different reasons for choosing treatment,they would make the same choice again.","BJU Int,107(11): 1762-1768","UK",2011,"Local","Radiotherapy,Surveillance,Brachytherapy,Surgery","Unclear","Patient",null,"Cross-sectional","UK","Patient","Local","Radiotherapy,Surveillance,Brachytherapy,Surgery",null,"Cross-sectional","Unclear","2010:2014","Satisfaction"]
[18,"Anast,J. W.,et al. (2005). \"The impact of obesity on health related quality of life before and after radical prostatectomy (data from CaPSURE).\" J Urol 173(4): 1132-1138.",null,"Anast,J. W.,et al.","The impact of obesity on health related quality of life before and after radical prostatectomy (data from CaPSURE)","PURPOSE: Health related quality of life (HRQOL) is an important measure of outcomes among patients with prostate cancer due to disease related and treatment related effects on physical and emotional health. We determined if there are differences in the HRQOL of obese men at diagnosis and after radical prostatectomy compared to the HRQOL of men with normal body mass index (BMI). MATERIALS AND METHODS: Data were abstracted from Cancer of the Prostate Strategic Urological Research Endeavor (CaPSURE),a disease registry of 10,018 men with prostate cancer. A total of 1,884 men were included in study who were treated with radical prostatectomy between 1989 and 2002,had BMI information available and had completed 1 initial HRQOL questionnaire. Of these men 672 who completed at least 2 followup questionnaires were assessed further. RESULTS: The BMI (kg/m) distributions were 24% normal (less than 24.9 kg/m),56% overweight (25 to 29.9),16% obese (30 to 34.9) and 4% very obese (greater than 35 kg/m). Higher BMI was associated with worse physical function,bodily pain,general health,vitality and role physical,but better bowel bother at diagnosis independent of race. Higher BMI was also associated with worse HRQOL after radical prostatectomy for physical function,general health and vitality,but better bowel bother. HRQOL differences between BMI groups were similar among times for all measured variables. Compared to the normal group,the higher BMI groups had similar HRQOL after radical prostatectomy. CONCLUSIONS: In the majority of domains men with higher BMI had lower HRQOL at diagnosis than men of normal BMI. Obese men have a similar recovery pattern of HRQOL after radical prostatectomy,with minimal additive long-term impairment in HRQOL relative to men of normal weight.","J Urol,173(4): 1132-1138","USA",2005,"Any or unknown","Surgery","Unclear","Patient",null,"Cohort","USA","Patient","Any or unknown","Surgery",null,"Cohort","Unclear","2005:2009","General"]
[19,"Anastasiadis,A. G.,et al. (2003). \"Comparison of health-related quality of life and prostate-associated symptoms after primary and salvage cryotherapy for prostate cancer.\" J Cancer Res Clin Oncol 129(12): 676-682.",null,"Anastasiadis,A. G.,et al.","Comparison of health-related quality of life and prostate-associated symptoms after primary and salvage cryotherapy for prostate cancer","PURPOSE: Recent advances in cryosurgery of the prostate have led to the ability to treat tumors successfully with decreased morbidity. The patients' perspectives of this relatively new technique,however,have not yet been addressed. The purpose of this study was to compare health related quality of life (QoL) as well as prostate-associated symptoms in patients after primary and salvage cryoablation for clinically localized prostate cancer using a self-administered questionnaire. METHODS: A total of 131 consecutive patients who underwent cryoablation of the prostate between 1997 and 2001 were included in this confidential mailing study. The patients were either (a) patients with localized prostate cancer with contraindications for radical surgery,including patients refusing other forms of therapy,or (b) had locally recurrent prostate cancer after failure of radiation therapy. All patients received 3 months of neoadjuvant androgen deprivation therapy prior to cryosurgery and were surgically treated by the same surgeon using an argon-based system. We used the EORTC QLQ-C30,a commonly used,multidimensional instrument together with a supplementing,prostate-cancer-specific module. RESULTS: Eighty-one of the 131 patients (response rate 62%) returned the questionnaires. The two groups were comparable regarding age (mean age 72.8 vs 70.1 for the primary and the salvage group,respectively; p=0.22). The overall QoL scores were high in both groups. Primary cryotherapy patients fared significantly better regarding physical (p=0.005) and social (p=0.024) functioning compared with salvage cryotherapy patients. The most prominent prostate-related symptom in both patient groups was sexual dysfunction,followed by urinary symptoms,which were significantly more severe in the salvage group (p=0.001). Incontinence rates were 5.9 and 10% in the primary and the salvage group,respectively. Severe erectile dysfunction was reported in 86 and 90% of the primary and the salvage group,respectively. CONCLUSIONS: The present study demonstrates that,in selected patients,cryotherapy is a treatment option which has a functional outcome comparable to traditionally used prostate cancer treatments. More information regarding QoL is necessary for appropriate patient counseling and individual decision-making in the presence of various treatment alternatives.","J Cancer Res Clin Oncol,129(12): 676-682","USA",2003,"Local,Recurrent","Various","EORTC QLQ-C30,EORTC QLQ-PR25","Patient",null,"Cross-sectional","USA","Patient","Local,Recurrent","Various",null,"Cross-sectional","EORTC QLQ-C30,EORTC QLQ-PR25","2000:2004","General,Disease"]
[20,"Andronis,L.,et al. (2017). \"Cost-effectiveness of zoledronic acid and strontium-89 as bone protecting treatments in addition to chemotherapy in patients with metastatic castrate-refractory prostate cancer: results from the TRAPEZE trial (ISRCTN 12808747).\" BJU Int 119(4): 522-529.",null,"Andronis,L.,et al.","Cost-effectiveness of zoledronic acid and strontium-89 as bone protecting treatments in addition to chemotherapy in patients with metastatic castrate-refractory prostate cancer: results from the TRAPEZE trial (ISRCTN 12808747)","OBJECTIVE: To evaluate the cost-effectiveness of adding zoledronic acid or strontium-89 to standard docetaxel chemotherapy for patients with castrate-refractory prostate cancer (CRPC). PATIENTS AND METHODS: Data on resource use and quality of life for 707 patients collected prospectively in the TRAPEZE 2 x 2 factorial randomised trial (ISRCTN 12808747) were used to assess the cost-effectiveness of i) zoledronic acid versus no zoledronic acid (ZA vs. no ZA),and ii) strontium-89 versus no strontium-89 (Sr89 vs. no Sr89). Costs were estimated from the perspective of the National Health Service in the UK and included expenditures for trial treatments,concomitant medications,and use of related hospital and primary care services. Quality-adjusted life-years (QALYs) were calculated according to patients' responses to the generic EuroQol EQ-5D-3L instrument,which evaluates health status. Results are expressed as incremental cost-effectiveness ratios (ICERs) and cost-effectiveness acceptability curves. RESULTS: The per-patient cost for ZA was pound12 667,pound251 higher than the equivalent cost in the no ZA group. Patients in the ZA group had on average 0.03 QALYs more than their counterparts in no ZA group. The ICER for this comparison was pound8 005. Sr89 was associated with a cost of pound13 230,pound1365 higher than no Sr89,and a gain of 0.08 QALYs compared to no Sr89. The ICER for Sr89 was pound16 884. The probabilities of ZA and Sr89 being cost-effective were 0.64 and 0.60,respectively. CONCLUSIONS: The addition of bone-targeting treatments to standard chemotherapy led to a small improvement in QALYs for a modest increase in cost (or cost-savings). ZA and Sr89 resulted in ICERs below conventional willingness-to-pay per QALY thresholds,suggesting that their addition to chemotherapy may represent a cost-effective use of resources.","BJU Int,119(4): 522-529","UK",2017,"Metastatic,Refractory","Chemotherapy,Bisphosphonate","EQ-5D","Patient",null,"Economic model","UK","Patient","Metastatic,Refractory","Chemotherapy,Bisphosphonate",null,"Economic model","EQ-5D","2015:2018","Utility"]
[21,"Anonymous (2002). \"A preliminary report on a patient-preference study to compare treatment options in early prostate cancer.\" BJU Int 90(3): 253-256.",null,"Anonymous","A preliminary report on a patient-preference study to compare treatment options in early prostate cancer","OBJECTIVE: To prospectively record prognostic factors,quality-of-life and outcome data in a patient-preference controlled study comparing radical prostatectomy with radical radiotherapy for the treatment of early prostate cancer. PATIENTS AND METHODS: All patients suitable for radical treatment of early prostate cancer were identified and provided with information from a urologist,oncologist and nurse to allow them to choose a treatment option. Prognostic and demographic data were recorded for all patients and patients followed up uniformly,with the additional collection of quality-of-life data. RESULTS: In a 38-month period,196 patients were recruited to the trial; of these,81 chose surgery,81 radiotherapy,30 brachytherapy and four 'watchful waiting'. The distribution of acknowledged prognostic factors was similar between the groups. CONCLUSION: If patient preference continues to divide this population into roughly equal and comparable arms,it should be possible to answer the underlying questions on the treatment of early prostate cancer using this study design.","BJU Int,90(3): 253-256","Unclear",2002,"Local","Radiotherapy,Surgery,Brachytherapy,Surveillance","Unclear","Patient",null,"Cross-sectional","Unclear","Patient","Local","Radiotherapy,Surgery,Brachytherapy,Surveillance",null,"Cross-sectional","Unclear","2000:2004","General"]
[22,"Anota,A.,et al. (2016). \"Cross-cultural adaptation and validation of the French version of the Expanded Prostate cancer Index Composite questionnaire for health-related quality of life in prostate cancer patients.\" Health Qual Life Outcomes 14(1): 168.",null,"Anota,A.,et al.","Cross-cultural adaptation and validation of the French version of the Expanded Prostate cancer Index Composite questionnaire for health-related quality of life in prostate cancer patients","BACKGROUND: Health-related quality of life (HRQoL) has been positioned as one of the major endpoints in oncology. Thus,there is a need to validate cancer-site specific survey instruments. This study aimed to perform a transcultural adaptation of the 50-item Expanded Prostate cancer Index Composite (EPIC) questionnaire for HRQoL in prostate cancer patients and to validate the psychometric properties of the French-language version. METHODS: The EPIC questionnaire measures urinary,bowel,sexual and hormonal domains. The first step,corresponding to transcultural adaptation of the original English version of the EPIC was performed according to the back translation technique. The second step,comprising the validation of the psychometric properties of the EPIC questionnaire,was performed in patients under treatment for localized prostate cancer (treatment group) and in patients cured of prostate cancer (cured group). The EORTC QLQ-C30 and QLQ-PR25 prostate cancer module were also completed by patients to assess criterion validity. Two assessments were performed,i.e.,before and at the end of treatment for the Treatment group,to assess sensitivity to change; and at 2 weeks' interval in the Cured group to assess test-retest reliability. Psychometric properties were explored according to classical test theory. RESULTS: The first step showed overall good acceptability and understanding of the questionnaire. In the second step,215 patients were included from January 2012 to June 2014: 125 in the Treatment group,and 90 in the Cured group. All domains exhibited good internal consistency,except the bowel domain (Cronbach's alpha = 0.61). No floor effect was observed. Test-retest reliability assessed in the cured group was acceptable,expect for bowel function (intraclass coefficient = 0.68). Criterion validity was good for each domain and subscale. Construct validity was not demonstrated for the hormonal and bowel domains. Sensitivity to change was exhibited for 5/8 subscales and 2/4 summary scores for patients who experienced toxicities during treatment. CONCLUSIONS: The French EPIC questionnaire seems to have adequate psychometric properties,comparable to those exhibited by the original English-language version,except for the construct validity,which was not available in original version.","Health Qual Life Outcomes,14(1): 168","France",2016,"Local,Survivors","None","EPIC,EORTC QLQ-C30,EORTC QLQ-PR25","Patient",null,"Validation","France","Patient","Local,Survivors","None",null,"Validation","EPIC,EORTC QLQ-C30,EORTC QLQ-PR25","2015:2018","Disease,General"]
[23,"Arai,Y.,et al. (1999). \"Patient-reported quality of life after radical prostatectomy for prostate cancer.\" Int J Urol 6(2): 78-86.",null,"Arai,Y.,et al.","Patient-reported quality of life after radical prostatectomy for prostate cancer","BACKGROUND: Increasingly,quality of life (QOL) assessments are receiving greater attention in the management of malignancies,including prostate cancer. We evaluated the impact of radical prostatectomy on patient QOL 12 months or longer after surgery. PATIENTS AND METHODS: We evaluated the impact of radical prostatectomy on QOL in 60 patients with prostate cancer. The patients comprised two groups: the first group (n = 32) was evaluated 12 months or longer after radical prostatectomy; the second group (n = 28) was evaluated while awaiting radical prostatectomy. General health-related QOL was measured with the European Organization for Research and Treatment of Cancer Prostate Cancer QOL Questionnaire. Sexual function was assessed with the Sapporo Medical University Sexual Function Questionnaire. A newly developed instrument assessing urinary function was prepared only for the postoperative group. RESULTS: No differences between the two groups were seen in comparisons of general health-related QOL subscales. Men who underwent surgery reported significant deterioration in sexual function (decreased quality of erection,decreased sexual activity and decreased satisfaction with sex life) than those awaiting surgery. Of the 32 postoperative patients,26 (81%) did not use pads at all,five (16%) used one or fewer pads per day due to occasional spotting and only one patient (3%) used two to four pads per day to deal with urine dripping. Twenty-six postoperative patients (81%) stated that,given the choice,they would undergo radical prostatectomy again. CONCLUSIONS: General health-related QOL does not appear to be compromised following radical prostatectomy. Patients are willing to accept some morbidity for a perceived survival benefit. Although minimal urinary dysfunction was reported,most patients were dissatisfied with postoperative sexual function. In preoperative counselling,greater emphasis should be placed on the risk of postoperative impotence.","Int J Urol,6(2): 78-86","Japan",1999,"Any or unknown","Surgery","EORTC QLQ-PR25,SMUF","Patient",null,"Cross-sectional","Japan","Patient","Any or unknown","Surgery",null,"Cross-sectional","EORTC QLQ-PR25,SMUF","1960:1999","Complication,Disease"]
[24,"Arai,Y.,et al. (2008). \"Evaluation of quality of life in patients with previously untreated advanced prostate cancer receiving maximum androgen blockade therapy or LHRHa monotherapy: a multicenter,randomized,double-blind,comparative study.\" J Cancer Res Clin Oncol 134(12): 1385-1396.",null,"Arai,Y.,et al.","Evaluation of quality of life in patients with previously untreated advanced prostate cancer receiving maximum androgen blockade therapy or LHRHa monotherapy: a multicenter,randomized,double-blind,comparative study","PURPOSE: To assess quality of life (QOL) data from a double-blind Phase III study evaluating bicalutamide (Casodex) 80 mg as part of maximum androgen blockade (MAB) in patients with previously untreated advanced prostate cancer. METHODS: Patients with untreated stage C/D prostate cancer were randomized to MAB with bicalutamide plus a luteinizing hormone-releasing hormone agonist (LHRHa) or LHRHa monotherapy. QOL was evaluated at baseline and at weeks 1,5,and 24 using the Japanese version of the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire. RESULTS: A total of 203 patients were assessed for QOL. The MAB group had more rapid and greater improvements in \"emotional well-being\" and \"prostate cancer-specific issues\" domain scores than the monotherapy group. Further analysis of \"prostate cancer-specific issues\" revealed that,compared with monotherapy,MAB provided a greater improvement in \"micturition disorder\"-related QOL. Complete improvement rates for items related to \"pain and micturition disorder\" were also higher with MAB. Item scores of \"pain and micturition disorder\" did not correlate strongly with prostate-specific antigen levels or tumor size. Fewer patients who had deterioration in their \"pain and micturition disorder\" item scores at week 1 in the MAB group than the monotherapy group. CONCLUSIONS: Maximum androgen blockade with bicalutamide plus LHRHa did not reduce the overall QOL of patients with previously untreated advanced prostate cancer. MAB was superior to monotherapy in achieving early improvement of QOL related to micturition disorder and pain.","J Cancer Res Clin Oncol,134(12): 1385-1396","Japan",2008,"Advanced","Hormonal","FACT-P","Patient",null,"Clinical trial","Japan","Patient","Advanced","Hormonal",null,"Clinical trial","FACT-P","2005:2009","Disease"]
[25,"Arraras Urdaniz,J. I.,et al. (2008). \"The eortc quality of life questionnaire QLQ-C30 (version 3.0). Validation study for Spanish prostate cancer patients.\" Arch Esp Urol 61(8): 949-954.",null,"Arraras Urdaniz,J. I.,et al.","The eortc quality of life questionnaire QLQ-C30 (version 3.0). Validation study for Spanish prostate cancer patients","OBJECTIVE: The EORTC Quality of Life Group has developed a questionnaire for evaluating Quality of Life in international clinical trials: EORTC QLQ-C30,which is widely used in many countries. The purpose of this study was to assess the psychometric properties of the third version of this questionnaire,EORTC QLQ-C30 (version 3.0),when applied to Spanish prostate cancer patients. METHODS: A sample of 137 prostate cancer patients prospectively filled in the questionnaire three times: on the first and last day of the treatment,and in the followup period. Psychometric evaluation of the structure,reliability and validity was made. RESULTS: Multitrait scaling analysis showed that most item-scale correlation coefficients met the standards of convergent and discriminant validity. Few exceptions appeared mainly in CF Most scales had low to moderate inter-correlations. Cronbach's coefficients of the scales were above 0.7,except for the CF and NV values. Group comparison analyses showed better QL in patients with higher Performance Status. Changes in functioning and symptom areas appeared throughout the different measurements,which were in line with the treatment process. CONCLUSIONS: The EORTC QLQC30 (version 3.0) appeared as a reliable and valid instrument when applied to a sample of Spanish prostrate cancer patients. The results are in line with previous studies.","Arch Esp Urol,61(8): 949-954","Spain",2008,"Any or unknown","None","EORTC QLQ-C30","Patient",null,"Validation","Spain","Patient","Any or unknown","None",null,"Validation","EORTC QLQ-C30","2005:2009","General"]
[26,"Arredondo,S. A.,et al. (2004). \"Watchful waiting and health related quality of life for patients with localized prostate cancer: data from CaPSURE.\" J Urol 172(5 Pt 1): 1830-1834.",null,"Arredondo,S. A.,et al.","Watchful waiting and health related quality of life for patients with localized prostate cancer: data from CaPSURE","PURPOSE: Watchful waiting is an alternative to active treatment for men with low risk prostate cancer but it is unclear how health related quality of life (HRQoL) may change over time for men who select this option. We report on HRQoL in men with localized prostate cancer who selected watchful waiting. MATERIALS AND METHODS: HRQoL outcomes were reviewed for 310 men diagnosed with prostate cancer from 1990 to 2001 within Cancer of the Prostate Strategic Urological Research Endeavor who chose watchful waiting. The UCLA Prostate Cancer Index and RAND 36-Item Health Survey were completed at enrollment and approximately every 6 months. A random slopes model was developed to assess time trends in HRQoL for up to 5 years after diagnosis,adjusting for age at diagnosis and specific comorbidities. RESULTS: Significant decreases with time were observed in 7 domains of the RAND 36-Item Health Survey and 4 of the UCLA Prostate Cancer Index scales. CONCLUSIONS: Men with prostate cancer who chose watchful waiting in the current study had better or similar HRQoL outcomes compared to men without prostate cancer at the start of the study. Many of these scores were significantly affected by increasing age and decreased with time. The physical domain scores as well as sexual function scores decreased more than expected from the aging process alone.","J Urol,172(5 Pt 1): 1830-1834","USA",2004,"Local","Surveillance","UCLA-PCI,SF-36","Patient",null,"Cohort","USA","Patient","Local","Surveillance",null,"Cohort","UCLA-PCI,SF-36","2000:2004","Disease,Utility"]
[27,"Arredondo,S. A.,et al. (2007). \"Quality of life for men receiving a second treatment for prostate cancer.\" J Urol 177(1): 273-278; discussion 278-279.",null,"Arredondo,S. A.,et al.","Quality of life for men receiving a second treatment for prostate cancer","PURPOSE: We assessed the impact of second treatment on health related quality of life for men with prostate cancer. This issue is important because second treatment resulting from prostate specific antigen recurrence has the potential to further negatively impact health related quality of life and affect the overall value of treatment. We compared differences in health related quality of life before and after second treatment for men who had asymptomatic prostate specific antigen recurrence with those who did not have biochemical failure. MATERIALS AND METHODS: Men in this analysis (897) had localized disease,initially underwent radical prostatectomy monotherapy,and completed at least 1 health related quality of life questionnaire before and after radical prostatectomy. In this cohort 175 men underwent second treatment (nonadjuvant). The Medical Outcomes Survey Short Form-36 and UCLA Prostate Cancer Index were used to measure health related quality of life. Associations between patient groups and time on health related quality of life were analyzed using repeated measures. RESULTS: Men who received a second treatment presented with more severe disease before radical prostatectomy and had worse general health related quality of life. Although health related quality of life differed significantly with time for the 2 groups,most domains for the second treatment group improved or remained stable until 15 months before second treatment,at which point they declined. Scores in the sexual functioning and role-physical domains showed clinically and statistically significant patterns of decreasing with time. CONCLUSIONS: Health related quality of life is affected following second treatment but starts to decline approximately 1 year before second treatment. Not all aspects of health related quality of life decreased at the same rate,so patients should be counseled that certain domains may be affected more by additional treatment.","J Urol,177(1): 273-278; discussion 278-279","USA",2007,"Local","Surgery","SF-36,UCLA-PCI","Patient",null,"Cohort","USA","Patient","Local","Surgery",null,"Cohort","SF-36,UCLA-PCI","2005:2009","Disease,Utility"]
[28,"Arterbery,V. E.,et al. (1997). \"Quality of life after permanent prostate implant.\" Semin Surg Oncol 13(6): 461-464.",null,"Arterbery,V. E.,et al.","Quality of life after permanent prostate implant","Quality of life is one of several endpoints commonly studied in prostate cancer treatment. It refers to how well an individual is functioning in life and his total sense of well being. There is increasing recognition that cancer therapy impacts significantly on the patient's ability to pursue relational,occupational and social interests. Fifty-one patients with clinically localized prostate cancer who had undergone transperineal permanent prostate implantation were evaluated. All patients were clinically staged as T1c or T2a and received an implant alone with Iodine 125 or Palladium 103 as definitive treatment. Six months after implant,data was collected using the European Organization for Research and Treatment of Cancer (EORTC) genitourinary group questionnaire and supplemental questions. Urinary symptoms such as nocturia,hesitancy,frequency,and dysuria were the most pronounced in the first few months after the implant and then decreased in most of patients; 40% noticed that they urinated more frequently and 17% had mild dysuria. All patients denied hematuria and none reported incontinence. Few patients reported any psychological distress or disruption in social or family life; none reported disruption in economic status or viability. All fifty-one patients said that they would have an implant again as definitive treatment. Seventy-nine percent reported an excellent quality of life post-implant. While survival is clearly a central goal of treatment for prostate cancer,the nature of this malignancy compels clinical attention to the quality of the patient's life after treatment. Sexual quality and function are maintained in the majority of patients and there is minimal interruption of their social and economic function.","Semin Surg Oncol,13(6): 461-464","USA",1997,"Local","Brachytherapy","EORTC QLQ-PR25","Patient",null,"Cross-sectional","USA","Patient","Local","Brachytherapy",null,"Cross-sectional","EORTC QLQ-PR25","1960:1999","Disease"]
[29,"Arving,C.,et al. (2013). \"Early rehabilitation of cancer patients - a randomized controlled intervention study.\" BMC Cancer 13: 9.",null,"Arving,C.,et al.","Early rehabilitation of cancer patients - a randomized controlled intervention study","BACKGROUND: Faced with a life-threatening illness,such as cancer,many patients develop stress symptoms,i.e. avoidance behaviour,intrusive thoughts and worry. Stress management interventions have proven to be effective; however,they are mostly performed in group settings and it is commonly breast cancer patients who are studied. We hereby present the design of a randomized controlled trial (RCT) evaluating the effectiveness and cost-effectiveness of an individual stress-management intervention with a stepped-care approach in several cancer diagnoses. METHOD: Patients (>/= 18 years) with a recent diagnosis of breast cancer,colorectal cancer,lymphoma,prostate cancer or testicle cancer and scheduled for adjuvant/curative oncology treatment,will consecutively be included in the study. In this prospective longitudinal intervention study with a stepped-care approach,patients will be randomized to control,treatment as usual,or an individual stress-management intervention in two steps. The first step is a low-intensity stress-management intervention,given to all patients randomized to intervention. Patients who continue to report stress symptoms after the first step will thereafter be given more intensive treatment at the second step of the programme. In the intervention patients will also be motivated to be physically active. Avoidance and intrusion are the primary outcomes. According to the power analyses,300 patients are planned to be included in the study and will be followed for two years. Other outcomes are physical activity level,sleep duration and quality recorded objectively,and anxiety,depression,quality of life,fatigue,stress in daily living,and patient satisfaction assessed using valid and standardized psychometric tested questionnaires. Utilization of hospital services will be derived from the computerized patient administration systems used by the hospital. The cost-effectiveness of the intervention will be evaluated through a cost-utility analysis. DISCUSSION: This RCT will provide empirical evidence of whether an individually administered stress-management programme in two steps can decrease stress as well as maintain or enhance patients' physical activity level,quality of life and psychological well-being. Further,this RCT,with a stepped-care approach,will provide knowledge regarding the cost-effectiveness of an individually administered stress-management programme whose aim is to help and support individual patients at the right level of care. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT 01588262.","BMC Cancer,13(9","Norway",2013,"Any or unknown","Psychological","Unclear","Patient",null,"Protocol","Norway","Patient","Any or unknown","Psychological",null,"Protocol","Unclear","2010:2014","General,Comorbidity,Symptom,Satisfaction"]
[30,"Ashford,A. R.,et al. (2001). \"Prostate carcinoma knowledge,attitudes,and screening behavior among African-American men in Central Harlem,New York City.\" Cancer 91(1): 164-172.",null,"Ashford,A. R.,et al.","Prostate carcinoma knowledge,attitudes,and screening behavior among African-American men in Central Harlem,New York City","BACKGROUND: Although the benefits of prostate carcinoma screening in reducing mortality rates have not been proven or shown to be cost-effective,screening,particularly using prostate specific antigen (PSA) tests,is widespread. A better understanding of screening behavior,knowledge of prostate carcinoma risk,and attitudes toward screening among men at high risk,such as African-American men,would be valuable. METHODS: A prevalence survey was conducted using 2 samples of African-American men,aged 50-74 years: a clinic sample drawn from all clinics in Central Harlem (n = 404) and a random-digit dial sample from the same geographic region (n = 319). The prevalence of self-reported PSA screening was estimated using a cognitive survey methodology based on the internal consistency of answers to four different questions. Prevalence estimates were adjusted to take into account the high proportion of nontelephone residences. RESULTS: The clinic sample,representing a poorer,more ill population (as determined by MOS Physical Function Scores,was less likely to report PSA screening than the community sample (11.1% in clinic sample vs. 25.5% in community). The prevalence of PSA testing in Central Harlem overall in this age group by using two different techniques was estimated to be 24%. In multiple logistic models,self-reported PSA screening was associated with age,education,favorable attitudes toward screening,and knowing someone who had prostate carcinoma. However,the association between these factors and the likelihood of self-reported PSA screening differed between clinic and community samples. CONCLUSIONS: The prevalence of self-reported PSA screening in Central Harlem was lower than that reported for other populations. These findings may be useful in the design of health education campaigns and for counseling innercity,low-income African-American patients appropriately about the disease.","Cancer,91(1): 164-172","USA",2001,"At risk","Screening","SF-36","General population",null,"Cross-sectional","USA","General population","At risk","Screening",null,"Cross-sectional","SF-36","2000:2004","Utility"]
[31,"Augustin,H.,et al. (2002). \"Patient self-reporting questionnaire on urological morbidity and bother after radical retropubic prostatectomy.\" Eur Urol 42(2): 112-117.",null,"Augustin,H.,et al.","Patient self-reporting questionnaire on urological morbidity and bother after radical retropubic prostatectomy","OBJECTIVES: We assessed the incidence of morbidity and bother on quality-of-life (QL) after radical retropubic prostatectomy for prostate cancer. METHODS: At least 12 months after surgery,self-reporting questionnaires were completed and returned by 368 (77.8%) of 473 eligible patients. Surgery related morbidity was evaluated by adhoc constructed questions. QL was assessed by the European Organization for Research and Treatment of Cancer QL core questionnaire (EORTC QLQ-C30). Multivariate and univariate analysis as well as regression analysis were used to assess the bother factors. RESULTS: Postoperative urinary incontinence significant enough for the patient to use some kind of protection was reported by 27.2%. After surgery,14.2% of preoperative potent men were able to get and maintain an erection sufficient enough for sexual intercourse without any aid. Overall 10.6% of respondents had undergone surgery for anastomotic stricture and 23.6% reported on adjuvant therapy. Furthermore,43.2% reported on fear of not being cured from cancer. Postoperative urinary incontinence and fear of not being cured were associated with significant lower global QL scores and turned out as independent predictors for global QL. In contrast,postoperative erectile dysfunction,anastomotic stricture and adjuvant therapy were not independent predictors. In addition,82.1% would vote for surgery again. CONCLUSION: The majority of the patients would opt for surgical treatment again,although morbidity is common after radical prostatectomy and may impair QL. Particularly urinary incontinence and fear of not being cured are independent predictors for global QL after surgery. Therefore,surgical techniques with a low morbidity are requested as well as some kind of psychological support in order to cope with existential fear.","Eur Urol,42(2): 112-117","Austria",2002,"Any or unknown","Surgery","EORTC QLQ-C30","Patient",null,"Cross-sectional","Austria","Patient","Any or unknown","Surgery",null,"Cross-sectional","EORTC QLQ-C30","2000:2004","General"]
[32,"Avila,M.,et al. (2014). \"Adaptation and validation of the Spanish version of the Patient-Oriented Prostate Utility Scale (PORPUS).\" Qual Life Res 23(9): 2481-2487.",null,"Avila,M.,et al.","Adaptation and validation of the Spanish version of the Patient-Oriented Prostate Utility Scale (PORPUS)","OBJECTIVE: The Patient-Oriented Prostate Utility Scale (PORPUS) is a combined profile and utility-based quality of life measure for prostate cancer patients. Our objectives were to adapt the PORPUS into Spanish and to assess its acceptability,reliability,and validity. METHODS: The PORPUS was adapted into Spanish using forward and back translations and cognitive debriefing. PORPUS was administered jointly with the SF-36 and the Expanded Prostate Index Composite (EPIC) to 480 Spanish prostate cancer patients treated with radical prostatectomy or radiotherapy. The Spanish PORPUS scores' distribution and reliability were examined and compared with the original instrument. To evaluate construct validity,relationships were assessed between PORPUS and other instruments (testing hypotheses of the original PORPUS study),and among known groups defined by side effect severity. RESULTS: Reliability coefficient was 0.76 (similar to the original PORPUS' 0.81). Spanish PORPUS items presented correlations ranging 0.57-0.88 with the corresponding EPIC domains,as in the original PORPUS study (0.60-0.83). Both PORPUS-P and PORPUS-U showed significant differences and large effect sizes (0.94-1.90) when comparing severe versus no problem groups on urinary,bowel,sexual and hormonal side effects defined by EPIC. CONCLUSIONS: A conceptually equivalent Spanish version was obtained,with high reliability and good construct validity,similar to the original Canadian PORPUS version. It can therefore be used to measure health-related quality of life and utilities in Spanish prostate cancer patients.","Qual Life Res,23(9): 2481-2487","Spain",2014,"Any or unknown","Radiotherapy,Surgery","SF-36,EPIC,PORPUS","Patient",null,"Mapping to utility,Validation","Spain","Patient","Any or unknown","Radiotherapy,Surgery",null,"Mapping to utility,Validation","SF-36,EPIC,PORPUS","2010:2014","Disease,Utility"]
[33,"Avila,M.,et al. (2015). \"Estimating preferences for treatments in patients with localized prostate cancer.\" Int J Radiat Oncol Biol Phys 91(2): 277-287.",null,"Avila,M.,et al.","Estimating preferences for treatments in patients with localized prostate cancer","PURPOSE: Studies of patients' preferences for localized prostate cancer treatments have assessed radical prostatectomy and external radiation therapy,but none of them has evaluated brachytherapy. The aim of our study was to assess the preferences and willingness to pay of patients with localized prostate cancer who had been treated with radical prostatectomy,external radiation therapy,or brachytherapy,and their related urinary,sexual,and bowel side effects. METHODS AND MATERIALS: This was an observational,prospective cohort study with follow-up until 5 years after treatment. A total of 704 patients with low or intermediate risk localized prostate cancer were consecutively recruited from 2003 to 2005. The estimation of preferences was conducted using time trade-off,standard gamble,and willingness-to-pay methods. Side effects were measured with the Expanded Prostate Index Composite (EPIC),a prostate cancer-specific questionnaire. Tobit models were constructed to assess the impact of treatment and side effects on patients' preferences. Propensity score was applied to adjust for treatment selection bias. RESULTS: Of the 580 patients reporting preferences,165 were treated with radical prostatectomy,152 with external radiation therapy,and 263 with brachytherapy. Both time trade-off and standard gamble results indicated that the preferences of patients treated with brachytherapy were 0.06 utilities higher than those treated with radical prostatectomy (P=.01). Similarly,willingness-to-pay responses showed a difference of euro57/month (P=.004) between these 2 treatments. Severe urinary incontinence presented an independent impact on the preferences elicited (P<.05),whereas no significant differences were found by bowel and sexual side effects. CONCLUSIONS: Our findings indicate that urinary incontinence is the side effect with the highest impact on preferences and that brachytherapy and external radiation therapy are more valued than radical prostatectomy. These time trade-off and standard gamble preference assessments as well as the willingness-to-pay estimation could be useful to perform respectively cost-utility or cost-benefit analyses,which can guide health policy decisions.","Int J Radiat Oncol Biol Phys,91(2): 277-287","Spain",2015,"Local","Radiotherapy,Surgery","EPIC,TTO,SG,WTP","Patient",null,"Cohort","Spain","Patient","Local","Radiotherapy,Surgery",null,"Cohort","EPIC,TTO,SG,WTP","2015:2018","Utility,Disease"]
[34,"Baco,E.,et al. (2014). \"Hemi salvage high-intensity focused ultrasound (HIFU) in unilateral radiorecurrent prostate cancer: a prospective two-centre study.\" BJU Int 114(4): 532-540.",null,"Baco,E.,et al.","Hemi salvage high-intensity focused ultrasound (HIFU) in unilateral radiorecurrent prostate cancer: a prospective two-centre study","OBJECTIVE: To report the oncological and functional outcomes of hemi salvage high-intensity focused ultrasound (HSH) in patients with unilateral radiorecurrent prostate cancer. PATIENTS AND METHODS: Between 2009 and 2012,48 patients were prospectively enrolled in two European centres. Inclusion criteria were biochemical recurrence (BCR) after primary radiotherapy (RT),positive magnetic resonance imaging and >/=1 positive biopsy in only one lobe. BCR was defined using Phoenix criteria (a rise by >/=2 ng/mL above the nadir prostate specific antigen [PSA] level). The following schemes and criteria for functional outcomes were used: Ingelman-Sundberg score using International Continence Society (ICS) questionnaire (A and B),International prostate symptom score (IPSS),International Index of Erectile Function-5 (IIEF-5) points,the European Organisation for the Research and Treatment of Cancer (EORTC) quality of life questionnaires (QLQ C-30). HSH was performed under spinal or general anaesthesia using the Ablatherm(R) Integrated Imaging device. Patients with obstructive voiding symptoms at the time of treatment underwent an endoscopic bladder neck resection or incision during the same anaesthesia to prevent the risk of postoperative obstruction. RESULTS: After HSH the mean (sd) PSA nadir was 0.69 (0.83) ng/mL at a median (interquartile range) follow-up of 16.3 (10.5-24.5) months. Disease progression occurred in 16/48 (33%). Of these,four had local recurrence in the untreated lobe and four bilaterally,six developed metastases,and two had rising PSA levels without local recurrence or radiological confirmed metastasis. Progression-free survival rates at 12,18,and 24 months were 83%,64%,and 52%. Severe incontinence occurred in four of the 48 patients (8%),eight (17%) required one pad a day,and 36/48 (75%) were pad-free. The ICS questionnaire showed a mean (sd) deterioration from 0.7 (2.0) to 2.3 (4.5) for scores A and 0.6 (1.4) to 1.6 (3.0) for B. The mean (sd) IPSS and erectile function (IIEF-5) scores decreased from a mean (sd) of 7.01 (5.6) to 8.6 (5.1) and from 11.2 (8.6) to 7.0 (5.8),respectively. The mean (sd) EORTC QLC-30 scores before and after HSH were 35.7 (8.6) vs 36.8 (8.6). CONCLUSION: HSH is a feasible therapeutic option in patients with unilateral radiorecurrent prostate cancer,which offers limited urinary and rectal morbidity,and preserves health-related quality of life.","BJU Int,114(4): 532-540","Norway",2014,"Recurrent","HIFU","ICSQ,IPSS,IIEF-5,EORTC QLQ-C30","Patient",null,"Cohort","Norway","Patient","Recurrent","HIFU",null,"Cohort","ICSQ,IPSS,IIEF-5,EORTC QLQ-C30","2010:2014","Symptom,Complication,General"]
[35,"Bacon, C. G., et al. (2001). \"The impact of cancer treatment on quality of life outcomes for patients with localized prostate cancer.\" J Urol 166(5): 1804-1810.",null,"Bacon, C. G., et al.","The impact of cancer treatment on quality of life outcomes for patients with localized prostate cancer","PURPOSE: We evaluated the impact of localized prostate cancer treatment on general, cancer specific and symptom domains of quality of life for up to 5 years after diagnosis. MATERIALS AND METHODS: A total of 842 men from the Health Professionals Followup Study, diagnosed between 1993 and 1998, were included in cross-sectional analyses of quality of life associated with prostate cancer treatment. A subset of 146 men diagnosed after 1995 were followed prospectively. Quality of life was assessed with the Medical Outcomes Study Short-Form 36 Health Status Survey, Cancer Rehabilitation Evaluation System Short Form and University of California Los Angeles Prostate Cancer Index by mailed questionnaires. Primary treatment modality was taken from medical records and patient self-report. RESULTS: Significant treatment differences were observed in all quality of life measures, with the largest occurring in sexual, urinary and bowel symptoms. Bowel function was significantly worse in patients who received external radiation and brachytherapy compared with prostatectomy (p <0.05). Although they had better or equivalent urinary and sexual function (p <0.05), patients treated with external radiation, hormones or watchful waiting had lower generic quality of life scores in multiple domains compared with those who underwent prostatectomy. Patients who had brachytherapy had similar generic quality of life outcomes compared with prostatectomy in all domains. CONCLUSIONS: Our findings suggest that important differences in quality of life go beyond known physical symptoms associated with various prostate cancer treatment options, many of which involve making a trade-off. It is important for patients with prostate cancer and health care providers to consider these differences while making treatment decisions.","J Urol, 166(5): 1804-1810","USA",2001,"Local","Radiotherapy,Surgery,Hormonal,Surveillance,Brachytherapy","SF-36,CARES-SF,UCLA-PCI","Patient",null,"Cross-sectional","USA","Patient","Local","Radiotherapy,Surgery,Hormonal,Surveillance,Brachytherapy",null,"Cross-sectional","SF-36,CARES-SF,UCLA-PCI","2000:2004","Disease,Utility,Treatment"]
[36,"Bacon, C. G., et al. (2002). \"The association of treatment-related symptoms with quality-of-life outcomes for localized prostate carcinoma patients.\" Cancer 94(3): 862-871.",null,"Bacon, C. G., et al.","The association of treatment-related symptoms with quality-of-life outcomes for localized prostate carcinoma patients","BACKGROUND: Most studies of treatment outcomes in men with localized prostate carcinoma have emphasized sexual, urinary, and bowel symptoms with the assumption that they have an impact on quality of life. However, very few studies have directly examined and compared the impact of these symptoms on overall and cancer specific quality of life. METHODS: The authors examined 783 incident cases of localized prostate carcinoma, diagnosed from 1993 to 1998, and 1928 age-matched healthy controls from the Health Professionals Follow-Up Study cohort. Information on frequency of ejaculation and urinary symptoms were collected before cancer diagnosis. After cancer diagnosis, the authors mailed a questionnaire including the Medical Outcomes Study Short Form-36 Health Status Survey (SF-36), the Cancer Rehabilitation Evaluation System-Short Form (CARES-SF), and the University of California at Los Angeles Prostate Cancer Index in 1998. RESULTS: Cases had slightly lower scores on most of the SF-36 scales and reported much more bother from sexual, urinary, and bowel symptoms compared with healthy controls. Among prostate carcinoma patients, bowel symptoms had the greatest negative impact on quality of life, followed by sexual and urinary symptoms. As expected, treatment-related symptoms were associated with the physical domains of quality of life, but psychosocial domains were just as strongly affected. CONCLUSIONS: Patients and health care providers need to consider the potential mental quality-of-life impacts associated with prostate carcinoma treatment symptoms when making treatment decisions. Even after patients have completed cancer treatment, significant health impairments may remain. Health care providers should continue to address the mental and physical well-being of prostate carcinoma patients in follow-up care.","Cancer, 94(3): 862-871","USA",2002,"Local","Unclear","SF-36,CARES-SF,UCLA-PCI","Patient",null,"Case-control","USA","Patient","Local","Unclear",null,"Case-control","SF-36,CARES-SF,UCLA-PCI","2000:2004","Disease,Treatment,Utility"]
[37,"Badalament, R. A., et al. (1999). \"Patient-reported complications after cryoablation therapy for prostate cancer.\" Urology 54(2): 295-300.",null,"Badalament, R. A., et al.","Patient-reported complications after cryoablation therapy for prostate cancer","OBJECTIVES: To define the patient-reported complications after cryoablation therapy for prostate cancer and to compare these results to previously published patient-reported complications for radical prostatectomy and external beam irradiation. METHODS: A questionnaire similar to previously published patient-reported complication studies was sent to the first 290 patients treated by cryoablation therapy at our institution. The questionnaire was returned by 267 patients. Forty-four patients were excluded from analysis because of prior irradiation, transurethral prostatectomy, or cryoablation, resulting in a study group of 223 patients. RESULTS: Of the 208 patients with good urinary control preoperatively, 9 (4.3%) patients used incontinence pads after cryoablation. Seven of the 8 patients who used one pad daily reported leakage of only a few drops. Impotency, defined as an inability to obtain erections adequate for vaginal penetration, occurred in 85% of men who were potent preoperatively. Urethrorectal fistula occurred in 1 patient (0.4%). Bladder outlet obstruction caused by stricture or sloughed necrotic prostatic tissue required dilation or transurethral resection in 10% of patients. Scrotal swelling, penile tingling, and pelvic pain occurred in 18%, 15%, and 12% of patients, respectively; typically, these resolved spontaneously within 3 months. CONCLUSIONS: Patient-reported complications for cryoablation compared favorably to those reported for radical prostatectomy and external beam irradiation. Patient satisfaction was high; 96% of patients reported that they would choose cryosurgery as a treatment option again.","Urology, 54(2): 295-300","USA",1999,"Any or unknown","Various","Unclear","Patient",null,"Cross-sectional","USA","Patient","Any or unknown","Various",null,"Cross-sectional","Unclear","1960:1999","Complication,Satisfaction"]
[38,"Badalament, R. A., et al. (2000). \"Patient-reported complications after cryoablation therapy for prostate cancer.\" Arch Ital Urol Androl 72(4): 305-312.",null,"Badalament, R. A., et al.","Patient-reported complications after cryoablation therapy for prostate cancer","To define the patient-reported complications after cryoablation therapy for prostate cancer and to compare these results to previously published patient-reported complications for radical prostatectomy and external beam irradiation. A questionnaire similar to previously published patient-reported complication studies was sent to the first 290 patients treated by cryoablation therapy at our Institution. The questionnaire was returned by 267 patients. Forty-four patients were excluded from analysis because of prior irradiation, transurethral prostatectomy, or cryoablation, resulting in a study group of 223 patients. Of the 208 patients with good urinary control preoperatively, 9 (4.3%) patients used incontinence pads after cryoablation. Seven of the 8 patients who used one pad daily reported leakage of only a few drops. Impotency, defined as an inability to obtain erections adequate for vaginal penetration, occurred in 85% of men who were potent preoperatively. Urethrorectal fistula occurred in 1 patient (0.4%). Bladder outlet obstruction caused by stricture of sloughed necrotic prostatic tissue required dilation or transurethral resection in 10% of patients. Scrotal swelling, penile tingling, and pelvic pain occurred in 18, 15, and 12% of patients, respectively; typically, these resolved spontaneously within 3 months. Patient-reported complications for cryoblation compared favorably to those reported for radical prostatectomy and external beam irradiation. Patient satisfaction was high; 96% of patients reported that they would choose cryosurgery as a treatment option again.","Arch Ital Urol Androl, 72(4): 305-312","USA",2000,"Any or unknown","Various","Unclear","Patient",null,"Cross-sectional","USA","Patient","Any or unknown","Various",null,"Cross-sectional","Unclear","2000:2004","Complication,Satisfaction"]
[39,"Bahl, A., et al. (2015). \"Final quality of life and safety data for patients with metastatic castration-resistant prostate cancer treated with cabazitaxel in the UK Early Access Programme (EAP) (NCT01254279).\" BJU Int 116(6): 880-887.",null,"Bahl, A., et al.","Final quality of life and safety data for patients with metastatic castration-resistant prostate cancer treated with cabazitaxel in the UK Early Access Programme (EAP) (NCT01254279)","OBJECTIVE: To compile the safety profile and quality of life (QoL) data for patients with metastatic castration-resistant prostate cancer (mCRPC) treated with cabazitaxel in the UK Early Access Programme (UK EAP). PATIENTS AND METHODS: A total of 112 patients participated at 12 UK cancer centres. All had mCRPC with disease progression during or after docetaxel. Patients received cabazitaxel 25 mg/m(2) every 3 weeks with prednisolone 10 mg daily for up to 10 cycles. Safety assessments were performed before each cycle and QoL was recorded at alternate cycles using the EQ-5D-3L questionnaire and visual analogue scale (VAS). The safety profile was compiled after completion of the UK EAP and QoL measures were analysed to record trends. No formal statistical analysis was carried out. RESULTS: The incidences of neutropenic sepsis (6.3%), grade 3 and 4 diarrhoea (4.5%) and grade 3 and 4 cardiac toxicity (0%) were low. Neutropenic sepsis episodes, though low, occurred only in patients who did not receive prophylactic granulocyte-colony stimulating factor. There were trends towards improved VAS and EQ-5D-3L pain scores during treatment. CONCLUSIONS: The UK EAP experience indicates that cabazitaxel might improve QoL in mCRPC and represents an advance and a useful addition to the armamentarium of treatment for patients whose disease has progressed during or after docetaxel. In view of the potential toxicity, careful patient selection is important.","BJU Int, 116(6): 880-887","UK",2015,"Metastatic","Taxane","EQ-5D,VAS","Patient",null,"Clinical trial","UK","Patient","Metastatic","Taxane",null,"Clinical trial","EQ-5D,VAS","2015:2018","Utility"]
[40,"Bales, G. T. and G. W. Chodak (1996). \"A controlled trial of bicalutamide versus castration in patients with advanced prostate cancer.\" Urology 47(1A Suppl): 38-43; discussion 48-53.",null,"Bales, G. T. and G. W. Chodak","A controlled trial of bicalutamide versus castration in patients with advanced prostate cancer","OBJECTIVES: Bicalutamide is a new, potent antiandrogen with potential efficacy in the treatment of men with advanced prostate cancer. Although no pure antiandrogen has been well studied versus castration, potentially fewer adverse effects could occur, making such an agent a potentially useful alternative therapy. To date, three randomized controlled trials have been performed comparing these two treatments. In preliminary studies, a dose of 50 mg bicalutamide per day was selected for these trials. In two of the studies (0302, 0303), this drug was compared to either medical or surgical castration, the latter choice being made by the patient. In the third study (0301), bicalutamide was compared to bilateral orchiectomy. METHODS: Using an intention-to-treat format, the outcomes assessed were time-to-treatment failure, time-to-objective disease progression, subjective response, and survival time in men with previously untreated metastatic disease. The incidence of breast tenderness, gynecomastia, and hot flushes was also determined in both treatment arms. A quality-of-life questionnaire was administered on multiple occasions after initiation of therapy. RESULTS: Based on an analysis of > 1000 patients, the objective and subjective results favored castration over bicalutamide (50 mg/day). The hazard ratios for time-to-treatment failure (1.59), time-to-disease progression (1.62), and median survival (1.44) were all significantly greater in the castration group (P > 0.001). Another difference noted at 3 months was a significantly lower median fall in prostate-specific antigen values in the bicalutamide group (86-88% versus 96-97%). Symptomatic patients receiving bicalutamide were only 0.43 times as likely to have subjective improvement as the patients treated by castration. A comparison of pharmacologic effects showed that only the incidence of hot flushes was lower in the bicalutamide group, whereas breast tenderness and gynecomastia were more common. This difference in hot flushes, however, translated into better quality of life during the first several months with regard to sexual relations and sexual functioning. CONCLUSIONS: Bicalutamide monotherapy at 50 mg/day appears inferior to castration in overall objective and subjective response rates. Whether higher doses of bicalutamide can compete more favorably will need to be tested in further clinical trials.","Urology, 47(1A Suppl): 38-43; discussion 48-53","USA",1996,"Metastatic","Surgery,Hormonal","Unclear","Patient",null,"Clinical trial","USA","Patient","Metastatic","Surgery,Hormonal",null,"Clinical trial","Unclear","1960:1999","General"]
[41,"Ball, A. J., et al. (2006). \"Prospective longitudinal comparative study of early health-related quality-of-life outcomes in patients undergoing surgical treatment for localized prostate cancer: a short-term evaluation of five approaches from a single institution.\" J Endourol 20(10): 723-731.",null,"Ball, A. J., et al.","Prospective longitudinal comparative study of early health-related quality-of-life outcomes in patients undergoing surgical treatment for localized prostate cancer: a short-term evaluation of five approaches from a single institution","BACKGROUND AND PURPOSE: Quality of life (QoL) issues are a vital concern for the majority of patients seeking therapeutic intervention once they are found to have prostate cancer. A prospective longitudinal comparison using validated QoL instruments is a valuable technique to evaluate outcome differences. We evaluated the short-term QoL changes from baseline of five surgical approaches for localized prostate carcinoma delivered at a single institution. PATIENTS AND METHODS: A prospective longitudinal survey of 719 patients with newly diagnosed prostate cancer was initiated in 2001. The surgical procedures performed during this time period were open radical prostatectomy (ORP), laparoscopic radical prostatectomy (LRP), da Vinci robotic prostatectomy (dVP), (103)Pd brachytherapy ((103)Pd), and prostate cryoablation (PCryo). An Institutional Review Board-approved questionnaire comprised of validated QoL instruments (UCLA Prostate Cancer Index and American Urological Association Symptom Index [SI]) was mailed to enrolled patients prior to their selected surgery and again at 1, 3, 6, 9, 12, 18, 24, and 36 months after therapy. A percent of baseline score calculation including data from all five treatment cohorts for follow-up months 1, 3, and 6 was compared within groups. Group I consisted of patients undergoing ORP, LRP, or dVP. Group II consisted of patients undergoing (103)Pd or PCryo. RESULTS: Between January 2000 and April 2005, 498 patients (69%) were enrolled who completed the baseline questionnaire and at least one follow-up survey at 1, 3, or 6 months. The mean patient age at ORP, LRP, dVP, (103)Pd, and PCryo was 59, 61, 60, 67, and 72 years, respectively. Within Group I, early recovery of sexual function (at 3 months) appeared to occur sooner after dVP (35% return to baseline [RTB]) than ORP (24% RTB) and LRP (21% RTB) (P = 0.03). No other significant differences were noted, and trends toward improvement were seen in all groups. Within Group II, PCryo (18% RTB) had a more negative impact on sexual function at 3 months than did 103Pd (63% RTB) (P = 0.007), although a significant difference in baseline sexual function was also noted (P = 0.001). Early urinary function (at 1 month) was better after (103)Pd (82% RTB) than PCryo (72%) (P = 0.05), but this difference was lost at 6 months. In addition, the irritative and obstructive symptoms evaluated by the AUA SI were significantly worse (P = 0.003) at 3 months after (103)Pd than after PCryo. CONCLUSIONS: Different surgical approaches for the treatment of localized prostate cancer affect the shortterm QoL results in different ways. Urinary, sexual, and bowel function and bother are affected to a similar degree by ORP, LRP, and dVP. In an older population, the tissue destruction resulting from PCryo appears to relieve obstructive and irritative urinary symptoms but at the sacrifice of sexual function compared with (103)Pd.","J Endourol, 20(10): 723-731","USA",2006,"Local","Various,Brachytherapy,Surgery","UCLA-PCI,AUA-SI","Patient",null,"Cohort","USA","Patient","Local","Various,Brachytherapy,Surgery",null,"Cohort","UCLA-PCI,AUA-SI","2005:2009","Disease,Symptom"]
[42,"Barkati, M., et al. (2012). \"High-dose-rate brachytherapy as a monotherapy for favorable-risk prostate cancer: a Phase II trial.\" Int J Radiat Oncol Biol Phys 82(5): 1889-1896.",null,"Barkati, M., et al.","High-dose-rate brachytherapy as a monotherapy for favorable-risk prostate cancer: a Phase II trial","PURPOSE: There are multiple treatment options for favorable-risk prostate cancer. High-dose-rate (HDR) brachytherapy as a monotherapy is appealing, but its use is still investigational. A Phase II trial was undertaken to explore the value of such treatment in low-to-intermediate risk prostate cancer. METHODS AND MATERIALS: This was a single-institution, prospective study. Eligible patients had low-risk prostate cancer features but also Gleason scores of 7 (51% of patients) and stage T2b to T2c cancer. Treatment with HDR brachytherapy with a single implant was administered over 2 days. One of four fractionation schedules was used in a dose escalation study design: 3 fractions of 10, 10.5, 11, or 11.5 Gy. Patients were assessed with the Common Terminology Criteria for Adverse Events version 2.0 for urinary toxicity, the Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer scoring schema for rectal toxicity, and the Expanded Prostate Cancer Index Composite (EPIC) questionnaire to measure patient-reported health-related quality of life. Biochemical failure was defined as a prostate-specific antigen (PSA) nadir plus 2 ng/ml. RESULTS: Between 2003 and 2008, 79 patients were enrolled. With a median follow-up of 39.5 months, biochemical relapse occurred in 7 patients. Three- and 5-year actuarial biochemical control rates were 88.4% (95% confidence interval [CI], 78.0-96.2%) and 85.1% (95% CI, 72.5-94.5%), respectively. Acute grade 3 urinary toxicity was seen in only 1 patient. There was no instance of acute grade 3 rectal toxicity. Rates of late grade 3 rectal toxicity, dysuria, hematuria, urinary retention, and urinary incontinence were 0%, 10.3%, 1.3%, 9.0%, and 0%, respectively. No grade 4 or greater toxicity was recorded. Among the four (urinary, bowel, sexual, and hormonal) domains assessed with the EPIC questionnaire, only the sexual domain did not recover with time. CONCLUSIONS: HDR brachytherapy as a monotherapy for favorable-risk prostate cancer, administered using a single implant over 2 days, is feasible and has acceptable acute and late toxicities. Further follow-up is still required to better evaluate the efficacy of such treatment.","Int J Radiat Oncol Biol Phys, 82(5): 1889-1896","Australia",2012,"Local","Brachytherapy","EPIC,CTCAE,RTOG-EORTC-SS","Patient",null,"Clinical trial","Australia","Patient","Local","Brachytherapy",null,"Clinical trial","EPIC,CTCAE,RTOG-EORTC-SS","2010:2014","Disease,Treatment"]
[43,"Basaria, S., et al. (2002). \"Long-term effects of androgen deprivation therapy in prostate cancer patients.\" Clin Endocrinol (Oxf) 56(6): 779-786.",null,"Basaria, S., et al.","Long-term effects of androgen deprivation therapy in prostate cancer patients","BACKGROUND: Prostate cancer (PCa) is one of the most common cancers in men and has an increasing incidence. In 1999, 37 000 men died from PCa in the USA. Androgen deprivation therapy (ADT) with GnRH agonists is frequently employed in the treatment of recurrent and metastatic PCa by inducing medical castration, rendering these men hypogonadal. Because hypogonadism in men is associated with a wide range of complications, we attempted to determine the effects of long-term ADT in men with PCa. METHODS: We conducted a cross-sectional study at a tertiary care centre to determine the effect of ADT on lean body mass (LBM), muscle strength, bone mineral density (BMD), sexual function, and quality of life (QOL) in men with PCa. Three groups of men were enrolled: (1) 20 men with PCa who were undergoing medical castration with GnRH agonists for at least 12 months prior to the onset of the study (ADT group); (2) 18 age-matched men with nonmetastatic PCa who were post prostatectomy and/or radiotherapy but had not yet undergone ADT (non-ADT group); and (3) 20 age-matched normal men who were healthy and ambulatory (control group). RESULTS: Men on ADT had castrate levels of serum total testosterone (P < 0.0001), free testosterone (P < 0.0001) and oestradiol (P < 0.0001), which were significantly lower than in the other groups. Total body (P = 0.03) and lumbar spine (P < 0.0001) BMD was significantly lower in patients on ADT compared to other groups and was associated with higher levels of urinary N-telopeptide (P = 0.02). The ADT group had higher fat mass compared to the other groups (P = 0.0001) and significantly reduced upper body strength (P = 0.001) when compared to non-ADT patients. The ADT group had lower overall scores on Watt's Sexual Function Questionnaire compared to other groups (P = 0.0001), in particular a decrease in desire, arousal and frequency of spontaneous early morning erections. The ADT group also had lower overall QOL scores, resulting in significant limitation of physical function (P = 0.001), role limitation (P = 0.02) and perception of physical health (P = 0.004). CONCLUSIONS: This study suggests that osteoporosis, unfavourable body composition, sexual dysfunction and reduced quality of life are seen in patients receiving androgen deprivation therapy for at least 12 months. Longitudinal studies in this patient population will shed further light on the timing of the development and the extent of these complications. Meanwhile, this information will assist both physicians and patients with prostate cancer to make informed decisions regarding androgen deprivation therapy.","Clin Endocrinol (Oxf), 56(6): 779-786","USA",2002,"Local,Advanced","Hormonal","WSFQ","Patient",null,"Cross-sectional","USA","Patient","Local,Advanced","Hormonal",null,"Cross-sectional","WSFQ","2000:2004","Complication"]
[44,"Basch, E., et al. (2013). \"Abiraterone acetate plus prednisone versus prednisone alone in chemotherapy-naive men with metastatic castration-resistant prostate cancer: patient-reported outcome results of a randomised phase 3 trial.\" Lancet Oncol 14(12): 1193-1199.",null,"Basch, E., et al.","Abiraterone acetate plus prednisone versus prednisone alone in chemotherapy-naive men with metastatic castration-resistant prostate cancer: patient-reported outcome results of a randomised phase 3 trial","BACKGROUND: Abiraterone acetate plus prednisone significantly improves radiographic progression-free survival in asymptomatic or mildly symptomatic, chemotherapy-naive patients with metastatic castration-resistant prostate cancer compared with prednisone alone. We describe analyses of data for patient-reported pain and functional status in a preplanned interim analysis of a phase 3 trial. METHODS: Between April 28, 2009, and June 23, 2010, patients with progressive, metastatic castration-resistant prostate cancer were enrolled into a multinational, double-blind, placebo-controlled trial. Patients were eligible if they were asymptomatic (score of 0 or 1 on item three of the Brief Pain Inventory Short Form [BPI-SF] questionnaire) or mildly symptomatic (score of 2 or 3) and had not previously received chemotherapy. Patients were randomly assigned (1:1) to receive oral abiraterone (1 g daily) plus prednisone (5 mg twice daily) or placebo plus prednisone in continuous 4-week cycles. Pain was assessed with the BPI-SF questionnaire, and health-related quality of life (HRQoL) with the Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire. We analysed data with prespecified criteria for clinically meaningful pain progression and deterioration in HRQoL. All patients who underwent randomisation were included in analyses. FINDINGS: 1088 patients underwent randomisation: 546 were assigned to abiraterone plus prednisone and 542 to placebo plus prednisone. At the time of the second prespecified interim analysis, median follow-up was 22.2 months (IQR 20.2-24.8). Median time to progression of mean pain intensity was longer in patients assigned to abiraterone plus prednisone (26.7 months [95% CI 19.3-not estimable]) than in those assigned to placebo plus prednisone (18.4 months [14.9-not estimable]; hazard ratio [HR] 0.82, 95% CI 0.67-1.00; p=0.0490), as was median time to progression of pain interference with daily activities (10.3 months [95% CI 9.3-13.0] vs 7.4 months [6.4-8.6]; HR 0.79, 95% CI 0.67-0.93; p=0.005). Median time to progression of worst pain was also longer with abiraterone plus prednisone (26.7 months [95% CI 19.4-not estimable]) than with placebo plus prednisone (19.4 months [16.6-not estimable]), but the difference was not significant (HR 0.85, 95% CI 0.69-1.04; p=0.109). Median time to HRQoL deterioration was longer in patients assigned to abiraterone plus prednisone than in those assigned to placebo plus prednisone as assessed by the FACT-P total score (12.7 months [95% CI 11.1-14.0] vs 8.3 months [7.4-10.6]; HR 0.78, 95% CI 0.66-0.92; p=0.003) and by the score on its prostate-cancer-specific subscale (11.1 months [8.6-13.8] vs 5.8 months [5.5-8.3]; HR 0.70, 95% CI 0.60-0.83; p<0.0001). INTERPRETATION: Abiraterone plus prednisone delays patient-reported pain progression and HRQoL deterioration in chemotherapy-naive patients with metastatic castration-resistant prostate cancer. These results provide further support for the efficacy of abiraterone in this population.","Lancet Oncol, 14(12): 1193-1199","USA",2013,"Metastatic","Abiraterone","BPI,FACT-P","Patient",null,"Clinical trial","USA","Patient","Metastatic","Abiraterone",null,"Clinical trial","BPI,FACT-P","2010:2014","Disease,Symptom"]
[45,"Basu, A., et al. (2010). \"A time tradeoff method for eliciting partner's quality of life due to patient's health states in prostate cancer.\" Med Decis Making 30(3): 355-365.",null,"Basu, A., et al.","A time tradeoff method for eliciting partner's quality of life due to patient's health states in prostate cancer","BACKGROUND: Cost-effectiveness analyses may better reflect the full costs and benefits of medical interventions if they incorporate the effects of patients' health on their family members. OBJECTIVE: To develop and apply a time tradeoff (TTO) technique to measure the impact of potential prostate cancer-related health states of the patients on the quality of life (QOL) of their partners. METHODS: We developed modified TTO questions and applied them in a pilot study in which we asked the partner of the patient to tradeoff his or her own life in order to reduce the burden that he himself or she herself expects to experience if the patient developed one of the prostate cancer-related health states. We reviewed the theoretical justification for this question and carefully framed the question so as to reduce measurement error and also to avoid possible double counting with the effect on the partner's health. RESULTS: We collected data from 26 partners about their preferences for their own health, which is influenced by the patient's health condition. The mean QOL weights for the partners when the patients are the following states are healthy, 0.81; impotent, 0.66; incontinent, 0.68; have metastatic disease, 0.50; and dead, 0.28. Partners' responses varied by how close they felt to the patients. Low correlations between partners' and patients' QOL ratings (n = 15) suggest that the partners were not responding as proxies for the patient. CONCLUSIONS: A new TTO method is proposed to measure a partner's QOL due to a patient's health. Preliminary test results of validity were promising.","Med Decis Making, 30(3): 355-365","USA",2010,"Any or unknown","None","TTO","Caregiver",null,"Validation","USA","Caregiver","Any or unknown","None",null,"Validation","TTO","2010:2014","Utility"]
[46,"Bates, T. S., et al. (1998). \"Prevalence and impact of incontinence and impotence following total prostatectomy assessed anonymously by the ICS-male questionnaire.\" Eur Urol 33(2): 165-169.",null,"Bates, T. S., et al.","Prevalence and impact of incontinence and impotence following total prostatectomy assessed anonymously by the ICS-male questionnaire","OBJECTIVES: The aim of this study was to assess the incidence of incontinence and impotence in patients following total prostatectomy and assess the impact their symptoms have on their quality of life. PATIENTS AND METHODS: Between 1987 and 1994, one surgeon performed retropubic total prostatectomies on 89 patients, of which 87 were available for follow-up. All patients were sent an ICS-male questionnaire. Patients' ages ranged from 49 to 73 years (median 65). The interval between surgery and completing the questionnaire ranged from 7 to 87 months (median 22). RESULTS: The response rate was 95%. No patients reported incontinence pre-operatively. Postoperatively, 69% (57/83) of patients suffered to some degree of leakage of urine and 24% (29/83) used pads. Of these, 60% used 1 pad per day, 15% 2 pads and 25% (5 patients) used 3 or more. Nocturnal incontinence was reported by 20% of patients. Urinary incontinence was considered a problem in only 34% (28/83) of patients. Sixty-five percent of patients using pads considered urinary leakage to be a problem, but only 1 considered it a serious problem. 89% claimed to have been potent prior to surgery. The overall postoperative potency rate was 41% (30/74) in those potent pre-operatively. However, 67% of patients reporting potency had severely reduced rigidity, and only 12% (9/74) achieved what they considered full erections. Ten percent of all patients considered postoperative impotence to be a serious problem, and 47% stated that it was not a problem at all. CONCLUSIONS: The incidence of incontinence and impotence following total prostatectomy is higher than earlier reports suggest, but the impact of these complications appears to be surprisingly low. These results allow patients to be given realistic expectations when counselled prior to this operation.","Eur Urol, 33(2): 165-169","UK",1998,"Any or unknown","Surgery","ICSQ","Patient",null,"Cross-sectional","UK","Patient","Any or unknown","Surgery",null,"Cross-sectional","ICSQ","1960:1999","Complication"]
[47,"Batista-Miranda, J. E., et al. (2003). \"Quality of life in prostate cancer patients and controls: psychometric validation of the FACTP-4 in Spanish, and relation to urinary symptoms.\" Arch Esp Urol 56(4): 447-454.",null,"Batista-Miranda, J. E., et al.","Quality of life in prostate cancer patients and controls: psychometric validation of the FACTP-4 in Spanish, and relation to urinary symptoms","OBJECTIVES: To assess the feasibility and a validity of the Spanish version of the FACT-P and its relation to urinary symptoms. METHODS: The Spanish version of the FACT-P was self-administered to 60 Prostate Cancer patients (pts) waiting to undergo radical treatment and 20 age-matched controls (con) with a negative biopsy. Clinical stage for patients was T1c in 34 and T2 in 26. FACT-P was analysed for internal consistency (Chronbach's a) and relation to symptom scales (IPSS, IPSS bother score and incontinence questionnaire (ICI-SF)). RESULTS: Feasibility (evaluable questionnaires) was 80.9 for con and 95% for pts. Internal consistency was high for all sub-scales (alpha > 0.7). Emotional well-being subscale and IPSS were significantly higher in pts. (worse emotional wellbeing and more lower urinary tract symptoms). There were no statistically significant differences between pts and con. in any of the other FACT-P sub-scores nor in symptom scores. Correlations were found between some FACT-P sub-scores and bother score. CONCLUSIONS: The Spanish version of the FACTP is feasible and psychometrically valid. Pts undergoing treatment for localized disease have similar QoL that a control group, but higher scores for emotional distress and IPSS.","Arch Esp Urol, 56(4): 447-454","Spain",2003,"Any or unknown","Surgery","FACT-P,IPSS,ICI-SF","Patient",null,"Validation","Spain","Patient","Any or unknown","Surgery",null,"Validation","FACT-P,IPSS,ICI-SF","2000:2004","Complication,Utility,Symptom"]
[48,"Bauer, R. M., et al. (2017). \"36-month data for the AdVance XP((R)) male sling: results of a prospective multicentre study.\" BJU Int 119(4): 626-630.",null,"Bauer, R. M., et al.","36-month data for the AdVance XP((R)) male sling: results of a prospective multicentre study","OBJECTIVES: To evaluate the efficacy and safety of the AdVance XP((R)) sling (Boston Scientific, formerly American Medical Systems) in male stress urinary incontinence (SUI) after radical prostatectomy in a prospective multicentre study, as in recent years several studies have shown the effectiveness and safety of the AdVance sling for treating male SUI and in 2010 the second-generation AdVance XP was introduced with several changes in the sling design and a new needle shape. PATIENTS AND METHODS: In all, 115 patients were included. Patients with nocturnal UI, previous UI surgery, previous radiotherapy and a coaptive zone of <1 cm in the preoperative repositioning test were excluded. Postoperatively, a standardised 24-h pad test, quality-of-life scores [International Quality of Life score (IQOL) and International Consultation on Incontinence Questionnaire short form (ICIQ-UI SF)], visual analogue scale (VAS) for pain, five-item version of the International Index of Erectile Function (IIEF-5), International Prostate Symptom Score (IPSS) and Patient Global Impression of Improvement (PGI-I) score, were performed. All patients with a 0-5 g pad test were defined as cured and improved with a reduction of urine loss of >50%. All others were classified as failures. Significance analysis was performed using the Wilcoxon test. RESULTS: The mean (median) preoperative urine loss in the 24-h pad test was 272.0 (272.0) g. After a follow-up of 3 months (114 patients), 64.9% of the patients were cured and 31.6% had an improved continence status. The mean urine loss decreased significantly to 34.9 g (P < 0.001), with a mean VAS score of 0.5, and mean PGI-I of 1.5. After a follow-up of 24 months (80 patients), 68.8% of the patients were cured and 22.5% had improved. The mean urine loss decreased significantly to 19.1 g (P < 0.001), with a mean VAS score of 0.3, and mean PGI-I of 1.5. After a follow-up of 36 months (47 patients), 66.0% of the patients were cured and 23.4% had improved. The mean urine loss decreased significantly to 21.8 g (P < 0.001), with a mean VAS score of 0.0, and mean PGI-I of 1.6. The mean IQOL and ICIQ-UI SF improved significantly (both P < 0.001) after 36 months. There were no significant postoperative changes in IIEF-5 and IPSS. No intraoperative and no long-term complications occurred. No erosion or explanations occurred. CONCLUSION: The AdVance XP shows good and stable effectiveness and low complication rates even at a mid-term follow-up of up to 36 months.","BJU Int, 119(4): 626-630","Germany",2017,"Any or unknown","Surgery","IQOL,ICIQ,VAS,IPSS,IIEF-5,PGI-I","Patient",null,"Clinical trial","Germany","Patient","Any or unknown","Surgery",null,"Clinical trial","IQOL,ICIQ,VAS,IPSS,IIEF-5,PGI-I","2015:2018","Symptom,Complication,Treatment,General"]
[49,"Beard, C. J., et al. (1997). \"Complications after treatment with external-beam irradiation in early-stage prostate cancer patients: a prospective multiinstitutional outcomes study.\" J Clin Oncol 15(1): 223-229.",null,"Beard, C. J., et al.","Complications after treatment with external-beam irradiation in early-stage prostate cancer patients: a prospective multiinstitutional outcomes study","PURPOSE: To use data from a prospective quality-of-life study to assess differences in disease-specific and general health-related quality-of-life changes after treatment with different external-beam irradiation techniques for prostate cancer. PATIENTS AND METHODS: Patients were divided into three groups based on their pretreatment field size and planning technique: whole pelvis, small field, or conformal. Measures of bowel, urinary, and sexual function and of global health-related quality-of-life parameters (from the Health Survey Short Form [SF-36] and the Profile of Mood States [POMS]) were obtained from self-report questionnaires completed before initiation of therapy and at 3 and 12 months after therapy. RESULTS: Irritative gastrointestinal and genitourinary side effects were frequent 3 months after treatment, but were substantially improved at 12 months. Sexual dysfunction increased steadily over the study period. The POMS and the SF-36 did not demonstrate significant changes over time. Despite small patient numbers, we found trends in favor of conformal therapy across several symptom measures, including sexual function. In the fatigue, energy, and vigor subscales, patients who received whole-pelvis treatment fared significantly worse than those in the other two groups. CONCLUSION: Prospective, detailed data from a feasibility study allowed us to assess the effect of technique on quality of life following external-beam irradiation. Although limited by the small planned sample size, these results suggest that smaller radiation fields limit treatment-related complications, including, unexpectedly, sexual dysfunction. However, confirmation in a larger study is necessary.","J Clin Oncol, 15(1): 223-229","USA",1997,"Local","Radiotherapy","SF-36,POMS","Patient",null,"Cohort","USA","Patient","Local","Radiotherapy",null,"Cohort","SF-36,POMS","1960:1999","Utility,Comorbidity"]
[50,"Beckendorf, V., et al. (2011). \"70 Gy versus 80 Gy in localized prostate cancer: 5-year results of GETUG 06 randomized trial.\" Int J Radiat Oncol Biol Phys 80(4): 1056-1063.",null,"Beckendorf, V., et al.","70 Gy versus 80 Gy in localized prostate cancer: 5-year results of GETUG 06 randomized trial","PURPOSE: To perform a randomized trial comparing 70 and 80 Gy radiotherapy for prostate cancer. PATIENTS AND METHODS: A total of 306 patients with localized prostate cancer were randomized. No androgen deprivation was allowed. The primary endpoint was biochemical relapse according to the modified 1997-American Society for Therapeutic Radiology and Oncology and Phoenix definitions. Toxicity was graded using the Radiation Therapy Oncology Group 1991 criteria and the late effects on normal tissues-subjective, objective, management, analytic scales (LENT-SOMA) scales. The patients' quality of life was scored using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-item cancer-specific and 25-item prostate-specific modules. RESULTS: The median follow-up was 61 months. According to the 1997-American Society for Therapeutic Radiology and Oncology definition, the 5-year biochemical relapse rate was 39% and 28% in the 70- and 80-Gy arms, respectively (p = .036). Using the Phoenix definition, the 5-year biochemical relapse rate was 32% and 23.5%, respectively (p = .09). The subgroup analysis showed a better biochemical outcome for the higher dose group with an initial prostate-specific antigen level >15 ng/mL. At the last follow-up date, 26 patients had died, 10 of their disease and none of toxicity, with no differences between the two arms. According to the Radiation Therapy Oncology Group scale, the Grade 2 or greater rectal toxicity rate was 14% and 19.5% for the 70- and 80-Gy arms (p = .22), respectively. The Grade 2 or greater urinary toxicity was 10% at 70 Gy and 17.5% at 80 Gy (p = .046). Similar results were observed using the LENT-SOMA scale. Bladder toxicity was more frequent at 80 Gy than at 70 Gy (p = .039). The quality-of-life questionnaire results before and 5 years after treatment were available for 103 patients with no differences found between the 70- and 80-Gy arms. CONCLUSION: High-dose radiotherapy provided a better 5-year biochemical outcome with slightly greater toxicity.","Int J Radiat Oncol Biol Phys, 80(4): 1056-1063","France",2011,"Local","Radiotherapy","EORTC QLQ-C30, EORTC QLQ-PR25,LENT-SOMA,RTOG-EORTC-SS","Patient",null,"Clinical trial","France","Patient","Local","Radiotherapy",null,"Clinical trial","EORTC QLQ-C30,LENT-SOMA,RTOG-EORTC-SS","2010:2014","Disease,General,Treatment"]
[51,"Beer, T. M., et al. (2004). \"Quality of life and pain relief during treatment with calcitriol and docetaxel in symptomatic metastatic androgen-independent prostate carcinoma.\" Cancer 100(4): 758-763.",null,"Beer, T. M., et al.","Quality of life and pain relief during treatment with calcitriol and docetaxel in symptomatic metastatic androgen-independent prostate carcinoma","BACKGROUND: The current study evaluated the analgesic activity and impact on quality of life (QOL) of a new chemotherapy regimen of calcitriol and docetaxel in men with androgen-independent prostate carcinoma. METHODS: Analgesic response was defined as a 2-point reduction on the Present Pain Intensity (PPI) scale (or compete relief if baseline PPI was 1) without an increase in analgesic use or a 50% decrease in analgesic medication use without an increase in pain, maintained for > or = 4 weeks. Pain, pain medication consumption, and QOL (measured by the European Organization for Research and Treatment of Cancer QLQ-C30) were evaluated every 4 weeks. RESULTS: Treatment resulted in an analgesic response in 14 of 29 evaluable patients (48%; 95% confidence interval [95% CI], 30-67%). The median time to symptomatic progression in the 14 patients who met criteria for analgesic response was 41 weeks (95% CI, 26-56 weeks). Worsening in physical and role functioning, fatigue, appetite, and global health status and improvement in constipation were detected using the QLQ-C30 QOL questionnaire. CONCLUSIONS: Significant analgesic activity was demonstrated, although worsening in several QOL domains was observed in a patient population with relatively low pain intensity (median PPI, 2).","Cancer, 100(4): 758-763","USA",2004,"Metastatic","Chemotherapy","MPQ,EORTC QLQ-C30","Patient",null,"Clinical trial","USA","Patient","Metastatic","Chemotherapy",null,"Clinical trial","MPQ,EORTC QLQ-C30","2000:2004","General,Symptom"]
[52,"Befort, C. A., et al. (2005). \"A measure of health-related quality of life among patients with localized prostate cancer: results from ongoing scale development.\" Clin Prostate Cancer 4(2): 100-108.",null,"Befort, C. A., et al.","A measure of health-related quality of life among patients with localized prostate cancer: results from ongoing scale development","BACKGROUND: We revised our prostate cancer-specific measure to better address the physiologic complications of the 3 major therapies for clinically localized prostate cancer and to assess the impact of symptoms on broader aspects of patient functioning. The study used a cross-sectional design, and participants completed the measure in a clinical setting. PATIENTS AND METHODS: Participants underwent radical prostatectomy (n = 130), external beam radiation therapy (n = 120), or brachytherapy (n = 129). Their mean age was 66 years (standard deviation [SD], 8.2 years), and the median time since treatment was 12.36 months (mean, 21.7; SD, 25.4). Items were derived from previously validated instruments or developed based on the clinical experience of a multidisciplinary group of health professionals. RESULTS: The revised instrument included 46 items that formed 8 physiologic scales (2 urinary, 3 sexual, and 3 bowel function); 3 associated bother scales; and cancer worry, treatment regret, and treatment satisfaction scales. Correlations among scales provided evidence of convergent/divergent validity. Significant group differences were found using analysis of covariance (with time since treatment and age as covariates) on 6 of the 8 physiologic scales and on bowel bother and treatment satisfaction. CONCLUSION: The instrument provides a sensitive measure of physiologic differences across the 3 primary treatment groups and indicates that there are few differences across treatment groups on broader aspects of health-related quality of life. Further development of the measure is recommended.","Clin Prostate Cancer, 4(2): 100-108","USA",2005,"Local","Radiotherapy,Surgery,Brachytherapy","Unclear","Patient",null,"Validation","USA","Patient","Local","Radiotherapy,Surgery,Brachytherapy",null,"Validation","Unclear","2005:2009","Disease"]
[53,"Bellardita, L., et al. (2016). \"Adaptation and validation of an Italian version of the Prostate Cancer Specific Quality of Life Instrument (PROSQOLI).\" Eur Rev Med Pharmacol Sci 20(13): 2773-2778.",null,"Bellardita, L., et al.","Adaptation and validation of an Italian version of the Prostate Cancer Specific Quality of Life Instrument (PROSQOLI)","OBJECTIVE: The Prostate Cancer Specific Quality of Life Instrument (PROSQOLI) is a measure of health-related quality of life (HRQoL) in advanced hormone-resistant prostate cancer. In this study, we aimed at performing a cross-cultural adaptation and validation of the Italian version of the PROSQOLI. PATIENTS AND METHODS: The original version of the PROSQOLI underwent several turnarounds of translations. A total of 472 patients treated with radical prostatectomy, radiotherapy or medical therapy were enrolled for the validation of the questionnaire. The PROSQOLI was administered together with the SF-12. Reliability indexes were calculated by using Cronbach alpha. To evaluate the validity of the construct, relationships between PROSQOLI and SF12 were assessed. The ANOVA test was used to evaluate the differences between groups of patients who had received different treatments. RESULTS: The reliability coefficient was 0.91. Item-to-total correlation indices were in most cases >0.70. The correlation between the scores of the PROSQOLI and those of the SF-12 questionnaire was high (r=0.8139, p<0.0001). The ANOVA test showed significant differences between groups (p<0.01) based on age, recurrence risk and treatment. CONCLUSIONS: The adaptation process showed that the PROSQOLI Italian version has high reliability and presents both convergent and discriminant validity. This version of the tool can be used to assess HRQoL in Italian men who underwent radical treatment for advanced prostate cancer.","Eur Rev Med Pharmacol Sci, 20(13): 2773-2778","Italy",2016,"Advanced","Radiotherapy,Surgery","PROSQoLI,SF-12","Patient",null,"Validation,Mapping to utility","Italy","Patient","Advanced","Radiotherapy,Surgery",null,"Validation,Mapping to utility","PROSQoLI,SF-12","2015:2018","Disease,Utility"]
[54,"Ben-Josef, A. M., et al. (2017). \"Effect of Eischens Yoga During Radiation Therapy on Prostate Cancer Patient Symptoms and Quality of Life: A Randomized Phase II Trial.\" Int J Radiat Oncol Biol Phys 98(5): 1036-1044.",null,"Ben-Josef, A. M., et al.","Effect of Eischens Yoga During Radiation Therapy on Prostate Cancer Patient Symptoms and Quality of Life: A Randomized Phase II Trial","PURPOSE: A randomized phase II study was performed to measure the potential therapeutic effects of yoga on fatigue, erectile dysfunction, urinary incontinence, and overall quality of life (QOL) in prostate cancer (PCa) patients undergoing external beam radiation therapy (RT). METHODS AND MATERIALS: The participants were randomized to yoga and no-yoga cohorts (1:1). Twice-weekly yoga interventions were offered throughout the 6- to 9-week courses of RT. Comparisons of standardized assessments were performed between the 2 cohorts for the primary endpoint of fatigue and the secondary endpoints of erectile dysfunction, urinary incontinence, and QOL before, during, and after RT. RESULTS: From October 2014 to January 2016, 68 eligible PCa patients underwent informed consent and agreed to participate in the study. Of the 68 patients, 18 withdrew early, mostly because of treatment schedule-related time constraints, resulting in 22 and 28 patients in the yoga and no-yoga groups, respectively. Throughout treatment, those in the yoga arm reported less fatigue than those in the control arm, with global fatigue, effect of fatigue, and severity of fatigue subscales showing statistically significant interactions (P<.0001). The sexual health scores (International Index of Erectile Function Questionnaire) also displayed a statistically significant interaction (P=.0333). The International Prostate Symptom Score revealed a statistically significant effect of time (P<.0001) but no significant effect of treatment (P=.1022). The QOL measures had mixed results, with yoga having a significant time by treatment effect on the emotional, physical, and social scores but not on functional scores. CONCLUSIONS: A structured yoga intervention of twice-weekly classes during a course of RT was associated with a significant reduction in pre-existing and RT-related fatigue and urinary and sexual dysfunction in PCa patients.","Int J Radiat Oncol Biol Phys, 98(5): 1036-1044","USA",2017,"Any or unknown","Radiotherapy,Various","IIEF-5,IPSS","Patient",null,"Clinical trial","USA","Patient","Any or unknown","Radiotherapy,Various",null,"Clinical trial","IIEF-5,IPSS","2015:2018","Complication,Symptom"]
[55,"Ben-Tovim, D. I., et al. (2002). \"Coping with prostate cancer: a quantitative analysis using a new instrument, the centre for clinical excellence in urological research coping with cancer instrument.\" Urology 59(3): 383-388.",null,"Ben-Tovim, D. I., et al.","Coping with prostate cancer: a quantitative analysis using a new instrument, the centre for clinical excellence in urological research coping with cancer instrument","OBJECTIVES: To assess the reliability (internal and interrater) and validity (concurrent) of a new interview measure for assessing patients' ability to cope with cancer, the Centre for Clinical Excellence in Urological Research Coping with Cancer Instrument (CCCI), and to determine whether there is an underlying structure to the various coping strategies used by patients with prostate cancer. METHODS: Eighty patients with prostate cancer were interviewed using the CCCI. The participants also completed measures of quality of life and anxiety and depression. RESULTS: The psychometric properties of the CCCI were acceptable. Factor analysis revealed that coping with prostate cancer can be described along five dimensions: positive problem solving (fighting against the illness, seeking information); self-reliance (developing a lay explanation, distrusting doctors); emotional availability (not withdrawing from others); distress (brooding, self-pity); and solace (taking alcohol or drugs to improve mood). These coping styles were correlated with age, quality of life, self-reported prostate-specific antigen level, and measures of anxiety and depression. CONCLUSIONS: The results of the present study have led to a greater understanding of the underlying coping styles used by patients with prostate cancer. Although some of these are similar to those found in other cancer populations, others, such as self-reliance and solace, represent unique and potentially clinically significant responses to prostate cancer diagnosis and treatment. A larger scale longitudinal study is needed to determine the wider clinical implications associated with each coping style.","Urology, 59(3): 383-388","Australia",2002,"Any or unknown","None","CCCI","Patient",null,"Validation","Australia","Patient","Any or unknown","None",null,"Validation","CCCI","2000:2004","General"]
[56,"Berg, R. S., et al. (2009). \"Half body irradiation of patients with multiple bone metastases: a phase II trial.\" Acta Oncol 48(4): 556-561.",null,"Berg, R. S., et al.","Half body irradiation of patients with multiple bone metastases: a phase II trial","AIM OF STUDY: The primary aim of this study was to evaluate the effect of half-body irradiation (HBI) on pain and quality of life in cancer patients with multiple bone metastases. The secondary aim was to evaluate side effects of the treatment. PATIENTS AND METHODS: A total of 44 patients received lower (n = 37), upper (n = 5), or sequential HBI (n = 2). The dose for lower HBI was 8 Gy in one fraction and for upper HBI 7 Gy in one fraction, with reduction of the lung dose to 6 Gy in one fraction by partial shielding. The majority of patients (n = 41) were males with prostate cancers (93%). Outcome and side effects were measured by the EORTC Quality of Life Questionnaire C30 (QLQ-C30), and by the doctors' toxicity scores in the medical record. Pain relief was defined as a reduction of more than 10 points on the QLQ-C30 scale. Evaluations were performed before and 2, 4, 8, 16, and 24 weeks after treatment. RESULTS: Relief of pain was observed in 76% of the patients receiving HBI with 8.8% of the patients experiencing complete pain relief with no residual pain in the treated field. For most patients, the pain relief was lasting throughout the follow-up period. About one third of the patients were able to reduce their intake of analgesics. Grade 1-2 diarrhoea was the most common side effect observed in 49% of the patients two weeks after treatment. Mild pulmonary symptoms (grade 1-2) were observed in four of seven patients receiving upper HBI. No clear effect was observed on the patients' global quality of life. CONCLUSION: Single fraction HBI is safe and effective providing long lasting pain reduction in 76% of patients with multiple bone metastases.","Acta Oncol, 48(4): 556-561","Denmark",2009,"Metastatic","Radiotherapy","EORTC QLQ-C30","Patient",null,"Clinical trial","Denmark","Patient","Metastatic","Radiotherapy",null,"Clinical trial","EORTC QLQ-C30","2005:2009","General"]
[57,"Bergman, J., et al. (2010). \"Responsiveness of the University of California-Los Angeles Prostate Cancer Index.\" Urology 75(6): 1418-1423.",null,"Bergman, J., et al.","Responsiveness of the University of California-Los Angeles Prostate Cancer Index","OBJECTIVES: To determine the responsiveness of the University of California-Los Angeles Prostate Cancer Index (UCLA-PCI) by studying its sensitivity to clinically perceptible changes in health over time in men treated for localized prostate cancer. METHODS: All subjects underwent radical prostatectomy (n=253), external beam radiotherapy (n=66), or interstitial seed brachytherapy (n=73). We assessed health-related quality of life (HRQOL) outcomes using the UCLA-PCI to capture disease-specific outcomes and the Medical Outcomes Study Short Form-36 to study general HRQOL. We assessed the UCLA-PCI's responsiveness to change by comparison with the health change item of the Medical Outcomes Study Short Form-36. We measured responsiveness by calculating effect sizes and Guyatt statistics when comparing UCLA-PCI scores between baseline and 1 year and between 1 and 2 years. RESULTS: Of the 475 men who completed all baseline questionnaires, 392 (83%) completed all surveys at 12-month follow-up. Although sexual function decreased from baseline to 12 months in all groups, the magnitude of the negative change was inversely proportional to general health. For those whose general health worsened, effect sizes were >0.50 across all 6 domains. Effect sizes and Guyatt statistics were lowest (<0.25) for urinary bother, bowel function, and bowel bother in the groups demonstrating either no change or improvement in general health. Responsiveness of the UCLA-PCI in the short-term recovery period (12 months post-treatment) was better than in the chronic recovery phase (12-24 months) across almost all domains. CONCLUSIONS: The UCLA-PCI is responsive to change in assessing HRQOL in men treated for prostate cancer.","Urology, 75(6): 1418-1423","USA",2010,"Local","Radiotherapy,Surgery","SF-36,UCLA-PCI","Patient",null,"Validation,Mapping to utility","USA","Patient","Local","Radiotherapy,Surgery",null,"Validation,Mapping to utility","SF-36,UCLA-PCI","2010:2014","Disease,Utility"]
[58,"Berlin, A., et al. (2015). \"Phase 2 trial of guideline-based postoperative image guided intensity modulated radiation therapy for prostate cancer: Toxicity, biochemical, and patient-reported health-related quality-of-life outcomes.\" Pract Radiat Oncol 5(5): e473-482.",null,"Berlin, A., et al.","Phase 2 trial of guideline-based postoperative image guided intensity modulated radiation therapy for prostate cancer: Toxicity, biochemical, and patient-reported health-related quality-of-life outcomes","PURPOSE: The purpose of this study was to characterize treatment-related toxicities, health-related quality of life (HRQOL), and biochemical outcomes in patients treated with postoperative image guided intensity modulated radiation therapy (IMRT) for prostate cancer using a consensus guideline for defining the clinical target volume. METHODS AND MATERIALS: Between August 2007 and October 2008, patients considered for radiation therapy (RT) after prostatectomy were enrolled. The clinical target volume (prostate bed) was delineated according to published consensus guidelines, and patients were prescribed a dose of 66 Gy in 33 fractions. Radiation treatment planning prioritized rectal dose constraints over target volume coverage. Treatment was delivered by use of IMRT and daily cone beam computed tomographic guidance. Toxicity (graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events) and HRQOL assessments according to the Expanded Prostate Cancer Index Composite (EPIC) questionnaire were collected prospectively at baseline, at week 5 (during RT), at 3 months, and at yearly follow-up visits. Cumulative toxicity and biochemical relapse-free rates were calculated by the Kaplan-Meier method. Paired Student t tests with multiple testing correction were used to assess changes in HRQOL. RESULTS: A total of 68 men were evaluated, with median follow-up of 5.9 years. Fifty-three patients (77.9%) and 15 patients (22.1%) were treated with salvage and adjuvant RT, respectively. Primary planning objectives were met in most cases (97.1%), but planning target volume coverage was compromised in 40% of cases because of large planning target volumes (mean 347.6 cm(3)). There were no grade 3 or 4 acute toxicities. Cumulative 5-year incidence of late gastrointestinal and genitourinary grade 2 toxicities was 12.3% (95% confidence interval [CI], 11.1%-13.5%) and 10.6% (95% CI, 9.5%-11.6%), respectively. No grade 3 or 4 late toxicities were observed. Transient declines in EPIC gastrointestinal domain summary score (mean 87.66 at 3 months vs 92.76 at baseline; P = .006) and genitourinary irritative subscale (week 5 mean score 83.37 vs 89.45 at baseline; P = .007) were observed. Complete recovery occurred between 3 and 12 months after therapy, remaining stable compared with baseline at 5-year follow-up. Sexual HRQOL remained stable at 5 years, with an improving trend in bother subscale. Biochemical relapse-free rate at 5 years was 72.7% (95% CI, 61.9%-83.5%). CONCLUSIONS: Guideline-based postprostatectomy image guided IMRT with rigid rectal dose constraints resulted in favorable toxicity profiles; long-term stability in gastrointestinal, genitourinary, and sexual HRQOL; and expected biochemical control rates. Concerns regarding toxicity and HRQOL should not preclude recommendation for RT after prostatectomy.","Pract Radiat Oncol, 5(5): e473-482","Canada,Chile,USA",2015,"Any or unknown","Radiotherapy","EPIC,CTCAE","Patient",null,"Clinical trial","Canada,Chile,USA","Patient","Any or unknown","Radiotherapy",null,"Clinical trial","EPIC,CTCAE","2015:2018","Disease,Treatment"]
[59,"Berry, D. L., et al. (2006). \"Quality of life and pain in advanced stage prostate cancer: results of a Southwest Oncology Group randomized trial comparing docetaxel and estramustine to mitoxantrone and prednisone.\" J Clin Oncol 24(18): 2828-2835.",null,"Berry, D. L., et al.","Quality of life and pain in advanced stage prostate cancer: results of a Southwest Oncology Group randomized trial comparing docetaxel and estramustine to mitoxantrone and prednisone","PURPOSE: Palliation of bone pain can be achieved in men with androgen-independent prostate cancer treated with docetaxel and estramustine (DE) or mitoxantrone and prednisone (MP). While Southwest Oncology Group trial 99-16 demonstrated a survival improvement of DE over MP, the study also was designed to compare the palliation of disease-related symptoms. METHODS: Pain palliation and global quality of life (QOL) were the two primary patient-reported outcomes. Pain was measured with the Present Pain Intensity scale of the McGill Pain Questionnaire-Short Form. The European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire C30 (QLQ-C30) and its Prostate Cancer Module (PR25) measured QOL and symptom status. Pain and analgesic use were measured at random assignment, every cycle for eight cycles, and 1 year from random assignment; the QLQ-C30 and the PR25 were administered at random assignment, before cycle four (week 10) and cycle eight (month 6) and at 1 year. In addition to the primary intent-to-treat, missing at random analysis, sensitivity analyses were performed to assess robustness of global QOL conclusions under alternative informative missing data assumptions. RESULTS: Six hundred seventy four eligible patients received DE (n = 338) or MP (n = 336). In an intention-to-treat analysis, median overall survival was 17.5 months for the DE arm and 15.6 months for the MP arm (P = .02). There were no statistically significant differences in pain palliation between the treatment arms. The sensitivity analyses showed a consistent lack of statistically significant global QOL differences for the two arms. CONCLUSION: DE had superior clinical efficacy (overall survival, time-to-progression, and prostate-specific antigen declines) with similar global QOL and pain palliation in the MP arm.","J Clin Oncol, 24(18): 2828-2835","USA",2006,"Advanced","Taxane,Chemotherapy","MPQ,EORTC QLQ-C30,EORTC QLQ-PR25","Patient",null,"Clinical trial","USA","Patient","Advanced","Taxane,Chemotherapy",null,"Clinical trial","MPQ,EORTC QLQ-C30,EORTC QLQ-PR25","2005:2009","Disease,Symptom,General"]
[60,"Berry, W. R., et al. (2004). \"Phase II randomized trial of weekly paclitaxel with or without estramustine phosphate in progressive, metastatic, hormone-refractory prostate cancer.\" Clin Prostate Cancer 3(2): 104-111.",null,"Berry, W. R., et al.","Phase II randomized trial of weekly paclitaxel with or without estramustine phosphate in progressive, metastatic, hormone-refractory prostate cancer","This study was conducted to determine the similarity of response rates and safety produced by weekly paclitaxel with or without oral estramustine in patients with metastatic hormone-refractory prostate cancer. Between December 1998 and December 1999, 163 patients were randomized to receive 28-day cycles of paclitaxel 100 mg/m2 on days 2, 9, and 16 plus estramustine 280 mg orally 3 times a day on days 1-3, 8-10, and 15-17, or to receive paclitaxel 100 mg/m2 alone on days 1, 8, and 15. Objective response was defined as a > oe = 50% decrease in prostate-specific antigen (PSA) maintained for 4 weeks with stable or improved performance status. Response rates included 37 partial responses for paclitaxel/estramustine (47%) and 22 partial responses for paclitaxel (27%; P < 0.01). Median duration of response was 15.1 months for paclitaxel/estramustine and 15.5 months for paclitaxel; median survival was 16.1 months and 13.1 months, respectively (P = 0.049). Common toxicities for both treatments included neutropenia, gastrointestinal events, neuropathy, and asthenia. Thromboembolic events were more frequent in the paclitaxel/estramustine arm (no prophylactic anticoagulants). The rate of PSA decline for paclitaxel/estramustine was almost 2 times that of paclitaxel (47% vs. 27%), with acceptable toxicity. Multivariate analysis of prognostic factors affecting survival was not significant for treatment arm (P = 0.08). Although the incidence of thromboembolic events appeared to be increased in the paclitaxel/ estramustine arm, the addition of estramustine was responsible for a 20% increase in the rate of PSA decline. Neither treatment arm had significant impact on quality of life as measured by the Functional Assessment of Cancer Therapy-Prostate quality of life questionnaire. This study produced encouraging data; further studies of paclitaxel/ estramustine are recommended.","Clin Prostate Cancer, 3(2): 104-111","USA",2004,"Metastatic","Taxane,Chemotherapy","FACT-P","Patient",null,"Clinical trial","USA","Patient","Metastatic","Taxane,Chemotherapy",null,"Clinical trial","FACT-P","2000:2004","Disease"]
[61,"Bertaccini, A., et al. (2003). \"BSP-PC (Bononian Satisfaction Profile--Prostate Cancer): development and validation of a \"disease-specific\" questionnaire for the evaluation of health-related quality of life in patients with prostate cancer.\" Arch Ital Urol Androl 75(4): 187-194.",null,"Bertaccini, A., et al.","BSP-PC (Bononian Satisfaction Profile--Prostate Cancer): development and validation of a \"disease-specific\" questionnaire for the evaluation of health-related quality of life in patients with prostate cancer","OBJECTIVES: Prostate cancer (PC) is the most common neoplasia in men over 50 years of age in western countries. Nowadays, since there are several alternative medical-surgical treatments for this cancer, health-related quality of life (HQoL) evaluation has become very important. The present study deals with the development and the validation of a questionnaire (BSP-PC), considering the HQoL in prostate cancer patients. The BSP-PC items are mainly related to the subjects' satisfaction. As far as we know, it does not exist any disease specific instrument based on such aspect. MATERIALS AND METHODS: Questionnaire development: During three different meetings, with ten experts and twenty patients, we have defined the life aspects which are the most affected by prostate cancer. Subsequently we have created a first 40-item version of the BSP-PC. Patients were asked to fill in this particular questionnaire in addition to a generic and validated one (the EuroQol). A final 24 item questionnaire version, was finally achieved by other statistical analysis and meetings with experts. Questionnaire validation: the BSP-PC was filled in by 261 patients divided into 3 groups: \"healthy\" (57), \"prostate cancer\" (103), \"other diseases\" (100). RESULTS: Questionnaire development: participants' mean age was 59 years (N=71); 46% had prostate cancer, while 53% of the sample did not report notable diseases. The 24 items were selected on the basis of the following criteria: a) r>0.50, p<0.05 (correlation test re-test), b) p<0.05 (ANOVA presence vs absence of PC), c) r>0.50, p<0.05 (correlation with EuroQol). Questionnaire validation: participants' mean age was 68 years (N=261). Four factors were identified: 1) satisfaction about physical functionality (Crombach alpha=0.95), 2) satisfaction about sexual functionality (alpha=0.94), 3) satisfaction about social functionality (alpha=0.77), 4) satisfaction about urinary functionality (alpha=0.89); total Crombach alpha was 0.94. CONCLUSIONS: The BSP-PC questionnaire can be used as an instrument in the evaluation of HQoL in PC patients by principally considering their subjective satisfaction.","Arch Ital Urol Androl, 75(4): 187-194","Italy",2003,"Any or unknown","None","BSP-PC,EQ-5D","Patient",null,"Validation,Mapping to utility","Italy","Patient","Any or unknown","None",null,"Validation,Mapping to utility","BSP-PC,EQ-5D","2000:2004","Treatment,Utility"]
[62,"Bertetto, O., et al. (2001). \"Quality of life studies and genito-urinary tumors.\" Ann Oncol 12 Suppl 3: S43-48.",null,"Bertetto, O., et al.","Quality of life studies and genito-urinary tumors","BACKGROUND: Genitourinary (GU) tumors represent a large proportion of solid cancers (1 of 4) and a wide variety of natural histories, based on various prognostic factors and resulting in different treatment options and end points. In some cases, for the same stage of disease, different treatment strategies do not impact differently on overall survival (OS): surgery vs. radiation, or radical vs. conservative multidisciplinary approach, adjuvant or neoadjuvant, chemotherapy vs. BSC. Quality of life (QoL) is considered a reasonable end point when differences in OS do not seem to be striking. DESIGN: A review of the literature on different disease stages was undertaken to show where and when QoL was used as the end point of treatment efficacy. RESULTS: Very few studies have been performed in prostate, bladder and testicular cancer to show the impact of different treatment approaches on QoL. Although these studies might be considered as non-conclusive, some data may allow a better choice for the patients. CONCLUSIONS: QoL as the principal end point has not been used in clinical trials of GU tumors comparing different treatment approaches. This makes the choice between treatments offering similar survival but different toxicity patterns, body and behavioral consequences more difficult. We suggest that future prospective randomized studies should be planned taking into account the QoL as the main end point.","Ann Oncol, 12 Suppl 3(S43-48","Italy",2001,"Any or unknown","Unclear","Unclear","Patient",null,"Systematic review","Italy","Patient","Any or unknown","Unclear",null,"Systematic review","Unclear","2000:2004","General"]
[63,"Bestmann, B., et al. (2006). \"Validation of the German prostate-specific module.\" World J Urol 24(1): 94-100.",null,"Bestmann, B., et al.","Validation of the German prostate-specific module","Theoretically, all patients newly diagnosed with prostate cancer are faced with a choice of treatment options: radical prostatectomy or radio therapy. Although these different treatments may have no differences in terms of survival, they may have very different consequences on the subsequent quality of life (QoL). Prerequisite to analyze QoL is a reliable and valid instrument to assess these differences not only in terms of general QoL (EORTC QLQ-C30) but prostate specific symptoms with a prostate specific module as well. Therefore, the aim of this study was a psychometric evaluation (validation) of the prostate-specific module (PSM). Five historical cohort studies were put together for an empirical meta-analysis. The main objective was to analyze the module's psychometric properties. The total sample consisted of 1,185 patients, of whom 950 completed the QoL questionnaires (EORTC QLQ-C30 and a prostate specific module developed by Kuechler et al.). First step of analysis was a principal component analysis that revealed the following scales: urinary problems, incontinence, erectile dysfunction, sexual problems, problems with partner, pain, heat, nutrition, and psychic strain. The module showed good reliability and concurrent validity and very good construct validity, since the module is able to discriminate between different treatment regimes, tumor stages and age. The German PSM is a reliable, valid and applicable tool for QoL in patients with prostate cancer.","World J Urol, 24(1): 94-100","Germany",2006,"Any or unknown","Surgery,Radiotherapy","EORTC QLQ-C30,EORTC QLQ-PR25","Patient",null,"Validation","Germany","Patient","Any or unknown","Surgery,Radiotherapy",null,"Validation","EORTC QLQ-C30,EORTC QLQ-PR25","2005:2009","Disease,General"]
[64,"Beydoun, H. A., et al. (2010). \"Development of a scale to assess patient misperceptions about treatment choices for localized prostate cancer.\" BJU Int 106(3): 334-341.",null,"Beydoun, H. A., et al.","Development of a scale to assess patient misperceptions about treatment choices for localized prostate cancer","OBJECTIVES: To develop a questionnaire to assess a patient's knowledge of his cancer, understanding of treatment choices, and judgement of his survival (KUJ) with and without treatment, as treatment for localized prostate cancer (LPC) can lead to urinary, sexual and bowel side-effects and might not improve survival in 75% of patients. PATIENTS AND METHODS: Although >90% of patients in the USA are diagnosed with LPC, approximately 94% of them choose treatment, such that newly diagnosed patients need individualized counselling to address misperceptions about the management of LPC. The internal consistency of an 18-item KUJ scale was evaluated among 184 patients recently diagnosed with LPC at a major urology practice. Principal-component analyses were applied for computing a KUJ index. Logistic regression modelling was used to identify predictors of the KUJ index. RESULTS: Cronbach's alpha for the KUJ scale was 0.76. Nearly half of the patients provided incorrect answers to most KUJ items. Of the patients, 68% had an income of >US$50,000 and 90% had at least high (or secondary) school literacy level. Quality-of-life measures suggested that most patients were physically, mentally and socially healthy. Higher education, income and functional capacity were associated with worse KUJ. CONCLUSION: The KUJ scale is internally consistent and clinicians can use it to identify the educational needs of patients with LPC before treatment selection. Overall, patients who were socioeconomically disadvantaged and those with physical ailments were better informed about the diagnosis, treatment options and prognosis of prostate cancer.","BJU Int, 106(3): 334-341","USA",2010,"Local","Unclear","KUJ","Patient",null,"Validation","USA","Patient","Local","Unclear",null,"Validation","KUJ","2010:2014","Disease"]
[65,"Bhatnagar, V., et al. (2009). \"Evaluation of an internet-based disease trajectory decision tool for prostate cancer screening.\" Value Health 12(1): 101-108.",null,"Bhatnagar, V., et al.","Evaluation of an internet-based disease trajectory decision tool for prostate cancer screening","OBJECTIVE: To evaluate the application of a chronic disease model (CDM) for prostate cancer to visual analog scale (VAS) and time trade-off (TTO) decision tools. METHODS: A total of 138 men (mean age 58 years) viewed a CDM module for prostate cancer with and without prostate specific antigen (PSA) screening. Participants rated their hypothetical quality of life with potential prostate cancer treatment complications using a CDM-based VAS decision tool. They were then asked to estimate how many years they would be willing to trade to be free of treatment complications using a CDM-based TTO decision tool. The consistency between VAS and TTO scores and the relationship between scores and preferences for PSA screening test and hypothetical treatment choice for prostate cancer were then evaluated. RESULTS: There was a significant relationship between the VAS and TTO ratings (regression P < 0.001). The TTO tool was sensitive to age. Mean scores with standard deviations for those less than 58 years compared to those 58 years and more were 7.78 (1.75) and 8.41 (1.52), respectively (P = 0.04). Using the VAS tool, men who chose PSA screening had higher quality of life ratings compared to men who did not choose PSA screening: 7.73 (1.78) and 6.59 (2.39), respectively (P = 0.01). Similar results were found with the TTO decision tool: 8.33 (1.45) and 7.04 (2.00), respectively (P = 0.005). Men who would hypothetically prefer treatment for moderately differentiated prostate cancer also had higher TTO scores compared to men who preferred watchful waiting: 8.54 (1.39) and 7.85 (1.73), respectively (P = 0.04). CONCLUSION: CDM-based for prostate cancer, VAS and TTO ratings were consistent and were concordant with patient preferences for screening; TTO ratings were also concordant with treatment choice. The use of the CDM-based TTO ratings to adjust for quality of life in decision analytic modeling needs to be explored.","Value Health, 12(1): 101-108","USA",2009,"At risk","Screening","VAS,TTO","General population",null,"Validation","USA","General population","At risk","Screening",null,"Validation","VAS,TTO","2005:2009","Utility"]
[66,"Bill-Axelson, A., et al. (2013). \"Long-term distress after radical prostatectomy versus watchful waiting in prostate cancer: a longitudinal study from the Scandinavian Prostate Cancer Group-4 randomized clinical trial.\" Eur Urol 64(6): 920-928.",null,"Bill-Axelson, A., et al.","Long-term distress after radical prostatectomy versus watchful waiting in prostate cancer: a longitudinal study from the Scandinavian Prostate Cancer Group-4 randomized clinical trial","BACKGROUND: Studies enumerating the dynamics of physical and emotional symptoms following prostate cancer (PCa) treatment are needed to guide therapeutic strategy. Yet, overcoming patient selection forces is a formidable challenge for observational studies comparing treatment groups. OBJECTIVE: To compare patterns of symptom burden and distress in men with localized PCa randomized to radical prostatectomy (RP) or watchful waiting (WW) and followed up longitudinally. DESIGN, SETTING, AND PARTICIPANTS: The three largest, Swedish, randomization centers for the Scandinavian Prostate Cancer Group-4 trial conducted a longitudinal study to assess symptoms and distress from several psychological and physical domains by mailed questionnaire every 6 mo for 2 yr and then yearly through 8 yr of follow-up. INTERVENTION: RP compared with WW. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: A questionnaire was mailed at baseline and then repeatedly during follow-up with questions concerning physical and mental symptoms. Each analysis of quality of life was based on a dichotomization of the outcome (yes vs no) studied in a binomial response, generalized linear mixed model. RESULTS AND LIMITATIONS: Of 347 randomized men, 272 completed at least five questionnaires during an 8-yr follow-up period. Almost all men reported that PCa negatively influenced daily activities and relationships. Health-related distress, worry, feeling low, and insomnia were consistently reported by approximately 30-40% in both groups. Men in the RP group consistently reported more leakage, impaired erection and libido, and fewer obstructive voiding symptoms. For men in the WW group, distress related to erectile symptoms increased gradually over time. Symptom burden and distress at baseline was predictive of long-term outlook. CONCLUSIONS: Cancer negatively influenced daily activities among almost all men in both treatment groups; health-related distress was common. Trade-offs exist between physiologic symptoms, highlighting the importance of tailored treatment decision-making. Men who are likely to experience profound long-term distress can be identified early in disease management.","Eur Urol, 64(6): 920-928","Sweden",2013,"Local","Surgery,Surveillance","Unclear","Patient",null,"Clinical trial","Sweden","Patient","Local","Surgery,Surveillance",null,"Clinical trial","Unclear","2010:2014","Comorbidity,Symptom"]
[67,"Bisson, J. I., et al. (2002). \"The prevalence and predictors of psychological distress in patients with early localized prostate cancer.\" BJU Int 90(1): 56-61.",null,"Bisson, J. I., et al.","The prevalence and predictors of psychological distress in patients with early localized prostate cancer","OBJECTIVE: To determine the level of psychopathology, traumatic distress and quality of life in men with newly diagnosed clinically localized prostate cancer, the effect on these of a consultation in a combined-specialist early-prostate clinic, and predictors of psychopathology. PATIENTS AND METHODS: Eighty-eight patients were recruited from the combined clinic; they completed a battery of questionnaires including the Hospital Anxiety and Depression Scale (HADS), the revised Impact of Event Scale (IES) and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, before their first appointment. Two weeks later they completed the HADS, IES and a patient-satisfaction survey. RESULTS: The overall level of psychopathology varied among the questionnaires used, from 0% on the HADS depression scale, 8% on the HADS anxiety scale and 14% on the IES. Anxiety and traumatic stress symptoms were commoner than depressive symptoms. The quality-of-life scores showed a relatively good level of functioning. Pre-morbid factors and disease status did not predict psychological distress. Younger age was mildly predictive of poorer psychological functioning. Anxiety symptoms reduced slightly after a joint clinic appointment, whereas depressive symptoms showed a slight increase. CONCLUSION: This study suggests that men with early localized prostate cancer have low levels of psychopathology overall. However, some men experience distressing psychological symptoms and it is important that future research is conducted to help develop clear guidelines on the optimal methods of detecting and managing men with prostate cancer who have mental health difficulties.","BJU Int, 90(1): 56-61","UK",2002,"Local","None","HADS,IES,EORTC-QOL-C30","Patient",null,"Cross-sectional","UK","Patient","Local","None",null,"Cross-sectional","HADS,IES,EORTC-QOL-C30","2000:2004","General,Complication,Comorbidity,Disease"]
[68,"Black, P. C., et al. (2007). \"A randomized prospective trial evaluating testosterone, haemoglobin kinetics and quality of life, during and after 12 months of androgen deprivation after prostatectomy: results from the Postoperative Adjuvant Androgen Deprivation trial.\" BJU Int 100(1): 63-69.",null,"Black, P. C., et al.","A randomized prospective trial evaluating testosterone, haemoglobin kinetics and quality of life, during and after 12 months of androgen deprivation after prostatectomy: results from the Postoperative Adjuvant Androgen Deprivation trial","OBJECTIVE: To assess testosterone and haemoglobin kinetics in the Postoperative Adjuvant Androgen Deprivation (PAAD) trial, and correlate these with quality of life (QoL) in this prospective randomized study. PATIENTS AND METHODS: Forty-three patients met the criteria for high-risk cancer after RRP (Gleason score > or = 8, pT3c or Gleason score 7 concomitant with pT3a/b and positive surgical margins) and were prospectively randomized to either observation or AD for 12 months. Haemoglobin and testosterone levels were determined and QoL surveyed at regular intervals for 24 months. RESULTS: Serum testosterone levels were castrate in 19 of 21 treated patients at 3 months and all at 6 months after starting AD. Levels failed to return to normal at 6 months after stopping treatment in six of 16 (38%) patients, and at 12 months in three of 17 (18%). AD caused a delay in the recovery of haemoglobin levels to normal after RRP. There was no statistically significant decline in the Short Form-36 QoL score with AD. Scores on the University of California-Los Angeles Sexual Functioning Scale were decreased during AD, but returned to a level not statistically significantly different from controls after stopping treatment. CONCLUSION: A year of adjuvant AD after RRP affected serum haemoglobin, testosterone and sexual function reversibly, with return to control levels within the subsequent year in most patients. No significant effect on overall QoL with AD was detected in the study.","BJU Int, 100(1): 63-69","USA",2007,"Advanced","Surgery,Hormonal","SF-36,UCLA-SFS","Patient",null,"Clinical trial","USA","Patient","Advanced","Surgery,Hormonal",null,"Clinical trial","SF-36,UCLA-SFS","2005:2009","Utility,Complication"]
[69,"Blanchard, C. M., et al. (2010). \"Body mass index, physical activity, and health-related quality of life in cancer survivors.\" Med Sci Sports Exerc 42(4): 665-671.",null,"Blanchard, C. M., et al.","Body mass index, physical activity, and health-related quality of life in cancer survivors","PURPOSE: To determine the independent and interactive associations among body mass index (BMI), physical activity (PA), and health-related quality of life (HRQoL) in breast, prostate, colorectal, bladder, uterine, and skin melanoma cancer survivors. METHODS: A total of 3241 cancer survivors completed a national cross-sectional survey that included PA questions and the RAND-36 Health Status Inventory. RESULTS: Compared with healthy-weight survivors, obese breast, prostate, bladder, and skin melanoma cancer survivors were significantly less likely to meet the PA guideline. Furthermore, healthy-weight and/or overweight breast, prostate, colorectal, uterine cancer, and skin melanoma survivors reported significantly better physical functioning compared with their obese counterparts, whereas overweight colorectal cancer survivors reported significantly better mental health compared with obese survivors. Finally, hierarchical linear regressions showed that none of the BMI x PA interactions was significant for the physical or mental component composite scores across the cancer types. CONCLUSIONS: The percentage of cancer survivors meeting the American Cancer Society's PA guideline seems to vary by weight status in breast, prostate, bladder, and skin melanoma cancer survivors. In addition, BMI and PA have independent associations with HRQoL; however, the interactive association of BMI and PA on HRQoL was negligible. Clarifying the relationship between BMI and PA across different cancer types will help identify potential target groups for future PA interventions that will help ameliorate the negative side effects of cancer and improve HRQoL.","Med Sci Sports Exerc, 42(4): 665-671","Canada",2010,"Survivors","None","SF-36","Patient",null,"Cross-sectional","Canada","Patient","Survivors","None",null,"Cross-sectional","SF-36","2010:2014","Utility"]
[70,"Bloomfield, D. J., et al. (1998). \"Economic evaluation of chemotherapy with mitoxantrone plus prednisone for symptomatic hormone-resistant prostate cancer: based on a Canadian randomized trial with palliative end points.\" J Clin Oncol 16(6): 2272-2279.",null,"Bloomfield, D. J., et al.","Economic evaluation of chemotherapy with mitoxantrone plus prednisone for symptomatic hormone-resistant prostate cancer: based on a Canadian randomized trial with palliative end points","PURPOSE: To evaluate the economic consequences of the use of chemotherapy in patients with symptomatic hormone-resistant prostate cancer (HRPC) in the context of a previously published Canadian open-label, phase III, randomized trial with palliative end points. PATIENTS AND METHODS: The trial randomized 161 patients to initial treatment with mitoxantrone and prednisone (M + P) or to prednisone alone (P) and showed better palliation with M + P. There was no significant difference in survival. A detailed retrospective chart review was performed of resources used from randomization until death of 114 of 161 patients enrolled at the three largest centers: these included hospital admissions, outpatient visits, investigations, therapies (which included all chemotherapy and radiation), and palliative care. Cancer center and community hospital costs were calculated by using the hotel approximation method and case costing from the Ontario Case Cost Project, respectively. Cost-utility analysis was performed by transforming the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 global quality-of-life item measured every 3 weeks on trial to an estimate of utility, and extending the last known value through to death or last follow-up. RESULTS: The mean total cost until death or last follow-up by intention-to-treat was M + P CDN $27,300; P CDN $29,000. The 95% confidence intervals on the observed cost difference ranged from a saving of $9,200 for M + P (with palliative benefit) to an increased cost of $5,800 for M + P. The major proportion of cost (M + P 53% v P 66%; CDN $14,500 v $19,100) was for inpatient care. Initial M + P was consistently less expensive in whichever time period was used to compare costs. Cost-utility analysis showed M + P to be the preferred strategy with an upper 95% confidence interval for the incremental cost-utility ratio of CDN $19,700 per quality-adjusted life-year (QALY). CONCLUSION: A treatment that reduces symptoms and improves quality of life has the potential to reduce costs in other areas. Economic factors should not influence the clinical decision as to whether to use M + P in a symptomatic patient.","J Clin Oncol, 16(6): 2272-2279","Canada",1998,"Any or unknown","Chemotherapy","EORTC QLQ-C30","Patient",null,"Clinical trial,Economic model","Canada","Patient","Any or unknown","Chemotherapy",null,"Clinical trial,Economic model","EORTC QLQ-C30","1960:1999","General"]
[71,"Bogdanos, J., et al. (2004). \"Epoetin beta (NeoRecormon) corrects anaemia in patients with hormone-refractory prostate cancer and bone metastases.\" Anticancer Res 24(3b): 1957-1961.",null,"Bogdanos, J., et al.","Epoetin beta (NeoRecormon) corrects anaemia in patients with hormone-refractory prostate cancer and bone metastases","BACKGROUND: Severe anaemia is common in patients with metastatic, hormone-refractory prostate cancer (HRPC). PATIENTS AND METHODS: We evaluated the efficacy of epoetin beta in correcting anaemia and maintaining haemoglobin (Hb) levels in this group of patients. Patients with HRPC, bone metastases and anaemia (Hb < 12 g/dl) were included. Epoetin beta, 30,000 IU per week in three divided doses, was administered subcutaneously, with iron supplementation when needed. If Hb increased by < 1 g/dl during the first 4 weeks of therapy the epoetin dose was increased (increments of 5,000 IU per dose) at fortnightly intervals to a maximum of 60,000 IU per week. Patients with haematopoietic response (Hb increase > or = 2 g/dl from baseline or Hb level > or = 12 g/dl without blood transfusions) went on to receive epoetin beta 10,000 IU once weekly for up to 24 weeks. RESULTS: All 29 evaluable patients demonstrated a haematopoietic response to epoetin beta treatment. None of the patients required blood transfusions. All patients showed improvements in quality of life (assessed using the EORTC QLQ-C30 questionnaire). Hb levels were maintained for the remainder of the trial. Epoetin beta was very well tolerated. CONCLUSION: Epoetin beta therapy resulted in a rapid and sustained improvement in Hb levels in patients with HRPC metastatic to bone.","Anticancer Res, 24(3b): 1957-1961","Greece",2004,"Metastatic","Various","EORTC QLQ-C30","Patient",null,"Clinical trial","Greece","Patient","Metastatic","Various",null,"Clinical trial","EORTC QLQ-C30","2000:2004","General"]
[72,"Boisen, S., et al. (2016). \"A Cross-Sectional Comparison of Quality of Life Between Physically Active and Underactive Older Men With Prostate Cancer.\" J Aging Phys Act 24(4): 642-648.",null,"Boisen, S., et al.","A Cross-Sectional Comparison of Quality of Life Between Physically Active and Underactive Older Men With Prostate Cancer","Men with prostate cancer experience many side effects and symptoms that may be improved by a physically active lifestyle. It was hypothesized that older men with prostate cancer who were physically active would report significantly higher levels of quality of life (QOL) as assessed by the WHOQOL-BREF and the WHOQOL-OLD. Of the 348 prostate cancer survivors who were invited to participate in the present postal survey, 137 men returned the questionnaires. Those who were physically active had significantly lower prostate specific antigen (PSA) scores and higher social participation than those insufficiently active. These findings offer some support for the benefits of physical activity (PA) within the prostate cancer population in managing the adverse side effects of their treatments on aspects of their QOL. Future research should more closely examine what types of PA best promote improvements in varying aspects of QOL and psychological well-being for prostate cancer survivors.","J Aging Phys Act, 24(4): 642-648","Unclear",2016,"Survivors","None","WHOQOL-BREF,WHOQOL-OLD","Patient",null,"Cross-sectional","Unclear","Patient","Survivors","None",null,"Cross-sectional","WHOQOL-BREF,WHOQOL-OLD","2015:2018","General"]
[73,"Borghede, G. and M. Sullivan (1996). \"Measurement of quality of life in localized prostatic cancer patients treated with radiotherapy. Development of a prostate cancer-specific module supplementing the EORTC QLQ-C30.\" Qual Life Res 5(2): 212-222.",null,"Borghede, G. and M. Sullivan","Measurement of quality of life in localized prostatic cancer patients treated with radiotherapy. Development of a prostate cancer-specific module supplementing the EORTC QLQ-C30","The purpose of this study was to construct a multidimensional self-administered quality of life questionnaire specific to prostate cancer within the EORTC framework and to test its applicability, clinical relevance and psychometry. A proposed prostate cancer-specific module and the standardized EORTC QLQ-C30 version 1.0 were tested in 192 post-irradiated patients. Psychometric analyses comprised item convergent and discriminant validity for scaling success, analysis of the internal consistency of the multi-item scales and the validity of the scales. The clinical relevance was explored by correlation analysis including disease and treatment related parameters. The minimum psychometric criteria were met. The measurements revealed problem areas in sexuality with a mean score of 54 (SD = 33) on a 0-100 scale, and in bowel functioning, scoring 25 on average (SD = 17). Urinary complaints only reached a mean score of 6 (SD = 19). Compared to earlier measurements on untreated or irradiated localized cancer patients using the same core questionnaire, the physical and psychological scales showed higher values and the symptom scales lower symptom burden. The constructed questionnaire seems applicable and clinically relevant. The psychometric analysis revealed a few items to be revised. Patients with localized prostatic carcinoma treated with radiotherapy have a high quality of life compared to patients with localized cancer of other origin.","Qual Life Res, 5(2): 212-222","Sweden",1996,"Local","Radiotherapy","EORTC QLQ-C30, EORTC QLQ-PR25","Patient",null,"Validation","Sweden","Patient","Local","Radiotherapy",null,"Validation","EORTC QLQ-C30","1960:1999","Disease,General"]
[74,"Borghede, G., et al. (1997). \"Quality of life in patients with prostatic cancer: results from a Swedish population study.\" J Urol 158(4): 1477-1485; discussion 1486.",null,"Borghede, G., et al.","Quality of life in patients with prostatic cancer: results from a Swedish population study","PURPOSE: We evaluated a prostate cancer-specific module in an unselected patient population. MATERIALS AND METHODS: A population study design was used to confirm the psychometric properties and clinical relevance of a prostate cancer-specific module, supplementing the standardized EORTC QLQ-C30 in Sweden. The study sample comprised 1,138 patients (81% response rate) examined by a mailout/mailback procedure 1.5 to 3.5 years after diagnosis. The standardized multitrait analysis method estimated the internal consistency and convergent and discriminant validity of 3 multi-item scales on sexuality, urinary symptoms and bowel symptoms. Confirmation of prostate-specific scales by disease stage and treatment used principal components analysis. The clinical relevance was tested by correlation analysis including disease and treatment-related parameters. RESULTS: Convergent and discriminant validity of all 3 prostate-specific scales was confirmed. The internal consistency was satisfactory for the sexuality and urinary scales (alpha 0.92 and 0.76, respectively), while the bowel scale failed to reach the alpha level of 0.70 required for group comparisons. The former scales showed invariance over all principal components analyses of subgroups (disease stage and treatment). The latter scale comprised differing numbers of items in the subgroup analyses, suggesting the use of single items at present. Descriptive data of the core and module questionnaires by disease and treatment-related parameters confirmed their interpretability and thus their clinical usefulness. CONCLUSIONS: The presented self-report questionnaire technique has great potential to inform clinicians about the quality of life in patients suffering from prostate cancer.","J Urol, 158(4): 1477-1485; discussion 1486","Sweden",1997,"Any or unknown","None","EORTC QLQ-C30, EORTC QLQ-PR25","Patient",null,"Validation","Sweden","Patient","Any or unknown","None",null,"Validation","EORTC QLQ-C30","1960:1999","Disease,General"]
[75,"Bourke, L., et al. (2015). \"Survivorship and improving quality of life in men with prostate cancer.\" Eur Urol 68(3): 374-383.",null,"Bourke, L., et al.","Survivorship and improving quality of life in men with prostate cancer","CONTEXT: Long-term survival following a diagnosis of cancer is improving in developed nations. However, living longer does not necessarily equate to living well. OBJECTIVE: To search systematically and synthesise narratively the evidence from randomised controlled trials (RCTs) of supportive interventions designed to improve prostate cancer (PCa)-specific quality of life (QoL). EVIDENCE ACQUISITION: A systematic search of Medline and Embase was carried out from inception to July 2014 to identify interventions targeting PCa QoL outcomes. We did not include nonrandomised studies or trials of mixed cancer groups. In addition to database searches, citations from included papers were hand-searched for any potentially eligible trials. EVIDENCE SYNTHESIS: A total of 2654 PCa survivors from 20 eligible RCTs were identified from our database searches and reference checks. Disease-specific QoL was assessed most frequently by the Functional Assessment of Cancer Therapy-Prostate questionnaire. Included studies involved men across all stages of disease. Supportive interventions that featured individually tailored approaches and supportive interaction with dedicated staff produced the most convincing evidence of a benefit for PCa-specific QoL. Much of these data come from lifestyle interventions. Our review found little supportive evidence for simple literature provision (either in booklets or via online platforms) or cognitive behavioural approaches. CONCLUSIONS: Physical and psychological health problems can have a serious negative impact on QoL in PCa survivors. Individually tailored supportive interventions such as exercise prescription/referral should be considered by multidisciplinary clinical teams where available. Cost-effectiveness data and an understanding of how to sustain benefits over the long term are important areas for future research. PATIENT SUMMARY: This review of supportive interventions for improving quality of life in prostate cancer survivors found that supervised and individually tailored patient-centred interventions such as lifestyle programmes are of benefit.","Eur Urol, 68(3): 374-383","International",2015,"Survivors","Various","FACT-P","Patient",null,"Systematic review","International","Patient","Survivors","Various",null,"Systematic review","FACT-P","2015:2018","Disease"]
[76,"Boyer, M. J., et al. (2017). \"Toxicity and quality of life report of a phase II study of stereotactic body radiotherapy (SBRT) for low and intermediate risk prostate cancer.\" Radiat Oncol 12(1): 14.",null,"Boyer, M. J., et al.","Toxicity and quality of life report of a phase II study of stereotactic body radiotherapy (SBRT) for low and intermediate risk prostate cancer","BACKGROUND: Clinical data indicates that delivery of larger daily doses of radiation may improve the therapeutic ratio for prostate cancer compared to conventional fractionation. A phase II study of stereotactic body radiotherapy with real-time motion management and daily plan re-optimization for low to intermediate risk prostate cancer was undertaken to evaluate this hypothesis. This report details the toxicity and quality of life following treatment. METHODS: From 2009 to 2013, 60 patients with T1-T2c prostate cancer with a Gleason score of 6 and PSA </= 15 or Gleason score of 7 and PSA </= 10 were enrolled. Patients with nodal metastases, an American Urological Association symptom score > 18, or gland size > 100 g were not eligible. Patients were treated to 37 Gy in 5 fractions. Early and late genitourinary and gastrointestinal toxicity were graded based on NCI CTCAE v4.0 and quality of life was assessed by the American Urological Association symptom score, International Index of Erectile Function, and Expanded Prostate cancer Index Composite Short Form up to 36 months after treatment. RESULTS: After a median follow-up of 27.6 months, no grade 3 or greater genitourinary toxicity was observed. Four patients (6.7%) reported a late grade 2 genitourinary toxicity. One patient (1.7%) reported a late grade 3 gastrointestinal toxicity. Five patients (8.3%) developed a late grade 2 gastrointestinal toxicity. The median American Urological Association symptom score increased from 4.5 prior to treatment to 11 while on treatment (p < 0.01), but was 5 at 36 months post-treatment (p = 0.65). Median International Index of Erectile Function scores decreased from 19 to 17 over the course of follow-up (p < 0.01). Only median scores within the Expanded Prostate Cancer Index Composite Short Form sexual domain were significantly decreased at 36 months post-treatment (67.9 vs 45.2, p = 0.02). There was no significant difference in median score within the urinary, bowel, or hormonal domains at 36 months of follow-up. CONCLUSIONS: Stereotactic body radiotherapy for low to intermediate risk prostate cancer is well tolerated with limited toxicity or decrease in quality of life. Longer follow-up is necessary to assess the efficacy of treatment. TRIAL REGISTRATION: Clinicaltrials.gov NCT00941915 Registered 17 June 2009.","Radiat Oncol, 12(1): 14","USA",2017,"Local","Radiotherapy","EPIC,IIEF-5,AUA-SI,CTCAE","Patient",null,"Clinical trial","USA","Patient","Local","Radiotherapy",null,"Clinical trial","EPIC,IIEF-5,AUA-SI,CTCAE","2015:2018","Disease,Complication,Symptom,Treatment"]
[77,"Bradley, E. B., et al. (2004). \"Determinants of long-term quality of life and voiding function of patients treated with radical prostatectomy or permanent brachytherapy for prostate cancer.\" BJU Int 94(7): 1003-1009.",null,"Bradley, E. B., et al.","Determinants of long-term quality of life and voiding function of patients treated with radical prostatectomy or permanent brachytherapy for prostate cancer","OBJECTIVE: To assess the long-term quality of life (QoL) outcomes of three treatments for localized prostate cancer: radical prostatectomy (RP); brachytherapy monotherapy (BTM); and BT combined with external beam radiotherapy (BTC). PATIENTS AND METHODS: In August 2000, questionnaires were mailed to men with T1c-T3 adenocarcinoma of the prostate treated with either RP, BTM ((103)Pd monotherapy) or BTC. Questionnaires included validated outcome measures, i.e. the Functional Assessment of Cancer Therapy - General (FACT-G), American Urological Association Symptom Score (AUA-SS), Urinary Function Questionnaire for men after RP, and the Brief Sexual Function Inventory. Returned questionnaires were assessed using cross-sectional analysis. RESULTS: Data from 214 patients were included in the analysis (60 RP, 102 BTM and 52 BTC); the median follow-up was 18.8, 25.5 and 29.9 months, respectively. There were differences between both BT groups and the RP group in total AUA-SS and obstructive subscale symptom scores, with the former having worse symptom scores at a longer follow-up. Differences in overall QoL were not detected between groups using the total FACT-G but the BTC group generally had worse scores in the physical well-being subscale. The BT groups had higher continence rates with time after treatment. Sexual function was better with BT initially, but these differences did not persist at a longer follow-up. There were significant correlations between the FACT-G and the urinary symptom scores, and the degree of sexual function. CONCLUSIONS: Although patients treated with BTM and RP have a different spectrum of side-effects, their overall long-term QoL is similar, with urinary and sexual function being the primary determinants of this outcome. Men treated with BTC have a worse QoL.","BJU Int, 94(7): 1003-1009","USA",2004,"Local","Brachytherapy,Surgery,Radiotherapy","FACT-G,AUA-SI,BSFI,UFQ-RP","Patient",null,"Cross-sectional","USA","Patient","Local","Brachytherapy,Surgery,Radiotherapy",null,"Cross-sectional","FACT-G,AUA-SI,BSFI,UFQ-RP","2000:2004","General,Complication,Symptom"]
[78,"Brandeis, J. M., et al. (2000). \"Quality of life outcomes after brachytherapy for early stage prostate cancer.\" J Urol 163(3): 851-857.",null,"Brandeis, J. M., et al.","Quality of life outcomes after brachytherapy for early stage prostate cancer","PURPOSE: We compare general and disease specific health related quality of life in men undergoing brachytherapy for early stage prostate cancer to those undergoing radical prostatectomy and age matched healthy controls. MATERIALS AND METHODS: Cohorts consisted of 48 men treated with brachytherapy with and without pretreatment external beam radiation therapy (brachytherapy group), 74 who underwent radical prostatectomy (prostatectomy group) and age matched healthy controls from the literature. The RAND 36-item general health survey, University of California Los Angeles Prostate Cancer Index, American Urological Association symptom index, validated Cancer Interference with Life and Family Scales, and sociodemographic and co-morbidity questionnaires were completed 3 to 17 months after treatment. RESULTS: General health related quality of life did not differ greatly among the 3 groups. Urinary function (leakage) was worse in the brachytherapy group than in controls but better than in the prostatectomy group. Brachytherapy group patients had more irritative urinary symptoms and worse bowel function than controls. Sexual function and bother were worse in prostatectomy and brachytherapy groups than in healthy controls. Physical function, bodily pain, urinary function, and bother and American Urological Association symptom index scores improved with time after brachytherapy. Patients who underwent brachytherapy after external beam radiation performed worse in all general and disease specific health related quality of life domains compared to those who did not undergo pretreatment radiation therapy. CONCLUSIONS: At an average of 7.5 months after treatment the general health related quality of life of patients undergoing brachytherapy with and without pretreatment external beam radiation was similar to age matched controls, although urinary, bowel and sexual problems were reported. These problems appeared to improve during the first year after treatment. Much of the impairment in disease specific health related quality of life among patients undergoing brachytherapy may be attributed to pretreatment radiation.","J Urol, 163(3): 851-857","USA",2000,"Local","Brachytherapy,Surgery","SF-36,UCLA-PCI,AUA-SI,CILFS","Patient",null,"Case-control","USA","Patient","Local","Brachytherapy,Surgery",null,"Case-control","SF-36,UCLA-PCI,AUA-SI,CILFS","2000:2004","Disease,Symptom,Carer,Utility"]
[79,"Bratt, O., et al. (2013). \"The Study of Active Monitoring in Sweden (SAMS): a randomized study comparing two different follow-up schedules for active surveillance of low-risk prostate cancer.\" Scand J Urol 47(5): 347-355.",null,"Bratt, O., et al.","The Study of Active Monitoring in Sweden (SAMS): a randomized study comparing two different follow-up schedules for active surveillance of low-risk prostate cancer","OBJECTIVE: Only a minority of patients with low-risk prostate cancer needs treatment, but the methods for optimal selection of patients for treatment are not established. This article describes the Study of Active Monitoring in Sweden (SAMS), which aims to improve those methods. MATERIAL AND METHODS: SAMS is a prospective, multicentre study of active surveillance for low-risk prostate cancer. It consists of a randomized part comparing standard rebiopsy and follow-up with an extensive initial rebiopsy coupled with less intensive follow-up and no further scheduled biopsies (SAMS-FU), as well as an observational part (SAMS-ObsQoL). Quality of life is assessed with questionnaires and compared with patients receiving primary curative treatment. SAMS-FU is planned to randomize 500 patients and SAMS-ObsQoL to include at least 500 patients during 5 years. The primary endpoint is conversion to active treatment. The secondary endpoints include symptoms, distant metastases and mortality. All patients will be followed for 10-15 years. RESULTS: Inclusion started in October 2011. In March 2013, 148 patients were included at 13 Swedish urological centres. CONCLUSIONS: It is hoped that the results of SAMS will contribute to fewer patients with indolent, low-risk prostate cancer receiving unnecessary treatment and more patients on active surveillance who need treatment receiving it when the disease is still curable. The less intensive investigational follow-up in the SAMS-FU trial would reduce the healthcare resources allocated to this large group of patients if it replaced the present standard schedule.","Scand J Urol, 47(5): 347-355","Sweden",2013,"Local","Surveillance","Unclear","Patient",null,"Protocol","Sweden","Patient","Local","Surveillance",null,"Protocol","Unclear","2010:2014","General"]
[80,"Bremner, K. E., et al. (2007). \"A review and meta-analysis of prostate cancer utilities.\" Med Decis Making 27(3): 288-298.",null,"Bremner, K. E., et al.","A review and meta-analysis of prostate cancer utilities","BACKGROUND: Health-related quality of life is a key issue in prostate cancer (PC) management. The authors summarized published utilities for common health-related quality of life outcomes of PC and determined how methodological factors affect them. METHODS: In their systematic review, the authors identified 23 articles in English, providing 173 unique utilities for PC health states, each obtained from 2 to 422 respondents. Data were pooled using linear mixed-effects modeling with utilities clustered within the study, weighted by the number of respondents divided by the variance of each utility. RESULTS: In the base model, the estimated utility of the reference case (scenario of a metastatic PC patient with severe sexual symptoms, rated by non-PC patients using time tradeoff) was 0.76. Disease stage, symptom type and severity, source of utility, and scaling method were associated with utility differences of 0.10 to 0.32 (P < 0.05). Utilities from PC patients rating their own health were 0.14 higher than those from the reference case, but utilities from PC patients rating scenarios were lowest. Time tradeoff yielded the highest utilities. Computer administration yielded lower utilities than personal interview (P = 0.02). Neither the scale's high anchor nor study purpose had significant effects on utilities. CONCLUSIONS: This study provides pooled utility estimates for common PC health states and describes how clinical and methodological factors can significantly affect these values. When possible, utility estimates for a modeling application should be derived similarly. Formal data synthesis methods might be useful to researchers integrating utility data from heterogeneous sources. Further exploration of these methods for this purpose is warranted.","Med Decis Making, 27(3): 288-298","Canada",2007,"Metastatic","None","TTO","Patient",null,"Systematic review","Canada","Patient","Metastatic","None",null,"Systematic review","TTO","2005:2009","Utility"]
[81,"Bremner, K. E., et al. (2014). \"Predicting utility scores for prostate cancer: mapping the Prostate Cancer Index to the Patient-Oriented Prostate Utility Scale (PORPUS).\" Prostate Cancer Prostatic Dis 17(1): 47-56.",null,"Bremner, K. E., et al.","Predicting utility scores for prostate cancer: mapping the Prostate Cancer Index to the Patient-Oriented Prostate Utility Scale (PORPUS)","BACKGROUND: The Prostate Cancer Index (PCI) is a health profile instrument that measures health-related quality of life with six subscales: urinary, sexual, and bowel function and bother. The Patient-Oriented Prostate Utility Scale (PORPUS-U) measures utility (0=dead and 1=full health). Utility is a preference-based approach to measure health-related quality of life, required for decision analyses and cost-effectiveness analyses. We developed a function to estimate PORPUS-U utilities from PCI scores. METHODS: The development data set included 676 community-dwelling prostate cancer (PC) survivors who completed the PCI and PORPUS-U by mail. We fit three linear regression models: one used original PORPUS-U scores and two used log-transformed PORPUS-U scores, one with a hierarchy constraint and one without. The model selection was performed using stepwise selection and fivefold cross validation. The validation data included 248 PC outpatients with three assessments on the PCI and PORPUS-U. Scores were retransformed for validation, with Duan's smearing estimator applied to correct potential bias. The predictive ability of the models was assessed with R(2), root mean square error (RMSE) and by comparing predicted and observed utilities. RESULTS: The best-fitting model used the log-transformed PORPUS-U with no hierarchy constraint. The R(2) was 0.72. The RMSE ranged from 0.040 to 0.061 for the three validation data sets. Differences between predicted and observed utilities ranged from 0.000 to 0.006 but predicted utilities overestimated the lowest 5% of observed PORPUS-U scores and underestimated the highest observed scores. CONCLUSIONS: Our algorithm can calculate PORPUS-U utility scores from PCI scores, thus supplementing descriptive quality of life measures with utility scores in PC patients. Utilities derived from mapping algorithms are useful for assigning utility to groups of patients but are less accurate at predicting utility of individual patients. We are exploring statistical methods to improve the mapping of utilities from descriptive instruments.","Prostate Cancer Prostatic Dis, 17(1): 47-56","USA,Canada",2014,"Survivors","None","PORPUS,PCIn","Patient",null,"Mapping to utility","USA,Canada","Patient","Survivors","None",null,"Mapping to utility","PORPUS,PCIn","2010:2014","Disease,Utility"]
[82,"Brien, J. C., et al. (2011). \"Posterior reconstruction before vesicourethral anastomosis in patients undergoing robot-assisted laparoscopic prostatectomy leads to earlier return to baseline continence.\" J Endourol 25(3): 441-445.",null,"Brien, J. C., et al.","Posterior reconstruction before vesicourethral anastomosis in patients undergoing robot-assisted laparoscopic prostatectomy leads to earlier return to baseline continence","INTRODUCTION: Reapproximation of Denonvilliers' fascia adjacent to bladder neck to the rectourethralis, or posterior reconstruction (PR), has been suggested to improve continence in postprostatectomy patients. We examined the impact of the PR on postoperative urinary and other quality-of-life (QoL) outcomes in patients undergoing robot-assisted laparoscopic prostatectomy (RALP). METHODS: We identified 89 patients who underwent RALP for prostate cancer between 2006 and 2009 by a single surgeon (R.G.), consented to participate in our prospective QoL study, which collects RAND-UCLA QoL and AUA symptom scores for all patients undergoing treatment for prostate cancer, and completed a baseline and a 3- or 6-month questionnaire. Of these, 31 patients had PR before vesicourethral anastomosis. We compared return to baseline function percentage at 3 and 6 months by PR group. Differences found in univariate analysis were further investigated using multiple linear regression models adjusting for demographics, clinical variables, and nerve-sparing status. RESULTS: While most patients had both 3- and 6-month follow-up (n = 74, 83%), sample size at 3 months was n = 86 and at 6 months was n = 77. Groups were comparable by preoperative characteristics, pathologic stage, nerve-sparing status, and baseline QoL/AUA symptom scores. At 3-months, there was a statistically significant improvement comparing PR to non-PR groups in return to baseline score for urinary bother (72% vs. 53%; p = 0.008) and urinary function (64% vs. 50%; p = 0.05), as well as change in absolute AUA symptom score (+0.2 vs. +3.8; p = 0.005). Differences in urinary bother (+20%; 95% confidence interval 5%, 34%) and AUA symptom score (-2.8; 95% confidence interval, -5.4, -0.2) persisted after multivariate adjustment. Groups had similar scores for all parameters by 6 months postprostatectomy. CONCLUSIONS: PR in patients undergoing RALP has a significant impact on early return to baseline parameters relating to urinary bother, urinary function, and AUA symptom score.","J Endourol, 25(3): 441-445","USA",2011,"Any or unknown","Surgery","UCLA-PCI,AUA-SI","Patient",null,"Cohort","USA","Patient","Any or unknown","Surgery",null,"Cohort","UCLA-PCI,AUA-SI","2010:2014","Symptom,Disease"]
[83,"Broering, J. M., et al. (2014). \"Measurement equivalence using a mixed-mode approach to administer health-related quality of life instruments.\" Qual Life Res 23(2): 495-508.",null,"Broering, J. M., et al.","Measurement equivalence using a mixed-mode approach to administer health-related quality of life instruments","PURPOSE: To evaluate the effects of mode, order of administration, and the interaction of mode and order on health-related quality of life scales when self-administered by mixed mode (paper-mode and web-mode) for measurement equivalence. METHODS: Health-related quality of life data was analyzed from the Cancer of the Prostate Strategic Urologic Research Endeavor using the Medical Outcomes Study (MOS) Short Form-36 (SF-36) and the University of California Los Angeles Prostate Cancer Index (UCLA-PCI). A randomized crossover design assigned participants to two groups with a preferred 2-5-day washout period. Cognitive debriefing evaluated participants' mode preference. RESULTS: Of the 245 men enrolled, 85 % completed both modes. The majority were White (97 %), college educated (66 %), reported an annual income >$75,000 (46 %), and a median age of 69 years. Intraclass correlation coefficients were high for each item on both instruments (r = .54-.97). Exact percentage agreement for yes/no items was high (>/=.88). For the SF-36, significant differences were observed for order of administration (physical component and physical function scores) and for the interaction between mode and order (mental component, role emotional, social function, vitality, and mental health scores). For the UCLA-PCI, the largest difference was 12.8 points lower for sexual bother for order of administration by web-mode first (p = .03). Seventy percent preferred the web-mode, 21 % had no preference, and 9 % preferred the paper-mode. CONCLUSION: Web-mode and paper-mode administrations of the SF-36 and UCLA-PCI are equivalent in men with prostate cancer, implying that mixed-mode survey administration is warranted.","Qual Life Res, 23(2): 495-508","USA",2014,"Any or unknown","None","SF-36,UCLA-PCI","Patient",null,"Clinical trial","USA","Patient","Any or unknown","None",null,"Clinical trial","SF-36,UCLA-PCI","2010:2014","Disease,Utility"]
[84,"Brown, G. C., et al. (2005). \"The burden of age-related macular degeneration: a value-based medicine analysis.\" Trans Am Ophthalmol Soc 103: 173-184; discussion 184-176.",null,"Brown, G. C., et al.","The burden of age-related macular degeneration: a value-based medicine analysis","PURPOSE: To assess the quality-of-life loss and the macroeconomic financial consequences associated with age-related macular degeneration (ARMD). METHODS: Time tradeoff utility analysis was performed to assess the quality-of-life diminution caused by ARMD (both dry and neovascular) in cohorts consisting of (1) patients with ARMD, (2) ophthalmologists asked to assume they had various degrees of severity of ARMD, (3) healthcare providers asked to assume they had various degrees of severity of ARMD, and (4) participants from the general community asked to assume they had various degrees of severity of ARMD. ARMD was classified according to vision in the better-seeing eye as (1) mild: 20/20 to 20/40, (2) moderate: 20/50 to 20/100, (3) severe: < or = 20/200, or (4) very severe: < or = 20/800. RESULTS: Mild ARMD caused a 17% decrement in the quality of life of the average patient, similar to that encountered with moderate cardiac angina or symptomatic human immunodeficiency virus syndrome. Moderate ARMD caused a 32% decrease in the average patient's quality of life, similar to that associated with severe cardiac angina or a fractured hip. Severe ARMD caused a 53% decrease in quality, more than that of dialysis, and very severe ARMD caused a 60% decrease in the average ARMD patient's quality of life, similar to that encountered with end-stage prostate cancer or a catastrophic stroke that leaves a person bedridden, incontinent, and requiring constant nursing care. Patients with varying degrees of severity of ARMD were found to have quality-of-life impairment ranging from 96% to 750% greater than that estimated by treating ophthalmologists for the same condition. An economic analysis based upon losses to the gross domestic product suggests that ARMD has approximately a $30 billion annual negative impact. The return on investment is therefore potentially high for both treatment with current ARMD therapies and the research costs invested in the development of new ARMD treatment modalities. CONCLUSIONS: ARMD is a major public health problem that has a devastating effect upon patients and marked adverse financial consequences for the economy.","Trans Am Ophthalmol Soc, 103(173-184; discussion 184-176","USA",2005,"End of life","None","TTO","Patient",null,"Cross-sectional","USA","Patient","End of life","None",null,"Cross-sectional","TTO","2005:2009","Utility"]
[85,"Brown, M. M., et al. (2006). \"The burden of age-related macular degeneration: a value-based analysis.\" Curr Opin Ophthalmol 17(3): 257-266.",null,"Brown, M. M., et al.","The burden of age-related macular degeneration: a value-based analysis","PURPOSE OF REVIEW: The quality-of-life loss and the financial consequences associated with age-related macular degeneration are assessed. RECENT FINDINGS: The quality-of-life loss associated with macular degeneration is markedly underestimated by the general public, nonophthalmic physicians, and ophthalmologists who treat patients with this condition. Mild age-related macular degeneration causes a 17% decrement in the quality of life of the average patient, similar to that encountered with moderate cardiac angina or symptomatic human immunodeficiency virus syndrome. Moderate age-related macular degeneration causes a 40% decrease in the average patient's quality of life, similar to that associated with severe cardiac angina or renal dialysis. Very severe age-related macular degeneration causes a large 63% decrease in the average patient's quality of life, similar to that encountered with end-stage prostatic cancer or a catastrophic stroke that leaves a person bedridden, incontinent and requiring constant nursing care. The return on investment is high for both treatment with current age-related macular degeneration therapies and the research costs invested in the development of age-related macular degeneration treatment modalities. SUMMARY: Age-related macular degeneration is a major public health problem that has a devastating effect upon patients and marked adverse financial consequences for the economy.","Curr Opin Ophthalmol, 17(3): 257-266","USA",2006,"Any or unknown","None","Unclear","Patient",null,"Narrative review","USA","Patient","Any or unknown","None",null,"Narrative review","Unclear","2005:2009","General"]
[86,"Bruner, D. W., et al. (2004). \"Predictors of preferences and utilities in men treated with 3D-CRT for prostate cancer.\" Int J Radiat Oncol Biol Phys 58(1): 34-42.",null,"Bruner, D. W., et al.","Predictors of preferences and utilities in men treated with 3D-CRT for prostate cancer","PURPOSE: To assess the preferences and utilities for prostate cancer health state scenarios of men treated with three-dimensional conformal radiotherapy and the predictors of treatment preferences. METHODS AND MATERIALS: The preferences and utilities for probabilistic health states of impotence and incontinence associated with prostate cancer therapies were elicited from prostate cancer registry participants using a modified time trade-off interview. Sociodemographic, disease, and treatment characteristics, as well as quality-of-life scores, were assessed to determine the predictors of preferences. RESULTS: Fifty-seven men treated with three-dimensional conformal radiotherapy completed the time trade-off interview. Of these men, 83% had Stage T1-T2 and 30% were receiving hormonal therapy. The utilities followed a linear trend with declining scores for increasing risk of poorer health states. Men showed an increased preference for health states associated with radiotherapy compared with surgery or hormonal therapy. Univariate predictors of preference included income and marital status. Multivariate predictors of preferences included more aggressive therapy and better prognostic indicators. Current quality-of-life scores in terms of global, sexual, or urinary function were poor predictors of preferences. CONCLUSION: Preference elicitation can assist in decision-making, and understanding the predictors of patient preferences can assist in identifying factors that may increase patient perceptions of poorer outcomes.","Int J Radiat Oncol Biol Phys, 58(1): 34-42","USA",2004,"Local","Radiotherapy,Hormonal,Surgery","TTO","Patient",null,"Cross-sectional","USA","Patient","Local","Radiotherapy,Hormonal,Surgery",null,"Cross-sectional","TTO","2000:2004","Utility"]
[87,"Buckley, B. S., et al. (2012). \"The effect of urinary incontinence on health utility and health-related quality of life in men following prostate surgery.\" Neurourol Urodyn 31(4): 465-469.",null,"Buckley, B. S., et al.","The effect of urinary incontinence on health utility and health-related quality of life in men following prostate surgery","AIMS: The impact of urinary incontinence (UI) on health-related quality of life (HRQoL) has been less well researched in men than women and the general population. This study aims to assess the association between UI and HRQoL in men 1 year after prostate surgery. METHODS: Planned secondary analysis of data from two parallel randomized controlled trials of active conservative treatment for UI in 853 men following radical prostatectomy (RP) and transurethral resection of the prostate (TURP). Men of any age were eligible for trial inclusion if they were experiencing UI 6 weeks after undergoing RP or TURP at 34 centers in the United Kingdom. Univariate and multivariate analysis considered associations between health status (SF-12 and EQ-5D) and self-reported UI. Multivariate analysis controlled for age, obesity, UI prior to surgery, and concomitant fecal incontinence. RESULTS: Mean age of 411 men in the RP trial was 62.3 years (SD 5.7) and 442 men in the TURP trial was 68.0 (SD 7.9). Of men with UI at 6 weeks after surgery, 76.7% in the RP group and 63.2% in the TURP group still had UI at 12 months. Any UI at 12 months was significantly associated with reduced HRQoL in the RP group and lower EQ-5D and SF-12 Mental Component Scores in the TURP group. CONCLUSION: Any UI is a significant factor in reduced HRQoL in men following prostate surgery, particularly younger men who undergo RP. Its importance to patients as an adverse outcome should not be underestimated.","Neurourol Urodyn, 31(4): 465-469","Ireland",2012,"Any or unknown","Surgery","SF-12,EQ-5D","Patient",null,"Clinical trial","Ireland","Patient","Any or unknown","Surgery",null,"Clinical trial","SF-12,EQ-5D","2010:2014","Complication,Utility"]
[88,"Burgio, K. L., et al. (2006). \"Preoperative biofeedback assisted behavioral training to decrease post-prostatectomy incontinence: a randomized, controlled trial.\" J Urol 175(1): 196-201; discussion 201.",null,"Burgio, K. L., et al.","Preoperative biofeedback assisted behavioral training to decrease post-prostatectomy incontinence: a randomized, controlled trial","PURPOSE: We tested the effectiveness of preoperative biofeedback assisted behavioral training for decreasing the duration and severity of incontinence, and improving quality of life in the 6 months following radical prostatectomy. MATERIALS AND METHODS: We performed a prospective, randomized, controlled trial comparing preoperative behavioral training to usual care. The volunteer sample included 125 men 53 to 68 years old who elected radical prostatectomy for prostate cancer. Patients were stratified according to age and tumor differentiation, and randomized to 1 preoperative session of biofeedback assisted behavioral training plus daily home exercise or a usual care control condition, consisting of simple postoperative instructions to interrupt the urinary stream. The main outcome measurements were duration of incontinence (time to continence), as derived from bladder diaries, incontinence severity (the proportion with severe/continual leakage), pad use, Incontinence Impact Questionnaire, psychological distress (Hopkins Symptom Checklist) and health related quality of life (Medical Outcomes Study Short Form Health Survey). RESULTS: Preoperative behavioral training significantly decreased time to continence (p = 0.03) and the proportion of patients with severe/continual leakage at the 6-month end point (5.9% vs 19.6%, p = 0.04). There were also significant differences between the groups for self-reported urine loss with coughing (22.0% vs 51.1%, p = 0.003), sneezing (26.0% vs 48.9%, p = 0.02) and getting up from lying down (14.0% vs 31.9%, p = 0.04). No differences were found on return to work and usual activities or quality of life measures. CONCLUSIONS: Preoperative behavioral training can hasten the recovery of urine control and decrease the severity of incontinence following radical prostatectomy.","J Urol, 175(1): 196-201; discussion 201","USA",2006,"Any or unknown","Surgery,Psychological","SF-36,IIQ,HSC","Patient",null,"Clinical trial","USA","Patient","Any or unknown","Surgery,Psychological",null,"Clinical trial","SF-36,IIQ,HSC","2005:2009","Symptom,Complication,Utility"]
[89,"Burns-Cox, N., et al. (2002). \"Prospective randomised trial comparing diethylstilboestrol and flutamide in the treatment of hormone relapsed prostate cancer.\" Int J Urol 9(8): 431-434.",null,"Burns-Cox, N., et al.","Prospective randomised trial comparing diethylstilboestrol and flutamide in the treatment of hormone relapsed prostate cancer","BACKGROUND: Patients with hormone relapsed prostate cancer (HRPC) are often treated with flutamide or diethylstilboestrol. However, which of these two options is the best treatment for HRPC remains unclear. METHODS: We carried out a prospective study to determine and compare the prostate-specific antigen (PSA) response and survival in patients with hormone relapsed prostate cancer (HRPC), all of whom had previously shown a good response to medical or surgical castration. The patients were randomised to treatment with diethylstilboestrol (DES) and aspirin, or the antiandrogen flutamide. In addition, quality of life was determined by interview and questionnaire. RESULTS: Twenty-eight patients were randomised for treatment options. There was a significantly greater fall in the PSA (65% vs 35%; P = 0.034) after treatment with diethylstilboestrol compared to treatment with flutamide. Median survival also rose after treatment with diethylstilboestrol (18 months) compared to flutamide (11 months), but this difference did not reach statistical significance. There was no difference in the quality of life parameters between the two groups. There were no cardiovascular complications in the stilboestrol group. CONCLUSIONS: In HRPC, treatment with stilboestrol is associated with a greater PSA fall and an increase in median survival when compared to flutamide treatment.","Int J Urol, 9(8): 431-434","UK",2002,"Refractory","Hormonal","Unclear","Patient",null,"Clinical trial","UK","Patient","Refractory","Hormonal",null,"Clinical trial","Unclear","2000:2004","General"]
[90,"Buron, C., et al. (2007). \"Brachytherapy versus prostatectomy in localized prostate cancer: results of a French multicenter prospective medico-economic study.\" Int J Radiat Oncol Biol Phys 67(3): 812-822.",null,"Buron, C., et al.","Brachytherapy versus prostatectomy in localized prostate cancer: results of a French multicenter prospective medico-economic study","PURPOSE: To prospectively compare health-related quality of life (HRQOL), patient-reported treatment-related symptoms, and costs of iodine-125 permanent implant interstitial brachytherapy (IB) with those of radical prostatectomy (RP) during the first 2 years after these treatments for localized prostate cancer. METHODS AND MATERIALS: A total of 435 men with localized low-risk prostate cancer, from 11 French hospitals, treated with IB (308) or RP (127), were offered to complete the European Organization for Research and Treatment of Cancer core Quality of Life Questionnaire QLQ-C30 version 3 (EORTC QLQ-C30) and the prostate cancer specific EORTC QLQ-PR25 module before and at the end of treatment, 2, 6, 12, 18, and 24 months after treatment. Repeated measures analysis of variance and analysis of covariance were conducted on HRQOL changes. Comparative cost analysis covered initial treatment, hospital follow-up, outpatient and production loss costs. RESULTS: Just after treatment, the decrease of global HRQOL was less pronounced in the IB than in the RP group, with a 13.5 points difference (p < 0.0001). A difference slightly in favor of RP was observed 6 months after treatment (-7.5 points, p = 0.0164) and was maintained at 24 months (-8.2 points, p = 0.0379). Impotence and urinary incontinence were more pronounced after RP, whereas urinary frequency, urgency, and urination pain were more frequent after IB. Mean societal costs did not differ between IB (8,019 euros at T24) and RP (8,715 euros at T24, p = 0.0843) regardless of the period. CONCLUSIONS: This study suggests a similar cost profile in France for IB and RP but with different HRQOL and side effect profiles. Those findings may be used to tailor localized prostate cancer treatments to suit individual patients' needs.","Int J Radiat Oncol Biol Phys, 67(3): 812-822","France",2007,"Local","Brachytherapy,Surgery","EORTC QLQ-C30,EORTC QLQ-PR25","Patient",null,"Cohort","France","Patient","Local","Brachytherapy,Surgery",null,"Cohort","EORTC QLQ-C30,EORTC QLQ-PR25","2005:2009","Disease,General"]
[91,"Butler, L., et al. (2006). \"Prevalence, correlates, and costs of patients with poor adjustment to mixed cancers.\" Cancer Nurs 29(1): 9-16.",null,"Butler, L., et al.","Prevalence, correlates, and costs of patients with poor adjustment to mixed cancers","Approximately 2% to 3% of the Canadian society has experienced cancer. Literature indicates that there is poor adjustment to chronic illness. Individuals with poor adjustment to chronic illness have been found to disproportionately use more health services. The purpose of this study was to determine the prevalence, correlates, and costs associated with poor adjustment to mixed cancer. A consecutive sample (n = 171) of breast, lung, and prostate cancer patients at the Nova Scotia Regional Cancer Center were surveyed. Twenty-eight percent of the cancer group showed fair to poor adjustment to illness using the Psychological Adjustment to Illness Self-report Scale Psychological Adjustment to Illness Self-Report Scale raw score. Poor adjustment was moderately correlated with depression (r = 0.50, P < .0001) and evasive coping (r = 0.38, P < .0001) and unrelated to demographic variables. Depression explained 25% of the variance in poor adjustment to illness in regression analysis. Cancer patients with fair to poor adjustment to illness had statistically significantly higher annual healthcare expenditures (P < .002) than those with good adjustment to illness. Expenditure findings agree with previous literature on chronic illnesses. The prevalence of fair to poor adjustment in this cancer population using the Psychological Adjustment to Illness Self-Report Scale measure is similar to that reported for chronic illness to date, suggesting that only those with better adjustment consented to this study.","Cancer Nurs, 29(1): 9-16","Canada",2006,"Any or unknown","None","PAIS","Patient",null,"Cross-sectional","Canada","Patient","Any or unknown","None",null,"Cross-sectional","PAIS","2005:2009","General"]
[92,"Caffo, O., et al. (1996). \"Assessment of quality of life after radical radiotherapy for prostate cancer.\" Br J Urol 78(4): 557-563.",null,"Caffo, O., et al.","Assessment of quality of life after radical radiotherapy for prostate cancer","OBJECTIVE: To assess the quality of life (QoL) of patients with localized prostate cancer (LPC) after treatment by radical radiotherapy (RR). PATIENTS AND METHODS: An \"ad hoc' self-administered questionnaire was developed, which comprised a series of 41 items grouped into seven subscales reflecting the main QoL domains, and the questionnaire's psychometric properties were assessed. A consecutive series of 118 patients treated with RR for LPC from 1981 to 1994 were then selected for a retrospective study and asked to complete the questionnaire. RESULTS: Ninety patients (76%) completed the questionnaire; because 20 of them were also treated with hormonal therapy, QoL was assessed only in the remaining 70 patients, to avoid confusion. The assessment of the psychometric properties showed that the questionnaire was valid and reliable (Cronbach's alpha coefficient > 0.8 for each subscale). The main side-effects of RR were urinary symptoms and sexual impairment, while physical, psychological and relational well-being were good. The degree of information available about the therapy and the disease seemed to play a major role in the patients' QoL adjustment after RR. CONCLUSION: The study assessed a sample of patients with LPC treated with RR and showed that QoL was acceptable after RR. Prospective studies are needed to improve knowledge of the factors involved in the restoration of the QoL after therapy for LPC.","Br J Urol, 78(4): 557-563","Italy",1996,"Local","Radiotherapy","Unclear","Patient",null,"Validation","Italy","Patient","Local","Radiotherapy",null,"Validation","Unclear","1960:1999","General"]
[93,"Caffo, O., et al. (2006). \"Prospective evaluation of quality of life after interstitial brachytherapy for localized prostate cancer.\" Int J Radiat Oncol Biol Phys 66(1): 31-37.",null,"Caffo, O., et al.","Prospective evaluation of quality of life after interstitial brachytherapy for localized prostate cancer","PURPOSE: Permanent interstitial brachytherapy (IB) has become an increasingly appealing therapeutic option for localized prostate cancer (LPC) among physicians and patients because it involves short hospitalization and treatment and its postulated low degree of toxicity may reduce its impact on the patients' quality of life (QoL). The aim of this prospective study was to assess the impact of IB on the QoL of patients with LPC. METHODS AND MATERIALS: A validated self-completed questionnaire was administered to the patients before and after IB and then at yearly intervals. The items allowed the identification of seven subscales exploring physical well-being (PHY), physical autonomy (POW), psychological well-being (PSY), relational life (REL), urinary function (URI), rectal function (REC), and sexual function (SEX). RESULTS: The assessment of the QoL of 147 patients treated between May 2000 and February 2005 revealed no relevant differences in the PHY scale scores 1 month after IB or later, and the same was true of the POW, PSY, and REL scales. Urinary function significantly worsened after IB and returned to pretreatment levels only after 3 years; the impact of the treatment on the URI scale was greater in the patients with good baseline urinary function than in those presenting more urinary symptoms before IB. Rectal and sexual functions were significantly worse only at the post-IB evaluation. CONCLUSIONS: The results of the present study confirm that the impact of IB on the patients' QoL is low despite its transient negative effects on some function, and extend existing knowledge concerning QoL after IB.","Int J Radiat Oncol Biol Phys, 66(1): 31-37","Italy",2006,"Local","Brachytherapy","Unclear","Patient",null,"Cohort","Italy","Patient","Local","Brachytherapy",null,"Cohort","Unclear","2005:2009","General"]
[94,"Caffo, O., et al. (2011). \"Impact of docetaxel-based chemotherapy on quality of life of patients with castration-resistant prostate cancer: results from a prospective phase II randomized trial.\" BJU Int 108(11): 1825-1832.",null,"Caffo, O., et al.","Impact of docetaxel-based chemotherapy on quality of life of patients with castration-resistant prostate cancer: results from a prospective phase II randomized trial","What's known on the subject? and What does the study add? Data on quality of life during docetaxel treatment in castration resistant prostate cancer was mainly provided by SWOG and TAX327 trials. In the TAX327 trial biochemical response and pain predicted survival, whereas quality of life outcomes did not. In the present study, there were no statistically significant changes in the quality of life scales during treatment except in the case of patients receiving docetaxel and estramustine, who experienced a significant decrease in pain. Our data seem to suggest that patients with a better baseline quality of life (and consequently with fewer symptoms) are more likely to achieve a biochemical response. OBJECTIVES: * To assess quality of life (QoL) outcomes and pain changes in patients affected by castration-resistant prostate cancer enrolled in a phase II randomized trial of 3-week docetaxel (DOC)-based chemotherapy. * To provide further data to clarify the conflicting published data concerning the impact of DOC on the patients' QoL. PATIENTS AND METHODS: * QoL outcomes were assessed using the European Organisation for the Research and Treatment of Cancer QLQ-C30 questionnaire. * Pain changes were evaluated by means of the Brief Pain Inventory at baseline and after every two DOC courses. * The patients completing at least two questionnaires (at baseline and before the third course) were considered evaluable. RESULTS: * In all, 59 patients were evaluable. * Asymptomatic patients and responders had a better baseline QoL than symptomatic patients and non-responders. * There were no statistically significant changes in the QLQ-C30 scales during treatment except in the case of patients receiving DOC and estramustine, who experienced a significant decrease in pain. * There was a progressive improvement in the mean intensity and interference scores of the Brief Pain Inventory. CONCLUSIONS: * Our data confirm that QoL is generally maintained during chemotherapy. * There is a substantial reduction in pain. * Our results also suggest that baseline QoL may predict treatment response.","BJU Int, 108(11): 1825-1832","Italy",2011,"Any or unknown","Taxane","EORTC QLQ-C30,BPI","Patient",null,"Clinical trial","Italy","Patient","Any or unknown","Taxane",null,"Clinical trial","EORTC QLQ-C30,BPI","2010:2014","General,Symptom"]
[95,"Calais da Silva, F. E., et al. (2009). \"Intermittent androgen deprivation for locally advanced and metastatic prostate cancer: results from a randomised phase 3 study of the South European Uroncological Group.\" Eur Urol 55(6): 1269-1277.",null,"Calais da Silva, F. E., et al.","Intermittent androgen deprivation for locally advanced and metastatic prostate cancer: results from a randomised phase 3 study of the South European Uroncological Group","BACKGROUND: Few randomised studies have compared intermittent hormonal therapy (IHT) with continuous therapy for the treatment of advanced prostate cancer (PCa). OBJECTIVE: To determine whether intermittent therapy is associated with a shorter time to progression. DESIGN, SETTING, AND PARTICIPANTS: 766 patients with locally advanced or metastatic PCa received a 3-mo induction treatment. The 626 patients whose prostate-specific antigen (PSA) level decreased to <4 ng/ml or to 80% below the initial value were randomised. INTERVENTION: Patients received cyproterone acetate (CPA) 200mg for 2 wk and then monthly depot injections of a luteinising hormone-releasing hormone (LHRH) analogue plus 200mg of CPA daily during induction. Patients randomised to the intermittent arm ceased treatment, while those randomised to the continuous arm received 200mg of CPA daily plus an LHRH analogue. MEASUREMENTS: Primary outcome measurement was time to subjective or objective progression. Secondary outcomes were survival and quality of life (QoL). Time off therapy in the intermittent arm was also recorded. RESULTS AND LIMITATIONS: 127 patients from the intermittent arm and 107 patients from the continuous arm progressed, with a hazard ratio (HR) of 0.81 (95% confidence interval [CI]: 0.63-1.05, p=0.11). There was no difference in survival, with an HR of 0.99 (95% CI: 0.80-1.23) and 170 deaths in the intermittent arm and 169 deaths in the continuous arm. The greater number of cancer deaths in the intermittent treatment arm (106 vs 84) was balanced by a greater number of cardiovascular deaths in the continuous arm (52 vs 41). Side-effects were more pronounced in the continuous arm. Men treated with intermittent therapy reported better sexual function. Median time off therapy for the intermittent patients was 52 wk (95% CI: 39.4-65.7). CONCLUSIONS: IHT should be considered for use in routine practice because it is associated with no reduction in survival, no clinically meaningful impairment in QoL, better sexual activity, and considerable economic benefit to the individual and the community.","Eur Urol, 55(6): 1269-1277","Portugal",2009,"Advanced,Metastatic","Hormonal","Unclear","Patient",null,"Clinical trial","Portugal","Patient","Advanced,Metastatic","Hormonal",null,"Clinical trial","Unclear","2005:2009","General"]
[96,"Carlson, L. E., et al. (2004). \"Mindfulness-based stress reduction in relation to quality of life, mood, symptoms of stress and levels of cortisol, dehydroepiandrosterone sulfate (DHEAS) and melatonin in breast and prostate cancer outpatients.\" Psychoneuroendocrinology 29(4): 448-474.",null,"Carlson, L. E., et al.","Mindfulness-based stress reduction in relation to quality of life, mood, symptoms of stress and levels of cortisol, dehydroepiandrosterone sulfate (DHEAS) and melatonin in breast and prostate cancer outpatients","OBJECTIVES: This study investigated the relationships between a mindfulness-based stress reduction meditation program for early stage breast and prostate cancer patients and quality of life, mood states, stress symptoms, and levels of cortisol, dehydroepiandrosterone-sulfate (DHEAS) and melatonin. METHODS: Fifty-nine patients with breast cancer and 10 with prostate cancer enrolled in an eight-week Mindfulness-Based Stress Reduction (MBSR) program that incorporated relaxation, meditation, gentle yoga, and daily home practice. Demographic and health behavior variables, quality of life, mood, stress, and the hormone measures of salivary cortisol (assessed three times/day), plasma DHEAS, and salivary melatonin were assessed pre- and post-intervention. RESULTS: Fifty-eight and 42 patients were assessed pre- and post-intervention, respectively. Significant improvements were seen in overall quality of life, symptoms of stress, and sleep quality, but these improvements were not significantly correlated with the degree of program attendance or minutes of home practice. No significant improvements were seen in mood disturbance. Improvements in quality of life were associated with decreases in afternoon cortisol levels, but not with morning or evening levels. Changes in stress symptoms or mood were not related to changes in hormone levels. Approximately 40% of the sample demonstrated abnormal cortisol secretion patterns both pre- and post-intervention, but within that group patterns shifted from \"inverted-V-shaped\" patterns towards more \"V-shaped\" patterns of secretion. No overall changes in DHEAS or melatonin were found, but nonsignificant shifts in DHEAS patterns were consistent with healthier profiles for both men and women. CONCLUSIONS: MBSR program enrollment was associated with enhanced quality of life and decreased stress symptoms in breast and prostate cancer patients, and resulted in possibly beneficial changes in hypothalamic-pituitary-adrenal (HPA) axis functioning. These pilot data represent a preliminary investigation of the relationships between MBSR program participation and hormone levels, highlighting the need for better-controlled studies in this area.","Psychoneuroendocrinology, 29(4): 448-474","Canada",2004,"Local","Psychological","Unclear","Patient",null,"Clinical trial","Canada","Patient","Local","Psychological",null,"Clinical trial","Unclear","2000:2004","General"]
[97,"Carlsson, S., et al. (2011). \"The excess burden of side-effects from treatment in men allocated to screening for prostate cancer. The Goteborg randomised population-based prostate cancer screening trial.\" Eur J Cancer 47(4): 545-553.",null,"Carlsson, S., et al.","The excess burden of side-effects from treatment in men allocated to screening for prostate cancer. The Goteborg randomised population-based prostate cancer screening trial","BACKGROUND: The number of men needed to treat to prevent one death is rather high in prostate cancer screening. How this affects the burden of treatment-related side-effects is unclear. The aim of this study was to evaluate the treatment related morbidity following radical prostatectomy in men participating in the Goteborg randomised population-based prostate cancer screening trial. METHODS: In 1995, 20,000 men aged 50-64 years were randomly allocated (1:1) to biennial PSA-screening or to a control group not invited. A subset of prostate cancer patients undergoing radical prostatectomy between 2001 and 2008 responded to questionnaires preoperatively and at 18 months postoperatively. The primary endpoint was patient-reported frequencies of erectile dysfunction as measured by the validated International Index of Erectile Function-5 questionnaire and urinary incontinence as assessed by use of pads. Analyses were made according to intention to screen. FINDINGS: After 14 years of follow-up, a total of 1849 men were detected with prostate cancer (1138 screened versus 711 controls, excluding 7 cancers detected at autopsy in the control group). Overall, 1047 received treatment with curative intent and radical prostatectomy was performed in 829 cases (79.2%). In this study, 294 of these men participated (205 screened and 89 controls). Of preoperatively potent men 79.1% (91/115) in the screening-group and 90.7% (49/54) in the control-group became impotent or sexually inactive 18 months postoperatively, whereas 14.3% (29/203) of screened men and 20.5% (18/88) of controls were considered postoperatively incontinent (regular use of pads). Extrapolated data yields that 120/10,000 more men become impotent and 25/10,000 more men will have the need of pads among men invited to regular PSA screening. The 'cost' per life saved at the same follow-up of screening is four men impotent and less than one man incontinent. INTERPRETATION: Despite the relatively high risk of erectile dysfunction and incontinence following radical prostatectomy for prostate cancer, the excess burden of permanent side-effects after population-based screening can be regarded as relatively low, when related to the number of men saved from prostate cancer death. These data can be useful when calculating the harms and benefits of screening. However, the outcome on a population-level may differ from the benefit for the individual.","Eur J Cancer, 47(4): 545-553","Sweden",2011,"Any or unknown","Surgery","IIEF-5","Patient",null,"Cohort","Sweden","Patient","Any or unknown","Surgery",null,"Cohort","IIEF-5","2010:2014","Complication"]
[98,"Carlsson, S., et al. (2016). \"Population-based study of long-term functional outcomes after prostate cancer treatment.\" BJU Int 117(6b): E36-45.",null,"Carlsson, S., et al.","Population-based study of long-term functional outcomes after prostate cancer treatment","OBJECTIVE: To evaluate long-term urinary, sexual and bowel functional outcomes after prostate cancer treatment at a median (interquartile range) follow-up of 12 (11-13) years. PATIENTS AND METHODS: In this nationwide, population-based study, we identified 6 003 men diagnosed with localized prostate cancer (clinical local stage T1-2, any Gleason score, prostate-specific antigen <20 ng/mL, NX or N0, MX or M0) between 1997 and 2002 from the National Prostate Cancer Register, Sweden. The men were aged </=70 years at diagnosis. A control group of 1 000 men without prostate cancer were also selected, matched for age and county of residence. Functional outcomes were evaluated with a validated self-reported questionnaire. RESULTS: Responses were obtained from 3 937/6 003 cases (66%) and 459/1 000 (46%) controls. At 12 years after diagnosis and at a median age of 75 years, the proportion of cases with adverse symptoms was 87% for erectile dysfunction/sexual inactivity, 20% for urinary incontinence and 14% for bowel disturbances. The corresponding proportions for controls were 62, 6 and 7%, respectively. Men with prostate cancer, except those on surveillance, had an increased risk of erectile dysfunction compared with the men in the control group. Radical prostatectomy was associated with an increased risk of urinary incontinence (odds ratio [OR] 1.89, 95% confidence interval [CI] 1.36-2.62) and radiotherapy increased the risk of bowel dysfunction (OR 2.46, 95% CI 1.73-3.49) compared with men in the control group. Multi-modal treatment, in particular treatment including androgen deprivation therapy (ADT), was associated with the highest risk of adverse effects; for instance, radical prostatectomy followed by radiotherapy and ADT was associated with an OR of 3.74 (95% CI 1.76-7.95) for erectile dysfunction and an OR of 3.22 (95% CI 1.93-5.37) for urinary incontinence. CONCLUSION: The proportion of men who experienced a long-term impact on functional outcomes after prostate cancer treatment was substantial.","BJU Int, 117(6b): E36-45","Sweden",2016,"Local","Surgery,Radiotherapy,Hormonal","Unclear","Patient",null,"Case-control","Sweden","Patient","Local","Surgery,Radiotherapy,Hormonal",null,"Case-control","Unclear","2015:2018","General"]
[99,"Carmack Taylor, C. L., et al. (2004). \"Quality of life intervention for prostate cancer patients: design and baseline characteristics of the active for life after cancer trial.\" Control Clin Trials 25(3): 265-285.",null,"Carmack Taylor, C. L., et al.","Quality of life intervention for prostate cancer patients: design and baseline characteristics of the active for life after cancer trial","Prostate cancer patients receiving androgen ablation therapy experience significant physical and psychological sequelae associated with their disease and treatment. Because physical activity improves physical and psychological well-being, a lifestyle physical activity intervention may help slow or reverse the associated decline in quality of life (QOL). No studies have evaluated an intervention to improve multiple QOL domains in patients receiving androgen ablation therapy. Active for Life After Cancer is a three-group randomized controlled trial designed to evaluate the effectiveness of a lifestyle physical activity intervention (Lifestyle Program) in improving QOL. The Lifestyle Program, a 6-month behavioral skills training group, is compared to an Educational Support Program and Standard Care. The purpose of this paper is to describe the design of the randomized trial and present baseline data that will characterize the QOL of the sample. Challenges to recruitment for the trial also will be presented and discussed.","Control Clin Trials, 25(3): 265-285","USA",2004,"Any or unknown","Various","Unclear","Patient",null,"Protocol","USA","Patient","Any or unknown","Various",null,"Protocol","Unclear","2000:2004","General"]
[100,"Carter, J. A., et al. (2011). \"Cost effectiveness of zoledronic acid in the management of skeletal metastases in hormone-refractory prostate cancer patients in France, Germany, Portugal, and the Netherlands.\" J Med Econ 14(3): 288-298.",null,"Carter, J. A., et al.","Cost effectiveness of zoledronic acid in the management of skeletal metastases in hormone-refractory prostate cancer patients in France, Germany, Portugal, and the Netherlands","OBJECTIVE: Zoledronic acid (ZOL) reduces the risk of skeletal related events (SREs) in hormone-refractory prostate cancer (HRPC) patients with bone metastases. This study assessed the cost effectiveness of ZOL for SRE management in French, German, Portuguese, and Dutch HRPC patients. METHODS: This analysis was based on the results of a randomized phase III clinical trial wherein HRPC patients received up to 15 months of ZOL (n = 214) or placebo (n = 208). Clinical inputs were obtained from the trial. Costs were estimated using hospital tariffs, published, and internet sources. Quality adjusted life-years (QALYs) gained were estimated from a separate analysis of EQ-5D scores reported in the trial. Uncertainty surrounding outcomes was addressed via univariate sensitivity analyses. RESULTS: ZOL patients experienced an estimated 0.759 fewer SREs and gained an estimated 0.03566 QALYs versus placebo patients. ZOL was associated with reduced SRE-related costs [net costs] (-euro2396 [euro1284] in France, -euro2606 [euro841] in Germany, -euro3326 [euro309] in Portugal and -euro3617 [euro87] in the Netherlands). Costs per QALY ranged from euro2430 (Netherlands) to euro36,007 (France). CONCLUSIONS: This analysis is subject to the limitations of most cost-effectiveness analyses: it combines data from multiple sources. Nevertheless, the results strongly suggest that ZOL is cost effective versus placebo in French, German, Portuguese, and Dutch HRPC patients.","J Med Econ, 14(3): 288-298","France,Germany,Portugal,Netherlands",2011,"Metastatic","Bisphosphonate","EQ-5D","Patient",null,"Economic model","France,Germany,Portugal,Netherlands","Patient","Metastatic","Bisphosphonate",null,"Economic model","EQ-5D","2010:2014","Utility"]
[101,"Carter, J. P., et al. (1993). \"Hypothesis: dietary management may improve survival from nutritionally linked cancers based on analysis of representative cases.\" J Am Coll Nutr 12(3): 209-226.",null,"Carter, J. P., et al.","Hypothesis: dietary management may improve survival from nutritionally linked cancers based on analysis of representative cases","A limited number of case histories was analyzed and verified to examine the effect of a very low fat, moderately high fiber, and moderately reduced calorie diet on the survival and quality of life of patients with primary cancer of the pancreas, metastatic stage D2 prostate cancer, and other nutritionally linked cancers. The retrospective study of pancreatic cancer patients disclosed that 1-year survival was higher among those who modified their diets than in those for whom there was no evidence as to diet alteration. For patients with metastatic prostate cancer (stage D2), a case control study demonstrated a statistical association of dietary modification with longer survival and improved quality of life. A retrospective study utilizing questionnaires supported such dietary modifications as a useful tool in the management of nutritionally linked cancers.","J Am Coll Nutr, 12(3): 209-226","USA",1993,"Metastatic","Various","Unclear","Patient",null,"Cohort","USA","Patient","Metastatic","Various",null,"Cohort","Unclear","1960:1999","General"]
[102,"Cary, K. C., et al. (2014). \"Impact of androgen deprivation therapy on mental and emotional well-being in men with prostate cancer: analysis from the CaPSURE registry.\" J Urol 191(4): 964-970.",null,"Cary, K. C., et al.","Impact of androgen deprivation therapy on mental and emotional well-being in men with prostate cancer: analysis from the CaPSURE registry","PURPOSE: While androgen deprivation therapy can delay cancer progression and reduce tumor burden, its use can be limited by adverse side effects. We evaluated the effect of androgen deprivation therapy on mental and emotional well-being in men with nonmetastatic prostate cancer. MATERIALS AND METHODS: Participants were enrolled in the national CaPSURE (Cancer of the Prostate Strategic Urologic Research Endeavor) registry, and treated with radical prostatectomy, external beam radiation therapy or brachytherapy with no androgen deprivation therapy (local); local with androgen deprivation therapy (combination); or primary androgen deprivation therapy. Emotional quality of life was evaluated by SF-36(R) social function, role emotional, vitality and mental health subscales before and up to 24 months after treatment. Subscales were assessed as continuous scores and as clinically meaningful declines of at least half a standard deviation since pretreatment. Associations between treatment and quality of life changes over time were evaluated with mixed modeling. Quality of life declines were evaluated with logistic regression. RESULTS: Among 3,068 men the combination and primary androgen deprivation therapy groups were older, single, with less education and higher clinical CAPRA (Cancer of the Prostate Risk Assessment) score risk than the local group (all values p <0.01). Androgen deprivation therapy exposure was associated with significant changes with time in adjusted role emotional (-8.4 points, p = 0.01) and vitality (-9.2 points, p = 0.02) scores. Treatment group was not associated with any clinically meaningful quality of life declines. A potential limitation is the observational nature of the study. CONCLUSIONS: Use of androgen deprivation therapy was associated with changes in mental and emotional well-being but did not result in clinically meaningful declines at 24 months. Patients must be counseled on possible quality of life changes related to androgen deprivation therapy as well as interventions to attenuate these effects before receiving treatment for prostate cancer.","J Urol, 191(4): 964-970","USA",2014,"Advanced,Local","Hormonal,Surgery,Radiotherapy","SF-36","Patient",null,"Cohort","USA","Patient","Advanced,Local","Hormonal,Surgery,Radiotherapy",null,"Cohort","SF-36","2010:2014","Utility"]
[103,"Cathala, N., et al. (2003). \"Patient followup after radical prostatectomy by Internet medical file.\" J Urol 170(6 Pt 1): 2284-2287.",null,"Cathala, N., et al.","Patient followup after radical prostatectomy by Internet medical file","PURPOSE: The development of the Internet and the need for regular followup of patients often living a long way from the hospital led us to develop a followup dossier for those with localized prostate cancer treated with laparoscopic radical prostatectomy. MATERIALS AND METHODS: This feasibility study was based on 140 patients who agreed to test this system. The website was opened on a server specifically devoted to this project with all required computer security. The website is composed of pages comprising the hospital discharge summary, and operative and histology reports. A quality of life questionnaire based on the assessment of urinary continence and sex life, and a prostate specific antigen (PSA) assay form are also included. RESULTS: The patient is able to enter his PSA data and complete the questionnaire at home. Results are then sent to the treating physician. A contact page allows the patient and physician to exchange information by text. Of these 100 patients 92 connected regularly to the site with a mean connection rate of 8 per patient (range 1 to 22). Of the patients 98% were satisfied with the various sections of the site, 95% were satisfied with the medical file, 11% noticed connection problems and 14% reported technical problems essentially attributable to incorrect PSA data entry or incorrect functioning of videos due to the absence of appropriate software. CONCLUSIONS: This type of Internet medical service for patients who have undergone surgery requiring regular followup appears to be a useful approach for the future by allowing the maintenance of close contact between the patient and physicians, while avoiding problems related to hospital visits regardless of the patient place of residence. It also provides general practitioners with access to the patient file with patient permission.","J Urol, 170(6 Pt 1): 2284-2287","France",2003,"Local","Surgery","Unclear","Patient",null,"Cross-sectional","France","Patient","Local","Surgery",null,"Cross-sectional","Unclear","2000:2004","Complication"]
[104,"Cella, D., et al. (2003). \"What are the most important symptom targets when treating advanced cancer? A survey of providers in the National Comprehensive Cancer Network (NCCN).\" Cancer Invest 21(4): 526-535.",null,"Cella, D., et al.","What are the most important symptom targets when treating advanced cancer? A survey of providers in the National Comprehensive Cancer Network (NCCN)","We derived a set of brief, clinically relevant symptom indices for assessing symptomatic response to chemotherapy for advanced bladder, brain, breast, colorectal, head and neck, hepatobiliary/pancreas, lung, ovarian, and prostate cancers. Questions were extracted from a multidimensional cancer quality of life (QOL) measurement system, the Functional Assessment of Cancer Therapy (FACT). Surveys of disease-related symptoms were presented to expert physicians and nurses at 17 National Comprehensive Cancer Network (NCCN) member institutions. In a two-step procedure, each expert narrowed the list to no more than five of the very most important to attend to when assessing the value of drug treatment for advanced disease. Symptoms endorsed at a frequency greater than chance probability were retained for the nine symptom indices. The resulting NCCN/FACT symptom indices are comprised of 6-15 items, depending on disease. Fatigue, pain, nausea, weight loss, worry about worsening condition, and contentment with current QOL were consistently selected by experts as priority symptoms across tumor sites. These nine tumor-specific symptom indices indicate the most important clinician-rated targets of chemotherapy for many advanced cancers. These results await validation in patient populations and examination of the extent to which changes in symptomatology translate into meaningful improvement to the patient.","Cancer Invest, 21(4): 526-535","USA",2003,"Advanced","Chemotherapy","FACT-G","HCP",null,"Validation","USA","HCP","Advanced","Chemotherapy",null,"Validation","FACT-G","2000:2004","Treatment"]
[105,"Cessna, J. M., et al. (2016). \"Evaluation of the psychometric properties of the PROMIS Cancer Fatigue Short Form with cancer patients.\" J Psychosom Res 81: 9-13.",null,"Cessna, J. M., et al.","Evaluation of the psychometric properties of the PROMIS Cancer Fatigue Short Form with cancer patients","OBJECTIVE: Fatigue is common among cancer patients and adversely impacts quality of life. As such, it is important to measure fatigue accurately in a way that is not burdensome to patients. The 7-item Patient Reported Outcome Measurement Information System (PROMIS) Cancer Fatigue Short Form scale was recently developed using item response theory (IRT). The current study evaluated the psychometric properties of this scale in two samples of cancer patients using classical test theory (CTT). METHODS: Two samples were used: 121 men with prostate cancer and 136 patients scheduled to undergo hematopoietic cell transplantation (HCT) for hematologic cancer. All participants completed the PROMIS Cancer Fatigue Short Form as well as validated measures of fatigue, vitality, and depression. HCT patients also completed measures of anxiety, perceived stress, and a clinical interview designed to identify cases of cancer-related fatigue. RESULTS: PROMIS Cancer Fatigue Short Form items loaded on a single factor (CFI=0.948) and the scale demonstrated good internal consistency reliability in both samples (Cronbach's alphas>0.86). Correlations with psychosocial measures were significant (p values<.0001) and in the expected direction, offering evidence for convergent and concurrent validity. PROMIS Fatigue scores were significantly higher in patients who met case definition criteria for cancer-related fatigue (p<.0001), demonstrating criterion validity. CONCLUSION: The current study provides evidence that the PROMIS Cancer Fatigue Short Form is a reliable and valid measure of fatigue in cancer patients.","J Psychosom Res, 81(9-13","USA",2016,"Any or unknown","None","PROMIS","Patient",null,"Validation","USA","Patient","Any or unknown","None",null,"Validation","PROMIS","2015:2018","Symptom"]
[106,"Chan, J. S., et al. (2008). \"A phase II study of high-dose calcitriol combined with mitoxantrone and prednisone for androgen-independent prostate cancer.\" BJU Int 102(11): 1601-1606.",null,"Chan, J. S., et al.","A phase II study of high-dose calcitriol combined with mitoxantrone and prednisone for androgen-independent prostate cancer","OBJECTIVE: To evaluate the preliminary efficacy, safety, and impact on quality of life (QoL) of high-dose calcitriol (DN-101) combined with mitoxantrone and glucocorticoids in androgen-independent prostate cancer (AIPC). PATIENTS AND METHODS: Nineteen patients with metastatic AIPC and no previous chemotherapy received DN-101 180 microg orally on day 1 and mitoxantrone 12 mg/m(2) intravenously on day 2 every 21 days with continuous daily prednisone 10 mg orally for a maximum of 12 cycles. A confirmed decline in prostate-specific antigen (PSA) levels by half was the primary endpoint. QoL was evaluated using the European Organization for Research and Treatment of Cancer QLQ-C30 questionnaire, and pain and analgesic use were evaluated. RESULTS: Five of 19 patients (26%; 95% confidence interval, CI, 9-51) achieved a >/=50% decline in PSA level. The median (95% CI) time to PSA progression was 16 (6-26) weeks. The overall median (95% CI) survival was 16 (6-26) months; 47 (21-73)% of patients achieved an analgesic response. Toxicity was similar to that expected with mitoxantrone and prednisone alone. The QoL analysis suggested a decrease in physical functioning and increase in fatigue, insomnia, and diarrhoea. CONCLUSIONS: DN-101 given every 3 weeks does not add significant activity to mitoxantrone and prednisone in AIPC, as measured by the PSA decline. The high rate of analgesic response is encouraging. The addition of DN-101 does not appear to increase the toxicity of mitoxantrone.","BJU Int, 102(11): 1601-1606","USA",2008,"Metastatic","Chemotherapy","EORTC QLQ-C30","Patient",null,"Clinical trial","USA","Patient","Metastatic","Chemotherapy",null,"Clinical trial","EORTC QLQ-C30","2005:2009","General"]
[107,"Chang, P., et al. (2011). \"Expanded prostate cancer index composite for clinical practice: development and validation of a practical health related quality of life instrument for use in the routine clinical care of patients with prostate cancer.\" J Urol 186(3): 865-872.",null,"Chang, P., et al.","Expanded prostate cancer index composite for clinical practice: development and validation of a practical health related quality of life instrument for use in the routine clinical care of patients with prostate cancer","PURPOSE: Measuring the health related quality of life of patients with prostate cancer in routine clinical practice is hindered by the lack of instruments enabling efficient, real-time, point of care scoring of multiple health related quality of life domains. Thus, we developed an instrument for this purpose. MATERIALS AND METHODS: The Expanded Prostate Cancer Index Composite for Clinical Practice is a 1-page, 16-item questionnaire that we constructed to measure urinary incontinence, urinary irritation, and the bowel, sexual and hormonal health related quality of life domains. We eliminated conceptually overlapping items from the 3-page Expanded Prostate Cancer Index Composite-26 and revised the questionnaire format to mirror the AUA symptom index, thereby enabling practitioners to calculate health related quality of life scores at the point of care. We administered the Expanded Prostate Cancer Index Composite for Clinical Practice to a new cohort of patients with prostate cancer in community based and academic oncology, radiation, and urology practices to evaluate instrument validity as well as ease of use in clinical practice. RESULTS: A total of 175 treated and 132 untreated subjects with prostate cancer completed the Expanded Prostate Cancer Index Composite for Clinical Practice. The domain scores of the Expanded Prostate Cancer Index Composite for Clinical Practice correlated highly with the respective domain scores from longer versions of the Expanded Prostate Cancer Index Composite (r>/=0.93 for all domains). The Expanded Prostate Cancer Index Composite for Clinical Practice showed high internal consistency (Cronbach's alpha 0.64-0.84) and sensitivity to prostate cancer treatment related effects (p<0.05 in each of 5 health related quality of life domains). Patients completed the Expanded Prostate Cancer Index Composite for Clinical Practice efficiently (96% in less than 10 minutes and with 11% missing items). It was deemed very convenient by clinicians in 87% of routine clinical encounters and clinicians accurately scored completed questionnaires 94% of the time. CONCLUSIONS: The Expanded Prostate Cancer Index Composite for Clinical Practice is a valid instrument that enables patient reported, health related quality of life to be measured efficiently and accurately at the point of care, and thereby facilitates improved emphasis and management of patient reported outcomes.","J Urol, 186(3): 865-872","USA",2011,"Any or unknown","None","EPIC","Patient",null,"Validation","USA","Patient","Any or unknown","None",null,"Validation","EPIC","2010:2014","Disease"]
[108,"Chang, V. T., et al. (2004). \"Shorter symptom assessment instruments: the Condensed Memorial Symptom Assessment Scale (CMSAS).\" Cancer Invest 22(4): 526-536.",null,"Chang, V. T., et al.","Shorter symptom assessment instruments: the Condensed Memorial Symptom Assessment Scale (CMSAS)","BACKGROUND: Rapid and efficient symptom assessment is an important aspect of palliative care. The objective was to determine whether a smaller number of symptoms from the 32-item Memorial Symptom Assessment Scale Short-Form (MSAS-SF) could convey equivalent quality of life (QOL) information. METHODS: Responses from 479 medical oncology patients who completed the MSAS-SF and the Functional Assessment Cancer Therapy (FACT-G) were analyzed. Canonical correlations were performed to assess the relationships of 32 MSAS-SF symptoms to quality of life (FACT-G domains) and clinical variables [age, Karnofsky performance status (KPS), stage of disease, and inpatient status]. The relation of the subscales of the Condensed MSAS (CMSAS) and FACT-G to survival was assessed in a multivariate model. RESULTS: The median age was 67 years (range, 20-89) and median KPS was 80% (range, 20-100). Primary sites were prostate in 141 (29%) patients, lung in 121 (26%) patients, colorectal in 53 (11%) patients, hematologic in 50 (10%) patients, head and neck in 30 (6%) patients and other in 84 (18%) patients. Median survival was 245 days (range, 1-2,215 days). Canonical correlation analyses identified a five-dimensional QOL factor structure. Symptoms important for QOL also correlated significantly with survival and provided the basis for the CMSAS with 14 symptoms and 3 subscales (CMSAS SUM, CMSAS PHYS, and CMSAS PSYCH). In multivariate analyses, the CMSAS PSYCH predicted survival independently of stage, performance status, and QOL. The CMSAS takes 2-4 minutes to complete. CONCLUSION: The CMSAS contains both QOL and survival information approximately equivalent to the original 32 items.","Cancer Invest, 22(4): 526-536","USA",2004,"Any or unknown","None","FACT-G,MSAS","Patient",null,"Validation","USA","Patient","Any or unknown","None",null,"Validation","FACT-G,MSAS","2000:2004","Treatment,Symptom"]
[109,"Chang, V. T., et al. (2015). \"Patient-Reported Outcomes for Determining Prognostic Groups in Veterans With Advanced Cancer.\" J Pain Symptom Manage 50(3): 313-320.",null,"Chang, V. T., et al.","Patient-Reported Outcomes for Determining Prognostic Groups in Veterans With Advanced Cancer","CONTEXT: Physicians overestimate survival in patients with advanced cancer. Patient-reported outcomes could provide another way to estimate survival. We previously reported four prognostic groups based on Karnofsky Performance Status, Functional Assessment of Cancer Therapy physical well-being subscale, and Memorial Symptom Assessment Scale-Short Form physical symptom distress subscale scores. OBJECTIVES: To determine the validity of these four prognostic groups. METHODS: We performed prospective surveys. Data from a total of 880 Veterans Affairs Medical Center patients, 417 in the First Cohort and 463 in the Validation Cohort, were analyzed. Both inpatients and outpatients were prospectively recruited in Institutional Review Board-approved studies from August 1999 to September 2009. Survival was measured from the date of entry until death or December 1, 2009. Patients completed self-assessments with the Functional Assessment of Cancer Therapy and Memorial Symptom Assessment Scale-Short Form. Analysis of variance was used to test differences between groups in continuous variables; a generalized Wilcoxon test was used for differences between groups for survival. RESULTS: The average age in the Validation Cohort was 66.5 years and 98% were men. The majority of patients had metastatic cancer (90%), with lung (28%) and prostate (26%) cancers being predominant. The median Karnofsky Performance Status was 70. Median survival was 33, 46.5, 124, and 209.5 days for the four prognostic groups (P < 0.0001, all pair-wise comparisons P < 0.02). CONCLUSION: The four prognostic groups remained distinct in the prospective cohort. Small differences in patient-reported physical well-being can halve survival estimates. Patient-reported outcomes can correct for physician overestimate of prognosis. This study provides a way to use patient-reported outcomes for prognosis in patients with advanced cancer, with important implications for assessment.","J Pain Symptom Manage, 50(3): 313-320","USA",2015,"Advanced,Metastatic","None","FACT-G,SF-36,MSAS","Patient",null,"Validation","USA","Patient","Advanced,Metastatic","None",null,"Validation","FACT-G,SF-36,MSAS","2015:2018","Treatment,Utility,Symptom"]
[110,"Chang, Y. J., et al. (2012). \"Psychometric evaluation of the Taiwan Chinese version of the EORTC QLQ-PR25 for HRQOL assessment in prostate cancer patients.\" Health Qual Life Outcomes 10: 96.",null,"Chang, Y. J., et al.","Psychometric evaluation of the Taiwan Chinese version of the EORTC QLQ-PR25 for HRQOL assessment in prostate cancer patients","OBJECTIVE: To evaluate the psychometric properties of the Taiwan Chinese Version of the EORTC QLQ-PR25 health-related quality of life (HRQOL) questionnaire for patients with prostate cancer. METHODS: 135 prostate cancer patients were recruited in the urology outpatient clinic of a university teaching hospital. Each patient completed the EORTC QLQ-PR25 at every clinic visit between 2004 and 2008, totaling 633 assessments. Confirmatory factor analysis and Rasch analysis were used to evaluate the domain- and item-level psychometric properties. RESULTS: The results supported the unidimensionality of each of the four EORTC QLQ-PR25 domains (urinary, bowel, and hormonal-treatment-related symptoms, and sexual functioning). Item calibrations for each domain were found invariant across the three assessment time periods. The item-person maps showed 71.3% of item coverage for the urinary symptoms domain and 13-42.7% for the other three domains. CONCLUSIONS: The Taiwan Chinese Version of the EORTC QLQ-PR25 questionnaire is reliable and can be used to measure HRQOL over time. Adding new items to each domain may improve its clinical content coverage and measurement precision.","Health Qual Life Outcomes, 10(96","Taiwan",2012,"Any or unknown","None","EORTC QLQ-PR25","Patient",null,"Validation","Taiwan","Patient","Any or unknown","None",null,"Validation","EORTC QLQ-PR25","2010:2014","Disease"]
[111,"Chang, Y. J., et al. (2014). \"Measurement equivalence and feasibility of the EORTC QLQ-PR25: paper-and-pencil versus touch-screen administration.\" Health Qual Life Outcomes 12: 23.",null,"Chang, Y. J., et al.","Measurement equivalence and feasibility of the EORTC QLQ-PR25: paper-and-pencil versus touch-screen administration","OBJECTIVE: We assessed the measurement equivalence and feasibility of the paper-and-pencil and touch-screen modes of administration of the Taiwan Chinese version of the EORTC QLQ-PR25, a commonly used questionnaire to evaluate the health-related quality of life (HRQOL) in patients with prostate cancer in Taiwan. METHODS: A cross-over design study was conducted in 99 prostate cancer patients at an urology outpatient clinic. Descriptive exact and global agreement percentages, intraclass correlation, and equivalence test based on minimal clinically important difference (MCID) approach were used to examine the equity of HRQOL scores between these two modes of administration. We also evaluated the feasibility of computerized assessment based on patients' acceptability and preference. Additionally, we used Rasch rating scale model to assess differential item functioning (DIF) between the two modes of administration. RESULTS: The percentages of global agreement in all domains were greater than 85% in the EORTC QLQ-PR25. All results from equivalence tests were significant, except for Sexual functioning, indicating good equivalence. Only one item exhibited DIF between the two modes. Although nearly 80% of the study patients had no prior computer-use experience, the overall proportion of acceptance and preference for the touch-screen mode were quite high and there was no significant difference across age groups or between computer-use experience groups. CONCLUSIONS: The study results showed that the data obtained from the modes of administration were equivalent. The touch-screen mode of administration can be a feasible and suitable alternative to the paper-and-pencil mode for assessment of patient-reported outcomes in patients with prostate cancer.","Health Qual Life Outcomes, 12(23","Taiwan",2014,"Any or unknown","None","EORTC QLQ-PR25","Patient",null,"Validation","Taiwan","Patient","Any or unknown","None",null,"Validation","EORTC QLQ-PR25","2010:2014","Disease"]
[112,"Chapman, G. B., et al. (1998). \"Prostate cancer patients' utilities for health states: how it looks depends on where you stand.\" Med Decis Making 18(3): 278-286.",null,"Chapman, G. B., et al.","Prostate cancer patients' utilities for health states: how it looks depends on where you stand","Two versions of the time-tradeoff (TTO) method were compared. In the personal TTO version, 31 prostate cancer patients decided whether they personally would give up some longevity to have perfect health rather than a longer life in a state of poor health associated with prostate cancer. In the impersonal version, 28 patients compared two hypothetical friends, one of whom has perfect health but will live less time than the other who is in poor health, and decided which person they would rather be. All patients evaluated three hypothetical health states. The two TTO methods were assessed by examining 1) how well they distinguished three health states of varying degrees of dysfunction and 2) patients' willingness to trade time for quality of life. Patients using the impersonal TTO version were more likely than those using the personal version to order the three health states appropriately (68% vs 16%, p < 0.0001) and were more willing to trade off length of life for quality of life (p < 0.05).","Med Decis Making, 18(3): 278-286","USA",1998,"Any or unknown","None","TTO","Patient",null,"Cross-sectional","USA","Patient","Any or unknown","None",null,"Cross-sectional","TTO","1960:1999","Utility"]
[113,"Chen, J. Y., et al. (2011). \"Patient-reported outcomes of prostate high-dose-rate brachytherapy boost comparing an outpatient and inpatient protocol: a two-center chronologic cohort study.\" Brachytherapy 10(6): 454-460.",null,"Chen, J. Y., et al.","Patient-reported outcomes of prostate high-dose-rate brachytherapy boost comparing an outpatient and inpatient protocol: a two-center chronologic cohort study","PURPOSE: To determine patients' self-reported experiences of outpatient high-dose-rate prostate brachytherapy boost, and compare with previous cohort treated as inpatients. METHODS AND MATERIALS: Using the Prostate Brachytherapy Questionnaire, we previously examined patients' subjective experience of the brachytherapy procedure when it involved one implant and hospitalization with the template in situ for 2 days (Group 1). The protocol was subsequently changed to two implants, 2 weeks apart as outpatients. Fifty-eight patients treated with the new protocol (Group 2) completed the same questionnaire. We compared the self-reported experiences between Groups 1 and 2 and also between the first and second implant for those in Group 2. Our hypothesis was that the worst rated issues in Group 1 might be reduced with the new approach. RESULTS: Group 2 patients were less troubled overall by the procedure (mean scores 2.3 vs. 3.2, p=0.0293). Specifically, they were less troubled by \"discomfort\" (2.8 vs. 3.8, p=0.0254); \"being stuck in bed\" (1.7 vs. 4.2 p<0.0001); \"feeling helpless\" (1.3 vs. 2.8, p=0.0009); \"fear of opening my bowels\" (2.1 vs. 3.3, p=0.0055); and \"fear of coping with the implant\" (1.3 vs. 2.5, p=0.0004). There was no significant increase in \"thought of implant\" or \"fear of implant\" before the second implant. However, more patients rated worse than expected \"fear of passing urine\" during the second implant. CONCLUSIONS: Patients rated high-dose-rate brachytherapy less troublesome when delivered as outpatient with two implants, 2 weeks apart than as inpatient over 3 days, despite the additional invasive procedure and anesthesia.","Brachytherapy, 10(6): 454-460","Australia",2011,"Any or unknown","Brachytherapy","PBQ","Patient",null,"Cohort","Australia","Patient","Any or unknown","Brachytherapy",null,"Cohort","PBQ","2010:2014","Treatment"]
[114,"Chen, R. C., et al. (2012). \"Patient-reported quality of life during radiation treatment for localized prostate cancer: results from a prospective phase II trial.\" BJU Int 110(11): 1690-1695.",null,"Chen, R. C., et al.","Patient-reported quality of life during radiation treatment for localized prostate cancer: results from a prospective phase II trial","Study Type--Therapy (cohort) Level of Evidence 2a. What's known on the subject? and What does the study add? Patient-reported quality of life (QoL) in prostate cancer is recognized as an important outcome, and has been shown in multiple studies to capture the incidence and timing of patient symptoms more accurately than physician-graded toxicity reports. Although the long-term QoL after completing radiation therapy (RT) has been previously studied, patient experience during RT is not well described in the literature. The present study collected patient-reported QoL during RT in a prospective phase II clinical trial. The study describes in detail the time course and severity of gastrointestinal and genitourinary symptoms during radiation, providing clinically useful information for patients and physicians considering RT during the treatment decision-making process. OBJECTIVE: * To evaluate data collected from a phase II trial to describe the time course and trajectory of patient-reported acute urinary and bowel symptom development during radiation therapy (RT) for prostate cancer. PATIENTS AND METHODS: * In all, 100 patients with intermediate- or high-risk prostate cancer received 72 Gy of RT to the prostate and seminal vesicles, with 6 months of concurrent androgen deprivation therapy; a rectal balloon was used for prostate immobilization. * Patients completed the validated Prostate Cancer Symptom Indices questionnaire every 1-2 weeks, reporting urinary and bowel symptoms on a four- or five-point Likert scale. * A score of >/= 3 in a symptom is associated with clinically meaningful distress. Cumulative incidence of each symptom is reported. Bonferroni corrections of P values were used to adjust for multiple comparisons. RESULTS: * Urinary symptoms were frequent at baseline and worsened during treatment. By the end of RT, 28-50% of patients developed clinically meaningful obstructive and irritative urinary symptoms. * Acute bowel symptoms were less frequent. Each bowel symptom increased in frequency by 9-26% from baseline to end of RT. * Urinary incontinence was rare. * Overall, symptom burden at the end of treatment was modest. CONCLUSIONS: * Urinary symptoms were common during RT, and bowel symptoms were less frequent. * These results inform patients and physicians during the decision-making process about potential patient quality of life experiences during RT, and also provide a benchmark for comparative effectiveness studies against newer treatments and technologies.","BJU Int, 110(11): 1690-1695","USA",2012,"Local","Radiotherapy","PCSI","Patient",null,"Clinical trial","USA","Patient","Local","Radiotherapy",null,"Clinical trial","PCSI","2010:2014","Symptom"]
[115,"Chen, R. C., et al. (2017). \"Association Between Choice of Radical Prostatectomy, External Beam Radiotherapy, Brachytherapy, or Active Surveillance and Patient-Reported Quality of Life Among Men With Localized Prostate Cancer.\" Jama 317(11): 1141-1150.",null,"Chen, R. C., et al.","Association Between Choice of Radical Prostatectomy, External Beam Radiotherapy, Brachytherapy, or Active Surveillance and Patient-Reported Quality of Life Among Men With Localized Prostate Cancer","Importance: Patients diagnosed with localized prostate cancer have to decide among treatment strategies that may differ in their likelihood of adverse effects. Objective: To compare quality of life (QOL) after radical prostatectomy, external beam radiotherapy, and brachytherapy vs active surveillance. Design, Setting, and Participants: Population-based prospective cohort of 1141 men (57% participation among eligible men) with newly diagnosed prostate cancer were enrolled from January 2011 through June 2013 in collaboration with the North Carolina Central Cancer Registry. Median time from diagnosis to enrollment was 5 weeks, and all men were enrolled with written informed consent prior to treatment. Final follow-up date for current analysis was September 9, 2015. Exposures: Treatment with radical prostatectomy, external beam radiotherapy, brachytherapy, or active surveillance. Main Outcomes and Measures: Quality of life using the validated instrument Prostate Cancer Symptom Indices was assessed at baseline (pretreatment) and 3, 12, and 24 months after treatment. The instrument contains 4 domains-sexual dysfunction, urinary obstruction and irritation, urinary incontinence, and bowel problems-each scored from 0 (no dysfunction) to 100 (maximum dysfunction). Propensity-weighted mean domain scores were compared between each treatment group vs active surveillance at each time point. Results: Of 1141 enrolled men, 314 pursued active surveillance (27.5%), 469 radical prostatectomy (41.1%), 249 external beam radiotherapy (21.8%), and 109 brachytherapy (9.6%). After propensity weighting, median age was 66 to 67 years across groups, and 77% to 80% of participants were white. Across groups, propensity-weighted mean baseline scores were 41.8 to 46.4 for sexual dysfunction, 20.8 to 22.8 for urinary obstruction and irritation, 9.7 to 10.5 for urinary incontinence, and 5.7 to 6.1 for bowel problems. Compared with active surveillance, mean sexual dysfunction scores worsened by 3 months for patients who received radical prostatectomy (36.2 [95% CI, 30.4-42.0]), external beam radiotherapy (13.9 [95% CI, 6.7-21.2]), and brachytherapy (17.1 [95% CI, 7.8-26.6]). Compared with active surveillance at 3 months, worsened urinary incontinence was associated with radical prostatectomy (33.6 [95% CI, 27.8-39.2]); acute worsening of urinary obstruction and irritation with external beam radiotherapy (11.7 [95% CI, 8.7-14.8]) and brachytherapy (20.5 [95% CI, 15.1-25.9]); and worsened bowel symptoms with external beam radiotherapy (4.9 [95% CI, 2.4-7.4]). By 24 months, mean scores between treatment groups vs active surveillance were not significantly different in most domains. Conclusions and Relevance: In this cohort of men with localized prostate cancer, each treatment strategy was associated with distinct patterns of adverse effects over 2 years. These findings can be used to promote treatment decisions that incorporate individual preferences.","Jama, 317(11): 1141-1150","USA",2017,"Local","Surgery,Radiotherapy,Surveillance,Brachytherapy","PCSI","Patient",null,"Cohort","USA","Patient","Local","Surgery,Radiotherapy,Surveillance,Brachytherapy",null,"Cohort","PCSI","2015:2018","Symptom"]
[116,"Chi, K. N., et al. (2012). \"A phase 2 study of patupilone in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel: Canadian Urologic Oncology Group study P07a.\" Ann Oncol 23(1): 53-58.",null,"Chi, K. N., et al.","A phase 2 study of patupilone in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel: Canadian Urologic Oncology Group study P07a","BACKGROUND: The purpose of this study was to determine the clinical activity of patupilone in patients with metastatic castration-resistant prostate cancer previously treated with docetaxel. PATIENTS AND METHODS: Eligible patients had progressive disease within 6 months of receiving docetaxel. Patupilone was administered 10 mg/m2 i.v. every 3 weeks. The primary end point was the proportion of patients with a confirmed>/=50% prostate-specific antigen (PSA) decline. RESULTS: Eighty-three patients were enrolled. At baseline, the median time to progression after prior docetaxel was 1.4 months (range 0-5.7). Gastrointestinal serious adverse events occurred in four of the six initial patients leading to a reduction of the starting dose of patupilone to 8 mg/m2 for subsequent patients. Grade 3-4 toxicity at this dose included diarrhea (22%), fatigue (21%), and anorexia (10%). One patient experienced grade 3-4 hematologic toxicity. A PSA decline of >/=50% occurred in 47% of patients. A partial measurable disease response occurred in 24% of assessable patients. A patient-reported pain response was observed in 59% of assessable patients. Median time to PSA progression was 6.1 months [95% confidence interval (CI) 4.7-8.0] and median overall survival was 11.3 months (95% CI 9.8-15.4). CONCLUSIONS: Patupilone at 8 mg/m2 was tolerable, had antitumor activity, and was associated with symptomatic improvement in patients previously treated with docetaxel.","Ann Oncol, 23(1): 53-58","Canada",2012,"Metastatic","Chemotherapy","Unclear","Patient",null,"Clinical trial","Canada","Patient","Metastatic","Chemotherapy",null,"Clinical trial","Unclear","2010:2014","Symptom"]
[117,"Chien, G. W., et al. (2017). \"Health-related quality of life outcomes from a contemporary prostate cancer registry in a large diverse population.\" BJU Int 120(4): 520-529.",null,"Chien, G. W., et al.","Health-related quality of life outcomes from a contemporary prostate cancer registry in a large diverse population","OBJECTIVE: To assess the health-related quality of life (HRQoL) of patients with prostate cancer up to 24 months after treatment in a contemporary large diverse population. PATIENTS AND METHODS: Patients with newly diagnosed prostate cancer from March 2011 to January 2014 in our healthcare system were included. The Expanded Prostate Cancer Index Composite (EPIC-26) questionnaire was administered before treatment, and at 1, 3, 6, 12, 18, and 24 months after treatment up to November 2014 for all methods of treatment. The Kruskall-Wallis test was used to compare the distribution of each EPIC-26 domain score at each time point, and mixed models were used to assess the overall scores over the period after treatment. RESULTS: In all, 5 727 patients were included. There were data for 3 422, 2 329, 2 017, 1 922, 1 772, 1 260, and 837 patients before treatment, and at 1, 3, 6, 12, 18, and 24 months after treatment, respectively. At 1 month, bowel scores were the lowest for patients that had had radiation therapy, and urinary irritative symptoms were the lowest for those who had had brachytherapy. There were sexual function declines for all the treatment methods, with surgery having the steepest decline; open radical prostatectomy (ORP) had a greater decline than robot-assisted laparoscopic prostatectomy (RALP). Patients who underwent RALP had a better return of sexual function, approaching that of brachytherapy and radiation therapy at 24 months. Urinary incontinence (UI) also declined the most in surgical patients, with RALP patients improving slightly more than ORP patients at 12-24 months. CONCLUSIONS: Patients' HRQoL after prostate cancer treatment varies by treatment method. Notably, sexual function recovers most for RALP patients. UI remains worse at 24 months after surgery, compared to other methods of prostate cancer treatment.","BJU Int, 120(4): 520-529","USA",2017,"Any or unknown","Radiotherapy,Surgery,Brachytherapy","EPIC","Patient",null,"Cohort","USA","Patient","Any or unknown","Radiotherapy,Surgery,Brachytherapy",null,"Cohort","EPIC","2015:2018","Disease"]
[118,"Chipperfield, K., et al. (2013). \"Factors associated with adherence to physical activity guidelines in patients with prostate cancer.\" Psychooncology 22(11): 2478-2486.",null,"Chipperfield, K., et al.","Factors associated with adherence to physical activity guidelines in patients with prostate cancer","OBJECTIVE: This study aimed to estimate the proportion of patients with prostate cancer (PCa) meeting the National Physical Activity Guidelines of Australia (NPAGA) and determine sociodemographic and medical factors associated with meeting these guidelines. Secondary aims included examining physical activity (PA) levels by treatment type and domain (leisure, work, transport and domestic) and establishing a predictive model of the likelihood that men with PCa would meet NPAGA. METHODS: A questionnaire was mailed to 638 men with PCa attending for treatment at the Alfred, Cabrini or Latrobe Regional Hospitals during 2010 and 2011, with a response rate of 59%. Measures included International Physical Activity Questionnaire, Hospital Anxiety and Depression Scale, Functional Assessment of Cancer Therapy - Prostate and sociodemographic items. Inclusion criteria were English speaking men aged 40 to 80 years, who had undergone radiotherapy (RT) between 9 and 30 months prior to the survey. RESULTS: Of 356 men with PCa, less than half were meeting NPAGA (41.9%). Lower education and quality of life (QoL), a higher number of comorbid conditions and symptoms of depression and anxiety were associated with decreased leisure-time PA. Patients treated with androgen deprivation therapy were significantly less active than patients treated with RT only. Logistic regression analyses indicated that the likelihood of meeting NPAGA was significantly lower with higher levels of depressive symptoms and lower levels of education. CONCLUSIONS: Meeting NPAGA is associated with higher QoL and psychosocial well-being in men with PCa. These findings contribute important information for targeting PA interventions to PCa survivors.","Psychooncology, 22(11): 2478-2486","Australia",2013,"Any or unknown","Radiotherapy,Hormonal","IPAQ,HADS,FACT-P","Patient",null,"Cross-sectional","Australia","Patient","Any or unknown","Radiotherapy,Hormonal",null,"Cross-sectional","IPAQ,HADS,FACT-P","2010:2014","Disease,Comorbidity,General"]
[119,"Chipperfield, K., et al. (2014). \"The impact of physical activity on psychosocial outcomes in men receiving androgen deprivation therapy for prostate cancer: a systematic review.\" Health Psychol 33(11): 1288-1297.",null,"Chipperfield, K., et al.","The impact of physical activity on psychosocial outcomes in men receiving androgen deprivation therapy for prostate cancer: a systematic review","OBJECTIVE: Depression, anxiety, and cognitive dysfunction are common complaints in men with prostate cancer (PCa) receiving androgen deprivation therapy (ADT). Consequently, the quality of life (QoL) of these men is negatively impacted. This systematic review evaluated the effectiveness of physical activity (PA) as an intervention to improve depression and anxiety symptoms, cognitive function, and QoL in patients receiving ADT for PCa. METHODS: Inclusion criteria and search strategy were defined and documented in a protocol registered with the International Prospective Register of Systematic Reviews (Registration # CRD42012002666). Due to the limited number of studies examining these outcomes in this patient group, no limitations were placed on study designs included. A systematic search of Ovid MEDLINE, PsycINFO, EMBASE, Informit, Scopus, Cochrane Library, and CINAHL databases identified 7 relevant peer-reviewed studies: 4 clinical PA interventions, 2 pilot studies, and 1 cross-sectional survey. Data extraction and risk of bias assessment tools developed by the Cochrane Collaboration were used to evaluate evidence. RESULTS: Existing data suggest that PA improved QoL in men with PCa receiving ADT. The existing evidence, however, is not sufficiently robust to determine the adequacy of PA as an intervention to improve depression, anxiety, and cognitive function outcomes in this patient group. CONCLUSIONS: Despite the lack of studies conducted, preliminary findings support the utility of PA for improving QoL in men undergoing ADT for PCa. A clear gap in the current literature was identified, confirming the need for further clinical trials in which depression, anxiety, and cognitive function are evaluated.","Health Psychol, 33(11): 1288-1297","International",2014,"Any or unknown","Various,Hormonal","Unclear","Patient",null,"Systematic review","International","Patient","Any or unknown","Various,Hormonal",null,"Systematic review","Unclear","2010:2014","General"]
[120,"Choudhury, A., et al. (2014). \"Patient-reported outcomes and health-related quality of life in prostate cancer treated with a single fraction of high dose rate brachytherapy combined with hypofractionated external beam radiotherapy.\" Clin Oncol (R Coll Radiol) 26(10): 661-667.",null,"Choudhury, A., et al.","Patient-reported outcomes and health-related quality of life in prostate cancer treated with a single fraction of high dose rate brachytherapy combined with hypofractionated external beam radiotherapy","AIMS: High dose rate (HDR) brachytherapy offers a highly conformal approach to radiotherapy delivery, enabling dose escalation. We report our experience using a combined HDR boost and external beam radiotherapy (EBRT) approach and its associated toxicity and effect on quality of life. MATERIALS AND METHODS: Patients with intermediate- or high-risk prostate cancer were treated with a single fraction HDR boost and EBRT between July 2008 and March 2010. Patient-reported toxicity data were collected at baseline and regular intervals after radiotherapy using International Prostate Symptom Score and Late Effects in Normal Tissues-Subjective, Objective, Management and Analytic scales (LENT-SOMA) questionnaires; health-related quality of life data were captured by the Expanded Prostate Cancer Index Composite (EPIC) questionnaire. RESULTS: Ninety-five patients received an HDR boost of 12.5 Gy followed by EBRT delivered as 37.5 Gy in 15 fractions over 3 weeks. The International Prostate Symptom Score peaked 6 weeks after radiotherapy (median value: 9). The LENT-SOMA bladder/urethra mean baseline score was 0.35 and peaked 6 weeks after radiotherapy (mean = 0.59). Difficulties with urinary flow and frequency were the most common reported symptoms. LENT-SOMA rectum/bowel mean scores at baseline were 0.24 and peaked after 6 months (mean = 0.37). Bowel urgency was the most common reported toxicity. EPIC urinary scores returned to baseline values at 6 months and bowel median scores recovered after 24 months. There were no statistically significant associations between patient or dosimetric parameters and patient-reported outcomes. CONCLUSION: A combined HDR boost and hypofractionated EBRT regimen offers a well-tolerated method of dose escalation with acceptable levels of patient-reported toxicity.","Clin Oncol (R Coll Radiol), 26(10): 661-667","UK",2014,"Any or unknown","Radiotherapy,Brachytherapy","IPSS,LENT-SOMA,EPIC","Patient",null,"Clinical trial","UK","Patient","Any or unknown","Radiotherapy,Brachytherapy",null,"Clinical trial","IPSS,LENT-SOMA,EPIC","2010:2014","Disease,Treatment,Symptom"]
[121,"Chu, S., et al. (2015). \"Veterans Affairs Telemedicine: Bringing Urologic Care to Remote Clinics.\" Urology 86(2): 255-260.",null,"Chu, S., et al.","Veterans Affairs Telemedicine: Bringing Urologic Care to Remote Clinics","OBJECTIVE: To report the use of telemedicine to deliver general urologic care to remote locations within the Veterans Affairs Greater Los Angeles Healthcare System. We describe the diagnoses managed, patient satisfaction, safety, and benefit to patients in terms of saved travel time and expense. METHODS: We conducted a retrospective chart review examining care delivered through urology telemedicine clinics over a 6-month period. We examined the urologic conditions, patient satisfaction, and emergency department visits within 30 days of the visit. We estimated patient benefit by calculating travel distance and time and the saved travel-associated costs using Google Maps and US Census income data. RESULTS: Ninety-seven unique telemedicine visits were conducted and a total of 171 urologic diseases were assessed. The most common conditions were lower urinary tract symptoms (35%), elevated prostate-specific antigen level (15%), and prostate cancer (14%). One patient was seen in the emergency department within 30 days with an unpreventable urologic complaint. Patient satisfaction was \"very good\" to \"excellent\" in 95% of cases, and 97% would refer another veteran to the urology telemedicine clinic. Patients saved an average of 277 travel miles, 290 minutes of travel time, $67 in travel expenses, and $126 in lost opportunity cost. CONCLUSION: Telemedicine was successfully and safely used to evaluate and treat a wide range of urologic conditions within the Veterans Affairs Greater Los Angeles Healthcare System, and saves patients nearly 5 hours and up to $193 per visit. Further investigation of the potential of telemedicine for the delivery of urologic care in a cost-effective manner is warranted.","Urology, 86(2): 255-260","USA",2015,"Any or unknown","Various","Unclear","Patient",null,"Cross-sectional","USA","Patient","Any or unknown","Various",null,"Cross-sectional","Unclear","2015:2018","Satisfaction"]
[122,"Clark, J. A. and J. A. Talcott (2001). \"Symptom indexes to assess outcomes of treatment for early prostate cancer.\" Med Care 39(10): 1118-1130.",null,"Clark, J. A. and J. A. Talcott","Symptom indexes to assess outcomes of treatment for early prostate cancer","BACKGROUND: Patients' perceptions of treatment outcomes are important in the management of early prostate cancer, but few studies have offered reliable and responsive measures to assess the likely side effects of the most common treatments. OBJECTIVE: To develop indexes of urinary, bowel, and sexual function, and related distress. RESEARCH DESIGN: Prospective cohort study of the outcomes of treatment for early prostate cancer, with self-administered questionnaires completed before treatment, and 3 and 12 months afterward. Hypothesized indexes, based on a clinical model of pathophysiological side effects of treatment, were defined and evaluated with respect to reliability and validity. SUBJECTS: Patients (n = 184) undergoing radical prostatectomy or external beam radiotherapy for early prostate cancer. MEASURES: Urinary and bowel items pertained to frequency or intensity of symptoms of dysfunction; parallel items assessed symptom-related distress. Sexual dysfunction items assessed the quality of erections, orgasm, and ejaculation; distress was assessed by 2 items adapted from the MOS Sexual Problems (MOS-SP) scale. HRQoL was assessed by the SF-36 and Profile of Mood States. RESULTS: Symptom and symptom-related distress indexes for urinary incontinence, urinary obstruction/irritation, bowel dysfunction, and sexual dysfunction were defined. Symptom and distress indexes in each domain were highly correlated. Responsiveness was substantial and varied by treatment in ways consistent with clinical experience. The indexes accounted for significant proportions of the variance in HRQoL measures. CONCLUSIONS: These indexes may be used in monitoring outcomes of treatment for early prostate cancer.","Med Care, 39(10): 1118-1130","USA",2001,"Local","Surgery,Radiotherapy","MOS-SP,SF-36,POMS","Patient",null,"Cohort","USA","Patient","Local","Surgery,Radiotherapy",null,"Cohort","MOS-SP,SF-36,POMS","2000:2004","Comorbidity,Utility,Complication"]
[123,"Clark, J. A., et al. (1997). \"Dimensions of quality of life expressed by men treated for metastatic prostate cancer.\" Soc Sci Med 45(8): 1299-1309.",null,"Clark, J. A., et al.","Dimensions of quality of life expressed by men treated for metastatic prostate cancer","Men who pursue active treatment for metastatic prostate cancer face a choice between medical or surgical castration. While both alternatives have documented side-effects (e.g. loss of libido, breast enlargement and tenderness, hot flashes, and nausea), their psychosocial impacts are not well understood. As part of a study of patients' treatment decision making, we have sought to construct a patient-based measure of the salient disease and treatment-related qualities of life experienced by these men subsequent to treatment. Focus groups (15 with patients, two with wives) were used to develop candidate Likert scale questionnaire items representing quality of life issues that patients said were important. These items were combined with assessments of symptoms, comorbidity, and generic measures of functional status and well-being in a mail survey of patients treated at the Houston VAMC and two other Houston hospitals (n = 201, response rate = 63%). Psychometric analyses (principal components and multitrait scaling) were used to identify distinct dimensions of life quality; correlations with generic measures, and symptom reports were used in validation analyses. Qualitative analyses of focus group data identified three major domains of life quality: self-perceptions, anxiety about the effects of treatment, and concern with the process of decision making and treatment. Psychometric analyses identified nine reliable and valid indicators of prostate cancer-related quality of life: body image, sexual problems, spouse affection, spouse worry, masculinity, cancer-related self-image, cancer distress, cancer acceptance, and regret of treatment decision. Internal consistency (alpha) ranged form 0.71 to 0.90. Correlations with reference scales (e.g. MOS Mental Health Index, Profile of Mood States) and symptom status supported concurrent validity. Prostate cancer patients perceive a number of important psychosocial consequences of their treatment. These consequences are represented by nine scales comprising a brief (35 items) disease and treatment sensitive health-related quality of life instrument, which we will use in monitoring the outcomes of patients' treatment choices.","Soc Sci Med, 45(8): 1299-1309","USA",1997,"Metastatic","Hormonal,Surgery","Likert scale,POMS,MOS-MHI","Patient",null,"Validation","USA","Patient","Metastatic","Hormonal,Surgery",null,"Validation","Likert scale,POMS,MOS-MHI","1960:1999","General,Comorbidity"]
[124,"Clark, J. A., et al. (1999). \"Changes in quality of life following treatment for early prostate cancer.\" Urology 53(1): 161-168.",null,"Clark, J. A., et al.","Changes in quality of life following treatment for early prostate cancer","OBJECTIVES: To explore the effects of urinary, bowel, and sexual symptoms following treatment for early (nonmetastatic) prostate cancer on health-related quality of life through an examination of the responsiveness of the Medical Outcomes Study Short Form Health Survey (SF-36). METHODS: We conducted a prospective observational cohort study of 125 men with early prostate cancer who underwent either radical prostatectomy or radical, external beam radiotherapy. Patients completed questionnaires, which included assessments of urinary, bowel, and sexual symptoms and the SF-36 at the time of their clinical consultation prior to deciding on primary therapy and at 3 and 12-month follow-up. RESULTS: Although cross-sectional analysis showed substantial associations between symptoms and the eight scales of the SF-36 12 months after the initiation of treatment, longitudinal analyses of changes in these scales showed only modest effects. Three scales registered changes associated with the development of new symptoms: General Health Perceptions, Vitality, and Social Function. Role Performance with Emotional Limitations demonstrated a surprising response: slight improvements in men with new symptoms, compared with substantial gains in men who survived treatment without developing new urinary, bowel, or sexual symptoms. Overall, the SF-36 demonstrated a pattern of decline at 3 months and recovery to baseline at 12 months. Rather than registering declines in response to increasing symptoms, negative changes occurred primarily in men who presented symptoms prior to treatment and whose symptoms were unchanged 12 months later. CONCLUSIONS: The SF-36 is associated with the presence of physical symptoms but demonstrates a complicated pattern of change following treatment and the development of new urinary, bowel, and sexual problems. Multidimensional approaches to the outcomes of treatment for early prostate cancer help to clarify the magnitude of both gains and losses in quality of life.","Urology, 53(1): 161-168","USA",1999,"Local","Radiotherapy,Surgery","SF-36","Patient",null,"Cohort","USA","Patient","Local","Radiotherapy,Surgery",null,"Cohort","SF-36","1960:1999","Utiilty"]
[125,"Clark, J. A., et al. (2001). \"Living with treatment decisions: regrets and quality of life among men treated for metastatic prostate cancer.\" J Clin Oncol 19(1): 72-80.",null,"Clark, J. A., et al.","Living with treatment decisions: regrets and quality of life among men treated for metastatic prostate cancer","PURPOSE: To examine variation in men's long-term regret of treatment decisions, ie, surgical versus chemical castration, for metastatic prostate cancer and its associations with quality of life. METHODS: Survey of previously treated patients to assess treatment decisions and quality of life, supplemented with focus groups. Two items addressing whether a patient wished he could change his mind and the belief that he would have been better off with the treatment not chosen were combined in classifying survey respondents as either satisfied or regretful. Chi(2) and t tests were used to test associations between regret and treatment history, complications, and quality of life. RESULTS: Survey respondents included 201 men aged 45 to 93 years (median, 71 years), who had begun treatment (71% chemical castration, 29% orchiectomy) a median of 2 years previously. Most reported complications: hot flashes (70%), nausea (34%), and erectile dysfunction (81%). Most were satisfied with the treatment decision, but 23% expressed regret. Regretful men more frequently reported surgical (43%) versus chemical (36%) castration (P: = .030) and nausea in the past week (54% v 32%; P: = .010) but less frequently reported erectile dysfunction (56% v 72%; P: = .048). Regretful men indicated poorer scores on every measure of generic and prostate cancer-related quality of life. Qualitative analyses revealed substantial uncertainty about the progress of their disease and the quality of the decisions in which patients participated. CONCLUSION: Regret was substantial and associated with treatment choice and quality of life. It may derive from underlying psychosocial distress and problematic communication with physicians when decisions are being reached and over subsequent years.","J Clin Oncol, 19(1): 72-80","USA",2001,"Metastatic","Surgery,Hormonal","Unclear","Patient",null,"Cross-sectional","USA","Patient","Metastatic","Surgery,Hormonal",null,"Cross-sectional","Unclear","2000:2004","Satisfaction"]
[126,"Clark, J. A., et al. (2003). \"Measuring patients' perceptions of the outcomes of treatment for early prostate cancer.\" Med Care 41(8): 923-936.",null,"Clark, J. A., et al.","Measuring patients' perceptions of the outcomes of treatment for early prostate cancer","BACKGROUND: Compared with careful attention to the physical (eg, urinary, bowel, sexual) dysfunction that may follow treatment, little attention has been given to the behavioral, emotional, and interpersonal changes that the diagnosis of early prostate cancer and subsequent physical dysfunction may bring. OBJECTIVE: To construct patient-centered measures of the outcomes of treatment for early prostate cancer. RESEARCH DESIGN: Qualitative study followed by survey of early prostate cancer patients and group of comparable patients with no history of prostate cancer. Analysis of focus groups identified relevant domains of quality of life, which were represented by Likert scale items included in survey questionnaires. Psychometric analyses of survey data defined scales evaluated with respect to internal consistency and validity. RESULTS: Qualitative analysis identified three domains: urinary control, sexuality, and uncertainty about the cancer and its treatment. Psychometric analysis defined 11 scales. Seven were generically relevant to most older men: urinary control (eg, embarrassment with leakage), sexual intimacy (eg, anxiety about completing intercourse), sexual confidence (eg, comfort with sexuality), marital affection (eg, emotional distance from spouse/partner), masculine self esteem (eg, feeling oneself a whole man), health worry (eg, apprehensiveness about health changes), and PSA concern (eg, closely attending to one's PSA). Four scales were specific to the treatment experience: perceived cancer control, quality of treatment decision making, regret of treatment choice, and cancer-related outlook. CONCLUSION: The scales provide definition and metrics for patient-centered research in this area. They complement measures of physical dysfunction and bring into resolution outcomes of treatment that have gone unnoticed in previous studies.","Med Care, 41(8): 923-936","USA",2003,"Local","Unclear","Likert scale","Patient",null,"Validation","USA","Patient","Local","Unclear",null,"Validation","Likert scale","2000:2004","General"]
[127,"Clark, J. A., et al. (2003). \"Patients' perceptions of quality of life after treatment for early prostate cancer.\" J Clin Oncol 21(20): 3777-3784.",null,"Clark, J. A., et al.","Patients' perceptions of quality of life after treatment for early prostate cancer","PURPOSE: Treatment for early prostate cancer produces problematic physical side effects, but prior studies have found little influence on patients' perceived health status. We examined psychosocial outcomes of treatment for early prostate cancer. PATIENTS AND METHODS: Patients with previously treated prostate cancer and a reference group of men with a normal prostate-specific antigen (PSA) level and no history of prostate cancer completed questionnaires. Innovative scales assessed behavioral consequences of urinary dysfunction, sexuality, health worry, PSA concern, perceived cancer control, treatment decision making, decision regret, and cancer-related outlook. Urinary, bowel, and sexual dysfunction were assessed with symptom indexes; health status was assessed by the Physical and Mental Summaries of the Short Form (SF-12) Health Survey. RESULTS: Compared with men without prostate cancer, prostate cancer patients reported greater urinary, bowel, and sexual dysfunction, but similar health status. They reported worse problems of urinary control, sexual intimacy and confidence, and masculinity, and greater PSA concern. Perceptions of cancer control and treatment decisions were positive, but varied by treatment: prostatectomy patients indicated the highest and observation patients indicated the lowest cancer control. Bowel and sexual dysfunction were associated with poorer sexual intimacy, masculinity, and perceived cancer control; masculinity and PSA concern were associated with greater confidence in treatment choice; and diminished sexual intimacy and less interest in PSA were associated with greater regret. CONCLUSION: The lack of change in global measures of health status after treatment for early prostate cancer obscures important influences in men's lives; cancer diagnosis and treatment complications may result in complex outcomes. Aggressive treatment may confer confidence in cancer control, yet be countered by diminished intimate relationships and masculinity, which accompany sexual dysfunction.","J Clin Oncol, 21(20): 3777-3784","USA",2003,"Local","Unclear","SF-12","Patient",null,"Cross-sectional","USA","Patient","Local","Unclear",null,"Cross-sectional","SF-12","2000:2004","Utility"]
[128,"Clark, M. J., et al. (2014). \"Patient-reported outcome labeling claims and measurement approach for metastatic castration-resistant prostate cancer treatments in the United States and European Union.\" Health Qual Life Outcomes 12: 104.",null,"Clark, M. J., et al.","Patient-reported outcome labeling claims and measurement approach for metastatic castration-resistant prostate cancer treatments in the United States and European Union","BACKGROUND: Metastatic castration-resistant prostate cancer (mCRPC) and its treatment significantly affect health-related quality of life (HRQOL). Our objectives were to evaluate and compare patient-reported outcome (PRO) claims granted by the Food and Drug Administration (FDA) and European Medicines Agency (EMA) for 5 recently approved mCRPC treatments and to examine key characteristics, development, and measurement properties of the PRO measures supporting these claims against current regulatory standards. METHODS: Five products approved for treatment of mCRPC by the FDA and the EMA (2010-2013) were examined: enzalutamide, abiraterone, sipuleucel-T, cabazitaxel, and radium Ra 223 dichloride. United States (US) drug approval packages and European Public Assessment Reports were reviewed. PRO claims in the US labels and European Summaries of Product Characteristics and supporting measures were identified. For PRO measures supporting claims, a targeted literature review was conducted to identify information on key characteristics and measurement properties; this information was compared against FDA PRO guidance criteria. RESULTS: Nine PRO \"claims\" were granted across 4 of 5 products reviewed. The EMA granted more claims (7 claims-4 for pain, 3 for HRQOL) than the FDA (2 claims, both for pain). The Brief Pain Inventory-Short Form (BPI-SF) worst pain item supported most pain claims and was the only measure supporting US claims. EMA pain claims were supported by BPI-SF worst pain (n = 2) and average pain (n = 1) items and the McGill Pain Questionnaire Present Pain Intensity component (n = 1). EMA HRQOL claims were supported by the Functional Assessment of Cancer Therapy-Prostate Module (n = 2) and the EuroQol 5 Dimensions with visual analogue scale (n = 1). Pain and prostate cancer-specific HRQOL measures supporting claims met US regulatory standards for construct validity, reliability, and responsiveness; these properties were strongest for the BPI-SF worst pain item. Only the BPI-SF worst pain item has documented content validity in mCRPC. CONCLUSIONS: PRO label claims were commonly granted across the mCRPC products reviewed. Among the measures reviewed, only the BPI-SF worst pain item supported US label claims. The BPI-SF worst pain item is recommended for pain assessment for the evaluation of new mCRPC treatments.","Health Qual Life Outcomes, 12(104","USA,Europe",2014,"Metastatic","Taxane,Chemotherapy,Brachytherapy","BPI,MPQ,FACT-P,EQ-5D","Patient",null,"Narrative review","USA,Europe","Patient","Metastatic","Taxane,Chemotherapy,Brachytherapy",null,"Narrative review","BPI,MPQ,FACT-P,EQ-5D","2010:2014","Symptom,Disease,Utility"]
[129,"Cleary, P. D., et al. (1995). \"Health-related quality of life in patients with advanced prostate cancer: a multinational perspective.\" Qual Life Res 4(3): 207-220.",null,"Cleary, P. D., et al.","Health-related quality of life in patients with advanced prostate cancer: a multinational perspective","To explore the value of antiandrogen therapy for advanced prostate cancer, two clinical trials of similar design were recently conducted in six countries throughout Europe. A total of 550 patients with previously untreated metastatic prostate cancer were randomized either to treatment with an antiandrogen or castration. While time to treatment failure, objective tumour response and survival were expected to be similar between study treatments, their effects on health-related quality of life (HRQOL) were expected to differ and were therefore a focus of concern in this trial. To assess these effects, we developed a brief self-administered patient questionnaire covering 10 domains of HRQOL (general health perceptions, pain, emotional well-being, vitality, social functioning, physical capacity, sexual interest, sexual functioning, activity limitation and bed disability), which we translated from English into several other languages. In this paper, we describe the development, content and translation of this survey instrument and report on its reliability and validity in six countries based on data collected for the first 487 patients to complete questionnaires at study entry.","Qual Life Res, 4(3): 207-220","USA",1995,"Advanced,Metastatic","Hormonal","Unclear","Patient",null,"Validation","USA","Patient","Advanced,Metastatic","Hormonal",null,"Validation","Unclear","1960:1999","General"]
[130,"Collette, L., et al. (2004). \"Is baseline quality of life useful for predicting survival with hormone-refractory prostate cancer? A pooled analysis of three studies of the European Organisation for Research and Treatment of Cancer Genitourinary Group.\" J Clin Oncol 22(19): 3877-3885.",null,"Collette, L., et al.","Is baseline quality of life useful for predicting survival with hormone-refractory prostate cancer? A pooled analysis of three studies of the European Organisation for Research and Treatment of Cancer Genitourinary Group","PURPOSE: Patients with symptomatic metastatic hormone-resistant prostate cancer (HRPC) survive a median of 10 months and are often regarded as a homogeneous group. Few prognostic factors have been identified so far. We examined whether baseline health-related quality of life (HRQOL) parameters assessed by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30 (EORTC QLQ-C30) were independent prognostic factors of survival and whether they bring extra precision to the predictions achievable with models based on clinical and biochemical factors only. PATIENTS AND METHODS: Data of 391 symptomatic (bone) metastatic HRPC patients from three randomized EORTC trials were used in multivariate Cox proportional hazards models. The significance level was set at alpha =.05. RESULTS: Of the 391 patients, 371 died, most of prostate cancer. Bone scan result, performance status, hemoglobin level, and insomnia and appetite loss as measured by the EORTC QLQ-C30 were independent predictors of survival. This model's area under the receiver operating curve was 0.65 compared with 0.63 without the two HRQOL factors. CONCLUSION: Certain HRQOL sores, at baseline, seem to be predictors for duration of survival in HRPC. However, such measurements do not add to the predictive ability of models based only on clinical and biochemical factors.","J Clin Oncol, 22(19): 3877-3885","Belgium",2004,"Metastatic","Unclear","EORTC QLQ-C30","Patient",null,"Systematic review","Belgium","Patient","Metastatic","Unclear",null,"Systematic review","EORTC QLQ-C30","2000:2004","General"]
[131,"Collingwood, S. A., et al. (2014). \"Decisional regret after robotic-assisted laparoscopic prostatectomy is higher in African American men.\" Urol Oncol 32(4): 419-425.",null,"Collingwood, S. A., et al.","Decisional regret after robotic-assisted laparoscopic prostatectomy is higher in African American men","OBJECTIVES: Longitudinal studies report racial disparities in prostate cancer (PCa) including greater incidence, more aggressive tumor biology, and increased cancer-specific mortality in African American (AA) men. Regret concerning primary treatment selection is underevaluated in patients with PCa. We investigated the relationships between clinicopathologic variables across racial and socioeconomic lines following robotic-assisted laparoscopic prostatectomy. MATERIALS AND METHODS: We assessed treatment decisional regret using a validated questionnaire in a total of 484 white and 72 AA patients with PCa who were followed up for a median of 16.6 months post-robotic-assisted laparoscopic prostatectomy. Socioeconomic status (SES) information was aggregated from 2010 US census zip code data. Perioperative clinicopathologic characteristics and functional outcomes were compared between groups. Univariate and multivariate regression analyses were used to evaluate the influence of race, aggregate SES, and other clinical and demographic characteristics on decisional regret. RESULTS: The majority (87.7%) of the population was not regretful of their decision to undergo treatment. However, a greater proportion of AA vs. white patients were regretful (20.6% vs. 11.2%, respectively; P = 0.03). AA and white men were similar on all functional, clinical, and pathologic features with the exception of younger age among AA men (56 vs. 60 y, respectively; P<0.001). Although there were significant differences in SES by race (P<0.001), regret did not differ by SES (beta =-1.53; P = 0.15). Race, postoperative sexual dysfunction, pad usage, and length of hospital stay, however, were significantly associated with decisional regret. CONCLUSIONS: AA men were more regretful than white men, after adjusting for clinicopathologic characteristics and postoperative functional outcomes.","Urol Oncol, 32(4): 419-425","USA",2014,"Any or unknown","Surgery","Unclear","Patient",null,"Cross-sectional","USA","Patient","Any or unknown","Surgery",null,"Cross-sectional","Unclear","2010:2014","Satisfaction"]
[132,"Cook, K. F., et al. (2001). \"A psychometric analysis of the measurement level of the rating scale, time trade-off, and standard gamble.\" Soc Sci Med 53(10): 1275-1285.",null,"Cook, K. F., et al.","A psychometric analysis of the measurement level of the rating scale, time trade-off, and standard gamble","A fundamental assumption of utility-based analyses is that patient utilities for health states can be measured on an equal-interval scale. This assumption, however, has not been widely examined. The objective of this study was to assess whether the rating scale (RS), standard gamble (SG), and time trade-off (TTO) utility elicitation methods function as equal-interval level scales. We wrote descriptions of eight prostate-cancer-related health states. In interviews with patients who had newly diagnosed, advanced prostate cancer, utilities for the health states were elicited using the RS, SG, and TTO methods. At the time of the study, 77 initial and 73 follow-up interviews had. been conducted with a consecutive sample of 77 participants. Using a Rasch model, the boundaries (Thurstone Thresholds) between four equal score sub-ranges of the raw utilities were mapped onto an equal-interval logit scale. The distance between adjacent thresholds in logit units was calculated to determine whether the raw utilities were equal-interval. None of the utility scales functioned as interval-level scales in our sample. Therefore, since interval-level estimates are assumed in utility-based analyses, doubt is raised regarding the validity of findings from previous analyses based on these scales. Our findings need to be replicated in other contexts, and the practical impact of non-interval measurement on utility-based analyses should be explored. If cost-effectiveness analyses are not found to be robust to violations of the assumption that utilities are interval, serious doubt will be cast upon findings from utility-based analyses and upon the wisdom of expending millions in research dollars on utility-based studies.","Soc Sci Med, 53(10): 1275-1285","USA",2001,"Advanced","None","TTO,SG,RatingS","Patient",null,"Validation","USA","Patient","Advanced","None",null,"Validation","TTO,SG,RatingS","2000:2004","Utility"]
[133,"Cooperberg, M. R., et al. (2003). \"How potent is potent? Evaluation of sexual function and bother in men who report potency after treatment for prostate cancer: data from CaPSURE.\" Urology 61(1): 190-196.",null,"Cooperberg, M. R., et al.","How potent is potent? Evaluation of sexual function and bother in men who report potency after treatment for prostate cancer: data from CaPSURE","OBJECTIVES: To characterize the association between potency and comprehensive sexual function. The accurate assessment of sexual function is critical for the evaluation of outcomes after treatment of prostate cancer. The assessments of potency typically used in this context, however, may be oversimplified. METHODS: CaPSURE is a large, observational database of men with prostate cancer. Participants complete health-related quality-of-life questionnaires, including the University of California, Los Angeles Prostate Cancer Index, every 6 months after treatment. A total of 5135 men completed at least one questionnaire and did not use medications for erectile function. The men were categorized as potent or impotent based on their ability to have erections and/or intercourse in the prior 4 weeks. Using the remaining questions on the Prostate Cancer Index, sexual function and bother scores were calculated for each group. RESULTS: Of the 5135 men, 27.4% were potent. The mean sexual function scores were 56 and 13 for potent and impotent men, respectively (P <0.0001). The corresponding mean bother scores were 62 and 36 (P <0.0001). The function scores ranged from 0 to 100 and 0 to 92 among potent and impotent men, respectively, and bother scores from 0 to 100 in both groups. Function was inversely associated with age in both groups, but bother did not change among potent men and ameliorated among impotent men. Individual Prostate Cancer Index questions correlated with potency to a variable extent. CONCLUSIONS: Although potent and impotent men have divergent sexual function and bother scores after treatment, the wide range of these scores in both groups denotes a complex picture of sexual function. The simple documentation of potency after treatment provides an insufficient measure of sexual health-related quality of life and should be supplemented with more comprehensive measures.","Urology, 61(1): 190-196","USA",2003,"Any or unknown","Unclear","UCLA-PCI","Patient",null,"Cohort","USA","Patient","Any or unknown","Unclear",null,"Cohort","UCLA-PCI","2000:2004","Disease"]
[134,"Cooperberg, M. R., et al. (2004). \"The contemporary management of prostate cancer in the United States: lessons from the cancer of the prostate strategic urologic research endeavor (CapSURE), a national disease registry.\" J Urol 171(4): 1393-1401.",null,"Cooperberg, M. R., et al.","The contemporary management of prostate cancer in the United States: lessons from the cancer of the prostate strategic urologic research endeavor (CapSURE), a national disease registry","PURPOSE: The epidemiology and treatment of prostate cancer have changed dramatically in the prostate specific antigen era. A large disease registry facilitates the longitudinal observation of trends in disease presentation, management and outcomes. MATERIALS AND METHODS: The Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) is a national disease registry of more than 10000 men with prostate cancer accrued at 31 primarily community based sites across the United States. Demographic, clinical, quality of life and resource use variables are collected on each patient. We reviewed key findings from the data base in the last 8 years in the areas of disease management trends, and oncological and quality of life outcomes. RESULTS: Prostate cancer is increasingly diagnosed with low risk clinical characteristics. With time patients have become less likely to receive pretreatment imaging tests, less likely to pursue watchful waiting and more likely to receive brachytherapy or hormonal therapy. Relatively few patients treated with radical prostatectomy in the database are under graded or under staged before surgery, whereas the surgical margin rate is comparable to that in academic series. CaPSURE data confirm the usefulness of percent positive biopsies in risk assessment and they have further been used to validate multiple preoperative nomograms. CaPSURE results strongly affirm the necessity of patient reported quality of life assessment. Multiple studies have compared the quality of life impact of various treatment options, particularly in terms of urinary and sexual function, and bother. CONCLUSIONS: The presentation and management of prostate cancer have changed substantially in the last decade. CaPSURE will continue to track these trends as well as oncological and quality of life outcomes, and will continue to be an invaluable resource for the study of prostate cancer at the national level.","J Urol, 171(4): 1393-1401","USA",2004,"Any or unknown","Radiotherapy,Surgery,Hormonal,Brachytherapy","Unclear","Patient",null,"Cohort","USA","Patient","Any or unknown","Radiotherapy,Surgery,Hormonal,Brachytherapy",null,"Cohort","Unclear","2000:2004","General"]
[135,"Cormie, P., et al. (2013). \"Exercise maintains sexual activity in men undergoing androgen suppression for prostate cancer: a randomized controlled trial.\" Prostate Cancer Prostatic Dis 16(2): 170-175.",null,"Cormie, P., et al.","Exercise maintains sexual activity in men undergoing androgen suppression for prostate cancer: a randomized controlled trial","BACKGROUND: Previous research has shown exercise to be an effective method to mitigate many adverse treatment-related effects of androgen suppression therapy (AST) but the potential impact of exercise on sexual activity remains unknown. The purpose of this investigation was to report the effect of a 12-week exercise program on sexual activity in prostate cancer patients undergoing AST. METHODS: Fifty-seven prostate cancer patients undergoing AST were randomly assigned to an exercise program (resistance and aerobic modes; n=29) or usual care control (n=28). Sexual activity was assessed by the European Organization for Research and Treatment of Cancer prostate cancer-specific quality of life questionnaire (QLQ-PR25). RESULTS: QLQ-PR25 data were log transformed and analysis of covariance was used to compare sexual activity between groups following the intervention adjusted for baseline activity. No differences in sexual activity were observed between the exercise and control groups before the intervention. There was a significant (P=0.045) adjusted group difference in sexual activity following the 12-week intervention. Patients undergoing usual care decreased sexual activity while patients in the exercise program maintained their level of sexual activity. At baseline, 20.6 and 22.2% of participants in the exercise and control groups reported a major interest in sex (that is, high libido). Following the intervention, the exercise group had a significantly higher percentage of participants reporting a major interest in sex (exercise=17.2% vs control=0%; P=0.024). CONCLUSIONS: Participation in a short-term exercise program resulted in the maintenance of sexual activity in prostate cancer patients undergoing AST.","Prostate Cancer Prostatic Dis, 16(2): 170-175","Australia",2013,"Any or unknown","Hormonal,Various","EORTC QLQ-PR25","Patient",null,"Clinical trial","Australia","Patient","Any or unknown","Hormonal,Various",null,"Clinical trial","EORTC QLQ-PR25","2010:2014","Disease"]
[136,"Cormier, L., et al. (2002). \"Impact of prostate cancer screening on health-related quality of life in at-risk families.\" Urology 59(6): 901-906.",null,"Cormier, L., et al.","Impact of prostate cancer screening on health-related quality of life in at-risk families","OBJECTIVES: To describe the impact of prostate-specific antigen (PSA) screening on the health-related quality of life (HRQOL) and anxiety of men with a family history of prostate cancer. METHODS: We asked 334 brothers or sons of men with prostate cancer who agreed to undergo PSA testing to fill out HRQOL questionnaires. The questionnaires were the RAND SF-36 (generic HRQOL) and State-Trait Anxiety Inventory (anxiety-specific). Participants completed the questionnaires at the time of screening, while waiting for the results, and after receiving normal results. Sociodemographic and HRQOL variables were entered into a logistic regression model to identify factors associated with the deterioration of HRQOL, defined as a decrease of at least one standard error of measurement. Only men with normal PSA results were considered. RESULTS: Among 334 candidates, 273 underwent PSA measurement and 220 candidates with a PSA of 4 ng/mL or less returned completed questionnaires. Of these, in 20% their anxiety moderately deteriorated and in 20% their HRQOL minimally deteriorated during the screening process. Factors associated with HRQOL deterioration included age between 50 and 60 years, having more than two relatives with prostate cancer, an anxious personality, a high level of education, and having no children presently living at home. CONCLUSIONS: Screening with normal PSA results is accompanied by a minimally to moderate deterioration of HRQOL in some subjects. The identification of such individuals before screening provides opportunities to improve their HRQOL during the screening process.","Urology, 59(6): 901-906","France",2002,"At risk","Screening","STAI,SF-36","General population",null,"Cohort","France","General population","At risk","Screening",null,"Cohort","STAI,SF-36","2000:2004","Comorbidity,Utility"]
[137,"Couper, J. W., et al. (2009). \"The psychological aftermath of prostate cancer treatment choices: a comparison of depression, anxiety and quality of life outcomes over the 12 months following diagnosis.\" Med J Aust 190(7 Suppl): S86-89.",null,"Couper, J. W., et al.","The psychological aftermath of prostate cancer treatment choices: a comparison of depression, anxiety and quality of life outcomes over the 12 months following diagnosis","OBJECTIVE: To assess the psychological impact of the different treatments for localised prostate cancer (PCA). DESIGN, PARTICIPANTS AND SETTING: Observational, prospective study of consecutive patients with PCA attending clinics in public hospitals and private practices in metropolitan Melbourne between 1 April 2001 and 30 December 2005. Data were collected at initial diagnosis of histologically confirmed localised PCA, and close to the commencement of definitive treatment (Time 1), and 12 months later (Time 2). Patients were stratified according to treatment type (radical prostatectomy [RP], hormone therapy [HT] or other early treatment including radiation therapies [OET]). Patients who elected to undergo active surveillance/watchful waiting (WW) rather than active treatment were treated as a naturalistic control group. MAIN OUTCOME MEASURES: Levels of depression and anxiety were assessed by the Brief Symptom Inventory, and physical and psychosocial aspects of health-related quality of life (HRQOL) were assessed by the 36-item Short-Form Health Survey. RESULTS: 211 patients with PCA were recruited; 193 completed the Time 1 questionnaires (38 RP, 56 HT, 38 OET and 61 WW); and 172 completed the Time 2 questionnaires (33 RP, 51 HT, 33 OET and 55 WW). At Time 1, the three active treatment groups all reported greater dysfunction in work role and daily activities compared with the WW group. The RP group also reported worse social and emotional role functioning, while the HT and OET groups reported poorer vitality levels. The HT group reported significantly higher depression scores. At Time 2, the RP and OET groups did not differ from the WW group on either HRQOL or psychological status. By contrast, the HT group reported significantly worse HRQOL (physical functioning, role-physical and vitality domains) and greater psychological distress compared with the WW group. CONCLUSIONS: Compared with the other active treatments for localised PCA, HT appears to be associated with poorer HRQOL and greater psychological distress 12 months after commencing treatment.","Med J Aust, 190(7 Suppl): S86-89","Australia",2009,"Local","Surgery,Hormonal,Radiotherapy,Surveillance","BSI,SF-36","Patient",null,"Cohort","Australia","Patient","Local","Surgery,Hormonal,Radiotherapy,Surveillance",null,"Cohort","BSI,SF-36","2005:2009","Symptom,Utility"]
[138,"Couper, J. W., et al. (2010). \"Predictors of psychosocial distress 12 months after diagnosis with early and advanced prostate cancer.\" Med J Aust 193(5 Suppl): S58-61.",null,"Couper, J. W., et al.","Predictors of psychosocial distress 12 months after diagnosis with early and advanced prostate cancer","OBJECTIVE: To assess psychosocial distress in patients with early (localised) and advanced (metastatic) prostate cancer (PCA) at diagnosis (Time 1) and 12 months later (Time 2), and identify psychosocial factors predictive of later distress. DESIGN, PARTICIPANTS AND SETTING: Observational, prospective study of 367 men with early (211) or advanced (156) PCA recruited as consecutive attendees at clinics at seven public hospitals and practices in metropolitan Melbourne between 1 April 2001 and 30 December 2005. Both groups completed questionnaires at Time 1 and Time 2. MAIN OUTCOME MEASURES: Health-related quality of life as assessed by the Short Form 36-item Health Survey; psychological distress, including depression and anxiety as assessed by the Brief Symptom Inventory; and coping patterns as assessed by the Mini-Mental Adjustment to Cancer scale. RESULTS: Over the 12 months, both the early and advanced PCA group showed reduced vitality and increased depression and anxiety; this effect was greater in the advanced PCA group. Mental health, social functioning and role-emotional functioning also deteriorated in the advanced group. Predictors of depression at Time 2 for the early PCA group were depression, vitality and a fatalistic coping pattern at Time 1; anxiety at Time 2 was predicted by anxiety and vitality at Time 1. In the advanced PCA group, depression at Time 2 was predicted by depression and mental health at Time 1; anxiety at Time 2 was predicted by anxiety, mental health, cognitive avoidance and lower anxious preoccupation at Time 1. CONCLUSIONS: Men with early PCA experience decreasing vitality and increasing psychological distress over the 12 months following diagnosis; this trend is accelerated after diagnosis with advanced PCA. A fatalistic coping pattern at diagnosis of early PCA predicts later depression while cognitive avoidance and lower anxious preoccupation at diagnosis of advanced PCA predict later anxiety.","Med J Aust, 193(5 Suppl): S58-61","Australia",2010,"Local,Advanced","None","SF-36,MMAC,BSI","Patient",null,"Cohort","Australia","Patient","Local,Advanced","None",null,"Cohort","SF-36,MMAC,BSI","2010:2014","Disease,Utility,Symptom"]
[139,"Courneya, K. S., et al. (2004). \"Three independent factors predicted adherence in a randomized controlled trial of resistance exercise training among prostate cancer survivors.\" J Clin Epidemiol 57(6): 571-579.",null,"Courneya, K. S., et al.","Three independent factors predicted adherence in a randomized controlled trial of resistance exercise training among prostate cancer survivors","OBJECTIVE: To examine predictors of adherence in a randomized controlled trial of resistance exercise training (RET) in prostate cancer survivors receiving androgen deprivation therapy. STUDY DESIGN AND SETTING: A randomized controlled trial conducted at fitness centers in Ottawa and Edmonton, Canada. Prostate cancer survivors (n=155) completed measures of social cognitive variables, quality of life (QOL), behavior, and fitness before being randomized to either an exercise (n=82) or control (n=73) group. The exercise group was asked to perform supervised RET three times per week for 12 weeks. RESULTS: The exercise group attended 28.2 of the 36 (78.3%) RET sessions. Univariate analyses revealed eight different significant (Ps <.05) predictors of exercise adherence including exercise stage of change, intention, age, QOL, fatigue, subjective norm, leg-press test, and perceived behavioral control. A multivariate analysis indicated that there were three independent predictors of adherence that explained 20.4% of the variance: exercise stage of change (beta=0.26; P=.013), age (beta=-0.22; P=.037), and intention (beta=0.19; P=.073). CONCLUSION: Exercise adherence in the trial was very good but not optimal. Adherence was predicted by variables from many different categories including social cognitive, QOL, behavioral, fitness, and demographic. These findings may have important implications for maximizing adherence during clinical trials of exercise in prostate cancer survivors.","J Clin Epidemiol, 57(6): 571-579","Canada",2004,"Survivors","Hormonal,Various","Unclear","Patient",null,"Clinical trial","Canada","Patient","Survivors","Hormonal,Various",null,"Clinical trial","Unclear","2000:2004","General"]
[140,"Cozzarini, C., et al. (2017). \"Patient-reported urinary incontinence after radiotherapy for prostate cancer: Quantifying the dose-effect.\" Radiother Oncol 125(1): 101-106.",null,"Cozzarini, C., et al.","Patient-reported urinary incontinence after radiotherapy for prostate cancer: Quantifying the dose-effect","BACKGROUND AND PURPOSE: Urinary incontinence following radiotherapy (RT) for prostate cancer (PCa) has a relevant impact on patient's quality of life. The aim of the study was to assess the unknown dose-effect relationship for late patient-reported urinary incontinence (LPRUI). METHODS AND MATERIALS: Patients were enrolled within the multi-centric study DUE01. Clinical and dosimetry data including the prescribed 2Gy equivalent dose (EQD2) were prospectively collected. LPRUI was evaluated through the ICIQ-SF questionnaire filled in by the patients at RT start/end and therefore every 6months. Patients were treated with conventional (74-80Gy, 1.8-2Gy/fr) or moderately hypo-fractionated RT (65-75.2Gy, 2.2-2.7Gy/fr) in 5 fractions/week with intensity-modulated radiotherapy. Six different end-points of 3-year LPRUI, including or not patient's perception (respectively, subjective and objective end-points), were considered. Multivariable logistic models were developed for each end-point. RESULTS: Data of 298 patients were analyzed. The incidence of the most severe end-point (ICIQ-SF>12) was 5.1%. EQD2 calculated with alpha-beta=0.8Gy showed the best performance in fitting data: the risk of LPRUI markedly increased for EQD2>80Gy. Previous abdominal/pelvic surgery and previous TURP were the clinical factors more significantly predictive of LPRUI. Models showed excellent performances in terms of goodness-of-fit and calibration, confirmed by bootstrap-based internal validation. When included in the analyses, baseline symptoms were a major predictor for 5 out of six end-points. CONCLUSIONS: LPRUI after RT for PCa dramatically depends on EQD2 and few clinical factors. Results are consistent with a larger than expected impact of moderate hypo-fractionation on the risk of LPRUI. As expected, baseline symptoms, as captured by ICIQ-SF, are associated to an increased risk of LPRUI.","Radiother Oncol, 125(1): 101-106","Italy",2017,"Any or unknown","Radiotherapy","ICIQ","Patient",null,"Cohort","Italy","Patient","Any or unknown","Radiotherapy",null,"Cohort","ICIQ","2015:2018","Complication"]
[141,"Crawford, E. D., et al. (1997). \"Comparison of perspectives on prostate cancer: analyses of survey data.\" Urology 50(3): 366-372.",null,"Crawford, E. D., et al.","Comparison of perspectives on prostate cancer: analyses of survey data","OBJECTIVES: Prostate cancer will account for 334,500 new cases and 41,800 deaths among men in the United States in 1997. Patients and physicians are faced with many concerns related to benefits and side effects of alternative treatments, educational needs, emotional support, and costs of care. Support groups for prostate cancer patients have been established to help satisfy needs in these areas. Therefore, we addressed three issues among patients who belong to a prostate cancer support group as well as among a second group of urologists who treat prostate cancer: (1) goals for prostate cancer treatment, (2) information that is given and recalled about the disease and therapy, and (3) extent to which educational and emotional needs are being met. METHODS: Random telephone surveys were made of 1000 men with prostate cancer who belong to the prostate cancer support group US TOO, the largest prostate cancer support group in the United States, and 200 urologists who provide care to men with prostate cancer. The surveys were conducted by the Louis Harris & Associates survey research firm. RESULTS: About four fifths of patients and urologists prefer aggressive therapy for prostate cancer. Patient goals with therapy included preservation of quality of life (45%), extension of life (29%), and delaying disease progression (13%), whereas physicians overwhelmingly focused on treatment efficacy (86%), with side effects (43%) and costs (29%) being secondary considerations. Urologists and patients differed markedly in the description of the patient-physician discussion. Whereas almost 100% of physicians stated that they always discussed important considerations such as options for no therapy, life expectancy with and without therapy, patient preferences, costs, and changes in sexual function, only about one fifth of patients recalled similar discussions. Patients and physicians both believed that physicians were an excellent source of educational support, but often did not report provision of emotional support. Although support groups were viewed as good providers of educational and emotional support by 85% to 90% of patients, physicians appeared to underestimate the benefit of support groups in these areas. CONCLUSIONS: Patients who belong to US TOO have many emotional and educational needs that are not currently being fulfilled by physicians. Although the goals of therapy are viewed similarly by patients and physicians, much of the important cancer- and treatment-related information that physicians report they have provided is not recalled by patients. Policy makers would be wise to devise systematic strategies such as shared decision-making tools and better linkages to support groups to ensure that patients' needs are being met.","Urology, 50(3): 366-372","USA",1997,"Any or unknown","Unclear","Unclear","HCP,Patient",null,"Cross-sectional","USA","HCP,Patient","Any or unknown","Unclear",null,"Cross-sectional","Unclear","1960:1999","Views"]
[142,"Crawford, E. D., et al. (2011). \"Validation of the modified American Urological Association symptom score.\" J Urol 186(3): 945-948.",null,"Crawford, E. D., et al.","Validation of the modified American Urological Association symptom score","PURPOSE: We created a shorter version of the American Urological Association symptom score, called UWIN (urgency, weak stream, incomplete emptying and nocturia). MATERIALS AND METHODS: Participants in Prostate Cancer Awareness Week from 2006 and 2007 were administered the regular American Urological Association symptom score and UWIN. A total of 278 participants completed each questionnaire. Total scores of each participant for the American Urological Association symptom score (range 0 to 35) and UWIN (range 0 to 12) were evaluated using Spearman's correlation coefficients and Bland-Altman plots to determine the level of agreement between the 2 questionnaires. RESULTS: The correlation between the total American Urological Association symptom score (range 0 to 35) and the total UWIN score (range 0 to 12) was 0.913 (p<0.0001). The correlation between the quality of life question on the American Urological Association symptom score and UWIN was 0.821 using the Spearman correlation coefficient (p<0.0001). A second analysis performed using Bland-Altman plots showed good agreement between the American Urological Association symptom score and UWIN. Overall, respondents tended to have slightly higher UWIN total scores than their American Urological Association symptom scores. CONCLUSIONS: This study validates that the UWIN questionnaire can be used in place of the American Urological Association symptom score. The UWIN questionnaire will lessen the burden on the respondent, broaden the applicability of the instrument and make collecting data as efficient and effective as possible.","J Urol, 186(3): 945-948","USA",2011,"At risk","None","AUA-SI,UWIN","General population",null,"Validation","USA","General population","At risk","None",null,"Validation","AUA-SI,UWIN","2010:2014","Complication,Symptom"]
[143,"Cresswell, S. M., et al. (1995). \"Pain relief and quality-of-life assessment following intravenous and oral clodronate in hormone-escaped metastatic prostate cancer.\" Br J Urol 76(3): 360-365.",null,"Cresswell, S. M., et al.","Pain relief and quality-of-life assessment following intravenous and oral clodronate in hormone-escaped metastatic prostate cancer","OBJECTIVE: To establish the efficacy of intravenous clodronate followed by maintenance oral clodronate in patients with painful bone metastases resulting from hormone-resistant prostate cancer. PATIENTS AND METHODS: A multicentre open study of 27 patients assessed the efficacy of clodronate treatment by estimating the reduction in World Health Organization (WHO) Pain Score, the increase in WHO Performance Status and by a novel quality-of-life/activity score. RESULTS: Ten of 27 patients achieved significant pain relief after receiving 300 mg/day of intravenous clodronate for 10 days. This was matched by an improvement in the activity score and WHO Performance Status. Three of 27 patients continued to have relief from pain after 3 months of oral clodronate therapy. CONCLUSION: Intravenous clodronate therapy was effective in relieving the pain resulting from prostate cancer bone metastases in 10 of 27 patients but the benefit was shortlived. The use of a personal quality-of-life/activity questionnaire which assesses aspects of everyday life that are important to the patient may be more appropriate for patients with very advanced prostate cancer than are other quality-of-life questionnaires in current use.","Br J Urol, 76(3): 360-365","UK",1995,"Metastatic","Bisphosphonate","WHO-Pain,WHO-PS","Patient",null,"Clinical trial","UK","Patient","Metastatic","Bisphosphonate",null,"Clinical trial","WHO-Pain,WHO-PS","1960:1999","General,Symptom"]
[144,"Crevenna, R., et al. (2009). \"Strength of skeletal muscle and quality of life in patients suffering from \"typical male\" carcinomas.\" Support Care Cancer 17(10): 1325-1328.",null,"Crevenna, R., et al.","Strength of skeletal muscle and quality of life in patients suffering from \"typical male\" carcinomas","AIM: This pilot study aimed to compare muscle strength and quality of life (QOL) in cancer patients suffering from two different \"typical male\" cancer entities (prostate cancer and head and neck cancer). METHODS: The Biodex System 3 device was used for isokinetic strength testing of thigh muscles in both groups. QOL was evaluated by using the SF-36 Health Survey. RESULTS AND DISCUSSION: Surprisingly, prostate cancer patients showed significantly higher values for muscular strength of thigh muscles than significant younger patients with head and neck cancer. Furthermore, prostate cancer patients revealed significantly better values in QOL subscales \"bodily pain\" and \"physical functioning\".","Support Care Cancer, 17(10): 1325-1328","Austria",2009,"Any or unknown","None","SF-36","Patient",null,"Cross-sectional","Austria","Patient","Any or unknown","None",null,"Cross-sectional","SF-36","2005:2009","Utility"]
[145,"Crook, J. M., et al. (2011). \"Comparison of health-related quality of life 5 years after SPIRIT: Surgical Prostatectomy Versus Interstitial Radiation Intervention Trial.\" J Clin Oncol 29(4): 362-368.",null,"Crook, J. M., et al.","Comparison of health-related quality of life 5 years after SPIRIT: Surgical Prostatectomy Versus Interstitial Radiation Intervention Trial","PURPOSE: The American College of Surgeons Oncology Group phase III Surgical Prostatectomy Versus Interstitial Radiation Intervention Trial comparing radical prostatectomy (RP) and brachytherapy (BT) closed after 2 years due to poor accrual. We report health-related quality of life (HRQOL) at a mean of 5.3 years for 168 trial-eligible men who either chose or were randomly assigned to RP or BT following a multidisciplinary educational session. PATIENTS AND METHODS: After initial lack of accrual, a multidisciplinary educational session was introduced for eligible patients. In all, 263 men attended 47 sessions. Of those, 34 consented to random assignment, 62 chose RP, and 94 chose BT. Five years later, these 190 men underwent HRQOL evaluation by using the cancer-specific 50-item Expanded Prostate Cancer Index Composite, the Short Form 12 Physical Component Score, and Short Form 12 Mental Component Score. Response rate was 88.4%. The Wilcoxon rank sum test was used to compare summary scores between the two interventions. RESULTS: Of 168 survey responders, 60.7% had BT (9.5% randomly assigned) and 39.3% had RP (9.5% randomly assigned). Median age was 61.4 years for BT and 59.4 for RP (P = .05). Median follow-up was 5.2 years (range, 3.2 to 6.5 years). For BT versus RP, there was no difference in bowel or hormonal domains, but men treated with BT scored better in urinary (91.8 v 88.1; P = .02) and sexual (52.5 v 39.2; P = .001) domains, and in patient satisfaction (93.6 v 76.9; P < .001). CONCLUSION: Although treatment allocation was random in only 19%, all patients received identical information in a multidisciplinary setting before selecting RP, BT, or random assignment. HRQOL evaluated 3.2 to 6.5 years after treatment showed an advantage for BT in urinary and sexual domains and in patient satisfaction.","J Clin Oncol, 29(4): 362-368","Canada",2011,"Any or unknown","Brachytherapy,Surgery,Various","EPIC,SF-12","Patient",null,"Clinical trial","Canada","Patient","Any or unknown","Brachytherapy,Surgery,Various",null,"Clinical trial","EPIC,SF-12","2010:2014","Disease,Utility"]
[146,"Culine, S. and J. P. Droz (2000). \"Chemotherapy in advanced androgen-independent prostate cancer 1990-1999: a decade of progress?\" Ann Oncol 11(12): 1523-1530.",null,"Culine, S. and J. P. Droz","Chemotherapy in advanced androgen-independent prostate cancer 1990-1999: a decade of progress?","BACKGROUND AND PURPOSE: A great number of clinical research studies have been reported in the field of chemotherapy for advanced androgen-independent prostate cancer during the last ten years. The aims of the present review were to assess their impact on management of the disease and on survival of patients. METHODS: The review of full published reports was facilited by the use of a MEDLINE computer search. RESULTS: Clinical research studies have focused on defining guidelines for eligibility criteria and accurate endpoints for patients to be enrolled onto clinical trials and developing new agents or combination of drugs including estramustine phosphate. Any combination of current chemotherapy has no impact on overall survival of patients. Among drugs in development, only the promising activity observed with docetaxel deserves randomized trials to assess its impact on survival. The major innovative advance of the 90s is the demonstration of the impact of chemotherapy (mitoxantrone + prednisone) on quality of life as compared to prednisone alone. A greater and longer-lasting improvement in quality of life along with a concomitant decrease in costs was observed. CONCLUSIONS: At the present time, chemotherapy should be considered as a palliative treatment in patients with symptomatic androgen-independent disease. The enrollment of patients into clinical trials dealing with quality of life as primary endpoint is strongly solicited. A standard methodology should be used in phase II trials with a primary goal of selection of agents which should progress to randomized trials using survival as an endpoint. Hopefully new specific strategies targeted to reverse the molecular changes that underlie prostate tumorigenesis should rapidly impact the multimodality management of AIPC in the third millenium.","Ann Oncol, 11(12): 1523-1530","International",2000,"Advanced","Taxane,Chemotherapy","Unclear","Patient",null,"Systematic review","International","Patient","Advanced","Taxane,Chemotherapy",null,"Systematic review","Unclear","2000:2004","General"]
[147,"Curigliano, G., et al. (2009). \"Health-related quality of life in patients with hormone refractory prostate cancer receiving gefitinib.\" Urol Int 82(2): 196-202.",null,"Curigliano, G., et al.","Health-related quality of life in patients with hormone refractory prostate cancer receiving gefitinib","OBJECTIVES: Improvements in quality of life (QoL) and disease-related symptoms are key goals in the treatment of hormone refractory prostate cancer (HRPC). Our aim was to evaluate the impact of gefitinib on QoL of patients with HRPC. METHODS: Patients with HRPC received gefitinib 250 mg daily in addition to antiandrogen plus luteinizing hormone-releasing hormone (LHRH) analogue for at least 2 months or until disease progression. QoL was evaluated monthly by the European Organisation for Research on the Treatment of Cancer (EORTC) QLQ-C30 questionnaire. Pain was assessed daily by patients and scored by visual analogue scale and analgesic consumption in a diary. Monthly pain intensity was estimated using the McGill-Melzack questionnaire. RESULTS: Analysis of global health status according to EORTC QLQ-C30 showed an improvement of the status in only 6 patients (26%). The greatest benefit in the patients was in the subscale representing prostate-specific concerns (including appetite, pain, physical comfort, and genitourinary function). Improvement of symptoms was correlated with antiandrogen withdrawal. Global health status and QoL decreased during treatment according to tumor progression. CONCLUSIONS: Among HRPC patients treated with gefitinib, improvement of symptoms preceded evidence of biochemical response of prostate-specific antigen following antiandrogen withdrawal. These findings suggest no beneficial effect of gefitinib in QoL improvement.","Urol Int, 82(2): 196-202","Italy",2009,"Any or unknown","Gefitinib,Hormonal","EORTC QLQ-C30,VAS,MPI","Patient",null,"Clinical trial","Italy","Patient","Any or unknown","Gefitinib,Hormonal",null,"Clinical trial","EORTC QLQ-C30,VAS,MPI","2005:2009","General,Symptom"]
[148,"Curran, D., et al. (1997). \"Baseline quality of life of patients with advanced prostate cancer. European Organization for Research and Treatment of Cancer (EORTC), Genito-Urinary Tract Cancer Cooperative Group (GUT-CCG).\" Eur J Cancer 33(11): 1809-1814.",null,"Curran, D., et al.","Baseline quality of life of patients with advanced prostate cancer. European Organization for Research and Treatment of Cancer (EORTC), Genito-Urinary Tract Cancer Cooperative Group (GUT-CCG)","Quality of life (QoL) is now commonly studied in prostate cancer. However, little is known about the appropriateness of the various QoL instruments in this group of patients. The purpose of this work was to study the baseline QoL assessment of patients with prostate cancer who were randomised into three EORTC phase III studies. The three trials included locoregional prostate cancer patients, poor prognosis metastatic patients and hormone resistance patients, respectively. In the three trials, patients were asked to complete a questionnaire assessing their physical and psychosocial functioning and their symptom levels. These questionnaires included questions from the EORTC QLQ-C30 (version 1): the physical functioning, role functioning, global health/QoL scales and a single pain item. The psychometric properties of the scales were assessed and an analysis was performed to investigate if differences existed in the scale scores between the three groups of patients, 638 baseline questionnaires were available for patients entered into the three trials. The Gutman coefficients of reproducibility and scalability were 0.94 and 0.71, respectively, for the physical functioning scale and 0.97 and 0.90, respectively, for the role functioning scale. The Cronbach's alpha reliability coefficients were 0.68, 0.48 and 0.90 for the physical functioning, role functioning and global health/QoL scales, respectively. The four scales were able to distinguish clearly between the patient populations under study. The physical functioning, role functioning, global health/QoL scales and the single pain item scale from the EORTC QLQ-C30 (version 1) are valid measures when used in the setting of prostate cancer.","Eur J Cancer, 33(11): 1809-1814","Belgium",1997,"Metastatic,Local","None","EORTC QLQ-C30","Patient",null,"Validation","Belgium","Patient","Metastatic,Local","None",null,"Validation","EORTC QLQ-C30","1960:1999","General"]
[149,"da Silva, F. C. (1993). \"Quality of life in prostatic carcinoma.\" Eur Urol 24 Suppl 2: 113-117.",null,"da Silva, F. C.","Quality of life in prostatic carcinoma","Subjective quality-of-life assessments obtained from investigators and patients were compared in a subset of 76 patients from an EORTC study (protocol 30853) on metastatic prostatic carcinoma. In this study the therapeutic effect of orchiectomy was compared with a luteinizing hormone-releasing hormone analogue depot preparation and flutamide in 327 patients in total. Pretreatment, 6- and 12-month quality-of-life assessments revealed large variations between the patients' and the investigators' evaluation of performance status and sexual status (potency). Correlation analysis showed that reduced social life, impaired sexual potency and fatigue played important roles in overall psychological well-being. It was concluded that quality-of-life assessments obtained by self-administration questionnaires is a feasible approach and provides a tool to evaluate the benefits of treatment in prostate cancer.","Eur Urol, 24 Suppl 2(113-117","Portugal",1993,"Metastatic","Surgery,Hormonal","Unclear","Patient",null,"Clinical trial","Portugal","Patient","Metastatic","Surgery,Hormonal",null,"Clinical trial","Unclear","1960:1999","General,Complication"]
[150,"da Silva, F. C., et al. (1996). \"The quality of life of patients with newly diagnosed M1 prostate cancer: experience with EORTC clinical trial 30853.\" Eur J Cancer 32a(1): 72-77.",null,"da Silva, F. C., et al.","The quality of life of patients with newly diagnosed M1 prostate cancer: experience with EORTC clinical trial 30853","This study was undertaken to evaluate the quality of life (QoL) of previously untreated patients with M1 prostate cancer before and during androgen-suppressive treatment. Assessment of QoL was included as an optimal component of EORTC protocol 30853, a phase III trial comparing LH-RH (luteinising hormone-releasing hormone) analogue combined with a non-steroidal anti-androgen versus orchiectomy in patients with M1 prostate cancer. At pretreatment and during the follow-up period, patients were asked to complete a questionnaire assessing their physical and psychosocial functioning, and their symptom levels. Physicians rated the patients' performance status, pain, urological symptoms and erectile function. Due to its optional nature, only a minority of the patients in the trial were recruited for the QoL investigation. 63 patients completed a pretreatment questionnaire, of whom 49 completed a second questionnaire at least once during the initial 15 month follow-up period. While statistically significant correlations were observed between patients' and physicians' ratings of physical functioning and pain, these were of only a moderate magnitude (r = 0.43 and 0.30, respectively). No significant association was observed between physicians' and patients' ratings of micturation problems or of erectile function. Before treatment, fatigue, pain and decreased social role and sexual functioning were the problems most frequently reported by patients. With an average of approximately 1 year follow-up, statistically significant improvements were observed in patients' self-reported urological symptoms and metastatic pain. No significant changes were noted for the other QoL domains assessed. The results of this study confirm earlier findings that physicians' ratings may not reflect accurately the functional health and symptom experience of their patients. Patient-based QoL questionnaires offer the most direct means of evaluating the subjective morbidity associated with prostate cancer and its treatment. To increase participation and compliance rates in future studies, it is recommended that QoL assessment be made mandatory in those clinical trials in which QoL is considered to be an important study endpoint.","Eur J Cancer, 32a(1): 72-77","Portugal",1996,"Metastatic","Hormonal,Surgery","Unclear","Patient,HCP",null,"Clinical trial","Portugal","Patient,HCP","Metastatic","Hormonal,Surgery",null,"Clinical trial","Unclear","1960:1999","Symptom,Complication"]
[151,"D'Agostino, G., et al. (2016). \"High-quality Linac-based Stereotactic Body Radiation Therapy with Flattening Filter Free Beams and Volumetric Modulated Arc Therapy for Low-Intermediate Risk Prostate Cancer. A Mono-institutional Experience with 90 Patients.\" Clin Oncol (R Coll Radiol) 28(12): e173-e178.",null,"D'Agostino, G., et al.","High-quality Linac-based Stereotactic Body Radiation Therapy with Flattening Filter Free Beams and Volumetric Modulated Arc Therapy for Low-Intermediate Risk Prostate Cancer. A Mono-institutional Experience with 90 Patients","AIMS: The aim of this phase II study was to evaluate the efficacy and toxicity of stereotactic body radiotherapy in patients with low or intermediate risk prostate cancer. MATERIALS AND METHODS: Biopsy-confirmed prostate cancer patients were enrolled, provided that they had the following characteristics: initial prostate-specific antigen (PSA) </= 20 ng/ml, Gleason Score < 7, International Prostate Symptom Score < 7. The treatment schedule was 35 Gy in five fractions, delivered with volumetric modulated arcs with flattening filter free beams. Toxicity was recorded according to CTCAE criteria v4.0. Biochemical failure was calculated according to the Phoenix definition. The Expanded Prostate Cancer Index Composite questionnaire was used to record health-related quality of life. RESULTS: Between December 2011 and March 2015, 90 patients were enrolled (53 low risk, 37 intermediate risk). The median age was 71 years (range 48-82). In total, 58 (64.5%) of the patients had Gleason Score=6, the remaining had Gleason Score=7.The median initial PSA was 6.9 ng/ml (range 2.7-17.0). Acute toxicity was mild, with 32.2 patients presenting grade 1 urinary toxicity and 32.2% of patients presenting grade 2 urinary toxicity, mainly represented by urgency, dysuria and stranguria. Rectal grade 1 toxicity was found in 15.5% of patients, whereas grade 2 toxicity was recorded in 6.6% of patients. Regarding late toxicity, grade 1 proctitis was recorded in 11.1% of patients and grade 1 urinary in 38.8%; only two events of grade 2 urinary toxicity were observed (transient urethral stenosis, resolved by a 24 h catheterisation). At a median follow-up of 27 months (6-62 months) only two intermediate risk patients experienced a biochemical failure. Health-related quality of life revealed a slight worsening in all the domains during treatment, with a return to baseline 3 months after treatment. CONCLUSIONS: Stereotactic body radiotherapy delivered using linac-based flattening filter free volumetric modulated arc radiotherapy in low and intermediate risk prostate cancer patients is associated with mild toxicity profiles and good patient-reported quality of life.","Clin Oncol (R Coll Radiol), 28(12): e173-e178","Italy",2016,"Local","Radiotherapy","EPIC,IPSS,CTCAE","Patient",null,"Clinical trial","Italy","Patient","Local","Radiotherapy",null,"Clinical trial","EPIC,IPSS,CTCAE","2015:2018","Disease,Treatment,Symptom"]
[152,"Dahn, J. R., et al. (2004). \"Sexual functioning and quality of life after prostate cancer treatment: considering sexual desire.\" Urology 63(2): 273-277.",null,"Dahn, J. R., et al.","Sexual functioning and quality of life after prostate cancer treatment: considering sexual desire","OBJECTIVES: To evaluate whether the relationship between sexual desire and quality of life (QOL) is moderated by sexual functioning in 91 men who had received treatment for localized prostate cancer within the past 18 months. METHODS: Items from the University of California, Los Angeles, Prostate Cancer Index and Expanded Prostate Cancer Index Composite were used to assess sexual factors, and the Functional Assessment of Cancer Therapy--General Module was administered to evaluate QOL. Education, income, and the Charlson comorbidity index were significantly related to QOL and controlled in all analyses. We tested a moderated regression model to predict QOL. RESULTS: Although a main effect was detected for sexual functioning, the interaction of sexual desire and sexual functioning added a significant amount to the explained variance in QOL. Post hoc tests of moderation revealed that men with lower sexual functioning had significantly lower QOL scores as the level of sexual desire increased, suggesting that desire in the absence of adequate functioning may result in poorer QOL. Additionally, a tendency was found for men with better sexual functioning to have higher QOL scores as the level of sexual desire increased. CONCLUSIONS: The results of our study suggest that both sexual desire and sexual functioning are necessary for optimal QOL and highlight the utility of considering these two facets of sexuality independently to maximize the prediction of variance in QOL scores.","Urology, 63(2): 273-277","USA",2004,"Local","Unclear","EPIC,FACT-G,UCLA-PCI","Patient",null,"Cross-sectional","USA","Patient","Local","Unclear",null,"Cross-sectional","EPIC,FACT-G,UCLA-PCI","2000:2004","Disease,Treatment"]
[153,"Dale, W., et al. (1999). \"Self-assessed health-related quality of life in men being treated for prostate cancer with radiotherapy: instrument validation and its relation to patient-assessed bother of symptoms.\" Urology 53(2): 359-366.",null,"Dale, W., et al.","Self-assessed health-related quality of life in men being treated for prostate cancer with radiotherapy: instrument validation and its relation to patient-assessed bother of symptoms","OBJECTIVES: To develop a psychometrically valid and clinically useful questionnaire to assess health-related quality of life (HRQOL) in patients with prostate cancer (PCa) undergoing external beam radiotherapy. The most important factors in three dimensions (bowel function [BF], urinary function [UF], and sexual function [SF]) were identified by patient survey. METHODS: Three HRQOL dimensions were assessed using Likert-type questions. Responses were analyzed by factor analysis to create HRQOL scales. Reliability and validity of the scales were assessed. Because patients can suffer symptoms yet not report their lives to be affected, the scales were compared with patient-reported bother. RESULTS: Two scales were identified within each dimension: BF, urgency and daily living; UF, urgency and weakness of stream; and SF, interest/satisfaction and impotence. Cronbach's alpha for the scales ranged from 0.63 to 0.94, and item-scale correlations and item-scale divergence correlations supported scale validity. Rising median scores correlated with rising levels of perceived bother. CONCLUSIONS: The questionnaire is a suitable tool for assessing HRQOL in three distinct dimensions for patients undergoing radiotherapy for PCa. Six dimensions of HRQOL were found to be related to bother, suggesting important relationships to be monitored for patients. Urgency of bowel movements, urgency of urination, and level of interest/satisfaction in sex correlated most strongly with bother.","Urology, 53(2): 359-366","USA",1999,"Any or unknown","Radiotherapy","Likert scale","Patient",null,"Validation","USA","Patient","Any or unknown","Radiotherapy",null,"Validation","Likert scale","1960:1999","Symptom,Complication"]
[154,"Dale, W., et al. (2011). \"The prevalence, correlates, and impact of logically inconsistent preferences in utility assessments for joint health states in prostate cancer.\" Med Care 49(1): 59-66.",null,"Dale, W., et al.","The prevalence, correlates, and impact of logically inconsistent preferences in utility assessments for joint health states in prostate cancer","BACKGROUND: Variations in health state utilities can impact cost-effectiveness analyses. One potential source of error is when joint health state (JS) utilities are rated higher than the embedded single state (SS) utilities. Knowing when and in whom this occurs can improve cost-effectiveness analyses. METHODS: Men (n = 323) were surveyed at the time of prostate biopsy. Time tradeoff SS and JS utilities for prevalent prostate cancer (PCa) health states were collected. JS utilities assessed included those most prevalent for PCa. \"Inconsistency\" was defined in the following 3 ways: (1) any size rank order violation; (2) total number of violations; and (3) differences greater than 1 standard deviation (SD). Regression analysis assessed independent patient characteristics associated with inconsistent responses. RESULTS: Aggregate JS utilities were consistent. At the individual level, 36% to 41% of responses violated rank order and 12% to 14% were larger than 1 SD. In all, 69% of respondents had at least 1 JS inconsistency, and 24% had >1 SD inconsistencies. Being married and feeling anxious were independently correlated with giving all types of inconsistent ratings, and lower education correlated with making >SD errors. SS utilities, and not JS utilities, were significantly lower for the inconsistent group. \"Correcting\" JS inconsistencies decreased aggregate utilities 1 to 9 units. CONCLUSIONS: Inconsistent JS utilities for PCa are prevalent in men at biopsy. Being married, more anxious, and having less education are correlated with inconsistencies. It is the SS utilities, rather than the JS utilities, that differ between consistent and inconsistent raters. Better understanding of the source of these inconsistencies is needed.","Med Care, 49(1): 59-66","USA",2011,"At risk","None","TTO","General population",null,"Validation","USA","General population","At risk","None",null,"Validation","TTO","2010:2014","Utility"]
[155,"Daubenmier, J. J., et al. (2006). \"Lifestyle and health-related quality of life of men with prostate cancer managed with active surveillance.\" Urology 67(1): 125-130.",null,"Daubenmier, J. J., et al.","Lifestyle and health-related quality of life of men with prostate cancer managed with active surveillance","OBJECTIVES: To assess the impact of lifestyle on health-related quality of life (HR-QOL), perceived stress, and self-reported sexual function in men with early-stage prostate cancer electing active surveillance. METHODS: A total of 44 intervention and 49 usual-care control participants were enrolled in a randomized clinical trial examining the effects of lifestyle changes on prostate cancer progression. The intervention consisted of a low-fat, vegan diet, exercise, and stress management. Participants completed the Medical Outcomes Study Short Form-36 Health Status Survey (a measure of mental and physical HR-QOL), the Perceived Stress Scale, the Sexual Function subscale of the University of California, Los Angeles, Prostate Cancer Index, and measures of lifestyle behaviors (to yield an overall lifestyle index) at baseline and 12 months. The data were analyzed using analysis of variance for repeated measures. The relationship between lifestyle and QOL was also analyzed using multiple linear regression analyses. RESULTS: Intervention participants had significantly improved their lifestyle compared with controls at 12 months. The quality-of-life scores were high across groups and time points. However, a healthier lifestyle was related to better QOL at baseline. Participants in both groups who reported a healthier lifestyle also reported better mental and physical HR-QOL and sexual function. Furthermore, participants whose lifestyle improved over time showed enhanced physical HR-QOL and decreased perceived stress. CONCLUSIONS: Men who choose active surveillance for early-stage prostate cancer are able to make comprehensive lifestyle changes. Although the average QOL was already high in this sample, individuals who improved their lifestyle enhanced their QOL further.","Urology, 67(1): 125-130","USA",2006,"Local","Surveillance","SF-36,UCLA-PCI,PcSS","Patient",null,"Clinical trial","USA","Patient","Local","Surveillance",null,"Clinical trial","SF-36,UCLA-PCI,PcSS","2005:2009","Utility,Disease,General"]
[156,"Davis, J. W., et al. (2001). \"Quality of life after treatment for localized prostate cancer: differences based on treatment modality.\" J Urol 166(3): 947-952.",null,"Davis, J. W., et al.","Quality of life after treatment for localized prostate cancer: differences based on treatment modality","PURPOSE: Brachytherapy with 103palladium (103Pd) is an increasingly administered treatment modality for localized prostate cancer. We compared general and disease specific health related quality of life after 103Pd treatment, radical prostatectomy and external beam radiation therapy given during the same time frame. MATERIALS AND METHODS: We performed a retrospective cross-sectional survey study of patients treated at a single community medical center between 1995 and 1999. We mailed 5 validated health related quality of life survey instruments to 269, 142 and 222 men who underwent radical prostatectomy, 103Pd treatment and external beam radiation therapy, respectively, with a response rate of greater than 80% in all groups. RESULTS: General health related quality of life assessed by the SF-36 showed the same scores in patients who underwent prostatectomy and 103Pd treatment. The University of California-Los Angeles Prostate Cancer Index was used to assess bowel, urinary and sexual function/bothersomeness. External beam radiation therapy reported was associated with worse bowel function and greater bowel bothersomeness. Prostatectomy was associated with worse urinary function compared to 103Pd and external beam radiation therapy. Prostatectomy was associated with worse sexual function than 103Pd or external beam radiation therapy, although nerve sparing surgery and erectile aids minimized the difference. American Urological Association symptom scores were initially higher for 103Pd but became equal to those in the other groups in patients treated greater than 12 months from survey time. Disease-free men who underwent prostatectomy and 103Pd brachytherapy were equally confident that cancer would not recur in the future. Satisfaction rates were equivalent and biochemical failure significantly decreased satisfaction in all groups. CONCLUSIONS: While general health related quality of life was mostly unaffected by the 3 most common treatments for prostate cancer, there were differences in bowel, urinary and sexual function. This information may aid patients in the decision making process.","J Urol, 166(3): 947-952","USA",2001,"Local","Radiotherapy,Surgery,Brachytherapy","SF-36,UCLA-PCI,AUA-SI","Patient",null,"Cross-sectional","USA","Patient","Local","Radiotherapy,Surgery,Brachytherapy",null,"Cross-sectional","SF-36,UCLA-PCI,AUA-SI","2000:2004","Disease,Utility,Symptom"]
[157,"Davison, B. J. and S. L. Goldenberg (2003). \"Decisional regret and quality of life after participating in medical decision-making for early-stage prostate cancer.\" BJU Int 91(1): 14-17.",null,"Davison, B. J. and S. L. Goldenberg","Decisional regret and quality of life after participating in medical decision-making for early-stage prostate cancer","OBJECTIVE: To determine the effect of men's reported levels of involvement in medical decision-making and quality of life (QoL) on their levels of decisional regret after definitive treatment. PATIENTS AND METHODS: Men referred to a hospital-based resource centre completed QoL and decisional-regret measures after definitive treatment for localized prostate cancer. Data from these questionnaires were linked with a previous study conducted to determine if providing individualized information to men newly diagnosed with prostate cancer would lower their levels of psychological distress and enable them to become more active participants in treatment decision-making. The preferred role in medical decision-making and QoL had previously been measured at the time of diagnosis and the assumed role at 4 months after the definitive treatment decision. This postal survey was conducted approximately 18 months after diagnosis. RESULTS: Of 74 men, 67 (91%) responded; the mean (sd) time since definitive treatment was 10.3 (4.7) months and the mean age of the men 62.5 (6.9) years. Radical prostatectomy was the most frequent treatment (72%). Most (94%) patients participated in medical decision-making either actively or collaboratively and did not regret their treatment choice. The type of definitive treatment received had no effect on decisional regret; patients' QoL scores were similar to the levels before treatment. Levels of sexual function were significantly lower after definitive treatment, but urinary incontinence was not significantly affected. Men who had neoadjuvant hormone therapy reported having significantly more treatment-related symptoms. CONCLUSIONS: There is no evidence that providing information to facilitate participation in medical decision-making causes decisional regret or psychological distress within the first year after definitive treatment. A longitudinal follow-up of these patients is required to adequately assess the long-term effects of treatment on QoL and decisional regret.","BJU Int, 91(1): 14-17","Canada",2003,"Local","Surgery","Unclear","Patient",null,"Cross-sectional","Canada","Patient","Local","Surgery",null,"Cross-sectional","Unclear","2000:2004","General,Satisfaction"]
[158,"Dawson, N. A., et al. (2000). \"A randomized study comparing standard versus moderately high dose megestrol acetate for patients with advanced prostate carcinoma: cancer and leukemia group B study 9181.\" Cancer 88(4): 825-834.",null,"Dawson, N. A., et al.","A randomized study comparing standard versus moderately high dose megestrol acetate for patients with advanced prostate carcinoma: cancer and leukemia group B study 9181","BACKGROUND: Megestrol acetate (MA) is a synthetic progestin with reported activity in both hormone-sensitive and hormone-refractory prostate carcinoma (HRPC). Based on limited data suggesting a possible dose-response effect, a trial was initiated to compare standard versus moderately high dose MA in HRPC. METHODS: One hundred forty-nine men with hormone-refractory prostate carcinoma were randomized to receive oral MA either at 160 mg/day (low dose) or 640 mg/day (high dose). Patients were stratified by performance status and measurable versus evaluable disease. The primary end point was tumor response. Secondary end points were survival, quality-of-life measures, and prostate specific antigen (PSA) decline. RESULTS: The median survival times of 11.2 months for patients who received the low dose and 12.1 months for patients who received the high dose therapy were not significantly different. Best response was equivalent in the 2 arms: 2 partial responses and 22 patients with stable disease for the 160 mg/day dose, and 1 partial response and 28 patients with stable disease for the 640 mg/day dose. A greater than 50% decline in PSA occurred in 13.8% and 8.8% of patients in the low and high dose treatment arms, respectively. There were no differences in the toxicity or quality-of-life outcomes between the two arms. Poorer performance status (2 vs. 0-1), greater than 5% weight loss, higher baseline PSA, and measurable disease all predicted shorter survival. CONCLUSIONS: MA has limited activity in hormone-refractory prostate carcinoma, and there is no apparent dose-response correlation.","Cancer, 88(4): 825-834","USA",2000,"Advanced","Hormonal","Unclear","Patient",null,"Clinical trial","USA","Patient","Advanced","Hormonal",null,"Clinical trial","Unclear","2000:2004","General"]
[159,"Dawson, N., et al. (2011). \"Health-related quality of life in pain-free or mildly symptomatic patients with metastatic hormone-resistant prostate cancer following treatment with the specific endothelin A receptor antagonist zibotentan (ZD4054).\" J Cancer Res Clin Oncol 137(1): 99-113.",null,"Dawson, N., et al.","Health-related quality of life in pain-free or mildly symptomatic patients with metastatic hormone-resistant prostate cancer following treatment with the specific endothelin A receptor antagonist zibotentan (ZD4054)","PURPOSE: Zibotentan (ZD4054) is a specific endothelin A receptor antagonist in clinical development for the treatment of hormone-resistant prostate cancer (HRPC). In a Phase II trial in patients with pain-free or mildly symptomatic metastatic HRPC, zibotentan was well tolerated with a promising signal for prolonged overall survival compared with placebo. As part of this trial, the impact of zibotentan compared with placebo on health-related quality of life (HRQoL) was assessed. METHODS: Patients were randomized to receive once-daily oral zibotentan 10 or 15 mg, or matching placebo. Patients were allocated to one of two questionnaires; the Functional Assessment of Cancer Therapy-Prostate (FACT-P) or the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), supplemented by PR25, specific for prostate cancer. Questionnaires were completed at baseline and every 4 weeks until disease progression when study treatment was discontinued. RESULTS: Compliance with questionnaire completion was >90% (286 of 312 patients) of the intention-to-treat population at baseline. Of baseline completers who were available for assessment (i.e., had not clinically progressed), 89% (164 of 184) and 83% (73 of 88) completed questionnaires at 12 and 24 weeks, respectively. HRQoL scores from both questionnaires were high at baseline and remained high throughout the study, with scores being similar in the zibotentan and placebo groups. However, some floor and ceiling effects were seen in the EORTC QLQ-C30 questionnaire. CONCLUSIONS: High-baseline HRQoL scores were maintained throughout treatment with zibotentan. The FACT-P instrument was selected to further assess the impact of zibotentan on HRQoL in the Phase III clinical trial program.","J Cancer Res Clin Oncol, 137(1): 99-113","UK",2011,"Metastatic","PDEi","FACT-P,EORTC QLQ-C30,EORTC QLQ-PR25","Patient",null,"Clinical trial","UK","Patient","Metastatic","PDEi",null,"Clinical trial","FACT-P,EORTC QLQ-C30,EORTC QLQ-PR25","2010:2014","Disease,General"]
[160,"de Cerqueira, M. A., et al. (2015). \"Burden of focal cryoablation versus brachytherapy versus active surveillance in the treatment of very low-risk prostate cancer: a preliminary head-to-head comprehensive assessment.\" Eur J Cancer Care (Engl) 24(6): 929-937.",null,"de Cerqueira, M. A., et al.","Burden of focal cryoablation versus brachytherapy versus active surveillance in the treatment of very low-risk prostate cancer: a preliminary head-to-head comprehensive assessment","Focal cryoablation (FC), brachytherapy (B) and active surveillance (AS) were offered to patients diagnosed with very low-risk prostate cancer (VLRPC) in an equal access protocol. Comprehensive validated self-report questionnaires accessed patients' erectile (IIEF-5) and voiding (IPSS) functions, Beck scales measured anxiety (BAI), hopelessness (BHS) and depression (BDI), SF-36 reflected patients' quality of life added to the emotional thermometers including five visual analogue scales (distress, anxiety, depression, anger and need for help). Kruskal-Wallis or ANOVA tests and Spearman's correlations were obtained among groups and studied variables. Thirty patients were included, median follow-up 18 months (15-21). Those on AS (n = 11) were older, presented higher hopelessness (BHS) and lower general health perceptions (SF-36) scores than patients opting for FC (n = 10) and B (n = 9), P = 0.0014, P = 0.0268 and P = 0.0168 respectively. Patients on B had higher IPSS scores compared to those under FC and AC, P = 0.0223. For all 30 included patients, Spearman's correlation (rs ) was very strong between BHS and general health perceptions (rs = -0.800, P < 0.0001), and weak/moderate between age and BHS (rs = 0.405, P = 0.026) and age and general health perceptions (rs = -0.564, P = 0.001). The sample power was >60%. To be considered in patients' counselling and care, current study supports the hypothesis that even VLRPC when untreated undermines psychosocial domains.","Eur J Cancer Care (Engl), 24(6): 929-937","Brazil",2015,"Local","Various,Brachytherapy,Surveillance","IIEF-5,IPSS,BAI,BHS,BDI,SF-36,VAS","Patient",null,"Clinical trial","Brazil","Patient","Local","Various,Brachytherapy,Surveillance",null,"Clinical trial","IIEF-5,IPSS,BAI,BHS,BDI,SF-36,VAS","2015:2018","Disease,Complication,Comorbidity,Utility"]
[161,"De Souza, P. L., et al. (2010). \"A phase II trial of weekly i.v. KW-2170 in advanced castrate-resistant prostate cancer.\" Asia Pac J Clin Oncol 6(4): 292-297.",null,"De Souza, P. L., et al.","A phase II trial of weekly i.v. KW-2170 in advanced castrate-resistant prostate cancer","AIM: KW-2170 is a novel pyrazoloacridone derivative that intercalates nucleic acids. It has promising in vitro properties against prostate and other cancers and is active in vivo against doxorubicin-resistant cell lines. We wished to investigate its activity and toxicity profile in this Phase II trial in androgen independent prostate cancer. METHODS: Overall 44 men were recruited to this multicenter, open label, non-randomized study, with 35 evaluable for prostatic specific antigen (PSA) response. RESULTS: Five patients had a PSA fall greater than 50% (overall RR 14.3%, 95% CI 4.8-30.3%). Overall median survival was 16 months. In the evaluable group (n = 35), median survival was 18.9 months. The drug was very well tolerated, with the most common toxicities being hematological (anemia, leucopenia, thrombocytopenia), alopecia, fatigue, and nausea. However, most of these were National Cancer Institute Grade 1 or 2; Grade 3 neutropenia occurred in only 11% of patients, and there was no Grade 4 neutropenia. Quality of life as measured by the FACT-P scale was not compromised. CONCLUSION: KW-2170 is a very well tolerated chemotherapy agent. It has a relatively low PSA response rate, and did not meet the pre-specified criteria for further studies.","Asia Pac J Clin Oncol, 6(4): 292-297","Australia",2010,"Advanced","Chemotherapy","FACT-P","Patient",null,"Clinical trial","Australia","Patient","Advanced","Chemotherapy",null,"Clinical trial","FACT-P","2010:2014","Disease"]
[162,"Dearnaley, D. P., et al. (2007). \"Escalated-dose versus standard-dose conformal radiotherapy in prostate cancer: first results from the MRC RT01 randomised controlled trial.\" Lancet Oncol 8(6): 475-487.",null,"Dearnaley, D. P., et al.","Escalated-dose versus standard-dose conformal radiotherapy in prostate cancer: first results from the MRC RT01 randomised controlled trial","BACKGROUND: In men with localised prostate cancer, conformal radiotherapy (CFRT) could deliver higher doses of radiation than does standard-dose conventional radical external-beam radiotherapy, and could improve long-term efficacy, potentially at the cost of increased toxicity. We aimed to present the first analyses of effectiveness from the MRC RT01 randomised controlled trial. METHODS: The MRC RT01 trial included 843 men with localised prostate cancer who were randomly assigned to standard-dose CFRT or escalated-dose CFRT, both administered with neoadjuvant androgen suppression. Primary endpoints were biochemical-progression-free survival (bPFS), freedom from local progression, metastases-free survival, overall survival, and late toxicity scores. The toxicity scores were measured with questionnaires for physicians and patients that included the Radiation Therapy Oncology Group (RTOG), the Late Effects on Normal Tissue: Subjective/Objective/Management (LENT/SOM) scales, and the University of California, Los Angeles Prostate Cancer Index (UCLA PCI) scales. Analysis was done by intention to treat. This trial is registered at the Current Controlled Trials website http://www.controlled-trials.com/ISRCTN47772397. FINDINGS: Between January, 1998, and December, 2002, 843 men were randomly assigned to escalated-dose CFRT (n=422) or standard-dose CFRT (n=421). In the escalated group, the hazard ratio (HR) for bPFS was 0.67 (95% CI 0.53-0.85, p=0.0007). We noted 71% bPFS (108 cumulative events) and 60% bPFS (149 cumulative events) by 5 years in the escalated and standard groups, respectively. HR for clinical progression-free survival was 0.69 (0.47-1.02; p=0.064); local control was 0.65 (0.36-1.18; p=0.16); freedom from salvage androgen suppression was 0.78 (0.57-1.07; p=0.12); and metastases-free survival was 0.74 (0.47-1.18; p=0.21). HR for late bowel toxicity in the escalated group was 1.47 (1.12-1.92) according to the RTOG (grade >/=2) scale; 1.44 (1.16-1.80) according to the LENT/SOM (grade >/=2) scales; and 1.28 (1.03-1.60) according to the UCLA PCI (score >/=30) scale. 33% of the escalated and 24% of the standard group reported late bowel toxicity within 5 years of starting treatment. HR for late bladder toxicity according to the RTOG (grade >/=2) scale was 1.36 (0.90-2.06), but this finding was not supported by the LENT/SOM (grade >/=2) scales (HR 1.07 [0.90-1.29]), nor the UCLA PCI (score >/=30) scale (HR 1.05 [0.81-1.36]). INTERPRETATION: Escalated-dose CFRT with neoadjuvant androgen suppression seems clinically worthwhile in terms of bPFS, progression-free survival, and decreased use of salvage androgen suppression. This additional efficacy is offset by an increased incidence of longer term adverse events.","Lancet Oncol, 8(6): 475-487","UK",2007,"Local","Radiotherapy","LENT-SOMA,UCLA-PCI,RTOG-EORTC-SS","Patient",null,"Clinical trial","UK","Patient","Local","Radiotherapy",null,"Clinical trial","LENT-SOMA,UCLA-PCI,RTOG-EORTC-SS","2005:2009","Disease,Treatment"]
[163,"Dearnaley, D. P., et al. (2007). \"The early toxicity of escalated versus standard dose conformal radiotherapy with neo-adjuvant androgen suppression for patients with localised prostate cancer: results from the MRC RT01 trial (ISRCTN47772397).\" Radiother Oncol 83(1): 31-41.",null,"Dearnaley, D. P., et al.","The early toxicity of escalated versus standard dose conformal radiotherapy with neo-adjuvant androgen suppression for patients with localised prostate cancer: results from the MRC RT01 trial (ISRCTN47772397)","BACKGROUND: Five-year disease-free survival rates for localised prostate cancer following standard doses of conventional radical external beam radiotherapy are around 80%. Conformal radiotherapy (CFRT) raises the possibility that radiotherapy doses can be increased and long-term efficacy outcomes improved, with safety an important consideration. METHODS: MRC RT01 is a randomised controlled trial of 862 men with localised prostate cancer comparing Standard CFRT (64Gy/32f) versus Escalated CFRT (74Gy/37f), both administered with neo-adjuvant androgen suppression. Early toxicity was measured using physician-reported instruments (RTOG, LENT/SOM, Royal Marsden Scales) and patient-reported questionnaires (MOS SF-36, UCLA Prostate Cancer Index, FACT-P). RESULTS: Overall early radiotherapy toxicity was similar, apart from increased bladder, bowel and sexual toxicity, in the Escalated Group during a short immediate post-radiotherapy period. Toxicity in both groups had abated by week 12. Using RTOG Acute Toxicity scores, cumulative Grade 2 bladder and bowel toxicity was 38% and 30% for Standard Group and 39% and 33% in Escalated Group, respectively. Urinary frequency (Royal Marsden Scale) improved in both groups from pre-androgen suppression to 6 months post-radiotherapy (p<0.001), but bowel and sexual functioning deteriorated. This pattern was supported by patient-completed assessments. Six months after starting radiotherapy the incidence of RTOG Grade > or = 2 side-effects was low (<1%); but there were six reports of rectal ulceration (6 Escalated Group), six haematuria (5 Escalated Group) and eight urethral stricture (6 Escalated Group). CONCLUSIONS: The two CFRT schedules with neo-adjuvant androgen suppression have broadly similar early toxicity profiles except for the immediate post-RT period. At 6 months and compared to before hormone therapy, bladder symptoms improved, whereas bowel and sexual symptoms worsened. These assessments of early treatment safety will be complemented by further follow-up to document late side-effects and efficacy.","Radiother Oncol, 83(1): 31-41","UK",2007,"Local","Radiotherapy,Hormonal","SF-36,UCLA-PCI,FACT-P,LENT-SOMA,RTOG-EORTC-SS,RMS","Patient",null,"Clinical trial","UK","Patient","Local","Radiotherapy,Hormonal",null,"Clinical trial","SF-36,UCLA-PCI,FACT-P,LENT-SOMA,RTOG-EORTC-SS,RMS","2005:2009","Disease,Treatment,Utility"]
[164,"Debruyne, F. J., et al. (1998). \"Liarozole--a novel treatment approach for advanced prostate cancer: results of a large randomized trial versus cyproterone acetate. Liarozole Study Group.\" Urology 52(1): 72-81.",null,"Debruyne, F. J., et al.","Liarozole--a novel treatment approach for advanced prostate cancer: results of a large randomized trial versus cyproterone acetate. Liarozole Study Group","OBJECTIVES: To compare the efficacy of oral liarozole, the first retinoic acid metabolism-blocking agent (RAMBA) to be developed as differentiation therapy for human solid tumors, with that of cyproterone acetate (CPA), an antiandrogen for the treatment of metastatic prostate cancer. Liarozole promotes differentiation of cancer cells by increasing the intratumoral levels of retinoic acid. METHODS: A total of 321 patients with metastatic prostate cancer in relapse after first-line endocrine therapy entered a Phase III international multicenter study (recruitment from February 1992 to August 1994) comparing liarozole (300 mg two times daily) with CPA (100 mg two times daily). RESULTS: Accounting for differences in baseline prognostic factors, the adjusted hazard ratio for survival was 0.74 in favor of liarozole (P = 0.039), indicating a 26% lower risk of death than in patients treated with CPA. Median crude (unadjusted) survival time was the same in the liarozole group as in the CPA group (10.3 months). More patients showed a PSA response (at least 50% reduction in PSA from baseline) when treated with liarozole (20%) than with CPA (4%) (P < 0.001). Prostate-specific antigen (PSA) responders had a median survival benefit of 10 months over nonresponders, irrespective of treatment (hazard ratio 0.43; P = 0.0018). PSA response was apparent within 3 months in approximately 90% of patients who responded. Pain improved more in the liarozole group than in the CPA group (P = 0.03). PSA responders had lower median pain scores than nonresponders (1.7 versus 2.5) and better quality of life (median Functional Living Index-Cancer score 108 versus 98) at end point, ie, treatment discontinuation, as well as throughout the treatment period. Among the most frequently occurring adverse events in the liarozole group were dry skin (51% of patients), pruritus (25%), rash (16%), nail disorders (16%), and hair loss (15%). These adverse events were generally mild to moderate in severity and did not affect the overall quality of life score. There were no detectable effects of either treatment on vital signs such as blood pressure, heart rate, electrocardiogram, and body weight. CONCLUSIONS: Liarozole is superior to CPA in terms of PSA response, PSA progression, and survival, and is capable of maintaining patients' quality of life. The observed adverse events were mild to moderate in nature. These results show that liarozole is a possible treatment option after first-line endocrine therapy has failed.","Urology, 52(1): 72-81","Netherlands",1998,"Metastatic","Various,Hormonal","FLIC","Patient",null,"Clinical trial","Netherlands","Patient","Metastatic","Various,Hormonal",null,"Clinical trial","FLIC","1960:1999","General"]
[165,"Deliveliotis, C., et al. (2004). \"Prostate operations: long-term effects on sexual and urinary function and quality of life. Comparison with an age-matched control population.\" Urol Res 32(4): 283-289.",null,"Deliveliotis, C., et al.","Prostate operations: long-term effects on sexual and urinary function and quality of life. Comparison with an age-matched control population","The purpose of this study was to investigate the effects of radical prostatectomy (RP) for prostate cancer, transurethral resection of the prostate (TURP) for benign prostate hyperplasia (BPH), and the alterations induced by ageing on quality of life, urinary and sexual function, and bother. We evaluated 283 patients who filled in and returned the questionnaire used. A total of 105 were treated with RP and were selected prostate cancer patients with localised disease without recurrences. An additional 98 underwent TURP for BPH and a third group consisted of 80 apparently healthy men. The general quality of life was estimated by the Rand 36-Item Health Survey 1.0. Urinary function was estimated by the AUA Symptom Index and the UCLA Prostate Cancer Index (urinary function and bother scale). Sexual function and bother, were explored using the Brief Male Sexual Function Inventory for Urology. Patient outcome 2 years post treatment was compared to the pre-treatment status and to that of the matched control population. General quality of life was not affected by RP or TURP, with the exception of an increase in the emotional/well being domain in RP patients to control group levels. After RP there was more bother reported for the urinary function than urinary malfunction itself, while TURP, as expected, restored urinary function and bother to normal population norms. Elderly males had urinary function and bother similar to the operated patients. Estimating sexual function on RP patients, erectile dysfunction (ED) predominates, leading to decreased sexual life. TURP marginally affects sexual life, mainly due to the loss of ejaculation, while in men from the control group, sexual function, although affected, was still present.","Urol Res, 32(4): 283-289","Greece",2004,"Local","Surgery","UCLA-PCI,BSFI,AUA-SI,SF-36","Patient",null,"Cross-sectional","Greece","Patient","Local","Surgery",null,"Cross-sectional","UCLA-PCI,BSFI,AUA-SI,SF-36","2000:2004","Disease,Complication,Utility,Symptom"]
[166,"Demark-Wahnefried, W., et al. (2006). \"Lifestyle intervention development study to improve physical function in older adults with cancer: outcomes from Project LEAD.\" J Clin Oncol 24(21): 3465-3473.",null,"Demark-Wahnefried, W., et al.","Lifestyle intervention development study to improve physical function in older adults with cancer: outcomes from Project LEAD","PURPOSE: Declines in physical functioning (PF) among elderly cancer patients threaten quality of life and the ability to maintain independence. Adherence to healthy lifestyle behaviors may prevent functional decline. PATIENTS AND METHODS: Project Leading the Way in Exercise and Diet (LEAD), an intervention development study of the Pepper Older Americans Independence Center, aimed to determine whether breast and prostate cancer survivors (age 65+ years) assigned to a 6-month home-based diet and exercise intervention experienced improvements in PF when compared with an attention control arm receiving general health information. An accrual target was set at 420, and PF (Short Form-36 subscale), physical activity (Community Healthy Activities Models Program for Seniors), and diet quality (index from 3-day recalls) were assessed at baseline and at 6 and 12 months (6 months after intervention). RESULTS: This developmental project did not achieve its accrual target (N = 182); however, PF change scores were in the direction and of the magnitude projected. Baseline to 6-month change scores in the intervention versus the control arms were as follows: PF, +3.1 v -0.5 (P = .23); physical activity energy expenditure, +111 kcal/wk v -400 kcal/wk (P = .13); and diet quality index, +2.2 v -2.9 (P = .003), respectively. Differences between arms diminished during the postintervention period. CONCLUSION: These findings suggest that home-based diet and exercise interventions hold promise in improving lifestyle behaviors among older cancer survivors, changes that trend toward improved PF. Future studies should incorporate larger sample sizes and interventions that sustain long-term effects and also take into account secular trends; these efforts will require adequate planning and resources to overcome the numerous barriers to intervening in this difficult to reach yet vulnerable population.","J Clin Oncol, 24(21): 3465-3473","USA",2006,"Survivors","Various","SF-36,CHAMPS","Patient",null,"Clinical trial","USA","Patient","Survivors","Various",null,"Clinical trial","SF-36,CHAMPS","2005:2009","Utility,General"]
[167,"Demark-Wahnefried, W., et al. (2007). \"Main outcomes of the FRESH START trial: a sequentially tailored, diet and exercise mailed print intervention among breast and prostate cancer survivors.\" J Clin Oncol 25(19): 2709-2718.",null,"Demark-Wahnefried, W., et al.","Main outcomes of the FRESH START trial: a sequentially tailored, diet and exercise mailed print intervention among breast and prostate cancer survivors","PURPOSE: Cancer survivors are at increased risk for cardiovascular disease, diabetes, osteoporosis, and second primary tumors. Healthful lifestyle practices may improve the health and well-being of survivors. The FRESH START trial tested the efficacy of sequentially tailored versus standardized mailed materials on improving cancer survivors' diet and exercise behaviors. METHODS: Five hundred forty-three individuals with newly diagnosed locoregional breast or prostate cancer were recruited from 39 states and two provinces within North America. Participants were randomly assigned either to a 10-month program of tailored mailed print materials promoting fruit and vegetable (F&V) consumption, reducing total/saturated fat intake, and/or increasing exercise or to a 10-month program of nontailored mailed materials on diet and exercise available in the public domain. Telephone surveys conducted at baseline and 1 year assessed body mass index (BMI), dietary consumption, physical activity, and other psychosocial/behavioral indices. Clinical assessments were conducted on a 23% subsample; information was used to validate self-reports. RESULTS: Five hundred nineteen participants completed the 1-year follow-up (4.4% attrition; sample characteristics: 57 +/- 10.8 years old, 83% white, 56% female, 64% overweight/obese, and 0% underweight). Although both arms significantly improved their lifestyle behaviors (P < .05), significantly greater gains occurred in the FRESH START intervention versus the control arm (practice of two or more goal behaviors: +34% v +18%, P < .0001; exercise minutes per week: +59.3 v +39.2 minutes, P = .02; F&V per day: +1.1 v +0.6 servings, P = .01; total fat: -4.4% v -2.1%, P < .0001; saturated fat: -1.3% v -0.3%, P < .0001; and BMI: -0.3 v +0.1 kg/m2, respectively, P = .004). CONCLUSION: Mailed material interventions, especially those that are tailored, are effective in promoting healthful lifestyle changes among cancer survivors. Further study is needed to determine sustainability, cost to benefit, and generalizability to other cancer populations.","J Clin Oncol, 25(19): 2709-2718","USA",2007,"Survivors","Various","Interview","Patient",null,"Clinical trial","USA","Patient","Survivors","Various",null,"Clinical trial","Interview","2005:2009","General"]
[168,"Descazeaud, A., et al. (2005). \"Evolution of health-related quality of life two to seven years after retropubic radical prostatectomy: evaluation by UCLA prostate cancer index.\" World J Urol 23(4): 257-262.",null,"Descazeaud, A., et al.","Evolution of health-related quality of life two to seven years after retropubic radical prostatectomy: evaluation by UCLA prostate cancer index","To determine changes in health-related quality of life (HRQOL) in patients treated with retropubic radical prostatectomy (RP) between two and seven years after surgery. A questionnaire from the University of California Los Angeles Prostate Index was sent to 142 patients previously treated with retropubic RP as mono-therapy for clinically localized prostate cancer. Patients were divided into five groups according to time from surgery. Demographics, clinical and pathological characteristics of patients were compared between these groups. Correlation coefficients controlled for age at the time of questionnaire between HRQOL scores and time from RP were assessed. A total of 105 patients (74%) returned the questionnaire. The mean time from surgery was 48 months (range 25-84). Demographics, clinical and pathological characteristics of patients were not statistically different between time groups. Several recoding items were found to decrease significantly with the time from RP including physical functioning, role limitations due to physical health problem, vitality, and general health. In contrary, urinary, bowel and sexual scores were not significantly correlated to time from RP. Although sexual, urinary and bowel scores seem to remain stable from 2 to 7 years following RP, general health appears to significantly deteriorate with time after RP, independent of the patient's age at the time of the questionnaire.","World J Urol, 23(4): 257-262","France",2005,"Local","Surgery","UCLA-PCI","Patient",null,"Cross-sectional","France","Patient","Local","Surgery",null,"Cross-sectional","UCLA-PCI","2005:2009","Disease"]
[169,"Devlin, N., et al. (2017). \"Health-related quality of life effects of enzalutamide in patients with metastatic castration-resistant prostate cancer: an in-depth post hoc analysis of EQ-5D data from the PREVAIL trial.\" Health Qual Life Outcomes 15(1): 130.",null,"Devlin, N., et al.","Health-related quality of life effects of enzalutamide in patients with metastatic castration-resistant prostate cancer: an in-depth post hoc analysis of EQ-5D data from the PREVAIL trial","BACKGROUND: The effect of enzalutamide on health-related quality of life (HRQoL) in the PREVAIL trial in chemotherapy-naive men with metastatic castration-resistant prostate cancer was analyzed using the generic EQ-5D instrument. METHODS: Patients received oral enzalutamide 160 mg/day (n = 872) or placebo (n = 845). EQ-5D index and EQ-5D visual analogue scale (EQ-5D VAS) scores were evaluated at baseline, week 13, and every 12 weeks until week 61 due to sample size reduction thereafter. Changes on individual dimensions were assessed, and Paretian Classification of Health Change (PCHC) and time-to-event analyses were conducted. RESULTS: With enzalutamide, EQ-5D index and EQ-5D VAS scores declined more slowly versus placebo and time to diverge from full health was prolonged. Average decline in EQ-5D index (-0.042 vs. -0.070; P < .0001) and EQ-5D VAS (-1.3 vs. -4.4; P < .0001) was significantly smaller with enzalutamide. There were significant (P < .05) between-group differences favoring enzalutamide in Pain/Discomfort to week 37, Anxiety/Depression at week 13, and Usual Activities at week 25, but no significant differences for Mobility and Self-care. The PCHC analysis showed more enzalutamide patients reporting improvement than placebo patients at weeks 13, 25, and 49 (all P < .05) and week 37 (P = .0512). Enzalutamide was superior (P </= .0003) to placebo for time to diverge from full health and time to first deterioration on Pain/Discomfort and Anxiety/Depression dimensions. CONCLUSIONS: This in-depth post hoc analysis showed that enzalutamide delayed HRQoL deterioration and had beneficial effects on several HRQoL domains, including Pain/Discomfort and the proportion of patients in full health, compared with placebo, and may help to support future analyses of this type. TRIAL REGISTRATION: NCT01212991.","Health Qual Life Outcomes, 15(1): 130","UK,Spain,Netherlands,Belgium,France,USA",2017,"Metastatic","Chemotherapy","EQ-5D","Patient",null,"Clinical trial","UK,Spain,Netherlands,Belgium,France,USA","Patient","Metastatic","Chemotherapy",null,"Clinical trial","EQ-5D","2015:2018","Utility"]
[170,"Di Lorenzo, G., et al. (2003). \"External beam radiotherapy in bone metastatic prostate cancer: impact on patients' pain relief and quality of life.\" Oncol Rep 10(2): 399-404.",null,"Di Lorenzo, G., et al.","External beam radiotherapy in bone metastatic prostate cancer: impact on patients' pain relief and quality of life","Bone metastases are a severe problem in oncology, since they usually are associated with pain. External beam radiation therapy (EBRT) has been, for many years, an important component of the treatment regimen to relieve pain. We have performed a clinical study to evaluate the relationship of response to EBRT in terms of pain relief and improvement in quality of life (QoL). We were also interested in the incidence of acute toxicity with EBRT. We have prospectively evaluated 75 patients (median age 68 years, range 64-79 years) with bone metastases from prostate cancer treated with EBRT, radiographically documented from June 1999 to September 2000. Additional therapies in these patients included: second-line hormonal therapy (HT) in 20 patients, chemotherapy (CT) in 25 patients, biphosphonates in 45 patients. For all patients a pain and narcotic evaluation was done before entering the study. Assessment of response was carried out by evaluating pain relief. QoL was measured by using the EORTC QLQ-C30 questionnaire. Toxicity analysis was based on the ROTG grading system. Survival was calculated by Kaplan-Meier estimate from the start of EBRT treatment until the last follow-up or death. A total of 61 out of 75 patients (81%) experienced some type of pain relief after treatment. The complete response rate was 23%. No significant difference in the response rates was found between the group treated with EBRT alone versus the groups treated with EBRT + CT or EBRT + HT. We noted a significant improvement in some of the scales of the considered EORTC-QLQC30 questionnaire. As expected all treatment-related complications were either grade 1-2 acute or subacute and transitory in nature. The group treated with EBRT + CT experienced slightly higher toxicity rates. There were no treatment-related fatalities. Forteen patients of 61 (23%) responders was alive at 12 months. Our results confirm the ability of EBRT to relieve bony pain in the majority of the cancer patients treated as measured by prospective analysis of pain scales prior to and after EBRT. Minimal side effects were experienced and QoL improved as shown by the results of the specific questionnaire.","Oncol Rep, 10(2): 399-404","Italy",2003,"Metastatic","Radiotherapy,Chemotherapy,Hormonal,Bisphosphonate","EORTC QLQ-C30","Patient",null,"Clinical trial","Italy","Patient","Metastatic","Radiotherapy,Chemotherapy,Hormonal,Bisphosphonate",null,"Clinical trial","EORTC QLQ-C30","2000:2004","General"]
[171,"Dickinson, L., et al. (2013). \"A multi-centre prospective development study evaluating focal therapy using high intensity focused ultrasound for localised prostate cancer: The INDEX study.\" Contemp Clin Trials 36(1): 68-80.",null,"Dickinson, L., et al.","A multi-centre prospective development study evaluating focal therapy using high intensity focused ultrasound for localised prostate cancer: The INDEX study","INTRODUCTION: Focal therapy offers the possibility of cancer control, without the side effect profile of radical therapies. Early single centre prospective development studies using high intensity focused ultrasound (HIFU) have demonstrated encouraging genitourinary functional preservation and short-term cancer control. Large multi-centre trials are required to evaluate medium-term cancer control and reproduce functional recovery. We describe the study design of an investigator-led UK multi-centre, single arm trial using HIFU to deliver focal therapy for men with localised prostate cancer. METHODS: One-hundred and forty men with histologically proven localised low or intermediate risk prostate cancer (PSA < 15, Gleason </= 7, </= T2cN0M0) will undergo precise characterisation of the prostate using a combination of multi-parametric (mp)MRI and transperineal template prostate mapping (TPM) biopsies. Unilateral dominant tumours, the so-called index lesion, will be eligible for treatment provided the contra-lateral side is free of 'clinically significant' disease (as defined by Gleason >/= 7 or maximum cancer core length >/=4 mm). Patients will receive focal therapy using HIFU (Sonablate 500(R)). Treatment effect will be assessed by targeted biopsies of the treated area and TPM biopsies at 36-months. RESULTS: Primary outcome is the absence of clinically significant disease based on 36-month post-treatment TPM biopsies. Secondary outcomes address a) genitourinary function using validated patient questionnaires (IPSS, IPSS-QoL, IIEF-15, EPIC-Urinary, EPIC-Bowel, FACT-P, EQ-5D), b) the predictive validity of imaging, and c) risk factors for treatment failure. CONCLUSIONS: INDEX will be the first multi-centre, medium term follow-up trial to evaluate the outcomes of a tissue preserving strategy for men with localised prostate cancer using the TPM-ablate-TPM strategy.","Contemp Clin Trials, 36(1): 68-80","UK",2013,"Local","HIFU","IPSS,IIEF-5,EPIC,FACT-P,EQ-5D","Patient",null,"Protocol","UK","Patient","Local","HIFU",null,"Protocol","IPSS,IIEF-5,EPIC,FACT-P,EQ-5D","2010:2014","Disease,Complication,Utility,Symptom"]
[172,"Diefenbach, M. A., et al. (2003). \"Clinical, demographic and psychosocial correlates of complementary and alternative medicine use by men diagnosed with localized prostate cancer.\" J Urol 170(1): 166-169.",null,"Diefenbach, M. A., et al.","Clinical, demographic and psychosocial correlates of complementary and alternative medicine use by men diagnosed with localized prostate cancer","PURPOSE: We examined complementary and alternative medicine (CAM) use among men who received standard therapy for localized prostate cancer. MATERIALS AND METHODS: A total of 417 men completed a questionnaire 6 months after their treatment decision assessing clinical and psychosocial variables and use of 41 available CAM therapies grouped into the 2 general categories of herbal/dietary and nonherbal (i.e. mind-body, bioelectromagnetic, traditional/folk medicine, pharmacological/biological). RESULTS: The prostate cancer diagnosis prompted 19% of our sample to start using some form of CAM for prostate health, and 67% of men reported having used some form of CAM for prostate health before being diagnosed. Initiation of CAM was associated with being a member of an ethnic minority group and a higher level of education. Initiation of nonherbal CAM was associated with being married, while use of herbal CAM therapies was significantly associated with choosing observation. Herbal use before diagnosis was associated with being white, higher level of education and being single. Prostate specific antigen at diagnosis, Gleason score, quality of life, participant perceptions of seriousness of prostate cancer or self-reported worry about prostate cancer were not related to initiation or prior use. Of those men reporting current use almost 50% did not inform their treating physician of using CAM therapies. CONCLUSIONS: Initiation of CAM therapies as a result of a prostate cancer diagnosis was fairly low, although two-thirds of men had used it before diagnosis. Half of the patients did not inform their physicians about such use and physicians should continue to probe patients about CAM use.","J Urol, 170(1): 166-169","USA",2003,"Local","Psychological,Various","Unclear","Patient",null,"Cross-sectional","USA","Patient","Local","Psychological,Various",null,"Cross-sectional","Unclear","2000:2004","General,Views"]
[173,"Dieperink, K. B., et al. (2013). \"The effects of multidisciplinary rehabilitation: RePCa-a randomised study among primary prostate cancer patients.\" Br J Cancer 109(12): 3005-3013.",null,"Dieperink, K. B., et al.","The effects of multidisciplinary rehabilitation: RePCa-a randomised study among primary prostate cancer patients","BACKGROUND: The objective of this study is the effectiveness of multidisciplinary rehabilitation on treatment-related adverse effects after completed radiotherapy in patients with prostate cancer (PCa). METHODS: In a single-centre oncology unit in Odense, Denmark, 161 PCa patients treated with radiotherapy and androgen deprivation therapy were randomly assigned to either a programme of two nursing counselling sessions and two instructive sessions with a physical therapist (n=79) or to usual care (n=82). Primary outcome was Expanded Prostate Cancer Index Composite (EPIC-26) urinary irritative sum-score. Before radiotherapy, pre-intervention 4 weeks after radiotherapy, and after a 20-week intervention, measurements included self-reported disease-specific quality of life (QoL; EPIC-26, including urinary, bowel, sexual, and hormonal symptoms), general QoL (Short-form-12, SF-12), pelvic floor muscle strength (Modified Oxford Scale), and pelvic floor electromyography. Intension-to-treat analyses were made with adjusted linear regression. RESULTS: The intervention improved, as compared with controls, urinary irritative sum-score 5.8 point (Cohen's d=0.40; P=0.011), urinary sum-score (d=0.34; P=0.023), hormonal sum-score (d=0.19; P=0.018), and the SF-12 Physical Component Summary, d=0.35; P=0.002. Patients with more severe impairment gained most. Pelvic floor muscle strength measured by electromyography declined in both groups, P=0.0001. CONCLUSION: Multidisciplinary rehabilitation in irradiated PCa patients improved urinary and hormonal symptoms, and SF-12 physical QoL.","Br J Cancer, 109(12): 3005-3013","Denmark",2013,"Any or unknown","Radiotherapy,Various,Hormonal","EPIC,SF-12","Patient",null,"Clinical trial","Denmark","Patient","Any or unknown","Radiotherapy,Various,Hormonal",null,"Clinical trial","EPIC,SF-12","2010:2014","Disease,Utility"]
[174,"Doria, C., et al. (2017). \"Treatment of osteoporosis secondary to hypogonadism in prostate cancer patients: a prospective randomized multicenter international study with denosumab vs. alendronate.\" Minerva Urol Nefrol 69(3): 271-277.",null,"Doria, C., et al.","Treatment of osteoporosis secondary to hypogonadism in prostate cancer patients: a prospective randomized multicenter international study with denosumab vs. alendronate","BACKGROUND: Osteoporosis is a complication of androgen deprivation therapy (ADT) in men with prostate carcinoma. This is a multicenter, randomized, double-blind prospective study on use of denosumab versus alendronate in the therapy of secondary osteoporosis related to ADT. METHODS: A total of 234 patients with diagnosis of osteoporosis underwent ADT for prostate cancer were enrolled. Patients were randomly assigned 1:1 to receive denosumab 60 mg subcutaneously every 6 months or alendronate (70 mg/week) for 2 years. All patient received supplemental vitamin D (600 IU/day) and supplemental calcium to maintain a calcium intake of 1200 mg per day. Effectiveness of therapy in both groups (denosumab group and alendronate group) was assessed by changes in bone turnover markers (BTMs), bone mineral density, fracture incidence, Visual Analogue Scale score for back pain, and Short Form-8 health survey score for health-related quality of life. RESULTS: In the denosumab study group, level of BTMs for bone formation were significantly increased from baseline at all time points during the study (P<0.001); in the alendronate study group level of BTMs for bone formation were increased too (P>0.05). Mean changes in BMD at final follow-up differed significantly between two groups. BMD changes at the lumbar spine at 24 months were 5.6% with denosumab vs. -1.1% with alendronate (P<0.001). CONCLUSIONS: Denosumab and alendronate showed similar clinical efficacy in the therapy of ADT-related osteoporosis in men with prostate carcinoma; both drugs provided significant improvements in back pain and general health conditions. Denosumab showed significant increase of BTMs and BMD than alendronate with lower rate of new vertebral fractures.","Minerva Urol Nefrol, 69(3): 271-277","Italy,France,Switzerland",2017,"Any or unknown","Various,Bisphosphonate","VAS,SF-8","Patient",null,"Clinical trial","Italy,France,Switzerland","Patient","Any or unknown","Various,Bisphosphonate",null,"Clinical trial","VAS,SF-8","2015:2018","Utility,Complication"]
[175,"Dragicevic, S. (2010). \"Evaluation of health-related quality of life in patients with prostate cancer after treatment with radical retropubic prostatectomy and permanent prostate brachytherapy.\" Urol Int 85(2): 173-179.",null,"Dragicevic, S.","Evaluation of health-related quality of life in patients with prostate cancer after treatment with radical retropubic prostatectomy and permanent prostate brachytherapy","AIM: The aims of this study were to evaluate the health-related quality of life (HRQOL) and make the treatment decision less difficult. METHODS: Between 2007 and 2009 radical retropubic prostatectomy (RRP) was performed in 96 patients and permanent prostate brachytherapy (PPB) in 88 patients at our hospital. The general and disease-specific HRQOL was measured using two instruments, the Medical Outcome Study 8-Item Short-Form Health Survey (SF-8) and the expanded prostate index composite (EPIC). RESULTS: Comparing RRP and PPB, there were significant differences in all scores except for general health in the 1st month after treatment which had the same score in both groups. The baseline quality of life scores in physical function (p < 0.05), physical role (p < 0.01), social functioning (p < 0.01), emotional role (p < 0.01) and mental health (p < 0.01) showed significant differences between the group and were better in the PPB group than in the RRP group. The physical component summary score in the PPB group was better than in the RRP group in the 1st month (p < 0.01) but recovered up to 3 months in the RRP group. The urinary bother and irritative/obstructive scores in the 1st month were worse from baseline in both groups (p < 0.05) and remained significantly worse up to 6 months in the PPB group than in the RRP group where these scores recovered within 3 months. The urinary incontinence score in the RRP group was still worse than in the PPB group up to 12 months (p < 0.01). Bowel function and bother were significantly better in the RRP group at 3 (p < 0.05) and 6 months (p < 0.01) than in the PPB group where bowel function at 12 months was worse than at baseline and in the RRP group. Sexual function (p < 0.01) and sexual bother were better in the PPB group and did not change until 12 months. CONCLUSION: The difference in disease-specific quality of life has become clearer using EPIC. As with other published studies, our results provide important information that will therefore be useful for selecting the optimal treatments for localized prostate cancer.","Urol Int, 85(2): 173-179","Serbia",2010,"Any or unknown","Brachytherapy,Surgery","EPIC,SF-8","Patient",null,"Cohort","Serbia","Patient","Any or unknown","Brachytherapy,Surgery",null,"Cohort","EPIC,SF-8","2010:2014","Disease,Utility"]
[176,"Duncan, G. G., et al. (2000). \"Report on the quality of life analysis from the phase III trial of pion versus photon radiotherapy in locally advanced prostate cancer.\" Eur J Cancer 36(6): 759-765.",null,"Duncan, G. G., et al.","Report on the quality of life analysis from the phase III trial of pion versus photon radiotherapy in locally advanced prostate cancer","This report examines the quality of life (QOL) of 215 patients entered into a randomised trial between pion and photon radiotherapy for prostate cancer at a single institution. The survival and local control results of the trial were equivalent in both arms. A modification of the Rotterdam Symptom Checklist (RSCL) was used to assess QOL. Global QOL, toxicity and physical scores were found to be worse in pion-treated patients at the end of treatment (P<0.001, P<0.001, and P=0.02 respectively). There are no long-term differences in the QOL of pion- versus photon-treated patients. Sexual function was a concern for patients even at baseline. There was a progressive loss of sexual interest and erectile function. There was a significant impact from hormonal therapy at relapse. Hormonal treatment produced a stepwise significant worsening in global QOL, particularly for physical and psychological domains.","Eur J Cancer, 36(6): 759-765","Canada",2000,"Any or unknown","Radiotherapy","RSCL","Patient",null,"Clinical trial","Canada","Patient","Any or unknown","Radiotherapy",null,"Clinical trial","RSCL","2000:2004","Symptom"]
[177,"Eandi, J. A., et al. (2002). \"Can single dose preoperative intrathecal morphine sulfate provide cost-effective postoperative analgesia and patient satisfaction during radical prostatectomy in the current era of cost containment?\" Prostate Cancer Prostatic Dis 5(3): 226-230.",null,"Eandi, J. A., et al.","Can single dose preoperative intrathecal morphine sulfate provide cost-effective postoperative analgesia and patient satisfaction during radical prostatectomy in the current era of cost containment?","We retrospectively analyzed the analgesic efficacy and surgical outcomes of a single preoperative intrathecal long-acting morphine sulfate injection (0.25-0.5 mg) and postoperative intravenous (i.v.) ketorolac in 62 patients who underwent radical retropubic prostatectomy (RRP). Total postoperative analgesic requirement was documented along with assessment of length of hospital stay, pain control and time for resumption of normal activity. Postoperatively, 45% of patients required only nonsteroidal agents (ketorolac), whereas 55% needed a mean of 13.3 mg of supplemental i.v. morphine sulfate. Mean hospital stay was 2.3+/-0.3 days. Eighty-two per cent of patients felt the length of hospital stay adequate. Ninety-seven per cent of patients were satisfied with anesthesia selected and 95% of patients considered pain control on postoperative days 1 and 2 as effective. All patients resumed to full physical activity by 5.3+/-0.4 weeks after surgery. We conclude that a single preoperative injection of intrathecal morphine sulfate combined with i.v. ketorolac postoperatively results in effective analgesia, diminished supplemental narcotic requirement and high patient satisfaction during radical retropubic prostatectomy.","Prostate Cancer Prostatic Dis, 5(3): 226-230","USA",2002,"Any or unknown","Surgery,Various","Unclear","Patient",null,"Cohort","USA","Patient","Any or unknown","Surgery,Various",null,"Cohort","Unclear","2000:2004","Satisfaction"]
[178,"Efficace, F., et al. (2003). \"Beyond the development of health-related quality-of-life (HRQOL) measures: a checklist for evaluating HRQOL outcomes in cancer clinical trials--does HRQOL evaluation in prostate cancer research inform clinical decision making?\" J Clin Oncol 21(18): 3502-3511.",null,"Efficace, F., et al.","Beyond the development of health-related quality-of-life (HRQOL) measures: a checklist for evaluating HRQOL outcomes in cancer clinical trials--does HRQOL evaluation in prostate cancer research inform clinical decision making?","PURPOSE: The aim of this study was to evaluate whether the inclusion of health-related quality of life (HRQOL), as a part of the trial design in a randomized controlled trial (RCT) setting, has supported clinical decision making for the planning of future medical treatments in prostate cancer. MATERIALS AND METHODS: A minimum standard checklist for evaluating HRQOL outcomes in cancer clinical trials was devised to assess the quality of the HRQOL reporting and to classify the studies on the grounds of their robustness. It comprises 11 key HRQOL issues grouped into four broader sections: conceptual, measurement, methodology, and interpretation. Relevant studies were identified in a number of databases, including MEDLINE and the Cochrane Controlled Trials Register. Both their HRQOL and traditional clinical reported outcomes were systematically analyzed to evaluate their consistency and their relevance for supporting clinical decision making. RESULTS: Although 54% of the identified studies did not show any differences in traditional clinical end points between treatment arms and 17% showed a difference in overall survival, 74% of the studies showed some difference in terms of HRQOL outcomes. One third of the RCTs provided a comprehensive picture of the whole treatment including HRQOL outcomes to support their conclusions. CONCLUSION: A minimum set of criteria for assessing the reported outcomes in cancer clinical trials is necessary to make informed decisions in clinical practice. Using a checklist developed for this study, it was found that HRQOL is a valuable source of information in RCTs of treatment in metastatic prostate cancer.","J Clin Oncol, 21(18): 3502-3511","International",2003,"Metastatic","None","Unclear","Patient",null,"Systematic review","International","Patient","Metastatic","None",null,"Systematic review","Unclear","2000:2004","General"]
[179,"Efficace, F., et al. (2003). \"Health related quality of life in prostate carcinoma patients: a systematic review of randomized controlled trials.\" Cancer 97(2): 377-388.",null,"Efficace, F., et al.","Health related quality of life in prostate carcinoma patients: a systematic review of randomized controlled trials","BACKGROUND: Health related quality of life (HRQOL) is increasingly reported as an important endpoint in cancer clinical trials. However, evidence suggests that HRQOL reporting is often inadequate. Given this, the authors undertook a systematic review to evaluate HRQOL assessment methodology and reported outcomes of randomized controlled clinical trials (RCTs) with prostate carcinoma patients. METHODS: A comprehensive search of the literature from 1980 to 2001, mainly on the following databases, was undertaken: MedLine, Cancerlit, and the Cochrane Controlled Trials Register. Studies were identified according to a predefined coding scheme, including HRQOL measure, cultural validity, compliance data reported and the clinical significance of the results. RESULTS: Twenty-five RCTs were identified, involving 8015 patients primarily with metastatic cancer. Bicalutamide was the medical treatment against which most treatment comparisons were made. Limitations identified included the fact that only 44% of the studies gave a rationale for selecting a specific HRQOL measure, 64% of the studies failed to report information about the administration of the HRQOL measure, and 56% failed to report compliance at baseline. The measure most often used was the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Care 30 (EORTC QLQ-C30), although some studies used non-validated HRQOL tools. CONCLUSIONS: The current study revealed a lack of a uniform approach to HRQOL assessment and several methodologic limitations. It is possible that such methodologic limitations have influenced trial findings for HRQOL outcomes.","Cancer, 97(2): 377-388","International",2003,"Metastatic","Hormonal","EORTC QLQ-C30","Patient",null,"Systematic review","International","Patient","Metastatic","Hormonal",null,"Systematic review","EORTC QLQ-C30","2000:2004","General"]
[180,"Efficace, F., et al. (2014). \"Patient-reported outcomes in randomised controlled trials of prostate cancer: methodological quality and impact on clinical decision making.\" Eur Urol 66(3): 416-427.",null,"Efficace, F., et al.","Patient-reported outcomes in randomised controlled trials of prostate cancer: methodological quality and impact on clinical decision making","CONTEXT: Patient-reported outcomes (PRO) data from randomised controlled trials (RCTs) are increasingly used to inform patient-centred care as well as clinical and health policy decisions. OBJECTIVE: The main objective of this study was to investigate the methodological quality of PRO assessment in RCTs of prostate cancer (PCa) and to estimate the likely impact of these studies on clinical decision making. EVIDENCE ACQUISITION: A systematic literature search of studies was undertaken on main electronic databases to retrieve articles published between January 2004 and March 2012. RCTs were evaluated on a predetermined extraction form, including (1) basic trial demographics and clinical and PRO characteristics; (2) level of PRO reporting based on the recently published recommendations by the International Society for Quality of Life Research; and (3) bias, assessed using the Cochrane Risk of Bias tool. Studies were systematically analysed to evaluate their relevance for supporting clinical decision making. EVIDENCE SYNTHESIS: Sixty-five RCTs enrolling a total of 22 071 patients were evaluated, with 31 (48%) in patients with nonmetastatic disease. When a PRO difference between treatments was found, it related in most cases to symptoms only (n=29, 58%). Although the extent of missing data was generally documented (72% of RCTs), few reported details on statistical handling of this data (18%) and reasons for dropout (35%). Improvements in key methodological aspects over time were found. Thirteen (20%) RCTs were judged as likely to be robust in informing clinical decision making. Higher-quality PRO studies were generally associated with those RCTs that had higher internal validity. CONCLUSIONS: Including PRO in RCTs of PCa patients is critical for better evaluating the treatment effectiveness of new therapeutic approaches. Marked improvements in PRO quality reporting over time were found, and it is estimated that at least one-fifth of PRO RCTs have provided sufficient details to allow health policy makers and physicians to make critical appraisals of results. PATIENT SUMMARY: In this report, we have investigated the methodological quality of PCa trials that have included a PRO assessment. We conclude that including PRO is critical to better evaluating the treatment effectiveness of new therapeutic approaches from the patient's perspective. Also, at least one-fifth of PRO RCTs in PCa have provided sufficient details to allow health policy makers and physicians to make a critical appraisal of results.","Eur Urol, 66(3): 416-427","International",2014,"Advanced,Local","Unclear","Unclear","Patient",null,"Systematic review","International","Patient","Advanced,Local","Unclear",null,"Systematic review","Unclear","2010:2014","Unclear"]
[181,"Egawa, S., et al. (2001). \"Toxicity and health-related quality of life during and after high dose rate brachytherapy followed by external beam radiotherapy for prostate cancer.\" Jpn J Clin Oncol 31(11): 541-547.",null,"Egawa, S., et al.","Toxicity and health-related quality of life during and after high dose rate brachytherapy followed by external beam radiotherapy for prostate cancer","BACKGROUND: The optimal protocol for combining high dose rate brachytherapy and external beam irradiation as treatment for localized prostate cancer is unknown. Toxicity rates and clinical and biochemical outcomes should be evaluated to validate the current treatment protocol. METHODS: Fifty-eight patients were treated for prostate cancer with high dose rate brachytherapy followed by 30 Gy of external beam radiation therapy. Toxicity during treatment and for 12-18 months thereafter, and treatment-related morbidity, were evaluated. Physician-assessed treatment-related toxicity was graded at the time of occurrence using the Radiation Therapy Oncology Group morbidity criteria. Four separate self-administered questionnaires were used to collect longitudinally demographic data and general and prostate disease-related measures of quality of life. RESULTS: Various degrees of rectal bleeding due to radiation proctitis were experienced by 13 patients (22%) at a median time of 11 months. Two of these patients needed hospitalization to undergo laser coagulation of the rectal mucosa. Study patients had statistically significant decreases in five SF-36 domains during the first month of treatment. All measures recovered by 12 months. Sexual function was not affected by irradiation. Lower urinary tract symptoms assessed by IPSS/QOL scores worsened significantly during the first month of treatment but later recovered to baseline levels. Physician-assessed RTOG scores failed to detect these changes. CONCLUSIONS: Morbidity associated with combined radiation therapy was greatest during the first month of treatment and affected quality of life significantly. Most measures recovered to baseline levels by 12 months following radiation therapy. Although the current protocol appears acceptable, measures should be taken to decrease treatment-related morbidity further.","Jpn J Clin Oncol, 31(11): 541-547","Japan",2001,"Local","Radiotherapy,Brachytherapy","SF-36,IPSS,RTOG-EORTC-SS","Patient,HCP",null,"Cohort","Japan","Patient,HCP","Local","Radiotherapy,Brachytherapy",null,"Cohort","SF-36,IPSS,RTOG-EORTC-SS","2000:2004","Symptom,Treatment,Utility"]
[182,"Elliott, S. P., et al. (2011). \"Projecting the clinical benefits of adjuvant radiotherapy versus observation and selective salvage radiotherapy after radical prostatectomy: a decision analysis.\" Prostate Cancer Prostatic Dis 14(3): 270-277.",null,"Elliott, S. P., et al.","Projecting the clinical benefits of adjuvant radiotherapy versus observation and selective salvage radiotherapy after radical prostatectomy: a decision analysis","Our purpose was to project and compare clinical and quality-adjusted life year (QALY) outcomes of adjuvant radiotherapy (ART) versus salvage RT (SRT) after radical prostatectomy for men with locally advanced prostate cancer. We constructed a Markov model to simulate the randomized studies of observation versus ART, assuming 75% of observation patients would receive SRT at PSA recurrence. Transition probabilities and utility inputs were drawn from randomized trials of ART and cohort studies of SRT. We projected 10-year PSA recurrence-free survival, metastasis-free survival and overall survival. We found that observation with selective SRT yielded slightly worse outcomes than ART for post-RT PSA recurrence-free survival (47 and 52%), metastasis-free survival (69 and 70%) and overall survival (72 and 73%). Findings were robust to sensitivity analyses. After adjusting for the disutility of RT, observation plus SRT yielded better QALYs at 10 years than ART (6.80 and 6.13 QALYs). Thus, observation plus SRT may be optimal for men likely to comply with surveillance who wish to minimize side effects of the treatment. These findings reflect outcomes for the average patient given the current level of evidence and are meant to help inform current decision-making as we await future clinical studies of comparative effectiveness.","Prostate Cancer Prostatic Dis, 14(3): 270-277","USA",2011,"Advanced,Recurrent","Radiotherapy,Surgery","Unclear","Patient",null,"Systematic review","USA","Patient","Advanced,Recurrent","Radiotherapy,Surgery",null,"Systematic review","Unclear","2010:2014","Utility"]
[183,"Emberton, M., et al. (1995). \"The feasibility and cost of a large multicentre audit of process and outcome of prostatectomy.\" Qual Health Care 4(4): 256-262.",null,"Emberton, M., et al.","The feasibility and cost of a large multicentre audit of process and outcome of prostatectomy","Objective--To determine the feasibility of performing multicentre process and outcome audits of common interventions taking prostatic procedures as an example. Design--Prospective, cohort study. Setting--All National Health Service and independent hospitals in Northern, Wessex, Mersey, and South West Thames health regions. Patients--5361 men undergoing prostatectomy identified by 103 of the 107 urologists and general surgeons performing prostatectomy in the study regions. Main measures-- Rates of participation by surgeons and patients; completeness of clinical data provided by surgeons; patient response rate and completeness of patient derived data; and cost. Results--Most surgeons (103,96%) agreed to participate. Overall, the proportion of eligible patients invited to take part was high (89%), although this was only measured in South West Thames, where dedicated data collectors were employed. Few men (80, 1.5%) declined to participate. Of those surviving for three months after surgery, 82.4% (4226) completed and returned the postal questionnaire. The response rate was higher in South West Thames (86.7%) than in the other regions (80.6%-80.8%). The audit was well received: 91% of patients found the questionnaire easy to complete and only 2.3% of them disapproved. Completeness of data was high with both the hospital and patient questionnaires. Missing data occurred in less than 5% of responses to most questions. The attributable cost was 34.50 pounds per patient identified or 44 pounds for patients in whom either the treatment outcome or vital status was known three months after their prostatectomy. Conclusions--This multicentre audit of process and outcome of prostatectomy proved feasible in terms of surgeon participation, patient identification, and the quantity and quality of data collection. Whether the cost was warranted will depend on how surgeons use the audit data to modify their practice.","Qual Health Care, 4(4): 256-262","UK",1995,"Any or unknown","Surgery","Unclear","Patient",null,"Cross-sectional","UK","Patient","Any or unknown","Surgery",null,"Cross-sectional","Unclear","1960:1999","Unclear"]
[184,"Ernstmann, N., et al. (2017). \"Patient-physician communication and health-related quality of life of patients with localised prostate cancer undergoing radical prostatectomy - a longitudinal multilevel analysis.\" BJU Int 119(3): 396-405.",null,"Ernstmann, N., et al.","Patient-physician communication and health-related quality of life of patients with localised prostate cancer undergoing radical prostatectomy - a longitudinal multilevel analysis","OBJECTIVES: To examine whether patient-physician communication is associated with health-related quality of life (HRQoL) in a sample of patients with localised prostate cancer undergoing radical prostatectomy (RP). PATIENTS AND METHODS: HAROW (Hormonal therapy, Active Surveillance, Radiation, Operation, Watchful Waiting) is a prospective, observational study designed to collect data of the different treatment options for newly diagnosed patients with localised prostate cancer under real-life conditions. At 6-months intervals, clinical data (D'Amico risk categories, Charlson comorbidity index), aspects of patient-provider communication (standardised psychosocial-care instrument for patients' assessment of communication; Cologne Patient Questionnaire), and HRQoL (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire) were assessed. Data were analysed by longitudinal multilevel analysis. RESULTS: Completed questionnaires for 1772 patients undergoing a RP were analysed over a 3-year follow-up period. Patients rated the patient-provider communication generally high with slight variations over the course of treatment (3.2-3.8). The HRQoL of the patients varied substantial over time and between the reported subscales (global HRQoL 71.1-77.2; physical functioning 89.1-92.1; role functioning 81.0-88.1; emotional functioning 74.4-84.0; cognitive functioning 84.3-87.7; social functioning (77.7-84.0). The longitudinal multilevel models showed significant associations between patient-provider communication in terms of devotion, support and shared decision-making, and functional aspects of HRQoL. CONCLUSION: Patient-provider communication is a valuable resource to support patients with prostate cancer coping with the disease and to improve their HRQoL. Future interventions should be designed especially for urologists to enhance their awareness for the importance of communication and the relationship with their patients with prostate cancer for treatment outcomes.","BJU Int, 119(3): 396-405","Germany",2017,"Local","Hormonal,Surgery,Radiotherapy,Surveillance","EORTC QLQ-C30,CPQ","Patient",null,"Cohort","Germany","Patient","Local","Hormonal,Surgery,Radiotherapy,Surveillance",null,"Cohort","EORTC QLQ-C30,CPQ","2015:2018","General"]
[185,"Escobar, A., et al. (2015). \"Cross-cultural adaptation, reliability and validity of the Spanish version of the Quality of Life in Adult Cancer Survivors (QLACS) questionnaire: application in a sample of short-term survivors.\" Health Qual Life Outcomes 13: 182.",null,"Escobar, A., et al.","Cross-cultural adaptation, reliability and validity of the Spanish version of the Quality of Life in Adult Cancer Survivors (QLACS) questionnaire: application in a sample of short-term survivors","BACKGROUND: The aim of this study was to validate the Quality of Life in Adult Cancer Survivors (QLACS) in short-term Spanish cancer survivor's patients. METHODS: Patients with breast, colorectal or prostate cancer that had finished their initial cancer treatment 3 years before the beginning of this study completed QLACS, WHOQOL, Short Form-36, Hospital Anxiety and Depression Scale, EORTC-QLQ-BR23 and EQ-5D. Cultural adaptation was made based on established guidelines. Reliability was evaluated using internal consistency and test-retest. Convergent validity was studied by mean of Pearson's correlation coefficient. Structural validity was determined by a second-order confirmatory factor analysis (CFA) and Rasch analysis was used to assess the unidimensionality of the Generic and Cancer-specific scales. RESULTS: Cronbach's alpha were above 0.7 in all domains and summary scales. Test-retest coefficients were 0.88 for Generic and 0.82 for Cancer-specific summary scales. QLACS generic summary scale was correlated with other generic criterion measures, SF-36 MCS (r = - 0.74) and EQ-VAS (r = - 0.63). QLACS cancer-specific scale had lower values with the same constructs. CFA provided satisfactory fit indices in all cases. The RMSEA value was 0.061 and CFI and TLI values were 0.929 and 0.925, respectively. All factor loadings were higher than 0.40 and statistically significant (P < 0.001). Generic summary scale had eight misfitting items. In the remaining 20 items, the unidimensionality was supported. Cancer Specific summary scale showed four misfitting items, the remaining showed unidimensionality. CONCLUSIONS: The findings support the validity and reliability of QLACS questionnaire to be used in short-term cancer survivors.","Health Qual Life Outcomes, 13(182","Spain",2015,"Survivors","Unclear","SF-36,HADS,EQ-5D,QLACS,WHOQOL-BREF","Patient",null,"Validation","Spain","Patient","Survivors","Unclear",null,"Validation","SF-36,HADS,EQ-5D,QLACS,WHOQOL-BREF","2015:2018","General,Comorbidity,utility"]
[186,"Esper, P., et al. (1997). \"Measuring quality of life in men with prostate cancer using the functional assessment of cancer therapy-prostate instrument.\" Urology 50(6): 920-928.",null,"Esper, P., et al.","Measuring quality of life in men with prostate cancer using the functional assessment of cancer therapy-prostate instrument","OBJECTIVES: As the incidence of prostate cancer in the United States exceeds 330,000 in 1997, increasingly more men are faced with treatment choices for which there is no clear approach. At every stage of disease, these treatment choices may involve clinically equivalent modalities that differ in side effects and impact upon quality of life (QOL). Comprehensive, yet efficient, questionnaires are needed to measure QOL in patients with prostate cancer. METHODS: Developed as a disease-specific adjunct to the Functional Assessment of Cancer Therapy (FACT) measurement system, a 12-item prostate cancer subscale (PCS) was developed and tested in three independent samples: a subscale development sample (n = 43), validity sample 1 (n = 34), and validity sample 2 (n = 96). The 12 items ask about symptoms and problems specific to prostate cancer. These questions are added to the general (FACT-G) instrument, thereby comprising a 47-item questionnaire. RESULTS: Internal consistency of the PCS ranged from 0.65 to 0.69, with coefficients for FACT-G subscales and aggregated scores ranging from 0.61 to 0.90. Concurrent validity was confirmed by the ability to discriminate patients by disease stage, performance status, and baseline prostate-specific antigen (PSA) level. Sensitivity to change in performance status and PSA score over a 2-month period suggested that some subscales of the FACT-Prostate (P) (including the PCS) are sensitive to meaningful clinical change. CONCLUSIONS: Our findings support use of the FACT-P as a meaningful component of QOL evaluation in men undergoing therapy for prostate cancer.","Urology, 50(6): 920-928","USA",1997,"Any or unknown","None","FACT-G,FACT-P","Patient",null,"Validation","USA","Patient","Any or unknown","None",null,"Validation","FACT-G,FACT-P","1960:1999","Disease,General"]
[187,"Espie, C. A., et al. (2008). \"Randomized controlled clinical effectiveness trial of cognitive behavior therapy compared with treatment as usual for persistent insomnia in patients with cancer.\" J Clin Oncol 26(28): 4651-4658.",null,"Espie, C. A., et al.","Randomized controlled clinical effectiveness trial of cognitive behavior therapy compared with treatment as usual for persistent insomnia in patients with cancer","PURPOSE: Persistent insomnia is a common complaint in cancer survivors, but is seldom satisfactorily addressed. The adaptation to cancer care of a validated, cost-effective intervention may offer a practicable solution. The aim of this study was to investigate the clinical effectiveness of protocol-driven cognitive behavior therapy (CBT) for insomnia, delivered by oncology nurses. PATIENTS AND METHODS: Randomized, controlled, pragmatic, two-center trial of CBT versus treatment as usual (TAU) in 150 patients (103 females; mean age, 61 years.) who had completed active therapy for breast, prostate, colorectal, or gynecological cancer. The study conformed to CONSORT guidelines. Primary outcomes were sleep diary measures at baseline, post-treatment, and 6-month follow-up. Actigraphic sleep, health-related quality of life (QOL), psychopathology, and fatigue were secondary measures. CBT comprised five, small group sessions across consecutive weeks, after a manualized protocol. TAU represented normal clinical practice; the appropriate control for a clinical effectiveness study. RESULTS: CBT was associated with mean reductions in wakefulness of 55 minutes per night compared with no change in TAU. These outcomes were sustained 6 months after treatment. Standardized relative effect sizes were large for complaints of difficulty initiating sleep, waking from sleep during the night, and for sleep efficiency (percentage of time in bed spent asleep). CBT was associated with moderate to large effect sizes for five of seven QOL outcomes, including significant reduction in daytime fatigue. There was no significant interaction effect between any of these outcomes and baseline demographic, clinical, or sleep characteristics. CONCLUSION: CBT for insomnia may be both clinically effective and feasible to deliver in real world practice.","J Clin Oncol, 26(28): 4651-4658","UK",2008,"Survivors","Psychological","Diary","Patient",null,"Clinical trial","UK","Patient","Survivors","Psychological",null,"Clinical trial","Diary","2005:2009","General,Symptom"]
[188,"Essink-Bot, M. L., et al. (1998). \"Short-term effects of population-based screening for prostate cancer on health-related quality of life.\" J Natl Cancer Inst 90(12): 925-931.",null,"Essink-Bot, M. L., et al.","Short-term effects of population-based screening for prostate cancer on health-related quality of life","BACKGROUND: Population-based screening for prostate cancer is currently being evaluated in randomized clinical trials in the United States and in Europe. Side effects arising from the process of screening and from the earlier treatment of screen-detected prostate cancer may be important factors in the evaluation. To examine health-related quality of life (or health status) among men screened for prostate cancer, we conducted a longitudinal study of 626 attenders to the Rotterdam (The Netherlands) prostate cancer screening program and of 500 nonparticipants. METHODS: Attenders of the screening program and nonparticipants completed self-assessment questionnaires (SF-36 [i.e., Medical Outcomes Study 36-Item Short-Form Health Survey] and EQ-5D [i.e., EuroQol measure for health-related quality of life] health surveys) to measure generic health status, as well as an additional questionnaire for anxiety and items relating to prostate cancer screening. RESULTS: Physical discomfort during digital rectal examination and during transrectal ultrasound was reported by 181 (37%) of 491 men and by 139 (29%) of 487 men, respectively; discomfort during prostate biopsy was reported by 64 (55%) of 116 men. Mean scores for health status and anxiety indicated that the participants did not experience relevant changes in physical, psychological, and social functioning during the screening procedure. However, high levels of anxiety were observed throughout the screening process among men with a high predisposition to anxiety. Similar scores for anxiety predisposition were observed among attenders and nonparticipants. CONCLUSIONS: At the group level, we did not find evidence that prostate cancer screening induced important short-term health-status effects, despite the short-lasting side effects related to the biopsy procedure. However, subgroups may experience high levels of anxiety. The implication is that unfavorable health-status effects of prostate cancer screening occur mainly in the treatment phase.","J Natl Cancer Inst, 90(12): 925-931","Netherlands",1998,"At risk","Screening","SF-36,EQ-5D","General population",null,"Cohort","Netherlands","General population","At risk","Screening",null,"Cohort","SF-36,EQ-5D","1960:1999","Utility"]
[189,"Essink-Bot, M. L., et al. (2003). \"Including the quality-of-life effects in the evaluation of prostate cancer screening: expert opinions revisited?\" BJU Int 92 Suppl 2: 101-105.",null,"Essink-Bot, M. L., et al.","Including the quality-of-life effects in the evaluation of prostate cancer screening: expert opinions revisited?","OBJECTIVE: To apply the general empirical framework for estimating utilities in cost-utility analysis (CUA) of population-based prostate cancer screening, including an assessment of empirical health status with a classifying measure (e.g. the EQ-5D) and linking these descriptions to utility estimates using the standard preference-based algorithm, combining them with the appropriate duration into quality-adjusted life years, and sensitivity analysis. MATERIALS AND METHODS: Empirical studies to describe and value the health status effects of prostate cancer screening have been ongoing within the Rotterdam centre of the European Randomised Study on Screening for Prostate Cancer since 1995. The results of these studies, including the screening, the primary treatment phase and advanced disease, will be used in estimating utilities for cost-utility analysis. RESULTS: Estimation of cost-utility of population-based prostate cancer screening with the results of the three empirical health status studies yielded partly counterintuitive results, underestimating the unfavourable health status effects that are inevitably associated with prostate cancer screening. This may be caused by other than health effects of the screening itself ('process effects') and adaptive changes in perception of their situation in patients after curative primary treatment ('response shift'), among other elements. CONCLUSIONS: These results prompted us to reconsider the suitability of the general framework of CUA for screening programmes. Possible directions for solutions are indicated.","BJU Int, 92 Suppl 2(101-105","Netherlands",2003,"At risk","Screening","EQ-5D","General population",null,"Cohort","Netherlands","General population","At risk","Screening",null,"Cohort","EQ-5D","2000:2004","Utility"]
[190,"Eton, D. T., et al. (2001). \"Early quality of life in patients with localized prostate carcinoma: an examination of treatment-related, demographic, and psychosocial factors.\" Cancer 92(6): 1451-1459.",null,"Eton, D. T., et al.","Early quality of life in patients with localized prostate carcinoma: an examination of treatment-related, demographic, and psychosocial factors","BACKGROUND: Men with localized prostate carcinoma are faced with important treatment decisions, and quality of life (QoL) information has become a crucial element of decision making. The first objective of this study was to compare the early, health-related QoL (HRQoL) of men with localized prostate carcinoma who were treated with radical prostatectomy, external beam radiotherapy, or brachytherapy. A second objective was to identify demographic and psychosocial variables that predict HRQoL. METHODS: Two-hundred fifty-six men with localized prostate carcinoma were interviewed within 7 weeks of treatment initiation. The interview included measures of prostate-specific HRQoL (the University of California-Los Angeles Prostate Cancer Index), general HRQoL (the SF-36), and psychosocial variables. RESULTS: After adjusting for covariates, treatment group differences were found for both prostate specific HRQoL and general HRQoL. Men who underwent prostatectomy reported more urinary and sexual problems and more general physical dysfunction compared with men who were treated with either form of radiation therapy. Men who were treated with brachytherapy reported the fewest problems in sexual function and the least general physical dysfunction. Few treatment group differences were found in mental functioning. Both demographic factors and psychosocial factors predicted HRQoL. Older men and African-American men reported more physical problems than younger men and Caucasian men, respectively. A supportive social environment, high self-efficacy, and high self-esteem were predictive of better HRQoL. CONCLUSIONS: Shortly after undergoing treatment for localized prostate carcinoma, men who underwent radical prostatectomy, older men, and African-American men are at heightened risk for experiencing prostate-specific and general deficits in HRQoL. Having psychosocial resources from which to draw may enhance HRQoL.","Cancer, 92(6): 1451-1459","USA",2001,"Local","Radiotherapy,Surgery,Brachytherapy","SF-36,UCLA-PCI","Patient",null,"Cross-sectional","USA","Patient","Local","Radiotherapy,Surgery,Brachytherapy",null,"Cross-sectional","SF-36,UCLA-PCI","2000:2004","Disease,Utility"]
[191,"Faithfull, S., et al. (2001). \"Evaluation of nurse-led follow up for patients undergoing pelvic radiotherapy.\" Br J Cancer 85(12): 1853-1864.",null,"Faithfull, S., et al.","Evaluation of nurse-led follow up for patients undergoing pelvic radiotherapy","This study reports results from a randomised controlled trial of nurse-led care and was designed to determine whether nurse-led follow up improved patients morbidity and satisfaction with care in men treated with radical radiotherapy for prostate and bladder cancer. The aim was to compare outcomes in terms of toxicity, symptoms experienced, quality of life, satisfaction with care and health care costs, between those receiving nurse-led care and a group receiving standard care. The study population was of men prescribed radical radiotherapy (greater than 60 Gy). Participants completed self-assessment questionnaires for symptoms and quality of life within the first week of radiotherapy treatment, at week 3, 6 and 12 weeks from start of radiotherapy. Satisfaction with clinical care was also assessed at 12 weeks post-treatment. Observer-rated RTOG toxicity scores were recorded pre-treatment, weeks 1, 3, 6 and 12 weeks from start of radiotherapy. The results presented in this paper are on 115 of 132 (87%) of eligible men who agreed to enter the randomised trial. 6 men (4%) refused and 11 (8%) were missed for inclusion in the study. Data were analysed as a comparison at cross-sectional time points and as a general linear model using multiple regression. There was no significant difference in maximum symptom scores over the time of the trial between nurse-led follow-up care and conventional medical care. Differences were seen in scores in the initial self assessment of symptoms (week 1) that may have been as a result of early nursing intervention. Those men who had received nurse-led care were significantly more satisfied (P < 0.002) at 12 weeks and valued the continuity of the service provided. There were also significant (P < 0.001) cost benefits, with a 31% reduction in costs with nurse-led, compared to medically led care. Evidence from this study suggests that a specialist nurse is able to provide safe follow up for men undergoing radiotherapy. The intervention focused on coping with symptoms, and provided continuity of care and telephone support. Further work is required to improve the management of patients during and after radiotherapy.","Br J Cancer, 85(12): 1853-1864","UK",2001,"Any or unknown","Radiotherapy,Various","RTOG-EORTC-SS","Patient",null,"Clinical trial","UK","Patient","Any or unknown","Radiotherapy,Various",null,"Clinical trial","RTOG-EORTC-SS","2000:2004","Treatment"]
[192,"Faithfull, S., et al. (2011). \"Self-management after prostate cancer treatment: evaluating the feasibility of providing a cognitive and behavioural programme for lower urinary tract symptoms.\" BJU Int 107(5): 783-790.",null,"Faithfull, S., et al.","Self-management after prostate cancer treatment: evaluating the feasibility of providing a cognitive and behavioural programme for lower urinary tract symptoms","OBJECTIVE: * To test the feasibility of a self-management intervention to help men cope with lower urinary tract symptoms as a result of radiotherapy for prostate cancer. PATIENTS AND METHODS: * A quasi-experimental design was used incorporating a pre-post-test evaluation. In total, a population of 71 men were screened for moderate to severe urinary symptoms 3 months or longer post-radiotherapy. Of these mean, 22 were recruited into the intervention from an eligible population of 43 symptomatic men. * Urinary symptoms were measured before the intervention and again after 4 months of follow-up through International Prostate Symptom Scores (IPSS) and bladder diaries. * Health-related quality of life was measured in relation to cancer per se and prostate cancer specifically, and confidence to cope was measured by a self-efficacy questionnaire. * The self-management intervention comprised pelvic floor muscle exercises, bladder retraining, patient education and problem solving and coping strategies RESULTS: * Lower urinary tract symptoms, as measured by the IPSS, showed a significant improvement, with a median score change of 5 (P < 0.005). * This was supported by objective changes in median bladder void volume of +7.5 mL (P < 0.05) and the median number of daily voids of -1 (P < 0.005). * In addition, decreases in emotional distress and problems associated with urinary function suggest that the intervention had a positive impact on health-related quality of life. CONCLUSIONS: * The provision of such an intervention was feasible within the clinical setting and provided benefits for men. * Symptom change vs those of normative recovery values for IPSS showed an intervention effect. * This intervention could be applied in routine practice and further testing is required in a randomized controlled trial.","BJU Int, 107(5): 783-790","UK",2011,"Any or unknown","Radiotherapy","IPSS,Diary","Patient",null,"Clinical trial","UK","Patient","Any or unknown","Radiotherapy",null,"Clinical trial","IPSS,Diary","2010:2014","Symptom,Complication"]
[193,"Farnell, D. J., et al. (2010). \"Development of a patient-reported questionnaire for collecting toxicity data following prostate brachytherapy.\" Radiother Oncol 97(1): 136-142.",null,"Farnell, D. J., et al.","Development of a patient-reported questionnaire for collecting toxicity data following prostate brachytherapy","PURPOSE: To improve a questionnaire used to collect patient-reported outcomes from patients with early stage prostate cancer treated with brachytherapy. A secondary aim was to adapt the Late Effects of Normal Tissue (LENT) subjective toxicity questionnaire for use to collect Common Terminology Criteria for Adverse Events (CTCAE) data, the current preferred platform for assessing radiation toxicity. MATERIALS AND METHODS: Three hundred and seventy-seven patients were treated with permanent iodine-125 seed implant brachytherapy for early prostate cancer. Toxicity data were collected before and at nine time points post-treatment (0-36 months). Compliance rates for patients completing individual items and item-subsection correlation coefficients were calculated. A factor analysis was carried out to analyse responses to the questionnaire and identify less informative questions, which could be removed. Cronbach's alpha coefficient was used to measure reliability. RESULTS: Two thousand one hundred and eighty-eight questionnaires were analysed. There was poor compliance for questions specifically relating to operations and bowel medication. We found that the division of the questionnaire into subsections based on anatomical site was reasonable and that certain items could be safely removed. The high mean value for Cronbach's alpha across all questionnaires (0.752; 95% CI: 0.726-0.779) indicated that the questionnaire was reliable. Fifteen of the 44 questions were removed from the original questionnaires. Questions on urinary incontinence severity, management of urinary and bowel incontinence, effects of reduced flow of urine and the effects of symptoms on activity of daily living and change in sexual function were required to adapt the LENT subjective questionnaire for use to collect CTCAE data. CONCLUSIONS: A questionnaire, validated over 6 years to collect LENT subjective data were adapted and is a reliable approach for collecting CTCAE data after prostate brachytherapy.","Radiother Oncol, 97(1): 136-142","UK",2010,"Local","Brachytherapy","CTCAE,LENT-SOMA","Patient",null,"Validation","UK","Patient","Local","Brachytherapy",null,"Validation","CTCAE,LENT-SOMA","2010:2014","Treatment"]
[194,"Farnell, D. J., et al. (2010). \"Efficacy of data capture for patient-reported toxicity following radiotherapy for prostate or cervical cancer.\" Eur J Cancer 46(3): 534-540.",null,"Farnell, D. J., et al.","Efficacy of data capture for patient-reported toxicity following radiotherapy for prostate or cervical cancer","We investigated the efficacy of data capture of patient-reported toxicity following radiotherapy by comparing electronic and paper formats. Patient-reported toxicity questionnaires based on items from the NCI Common Terminology Criteria for Adverse Events (CTCAE) were created for patients receiving radiotherapy. Electronic and paper questionnaires had identical questions. Thirty seven gynaecological cancer and 40 prostate cancer patients completed questionnaires. Both questionnaire formats (electronic and paper) were completed by each patient at time points before and after radiotherapy. The average questionnaire and subsection scores for each format were compared directly and by using intra-class correlation (ICC) coefficients. The internal consistency/reliability was assessed by determining Cronbach's alpha coefficient. Patient preference for questionnaire format including clarity and ease-of-use was recorded. 324 questionnaires were collected as part of this study. A similar pattern of average subsection scores was found for the electronic and paper questionnaires. ICC coefficients for the mean overall questionnaire scores and subsection scores were high (>0.8). Cronbach's alpha was generally greater than 0.6, indicating that the reliability was high. Of the patients that responded, 27.3% preferred the electronic format, 25.7% preferred the paper format and 47% had no preference. The average time taken to complete a questionnaire was about 9 minutes for each format. The different questionnaire formats measured toxicity effects consistently and were reliable for both gynaecological cancer and prostate cancer patients. The survey indicated that patients found the questionnaires clear, easy to understand and straightforward to complete. Electronic data capture of patient-reported toxicity for CTCAE is feasible and acceptable.","Eur J Cancer, 46(3): 534-540","UK",2010,"Any or unknown","Radiotherapy","CTCAE","Patient",null,"Validation","UK","Patient","Any or unknown","Radiotherapy",null,"Validation","CTCAE","2010:2014","Treatment"]
[195,"Feigenberg, S. J., et al. (2005). \"Health-related quality of life in men receiving prostate brachytherapy on RTOG 98-05.\" Int J Radiat Oncol Biol Phys 62(4): 956-964.",null,"Feigenberg, S. J., et al.","Health-related quality of life in men receiving prostate brachytherapy on RTOG 98-05","PURPOSE: To prospectively assess health-related quality of life (HRQOL) during the first year after treatment with prostate brachytherapy (PB) alone for T1c-2a prostate cancer. MATERIALS AND METHODS: Ninety-eight patients from 24 institutions were eligible and properly entered on this study. All patients were treated with PB alone using I-125 (Oncura Model 6711). The prescription dose was 145 Gy. Three separate health-related quality of life questionnaires (HRQOL) (Functional Assessment of Cancer Therapy-Prostate [FACT-P], Sexual Adjustment Questionnaire [SAQ], and International Prostate Symptom Score [IPSS]) were self-administered before and after PB (baseline; 3, 6, 9, and 12 months after PB). The standard error of the mean (SEM) was used to analyze changes in HRQOL scores over time. Patients who improved greater than the SEM were categorized as improved; patients that declined greater than the SEM were categorized as declined; patients were otherwise categorized as stable. All changes are measured using the pretreatment HRQOL score as baseline. RESULTS: The percentage of men who reported the ability to have an erection decreased from 73% at baseline (65% unassisted, 8% assisted) to 57% at 1 year (36% unassisted, 21% assisted). The rate of urinary incontinence increased to 14% at 6 months but had decreased to 1% at the 12-month follow-up. At 1 year after PB, 80% of men reported decreased sexual functioning according to SAQ scores. More than 60% of men reported decreased urinary function at 12 months compared with baseline. CONCLUSIONS: This article represents the first prospective, multi-institutional study of HRQOL in men treated with PB and demonstrates that patients undergoing PB have a very high overall HRQOL. The rate of incontinence by 1 year after PB is low, but many patients continue to have obstructive symptoms at 1 year. Although 78% of 1-year respondents state that they can achieve an erection with or without assistance, almost 50% report a decrease in sexual function.","Int J Radiat Oncol Biol Phys, 62(4): 956-964","USA",2005,"Local","Brachytherapy","FACT-P,SAQ,IPSS","Patient",null,"Clinical trial","USA","Patient","Local","Brachytherapy",null,"Clinical trial","FACT-P,SAQ,IPSS","2005:2009","Disease,Complication"]
[196,"Ferrer, M., et al. (2008). \"Health-related quality of life 2 years after treatment with radical prostatectomy, prostate brachytherapy, or external beam radiotherapy in patients with clinically localized prostate cancer.\" Int J Radiat Oncol Biol Phys 72(2): 421-432.",null,"Ferrer, M., et al.","Health-related quality of life 2 years after treatment with radical prostatectomy, prostate brachytherapy, or external beam radiotherapy in patients with clinically localized prostate cancer","PURPOSE: To compare treatment impact on health-related quality of life (HRQL) in patients with localized prostate cancer, from before treatment to 2 years after the intervention. METHODS AND MATERIALS: This was a longitudinal, prospective study of 614 patients with localized prostate cancer treated with radical prostatectomy (134), three-dimensional external conformal radiotherapy (205), and brachytherapy (275). The HRQL questionnaires administered before and after treatment (months 1, 3, 6, 12, and 24) were the Medical Outcomes Study 36-Item Short Form, the Functional Assessment of Cancer Therapy (General and Prostate Specific), the Expanded Prostate Cancer Index Composite (EPIC), and the American Urological Association Symptom Index. Differences between groups were tested by analysis of variance and within-group changes by univariate repeated-measures analysis of variance. Generalized estimating equations (GEE) models were constructed to assess between-group differences in HRQL at 2 years of follow-up after adjusting for clinical variables. RESULTS: In each treatment group, HRQL initially deteriorated after treatment with subsequent partial recovery. However, some dimension scores were still significantly lower after 2 years of treatment. The GEE models showed that, compared with the brachytherapy group, radical prostatectomy patients had worse EPIC sexual summary and urinary incontinence scores (-20.4 and -14.1; p < 0.001), and external radiotherapy patients had worse EPIC bowel, sexual, and hormonal summary scores (-3.55, -5.24, and -1.94; p < 0.05). Prostatectomy patients had significantly better EPIC urinary irritation scores than brachytherapy patients (+4.16; p < 0.001). CONCLUSIONS: Relevant differences between treatment groups persisted after 2 years of follow-up. Radical prostatectomy had a considerable negative effect on sexual functioning and urinary continence. Three-dimensional conformal radiotherapy had a moderate negative impact on bowel functioning, and brachytherapy caused moderate urinary irritation. These results provide relevant information for clinical decision making.","Int J Radiat Oncol Biol Phys, 72(2): 421-432","Spain",2008,"Local","Radiotherapy,Surgery,Brachytherapy","SF-36,FACT-G,FACT-P,EPIC,AUA-SI","Patient",null,"Cohort","Spain","Patient","Local","Radiotherapy,Surgery,Brachytherapy",null,"Cohort","SF-36,FACT-G,FACT-P,EPIC,AUA-SI","2005:2009","Disease,General,Utility,Symptom"]
[197,"Ferrer, M., et al. (2013). \"Quality of life impact of treatments for localized prostate cancer: cohort study with a 5 year follow-up.\" Radiother Oncol 108(2): 306-313.",null,"Ferrer, M., et al.","Quality of life impact of treatments for localized prostate cancer: cohort study with a 5 year follow-up","PURPOSE: To assess long-term quality of life (QoL) impact of treatments in localized prostate cancer patients treated with radical prostatectomy, external beam radiotherapy or brachytherapy. MATERIAL AND METHODS: Observational, prospective cohort study with pre-treatment QoL evaluation and follow-up until five years after treatment. 704 patients with low or intermediate risk localized prostate cancer were consecutively recruited in 2003-2005. QoL was measured by the EPIC questionnaire, with urinary irritative-obstructive, incontinence, bowel, sexual, and hormonal scores (ranging 0-100). RESULTS: Brachytherapy's QoL impact was restricted to the urinary domain, Generalized Estimating Equation models showed score changes at five years of -12.0 (95% CI=-15.0, -9.0) in incontinence and -5.3 (95% CI=-7.5, -3.1) in irritative-obstructive scales. Compared to brachytherapy, radical prostatectomy fared +3.3 (95% CI=+0.0, +6.5) points better in irritative-obstructive but -17.1 (95% CI=-22.7, -11.5) worse in incontinence. Sexual deterioration was observed in radical prostatectomy (-19.1; 95% CI=-25.1, -13.1) and external radiotherapy groups (-7.5; 95% CI=-12.5, -2.5). CONCLUSIONS: Brachytherapy is the treatment causing the least impact on QoL except for moderate urinary irritative-obstructive symptoms. Our study provides novel long-term valuable information for clinical decision making, supporting brachytherapy as a possible alternative to radical prostatectomy for patients seeking an attempted curative treatment, while limiting the risk for urinary incontinence and sexual impact on QoL.","Radiother Oncol, 108(2): 306-313","Spain",2013,"Local","Radiotherapy,Surgery,Brachytherapy","EPIC","Patient",null,"Cohort","Spain","Patient","Local","Radiotherapy,Surgery,Brachytherapy",null,"Cohort","EPIC","2010:2014","Disease"]
[198,"Ferro, T., et al. (2014). \"Health status and health resource use among long-term survivors of breast, colorectal and prostate cancer.\" Gac Sanit 28(2): 129-136.",null,"Ferro, T., et al.","Health status and health resource use among long-term survivors of breast, colorectal and prostate cancer","INTRODUCTION: The growing number of long-term cancer survivors poses a new challenge to health care systems. In Spain, follow-up is usually carried out in oncology services, but knowledge of cancer survivors' health care needs in this context is limited. The purpose of this study was to ascertain the health status of long-term survivors of breast, prostate, and colorectal cancer and to characterize their use of health care services. METHODS: Retrospective multicenter cohort study. We collected data from patients' clinical histories and through telephone interviews, using a specially designed questionnaire that included the SF-36v2 Quality of Life and Nottingham Health Profile scales. RESULTS: The questionnaire was completed by 51.2% (n= 583) of the potential sample. No significant differences were observed between 5-year and 10-year survivors. Overall, more than 80% of respondents were undergoing drug treatment for morbidity related to advanced age. Quality of life was good in most patients, and cancer-related morbidity was low and of little complexity. For the most part, participants reported using primary care services for care of chronic diseases and opportunistic treatment of sequelae related to the cancer treatment. Oncological follow-up was centralized at the hospital. CONCLUSIONS: Survivors of breast, prostate and colorectal cancer with tumoral detection at an early stage and without recurrences or second neoplasms experienced little morbidity and enjoyed good quality of life. This study proposes exploration of a follow-up model in the Spanish health system in which primary care plays a more important role than is customary in cancer survivors in Spain.","Gac Sanit, 28(2): 129-136","Spain",2014,"Survivors","None","SF-36,NHP","Patient",null,"Cross-sectional","Spain","Patient","Survivors","None",null,"Cross-sectional","SF-36,NHP","2010:2014","General,Utility"]
[199,"Ficarra, V., et al. (2006). \"Twelve-month self-reported quality of life after retropubic radical prostatectomy: a prospective study with Rand 36-Item Health Survey (Short Form-36).\" BJU Int 97(2): 274-278.",null,"Ficarra, V., et al.","Twelve-month self-reported quality of life after retropubic radical prostatectomy: a prospective study with Rand 36-Item Health Survey (Short Form-36)","OBJECTIVES: To evaluate the health-related quality of life (HRQoL) in patients undergoing retropubic radical prostatectomy (RRP) for clinically localized prostate cancer. PATIENTS AND METHODS: From February 2002 to September 2003 all patients undergoing RRP in our department were invited to participate in the study; the data from 75 of them comprised the present analysis. For evaluating HRQoL the RAND 36-Item Health Survey (SF-36) was used. RESULTS: Comparing the baseline scores of the SF-36 domains to those at 3, 6 and 12 months, there was a statistically significant difference in 'physical function', 'role limitations due to physical health problems', 'role limitations due to emotional problems', and 'energy/fatigue'. There were no statistically significant changes in the follow-up values for the other scales of the questionnaire. However, the baseline scores overlapped the 12-month follow-up values for all the SF-36 scales. The mean SF-36 scores reported by incontinent patients were lower than those of the continent patients, although this trend was not statistically significant. At the 12-month follow-up some variables were independent predictors of lower mean scores of some SF-36 scales, i.e. age >65 years, education level less than secondary school, pathological extracapsular extension of cancer and erectile dysfunction. CONCLUSION: At 1 year after RRP, HRQoL levels in each of the SF-36 domains overlapped those of the baseline in >80% of patients. The age, educational level of patients, local extension of the tumour, and erectile dysfunction could significantly affect the HRQoL scores.","BJU Int, 97(2): 274-278","Italy",2006,"Local","Surgery","SF-36","Patient",null,"Cohort","Italy","Patient","Local","Surgery",null,"Cohort","SF-36","2005:2009","Utility"]
[200,"Fillion, L., et al. (2003). \"Validation evidence for the French Canadian adaptation of the Multidimensional Fatigue Inventory as a measure of cancer-related fatigue.\" Cancer Nurs 26(2): 143-154.",null,"Fillion, L., et al.","Validation evidence for the French Canadian adaptation of the Multidimensional Fatigue Inventory as a measure of cancer-related fatigue","Cancer-related fatigue is the most reported symptom among patients with cancer. Researchers in the field of psychooncology have encouraged the development of short instruments, which allow for easier completion by clinical populations while still maintaining solid psychometric properties. The current study examined the validity and reliability of the French Canadian adaptation of the Multidimensional Fatigue Inventory (MFI) among women (n = 277) and men (n = 327) undergoing therapy for breast or prostate cancer, respectively. An exploratory factor analysis of the selected 15-item MFI yielded the following four factors: general/physical, mental, reduced motivation, and reduced activity. This was supported by a confirmatory factor analysis. The reliability, as evaluated by test-retest and Cronbach alpha internal consistency reliability coefficients of the French Canadian shortened MFI, was acceptable. In addition, the four factor-based scores correlated in a theoretically meaningful manner with existing measures of mood disturbance (Profile of Mood States and Hospital Anxiety and Depression Scale), cancer-related stressors (Inventory of Recent Life Experiences), coping with illness (Coping with Health Injuries and Problems Scale), quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire), and insomnia (Insomnia Severity Index), suggesting good construct, convergent, and concurrent criterion validity. Although further validation is recommended, the results for the French Canadian MFI in assessing cancer-related fatigue in both women and men undergoing cancer treatments showed good psychometric qualities.","Cancer Nurs, 26(2): 143-154","Canada",2003,"Any or unknown","Unclear","MFI,HADS,EORTC QLQ-C30,ISvI,IRLE,CHIPS,POMS","Patient",null,"Validation","Canada","Patient","Any or unknown","Unclear",null,"Validation","MFI,HADS,EORTC QLQ-C30,ISvI,IRLE,CHIPS,POMS","2000:2004","General,Symptom,Comorbidity"]
[201,"Filocamo, M. T., et al. (2007). \"Pharmacologic treatment in postprostatectomy stress urinary incontinence.\" Eur Urol 51(6): 1559-1564.",null,"Filocamo, M. T., et al.","Pharmacologic treatment in postprostatectomy stress urinary incontinence","OBJECTIVES: The aim of this study was to assess efficacy and safety of association of duloxetine and rehabilitation compared with rehabilitation alone in men with SUI after radical retropubic prostatectomy (RRP), and to compare continence rate even after planned duloxetine suspension. METHODS: After catheter removal, 112 patients were randomized to receive rehabilitation and duloxetine (group A) or rehabilitation alone (group B), for 16 wk. INCLUSION CRITERIA: postprostatectomy SUI with daily incontinent episodes frequency (IEF) of four or greater. After 16 wk both groups suspended duloxetine/placebo and continued rehabilitation. All patients completed incontinence quality of life (I-QoL) questionnaire and bladder diary. Wilcoxon test was used to analyse changes in IEF and in I-QoL score; Fisher exact test was used to compare continent patients between the groups. RESULTS: Adverse events for duloxetine was 15.2%. 102 men completed the study. There was a significant decrease in pad use in group A. After 16 wk, 39 patients versus 27 were dry (p=0.007). At 20 wk, 4 wk after planned interruption of duloxetine, we observed a U-turn, 23 patients were completely dry in group A versus 38 in group B (p=0.008). Whereas, after 24 wk, 31 in group A versus 41 in group B were dry (p=0.08). The decrease in IEF and improvements in I-QoL scores were significantly greater in group A for the first 16 wk. CONCLUSIONS: The data suggest that combination therapy might provide another treatment option for SUI in men that might increase the percentage of early postsurgery continence.","Eur Urol, 51(6): 1559-1564","Italy",2007,"Any or unknown","Surgery,Various","I-QoL,Diary","Patient",null,"Clinical trial","Italy","Patient","Any or unknown","Surgery,Various",null,"Clinical trial","I-QoL,Diary","2005:2009","Complication"]
[202,"Fizazi, K., et al. (2014). \"Effect of enzalutamide on time to first skeletal-related event, pain, and quality of life in men with castration-resistant prostate cancer: results from the randomised, phase 3 AFFIRM trial.\" Lancet Oncol 15(10): 1147-1156.",null,"Fizazi, K., et al.","Effect of enzalutamide on time to first skeletal-related event, pain, and quality of life in men with castration-resistant prostate cancer: results from the randomised, phase 3 AFFIRM trial","BACKGROUND: In the AFFIRM trial of patients with metastatic castration-resistant prostate cancer after progression with docetaxel treatment, enzalutamide significantly increased overall survival compared with placebo. Here we present the prospectively defined analyses of some secondary endpoints, including occurrence of skeletal-related events, measures of pain control, and patient-reported health-related quality of life (HRQoL). METHODS: In this phase 3, double-blind trial, patients were randomly assigned (2:1) to receive enzalutamide 160 mg/day or placebo orally, stratified by ECOG baseline performance status (0 or 1 vs 2) and mean pain score (Brief Pain Inventory-Short Form [BPI-SF] question 3 worst pain, score </=3 vs >/=4). Secondary endpoints were time to first skeletal-related event (defined as radiation therapy or surgery to bone); change from baseline to week 13 in pain severity and interference; pain palliation and progression at week 13; time to pain progression; overall improvement in HRQoL; improvements in HRQoL domains; and time to HRQoL deterioration. Analysis was done on the intention-to-treat population for each endpoint. AFFIRM is registered with ClinicalTrials.gov, number NCT00974311. FINDINGS: Median time to first skeletal-related event in the enzalutamide (n=800) and placebo (n=399) groups was 16.7 months (95% CI 14.6 to 19.1) and 13.3 months (95% CI 9.9 to not yet reached), respectively (hazard ratio [HR] 0.69 [95% CI 0.57-0.84]; p=0.0001). Pain progression at week 13 occurred in 174 (28%) of 625 evaluable patients in the enzalutamide group versus 101 (39%) of 259 patients in the placebo group (difference -11.2%, 95% CI -18.1 to -4.3; p=0.0018). Median time to pain progression was not yet reached in the enzalutamide group (95% CI not yet reached to not yet reached) versus 13.8 (13.8 to not yet reached) months in the placebo group (HR 0.56 [95% CI 0.41 to 0.78]; p=0.0004). Mean treatment effects for pain severity (mean change from baseline in the enzalutamide group -0.15, 95% CI -0.28 to -0.02, vs placebo 0.50, 0.29 to 0.70; difference -0.65, 95% CI -0.89 to -0.41; p<0.0001) and interference (-0.01, -0.18 to 0.16, vs 0.74, 0.47 to 1.00; respectively, difference -0.74, 95% -1.06 to -0.43; p<0.0001) were significantly better with enzalutamide than with placebo. 22 (45%) of 49 evaluable patients in the enzalutamide group reported pain palliation at week 13 versus one (7%) of 15 in the placebo group (difference 38.2%, 95% CI 19.4-57.0; p=0.0079). Overall improvement in HRQoL was reported in more patients receiving enzalutamide (275 [42%] of 652) than in those receiving placebo (36 [15%] of 248; p<0.0001). Patients in the enzalutamide group had longer median time to HRQoL deterioration than did those in the placebo group (9.0 months, 95% CI 8.3-11.1, vs 3.7 months, 95% CI 3.0-4.2; HR 0.45, 95% CI 0.37-0.55; p<0.0001) in risk of deterioration. INTERPRETATION: Our results show that, in addition to improving overall survival, enzalutamide improves wellbeing and everyday functioning of patients with metastatic castration-resistant prostate cancer. FUNDING: Astellas Pharma and Medivation.","Lancet Oncol, 15(10): 1147-1156","USA",2014,"Metastatic","Hormonal","BPI","Patient",null,"Clinical trial","USA","Patient","Metastatic","Hormonal",null,"Clinical trial","BPI","2010:2014","Symptom"]
[203,"Fizazi, K., et al. (2015). \"Phase III, randomized, double-blind, multicenter trial comparing orteronel (TAK-700) plus prednisone with placebo plus prednisone in patients with metastatic castration-resistant prostate cancer that has progressed during or after docetaxel-based therapy: ELM-PC 5.\" J Clin Oncol 33(7): 723-731.",null,"Fizazi, K., et al.","Phase III, randomized, double-blind, multicenter trial comparing orteronel (TAK-700) plus prednisone with placebo plus prednisone in patients with metastatic castration-resistant prostate cancer that has progressed during or after docetaxel-based therapy: ELM-PC 5","PURPOSE: Orteronel (TAK-700) is an investigational, nonsteroidal, reversible, selective 17,20-lyase inhibitor. This study examined orteronel in patients with metastatic castration-resistant prostate cancer that progressed after docetaxel therapy. PATIENTS AND METHODS: In our study, 1,099 men were randomly assigned in a 2:1 schedule to receive orteronel 400 mg plus prednisone 5 mg twice daily or placebo plus prednisone 5 mg twice daily, stratified by region (Europe, North America [NA], and non-Europe/NA) and Brief Pain Inventory-Short Form worst pain score. Primary end point was overall survival (OS). Key secondary end points (radiographic progression-free survival [rPFS], >/= 50% decrease of prostate-specific antigen [PSA50], and pain response at 12 weeks) were to undergo statistical testing only if the primary end point analysis was significant. RESULTS: The study was unblinded after crossing a prespecified OS futility boundary. The median OS was 17.0 months versus 15.2 months with orteronel-prednisone versus placebo-prednisone (hazard ratio [HR], 0.886; 95% CI, 0.739 to 1.062; P = .190). Improved rPFS was observed with orteronel-prednisone (median, 8.3 v 5.7 months; HR, 0.760; 95% CI, 0.653 to 0.885; P < .001). Orteronel-prednisone showed advantages over placebo-prednisone in PSA50 rate (25% v 10%, P < .001) and time to PSA progression (median, 5.5 v 2.9 months, P < .001) but not pain response rate (12% v 9%; P = .128). Adverse events (all grades) were generally more frequent with orteronel-prednisone, including nausea (42% v 26%), vomiting (36% v 17%), fatigue (29% v 23%), and increased amylase (14% v 2%). CONCLUSION: Our study did not meet the primary end point of OS. Longer rPFS and a higher PSA50 rate with orteronel-prednisone indicate antitumor activity.","J Clin Oncol, 33(7): 723-731","Greece,France,USA,Spain,UK,Netherlands,Canada,Brazil",2015,"Metastatic,Refractory","Chemotherapy","BPI","Patient",null,"Clinical trial","Greece,France,USA,Spain,UK,Netherlands,Canada,Brazil","Patient","Metastatic,Refractory","Chemotherapy",null,"Clinical trial","BPI","2015:2018","Symptom"]
[204,"Forster, J. A., et al. (2009). \"Technical description and outcomes of a continuous anastomosis in open radical prostatectomy.\" BJU Int 104(7): 929-933.",null,"Forster, J. A., et al.","Technical description and outcomes of a continuous anastomosis in open radical prostatectomy","OBJECTIVE: To describe the surgical technique, objective and subjective medium-term outcomes of a novel continuous vesico-urethral anastomotic suture in open radical prostatectomy (ORP). PATIENTS AND METHODS: A continuous anastomosis comprising separate anterior and posterior monofilament 3-0 polydioxanone sutures, with the bladder neck 'parachuted' down on to the urethral stump, was used in 39 consecutive patients. A cystogram was taken after ORP in the first 23 patients. The catheter was removed as soon as patients were fully mobile. A validated postal questionnaire to determine continence and its effect on quality of life was sent to all patients >/=3 months after ORP. RESULTS: The mean follow-up was 18 months; there were no major complications. There was an insignificant or no leak in 91% of the patients who had a cystogram. Before discharge, 33 patients reported that they were continent, whilst five required a pad(s) for stress incontinence, and one was discharged with a catheter after failing the first catheter removal. Of the 95% who completed the questionnaire, 95% either did not leak urine, or only leaked a small amount; 84% of patients reported that leaking had a minimal effect on everyday life. No patients developed symptomatic urethral or bladder neck stricture/contracture. CONCLUSIONS: Our technique of continuous anastomotic suturing for ORP is safe, reliable and well tolerated. Further randomized studies are warranted to compare the outcome with the standard interrupted vesico-urethral anastomosis.","BJU Int, 104(7): 929-933","UK",2009,"Any or unknown","Surgery","Unclear","Patient",null,"Clinical trial","UK","Patient","Any or unknown","Surgery",null,"Clinical trial","Unclear","2005:2009","Complication"]
[205,"Forsythe, K., et al. (2012). \"Intensity-modulated radiotherapy causes fewer side effects than three-dimensional conformal radiotherapy when used in combination with brachytherapy for the treatment of prostate cancer.\" Int J Radiat Oncol Biol Phys 83(2): 630-635.",null,"Forsythe, K., et al.","Intensity-modulated radiotherapy causes fewer side effects than three-dimensional conformal radiotherapy when used in combination with brachytherapy for the treatment of prostate cancer","PURPOSE: To measure the benefits of intensity-modulated radiotherapy (IMRT) compared with three-dimensional conformal radiotherapy (3D-CRT) when used in combination with brachytherapy for the treatment of prostate cancer. METHODS AND MATERIALS: We conducted a retrospective review of all patients with localized prostate cancer who received external-beam radiotherapy (EBRT) in combination with brachytherapy with at least 1 year follow-up (n = 812). Combination therapy consisted of (103)Pd or (125)I implant, followed by a course of EBRT. From 1993 to March 2003 521 patients were treated with 3D-CRT, and from April 2003 to March 2009 291 patients were treated with IMRT. Urinary symptoms were prospectively measured with the International Prostate Symptom Score questionnaire with a single quality of life (QOL) question; rectal bleeding was assessed per the Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer Late Radiation Morbidity Scoring Schema. The Pearson chi(2) test was used to compare toxicities experienced by patients who were treated with either IMRT or 3D-CRT. Logistic regression analyses were also performed to rule out possible confounding factors. RESULTS: Within the first 3 months after treatment, patients treated with 3D-CRT scored their urinary symptoms as follows: 19% mild, 44% moderate, and 37% severe; patients treated with IMRT scored their urinary symptoms as follows: 36% mild, 47% moderate, and 17% severe (p < 0.001). The 3D-CRT patients rated their QOL as follows: 35% positive, 20% neutral, and 45% negative; IMRT patients rated their QOL as follows: 51% positive, 18% neutral, and 31% negative (p < 0.001). After 1 year of follow-up there was no longer any difference in urinary morbidity between the two groups. Logistic regression confirmed the differences in International Prostate Symptom Score and QOL in the acute setting (p < 0.001 for both). Grade >/= 2 rectal bleeding was reported by 11% of 3D-CRT patients and 7% of IMRT patients (p = 0.046); logistic regression analysis also confirmed this observation (p = 0.040). CONCLUSIONS: When used in combination with brachytherapy, IMRT offers less Grade >/= 2 rectal bleeding, less acute urinary toxicities, and is associated with a higher QOL compared with 3D-CRT.","Int J Radiat Oncol Biol Phys, 83(2): 630-635","USA",2012,"Local","Radiotherapy,Brachytherapy","IPSS,RTOG-EORTC-SS","Patient",null,"Cohort","USA","Patient","Local","Radiotherapy,Brachytherapy",null,"Cohort","IPSS,RTOG-EORTC-SS","2010:2014","Symptom,Treatment"]
[206,"Fossa, S. D. (1994). \"Quality of life after palliative radiotherapy in patients with hormone-resistant prostate cancer: single institution experience.\" Br J Urol 74(3): 345-351.",null,"Fossa, S. D.","Quality of life after palliative radiotherapy in patients with hormone-resistant prostate cancer: single institution experience","OBJECTIVE: To review the development, methodology and difficulties of evaluating the quality of life (QoL) in patients with hormone-resistant prostate cancer, and to analyse the subjective effect of palliative radiotherapy among these patients. PATIENTS AND METHODS: Since 1986, a self-administered QoL questionnaire has been developed for patients with hormone-resistant prostate cancer. The study group included 137 such patients, with a median age of 70 years (range 48-87), who received either 89Sr (31) or external beam radiotherapy (106) because of painful bone metastases. Quality of life was assessed in all patients before treatment and, if possible, 3 months afterwards. RESULTS: The questionnaire had acceptable psychometric properties (validity, reliability). In these patients with very advanced disease, palliative radiotherapy proved less effective than reports in the literature might suggest. CONCLUSIONS: In patients with hormone-resistant prostate cancer, quality of life assessment is both possible and desirable for the evaluation of palliative treatment. The patients' perception of physical function represents an independent prognostic factor of overall survival together with alkaline phosphatase and performance status. Valid and reliable QoL questionnaires are now available, though further research is required to establish the most effective way of using them. At 3 months palliative radiotherapy was effective in only 25% of the patients investigated, two-thirds of whom had > or = 20 hot spots on bone scan. Palliative radiotherapy should probably be offered during an earlier phase of the disease.","Br J Urol, 74(3): 345-351","Norway",1994,"Metastatic","Radiotherapy","Unclear","Patient",null,"Cohort","Norway","Patient","Metastatic","Radiotherapy",null,"Cohort","Unclear","1960:1999","General"]
[207,"Fossa, S. D., et al. (1989). \"Quality of life in patients with muscle-infiltrating bladder cancer and hormone-resistant prostatic cancer.\" Eur Urol 16(5): 335-339.",null,"Fossa, S. D., et al.","Quality of life in patients with muscle-infiltrating bladder cancer and hormone-resistant prostatic cancer","A questionnaire, filled in by the patient, was used to assess the quality of life of 65 patients with previously untreated T2-T4 NX MO bladder cancer and of 67 patients with hormone-resistant prostatic cancer. This study examines the initial questionnaire filled in before any nonsurgical treatment had been started in the patients referred to an oncological ward. The aim was to identify domains in which distress was frequent, in the hope of indicating where treatment directed forward improving the patients' quality of life should be directed. The questionnaires yielded reliable and valid data. Among bladder cancer patients micturition disturbances and sexual problems dominated. Bone pain, fatigue, sexual disturbances and interruption of social relationships were the most frequent and most severe complaints of prostatic cancer patients. It was concluded that routine quality of life evaluation by self-assessment questionnaires is possible in a clinical ward provided some assistance by the nursing staff is available. Future treatment in patients for whom palliation is the main goal of therapy should be concentrated on improving the quality of life in areas where distress is evident. The effect of treatment on quality of life could be monitored by similar questionnaires.","Eur Urol, 16(5): 335-339","Norway",1989,"Advanced","None","Unclear","Patient",null,"Validation","Norway","Patient","Advanced","None",null,"Validation","Unclear","1960:1999","General"]
[208,"Fossa, S. D., et al. (1990). \"Quality of life and treatment of hormone resistant metastatic prostatic cancer. The EORTC Genito-Urinary Group.\" Eur J Cancer 26(11-12): 1133-1136.",null,"Fossa, S. D., et al.","Quality of life and treatment of hormone resistant metastatic prostatic cancer. The EORTC Genito-Urinary Group","72 patients with hormone resistant, progressing prostatic cancer completed a self-administered questionnaire to assess subjective morbidity and quality of life before they were entered into a phase III trial of estramustine (34) vs. mitomycin (38). At least one post-treatment assessment was available in 43 patients. This considerable degree of non-compliance is explained by practical problems related to completion and collection of the questionnaires in these rapidly deteriorating patients. Doctors underestimated subjective morbidity (pain, decreased performance status, nausea) in 30-50% of the cases. Decreased functional status, fatigue and pain were identified as the most frequent major morbidities before study entry. In most patients, treatment did not reduce this morbidity. The routine application of self-administered quality of life questionnaires has considerable practical problems but yields clinically worthwhile information about subjective morbidity. Simple but relevant monitoring of subjective morbidity by the patient should be mandatory in cancer trials where palliation is a major endpoint.","Eur J Cancer, 26(11-12): 1133-1136","Norway",1990,"Metastatic","Chemotherapy","Unclear","Patient,HCP",null,"Clinical trial","Norway","Patient,HCP","Metastatic","Chemotherapy",null,"Clinical trial","Unclear","1960:1999","Symptom,General"]
[209,"Fossa, S. D., et al. (2000). \"Quality of life of patients with newly diagnosed poor prognosis M1 prostate cancer undergoing orchiectomy without or with mitomycin C. Results from the EORTC Phase-III trial 30893.\" Eur Urol 37(5): 541-551.",null,"Fossa, S. D., et al.","Quality of life of patients with newly diagnosed poor prognosis M1 prostate cancer undergoing orchiectomy without or with mitomycin C. Results from the EORTC Phase-III trial 30893","OBJECTIVES: To compare the quality of life (QL) of patients with poor prognosis M1 prostate cancer treated with orchiectomy alone (ORCH) or orchiectomy combined with adjuvant mitomycin C (MMC; 15 mg/m(2) i.v. q 6 weeks: ORCH+MMC; EORTC trial 30893). METHODS: Patients with newly diagnosed M1 poor prognosis prostate cancer completed a truncated version of the EORTC QLQ-C30 (V 1.0) at randomization (baseline) and every 6-12 weeks thereafter until going off the protocol. Five ad hoc questions assessing lower urinary tract symptoms were included in the QL questionnaire. RESULTS: At least one QL form was completed by 177 of the 189 patients included in the trial, with baseline questionnaires available for 113 patients (ORCH n = 52; ORCH+MMC n = 61). In both arms, pain and urinary dysfunction improved during treatment. Compared with patients from the ORCH arm, the use of adjuvant MMC was associated with a significant reduction in global health status/QL and with impairment in 7 of 11 QL dimensions covered by the questionnaire. Some improvement in QL was observed after discontinuation of MMC. A survival benefit was not observed in the ORCH+MMC arm. CONCLUSIONS: Intravenous MMC (15 mg/m(2) q 6 weeks) cannot be recommended as adjuvant treatment in M1 poor prognosis prostate cancer due to its negative impact on QL and lack of efficacy. In general, QL assessments should be mandatory when adjuvant chemotherapy is evaluated in patients with metastatic prostate cancer.","Eur Urol, 37(5): 541-551","Norway",2000,"Metastatic","Surgery,Chemotherapy","EORTC QLQ-C30","Patient",null,"Clinical trial","Norway","Patient","Metastatic","Surgery,Chemotherapy",null,"Clinical trial","EORTC QLQ-C30","2000:2004","General"]
[210,"Fossa, S. D., et al. (2001). \"Flutamide versus prednisone in patients with prostate cancer symptomatically progressing after androgen-ablative therapy: a phase III study of the European organization for research and treatment of cancer genitourinary group.\" J Clin Oncol 19(1): 62-71.",null,"Fossa, S. D., et al.","Flutamide versus prednisone in patients with prostate cancer symptomatically progressing after androgen-ablative therapy: a phase III study of the European organization for research and treatment of cancer genitourinary group","PURPOSE: Time to progression (TTP), overall survival, and quality of life (QL) were compared in patients with hormone-resistant prostate cancer (HRPC) treated with prednisone (5 mg orally, four times a day) or flutamide (250 mg orally, three times a day). PATIENTS AND METHODS: Symptomatic patients were randomized to receive either prednisone (101 patients) or flutamide (100 patients). Subjective response was assessed based on performance status, the use of analgesics, and the need to apply alternative palliative treatment. Prostate-specific antigen (PSA)-based biochemical response (>or= 50% reduction of baseline PSA) was recorded. At baseline and at 6-week intervals during follow-up, patients completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C-30. RESULTS: There was no difference between the groups in median TTP (prednisone, 3.4 months; flutamide, 2.3 months) or overall survival (prednisone, 10.6 months; flutamide, 11.2 months). In the prednisone group, 56% of the patients experienced a subjective response, compared with 45% in the flutamide group (P: = .18). The median response duration was 4.8 months for prednisone and 4.2 months for flutamide. A biochemical response was observed in 21% and 23% of the prednisone and flutamide groups, respectively. Gastrointestinal toxicity was the reason for trial discontinuation in seven patients receiving flutamide and two patients receiving prednisone. The QL assessment parameters favored the use of prednisone with statistically significant differences in pain, fatigue, role functioning, appetite loss, gastrointestinal distress, and overall QL. CONCLUSION: In symptomatic HRPC, treatment with prednisone or flutamide leads to similar rates of TTP and overall survival and no difference in subjective or biochemical response. The QL results favor the use of low-cost prednisone in patients with HRPC.","J Clin Oncol, 19(1): 62-71","Norway",2001,"Refractory","Hormonal","EORTC QLQ-C30","Patient",null,"Clinical trial","Norway","Patient","Refractory","Hormonal",null,"Clinical trial","EORTC QLQ-C30","2000:2004","General"]
[211,"Fowler, F. J., Jr., et al. (1995). \"Effect of radical prostatectomy for prostate cancer on patient quality of life: results from a Medicare survey.\" Urology 45(6): 1007-1013; discussion 1013-1005.",null,"Fowler, F. J., Jr., et al.","Effect of radical prostatectomy for prostate cancer on patient quality of life: results from a Medicare survey","OBJECTIVES: To assess patient responses to radical prostatectomy and its effects. METHODS: A national sample was taken of 1072 Medicare patients who underwent radical prostatectomy for prostate cancer (1988 through 1990) by mail, telephone, and personal interviews. The effects of the surgery and its complications on these patients' lives were studied through: (1) patient ratings of the extent to which sexual and urinary dysfunctions were \"problems\" in their lives; (2) two general measures of quality of life, the Mental Health Index and the General Health Index; (3) patient reports of how they felt about the results of treatment and whether they would choose surgery again. RESULTS: On average, dripping urine, particularly to the point where subjects were wearing pads, had a more significant effect on patients than loss of sexual function; incontinence had significant adverse effects on the measures of quality of life and self-reported results of surgery. Overall, postsurgical patients scored comparatively high on the quality of life measures (similar to a cohort of patients with benigh prostatic hyperplasia who had undergone transurethral resection of the prostate), reported feeling positive about the results (81%), and would choose surgical treatment again (89%). Nonetheless, there was variability in patient response to the effects of surgery. CONCLUSIONS: The results demonstrate the ability of many Medicare patients to adapt to adverse outcomes, such as loss of sexual function and incontinence. They also provide evidence of the variability of individual patients' responses to surgical results and reinforce the importance of individualized decision making for patients facing a decision about radical prostatectomy for prostate cancer.","Urology, 45(6): 1007-1013; discussion 1013-1005","USA",1995,"Any or unknown","Surgery","MHI,GHI","Patient",null,"Cross-sectional","USA","Patient","Any or unknown","Surgery",null,"Cross-sectional","MHI,GHI","1960:1999","General,Comorbidity"]
[212,"Fowler, F. J., Jr., et al. (2002). \"The impact of androgen deprivation on quality of life after radical prostatectomy for prostate carcinoma.\" Cancer 95(2): 287-295.",null,"Fowler, F. J., Jr., et al.","The impact of androgen deprivation on quality of life after radical prostatectomy for prostate carcinoma","BACKGROUND: Androgen deprivation is commonly prescribed for men with a rising prostate specific antigen level after radical prostatectomy, despite scant evidence regarding its efficacy and side effects. In the current study, the authors compared measures of health-related quality of life (HRQOL) in men who were treated with androgen deprivation after radical prostatectomy with those for men who underwent surgery but were not treated with androgen deprivation. METHODS: Medicare Provider and Analysis and Review (MedPAR) files were used to identify men who had undergone radical prostatectomies between 1991-1992. Medicare Part B data then were used to select two samples: men who subsequently were androgen deprived and those who were not. In 1999, a mail survey was administered that addressed a range of disease-related and treatment-related issues, including HRQOL. Age-adjusted comparisons of responses to seven multiitem measures of HRQOL were performed. RESULTS: The overall response rate was 82%. On all seven HRQOL measures (impact of cancer and treatment, concern regarding body image, mental health, general health, activity, worries about cancer and dying, and energy), there were statistically significant decrements associated with androgen deprivation. CONCLUSIONS: Patients and physicians must weigh the price patients pay with regard to HRQOL against the uncertain benefits of early androgen deprivation.","Cancer, 95(2): 287-295","USA",2002,"Any or unknown","Surgery,Hormonal","Unclear","Patient",null,"Cross-sectional","USA","Patient","Any or unknown","Surgery,Hormonal",null,"Cross-sectional","Unclear","2000:2004","General"]
[213,"Fowler, J. E., Jr. (2001). \"Patient-reported experience with the Viadur 12-month leuprolide implant for prostate cancer.\" Urology 58(3): 430-434.",null,"Fowler, J. E., Jr.","Patient-reported experience with the Viadur 12-month leuprolide implant for prostate cancer","OBJECTIVES: To assess patient-reported general satisfaction, effect on daily activities, and effect on health-related quality of life of a 12-month leuprolide implant for prostate cancer. METHODS: A total of 80 men with prostate cancer participated in an open-label Phase III study of the Viadur leuprolide implant. One implant was inserted in each patient at enrollment and was removed after 52 weeks. At 24 and 52 weeks after implantation, patients were asked to complete a questionnaire about their experience with the implant, and at 0, 12, 24, 36, and 52 weeks after implantation, the patients were asked to complete the Medical Outcome Study Short Form-36 health-related quality-of-life instrument. RESULTS: The surveys about the patients' experience with the implant were completed by 70 subjects, and two or more SF-36 questionnaires were completed by 72 patients. At weeks 24 and 52 after implantation, greater than 90% of patients were extremely satisfied or satisfied with the overall treatment, found the implant convenient, forgot about the implant most of the time or were occasionally aware of the implant, and found the implant very comfortable or somewhat comfortable. No meaningful change was found in the summary scores of the mental and physical aspects of the SF-36 assessments during treatment. Of 73 men who were eligible for reimplantation after the 12-month study period, 70 (96%) elected to undergo reimplantation. CONCLUSIONS: In this study, patients found the Viadur 12-month leuprolide implant convenient, and the implant did not affect their health-related quality of life.","Urology, 58(3): 430-434","USA",2001,"Any or unknown","Hormonal","SF-36","Patient",null,"Clinical trial","USA","Patient","Any or unknown","Hormonal",null,"Clinical trial","SF-36","2000:2004","Utility"]
[214,"Fransson, P. (2008). \"Patient-reported lower urinary tract symptoms, urinary incontinence, and quality of life after external beam radiotherapy for localized prostate cancer--15 years' follow-up. A comparison with age-matched controls.\" Acta Oncol 47(5): 852-861.",null,"Fransson, P.","Patient-reported lower urinary tract symptoms, urinary incontinence, and quality of life after external beam radiotherapy for localized prostate cancer--15 years' follow-up. A comparison with age-matched controls","BACKGROUND: To prospectively examine the urinary toxicity and quality of life (QOL) in patients 15 years after external beam radiotherapy (EBRT) for localized prostate cancer (LPC) and compare the outcomes with results for age-matched controls. MATERIAL AND METHODS: Urinary symptoms were assessed using the symptom-specific Prostate Cancer Symptom Scale (PCSS) questionnaire, and QOL was assessed with the European Organization for Research and Treatment of Cancer (EORTC)'s Quality of Life Questionnaire (QLQ-C30). Both questionnaires were sent to the surviving 41 patients(25%) and the PCSS questionnaire was sent to 69 age-matched controls for comparison. RESULTS: The response rate was 71% in the patient group and 59% in the control group. Two patients and four controls were excluded due to other cancer diagnoses, resulting in a total of 27 patients and 37 controls for inclusion in the analyses. The mean age in both groups was 78 years. In the patient group, incontinence had increased between the 8-year (mean 0.6) and the 15-year follow-up (mean 2.1; p0.038). No other differences in urinary problems were seen between these two follow-ups. Increased incontinence, stress incontinence, and pain while urinating were reported by the patients in comparison with the controls at 15 years. Role function was worse in the patient group (mean 67.3) compared with the controls (mean 82.4; p0.046). The patients also reported more appetite loss, diarrhea, nausea/vomiting, and pain than the controls. CONCLUSION: EBRT for LPC has divergent effects on urinary symptoms and QOL in comparison with age-matched controls. In our patient population, urinary incontinence increased between 8 and 15 years of follow-up. Otherwise, no differences in urinary symptoms were seen between 4 and 15 years. Incontinence, stress incontinence, and pain while urinating were increased after EBRT in comparison with the controls. Conventional EBRT did not result in a major deterioration in QOL 15 years after treatment.","Acta Oncol, 47(5): 852-861","Sweden",2008,"Local","Radiotherapy","PCSI,EORTC QLQ-C30","Patient",null,"Case-control","Sweden","Patient","Local","Radiotherapy",null,"Case-control","PCSI,EORTC QLQ-C30","2005:2009","Disease,General"]
[215,"Fransson, P. and A. Widmark (1996). \"Self-assessed sexual function after pelvic irradiation for prostate carcinoma. Comparison with an age-matched control group.\" Cancer 78(5): 1066-1078.",null,"Fransson, P. and A. Widmark","Self-assessed sexual function after pelvic irradiation for prostate carcinoma. Comparison with an age-matched control group","BACKGROUND: Treatment of localized prostate carcinoma is often accompanied by disturbances in sexual function. The patient's own opinion and experience with these problems can be of great importance for his quality of life. In men older than 50 years, disturbances in sexual function are common. Treatment such as radiotherapy (RT), which can induce sexual dysfunction, should be evaluated in relation to the problems in an age-matched population without prostate carcinoma. METHODS: Sexual function was evaluated with a self-assessment questionnaire using linear-analogue scales. The questionnaire was sent to 199 patients with prostate carcinoma, median age 71 years (range, 51-86 years), who had received pelvic RT with curative intent and to 200 age-matched men in northern Sweden. Mean follow-up time after RT was 48 months (range, 24-56 months). RESULTS: The response rate was high: 141 (71%) and 181 (91%) in the control and patient groups, respectively. Field reduction and treatment pause during RT was not associated with decreased problems in the patient groups. A failure to achieve erection was indicated in 12% of the control subjects, 56% of the patients who had received (RT only) and 87% of the RT + castration (RT + A) patients. In general, patients < 70 years treated with RT+A indicated more sexual problems than the RT only patients < 70 years. There was a strong negative correlation between age and sexual problems in the RT + A < 70 years group. However, in patients < 70 years, sexual activity after RT only, was not significantly different from the age-matched control population. CONCLUSIONS: Patients with prostate carcinoma treated with RT only indicated higher levels of sexual dysfunction than age-matched controls. This was most obvious in patients younger than 70 years, although their sexual activity was comparable to age-matched controls. The addition of castration to RT tended to increase sexual problems, especially in patients < 70 years. In men between 70 and 74 years, the maintenance of sexual function seems to be very susceptible to disturbances. For patients older than 74 years, decreased sexual function was not perceived as such a significant problem, despite abolished desire and erection.","Cancer, 78(5): 1066-1078","Sweden",1996,"Local","Radiotherapy","VAS","Patient",null,"Cross-sectional","Sweden","Patient","Local","Radiotherapy",null,"Cross-sectional","VAS","1960:1999","Complication"]
[216,"Fransson, P., et al. (2001). \"Quality of life and symptoms in a randomized trial of radiotherapy versus deferred treatment of localized prostate carcinoma.\" Cancer 92(12): 3111-3119.",null,"Fransson, P., et al.","Quality of life and symptoms in a randomized trial of radiotherapy versus deferred treatment of localized prostate carcinoma","BACKGROUND: Treatment of localized prostate carcinoma (LPC) using radiotherapy (RT) can induce disturbances in a patient's quality of life (QOL) and urinary and intestinal function. Late symptoms and QOL were evaluated in a randomized trial between RT and deferred treatment (DT). METHODS: Quality of life was evaluated with European Organization for Research and Treatment of Cancer's QLQ-C30 (+3) formula. Urinary and intestinal problems were evaluated with a validated symptom specific self-assessment questionnaire, QUFW94. The questionnaires were sent to 108 randomized patients with LPC and to an age-matched control group (n = 68). Mean age was 72 years. Mean total dose was 65 grays (Gy; 62.3-70 Gy). The median follow-up time from randomization was 40.6 months for the RT group and 30.4 months for the DT group. RESULTS: Social functioning was the only QOL scale in which a significant difference was found between the two patient groups and compared with the control group. Multivariate regression analysis showed that hematuria, incontinence, mucus, and planning of daily activities in response to intestinal problems caused this decrease in QOL in the RT group. A significant increase of intestinal problems was observed in the RT versus DT groups regarding mucus, stool leakage, intestinal blood, and planning of daily activity in response to intestinal problems. CONCLUSIONS: The RT patients showed increased levels of minor intestinal side effects compared with the DT patients and the controls, but the RT patients reported no decreased QOL except for decreased social functioning. This could be because this group developed coping skills or because of a low magnitude of side effects to influence the QOL.","Cancer, 92(12): 3111-3119","Sweden",2001,"Local","Radiotherapy,Surveillance","EORTC QLQ-C30,QUFW94","Patient",null,"Clinical trial","Sweden","Patient","Local","Radiotherapy,Surveillance",null,"Clinical trial","EORTC QLQ-C30,QUFW94","2000:2004","Disease,General"]
[217,"Fransson, P., et al. (2009). \"Quality of life in patients with locally advanced prostate cancer given endocrine treatment with or without radiotherapy: 4-year follow-up of SPCG-7/SFUO-3, an open-label, randomised, phase III trial.\" Lancet Oncol 10(4): 370-380.",null,"Fransson, P., et al.","Quality of life in patients with locally advanced prostate cancer given endocrine treatment with or without radiotherapy: 4-year follow-up of SPCG-7/SFUO-3, an open-label, randomised, phase III trial","BACKGROUND: Androgen treatment for prostate cancer can adversely affect functional domains of quality of life. We aimed to assess quality of life in men with locally advanced prostate cancer in an open-label phase III randomised comparison between lifelong endocrine treatment with and without radiotherapy. METHODS: We obtained quality-of-life information from 872 (99%) of 875 eligible men with locally advanced prostate cancer (T3; 78%) who were randomly assigned, between 1996 and 2002, to 3 months of total androgen blockade followed by continuous endocrine treatment (439 patients) or the same hormonal treatment with radiotherapy 3 months after randomisation (436 patients). Prospective outcomes included patient-reported symptoms and quality of life assessed with questionnaires from baseline to 4 years after randomisation. Analysis was by intention to treat. This study is registered as an international standard randomised controlled trial, number ISRCTN01534787. FINDINGS: 438 of 439 men assigned endocrine treatment and 434 of 436 assigned endocrine plus radiotherapy completed at least one questionnaire. Missing data at baseline and during follow-up was equally distributed between groups. At 4 years, 64 (18%) of 353 patients on combined therapy and 39 (12%) of 337 on endocrine-alone therapy had moderate to severe urinary bother (p=0.005), and 16 (4%) of 355 on combined therapy and five (2%) of 338 on endocrine treatment alone had pain while urinating (p=0.024). 37 (11%) of 350 in the combined group and 23 (7%) of 35 in the endocrine-only group had overall bother from all bowel symptoms (p=0.022). 281 (85%) of 332 in the combined-treatment group and 227 (72%) of 313 in the endocrine-only group had erectile dysfunction (p=0.0002). Quality of life at 4 years was similar, with the exception of decreased social function in patients receiving endocrine treatment plus radiotherapy. INTERPRETATION: Although addition of radiotherapy to endocrine treatment significantly increased some treatment-related symptoms, none were serious. Given the substantial survival benefit of combined treatment, the increase of symptoms seems acceptable and has little extra effect on quality of life after 4 years compared with endocrine treatment alone.","Lancet Oncol, 10(4): 370-380","Sweden",2009,"Advanced","Hormonal,Radiotherapy","Unclear","Patient",null,"Clinical trial","Sweden","Patient","Advanced","Hormonal,Radiotherapy",null,"Clinical trial","Unclear","2005:2009","General,Symptom"]
[218,"Frazer, G. H., et al. (1998). \"Assessment of quality of life indicators among selected patients in a community cancer center.\" Issues Ment Health Nurs 19(3): 241-262.",null,"Frazer, G. H., et al.","Assessment of quality of life indicators among selected patients in a community cancer center","Quality of life and outcome assessments are particularly critical for nurses in assessing clinical care for diseases such as cancer because of potential mortality and the exacting modalities of treatment. The 278 study participants were patients at the M.D. Anderson Cancer Center Orlando. The respondents were assessed with the Health Status Questionnaire (HSQ; D. M. Radosevich, H. Wetzler, & S. M. Wilson, 1995). Prostate cancer patients scored higher (had a higher quality of life) on average (6.08%) than breast cancer patients on all subscales except Physical Functioning. The diagnostic center patients scored higher (9.68%) than breast cancer patients and prostate cancer patients (3.47%). Breast cancer respondents scored 16.61% lower than the normative values for individuals less than 65 years of age, whereas prostate cancer respondents scored 10.91% higher than the normative values for those older than 65. The data analysis confirmed that breast cancer and prostate cancer patients have statistically different scores on the HSQ, implying different quality of life concerns for each group.","Issues Ment Health Nurs, 19(3): 241-262","USA",1998,"Any or unknown","None","HSQ","Patient",null,"Cross-sectional","USA","Patient","Any or unknown","None",null,"Cross-sectional","HSQ","1960:1999","General"]
[219,"Froehner, M., et al. (2013). \"Urinary tract-related quality of life after radical prostatectomy: open retropubic versus robot-assisted laparoscopic approach.\" Urol Int 90(1): 36-40.",null,"Froehner, M., et al.","Urinary tract-related quality of life after radical prostatectomy: open retropubic versus robot-assisted laparoscopic approach","BACKGROUND: The best technique of radical prostatectomy--open retropubic versus robot-assisted surgery--is a subject of controversy. PATIENTS AND METHODS: Between January 1st, 2007 and December 31st, 2011, 2,177 men underwent radical prostatectomy at our department. 252 (12%) cases were laparoscopic robot-assisted, the remainder open retropubic procedures. In Germany, certified prostate cancer centers are required to collect urinary tract-related outcome data after radical prostatectomy using the International Consultation of Incontinence Questionnaire Male Lower Urinary Tract Symptoms. The questionnaire data were used to compare both surgical approaches concerning the urinary tract-related outcome 1, 2 and 3 years postoperatively. RESULTS: Neither the voiding score nor the incontinence score or the bother scale sum differed between the two cohorts at any of the measurement times. CONCLUSIONS: Concerning continence recovery, in this series, there were no detectable differences between robot-assisted and open radical prostatectomy.","Urol Int, 90(1): 36-40","Germany",2013,"Any or unknown","Surgery","ICIQ","Patient",null,"Cohort","Germany","Patient","Any or unknown","Surgery",null,"Cohort","ICIQ","2010:2014","Complication"]
[220,"Frohmuller, H. G., et al. (1995). \"Survival and quality of life of patients with stage D1 (T1-3 pN1-2 M0) prostate cancer. Radical prostatectomy plus androgen deprivation versus androgen deprivation alone.\" Eur Urol 27(3): 202-206.",null,"Frohmuller, H. G., et al.","Survival and quality of life of patients with stage D1 (T1-3 pN1-2 M0) prostate cancer. Radical prostatectomy plus androgen deprivation versus androgen deprivation alone","A series of 139 patients with histologically proven stage D1 (T1-3 pN1-2 M0) prostate cancer was reviewed in order to determine the influence of radical surgery in addition to hormonal treatment on long-term outcome with respect to survival and quality of life. In all 139 patients a pelvic lymphadenectomy was performed. In 87 patients, lymphadenectomy was followed by androgen deprivation alone (group 1). Fifty-two patients underwent additional radical prostatectomy (group 2). The actuarial 10-year nonprogression rates were 14.6% in group 1 and 35.8% in group 2, respectively (p = 0.0016). The overall and disease-specific 10-year survival rates were found to be 29.7 and 32.1%, respectively, for group 1 and 50.8 and 70.7%, respectively, for group 2. Local progression as the main parameter influencing quality of life occurred in 60 of the 87 patients (69%) not subjected to radical prostatectomy. Transurethral resection of the prostate was required in 29 of these patients. In contrast, following radical prostatectomy, only 4 of the 52 patients (8%) had local progression and only 1 patient (2%) needed a dilatation of the vesicourethral anastomosis for relief of infravesical obstruction. Thus, radical prostatectomy plus androgen deprivation for patients with stage D1 prostate cancer appeared to be superior to androgen deprivation alone with respect to survival expectancy and quality of life. Prospective randomized trials, however, have to be undertaken to verify these results.","Eur Urol, 27(3): 202-206","Germany",1995,"Advanced","Surgery,Hormonal","Unclear","Patient",null,"Cohort","Germany","Patient","Advanced","Surgery,Hormonal",null,"Cohort","Unclear","1960:1999","General"]
[221,"Fromme, E. K., et al. (2004). \"How accurate is clinician reporting of chemotherapy adverse effects? A comparison with patient-reported symptoms from the Quality-of-Life Questionnaire C30.\" J Clin Oncol 22(17): 3485-3490.",null,"Fromme, E. K., et al.","How accurate is clinician reporting of chemotherapy adverse effects? A comparison with patient-reported symptoms from the Quality-of-Life Questionnaire C30","PURPOSE: Adverse events in chemotherapy clinical trials are assessed and reported by clinicians, yet clinician accuracy in assessing symptoms has been questioned. We compared patient reporting of eight symptoms using a validated instrument, the European Organization for the Research and Treatment of Cancer Quality-of-Life Questionnaire C30 (QLQ-C30 or QLQ) with physicians' reporting of the same symptoms in the study's adverse events log. PATIENTS AND METHODS: Thirty-seven men with metastatic, androgen-independent prostate cancer enrolled onto a phase II trial of weekly calcitriol and docetaxel completed the QLQ every 4 weeks for up to 28 weeks. A patient-reported symptom was defined as an increase in a QLQ symptom score by at least 10 points (0 to 100 scale), sustained for at least 4 weeks. A physician-reported symptom was considered present if it was ever documented in the adverse event log. RESULTS: Forty-nine (new or worsened) symptoms were detected by both physician and QLQ, 48 symptoms were detected by the physician alone, and 55 symptoms were detected by the QLQ alone. They agreed on the absence of a symptom in 102 instances of 254 possible opportunities. Their uncorrected agreement was 59.4%, but Cohen's kappa, a coefficient of agreement that corrects for chance, was 0.15, indicating only slight agreement. Using the QLQ as the standard, overall physician sensitivity and specificity was 47% and 68%, respectively, although it varied considerably among symptoms. CONCLUSION: Even in a tightly controlled clinical trial, physician reporting was neither sensitive nor specific in detecting common chemotherapy adverse effects. Tools for collecting patient-reported adverse event data in chemotherapy clinical trials should be developed.","J Clin Oncol, 22(17): 3485-3490","USA",2004,"Metastatic","Taxane","EORTC QLQ-C30","Patient,HCP",null,"Clinical trial","USA","Patient,HCP","Metastatic","Taxane",null,"Clinical trial","EORTC QLQ-C30","2000:2004","General"]
[222,"Frosch, D., et al. (2001). \"Comparison of German language versions of the QWB-SA and SF-36 evaluating outcomes for patients with prostate disease.\" Qual Life Res 10(2): 165-173.",null,"Frosch, D., et al.","Comparison of German language versions of the QWB-SA and SF-36 evaluating outcomes for patients with prostate disease","BACKGROUND: The quality of well-being scale (QWB) and the Medical Outcome Study 36-item short form (SF-36) are alternative methods for measuring general health outcomes. Few studies compare these approaches against one another and no studies have compared German language versions. METHOD: A German language version of the self-administered quality of well-being scale (QWB-SA) was developed using forward and back translation methods. The German QWB-SA and a German language version of the SF-36 were administered to clinical population groups with current diagnoses of prostate cancer, benign hyperplasia of the prostate, colon cancer, and rectal cancer. Data were obtained from four German clinics. In addition to the quality of life measures, data on cancer stage and disease state were obtained. RESULTS: The QWB-SA and SF-36 were highly correlated. The QWB-SA was systematically related to disease state. Those with no symptomatic evidence had the highest scores followed by those who were stable with no metastatic disease and those with metastatic progression. Similar patterns were found for most SF-36 scales although the SF-36 failed to discriminate between those with no evidence of disease and those with stable disease without metastasis. CONCLUSIONS: Both the QWB-SA and SF-36 perform as expected using German language translations. Although both measures differentiate patients with metastasis from those without symptoms, the QWB-SA better differentiated those with no evidence of disease from those with stable disease without metastasis.","Qual Life Res, 10(2): 165-173","Germany",2001,"Any or unknown","None","QWB,SF-36","Patient",null,"Validation","Germany","Patient","Any or unknown","None",null,"Validation","QWB,SF-36","2000:2004","General,Utility"]
[223,"Fujimura, T., et al. (2012). \"Assessment of lower urinary tract symptoms in men by international prostate symptom score and core lower urinary tract symptom score.\" BJU Int 109(10): 1512-1516.",null,"Fujimura, T., et al.","Assessment of lower urinary tract symptoms in men by international prostate symptom score and core lower urinary tract symptom score","Study Type - Therapy (symptom prevalence). Level of Evidence 2a. What's known on the subject? and What does the study add? The International Prostate Symptom Score (IPSS) has been most commonly used for the symptom assessment of men with lower urinary tract symptoms (LUTS). However, LUTS in men are so variable that they may not be fully captured by the IPSS questionnaire alone. This study has demonstrated that the Core Lower Urinary Tract Symptom Score (CLSS) questionnaire, which addresses 10 important symptoms, is an appropriate initial assessment tool for LUTS in men with various diseases/conditions. OBJECTIVE: International Prostate Symptom Score (IPSS) has been commonly used to assess lower urinary tract symptoms (LUTS). We have recently developed Core Lower Urinary Tract Symptom Score (CLSS). The aim of this study is to compare IPSS and CLSS for assessing LUTS in men. PATIENTS AND METHODS: Consecutive 515 men fulfilled IPSS and CLSS questionnaires. IPSS QOL Index was used as the QOL surrogate. The clinical diagnoses were BPH (n = 116), BPH with OAB wet (n =80), prostate cancer (n = 128), prostatitis (n = 68), underactive bladder (n = 8), others (n = 72), and controls (e.g., occult blood) (n = 42). Simple statistics and predictability of poor QOL (QOL Index 4 or greater) were examined. RESULTS: All symptom scores were significantly increased in symptomatic men compared with controls. Scores of corresponding symptoms of two questionnaires were significantly correlated (r = 0.58-0.85, all P < 0.0001). A multivariate regression model to predict poor QOL indicated nine symptoms (daytime frequency, nocturia, urgency, urgency incontinence, slow stream, straining, incomplete emptying, bladder pain and urethral pain) as independent factors. The hazard ratios for bladder pain (2.2) and urgency incontinence (2.0) were among the highest. All the nine symptoms are addressed in CLSS, while three symptoms (urgency incontinence, bladder, and urethral pain) are dismissed in IPSS. CONCLUSION: CLSS questionnaire is more comprehensive than IPSS questionnaire for symptom assessment of men with various diseases/conditions, although both questionnaires can capture LUTS with possible negative impact on QOL.","BJU Int, 109(10): 1512-1516","Japan",2012,"Any or unknown","None","IPSS,CLSS","Patient",null,"Validation","Japan","Patient","Any or unknown","None",null,"Validation","IPSS,CLSS","2010:2014","Symptom"]
[224,"Fulmer, B. R., et al. (2001). \"Prospective assessment of voiding and sexual function after treatment for localized prostate carcinoma: comparison of radical prostatectomy to hormonobrachytherapy with and without external beam radiotherapy.\" Cancer 91(11): 2046-2055.",null,"Fulmer, B. R., et al.","Prospective assessment of voiding and sexual function after treatment for localized prostate carcinoma: comparison of radical prostatectomy to hormonobrachytherapy with and without external beam radiotherapy","BACKGROUND: Voiding and sexual function after treatment are major determinants of quality of life in prostate carcinoma patients. Erectile dysfunction, incontinence, and urinary symptoms, both obstructive and irritative, have a significant negative impact on patient quality of life. This prospective study was undertaken to evaluate voiding, sexual function, and their impact on patients with localized prostate carcinoma who were treated with radical retropubic prostatectomy (RP) and to compare these patients with patients who were undergoing hormonobrachytherapy with external bean radiotherapy (HBTC) and patients who were undergoing hormonobrachytherapy without external beam radiotherapy (HBT). METHODS: Patients treated for localized prostate carcinoma with either RP or interstitial palladium-103 (103Pd) HBTC or HBT were prospectively administered a voiding and sexual function questionnaire before any treatment was initiated and at posttreatment visits. Questionnaire components included the American Urological Association Symptom Score (AUASS) and specific items that addressed urinary control and sexual function from the University of California at Los Angeles Prostate Cancer Index. Questionnaire results were compiled, and differences among treatment groups were assessed over time. RESULTS: From January 1997 to November 1999, 127 consecutive patients were treated with either unilateral or bilateral nerve-sparing RP (42 patients), HBTC (40 patients) or HBT (45 patients) by 2 surgeons proficient in all procedures. Using the overall score and the obstructive subscale (OAUA) of the AUASS, the RP group showed a posttreatment decrease in scores compared with both HBTC and HBT groups. OAUA scores of HBTC and HBT groups were significantly greater than scores in RP patients over the course of the study. HBTC patients had increased irritative symptoms initially when compared with RP patients, and, although not statistically significant, the magnitude of the difference persisted over the course of the study. Total AUASS and subscale scores for the RP group returned to near baseline levels within 12 months. The use of incontinence pads was a criterion for urinary incontinence, and the proportion of patients returning to baseline continence was lower in RP patients over the course of the study. No notable differences in Voiding Bother (VB) scores were found. Initially RP patients experienced worse Sexual Function (SF) scores; however, scores for RP patients changed over time and approached the levels seen in HBTC patients at 18 months. The Sexual Function Bother (SFB) scores also were higher initially in the RP group but then decreased to similar levels observed for HBTC patients by 18 months. None of the treatment groups returned to near baseline SF or SFB scores during the course of this study. CONCLUSIONS: Comparison of voiding function indicated that HBTC and HBT patients initially have more obstructive voiding symptoms, whereas urinary incon- tinence is initially worse in RP patients. Initially RP patients demonstrated worse SF and SFB scores, but RP patients returned to HBTC levels within 18 months.","Cancer, 91(11): 2046-2055","USA",2001,"Local","Surgery,Brachytherapy","AUA-SI,UCLA-PCI","Patient",null,"Cohort","USA","Patient","Local","Surgery,Brachytherapy",null,"Cohort","AUA-SI,UCLA-PCI","2000:2004","Symptom,Disease"]
[225,"Furst, C. J. (1996). \"Radiotherapy for cancer. Quality of life.\" Acta Oncol 35 Suppl 7: 141-148.",null,"Furst, C. J.","Radiotherapy for cancer. Quality of life","This synthesis of the literature on the quality of life in relation to radiotherapy is based on 78 scientific articles, including 12 randomized studies, 25 prospective studies, and 20 retrospective studies. These studies involve 9884 patients. Radiotherapy is often organ-preserving, which inherently promotes a better quality of life. Many quality of life aspects related to radiotherapy have been studied, but seldom by prospective randomized studies that compare radiotherapy to other treatment (eg, surgery or chemotherapy). Radiotherapy involves numerous physical and psychological symptoms, mainly during the course of treatment. Examples include skin irritation and fatigue. Radiotherapy directed at the brain has delayed effects, in children treatment carries a substantial risk for lowering the IQ. The risk for encephalopathy in adults is probably underestimated. Patients with cancer in the head and neck may experience adverse side effects in the irradiated area long after the conclusion of radiotherapy. There are no confirmed differences in quality of life between breast cancer patients receiving adjuvant radiotherapy and those receiving chemotherapy. Impotency problems and urinary incontinence appear following radical surgery and radiotherapy for prostate cancer. The risk for delayed complications is low after radiotherapy for testicular cancer. Patients receiving radiotherapy for gynecologic cancers are often troubled by local side effects long after the conclusion of treatment.","Acta Oncol, 35 Suppl 7(141-148","Sweden",1996,"Any or unknown","Radiotherapy","Unclear","Patient",null,"Systematic review","Sweden","Patient","Any or unknown","Radiotherapy",null,"Systematic review","Unclear","1960:1999","Complication"]
[226,"Gacci, M., et al. (2005). \"Quality of life after radical treatment of prostate cancer: validation of the Italian version of the University of California-Los Angeles Prostate Cancer Index.\" Urology 66(2): 338-343.",null,"Gacci, M., et al.","Quality of life after radical treatment of prostate cancer: validation of the Italian version of the University of California-Los Angeles Prostate Cancer Index","OBJECTIVES: To validate an Italian version of the University of California-Los Angeles Prostate Cancer Index (UCLA-PCI). METHODS: Men with prostate cancer treated with radical retropubic prostatectomy (RRP) or external beam radiation (EBR) were retrospectively selected. Each subject was asked to complete the UCLA-PCI short form and the 36-item short-form health survey (SF-36) questionnaires (principal sample); a subgroup completed both questionnaires twice (retest sample). A linguistic translation and validation was performed. Psychometric properties were analyzed. RESULTS: A total of 595 men were included in the study: 394 from the Department of Urology (treated with RRP) and 201 from the Department of Radiotherapy (treated with EBR). Of these, 75 patients (50 from the RRP group and 25 from the EBR group) were selected as the retest cohort. Internal consistency reliability of the SF-36 and UCLA-PCI for the primary sample of the surgery and radiotherapy populations ranged from 0.82 to 0.94; the mean values of sexual function were superior in the principal urology group, whereas the principal radiotherapy group demonstrated superior mean values of urinary function and urinary bother. A strong correlation between urinary function and sexual and bowel function, and between urinary function and all bother scales, was reported only for patients treated with RRP. The expected correlation between sexual function and sexual bother was reported for the EBR group but not for the RRP group. CONCLUSIONS: Our study demonstrated the excellent psychometric properties of the Italian version of the UCLA-PCI; the Italian version of the UCLA-PCI questionnaire will allow cross-cultural comparative studies in men with prostate cancer.","Urology, 66(2): 338-343","Italy",2005,"Any or unknown","Surgery,Radiotherapy","SF-36,UCLA-PCI","Patient",null,"Validation","Italy","Patient","Any or unknown","Surgery,Radiotherapy",null,"Validation","SF-36,UCLA-PCI","2005:2009","Disease,Utility"]
[227,"Galalae, R. M., et al. (2004). \"Health-related quality of life measurement in long-term survivors and outcome following radical radiotherapy for localized prostate cancer.\" Strahlenther Onkol 180(9): 582-589.",null,"Galalae, R. M., et al.","Health-related quality of life measurement in long-term survivors and outcome following radical radiotherapy for localized prostate cancer","PURPOSE: To report long-term outcomes in terms of health-related quality of life (HRQoL) and survival of a dose-escalating radiotherapy protocol and to validate a new disease-specific HRQoL instrument. PATIENTS AND METHODS: 189 consecutive men with prostate cancer were analyzed; 127 patients had T1-2 (1% T1, 66% T2) and 62 patients (33%) T3 tumors. The pelvic lymphatics were treated to a dose of 50 Gy by external-beam irradiation. The prostate dose was limited to 40 Gy using compensators. The prostate was treated to the total nominal dose of 70 Gy using high-dose-rate (HDR) brachytherapy. The fraction dose was 15 Gy in the McNeal zone (planning target volume [PTV] 1), while 8-9 Gy were applied in the entire prostate (PTV 2). The HRQoL of the 145 long-term survivors was assessed using the EORTC QLQ-C30 and a new prostate-specific instrument (PSM-G 1.0). The reliability of the instruments used and HRQoL scale scores were calculated. Uni-/multivariate analyses of variance were performed. RESULTS: At a mean follow-up of 6.5 years 86.3% of the patients were disease-free, and 78% were biochemically controlled. The mean Cronbach's alpha-values were 0.81 for the QLQ-C30, and 0.74 for the prostate-specific module. Univariate analyses of variance by T-stage, grading, prostata-specific antigen (PSA) status after therapy and adjuvant androgen suppression (AS) revealed that PSA elevation after irradiation and AS were associated with significantly diminished HRQoL. In multivariate analyses AS significantly lowered the HRQoL without survival benefit. CONCLUSION: The described radiotherapy regimen represents a curative and well-tolerated treatment for localized prostate cancer. The HRQoL assessment with both instruments used was reliable. Adjuvant AS and PSA elevation were associated with diminished HRQoL.","Strahlenther Onkol, 180(9): 582-589","Germany",2004,"Survivors","Radiotherapy","EORTC QLQ-C30,PSM-G","Patient",null,"Validation","Germany","Patient","Survivors","Radiotherapy",null,"Validation","EORTC QLQ-C30,PSM-G","2000:2004","General,Disease"]
[228,"Galbraith, M. E., et al. (2001). \"Quality of life, health outcomes, and identity for patients with prostate cancer in five different treatment groups.\" Oncol Nurs Forum 28(3): 551-560.",null,"Galbraith, M. E., et al.","Quality of life, health outcomes, and identity for patients with prostate cancer in five different treatment groups","PURPOSE/OBJECTIVES: To describe how different treatments for prostate cancer affect health-related quality of life (QOL), health status, and masculinity. DESIGN: Longitudinal survey design with descriptive, correlational, and comparative elements. SETTING: A tertiary medical center and associated clinics in a suburban community in the Southwestern United States. SAMPLE: 185 men with localized prostate cancer were enrolled from five treatment groups: watchful waiting (n = 30), surgery (n = 59), conventional radiation (n = 25), proton-beam radiation (n = 24), and a combination of conventional radiation and proton-beam radiation or mixed-beam radiation (n = 47). At six months, 163 remained on the study; at 12 months, 154 remained: and at 18 months, 153 remained. The average age was 68 years, and 82% of the men were white. METHODS: Men were enrolled at treatment and given a questionnaire with a self-addressed, stamped envelope for return. Questionnaires were mailed again at 6, 12, and 18 months. MAIN RESEARCH VARIABLES: Health-related QOL health status, prostate treatment-specific symptoms, and sex-role identity. FINDINGS: No overall difference in health-related QOL or health status was found, but post-hoc analysis revealed specific differences. The differences existed in sexual functioning and gastrointestinal treatment-specific symptoms. No relationship existed between masculinity and health-related QOL. CONCLUSIONS: Health-related QOL and health status are similar regardless of type of treatment. Radiation tends to produce more gastrointestinal symptoms, and surgery tends to produce more sexual functioning symptoms. Watchful waiting is associated with poorer general health. IMPLICATIONS FOR NURSING PRACTICE: Nurses can provide specific treatment-related information to men who are faced with making treatment decisions for prostate cancer and, in consultation with the healthcare team, can select a treatment best sulted to them.","Oncol Nurs Forum, 28(3): 551-560","USA",2001,"Local","Radiotherapy,Surveillance,Surgery","Unclear","Patient",null,"Clinical trial","USA","Patient","Local","Radiotherapy,Surveillance,Surgery",null,"Clinical trial","Unclear","2000:2004","General,Symptom"]
[229,"Garcia-Sanchez, C., et al. (2017). \"Comparative analysis of short - term functional outcomes and quality of life in a prospective series of brachytherapy and Da Vinci robotic prostatectomy.\" Int Braz J Urol 43(2): 216-223.",null,"Garcia-Sanchez, C., et al.","Comparative analysis of short - term functional outcomes and quality of life in a prospective series of brachytherapy and Da Vinci robotic prostatectomy","INTRODUCTION: There is a growing interest in achieving higher survival rates with the lowest morbidity in localized prostate cancer (PC) treatment. Consequently, minimally invasive techniques such as low-dose rate brachytherapy (BT) and robotic-assisted prostatectomy (RALP) have been developed and improved. Comparative analysis of functional outcomes and quality of life in a prospective series of 51BT and 42Da Vinci prostatectomies DV Materials and Methods: Comparative analysis of functional outcomes and quality of life in a prospective series of 93 patients with low-risk localized PC diagnosed in 2011. 51patients underwent low-dose rate BT and the other 42 patients RALP. IIEF to assess erectile function, ICIQ to evaluate continence and SF36 test to quality of life wee employed. RESULTS: ICIQ at the first revision shows significant differences which favour the BT group, 79% present with continence or mild incontinence, whereas in the DV group 45% show these positive results. Differences disappear after 6 months, with 45 patients (89%) presenting with continence or mild incontinence in the BT group vs. 30 (71%) in the DV group. 65% of patients are potent in the first revision following BT and 39% following DV. Such differences are not significant and cannot be observed after 6 months. No significant differences were found in the comparative analysis of quality of life. CONCLUSIONS: ICIQ after surgery shows significant differences in favour of BT, which disappear after 6 months. Both procedures have a serious impact on erectile function, being even greater in the DV group. Differences between groups disappear after 6 months.","Int Braz J Urol, 43(2): 216-223","Spain",2017,"Local","Brachytherapy,Surgery","IIEF-5,ICIQ,SF-36","Patient",null,"Cohort","Spain","Patient","Local","Brachytherapy,Surgery",null,"Cohort","IIEF-5,ICIQ,SF-36","2015:2018","Complication,Utility"]
[230,"Gavin, A. T., et al. (2016). \"Effect of investigation intensity and treatment differences on prostate cancer survivor's physical symptoms, psychological well-being and health-related quality of life: a two country cross-sectional study.\" BMJ Open 6(12): e012952.",null,"Gavin, A. T., et al.","Effect of investigation intensity and treatment differences on prostate cancer survivor's physical symptoms, psychological well-being and health-related quality of life: a two country cross-sectional study","AIM: To investigate effects on men's health and well-being of higher prostate cancer (PCa) investigation and treatment levels in similar populations. PARTICIPANTS: PCa survivors in Ireland where the Republic of Ireland (RoI) has a 50% higher PCa incidence than Northern Ireland (NI). METHOD: A cross-sectional postal questionnaire was sent to PCa survivors 2-18 years post-treatment, seeking information about current physical effects of treatment, health-related quality of life (HRQoL; EORTC QLQ-C30; EQ-5D-5L) and psychological well-being (21 question version of the Depression, Anxiety and Stress Scale, DASS-21). Outcomes in RoI and NI survivors were compared, stratifying into 'late disease' (stage III/IV and any Gleason grade (GG) at diagnosis) and 'early disease' (stage I/II and GG 2-7). Responses were weighted by age, jurisdiction and time since diagnosis. Between-country differences were investigated using multivariate logistic and linear regression. RESULTS: 3348 men responded (RoI n=2567; NI n=781; reflecting population sizes, response rate 54%). RoI responders were younger; less often had comorbidities (45% vs 38%); were more likely to present asymptomatically (66%; 41%) or with early disease (56%; 35%); and less often currently used androgen deprivation therapy (ADT; 2%; 28%). Current prevalence of incontinence (16%) and impotence (56% early disease, 67% late disease) did not differ between RoI and NI. In early disease, only current bowel problems (RoI 12%; NI 21%) differed significantly in multivariate analysis. In late disease, NI men reported significantly higher levels of gynaecomastia (23% vs 9%) and hot flashes(41% vs 19%), but when ADT users were analysed separately, differences disappeared. For HRQoL, in multivariate analysis, only pain (early disease: RoI 11.1, NI 19.4) and financial difficulties (late disease: RoI 10.4, NI 7.9) differed significantly between countries. There were no significant between-country differences in DASS-21 or index ED-5D-5L score. CONCLUSIONS: Treatment side effects were commonly reported and increased PCa detection in RoI has left more men with these side effects. We recommended that men be offered a PSA test only after informed discussion.","BMJ Open, 6(12): e012952","UK,Ireland",2016,"Survivors","None","EORTC QLQ-C30,EQ-5D,DASS-21","Patient",null,"Cross-sectional","UK,Ireland","Patient","Survivors","None",null,"Cross-sectional","EORTC QLQ-C30,EQ-5D,DASS-21","2015:2018","General,Comorbidity,Utility"]
[231,"Gay, H. A., et al. (2013). \"Neoadjuvant androgen deprivation therapy leads to immediate impairment of vitality/hormonal and sexual quality of life: results of a multicenter prospective study.\" Urology 82(6): 1363-1368.",null,"Gay, H. A., et al.","Neoadjuvant androgen deprivation therapy leads to immediate impairment of vitality/hormonal and sexual quality of life: results of a multicenter prospective study","OBJECTIVE: To evaluate the immediate effects of neoadjuvant androgen deprivation therapy (NADT) on health-related quality of life (HRQOL) among patients undergoing radiation therapy (RT) for newly diagnosed prostate cancer. METHODS: The Prostate Cancer Outcomes and Satisfaction with Treatment Quality Assessment Consortium is a prospective multi-institutional study. HRQOL is measured with the Expanded Prostate Cancer Index Composite-26 questionnaire. Differences in patient-reported HRQOL were observed between pretreatment and 2 months after NADT start (and before definitive RT) with significant differences evaluated by paired t test. RESULTS: From among 450 patients who completed the Expanded Prostate Cancer Index Composite-26 before and 2 months after NADT start, 71 received NADT before proceeding with definitive RT. Patients receiving NADT experienced significant impairment in vitality/hormonal (P <.0001) and sexual (P <.0001) HRQOL after NADT initiation. The mean +/- standard deviation vitality/hormonal score fell from an average of 94.1 +/- 9.7 before NADT to 78.7 +/- 16.3 two months after NADT initiation; and sexual HRQOL fell from a mean of 51.7 +/- 31.1 pretreatment to 32.3 +/- 26.1 after NADT initiation. Both these HRQOL domain changes exceeded the thresholds for clinical significance. Patients receiving NADT also experienced a significant impairment in urinary continence (P = .024), although this difference did not meet the criteria for clinical significance. CONCLUSION: In this analysis, patients receiving NADT experience significant impairment in sexual and vitality/hormonal HRQOL even before starting definitive RT. The significant effect of this therapy on HRQOL needs to be considered before initiating NADT in men where there is no clear evidence of clinical benefit.","Urology, 82(6): 1363-1368","USA",2013,"Any or unknown","Hormonal,Radiotherapy","EPIC","Patient",null,"Clinical trial","USA","Patient","Any or unknown","Hormonal,Radiotherapy",null,"Clinical trial","EPIC","2010:2014","Disease"]
[232,"Gay, H. A., et al. (2017). \"External Beam Radiation Therapy or Brachytherapy With or Without Short-course Neoadjuvant Androgen Deprivation Therapy: Results of a Multicenter, Prospective Study of Quality of Life.\" Int J Radiat Oncol Biol Phys 98(2): 304-317.",null,"Gay, H. A., et al.","External Beam Radiation Therapy or Brachytherapy With or Without Short-course Neoadjuvant Androgen Deprivation Therapy: Results of a Multicenter, Prospective Study of Quality of Life","PURPOSE: The long-term effects of neoadjuvant androgen deprivation therapy (NADT) with radiation therapy on participant-reported health-related quality of life (HRQOL) have not been characterized in prospective multicenter studies. We evaluated HRQOL for 2 years among participants undergoing radiation therapy (RT) with or without NADT for newly diagnosed, early-stage prostate cancer. METHODS AND MATERIALS: We analyzed longitudinal cohort data from the Prostate Cancer Outcomes and Satisfaction with Treatment Quality Assessment Consortium to ascertain the HRQOL trajectory of men receiving NADT with external beam RT (EBRT) or brachytherapy. HRQOL was measured using the expanded prostate cancer index composite 26-item questionnaire at 2, 6, 12, and 24 months after the initiation of NADT. We used the chi(2) or Fisher exact test to compare the shift in percentages between groups that did or did not receive NADT. Analyses were conducted at the 2-sided 5% significance level. RESULTS: For subjects receiving EBRT, questions regarding the ability to have an erection, ability to reach an orgasm, quality of erections, frequency of erections, ability to function sexually, and lack of energy were in a significantly worse dichotomized category for the patients receiving NADT. Comparing the baseline versus 24-month outcomes, 24%, 23%, and 30% of participants receiving EBRT plus NADT shifted to the worse dichotomized category for the ability to reach an orgasm, quality of erections, and ability to function sexually compared with 14%, 13%, and 16% in the EBRT group, respectively. CONCLUSIONS: Compared with baseline, at 2 years, participants receiving NADT plus EBRT compared with EBRT alone had worse HRQOL, as measured by the ability to reach orgasm, quality of erections, and ability to function sexually. However, no difference was found in the ability to have an erection, frequency of erections, overall sexual function, hot flashes, breast tenderness/enlargement, depression, lack of energy, or change in body weight. The improved survival in intermediate- and high-risk patients receiving NADT and EBRT necessitates pretreatment counseling of the HRQOL effect of NADT and EBRT.","Int J Radiat Oncol Biol Phys, 98(2): 304-317","USA",2017,"Local","Hormonal,Brachytherapy,Radiotherapy","EPIC","Patient",null,"Cohort","USA","Patient","Local","Hormonal,Brachytherapy,Radiotherapy",null,"Cohort","EPIC","2015:2018","Disease"]
[233,"Gaylis, F. D., et al. (1998). \"Radical retropubic prostatectomy outcomes at a community hospital.\" J Urol 159(1): 167-171.",null,"Gaylis, F. D., et al.","Radical retropubic prostatectomy outcomes at a community hospital","PURPOSE: We reviewed a 6-year experience performing radical retropubic prostatectomy at 2 community hospitals (for-profit and not-for-profit) to assess outcomes and to compare them to the published literature reflecting outcomes from major academic hospitals. MATERIALS AND METHODS: Charts of 116 patients who underwent radical retropubic prostatectomy (nerve sparing in select cases) between 1990 and 1996 were reviewed for clinical and pathological outcomes as well as hospital charges. Subjective patient reports of urinary continence, potency and satisfaction were evaluated postoperatively. RESULTS: Average patient age was 66.6 years and average preoperative prostate specific antigen level was 9.6 ng./ml. Of the patients 43% had T1c disease, 63% pT2 and 37% pT3. Positive margins were present in 17.2% of the specimens and 66% of the patients had Gleason scores of 5 and 6. No deaths occurred. Major complications occurred in 5.4% of patients and included deep venous thrombosis (1.8%), pulmonary embolism (1.8%), rectal injury requiring ileostomy (0.9%) and fascial dehiscence (0.9%). Mean blood loss was 872 cc and mean blood transfusion rate was 1.7 units (almost exclusively autologous blood). Hospital charges decreased at the not-for-profit hospital to $13,233 in 1996 from $17,743 in 1990 to 1995, whereas charges increased at the for-profit hospital to $25,979 in 1996 from $24,481 in 1990 to 1995. Mean length of stay decreased from 5 days in 1990 to 1995 to 3 days in 1996. Of the patients 80% were totally continent (pad-free), 12% wore a protective pad once per day for minimal incontinence and 8% wore 2 or more pads. Of the men who were potent preoperatively 18% retained potency and 46% remained sexually active postoperatively either spontaneously or with assistance. Of the patients 84% were satisfied with surgical outcomes, 11% were somewhat satisfied and 5% were dissatisfied. CONCLUSIONS: Radical retropubic prostatectomy can be performed safely and with acceptable clinical and pathological outcomes at a community hospital. Impotence continues to be one of the most bothersome morbidities, particularly in older men. Increasing cost awareness, coincident with the proliferation of managed care, has led to reductions in length of hospital stay and charges at certain hospitals.","J Urol, 159(1): 167-171","USA",1998,"Local,Advanced","Surgery","Unclear","Patient",null,"Cross-sectional","USA","Patient","Local,Advanced","Surgery",null,"Cross-sectional","Unclear","1960:1999","Complication"]
[234,"Geiger-Gritsch, S., et al. (2015). \"Patient-reported urinary incontinence and erectile dysfunction following radical prostatectomy: results from the European Prostate Centre Innsbruck.\" Urol Int 94(4): 419-427.",null,"Geiger-Gritsch, S., et al.","Patient-reported urinary incontinence and erectile dysfunction following radical prostatectomy: results from the European Prostate Centre Innsbruck","INTRODUCTION: Urinary and erectile functions were assessed by using self-administered validated questionnaires in patients undergoing radical prostatectomy. MATERIALS AND METHODS: In a prospective observational study, a total of 253 consecutive patients diagnosed with clinically localised prostate cancer between 2008 and 2009 at the European Prostate Centre Innsbruck were included. Patient-reported outcomes were assessed before radical prostatectomy and 12 months postoperatively using the validated International Consultation on Incontinence Questionnaire (ICIQ) and the International Index of Erectile Function (IIEF). The Wilcoxon signed-rank test and Chi square statistics were used for analysis. RESULTS: The study showed that before radical prostatectomy, urinary incontinence of various severity grades was reported in 18.8, postoperatively in 63.0% (p < 0.001) and erectile dysfunction of various degrees was reported in 39.6 at baseline compared to 80.1% 12 months postoperatively (p < 0.001). CONCLUSIONS: This study suggests that radical prostatectomy is associated with a significantly increased risk of urinary incontinence and erectile dysfunction 12 months postoperatively.","Urol Int, 94(4): 419-427","Austria",2015,"Local","Surgery","ICIQ,IIEF-5","Patient",null,"Cohort","Austria","Patient","Local","Surgery",null,"Cohort","ICIQ,IIEF-5","2015:2018","Complication"]
[235,"Geinitz, H., et al. (2006). \"Late rectal symptoms and quality of life after conformal radiation therapy for prostate cancer.\" Radiother Oncol 79(3): 341-347.",null,"Geinitz, H., et al.","Late rectal symptoms and quality of life after conformal radiation therapy for prostate cancer","BACKGROUND AND PURPOSE: This study was carried out in order to analyze the prevalence of late rectal and anal symptoms after conformal radiation therapy for prostate cancer and to assess their association with quality of life. PATIENTS AND METHODS: Two-hundred and forty nine patients were interviewed at 24-111 months after definitive conformal radiation therapy of localized prostate cancer with a median dose of 70 Gy. Rectal symptoms and fecal incontinence were evaluated with standardized questionnaires. Quality of life was assessed with the EORTC Quality of Life Questionnaire-C30 and the prostate cancer module PR25. RESULTS: Rectal symptoms were mostly intermittent. Daily symptoms occurred in < or =5% of the patients. Incontinence was mostly mild with only 3% of the patients reporting daily incontinence episodes. Quality of life was comparable to that of the male German general population except that cognitive functioning and diarrhea were worse in the study population and pain was worse in the reference population. Global quality of life was associated with fecal incontinence, fecal urge, tenesmus, therapy for rectal symptoms and hormonal therapy for biochemical/clinical recurrence. CONCLUSIONS: Rectal symptoms and fecal incontinence after conformal radiation therapy for prostate cancer are mostly intermittent. Fecal incontinence, fecal urge and tenesmus are associated with lower global quality of life levels.","Radiother Oncol, 79(3): 341-347","Germany",2006,"Local","Radiotherapy","EORTC QLQ-C30,EORTC QLQ-PR25","Patient",null,"Cross-sectional","Germany","Patient","Local","Radiotherapy",null,"Cross-sectional","EORTC QLQ-C30,EORTC QLQ-PR25","2005:2009","Disease,General"]
[236,"Giesler, R. B., et al. (2000). \"Assessing quality of life in men with clinically localized prostate cancer: development of a new instrument for use in multiple settings.\" Qual Life Res 9(6): 645-665.",null,"Giesler, R. B., et al.","Assessing quality of life in men with clinically localized prostate cancer: development of a new instrument for use in multiple settings","BACKGROUND: Quality of life in prostate cancer patients with clinically localized disease has become the focus of increasing attention over the past decade. However, few instruments have been developed and validated to assess quality of life specifically in this patient population. OBJECTIVE: The purpose of this investigation was to create a comprehensive, multi-scale quality of life instrument that can be tailored to the needs of the clinician/investigator in multiple settings. DESIGN, SUBJECTS, AND MEASURES: Patients diagnosed with clinically localized prostate cancer were mailed a questionnaire consisting of new and previously validated quality of life items and ancillary scales. Data from returned questionnaires were analyzed and used to create a multiscale instrument that assesses the effects of treatment and disease on urinary, sexual, and bowel domains, supplemented by a scale assessing anxiety over disease course/effectiveness of treatment. The instrument was then mailed to a second sample of prostate cancer patients once and then again two weeks later to assess test retest reliability. To assess feasibility in clinical settings, the instrument was self-administered to a third patient sample during a urology clinic visit. RESULTS: All scales exhibited good internal consistency and test retest reliability, convergent and discriminant validity, and significant correlations with disease specific, generic health-related, and global measures of quality of life. Men with greater physiologic impairment reported more limitations in role activities and more bother. Scales were also able to differentiate patients undergoing different therapies. All scales exhibited negligible correlations with a measure of socially desirable responding. Additionally, the instrument proved feasible when used as a self-administered questionnaire in a clinical setting. CONCLUSIONS: The current instrument possesses brief multi-item scales that can be successfully self-administered in multiple settings. The instrument is flexible, relatively quick, psychometrically reliable and valid, and permits a more comprehensive assessment of patients' quality of life.","Qual Life Res, 9(6): 645-665","USA",2000,"Local","None","Unclear","Patient",null,"Validation","USA","Patient","Local","None",null,"Validation","Unclear","2000:2004","General"]
[237,"Gilbert, D. C., et al. (2017). \"Quality-of-life outcomes from the Prostate Adenocarcinoma: TransCutaneous Hormones (PATCH) trial evaluating luteinising hormone-releasing hormone agonists versus transdermal oestradiol for androgen suppression in advanced prostate cancer.\" BJU Int 119(5): 667-675.",null,"Gilbert, D. C., et al.","Quality-of-life outcomes from the Prostate Adenocarcinoma: TransCutaneous Hormones (PATCH) trial evaluating luteinising hormone-releasing hormone agonists versus transdermal oestradiol for androgen suppression in advanced prostate cancer","OBJECTIVES: To compare quality-of-life (QoL) outcomes at 6 months between men with advanced prostate cancer receiving either transdermal oestradiol (tE2) or luteinising hormone-releasing hormone agonists (LHRHa) for androgen-deprivation therapy (ADT). PATIENTS AND METHODS: Men with locally advanced or metastatic prostate cancer participating in an ongoing randomised, multicentre UK trial comparing tE2 versus LHRHa for ADT were enrolled into a QoL sub-study. tE2 was delivered via three or four transcutaneous patches containing oestradiol 100 mug/24 h. LHRHa was administered as per local practice. Patients completed questionnaires based on the European Organisation for Research and Treatment of Cancer quality of life questionnaire 30-item core (EORTC QLQ-C30) with prostate-specific module QLQ PR25. The primary outcome measure was global QoL score at 6 months, compared between randomised arms. RESULTS: In all, 727 men were enrolled between August 2007 and October 2015 (412 tE2, 315 LHRHa) with QoL questionnaires completed at both baseline and 6 months. Baseline clinical characteristics were similar between arms: median (interquartile range) age of 74 (68-79) years and PSA level of 44 (19-119) ng/mL, and 40% (294/727) had metastatic disease. At 6 months, patients on tE2 reported higher global QoL than those on LHRHa (mean difference +4.2, 95% confidence interval 1.2-7.1; P = 0.006), less fatigue, and improved physical function. Men in the tE2 arm were less likely to experience hot flushes (8% vs 46%), and report a lack of sexual interest (59% vs 74%) and sexual activity, but had higher rates of significant gynaecomastia (37% vs 5%). The higher incidence of hot flushes among LHRHa patients appear to account for both the reduced global QoL and increased fatigue in the LHRHa arm compared to the tE2 arm. CONCLUSION: Patients receiving tE2 for ADT had better 6-month self-reported QoL outcomes compared to those on LHRHa, but increased likelihood of gynaecomastia. The ongoing trial will evaluate clinical efficacy and longer term QoL. These findings are also potentially relevant for short-term neoadjuvant ADT.","BJU Int, 119(5): 667-675","UK",2017,"Advanced,Metastatic","Hormonal","EORTC QLQ-C30,EORTC QLQ-PR25","Patient",null,"Clinical trial","UK","Patient","Advanced,Metastatic","Hormonal",null,"Clinical trial","EORTC QLQ-C30,EORTC QLQ-PR25","2015:2018","General,Disease"]
[238,"Gladwish, A., et al. (2015). \"Accelerated hypofractioned postoperative radiotherapy for prostate cancer: a prospective phase I/II study.\" Clin Oncol (R Coll Radiol) 27(3): 145-152.",null,"Gladwish, A., et al.","Accelerated hypofractioned postoperative radiotherapy for prostate cancer: a prospective phase I/II study","AIMS: To present the initial findings of a single institution, phase I/II study investigating hypofractionated radiotherapy in patients undergoing post-prostatectomy treatment. MATERIALS AND METHODS: Patients requiring postoperative radiotherapy were prospectively enrolled. Dose was prescribed to the prostate bed with 51 Gy in 17 daily fractions. Androgen deprivation was optional. Acute and late gastrointestinal/genitourinary toxicity were assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 and quality of life was assessed using the Expanded Prostate Cancer Index Composite evaluation tool. Prostate-specific antigen (PSA) was evaluated at every follow-up. RESULTS: Thirty patients were enrolled between 2009 and 2011. The median age was 65 years and most had Gleason 7 disease (86%) with pT2c or pT3a (82%). Positive margins were documented in 67% of the patients. The median pre-treatment PSA was 0.12 ng/ml. The median follow-up was 24 months. Overall toxicity was low, with >80% of patients having </= grade 1 acute toxicity in both genitourinary and gastrointestinal realms. Similarly, only two patients (6%) experienced grade 2/3 late gastrointestinal/genitourinary toxicity. Quality of life scores were also indicative of a well-tolerated treatment. PSA failure was seen in five patients (17%). CONCLUSIONS: We present a hypofractionated schedule of postoperative prostate radiotherapy that is both well tolerated in terms of both toxicity and quality of life measures. Initial PSA control is encouraging. Further evaluation with a longer follow-up and a larger cohort is warranted.","Clin Oncol (R Coll Radiol), 27(3): 145-152","Canada",2015,"Local,Advanced","Radiotherapy,Surgery,Hormonal","EPIC,CTCAE","Patient",null,"Clinical trial","Canada","Patient","Local,Advanced","Radiotherapy,Surgery,Hormonal",null,"Clinical trial","EPIC,CTCAE","2015:2018","Disease,Treatment"]
[239,"Glazener, C., et al. (2011). \"Conservative treatment for urinary incontinence in Men After Prostate Surgery (MAPS): two parallel randomised controlled trials.\" Health Technol Assess 15(24): 1-290, iii-iv.",null,"Glazener, C., et al.","Conservative treatment for urinary incontinence in Men After Prostate Surgery (MAPS): two parallel randomised controlled trials","OBJECTIVE: To determine the clinical effectiveness and cost-effectiveness of active conservative treatment, compared with standard management, in regaining urinary continence at 12 months in men with urinary incontinence at 6 weeks after a radical prostatectomy or a transurethral resection of the prostate (TURP). BACKGROUND: Urinary incontinence after radical prostate surgery is common immediately after surgery, although the chance of incontinence is less after TURP than following radical prostatectomy. DESIGN: Two multicentre, UK, parallel randomised controlled trials (RCTs) comparing active conservative treatment [pelvic floor muscle training (PFMT) delivered by a specialist continence physiotherapist or a specialist continence nurse] with standard management in men after radial prostatectomy and TURP. SETTING: Men having prostate surgery were identified in 34 centres across the UK. If they had urinary incontinence, they were invited to enroll in the RCT. PARTICIPANTS: Men with urinary incontinence at 6 weeks after prostate surgery were eligible to be randomised if they consented and were able to comply with the intervention. INTERVENTIONS: Eligible men were randomised to attend four sessions with a therapist over a 3-month period. The therapists provided standardised PFMT and bladder training for male urinary incontinence and erectile dysfunction. The control group continued with standard management. MAIN OUTCOME MEASURES: The primary outcome of clinical effectiveness was urinary incontinence at 12 months after randomisation, and the primary measure of cost-effectiveness was incremental cost per quality-adjusted life-year (QALY). Outcome data were collected by postal questionnaires at 3, 6, 9 and 12 months. RESULTS: Within the radical group (n = 411), 92% of the men in the intervention group attended at least one therapy visit and were more likely than those in the control group to be carrying out any PFMT at 12 months {adjusted risk ratio (RR) 1.30 [95% confidence interval (CI) 1.09 to 1.53]}. The absolute risk difference in urinary incontinence rates at 12 months between the intervention (75.5%) and control (77.4%) groups was -1.9% (95% CI -10% to 6%). NHS costs were higher in the intervention group [ pound 181.02 (95% CI pound 107 to pound 255)] but there was no evidence of a difference in societal costs, and QALYs were virtually identical for both groups. Within the TURP group (n = 442), over 85% of men in the intervention group attended at least one therapy visit and were more likely to be carrying out any PFMT at 12 months after randomisation [adjusted RR 3.20 (95% CI 2.37 to 4.32)]. The absolute risk difference in urinary incontinence rates at 12 months between the intervention (64.9%) and control (61.5%) groups for the unadjusted intention-to-treat analysis was 3.4% (95% CI -6% to 13%). NHS costs [ pound 209 (95% CI pound 147 to pound 271)] and societal costs [ pound 420 (95% CI pound 54 to pound 785)] were statistically significantly higher in the intervention group but QALYs were virtually identical. CONCLUSIONS: The provision of one-to-one conservative physical therapy for men with urinary incontinence after prostate surgery is unlikely to be effective or cost-effective compared with standard care that includes the provision of information about conducting PFMT. Future work should include research into the value of different surgical options in controlling urinary incontinence.","Health Technol Assess, 15(24): 1-290, iii-iv","UK",2011,"Any or unknown","Various,Surgery","Unclear","Patient",null,"Clinical trial,Economic model","UK","Patient","Any or unknown","Various,Surgery",null,"Clinical trial,Economic model","Unclear","2010:2014","Complication"]
[240,"Glazener, C., et al. (2011). \"Urinary incontinence in men after formal one-to-one pelvic-floor muscle training following radical prostatectomy or transurethral resection of the prostate (MAPS): two parallel randomised controlled trials.\" Lancet 378(9788): 328-337.",null,"Glazener, C., et al.","Urinary incontinence in men after formal one-to-one pelvic-floor muscle training following radical prostatectomy or transurethral resection of the prostate (MAPS): two parallel randomised controlled trials","BACKGROUND: Urinary incontinence is common immediately after prostate surgery. Men are often advised to do pelvic-floor exercises, but evidence to support this is inconclusive. Our aim was to establish if formal one-to-one pelvic floor muscle training reduces incontinence. METHODS: We undertook two randomised trials in men in the UK who were incontinent 6 weeks after radical prostatectomy (trial 1) or transurethral resection of the prostate (TURP; trial 2) to compare four sessions with a therapist over 3 months with standard care and lifestyle advice only. Randomisation was by remote computer allocation. Our primary endpoints, collected via postal questionnaires, were participants' reports of urinary incontinence and incremental cost per quality-adjusted life year (QALY) after 12 months. Group assignment was masked from outcome assessors, but this masking was not possible for participants or caregivers. We used intention-to-treat analyses to compare the primary outcome at 12 months. This study is registered, number ISRCTN87696430. FINDINGS: In the intervention group in trial 1, the rate of urinary incontinence at 12 months (148 [76%] of 196) was not significantly different from the control group (151 [77%] of 195; absolute risk difference [RD] -1.9%, 95% CI -10 to 6). In trial 2, the difference in the rate of urinary incontinence at 12 months (126 [65%] of 194) from the control group was not significant (125 [62%] of 203; RD 3.4%, 95% CI -6 to 13). Adjusting for minimisation factors or doing treatment-received analyses did not change these results in either trial. No adverse effects were reported. In both trials, the intervention resulted in higher mean costs per patient ( pound180 and pound209 respectively) but we did not identify evidence of an economically important difference in QALYs (0.002 [95% CI -0.027 to 0.023] and -0.00003 [-0.026 to 0.026]). INTERPRETATION: In settings where information about pelvic-floor exercise is widely available, one-to-one conservative physical therapy for men who are incontinent after prostate surgery is unlikely to be effective or cost effective. The high rates of persisting incontinence after 12 months suggest a substantial unrecognised and unmet need for management in these men. FUNDING: National Institute of Health Research, Health Technology Assessment (NIHR HTA) Programme.","Lancet, 378(9788): 328-337","UK",2011,"Any or unknown","Various,Surgery","Unclear","Patient",null,"Clinical trial,Economic model","UK","Patient","Any or unknown","Various,Surgery",null,"Clinical trial,Economic model","Unclear","2010:2014","Complication"]
[241,"Goldenberg, S. L., et al. (1995). \"Intermittent androgen suppression in the treatment of prostate cancer: a preliminary report.\" Urology 45(5): 839-844; discussion 844-835.",null,"Goldenberg, S. L., et al.","Intermittent androgen suppression in the treatment of prostate cancer: a preliminary report","OBJECTIVES: To test the feasibility of using intermittent androgen suppression in the treatment of prostate cancer by taking advantage of the reversible action of medical castration. METHODS: Observations were made on a group of 47 patients (clinical Stage D2, 14; D1, 10; C, 19; B2, 2; and A2, 2) with a mean follow-up time of 125 weeks. Treatment was initiated with combined androgen blockade and continued for at least 6 months until a serum prostate-specific antigen (PSA) nadir was observed. Medication was then withheld until the serum PSA increased to a mean value between 10 and 20 ng/mL. This cycle of treatment and no treatment was repeated until the regulation of serum PSA became androgen independent. RESULTS: The first two treatment cycles lasted 73 and 75 weeks, with a mean time off therapy of 30 and 33 weeks and an overall mean percentage time off therapy of 41% and 45%, respectively. The mean time to achieve a nadir level of serum PSA was 20 weeks in cycle 1 and 18 weeks in cycle 2. Serum testosterone returned to the normal range within 8 weeks (range, 1 to 26) of stopping treatment. The off-treatment period in both cycles was associated with an improvement in sense of well-being and the recovery of libido and potency in the men who reported normal or near-normal sexual function before the start of therapy. In 7 patients with Stage D2 disease, the cancer progressed to an androgen-independent state. The mean and median times to progression were 128 weeks and 108 weeks, respectively. Seven patients have died, 1 from a noncancer-related illness, with mean and median overall survival times of 210 weeks and 166 weeks, respectively. CONCLUSIONS: Prostate cancer is amenable to control by intermittent androgen suppression. This approach affords an improved quality of life when the patient is off therapy. It also results in reduced toxicity and cost of treatment and possibly delays tumor progression. Whether survival is affected in a beneficial or adverse way remains to be studied in a randomized, prospective study.","Urology, 45(5): 839-844; discussion 844-835","Canada",1995,"Local,Advanced,Metastatic","Hormonal","Unclear","Patient",null,"Clinical trial","Canada","Patient","Local,Advanced,Metastatic","Hormonal",null,"Clinical trial","Unclear","1960:1999","General"]
[242,"Gomez Caamano, A., et al. (2016). \"Management of prostate cancer patients following radiation therapy after radical surgery referred from urology to radiation oncology departments in Spain.\" Clin Transl Oncol 18(9): 884-892.",null,"Gomez Caamano, A., et al.","Management of prostate cancer patients following radiation therapy after radical surgery referred from urology to radiation oncology departments in Spain","PURPOSE: To define usual clinical management of prostate cancer (PCa) patients following postoperative radiation therapy (RT) (adjuvant or salvage) and its evolution over time in radiation oncology (RO) departments in Spain. METHODS: An epidemiological, cross-sectional, multicentre study was conducted. 567 PCa patients that had undergone radical prostatectomy (RP) and received postoperative RT between February and December of both 2006 and 2011 participated in the study. In patients from 2006, health-related quality of life (HRQoL) was assessed using the EPIC questionnaire. Investigators completed a specific survey on two clinical cases of adjuvant and salvage RT. RESULTS: 70.6 % of patients received salvage RT versus 29.4 % who received adjuvant RT; no significant differences were found in terms of frequency for each procedure between both the years. Regarding the survey, a positive surgical margin was the main criteria used in adjuvant RT decision making. In terms of salvage RT scenario, 85.7 % of the investigators stated that adjuvant RT should have been offered instead, 81.4 % of the investigators agreed on a PSA score >0.2 ng/mL as the main criteria for identifying biochemical recurrence after RP, and 67.4 % of investigators did not consider any PSA score for ruling out salvage RT treatment. CONCLUSIONS: Most patients are referred to RO departments to receive salvage RT. Despite the publication of three IA evidence level randomized clinical trials, the patterns for using adjuvant and salvage RT did not change from 2006 to 2011, although patients' profile did. A consensus regarding postoperative RT indications should be reached in order to correct this controversial situation.","Clin Transl Oncol, 18(9): 884-892","Spain",2016,"Any or unknown","Radiotherapy,Surgery","EPIC","Patient",null,"Cross-sectional","Spain","Patient","Any or unknown","Radiotherapy,Surgery",null,"Cross-sectional","EPIC","2015:2018","Disease"]
[243,"Gomez-Veiga, F., et al. (2014). \"Reference values for the CAVIPRES-30 questionnaire, a global questionnaire on the health-related quality of life of patients with prostate cancer.\" Actas Urol Esp 38(5): 304-312.",null,"Gomez-Veiga, F., et al.","Reference values for the CAVIPRES-30 questionnaire, a global questionnaire on the health-related quality of life of patients with prostate cancer","OBJECTIVE: Define and establish the reference values of the CAVIPRES-30 Questionnaire, a health related quality of life questionnaire specific for prostate cancer patients. MATERIAL AND METHODS: The CAVIPRES-30 was administered to 2,630 males with prostate cancer included by 238 Urologist belonging to the Spanish National Healthcare System. Descriptive analysis on socio-demographic and clinical data were performed, and multivariate analyses were used to corroborate that stratification variables were statistically significantly and independently associated to the overall score of the questionnaire. RESULTS: The variables Time since diagnosis of the illness, whether the patient had a Stable partner or not, if he was, or not, undergoing Symptomatic treatment were statistically significantly and independently associated (P < .001) to the overall score of the questionnaire. The reference values table of the CAVIPRES-30 questionnaire is made up of different kinds of information of each patient profile: sample size, descriptive statistics with regard to the overall score, Cronbach's alpha value (between .791 and .875) and the questionnaire's values are reported by deciles. CONCLUSIONS: The results of this study contribute new proof as to the suitability and usefulness of the CAVIPRES-30 questionnaire as an instrument for assessing individually the quality of life of prostate cancer.","Actas Urol Esp, 38(5): 304-312","Spain",2014,"Any or unknown","None","CAVIPRES-30","Patient",null,"Validation","Spain","Patient","Any or unknown","None",null,"Validation","CAVIPRES-30","2010:2014","Disease"]
[244,"Good, D. W., et al. (2016). \"Consultation audio-recording reduces long-term decision regret after prostate cancer treatment: A non-randomised comparative cohort study.\" Surgeon 14(6): 308-314.",null,"Good, D. W., et al.","Consultation audio-recording reduces long-term decision regret after prostate cancer treatment: A non-randomised comparative cohort study","INTRODUCTION: The life expectancy of prostate patients is long and patients will spend many years carrying the burdens & benefits of the treatment decisions they have made, therefore, it is vital that decisions on treatments are shared between patient and physician. The objective was to determine if consultation audio-recording improves quality of life, reduces regret or improves patient satisfaction in comparison to standard counselling. PATIENTS AND METHODS: In 2012 we initiated consultation audio-recordings, where patients are given a CD of their consultation to keep and replay at home. We conducted a prospective non-randomised study of patient satisfaction, quality of life (QOL) and decision regret at 12 months follow-up using posted validated questionnaires for the audio-recording (AR) patients and a control cohort. Qualitative and thematic analyses were used. RESULTS: Forty of 59 patients in the AR group, and 27 of 45 patients in the control group returned the questionnaires. Patient demographics were similar in both groups with no statistically significant differences between the two groups. Decision regret was lower in the audio-recording group (11/100) vs control group (19/100) (p = 0.04). The risk ratio for not having any long-term decision regret was 5.539 (CI 1.643-18.674), with NNT to prevent regret being 4. Regression analysis showed that receiving audio-recording was strongest predictor for absence of regret even greater than potency and incontinence. CONCLUSION: The study has shown that audio-recording clinic consultation reduces long-term decision regret, increases patient information recall, understanding and confidence in their decision. There is great potential for further expansion of this low-cost intervention.","Surgeon, 14(6): 308-314","UK",2016,"Any or unknown","Unclear","Unclear","Patient",null,"Cohort","UK","Patient","Any or unknown","Unclear",null,"Cohort","Unclear","2015:2018","Satisfaction"]
[245,"Gotay, C. C., et al. (2002). \"Ethnic differences in quality of life among early breast and prostate cancer survivors.\" Psychooncology 11(2): 103-113.",null,"Gotay, C. C., et al.","Ethnic differences in quality of life among early breast and prostate cancer survivors","This study assessed quality of life (QOL) in recently diagnosed breast and prostate cancer patients of European American and Asian Pacific Islanders (specifically, individuals of Filipino, Japanese, and Native Hawaiian ancestry) to investigate whether QOL varied according to ethnicity and the relative importance of ethnicity as a predictor of QOL. Participants were identified through consecutive registrations on the Hawaii Tumor Registry, based on a diagnosis of breast or prostate cancer 4-6 months previously. QOL was measured by the QLQ-C30, a standardized questionnaire widely used in cancer patient populations. Two hundred and twenty-seven individuals participated (101 prostate and 126 breast cancer patients). QOL was similar across ethnic groups in most areas of QOL. However, differences were found in several areas, all in the direction of Filipino patients reporting worse outcomes. Hierarchical stepwise regressions supported the importance of ethnicity, controlling for clinical and demographic predictors. We conclude that additional research is needed to understand the relationship between ethnicity and QOL in cancer survivors.","Psychooncology, 11(2): 103-113","USA",2002,"Any or unknown","None","EORTC QLQ-C30","Patient",null,"Cross-sectional","USA","Patient","Any or unknown","None",null,"Cross-sectional","EORTC QLQ-C30","2000:2004","General"]
[246,"Gravis, G., et al. (2014). \"Patients' self-assessment versus investigators' evaluation in a phase III trial in non-castrate metastatic prostate cancer (GETUG-AFU 15).\" Eur J Cancer 50(5): 953-962.",null,"Gravis, G., et al.","Patients' self-assessment versus investigators' evaluation in a phase III trial in non-castrate metastatic prostate cancer (GETUG-AFU 15)","BACKGROUND: Toxicity, which is a key parameter in the evaluation of cancer treatments, can be underestimated by clinicians. We investigated differences between patients and physicians in reporting adverse events of androgen deprivation therapy (ADT) with or without docetaxel in a multicentre phase III trial in non-castrate metastatic prostate cancer. METHODS: The 385 patients included were invited to complete a 26-symptom questionnaire 3 and 6 months after the start of treatment, among which eighteen symptoms were also assessed by physicians, reported in medical records and graded using the Common Toxicity Criteria of the National Cancer Institute. Positive and negative agreements as well as Kappa concordance coefficients were computed. FINDINGS: Data were available for 220 and 165 patients at 3 and 6 months respectively. Physicians systematically under-reported patients' symptoms. Positive agreement rates (at respectively 3 and 6 months) for the five most commonly reported symptoms were: 61.0% and 64.3% hot flushes, 50.0% and 43.6% fatigue, 29.4% and 31.1% sexual dysfunction, 24.4% and 14.4% weigh gain/loss, 16.7% and 19.3% for joint/muscle pain. For symptoms most frequently reported as disturbing or very disturbing by patients, the clinicians' failure to report them ranged from 50.8% (hot flushes) to 89.5% (joint/muscle pain) at 3 months, and from 48.2% (hot flushes) to 88.4% (joint/muscle pain) at 6 months. INTERPRETATION: Physicians often failed to report treatment-related symptoms, even the most common and disturbing ones. Patients' self-evaluation of toxicity should be used in clinical trials to improve the process of drug assessment in oncology. FUNDING: French Health Ministry and Institut National du Cancer (PHRC), Sanofi-Aventis, Astra-Zeneca, and Amgen.","Eur J Cancer, 50(5): 953-962","France",2014,"Metastatic","Hormonal,Taxane","CTCAE","Patient,HCP",null,"Clinical trial","France","Patient,HCP","Metastatic","Hormonal,Taxane",null,"Clinical trial","CTCAE","2010:2014","Treatment"]
[247,"Green, C. R., et al. (2009). \"Consistent and breakthrough pain in diverse advanced cancer patients: a longitudinal examination.\" J Pain Symptom Manage 37(5): 831-847.",null,"Green, C. R., et al.","Consistent and breakthrough pain in diverse advanced cancer patients: a longitudinal examination","Although cancer pain, both consistent and breakthrough pain ([BTP]; pain flares interrupting well-controlled baseline pain), is common among cancer patients, its prevalence, characteristics, etiology, and impact on health-related quality of life (HRQOL) are poorly understood. This longitudinal study examined the experience and treatment of cancer-related pain over six months, including an evaluation of ethnic differences. Patients with Stage III or IV breast, prostate, colorectal, or lung cancer, or Stage II-IV multiple myeloma with BTP completed surveys on initial assessment and at three and six months. Each survey assessed consistent pain, BTP, depressed affect, active coping ability, and HRQOL. Among the respondents (n=96), 70% were white, 66% were female, and had a mean age of 56+/-10 years. Nonwhites reported significantly greater severity for consistent pain at its worst (P = 0.009), least (P < or = 0.001), on average (P = 0.004), and upon initial assessment (P = 0.04), and greater severity for BTP at its worst (P = 0.03), least (P = 0.02), and at initial assessment (P = 0.008). Women also had higher levels of some BTP measures. Ethnic disparities persisted when data estimation techniques were used. Examined longitudinally, consistent pain on average and several BTP measures reduced over time, although not greatly, indicating the persistence of pain in the cancer experience. These data provide evidence for the significant toll of cancer pain, while demonstrating further health care disparities in the cancer pain experience.","J Pain Symptom Manage, 37(5): 831-847","USA",2009,"Advanced,Metastatic","None","Unclear","Patient",null,"Cohort","USA","Patient","Advanced,Metastatic","None",null,"Cohort","Unclear","2005:2009","Symptom"]
[248,"Green, H. J., et al. (2002). \"Coping and health-related quality of life in men with prostate cancer randomly assigned to hormonal medication or close monitoring.\" Psychooncology 11(5): 401-414.",null,"Green, H. J., et al.","Coping and health-related quality of life in men with prostate cancer randomly assigned to hormonal medication or close monitoring","Prostatic carcinoma and its treatment have been associated with adverse effects on health-related quality of life (HRQoL). Individual differences in appraisal and coping have been suggested to mediate these HRQoL outcomes. A randomized trial of 65 men with non-localized prostate cancer compared several treatments and tested associations between appraisal, coping, and HRQoL. These patients, and 16 community volunteers matched for age and general health, undertook psychosocial assessments before treatment and after 6 months of treatment. Compared with baseline assessments, men on hormonal treatments reported impaired sexual function. Groups did not differ on emotional distress, existential satisfaction, subjective cognitive function, physical symptoms, or social and role functioning. For individuals, hormonal treatments were more frequently associated with decreased sexual, social and role functioning, but were also associated with improved physical symptoms. In hierarchical regression analysis, HRQoL was lower for men who had more comorbid illnesses, a history of neurological dysfunction, higher threat appraisals, or higher use of coping strategies at baseline. These results showed that pharmacological hormonal ablation for prostate cancer can improve or decrease HRQoL in different domains. HRQoL in men with prostate cancer was associated more strongly with appraisal and coping than with medical variables.","Psychooncology, 11(5): 401-414","Australia",2002,"Advanced,Metastatic","Hormonal,Surveillance","Interview","Patient",null,"Clinical trial","Australia","Patient","Advanced,Metastatic","Hormonal,Surveillance",null,"Clinical trial","Interview","2000:2004","General"]
[249,"Green, H. J., et al. (2004). \"Quality of life compared during pharmacological treatments and clinical monitoring for non-localized prostate cancer: a randomized controlled trial.\" BJU Int 93(7): 975-979.",null,"Green, H. J., et al.","Quality of life compared during pharmacological treatments and clinical monitoring for non-localized prostate cancer: a randomized controlled trial","OBJECTIVES: To investigate the effects of different management strategies for non-localized prostate cancer on men's quality of life and cognitive functioning. PATIENTS, SUBJECTS AND METHODS: Men with prostate cancer were randomly assigned to one of four treatment arms: leuprorelin, goserelin, cyproterone acetate (CPA), or close clinical monitoring. In a repeated-measures design, men were assessed before treatment (baseline) and after 6 and 12 months of treatment. A community comparison group of men of the same age with no prostate cancer participated for the same length of time. The men were recruited from public and private urology departments from university teaching hospitals. All those with prostate cancer who were eligible for hormonal therapy had no symptoms requiring immediate therapy. In all, 82 patients were randomized and 62 completed the 1-year study, and of the 20 community participants, 15 completed the study. The main outcome measures were obtained from questionnaires on emotional distress, existential satisfaction, physical function and symptoms, social and role function, subjective cognitive function, and sexual function, combined with standard neuropsychological tests of memory, attention, and executive functions. RESULTS: Sexual dysfunction increased for patients on androgen-suppressing therapies, and emotional distress increased in those assigned to CPA or close clinical monitoring. Compared with before treatment there was evidence of an adverse effect of leuprorelin, goserelin, and CPA on cognitive function. CONCLUSIONS: In deciding the timing of androgen suppression therapy for prostate cancer, consideration should be given to potential adverse effects on quality of life and cognitive function.","BJU Int, 93(7): 975-979","Australia",2004,"Advanced,Metastatic","Hormonal,Surveillance","Unclear","Patient",null,"Clinical trial","Australia","Patient","Advanced,Metastatic","Hormonal,Surveillance",null,"Clinical trial","Unclear","2000:2004","General"]
[250,"Greene, K. L., et al. (2005). \"Who is the average patient presenting with prostate cancer?\" Urology 66(5 Suppl): 76-82.",null,"Greene, K. L., et al.","Who is the average patient presenting with prostate cancer?","Prostate cancer screening, diagnosis, and treatment have changed dramatically in the last 20 years. Patients with newly diagnosed prostate cancer have many treatment options available. We attempted to determine how patient demographics and quality of life (QOL) have changed, and we describe the average patient with newly diagnosed prostate cancer in the early 21st century. From the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) we identified 3003 men with prostate cancer diagnosed between 1997 and 2003 for whom pretreatment demographic and QOL data were available. All patients completed both the University of California-Los Angeles Prostate Cancer Index (UCLA-PCI) and the Rand Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) as self-administered questionnaires at the time of diagnosis. We compared demographic variables (age at diagnosis, race/ethnicity, education, number of comorbidities, body mass index [BMI], and insurance type), treatment choice, and pretreatment QOL scores on the SF-36 and UCLA-PCI scales for the periods 1997 to 1999 or 2000 to 2003. Stratified analysis by risk category was performed for demographic and QOL data for the 2 periods. Race/ethnicity and insurance demographics were statistically different for the 2 periods. Low-risk patients also showed a statistically increased BMI in the 2000 to 2003 period. Risk category predicted performance on both inventories, with low-risk patients having better function than intermediate-risk patients and high-risk patients in the areas of urinary bother, bowel function and bother, and sexual function and bother, as well as in many general well-being and emotional health scales on the SF-36. We conclude that the \"average\" prostate cancer patient is white, 65 years of age, overweight, educated at a college level, and has 1 to 2 comorbidities. Patients report average or above-average pretreatment health-related QOL for all scales based on 2 validated instruments. In this cohort, more patients chose radical prostatectomy than any other form of treatment.","Urology, 66(5 Suppl): 76-82","USA",2005,"Any or unknown","None","SF-36,UCLA-PCI","Patient",null,"Cohort","USA","Patient","Any or unknown","None",null,"Cohort","SF-36,UCLA-PCI","2005:2009","Disease,Utility"]
[251,"Grise, P., et al. (2012). \"I-STOP TOMS transobturator male sling, a minimally invasive treatment for post-prostatectomy incontinence: continence improvement and tolerability.\" Urology 79(2): 458-463.",null,"Grise, P., et al.","I-STOP TOMS transobturator male sling, a minimally invasive treatment for post-prostatectomy incontinence: continence improvement and tolerability","OBJECTIVE: To prospectively evaluate the efficacy and tolerability of the I-STOP TOMS transobturator male sling in patients with post-prostatectomy stress urinary incontinence. Minimally invasive techniques, such as slings, are becoming the standard of care for mild to moderate post-prostatectomy incontinence. METHODS: From March 2007 to June 2009, 122 patients with post-prostatectomy stress urinary incontinence were treated with the I-STOP TOMS sling and followed up for 1 year in the Phase IV HOMme INContinence trial. The preoperative and postoperative evaluation included daily pad use, pad test, questionnaires evaluating urinary function and bother (University of California, Los Angeles, Prostate Cancer Index--urinary function short form, and International Consultation on Incontinence Modular Questionnaire--urinary incontinence short form) and uroflowmetry, including the post-void residual urine volume. Patient satisfaction and perineal pain were also assessed. RESULTS: A total of 103 patients were followed up for 12 months. The surgical procedure was considered easy to perform. The mean daily pad use decreased significantly from 2.4 to 0.6 at 12 months of follow-up; 87.0% of the patients reported improved continence (59.4% completely dry, 20.3% 1 pad/d, 7.3%>1 pad/d), and 13.0% reported no improvement. All quality-of-life scores (University of California, Los Angeles, Prostate Cancer Index--urinary function short form, and International Consultation on Incontinence Modular Questionnaire--urinary incontinence short form) improved significantly after sling implantation. Treatment satisfaction was >90%. The post-void residual urine volume did not increase substantially, and acute urinary retention did not occur. The perineal pain scores were very low at follow-up. Wound infection was seen in 2 patients at the 1-month follow-up visit. CONCLUSION: The I-STOP TOMS is a good treatment option for patients with post-prostatectomy stress urinary incontinence. With follow-up</=12 months, most patients were continent or had improved continence. The intervention was well tolerated, with few infections.","Urology, 79(2): 458-463","France",2012,"Any or unknown","Surgery","UCLA-PCI,ICIQ","Patient",null,"Clinical trial","France","Patient","Any or unknown","Surgery",null,"Clinical trial","UCLA-PCI,ICIQ","2010:2014","Disease,Complication"]
[252,"Guerra, N. A. (2009). \"Outcomes of maximal androgen blockade in prostate cancer patients at a health area with type 2 reference hospital. Part 2. Quality of life: application of EORTC QLQ-PR25 instrument and global results. Quality-of-life adjusted survival. Pharmaceutical expenses and cost-utility.\" Arch Esp Urol 62(7): 543-570.",null,"Guerra, N. A.","Outcomes of maximal androgen blockade in prostate cancer patients at a health area with type 2 reference hospital. Part 2. Quality of life: application of EORTC QLQ-PR25 instrument and global results. Quality-of-life adjusted survival. Pharmaceutical expenses and cost-utility","OBJECTIVES: To study quality of life in patients from the health area of Zamora diagnosed of prostate adenocarcinoma between 2000-2005 treated with maximal androgen blockade (MAB). To evaluate the pharmacoeconomics of the treatment. METHODS: Basal, 12-month, 24-month and 36-month application of the health-related quality of life measurement instrument EORTC QLQ-C30 to the population sample (n= 111), as well as a control sample (n= 100). Comparative study of outcomes: between groups; between different time measurements in MAB patients; and inter-categories/ -intervals of some variables in patients with hormonal deprivation therapy (third year of follow-up). Analysis of health-related quality of life global outcomes (QLQ-C30 + QLQ-PR25). Description of the pharmaceutical expenses in androgen blockade patients. Cost-utility analysis by means of quality-adjusted life years (QALYs) obtained using preference-based weighted index from the EUROQOL 5-D tool. RESULTS: Hot flushes and sexual field worsening as mean expressions related to hormonal suppression. Treated patients had worse subjective perception of health condition and quality of life, in opposition to non-tumoral individuals. Positive bone scan, was a negative-influence factor on quality of life. Most patients undergoing MAB needed cost-utility figures of less than 5000 Euros/ QALY. CONCLUSIONS: There was a negative initial repercussion of MAB on quality of life, although tinged according to the different fields studied. The economic impact of this therapy on overall pharmaceutical expenses is relative.","Arch Esp Urol, 62(7): 543-570","Spain",2009,"Any or unknown","Hormonal","EORTC QLQ-C30,EORTC QLQ-PR25,EQ-5D","Patient",null,"Cohort","Spain","Patient","Any or unknown","Hormonal",null,"Cohort","EORTC QLQ-C30,EORTC QLQ-PR25,EQ-5D","2005:2009","Disease,General,Utility"]
[253,"Guidry, J. J., et al. (1997). \"Transportation as a barrier to cancer treatment.\" Cancer Pract 5(6): 361-366.",null,"Guidry, J. J., et al.","Transportation as a barrier to cancer treatment","PURPOSE: Patients with cancer must overcome many psychological, social, and economic barriers to obtain needed treatment. Because of the need for repeated visits for cancer treatment on either an outpatient or an inpatient basis, one of the major issues that patients with cancer must confront is that of arranging for transportation to care. METHODS: This study compares the distance and mode of transportation to radiotherapy and chemotherapy and perceptions of transportation as a barrier to care among white, black, and Hispanic cancer patients receiving treatment from a consortium of cancer treatment facilities in Texas. A mail questionnaire was developed to assess the perceived barriers to cancer treatment for patients who had been diagnosed clinically with breast, colon, cervical, or prostate cancer, or lymphoma between 1989 and 1993. A total of 910 surveys were mailed to prospective participants. Of the surveys mailed, 593 were returned, yielding a 65.2% response rate. By race, the respondents included whites (42%), blacks (40%), Hispanics (15%), and Asian-Pacific Islanders (3%). Two respondents were 17 years of age; the remaining respondents were 18 years or older. RESULTS: This study shows that some patients may forgo needed treatment because of problems with transportation. This was perceived as an issue more for minority patients than for white patients. Black and Hispanic patients consistently reported that barriers such as distance, access to an automobile, and availability of someone to drive them to the treatment center were potential major problems. The distance to the facilities was farther for whites than for blacks and Hispanics. Patients generally had to travel farther for chemotherapy than for radiotherapy. CLINICAL IMPLICATIONS: Patients, particularly minorities, may opt to forgo needed care in the absence of available and affordable means of transportation to treatment facilities. These findings demonstrate the need for healthcare providers to be aware of the transportation problems that patients with cancer experience in obtaining treatment. Healthcare providers must work with patients, their families, and volunteer agencies in the community to facilitate transportation to cancer treatment services.","Cancer Pract, 5(6): 361-366","USA",1997,"Any or unknown","Radiotherapy,Chemotherapy","Unclear","Patient",null,"Cross-sectional","USA","Patient","Any or unknown","Radiotherapy,Chemotherapy",null,"Cross-sectional","Unclear","1960:1999","Costs"]
[254,"Guidry, J. J., et al. (1998). \"Cost considerations as potential barriers to cancer treatment.\" Cancer Pract 6(3): 182-187.",null,"Guidry, J. J., et al.","Cost considerations as potential barriers to cancer treatment","PURPOSE: An analytical cross-sectional survey was conducted to determine the prevalence of barriers to cancer treatment in Texas as perceived by diagnosed cancer patients. Results reported here address the role of insurance coverage, indirect costs (transportation, lodging, and work days lost), and direct costs of care as barriers to treatment for white, black, and Hispanic cancer patients. Specific objectives of the analyses undertaken here are to examine 1) racial/ethnic differences in insurance coverage; 2) barriers relating to insurance coverage experienced by cancer patients; and 3) role of treatment-related costs as barriers to cancer treatment. DESCRIPTION OF STUDY: A mail questionnaire was developed to assess the perceived barriers to cancer treatment in Texas for adult cancer patients, 17 years and older, who had been diagnosed with breast, colon, cervical, prostate, or lymphoma during the period of 1989 to 1993. The sampling frame for this study was obtained from a network of cancer treatment facilities throughout the state of Texas within the University of Texas M.D. Anderson Cancer Center Texas Community Oncology Network. A total of 593 cancer patients returned their surveys, yielding a 65.2% response rate. Weighting adjustments were then made to correct for differential sampling and response rates by racial groupings and type of cancer. All of the analyses used adjusted weights. RESULTS: The findings document the financial considerations (insurance, direct and indirect costs) as they relate to barriers to cancer treatment. Specific insurance premium-related barriers with regard to maintaining and affording coverage were more prevalent for blacks. Hispanics were less likely to have insurance coverage; however, more blacks reported being denied insurance coverage when they changed jobs compared with whites and Hispanics. Minorities, particularly Hispanics, were more likely to have experienced cost-related barriers associated with medications, diagnostic tests, and hospitalizations. In addition, Hispanics experienced significant out-of-pocket costs in paying for cancer treatment. CLINICAL IMPLICATIONS: This research shows the need for staff at cancer treatment facilities to be aware that there are nonclinical, financial factors that are important considerations in the treatment of cancer patients. Assessment of cancer patients during the diagnostic and treatment stages, possibly through case management, will provide information on potential barriers to treatment for individual patients. Hospital programs that reimburse out-of-pocket costs, transportation costs to obtain services, and lodging accommodations may be available. Additional services may be offered through cancer advocacy groups, such as the American Cancer Society and the National Coalition for Cancer Survivors, to assist patients with managing costs and overcoming barriers to care.","Cancer Pract, 6(3): 182-187","USA",1998,"Any or unknown","Unclear","Unclear","Patient",null,"Cross-sectional","USA","Patient","Any or unknown","Unclear",null,"Cross-sectional","Unclear","1960:1999","Costs"]
[255,"Guillonneau, B. and G. Vallancien (2000). \"Laparoscopic radical prostatectomy: the Montsouris experience.\" J Urol 163(2): 418-422.",null,"Guillonneau, B. and G. Vallancien","Laparoscopic radical prostatectomy: the Montsouris experience","PURPOSE: We evaluate our experience with laparoscopic radical prostatectomy. MATERIALS AND METHODS: Between February 1, 1998 and May 1, 1999, 120 consecutive patients underwent laparoscopic radical prostatectomy. Morbidity of the first 40 (group 1), next 40 (group 2) and last 40 (group 3) procedures was compared. Oncological data were assessed by pathological examination and postoperative prostate specific antigen (PSA). Functional results were assessed by a self-administered questionnaire for the first 60 patients and potency was assessed in the last 40. RESULTS: Mean operating time plus or minus standard deviation was 239+/-59 minutes (range 150 to 450) for the series, and 282, 247 and 231, respectively, for groups 1, 2 and 3. Surgical conversion was necessary in 7 cases (5.8%) overall, including 10% (4) in group 1, 7.5% (3) in group 2 and 0% in group 3. Mean intraoperative bleeding was 402+/-293 ml. (range 50 to 1,500) in the series, and 534, 517 and 277, respectively, for groups 1, 2 and 3. The transfusion rate was 10% overall, and 15%, 12.5% and 2.5%, respectively, in groups 1, 2 and 3. The reoperation rate was 1.7%. Mean postoperative bladder catheterization time was 6.6+/-2.4 days. The positive and questionable surgical margin rate was 15%. Pathological tumor stage was pT2a in 4 specimens (11%), pT2b in 11 (16%), pT3a in 0 and pT3b in 3 (50%) with positive surgical margins. PSA assays were available in 94 patients with a mean postoperative followup of 2.2 months (range 1 to 12). Serum PSA was 0.1 ng./ml. or less in 89 men (94.7%). The continence rate at 6 months postoperatively was 72% among the first 60 patients. Of 20 group 3 patients who were sexually active preoperatively 9 (45%) reported postoperative spontaneous erections. The overall cost of retropubic radical prostatectomy was about $1,237 more than that for laparoscopy. CONCLUSIONS: Laparoscopic radical prostatectomy is feasible and perioperative morbidity is low. Based on our postoperative followup, oncological results are identical to those of conventional surgery and functional results are encouraging.","J Urol, 163(2): 418-422","France",2000,"Advanced,Local","Surgery","Unclear","Patient",null,"Cohort","France","Patient","Advanced,Local","Surgery",null,"Cohort","Unclear","2000:2004","General,Complication"]
[256,"Haga, N., et al. (2015). \"Timing of Urinary Pad Exchanges Was the Most Important Factor Affecting Quality of Life in the Early Postoperative Period After Robot-Assisted Laparoscopic Radical Prostatectomy.\" J Endourol 29(9): 1044-1051.",null,"Haga, N., et al.","Timing of Urinary Pad Exchanges Was the Most Important Factor Affecting Quality of Life in the Early Postoperative Period After Robot-Assisted Laparoscopic Radical Prostatectomy","PURPOSE: The aim of the present study is to investigate the effect of pad use for postprostatectomy incontinence on urinary quality of life (QoL) after robot-assisted laparoscopic radical prostatectomy (RARP) in the early postoperative period. METHODS: Ninety patients underwent RARP simultaneously completed International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) and modified pad use questionnaire that evaluated pad use and urinary QoL and a 24-hour pad test. Pad use was also assessed by pad form, pad size, the number of pad exchanges per day, and the timing of pad exchanges (i.e., to what extent the pad was wet when the patients exchanged it.). The investigation involved patients visiting the outpatient clinic for the first time after RARP. The association between pad use and urinary QoL was investigated. RESULTS: The mean frequency of pad exchanges was 2+/-2/day. The mean 24-hour pad test was 139+/-193 g/day. Multivariate analyses revealed the timing of pad exchanges was significantly associated with QoL on the ICIQ-SF and the modified pad use questionnaire (P=0.007 and P<0.001, respectively) and the number of pad exchanges per day was significantly associated with QoL on the ICIQ-SF (P=0.01); QoL worsened with pad wetness and increasing frequency of pad exchange. The other factors relating to pad use were not significantly associated with aggravation of QoL. CONCLUSIONS: In the early postoperative period after RARP, the timing of pad exchanges was the most important factor affecting QoL. Namely, patients with postprostatectomy incontinence should wear the appropriate size of pad according to the volume of urinary incontinence and exchange pads when the pad is not too wet. On the other hand, pad form, pad size, and volume of urinary incontinence were not associated with decreased QoL.","J Endourol, 29(9): 1044-1051","Japan",2015,"Any or unknown","Surgery","ICIQ","Patient",null,"Cohort","Japan","Patient","Any or unknown","Surgery",null,"Cohort","ICIQ","2015:2018","Complication"]
[257,"Hajjar, J. H., et al. (1998). \"Ambulatory radical retropubic prostatectomy.\" Urology 51(3): 443-448.",null,"Hajjar, J. H., et al.","Ambulatory radical retropubic prostatectomy","OBJECTIVES: To review the experience of 40 consecutive patients who underwent radical retropubic prostatectomy and to determine if and how the procedure could be performed safely on an ambulatory basis. METHODS: Between June 20, 1994 and November 26, 1996, 40 consecutive men with clinically localized prostate carcinoma underwent radical retropubic prostatectomy. Retrospective data regarding the patient population, patient satisfaction, clinical outcome, and length of hospitalization were evaluated. RESULTS: The average age for the patients was 62.6 years (range 44 to 75) with an average PSA of 10.44 ng/mL. Eighty percent (32 of 40) of the patients were discharged on postoperative day 1, 17.5% (7 of 40) were discharged on postoperative day 2, and 2.5% (1 of 40) were discharged on postoperative day 7. The average operative time was 89.5 minutes (range 65 to 135), measured from the time of incision to completion of closure. The organ-confined rate was 80% (32 of 40). The continence evaluated at 6 months was 90.9% (30 of 33). The potency at 4 months was 35% (10 of 28) and at 1 year was 55.6% (10 of 18). Postoperative complications were minimal, with 7.5% (3 of 40) bladder neck contractures and 2.5% (1 of 40) wound infections. Patient satisfaction assessed by questionnaires revealed that 90% (36 of 40) thought that the length of hospitalization was adequate and 97.5% (39 of 40) would choose to have the procedure again. A second series of 15 patients have also undergone radical retropubic prostatectomy utilizing a pelvic block to expedite discharge. Of these 15 procedures, 10 were performed on an ambulatory basis. CONCLUSIONS: Radical retropubic prostatectomy can be performed expediently with the maintenance of patient satisfaction, continence rates, potency rates, recurrence rates, complication rates, and pathologic results. The advantage to such an approach is expedited patient discharge, cost savings to the medical system, and no alteration in patient recovery or clinical outcome, such as organ-confined rate, potency, and continence. In this series, the majority of patients were discharged on postoperative day 1. On the basis of this experience, we have performed the procedure on an outpatient basis, while maintaining the same high quality of care. To date, 10 patients have undergone ambulatory radical retropubic prostatectomy and were discharged the same day of surgery without complications.","Urology, 51(3): 443-448","USA",1998,"Local","Surgery","Unclear","Patient",null,"Cohort","USA","Patient","Local","Surgery",null,"Cohort","Unclear","1960:1999","Satisfaction"]
[258,"Hall, P. S., et al. (2015). \"Costs of cancer care for use in economic evaluation: a UK analysis of patient-level routine health system data.\" Br J Cancer 112(5): 948-956.",null,"Hall, P. S., et al.","Costs of cancer care for use in economic evaluation: a UK analysis of patient-level routine health system data","BACKGROUND: The rising financial burden of cancer on health-care systems worldwide has led to the increased demand for evidence-based research on which to base reimbursement decisions. Economic evaluations are an integral component of this necessary research. Ascertainment of reliable health-care cost and quality-of-life estimates to inform such studies has historically been challenging, but recent advances in informatics in the United Kingdom provide new opportunities. METHODS: The costs of hospital care for breast, colorectal and prostate cancer disease-free survivors were calculated over 15 months from initial diagnosis of cancer using routinely collected data within a UK National Health Service (NHS) Hospital Trust. Costs were linked at patient level to patient-reported outcomes and registry-derived sociodemographic factors. Predictors of cost and the relationship between costs and patient-reported utility were examined. RESULTS: The study population included 223 breast cancer patients, 145 colorectal and 104 prostate cancer patients. The mean 15-month cumulative health-care costs were pound12 595 (95% CI pound11 517- pound13 722), pound12 643 ( pound11 282- pound14 102) and pound3722 ( pound3263- pound4208), per-patient respectively. The majority of costs occurred within the first 6 months from diagnosis. Clinical stage was the most important predictor of costs for all cancer types. EQ-5D score was predictive of costs in colorectal cancer but not in breast or prostate cancer. CONCLUSION: It is now possible to evaluate health-care cost using routine NHS data sets. Such methods can be utilised in future retrospective and prospective studies to efficiently collect economic data.","Br J Cancer, 112(5): 948-956","UK",2015,"Survivors","Unclear","EQ-5D","Patient",null,"Cohort","UK","Patient","Survivors","Unclear",null,"Cohort","EQ-5D","2015:2018","Utililty"]
[259,"Hamoen, E. H., et al. (2015). \"Measuring health-related quality of life in men with prostate cancer: A systematic review of the most used questionnaires and their validity.\" Urol Oncol 33(2): 69.e19-28.",null,"Hamoen, E. H., et al.","Measuring health-related quality of life in men with prostate cancer: A systematic review of the most used questionnaires and their validity","OBJECTIVES: To identify and study the psychometric properties of the most used health-related quality-of-life (HRQoL) instruments in men with prostate cancer. METHODS: We performed a literature search using PubMed and EMBASE to identify all studies on prostate cancer using a HRQoL instrument. The most often used HRQoL instruments were investigated in detail by 2 independent reviewers. Data were extracted regarding the characteristics and psychometric values of the instruments, i.e., content validity, internal consistency, criterion validity, construct validity, reproducibility, responsiveness, floor and ceiling effects, and interpretability. Good psychometric outcomes indicate a high methodological quality of the instrument. RESULTS: Our systematic search revealed 13,812 potential relevant articles, of which 2,258 appeared relevant after screening the titles and reading the abstracts. We studied the psychometric properties of the 20 most often used HRQoL instruments, the first 3 of which were the Expanded Prostate Index Composite, University of California-Los Angeles Prostate Cancer Index, and Short Form-36 (SF-36). Content validity, internal consistency (alpha>0.70), criterion validity, construct validity, and reproducibility were good in 60%, 90%, 10%, 35%, and 65% of the 20 instruments, respectively. Responsiveness was not reported for 12 of 20 instruments (60%). Floor and ceiling effects and the interpretability of the questionnaires were only reported in 3 (15%) and 6 (30%) instruments. CONCLUSIONS: Considering the psychometric properties, we advise to use the SF-12 as a generic instrument, the Cancer Rehabilitation Evaluation System-SF or the Functional Assessment of Cancer Therapy-General as cancer-specific HRQoL instruments, and the University of California-Los Angeles Prostate Cancer Index, the QUFW94, or the Functional Assessment of Cancer Therapy-Prostate as prostate cancer-specific instruments.","Urol Oncol, 33(2): 69.e19-28","International",2015,"Any or unknown","None","SF-36,FACT-G,FACT-P,EPIC,UCLA-PCI,CARES-SF,SF-12,QUFW94","Patient",null,"Systematic review,Validation","International","Patient","Any or unknown","None",null,"Systematic review,Validation","SF-36,FACT-G,FACT-P,EPIC,UCLA-PCI,CARES-SF,SF-12,QUFW94","2015:2018","Disease,General,Utility,Treatment"]
[260,"Hamstra, D. A., et al. (2013). \"Multi-institutional prospective evaluation of bowel quality of life after prostate external beam radiation therapy identifies patient and treatment factors associated with patient-reported outcomes: the PROSTQA experience.\" Int J Radiat Oncol Biol Phys 86(3): 546-553.",null,"Hamstra, D. A., et al.","Multi-institutional prospective evaluation of bowel quality of life after prostate external beam radiation therapy identifies patient and treatment factors associated with patient-reported outcomes: the PROSTQA experience","PURPOSE: To evaluate patients treated with external beam radiation therapy as part of the multicenter Prostate Cancer Outcomes and Satisfaction with Treatment Quality Assessment (PROSTQA), to identify factors associated with posttreatment patient-reported bowel health-related quality of life (HRQOL). METHODS AND MATERIALS: Pretreatment characteristics and treatment details among 292 men were evaluated using a general linear mixed model for their association with measured HRQOL by the Expanded Prostate Cancer Index Composite instrument through 2 years after enrollment. RESULTS: Bowel HRQOL had a median score of 100 (interquartile range 91.7-100) pretreatment and 95.8 (interquartile range 83.3-100) at 2 years, representing new moderate/big problems in 11% for urgency, 7% for frequency, 4% for bloody stools, and 8% for an overall bowel problems. Baseline bowel score was the strongest predictor for all 2-year endpoints. In multivariable models, a volume of rectum >/=25% treated to 70 Gy (V70) yielded a clinically significant 9.3-point lower bowel score (95% confidence interval [CI] 16.8-1.7, P=.015) and predicted increased risks for moderate to big fecal incontinence (P=.0008). No other radiation therapy treatment-related variables influenced moderate to big changes in rectal HRQOL. However, on multivariate analyses V70 >/=25% was associated with increases in small, moderate, or big problems with the following: incontinence (3.9-fold; 95% CI 1.1-13.4, P=.03), rectal bleeding (3.6-fold; 95% CI 1.3-10.2, P=.018), and bowel urgency (2.9-fold; 95% CI 1.1-7.6, P=.026). Aspirin use correlated with a clinically significant 4.7-point lower bowel summary score (95% CI 9.0-0.4, P=.03) and an increase in small, moderate, or big problems with bloody stools (2.8-fold; 95% CI 1.2-6.4, P=.018). Intensity modulated radiation therapy was associated with higher radiation therapy doses to the prostate and lower doses to the rectum but did not independently correlate with bowel HRQOL. CONCLUSION: After contemporary dose-escalated external beam radiation therapy up to 11% of patients have newly identified moderate/big problems with bowel HRQOL 2 years after treatment. Bowel HRQOL is related to baseline function, rectal V70, and aspirin use. Finally, our findings validate the commonly utilized cut-point of rectal V70 >/=25% as having significant impact on patient-reported outcomes.","Int J Radiat Oncol Biol Phys, 86(3): 546-553","USA",2013,"Any or unknown","Radiotherapy","EPIC","Patient",null,"Cohort","USA","Patient","Any or unknown","Radiotherapy",null,"Cohort","EPIC","2010:2014","Disease"]
[261,"Han, B. H., et al. (2001). \"Patient reported complications after prostate brachytherapy.\" J Urol 166(3): 953-957.",null,"Han, B. H., et al.","Patient reported complications after prostate brachytherapy","PURPOSE: Prostate brachytherapy has gained popularity due partly to the low rates of short-term complications shown in studies from highly select clinical practices. These series rely on medical records generated by the treating physician and are prone to underreport complications. We summarize the complication reports obtained directly from patients to establish a more realistic incidence of treatment related problems. MATERIALS AND METHODS: In 1997, 160 consecutive patients treated with prostate brachytherapy at the University of Washington were studied. A questionnaire was designed to determine the rate of complications occurring within 1 year of the procedure. The questions were formulated for ease of use and conciseness, while accounting for easily recalled events associated with complications. A total of 147 (92%) patients completed the questionnaire. RESULTS: There were 8 (5%) patients who required hospital admission for an average of 2 days (range 1 to 7) as a result of the procedure. A total of 56 (38%) patients required nonroutine visits with a physician in an office setting or at an emergency room. Radiation proctitis diagnosed by endoscopy developed in 8 (5%) patients but no one needed surgical intervention. A total of 47 (32%) patients required urinary catheterization at some point after implantation. CONCLUSIONS: We demonstrated a higher rate of short-term complications than those previously reported. Fortunately, the majority of side effects were self-limited and no treatment related mortality or cardiovascular morbidity was seen. Our findings may provide a more realistic account of the complications likely to occur after implantation than might be surmised from previous reports.","J Urol, 166(3): 953-957","USA",2001,"Any or unknown","Brachytherapy","Unclear","Patient",null,"Cross-sectional","USA","Patient","Any or unknown","Brachytherapy",null,"Cross-sectional","Unclear","2000:2004","Complication"]
[262,"Hanssen, S. and J. Norum (2008). \"Bladder and rectal toxicity of BeamCath application in radiotherapy of prostate cancer.\" Anticancer Res 28(5b): 2865-2868.",null,"Hanssen, S. and J. Norum","Bladder and rectal toxicity of BeamCath application in radiotherapy of prostate cancer","BACKGROUND: Patient-reported toxicity in two radiotherapy regimens for early stage prostate cancer was investigated. In 2003, the Swedish BeamCath technique was adapted for Northern Norway. MATERIALS AND METHODS: Ninety men underwent radiotherapy for early-stage prostate cancer in February 2002 to March 2005. They were invited to participate in a telephone interview employing a questionnaire guide focusing on bladder, intestinal and sexual function. RESULTS: Eighty patients responded, which represents 89% of all patients. The treatment group (23 patients) had received 76 Gy with the BeamCath technique and the control group (57 patients) received 70 Gy employing a conformal technique. The BeamCath technique was associated with a lower median rectal (p=0.004; 50.6 Gy versus 56.2 Gy) and bladder dose (p=0.017; 48.5 Gy versus 61.5 Gy). There were no differences in scores on masculinity and sexual function. In conclusion, the BeamCath technique did not increase rectal or bladder toxicity.","Anticancer Res, 28(5b): 2865-2868","Norway",2008,"Local","Radiotherapy","Unclear","Patient",null,"Cross-sectional","Norway","Patient","Local","Radiotherapy",null,"Cross-sectional","Unclear","2005:2009","Complication"]
[263,"Hara, I., et al. (2003). \"Comparison of quality of life following laparoscopic and open prostatectomy for prostate cancer.\" J Urol 169(6): 2045-2048.",null,"Hara, I., et al.","Comparison of quality of life following laparoscopic and open prostatectomy for prostate cancer","PURPOSE: We compare the quality of life after laparoscopic prostatectomy to that after standard radical prostatectomy. MATERIAL AND METHODS: The quality of life of 52 and 54 patients who underwent laparoscopic and open radical prostatectomy, respectively, was analyzed using the European Organization for the Research and Treatment of Cancer Prostate Cancer quality of life questionnaire for general health related quality of life, International Index of Erectile Function 5 for screening erectile dysfunction and International Continence Society MaleSF questionnaire to evaluate urinary status. These questionnaires were given to patients before and 6 months after surgery. RESULTS: The general health related quality of life survey revealed no significant differences in health before and after laparoscopic and open prostatectomy. However, sexual quality of life was markedly lower after surgery (p <0.01). In addition, the International Index of Erectile Function score was markedly abrogated by surgery (p <0.05) and quality of life due to urinary incontinence was significantly disturbed by surgery (p <0.05). In contrast, quality of life due to voiding dysfunction was impaired before surgery and significantly improved by surgery (p <0.05). Patients were also asked if they would choose the same treatment if suffering from the same disease, with more patients treated laparoscopically choosing the same treatment than those treated with open surgery (p <0.05). CONCLUSIONS: While general health related quality of life was not impaired, sexual quality of life was diminished by surgery. Patients were generally satisfied with postoperative urinary status. Although patients who underwent laparoscopic prostatectomy expressed a more favorable attitude toward surgery, there was no significant difference in quality of life at 6 months after surgery between the 2 groups.","J Urol, 169(6): 2045-2048","Japan",2003,"Any or unknown","Surgery","EORTC QLQ-PR25,IIEF-5,ICSQ","Patient",null,"Cross-sectional","Japan","Patient","Any or unknown","Surgery",null,"Cross-sectional","EORTC QLQ-PR25,IIEF-5,ICSQ","2000:2004","Disease,Complication"]
[264,"Harding, C., et al. (2009). \"Auricular acupuncture: a novel treatment for vasomotor symptoms associated with luteinizing-hormone releasing hormone agonist treatment for prostate cancer.\" BJU Int 103(2): 186-190.",null,"Harding, C., et al.","Auricular acupuncture: a novel treatment for vasomotor symptoms associated with luteinizing-hormone releasing hormone agonist treatment for prostate cancer","OBJECTIVES: To evaluate the role of auricular acupuncture (AA) in men receiving luteinizing-hormone releasing hormone (LHRH) analogues for carcinoma of the prostate, as vasomotor symptoms can affect the quality of life in such men, and similar symptoms in postmenopausal women have been successfully treated with AA. PATIENTS AND METHODS: In all, 60 consecutive patients with prostate cancer and on LHRH agonist treatment (median age 74 years, range 58-83) consented to weekly AA for 10 weeks. The validated 'Measure Yourself Concerns and Well-Being' questionnaire (a six-point scale to assess symptom severity) was used to assess concerns and well-being before and after treatment. RESULTS: All men completed the treatment with no adverse events recorded, apart from transient exacerbation of symptoms in two men; 95% of patients reported a decrease in the severity of symptoms, from a mean 5.0 to 2.1 (Student's t-test, P < 0.01). CONCLUSIONS: The symptomatic improvement was at levels comparable with that from pharmacotherapy, and cost analysis showed AA to be a viable alternative. Larger randomized studies are needed to fully evaluate AA against more conventional treatments, and these are planned.","BJU Int, 103(2): 186-190","UK",2009,"Any or unknown","Hormonal,Various","MYCWB","Patient",null,"Clinical trial","UK","Patient","Any or unknown","Hormonal,Various",null,"Clinical trial","MYCWB","2005:2009","General"]
[265,"Hardy, C., et al. (2007). \"Attitudes of prostate cancer patients towards the diagnosis and treatment of their disease: findings from a multinational survey.\" Curr Med Res Opin 23(9): 2107-2116.",null,"Hardy, C., et al.","Attitudes of prostate cancer patients towards the diagnosis and treatment of their disease: findings from a multinational survey","OBJECTIVE: To explore the attitudes of patients with locally advanced or metastatic prostate cancer towards the diagnosis and treatment of their disease. RESEARCH DESIGN AND METHODS: Patients who had been receiving hormonal therapy for > or = 1 year were recruited from France, Germany, Italy, Spain, the UK and the USA. All patients were required to complete a 10- to 15-minute fully structured questionnaire (either online or on paper) during September 2006. RESULTS: A total of 382 patients completed the questionnaire. Patients were currently receiving luteinising hormone-releasing hormone agonist monotherapy (73%), antiandrogen monotherapy (10%), or combined androgen blockade (17%). Since diagnosis, while being treated with hormonal therapy, many patients felt that they had a more reasonable quality of life (36%) and were more able to lead an active life (36%). Although patients generally wanted to be involved in treatment decisions, many felt they had missed out on hormonal treatment options (26%) and/or were unaware of all the treatment options available (29%). Patients felt that information on hormonal treatments from their specialist physician could be trusted more than that from other sources. The most important factors for patients in terms of their treatment were disease control (39%) and outliving their disease (31%). CONCLUSIONS: Patients can miss information regarding their disease and the hormonal treatments available. As patients place the most emphasis on disease control and outliving their disease, and may experience improved quality of life while on hormonal therapy, physicians should not exclude treatment options on the basis of potential side effects alone.","Curr Med Res Opin, 23(9): 2107-2116","UK,France,Germany,Italy,Spain,USA",2007,"Advanced,Metastatic","Hormonal","Unclear","Patient",null,"Cross-sectional","UK,France,Germany,Italy,Spain,USA","Patient","Advanced,Metastatic","Hormonal",null,"Cross-sectional","Unclear","2005:2009","Views"]
[266,"Harke, N., et al. (2017). \"Postoperative patient comfort in suprapubic drainage versus transurethral catheterization following robot-assisted radical prostatectomy: a prospective randomized clinical trial.\" World J Urol 35(3): 389-394.",null,"Harke, N., et al.","Postoperative patient comfort in suprapubic drainage versus transurethral catheterization following robot-assisted radical prostatectomy: a prospective randomized clinical trial","PURPOSE: To evaluate the impact of the type of urinary diversion (suprapubic vs. transurethral catheterization) on patients' postoperative pain after radical prostatectomy, development of bacteriuria and long-term functional results. METHODS: A randomized, prospective clinical trial was performed including 160 patients who underwent robot-assisted radical prostatectomy after randomization into two groups: intraoperatively, a transurethral catheter (control group) or an additional suprapubic tube (with removal of the transurethral catheter in the morning of postoperative day 1; intervention group) was placed. Primary study endpoint was postoperative pain objectified by the numeric rating scale questionnaire. Secondary endpoints were bacteriuria after catheter removal and functional outcomes after up to 2 years of follow-up. RESULTS: There were no significant differences in demographic and perioperative data. Starting on postoperative day 2, patients in the suprapubic diversion group had significantly less pain on every time point preceding the removal of the catheter compared to the control cohort with a median overall numeric rating score on postoperative day 1-4 of 2.4 points in the transurethral versus 1.3 in the intervention group (p = 0.012). No statistical difference was found in postoperative bacteriuria and complications as well as in functional results, quality of life and incontinence rates after a median follow-up of 22 months. CONCLUSIONS: Suprapubic drainage in robot-assisted radical prostatectomy shows significantly decreased pain levels during the catheterization period compared to the transurethral diversion without compromising long-term functional results. Intraoperative placement of a suprapubic tube should be discussed as a standard procedure for further improvement of patients' postoperative comfort.","World J Urol, 35(3): 389-394","Germany",2017,"Any or unknown","Surgery","NPS","Patient",null,"Clinical trial","Germany","Patient","Any or unknown","Surgery",null,"Clinical trial","NPS","2015:2018","Symptom"]
[267,"Harland, S., et al. (2013). \"Effect of abiraterone acetate treatment on the quality of life of patients with metastatic castration-resistant prostate cancer after failure of docetaxel chemotherapy.\" Eur J Cancer 49(17): 3648-3657.",null,"Harland, S., et al.","Effect of abiraterone acetate treatment on the quality of life of patients with metastatic castration-resistant prostate cancer after failure of docetaxel chemotherapy","BACKGROUND: In a recent randomised, double-blind, phase III clinical trial among 1195 patients with metastatic castration-resistant prostate cancer (mCRPC) who had failed docetaxel chemotherapy, abiraterone acetate was shown to significantly prolong overall survival compared with prednisone alone. Here we report on the impact of abiraterone therapy on the health-related quality of life (HRQoL) observed during this trial, assessed using the validated Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire. METHODS: All analyses were conducted using prespecified criteria for clinically meaningful improvement and deterioration in FACT-P total score as well as subscale scores; all respective thresholds were defined using an accepted methodology. Improvement was assessed only in patients with clinically significant functional status impairment at baseline. RESULTS: Significant improvements in the FACT-P total score were observed in 48% of patients receiving abiraterone versus 32% of patients receiving prednisone (p < 0.0001). Also, the median time to deterioration in FACT-P total score was longer (p < 0.0001) in patients receiving abiraterone (59.9 weeks versus 36.1 weeks). Similar differences were observed in all FACT-P subscales, with the exception of the social/family well-being domain. Median time to improvement in the physical well-being domain and the trial outcome index was significantly shorter (p < 0.01) with abiraterone when compared with the prednisone arm. CONCLUSIONS: The previously demonstrated survival benefit for abiraterone is accompanied by improvements in patient-reported HRQoL and a significant delay in HRQoL deterioration when compared with prednisone.","Eur J Cancer, 49(17): 3648-3657","UK",2013,"Metastatic,Refractory","Abiraterone","FACT-P","Patient",null,"Clinical trial","UK","Patient","Metastatic,Refractory","Abiraterone",null,"Clinical trial","FACT-P","2010:2014","Disease"]
[268,"Harrington, C., et al. (2010). \"Randomised, placebo-controlled, crossover trial of sildenafil citrate in the treatment of erectile dysfunction following external beam radiation treatment of prostate cancer.\" J Med Imaging Radiat Oncol 54(3): 224-228.",null,"Harrington, C., et al.","Randomised, placebo-controlled, crossover trial of sildenafil citrate in the treatment of erectile dysfunction following external beam radiation treatment of prostate cancer","Erectile dysfunction (ED) commonly affects the quality of life of men after treatment of prostate cancer. We conducted a placebo-controlled, crossover randomised trial to assess the efficacy and tolerability of sildenafil citrate in the treatment of ED developing after external beam radiation treatment (EBRT) of localized prostate cancer. Sixty-six patients who had developed ED following radiation treatment agreed to participate and were allocated to sildenafil or placebo to be taken prior to four sexual attempts. In the crossover period, subjects received the alternative tablet for a further four attempts. Allocation was centrally randomized, and researchers and patients were both blinded to the trial arm. Efficacy was assessed using the International Index of Erectile Function (IIEF) questionnaire and with a separate global efficacy question. Forty-three subjects completed the study. There was a significant increase in mean scores from baseline for all domains of the IIEF with sildenafil compared with placebo (P < 0.001). Affirmative response to the global efficacy question was more common after taking sildenafil compared with placebo. In approximately half of the patients, the improvement in the erectile function domain score corresponded to a moderate improvement in ED (e.g. success 'sometimes' to 'most times'). Sildenafil was associated with mild flushing, nasal stuffiness or indigestion in 8-10% patients and moderate flushing in 10%. The current study adds to the evidence that phosphodiesterase inhibitors are an effective and well-tolerated treatment for ED after EBRT for prostate cancer.","J Med Imaging Radiat Oncol, 54(3): 224-228","New Zealand",2010,"Local","PDEi,Radiotherapy","IIEF-5","Patient",null,"Clinical trial","New Zealand","Patient","Local","PDEi,Radiotherapy",null,"Clinical trial","IIEF-5","2010:2014","Complication"]
[269,"Harris, M. J. (2003). \"Radical perineal prostatectomy: cost efficient, outcome effective, minimally invasive prostate cancer management.\" Eur Urol 44(3): 303-308; discussion 308.",null,"Harris, M. J.","Radical perineal prostatectomy: cost efficient, outcome effective, minimally invasive prostate cancer management","OBJECTIVE: Localized prostate cancer is a common disease for which minimally invasive treatment methods are being explored. Perineal prostatectomy, as a historical open procedure, is modified to incorporate contemporary surgical ideas. There is relatively little in the literature regarding modern adaptations of perineal prostatectomy. This method of anatomic radical perineal prostatectomy has been developed to accomplish a minimally invasive method of achieving goals of disease control and preservation of genito-urinary functions. METHODS: Prospective outcome data is accumulated on 508 consecutive radical perineal prostatectomies by a single surgeon. Pathologic stage and PSA detectability are measures of cancer control. Pad use and ability to complete intercourse measure urinary and sexual function. General complications and other outcome measures are evaluated. RESULTS: Freedom from PSA detectability by pathologic stage is 96.3%, 79.4%, and 69.4% for organ confined, specimen confined and margin positive in the absence of seminal vesical invasion with an average 4 years follow up (3-114 months). Margins are positive in 18% of cases. The average cancer size is 9.4g and 36% of cases have extracapsular invasion. By the first, third, sixth months and one year, 38%, 65%, 88% and 96% are free of pad use and report being dry. While over 80% of nerve-spared patients enjoy the return of spontaneous erectile function, the men with bilateral nerve preservation note earlier and more complete return of function. There are no cardiopulmonary complications or deaths. Transfusions occurred in 1%, none in the past 400 cases. Average total hospital charges are USD$4889.00 in 1999 and 2000. Anterior urethral strictures, anastomotic strictures and fecal urgency/stress flatus occur 2%, 2% and 2-4%, respectively. CONCLUSIONS: This method of prostatectomy is able to achieve complete cancer resection while preserving urinary and sexual function as well as laparoscopic or retropubic prostatectomy. The simplicity and minimally invasive nature of this procedure contribute to a short recovery and low overall cost of therapy. The anatomic radical perineal prostatectomy is a cost-efficient, outcome effective minimally invasive method of treating men with localized prostate cancer.","Eur Urol, 44(3): 303-308; discussion 308","USA",2003,"Local","Surgery","Unclear","Patient",null,"Cohort","USA","Patient","Local","Surgery",null,"Cohort","Unclear","2000:2004","Complication"]
[270,"Harris, P., et al. (2003). \"Complementary and alternative medicine use by patients with cancer in Wales: a cross sectional survey.\" Complement Ther Med 11(4): 249-253.",null,"Harris, P., et al.","Complementary and alternative medicine use by patients with cancer in Wales: a cross sectional survey","OBJECTIVES: To determine the prevalence and cost of complementary and alternative medicine (CAM) use, and examine perceived satisfaction and reasons for using CAM. DESIGN AND SETTING: Cross sectional survey of 1697 patients with breast, prostate, lung or neurological cancer registered with a single NHS authority in Wales. PARTICIPANTS: One thousand and seventy-seven (64%) of patients, aged 18 years or over with cancer diagnosis of at least 3 months, returned analysable questionnaires. Thirty patients were interviewed by telephone. MAIN OUTCOME MEASURES: Number and proportion that had used CAM in the past 12 months, the types of CAM used, expenditure, satisfaction, demographic characteristics, and reasons for using CAM. RESULTS: Five hundred and thirty-four, 49.6% (95% CI 46.6-52.6) of participants, reported using at least one type of CAM during the past 12 months: 221, 16.4% (95% CI 14.3-18.8), had consulted a CAM practitioner (average cost per person, 28 lbs. per month); 166, 15.4% (95% CI 13.4-17.7), indicated using CAM techniques (average cost per person, 16 lbs. per month); 456, 42.3% (95% CI 39.4-45.3), reported using over-the-counter diets, remedies or supplements (average cost per person, 10 lbs. per month). Dissatisfaction with CAM use was low, and most users indicated that they represented value for money. CAM users were more likely to be female, younger, better qualified, and to have used CAM before their current illness than non-users. Patients used CAM primarily for symptom relief and relaxation. CONCLUSIONS: Nearly half the cancer patients in this study had used CAM. A co-ordinated approach to quality assurance, information and advice, and the assessment of risk/benefit and cost effectiveness of CAM use is needed.","Complement Ther Med, 11(4): 249-253","UK",2003,"Any or unknown","Various","Unclear","Patient",null,"Cross-sectional","UK","Patient","Any or unknown","Various",null,"Cross-sectional","Unclear","2000:2004","Views"]
[271,"Hartung, T. J., et al. (2017). \"The risk of being depressed is significantly higher in cancer patients than in the general population: Prevalence and severity of depressive symptoms across major cancer types.\" Eur J Cancer 72: 46-53.",null,"Hartung, T. J., et al.","The risk of being depressed is significantly higher in cancer patients than in the general population: Prevalence and severity of depressive symptoms across major cancer types","BACKGROUND: Depression is a common co-morbidity of cancer that has a detrimental effect on quality of life, treatment adherence and potentially survival. We conducted an epidemiological multi-center study including a population-based random comparison sample and estimated the prevalence of depressive symptoms by cancer site, thereby identifying cancer patients with the highest prevalence of depression. PATIENTS AND METHODS: We included 4020 adult cancer inpatients and outpatients from five distinct regions across Germany in a proportional stratified random sample based on the nationwide cancer incidence and a comparison group consisting of 5018 participants. Both groups reported depressive symptoms by filling in the Patient Health Questionnaire (PHQ-9). In multivariate analyses adjusted for age and sex, we calculated the odds of being depressed. RESULTS: Out of 5818 eligible patients, 69% participated (51% women, mean age = 58 years). We estimated that one in four cancer patients (24%) is depressed (PHQ-9 >/= 10). The odds of being depressed among cancer patients were more than five times higher than in the general population (OR, 5.4; 95% CI, 4.6-6.2). Patients with pancreatic (M = 8.0, SD = 5.0), thyroid (M = 7.8, SD = 6.3) and brain tumours (M = 7.6, SD = 4.9) showed the highest prevalence, whereas patients with prostate cancer (M = 4.3, SD = 3.8) and malignant melanoma (M = 5.3, SD = 4.3) had the lowest levels of depressive symptoms. CONCLUSION: Our results help clinicians identify cancer patients in need of psychosocial support when navigating in the growing survivor population.","Eur J Cancer, 72(46-53","Germany",2017,"Any or unknown","None","PHQ-9","Patient,General population",null,"Cross-sectional","Germany","Patient,General population","Any or unknown","None",null,"Cross-sectional","PHQ-9","2015:2018","Comorbidity"]
[272,"Hashine, K., et al. (2008). \"A prospective longitudinal study comparing a radical retropubic prostatectomy and permanent prostate brachytherapy regarding the health-related quality of life for localized prostate cancer.\" Jpn J Clin Oncol 38(7): 480-485.",null,"Hashine, K., et al.","A prospective longitudinal study comparing a radical retropubic prostatectomy and permanent prostate brachytherapy regarding the health-related quality of life for localized prostate cancer","OBJECTIVE: The health-related quality of life (HRQOL) after a radical retropubic prostatectomy (RRP) or a permanent prostate brachytherapy (PPB) was prospectively compared at a single institute. METHODS: Between 2003 and 2005, 122 patients were treated by RRP and 82 patients were treated by PPB. A QOL survey was completed at baseline, and 1, 3, 6 and 12 months after treatment, prospectively. RESULTS: The general HRQOL was not different between the RRP and PPB groups after 3 months. However, at 1 month after treatment, the general HRQOL scores, except for general health, were significantly better in the PPB group than that in the RRP group. Moreover, the disease-specific QOL was worse in urinary and sexual functions in the RRP group. Urinary function in the RRP group had not recovered to baseline after 12 months. Although the urinary function in the PPB group was better than that of the RRP group, urinary bother continued to worsen until 6 months and thereafter it recovered gradually. The bowel function was not worse in the PPB group but bowel bother was worse at 6 months in the PPB group. In the RRP group, the patients with nerve sparing demonstrated better in sexual function than those without nerve sparing, but the recovery did not reach the level of the PPB group. CONCLUSIONS: This prospective study revealed the differences in the QOL after RRP and PPB. These results will be helpful for making treatment decisions.","Jpn J Clin Oncol, 38(7): 480-485","Japan",2008,"Local","Brachytherapy,Surgery","Unclear","Patient",null,"Cohort","Japan","Patient","Local","Brachytherapy,Surgery",null,"Cohort","Unclear","2005:2009","General"]
[273,"Hashine, K., et al. (2009). \"Health-related quality of life using SF-8 and EPIC questionnaires after treatment with radical retropubic prostatectomy and permanent prostate brachytherapy.\" Jpn J Clin Oncol 39(8): 502-508.",null,"Hashine, K., et al.","Health-related quality of life using SF-8 and EPIC questionnaires after treatment with radical retropubic prostatectomy and permanent prostate brachytherapy","OBJECTIVE: The health-related quality of life (HRQOL) after treatment of prostate cancer is examined using a new HRQOL tool. HRQOL, based on the expanded prostate cancer index composite (EPIC) and SF-8 questionnaires, was prospectively compared after either a radical retropubic prostatectomy (RRP) or a permanent prostate brachytherapy (PPB) at a single institute. METHODS: Between October 2005 and June 2007, 96 patients were treated by an RRP and 88 patients were treated by a PPB. A HRQOL survey was completed at baseline, and at 1, 3, 6 and 12 months after treatment, prospectively. RESULTS: The general HRQOL in the RRP and PPB groups was not different after 3 months. However, at baseline and 1 month after treatment, the mental component summary was significantly better in the PPB group than in the RRP group. Moreover, the disease-specific HRQOL was worse regarding urinary and sexual functions in the RRP group. Urinary irritative/obstructive was worse in the PPB group, but urinary incontinence was worse in the RRP group and had not recovered to baseline after 12 months. The bowel function and bother were worse in the PPB group than in the RRP group after 3 months. In the RRP group, the patients with nerve sparing demonstrated the same scores in sexual function as the PPB group. CONCLUSIONS: This prospective study revealed the differences in the HRQOL after an RRP and PPB. Disease-specific HRQOL is clarified by using EPIC survey. These results will be helpful for making treatment decisions.","Jpn J Clin Oncol, 39(8): 502-508","Japan",2009,"Any or unknown","Brachytherapy,Surgery","EPIC,SF-8","Patient",null,"Cohort","Japan","Patient","Any or unknown","Brachytherapy,Surgery",null,"Cohort","EPIC,SF-8","2005:2009","Disease,Utility"]
[274,"Hashine, K., et al. (2014). \"Health-related quality of life in the first year after laparoscopic radical prostatectomy compared with open radical prostatectomy.\" Jpn J Clin Oncol 44(7): 686-691.",null,"Hashine, K., et al.","Health-related quality of life in the first year after laparoscopic radical prostatectomy compared with open radical prostatectomy","OBJECTIVE: To assess health-related quality of life in the first year after laparoscopic radical prostatectomy compared with that after open radical prostatectomy. METHODS: The subjects were 105 consecutive patients with localized prostate cancer treated with laparoscopic radical prostatectomy between January 2011 and June 2012. Health-related quality of life was evaluated using the International Prostate Symptom Score, Medical Outcome Study 8-Items Short Form Health Survey (SF-8) and Expanded Prostate Cancer Index Composite at baseline and 1, 3, 6 and 12 months after surgery. Comparisons were made with data for 107 consecutive patients treated with open radical prostatectomy between October 2005 and July 2007. RESULTS: The International Prostate Symptom Score change was similar in each group. The laparoscopic radical prostatectomy group had a better baseline Medical Outcome Study 8-Items Short Form Health Survey mental component summary score and a better Medical Outcome Study 8-Items Short Form Health Survey physical component summary score at 1 month after surgery. In Expanded Prostate Cancer Index Composite, obstructive/irritative symptoms did not differ between the groups, but urinary incontinence was worse until 12 months after surgery and particularly severe after 1 month in the laparoscopic radical prostatectomy group. The rate of severe urinary incontinence was much higher in the laparoscopic radical prostatectomy group in the early period. Urinary bother was worse in the laparoscopic radical prostatectomy group at 1 and 3 months, but did not differ between the groups thereafter. Urinary function and bother were good after nerve sparing procedures and did not differ between the groups. Bowel and sexual function and bother were similar in the two groups. CONCLUSION: Urinary function in the first year after laparoscopic radical prostatectomy is worse than that after open radical prostatectomy.","Jpn J Clin Oncol, 44(7): 686-691","Japan",2014,"Local","Surgery","SF-8,EPIC,IPSS","Patient",null,"Cohort","Japan","Patient","Local","Surgery",null,"Cohort","SF-8,EPIC,IPSS","2010:2014","Disease,Utility"]
[275,"Hays, R. D., et al. (2000). \"Health-related quality of life in patients with human immunodeficiency virus infection in the United States: results from the HIV Cost and Services Utilization Study.\" Am J Med 108(9): 714-722.",null,"Hays, R. D., et al.","Health-related quality of life in patients with human immunodeficiency virus infection in the United States: results from the HIV Cost and Services Utilization Study","PURPOSE: To measure health-related quality of life among adult patients with human immunodeficiency virus (HIV) disease; to compare the health-related quality of life of adults with HIV with that of the general population and with patients with other chronic conditions; and to determine the associations of demographic variables and disease severity with health-related quality of life. SUBJECTS AND METHODS: We studied 2,864 HIV-infected adults participating in the HIV Cost and Services Utilization Study, a probability sample of adults with HIV receiving health care in the contiguous United States (excluding military hospitals, prisons, or emergency rooms). A battery of 28 items covering eight domains of health (physical functioning, emotional well-being, role functioning, pain, general health perceptions, social functioning, energy, disability days) was administered. The eight domains were combined into physical and mental health summary scores. SF-36 physical functioning and emotional well-being scales were compared with the US general population and patients with other chronic diseases on a 0 to 100 scale. RESULTS: Physical functioning was about the same for adults with asymptomatic HIV disease as for the US population [mean (+/- SD) of 92+/-16 versus 90+/-17) but was much worse for those with symptomatic HIV disease (76+/-28) or who met criteria for the acquired immunodeficiency syndrome (AIDS; 58+/-31). Patients with AIDS had worse physical functioning than those with other chronic diseases (epilepsy, gastroesophageal reflux disease, clinically localized prostate cancer, clinical depression, diabetes) for which comparable data were available. Emotional well-being was comparable among patients with various stages of HIV disease (asymptomatic, 62+/-9; symptomatic, 59+/-11; AIDS, 59+/-11), but was significantly worse than the general population and patients with other chronic diseases except depression. In multivariate analyses, HIV-related symptoms were strongly associated with physical and mental health, whereas race, sex, health insurance status, disease stage, and CD4 count were at most weakly associated with physical and mental health. CONCLUSIONS: There is substantial morbidity associated with HIV disease in adults. The variability in health-related quality of life according to disease progression is relevant for health policy and allocation of resources, and merits the attention of clinicians who treat patients with HIV disease.","Am J Med, 108(9): 714-722","USA",2000,"Local","None","SF-36","Patient",null,"Cross-sectional","USA","Patient","Local","None",null,"Cross-sectional","SF-36","2000:2004","Utility"]
[276,"Haythornthwaite, J. A., et al. (1998). \"Pain and quality of life following radical retropubic prostatectomy.\" J Urol 160(5): 1761-1764.",null,"Haythornthwaite, J. A., et al.","Pain and quality of life following radical retropubic prostatectomy","PURPOSE: We assess pain and quality of life following radical retropubic prostatectomy and determine whether intraoperative anesthetic management has any long-term effects on outcomes. MATERIALS AND METHODS: A total of 110 patients undergoing radical retropubic prostatectomy were randomly assigned to receive epidural and/or general anesthesia. Patients responded to a questionnaire mailed 3 and 6 months following surgery that assessed prostate symptoms, pain related to surgery, quality of life and mood. RESULTS: No long-term effects of anesthesia were observed. Of the 103 respondents (94%) at 3 months 49% had some pain related to surgery. Although pain was not related to anesthesic technique, patients who had it at 3 months used significantly more pain medication on postoperative day 3. Pain at 3 months was mild, averaging 1.5 on a scale of 0 to 10, and associated with poor perceptions of overall health (p <0.02), and reduced physical (p <0.01) and social (p <0.01) functioning. Pain at 3 months was associated with higher levels of preoperative anxiety (p <0.05). At 6 months 36 of 90 patients (35%) had some pain related to surgery and the impact was similar. CONCLUSIONS: Long-term effects of intraoperative anesthesic technique were not apparent. Mild pain following radical retropubic prostatectomy was common and associated with reduced quality of life, particularly social functioning. Affective distress, particularly anxiety, before surgery and use of pain medications following surgery may be predictors of chronic pain following radical retropubic prostatectomy.","J Urol, 160(5): 1761-1764","USA",1998,"Any or unknown","Surgery,Various","NPS","Patient",null,"Clinical trial","USA","Patient","Any or unknown","Surgery,Various",null,"Clinical trial","NPS","1960:1999","Symptom"]
[277,"Heathcote, P. S., et al. (1998). \"Health-related quality of life in Australian men remaining disease-free after radical prostatectomy.\" Med J Aust 168(10): 483-486.",null,"Heathcote, P. S., et al.","Health-related quality of life in Australian men remaining disease-free after radical prostatectomy","OBJECTIVE: To determine the health-related quality of life (HRQOL) of Australian men after radical prostatectomy. DESIGN: Cross-sectional study. SETTING: Private and public practices of three urologists in south-east Queensland, July 1989 to June 1995. PARTICIPANTS: 140 men with no evidence of disease recurrence 1 to 6 years after radical prostatectomy. MAIN OUTCOME MEASURES: Voiding and erectile potency and HRQOL. Recall of preoperative status and status at survey were established by an independently administered multi-item questionnaire. RESULTS: 112 men (80%) completed the study questionnaire. Difficulty with bladder control before the operation was reported by 25 (22%; 95% confidence interval [CI], 15%-31.2%), and the incontinence rate after treatment was 22/112 (20%; 95% CI, 12.7%-28.2%). Men with incontinence after operation were more likely to recall preoperative urinary symptoms. Eighty-four (75%) men were happy or coping with their sexual function after radical prostatectomy despite an erectile potency rate of only 12% (95% CI, 7%-20%). Twenty-eight (25%) had tried penile injections and three have had penile prostheses since their operation. Impotence was reported more frequently (40%) as the treatment-related problem most affecting life, followed by \"concern about cancer\" (12%) and incontinence (8%). Impotence was also the most common cause given for diminished HRQOL. CONCLUSIONS: Loss of sexual function after radical prostatectomy is more commonly perceived as a major problem and is more likely than urinary incontinence to adversely affect HRQOL. Loss of sexual function and its effect on HRQOL needs to be given greater emphasis in counselling before radical prostatectomy.","Med J Aust, 168(10): 483-486","Australia",1998,"Survivors","Surgery","Unclear","Patient",null,"Cross-sectional","Australia","Patient","Survivors","Surgery",null,"Cross-sectional","Unclear","1960:1999","Complication"]
[278,"Hedgepeth, R. C., et al. (2009). \"Expanded Prostate Cancer Index Composite versus Incontinence Symptom Index and Sexual Health Inventory for Men to measure functional outcomes after prostatectomy.\" J Urol 182(1): 221-227; discussion 227-228.",null,"Hedgepeth, R. C., et al.","Expanded Prostate Cancer Index Composite versus Incontinence Symptom Index and Sexual Health Inventory for Men to measure functional outcomes after prostatectomy","PURPOSE: Evaluating quality of life outcomes following prostate cancer treatment is important because different treatments provide similar survival outcomes. A wide variety of quality of life surveys are used with an unknown correlation between domain specific and broad domain instruments. We compared the urinary and sexual outcome measures of the Expanded Prostate Cancer Index Composite, a broad domain instrument, to those of the Incontinence Symptom Index and the Sexual Health Inventory for Men, which are domain specific instruments. MATERIALS AND METHODS: A total of 640 patients undergoing radical prostatectomy at our institution completed a combination of the Expanded Prostate Cancer Index Composite, Incontinence Symptom Index and Sexual Health Inventory for Men questionnaires. Matching functional domains were compared and correlation coefficients were calculated. Subgroup analysis was performed to compare specific information pertinent to recovery from prostatectomy. RESULTS: Correlations between measures of incontinence were 0.26 to 0.84, while indicators of sexual function were 0.70 to 0.84. Subgroup analysis comparing measures of irritative symptoms demonstrated weaker correlations. Analysis in patients reporting no sexual activity also showed a significantly lower correlation of scores than that in patients reporting sexual activity. CONCLUSIONS: Expanded Prostate Cancer Index Composite scores generally demonstrate strong correlations with corresponding Incontinence Symptom Index and Sexual Health Inventory for Men scores, indicating similar measurements of information. Divergent correlations between irritative scores as well as scores in men who are not sexually active may indicate that the Expanded Prostate Cancer Index Composite has more descriptive validity in this population. Wider use of a single broad domain instrument such as the Expanded Prostate Cancer Index Composite to assess outcomes after prostate cancer treatment may improve clinical efficiency and allow comparative quality of life research across treatment types in the future.","J Urol, 182(1): 221-227; discussion 227-228","USA",2009,"Any or unknown","Surgery","EPIC,ISyI,SHIM","Patient",null,"Validation","USA","Patient","Any or unknown","Surgery",null,"Validation","EPIC,ISyI,SHIM","2005:2009","Disease,Complication"]
[279,"Heedman, P. A. and P. Strang (2001). \"Symptom assessment in advanced palliative home care for cancer patients using the ESAS: clinical aspects.\" Anticancer Res 21(6a): 4077-4082.",null,"Heedman, P. A. and P. Strang","Symptom assessment in advanced palliative home care for cancer patients using the ESAS: clinical aspects","Four hundred and thirty-one cancer patients were assessed with the ESAS and a VAS-QoL at admission to Hospital-based home care (HBHC) and subsequently. RESULTS: Pain and nausea were well-controlled (mean 2.5 and 1.8) whereas patients were less satisfied with appetite, activity and sense of well-being. Dyspnoea and anxiety (lung cancer, p<0.001 and p<0.01) and pain (prostate cancer, p<0.01), were related to diagnosis while activity, drowsiness, appetite and well-being to survival (p<0.05 to p<0.001). The correlations between individual symptoms and well-being were low (0.2-0.5), whereas the correlation between well-being and the Symptom Distress Score (SDS) was 0.76. \"Well-being\" was a better word to use than QoL. DISCUSSION: ESAS is useful in HBHC and data show that symptoms other than merely pain and nausea are of importance. As the global measurement (one VAS) of well-being has a high correlation with SDS, this single measurement may be clinically adequate for quality assurance of symptom control in dying cancer patients.","Anticancer Res, 21(6a): 4077-4082","Sweden",2001,"End of life","None","VAS,ESAS","Patient",null,"Validation","Sweden","Patient","End of life","None",null,"Validation","VAS,ESAS","2000:2004","Symptom"]
[280,"Hegarty, J. M., et al. (2008). \"Uncertainty and quality of life among men undergoing active surveillance for prostate cancer in the United States and Ireland.\" Am J Mens Health 2(2): 133-142.",null,"Hegarty, J. M., et al.","Uncertainty and quality of life among men undergoing active surveillance for prostate cancer in the United States and Ireland","BACKGROUND: Prostate cancer continues to be the most common site of male cancers, particularly among older men in Europe and the United States, and the second most common male cancer worldwide. Active surveillance involves the use of no local or systemic therapy once prostate cancer has been diagnosed. A description of uncertainty and quality of life among men undergoing active surveillance in samples from both the United States and Ireland has the potential to enhance global health care delivery. METHODS: The specific aim of this study is to enhance the understanding of the experience of active surveillance for prostate cancer among Irish and American men by measuring quality of life and levels of uncertainty among men over the age of 65 in receipt of the active surveillance management option for prostate cancer. A quantitative, descriptive survey design was used. RESULTS: Twenty-nine men completed questionnaires. The results reveal that men undergoing active surveillance in the United States have slightly higher levels of uncertainty. Primary appraisal, opportunity, and danger appraisal were consistent between samples from both countries. Total affective and health-related quality-of-life scores were similar among active surveillance participants in both countries, but subscale scores identified both similarities and differences. Irish men had lower mean role and social function than U.S. men, and higher general health and energy. Irish men reported more urine bother and less sexual bother than U.S. men. CONCLUSION: To assist men with prostate cancer who are treated with the active surveillance management option, health care professionals must develop an awareness of how prostate cancer affects the man's physical and psychological health care outcomes.","Am J Mens Health, 2(2): 133-142","USA,Ireland",2008,"Any or unknown","Surveillance","Unclear","Patient",null,"Cross-sectional","USA,Ireland","Patient","Any or unknown","Surveillance",null,"Cross-sectional","Unclear","2005:2009","General"]
[281,"Hegarty, J., et al. (2010). \"Radical prostatectomy versus watchful waiting for prostate cancer.\" Cochrane Database Syst Rev (11): Cd006590.",null,"Hegarty, J., et al.","Radical prostatectomy versus watchful waiting for prostate cancer","BACKGROUND: The lack of evidence regarding the effectiveness of treatment options for clinically localised prostate cancer continues to impact on clinical decision-making. Two such options are radical prostatectomy (RP) and watchful waiting (WW). WW involves providing no initial treatment and monitoring the patient with the intention of providing palliative treatment if there is evidence of disease progression. OBJECTIVES: To compare the beneficial and harmful effects of RP versus WW for the treatment of localised prostate cancer. SEARCH STRATEGY: MEDLINE, EMBASE, The Cochrane Library, ISI Science Citation Index, DARE and LILACS were searched through 30 July 2010. SELECTION CRITERIA: Randomised or quasi-randomised controlled trials comparing the effects of RP versus WW for clinically localised prostate cancer. DATA COLLECTION AND ANALYSIS: Data extraction and quality assessment were carried out independently by two authors. MAIN RESULTS: Two trials met the inclusion criteria. Both trials commenced prior to the widespread availability of prostate-specific antigen (PSA) screening; hence the results may not be applicable to men with PSA-detected disease.One trial (N = 142), conducted in the US, was judged to be of poor quality. All cause (overall) mortality was not significantly different between RP and WW groups after fifteen years of follow up (Hazard Ratio (HR) 0.9 (95% Confidence Interval (CI) 0.56 to 1.43).The second trial (N = 695), conducted in Scandinavia, was judged to be of good quality. After 12 years of follow up, the trial results were compatible with a beneficial effect of RP on the risks of overall mortality, prostate cancer mortality and distant metastases compared with WW but the precise magnitude of the effect is uncertain as indicated by the width of the confidence intervals for all estimates (risk difference (RD) -7.1% (95% CI -14.7 to 0.5); RD -5.4% (95% CI -11.1 to 0.2); RD -6.7% (95% CI -13.2 to -0.2), respectively). Compared to WW, RP increased the absolute risks of erectile dysfunction (RD 35% (95% CI 25 to 45)) and urinary leakage (RD 27% (95% CI 17 to 37)). These estimates must be interpreted cautiously as they are derived from data obtained from a self-administered questionnaire survey of a sample of the trial participants (N = 326), no baseline quality of life data were obtained and nerve-sparing surgery was not routinely performed on trial participants undergoing RP. AUTHORS' CONCLUSIONS: The existing trials provide insufficient evidence to allow confident statements to be made about the relative beneficial and harmful effects of RP and WW for patients with localised prostate cancer. The results of ongoing trials should help to inform treatment decisions for men with screen-detected localised prostate cancer.","Cochrane Database Syst Rev, 11): Cd006590","International",2010,"Local","Surgery,Surveillance","Unclear","Patient",null,"Systematic review","International","Patient","Local","Surgery,Surveillance",null,"Systematic review","Unclear","2010:2014","Complication"]
[282,"Heidenreich, A., et al. (2004). \"Prospective randomized Phase II trial of pegylated doxorubicin in the management of symptomatic hormone-refractory prostate carcinoma.\" Cancer 101(5): 948-956.",null,"Heidenreich, A., et al.","Prospective randomized Phase II trial of pegylated doxorubicin in the management of symptomatic hormone-refractory prostate carcinoma","BACKGROUND: Liposomal encapsulation of doxorubicin has been shown to reduce nonspecific delivery of this agent to normal tissue and to increase specific delivery to malignant cells. On the basis of doxorubicin's demonstrated clinical efficacy against hormone-refractory prostate carcinoma (HRPCA), the authors conducted a prospective, randomized Phase II clinical trial to evaluate the feasibility, toxicity, and therapeutic efficacy associated with the pegylated form of this agent. METHODS: Forty-eight patients with symptomatic HRPCA were randomized to receive pegylated liposomal doxorubicin at either 25 mg/m2 every 2 weeks for 12 cycles (Group A) or 50 mg/m2 every 4 weeks for 6 cycles (Group B). Thirty-eight of these 48 patients (79%) presented with severe pain (corresponding to a pain score of 7.5 on a visual analog scale [VAS] ranging from 0 to 10) due to osseous metastases. Therapeutic efficacy was assessed by serial evaluation of serum prostate-specific antigen (PSA) concentrations and by serial measurement of pain levels (using a VAS ranging from 0 to 10). Toxicity data were obtained using the National Cancer Institute of Canada/Cancer and Leukemia Group B criteria and the 30-item European Organization for Research and Treatment of Cancer Quality of Life Questionnaire. RESULTS: The median patient age was 68.9 years (range, 58-79 years), and the mean follow-up duration was 42 months. The mean pretreatment PSA level was 660.4 ng/mL (mean, 8-6340 ng/mL); an objective decrease in PSA levels (i.e., a decrease of > 50%) was observed in 8 of 31 patients (25.8%) in Group B, whereas no other patient in either group experienced such a decrease. The mean time to disease progression was 6.5 months, and the mean survival duration was 13.4 months. Patients in Group B had a significantly higher rate of response with respect to pain (52.6% vs. 28.6%; P = 0.04), and the mean 1-year survival rate also was significantly higher in Group B (42% vs. 15%; P = 0.02). Severe side effects were observed, with 24 patients (50%) experiencing World Health Organization Grade 3/4 toxicity. Toxicity types differed significantly between Group A and Group B; palmar-plantar erythrodysesthesia developed in 60% of patients in the former group (P < 0.0005), whereas tachycardia was more common in the latter group (39% of patients; P < 0.0005). No dose-limiting cardiotoxicities or hematotoxicities were documented. CONCLUSIONS: Pegylated liposomal doxorubicin yielded a noteworthy objective palliative response rate and a mean survival of 13 months for patients with symptomatic HRPCA. The dosage tested in the current study should be used in future Phase II and Phase III trials of pegylated liposomal doxorubicin-containing combination regimens for patients with HRPCA.","Cancer, 101(5): 948-956","Germany",2004,"Advanced,Metastatic","Chemotherapy","VAS,EORTC QLQ-C30","Patient",null,"Clinical trial","Germany","Patient","Advanced,Metastatic","Chemotherapy",null,"Clinical trial","VAS,EORTC QLQ-C30","2000:2004","General,Symptom"]
[283,"Helgesen, F., et al. (2000). \"Follow-up of prostate cancer patients by on-demand contacts with a specialist nurse: a randomized study.\" Scand J Urol Nephrol 34(1): 55-61.",null,"Helgesen, F., et al.","Follow-up of prostate cancer patients by on-demand contacts with a specialist nurse: a randomized study","OBJECTIVE: The effectiveness of traditional follow-up programs and the intensive search for disease progression in men with prostate cancer have been questioned. The aims of this randomized multi-centre study were to evaluate medical safety, patient satisfaction and resource utilization in an on-demand follow-up by a specialist nurse compared with traditional follow-up by a urologist. MATERIAL AND METHODS: Four hundred consecutively approached men with newly diagnosed or previously known prostate cancer in any stage at three hospitals in Sweden were randomized to follow-up in the nurse group (NG, 200 patients) or the urologist group (UG, 200 patients). In the NG, the nurse contacted the patient by phone every 6 months unless the patient himself initiated the contact. Patient satisfaction was evaluated twice a year via questionnaire. The questionnaire included the validated Hospital Anxiety and Depression Scale (HADS). The costs of all medical interventions and adverse events related to prostate cancer were calculated for all patients. RESULTS: Medical safety, measured as complication frequency and lag time from symptoms to intervention, during the first 3 years of the observation period, was similar in the NG and the UG. The total number of interventions due to symptoms from prostate cancer was also similar in both groups. The analysis of accessibility and the HAD scale showed no significant differences between the groups. The mean outpatient cost (excluding pharmaceutical costs) per patient was lower in the NG compared to the UG, especially among patients without metastases at inclusion (37% lower cost). CONCLUSIONS: Our study indicates that men with prostate cancer can be safely followed up by a specialist nurse. The study results show that this alternative follow-up is cost-effective, especially in men without metastases.","Scand J Urol Nephrol, 34(1): 55-61","Sweden",2000,"Any or unknown","Various","HADS","Patient",null,"Clinical trial","Sweden","Patient","Any or unknown","Various",null,"Clinical trial","HADS","2000:2004","Comorbidity"]
[284,"Henderson, A., et al. (2004). \"Quality of life following treatment for early prostate cancer: does low dose rate (LDR) brachytherapy offer a better outcome? A review.\" Eur Urol 45(2): 134-141.",null,"Henderson, A., et al.","Quality of life following treatment for early prostate cancer: does low dose rate (LDR) brachytherapy offer a better outcome? A review","OBJECTIVE: Due to a lack of evidence from randomised studies, there is little agreement on the best form of treatment among men who require curative treatment for prostate cancer. The relative impact of the various treatments on symptoms and health-related quality of life is also controversial. We review the literature on quality of life changes following low dose rate brachytherapy (BXT) and compare BXT to other treatments for early prostate cancer. METHODS: Systematic literature review 1988-2003 (Medline). KEYWORDS: Brachytherapy; Radical prostatectomy; External beam radiotherapy; Quality of life; Symptoms. RESULTS: Review of the current literature suggests that radical prostatectomy, external beam radiotherapy and BXT either alone or in combination with supplementary external beam radiotherapy offer good long-term health-related quality of life. However differences exist in the toxicity of treatment in terms of erectile function, voiding difficulty, incontinence and bowel function. These differences seem to persist for at least 3-5 years post-treatment though longer-term quality of life outcomes from modern techniques are unknown. CONCLUSION: BXT offers a high probability of maintaining continence, potency and normal rectal function though both storage and voiding urinary symptoms have been reported. Addition of androgen deprivation and EBRT to BXT may increase urinary, bowel and sexual toxicity of treatment. Quality of life outcome following brachytherapy compares favourably with other radical treatment options for the management of early prostate cancer.","Eur Urol, 45(2): 134-141","International",2004,"Local","Surgery,Radiotherapy,Brachytherapy","Unclear","Patient",null,"Systematic review","International","Patient","Local","Surgery,Radiotherapy,Brachytherapy",null,"Systematic review","Unclear","2000:2004","Unclear"]
[285,"Hoffman, R. M., et al. (2004). \"Cross-sectional and longitudinal comparisons of health-related quality of life between patients with prostate carcinoma and matched controls.\" Cancer 101(9): 2011-2019.",null,"Hoffman, R. M., et al.","Cross-sectional and longitudinal comparisons of health-related quality of life between patients with prostate carcinoma and matched controls","BACKGROUND: Prostate carcinoma and treatments affect health-related quality of life (HRQOL). The authors prospectively compared prostate and general HRQOL between prostate carcinoma cases and an age-matched and ethnicity-matched control group. METHODS: The case cohort consisted of 293 men with localized prostate carcinoma who were selected randomly from the population-based New Mexico Tumor Registry, and the control cohort consisted of 618 men who were selected randomly from administrative databases and matched for age and ethnicity. Subjects completed a baseline survey of demographics, socioeconomic status, comorbidity, and prostate and general HRQOL. Also, 210 cases (71.7%) and 421 controls (67.8%) completed a follow-up survey 5 years later. Multinomial logistic regression models compared baseline characteristics as well as 5-year general HRQOL outcomes measured by selected domains of the Medical Outcomes Study SF-36. The authors used a mixed-model repeated-measures analysis of variance and multinomial regression analyses to compare longitudinal changes in urinary, bowel, and sexual function between groups. RESULTS: At baseline, patients with prostate carcinoma had better urinary control and sexual function than controls. Over 5 years, sexual function declined significantly among controls, although urinary function remained stable. However, patients with cancer subsequently reported significant declines in both domains and were left with much worse function and more bother than controls. Bowel function and general HRQOL were similar for both groups at follow-up. CONCLUSIONS: Prostate carcinoma treatment led to significant 5-year declines in urinary and sexual function that far exceeded age-related changes in controls. Patients with cancer had significantly worse function and more bother than controls for these disease-specific domains of HRQOL. Bowel function and general HRQOL were not affected by cancer status.","Cancer, 101(9): 2011-2019","USA",2004,"Local","None","SF-36","Patient",null,"Case-control","USA","Patient","Local","None",null,"Case-control","SF-36","2000:2004","Utility"]
[286,"Holch, P., et al. (2017). \"Acute and Late Adverse Events Associated With Radical Radiation Therapy Prostate Cancer Treatment: A Systematic Review of Clinician and Patient Toxicity Reporting in Randomized Controlled Trials.\" Int J Radiat Oncol Biol Phys 97(3): 495-510.",null,"Holch, P., et al.","Acute and Late Adverse Events Associated With Radical Radiation Therapy Prostate Cancer Treatment: A Systematic Review of Clinician and Patient Toxicity Reporting in Randomized Controlled Trials","PURPOSE: This review aimed to determine the clinician and patient reported outcome (PRO) instruments currently usedin randomized controlled trials (RCTs) of radical radiation therapy for nonmetastatic prostate cancer to report acute and late adverse events (AEs), review the quality of methodology and PRO reporting, and report the prevalence of acute and late AEs. METHODS AND MATERIALS: The MEDLINE, EMBASE, and Cochrane databases were searched between April and August 2014 according to the Preferred Reporting Items for Systematic Review and Meta-analysis (PRISMA) statement. Identified reports were reviewed according to the PRO Consolidated Standards of Reporting Trials (CONSORT) guidelines and the Cochrane Risk of Bias tool. In all, 1149 records were screened, and 21 articles were included in the final review. RESULTS: We determined the acute and late AEs for 9040 patients enrolled in 15 different RCTs. Only clinician reported instruments were used to report acute AEs <3 months (eg, Radiation Therapy Oncology Group [RTOG] and Common Terminology Criteria for Adverse Events [CTCAE]). For late clinician reporting, the Late Effects on Normal Tissues-Subjective, Objective, Management and Analytic scale and RTOG were used and were often augmented with additional items to provide comprehensive coverage of sexual functioning and anorectal symptoms. Some late AEs were reported (48% articles) using PROs (eg, ULCA-PCI [University of California, Los Angeles Prostate Cancer Index], FACT-G and P [Functional Assessment of Cancer Therapy General & Prostate Module], EORTC QLQC-30 + PR25 [European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire & Prostate Module]); however, a definitive \"preferred\" instrument was not evident. DISCUSSION: Our findings are at odds with recent movements toward including patient voices in reporting of AEs and patient engagement in clinical research. We recommend including PRO to evaluate radical radiation therapy before, during, and after the treatment to fully capture patient experiences, and we support the development of predictive models for late effects based on the severity of early toxicity. CONCLUSION: Patient reporting of acute and late AEs is underrepresented in radiation therapy trials. We recommend working toward a consistent approach to PRO assessment of radiation therapy-related AEs.","Int J Radiat Oncol Biol Phys, 97(3): 495-510","International",2017,"Advanced,Local","Radiotherapy","FACT-G,FACT-P,EORTC QLQ-C30,EORTC QLQ-PR25,UCLA-PCI,CTCAE,RTOG-EORTC-SS,LENT-SOMA","Patient",null,"Systematic review","International","Patient","Advanced,Local","Radiotherapy",null,"Systematic review","FACT-G,FACT-P,EORTC QLQ-C30,EORTC QLQ-PR25,UCLA-PCI,CTCAE,RTOG-EORTC-SS,LENT-SOMA","2015:2018","Disease,Treatment,General"]
[287,"Hollenbeck, B. K., et al. (2002). \"Neoadjuvant hormonal therapy and older age are associated with adverse sexual health-related quality-of-life outcome after prostate brachytherapy.\" Urology 59(4): 480-484.",null,"Hollenbeck, B. K., et al.","Neoadjuvant hormonal therapy and older age are associated with adverse sexual health-related quality-of-life outcome after prostate brachytherapy","OBJECTIVES: Brachytherapy is increasingly used as a treatment for localized prostate cancer but information regarding long-term, postimplantation, patient-reported sexual health-related quality-of-life (HRQOL) is scant. Neoadjuvant hormonal therapy is commonly administered with brachytherapy, yet its potentially adverse effects on subsequent sexual health have not been described using a validated HRQOL instrument. We used a validated HRQOL survey to characterize the significance of neoadjuvant hormonal therapy and other baseline factors on postimplantation sexual function and impairment. METHODS: A cross-sectional survey using the expanded prostate cancer index composite HRQOL instrument was administered to all 114 localized prostate cancer patients who underwent ultrasound-guided, transperineal brachytherapy during a 4-year period and to 142 age-matched control men. Multivariable models measured the association of baseline factors and covariates with postimplantation sexual HRQOL. RESULTS: Older age (P = 0.01) and neoadjuvant hormonal therapy (P = 0.009) were independently associated with diminished sexual HRQOL after prostate brachytherapy. Among patients younger than 69 years old, 33% reported at least fair sexual function after brachytherapy alone compared with 19% of men after brachytherapy with neoadjuvant hormonal therapy. Of the age-matched control men younger than 69 years old, 78% reported at least fair sexual function. Among patients older than 69 years, 26% reported at least fair sexual function after brachytherapy alone compared with 5% after brachytherapy with neoadjuvant hormonal therapy, and 61% of age-matched controls reported at least fair sexual function. CONCLUSIONS: Patient age and neoadjuvant hormonal therapy are independent, significant determinants of sexual HRQOL after prostate brachytherapy. These factors should be taken into consideration when counseling patients with localized prostate cancer regarding the expected, postimplantation sexual HRQOL outcome.","Urology, 59(4): 480-484","USA",2002,"Local","Brachytherapy,Hormonal","EPIC","Patient",null,"Case-control","USA","Patient","Local","Brachytherapy,Hormonal",null,"Case-control","EPIC","2000:2004","Disease"]
[288,"Hollenbeck, B. K., et al. (2003). \"Determinants of long-term sexual health outcome after radical prostatectomy measured by a validated instrument.\" J Urol 169(4): 1453-1457.",null,"Hollenbeck, B. K., et al.","Determinants of long-term sexual health outcome after radical prostatectomy measured by a validated instrument","PURPOSE: We combined the strengths of previous patient reported studies (that is use of a validated instrument) with the assets of previous single surgeon, physician reported series (that is prospective collection of operative data) by performing a multiple surgeon study to identify demographic and operative determinants of post-prostatectomy sexual health related quality of life outcomes. MATERIALS AND METHODS: Sexual outcome was measured after prostatectomy in 671 prostate cancer cases with a followup of 4 to 52 months treated by any of 7 urologists at a high volume medical center and 112 age matched controls by cross-sectional health related quality of life assessment using the Expanded Prostate Cancer Index Composite validated questionnaire. Multivariable ANCOVA was done to identify the baseline determinants affecting post-prostatectomy sexual health outcomes among 17 clinical and demographic factors. RESULTS: Factors independently associated with better sexual health outcome in patients included younger age (p <0.0001), nerve sparing technique (p <0.0001), time since prostatectomy (p = 0.0001), smaller prostate size (p = 0.003), higher education level (p = 0.02), and higher household income (p = 0.02). Orgasm was achieved at a higher rate than erection. In controls only age (p = 0.0004) and having a partner (p = 0.04) were significantly associated with sexual health. CONCLUSIONS: Larger prostate size adversely affected sexual health outcome after radical prostatectomy independent of all other measured factors. Patient sexual outcome did not differ significantly among surgeons who performed a broad range of such procedures yearly, suggesting that surgical expertise cannot be measured simply by the number of such operations that a surgeon performs. Stratifying patient reported sexual function by the principal determinants of age, nerve sparing and prostate size provides a basis for counseling patients.","J Urol, 169(4): 1453-1457","USA",2003,"Any or unknown","Surgery","EPIC","Patient",null,"Case-control","USA","Patient","Any or unknown","Surgery",null,"Case-control","EPIC","2000:2004","Disease"]
[289,"Hollenbeck, B. K., et al. (2004). \"Neoadjuvant hormonal therapy impairs sexual outcome among younger men who undergo external beam radiotherapy for localized prostate cancer.\" Urology 63(5): 946-950.",null,"Hollenbeck, B. K., et al.","Neoadjuvant hormonal therapy impairs sexual outcome among younger men who undergo external beam radiotherapy for localized prostate cancer","OBJECTIVES: To evaluate the effects of treatment factors and other covariates on sexual health-related quality of life (HRQOL) after radiotherapy (RT) for prostate cancer. The effects of clinical and treatment factors on sexual health after external beam RT have not been fully characterized by patient-reported, validated questionnaires. METHODS: A total of 259 subjects (147 patients who had undergone RT for prostate cancer and 112 age-matched controls) participated in a cross-sectional assessment of HRQOL using the validated expanded prostate cancer index to measure patient-reported sexual function and bother. Multivariable models were used to determine the association of 13 prospectively measured clinical and treatment factors with post-RT sexual HRQOL. RESULTS: Increasing age, time since RT, and use of neoadjuvant hormonal therapy (NHT) were independently associated with sexual function (P <0.01) after RT. The effects of NHT on sexual HRQOL were most notable among the youngest (younger than 67 years) patients and among those closest to treatment. These effects may be conceptualized by examining the distribution of responses to individual Expanded Prostate Cancer Index Composite questions. For example, among the youngest patients, those treated with NHT were less than half as likely to report a fair ability to have erections compared with hormone-naive men. CONCLUSIONS: These patient-reported data, elicited using a validated HRQOL instrument, indicate that older age and NHT significantly and independently hinder post-RT sexual HRQOL outcome among men with localized prostate cancer and provide a framework for counseling patients regarding long-term sexual outcome on the basis of treatment plan and age.","Urology, 63(5): 946-950","USA",2004,"Local","Hormonal,Radiotherapy","EPIC","Patient",null,"Cross-sectional","USA","Patient","Local","Hormonal,Radiotherapy",null,"Cross-sectional","EPIC","2000:2004","Disease"]
[290,"Holmberg, L., et al. (2012). \"Results from the Scandinavian Prostate Cancer Group Trial Number 4: a randomized controlled trial of radical prostatectomy versus watchful waiting.\" J Natl Cancer Inst Monogr 2012(45): 230-233.",null,"Holmberg, L., et al.","Results from the Scandinavian Prostate Cancer Group Trial Number 4: a randomized controlled trial of radical prostatectomy versus watchful waiting","In the Scandinavian Prostate Cancer Group Trial Number 4 (SPCG-4), 347 men were randomly assigned to radical prostatectomy and 348 to watchful waiting. In the most recent analysis (median follow-up time = 12.8 years), the cumulative mortality curves had been stable over the follow-up. At 15 years, the absolute risk reduction of dying from prostate cancer was 6.1% following randomization to radical prostatectomy, compared with watchful waiting. Hence, 17 need to be randomized to operation to avert one death. Data on self-reported symptoms, stress from symptoms, and quality of life were collected at 4 and 12.2 years of median follow-up. These questionnaire studies show an intricate pattern of symptoms evolving after surgery, hormonal treatments, signs of tumor progression, and also from natural aging. This article discusses some of the main findings of the SPCG-4 study.","J Natl Cancer Inst Monogr, 2012(45): 230-233","UK",2012,"Any or unknown","Surgery,Surveillance","Unclear","Patient",null,"Clinical trial","UK","Patient","Any or unknown","Surgery,Surveillance",null,"Clinical trial","Unclear","2010:2014","General,Symptoms"]
[291,"Homma, Y., et al. (1999). \"Early results of radical prostatectomy and adjuvant endocrine therapy for prostate cancer with or without preoperative androgen deprivation. The Prostate Cancer Study Group.\" Int J Urol 6(5): 229-237; discussion 238-229.",null,"Homma, Y., et al.","Early results of radical prostatectomy and adjuvant endocrine therapy for prostate cancer with or without preoperative androgen deprivation. The Prostate Cancer Study Group","BACKGROUND: The effects of preoperative androgen deprivation were explored in the patients who received radical prostatectomy and subsequent adjuvant endocrine therapy for prostate cancer. METHODS: Stage A2, B or C prostate cancers were randomized to one of two groups: (i) group I (n=90), who received androgen deprivation (leuploride and chlormadinone acetate) for 3 months preoperatively followed by radical prostatectomy and adjuvant endocrine therapy (leuploride only); and (ii) group II (n=86), who underwent the surgery followed by 3 month androgen deprivation and subsequent adjuvant endocrine therapy. The effects of preoperative androgen deprivation on clinical relapse (serum prostate specific antigen (PSA) > 1.98 ng/mL, local recurrence or distant metastasis) and PSA relapse (PSA >0.2ng/mL) were evaluated at 2 years after randomization. RESULTS: There was no significant difference in clinical or PSA relapse-free survival and quality of life measures between the two groups, although relapses occurred significantly more frequently in patients who had more advanced stages, higher pretreatment PSA values or lower histologic differentiation in either group. Subgroup analysis indicated that clinical relapse-free survival in stage C cancer tended to be better in patients with preoperative androgen deprivation than in those patients without it (P< 0.1). CONCLUSIONS: Preoperative androgen deprivation may be beneficial for stage C prostate cancer patients receiving radical prostatectomy and adjuvant endocrine therapy over the 2 year observation period. A longer follow up is needed to clarify the exact extent of benefit in terms of survival and quality of life.","Int J Urol, 6(5): 229-237; discussion 238-229","Japan",1999,"Advanced,Local","Surgery,Hormonal","Unclear","Patient",null,"Clinical trial","Japan","Patient","Advanced,Local","Surgery,Hormonal",null,"Clinical trial","Unclear","1960:1999","General"]
[292,"Hong, J. H., et al. (2006). \"The Functional Assessment of Cancer Therapy-Prostate (FACT-P) scales in men with prostate cancer: reliability and validity of the Korean version.\" J Korean Med Sci 21(2): 295-299.",null,"Hong, J. H., et al.","The Functional Assessment of Cancer Therapy-Prostate (FACT-P) scales in men with prostate cancer: reliability and validity of the Korean version","The Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire is a relevant, worldwide tool used for assessing the health-related quality of life in men with prostate cancer. The purpose of this study was to translate the FACT-P into Korean, to assess its reliability and validity, and to test its discriminative ability between the cancer patients and normal controls. The Korean version was developed via the FACT multilingual translation project. The translated questionnaire was self-administered to 70 prostate cancer patients and 70 age-matched controls. In evaluating its psychometric properties for cancer patients, internal consistency and test-retest reliability were used. Validity was estimated by using inter-subscale correlations and discriminant validity between cancer patients and controls. Cronbach's alpha coefficient for the individual subscales were 0.7 or greater (range 0.73 to 0.89), except for emotional well-being (0.61). The test-retest reliability showed high correlations (intraclass coefficients ranged from 0.72 to 0.93). Inter-subscale correlations demonstrated each subscale was unrelated, but moderate correlation was observed between social/family well-being and functional well-being subscales (r=0.56). The FACT-P scale could discriminate reliably between the cancer patients and controls in most subscales. In conclusion, the Korean version of the FACT-P is a reliable and valid questionnaire in patients with prostate cancer.","J Korean Med Sci, 21(2): 295-299","Korea",2006,"Any or unknown","None","FACT-P","Patient",null,"Validation","Korea","Patient","Any or unknown","None",null,"Validation","FACT-P","2005:2009","Disease"]
[293,"Hong, S. J., et al. (2007). \"A prospective, multicenter, open-label trial of zoledronic acid in patients with hormone refractory prostate cancer.\" Yonsei Med J 48(6): 1001-1008.",null,"Hong, S. J., et al.","A prospective, multicenter, open-label trial of zoledronic acid in patients with hormone refractory prostate cancer","PURPOSE: The short-term safety and efficacy of zoledronic acid for the treatment of skeletal metastasis was evaluated in patients with hormone-refractory prostate cancer. PATIENTS AND METHODS: A total of 19 hormone-refractory prostate cancer patients with bone metastases were enrolled. All patients received up to six infusions of zoledronic acid (4 mg, given intravenously over 15 minutes, every 3-4 weeks). Safety was assessed by monitoring adverse events and serum creatinine levels. Efficacy was assessed by monitoring skeletal-related events, brief pain inventory score, quality of life score, type of pain medication, and analgesic score. Mean age of patients was 67.3 years (46-86 years), mean time from diagnosis of bone metastases was 27.6 months (0-117 months), and mean time from diagnosis of hormone-refractory disease was 7.5 months (0-26 months). RESULTS: There was no clinically significant change in serum creatinine levels. Eleven adverse events (musculoskeletal disorders and systemic disorders) in 8 patients were classed as having a possible relationship to study drug. Fifteen patients completed six courses of zoledronic acid infusion. There were no significant changes in the brief pain inventory composite scores, quality of life questionnaire scores or analgesic score. No new skeletal-related events developed during the treatment period. CONCLUSION: Zoledronic acid administered in this study as a 15-minute infusion demonstrated an acceptable and well-known safety profile in patients with refractory prostate cancer with bone metastases. However, prospective placebo- controlled clinical trials are required to elucidate the efficacy of zoledronic acid.","Yonsei Med J, 48(6): 1001-1008","Korea",2007,"Metastatic","Bisphosphonate","BPI","Patient",null,"Clinical trial","Korea","Patient","Metastatic","Bisphosphonate",null,"Clinical trial","BPI","2005:2009","Symptom"]
[294,"Hooper, G. and E. Gerber (2014). \"Measuring the quality of life in men with prostate cancer.\" Urol Nurs 34(4): 177-184.",null,"Hooper, G. and E. Gerber","Measuring the quality of life in men with prostate cancer","Men diagnosed with prostate cancer (PCa) choose treatments based on known side effects that impact health-related quality of life (HRQL). This study evaluated the psychometric properties of the UCLA Prostate Cancer Index (UCLA-PCI) and the Short Form Health Survey (SF-12v2).","Urol Nurs, 34(4): 177-184","Unclear",2014,"Any or unknown","Unclear","UCLA-PCI,SF-12","Patient",null,"Validation","Unclear","Patient","Any or unknown","Unclear",null,"Validation","UCLA-PCI,SF-12","2010:2014","Disease,Utility"]
[295,"Hoque, D. M., et al. (2017). \"Study protocol of an equivalence randomized controlled trial to evaluate the effectiveness of three different approaches to collecting Patient Reported Outcome Measures (PROMs) data using the Prostate Cancer Outcomes Registry-Victoria (PCOR-VIC).\" BMC Health Serv Res 17(1): 75.",null,"Hoque, D. M., et al.","Study protocol of an equivalence randomized controlled trial to evaluate the effectiveness of three different approaches to collecting Patient Reported Outcome Measures (PROMs) data using the Prostate Cancer Outcomes Registry-Victoria (PCOR-VIC)","BACKGROUND: Patient-reported outcome measures (PROMs) are used by clinical quality registries to assess patients' perspectives of care outcomes and quality of life. PROMs can be assessed through a self-administered survey or by a third party. Use of mixed mode approaches where PROMs are completed using a single or combination of administration method is emerging. The aim of this study is to identify the most cost-effective efficient approach to collecting PROMs among three modes (telephone, postal service/mail and email) in a population-based clinical quality registry monitoring survivorship after a diagnosis of prostate cancer. This is important to assist the registry in achieving representative PROMs capture using the most cost-effective technique and in developing cost projections for national scale-up. METHODS/DESIGN: This study will adopt an equivalence randomised controlled design. Participants are men diagnosed with and/or treated for prostate cancer (PCa) participating in PCOR-VIC and meet the criteria for 12-month follow-up. Participants will be individually randomized to three independent groups: telephone, mail/postal, or email to complete the 26-item Expanded Prostate Cancer Index Composite (EPIC-26) survey. It is estimated each group will have 229 respondents. We will compare the proportion of completed surveys across the three groups. The economic evaluation will be undertaken from the perspective of the data collection centre and consider all operating costs (personnel, supplies, training, operation and maintenance). Cost data will be captured using an Activity Based Costs method. To estimate the most cost-effective approach, we will calculate incremental cost-effectiveness ratios. A cost projection model will be developed based on most cost-effective approach for nationwide scale-up of the PROMs tool for follow-up of PCa patients in Australia. DISCUSSION: This study will identify the most cost-effective approach for collecting PROMs from men with PCa, and enable estimation of costs for national implementation of the PCa PROMs survey. The findings will be of interest to other registries embarking on PROMs data collection. TRIAL REGISTRATION: ACTRN12615001369516 (Registered on December 16, 2015).","BMC Health Serv Res, 17(1): 75","Australia,UK",2017,"Any or unknown","None","EPIC","Patient",null,"Protocol","Australia,UK","Patient","Any or unknown","None",null,"Protocol","EPIC","2015:2018","Disease"]
[296,"Hu, J. C., et al. (2003). \"Regret in men treated for localized prostate cancer.\" J Urol 169(6): 2279-2283.",null,"Hu, J. C., et al.","Regret in men treated for localized prostate cancer","PURPOSE: We identify the predictors of medical regret in men treated for localized prostate cancer. MATERIALS AND METHODS: Patients previously treated for early stage prostate cancer were assessed for treatment regret using validated items. Univariate and multivariate analyses identified associations between regret and demographic characteristics, clinical outcomes, medical knowledge, and general and disease specific health related quality of life as measured by the general health perceptions domain of the RAND 36-Item Health Survey and a validated short form of the University of California, Los Angeles Prostate Cancer Index. RESULTS: Of 96 respondents (mean age 64 years, mean followup 2.8 years) 16% expressed regret with treatment decisions. Regretful men were almost twice as likely as nonregretful men to have less than a college education (60% versus 33%, p = 0.05) and worse current health related quality of life (p <0.05). In addition, regretful men tended to be unable to recall the most recent prostate specific antigen accurately (p = 0.06). Men with and without regret did not differ in other demographic characteristics, treatment choice or clinical outcomes. Regretful men were more likely to say they would choose a different treatment if they could. In multivariate analyses worse quality of life predicted regret but decline in quality of life with time was not associated with regret. CONCLUSIONS: Men expressing regret over treatment choice for localized prostate cancer have poorer health related quality of life. Further study is needed to identify factors that predict posttreatment regret. Such information will allow patients and physicians to individualize treatment decisions, optimize quality of life and avoid medical regret.","J Urol, 169(6): 2279-2283","USA",2003,"Local","Unclear","SF-36,UCLA-PCI","Patient",null,"Cross-sectional","USA","Patient","Local","Unclear",null,"Cross-sectional","SF-36,UCLA-PCI","2000:2004","Disease,Utility"]
[297,"Hu, J. C., et al. (2004). \"Predicting quality of life after radical prostatectomy: results from CaPSURE.\" J Urol 171(2 Pt 1): 703-707; discussion 707-708.",null,"Hu, J. C., et al.","Predicting quality of life after radical prostatectomy: results from CaPSURE","PURPOSE: We investigated the usefulness of patient and tumor characteristics in predicting continence, potency, and physical and mental health 1 year after radical prostatectomy. MATERIALS AND METHODS: We studied 372 men drawn from Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE), a national, longitudinal cohort, who underwent radical prostatectomy alone for localized prostate cancer. Health related quality of life (HRQOL) was assessed before and 12 months after (range 9 to 15) surgery with the Physical and Mental Component Summaries of the RAND 36-Item Health Survey and the Sexual and Urinary Function scales of the UCLA Prostate Cancer Index. Covariates included clinical T stage, prostate specific antigen Gleason sum, age, race, income, education, relationship status, comorbidity and overall health self-rating. Chi-square and backward stepwise multivariate analysis identified differences between men who did and did not return to baseline HRQOL postoperatively. Return to baseline HRQOL score was set at 90% or greater for physical and mental health, 80% for continence and 75% for potency. RESULTS: After 1 year 63%, 20%, 80% and 86% returned to baseline continence, potency, physical health and mental health, respectively. Men younger than 65 years were more likely to return to baseline continence, potency, and physical but not mental health. Univariate analyses also revealed several other characteristics to predict (p <0.05) better outcomes including household income greater than 30,000 US dollars (potency, physical health), fewer comorbidities (potency, physical health), and excellent or very good health self-rating (mental health). In multivariate analyses subjects younger than 65 years were more likely to return to baseline urinary (OR 1.8, p <0.01), sexual (OR 2.5, p <0.01) and physical health (OR 1.8, p = 0.03). Furthermore, subjects with no comorbidities were more likely to return to baseline physical health (OR 2.5, p = 0.01), while those with an excellent or very good baseline health self-rating were more likely to return to baseline mental health (OR 2.3, p = 0.01). Clinical T stage, prostate specific antigen and Gleason sum did not predict return to baseline HRQOL. CONCLUSIONS: Younger patient age (less than 65) is associated with a greater likelihood of returning to baseline continence, potency and physical health after radical prostatectomy. In addition, patients who underwent radical prostatectomy without comorbidities and those with high health self-ratings are more likely to return to baseline physical and mental health, respectively. Preoperative tumor characteristics do not appear to be associated with regaining baseline HRQOL, suggesting that factors not measured in this model may be important in optimizing quality of life after radical prostatectomy.","J Urol, 171(2 Pt 1): 703-707; discussion 707-708","USA",2004,"Local","Surgery","SF-36,UCLA-PCI","Patient",null,"Cohort","USA","Patient","Local","Surgery",null,"Cohort","SF-36,UCLA-PCI","2000:2004","Disease,Utility"]
[298,"Huguenin, P. U., et al. (1999). \"Localized prostate cancer in elderly patients. Outcome after radiation therapy compared to matched younger patients.\" Strahlenther Onkol 175(11): 554-558.",null,"Huguenin, P. U., et al.","Localized prostate cancer in elderly patients. Outcome after radiation therapy compared to matched younger patients","PURPOSE: To detect a difference in outcome (disease-specific survival, local tumor progression, late toxicity, quality of life) after curative radiotherapy for localized prostate cancer in elderly as compared to younger patients. PATIENTS AND METHODS: In a retrospective analysis 59 elderly patients (> 74 years old) were matched 1:2 with younger patients from the data base according to tumor stage, grading, pre-treatment PSA values and year of radiotherapy. Surviving patients were contacted to fill in a validated questionnaire for quality of life measurement (EORTC QLQ-C30). Median follow-up for elderly and younger patients was 5.2 and 4.5 years, respectively. RESULTS: Overall survival at 5 years was 66% for the elderly and 80% for younger patients. Intercurrent deaths were observed more frequently in the elderly population. There was no age-specific difference in disease-specific survival (78% vs 82%), late toxicity or quality of life. Clinically meaningful local tumor progression was observed in 15% and 14%, respectively, corresponding to data from the literature following hormonal ablation. CONCLUSIONS: There is no obvious difference in outcome including disease-specific survival, late toxicity and quality of life in elderly patients, compared to a matched younger population. A clinically meaningful local tumor progression following radiotherapy or hormonal ablation only is rare. Local radiotherapy or, alternatively, hormonal ablation is recommended to preserve local progression-free survival in elderly patients except for very early stage of disease (i.e. T1 G1-2 M0).","Strahlenther Onkol, 175(11): 554-558","Switzerland",1999,"Local","Radiotherapy","EORTC QLQ-C30","Patient",null,"Case-control","Switzerland","Patient","Local","Radiotherapy",null,"Case-control","EORTC QLQ-C30","1960:1999","General"]
[299,"Hummel, S., et al. (2010). \"Intensity-modulated radiotherapy for the treatment of prostate cancer: a systematic review and economic evaluation.\" Health Technol Assess 14(47): 1-108, iii-iv.",null,"Hummel, S., et al.","Intensity-modulated radiotherapy for the treatment of prostate cancer: a systematic review and economic evaluation","BACKGROUND: Prostate cancer (PC) is the most common cancer in men in the UK. Radiotherapy (RT) is a recognised treatment for PC and high-dose conformal radiotherapy (CRT) is the recommended standard of care for localised or locally advanced tumours. Intensity-modulated radiotherapy (IMRT) allows better dose distributions in RT. OBJECTIVE: This report evaluates the clinical effectiveness and cost-effectiveness of IMRT for the radical treatment of PC. DATA SOURCES: The following databases were searched: MEDLINE (1950-present), EMBASE (1980-present), Cumulative Index to Nursing and Allied Health Literature (CINAHL) (1982-present), BIOSIS (1985-present), the Cochrane Database of Systematic Reviews (1991-present), the Cochrane Controlled Trials Register (1991-present), the Science Citation Index (1900-present) and the NHS Centre for Reviews and Dissemination databases (Database of Abstracts of Reviews of Effects, NHS Economic Evaluation Database, Health Technology Assessment) (1991-present). MEDLINE In-Process & Other Non-Indexed Citations was searched to identify any studies not yet indexed on MEDLINE. Current research was identified through searching the UK Clinical Research Network, National Research Register archive, the Current Controlled Trials register and the Medical Research Council Clinical Trials Register. In addition, abstracts of the American Society of Clinical Oncology, the American Society for Therapeutic Radiology and Oncology, and European Society for Therapeutic Radiology and Oncology conferences were browsed. REVIEW METHODS: A systematic literature review of the clinical effectiveness and cost-effectiveness of IMRT in PC was conducted. Comparators were three-dimensional conformal radiotherapy (3DCRT) or radical prostatectomy. Outcomes sought were overall survival, biochemical [prostate-specific antigen (PSA)] relapse-free survival, toxicity and health-related quality of life (HRQoL). Fifteen electronic bibliographic databases were searched in January 2009 and updated in May 2009, and the reference lists of relevant articles were checked. Studies only published in languages other than English were excluded. An economic model was developed to examine the cost-effectiveness of IMRT in comparison to 3DCRT. Four scenarios were modelled based on the studies which reported both PSA survival and late gastrointestinal (GI) toxicity. In two scenarios equal PSA survival was assumed for IMRT and 3DCRT, the other two having greater PSA survival for the IMRT cohort. As there was very limited data on clinical outcomes, the model estimates progression to clinical failure and PC death from the surrogate outcome of PSA failure. RESULTS: No randomised controlled trials (RCTs) of IMRT versus 3DCRT in PC were available, but 13 non-randomised studies comparing IMRT with 3DCRT were found, of which five were available only as abstracts. One abstract reported overall survival. Biochemical relapse-free survival was not affected by treatment group, except where there was a dose difference between groups, in which case higher dose IMRT was favoured over lower dose 3DCRT. Most studies reported an advantage for IMRT in GI toxicity, attributed to increased conformality of treatment compared with 3DCRT, particularly with regard to volume of rectum treated. There was some indication that genitourinary toxicity was worse for patients treated with dose escalated IMRT, although most studies did not find a significant treatment effect. HRQoL improved for both treatment groups following radiotherapy, with any group difference resolved by 6 months after treatment. No comparative studies of IMRT versus prostatectomy were identified. No comparative studies of IMRT in PC patients with bone metastasis were identified. LIMITATIONS: The strength of the conclusions of this review are limited by the lack of RCTs, and any comparative studies for some patient groups. CONCLUSIONS: The comparative data of IMRT versus 3DCRT seem to support the theory that higher doses, up to 81 Gy, can improve biochemical survival for patients with localised PC, concurring with data on CRT. The data also suggest that toxicity can be reduced by increasing conformality of treatment, particularly with regard to GI toxicity, which can be more easily achieved with IMRT than 3DCRT. Whether differences in GI toxicity between IMRT and 3DCRT are sufficient for IMRT to be cost-effective is uncertain, depending on the difference in incidence of GI toxicity, its duration and the cost difference between IMRT and 3DCRT.","Health Technol Assess, 14(47): 1-108, iii-iv","International",2010,"Local","Radiotherapy,Surgery","Unclear","Patient",null,"Systematic review","International","Patient","Local","Radiotherapy,Surgery",null,"Systematic review","Unclear","2010:2014","General"]
[300,"Hunt-Shanks, T. T., et al. (2006). \"Exercise use as complementary therapy among breast and prostate cancer survivors receiving active treatment: examination of exercise intention.\" Integr Cancer Ther 5(2): 109-116.",null,"Hunt-Shanks, T. T., et al.","Exercise use as complementary therapy among breast and prostate cancer survivors receiving active treatment: examination of exercise intention","BACKGROUND: Exercise is associated with an improved quality of life among cancer survivors. Previous research has highlighted the utility of the theory of planned behavior in understanding cancer survivors' intention to exercise. The purpose of this study was to extend the research on the theory of planned behavior in relation to exercise intention in breast cancer survivors and to provide preliminary evidence supporting its application with prostate cancer survivors during treatment. METHODS: Participants consisted of 126 breast and 82 prostate cancer survivors receiving active treatment. Participants completed self-administered, mail-in questionnaires that assessed demographic and medical variables, past exercise, and the theory of planned behavior. RESULTS: For breast cancer survivors, the results revealed that attitudes, subjective norm, and perceived behavioral control explained 66% of the variance in exercise intention with the instrumental component of attitude, subjective norm, and perceived behavioral control making significant unique contributions to intention. For prostate cancer survivors, attitudes, subjective norm, and perceived behavioral control explained 57% of the variance in exercise intention, with subjective norm and perceived behavioral control making significant unique contributions to intention. CONCLUSIONS: The results provide further support that the theory of planned behavior is a useful framework for understanding determinants of exercise intention in breast cancer survivors undergoing active treatment and preliminary support for prostate cancer survivors undergoing active treatment. When designing exercise interventions, differences in breast and prostate cancer survivors' exercise intention merit consideration.","Integr Cancer Ther, 5(2): 109-116","Canada",2006,"Survivors","Various","Unclear","Patient",null,"Clinical trial","Canada","Patient","Survivors","Various",null,"Clinical trial","Unclear","2005:2009","Views"]
[301,"Huri, M., et al. (2015). \"Effects of occupational therapy on quality of life of patients with metastatic prostate cancer. A randomized controlled study.\" Saudi Med J 36(8): 954-961.",null,"Huri, M., et al.","Effects of occupational therapy on quality of life of patients with metastatic prostate cancer. A randomized controlled study","OBJECTIVES: To evaluate the efficiency of occupational therapy relative to a home program in improving quality of life (QoL) among men who were treated for metastatic prostate cancer (MPC). METHODS: Fifty-five men were assigned randomly to either the 12-week cognitive behavioral therapy based occupational therapy (OT-CBSM) intervention (treatment group) or a home program (control group) between March 2012 and August 2014 in the Department of Occupational Therapy, Faculty of Health Sciences, Hacettepe University, Ankara, Turkey. The Canadian Occupational Performance Measure (COPM) was used to measure the occupational performance and identify difficulties in daily living activities. The QoL and symptom status were measured by The European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire C30 and its Prostate Cancer Module. A 12-week OT-CBSM intervention including client-centered training of daily living activities, recreational group activities, and cognitive behavioral stress management intervention were applied. RESULTS: The COPM performance and satisfaction scores, which indicate occupational participation and QoL increased statistically in the treatment group in relation to men who were included in the home-program (p less than or equal to 0.05). CONCLUSION: A 12-week OT-CBSM intervention was effective in improving QoL in men treated for MPC, and these changes were associated significantly with occupational performance.","Saudi Med J, 36(8): 954-961","Turkey",2015,"Metastatic","Psychological","EORTC QLQ-C30,EORTC QLQ-PR25,COPM","Patient",null,"Clinical trial","Turkey","Patient","Metastatic","Psychological",null,"Clinical trial","EORTC QLQ-C30,EORTC QLQ-PR25,COPM","2015:2018","Disease,General,Work"]
[302,"Imbimbo, C., et al. (2011). \"Patients' desire to preserve sexual activity and final decision for a nerve-sparing approach: results from the MIRROR (Multicenter Italian Report on Radical Prostatectomy Outcomes and Research) Study.\" J Sex Med 8(5): 1495-1502.",null,"Imbimbo, C., et al.","Patients' desire to preserve sexual activity and final decision for a nerve-sparing approach: results from the MIRROR (Multicenter Italian Report on Radical Prostatectomy Outcomes and Research) Study","INTRODUCTION: Preservation of sexual function after surgery represents a major issue for patients undergoing radical prostatectomy (RP). AIM: To investigate determinants of patients' desire to preserve sexual activity before RP and surgeons' final decision to perform a nerve-sparing RP (NSRP). METHODS: Overall, 2,408 prostate cancer patients, candidates to RP, from 136 urologic departments across the Italian territory were evaluated in a multicenter prospective observational study. All patients underwent RP, according to single-center indications and procedures. MAIN OUTCOME MEASURES: Age, body mass index, previous benign prostatic hyperplasia history, preoperative tumor characteristics, quality of life through the Short Form Health Survey (SF-12), and the University of California Los Angeles Prostate Cancer Index (UCLA-PCI), erectile function through the International Index of Erectile Function (IIEF-5), desire to preserve sexual activity, NS operative outcomes, and surgical margins status were recorded. RESULTS: Overall, 1,667 were interested to preserve sexual activity. Age, physical component summary of SF12 (PCS-12), sexual function score of UCLA-PCI, and IIEF-5 score were the main determinants of such interest. Only 1,246 patients were suitable for a NSRP according to guidelines. Surgeons performed a non-NSRP (NNSRP) in 1,234 patients, a unilateral NSRP in 318 and a bilateral NSRP in 856. Age, bioptical Gleason score, percentage of positive cores, PCS-12, and patient's desire to preserve sexual activity were the main determinants of final decision for a NSRP. Surgeons performed a NSRP in 424 not suitable and in 121 not interested patients. Positive surgical margins in not suitable patients submitted to NSRP were not higher if compared to that obtained after NNSRP in the same subgroup. Limits include lack of oncological and functional follow-up. CONCLUSIONS: Most patients are interested to preserve sexual activity. Discrepancies exist among patients' preferences, guidelines' indications, and surgeon's final decision.","J Sex Med, 8(5): 1495-1502","Italy",2011,"Any or unknown","Surgery","UCLA-PCI,IIEF-5,SF-12","Patient",null,"Cohort","Italy","Patient","Any or unknown","Surgery",null,"Cohort","UCLA-PCI,IIEF-5,SF-12","2010:2014","Disease,Complication,Utility"]
[303,"Inoue, S., et al. (2009). \"Five-year longitudinal effect of radical perineal prostatectomy on health-related quality of life in Japanese men, using general and disease-specific measures.\" BJU Int 104(8): 1077-1084.",null,"Inoue, S., et al.","Five-year longitudinal effect of radical perineal prostatectomy on health-related quality of life in Japanese men, using general and disease-specific measures","OBJECTIVE: To investigate the longitudinal alteration of health-related quality of life (HRQL) up to 5 years after radical perineal prostatectomy (RPP) among Japanese patients with localized prostate cancer. PATIENTS AND METHODS: In all, 194 patients who had RPP were included in this longitudinal survey. The validated RAND 36-Item Health Survey (SF-36) and the University of California, Los Angeles Prostate Cancer Index (UCLA-PCI) were used to evaluate the HRQL. RESULTS: Among the UCLA-PCI urinary domains, urinary function scores decreased at 3 months after RPP, but they increased 6 months after RPP. Likewise, urinary bother showed a transient decrease at 3 months, but had returned to the baseline level 6 months after RPP. Sexual function (SF) was drastically decreased at 3 months after RPP, but had slightly increased 1 year after RPP. Patients who had a nerve-sparing (NS) RPP showed better SF-related HRQL than those who did not at 6 months after RPP. This favourable alteration involving SF-related HRQL was closely associated with the NS procedure, but not with the patient age. Multivariate analysis showed that later recovery of SF was essentially related to the use of NS RPP, while early recovery of sexual bother was closely related to the patient age. CONCLUSIONS: Our results confirmed the positive effect of RPP on the long-term HRQL in Japanese patients. Although NS surgery conferred the benefit of the recovery of SF, older Japanese patients were not greatly concerned about their decreased SF-related HRQL. The current results provide primary evidence for predicting the alteration of HRQL and understanding the effect of patient age and NS surgery on HRQL after RPP.","BJU Int, 104(8): 1077-1084","Japan",2009,"Local","Surgery","SF-36,UCLA-PCI","Patient",null,"Cohort","Japan","Patient","Local","Surgery",null,"Cohort","SF-36,UCLA-PCI","2005:2009","Utility,Disease"]
[304,"Inoue, T., et al. (2016). \"Effective and Safe Administration of Low-Dose Estramustine Phosphate for Castration-Resistant Prostate Cancer.\" Clin Genitourin Cancer 14(1): e9-e17.",null,"Inoue, T., et al.","Effective and Safe Administration of Low-Dose Estramustine Phosphate for Castration-Resistant Prostate Cancer","Despite the favorable toxicity profile at the standard dose of 560 mg daily, the tolerability and toxicology of estramustine phosphate (EMP) have been a cause for concern at administration. Moreover, we do not know whether a lower dose of 280 mg of EMP daily can be administered with some efficacy and fewer side effects. The results of our phase II study suggest that low-dose EMP is a safe treatment option with the same efficacy in patients with castration-resistant prostate cancer. BACKGROUND: We evaluated the efficacy and safety of low-dose estramustine phosphate (EMP) in Japanese patients with castration-resistant prostate cancer (CRPC). PATIENTS AND METHODS: The present study was a single-arm, nonrandomized prospective study in which all patients received EMP orally twice daily for a total dose of 280 mg/day. A total of 31 patients with CRPC were enrolled from December 2009 to December 2012 at 5 institutions in Japan. The primary endpoint was the prostate-specific antigen (PSA) response, defined as a 50% decline in the serum PSA level, confirmed >/= 3 weeks later. The secondary endpoints included the objective response rate, interval to PSA progression, PSA response duration, progression-free survival, disease-specific survival, overall survival, safety, and quality-of-life assessment using the Functional Assessment of Cancer Therapy-Prostate scores. RESULTS: Ten patients (32%) had a PSA response, and no patient had an objective response. The treatment was well tolerated, and the most frequent toxicities were grade 1 to 2 nausea/vomiting, anorexia, and gynecomastia. The median interval to PSA progression was 140 days (95% confidence interval [CI], 117-260 days). The PSA response duration was 119 days (95% CI, 49-219 days). The median progression-free survival was 213 days (95% CI, 167-422 days). The 3-year disease-specific survival and overall survival rates were 68.6% (median not reached; 95% CI, 33 months to not available) and 59.9% (median 42 months, 95% CI, 28 months to not available), respectively. CONCLUSION: Low-dose EMP seems to be a safe treatment option with some efficacy in patients with CRPC.","Clin Genitourin Cancer, 14(1): e9-e17","Japan",2016,"Any or unknown","Chemotherapy","FACT-P","Patient",null,"Clinical trial","Japan","Patient","Any or unknown","Chemotherapy",null,"Clinical trial","FACT-P","2015:2018","Disease"]
[305,"Irani, J., et al. (2010). \"Efficacy of venlafaxine, medroxyprogesterone acetate, and cyproterone acetate for the treatment of vasomotor hot flushes in men taking gonadotropin-releasing hormone analogues for prostate cancer: a double-blind, randomised trial.\" Lancet Oncol 11(2): 147-154.",null,"Irani, J., et al.","Efficacy of venlafaxine, medroxyprogesterone acetate, and cyproterone acetate for the treatment of vasomotor hot flushes in men taking gonadotropin-releasing hormone analogues for prostate cancer: a double-blind, randomised trial","BACKGROUND: Hot flushes are the most common complaints reported by men undergoing androgen suppression treatment for prostate cancer. We designed a randomised double-blind trial to compare the efficacy of three drugs, each of which has proven effective for preventing hot flushes in previous studies. METHODS: Men with prostate cancer with an indication for androgen suppression were enrolled in the study at 106 urology centres in France between April 14, 2004, and April 20, 2007. All patients were treated for 6 months with leuprorelin (11.25 mg). At month 6, patients who spontaneously asked for treatment, or those who presented with 14 hot flushes or more during the week before the visit, were randomly assigned to either venlafaxine 75 mg daily, medroxyprogesterone acetate 20 mg daily, or cyproterone acetate 100 mg daily. All patients received two indistinguishable pills in the morning and one in the evening from week 1 to week 8, and one indistinguishable pill in the morning from week 9 to week 10, to comply with the double-blind design. Random assignment with a block size of three was done centrally, by fax, and each patient was given a randomisation number. The allocation sequence was stratified by centre. Assessment was done at inclusion, at randomisation, and then at 4 weeks, 8 weeks, and 12 weeks after randomisation. Participants completed a daily hot-flush diary for 1 week, and a quality of life questionnaire before each visit throughout the study. The primary outcome was the change in median daily hot-flush score between randomisation and 1 month. All patients who received at least one study treatment dose were included in the efficacy analysis. This trial is registered with ClinicalTrials.gov, number NCT01011751. FINDINGS: Of the 919 men initially enrolled, 311 were randomly assigned to one of the study treatments at 6 months: 102 to venlafaxine, 101 to cyproterone, and 108 to medroxyprogesterone. 309 patients were included in the efficacy analysis, since two were excluded for protocol deviations (one in the cyproterone and one in the medroxyprogesterone group; both were excluded because they were already undergoing treatment with serotonin reuptake inhibitor antidepressants at randomisation). The change in median daily hot-flush score between randomisation and 1 month was -47.2% (IQR -74.3 to -2.5) in the venlafaxine group, -94.5% (-100.0 to -74.5) in the cyproterone group, and -83.7% (-98.9 to -64.3) in the medroxyprogesterone group. The decrease from baseline was significant for all three groups (p<0.0001). Pairwise comparison of treatment groups adjusted by the Bonferroni method confirmed that the decreases in hot-flush score were significantly larger in the cyproterone and medroxyprogesterone groups than in the venlafaxine group, regardless of the interval considered (p<0.0001 in all cases). There was no significant difference between the cyproterone and medroxyprogesterone groups (p>0.2 in all cases). Serious side-effects occurred in four, seven, and five patients in the venlafaxine, cyproterone, and medroxyprogesterone groups, respectively, of which none, one (dyspnoea), and one (urticaria) were considered related to the drug, respectively. INTERPRETATION: After 6 months of treatment with leuprorelin, venlafaxine, cyproterone, and medroxyprogesterone proved to be effective in reducing hot flushes. However, the hormonal treatments cyproterone and medroxyprogesterone were significantly more effective than venlafaxine. As cyproterone is a recognised treatment in prostate cancer, and its use could interfere with hormonal therapy, medroxyprogesterone could be considered to be the standard treatment for hot flushes in men undergoing androgen suppression for prostate cancer. FUNDING: Takeda Laboratories, Puteaux, France.","Lancet Oncol, 11(2): 147-154","France",2010,"Any or unknown","Hormonal,Various","Diary","Patient",null,"Clinical trial","France","Patient","Any or unknown","Hormonal,Various",null,"Clinical trial","Diary","2010:2014","Symptom,General"]
[306,"Isa, M. R., et al. (2013). \"Impact of applied progressive deep muscle relaxation training on the health related quality of life among prostate cancer patients--a quasi experimental trial.\" Prev Med 57 Suppl: S37-40.",null,"Isa, M. R., et al.","Impact of applied progressive deep muscle relaxation training on the health related quality of life among prostate cancer patients--a quasi experimental trial","PURPOSE: To determine the impact of applied progressive muscle relaxation training on health related quality of life among prostate cancer patients. METHOD: A quasi-experimental study was conducted at the University Malaya Medical Centre (UMMC) and Universiti Kebangsaan Malaysia Medical Centre (UKMMC) over six months. Patients from UMMC received the intervention and patients from UKMMC as a comparison group. The general health related quality of life was measured using Short Form-36 (SF-36). RESULTS: A total of 77 patients from the intervention group and 78 patients from the comparison group participated in the study. At the end of the study, only 90.9% in intervention group and 87.2% in comparison group completed the study. There were significant differences between intervention and comparison groups for mental component summary (MCS) (p=0.032) and overall health related quality of life (p=0.042) scores. However, there was no significant difference between groups for physical component summary (PCS) (p=0.965). CONCLUSION: The improvement in MCS and overall QOL showed the potential of APMRT in the management of prostate cancer patients. Future studies should be carried out over a longer duration to provide stronger evidence for the introduction of relaxation therapy among prostate cancer patients as a coping strategy to improve their QOL.","Prev Med, 57 Suppl(S37-40","Malaysia",2013,"Any or unknown","Various","SF-36","Patient",null,"Clinical trial","Malaysia","Patient","Any or unknown","Various",null,"Clinical trial","SF-36","2010:2014","Utility"]
[307,"Ishihara, M., et al. (2006). \"Baseline health-related quality of life in the management of prostate cancer.\" Int J Urol 13(7): 920-925.",null,"Ishihara, M., et al.","Baseline health-related quality of life in the management of prostate cancer","OBJECTIVE: The purpose of this study was to clarify characteristics of baseline health-related quality of life (HRQOL) during the diagnostic process of prostate cancer. METHODS: A prospective study was conducted to measure HRQOL in a cohort of 141 patients in whom prostate cancer was suspected and prostate biopsy was scheduled, using both generic and disease-specific HRQOL measures (SF-36, UCLA-Prostate Cancer Index) at two points: before prostate biopsy (prediagnosis) and after giving biopsy results (postdiagnosis). Seventy-three patients were diagnosed with prostate cancer and 68 were not. RESULTS: Compared to age-gender adjusted population norms, patients demonstrated better physical function (PF) and worse mental health (MH). Characteristic age-related changes were found in PF and sexual function (SXF); however, disease stage exhibited no relevant effects in HRQOL. No significant difference was detected between pre- and postdiagnosis SF-36 and UCLA-PCI scores. CONCLUSION: The present study discovered no relevant impact of the diagnostic process of prostate cancer on baseline HRQOL using SF-36 and UCLA-PCI. Combined with results of previous studies, it is supportive of regarding pretreatment levels of HRQOL as the baseline.","Int J Urol, 13(7): 920-925","Japan",2006,"At risk","Screening","SF-36,UCLA-PCI","Patient",null,"Cohort","Japan","Patient","At risk","Screening",null,"Cohort","SF-36,UCLA-PCI","2005:2009","Disease,Utility"]
[308,"Ishikawa, H., et al. (2015). \"Carbon-ion Radiotherapy for Prostate Cancer: Analysis of Morbidities and Change in Health-related Quality of Life.\" Anticancer Res 35(10): 5559-5566.",null,"Ishikawa, H., et al.","Carbon-ion Radiotherapy for Prostate Cancer: Analysis of Morbidities and Change in Health-related Quality of Life","AIM: To prospectively evaluate the feasibility of carbon-ion radiotherapy (C-ion RT) for prostate cancer using a new compact-sized accelerator. PATIENTS AND METHODS: Seventy-six patients underwent C-ion RT at our center using a recommended dose fractionation of 57.6 GyE in 16 fractions established at the National Institute of Radiological Sciences. Health-related Quality of Life (HRQOL) assessment was also performed using the Medical Outcome Study 8-items Short Form Health Survey (SF-8) questionnaire. RESULTS: The median follow-up time was 51 months (range=8-58 months). Grade 2 gastrointestinal and genitourinary complications developed in 1 (1.3%) and 5 (6.6%) patients, respectively. Recurrences occurred in 4 patients, and the 4-year biochemical relapse-free rate was 94.6%. The HRQOL scores after C-ion RT were objectively well-maintained. CONCLUSION: Irrespective of the small number of patients of the study, C-ion RT for prostate cancer using the first commercial-based accelerator reproduced the toxicity outcomes at the NIRS.","Anticancer Res, 35(10): 5559-5566","Japan",2015,"Any or unknown","Radiotherapy","SF-8","Patient",null,"Clinical trial","Japan","Patient","Any or unknown","Radiotherapy",null,"Clinical trial","SF-8","2015:2018","Utility"]
[309,"Izard, J., et al. (2014). \"User-centered design of quality of life reports for clinical care of patients with prostate cancer.\" Surgery 155(5): 789-796.",null,"Izard, J., et al.","User-centered design of quality of life reports for clinical care of patients with prostate cancer","BACKGROUND: Primary treatment of localized prostate cancer can result in bothersome urinary, sexual, and bowel symptoms. Yet clinical application of health-related quality-of-life (HRQOL) questionnaires is rare. We employed user-centered design to develop graphic dashboards of questionnaire responses from patients with prostate cancer to facilitate clinical integration of HRQOL measurement. METHODS: We interviewed 50 prostate cancer patients and 50 providers, assessed literacy with validated instruments (Rapid Estimate of Adult Literacy in Medicine short form, Subjective Numeracy Scale, Graphical Literacy Scale), and presented participants with prototype dashboards that display prostate cancer-specific HRQOL with graphic elements derived from patient focus groups. We assessed dashboard comprehension and preferences in table, bar, line, and pictograph formats with patient scores contextualized with HRQOL scores of similar patients serving as a comparison group. RESULTS: Health literacy (mean score, 6.8/7) and numeracy (mean score, 4.5/6) of patient participants was high. Patients favored the bar chart (mean rank, 1.8 [P = .12] vs line graph [P < .01] vs table and pictograph); providers demonstrated similar preference for table, bar, and line formats (ranked first by 30%, 34%, and 34% of providers, respectively). Providers expressed unsolicited concerns over presentation of comparison group scores (n = 19; 38%) and impact on clinic efficiency (n = 16; 32%). CONCLUSION: Based on preferences of prostate cancer patients and providers, we developed the design concept of a dynamic HRQOL dashboard that permits a base patient-centered report in bar chart format that can be toggled to other formats and include error bars that frame comparison group scores. Inclusion of lower literacy patients may yield different preferences.","Surgery, 155(5): 789-796","USA",2014,"Local","None","Unclear","Patient",null,"Validation","USA","Patient","Local","None",null,"Validation","Unclear","2010:2014","Disease"]
[310,"Jacobsen, N. E., et al. (2007). \"Open versus laparoscopic radical prostatectomy: a prospective comparison of postoperative urinary incontinence rates.\" J Urol 177(2): 615-619.",null,"Jacobsen, N. E., et al.","Open versus laparoscopic radical prostatectomy: a prospective comparison of postoperative urinary incontinence rates","PURPOSE: We compared the 12-month postoperative urinary incontinence rates of open radical retropubic and laparoscopic radical prostatectomy. MATERIALS AND METHODS: This prospective study included all men with clinically localized prostate cancer scheduled for radical prostatectomy (open retropubic or laparoscopic) at the University of Alberta between October 1999 and July 2002. Preoperative evaluation included a 24-hour pad test, fluid volume voiding diary and International Prostate Symptom Score questionnaire. Postoperative evaluation included a 24-hour pad test at 3 and 12 months, as well as a voiding diary and International Prostate Symptom Score questionnaire at 3, 6, 9 and 12 months. RESULTS: A total of 239 patients met the eligibility criteria and consented to participate (172 open radical retropubic prostatectomy, 67 laparoscopic radical prostatectomy). Of the patients 87% (148) treated with open radical retropubic prostatectomy and 88% (57) of those treated with laparoscopic radical prostatectomy completed 12-month followup (p = 0.50). According to 24-hour pad testing 13% of those treated with open radical retropubic prostatectomy and 17% of those treated with laparoscopic radical prostatectomy remained incontinent at 1 year (p = 0.26). There was no difference in 24-hour pad weight, urinary symptom score and urinary quality of life at 1 year between the open and laparoscopic groups overall, or when stratified according to 12-month continence status. The majority of subjects in both groups described mild symptoms and a general satisfaction with urinary quality of life. CONCLUSIONS: Based on objective and subjective measures, there were no differences in urinary functional outcomes 1 year after open radical retropubic prostatectomy or laparoscopic radical prostatectomy. Urinary incontinence was found to affect a similar proportion of patients who underwent open (13%) and laparoscopic (17%) radical prostatectomy 12 months postoperatively.","J Urol, 177(2): 615-619","Canada",2007,"Local","Surgery","IPSS","Patient",null,"Cohort","Canada","Patient","Local","Surgery",null,"Cohort","IPSS","2005:2009","Disease"]
[311,"Jain, R., et al. (2012). \"The effect of surgical intervention for stress urinary incontinence (UI) on post-prostatectomy UI during sexual activity.\" BJU Int 109(8): 1208-1212.",null,"Jain, R., et al.","The effect of surgical intervention for stress urinary incontinence (UI) on post-prostatectomy UI during sexual activity","OBJECTIVE: To determine the impact of anti-incontinence surgical procedures (artificial urinary sphincter [AUS] or male sling) on bother due to urinary incontinence (UI) during sexual activity after radical prostatectomy (RP). PATIENTS AND METHODS: Between October 2000 and December 2007, 27 men in a large single-surgeon RP series underwent anti-incontinence surgery with an AUS or male sling. In all, 16 of these 27 men completed a questionnaire retrospectively capturing bother attributable to UI during arousal and orgasm and the impact of the AUS/male sling on UI and sexual quality of life (QoL). RESULTS: In all, 15 men were evaluable. Of these, 11 were sexually active; four and seven men underwent AUS and sling placement, respectively. All 11 men had a marked improvement in stress UI symptoms, which was the primary indication for surgery. All men undergoing AUS had an improvement in their sexual QoL, and most (three of four men) indicated marked improvement. Slightly more than half of men undergoing the sling procedure reported marked improvement in sexual QoL. CONCLUSIONS: Our study shows a beneficial effect of anti-incontinence surgery on UI during sexual activity. Whether these surgical approaches would benefit men with significant bother due to UI limited to sexual activity warrants further investigation.","BJU Int, 109(8): 1208-1212","USA",2012,"Any or unknown","Surgery","Unclear","Patient",null,"Cohort","USA","Patient","Any or unknown","Surgery",null,"Cohort","Unclear","2010:2014","Complication"]
[312,"Jakobsson, L. (2002). \"Indwelling catheter treatment and health-related quality of life in men with prostate cancer in comparison with men with benign prostatic hyperplasia.\" Scand J Caring Sci 16(3): 264-271.",null,"Jakobsson, L.","Indwelling catheter treatment and health-related quality of life in men with prostate cancer in comparison with men with benign prostatic hyperplasia","Experiences from indwelling urinary catheter treatment periods were studied. Little is known of what is felt from a male perspective although catheter treatment is a common pre- and postoperative measure for men with prostate cancer and benign prostatic hyperplasia (BPH). Also studied were health-related quality of life (HRQOL) and sense of coherence (SOC). Men with catheter experience (prostate cancer n = 71, BPH n = 37) were selected from a larger questionnaire study. Assessment was made with study-specific questions together with the QLQ C-30 assessing HRQOL and the SOC questionnaire measuring sense of coherence. Data reduction method was applied to study specific variables to determine problem patterns. Correlation between HRQOL and SOC was determined. Results showed similar problem patterns in men with prostate cancer and BPH: discomfort in wearing catheter (e.g. uneasiness 48.2%), practical and psychosocial difficulties in handling and wearing catheter (e.g. attaching catheter 32.4%) and discomfort at installation (e.g. pain 29.7%). There was lack of knowledge about wearing and practical handling of the catheter. Having a cancer diagnosis did not add to uneasiness or practical problems. Life quality was correlated to SOC (p <or= 0.001).","Scand J Caring Sci, 16(3): 264-271","Sweden",2002,"Any or unknown","Various","EORTC QLQ-C30,SOC","Patient",null,"Validation","Sweden","Patient","Any or unknown","Various",null,"Validation","EORTC QLQ-C30,SOC","2000:2004","General"]
[313,"Jakobsson, L., et al. (1997). \"Experiences of daily life and life quality in men with prostate cancer. An explorative study. Part I.\" Eur J Cancer Care (Engl) 6(2): 108-116.",null,"Jakobsson, L., et al.","Experiences of daily life and life quality in men with prostate cancer. An explorative study. Part I","Eleven men with prostate cancer were randomly chosen and interviewed during an in-patient period at a southern Swedish hospital. The interview focused on functional health status in relation to daily life and life quality. In addition the sense of coherence scale was used, as well as the European Organization or Research and Treatment of Cancer (EORTC) QLQ C-30 questionnaire. The interview findings were analysed from a phenomenological-hermeneutic perspective and interpreted within the concept of transition. The entry to transition was marked by the men when experiencing an altered life continuum in terms of physical and existential fatigue, pain, micturition problems and an altered sex life. The passage phase was marked by descriptions of a new lifestyle where hope was a central internal resource, creating a positive illusion of life in order to endure. Their external resources were wives and family who supported physically (household matters, gardening) and psycho-logically (comfort, encouragement). The exit phase meant continuously adapting to a new life style, living with a slowly deteriorating functional health status, a new sense of dependency on others, daily life routine broken by in-patient hospital periods and contacts with primary health care. Thus the findings pointed more at continuously facing new passages than a stable exit, i.e. an ongoing transition. The areas of life imbalance described may serve as a basis for care assessment and intervention as well as supplying support of the transitional process.","Eur J Cancer Care (Engl), 6(2): 108-116","Sweden",1997,"Any or unknown","None","EORTC QLQ-C30,SOC","Patient",null,"Cross-sectional","Sweden","Patient","Any or unknown","None",null,"Cross-sectional","EORTC QLQ-C30,SOC","1960:1999","General"]
[314,"Janda, M., et al. (2000). \"Quality of life changes during conformal radiation therapy for prostate carcinoma.\" Cancer 89(6): 1322-1328.",null,"Janda, M., et al.","Quality of life changes during conformal radiation therapy for prostate carcinoma","BACKGROUND: The objective of this study was to describe prospectively quality of life (QOL) before and after radiotherapy for patients with prostate carcinoma. METHODS: Forty-three patients with T1-T3 prostate carcinoma who underwent conformal external beam radiation therapy were randomized either to the complete European Organization for Research and Treatment of Cancer (EORTC) QOL questionnaire (EORTC QLQ-C30) or the Medical Outcomes Study Group Short Form Health Survey (SF-36) at baseline, at 3 weeks and 6 weeks after initial treatment, and at 6 weeks and 5 months after the completion of radiotherapy. The measures were self-reported patient QOL, and values are given as the mean +/- standard error of the mean. Changes in QOL are described from baseline to the end of treatment in both questionnaire groups. RESULTS: Emotional role functioning, as measured with the SF-36 questionnaire, significantly improved from 68.2 +/- 9.9 at baseline to 93.3 +/- 5.2 at the end of therapy (P = 0.02). The EORTC QLQ-C30 questionnaire revealed consistent values of emotional functioning during treatment (72.7 +/- 5.9 at baseline) but showed a significant improvement 6 weeks after therapy (89.0 +/- 4.4; P = 0.01). Role functioning deteriorated from 80.1 +/- 6.5 at baseline to 62.5 +/- 8.8 at the end of radiotherapy (P = 0.02). Symptoms of fatigue were shown to increase significantly from 26.9 +/- 6.0 at baseline to 37.7 +/- 7.6 at the end of therapy (P = 0.02). No significant changes in the other dimensions were observed in either questionnaire. CONCLUSIONS: After radiotherapy for prostate carcinoma, patients experience a temporary deterioration of fatigue and role functioning, as measured with the EORTC QLQ-C-30. Despite physical deterioration, the authors observed an improvement in emotional functioning scores with both questionnaires. This may have been due to psychological adaptation and coping.","Cancer, 89(6): 1322-1328","Austria",2000,"Local,Advanced","Radiotherapy","EORTC QLQ-C30,SF-36","Patient",null,"Cohort","Austria","Patient","Local,Advanced","Radiotherapy",null,"Cohort","EORTC QLQ-C30,SF-36","2000:2004","General,Utility"]
[315,"Jayadevappa, R., et al. (2006). \"Health-related quality of life and satisfaction with care among older men treated for prostate cancer with either radical prostatectomy or external beam radiation therapy.\" BJU Int 97(5): 955-962.",null,"Jayadevappa, R., et al.","Health-related quality of life and satisfaction with care among older men treated for prostate cancer with either radical prostatectomy or external beam radiation therapy","OBJECTIVE: To analyse health-related quality of life (HRQoL) and satisfaction with care across potential curative treatments for older patients newly diagnosed with prostate cancer. PATIENTS AND METHODS: In a prospective cohort study we recruited 115 older patients (> or =65 years) newly diagnosed with prostate cancer from the urology clinics of an urban academic and a Veterans' Administration (VA) hospital. Patients completed generic (Short Form-36), prostate-specific (University of California Los Angeles Prostate Cancer Index) HRQoL, and Client Satisfaction with Care (CSQ-8) surveys before treatment with either radical prostatectomy (RP) or external beam irradiation (EBRT) and at 3, 6 and 12 months afterward. Clinical and demographic data were obtained via medical chart review. A repeated-measures analysis of variance was used to examine changes in generic and prostate cancer-specific HRQoL between treatments. Log-linear regression was used to analyse the factors associated with 12-month HRQoL scores, and Kaplan-Meier survival curves were used to compare the return to baseline values for HRQoL. RESULTS: The RP group had significantly higher income, education and better general health than the EBRT group. Age (odds ratio 0.5, 95% confidence interval 0.32-0.82), non-VA hospital (28.8, 2-402) and prostate-specific antigen level at diagnosis (2.8, 1.05-7.5) were associated with RP. The analysis results indicated that the RP group had higher scores for generic HRQoL subscales of physical function (P = 0.019), role emotional (P = 0.037), vitality (P = 0.033) and general health (P = 0.05) than the EBRT group. A log-linear regression model for predicting the 12-month scores showed that RP was associated with higher scores for most of the generic HRQoL and bowel function (odds ratio 1.12, P = 0.03), urinary bother (1.6, P = 0.014) and bowel bother (1.5, P = 0.013). Being older was associated with a lower score on bowel function (0.98, P = 0.05) and sexual function (0.92, P = 0.05). Satisfaction with care was comparable between treatment groups at baseline and at the follow-up. CONCLUSIONS: Older patients tolerate RP well from the HRQoL perspective and thus decisions for therapy in this age cohort should not be based primarily on age.","BJU Int, 97(5): 955-962","USA",2006,"Any or unknown","Surgery,Radiotherapy","SF-36,UCLA-PCI,CSQ-8","Patient",null,"Cohort","USA","Patient","Any or unknown","Surgery,Radiotherapy",null,"Cohort","SF-36,UCLA-PCI,CSQ-8","2005:2009","Disease,Utility,Satisfaction"]
[316,"Jayadevappa, R., et al. (2007). \"Ethnic variation in return to baseline values of patient-reported outcomes in older prostate cancer patients.\" Cancer 109(11): 2229-2238.",null,"Jayadevappa, R., et al.","Ethnic variation in return to baseline values of patient-reported outcomes in older prostate cancer patients","BACKGROUND: Ethnic variation in patient-reported outcomes such as health-related quality of life (HRQoL) and satisfaction with care are understudied areas in the management of elderly prostate cancer (PCa) patients. METHODS: In this prospective cohort study, between the years 2002 and 2004, the authors recruited 214 older (>or=65 years) men with newly diagnosed PCa from an urban academic hospital and a Veterans Administration hospital. Participants completed generic (SF-36), prostate-specific (UCLA-PCI) HRQoL, and satisfaction with care (CSQ-8) surveys at baseline and at 3, 6, and 12-months follow-up. Clinically significant difference was used to compute return to baseline. The authors compared time to return to baseline HRQoL after controlling for confounding variables by using ANOVA and log-linear models. Survival curves were used to compare time to return to baseline across ethnicity. RESULTS: Regression analysis revealed that age and marital status, not ethnicity, were independent predictors of radical prostatectomy, rather than radiation treatment. African Americans reported lower HRQoL scores at diagnosis and required a longer time to return to baseline. Log-linear analysis indicated that African-American ethnicity was associated with lower 12-month scores for role physical (odds ratio [OR], 0.46; standard error [SE], 0.40), role emotional (OR, 0.37; SE, 0.43), bodily pain (OR, 0.74; SE, 0.10), urinary function (OR, 0.90; SE, 0.11), and urinary bother (OR, 0.72; SE, 0.17). Both groups reported comparably high levels of satisfaction with care. CONCLUSIONS: African-American elderly exhibited poorer outcomes and required a longer time to return to baseline HRQoL. These differences highlight the need for discussion with patients and families prior to treatment about expectations and the need for support services post-treatment.","Cancer, 109(11): 2229-2238","USA",2007,"Any or unknown","Surgery,Radiotherapy","SF-36,UCLA-PCI,CSQ-8","Patient",null,"Cohort","USA","Patient","Any or unknown","Surgery,Radiotherapy",null,"Cohort","SF-36,UCLA-PCI,CSQ-8","2005:2009","Disease,Utility,Treatment"]
[317,"Jayadevappa, R., et al. (2009). \"Predictors of patient reported outcomes and cost of care in younger men with newly diagnosed prostate cancer.\" Prostate 69(10): 1067-1076.",null,"Jayadevappa, R., et al.","Predictors of patient reported outcomes and cost of care in younger men with newly diagnosed prostate cancer","BACKGROUND: The proportion of younger men (<65 years) diagnosed with prostate cancer (PCa) has increased significantly. We sought to analyze the association between race/ethnicity, biochemical recurrence risk and outcomes in younger men with PCa. METHODS: In this prospective cohort study, we recruited 318 younger men with newly diagnosed PCa. Participants completed generic and prostate-specific Health Related Quality of Life (HRQoL), out-of-pocket cost and satisfaction with care surveys at baseline and at 3, 6, 12, and 24 months of follow-up. Health resource utilization and cost data were obtained from the hospital based administrative databases. We compared time to return to baseline (RTB) of HRQoL scores across groups. Survival curves were used to compare mean time to RTB across groups. Linear mixed effects (LMEs) and generalized linear (GLM) models were used to analyze the association of race/ethnicity and biochemical recurrence groups with outcomes. RESULTS: African Americans reported lower generic and prostate-specific HRQoL scores at diagnosis and required more time to RTB values for generic HRQoL. The results of LME models showed that low risk of biochemical recurrence was associated with better physical function, vitality, mental health, and general health. For prostate-specific HRQoL items, low risk of biochemical recurrence was associated with impaired urinary function and better bowel function and bowel bother. GLM model showed that treatment, hospital type and comorbidity were associated with cost. CONCLUSIONS: Biochemical recurrence risk and treatment groups, not ethnicity, were associated poorer post-treatment outcomes. This information is important in planning for and communicating with patients about post-treatment care.","Prostate, 69(10): 1067-1076","USA",2009,"Any or unknown","Unclear","Unclear","Patient",null,"Cohort","USA","Patient","Any or unknown","Unclear",null,"Cohort","Unclear","2005:2009","General,Costs,Satisfaction"]
[318,"Jayadevappa, R., et al. (2012). \"Comparison of distribution- and anchor-based approaches to infer changes in health-related quality of life of prostate cancer survivors.\" Health Serv Res 47(5): 1902-1925.",null,"Jayadevappa, R., et al.","Comparison of distribution- and anchor-based approaches to infer changes in health-related quality of life of prostate cancer survivors","OBJECTIVE: To determine the minimal important difference (MID) in generic and prostate-specific health-related quality of life (HRQoL) using distribution- and anchor-based methods. STUDY DESIGN AND SETTING: Prospective cohort study of 602 newly diagnosed prostate cancer patients recruited from an urban academic hospital and a Veterans Administration hospital. Participants completed generic (SF-36) and prostate-specific HRQoL surveys at baseline and at 3, 6, 12, and 24 months posttreatment. Anchor-based and distribution-based methods were used to develop MID estimates. We compared the proportion of participants returning to baseline based on MID estimates from the two methods. RESULTS: MID estimates derived from combining distribution- and anchor-based methods for the SF-36 subscales are physical function = 7, role physical = 14, role emotional = 12, vitality = 9, mental health = 6, social function = 9, bodily pain = 9, and general health = 8; and for the prostate-specific scales are urinary function = 8, bowel function = 7, sexual function = 8, urinary bother = 9, bowel bother = 8, and sexual bother = 11. Proportions of participants returning to baseline values corresponding to MID estimates from the two methods were comparable. CONCLUSIONS: This is the first study to assess the MID for generic and prostate-specific HRQoL using anchor-based and distribution-based methods. Although variation exists in the MID estimates derived from these two methods, the recovery patterns corresponding to these estimates were comparable.","Health Serv Res, 47(5): 1902-1925","USA",2012,"Any or unknown","Unclear","SF-36","Patient",null,"Validation","USA","Patient","Any or unknown","Unclear",null,"Validation","SF-36","2010:2014","Utility,Disease"]
[319,"Jayadevappa, R., et al. (2015). \"Treatment preference and patient centered prostate cancer care: Design and rationale.\" Contemp Clin Trials 45(Pt B): 296-301.",null,"Jayadevappa, R., et al.","Treatment preference and patient centered prostate cancer care: Design and rationale","Prostate cancer is a slow progressing cancer that affects millions of men in the US. Due to uncertainties in outcomes and treatment complications, it is important that patients engage in informed decision making to choose the \"optimal treatment\". Patient centered care that encompasses informed decision-making can improve treatment choice and quality of care. Thus, assessing patient treatment preferences is critical for developing an effective decision support system. The objective of this patient-centered randomized clinical trial was to study the comparative effectiveness of a conjoint analysis intervention compared to usual care in improving subjective and objective outcomes in prostate cancer patients. We identified preferred attributes of alternative prostate cancer treatments that will aid in evaluating attributes of treatment options. In this two-phase study, in Phase 1 we used mixed methods to develop an adaptive conjoint task instrument. The conjoint task required the patients to trade-off attributes associated with treatments by assessing their relative importance. Phase 2 consisted of a randomized controlled trial of men with localized prostate cancer. We analyzed the effect of conjoint task intervention on the association between preferences, treatment and objective and subjective outcomes. Our conjoint task instrument can lead to a values-based patient-centered decision aid tool and help tailor treatment decision making to the values of prostate cancer patients. This will ultimately improve clinical decision making, clinical policy process, enhance patient centered care and improve prostate cancer outcomes.","Contemp Clin Trials, 45(Pt B): 296-301","USA",2015,"Any or unknown","Unclear","TTO","Patient",null,"Validation,Clinical trial","USA","Patient","Any or unknown","Unclear",null,"Validation,Clinical trial","TTO","2015:2018","Utility"]
[320,"Jayadevappa, R., et al. (2017). \"Minimal important difference to infer changes in health-related quality of life-a systematic review.\" J Clin Epidemiol 89: 188-198.",null,"Jayadevappa, R., et al.","Minimal important difference to infer changes in health-related quality of life-a systematic review","OBJECTIVES: The objective of the study was to assess the usability of minimal important difference (MID) and minimal clinically important difference (MCID) for measuring meaningful changes in disease-specific and generic health-related quality-of-life (HRQoL) outcomes in patient-centered care. STUDY DESIGN AND SETTING: We adopted a two-step literature review process. First, we used PubMed and Google scholar to identify a broad range of search terms. Next, we searched OVID Medline, JSTOR, and PubMed for terms \"MID,\" and \"MCID.\" We excluded non-English language studies, articles older than 1995, those not related to generic- and disease-specific HRQoL measures, and protocols of future studies. Studies were grouped according to generic- and disease-specific measures. We assessed MID or MCID calculation methods, effect sizes, estimated values, and significance. RESULTS: Eighty articles satisfied the inclusion criteria. Our synthesis provides a comprehensive assessment of MID or MCID for 10 generic-specific and 80 disease-specific instruments. We observed a lack of consistency in the application of methods for computing MID or MCID for generic and disease-specific HRQoL measures. Only 43 (54%) studies used both anchor and distribution methods to elicit MID or MCID. Thirty-four articles estimated MID values only, whereas 47 articles estimated MCID. CONCLUSION: The anchor-based method yields conservative estimates of MID or MCID, compared to the distribution-based method. The distribution method does not take into account patient perspectives and should be accompanied by anchor method while computing MID. The MID should be interpreted with caution, and available estimates for a particular instrument must be used. This will help in integrating the MID estimates into the overall research or clinical plan for a specific context.","J Clin Epidemiol, 89(188-198","USA",2017,"Any or unknown","None","Unclear","Patient",null,"Systematic review,Validation","USA","Patient","Any or unknown","None",null,"Systematic review,Validation","Unclear","2015:2018","Disease,General"]
[321,"Jenkins, R., et al. (2004). \"Sexuality and health-related quality of life after prostate cancer in African-American and white men treated for localized disease.\" J Sex Marital Ther 30(2): 79-93.",null,"Jenkins, R., et al.","Sexuality and health-related quality of life after prostate cancer in African-American and white men treated for localized disease","The purpose of this study was to examine differences in sexual attitudes and quality of life of White and African-American men who have undergone radical prostatectomy or radiation therapy for localized prostate cancer. Respondents included 1,112 White and 118 African-American men. Response rates differed by race, with 51% of White men and 28% of African-American men returning the questionnaire assessing demographics, medical history, sexual functioning, attitudes about seeking help for sexual problems, sexual self-schema, and health-related quality of life. African Americans were more likely than Whites to have undergone radiation therapy (p <.0001) and were more likely to indicate that a desire to maintain sexual functioning influenced their treatment choice (p <.0001). African-American men also had more positive attitudes than did White men toward seeking help for sexual problems and were more likely to report seeking past help and intending to seek future help. African-American men reported more problems with sexual desire (p =.0003), although their sexual function scores did not differ significantly from those of Whites. African-American men may be more at risk for distress when prostate cancer treatment causes sexual dysfunction.","J Sex Marital Ther, 30(2): 79-93","USA",2004,"Local","Surgery,Radiotherapy","Unclear","Patient",null,"Cross-sectional","USA","Patient","Local","Surgery,Radiotherapy",null,"Cross-sectional","Unclear","2000:2004","General,Complicaiton,Views"]
[322,"Jensen, R. E., et al. (2015). \"Validation of the PROMIS physical function measures in a diverse US population-based cohort of cancer patients.\" Qual Life Res 24(10): 2333-2344.",null,"Jensen, R. E., et al.","Validation of the PROMIS physical function measures in a diverse US population-based cohort of cancer patients","PURPOSE: To evaluate the validity of the Patient-Reported Outcomes Measurement Information System (PROMIS) physical function measures in a diverse, population-based cancer sample. METHODS: Cancer patients 6-13 months post-diagnosis (n = 4840) were recruited for the Measuring Your Health study. Participants were diagnosed between 2010 and 2013 with non-Hodgkin lymphoma or cancers of the colorectum, lung, breast, uterus, cervix, or prostate. Four PROMIS physical function short forms (4a, 6b, 10a, and 16) were evaluated for validity and reliability across age and race-ethnicity groups. Covariates included gender, marital status, education level, cancer site and stage, comorbidities, and functional status. RESULTS: PROMIS physical function short forms showed high internal consistency (Cronbach's alpha = 0.92-0.96), convergent validity (fatigue, pain interference, FACT physical well-being all r >/= 0.68), and discriminant validity (unrelated domains all r </= 0.3) across survey short forms, age, and race-ethnicity. Known-group differences by demographic, clinical, and functional characteristics performed as hypothesized. Ceiling effects for higher-functioning individuals were identified on most forms. CONCLUSIONS: This study provides strong evidence that PROMIS physical function measures are valid and reliable in multiple race-ethnicity and age groups. Researchers selecting specific PROMIS short forms should consider the degree of functional disability in their patient population to ensure that length and content are tailored to limit response burden.","Qual Life Res, 24(10): 2333-2344","USA",2015,"Any or unknown","None","PROMIS","Patient",null,"Validation","USA","Patient","Any or unknown","None",null,"Validation","PROMIS","2015:2018","General,Treatment"]
[323,"Jo, Y., et al. (2005). \"Radical prostatectomy versus high-dose rate brachytherapy for prostate cancer: effects on health-related quality of life.\" BJU Int 96(1): 43-47.",null,"Jo, Y., et al.","Radical prostatectomy versus high-dose rate brachytherapy for prostate cancer: effects on health-related quality of life","OBJECTIVE: To examine the effects of different treatments on the health-related quality of life (HRQoL) of men with localized prostate cancer. PATIENTS AND METHODS: Between October 1997 and August 2002, 182 men diagnosed with prostate cancer (T1c to T3bN0M0) had radical prostatectomy (RP, 89) or (192)iridium high-dose rate brachytherapy (HDR-BT, 93) with external beam radiotherapy, and were followed for > or = 6 months. A postal survey was sent in which HRQoL was assessed using the 36-item Short-Form Health Survey (SF-36) QoL questionnaire, and disease-specific QoL using the University of California Los Angeles Prostate Cancer Index (UCLA-PCI). RESULTS: Questionnaire responses were obtained from 151 of 182 patients; there was no significant difference in SF-36 scale scores between men treated with RP or HDR-BT. In the UCLA-PCI, the HDR-BT group had better urinary function (P < 0.001) and sexual function scores (P= 0.043). Men treated with RP had better bowel bother scores (P = 0.027). In patients with > or = 2 years of follow-up, urinary function (P < 0.001) and sexual bother (P = 0.029) were better for men treated with HDR-BT than for men treated with RP. Men treated with HDR-BT had significantly better urinary function (P = 0.009) and sexual bother (P = 0.013) even than 30 men treated with unilateral nerve-sparing RP. CONCLUSIONS: In terms of HRQoL, RP and HDR-BT did not differ, but HDR-BT resulted in better urinary and sexual function than RP. When planning treatment, QoL concerns, including mental health issues associated with prostate cancer, need to be addressed with the patients, as do the potential side-effects.","BJU Int, 96(1): 43-47","Japan",2005,"Local","Surgery,Brachytherapy","SF-36,UCLA-PCI","Patient",null,"Cross-sectional","Japan","Patient","Local","Surgery,Brachytherapy",null,"Cross-sectional","SF-36,UCLA-PCI","2005:2009","Disease,Utility"]
[324,"Johansson, E., et al. (2009). \"Time, symptom burden, androgen deprivation, and self-assessed quality of life after radical prostatectomy or watchful waiting: the Randomized Scandinavian Prostate Cancer Group Study Number 4 (SPCG-4) clinical trial.\" Eur Urol 55(2): 422-430.",null,"Johansson, E., et al.","Time, symptom burden, androgen deprivation, and self-assessed quality of life after radical prostatectomy or watchful waiting: the Randomized Scandinavian Prostate Cancer Group Study Number 4 (SPCG-4) clinical trial","BACKGROUND: Quality-of-life outcomes are important in the choice of treatment strategy for men with localized prostate cancer. OBJECTIVE: To evaluate how follow-up time, number of physical symptoms, and presence of androgen deprivation affected quality of life among men randomized to radical prostatectomy or watchful waiting. DESIGN, SETTING, AND PARTICIPANTS: The study group was composed of all 376 living men included in the Swedish part of the Scandinavian Prostate Cancer Group Study Number 4 (SPCG-4) between January 1, 1989, and February 29, 1996. Quality-of-life data were collected after a mean follow-up time of 4.1 yr. INTERVENTION: All patients were randomly assigned to radical prostatectomy or watchful waiting. Forty-five men were androgen deprived. MEASUREMENTS: Data of specific symptoms, symptom-induced stress, sense of well-being, and self-assessed quality of life were obtained by means of a questionnaire. Psychological symptoms were assessed using seven-point visual digital scales. RESULTS AND LIMITATIONS: In analyses stratified on the basis of the numbers of physical symptoms, anxiety and depressed mood were less common, and sense of well-being and self-assessed quality of life were better throughout in the radical prostatectomy group than in the watchful waiting group. As the number of physical symptoms increased, all psychological variables became worse and more prominent in the watchful waiting group. After a follow-up time of 6-8 yr, a significant decrease in quality of life (p=0.03) was seen in the watchful waiting group. Twenty-four percent of androgen-deprived patients assigned to watchful waiting reported high self-assessed quality of life compared with 60% in the radical prostatectomy group. Eighty-eight percent of patients had clinically detected tumors. CONCLUSIONS: Androgen deprivation negatively affected self-assessed quality of life in men assigned to watchful waiting. The number of physical symptoms was associated with the level of quality of life. Quality of life was lower with longer follow-up time in both groups and was statistically significant in the watchful waiting group (p=0.03).","Eur Urol, 55(2): 422-430","Sweden",2009,"Local","Surgery,Surveillance","VAS","Patient",null,"Clinical trial","Sweden","Patient","Local","Surgery,Surveillance",null,"Clinical trial","VAS","2005:2009","Symptom"]
[325,"Johansson, E., et al. (2011). \"Long-term quality-of-life outcomes after radical prostatectomy or watchful waiting: the Scandinavian Prostate Cancer Group-4 randomised trial.\" Lancet Oncol 12(9): 891-899.",null,"Johansson, E., et al.","Long-term quality-of-life outcomes after radical prostatectomy or watchful waiting: the Scandinavian Prostate Cancer Group-4 randomised trial","BACKGROUND: For men with localised prostate cancer, surgery provides a survival benefit compared with watchful waiting. Treatments are associated with morbidity. Results for functional outcome and quality of life are rarely reported beyond 10 years and are lacking from randomised settings. We report results for quality of life for men in the Scandinavian Prostate Cancer Group Study Number 4 (SPCG-4) after a median follow-up of more than 12 years. METHODS: All living Swedish and Finnish men (400 of 695) randomly assigned to radical prostatectomy or watchful waiting in SPCG-4 from 1989 to 1999 were included in our analysis. An additional 281 men were included in a population-based control group matched for region and age. Physical symptoms, symptom-induced stress, and self-assessed quality of life were evaluated with a study-specific questionnaire. Longitudinal data were available for 166 Swedish men who had answered quality-of-life questionnaires at an earlier timepoint. FINDINGS: 182 (88%) of 208 men in the radical prostatectomy group, 167 (87%) of 192 men in the watchful-waiting group, and 214 (76%) of 281 men in the population-based control group answered the questionnaire. Men in SPCG-4 had a median follow-up of 12.2 years (range 7-17) and a median age of 77.0 years (range 61-88). High self-assessed quality of life was reported by 62 (35%) of 179 men allocated radical prostatectomy, 55 (34%) of 160 men assigned to watchful waiting, and 93 (45%) of 208 men in the control group. Anxiety was higher in the SPCG-4 groups (77 [43%] of 178 and 69 [43%] of 161 men) than in the control group (68 [33%] of 208 men; relative risk 1.42, 95% CI 1.07-1.88). Prevalence of erectile dysfunction was 84% (146 of 173 men) in the radical prostatectomy group, 80% (122 of 153) in the watchful-waiting group, and 46% (95 of 208) in the control group and prevalence of urinary leakage was 41% (71 of 173), 11% (18 of 164), and 3% (six of 209), respectively. Distress caused by these symptoms was reported significantly more often by men allocated radical prostatectomy than by men assigned to watchful waiting. In a longitudinal analysis of men in SPCG-4 who provided information at two follow-up points 9 years apart, 38 (45%) of 85 men allocated radical prostatectomy and 48 (60%) of 80 men allocated watchful waiting reported an increase in number of physical symptoms; 50 (61%) of 82 and 47 (64%) of 74 men, respectively, reported a reduction in quality of life. INTERPRETATION: For men in SPCG-4, negative side-effects were common and added more stress than was reported in the control population. In the radical prostatectomy group, erectile dysfunction and urinary leakage were often consequences of surgery. In the watchful-waiting group, side-effects can be caused by tumour progression. The number and severity of side-effects changes over time at a higher rate than is caused by normal ageing and a loss of sexual ability is a persistent psychological problem for both interventions. An understanding of the patterns of side-effects and time dimension of their occurrence for each treatment is important for full patient information. FUNDING: US National Institutes of Health; Swedish Cancer Society; Foundation in Memory of Johanna Hagstrand and Sigfrid Linner.","Lancet Oncol, 12(9): 891-899","Sweden",2011,"Local","Surgery,Surveillance","Unclear","Patient",null,"Clinical trial","Sweden","Patient","Local","Surgery,Surveillance",null,"Clinical trial","Unclear","2010:2014","General,Symptoms"]
[326,"Johansson, J. E., et al. (2001). \"Efficacy of epoetin beta on hemoglobin, quality of life, and transfusion needs in patients with anemia due to hormone-refractory prostate cancer--a randomized study.\" Scand J Urol Nephrol 35(4): 288-294.",null,"Johansson, J. E., et al.","Efficacy of epoetin beta on hemoglobin, quality of life, and transfusion needs in patients with anemia due to hormone-refractory prostate cancer--a randomized study","OBJECTIVE: Erythropoietin is shown to be an effective treatment for anemia in various types of cancers, however only limited studies have evaluated its benefits in advanced hormone-refractory prostate cancer (HRPC). This multi-center study investigated the influence of 2 different doses of epoetin beta on quality of life, hemoglobin level, need for blood transfusion, and safety, in the treatment of anemia in patients with metastatic HRPC. MATERIALS AND METHODS: This study randomized 180 patients to receive either epoetin beta 1000 IU or 5000 IU subcutaneously 3 times per week for 12 weeks. Hemoglobin was evaluated at study start and 6 time-points during the study. Quality of life (QoL) was assessed by the European Organization for Research and Treatment of Cancer questionnaire, QLC-C30, before treatment start and after 6 and 12 weeks of treatment. Best supportive care and blood transfusions were given, if clinically indicated. Additional laboratory values and adverse events were followed for safety. RESULTS: Hemoglobin increased significantly (>20 g/l) in 43% in the high dose (HD) group and 25% in the low dose (LD) group in response to treatment. Levels were significantly higher in the HD group than the LD group (p < 0.001) after 8 and 12 weeks. QoL improved significantly if the increase in hemoglobin was >20 g/l. Significantly more patients in the LD group received blood transfusions than the HD group (p < 0.005). There were no differences between the groups regarding overall quality of life and fatigue. The treatment was well tolerated in both groups. CONCLUSIONS: Epoetin beta is shown to be safe and effective for the treatment of anemia in many patients with HRPC. It is found to improve QoL and physical functioning, and relieve fatigue symptoms, in many of these critically ill patients.","Scand J Urol Nephrol, 35(4): 288-294","Sweden",2001,"Metastatic","Various","EORTC QLQ-C30","Patient",null,"Clinical trial","Sweden","Patient","Metastatic","Various",null,"Clinical trial","EORTC QLQ-C30","2000:2004","General"]
[327,"Johnson, E. K., et al. (2011). \"The impact of anterior urethropexy during robotic prostatectomy on urinary and sexual outcomes.\" J Endourol 25(4): 615-619.",null,"Johnson, E. K., et al.","The impact of anterior urethropexy during robotic prostatectomy on urinary and sexual outcomes","OBJECTIVES: We determined the effect of an anterior urethropexy (AU) stitch on postoperative urinary continence, irritative urinary symptoms, and sexual function after robotic radical prostatectomy (RP). METHODS: Consecutive patients undergoing robotic RP for prostate cancer were prospectively evaluated. The Expanded Prostate Cancer Index Composite (EPIC) questionnaire was administered pre- and postoperatively to all patients. Patients were then grouped by AU status. A linear mixed model was used to compare the rate of recovery in incontinence (UIN), irritative (UIR), and sexual domain scores between the two groups. A t-test was used to compare UIN, UIR, and sexual domain scores at specific time points. RESULTS: A total of 229 patients underwent robotic RP and filled out a preoperative and at least one postoperative EPIC questionnaire. In this population, 87 did have and 142 did not have an AU performed. The mean EPIC-UIN score at 3 months was 68 in the AU group and 58 in the non-AU group (p = 0.015). Comparison of all other time points and overall urinary scores revealed no other statistically significant differences after surgery. Sexual domain scores were also improved at 3 months in the AU group (p = 0.002). CONCLUSIONS: AU during robotic RP leads to improved urinary continence and sexual functioning at 3 months of follow-up. An earlier return to continence may facilitate an earlier return to sexual activity. AU may offer a short-term quality-of-life advantage for patients undergoing robotic RP.","J Endourol, 25(4): 615-619","USA",2011,"Any or unknown","Surgery","EPIC","Patient",null,"Cohort","USA","Patient","Any or unknown","Surgery",null,"Cohort","EPIC","2010:2014","Disease"]
[328,"Johnstone, P. A., et al. (2000). \"Quality of life in T1-3N0 prostate cancer patients treated with radiation therapy with minimum 10-year follow-up.\" Int J Radiat Oncol Biol Phys 46(4): 833-838.",null,"Johnstone, P. A., et al.","Quality of life in T1-3N0 prostate cancer patients treated with radiation therapy with minimum 10-year follow-up","PURPOSE: To describe patient-reported quality of life using a validated survey in a cohort of patients who are long-term survivors of definitive radiotherapy for T1-3N0 prostate cancer. METHODS AND MATERIALS: Survivors of a previously reported cohort of prostate cancer patients treated with staging pelvic lymphadenectomy and definitive radiotherapy between November 1974 and August 1988 were queried using a questionnaire incorporating the RAND 36-Item Health Survey and the University of California, Los Angeles Prostate Cancer Index. Responses were reviewed and analyzed. Of the 146 N0 patients, 88 have survived for 10 years postdiagnosis. Fifty-six (64%) of these patients were still alive with valid addresses and were mailed copies of the questionnaires, of which 46 (82%) responded. Median potential follow-up from date of diagnosis was 13.9 years, with a median age of responders of 80 years. RESULTS: The mean sexual function score was 15.4, with a bother score of 42. The mean urinary function score was 65, with a bother score of 61. The mean bowel function score was 72.6, with a bother score of 64.8. The amount of patient bother reported in the sexual category is similar to that previously reported for cohorts of prostate cancer patients undergoing radiotherapy or observation. This is despite the fact that sexual function was similar to that previously reported for patients postprostatectomy. Patient-reported function and bother scores in urinary and bowel categories were somewhat more severe than a previously reported radiotherapy cohort with shorter follow-up. CONCLUSIONS: With long follow-up, most patients who underwent radiotherapy for prostate cancer in the era described exhibit somewhat worse bladder, bowel, and erectile function than recently published controls without prostate cancer. In this cohort of older men with long follow-up, erectile function is similar to reported prostatectomy series. However, patient bother related to erectile function is similar to that of controls in earlier published radiotherapy series. Worse urinary and bowel function may be due to progressive symptoms with aging and longer follow-up, or to the radiotherapy techniques performed during the era in question.","Int J Radiat Oncol Biol Phys, 46(4): 833-838","USA",2000,"Survivors","Radiotherapy","SF-36,UCLA-PCI","Patient",null,"Cross-sectional","USA","Patient","Survivors","Radiotherapy",null,"Cross-sectional","SF-36,UCLA-PCI","2000:2004","Utility,Disease"]
[329,"Joly, F., et al. (1998). \"Health-related quality of life and sequelae in patients treated with brachytherapy and external beam irradiation for localized prostate cancer.\" Ann Oncol 9(7): 751-757.",null,"Joly, F., et al.","Health-related quality of life and sequelae in patients treated with brachytherapy and external beam irradiation for localized prostate cancer","PURPOSE: To evaluate late physical and psychosocial sequelae in patients treated with an association of external beam irradiation (EBI) and brachytherapy (BT) for localized prostate cancer. PATIENTS AND METHODS: Seventy-one patients free of disease, treated at the Centre Francois Baclesse from 1988 to 1992, were enrolled in a case-control study. Seventy-one healthy controls, matched on age and residence, were selected at random from electoral rolls. Two self-administered questionnaires were mailed in January 1996. The French translation of the Nottingham Health Profile questionnaire and the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 core questionnaire were used to evaluate physical, role, emotional, cognitive and social functioning, global health status as well as energy and sleep disturbance. Specific problems related to prostate cancer were explored using the prostate specific module developed by the EORTC Genito-Urinary Tract Cancer Cooperative Group. Concordance between clinical complications reported by patients and those reported by physicians was also analyzed. RESULTS: General health quality of life scale scores did not significantly differ between patients and controls, nor did general symptom scale scores. Furthermore, no more late psychosocial sequelae were reported by patients than by controls. No major digestive complications were observed among patients. However, statistical differences were observed concerning interest in sex (P = 0.016) and sexual activity (P < 0.001), urinary incontinence (P < 0.001) and cystitis (P = 0.01). Late subjective morbidity (dysuria, nocturia, urinary incontinence, pelvic pain) appraisal differed slightly between patients and physicians who generally underestimate its severity. While nocturia was reported more often by physicians than by patients (P = 0.0016), patients reported urinary incontinence and pelvic pain more often than physicians (P < 0.001 and P < 0.001, respectively). CONCLUSIONS: The study demonstrates that survivors from localized prostate cancer treated with an association of BT and EBI have good global health status. Major problems that persist are sexual disorders, urinary incontinence and cystitis while digestive disorders were rare. This association could be an alternative to standard EBI in patients with localized prostate cancer. Whatever the treatment choice, patients should be involved in the therapeutic decision which should consider not only expected survival rate but also quality of life.","Ann Oncol, 9(7): 751-757","France",1998,"Local","Radiotherapy,Brachytherapy","NHP,EORTC QLQ-C30","Patient",null,"Cross-sectional","France","Patient","Local","Radiotherapy,Brachytherapy",null,"Cross-sectional","NHP,EORTC QLQ-C30","1960:1999","General"]
[330,"Jones, J. S., et al. (2002). \"Saturation prostate biopsy with periprostatic block can be performed in office.\" J Urol 168(5): 2108-2110.",null,"Jones, J. S., et al.","Saturation prostate biopsy with periprostatic block can be performed in office","PURPOSE: Recent reports of saturation prostate biopsy performed in the operating room with the patient under anesthesia have shown increased cancer detection rates over repeat office based prostate biopsy. We report equivalent success and tolerability of saturation biopsy in the office using local anesthesia. MATERIALS AND METHODS: We performed 24 core saturation prostate biopsies in 15 patients using periprostatic local anesthesia. Before biopsy 20 cc 2% lidocaine (10 cc per side) were injected under ultrasound guidance into the periprostatic nerve entry into the prostate bilaterally. After measurements were made a random 24 core prostate biopsy was performed using a spring loaded biopsy gun. Pain was determined using a visual analog scale to assess tolerability. RESULTS: Complete 24 core biopsies were successful and well tolerated in all 15 patients. Cancer detected in 5 patients (33%) was clinical stage T1C. Mean prostate specific antigen before biopsy was 11.2 ng./dl. (range 5 to 24.1). The indication for biopsy was elevated prostate specific antigen after a previous normal biopsy in 12 patients. In 2 patients prostatic intraepithelial neoplasia was noted on a previous biopsy and in 1 previous atypia was identified on biopsy. The mean visual analog scale pain score was 0.7 (range 0 to 3). Prolonged minor hematuria greater than 5 days in duration occurred in 3 cases requiring no intervention. No other complications occurred. Nerve sparing was not more difficult in the single patient who underwent radical prostatectomy. CONCLUSIONS: Saturation prostate biopsy is well tolerated in the office setting with the patient under local anesthesia. The additional risk, time and cost of performing these procedures in the operating room using anesthesia may be safely avoided.","J Urol, 168(5): 2108-2110","USA",2002,"At risk","Screening","VAS","Patient",null,"Clinical trial","USA","Patient","At risk","Screening",null,"Clinical trial","VAS","2000:2004","Symptom"]
[331,"Jonler, M., et al. (1994). \"Sequelae of definitive radiation therapy for prostate cancer localized to the pelvis.\" Urology 44(6): 876-882.",null,"Jonler, M., et al.","Sequelae of definitive radiation therapy for prostate cancer localized to the pelvis","OBJECTIVES: To evaluate sequelae and estimate quality of life utilizing a survey instrument in 133 consecutive patients who have undergone definitive radiation therapy for localized prostate cancer. METHODS: All patients reported on have been followed for 14 to 60 months (median, 31 months) after radiation therapy and only patients with definitive prostate radiation therapy are included. Of the patients still alive at time of follow-up, 115 were mailed the questionnaire. Data regarding tumor grade and stage as well as treatment were extracted from patient files. RESULTS: Of the 91% of patients who returned the questionnaire, 11% used a pad and 13% leaked more than a few drops of urine daily. Of all the respondents, 9% stated that incontinence was a problem, and 31% found urinary leaking significantly worsened after radiation therapy compared with before their diagnosis of prostate cancer. With respect to sexual function, 77% recalled being able to have full or partial erections prior to radiation therapy. At some time after radiation therapy, 22% of previously potent respondents were able to have a full erection and 41% were able to have a partial erection. Twenty-nine percent of all patients who were able to establish an erection prior to radiation therapy reported that impotence was a problem at the time of follow-up. Forty-nine percent of patients had abdominal pain, diarrhea, or abdominal cramping during or after radiation therapy and 31% of all patients still had some intestinal symptoms at the time of follow-up. Eighteen percent of all patients were significantly bothered by one or more of these bowel problems. Overall, 31% of all patients reported a persistent degree of physical discomfort that they believed was secondary to their prostate cancer or the effect of treatment. Eighty-one percent were satisfied with radiation therapy and 97% of the patients said they would have radiation therapy again if faced with the decision. CONCLUSIONS: Utilizing a sensitive questionnaire on patients who had definitive radiation therapy for prostate cancer, we found the incidence of patients bothered by incontinence to be surprisingly frequent and higher than previously reported. The frequency of impotence is similar to previous studies. However, when our incontinence and impotence data were compared to Medicare patients who had undergone radical prostatectomy, the frequencies after radiation therapy were significantly lower. Despite the rates of sequelae, the patients were generally satisfied with the decision to undergo radiation therapy and with the medical treatment received.","Urology, 44(6): 876-882","USA",1994,"Local","Radiotherapy","Unclear","Patient",null,"Cross-sectional","USA","Patient","Local","Radiotherapy",null,"Cross-sectional","Unclear","1960:1999","Complication"]
[332,"Jonler, M., et al. (1996). \"A prospective study of quantification of urinary incontinence and quality of life in patients undergoing radical retropubic prostatectomy.\" Urology 48(3): 433-440.",null,"Jonler, M., et al.","A prospective study of quantification of urinary incontinence and quality of life in patients undergoing radical retropubic prostatectomy","OBJECTIVES: To prospectively evaluate the level of urinary incontinence and its impact on quality of life in patients undergoing radical retropubic prostatectomy. METHODS: Patients completed a 24-hour pad test together with an incontinence and quality-of-life questionnaire before and after surgery. RESULTS: Patients were followed up for an average of 7.6 months (range 4.7 to 12.5) after radical prostatectomy. The 24-hour pad test demonstrated that 87% of patients had some incontinence at 1 month and 63% at 6 months after surgery. The median volume of urine leakage was 34 mL at the last follow-up visit; 55% of patients indicated substantial bother from incontinence at the 1-month follow-up visit and 29% at the 6-month follow-up visit. For most patients, there was a substantial discrepancy between the reported and the measured level of incontinence. Patient-reported bother regarding incontinence correlated best to the actual amount of urine loss. CONCLUSIONS: Patients become incontinent after surgery but improve over time. Seventeen percent of patients still experienced leakage of more than 150 mL daily at the last follow-up visit. The questionnaire utilized in this study identifies the presence of incontinence but was not accurate in estimating the amount of urine loss. Initially, quality of life was reduced by surgery but improved over time and nearly returned to the preoperative level.","Urology, 48(3): 433-440","USA",1996,"Any or unknown","Surgery","Unclear","Patient",null,"Cohort","USA","Patient","Any or unknown","Surgery",null,"Cohort","Unclear","1960:1999","General,Complication"]
[333,"Jonler, M., et al. (1998). \"Urinary symptoms, potency, and quality of life in patients with localized prostate cancer followed up with deferred treatment.\" Urology 52(6): 1055-1062; discussion 1063.",null,"Jonler, M., et al.","Urinary symptoms, potency, and quality of life in patients with localized prostate cancer followed up with deferred treatment","OBJECTIVES: To evaluate urinary symptoms, potency, and quality of life in a group of patients with prostate cancer followed up with deferred treatment. METHODS: A self-administered questionnaire was mailed to patients with localized prostate cancer who were followed up with deferred treatment. Data regarding clinical stage, pathologic grade, and treatment after diagnosis were obtained from patient files. RESULTS: A total of 71 consecutive patients (age 79 years or less) were included. Of the 52 patients (73%) who responded, 31% had undergone transurethral resection of the prostate, 8% underwent radiation therapy, and 44% underwent hormonal deprivation during the follow-up period. With respect to incontinence, 21% were using pads and 37% leaked urine daily; in 21% of the patients, urine dripping or leaking was a substantial problem. Before the diagnosis of their prostate cancer, 81% stated they were able to have an erection. At the time of the questionnaire, 77% stated that their ability to have erections was reduced and only 29% had had an erection after the prostate cancer was diagnosed. For 12%, impotence was a problem. With respect to quality of life, 52% of the patients rated their health as excellent or good and 61% would be happy to spend the rest of their life feeling the way they did at the time of the questionnaire. Eighty-five percent were satisfied with the treatment policy for their prostate cancer, and 96% would choose deferred treatment again if faced with the decision. CONCLUSIONS: By use of a self-administered questionnaire, a high frequency of incontinence and impotence was found in a group of patients with prostate cancer followed up with deferred treatment. Despite these problems, more than half of the patients rated their health as good and would undergo expectant management again if faced with the decision.","Urology, 52(6): 1055-1062; discussion 1063","Denmark",1998,"Local","Surgery,Radiotherapy,Hormonal","Unclear","Patient",null,"Cross-sectional","Denmark","Patient","Local","Surgery,Radiotherapy,Hormonal",null,"Cross-sectional","Unclear","1960:1999","Complication"]
[334,"Jonler, M., et al. (2005). \"Quality of life in patients with skeletal metastases of prostate cancer and status prior to start of endocrine therapy: results from the Scandinavian Prostate Cancer Group Study 5.\" Scand J Urol Nephrol 39(1): 42-48.",null,"Jonler, M., et al.","Quality of life in patients with skeletal metastases of prostate cancer and status prior to start of endocrine therapy: results from the Scandinavian Prostate Cancer Group Study 5","OBJECTIVES: Prostate cancer (PC) is a highly lethal neoplastic disease affecting the physical, mental and social well-being of patients, i.e. their quality of life (QOL). Patients suffering from metastatic PC are faced with serious decisions regarding treatment strategies. Therefore, QOL information has become a crucial element of decision making in this group of patients. The first objective of this study was to describe QOL in a group of patients diagnosed with metastatic PC and skeletal metastases. At the time of evaluation the patients had not received any treatment but were evaluated before entering a study of androgen-modulating therapy (the Scandinavian Prostate Cancer Group study 5). The second objective was to identify demographic and disease-related factors affecting QOL. MATERIAL AND METHODS: A total of 917 patients with metastatic PC were evaluated using a well-described and validated questionnaire [European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-C30 (EORTC QLQ-C30)]. The characteristics of the PC were noted, and simultaneously patients were evaluated with respect to use of analgesics, pain and performance status using a scoring system. Biochemical tests were performed when patients entered the study. A multivariate regression analysis was performed to analyse the correlations between QOL scores, patient demographics and disease-related data. RESULTS: The patients reported QOL scores significantly lower than those in the background population. Pain and fatigue were pronounced, whereas dyspnoea, insomnia, loss of appetite, constipation and diarrhoea were less prominent. Patients with high tumour grades, high PSPA scores (the sum of the pain score, the performance status and the use of analgesics) and those using analgesics had significantly lower QOL scores than the other patients. CONCLUSIONS: Patients with metastatic PC have reduced QOL. Our findings are in line with those of other studies of QOL among patients with this disease as evaluated by means of the EORTC QLQ-C30 questionnaire. Baseline data from studies like this provide important information when treatment modalities for PC are evaluated.","Scand J Urol Nephrol, 39(1): 42-48","Denmark",2005,"Metastatic","Hormonal","EORTC QLQ-C30","Patient",null,"Clinical trial","Denmark","Patient","Metastatic","Hormonal",null,"Clinical trial","EORTC QLQ-C30","2005:2009","General"]
[335,"Joshi, N., et al. (2010). \"Impact of posterior musculofascial reconstruction on early continence after robot-assisted laparoscopic radical prostatectomy: results of a prospective parallel group trial.\" Eur Urol 58(1): 84-89.",null,"Joshi, N., et al.","Impact of posterior musculofascial reconstruction on early continence after robot-assisted laparoscopic radical prostatectomy: results of a prospective parallel group trial","BACKGROUND: A significant proportion of patients develop urinary incontinence early after radical prostatectomy. Posterior reconstruction of supporting tissues has been found to reduce incontinence in open and conventional laparoscopic prostatectomy series. OBJECTIVE: To investigate whether our version of a posterior musculofascial reconstruction will reduce early incontinence and have a beneficial effect on patients' quality of life (QoL). DESIGN, SETTING, AND PARTICIPANTS: One hundred seven consecutive patients undergoing primary robot-assisted radical laparoscopic prostatectomy (RALP) performed by a single surgeon at one tertiary referral oncology institution were alternately assigned (not randomised) to intervention (n=53) or control groups (n=54). SURGICAL PROCEDURE: RALP with median fibrous raphe reconstruction (MFRR) followed by formation of the urethrovesical anastomosis (intervention group) versus standard anastomosis without posterior reconstruction (control group). MEASUREMENTS: Measurements included incontinence at baseline and 3-mo intervals; QoL as measured by a simple questionnaire, the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life-Core 30 (QLQ-C30), and Prostate Cancer Module (PR25) questionnaires preoperatively and at 6 mo postprocedure; tumour characteristics; operative time; fascial preservation score; duration of catheterisation; and anastomotic leakage on cystogram. RESULTS AND LIMITATIONS: For intervention and control groups respectively, mean catheter duration was 11.74 d and 12.74 d (p=0.451); leakage on cystogram was present in six and eight cases (p=0.28); and incontinence (any involuntary urine loss) at 3 mo was 75% and 69% (p=0.391) and at 6 mo was 51% and 43% (p=0.686). Urinary retention occurred only in one case (control group). The percentage of cases returning to baseline in all QoL domains (except insomnia) was similar at 6 mo between the two groups. Short follow-up, lack of blinding, and probable small differences in our method of MFRR performed compared with other studies were identified as significant limitations. CONCLUSIONS: No significant difference in any of the analysed outcome measures was observed. Posterior reconstruction of the musculofascial complex does not appear to improve early urinary incontinence after RALP.","Eur Urol, 58(1): 84-89","Netherlands",2010,"Any or unknown","Surgery","EORTC QLQ-C30,EORTC QLQ-PR25","Patient",null,"Clinical trial","Netherlands","Patient","Any or unknown","Surgery",null,"Clinical trial","EORTC QLQ-C30,EORTC QLQ-PR25","2010:2014","Disease,General"]
[336,"Kakehi, Y., et al. (2002). \"Development of Japanese version of the UCLA Prostate Cancer Index: a pilot validation study.\" Int J Clin Oncol 7(5): 306-311.",null,"Kakehi, Y., et al.","Development of Japanese version of the UCLA Prostate Cancer Index: a pilot validation study","METHODS: The Japanese version (version 1.2) of the UCLA PCI was developed through a process of translation, back-translation, and refinement after interviewing patients. Reliability and validity were examined for 125 Japanese patients with localized prostate cancer. The patients simultaneously responded to the Japanese version of the RAND 36-Item Health Survey (SF-36) and five representative questions from the International Index of Erectile Function (IIEF). RESULTS: Internal consistency reliability was very high for both urinary and sexual function scales, and lower for bowel function. The test-retest reliability of the urinary and sexual function scales and the urinary bother scales was stable, while that of the bowel function and bother scales was relatively unstable. Sexual function scores did not correlate highly with sexual bother scores. Furthermore, poor sexual function and bother had little association with the SF-36 scores. Missing data as to urinary and bowel function/bother scales were minimal (0.8%-2.4%), while those for sexual function and bother were relatively high (4.8%-11.2%). CONCLUSIONS: The results of this pilot study, together with the previous American study, suggest ethnic or cultural difference in how impaired sexual function is integrated into overall QOL. A future cross-cultural comparative study using the UCLA PCI and SF-36 will provide useful information about the influence of cultural or ethnic differences on health-related QOL in prostate cancer patients.","Int J Clin Oncol, 7(5): 306-311","Japan",2002,"Local","None","UCLA-PCI,SF-36,IIEF-5","Patient",null,"Validation","Japan","Patient","Local","None",null,"Validation","UCLA-PCI,SF-36,IIEF-5","2000:2004","Disease,Complication,Utility"]
[337,"Kalkner, K. M., et al. (1998). \"Pain figures are unsuitable for determination of palliative radiotherapy portals in patients with hormone refractory prostatic cancer.\" Anticancer Res 18(3b): 1983-1987.",null,"Kalkner, K. M., et al.","Pain figures are unsuitable for determination of palliative radiotherapy portals in patients with hormone refractory prostatic cancer","We aimed to compare bone scintigraphy with pain extension and other quality of life (QoL) factors in order to evaluate QoL and the appropriateness of using pain figures and a subjective pain description as the basis for palliative radiotherapy (RT) portals. Twenty-three patients with progressive hormone-refractory prostatic adenocarcinoma were investigated with bone scintigraphy and completed pain figures, VAS (visual analogue scales) and a comprehensive self-questionnaire concerning QoL. The Soloway score was significantly correlated with Impaired overall QoL (p = 0.05), and especially with questions regarding restriction of movements (p = 0.001). Weight bearing regions were significantly more often affected at bone scintigraphy than other locations in the group of patients reporting incidental pain during exercise. Surprisingly, a poor level of correlation existed when comparing location of pain with location of uptake on bone scintigraphy, even if an adjacent region was included in the comparison. The subjective description of pain extension in pain figures correlates poorly with the uptake patterns at bone scintigraphy--an interesting finding since pain extensions is regularly used for the definition of palliative RT portals. Furthermore, it appears that the tumour burden itself is not and indicator of the pain score at rest, but affects aspects of QoL. Moreover, it would appears as though the location of metastases in the skeleton significantly affects physical quality of life aspects. It is probably more important to irradiate weight bearing regions of skeleton in order to increase QoL.","Anticancer Res, 18(3b): 1983-1987","Sweden",1998,"Metastatic","Radiotherapy","VAS","Patient",null,"Cross-sectional","Sweden","Patient","Metastatic","Radiotherapy",null,"Cross-sectional","VAS","1960:1999","Symptom,General"]
[338,"Kang, S. G., et al. (2011). \"Efficacy and cost analysis of transrectal ultrasound-guided prostate biopsy under monitored anesthesia.\" Asian J Androl 13(5): 724-727.",null,"Kang, S. G., et al.","Efficacy and cost analysis of transrectal ultrasound-guided prostate biopsy under monitored anesthesia","Sedation may result in reduction in pain during transrectal ultrasound (TRUS)-guided prostate biopsies. We aimed to evaluate the efficacy and safety of a combination of propofol and remifentanil infusion during TRUS-guided prostate biopsy and the related increases in health care costs. From January to September 2010, 100 men undergoing a transrectal prostate biopsy were randomized into two groups. In Group 1, 50 patients received a combined infusion of propofol and remifentanil; in Group 2, 50 patients received lidocaine jelly. After TRUS-guided biopsies were performed, pain and patient satisfaction were evaluated by a 10-point visual analog scale (VAS), and a cost-related patient satisfaction questionnaire was completed by all patients. Patients were also asked whether they would be willing to undergo repeat biopsy by the same method. Patients in Group 1 showed a significantly lower VAS score than those in Group 2 (mean VAS score: 0.9+/-1.1 versus 6.3+/-2.5; P<0.001). In addition, the patient satisfaction scale was significantly higher in Group 1 (P=0.002). Although the overall cost was significantly higher in Group 1 (P=0.006), patient satisfaction scales considering cost were also higher in this group (P=0.009). A combination of propofol and remifentanil is a safe and effective way to decrease patient pain and increase patient satisfaction during TRUS-guided prostate biopsy. Although the costs were higher in the group that received sedation, as expected, the patients exhibited heightened satisfaction and willingness to repeat biopsies by the same method.","Asian J Androl, 13(5): 724-727","Korea",2011,"At risk","Screening","VAS","Patient",null,"Clinical trial","Korea","Patient","At risk","Screening",null,"Clinical trial","VAS","2010:2014","Symptom,Costs"]
[339,"Kantrowitz, W., et al. (1995). \"Prostate cancer screening in a large corporation population.\" J Occup Environ Med 37(10): 1193-1198.",null,"Kantrowitz, W., et al.","Prostate cancer screening in a large corporation population","The Polaroid Medical Department conducted a prostate cancer screening program of all male employees over the age of 49 years. The screening consisted of a World Health Organization (WHO) questionnaire, a digital rectal examination (DRE) by an occupational medicine doctor, and a serum prostate-specific antigen (PSA) study. There were 2241 eligible employees (males between 50 and 65 years of age). 1219 (54%) took part in the screening. Thirty-seven PSAs above the 3.9 level were found (3%) and were further evaluated with ultrasound and/or biopsy. Twelve previously unknown cancers of the prostate (1%) were discovered. The cost of the entire program to the Polaroid Medical Department, including ultrasound and biopsy studies, was $72,130 ($6,012 per cancer detected). Of the 12 cancers, two were discovered by abnormal DRE alone, eight by an elevated PSA alone, and two by both an abnormal DRE and elevated PSA. There appeared to be no correlation between the WHO symptom score and the detection of prostate cancer. Our final conclusion was that a corporate medical department screening for cancer of the prostate is both effective and cost efficient.","J Occup Environ Med, 37(10): 1193-1198","USA",1995,"At risk","Screening","WHOQOL-BREF","General population",null,"Clinical trial","USA","General population","At risk","Screening",null,"Clinical trial","WHOQOL-BREF","1960:1999","General"]
[340,"Kao, T. C., et al. (2000). \"Multicenter patient self-reporting questionnaire on impotence, incontinence and stricture after radical prostatectomy.\" J Urol 163(3): 858-864.",null,"Kao, T. C., et al.","Multicenter patient self-reporting questionnaire on impotence, incontinence and stricture after radical prostatectomy","PURPOSE: We determined the incidence of patient self-reported post-prostatectomy incontinence, impotence, bladder neck contracture and/or urethral stricture, sexual function satisfaction, quality of life and willingness to undergo treatment again in a large multicenter group of men who underwent radical prostatectomy. We also determined whether the morbidities of sexual function satisfaction, quality of life and bladder neck contracture and/or urethral stricture are predictable from demographic and postoperative prostate cancer factors. MATERIALS AND METHODS: A self-reporting questionnaire was completed and returned by 1,069 of 1,396 eligible patients (77%) who underwent radical prostatectomy between 1962 and 1997. Of the respondents 868 (85.7%) underwent surgery after 1990 and in all prostatectomy had been done a minimum of 6 months previously. Questionnaire results were independently analyzed by a third party for morbidity tabulation and the association of patient reported satisfaction. RESULTS: The patient self-reported incidence of any degree of post-prostatectomy incontinence, impotence and bladder neck contracture or urethral stricture was 65.6%, 88.4% and 20.5%, respectively. The incidence of incontinence requiring protection was 33% and only 2.8% of respondents had persistent bladder neck contracture or urethral stricture. Although incontinence and impotence significantly affected self-reported sexual function satisfaction, quality of life and willingness to undergo treatment again (p = 0.001), 77.5% of patients would elect surgery again. This finding remained true even after adjusting for demographic variables, and the time between surgery and the survey by multiple logistic regression. CONCLUSIONS: Although radical prostatectomy morbidity is common and affects self-reported overall quality of life, most patients would elect the same treatment again. Impotence and post-prostatectomy incontinence were significantly associated with sexual function satisfaction, quality of life and willingness to undergo treatment again. Bladder neck contracture and/or urethral stricture was associated with willingness to undergo treatment again after adjusting for demographic variables and time from surgery to the survey.","J Urol, 163(3): 858-864","USA",2000,"Any or unknown","Surgery","Unclear","Patient",null,"Cross-sectional","USA","Patient","Any or unknown","Surgery",null,"Cross-sectional","Unclear","2000:2004","Complication"]
[341,"Karakiewicz, P. I., et al. (2003). \"Cross-cultural validation of the UCLA prostate cancer index.\" Urology 61(2): 302-307.",null,"Karakiewicz, P. I., et al.","Cross-cultural validation of the UCLA prostate cancer index","OBJECTIVES: To explore the impact of cross-cultural differences on University of California, Los Angeles, Prostate Cancer Index (PCI) reliability and validity, which is unknown. The PCI represents the most widely used prostate cancer-specific health-related quality-of-life assessment tool. METHODS: The PCI sexual and urinary scales, the RAND SF-36 survey, and the Prostate Outcomes Research Team (PORT) prostate cancer treatment complication profile were self-administered. The principal sample consisted of 2415 men (anglophone 256, francophone 2159) treated with radical prostatectomy in Quebec between 1988 and 1996. An additional 35 men (anglophone 17, francophone 18) formed the retest sample. RESULTS: The PCI demonstrated excellent internal consistency and test-retest reliability in tests based on the entire cohort and in tests addressing the two linguistically different groups. The instrument showed a lack of convergence with the SF-36 scales, confirming the distinctness of the generic and prostate cancer-specific constructs. The PCI sexual scales converged with the aggregate PORT sexual items (r = 0.8), and the PCI urinary scales were strongly related to the aggregate PORT urinary items (r = 0.7). Convergence between PCI urinary bother and function was strong (r = 0.8), but only moderate convergence was noted between PCI sexual bother and function (r = 0.4). The relation between bother and function in both urinary and sexual domains was weaker in anglophone participants relative to their francophone counterparts. CONCLUSIONS: The PCI is reliable and, at best, only modestly affected by cultural differences when administered to culturally distinct English-speaking men or when translated into French.","Urology, 61(2): 302-307","USA",2003,"Any or unknown","Surgery","SF-36,UCLA-PCI,PORT","Patient",null,"Validation","USA","Patient","Any or unknown","Surgery",null,"Validation","SF-36,UCLA-PCI,PORT","2000:2004","Disease,Utility,Treatment"]
[342,"Karakiewicz, P. I., et al. (2004). \"Erectile and urinary dysfunction after radical prostatectomy for prostate cancer in Quebec: a population-based study of 2415 men.\" Eur Urol 46(2): 188-194.",null,"Karakiewicz, P. I., et al.","Erectile and urinary dysfunction after radical prostatectomy for prostate cancer in Quebec: a population-based study of 2415 men","OBJECTIVE: To assess and quantify urinary and sexual function outcomes from a large scale cohort of Canadian men treated for localized prostate cancer. METHODS: A self-administered survey focusing on erectile (ED) and urinary dysfunction (UD) was completed by 2415 of 4546 men (response rate 53.1%) treated with prostatectomy for prostate cancer in the Province of Quebec between 1988 and 1996. The time between treatment and survey completion ranged from 17 months to 8.5 years. RESULTS: After prostatectomy, of 2227 men without ED before surgery, erections of adequate firmness for intercourse were reported by 25%. ED rate increased with age and ranged from 55% in men aged <60 years to 85% in men 75 years or older. Of all, 19.1% reported ED treatment. ED rate was significantly related to UD severity. Severe UD, quantified as urinary leakage exceeding one tablespoon, was reported by 6.6%. Severe UD rate ranged from 4% in men aged <60 years to 10% in men 75 years or older. Strictures were reported by 16.3% and were associated with a two-fold increase in severe UD rate (p<0.001). Finally, age and socioeconomic status represented important predictor variables in univariate and multivariate regression models. CONCLUSION: ED rate of 75% and severe UD rate of 6.6% could be anticipated after RP. These outcomes are similar to unselected large scale, patient reported outcomes from the United States.","Eur Urol, 46(2): 188-194","Canada",2004,"Local","Surgery","Unclear","Patient",null,"Cross-sectional","Canada","Patient","Local","Surgery",null,"Cross-sectional","Unclear","2000:2004","Complication"]
[343,"Katz, A., et al. (2012). \"Comparison of quality of life after stereotactic body radiotherapy and surgery for early-stage prostate cancer.\" Radiat Oncol 7: 194.",null,"Katz, A., et al.","Comparison of quality of life after stereotactic body radiotherapy and surgery for early-stage prostate cancer","BACKGROUND: As the long-term efficacy of stereotactic body radiation therapy (SBRT) becomes established and other prostate cancer treatment approaches are refined and improved, examination of quality of life (QOL) following prostate cancer treatment is critical in driving both patient and clinical treatment decisions. We present the first study to compare QOL after SBRT and radical prostatectomy, with QOL assessed at approximately the same times pre- and post-treatment and using the same validated QOL instrument. METHODS: Patients with clinically localized prostate cancer were treated with either radical prostatectomy (n = 123 Spanish patients) or SBRT (n = 216 American patients). QOL was assessed using the Expanded Prostate Cancer Index Composite (EPIC) grouped into urinary, sexual, and bowel domains. For comparison purposes, SBRT EPIC data at baseline, 3 weeks, 5, 11, 24, and 36 months were compared to surgery data at baseline, 1, 6, 12, 24, and 36 months. Differences in patient characteristics between the two groups were assessed using Chi-squared tests for categorical variables and t-tests for continuous variables. Generalized estimating equation (GEE) models were constructed for each EPIC scale to account for correlation among repeated measures and used to assess the effect of treatment on QOL. RESULTS: The largest differences in QOL occurred in the first 1-6 months after treatment, with larger declines following surgery in urinary and sexual QOL as compared to SBRT, and a larger decline in bowel QOL following SBRT as compared to surgery. Long-term urinary and sexual QOL declines remained clinically significantly lower for surgery patients but not for SBRT patients. CONCLUSIONS: Overall, these results may have implications for patient and physician clinical decision making which are often influenced by QOL. These differences in sexual, urinary and bowel QOL should be closely considered in selecting the right treatment, especially in evaluating the value of non-invasive treatments, such as SBRT.","Radiat Oncol, 7(194","USA",2012,"Local","Surgery,Radiotherapy","EPIC","Patient",null,"Clinical trial","USA","Patient","Local","Surgery,Radiotherapy",null,"Clinical trial","EPIC","2010:2014","Disease"]
[344,"Katz, D., et al. (2002). \"Sociodemographic characteristics and health related quality of life in men attending prostate cancer support groups.\" J Urol 168(5): 2092-2096.",null,"Katz, D., et al.","Sociodemographic characteristics and health related quality of life in men attending prostate cancer support groups","PURPOSE: Prostate cancer can be associated with anxiety, depression and fears of recurrence and side effects of treatment. Support groups may help meet the needs of patients with cancer by providing treatment information and emotional support. We describe men in prostate cancer support groups and compare them to a national registry. METHODS AND METHODS: Men attending prostate cancer support groups in the San Francisco Bay area completed a questionnaire including sociodemographic and clinical characteristics, health related quality of life items, satisfaction with treatment, relief of prostate cancer symptoms and bother from perceived side effects of treatment. Patients in support groups were compared to men enrolled in a national prostate cancer registry (Cancer of the Prostate Strategic Urological Research Endeavor). RESULTS: Men attending support groups had higher annual income and education levels, lower median serum prostate specific antigen and higher cancer grades than men in Cancer of the Prostate Strategic Urological Research Endeavor. Clinical stage was comparable for the 2 groups. Men in support groups were satisfied with treatment and alleviation from symptoms. Adjusting for ethnicity, marital status, age and type of treatment, sexual function scores were higher in men who attended support groups (p = 0.001). There was no statistically significant difference in bowel and urinary function between groups, although urinary function approached statistical significance at p = 0.05. Sexual and bowel bother scores indicated less bother for men in support groups (p < or = 0.025). CONCLUSIONS: Men enrolled in support groups have unique sociodemographic characteristics. Their health related quality of life appears to be better than that of other men with prostate cancer. Whether this is related to support group participation is not known. Additional studies are required to determine whether routine support group participation improves outcomes in men with prostate cancer.","J Urol, 168(5): 2092-2096","USA",2002,"Any or unknown","None","Unclear","Patient",null,"Cross-sectional","USA","Patient","Any or unknown","None",null,"Cross-sectional","Unclear","2000:2004","General,Symptom,Satisfaction,Treatment"]
[345,"Katz, G. and R. Rodriguez (2001). \"Use of a modified American Urological Association Symptom Score for the evaluation of the quality of life of patients with prostate cancer.\" Urology 57(1): 112-116.",null,"Katz, G. and R. Rodriguez","Use of a modified American Urological Association Symptom Score for the evaluation of the quality of life of patients with prostate cancer","OBJECTIVES: To present our experience with the clinical use of a modified American Urological Association Symptom Score (AUASS) and a quality-of-life (QOL) questionnaire in obtaining clinically available information and to investigate whether a relatively short questionnaire, administered in the clinic, can help in identifying symptoms and QOL issues associated with various types of definitive treatments (DTs) for prostate cancer (PCa) and its impact on patients' QOL. METHODS: The AUASS was modified to contain questions on continence and was combined with a short QOL questionnaire. It was administered to control groups and all patients with PCa during their clinic visit. The responses were analyzed and correlated with the DT of PCa. RESULTS: The questionnaire was administered 846 times to 375 patients with PCa and to 170 controls during clinic visits. We found that patients on watchful waiting had symptom scores and QOL responses similar to controls and that DT was associated with worse scores and a reduced QOL. DT with continence was associated with a better QOL than DT with incontinence. Incontinence of either urine or stool, among DT patients, had similar adverse impact on QOL, compared with continent DT patients. CONCLUSIONS: The questionnaire, administered in a clinical setting, provides insight into the QOL and symptoms associated with interventions aimed at curing PCa. The use of such a questionnaire enhances the objective documentation of treatment outcomes of PCa and benefits the patients by increasing their opportunities to express their problems.","Urology, 57(1): 112-116","USA",2001,"Any or unknown","None","AUA-SI","Patient",null,"Validation","USA","Patient","Any or unknown","None",null,"Validation","AUA-SI","2000:2004","Symptom"]
[346,"Katz, G. and R. Rodriguez (2007). \"Changes in continence and health-related quality of life after curative treatment and watchful waiting of prostate cancer.\" Urology 69(6): 1157-1160.",null,"Katz, G. and R. Rodriguez","Changes in continence and health-related quality of life after curative treatment and watchful waiting of prostate cancer","OBJECTIVES: To investigate the long-term changes in health-related quality of life (HRQOL), continence, and sexual function after curative therapy (CT) and watchful waiting (WW) for prostate cancer. METHODS: A self-reported questionnaire of HRQOL and continence was administered to patients with prostate cancer who were candidates for CT and WW. The questionnaire was re-administered during follow-up. The pretreatment and posttreatment HRQOL burden scores were compared and correlated with the treatment, continence, and sexual function. RESULTS: Of the 61 patients, 41 chose CT (26 chose prostatectomy and 15 radiotherapy). The average follow-up for the CT patients was 24.3 +/- 13.3 months. The pretreatment incontinence score was 0.38 +/- 0.9 and the HRQOL burden score was 16.3 +/- 8.8 (CT versus WW, P = 0.55). On follow-up, 23 (56%) of 41 CT patients were continent. The HRQOL burden score after treatment was similar between the CT and WW patients (20.4 +/- 9.6 versus 18.4 +/- 9.0, P = 0.45). The continent patients had a significantly lower HRQOL burden compared with the post-CT incontinent patients (17.41 +/- 7.4 versus 24.2 +/- 10.8, P = 0.02). The HRQOL burden score after treatment for CT patients who maintained sexual activity and CT patients who lost their sexual activity was similar (P = 0.28). CONCLUSIONS: The HRQOL after CT of prostate cancer was related to patients' self-perception of continence. Incontinence, either urinary or fecal, was associated with an increased self-reported HRQOL burden, although reduced sexual function was not associated with such a change. The WW patients maintain their HRQOL. Separating the continent and incontinent patients during the analysis of the posttreatment HRQOL brought to light the adverse outcomes associated with post-CT incontinence.","Urology, 69(6): 1157-1160","USA",2007,"Any or unknown","Surgery,Radiotherapy,Surveillance","Unclear","Patient",null,"Clinical trial","USA","Patient","Any or unknown","Surgery,Radiotherapy,Surveillance",null,"Clinical trial","Unclear","2005:2009","General,Complication"]
[347,"Katz, R., et al. (2002). \"Patient reported sexual function following laparoscopic radical prostatectomy.\" J Urol 168(5): 2078-2082.",null,"Katz, R., et al.","Patient reported sexual function following laparoscopic radical prostatectomy","PURPOSE: We evaluated the sexual function of patients who underwent laparoscopic radical prostatectomy. We assessed the effect of unilateral or bilateral preservation of the neurovascular bundle on the ability to achieve erections and have sexual intercourse postoperatively. MATERIAL AND METHODS: Between May 1998 and September 2001, 232 men underwent laparoscopic radical prostatectomy for localized prostate cancer at our institution. Sexual function questionnaires were given to the patients preoperatively. The study included 143 patients who were potent preoperatively. After the procedure the surgeon noted whether he performed unilateral, bilateral or no nerve sparing. Sexual function questionnaires were collected at 1, 3, 6 and 12 months after surgery. RESULTS: Of the 143 patients, 100, 80, 48 and 26 responded to the questionnaire at 1, 3, 6 and 12 months respectively. Of the nonnerve sparing group 11.7%, 11.1%, 16.6% and 30%, of the unilateral nerve sparing group 20%, 35%, 41.6% and 50% and of the bilateral nerve sparing group 32.5%, 41.1%, 29.1% and 87.5% respectively reported spontaneous erections 1, 3, 6 and 12 months after surgery, respectively. The overall incidence of positive lateral surgical margins in pT2 cases treated with a nerve sparing procedure was 8.4%. CONCLUSIONS: The overall rate of patients who had erections preoperatively and maintained erections after surgery (53.8%) is comparable to the results for open surgery. Patients with bilateral preservation did better than those with unilateral preservation. Our preliminary results show a promising rate of potency at 1 year after laparoscopic radical prostatectomy.","J Urol, 168(5): 2078-2082","France",2002,"Local","Surgery","Unclear","Patient",null,"Cross-sectional","France","Patient","Local","Surgery",null,"Cross-sectional","Unclear","2000:2004","Complication"]
[348,"Keller, L. M., et al. (2012). \"Stamp test delivers message on erectile dysfunction after high-dose intensity-modulated radiotherapy for prostate cancer.\" Urology 80(2): 337-342.",null,"Keller, L. M., et al.","Stamp test delivers message on erectile dysfunction after high-dose intensity-modulated radiotherapy for prostate cancer","OBJECTIVE: To evaluate erectile function after high-dose radiotherapy for prostate cancer using the International Index of Erectile Function, Expanded Prostate Cancer Index Composite, and stamp test. METHODS: Men with favorable and intermediate-risk prostate cancer were assigned to receive prostate intensity-modulated radiotherapy (IMRT) versus an erectile tissue-sparing IMRT technique in a Phase III randomized, prospective study. The stamp test and International Index of Erectile Function and Expanded Prostate Cancer Index Composite questionnaires were completed at baseline and 6 months, 1 year, and 2 years after IMRT. The Sexual Health Inventory for Men scores were abstracted from the International Index of Erectile Function questionnaire. A partner questionnaire, designated IIEF-P, modeled after the International Index of Erectile Function questionnaire but from the perspective of the partner, was also collected. RESULTS: The data from 94 men who were enrolled in the trial and who had completed >/=1 questionnaire or 1 stamp test were analyzed. The median age of the patient population was 62.5 years. The median radiation dose was 76 Gy (range 74-80). At 6 months and 1 year after high-dose IMRT, a positive stamp result correlated significantly with the median Expanded Prostate Cancer Index Composite sexual summary, sexual function, and bother subscale scores. Additionally, 6 months after IMRT, the stamp test correlated with the median International Index of Erectile Function, International Index of Erectile Function sexual function domain, and Sexual Health Inventory for Men scores. Robust concordance for the International Index of Erectile Function and Sexual Health Inventory for Men scores was appreciated between responding patient and partner pairs. CONCLUSION: Nocturnal tumescence, as indicated by a positive stamp test, correlated well with established quality of life questionnaires after IMRT. The stamp test should strongly be considered as an objective measure of erectile function in future studies of erectile dysfunction in patients with prostate cancer.","Urology, 80(2): 337-342","USA",2012,"Any or unknown","Radiotherapy","EPIC,IIEF-5,SHIM","Patient",null,"Validation","USA","Patient","Any or unknown","Radiotherapy",null,"Validation","EPIC,IIEF-5,SHIM","2010:2014","Disease,Complication"]
[349,"Kendel, F., et al. (2016). \"Patients' perceptions of mortality risk for localized prostate cancer vary markedly depending on their treatment strategy.\" Int J Cancer 139(4): 749-753.",null,"Kendel, F., et al.","Patients' perceptions of mortality risk for localized prostate cancer vary markedly depending on their treatment strategy","Treatment choice for localized prostate cancer (PCa) is a controversial issue, and mortality risk is probably the most decisive factor in this regard. The study aimed to compare prostate-cancer-specific mortality risk estimates for different treatment options assigned by patients managed with active surveillance (AS), radical prostatectomy (RP) and patients who had discontinued AS (DAS). Patients initially managed with AS or RP (N = 370) were matched according to length of therapy. All patients completed mailed questionnaires assessing their mortality risk estimates (in %) and prostate-cancer-specific anxiety. Differences in risk estimates among the three treatment groups were analyzed using ANOVA, relationships of clinical and psychosocial variables with risk estimates using standard multiple regression. In all treatment groups, the prostate- cancer-specific mortality risk was overestimated. This applied whether it was the patient's own treatment or the alternative treatment option. RP patients assigned a mortality risk to AS that was almost three times higher than that assigned to RP (50.9 +/- 25.0 vs. 17.8 +/- 19.7, d = 1.48; p < 0.001). Anxiety was significantly associated with risk estimates for AS (p = 0.008) and RP (p = 0.001). Compared with clinical data that suggest that the prostate-cancer-specific mortality risk for AS is low and does not significantly differ from that for RP, patients strongly overestimated the mortality risk. This was most markedly so in RP patients, who drastically overestimated the benefits of RP compared to the risk of AS. This overestimation could increase overtreatment and should therefore be corrected by better patient education.","Int J Cancer, 139(4): 749-753","Germany",2016,"Local","Surgery,Surveillance","Unclear","Patient",null,"Cross-sectional","Germany","Patient","Local","Surgery,Surveillance",null,"Cross-sectional","Unclear","2015:2018","Comorbidity"]
[350,"Keogh, J. W., et al. (2010). \"Predictors of physical activity and quality of life in New Zealand prostate cancer survivors undergoing androgen-deprivation therapy.\" N Z Med J 123(1325): 20-29.",null,"Keogh, J. W., et al.","Predictors of physical activity and quality of life in New Zealand prostate cancer survivors undergoing androgen-deprivation therapy","AIMS: The aims of this study were to: quantify the levels and predictors of physical activity in prostate cancer survivors on androgen-deprivation therapy (ADT); gain some insight into the effect of physical activity on the quality of life of prostate cancer survivors on ADT; and compare the quality of life of prostate cancer survivors on ADT with matched controls. METHODS: A sample of 84 prostate cancer survivors on ADT were recruited from a register held by the Auckland District Health Board. Participants were mailed a collection of self-report surveys probing quality of life, physical activity and determinants of physical activity. RESULT: Less than half the prostate cancer sample were categorised as physically active, and there was no relationship between physical activity and age, PSA levels, or time on ADT. Compared to a matched control group the sample had lower scores for global quality of life, as well as on the physical and environmental quality of life domains. Results also showed that those prostate cancer survivors classified as active had higher levels of quality of life on average than those classified as insufficiently active. Attitude towards physical activity was the dominant predictor of the intention to be physically active, while perceived behavioural control was the dominant predictor of actual behaviour. CONCLUSIONS: Our findings describe a positive relationship between physical activity and quality of life in men with prostate cancer currently undergoing ADT. However, only half the sample was physically active, indicating that physical activity interventions aimed at prostate cancer survivors are of utility. Our data suggests targeting both attitudes and factors related to the ability to perform physical activity will be fruitful approaches.","N Z Med J, 123(1325): 20-29","New Zealand",2010,"Survivors","Hormonal","Unclear","Patient",null,"Case-control","New Zealand","Patient","Survivors","Hormonal",null,"Case-control","Unclear","2010:2014","General"]
[351,"Kim, S. P., et al. (1999). \"QOL and outcomes research in prostate cancer patients with low socioeconomic status.\" Oncology (Williston Park) 13(6): 823-832; discussion 835-828.",null,"Kim, S. P., et al.","QOL and outcomes research in prostate cancer patients with low socioeconomic status","The VA Cancer of the Prostate Outcomes Study (VA CaPOS) is collecting quality-of-life (QOL) information from prostate cancer patients, spouses, and physicians at six VA medical centers. Currently, 601 men with prostate cancer are included in the study, most of whom are of low socioeconomic status and over half of whom are African-American. Quality-of-life responses were most favorable for newly diagnosed patients, intermediate for those with stable metastatic disease, and poorest for those with progressive metastatic disease. Patients could not provide reliable estimates of their own preferences for future QOL states but responded reliably to questions phrased as a comparison of the preferences of two hypothetical patients. High out-of-pocket costs for hormonal therapies, lack of health insurance, and a belief that the non-VA system offered poorer services were the most common reasons for patient transferral to the VA system. Satisfaction with medical care was generally high. While African-American patients were more likely to have advanced prostate cancer at diagnosis, after adjustment for differences in health literacy, race was no longer a significant predictor of advanced disease. The VA CaPOS provides useful information on health status and patient satisfaction of VA prostate cancer patients. Long-term evaluations are needed to detect clinically meaningful QOL information as the disease progresses.","Oncology (Williston Park), 13(6): 823-832; discussion 835-828","USA",1999,"Any or unknown","None","Unclear","Patient",null,"Cross-sectional","USA","Patient","Any or unknown","None",null,"Cross-sectional","Unclear","1960:1999","General"]
[352,"Kim, S. P., et al. (2001). \"Health literacy and shared decision making for prostate cancer patients with low socioeconomic status.\" Cancer Invest 19(7): 684-691.",null,"Kim, S. P., et al.","Health literacy and shared decision making for prostate cancer patients with low socioeconomic status","Quality of life (QOL) considerations are important in the treatment decision making process for prostate cancer patients. Although patient involvement in the treatment decision process has been encouraged, low health literacy can limit patient understanding of the complex information about treatments and their probable QOL outcomes and is a barrier to patient participation in the decision-making process. The objectives of the study were to evaluate (i) knowledge, level of satisfaction, and treatment preferences and intentions of men newly diagnosed with prostate cancer after participation in a CD-ROM shared decision making program; and (ii) the relationship between prostate cancer knowledge and health literacy. Thirty newly diagnosed prostate cancer patients from two Veteran's Administration (VA) hospitals in Chicago completed a demographic questionnaire and participated in an interactive CD-ROM shared decision making program. Subsequently, knowledge of prostate cancer, satisfaction with the information in the computer CD-ROM program, treatment preferences, and likelihood of following treatment preferences were assessed using interviewer-administered questionnaires. Health literacy was assessed using the Rapid Estimate of Adult Literacy in Medicine (REALM). The Pearson correlation test was used to assess the relationship between health literacy and prostate cancer knowledge. The chi2 test and the Fischer exact test were used to evaluate relationships between patient demographics and other variables. More than three-quarters of the patients rated the information in the CD-ROM as \"very satisfactory\" (highest possible rating). Two-thirds of the patients (21 of 30) selected a treatment after participation in the CD-ROM program and 90.5% of these patients stated that they were very or somewhat likely to adhere to their selection. However, prostate cancer knowledge was variable, with one-third of the patients scoring 69.9% or lower. Participants' health literacy was equivalent to a 7th-8th grade reading level (mean = 57.1+/-10.9), and more than one-third of participants (36.7%) had lower than 9th grade literacy levels. Participants' prostate cancer knowledge was correlated with health literacy (Pearson correlation rhor = 0.65, rhop = 0.0001). Patients were satisfied with the interactive shared decision making CD-ROM program, and two-thirds of patients were able to select a preferred treatment based on the information presented in the program that they intended to follow. However, prostate cancer knowledge scores varied among participants after participation in the CD-ROM program, raising doubts that patients were adequately informed to make appropriate choices regarding their treatment. Lower prostate cancer knowledge scores corresponded to lower literacy scores, indicating that low literacy may have hindered patient understanding of the shared decision making program. The development of shared decision making tools should include collaborative efforts with the target population to improve the success of shared decision making programs among patients with low health literacy.","Cancer Invest, 19(7): 684-691","USA",2001,"Any or unknown","None","Unclear","Patient",null,"Cross-sectional","USA","Patient","Any or unknown","None",null,"Cross-sectional","Unclear","2000:2004","Knowledge,Views"]
[353,"King, C. R., et al. (2013). \"Health-related quality of life after stereotactic body radiation therapy for localized prostate cancer: results from a multi-institutional consortium of prospective trials.\" Int J Radiat Oncol Biol Phys 87(5): 939-945.",null,"King, C. R., et al.","Health-related quality of life after stereotactic body radiation therapy for localized prostate cancer: results from a multi-institutional consortium of prospective trials","PURPOSE: To evaluate the early and late health-related quality of life (QOL) outcomes among prostate cancer patients following stereotactic body radiation therapy (SBRT). METHODS AND MATERIALS: Patient self-reported QOL was prospectively measured among 864 patients from phase 2 clinical trials of SBRT for localized prostate cancer. Data from the Expanded Prostate Cancer Index Composite (EPIC) instrument were obtained at baseline and at regular intervals up to 6 years. SBRT delivered a median dose of 36.25 Gy in 4 or 5 fractions. A short course of androgen deprivation therapy was given to 14% of patients. RESULTS: Median follow-up was 3 years and 194 patients remained evaluable at 5 years. A transient decline in the urinary and bowel domains was observed within the first 3 months after SBRT which returned to baseline status or better within 6 months and remained so beyond 5 years. The same pattern was observed among patients with good versus poor baseline function and was independent of the degree of early toxicities. Sexual QOL decline was predominantly observed within the first 9 months, a pattern not altered by the use of androgen deprivation therapy or patient age. CONCLUSION: Long-term outcome demonstrates that prostate SBRT is well tolerated and has little lasting impact on health-related QOL. A transient and modest decline in urinary and bowel QOL during the first few months after SBRT quickly recovers to baseline levels. With a large number of patients evaluable up to 5 years following SBRT, it is unlikely that unexpected late adverse effects will manifest themselves.","Int J Radiat Oncol Biol Phys, 87(5): 939-945","USA",2013,"Local","Radiotherapy,Hormonal","EPIC","Patient",null,"Clinical trial","USA","Patient","Local","Radiotherapy,Hormonal",null,"Clinical trial","EPIC","2010:2014","Disease"]
[354,"Klaff, R., et al. (2016). \"Clinical characteristics and quality-of-life in patients surviving a decade of prostate cancer with bone metastases.\" BJU Int 117(6): 904-913.",null,"Klaff, R., et al.","Clinical characteristics and quality-of-life in patients surviving a decade of prostate cancer with bone metastases","OBJECTIVE: To describe characteristics and quality-of-life (QoL), and to define factors associated with long-term survival in a subgroup of patients with prostate cancer with M1b disease. PATIENTS AND METHODS: The study was based on 915 patients from a prospective randomised multicentre trial (No. 5) by the Scandinavian Prostate Cancer Group, comparing parenteral oestrogen with total androgen blockade. Long-term survival was defined as patients having an overall survival of >/=10 years, and logistic regression models were constructed to identity clinical predictors of survival. QoL during follow-up was assessed using the European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire - C30 version 1 (EORTC-C30) ratings. RESULTS: In all, 40 (4.4%) of the 915 men survived for >10 years. Factors significantly associated with increased likelihood of surviving for >10 years in the univariate analyses were: absence of cancer-related pain; Eastern Cooperative Oncology Group (ECOG) performance status of <2; negligible analgesic consumption; T-category of 1-2; prostate-specific antigen (PSA) level of <231 mug/L; and a Soloway score of 1. In the multivariate analyses, ECOG performance status of <2, PSA level of <231 mug/L, and Soloway score of 1, were all independent predictors of long-term survival. All subscales of the EORTC-C30 were higher in this group than for patients with short survival, but slowly declined over the decade. CONCLUSION: A subgroup of patients with prostate cancer with M1b disease and certain characteristics showed a positive long-term response to androgen-deprivation therapy with an acceptable QoL over a decade or more. Independent predictors of long-term survival were identified as ECOG performance status of <2, limited extent of bone metastases (Soloway score of 1), and a PSA level of <231 mug/L at the time of enrolment.","BJU Int, 117(6): 904-913","Sweden",2016,"Survivors","None","EORTC QLQ-C30","Patient",null,"Clinical trial","Sweden","Patient","Survivors","None",null,"Clinical trial","EORTC QLQ-C30","2015:2018","General"]
[355,"Klein, J., et al. (2016). \"Socioeconomic status and health-related quality of life among patients with prostate cancer 6 months after radical prostatectomy: a longitudinal analysis.\" BMJ Open 6(6): e010968.",null,"Klein, J., et al.","Socioeconomic status and health-related quality of life among patients with prostate cancer 6 months after radical prostatectomy: a longitudinal analysis","OBJECTIVES: To identify the associations between socioeconomic status (SES) and health-related quality of life (HRQOL) and the explanatory contribution of disease, patient and healthcare factors among patients with prostate cancer. DESIGN: Prospective cohort study. SETTING AND PARTICIPANTS: In all, 246 patients from 2 hospitals in Hamburg/Germany who underwent radical prostatectomy completed a questionnaire shortly before discharge from hospital and again 6 months later. OUTCOME MEASURES: HRQOL as assessed by the European Organisation for Research and Treatment of Cancer (EORTC) QLQ C-30 including global quality of life, 5 functional scales and 9 symptom scales/items. Generalised estimating equations were calculated to analyse longitudinal data. RESULTS: Lower SES measured by income, education and occupational status is significantly associated with lower HRQOL 6 months after treatment. This especially holds true for the functional scales. After introducing disease, patient and healthcare factors, associations remain significant in the majority of cases. The explanatory contribution of patient factors such as comorbidity or psychosocial characteristics and of healthcare factors is slightly stronger than that of disease factors. CONCLUSIONS: We identified strong social inequalities in HRQOL among patients with prostate cancer 6 months after surgery, in Germany. The underlying causes could not be sufficiently identified, and further research regarding these associations and their explanatory factors is needed.","BMJ Open, 6(6): e010968","Germany",2016,"Any or unknown","Surgery","EORTC QLQ-C30","Patient",null,"Cohort","Germany","Patient","Any or unknown","Surgery",null,"Cohort","EORTC QLQ-C30","2015:2018","General"]
[356,"Klotz, L. (2000). \"Hormone therapy for patients with prostate carcinoma.\" Cancer 88(12 Suppl): 3009-3014.",null,"Klotz, L.","Hormone therapy for patients with prostate carcinoma","BACKGROUND: Androgen ablation as a treatment for patients with prostate carcinoma was described 60 years ago. Despite the long pedigree for this treatment, the optimal use of androgen ablation therapy remains extremely controversial. Monitoring the level of prostate specific antigen (PSA) has created a dramatic shift in the population of patients in whom androgen ablation is initiated. This has resulted in a number of changing concepts of treatment. Patients with recurrent prostate carcinoma after the failure of local therapy are now diagnosed with recurrent disease on the basis of a rising PSA level. These patients have a median life expectancy of 10-15 years compared with 3 years for patients who present with metastatic disease. This means that the systemic side effects of androgen ablation and the impact on quality of life have become more important. Controversies exist with respect to the timing of therapy, the use of intermittent androgen ablation, and the role of total androgen blockade. METHODS: A critical review of the literature, with an emphasis on quality of life and recent publications, was performed. RESULTS: Data support the early initiation of androgen ablation for patients with locally advanced or lymph node positive prostate carcinoma. There are no data supporting a particular PSA trigger point or a PSA doubling time for the initiation of androgen ablation therapy after the failure of local radical therapy. The combined results of 27 prospective randomized trials of total androgen blockade support the finding of a modest survival benefit for patients who undergo androgen ablation with combined therapy. The average, absolute 5-year survival rate was improved by 3% (a 10% reduction in the risk of dying), with a 95% confidence interval between 0.4% and 6.0%. Intermittent therapy resulted in an improved quality of life in the off-treatment interval. Uncertainty remains with respect to the long term effect of intermittent androgen ablation therapy on patient survival. This is being studied in a prospective intergroup trial comparing continuous therapy with intermittent therapy carried out by the National Cancer Institute Criteria/Canadian Uro-Oncology Group and the Southwest Oncology Group. CONCLUSIONS: Androgen ablation therapy is an effective treatment for patients with advanced prostate carcinoma. It has serious limitations, however. Although it improves patient survival, it is not curative, and it is associated with a substantial adverse impact on the quality of life for patients, particularly when its use is prolonged. The advent of intermittent therapy may reduce this impact. The real challenge, however, is to develop better means to avert hormone-refractory prostate carcinoma and better treatments for patients with hormone-refractory disease when it occurs.","Cancer, 88(12 Suppl): 3009-3014","International",2000,"Advanced","Hormonal","Unclear","Patient",null,"Systematic review","International","Patient","Advanced","Hormonal",null,"Systematic review","Unclear","2000:2004","General"]
[357,"Knight, S. J., et al. (1998). \"Quality of life in metastatic prostate cancer among men of lower socioeconomic status: feasibility and criterion related validity of 3 measures.\" J Urol 160(5): 1765-1769.",null,"Knight, S. J., et al.","Quality of life in metastatic prostate cancer among men of lower socioeconomic status: feasibility and criterion related validity of 3 measures","PURPOSE: Identification of metastatic disease progression is often difficult but important. Previous studies of quality of life in metastatic disease have been limited by the small number of respondents who were not white or of lower socioeconomic status. Quality of life assessment is generally done using self-administration techniques but this method is of limited usefulness for patients of low socioeconomic status, many of whom have limited reading abilities. We evaluated the feasibility and validity of interviewer administration of 3 quality of life instruments for patients of low socioeconomic status with metastatic prostate cancer. MATERIALS AND METHODS: We used instruments previously validated with self-administration methodology, including the European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire-30, Functional Assessment of Cancer Therapy-General Scale and Quality of Life Index. Subjects were men with metastatic prostate cancer with stable (78) or progressive (32) disease at 4 Veterans Affairs medical centers and 1 other site. Of the patients 94% were Veterans Affairs patients and more than 60% were black. RESULTS: Each quality of life instrument required less than 10 minutes of interviewer administration and was able to discriminate between patients with stable versus progressive disease on several health status domains. CONCLUSIONS: These data support the feasibility and validity of quality of life measurement in patients of low socioeconomic status with metastatic prostate cancer. Consideration should be given to adding quality of life instruments to patient encounter even among low socioeconomic status, low literacy populations.","J Urol, 160(5): 1765-1769","USA",1998,"Metastatic","None","EORTC QLQ-C30,FACT-G,QLI","Patient",null,"Validation","USA","Patient","Metastatic","None",null,"Validation","EORTC QLQ-C30,FACT-G,QLI","1960:1999","General,Treatment"]
[358,"Knight, S. J., et al. (2004). \"Ethnic variation in localized prostate cancer: a pilot study of preferences, optimism, and quality of life among black and white veterans.\" Clin Prostate Cancer 3(1): 31-37.",null,"Knight, S. J., et al.","Ethnic variation in localized prostate cancer: a pilot study of preferences, optimism, and quality of life among black and white veterans","Ethnic variations that may influence the preferences and outcomes associated with prostate cancer treatment are not well delineated. Our objective was to evaluate prospectively preferences, optimism, involvement in care, and quality of life (QOL) in black and white veterans newly diagnosed with localized prostate cancer. A total of 95 men who identified themselves as black/African-American or white who had newly diagnosed, localized prostate cancer completed a \"time trade-off\" task to assess utilities for current health and mild, moderate, and severe functional impairment; importance rankings for attributes associated with prostate cancer (eg, urinary function); and baseline and follow-up measures of optimism, involvement in care, and QOL. Interviews were scheduled before treatment, and at 3 and 12 months after treatment. At baseline, both blacks and whites ranked pain, bowel, and bladder function as their most important concerns. Optimism, involvement in care, and QOL were similar. Utilities for mild impairment were lower for blacks than whites, but were similar for moderate and severe problems. Decline in QOL at 3 and 12 months compared to baseline occurred for both groups. However, even with adjustment for marital status, education level, and treatment, blacks had less increase in nausea and vomiting and more increase in difficulty with sexual interest and weight gain compared with whites. Black and white veterans entered localized prostate cancer treatment with similar priorities, optimism, and involvement in care. Quality-of-life declines were common to both groups during the first year after diagnosis, but ethnic variation occurred with respect to nausea and vomiting, sexual interest, and weight gain.","Clin Prostate Cancer, 3(1): 31-37","USA",2004,"Local","Unclear","TTO","Patient",null,"Cohort","USA","Patient","Local","Unclear",null,"Cohort","TTO","2000:2004","Utility"]
[359,"Koch, M. O., et al. (2003). \"Early catheter removal after radical retropubic prostatectomy: long-term followup.\" J Urol 169(6): 2170-2172.",null,"Koch, M. O., et al.","Early catheter removal after radical retropubic prostatectomy: long-term followup","PURPOSE: We examine the complication and continence rates with early catheter removal (day 3 or 4) after radical retropubic prostatectomy. MATERIALS AND METHODS: A total of 365 patients with localized prostate cancer underwent radical retropubic prostatectomy at Indiana University Hospital with planned urethral catheter removal before discharge home. Low pressure cystograms were performed on postoperative day 3 or 4 to determine if catheter removal was possible. A subset of patients were analyzed using a validated prostate cancer specific questionnaire (University of California, Los Angeles Prostate Cancer Symptom Index) to determine quality of life outcomes. RESULTS: The catheter was removed on postoperative day 3 or 4 in 263 patients (72%). The reasons for leaving the catheter indwelling were significant leak on cystogram or excessive suprapubic drainage (21%), extensive bladder neck reconstruction (1%) and prolonged hospitalization because of an ileus or other complicating factor (6%). Thirteen patients (3.6%) were either unable to void after catheter removal or presented with retention (not associated with hematuria or clots) after hospital discharge, requiring reinsertion of the Foley catheter. A total of 41 patients (11%) had either an early or late complication (excluding incontinence). There were 3 complications (0.8%) that were considered major because they were potentially life threatening or required a return to the operating room. A pelvic abscess developed in 2 patients and a lymphocele in 1, which required percutaneous drainage. After at least 6 months (mean 20.9 months) 140 patients (89.2%) and 14 (8.9%) reported excellent and good continence, respectively. The patient questionnaire demonstrated bother scores to be minimal to no bother for 95% to 98% of patients at 6 and 12 months. CONCLUSIONS: This study confirms that it is safe to remove catheters in most patients 3 to 4 days after prostatectomy if a cystogram demonstrates no extravasation. Complication rates and continence rates with this approach compare favorably with series in which catheters are left indwelling for longer periods.","J Urol, 169(6): 2170-2172","USA",2003,"Local","Surgery","UCLA-PCI","Patient",null,"Cohort","USA","Patient","Local","Surgery",null,"Cohort","UCLA-PCI","2000:2004","Disease"]
[360,"Komiya, A., et al. (2013). \"Early quality of life outcomes in patients with prostate cancer managed by high-dose-rate brachytherapy as monotherapy.\" Int J Urol 20(2): 185-192.",null,"Komiya, A., et al.","Early quality of life outcomes in patients with prostate cancer managed by high-dose-rate brachytherapy as monotherapy","OBJECTIVES: To evaluate the early quality of life outcomes in prostate cancer patients managed by high-dose-rate brachytherapy as monotherapy. METHODS: A total of 51 patients with cT1c-T3aN0M0 prostate cancer treated between July 2007 and January 2010 were included in this study. The average age was 69 years, and the average initial serum prostate-specific antigen was 10.98 ng/mL. A total of 25, 18 and eight patients were considered to be low, intermediate and high risk, respectively. All patients received one implant of Ir-192 and seven fractions of 6.5 Gy within 3.5 days for a total prescribed dose of 45.5 Gy. For high-risk prostate cancer, neoadjuvant androgen deprivation therapy was carried out for at least 6 months, and continued after high-dose-rate brachytherapy. Quality of life outcomes were measured by using the International Prostate Symptom Score, the Functional Assessment of Cancer Therapy-Prostate and the International Index of Erectile Function Questionnaire. The oncological outcome was assessed by serum prostate-specific antigen and diagnostic imaging. Adverse events were also recorded. RESULTS: The Functional Assessment of Cancer Therapy-Prostate scores decreased for a few months after high-dose-rate brachytherapy, and recovered to pretreatment condition thereafter. The International Prostate Symptom Score significantly increased 2 weeks after treatment for each of its items and their sum, and it returned to baseline after 12 weeks. Sexual function decreased at 2 and 4 weeks, and recovered after 12 weeks. Severe complications were rare. Within a median follow up of 17.2 months, two patients showed a prostate-specific antigen recurrence. CONCLUSIONS: High-dose-rate brachytherapy for prostate cancer is a feasible treatment modality with acceptable toxicity and only a limited impact on the quality of life.","Int J Urol, 20(2): 185-192","Japan",2013,"Local,Advanced","Brachytherapy","FACT-P,IIEF-5,IPSS","Patient",null,"Cohort","Japan","Patient","Local,Advanced","Brachytherapy",null,"Cohort","FACT-P,IIEF-5,IPSS","2010:2014","Disease,Complication"]
[361,"Korfage, I. J., et al. (2003). \"Measuring disease specific quality of life in localized prostate cancer: the Dutch experience.\" Qual Life Res 12(4): 459-464.",null,"Korfage, I. J., et al.","Measuring disease specific quality of life in localized prostate cancer: the Dutch experience","OBJECTIVE: We aimed at developing and testing a Dutch health-related quality of life measure for localized prostate cancer patients. METHODS: Scales on urinary and bowel function and bother from the UCLA Prostate Cancer Index (PCI) underwent formal linguistic and cultural translation. PCI sexual scales were replaced by an existing Dutch sexual activities module (SAc). After qualitative pilot testing 389 patients with localized prostate cancer (mean age 67 +/- 7 years) completed the measure before and at 2 time points after primary treatment. Psychometric properties (feasibility, score distribution, reliability, construct validity and responsiveness to change) of the new instrument were analyzed. RESULTS: Response rates ranged from 93% at baseline to 87% after treatment. Urinary and bowel function scales showed Cronbach's alphas >0.7. Urinary function and bother, and bowel function and bother were significantly correlated. Pre- vs. post-prostatectomy effect sizes were >0.9 only for urinary scales; while pre- vs. post-radiotherapy effect sizes were >0.75 only for bowel scales. Six months after baseline erectile dysfunction was reported by 64% of respondents, either as a problem in sexual activity or as a reason for not being sexually active. CONCLUSION: The Dutch PCI and SAc performed well in men treated for early stage prostate cancer.","Qual Life Res, 12(4): 459-464","Netherlands",2003,"Local","Surgery,Radiotherapy","UCLA-PCI,SAc","Patient",null,"Validation","Netherlands","Patient","Local","Surgery,Radiotherapy",null,"Validation","UCLA-PCI,SAc","2000:2004","Disease,Complication"]
[362,"Kornblith, A. B., et al. (1994). \"Quality of life of patients with prostate cancer and their spouses. The value of a data base in clinical care.\" Cancer 73(11): 2791-2802.",null,"Kornblith, A. B., et al.","Quality of life of patients with prostate cancer and their spouses. The value of a data base in clinical care","BACKGROUND: Because of the dearth of information concerning the quality of life of patients with prostate cancer, a data base was established to examine the nature and extent of problems in patients' and spouses' adaptation and their interrelationships and to examine the effect of disease stage combined with treatment regimen on patients' quality of life. METHODS: One hundred seventy-two patients and 83 spouses/partners completed quality of life questionnaires in a prostate cancer health education lecture series. The measures used were the European Organization for Research and Treatment of Cancer (EORTC) Prostate Cancer Quality of Life Questionnaire, the Intrusion subscale (IS) of the Impact of Event Scale; and Selby's QL Uniscale. Fifty-five percent of patients had received medical and/or surgical hormonal therapy, 28% had received a radical prostatectomy and/or radiation therapy only, and 18% had not been placed on any treatment. RESULTS: Patients experiencing problems in adaptation were significantly more likely to have advanced stage disease; received surgical or medical hormonal therapy; and were reporting greater pain, fatigue, urinary problems, and deteriorating physical functioning. Spouses reported significantly greater psychological distress than did patients (EORTC Psychological Distress subscale, P < 0.001; IS, P < 0.001). CONCLUSIONS: A two-stage clinical evaluation is recommended, in which quality of life questionnaires would initially be used to identify patients and spouses experiencing problems in adaptation for further evaluation by a mental health professional for appropriate treatment.","Cancer, 73(11): 2791-2802","USA",1994,"Any or unknown","Surgery,Radiotherapy,Hormonal","EORTC QLQ-PR25,IES,SQLU","Caregiver,Patient",null,"Cross-sectional","USA","Caregiver,Patient","Any or unknown","Surgery,Radiotherapy,Hormonal",null,"Cross-sectional","EORTC QLQ-PR25,IES,SQLU","1960:1999","Disease,General,Complication"]
[363,"Kornblith, A. B., et al. (2006). \"Telephone monitoring of distress in patients aged 65 years or older with advanced stage cancer: a cancer and leukemia group B study.\" Cancer 107(11): 2706-2714.",null,"Kornblith, A. B., et al.","Telephone monitoring of distress in patients aged 65 years or older with advanced stage cancer: a cancer and leukemia group B study","BACKGROUND: Significant barriers to cancer patients receiving mental health treatment for distress have been reported in the literature. The objective of the current study was to determine whether distress in older patients (aged 65 years and older) would be reduced with educational materials (EM) supplemented by monthly telephone monitoring (TM) (TM + EM) compared with the use of EM alone because of more timely referrals to appropriate health professionals. METHODS: One hundred ninety-two older patients with breast, prostate, and colorectal cancers who had advanced disease and currently were receiving treatment were randomized to receive either TM + EM or EM alone. One hundred thirty-one patients were evaluated by telephone interview for psychologic and physical distress and for social support at baseline and at 6 months using the Hospital Anxiety and Depression Scale (HADS), the European Organization for Research and Treatment of Cancer (EORTC)-QLQ-C30 quality-of-life questionnaire, and the Medical Outcomes Study (MOS) Social Support Survey. Patients who in the TM + EM group were called monthly for 6 months to monitor their distress using the HADS and EORTC physical symptom items and the MOS Social Support Survey items, with cutoff levels were established to indicate which patients were in greater distress. Those patients who scored above the cutoff levels were referred to their oncology nurse for referral to the appropriate professional. Patients in the EM group received written materials regarding cancer-related psychosocial issues and available resources. RESULTS: At 6 months, patients in the TM + EM group reported significantly less anxiety (HADS; P < .0001), depression (HADS; P = .0004), and overall distress (HADS; P < .0001) compared with patients in the EM group. CONCLUSIONS: Monthly monitoring of older patients' distress with TM and EM along with referral for appropriate help was found to be an efficient means of reducing patients' anxiety and depression compared with patients who received only EM.","Cancer, 107(11): 2706-2714","USA",2006,"Advanced","Various","HADS,EORTC QLQ-C30,MOS-SSS","Patient",null,"Clinical trial","USA","Patient","Advanced","Various",null,"Clinical trial","HADS,EORTC QLQ-C30,MOS-SSS","2005:2009","General,Comorbidity,Social"]
[364,"Kouba, E., et al. (2007). \"A prospective evaluation of the short-term impact and recovery of health-related quality of life in men undergoing radical prostatectomy.\" BJU Int 99(1): 72-76.",null,"Kouba, E., et al.","A prospective evaluation of the short-term impact and recovery of health-related quality of life in men undergoing radical prostatectomy","OBJECTIVE: To prospectively evaluate the acute and short-term effects of radical retropubic prostatectomy (RRP) on health-related quality of life (HRQoL) using a validated generic HRQoL instrument that measures overall health status, as although there is increasing interest in the HRQoL of patients being treated for prostate cancer, most studies have focused on long-term outcomes. PATIENTS AND METHODS: In all, 121 men undergoing RRP for clinically localized prostate cancer were prospectively evaluated for short-term HRQoL using an acute Short Form-12 version-2 Physical and Mental Health Survey Acute Form before and serially each week from 1 to 6 weeks after RRP. The physical (PCS) and mental component score (MCS) were calculated from the questionnaires at each time and the data analysed by random coefficient modelling. Separate models were fitted for MCS and PCS using covariates of race, age, estimated blood loss (EBL), time after RRP, and their interaction terms. RESULTS: The PCS initially declined and improved linearly. and the baseline level was not achieved by 6 weeks, but modelling lines showed an expected return to baseline at 7-8 weeks for all patients. Age had a significant relationship with the PCS; older men (>60 years) scored higher, and their PCS remained significantly higher after RRP than younger men (< or =60 years) until 5 weeks. EBL also had a significant relationship with PCS; men with an EBL of >500 mL had a significantly lower PCS at 1 week and this remained significantly lower than for men with an EBL of < or = 500 mL until approximately 7 weeks. The MCS improved immediately after RRP and remained higher throughout the study than at baseline. Race was the only covariate for which there were significant differences in the MCS. The MCS was significantly lower at baseline for African-Americans than for Caucasian Americans, and remained lower until 6 weeks after RRP. CONCLUSIONS: There were significant changes in HRQoL during in the short-term after RRP. Younger men and those with a higher EBL might have a slower recovery of the PCS after RRP. African-Americans had a slower increase in MCS and might have a different initial emotional or mental health response to RRP than have Caucasians.","BJU Int, 99(1): 72-76","USA",2007,"Local","Surgery","SF-12","Patient",null,"Cohort","USA","Patient","Local","Surgery",null,"Cohort","SF-12","2005:2009","Utility"]
[365,"Krahn, M. D., et al. (1994). \"Screening for prostate cancer. A decision analytic view.\" Jama 272(10): 773-780.",null,"Krahn, M. D., et al.","Screening for prostate cancer. A decision analytic view","OBJECTIVE: To determine the clinical and economic effects of screening for prostate cancer with prostate-specific antigen (PSA), transrectal ultrasound (TRUS), and digital rectal examination (DRE). DESIGN: Decision analytic cost-utility analysis comparing four screening strategies with a strategy of not screening. We assumed that the cancer detection rate and stage distribution were predicted by each combination of tests and that localized cancer was treated with radical prostatectomy. For each strategy, we calculated life expectancy, quality-adjusted life expectancy (QALE), and cost-utility ratios for unselected and high-prevalence populations. DATA: Probabilities and rates for clinical events were gathered from published data. We assessed utilities by the time-trade-off method using urologists, radiation oncologists, and internists as subjects. The Clinical Cost Manager at the New England Medical Center provided cost data. RESULTS: In unselected men between the ages of 50 and 70 years, screening with PSA or TRUS prolonged unadjusted life expectancy but diminished QALE. Screening with DRE alone yielded no reduction in mortality at any age. All programs increased costs. Results were sensitive only to assumptions about the efficacy of treatment. In high-prevalence populations, screening produced a similar pattern: gains in unadjusted life expectancy, losses in QALE, and increased costs. CONCLUSIONS: Our analysis does not support using PSA, TRUS, or DRE to screen asymptomatic men for prostatic cancer. Screening may result in poorer health outcomes and will increase costs dramatically. Assessment of comorbidity, risk attitude, and valuation of sexual function may identify individuals who will benefit from screening, but selecting high-prevalence populations will not improve the benefit of screening.","Jama, 272(10): 773-780","Canada",1994,"At risk","Screening","TTO","HCP",null,"Economic model","Canada","HCP","At risk","Screening",null,"Economic model","TTO","1960:1999","Utility"]
[366,"Krahn, M. D., et al. (2013). \"A reference set of health utilities for long-term survivors of prostate cancer: population-based data from Ontario, Canada.\" Qual Life Res 22(10): 2951-2962.",null,"Krahn, M. D., et al.","A reference set of health utilities for long-term survivors of prostate cancer: population-based data from Ontario, Canada","PURPOSE: To measure quality of life (QOL) and utilities for prostate cancer (PC) patients and determine their predictors. METHODS: A population-based, community-dwelling, geographically diverse sample of long-term PC survivors in Ontario, Canada, was identified from the Ontario Cancer Registry and contacted through their referring physician. Consenting patients completed questionnaires by mail: Health Utilities Index (HUI 2/3), Patient Oriented Prostate Utility Scale PORPUS-U (utility), PORPUS-P (health profile), Functional Assessment of Cancer Therapy-Prostate (FACT-P), and Prostate Cancer Index (PCI). Clinical data were obtained from chart reviews. Regression models determined the effects of a series of variables on QOL and utility. RESULTS: We received questionnaires and reviewed charts for 585 patients (mean age 72.6, 2-13 years postdiagnosis). Mean utility scores were as follows: PORPUS-U = 0.92, HUI2 = 0.85, and HUI3 = 0.78. Mean health profile scores were as follows: PORPUS-P = 71.7, PCI sexual, urinary, and bowel function = 23.7, 79.1, and 84.6, respectively (0 = worst, 100 = best), and FACT-P = 125.1 (0 = worst, 156 = best). In multiple regression analyses, comorbidity and PCI urinary, sexual, and bowel function were significant predictors of other QOL measures. With all variables, 32-50 % of the variance in utilities was explained. CONCLUSIONS: Many variables affect global QOL of PC survivors; only prostate symptoms and comorbidity have independent effects. Our model allows estimation of the effects of multiple factors on utilities. These utilities for long-term outcomes of PC and its treatment are valuable for decision/cost-effectiveness models of PC treatment.","Qual Life Res, 22(10): 2951-2962","Canada",2013,"Survivors","None","PORPUS,FACT-P,UCLA-PCI,HUI","Patient",null,"Cross-sectional","Canada","Patient","Survivors","None",null,"Cross-sectional","PORPUS,FACT-P,UCLA-PCI,HUI","2010:2014","Utility,Disease"]
[367,"Krahn, M., et al. (2000). \"Construction of the Patient-Oriented Prostate Utility Scale (PORPUS): a multiattribute health state classification system for prostate cancer.\" J Clin Epidemiol 53(9): 920-930.",null,"Krahn, M., et al.","Construction of the Patient-Oriented Prostate Utility Scale (PORPUS): a multiattribute health state classification system for prostate cancer","Health status indexes, such as the EuroQol, consist of a health state classification system and a set of utility weights. Indexes measure quality of life using a 0-1 utility score. Utilities for outcomes in prostate cancer (PC) are of unique importance, but generic indexes do not represent PC outcomes (e.g., sexual, urinary, bowel dysfunction) well, and may not capture their full impact. As a step toward improved utility measurement, we constructed a classification system for PC. We generated items for each of six health domains and rated their importance using interviews with 10 clinical experts and 80 patients. Key concepts were selected for each domain using item importance weightings, and a set of predetermined criteria. Text was developed to express levels of severity within each domain. Experts and two additional groups of patients (n = 40, n = 96) evaluated textual clarity and endorsed the content validity of the instrument. The final system consists of 10 domains with 4-6 levels each. The content validity of the system was endorsed by patients and experts. In conjunction with a set of utility weights, it may be used to develop a health status index, to improve utility measurement in patients, and to serve as a short psychometric (nonutility) instrument.","J Clin Epidemiol, 53(9): 920-930","Canada",2000,"Any or unknown","None","PORPUS","Patient",null,"Validation","Canada","Patient","Any or unknown","None",null,"Validation","PORPUS","2000:2004","Utility"]
[368,"Krahn, M., et al. (2003). \"Patient and community preferences for outcomes in prostate cancer: implications for clinical policy.\" Med Care 41(1): 153-164.",null,"Krahn, M., et al.","Patient and community preferences for outcomes in prostate cancer: implications for clinical policy","BACKGROUND: Preferences, or utilities, for health outcomes are central in prostate cancer decision-making. Utilities can be elicited directly from patients using standard techniques, or indirectly, using questionnaires that incorporate preference weights from community members. OBJECTIVES: To evaluate directly elicited and indirectly elicited (questionnaire-derived, community-weighted) utilities for prostate cancer outcomes and the effects of sexual, urinary, and bowel dysfunction on them. MATERIALS AND METHODS: Utilities for the current health of 141 prostate cancer patients, recruited from ambulatory clinics, were elicited directly with the Patient Oriented Prostate Utility Scale, rating scale (PORPUS-U(RS)) and standard gamble (PORPUS-U(SG)) subscales. Patients completed the Health Utilities Index (HUI) and Quality of Well Being Scale (QWB), utility instruments incorporating community preferences, and the UCLA Prostate Cancer Index. RESULTS: Patients' treatments included radical prostatectomy (18%), radiation (60%), and hormonal (42%). Mean utility scores for current health were 0.65 (QWB), 0.79 (PORPUS-U(RS)), 0.80 (HUI), 0.86 (PORPUS-U(SG)). Utility decrements for dysfunction were small (0.08-0.14 [sexual], 0.06 to 0.13 [urinary], and 0.01 to 0.13 [bowel]), and even smaller when adjusted for concomitant changes in other quality of life (QOL) domains. CONCLUSIONS: Patients' directly elicited utilities for their own health were higher than community-derived utilities obtained from HUI and QWB administration to the same patients. HUI scores of these patients were similar to those of age-matched Canadian men. Sexual, urinary, and bowel problems were common but had less impact on overall QOL than reported in previous utility studies. These results weaken the argument that prostate cancer screening and treatment should be limited because of severe and debilitative side effects.","Med Care, 41(1): 153-164","Canada",2003,"Any or unknown","Surgery,Radiotherapy,Hormonal","PORPUS,UCLA-PCI,QWB,HUI","Patient",null,"Cross-sectional","Canada","Patient","Any or unknown","Surgery,Radiotherapy,Hormonal",null,"Cross-sectional","PORPUS,UCLA-PCI,QWB,HUI","2000:2004","Disease,Utility"]
[369,"Krahn, M., et al. (2007). \"Responsiveness of disease-specific and generic utility instruments in prostate cancer patients.\" Qual Life Res 16(3): 509-522.",null,"Krahn, M., et al.","Responsiveness of disease-specific and generic utility instruments in prostate cancer patients","BACKGROUND: Preferences (utilities) for health outcomes have an important role in decisions about prostate cancer screening and treatment. The responsiveness of utility instruments has not been evaluated. SUBJECTS: Prostate cancer outpatients from the Princess Margaret Hospital, Toronto (n = 248) were allocated into three cohorts: N - newly diagnosed and treated; M - metastatic disease; O - all others. MEASURES: We measured quality of life at 3 points within 12 months using 3 disease-specific utility instruments (Patient Oriented Prostate Utility Scales), 3 generic utility instruments (Health Utilities Index, EQ-5D, Quality of Well-Being Scale), and 3 profile scales (PORPUS-P profile, Prostate Cancer Index, QLQ-C-30). Responsiveness was assessed using measures of internal responsiveness (standardized effect size, standardized response mean) and external responsiveness (receiver operator curve analysis, mixed model regression). RESULTS: Cohort N patients showed post-treatment declines followed by improvement in global health and functional status. Disease specific instruments detected moderate (0.4-1.3) decrements followed by small increments (0.1-0.4) in standardized effect size and standardized response mean. Most instruments detected change using external responsiveness measures (all cohorts). CONCLUSIONS: Disease-specific utility instruments appeared to be more responsive than generic instruments. Use of generic instruments should be supplemented with a responsive disease-specific instrument, particularly for applications in early prostate cancer.","Qual Life Res, 16(3): 509-522","Canada",2007,"Any or unknown","Unclear","PORPUS,EQ-5D,HUI,QWB,UCLA-PCI,EORTC QLQ-C30","Patient",null,"Validation","Canada","Patient","Any or unknown","Unclear",null,"Validation","PORPUS,EQ-5D,HUI,QWB,UCLA-PCI,EORTC QLQ-C30","2005:2009","Utility"]
[370,"Krambeck, A. E., et al. (2009). \"Radical prostatectomy for prostatic adenocarcinoma: a matched comparison of open retropubic and robot-assisted techniques.\" BJU Int 103(4): 448-453.",null,"Krambeck, A. E., et al.","Radical prostatectomy for prostatic adenocarcinoma: a matched comparison of open retropubic and robot-assisted techniques","OBJECTIVE: To assess the perioperative complications and early oncological results in a comparative study matching open radical retropubic (RRP) and robot-assisted radical prostatectomy (RARP) groups. PATIENTS AND METHODS: From August 2002 to December 2005 we identified 294 patients undergoing RARP for clinically localized prostate cancer. A comparison RRP group of 588 patients from the same period was matched 2:1 for surgical year, age, preoperative prostate-specific antigen level, clinical stage and biopsy Gleason grade. Perioperative complications were compared. Patients completed a standardized quality-of-life questionnaire. Pathological features were assessed and Kaplan-Meier estimates of biochemical progression-free survival (PFS) were compared. RESULTS: There was no significant difference in overall perioperative complications between the RARP and RRP groups (8.0% vs 4.8%, P = 0.064). Wound herniation was more common after RARP (1.0% vs none, P = 0.038), and development of bladder neck contracture was more common after RRP (1.2% vs 4.6%; P < 0.018). The hospital stay was less after RARP (29.3% vs 19.4%, P = 0.004, for a stay of 1 day). At the 1-year follow-up there was no significant difference in continence (RARP 91.8%, RRP 93.7%, P = 0.344) or potency (RARP 70.0%, RRP 62.8%, P = 0.081) rates. The biochemical PFS was no different between treatments at 3 years (RARP 92.4%, RRP 92.2%; P = 0.69). CONCLUSION: There was no significant difference in overall early complication, long-term continence or potency rates between the RARP and RRP techniques. Furthermore, early oncological outcomes were similar, with equivalent margin positivity and PFS between the groups.","BJU Int, 103(4): 448-453","USA",2009,"Local","Surgery","Unclear","Patient",null,"Case-control","USA","Patient","Local","Surgery",null,"Case-control","Unclear","2005:2009","General"]
[371,"Krongrad, A., et al. (1997). \"Reliability of Spanish translations of select urological quality of life instruments.\" J Urol 158(2): 493-496.",null,"Krongrad, A., et al.","Reliability of Spanish translations of select urological quality of life instruments","PURPOSE: Many patients with urological disease do not speak English. In medical studies restricting patients to those who speak only English undermines efforts to understand disease because restrictions decrease efficiency of patient recruitment, and because language and culture are associated with variable outcomes. In Spanish speaking locations, such as South Florida, studies would suffer severe selection bias if patients were required to speak English. To allow grouping in future studies of English and Spanish speaking patients we examined the English-Spanish reliability of select instruments that measure health related quality of life in patients with urological disease. MATERIALS AND METHODS: We assembled available Spanish versions and translated English versions of questions regarding satisfaction, the American Urological Association symptom index, the University of California, Los Angeles Prostate Cancer Index and a pain inventory. We then examined English-Spanish reliability by asking bilingual men 50 years old or older to complete English and Spanish versions at the same sitting. A convenience sample was recruited from outpatients and volunteers at the Miami Veterans Affairs Medical Center and population based subjects living in largely Hispanic Hialeah, Florida. Reliability estimates were calculated with kappa coefficients for categorical data and intraclass correlation coefficients for quantitative data. RESULTS: A total of 100 subjects a median of 59 years old completed the questionnaire, including 55 born in Puerto Rico or Cuba, while the remainder were born at various sites throughout the Americas and Spain. Reliability estimates showed that kappa = > 0.81 for almost all items. For 2 items relating to health and social interactions reliability was poor, and stratification showed that poor reliability was primarily a feature of subjects in good health who are theoretically socially active. CONCLUSIONS: Almost all items tested have excellent English-Spanish reliability in a mixed sample of bilingual men. Nonreliability of 2 items relating to health and social interactions probably originates from the effect of language on perception, and invalidates English and Spanish grouping of these items. Because the sample represents many dialects of Spanish, the translations tested may be transported to other cities. In studies that use these instruments investigators can reasonably group answers from English and Spanish speaking study subjects or study the effects of acculturation on quality of life.","J Urol, 158(2): 493-496","USA",1997,"Any or unknown","None","AUA-SI,UCLA-PCI","Patient",null,"Validation","USA","Patient","Any or unknown","None",null,"Validation","AUA-SI,UCLA-PCI","1960:1999","Disease,Symptom"]
[372,"Krongrad, A., et al. (1998). \"Dimensions of quality of life in prostate cancer.\" J Urol 160(3 Pt 1): 807-810.",null,"Krongrad, A., et al.","Dimensions of quality of life in prostate cancer","PURPOSE: Quality of life research in prostate cancer involves the use of many questionnaires and specific items that may be partly redundant. We examine dimensions of quality of life in prostate cancer in the hope of somewhat simplifying communication of basic information. MATERIALS AND METHODS: We analyzed cross-sectional survey data on quality of life in patients with prostate cancer belonging to a Southern California HMO. Quality of life was assessed with the University of California, Los Angeles prostate cancer index. Scree plot and parallel analysis were used to identify factors for extraction and orthogonal (varimax) rotation to examine scale loadings. RESULTS: Four extracted factors explained a cumulative variance of 86%. The 8 physical and emotional scales loaded on 1 general factor explained 41% of the cumulative variance. Urinary function and bother, sexual function and bother, and bowel function and bother scales loaded on factors explained 16, 15 and 14% of the cumulative variance, respectively. CONCLUSIONS: The observation of only 1 general quality of life factor diverges from consistent previous observations of distinct physical and emotional factors in other types of patients, and the tight interaction of emotional and physical scales supports the vulnerability hypothesis, \"with age the increasing interactions across dimensions of health leave a patient vulnerable in all when any is affected.\" The tight interaction of physical and emotional scales in these but not other patients opens the door theoretically to better evaluation of and targeting of health services for patients with prostate cancer.","J Urol, 160(3 Pt 1): 807-810","USA",1998,"Any or unknown","None","UCLA-PCI","Patient",null,"Validation","USA","Patient","Any or unknown","None",null,"Validation","UCLA-PCI","1960:1999","Disease"]
[373,"Krupski, T. L., et al. (2003). \"Variation in continence and potency by definition.\" J Urol 170(4 Pt 1): 1291-1294.",null,"Krupski, T. L., et al.","Variation in continence and potency by definition","PURPOSE: The reporting of quality of life outcomes after prostate cancer treatment has improved with the use of validated instruments and third party data collection, and yet widely disparate continence and potency rates persist among providers. We assessed how well various definitions of these outcomes correspond with each other in the same patients. MATERIALS AND METHODS: A longitudinal cohort of 269 men undergoing radical prostatectomy for early stage prostate cancer completed quality of life questionnaires, including the University of California-Los Angeles Prostate Cancer Index. Six definitions of urinary continence and 6 definitions of potency represented by individual or aggregated items in the survey were analyzed. Using 2,506 questionnaires patients meeting the criteria for continence or potency by each definition were compared. RESULTS: Correspondence among continence definitions varied widely. Of the men who reported using no pads only 42% leaked urine not at all. Other definitions had higher rates of concordance with 98% of patients who reported total control also claiming no pads. Correspondence among potency definitions was even more disparate. Only 5% of men with erections firm enough for intercourse reported having morning erection very often, while 61% rated their ability to function sexually as good or very good. CONCLUSIONS: Variations in outcomes from items intended to measure the same domain reflect the idiosyncrasy of patient definitions of urinary and erectile function. Disease targeted, health related quality of life outcomes vary greatly depending on the specific definition used.","J Urol, 170(4 Pt 1): 1291-1294","USA",2003,"Local","Surgery","UCLA-PCI","Patient",null,"Cohort","USA","Patient","Local","Surgery",null,"Cohort","UCLA-PCI","2000:2004","Disease"]
[374,"Krupski, T. L., et al. (2005). \"Health-related quality-of-life in low-income, uninsured men with prostate cancer.\" J Health Care Poor Underserved 16(2): 375-390.",null,"Krupski, T. L., et al.","Health-related quality-of-life in low-income, uninsured men with prostate cancer","The objective was to describe health-related quality-of-life (HRQOL) in low-income men with prostate cancer. Subjects were drawn from a statewide public assistance prostate cancer program. Telephone and mail surveys included the RAND 12-item Health Survey and UCLA Prostate Cancer Index Short Form and were compared with normative age-matched men without cancer from the general population reported on in the literature. Of 286 eligible men, 233 (81%) agreed to participate and completed the necessary items. The sample consisted of 51% Hispanics, 23% non-Hispanic whites, and 17% African Americans. The low-income men had worse scores in every domain of prostate-specific and general HRQOL than had the age-matched general population controls. The degree of disparity indicated substantial clinical differences in almost every domain of physical and emotional functioning between the sample group and the control group. Linear regression modeling determined that among the low-income men, Hispanic race, and income level were predictive of worse physical functioning, whereas only comorbidities predicted mental health. Low-income patients with prostate cancer appear to have quality-of-life profiles that are meaningfully worse than age-matched men from the general population without cancer reported on in the literature.","J Health Care Poor Underserved, 16(2): 375-390","USA",2005,"Any or unknown","None","UCLA-PCI,SF-12","Patient,General population",null,"Cross-sectional","USA","Patient,General population","Any or unknown","None",null,"Cross-sectional","UCLA-PCI,SF-12","2005:2009","Disease,Utility"]
[375,"Krupski, T., et al. (2000). \"Quality-of-life comparison of radical prostatectomy and interstitial brachytherapy in the treatment of clinically localized prostate cancer.\" Urology 55(5): 736-742.",null,"Krupski, T., et al.","Quality-of-life comparison of radical prostatectomy and interstitial brachytherapy in the treatment of clinically localized prostate cancer","OBJECTIVES: Interstitial brachytherapy (BT) is increasingly utilized as a curative treatment for localized prostate cancer because it is perceived as less morbid than surgical alternatives. However, to date no studies have directly compared the quality of life and symptoms of patients with localized prostate cancer treated with curative intent by radical prostatectomy with those treated by either BT alone or BT combined with external beam radiation. METHODS: On June 1, 1998, 242 men with clinically localized Stage T1c to T3 adenocarcinoma of the prostate, treated at our institution with curative intent from January 1, 1997 to June 1, 1998, were mailed a questionnaire. Cross-sectional analysis of returned questionnaires was carried out. Patients were treated with either radical prostatectomy (RP), palladium-103 (Pd(103)) brachytherapy (115 Gy) monotherapy (BTM), or Pd(103) combined brachytherapy (90 Gy) and external beam radiation (40 to 45 Gy) (BTC). The primary outcome measures were the Functional Assessment of Cancer Therapy scale (FACT-G), American Urological Association (AUA)/international prostate symptom score (IPSS), \"Urinary Function Questionnaire for Men after Radical Prostatectomy,\" and Brief Sexual Function Inventory. RESULTS: Data from 138 patients were included in the analysis; 27 had RP, 70 had BTM, and 41 had BTC. Total FACT-G and personal well-being scores were significantly lower in the BTC group. Brachytherapy monotherapy and RP had similar scores on the FACT-G, with surgical patients having the lowest IPSS scores. Correlations were noted between total FACT-G and urinary symptom score, degree of sexual function, frequency of diarrhea, and frequency of hot flashes. Bothersomeness of urinary function correlated with the degree of urinary control. The radical prostatectomy and BTM groups had improvement in quality of life, voiding, diarrhea, and sexual function with time, whereas the BTC group experienced a decline. CONCLUSIONS: Patients treated with BTC had an overall lower quality of life compared with those treated by RP and BTM, and RP patients reported fewer irritative or obstructive voiding complaints. Although the consistency and magnitude of these trends require further study, our data suggest that RP remains a well-tolerated and accepted option.","Urology, 55(5): 736-742","USA",2000,"Local","Surgery,Radiotherapy,Brachytherapy","FACT-G,IPSS,UFQ-RP,BSFI","Patient",null,"Cross-sectional","USA","Patient","Local","Surgery,Radiotherapy,Brachytherapy",null,"Cross-sectional","FACT-G,IPSS,UFQ-RP,BSFI","2000:2004","Disease,Treatment,Complication"]
[376,"Kubler, H. R., et al. (2007). \"Impact of nerve sparing technique on patient self-assessed outcomes after radical perineal prostatectomy.\" J Urol 178(2): 488-492; discussion 492.",null,"Kubler, H. R., et al.","Impact of nerve sparing technique on patient self-assessed outcomes after radical perineal prostatectomy","PURPOSE: We investigated the impact of nerve sparing technique on erectile function, urinary continence and health related quality of life after radical perineal prostatectomy using a validated self-assessment questionnaire. MATERIALS AND METHODS: The Expanded Prostate Cancer Index Composite questionnaire was administered preoperatively and at defined intervals after surgery to 265 patients who underwent radical perineal prostatectomy at 2 institutions between January 2001 and December 2004. Of these patients 153 (57.7%) and 112 (42.3%) underwent nonnerve sparing and nerve sparing approaches, respectively. Kaplan-Meier analysis was used to determine time to recovery of erectile function (erections firm enough for intercourse) and urinary continence (0 pads per day). RESULTS: Median patient age was 60.6 years. Median followup was 15 months. In multivariate analysis preoperative erectile function (p = 0.005) and preservation of the neurovascular bundle (p = 0.018) were independent predictors of earlier recovery of erectile function, with hazard ratios of 2.3 (95% CI 1.2-4.6) and 4.0 (95% CI 1.5-10.3), respectively. Median time to recovery of urinary continence was 4.8 months in the nerve sparing group and 6.1 months in the nonnerve sparing group (p = 0.001). In multivariate analysis nerve sparing technique (p = 0.001, HR 1.4, 95% CI 1.1-1.9) and age (p = 0.012, HR 1.7, 95% CI 1.3-2.2) were independent predictors of recovery of continence. CONCLUSIONS: This analysis suggests that nerve sparing radical perineal prostatectomy is associated with improved recovery of urinary continence and favorable health related quality of life scores and, therefore, should be considered a viable alternative to other nerve sparing approaches.","J Urol, 178(2): 488-492; discussion 492","USA",2007,"Any or unknown","Surgery","EPIC","Patient",null,"Cross-sectional","USA","Patient","Any or unknown","Surgery",null,"Cross-sectional","EPIC","2005:2009","Disease"]
[377,"Kumar, V., et al. (2004). \"The benefits of radical prostatectomy beyond cancer control in symptomatic men with prostate cancer.\" BJU Int 93(4): 507-509.",null,"Kumar, V., et al.","The benefits of radical prostatectomy beyond cancer control in symptomatic men with prostate cancer","OBJECTIVE: To evaluate lower urinary tract symptoms (LUTS) and the symptom-associated quality of life (QoL) after radical prostatectomy. PATIENTS AND METHODS: We carried out a prospective study (January 1999 to March 2001) of 50 consecutive men initially assessed in the nurse-led prostate assessment clinic for their LUTS and subsequently diagnosed to have localized prostate cancer. They had a radical retropubic prostatectomy and were assessed before, 3 and 6 months after surgery with a self-administered International Prostate Symptom Score (IPSS) and QoL questionnaires, and measurements of urinary flow rate and postvoid residual urinary (PVR) volumes. Finally, each patient completed a self-administered continence questionnaire at 6 weeks, 3 and 6 months after surgery. RESULTS: In men with moderate to severe LUTS before surgery there were significant improvements in total IPSS, symptom-associated QoL, mean peak flow rate and PVR (P < 0.05). However, in eight men with mild LUTS, although there was a 33% improvement in the total symptom score, it was not statistically significant. Thirty-eight patients reported complete continence, nine had infrequent stress leaks only on heavy physical activity, and the remaining three used < 2 pads/day for protection before heavy physical activity at 3 months after surgery. CONCLUSIONS: Radical prostatectomy provides major benefits to men with LUTS besides cancer control. These data are important in counselling patients about the treatment options, especially in view of the current enthusiasm for brachytherapy and conformal radiotherapy, which may worsen LUTS.","BJU Int, 93(4): 507-509","UK",2004,"Local","Surgery","IPSS","Patient",null,"Cohort","UK","Patient","Local","Surgery",null,"Cohort","IPSS","2000:2004","Disease"]
[378,"Kupelian, P. A., et al. (2001). \"Short-course intensity-modulated radiotherapy (70 GY at 2.5 GY per fraction) for localized prostate cancer: preliminary results on late toxicity and quality of life.\" Int J Radiat Oncol Biol Phys 51(4): 988-993.",null,"Kupelian, P. A., et al.","Short-course intensity-modulated radiotherapy (70 GY at 2.5 GY per fraction) for localized prostate cancer: preliminary results on late toxicity and quality of life","PURPOSE: To present our preliminary observations on the late toxicity and quality of life (QOL) of patients treated with short-course intensity-modulated radiotherapy (SCIM-RT). METHODS AND MATERIALS: Fifty-one patients were treated with SCIM-RT at the Cleveland Clinic Foundation between October 1998 and May 1999. The technique consisted of intensity-modulated radiotherapy using 5 static fields (anterior, 2 laterals, and 2 anterior obliques). Inverse plans were generated by the Corvus treatment-planning system. The treatment delivery was performed with a dynamic multileaf collimator. A total of 70.0 Gy was prescribed in all cases at 2.5 Gy per fraction to be delivered in 28 fractions over 5 and a half weeks. The location of the prostate gland was verified and adjusted daily with the BAT transabdominal ultrasound system. The median follow-up was 18 months (range: 11 to 26 months). The Radiation Therapy Oncology Group (RTOG) scales were used to evaluate late toxicity. The Expanded Prostate Cancer Index Composite (EPIC) was used to evaluate QOL. A total of 24 patients completed the EPIC questionnaire at approximately 2 years after therapy (median time from treatment to questionnaire administration: 24 months; range: 21 to 26 months). The results from the EPIC questionnaires were compared to scores from 46 patients treated during the same time period with conformal radiotherapy (CRT) to 78 Gy at 2 Gy per fraction. RESULTS: The dose was prescribed to an isodose line ranging from 82.0% to 90.0% (mean: 87.2%). The range of the individual prostate mean doses was 73.5 to 78.5 Gy (average: 75.3 Gy). To date, only 1 patient had Grade 1 late urinary toxicity. To date, only 4 patients had Grade 1 late rectal toxicity. No Grade 2 or 3 late urinary or rectal complications have occurred. The actuarial rectal bleeding rate observed at 18 months was 7%. There were no differences in scores from the urinary, bowel, hormonal, and overall QOL domains between SCIM-RT patients and patients treated with CRT. The overall physical and mental QOL scores were also nearly identical to scores reported for the general U.S. population. CONCLUSION: Preliminary late toxicity results up to 2 years after SCIM-RT are encouraging, with a median follow-up of 18 months (range 11 to 26 months). Late toxicity assessed by the physicians using RTOG late toxicity scores has been excellent. QOL reported by the patients using the EPIC questionnaire reveals no difference between patients treated with high-dose CRT at standard fractionation and patients treated with SCIM-RT. SCIM-RT is an alternative method of dose escalation in the treatment of localized prostate cancer. The proposed schedule significantly increases convenience to patients due to the decrease in overall treatment time.","Int J Radiat Oncol Biol Phys, 51(4): 988-993","USA",2001,"Local","Radiotherapy","EPIC,RTOG-EORTC-SS","Patient",null,"Clinical trial","USA","Patient","Local","Radiotherapy",null,"Clinical trial","EPIC,RTOG-EORTC-SS","2000:2004","Disease,Treatment"]
[379,"Kuwata, Y., et al. (2007). \"Dissociation of sexual function and sexual bother following autologous sural nerve grafting during radical prostatectomy.\" Int J Urol 14(6): 510-514.",null,"Kuwata, Y., et al.","Dissociation of sexual function and sexual bother following autologous sural nerve grafting during radical prostatectomy","AIM: We prospectively investigated health-related quality of life (HR-QOL), including sexual function and sexual bother, in patients who underwent nerve grafting during a radical prostatectomy in comparison with those who underwent a non-nerve-sparing radical prostatectomy. METHODS: Between August 2001 and May 2004, radical prostatectomies were performed on 69 patients with clinical T1-T2N0/M0 prostate cancer. Of these, 66 patients (22: nerve-grafting patients, 44: non-nerve-sparing and non-nerve-grafting patients) were enroled into this study. The observation periods ranged from 12-46 months (median: 29 months). The general HR-QOL was measured with the SF-36 General Health Survey and disease-specific HR-QOL was measured with the University of California Los Angeles-Prostate Cancer Index. RESULTS: Penile tumescence was observed in 11 out of 15 (73.3%) prostate-specific antigen failure-free patients who underwent unilateral nerve grafting with contra-lateral nerve-sparing or bilateral nerve grafting. Vaginal penetration was observed in six out of 15 (40.0%) patients. The time for partial erection and for intercourse, respectively, ranged from 3-21 months (median = 6 months) and 6-36 months (median = 13.5 months). There were no significant differences in general HR-QOL changes over time between the nerve-grafting patients and the patients without any nerve-preserving procedures. The sexual function score was significantly better in the nerve-grafting (bilateral nerve graft or unilateral nerve graft with contra-lateral nerve-sparing) patients than in the non-nerve-sparing/non-nerve-grafting patients. The sexual bother score, however, was more serious for the patients who underwent nerve-grafting surgery than for the non-nerve-sparing/non-nerve-grafting patients. CONCLUSION: Sexual bother is serious for patients who attempt to maintain sexual function after special surgical procedures, such as nerve-grafting surgery. We should be aware that careful counseling is needed to avoid impatient and excessive hope for the recovery of sexual function.","Int J Urol, 14(6): 510-514","Japan",2007,"Local","Surgery","SF-36,UCLA-PCI","Patient",null,"Cohort","Japan","Patient","Local","Surgery",null,"Cohort","SF-36,UCLA-PCI","2005:2009","Disease,Utility"]
[380,"Ladoire, S., et al. (2010). \"Metronomic oral cyclophosphamide prednisolone chemotherapy is an effective treatment for metastatic hormone-refractory prostate cancer after docetaxel failure.\" Anticancer Res 30(10): 4317-4323.",null,"Ladoire, S., et al.","Metronomic oral cyclophosphamide prednisolone chemotherapy is an effective treatment for metastatic hormone-refractory prostate cancer after docetaxel failure","BACKGROUND: There is currently no standard of treatment for patients with hormone refractory prostate cancer (HRPC) after failure of docetaxel-based chemotherapy. The purpose of this study was to assess the anticancer activity and tolerance of metronomic cyclophosphamide prednisolone combination in this setting. PATIENTS AND METHODS: From 2005 to 2010, patients with HRPC who failed at least docetaxel-based chemotherapy were proposed metronomic cyclophosphamide-prednisolone regimen, and were prospectively registered. Twenty-three patients received 50 mg cyclophosphamide and 10 mg prednisolone per os daily until disease progression. Treatment tolerance and efficacy on PSA decrease and pain were studied. RESULTS: Metronomic cyclophosphamide prednisolone was safe, well tolerated, and demonstrated interesting clinical activity, yielding a prostate specific antigen decrease by >/=50% in 26% of patients and decrease by >/=30% in 48% of patients, but also favorable palliative effects on pain in 43% of patients. The median progression-free survival was 6 months (95% CI: 4-8 months) and the median overall survival was 11 months (95% CI: 7-19 months). CONCLUSION: For this patient population, low dose metronomic cyclophosphamide prednisolone might be a viable alternative. Its convenient oral administration, low cost, and lack of toxicity justify further studies alone, or in combination with other agents in HRPC patients.","Anticancer Res, 30(10): 4317-4323","France",2010,"Metastatic","Chemotherapy","Unclear","Patient",null,"Clinical trial","France","Patient","Metastatic","Chemotherapy",null,"Clinical trial","Unclear","2010:2014","Symptom"]
[381,"Lamb, M. N., et al. (2011). \"Patients' perspectives on fecal incontinence after brachytherapy for localized prostate cancer.\" Dis Colon Rectum 54(5): 615-621.",null,"Lamb, M. N., et al.","Patients' perspectives on fecal incontinence after brachytherapy for localized prostate cancer","BACKGROUND: When a patient is deciding between treatment options for localized prostate cancer, brachytherapy is commonly chosen for its perceived low complication profile. Brachytherapy can frequently be complicated by the development of fecal incontinence. The potential long-term impact of this dysfunction on a patient's life should be discussed. OBJECTIVE: This study aimed to assess the long-term impact of brachytherapy for localized prostate cancer on fecal incontinence and to determine the impact and severity of the incontinence on patients' ability to engage in activities of daily living. DESIGN: A retrospective observational study was performed. A questionnaire packet was mailed to patients who had received brachytherapy treatment for localized prostate cancer and were now more than 2 years out from initial seed implantation. Each packet contained the Colon and Ano-Rectal Impact Questionnaire (assessing quality of life), the Colon and Ano-Rectal Distress Inventory, and the Cleveland Clinic Fecal Incontinence Score (both measured existence and severity of fecal incontinence). SETTINGS: This study was conducted at Caritas Christi St. Elizabeth's Medical Center, a tertiary referral center in Boston, Massachusetts from January 1, 1998 to December 31, 2007. PATIENTS: One hundred forty-three of 568 patients (a 25% response rate) responded and were analyzed. INTERVENTIONS: No interventions were performed. MAIN OUTCOME MEASURES: The main outcome was impact of fecal incontinence on quality of life. RESULTS: : Of the responses to the Colon and Ano-Rectal Impact Questionnaire, 13.2% (19 patients) (P < .001) stated that fecal incontinence was impacting their ability to participate in their daily activities. Sixty-three percent (12 patients) (P < .001) of patients described the impact of the incontinence as slight, 21% (4 patients) (P < .001) described it as moderate, and 15.8% (3 patients) (P < .001) described it as severe. LIMITATIONS: There were no case-matched controls and the response rate to the surveys was low. CONCLUSIONS: Postbrachytherapy fecal incontinence leaves a long-term impact on patients' ability to engage in activities of daily living.","Dis Colon Rectum, 54(5): 615-621","USA",2011,"Local","Brachytherapy","CARIQ,CARDI,CCFIS","Patient",null,"Cross-sectional","USA","Patient","Local","Brachytherapy",null,"Cross-sectional","CARIQ,CARDI,CCFIS","2010:2014","Complication"]
[382,"Landrey, A. R., et al. (2013). \"Shared decision making in prostate-specific antigen testing: the effect of a mailed patient flyer prior to an annual exam.\" J Prim Care Community Health 4(1): 67-74.",null,"Landrey, A. R., et al.","Shared decision making in prostate-specific antigen testing: the effect of a mailed patient flyer prior to an annual exam","INTRODUCTION AND AIMS: Professional societies recommend that the decision to screen for prostate cancer involves a shared discussion between patient and provider. Many men are tested without this discussion. Prostate cancer screening decision aids increase patient knowledge and participation in prostate-specific antigen (PSA) testing decisions under ideal circumstances but are often resource intensive and elaborate. There is a need for evaluation of interventions that are low cost, low literacy, and practical for widespread distribution. The authors evaluated the effect of a mailed low-literacy informational patient flyer about the PSA test on measures of shared decision making. METHODS: A pragmatic randomized controlled trial comparing the mailed flyer versus usual care was conducted among 303 men aged 50 to 74 years who were scheduled for annual health maintenance exams in 2 general internal medicine clinics (University of Colorado and University of Colorado Hospital). Charts were reviewed after the visits for documentation of PSA screening discussions and PSA testing rates. Follow-up patient surveys assessed include perceived participation in PSA screening decisions, knowledge of the PSA test, and flyer acceptability. RESULTS: Rates of chart-documented PSA discussions were low with no difference between the flyer and control groups (17.7% and 13.6%, respectively; P = .28). Rates of PSA testing were also similar in both groups (62.5% vs 58.5%; P = .48). Rates of patient-reported PSA discussions were higher than the documented rates but also without differences between the groups (71.8% vs 62.3%; P = .22). The intervention had no effect in the PSA knowledge scores (3.5/5 vs 3.3/5, P = .60). Patients found the flyer to be highly acceptable. CONCLUSIONS: A mailed low-literacy informational flyer was well received by patients but had no effect on rates of PSA discussions, PSA testing, or patient knowledge of prostate cancer screening.","J Prim Care Community Health, 4(1): 67-74","USA",2013,"At risk","Screening,Various","Unclear","General population",null,"Clinical trial","USA","General population","At risk","Screening,Various",null,"Clinical trial","Unclear","2010:2014","Knowledge,Views"]
[383,"Lane, A., et al. (2016). \"Patient-reported outcomes in the ProtecT randomized trial of clinically localized prostate cancer treatments: study design, and baseline urinary, bowel and sexual function and quality of life.\" BJU Int 118(6): 869-879.",null,"Lane, A., et al.","Patient-reported outcomes in the ProtecT randomized trial of clinically localized prostate cancer treatments: study design, and baseline urinary, bowel and sexual function and quality of life","OBJECTIVES: To present the baseline patient-reported outcome measures (PROMs) in the Prostate Testing for Cancer and Treatment (ProtecT) randomized trial comparing active monitoring, radical prostatectomy and external-beam conformal radiotherapy for localized prostate cancer and to compare results with other populations. MATERIALS AND METHODS: A total of 1643 randomized men, aged 50-69 years and diagnosed with clinically localized disease identified by prostate-specific antigen (PSA) testing, in nine UK cities in the period 1999-2009 were included. Validated PROMs for disease-specific (urinary, bowel and sexual function) and condition-specific impact on quality of life (Expanded Prostate Index Composite [EPIC], 2005 onwards; International Consultation on Incontinence Questionnaire-Urinary Incontinence [ICIQ-UI], 2001 onwards; the International Continence Society short-form male survey [ICSmaleSF]; anxiety and depression (Hospital Anxiety and Depression Scale [HADS]), generic mental and physical health (12-item short-form health survey [SF-12]; EuroQol quality-of-life survey, the EQ-5D-3L) were assessed at prostate biopsy clinics before randomization. Descriptive statistics are presented by treatment allocation and by men's age at biopsy and PSA testing time points for selected measures. RESULTS: A total of 1438 participants completed biopsy questionnaires (88%) and 77-88% of these were analysed for individual PROMs. Fewer than 1% of participants were using pads daily (5/754). Storage lower urinary tract symptoms were frequent (e.g. nocturia 22%, 312/1423). Bowel symptoms were rare, except for loose stools (16%, 118/754). One third of participants reported erectile dysfunction (241/735) and for 16% (118/731) this was a moderate or large problem. Depression was infrequent (80/1399, 6%) but 20% of participants (278/1403) reported anxiety. Sexual function and bother were markedly worse in older men (65-70 years), whilst urinary bother and physical health were somewhat worse than in younger men (49-54 years, all P < 0.001). Bowel health, urinary function and depression were unaltered by age, whilst mental health and anxiety were better in older men (P < 0.001). Only minor differences existed in mental or physical health, anxiety and depression between PSA testing and biopsy assessments. CONCLUSION: The ProtecT trial baseline PROMs response rates were high. Symptom frequencies and generic quality of life were similar to those observed in populations screened for prostate cancer and control subjects without cancer.","BJU Int, 118(6): 869-879","UK",2016,"Local","Surgery,Radiotherapy,Surveillance","EPIC,ICIQ,ICSQ,HADS,SF-12,EQ-5D","general population",null,"Clinical trial","UK","General population","Local","Surgery,Radiotherapy,Surveillance",null,"Clinical trial","EPIC,ICIQ,ICSQ,HADS,SF-12,EQ-5D","2015:2018","Disease,Complication,Comorbidity,Utility"]
[384,"Langenhuijsen, J. F., et al. (2013). \"Continuous vs. intermittent androgen deprivation therapy for metastatic prostate cancer.\" Urol Oncol 31(5): 549-556.",null,"Langenhuijsen, J. F., et al.","Continuous vs. intermittent androgen deprivation therapy for metastatic prostate cancer","OBJECTIVES: To analyze the predictive value of PSA for progression and the role of testosterone for quality of life (QOL) in patients with androgen deprivation therapy (ADT) for metastatic prostate cancer. MATERIALS AND METHODS: PSA and testosterone data were used from a phase III trial randomizing patients without progression and PSA < 4 ng/ml (n = 193), after 6 months induction course, between continuous (CAD) (n = 96) and intermittent (IAD) (n = 97) ADT. The 2-year risk of progression was calculated for baseline PSA, 'fast' and 'slow' PSA decline to < 4 ng/ml (60 days cut-off), PSA nadir, performance status and pain. Testosterone kinetics and QOL were also evaluated. Univariate Kaplan Meier survival analysis and log rank tests were used to compare the risk of progression. RESULTS: For progression analysis, 173 patients' data were available. The 2-year risk of progression for baseline PSA < 50 ng/ml, 50 to <500 ng/ml, and >/= 500 ng/ml was 25%, 55%, and 76% (P = 0.03) in CAD, and 38%, 64%, and 85% (P = 0.006) in IAD, respectively. The 2-year risk of progression for PSA nadir </= 0.2 ng/ml, and > 0.2 to 4 ng/ml in CAD was 31% and 70% (P < 0.001), respectively. In the IAD group, a similar trend was seen. Patients with PSA nadir </= 0.2 ng/ml, though had significantly higher 2-year risk of progression compared to CAD (53% vs. 31% (P = 0.03), respectively. PSA decline showed no predictive value. Patients without pain had a significantly lower 2-year risk of progression in both groups. Without ADT testosterone remained at castrate level for 4 months. After the first and second IAD cycle 92% and 46%, respectively, had a normalized testosterone. No QOL difference was found, although more side effects occurred in CAD. CONCLUSIONS: Metastatic prostate cancer patients with high baseline PSA, pain, and high PSA nadir have a poor prognosis with ADT. Patients with low PSA nadir do significantly worse with IAD compared with CAD. Low testosterone after ADT and incomplete testosterone recovery may explain similar QOL. Therefore, IAD is not a good treatment option for many metastatic prostate cancer patients.","Urol Oncol, 31(5): 549-556","Netherlands",2013,"Metastatic","Hormonal","Unclear","Patient",null,"Clinical trial","Netherlands","Patient","Metastatic","Hormonal",null,"Clinical trial","Unclear","2010:2014","General"]
[385,"Lebeau, T., et al. (2005). \"Validation of prostate cancer index and SF-12 short forms.\" Can J Urol 12(6): 2873-2879.",null,"Lebeau, T., et al.","Validation of prostate cancer index and SF-12 short forms","BACKGROUND: Assessment of prostate cancer (PCa) specific and generic health-related quality-of-life (HRQOL) is frequently omitted due to several obstacles, such as respondent burden and infrastructure-related limitations. We attempted to reduce the number of items of two commonly used HRQOL assessment tools, namely the UCLA PCa Index (PCI) and the RAND SF-12, with the intent of generating the most parsimonious, yet psychometrically valid and reliable HRQOL assessment tool. METHODS: The PCI and SF-12 were administered to 2415 radical prostatectomy patients, and re-tested in a convenience sample of 35 men with PCa. Multivariate linear regression models defined the most predictive and item-reduced SF-12 and PCI item combinations. These were subjected to standard psychometric reliability and validity tests. RESULTS: The 8-item PCI sexual function (SF) scale was reduced to three items. The 5-item PCI urinary function (UF) scale was reduced to three items. The 6-item SF-12 mental health scale was reduced to three items, and the 6-item SF-12 physical scale was also reduced to three items. The total number of items was reduced from 27 to 12 (44%). The item-reduced scales accounted for over 85% of full-scale variance. All reliability and validity tests yielded highly satisfactory results. CONCLUSION: We developed SF-12 and PCI short-forms, which consist of 12 of 27 (44%) original items and can be completed by most men within 2 minutes. The short-forms represent a valid substitute for the full scales, as they provide over 85% of full-scale information and demonstrate excellent reliability statistics. The short forms have the potential for decreasing respondent burden and infrastructure-related requirements, which may in turn promote HRQOL assessment after radical prostatectomy.","Can J Urol, 12(6): 2873-2879","Canada",2005,"Any or unknown","Surgery","SF-12,UCLA-PCI","Patient",null,"Validation","Canada","Patient","Any or unknown","Surgery",null,"Validation","SF-12,UCLA-PCI","2005:2009","Disease,Utility"]
[386,"Lebret, T. and A. Bouregba (2008). \"Roles of the urologist and nurse from the perspective of patients with prostate cancer receiving luteinizing hormone-releasing hormone analogue therapy.\" BJU Int 102(10): 1419-1424.",null,"Lebret, T. and A. Bouregba","Roles of the urologist and nurse from the perspective of patients with prostate cancer receiving luteinizing hormone-releasing hormone analogue therapy","OBJECTIVES: To establish the roles of the urologist, general practitioner (GP) and nurse from the perspective of the patient with prostate cancer receiving hormone therapy, and to assess patient satisfaction, in particular with management and information needs. PATIENTS AND METHODS: Patients with prostate cancer receiving luteinizing hormone-releasing hormone analogue (LHRH-a) therapy were recruited by a representative sample of 58 French urologists (March to April 2007) and invited to complete a 42-item questionnaire. RESULTS: In all, 350 representative patients participated in the study; >90% were totally or quite satisfied with the information given by their urologist at diagnosis and the start of treatment. Their main contact during treatment was with the nurse who gave the injection (84% of patients). The nurse's main role was to provide clarity (60% of patients), guidance (35%) and support to the family (28%). Fewer patients discussed disease stage and progression with their nurse (29%) than with a doctor (urologist, 63%; or GP, 61%). Fewer also discussed treatment (24% vs 32%) but as many patients discussed the impact of their disease and treatment with their nurse as with their doctor (e.g. 33% discussed general health and fatigue with the nurse, vs 26% with the urologist). The need for contact with a health professional was greater during the early stages of treatment. Patients treated for <12 months with 3-monthly injections were less likely to be in favour of spacing injections than patients treated for >or=3 years. CONCLUSION: The patient consults the urologist for reliable information on disease and treatment, and to the GP for further support, if needed, but the nurse has the pivotal role. A 3-monthly injection schedule enables regular face-to-face contact between the nurse and the patient and their family, and contributes towards the patient's coping strategies and quality of life.","BJU Int, 102(10): 1419-1424","France",2008,"Any or unknown","Hormonal","Unclear","Patient",null,"Cross-sectional","France","Patient","Any or unknown","Hormonal",null,"Cross-sectional","Unclear","2005:2009","Views"]
[387,"Lebret, T., et al. (2014). \"Quality of life of 1276 elderly patients with prostate cancer, starting treatment with a gonadotropin-releasing hormone agonist: results of a French observational study.\" Aging Male 17(2): 87-93.",null,"Lebret, T., et al.","Quality of life of 1276 elderly patients with prostate cancer, starting treatment with a gonadotropin-releasing hormone agonist: results of a French observational study","This French observational, longitudinal, prospective study described the health-related quality of life (HRQoL) of elderly men (>/=75 years old) with prostate cancer after initiating gonadotropin-releasing hormone (GnRH) agonist therapy. At baseline and 3-6 months after baseline, European Organisation for Research and Treatment of Cancer quality of life questionnaire-core 30 (QLQ-C30) and prostate-specific (QLQ-PR25) questionnaires were completed by patients. Data from 1276 patients were analyzed. At baseline, mean (+/-SD) age was 80 (+/-4.1) years, 29.1% of patients had Gleason scores >/=8 and 24.9% had metastases. At baseline, increasing age, presence of metastasis and presence of comorbidity had a negative impact on QLQ-C30 and QLQ-PR25 scores. At follow-up, improvement in emotional-functioning (2.8; p < 0.001), social-functioning (1.7; p = 0.011), global HRQoL (1.6; p = 0.029), sleep-disturbance (-2.1; p = 0.011), appetite-loss (-4.0; p < 0.001) and pain (-4.1; p < 0.001) QLQ-C30 scores were observed. In addition, there was a worsening in treatment-related symptom (8.6; p < 0.001), sexual-activity (-5.5; p < 0.001) and sexual-functioning (-22.6; p < 0.001) QLQ-PR25 scores, and an improvement in urinary symptoms (-3.7; p < 0.001) and incontinence aid (-2.9; p = 0.023) QLQ-PR25 scores. This study shows that, apart from the expected impact on sexual functioning domains, HRQoL is not adversely affected by 3-6 months of GnRH agonist therapy in older men with prostate cancer.","Aging Male, 17(2): 87-93","France",2014,"Any or unknown","Hormonal","EORTC QLQ-C30,EORTC QLQ-PR25","Patient",null,"Cohort","France","Patient","Any or unknown","Hormonal",null,"Cohort","EORTC QLQ-C30,EORTC QLQ-PR25","2010:2014","Disease,General"]
[388,"Lee, C. E., et al. (2012). \"A pilot study of exercise in men with prostate cancer receiving androgen deprivation therapy.\" BMC Cancer 12: 103.",null,"Lee, C. E., et al.","A pilot study of exercise in men with prostate cancer receiving androgen deprivation therapy","BACKGROUND: Androgen deprivation therapy (ADT) is the mainstay therapy for men with prostate cancer. However, there are musculoskeletal side effects from ADT that increase the risk for osteoporosis and fracture, and can compromise the quality of life of these individuals. The objectives of this study are to determine the efficacy of a home-based walking exercise program in promoting bone health, physical function and quality of life in men with prostate cancer receiving ADT. METHODS/DESIGN: A 12-month prospective, single-blinded, randomized controlled trial will be conducted to compare the Exercise Group with the Control Group. Sixty men with prostate cancer who will be starting ADT will be recruited and randomly assigned to one of the two groups: the Exercise Group will receive instructions in setting up an individualized 12-month home-based walking exercise program, while the Control Group will receive standard medical advice from the attending physician. A number of outcome measures will be used to assess bone health, physical function, and health-related quality of life. At baseline and 12 months, bone health will be assessed using dual-energy X-ray absorptiometry. At baseline and every 3 months up to 12 months, physical function will be evaluated using the Functional Assessment of Chronic Illness Therapy - Fatigue Scale, Activities-specific Balance Confidence Scale, Short Physical Performance Battery, and Six-Minute Walk Test; and health-related quality of life will be assessed using the Functional Assessment of Cancer Therapy Prostate Module and the Medical Outcomes Study 12-item Short Form Health Survey Version 2. A mixed multiple analysis of variance will be used to analyze the data. DISCUSSION: Musculoskeletal health management remains a challenge in men with prostate cancer receiving ADT. This study addresses this issue by designing a simple and accessible home-based walking exercise program that will potentially have significant impact on reducing the risk of fracture, promoting physical function, and ultimately improving the health-related quality of life in men with prostate cancer receiving ADT. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00834392.","BMC Cancer, 12(103","Canada",2012,"Any or unknown","Hormonal,Various","FACT-P,SF-12,FACIT-F,ABC,PPB","Patient",null,"Protocol","Canada","Patient","Any or unknown","Hormonal,Various",null,"Protocol","FACT-P,SF-12,FACIT-F,ABC,PPB","2010:2014","Disease,Symptom,Utility"]
[389,"Lee, J. Y., et al. (2016). \"Multinational Prospective Study of Patient-Reported Outcomes After Prostate Radiation Therapy: Detailed Assessment of Rectal Bleeding.\" Int J Radiat Oncol Biol Phys 96(4): 770-777.",null,"Lee, J. Y., et al.","Multinational Prospective Study of Patient-Reported Outcomes After Prostate Radiation Therapy: Detailed Assessment of Rectal Bleeding","PURPOSE: The new short Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) patient-reported health-related quality of life (HRQOL) tool has removed the rectal bleeding question from the previous much longer version, EPIC-26. Herein, we assess the impact of losing the dedicated rectal bleeding question in 2 independent prospective multicenter cohorts. METHODS AND MATERIALS: In a prospective multicenter test cohort (n=865), EPIC-26 patient-reported HRQOL data were collected for 2 years after treatment from patients treated with prostate radiation therapy from 2003 to 2011. A second prospective multicenter cohort (n=442) was used for independent validation. A repeated-effects model was used to predict the change from baseline in bowel summary scores from longer EPIC instruments using the change in EPIC-CP bowel summary scores with and without rectal bleeding scores. RESULTS: Two years after radiation therapy, 91% of patients were free of bleeding, and only 2.6% reported bothersome bleeding problems. Correlations between EPIC-26 and EPIC-CP bowel scores were very high (r(2)=0.90-0.96) and were statistically improved with the addition of rectal bleeding information (r(2)=0.94-0.98). Considering all patients, only 0.2% of patients in the test cohort and 0.7% in the validation cohort reported bothersome bleeding and had clinically relevant HRQOL changes missed with EPIC-CP. However, of the 2.6% (n=17) of men with bothersome rectal bleeding in the test cohort, EPIC-CP failed to capture 1 patient (6%) as experiencing meaningful declines in bowel HRQOL. CONCLUSIONS: Modern prostate radiation therapy results in exceptionally low rates of bothersome rectal bleeding, and <1% of patients experience bothersome bleeding and are not captured by EPIC-CP as having meaningful HRQOL declines after radiation therapy. However, in the small subset of patients with bothersome rectal bleeding, the longer EPIC-26 should strongly be considered, given its superior performance in this patient subset.","Int J Radiat Oncol Biol Phys, 96(4): 770-777","USA",2016,"Any or unknown","Radiotherapy","EPIC","Patient",null,"Validation","USA","Patient","Any or unknown","Radiotherapy",null,"Validation","EPIC","2015:2018","Disease"]
[390,"Lee, T. K., et al. (2015). \"A systematic review of expanded prostate cancer index composite (EPIC) quality of life after surgery or radiation treatment.\" Can J Urol 22(1): 7599-7606.",null,"Lee, T. K., et al.","A systematic review of expanded prostate cancer index composite (EPIC) quality of life after surgery or radiation treatment","INTRODUCTION: The Expanded Prostate Cancer Index Composite (EPIC) is a validated and widely adopted instrument that measures patient quality of life. This study aims to describe and compare patient quality of life in the bowel, urinary, and sexual domains across different prostate cancer treatments. MATERIALS AND METHODS: A systematic review of English articles published prior to 2012 was conducted. Peer reviewed articles reporting longitudinal EPIC data in a statistically analyzable form with clearly defined time points were included. Articles were assessed by content experts to ensure optimal treatment quality. Screening of studies and extraction of data were completed using a predefined data abstraction tool. Data on bowel, urinary, and sexual domains were documented. Scores in each domain range from a low of 0 to a high of 100. RESULTS: Twenty-six articles, representing 8302 patients, were included. All treatments were associated with short term or long term reductions in urinary, bowel, and sexual domains. Surgery patients had better post-treatment bowel quality of life; however, average declines were small regardless of treatment. Post-treatment urinary incontinence scores were lower for surgery patients; while radiation patients had worse urinary irritation. Average urinary bother and function were similar between treatment groups at 18 months post-treatment. Surgery patients had better baseline sexual function. A greater decline in sexual function was observed in surgery patients compared to radiation patients. CONCLUSIONS: Prostate cancer treatments have different impacts on patient quality of life and function. The magnitude of difference between treatment-related adverse effects may be important to patients when choosing therapy.","Can J Urol, 22(1): 7599-7606","International",2015,"Any or unknown","Radiotherapy,Surgery","EPIC","Patient",null,"Systematic review","International","Patient","Any or unknown","Radiotherapy,Surgery",null,"Systematic review","EPIC","2015:2018","Disease"]
[391,"Lee, W. R., et al. (1999). \"Early quality of life assessment in men treated with permanent source interstitial brachytherapy for clinically localized prostate cancer.\" J Urol 162(2): 403-406.",null,"Lee, W. R., et al.","Early quality of life assessment in men treated with permanent source interstitial brachytherapy for clinically localized prostate cancer","PURPOSE: We prospectively assessed quality of life changes with time using validated instruments in men with clinically localized prostate cancer treated with permanent source interstitial brachytherapy. MATERIALS AND METHODS: A total of 46 men consecutively treated with permanent source interstitial brachytherapy between September 1997 and June 1998 completed quality of life (Functional Assessment of Cancer Therapy-Prostate [FACT-P]) and urinary symptom (International Prostate Symptom Score [I-PSS]) questionnaires before (T0), and 1 (T1) and 3 (T3) months after treatment. All participants were treated with 125iodine alone. Repeated measures analyses of variance were conducted on all quality of life and urinary outcome measures for 44 patients with data at all 3 time points. RESULTS: Median patient age was 68 years (range 51 to 80). All men had clinical T1c to T2b prostate cancer, Gleason score was 6 or less in 36 (78%) and median pretreatment prostate specific antigen was 7 ng./ml. (range 1.1 to 20.6). Mean score (and standard deviation) at T0, T1 and T3 for each questionnaire was FACT-P 138.9 (14.4), 128.6 (19.4) and 136.7 (17.4), TO versus T1 p = 0.0005 and T0 versus T3 p = 0.6612, and I-PSS 8.3 (5.4), 19.7 (9.0) and 15.7 (7.2), T0 versus T1 p = 0.0001 and T0 versus T3 p = 0.0001. For the global test across time statistically significant differences were observed for the cumulative scores of FACT-P, I-PSS, physical well-being and prostate cancer subscales of the FACT-P and the Trial Outcome Index. By 3 months all quality of life measures had returned to baseline. Urinary symptoms as measured by I-PSS persisted for at least 3 months. CONCLUSIONS: Clinically meaningful decreases in quality of life, as measured by the FACT-P instrument, were evident within weeks after permanent source interstitial brachytherapy. However, by 3 months FACT-P scores returned to near baseline levels. A validated instrument designed to measure urinary symptoms (I-PSS) demonstrated that moderate to severe urinary symptoms persisted for at least 3 months following permanent source interstitial brachytherapy. An instrument specifically designed to measure urinary symptoms can provide additional clinical information when combined with FACT-P.","J Urol, 162(2): 403-406","USA",1999,"Local","Brachytherapy","FACT-P,IPSS","Patient",null,"Cohort","USA","Patient","Local","Brachytherapy",null,"Cohort","FACT-P,IPSS","1960:1999","Disease"]
[392,"Lee, W. R., et al. (2000). \"A preliminary analysis of health-related quality of life in the first year after permanent source interstitial brachytherapy (PIB) for clinically localized prostate cancer.\" Int J Radiat Oncol Biol Phys 46(1): 77-81.",null,"Lee, W. R., et al.","A preliminary analysis of health-related quality of life in the first year after permanent source interstitial brachytherapy (PIB) for clinically localized prostate cancer","PURPOSE: To prospectively assess the health-related quality of life (HRQOL) and changes in HRQOL during the first year after permanent source interstitial brachytherapy (PIB). METHODS AND MATERIALS: Thirty-one men treated with PIB between September 1997 and March 1998 completed a quality of life (functional assessment of cancer therapy-prostate: FACT-P) and a urinary symptom questionnaire (international prostate symptom score: IPSS) prior to treatment (T0), 1 month (T1), 3 months (T3), 6 months (T6), and 12 months (T12) following PIB. All participants were treated with 125I alone. Repeated measures analyses of variance (ANOVA) were conducted on all quality of life and urinary outcome measures for all 31 patients at all time points. RESULTS: The median age of the study population was 66 (range 51-80). All men had clinical T1c-T2b prostate cancer. The Gleason score was < or =6 in 27/31 (87%). Median pretreatment PSA was 7.8 ng/ml (range 1.1-20.6). The mean score (and standard deviation) at T0, T1, T3, T6, and T12 for the FACT-P questionnaire are as follows: 140.5 (13.5), 132.7 (15.3), 137.2 (17.4), 140.1 (16.0), and 142.4 (15.3). For the global test across time, statistically significant differences were observed for the cumulative scores of FACT-P (p<0.0012). The decrease in HRQOL was most marked 1 month following PIB. Examination of the subscales within the FACT-P instrument demonstrated statistically significant changes over time for the following: physical well-being (PWB), functional well-being (FWB), and prostate cancer (PCS). By 3 months, all HRQOL measures had returned to near baseline. The mean score (and standard deviation) at T0, T1, T3, T6, and T12 for the IPSS questionnaire are as follows: 8.3 (5.5), 18.4 (8.0), 15.7 (7.4), 13.7 (7.4), and 10.2 (5.7). For the global test across time, statistically significant differences were observed for the IPSS scores (p<0.0001). The maximum increase in IPSS occurred 1 month following PIB. CONCLUSION: The results of this preliminary analysis suggest that clinically meaningful decreases in HRQOL, as measured by the FACT-P instrument, are evident within weeks after PIB. By 3 months, however, FACT-P scores return to near baseline levels. A validated instrument designed to measure urinary symptoms (IPSS) demonstrates that moderate to severe urinary symptoms persist for at least 3-6 months following PIB. One year following PIB, the scores on the FACT-P and IPSS questionnaires had returned to baseline.","Int J Radiat Oncol Biol Phys, 46(1): 77-81","USA",2000,"Local","Brachytherapy","FACT-P,IPSS","Patient",null,"Cohort","USA","Patient","Local","Brachytherapy",null,"Cohort","FACT-P,IPSS","2000:2004","Disease"]
[393,"Lee, W. R., et al. (2000). \"A prospective analysis of patient-reported quality of life after prostate brachytherapy.\" Semin Urol Oncol 18(2): 147-151.",null,"Lee, W. R., et al.","A prospective analysis of patient-reported quality of life after prostate brachytherapy","The purpose of this study was to prospectively assess the patient-reported quality of life (QOL) and changes in QOL during the first 3 months after prostate brachytherapy (PB). Seventy-four men treated with PB between September 1997 and December 1998 completed a QOL questionnaire (Functional Assessment of Cancer Therapy-Prostate [FACT-P]) and a measurement of urinary symptoms (International Prostate Symptom Score [IPSS]) before treatment (T0), 1 month (T1), and 3 months (T3) following PB. All participants were treated with (125)I alone. The mean score (and standard deviation) at T0, T1, and T3 FACT-P questionnaire are as follows: 139.2 (15.7), 125.4 (20.2), and 133.0 (18.2). For the global test across time, statistically significant differences were observed for the cumulative scores of FACT-P (P < .0001). Examination of the subscales within the FACT-P instrument demonstrated statistically significant changes over time for the following: physical well-being, functional well-being and the prostate cancer subscale. The mean score (and standard deviation) at T0, T1, and T3 for the IPSS questionnaire are as follows: 9.1 (5.9), 20.0 (7.8), and 16.6 (7.2). For the global test across time, statistically significant differences were observed for the IPSS scores (P < .0001). Clinically meaningful decreases in QOL are evident within weeks after PB. Moderate to severe urinary symptoms persist for at least 3 months following PB.","Semin Urol Oncol, 18(2): 147-151","USA",2000,"Any or unknown","Brachytherapy","FACT-P,IPSS","Patient",null,"Cohort","USA","Patient","Any or unknown","Brachytherapy",null,"Cohort","FACT-P,IPSS","2000:2004","Disease"]
[394,"Lee, W. R., et al. (2001). \"A prospective quality-of-life study in men with clinically localized prostate carcinoma treated with radical prostatectomy, external beam radiotherapy, or interstitial brachytherapy.\" Int J Radiat Oncol Biol Phys 51(3): 614-623.",null,"Lee, W. R., et al.","A prospective quality-of-life study in men with clinically localized prostate carcinoma treated with radical prostatectomy, external beam radiotherapy, or interstitial brachytherapy","PURPOSE: To prospectively assess the health-related quality of life (HRQOL) and changes in HRQOL during the first year after 3 different treatments for clinically localized prostate cancer. METHODS AND MATERIALS: Ninety men with T1-T2 adenocarcinoma of the prostate were treated with curative intent between May 1998 and June 1999 and completed a quality-of-life Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire before treatment (T0) and 1 month (T1), 3 months (T3), and 12 months (T12) after treatment. Forty-four men were treated with permanent source interstitial brachytherapy (IB), 23 received external beam radiotherapy (EBRT), and 23 men were treated with radical prostatectomy (RP). The mean age of the entire study population was 65.9 years (median 67, range 42-79). The mean pretreatment prostate-specific antigen level of the entire study population was 6.81 ng/mL (median 6.25, range 1.33-19.6). The Gleason score was <or=6 in 65 (72%) of 90. The repeated measures analysis of variance and analysis of covariance were conducted on all quality-of-life and urinary outcome measures. RESULTS: A comparison of the demographic characteristics of the 3 treatment groups demonstrated significant differences. The men treated with RP were significantly younger than the men in either the IB or EBRT group (median age 61.0 RP, 67.1 IB, 68.8 EBRT; p = 0.0006). The men in the IB group were more likely to have a Gleason score of <or=6 than the EBRT group (Gleason score <or=6, 86% IB and 48% EBRT; p = 0.015). The mean score (standard deviation) at T0, T1, T3, and T12 for the FACT-P questionnaire for each group was as follows: IB 138.4 (17.0), 120.5 (21.7), 130.0 (18.4), and 138.5 (14.2); EBRT 137.1 (12.1), 129.5 (21.0), 134.4 (19.2), and 136.9 (15.6); and RP 138.3 (14.7), 117.7 (18.3), 134.4 (17.8), and 140.4 (14.9), respectively. Statistically significant differences over time were observed for the FACT-P in the IB and RP groups (p <0.0001), but not for the EBRT group (p = 0.08). The examination of the subscales within the FACT-P instrument demonstrated statistically significant changes over time in the IB and RP groups for the following: physical well-being, functional well-being, and prostate cancer symptoms. After adjusting for age, race, T stage, Gleason score, use of hormonal therapy, and baseline FACT-P scores, statistically significant differences in the FACT-P score at T1 according to treatment group were observed. At T12, the FACT-P scores were not significantly different than the baseline FACT-P scores for any group. CONCLUSIONS: The results of this analysis suggest that significant decreases in HRQOL, as measured by the FACT-P instrument, are evident in the first month after IB or RP, but not after EBRT. One year after treatment, however, the FACT-P scores were not statistically different from the baseline measures for any group. For all treatment groups, most of the HRQOL decreases were observed in the physical, functional, and prostate cancer-specific domains. These results suggest that the HRQOL changes are likely to be treatment-specific, further emphasizing the importance of a randomized trial comparing the different treatment options in this population of men.","Int J Radiat Oncol Biol Phys, 51(3): 614-623","USA",2001,"Local","Radiotherapy,Surgery,Brachytherapy","FACT-P","Patient",null,"Cohort","USA","Patient","Local","Radiotherapy,Surgery,Brachytherapy",null,"Cohort","FACT-P","2000:2004","Disease"]
[395,"Lennernas, B., et al. (2015). \"Radical prostatectomy versus high-dose irradiation in localized/locally advanced prostate cancer: A Swedish multicenter randomized trial with patient-reported outcomes.\" Acta Oncol 54(6): 875-881.",null,"Lennernas, B., et al.","Radical prostatectomy versus high-dose irradiation in localized/locally advanced prostate cancer: A Swedish multicenter randomized trial with patient-reported outcomes","BACKGROUND: Treatment of localized prostate cancer (PC) is controversial. This is the first randomized study comparing an open surgery procedure (radical prostatectomy) with a combination of high-dose rate brachytherapy (2x10 Gy) and external beam radiotherapy (25x2 Gy) in PC patients in Sweden 1996-2001. The two randomization arms were compared regarding differences in patients-reported outcomes, such as complications and health-related quality of life (HRQoL). MATERIAL AND METHODS: The patients had localized/locally advanced PC, clinical category T1b-T3a, N0, M0 and PSA</=50 ng/ml. All underwent total androgen blockade (six months). Self-reported HRQoL and symptoms including urinary, bowel, and sexual side effects were investigated prospectively before randomization and 12 and 24 months after randomization. A total of 89 patients were randomized and completed the EORTC QLQ C-33 and EORTC PR-25 questionnaires. RESULTS: Over the study period, there were no discernible differences in HRQoL, or complications between the two groups. Emotional functioning, however, improved statistically significantly over time, whereas Social functioning decreased, and financial difficulties increased. No statistically significant differences in group-by-time interactions were found. The survival rate was 76%. Only eight patients (9%) died of PC. CONCLUSION: Open radical prostatectomy and the combined high-dose rate brachytherapy with external beam radiation appeared to be comparable in the measured outcomes. It was not possible to draw any conclusion on the efficacy of the two treatments due to insufficient power of the study.","Acta Oncol, 54(6): 875-881","Sweden",2015,"Advanced,Local","Radiotherapy,Surgery","EORTC QLQ-C30,EORTC QLQ-PR25","Patient",null,"Clinical trial","Sweden","Patient","Advanced,Local","Radiotherapy,Surgery",null,"Clinical trial","EORTC QLQ-C30,EORTC QLQ-PR25","2015:2018","Disease,General"]
[396,"Lepore, S. J., et al. (2003). \"Improving quality of life in men with prostate cancer: a randomized controlled trial of group education interventions.\" Health Psychol 22(5): 443-452.",null,"Lepore, S. J., et al.","Improving quality of life in men with prostate cancer: a randomized controlled trial of group education interventions","Men who were recently treated for prostate cancer (N=250) were randomly assigned to a control group, a group education intervention (GE), or a group education-plus-discussion intervention (GED). Both GE and GED increased prostate cancer knowledge. In the year postintervention, men in the GED condition were less bothered by sexual problems than men in the control condition, and they were more likely to remain steadily employed (93.0%) than men in the GE (75.6%) or control (72.5%) conditions. Among noncollege graduates, GED and GE resulted in better physical functioning than the control condition, and GED resulted in more positive health behaviors than the control or GE condition. Among college graduates, controls were comparable with the GE and GED groups in physical functioning and positive health behaviors.","Health Psychol, 22(5): 443-452","USA",2003,"Any or unknown","Various","Unclear","Patient",null,"Clinical trial","USA","Patient","Any or unknown","Various",null,"Clinical trial","Unclear","2000:2004","Knowledge,Costs"]
[397,"Lev, E. L., et al. (2004). \"Quality of life of men treated with brachytherapies for prostate cancer.\" Health Qual Life Outcomes 2: 28.",null,"Lev, E. L., et al.","Quality of life of men treated with brachytherapies for prostate cancer","BACKGROUND: Most studies of men undergoing treatment for prostate cancer examine physical symptoms as predictors of Quality of Life (QOL). However, symptoms vary by treatment modality in this population, and psychosocial variables, shown to be important to QOL, have rarely been examined. Litwin noted a need for analysis of QOL data in men treated for prostate cancer with different modes of therapy, as studies focusing on specific treatments will increase the homogeneity of research findings. METHODS: This cross-sectional study explored physical and psychosocial predictors of QOL in men receiving one of two types of radiation treatment for prostate cancer: Intensity Modulated Radiation Therapy (IMRT) + High Dose Rate (HDR) Brachytherapy or IMRT + seed implantation. Subjects completed a biographic questionnaire; quality of life measures, which were the eight subscales of the Medical Outcome Study Short Form Health Survey (SF-36); measures of physical symptoms including the Radiation Therapy Oncology Group and the European Organization for Research and Treatment of Cancer (RTOG/EORTC) and the Prostate Symptom Self-Report (PSSR); and measures of psychological factors, the Ways of Coping Scale (WOC), Perceived Stress Scale, the Anxiety Subscale of the SCL-90, and Strategies Used by Patients to Promote Health (SUPPH). Eight regression models including both physical and psychosocial variables were used to predict quality of life. RESULTS: Sixty-three subjects with complete data on all variables were studied. Treatment effect sizes were medium to large in predicting each of the quality of life subscales of the SF-36. Psychosocial variables were related to physical function, role function, bodily pain, general health, social function, emotional role, and mental health. Physical symptoms were related to subjects' perceived general health and mental health. DISCUSSION: The number of significant relationships among psychosocial variables and indicators of QOL exceeded the number of relationships among symptoms and QOL suggesting that psychosocial variables associate strongly with prostate cancer patients' reports of quality of life. Findings of the study may provide patients and families with knowledge that contributes to their understanding of quality of life outcomes of IMRT+ HDR and IMRT + seed implantation and their ability to make more informed treatment choices.","Health Qual Life Outcomes, 2(28","USA",2004,"Any or unknown","Brachytherapy","SF-36,RTOG-EORTC-SS,PSSR,WOC,PcSS,SCL-90,SUPPH","Patient",null,"Cross-sectional","USA","Patient","Any or unknown","Brachytherapy",null,"Cross-sectional","SF-36,RTOG-EORTC-SS,PSSR,WOC,PcSS,SCL-90,SUPPH","2000:2004","Disease,General,Utility,Treatment,Symptom"]
[398,"Levinson, A. W., et al. (2011). \"Is a return to baseline sexual function possible? An analysis of sexual function outcomes following laparoscopic radical prostatectomy.\" World J Urol 29(1): 29-34.",null,"Levinson, A. W., et al.","Is a return to baseline sexual function possible? An analysis of sexual function outcomes following laparoscopic radical prostatectomy","OBJECTIVES: Outcome measures following radical prostatectomy are not standardized. Though excellent potency rates are widely reported, few studies address a return to baseline function. We analyze validated sexual health-related quality-of-life outcomes by a strict definition, a return to baseline function, and compare them to less stringent, yet more frequently referenced, categorical definitions of potency. METHODS: Patients undergoing laparoscopic radical prostatectomy from April 2001 to September 2007 completed the Expanded Prostate Cancer Index Composite (EPIC) questionnaire at baseline and 3, 6, 12, and 24 months postoperatively. We defined a return to baseline as a recovery to greater than one-half standard deviation of the studied population below the patient's own baseline (clinically detectable threshold). We compared these outcomes to a categorical definition of potency involving intercourse frequency. To limit confounders, we performed subset analyses of preoperatively potent men who received bilateral nerve preservation. Factors predictive of return to baseline function were assessed in multivariable analysis. RESULTS: A total of 568 patients met inclusion criteria. Mean age and follow-up were 57.2 years and 16.9 months, respectively. Using the categorical definition, 85% of preoperatively potent men with bilateral nerve preservation were \"potent\" at 24 months; however, only 27% returned to their baseline sexual function. In multivariable analyses baseline function, number of nerves spared, and age were independent predictors of a return to baseline function. CONCLUSION: While most preoperatively potent men who receive bilateral nerve preservation engage in intercourse postoperatively, few return to their baseline sexual function. We believe that these data provide context for the expectations of patients who elect extirpative therapy.","World J Urol, 29(1): 29-34","USA",2011,"Any or unknown","Surgery","EPIC","Patient",null,"Cohort","USA","Patient","Any or unknown","Surgery",null,"Cohort","EPIC","2010:2014","Disease"]
[399,"Lilleby, W., et al. (1999). \"Long-term morbidity and quality of life in patients with localized prostate cancer undergoing definitive radiotherapy or radical prostatectomy.\" Int J Radiat Oncol Biol Phys 43(4): 735-743.",null,"Lilleby, W., et al.","Long-term morbidity and quality of life in patients with localized prostate cancer undergoing definitive radiotherapy or radical prostatectomy","PURPOSE: To assess morbidity, side effects, and quality of life (QoL) in patients treated for localized prostate cancer with curative aim. METHODS AND MATERIALS: This descriptive cross-sectional study comprises 154 patients who had undergone definitive radiotherapy (RAD) and 108 patients with radical prostatectomy (PRECT) at the Norwegian Radium Hospital during 1987-1995. At least 1 year after treatment the patients completed several questionnaires assessing quality of life (European Organization for Research and Treatment of Cancer QLQ-C30 instrument [EORTC QLQ-C30]), lower urinary tract symptoms (LUTS): International Prostate Symptom Score (IPSS), or sexuality (selected questions from the Psychosocial Adjustment to Illness Scale [PAIS]). Urinary incontinence and bowel distress were evaluated by ad hoc constructed questionnaires. A control group (OBS) consisted of 38 patients following the watch-and-wait policy. RESULTS: Twenty percent of the patients from the RAD Group had moderate (14%) or severe (6%) LUTS as compared to 12% in the PRECT group. However, 35% of men from the latter group reported moderate to severe urinary incontinence. \"Overall\" sexuality was moderately or severely impaired in 71% of the PRECT and 50% of the RAD patients. In the former group high age was correlated with erectile impotency (p < 0.001). In the RAD comorbidity was associated with erectile impotency (p < 0.001). Between 13-38% of the patients recorded moderate or severe bowel distress (blood per rectum: 13%; bowel cramps: 26%; flatulence: 38%), without significant differences comparing patients who had received conventional small 4-field box radiotherapy and patients who had undergone strictly conformal radiotherapy. Despite malignancy and/or treatment-related morbidity, QoL was comparable in both groups with respectively 9% and 6% RAD and PRECT patients, reporting moderately or severely impaired QoL. In the multivariate analysis physical function, emotional function and fatigue were significantly correlated with QoL, whereas sexuality, lower urinary symptoms, and urinary incontinence correlated with QoL only in the univariate analysis. CONCLUSION: In spite of considerable malignancy and/or treatment-related morbidity QoL was good or only slightly impaired in the majority of patients with localized prostate cancer who presented with stable disease > 1 year after definitive radiotherapy or radical prostatectomy with no difference as compared to the age-matched normal population. Clinicians should be aware of the fact that general QoL dimensions (physical function, emotional function, fatigue) are as a rule of greater significance for QoL than sexuality and lower urinary tract symptoms.","Int J Radiat Oncol Biol Phys, 43(4): 735-743","Norway",1999,"Local","Radiotherapy,Surgery","EORTC QLQ-C30,IPSS,PAIS","Patient",null,"Cross-sectional","Norway","Patient","Local","Radiotherapy,Surgery",null,"Cross-sectional","EORTC QLQ-C30,IPSS,PAIS","1960:1999","Disease,General"]
[400,"Lilleby, W., et al. (2014). \"Adding intensity-modulated radiotherapy to the pelvis does not worsen the adverse effect profiles compared to limited field radiotherapy in men with prostate cancer at 12-month follow-up.\" Acta Oncol 53(10): 1380-1389.",null,"Lilleby, W., et al.","Adding intensity-modulated radiotherapy to the pelvis does not worsen the adverse effect profiles compared to limited field radiotherapy in men with prostate cancer at 12-month follow-up","To compare adverse effects and toxicity in men with high-risk or locally advanced prostate cancer when adding intensity-modulated radiotherapy (IMRT) technique to the pelvis. PATIENTS AND METHODS: In this prospective follow-up study 180 patients treated with conformal radiotherapy (RAD) to the prostate and vesiculae seminales (boost volumes; PV) and long-term androgen deprivation therapy (LADT), were compared to 90 patients managed by LADT, RAD to the PV and additionally pelvic IMRT. Adverse effects were self-reported at baseline, at 3- and 12-month follow-up. At each time point, the patients rated a questionnaire covering urinary, bowel, and sexual function and bother, quality of life, fatigue, and mental distress. RESULTS: At 3-month follow-up urinary and bowel functions were significantly decreased among IMRT compared to RAD. At 12-month follow-up both groups showed the same reductions within the urinary, bowel and sexual domains. RAD patients had more mental distress than IMRT patients. The scores on quality of life, fatigue and mental distress hardly influenced function or bother within the urinary, bowel or sexual domains. CONCLUSIONS: Men treated for high-risk or locally advanced prostate cancer with a combination of LADT, RAD and IMRT including PV and pelvic structures had considerably more acute side effects at 3 months than men treated with LADT and RAD to the PV only. However, at 12-month follow-up, the observed genitourinary and gastrointestinal function and bother were similar in both groups.","Acta Oncol, 53(10): 1380-1389","Norway",2014,"Advanced","Radiotherapy,Hormonal","Unclear","Patient",null,"Clinical trial","Norway","Patient","Advanced","Radiotherapy,Hormonal",null,"Clinical trial","Unclear","2010:2014","General,Complication,Symptom"]
[401,"Lim, A. J., et al. (1995). \"Quality of life: radical prostatectomy versus radiation therapy for prostate cancer.\" J Urol 154(4): 1420-1425.",null,"Lim, A. J., et al.","Quality of life: radical prostatectomy versus radiation therapy for prostate cancer","PURPOSE: The impact of radical prostatectomy and external beam radiotherapy on the quality of life of patients was compared. MATERIALS AND METHODS: A total of 136 patients underwent radical prostatectomy and 60 underwent external beam radiotherapy for clinically localized prostate cancer. Patients were asked to complete a questionnaire containing The Functional Living Index: Cancer, the Profile of Moods States, and a series of questions evaluating bladder, bowel and sexual function. RESULTS: The radical prostatectomy group had worse sexual function and urinary incontinence, while the external beam radiotherapy group had worse bowel function. Of the patients 90% from both groups stated that they would undergo the treatment again. CONCLUSIONS: Radical prostatectomy and external beam radiotherapy have comparable impact upon quality of life.","J Urol, 154(4): 1420-1425","USA",1995,"Local","Radiotherapy,Surgery","FLIC,POMS","Patient",null,"Clinical trial","USA","Patient","Local","Radiotherapy,Surgery",null,"Clinical trial","FLIC,POMS","1960:1999","General,Comorbidity"]
[402,"Lin, Y. H., et al. (2012). \"Comparison of health-related quality of life between subjects treated with radical prostatectomy and brachytherapy.\" J Clin Nurs 21(13-14): 1906-1912.",null,"Lin, Y. H., et al.","Comparison of health-related quality of life between subjects treated with radical prostatectomy and brachytherapy","AIMS AND OBJECTIVES: To evaluate the symptoms and self-assessment of quality of life in men with localised prostate cancer after having had a radical prostatectomy or brachytherapy treatment. BACKGROUND: Prostate cancer is a significant growing disease among men in Taiwan. Quality of life issues for the men who are living with this disease and the consequences of treatment. DESIGN: A postal questionnaire survey. METHODS: The study population came from one 1170-bed hospital in Kaohsiung County, Taiwan. Data was collected from 20 August 2007-20 November 2009. Seventy-eight men met the inclusion criteria. The researchers mailed a survey to each participant, which they completed at home and returned in a pre-stamped, addressed envelope. Sixty-four subjects participated and self-reported using a structured questionnaire. The reliability of overall prostate cancer index was 0.90 and 0.85, 0.93 and 0.72 for each subscale, respectively. RESULTS: The results indicate that the number of months post-treatment was positively correlated with urinary function and age was negatively correlated with sexual, bowel function and bowel bothers. One predictor (month post-treatment) was related to urinary function; one predictor (treatment method) was related to bowel function and four predictors (marital status, age, treatment method and month post-treatment) were related to sexual function. Findings showed that patients who received brachytherapy have better urinary functions, as compared with prostatectomy patients. CONCLUSION: Study findings suggest that healthcare providers should have a better understanding of patients' complications after treatment and this can ultimately raise the quality of life for prostate cancer patients. RELEVANCE TO CLINICAL PRACTICE: The impact of quality of life among post prostate cancer treatment is common. Urological nurses should therefore take the responsibility regarding the consequence of urinary incontinence and sexual function and seeking appropriate nursing interventions for these complications.","J Clin Nurs, 21(13-14): 1906-1912","Taiwan",2012,"Local","Brachytherapy,Surgery","Unclear","Patient",null,"Cross-sectional","Taiwan","Patient","Local","Brachytherapy,Surgery",null,"Cross-sectional","Unclear","2010:2014","Complication"]
[403,"Lintz, K., et al. (2003). \"Prostate cancer patients' support and psychological care needs: Survey from a non-surgical oncology clinic.\" Psychooncology 12(8): 769-783.",null,"Lintz, K., et al.","Prostate cancer patients' support and psychological care needs: Survey from a non-surgical oncology clinic","While there are numerous uncertainties surrounding prostate cancer's detection and treatment, more research focusing on the psychological needs of prostate patients is required. This study investigated the support and psychological care needs of men with prostate cancer. Patients were approached during urological oncology clinics and asked to complete the: Support Care Needs Survey (SCNS), Support Care Preferences Questionnaire, EORTC QLQ-C30 (Version 3) Measure plus Prostate Module, and the Hospital Anxiety and Depression Scale (HADS). Of the 249 patients meeting study entry criteria, there was an 89% response rate resulting in a cohort of 210 patients. The data showed that significant unmet need exists across a number of domains in the areas of psychological and health system/information. The more commonly reported needs were 'fears about cancer spreading (44%),' 'concerns about the worries of those close to you (43%),' and 'changes in sexual feelings (41%).' Half of all patients reported some need in the domain of sexuality, especially men younger than 65 years. Needs were being well met in the domain of patient care and support. A significant number of patients reported having used or desiring support services, such as information about their illness, brochures about services and benefits for patients with cancer (55%), a series of talks by staff members about aspects of prostate cancer (44%), and one-on-one counselling (48%). Quality of life (QoL) was most negatively impacted in those who: were < or =65 years old, had been diagnosed within one year, or had metastatic disease. Men < or =65 had decreased social functioning, greater pain, increased sleep disturbance, and were more likely to be uncomfortable about being sexually intimate. Patients recently diagnosed had increased fatigue, more frequent urination, greater disturbance of sleep, and were more likely to have hot flushes. Those with advanced disease scored lower on 12 out of 15 QoL categories. PSA level had no effect on QoL or anxiety/depression scores. Men with advanced disease had greater levels of depression and those < or =65 years old were more likely to be anxious. Although most men with prostate cancer seem to function quite well, a substantial minority report areas of unmet need that may be targets for improving care.","Psychooncology, 12(8): 769-783","UK",2003,"Any or unknown","None","EORTC QLQ-C30,HADS,EORTC QLQ-PR25,SCN-SF34,SCPQ","Patient",null,"Cross-sectional","UK","Patient","Any or unknown","None",null,"Cross-sectional","EORTC QLQ-C30,HADS,EORTC QLQ-PR25,SCN-SF34,SCPQ","2000:2004","Disease,General,Comorbidity,Social"]
[404,"Lips, I., et al. (2007). \"Health-related quality of life in patients with locally advanced prostate cancer after 76 Gy intensity-modulated radiotherapy vs. 70 Gy conformal radiotherapy in a prospective and longitudinal study.\" Int J Radiat Oncol Biol Phys 69(3): 656-661.",null,"Lips, I., et al.","Health-related quality of life in patients with locally advanced prostate cancer after 76 Gy intensity-modulated radiotherapy vs. 70 Gy conformal radiotherapy in a prospective and longitudinal study","PURPOSE: To compare quality of life (QoL) after 70 Gy conformal radiotherapy with QoL after 76 Gy intensity-modulated radiotherapy (IMRT) in patients with locally advanced prostate carcinoma. METHODS AND MATERIALS: Seventy-eight patients with locally advanced prostate cancer were treated with 70 Gy three-field conformal radiotherapy, and 92 patients received 76 Gy IMRT with fiducial markers for position verification. Quality of life was measured by RAND-36, the European Organization for Research and Treatment of Cancer core questionnaire (EORTC QLQ-C30(+3)), and the prostate-specific EORTC QLQ-PR25, before radiotherapy (baseline) and 1 month and 6 months after treatment. Quality of life changes in time (baseline vs. 1 month and baseline vs. 6 months) of > or =10 points were considered clinically relevant. RESULTS: Differences between the treatment groups for QoL changes over time occurred in several QoL domains. The 76-Gy group revealed no significant deterioration in QoL compared with the 70-Gy group. The IMRT 76-Gy group even demonstrated a significantly better change in QoL from baseline to 1 month in several domains. The conformal 70-Gy group revealed temporary deterioration in pain, role functioning, and urinary symptoms; for the IMRT 76-Gy group a better QoL in terms of change in health existed after 1 month, which persisted after 6 months. For both treatment groups temporary deterioration in physical role restriction occurred after 1 month, and an improvement in emotional role restriction occurred after 6 months. Sexual activity was reduced after treatment for both groups and remained decreased after 6 months. CONCLUSIONS: Intensity-modulated radiotherapy and accurate position verification seem to provide a possibility to increase the radiation dose for prostate cancer without deterioration in QoL.","Int J Radiat Oncol Biol Phys, 69(3): 656-661","Netherlands",2007,"Advanced","Radiotherapy","EORTC QLQ-C30,EORTC QLQ-PR25,SF-36","Patient",null,"Clinical trial","Netherlands","Patient","Advanced","Radiotherapy",null,"Clinical trial","EORTC QLQ-C30,EORTC QLQ-PR25,SF-36","2005:2009","Disease,General,Utility"]
[405,"Little, D. J., et al. (2003). \"Quality-of-life questionnaire results 2 and 3 years after radiotherapy for prostate cancer in a randomized dose-escalation study.\" Urology 62(4): 707-713.",null,"Little, D. J., et al.","Quality-of-life questionnaire results 2 and 3 years after radiotherapy for prostate cancer in a randomized dose-escalation study","OBJECTIVES: To assess patient-reported prostate cancer-specific quality of life 2 and 3 years after radiotherapy to the prostate in a randomized dose-escalation trial of 70 versus 78 Gy conducted from 1993 to 1998. METHODS: Two years after completing radiotherapy, a questionnaire that assessed bladder, rectal, and sexual function was sent to 301 patients in the study. Three years after treatment, a second questionnaire was sent to the 175 patients with adequate follow-up. RESULTS: Three years after radiotherapy, urinary incontinence was reported by 35% of patients, but only 6% required the use of a pad or other protective device. Patients reported increased leakage with a full bladder (urge incontinence) between the 2 and 3-year questionnaires (42% versus 50%; P = 0.03). At 3 years, 33% of patients reported rectal bleeding compared with 47% at 2 years (P = 0.006). Patients in the 78-Gy arm reported more frequent bowel movements at 3 years and less change in bowel function at 2 years than patients in the 70-Gy arm. Before radiotherapy, 84% of patients reported erections adequate for intercourse at least a few times during the previous year. After 2 and 3 years, this had decreased to 49% and 41%, respectively (P <0.02). CONCLUSIONS: By patient-reported questionnaire, 78 Gy produced an increase in bowel movement frequency and no increase in bladder or sexual side effects at 3 years compared with 70 Gy. Comparing the results 2 and 3 years after radiotherapy, the symptoms of rectal bleeding had improved, erectile function had decreased, and urinary urge incontinence had increased.","Urology, 62(4): 707-713","USA",2003,"Any or unknown","Radiotherapy","Unclear","Patient",null,"Clinical trial","USA","Patient","Any or unknown","Radiotherapy",null,"Clinical trial","Unclear","2000:2004","Complication"]
[406,"Litwin, M. S. and K. A. McGuigan (1999). \"Accuracy of recall in health-related quality-of-life assessment among men treated for prostate cancer.\" J Clin Oncol 17(9): 2882-2888.",null,"Litwin, M. S. and K. A. McGuigan","Accuracy of recall in health-related quality-of-life assessment among men treated for prostate cancer","PURPOSE: To determine the accuracy of patient recall of health-related quality of life (HRQOL) in men who have undergone radical prostatectomy for early-stage prostate cancer. PATIENTS AND METHODS: Patients enrolled onto a longitudinal, observational cohort study of HRQOL after radical prostatectomy for early-stage prostate cancer were asked to assess their baseline HRQOL before surgery. They were later asked to recall their baseline HRQOL at intervals of 7 to 37 months after surgery. The two views of baseline HRQOL (actual and recall) were compared. HRQOL was measured with established instruments (the RAND 12-Item Short-Form Health Survey and a validated short form of the University of California Los Angeles Prostate Cancer Index) that addressed impairment in the physical, mental, urinary, bowel, and sexual domains. RESULTS: Overall, recall was poor. Patients tended to remember their baseline HRQOL as being better than it actually was. This effect was particularly striking for urinary and sexual function. Greater education and younger age diminished this effect in some domains. The effect did not vary with time since surgery. CONCLUSION: Men undergoing radical prostatectomy for early-stage prostate cancer do not accurately recall their pretreatment HRQOL when asked several months or years later. This recall bias is constant throughout a period of 6 months to 3 years after surgery. By collecting data before treatment and observing subjects longitudinally, investigators can ensure that HRQOL changes are analyzed in the context of any impairment that may have been present at baseline. If a longitudinal study is not feasible, then great caution must be used if patients are asked to recall their pretreatment HRQOL.","J Clin Oncol, 17(9): 2882-2888","USA",1999,"Local","Surgery","UCLA-PCI,SF-12","Patient",null,"Cohort","USA","Patient","Local","Surgery",null,"Cohort","UCLA-PCI,SF-12","1960:1999","Disease,Utility"]
[407,"Litwin, M. S., et al. (1995). \"Quality-of-life outcomes in men treated for localized prostate cancer.\" Jama 273(2): 129-135.",null,"Litwin, M. S., et al.","Quality-of-life outcomes in men treated for localized prostate cancer","OBJECTIVE: To assess health-related quality of life (HRQOL) in men treated for clinically localized prostate cancer. DESIGN: A cross-sectional analysis of HRQOL after treatment with radical prostatectomy, pelvic irradiation, or observation alone for clinically localized prostatic adenocarcinoma, and in age-matched comparison patients. SETTING: A large managed care population in California. SUBJECTS: A total of 528 men, including 214 treated for clinically localized prostate cancer (41 with evidence of metastatic disease were excluded from this analysis) and 273 age-matched, ZIP code-matched comparison patients without prostate cancer. Cancer patients were analyzed in three treatment groups: radical prostatectomy (n = 98), primary pelvic irradiation (n = 56), and observation alone (n = 60). MAIN OUTCOME MEASURES: General HRQOL was measured with the RAND 36-Item Health Survey 1.0. Cancer-specific HRQOL was measured with the CAncer Rehabilitation Evaluation System-Short Form and the Functional Assessment of Cancer Therapy-General form. Disease-targeted quality of life was measured with a new instrument assessing function and bother in three organ systems: sexual, urinary, and bowel. RESULTS: No differences among treatment groups were seen in comparisons of general HRQOL: Significant differences among treatment groups were seen in both function and bother in the prostate-targeted measures of sexual, urinary, and bowel domains. When cancer patients were compared with men of similar age without prostate cancer, differences were seen in the sexual, urinary, and bowel function and bother but not in general HRQOL measures. Although cancer-free men were found not to have full potency or continence, prostate cancer patients treated with surgery or radiation reported significantly worse sexual, urinary, and bowel function than men without cancer. Men who had undergone nerve-sparing prostatectomy did not differ from those who had undergone standard prostatectomy, but the power to detect a difference was low. CONCLUSIONS: Although no differences were seen in general HRQOL, three disease-targeted domains were found to differ significantly among the treatment groups and comparison patients. Even after controlling for the sexual and urinary dysfunction experienced by older men without cancer, those receiving therapeutic interventions for their prostate cancer were found to have poorer disease-targeted HRQOL: We conclude that in addition to general HRQOL, disease-targeted measures must be used to assess outcomes of care in men treated for localized prostate cancer.","Jama, 273(2): 129-135","USA",1995,"Local","Surgery,Radiotherapy,Surveillance","SF-36,FACT-G,CARES-SF","Patient",null,"Case-control","USA","Patient","Local","Surgery,Radiotherapy,Surveillance",null,"Case-control","SF-36,FACT-G,CARES-SF","1960:1999","Treatment,Utility"]
[408,"Litwin, M. S., et al. (1997). \"Health related quality of life outcomes in patients treated for metastatic kidney cancer: a pilot study.\" J Urol 157(5): 1608-1612.",null,"Litwin, M. S., et al.","Health related quality of life outcomes in patients treated for metastatic kidney cancer: a pilot study","PURPOSE: We assessed health related quality of life in patients with advanced renal cell carcinoma treated with nephrectomy and tumor infiltrating lymphocyte therapy in combination with interleukin-2. MATERIALS AND METHODS: A total of 20 patients with advanced renal cell carcinoma who underwent nephrectomy and combination immunotherapy with tumor infiltrating lymphocytes and interleukin-2 completed a retrospective, cross-sectional health related quality of life instrument. Established reference populations with other chronic medical conditions, or breast, prostate or other cancers were used for comparison of health related quality of life scores. General health related quality of life was measured with a RAND 36-Item Health Survey 1.0. Cancer targeted quality of life was measured with the Cancer Rehabilitation Evaluation System-Short Form. Sociodemographic and co-morbidity variables were also collected. RESULTS: General health related quality of life in patients treated with tumor infiltrating lymphocytes and interleukin-2 was significantly better than that in heart failure patients on 1 of 8 scales but significantly worse than in the general population on 6 of 8 scales. General health related quality of life in the former patients was also significantly worse than in those with hypertension on 5 of 8 scales and significantly worse than in diabetics on 2 scales. Cancer targeted health related quality of life in patients given immunotherapy was significantly better than in men with prostate cancer on 1 of 5 scales, significantly better than in women with breast cancer on 2 of 5 scales and significantly better than patients with other cancers (nonbreast and nonprostate) on 3 of 5 scales. CONCLUSIONS: Patients undergoing nephrectomy and adjuvant tumor infiltrating lymphocytes plus interleukin-2 therapy for advanced renal cell carcinoma report better health related quality of life than those with other malignancies and better physical function than patients with congestive heart failure. However, health related quality of life is worse than in the general population and similar or worse than in patients with hypertension or type II diabetes. This surveyed population is selective and may represent the best responders among survivors of a highly toxic therapy. Nevertheless, quality and quantity of life should be addressed with patients when considering immunotherapy for metastatic kidney cancer.","J Urol, 157(5): 1608-1612","USA",1997,"Any or unknown","None","SF-36,CARES-SF","Patient",null,"Cross-sectional","USA","Patient","Any or unknown","None",null,"Cross-sectional","SF-36,CARES-SF","1960:1999","Treatment,Utility"]
[409,"Litwin, M. S., et al. (1998). \"Differences in urologist and patient assessments of health related quality of life in men with prostate cancer: results of the CaPSURE database.\" J Urol 159(6): 1988-1992.",null,"Litwin, M. S., et al.","Differences in urologist and patient assessments of health related quality of life in men with prostate cancer: results of the CaPSURE database","PURPOSE: We determine whether urologists caring for men with prostate cancer accurately captured the nuances of quality of life, as disclosed by patients in validated, self-administered health related quality of life instruments. MATERIALS AND METHODS: We analyzed information on 2,252 patients 42 to 95 years old enrolled in CaPSURE, a large, observational cancer of the prostate strategic urological research endeavor database, in which men with all stages of prostate cancer are followed quarterly with standardized validated written surveys to assess clinical parameters, symptoms and health related quality of life. At each visit urologists recorded Karnofsky performance status rating and the presence or absence of various symptoms, such as fatigue, pain and dysfunction in the sexual, urinary and bowel domains. Within 30 days of the visit patients independently completed self-administered health related quality of life instruments, including the RAND 36-Item Health Survey and University of California, Los Angeles Prostate Cancer Index, in which scores of 80 to 100 and 0 to 79 were interpreted as absence of impairment and moderate to severe impairment, respectively. Using chi-square analysis we compared symptoms, as recorded by the urologist, with health related quality of life impairment in relevant domains, as reported by the patient. RESULTS: Significant differences (p < or = 0.002) were noted between physician and patient assessment of clinical domains, such as physical, sexual, urinary and bowel function, fatigue and bone pain. In all domains urologists underestimated patient symptoms, causing health related quality of life impairment. CONCLUSIONS: In men with early stage and advanced prostate cancer physician ratings of patient symptoms do not correlate well with patient self-assessments of health related quality of life. Hence, urologists should attempt to elucidate more completely the components of patient quality of life after the diagnosis and treatment of prostate cancer.","J Urol, 159(6): 1988-1992","USA",1998,"Any or unknown","Unclear","SF-36,UCLA-PCI","HCP,Patient",null,"Validation","USA","HCP,Patient","Any or unknown","Unclear",null,"Validation","SF-36,UCLA-PCI","1960:1999","Disease,Utility"]
[410,"Litwin, M. S., et al. (1998). \"Quality-of-life outcomes in long-term survivors of advanced prostate cancer.\" Am J Clin Oncol 21(4): 327-332.",null,"Litwin, M. S., et al.","Quality-of-life outcomes in long-term survivors of advanced prostate cancer","The authors evaluate the temporal progression of health-related quality of life (HRQOL) in men treated hormonally with surgical or medical castration, as well as to see if either treatment would be associated with a greater impact on patients' quality of life. The authors assessed general and prostate-targeted HRQOL with two self-administered, validated instruments (the RAND 36-Item Health Survey and the UCLA Prostate Cancer Index) in a longitudinal, observational study of 63 men newly diagnosed with metastatic prostate cancer and treated with bilateral orchiectomy or combined androgen blockade with leuprolide and flutamide. Patients completed the two HRQOL instruments by mail at baseline and at 3- and 6-month intervals after initiation of treatment. Significant improvements were demonstrated in 10 of 14 HRQOL domains for all men during the first 12 months. These include all eight of the general HRQOL domains and the disease-specific domains that address bowel function. The authors identified no differences in any of the general or prostate-targeted HRQOL domains when comparing men who underwent orchiectomy versus combined androgen blockade. Patients with metastatic prostate cancer can be informed that general and prostate-specific HRQOL will be similar, regardless of whether they choose medical or surgical castration, and that health status will likely remain stable or improve during the initial months of treatment. Physicians must make patients aware of both the quantity and quality of life they can expect with advanced prostate cancer, and must actively involve them in their treatment decisions.","Am J Clin Oncol, 21(4): 327-332","USA",1998,"Metastatic","Surgery,Hormonal","SF-36,UCLA-PCI","Patient",null,"Cohort","USA","Patient","Metastatic","Surgery,Hormonal",null,"Cohort","SF-36,UCLA-PCI","1960:1999","Disease,Utility"]
[411,"Litwin, M. S., et al. (1998). \"The UCLA Prostate Cancer Index: development, reliability, and validity of a health-related quality of life measure.\" Med Care 36(7): 1002-1012.",null,"Litwin, M. S., et al.","The UCLA Prostate Cancer Index: development, reliability, and validity of a health-related quality of life measure","OBJECTIVES: The need for accurate measures of health-related quality of life (HRQOL) in men treated for prostate cancer is of paramount importance because patients may survive for many years after their diagnosis. Hence, interest has increased in choosing treatments that optimize both the quality and quantity of life in patients with this disease. This study sought to develop and evaluate a self-administered, multiitem, disease-specific instrument to capture the health concerns central to the quality of life of men treated for early stage prostate cancer. METHODS: After focus group analysis and pilot testing, the instrument was tested with a large retrospective, cross-sectional survey. Exploratory factor analysis and multitrait scaling analysis were used to facilitate the formation of six scales containing 20 disease-targeted items that address impairment in the urinary, bowel, and sexual domains. The psychometric properties of the new scales were assessed by measuring test-retest reliability, internal consistency reliability, and construct validity. Performance on the new scales was compared with scores on other established cancer-related health-related quality of life instruments. Two hundred fifty-five long-term survivors of prostate cancer treatment and 273 age-matched and ZIP code-matched comparison subjects without prostate cancer from a large managed care population in California were studied. Mean age was 72.7 years. In addition to the new scales, the RAND 36-Item Health Survey (SF-36) was used as a generic core measure, and a cancer-related health-related quality of life instrument (the Cancer Rehabilitation System-Short Form) was used to provide construct validity. RESULTS: For the new scales, test-retest reliability ranged from 0.66 to 0.93, and internal consistency ranged from 0.65 to 0.93. Disease-targeted measures of function and bother in the three domains correlated substantially with one another. Scale scores correlated well with related, established scales. Men undergoing prostatectomy or pelvic irradiation demonstrated the expected differences in performance on the disease-specific health-related quality of life scales when compared with each other or with comparison subjects. Age was inversely related to sexual and bowel function. CONCLUSIONS: The UCLA Prostate Cancer Index performed well in this population of older men with and without prostate cancer. It demonstrated good psychometric properties and appeared to be well understood and easily completed. The high response among patients suggests that these men especially are interested in addressing both the general and disease-specific concerns that impact their daily quality of life.","Med Care, 36(7): 1002-1012","USA",1998,"Local","Unclear","SF-36,UCLA-PCI,CARES-SF","Patient",null,"Validation","USA","Patient","Local","Unclear",null,"Validation","SF-36,UCLA-PCI,CARES-SF","1960:1999","Disease,Treatment,Utility"]
[412,"Litwin, M. S., et al. (1999). \"Recovery of health related quality of life in the year after radical prostatectomy: early experience.\" J Urol 161(2): 515-519.",null,"Litwin, M. S., et al.","Recovery of health related quality of life in the year after radical prostatectomy: early experience","PURPOSE: We determined the temporal course of patient return to baseline quality of life after treatment with radical prostatectomy for early stage prostate cancer. MATERIALS AND METHODS: After establishing a longitudinal observational database of men undergoing radical retropubic prostatectomy we used established, validated quality of life questionnaires (RAND 36-Item Health Survey and University of California, Los Angeles Prostate Cancer Index) to document changes in general and disease specific health related quality of life (HRQOL). We assessed 90 patients at baseline before surgery and then at 3-month intervals for 1 year postoperatively. Logistic regression was used to explore predictors of the return to baseline. RESULTS: After prostatectomy patients had a significant decrease in all domains of HRQOL. Return to baseline was rapid in the general and bowel domains with at least two-thirds to three-fourths of patients reaching pretreatment levels within 6 months of surgery. Return to baseline was slower in the urinary and sexual function domains with 61 and 31% of the men, respectively, reaching pretreatment levels by 1 year after surgery. Of those who reached baseline the average intervals for the bowel, sexual and urinary domains were 5, 6 and 7 months, respectively. Married and white patients were more likely to achieve a return to baseline HRQOL during year 1 postoperatively. However, education level was inversely associated with the likelihood of returning to baseline. CONCLUSIONS: During the year after radical prostatectomy for early stage prostate cancer patient quality of life steadily improved. By 3 months postoperatively 30 to 40% of the patients had already recovered baseline levels of physical, mental and social functioning, and by 6 months more than 70% had reached baseline in the general HRQOL domains. By 12 months after surgery 86 to 97% of the patients had returned to baseline levels in each domain. Each domain continued to improve throughout the year. For the patients who reached baseline general HRQOL during followup average recovery time was 5 to 6 months.","J Urol, 161(2): 515-519","USA",1999,"Local","Surgery","SF-36,UCLA-PCI","Patient",null,"Cohort","USA","Patient","Local","Surgery",null,"Cohort","SF-36,UCLA-PCI","1960:1999","Disease,Utility"]
[413,"Litwin, M. S., et al. (1999). \"Sexual function and bother after radical prostatectomy or radiation for prostate cancer: multivariate quality-of-life analysis from CaPSURE. Cancer of the Prostate Strategic Urologic Research Endeavor.\" Urology 54(3): 503-508.",null,"Litwin, M. S., et al.","Sexual function and bother after radical prostatectomy or radiation for prostate cancer: multivariate quality-of-life analysis from CaPSURE. Cancer of the Prostate Strategic Urologic Research Endeavor","OBJECTIVES: To measure the effect of treatment choice (pelvic irradiation [XRT] versus radical prostatectomy [RP] with or without nerve sparing) on sexual function and sexual bother during the first 2 years after treatment. METHODS: We studied sexual function and sexual bother in 438 men recently diagnosed with early-stage prostate cancer and treated with XRT or RP with or without nerve sparing. Outcomes were assessed with the University of California, Los Angeles Prostate Cancer Index, a validated health-related quality-of-life instrument that includes these two domains. To minimize the influence of other factors, we adjusted for age, comorbidity, general health, and previous treatment for erectile dysfunction. All subjects were drawn from CaPSURE, a national, longitudinal data base. RESULTS: Sexual function improved over time during the first year in all treatment groups; however, during the second year, sexual function began to decline in the XRT group. Older patients who received XRT showed substantial declines in sexual function throughout the 2 years, and older patients who underwent RP experienced a return of very low baseline sexual function. Sexual function was improved by the use of nerve-sparing procedures or erectile aids. Alterations in sexual bother were ameliorated by many factors, including age, general health perceptions, and sexual function. CONCLUSIONS: Patients undergoing XRT or RP with or without nerve sparing all showed comparable rates of improvement in sexual function during the first year after treatment for early-stage prostate cancer. However, in the second year after treatment, patients treated with XRT began to show declining sexual function; patients treated with RP did not.","Urology, 54(3): 503-508","USA",1999,"Local","Surgery,Radiotherapy","UCLA-PCI","Patient",null,"Cohort","USA","Patient","Local","Surgery,Radiotherapy",null,"Cohort","UCLA-PCI","1960:1999","Disease"]
[414,"Litwin, M. S., et al. (2000). \"Urinary function and bother after radical prostatectomy or radiation for prostate cancer: a longitudinal, multivariate quality of life analysis from the Cancer of the Prostate Strategic Urologic Research Endeavor.\" J Urol 164(6): 1973-1977.",null,"Litwin, M. S., et al.","Urinary function and bother after radical prostatectomy or radiation for prostate cancer: a longitudinal, multivariate quality of life analysis from the Cancer of the Prostate Strategic Urologic Research Endeavor","PURPOSE: We measure the effect of time on urinary function and bother during the first 2 years following treatment for early stage prostate cancer. MATERIALS AND METHODS: We studied urinary function and bother in 564 men recently diagnosed with early stage prostate cancer and treated with radiotherapy or radical prostatectomy with or without nerve sparing. Outcomes were assessed with the UCLA Prostate Cancer Index, which is a validated, health related quality of life instrument that includes these 2 domains. To minimize the influence of other factors we adjusted for age, co-morbidity, general health, pad use, anticholinergics or procedures for urethral stricture. All subjects were drawn from the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE), which is a national longitudinal database. RESULTS: Urinary function improved with time during the first year after surgery but remained fairly constant during year 2. Urinary function remained stable throughout the 2 years after radiation. Urinary bother was worse after radiation throughout the 2 years, although it improved markedly by the end of year 1. Age, ethnicity and co-morbidity did not impact urinary function or bother but being married did have an advantage. CONCLUSIONS: Patients undergoing surgery or radiation showed different longitudinal profiles of urinary function and bother during the first 2 years after treatment.","J Urol, 164(6): 1973-1977","USA",2000,"Local","Surgery,Radiotherapy","UCLA-PCI","Patient",null,"Cohort","USA","Patient","Local","Surgery,Radiotherapy",null,"Cohort","UCLA-PCI","2000:2004","Disease"]
[415,"Litwin, M. S., et al. (2001). \"Life after radical prostatectomy: a longitudinal study.\" J Urol 166(2): 587-592.",null,"Litwin, M. S., et al.","Life after radical prostatectomy: a longitudinal study","PURPOSE: We investigate the longitudinal recovery of quality of life after radical prostatectomy in men with localized prostate cancer. MATERIALS AND METHODS: We assessed the self-reported health related quality of life in 247 men undergoing radical prostatectomy for prostate cancer. Patients were assessed at baseline before surgery and postoperatively every 3 months for 1 year and then every 6 months for up to 48 months (median 30). We measured general and prostate specific health related quality of life with the RAND 36-Item Health Survey 1.0 SF-36 and University of California, Los Angeles Prostate Cancer Index. The Cox proportional hazards regression model was used to determine whether some patients were more likely than others to have a successful return to baseline functioning after treatment. RESULTS: In the SF-36 60% of patients reached baseline in all domains by 3 months. By 12 months, greater than 90% of patients reached baseline in all domains. Mean recovery time for these domains was about 4(1/2) months. The recovery of urinary function to baseline was 21% at 3, 56% at 12 and 63% at 30 months, respectively. About 80% of patients recovered to baseline urinary bother. In the urinary domains patients who recovered did so at an average of 7 to 8 months, and there was little additional recovery after 18 months. By 1 year postoperatively, approximately a third of patients reached baseline sexual function and about half recovered to baseline sexual bother. At 2 years postoperatively, sexual function and bother returned to baseline in 40% and 60% of patients, respectively. Mean recovery time was about 11 months for sexual function and about 9 months for sexual bother. There was little additional recovery in the sexual domains after 18 to 24 months. In the bowel domains more than two thirds of patients returned to baseline by 3 months, and greater than 90% recovered by 12 months, with a mean recovery of 4.8 months. Unmarried men were more likely than those married to regain baseline sexual function (p = 0.03) and urinary function (p = 0.07). Patients who were 65 years and older were more likely than those younger to return to baseline sexual bother (p = 0.03). There were trends that showed patients with higher incomes as well as those who were white were more likely to recover baseline scores for urinary function and the physical component summary. Another trend suggested that men with a higher education were less likely to regain urinary function (p = 0.08). CONCLUSIONS: Most quality of life recovery occurs early after radical prostatectomy, except in several domains, including urinary and sexual, which continue to improve even beyond 2 years postoperatively. Patients should be encouraged that recovery may continue for months or years after surgery.","J Urol, 166(2): 587-592","USA",2001,"Local","Surgery","SF-36,UCLA-PCI","Patient",null,"Cohort","USA","Patient","Local","Surgery",null,"Cohort","SF-36,UCLA-PCI","2000:2004","Disease,Utility"]
[416,"Litwin, M. S., et al. (2001). \"Quality of life before death for men with prostate cancer: results from the CaPSURE database.\" J Urol 165(3): 871-875.",null,"Litwin, M. S., et al.","Quality of life before death for men with prostate cancer: results from the CaPSURE database","PURPOSE: We examined changes in health related quality of life during the 12 months before death in men with prostate cancer. MATERIALS AND METHODS: We studied patients from CapSure, which is a longitudinal observational cohort of men with biopsy proved prostate cancer treated in community and academic urology practices across the United States. Of all men in the cohort who died while being followed for prostate cancer 131 who had submitted health related quality of life surveys during the 6 months before death were included in this analysis. Health related quality of life was measured with the RAND 36-Item Health Survey, an established validated instrument that comprises 4 physical and 4 mental domains. RESULTS: On univariate analysis all 8 domains of the 36-Item Health Survey substantially decreased in the final year of life. On multivariate analysis only physical function decreased more rapidly in men dying of prostate cancer compared to those dying of other cancer or benign causes. CONCLUSIONS: Quality of life begins a steady and inexorable decline in the final 12 months of life in men with prostate cancer. Increased attention to quality of life changes may provide new clinical opportunities to enhance quality of care in the final year of life in these men.","J Urol, 165(3): 871-875","USA",2001,"End of life","None","SF-36","Patient",null,"Cohort","USA","Patient","End of life","None",null,"Cohort","SF-36","2000:2004","Utility"]
[417,"Litwin, M. S., et al. (2002). \"Mental health in men treated for early stage prostate carcinoma: a posttreatment, longitudinal quality of life analysis from the Cancer of the Prostate Strategic Urologic Research Endeavor.\" Cancer 95(1): 54-60.",null,"Litwin, M. S., et al.","Mental health in men treated for early stage prostate carcinoma: a posttreatment, longitudinal quality of life analysis from the Cancer of the Prostate Strategic Urologic Research Endeavor","BACKGROUND: The current study was conducted to assess posttreatment changes in the mental components of health related quality of life in prostate carcinoma patients during the two years following diagnosis and management with radical prostatectomy, pelvic irradiation, or watchful waiting. METHODS: The authors studied the mental domains of general health related quality of life in 452 men recently diagnosed with early stage prostate carcinoma and treated with radical prostatectomy, pelvic radiation, or watchful waiting. Outcomes were assessed with the RAND 36-Item Health Survey, a validated health-related quality of life instrument that includes four mental domains. To minimize the influence of potentially confounding factors, the authors adjusted for age, comorbidity, prostate specific antigen (PSA) at diagnosis, and biopsy Gleason score. All subjects were drawn from CaPSURE, a national, longitudinal cohort. RESULTS: By 6-12 months after treatment, the active treatment groups began to show differences in mental health and vitality. By 15 months, surgery and radiation patients scored differently in all four mental domains. Over time, the gaps between mental domain scores grew wider among the treatment groups, with surgery patients performing the best, radiation patients performing the worst, and watchful waiting patients falling in between. CONCLUSIONS: The mental health profiles differ for patients undergoing surgery, radiation, or watchful waiting for early stage prostate carcinoma. Men with more serious disease, as evidenced by higher PSA levels or more aggressive histology, tended to worry more about it. Older men performed better, while sicker men performed worse, even though the older men tended to be sicker.","Cancer, 95(1): 54-60","USA",2002,"Local","Surgery,Radiotherapy,Surveillance","SF-36","Patient",null,"Cohort","USA","Patient","Local","Surgery,Radiotherapy,Surveillance",null,"Cohort","SF-36","2000:2004","Utility"]
[418,"Litwin, M. S., et al. (2003). \"Health-related quality of life in men with metastatic prostate cancer: the misleading effect of lead-time bias.\" BJU Int 91(1): 9-13.",null,"Litwin, M. S., et al.","Health-related quality of life in men with metastatic prostate cancer: the misleading effect of lead-time bias","OBJECTIVE: To ascertain whether the difference in health-related quality of life, which appears to be worse in men with metastatic prostate cancer when the metastases are noted at initial diagnosis than during follow-up after treatment for clinically localized disease, can be attributed to previous local control or to some form of measurement bias. PATIENTS AND METHODS: We analysed by univariate and multivariate methods 375 men with metastatic prostate cancer who were enrolled in CaPSURE, a national observational cohort of patients with prostate cancer treated in community and academic settings throughout the USA. In particular, we assessed whether group differences in health-related quality of life were explained by the timing of metastatic diagnosis in the course of their disease. Health-related quality of life was measured with the RAND 36-Item Health Survey (SF-36). RESULTS: After controlling for relevant covariates (age, comorbidity and ethnicity), multivariate models suggested that men whose metastases were noted at the time of initial diagnosis scored 5-15 points worse in all eight domains of the SF-36. CONCLUSION: Men who are diagnosed with metastatic prostate cancer during the follow-up after treatment for clinically localized disease report a better quality of life than those who are metastatic at the time of diagnosis, not because the primary treatment confers any benefit but because they are followed more closely over time and diagnosed with metastases earlier in the course of their disease. This apparent difference in quality of life is an effect of lead-time bias in the diagnosis of metastasis.","BJU Int, 91(1): 9-13","USA",2003,"Metastatic","Unclear","SF-36","Patient",null,"Cohort","USA","Patient","Metastatic","Unclear",null,"Cohort","SF-36","2000:2004","Utility"]
[419,"Litwin, M. S., et al. (2004). \"Bowel function and bother after treatment for early stage prostate cancer: a longitudinal quality of life analysis from CaPSURE.\" J Urol 172(2): 515-519.",null,"Litwin, M. S., et al.","Bowel function and bother after treatment for early stage prostate cancer: a longitudinal quality of life analysis from CaPSURE","PURPOSE: We measured bowel function and bowel bother longitudinally the first 2 years after treatment for early stage prostate cancer. MATERIALS AND METHODS: We studied bowel function and bother in 1,584 men recently diagnosed with early stage prostate cancer and followed for 2 years after radical prostatectomy, external beam radiation or brachytherapy. Principal outcomes were assessed with the UCLA Prostate Cancer Index, a validated instrument that includes these 2 domains. Multivariate analyses were conducted to ascertain significant predictors of bowel function and bother. Subjects were drawn from Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE, TAP Pharmaceutical Products, Inc., Lake Forest, Illinois), a national, longitudinal registry of men with prostate cancer. RESULTS: Men treated with external beam radiation or brachytherapy suffered worse bowel function and were more bothered by it than men treated surgically. After an initial period of posttreatment impairment, all 3 groups demonstrated improvement with time in both domains, although bowel bother persisted longer in men treated with external beam radiation. Surgery patients reached a steady state by 3 months, while those treated with external beam radiation or brachytherapy continued to improve for more than a year after treatment. Older men were more bothered by bowel dysfunction than younger men. Ethnicity, comorbidity and education did not affect either bowel function or bother. CONCLUSIONS: Patients undergoing surgery, external beam radiation or brachytherapy have different longitudinal profiles of bowel function and bother during the first 2 years after treatment. Bowel function and bother are worse after external beam radiation but they are also impaired after brachytherapy. Men choosing surgery experience transient impairment in the bowel domains. This information may be useful to patients making treatment decisions for early stage prostate cancer.","J Urol, 172(2): 515-519","USA",2004,"Local","Surgery,Radiotherapy,Brachytherapy","UCLA-PCI","Patient",null,"Cohort","USA","Patient","Local","Surgery,Radiotherapy,Brachytherapy",null,"Cohort","UCLA-PCI","2000:2004","Disease"]
[420,"Livsey, J. E., et al. (2002). \"Scoring of treatment-related late effects in prostate cancer.\" Radiother Oncol 65(2): 109-121.",null,"Livsey, J. E., et al.","Scoring of treatment-related late effects in prostate cancer","BACKGROUND AND PURPOSE: To assess the correlation between different general and organ specific quality of life and morbidity scoring methods in a cohort of men treated with radical radiotherapy for prostate cancer. MATERIALS AND METHODS: Men who had been treated with radical radiotherapy (50 Gy in 16 fractions over 21 days) for localized prostate cancer more than 3 years previously and who had no evidence of recurrent disease were invited to take part in the study. A total of 101 of 135 invited patients agreed and completed LENT/SOMA, UCLA Prostate Cancer Index, and 36 item RAND Health survey questionnaires. RESULTS: The patients had comparable results with other published series with respect to the UCLA and SF-36 indices. There was significant correlation between the corresponding parts of the UCLA and LENT/SOMA scales (P<0.0005). However, for the same symptoms, a patient tended to score lower (worse) on the UCLA scale in comparison to LENT/SOMA. The relationship between the average LENT/SOMA score and maximum score was also not straightforward with each set of data revealing different information. CONCLUSIONS: The LENT/SOMA questions were, in the main, more wide-ranging and informative than the UCLA index. It is helpful to give both the overall and maximum LENT/SOMA scores to most efficiently use all of the data. There may need to be a further LENT/SOMA question to allow both symptoms of tenesmus and faecal urgency to be fully addressed.","Radiother Oncol, 65(2): 109-121","UK",2002,"Local","Radiotherapy","UCLA-PCI,SF-36,LENT-SOMA","Patient",null,"Validation","UK","Patient","Local","Radiotherapy",null,"Validation","UCLA-PCI,SF-36,LENT-SOMA","2000:2004","Disease,Treatment,Utility"]
[421,"Lloyd, A. J., et al. (2015). \"Health-Related Quality of Life and Health Utilities in Metastatic Castrate-Resistant Prostate Cancer: A Survey Capturing Experiences from a Diverse Sample of UK Patients.\" Value Health 18(8): 1152-1157.",null,"Lloyd, A. J., et al.","Health-Related Quality of Life and Health Utilities in Metastatic Castrate-Resistant Prostate Cancer: A Survey Capturing Experiences from a Diverse Sample of UK Patients","BACKGROUND: The collection of preference-based health outcomes data (or utility values) is required to support cost-effectiveness analyses. OBJECTIVE: This study aimed to collect health-related quality of life (HRQOL) data in men with metastatic castration-resistant prostate cancer (CRPC) stratified by disease states. METHODS: Men with metastatic CRPC were recruited via UK patient associations, patient panels, and specialist recruiters and classified into four subgroups reflecting disease state: asymptomatic/mildly symptomatic before chemotherapy, symptomatic before chemotherapy, receiving chemotherapy, and postchemotherapy. HRQOL data (including five-level EuroQol five-dimensional questionnaire [EQ-5D-5L], European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire [EORTC QLQ-C30], and 25-item prostate cancer-specific questionnaire module designed to supplement the EORTC QLQ-C30) along with background and medical history data were collected via an online survey. The EQ-5D-5L and the EORTC-8D (EORTC-8D is an 8 dimensional utility index scored from QLQ-C30 data) were both used to estimate utilities. RESULTS: Data were collected from a total sample of 163 men with metastatic CRPC. Utility values elicited by the EQ-5D-5L ranged from 0.830 for the asymptomatic/mildly symptomatic before chemotherapy disease state (95% confidence interval [CI] 0.795-0.865) to 0.625 for the symptomatic before chemotherapy disease state (95% CI 0.577-0.673). EORTC-8D utilities ranged from 0.856 (95% CI 0.831-0.882) to 0.697 (95% CI 0.664-0.731) for the same disease/treatment states. CONCLUSIONS: This online survey was designed to capture real-world HRQOL data describing men with CRPC. The study estimated utilities using two alternative methods, and the results show good agreement, suggesting that they are robust. This methodology offers a potentially higher quality alternative to vignette-based methods that are commonly used in oncology submissions.","Value Health, 18(8): 1152-1157","UK",2015,"Metastatic","Chemotherapy","EQ-5D,EORTC QLQ-C30,EORTC-8D,EORTC QLQ-PR25","Patient",null,"Cross-sectional","UK","Patient","Metastatic","Chemotherapy",null,"Cross-sectional","EQ-5D,EORTC QLQ-C30,EORTC-8D,EORTC QLQ-PR25","2015:2018","General,Utility,Disease"]
[422,"Loblaw, A., et al. (2013). \"Prostate stereotactic ablative body radiotherapy using a standard linear accelerator: toxicity, biochemical, and pathological outcomes.\" Radiother Oncol 107(2): 153-158.",null,"Loblaw, A., et al.","Prostate stereotactic ablative body radiotherapy using a standard linear accelerator: toxicity, biochemical, and pathological outcomes","BACKGROUND AND PURPOSE: Biological dose escalation through stereotactic ablative radiotherapy (SABR) holds promise of improved patient convenience, system capacity and tumor control with decreased cost and side effects. The objectives are to report the toxicities, biochemical and pathologic outcomes of this prospective study. MATERIALS AND METHODS: A phase I/II study was performed where low risk localized prostate cancer received SABR 35 Gy in 5 fractions, once weekly on standard linear accelerators. Common Terminology Criteria for Adverse Events v3.0 and Radiation Therapy Oncology Group late morbidity scores were used to assess acute and late toxicities, respectively. Biochemical control (BC) was defined by the Phoenix definition. RESULTS: As of May 2012, 84 patients have completed treatment with a median follow-up of 55 months (range 13-68 months). Median age was 67 years and median PSA was 5.3 ng/ml. The following toxicities were observed: acute grade 3+: 0% gastrointestinal (GI), 1% genitourinary (GU), 0% fatigue; late grade 3+: 1% GI, 1% GU. Ninety-six percent were biopsy negative post-treatment. The 5-year BC was 98%. CONCLUSIONS: This novel technique employing standard linear accelerators to deliver an extreme hypofractionated schedule of radiotherapy is feasible, well tolerated and shows excellent pathologic and biochemical control.","Radiother Oncol, 107(2): 153-158","Canada",2013,"Local","Radiotherapy","CTCAE,RTOG-EORTC-SS","Patient",null,"Clinical trial","Canada","Patient","Local","Radiotherapy",null,"Clinical trial","CTCAE,RTOG-EORTC-SS","2010:2014","Treatment"]
[423,"Lofters, A., et al. (2002). \"\"PSA-itis\": knowledge of serum prostate specific antigen and other causes of anxiety in men with metaststic prostate cancer.\" J Urol 168(6): 2516-2520.",null,"Lofters, A., et al.","PSA-itis: knowledge of serum prostate specific antigen and other causes of anxiety in men with metaststic prostate cancer","PURPOSE: High or increasing prostatic specific antigen (PSA) levels may be a source of anxiety in patients with metastatic prostate cancer. MATERIALS AND METHODS: Patients with metastatic prostate cancer completed questionnaires, including the Prostate Cancer Specific Quality of Life Instrument, Hospital Anxiety and Depression Scale, and a questionnaire to assess the impact of the knowledge of PSA levels on anxiety. These were completed at home more than 3 days before or after a clinic appointment and returned by mail. Patient medical history was obtained from the record. RESULTS: Of the 65 patients who consented to the study 52 returned the completed questionnaires. Median age was 70 years (range 55 to 86) and median time since diagnosis was 53 months. Of the patients 81% had hormone resistant disease. Most reported good overall quality of life with a median Prostate Cancer Specific Quality of Life Instrument score of 93 (maximum 100). Of the patients 77% indicated that PSA levels were one of the ways and 44% indicated they were the only way that they knew whether disease was progressing. When asked to rate preferences for treatment outcome, 25% of the men rated decreasing PSA and worse physical symptoms above increasing PSA and better physical symptoms. If measurement of PSA levels ceased, 52% of patients would believe that their doctor was giving up on them and only 1 would be relieved. Before receiving PSA results 76% reported some level of anxiety and 15% reported extreme anxiety. CONCLUSIONS: PSA related anxiety represents a substantial problem in patients with metastatic prostate cancer.","J Urol, 168(6): 2516-2520","Canada",2002,"Metastatic","None","HADS,PCSQLI","Patient",null,"Cross-sectional","Canada","Patient","Metastatic","None",null,"Cross-sectional","HADS,PCSQLI","2000:2004","Disease,Comorbidity"]
[424,"Lopez-Calderero, I., et al. (2017). \"Impact of locally advanced or metastatic prostate cancer on the quality of life.\" Actas Urol Esp 41(6): 368-375.",null,"Lopez-Calderero, I., et al.","Impact of locally advanced or metastatic prostate cancer on the quality of life","OBJECTIVE: The aim of this study was to assess the health-related quality of life of patients with prostate cancer in advanced phases to obtain additional information on the patients' health. The growing interest in understanding the patient's perspective and the scarcity of prospective studies of this population motivated this research study. MATERIAL AND METHODS: We present an observational study performed on 131 urology consultations, with a sample of 601 patients with locally advanced or metastatic prostate cancer, assessed during 2 visits: baseline and at 12 months. We collected demographic, clinical, quality-of-life (PROSQoLI and EuroQoL-5D-5L questionnaires) and anxiety/depression (HADS questionnaire) endpoints. RESULTS: The mean age (SD) was 73.8 (8.2) years, and 87.2% of the participants were retired or pensioners. Some 58.7% of the patients presented locally advanced prostate cancer. Urinary symptoms were the most common, decreasing significantly after one year (P<.05). Urinary problems and fatigue were the most affected measures, and pain/discomfort was the dimension present in most patients (65.3%). According to the linear regression model, asthenia and pain were 2 of the factors most closely related to a poorer quality of life. The presence of anxiety/depression was low. Finally, the health condition as assessed by the clinician was more positive than when assessed by the patients. CONCLUSIONS: This study broadens the scarce information on the quality of life of the population with advanced prostate cancer, information of use for the clinical management of these patients.","Actas Urol Esp, 41(6): 368-375","France,Spain",2017,"Advanced,Metastatic","None","HADS,PROSQoLI,EQ-5D","Patient",null,"Cohort","France,Spain","Patient","Advanced,Metastatic","None",null,"Cohort","HADS,PROSQoLI,EQ-5D","2015:2018","Disease,Utility,Comorbidity"]
[425,"Loriot, Y., et al. (2015). \"Effect of enzalutamide on health-related quality of life, pain, and skeletal-related events in asymptomatic and minimally symptomatic, chemotherapy-naive patients with metastatic castration-resistant prostate cancer (PREVAIL): results from a randomised, phase 3 trial.\" Lancet Oncol 16(5): 509-521.",null,"Loriot, Y., et al.","Effect of enzalutamide on health-related quality of life, pain, and skeletal-related events in asymptomatic and minimally symptomatic, chemotherapy-naive patients with metastatic castration-resistant prostate cancer (PREVAIL): results from a randomised, phase 3 trial","BACKGROUND: Enzalutamide significantly increased overall survival and radiographic progression-free survival compared with placebo in the PREVAIL trial of asymptomatic and minimally symptomatic, chemotherapy-naive patients with metastatic castration-resistant prostate cancer. We report the effect of enzalutamide on health-related quality of life (HRQoL), pain, and skeletal-related events observed during this trial. METHODS: In this phase 3, double-blind trial, patients were randomly assigned (1:1) to receive enzalutamide 160 mg/day (n=872) or placebo (n=845) orally. HRQoL was assessed at baseline and during treatment using the Functional Assessment of Cancer Therapy-Prostate (FACT-P) and EQ-5D questionnaires. Pain status was assessed at screening, baseline, week 13, and week 25 with the Brief Pain Inventory Short Form (BPI-SF). The primary analysis of HRQoL data used a mixed-effects model to test the difference between least square means change from baseline at week 61. We assessed change from baseline, percentage improvement, and time to deterioration in HRQoL and pain, the proportion of patients with a skeletal-related event, and time to first skeletal-related event. Analysis was done on the intention-to-treat population. This study is registered with ClinicalTrials.gov, number NCT01212991. FINDINGS: Median treatment duration was 16.6 months (IQR 10.1-21.1) in the enzalutamide group and 4.6 months (2.8-9.7) in the placebo group. The mixed-effects model analyses showed significant treatment differences in change from baseline to week 61 with enzalutamide compared with placebo for most FACT-P endpoints and EQ-5D visual analogue scale. Median time to deterioration in FACT-P total score was 11.3 months (95% CI 11.1-13.9) in the enzalutamide group and 5.6 months (5.5-5.6) in the placebo groups (hazard ratio [HR] 0.62 [95% CI 0.54-0.72]; p<0.0001). A significantly greater proportion of patients in the enzalutamide group than in the placebo group reported clinically meaningful improvements in FACT-P total score (327 [40%] of 826 vs 181 [23%] of 790), in EQ-5D utility index (224 [28%] of 812 vs 99 [16%] of 623), and visual analogue scale (218 [27%] of 803 vs 106 of [18%] 603; all p<0.0001). Median time to progression in BPI-SF pain at its worst was 5.7 months (95% CI 5.6-5.7) in the enzalutamide group and 5.6 months (5.4-5.6) in the placebo group (HR 0.62 [95% CI 0.53-0.74]; p<0.0001). Progression of pain at its worst was less common in the enzalutamide group than in the placebo group at week 13 (220 [29%] of 769 vs 257 [42%] of 610; p<0.0001), but not at week 25 (225 [32%] of 705 vs 135 [38%] of 360; p=0.068). 278 (32%) of 872 patients in the enzalutamide group and 309 (37%) of 845 patients in the placebo group had experienced a skeletal-related event by data cutoff. Median time to first skeletal-related events in the enzalutamide group was 31.1 months (95% CI 29.5-not reached) and 31.3 months (95% CI 23.9-not reached) in the placebo group (HR 0.72 [95% CI 0.61-0.84]; p<0.0001). INTERPRETATION: In addition to improving overall survival relative to placebo, enzalutamide significantly improves patient-related outcomes and delays occurrence of first skeletal-related event in chemotherapy-naive men with metastatic castration-resistant prostate cancer. FUNDING: Astellas Pharma and Medivation.","Lancet Oncol, 16(5): 509-521","Germany,Italy,France,UK,USA,Spain,Norway,Netherlands,Belgium",2015,"Metastatic","Hormonal","FACT-P,EQ-5D,BPI","Patient",null,"Clinical trial","Germany,Italy,France,UK,USA,Spain,Norway,Netherlands,Belgium","Patient","Metastatic","Hormonal",null,"Clinical trial","FACT-P,EQ-5D,BPI","2015:2018","Disease,Symptom,Utility"]
[426,"LoRusso, P. M., et al. (2003). \"Improvements in quality of life and disease-related symptoms in phase I trials of the selective oral epidermal growth factor receptor tyrosine kinase inhibitor ZD1839 in non-small cell lung cancer and other solid tumors.\" Clin Cancer Res 9(6): 2040-2048.",null,"LoRusso, P. M., et al.","Improvements in quality of life and disease-related symptoms in phase I trials of the selective oral epidermal growth factor receptor tyrosine kinase inhibitor ZD1839 in non-small cell lung cancer and other solid tumors","PURPOSE: The feasibility and utility of assessing quality of life (QoL) and disease-related symptoms in patients with advanced cancer have been evaluated in two Phase I clinical trials of p.o. administered ZD1839 ('Iressa'), an epidermal growth factor receptor tyrosine kinase inhibitor, in patients with advanced cancer. EXPERIMENTAL DESIGN: Functional Assessment of Cancer Therapy (FACT) questionnaires, including disease-specific subscales for lung, head and neck, colorectal, prostate, and ovarian cancer, were completed by patients in two open-label, Phase I, escalating multiple-dose safety and tolerability trials. RESULTS: In 157 patients, 92% of whom had received prior therapy, compliance in returning FACT questionnaires was 87% (European/Australian trial) and 57% (United States trial). This did not appear to be influenced by dose level or tumor type. For patients with colorectal, prostate, or ovarian cancer, median QoL [FACT and Trial Outcome Index (TOI)] scores deteriorated over time. In contrast, for patients with non-small cell lung cancer (NSCLC) or head and neck cancer, median FACT and TOI scores did not deteriorate significantly, and in the United States trial, head and neck cancer scores improved significantly over time. In patients with NSCLC, symptom-related scores measured by the Lung Cancer Subscale of FACT-L appeared sensitive to clinical change. CONCLUSIONS: QoL (FACT-L) questionnaires were used successfully in the Phase I clinical trials of ZD1839. They appeared to be a sensitive tool to monitor clinical changes for the five tumor types in these trials and showed that ZD1839 has the potential to improve patients' QoL.","Clin Cancer Res, 9(6): 2040-2048","USA",2003,"Advanced","Gefitinib","FACT-P,TOI","Patient",null,"Clinical trial","USA","Patient","Advanced","Gefitinib",null,"Clinical trial","FACT-P,TOI","2000:2004","Disease,Treatment"]
[427,"Lubeck, D. P., et al. (1997). \"Measurement of health-related quality of life in men with prostate cancer: the CaPSURE database.\" Qual Life Res 6(5): 385-392.",null,"Lubeck, D. P., et al.","Measurement of health-related quality of life in men with prostate cancer: the CaPSURE database","This paper reviews the reliability and validity of an instrument for assessing health-related quality of life (HRQOL) in CaPSURE (Cancer of the Prostate Strategic Urologic Research Endeavor), an observational database of men with biopsy-confirmed prostate cancer. The questionnaire includes the RAND 36 item Health Survey 1.0, the UCLA Prostate Cancer Index and items measuring self-esteem and the impact of prostate cancer in general and on the family. The reliability and validity of this instrument are reported for a group of 2,382 men enrolled in CaPSURE. Individuals complete HRQOL questionnaires at enrollment and quarterly thereafter. The subscales of the instrument resulted in a high internal-consistency reliability across all subscales (range = 0.75-0.94). The test-retest reliability was good with the exception of the comparative health item (intraclass correlation coefficient (ICC) = 0.55). The concurrent validity data included moderately strong associations with subscales of similar concepts and the ability to distinguish between patients who are known to be different--newly diagnosed (within 6 months) and patients diagnosed and treated an average of 3 years ago. Overall, this instrument demonstrated good reliability and validity and supported the need for incorporating HRQOL as a component of outcomes assessment in the management of patients with prostate cancer.","Qual Life Res, 6(5): 385-392","USA",1997,"Any or unknown","Unclear","UCLA-PCI,SF-36","Patient",null,"Validation","USA","Patient","Any or unknown","Unclear",null,"Validation","UCLA-PCI,SF-36","1960:1999","Disease,Utility"]
[428,"Lubeck, D. P., et al. (2000). \"An instrument to measure patient satisfaction with healthcare in an observational database: results of a validation study using data from CaPSURE.\" Am J Manag Care 6(1): 70-76.",null,"Lubeck, D. P., et al.","An instrument to measure patient satisfaction with healthcare in an observational database: results of a validation study using data from CaPSURE","OBJECTIVE: To validate a satisfaction measure for use in longitudinal, prospective studies of patient care. STUDY DESIGN: Patients with biopsy-confirmed prostate cancer (n = 228) who were enrolled in CaPSURE (Cancer of the Prostate Strategic Urologic Research Endeavor) completed a self-administered questionnaire that included a health-related quality-of-life and satisfaction measure. A subset of patients completed the questionnaire again within 30 days. METHODS: The satisfaction measure contained 6 individual subscales: overall satisfaction with care, contact with providers, confidence in providers, communication skills, humaneness, and a summary scale. Six items surveyed patients' willingness to participate in decision making (participatory style), and these were averaged into a single score. Variability, reliability, stability, and validity were evaluated. RESULTS: Responses to the items varied substantially. The overall satisfaction scale demonstrated good internal consistency reliability (Cronbach alpha = 0.82) and moderate test-retest reliability (0.62), and it could discriminate between groups of individuals expected to differ with regard to satisfaction (by age and disease stage). Subscale internal consistency reliability (0.37-0.54) and stability (0.38-0.63) were weaker, suggesting that only a single scale should be reported. The participatory scale performed poorly and could not be recommended for future use. CONCLUSION: The overall satisfaction measure developed for this study demonstrated good reliability and validity and should be useful in other population-based studies in conjunction with other outcome measures.","Am J Manag Care, 6(1): 70-76","USA",2000,"Any or unknown","Unclear","Unclear","Patient",null,"Validation","USA","Patient","Any or unknown","Unclear",null,"Validation","Unclear","2000:2004","General,Satisfaction"]
[429,"Lubeck, D. P., et al. (2001). \"The effect of androgen deprivation therapy on health-related quality of life in men with prostate cancer.\" Urology 58(2 Suppl 1): 94-100.",null,"Lubeck, D. P., et al.","The effect of androgen deprivation therapy on health-related quality of life in men with prostate cancer","Treatment for prostate cancer has a significant impact on health-related quality of life (HRQOL). We examined HRQOL in a cohort of men receiving androgen deprivation therapy (ADT) and a cohort who opted for surveillance. The cohort consisted of 1178 newly diagnosed patients from the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) database (a national longitudinal registry of patients with prostate cancer). General and disease-specific HRQOL outcomes were measured with validated instruments (the SF-36 and University of California at Los Angeles [UCLA] Prostate Cancer Index) at study entry and quarterly thereafter. Individuals were grouped by initial treatment: ADT, surveillance, radical prostatectomy, or radiation therapy. There were 106 men who selected surveillance, 167 men receiving ADT, 351 men treated by radical prostatectomy, and 75 men receiving radiation therapy in the first year after diagnosis. Mean age at diagnosis was 73 years of age, with surveillance patients the oldest and radical prostatectomy patients the youngest. Men receiving ADT reported poorer urinary and sexual function and a higher rate of urinary and sexual bother than patients selecting surveillance. ADT and surveillance HRQOL scores remained low (ie, poorer function) in the year after treatment, whereas men undergoing radical prostatectomy showed improvement in these scales. Patients who received ADT had reduced energy, poorer sexual and urinary function, and were more bothered by their urine and sexual function than patients undergoing other treatments, except surveillance. Longer follow-up time after start of ADT and surveillance is needed to discern the impact of comorbidities on HRQOL.","Urology, 58(2 Suppl 1): 94-100","USA",2001,"Any or unknown","Hormonal,Surveillance,Surgery,Radiotherapy","SF-36,UCLA-PCI","Patient",null,"Cohort","USA","Patient","Any or unknown","Hormonal,Surveillance,Surgery,Radiotherapy",null,"Cohort","SF-36,UCLA-PCI","2000:2004","Disease,Utility"]
[430,"Lucas, M. D., et al. (1995). \"Quality of life, sexual functioning and sex role identity after surgical orchidectomy in patients with prostatic cancer.\" Scand J Urol Nephrol 29(4): 497-500.",null,"Lucas, M. D., et al.","Quality of life, sexual functioning and sex role identity after surgical orchidectomy in patients with prostatic cancer","Surgical orchidectomy is a simple procedure with few physical side effects, low mortality, and cost effectiveness. Nevertheless, there can be negative sequelae such as sexual dysfunction, impaired quality of life, and poor body image. Although it is a frequent treatment approach for prostate cancer, it is not clear whether these sequelae are problematic for this patient group. It is possible that relief from painful metastases and the prolongation of life outweigh these negative factors. The present study investigated quality of life, sex-role identity, and sexual function in 15 patients with stage D prostate cancer, before and after surgery. Orchidectomy did not appear to affect quality of life, or sex-role identity. However, loss of sexual function did present as an area of concern. It was noted that 55% of premorbidly sexually active patients found this loss disturbing. These patients, premorbidly, appeared to have higher sex-role stereotypy.","Scand J Urol Nephrol, 29(4): 497-500","South Africa",1995,"Metastatic","Surgery","Unclear","Patient",null,"Cohort","South Africa","Patient","Metastatic","Surgery",null,"Cohort","Unclear","1960:1999","General,Complication"]
[431,"Macaulay, M., et al. (2015). \"A trial of devices for urinary incontinence after treatment for prostate cancer.\" BJU Int 116(3): 432-442.",null,"Macaulay, M., et al.","A trial of devices for urinary incontinence after treatment for prostate cancer","OBJECTIVE: To compare the performance of three continence management devices and absorbent pads used by men with persistent urinary incontinence (>1 year) after treatment for prostate cancer. PATIENTS AND METHODS: Randomised, controlled trial of 56 men with 1-year follow-up. Three devices were tested for 3 weeks each: sheath drainage system, body-worn urinal (BWU) and penile clamp. Device and pad performance were assessed. Quality of life (QoL) was measured at baseline and follow-up with the King's Health Questionnaire. Stated (intended use) and revealed (actual use) preference for products were assessed. Value-for-money was gathered. RESULTS: Substantial and significant differences in performance were found. The sheath was rated as 'good' for extended use (e.g. golf and travel) when pad changing is difficult; for keeping skin dry, not leaking, not smelling and convenient for storage and travel. The BWU was generally rated worse than the sheath and was mainly used for similar activities but by men who could not use a sheath (e.g. retracted penis) and was not good for seated activities. The clamp was good for short vigorous activities like swimming/exercise; it was the most secure, least likely to leak, most discreet but almost all men described it as uncomfortable or painful. The pads were good for everyday activities and best for night-time use; most easy to use, comfortable when dry but most likely to leak and most uncomfortable when wet. There was a preference for having a mixture of products to meet daytime needs; around two-thirds of men were using a combination of pads and devices after testing compared with baseline. CONCLUSIONS: This is the first trial to systematically compare different continence management devices for men. Pads and devices have different strengths, which make them particularly suited to certain circumstances and activities. Most men prefer to use pads at night but would choose a mixture of pads and devices during the day. Device limitations were important but may be overcome by better design.","BJU Int, 116(3): 432-442","Canada",2015,"Any or unknown","Various","KHQ","Patient",null,"Clinical trial","Canada","Patient","Any or unknown","Various",null,"Clinical trial","KHQ","2015:2018","General"]
[432,"Machold, S., et al. (2009). \"Comparison of a 20-min pad test with the 1-hour pad test of the international continence society to evaluate post-prostatectomy incontinence.\" Urol Int 83(1): 27-32.",null,"Machold, S., et al.","Comparison of a 20-min pad test with the 1-hour pad test of the international continence society to evaluate post-prostatectomy incontinence","OBJECTIVES: Urinary incontinence is a hygienic and socially distressing problem for affected people and causes high healthcare costs. Objective standardized noninvasive quantification of urinary incontinence is highly important and, in addition, enables control of therapeutic efficacy. The aim of this prospective study was to evaluate the feasibility, accuracy and reproducibility of a standardized 20-min pad test to measure urinary incontinence after radical prostatectomy in comparison to the 1-hour pad-weighing test recommended by the International Continence Society (ICS). METHODS: We applied a standardized questionnaire, the ICS 1-hour pad test and a simplified 20-min pad test to evaluate subjective and objective post-prostatectomy urinary incontinence in 56 men. RESULTS: The technical feasibility of the 20-min pad test was excellent; the results correlated significantly with both the self-assessment via questionnaire (r = 0.63; p < 0.001) and the 1-hour pad test (ICS; r = 0.66; p < 0.001). Moreover, it was highly reliable (r = 0.74; p < 0.0005) with excellent patient acceptance. CONCLUSIONS: The 20-min pad test qualified as a reliable, cost-effective and noninvasive tool which can easily be applied in urologic or physiotherapeutic practice to assess post-prostatectomy urinary incontinence and to evaluate the success of therapeutic approaches.","Urol Int, 83(1): 27-32","Germany",2009,"Any or unknown","Surgery","Unclear","Patient",null,"Validation","Germany","Patient","Any or unknown","Surgery",null,"Validation","Unclear","2005:2009","Complication"]
[433,"Madalinska, J. B., et al. (2001). \"Health-related quality-of-life effects of radical prostatectomy and primary radiotherapy for screen-detected or clinically diagnosed localized prostate cancer.\" J Clin Oncol 19(6): 1619-1628.",null,"Madalinska, J. B., et al.","Health-related quality-of-life effects of radical prostatectomy and primary radiotherapy for screen-detected or clinically diagnosed localized prostate cancer","PURPOSE: The current study was undertaken within the framework of a screening trial to compare the health-related quality-of-life (HRQOL) outcomes of two primary treatment modalities for localized prostate cancer: radical prostatectomy and external-beam radiotherapy. PATIENTS AND METHODS: We conducted a prospective longitudinal cohort study among 278 patients with early screen-detected (59%) or clinically diagnosed (41%) prostate cancer using both generic and disease-specific HRQOL measures (SF-36, UCLA Prostate Cancer Index [urinary and bowel modules] and items relating to sexual functioning) at three points in time: t1 (baseline), t2 (6 months later), and t3 (12 months after t1). RESULTS: Questionnaires were completed by 88% to 93% of all initially enrolled patients. Patients referred for primary radiotherapy were significantly older than prostatectomy patients (63 v 68 years, P <.01). Analyses (adjusted for age and pretreatment level of functioning) revealed poorer levels of generic HRQOL after radiotherapy. Prostatectomy patients reported significantly higher (P <.01) posttreatment incidences of urinary incontinence (39% to 49%) and erectile dysfunction (80% to 91%) than radiotherapy patients (respectively, 6% to 7% and 41% to 55%). Bowel problems (urgency) affected 30% to 35% of the radiotherapy group versus 6% to 7% of the prostatectomy group (P <.01). Patients with screen-detected and clinically diagnosed cancer reported similar posttreatment HRQOL. CONCLUSION: Prostatectomy and radiotherapy differed in the type of HRQOL impairment. Because the HRQOL effects may be valued differently at the individual level, patients should be made fully aware of the potential benefits and adverse consequences of therapies for early prostate cancer. Differences in posttreatment HRQOL were not related to the method of cancer detection.","J Clin Oncol, 19(6): 1619-1628","Netherlands",2001,"Local","Surgery,Radiotherapy","SF-36,UCLA-PCI","Patient",null,"Cohort","Netherlands","Patient","Local","Surgery,Radiotherapy",null,"Cohort","SF-36,UCLA-PCI","2000:2004","Disease,Utility"]
[434,"Mahal, B. A., et al. (2014). \"Use of a rectal spacer with low-dose-rate brachytherapy for treatment of prostate cancer in previously irradiated patients: Initial experience and short-term results.\" Brachytherapy 13(5): 442-449.",null,"Mahal, B. A., et al.","Use of a rectal spacer with low-dose-rate brachytherapy for treatment of prostate cancer in previously irradiated patients: Initial experience and short-term results","BACKGROUND: Salvage brachytherapy in patients with prior pelvic radiation carries a risk of rectal injury. Herein, we report our initial experience using a hydrogel spacer between the prostate and the rectum during salvage brachytherapy. METHODS AND MATERIALS: A total of 11 patients with prostate cancer and prior radiotherapy (5 prostate brachytherapy, 2 prostate external beam radiation therapy [EBRT], and 4 rectal cancer EBRT) received (125)I brachytherapy after attempted placement of 10cc of a diluted hydrogel spacer between the prostate and rectum. RESULTS: Spacing was achieved in 8 of the 11 (73%) patients but was not possible in 3 (1 prior brachytherapy and 2 prior EBRT) owing to fibrosis and adhesions. For the 8 patients in whom spacing was accomplished, the median space between the prostate and rectum was 10.9mm (prior EBRT) vs. 7.7mm (prior brachytherapy), p=0.048. Median followup was 15.7 months. One patient developed a prostato-rectal fistula requiring a diverting colostomy. The 16-month estimate of late Grade 3 or 4 gastrointestinal or genitourinary toxicity was 26%. One patient developed lymph node-positive recurrence. The 16-month prostate-specific antigen failure-free survival rate was 89%. Compared with baseline, Expanded Prostate Cancer Index Composite for Clinical Practice urinary quality of life (QoL) was significantly worse at 3 and 6 months but not significantly worse by 1 year. There were no significant changes throughout the study period in bowel or sexual QoL. CONCLUSION: Hydrogel spacer placements may be feasible in most patients with prior pelvic radiation. Further followup is needed to determine whether spacer placement will produce long-term improvements in toxicity or QoL.","Brachytherapy, 13(5): 442-449","USA",2014,"Any or unknown","Brachytherapy,Radiotherapy","EPIC","Patient",null,"Cohort","USA","Patient","Any or unknown","Brachytherapy,Radiotherapy",null,"Cohort","EPIC","2010:2014","Disease"]
[435,"Majumder, K., et al. (2014). \"Less satisfaction with information in patients with prostate cancer treated with surgery and salvage radiotherapy compared with patients treated with curative radiotherapy alone, despite similar health-related quality of life.\" Clin Genitourin Cancer 12(3): e71-82.",null,"Majumder, K., et al.","Less satisfaction with information in patients with prostate cancer treated with surgery and salvage radiotherapy compared with patients treated with curative radiotherapy alone, despite similar health-related quality of life","BACKGROUND: This study examined patient perception of information received, satisfaction with that information, and its relation to health-related quality of life (HRQoL) and clinical and demographic variables before, during, and after radiotherapy (RT) for localized prostate cancer. PATIENTS AND METHODS: In 2010, 2 questionnaires (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 [EORTC QLQ-C30] and EORTC QLQ information module [QLQ-INFO25]) were sent to 660 consecutive patients with prostate cancer who had undergone or were to undergo RT with curative intent between December 2006 and March 2010. RESULTS: The response rate was 92%. Although most patients (69%) were satisfied with the information they received, statistically significant differences were found for all but 2 EORTC QLQ-INFO25 variables, favoring those who were treated with RT alone compared with those treated with both prostatectomy and salvage RT. Statistically significant associations between all HRQoL variables and satisfaction with information were found; higher levels of satisfaction were associated with better functioning and lower levels of symptoms and problems. CONCLUSION: Satisfaction with the information received was studied in patients with prostate cancer with localized disease. Despite the fact that the majority of patients reported being satisfied with the information received, there is room for improvement, especially regarding \"the disease,\" \"other services,\" \"different places of care,\" and \"things you can do to help yourself.\" Patients treated with both prostatectomy and salvage RT reported significantly lower levels of satisfaction with information received and of having received significantly less information than did patients treated with RT alone.","Clin Genitourin Cancer, 12(3): e71-82","Sweden",2014,"Local","Surgery,Radiotherapy","EORTC QLQ-C30,EORTC-QLQ-INFO25","Patient",null,"Cross-sectional","Sweden","Patient","Local","Surgery,Radiotherapy",null,"Cross-sectional","EORTC QLQ-C30,EORTC-QLQ-INFO25","2010:2014","General,Knowledge"]
[436,"Majumder, K., et al. (2016). \"Higher sexual interest with androgen receptor inhibitor monotherapy than with castration plus an androgen receptor inhibitor in prostate cancer patients treated with curative radiotherapy, but otherwise small health-related quality of life differences: A randomised prospective 18-month follow-up study.\" Eur J Cancer 65: 43-51.",null,"Majumder, K., et al.","Higher sexual interest with androgen receptor inhibitor monotherapy than with castration plus an androgen receptor inhibitor in prostate cancer patients treated with curative radiotherapy, but otherwise small health-related quality of life differences: A randomised prospective 18-month follow-up study","PURPOSE: To prospectively study differences in health-related quality of life (HRQoL) in patients with localised/locally advanced prostate cancer (PC) treated with curative intended radiation therapy and randomised to androgen receptor inhibitor monotherapy treatment versus castration plus an androgen receptor inhibitor used continuously. Time to Prostate Specific Antigen (PSA) relapse, time to symptomatic metastasis and overall survival (OS) were also described for the two groups. PATIENTS AND METHODS: From 2005 to 2011, a total of 110 patients were randomised at a ratio of 1:1. HRQoL was assessed at six time points: before randomisation, before radiotherapy (RT) start and 9, 12, 15 and 18 months after randomisation, using the European Organization for Research and Treatment of Cancer Quality of Life Core Questionnaire (EORTC QLQ-C30) and EORTC QLQ-PR25. RESULTS: At the 3-month follow-up, statistically significant differences between the two groups were found for overall quality of life (p = 0.006), fatigue (p = 0.023), sexual interest (p < 0.001) and urinary problems (p = 0.036). Small clinical differences were noted for overall quality of life, role functioning, fatigue, pain, sleeping problems and urinary problems. At that assessment point, clinical differences between the groups were substantial regarding sexual interest and moderate regarding sexual functioning (the latter indicated only by patients reporting having sexual interest at baseline). All statistical and clinical differences favoured the androgen receptor inhibitor monotherapy arm. At 18 months after randomisation, statistically significant differences were found for cognitive functioning (p = 0.040) and sexual interest (p = 0.011), both favouring the androgen receptor inhibitor monotherapy arm. CONCLUSION: The results suggest that neo-adjuvant androgen receptor inhibitor monotherapy might be preferred compared to castration plus an androgen receptor inhibitor before curative intended RT in men with localised/locally advanced PC, with higher levels of HRQoL, especially concerning sexual interest. HRQoL differences over time were small. The observation time and study sample were too small for evaluating time to PSA progression and OS. Further studies are needed to confirm the results. The study was registered in, identification number NCT02382094.","Eur J Cancer, 65(43-51","Sweden",2016,"Advanced,Local","Hormonal,Radiotherapy,Surgery","EORTC QLQ-C30,EORTC QLQ-PR25","Patient",null,"Clinical trial","Sweden","Patient","Advanced,Local","Hormonal,Radiotherapy,Surgery",null,"Clinical trial","EORTC QLQ-C30,EORTC QLQ-PR25","2015:2018","Disease,General"]
[437,"Malcolm, J. B., et al. (2010). \"Quality of life after open or robotic prostatectomy, cryoablation or brachytherapy for localized prostate cancer.\" J Urol 183(5): 1822-1828.",null,"Malcolm, J. B., et al.","Quality of life after open or robotic prostatectomy, cryoablation or brachytherapy for localized prostate cancer","PURPOSE: Health related quality of life concerns factor prominently in prostate cancer management. We describe health related quality of life impact and recovery profiles of 4 commonly used operative treatments for localized prostate cancer. MATERIALS AND METHODS: Beginning in February 2000 all patients treated with open radical prostatectomy, robot assisted laparoscopic prostatectomy, brachytherapy or cryotherapy were asked to complete the UCLA-PCI questionnaire before treatment, and at 3, 6, 12, 18, 24, 30 and 36 months after treatment. Outcomes were compared across treatment types with statistical analysis using univariate and multivariate models. RESULTS: A total of 785 patients treated between February 2000 and December 2008 were included in the analysis with a mean followup of 24 months. All health related quality of life domains were adversely affected by all treatments and recovery profiles varied significantly by treatment type. Overall urinary function and bother outcomes scored significantly higher after brachytherapy and cryotherapy compared to open radical prostatectomy and robotic assisted laparoscopic radical prostatectomy. Brachytherapy and cryotherapy had a 3-fold higher rate of return to baseline urinary function compared to open radical prostatectomy and robotic assisted laparoscopic radical prostatectomy. Sexual function and bother scores were highest after brachytherapy, with a 5-fold higher rate of return to baseline function compared to cryotherapy, open radical prostatectomy and robotic assisted laparoscopic radical prostatectomy. All 4 treatments were associated with relatively transient and less pronounced impact on bowel function and bother. CONCLUSIONS: In a study of sequential health related quality of life assessments brachytherapy and cryotherapy were associated with higher urinary function and bother scores compared to open radical prostatectomy and da Vinci prostatectomy. Brachytherapy was associated with higher sexual function and bother scores compared to open radical prostatectomy, robotic assisted laparoscopic radical prostatectomy and cryotherapy.","J Urol, 183(5): 1822-1828","USA",2010,"Local","Surgery,Radiotherapy,Brachytherapy,Various","UCLA-PCI","Patient",null,"Cohort","USA","Patient","Local","Surgery,Radiotherapy,Brachytherapy,Various",null,"Cohort","UCLA-PCI","2010:2014","Disease"]
[438,"Malmi, H., et al. (2010). \"Why do men opt out of prostate-cancer screening? Attitudes and perception among participants and non-participants of a screening trial.\" BJU Int 106(4): 472-477.",null,"Malmi, H., et al.","Why do men opt out of prostate-cancer screening? Attitudes and perception among participants and non-participants of a screening trial","OBJECTIVE: To evaluate attitudes to prostate cancer screening with prostate-specific antigen (PSA) of men who complied with offered screening and those who declined it within the Finnish randomized population-based screening trial, and to compare general health-related quality of life (HRQL) between participants and non-participants. SUBJECTS AND METHODS: Self-administered questionnaires were sent to 500 men randomized into the screening arm in 1996-99 within the Finnish component of the European Randomized Study on Screening for Prostate Cancer. A similar survey was conducted among 500 non-participants. RESULTS: Response proportions among the screening participants and non-participants were 59% and 28%, respectively. Current smoking was less frequent (P < 0.05) among the participants. In terms of attitude, the participants regarded the prostate cancer study as more important and the invitation letter as more informative than the non-participants (P < 0.001). There was no clear difference in worry about treatment consequences. The most commonly given reasons for not participating included previous PSA testing (41%), forgetting the invitation (51%), or not wanting to think of prostate cancer (39%) and regarding possible further diagnostic examinations as unpleasant (28%). The non-participants had a lower mental health score (P < 0.001) than the participants in the RAND-36 Survey. CONCLUSION: Most men who chose not to attend screening had a positive attitude, but did not participate due to practical reasons. However, two-thirds of the non-participants indicated a willingness to participate in the next screening round.","BJU Int, 106(4): 472-477","USA",2010,"At risk","Screening","Unclear","General population",null,"Clinical trial","USA","General population","At risk","Screening",null,"Clinical trial","Unclear","2010:2014","Views"]
[439,"Mason, M., et al. (2013). \"Neoadjuvant androgen deprivation therapy for prostate volume reduction, lower urinary tract symptom relief and quality of life improvement in men with intermediate- to high-risk prostate cancer: a randomised non-inferiority trial of degarelix versus goserelin plus bicalutamide.\" Clin Oncol (R Coll Radiol) 25(3): 190-196.",null,"Mason, M., et al.","Neoadjuvant androgen deprivation therapy for prostate volume reduction, lower urinary tract symptom relief and quality of life improvement in men with intermediate- to high-risk prostate cancer: a randomised non-inferiority trial of degarelix versus goserelin plus bicalutamide","AIMS: The treatment of intermediate- to high-risk prostate cancer with radical radiotherapy is usually in combination with neoadjuvant androgen deprivation therapy. The aim of the present trial was to investigate whether degarelix achieves comparable efficacy with that of goserelin plus bicalutamide as neoadjuvant therapy before radiotherapy. MATERIALS AND METHODS: The study was a randomised, parallel-arm, active-controlled, open-label trial in 244 men with a UICC prostate cancer TNM category T2b-T4, N0, M0, Gleason score >/=7, or prostate-specific antigen >/=10 ng/ml and a total prostate volume >30 ml, who were scheduled to undergo radical radiotherapy and in whom neoadjuvant androgen deprivation therapy was indicated. Eligible patients received treatment with either monthly degarelix (240/80 mg) or goserelin (3.6 mg) for 12 weeks, the latter patients also receiving bicalutamide (50 mg) for 17 days initially. The primary efficacy measure was the mean percentage reduction in total prostate volume from baseline at week 12 measured by transrectal ultrasound. The severity and relief of lower urinary tract symptoms were assessed by the International Prostate Symptom Score questionnaire. Quality of life was assessed by the eighth question of the International Prostate Symptom Score. About 50% of the patients had moderate to severe lower urinary tract symptoms at baseline. RESULTS: The total prostate volume decreased significantly from baseline to week 12 in both treatment groups, reaching -36.0 +/- 14.5% in degarelix-treated patients and -35.3 +/- 16.7% in goserelin-treated patients (adjusted difference: -0.3%; 95% confidence interval: -4.74; 4.14%). At the end of the therapy, more degarelix- than goserelin-treated patients reported International Prostate Symptom Score decreases of >/=3 points (37% versus 27%, P = 0.21). In addition, in patients with a baseline International Prostate Symptom Score of >/=13, the magnitude of the decrease was larger in degarelix- (n = 53) versus goserelin-treated patients (n = 17) (6.04 versus 3.41, P = 0.06). CONCLUSIONS: The efficacy of degarelix in terms of prostate shrinkage is non-inferior to that of goserelin plus bicalutamide. The added benefits of degarelix in terms of more pronounced lower urinary tract symptom relief in symptomatic patients could be the reflection of differences in the direct effects on extra-pituitary receptors in the lower urinary tract [Clinicaltrials.gov ID: NCT00833248].","Clin Oncol (R Coll Radiol), 25(3): 190-196","UK",2013,"Local,Advanced","Radiotherapy,Hormonal","IPSS","Patient",null,"Clinical trial","UK","Patient","Local,Advanced","Radiotherapy,Hormonal",null,"Clinical trial","IPSS","2010:2014","Disease"]
[440,"Matthew, A. G., et al. (2007). \"Serial personal digital assistant data capture of health-related quality of life: a randomized controlled trial in a prostate cancer clinic.\" Health Qual Life Outcomes 5: 38.",null,"Matthew, A. G., et al.","Serial personal digital assistant data capture of health-related quality of life: a randomized controlled trial in a prostate cancer clinic","BACKGROUND: In clinical and research practice linked to prostate cancer treatment, frequent monitoring of patient health-related quality of life (HRQOL) is essential. Practical and analytic limitations of paper questionnaire data capture may be overcome with the use of self-administered personal digital assistant (PDA) data collection. The objective of this study was to assess the reliability, validity, and feasibility of using PDA in place of paper versions of the International Prostate Symptom Score (IPSS), the Patient Oriented Prostate Cancer Utility Survey (PORPUS), and the International Index of Erectile Function-5 (IIEF-5) in a prostate cancer clinic setting. METHODS: 152 participants were randomly assigned to one of three conditions: 1) paper followed by PDA survey; 2) PDA followed by paper survey; or 3) PDA followed by PDA survey. Evaluation included an assessment of data quality (internal consistency, test-retest reliability, response correlation, completeness of data), and feasibility (participation rates, time to completion, preference and difficulty/ease of using PDA). RESULTS: Internal consistency was similar for both PDA and paper applications. Test-retest reliability was confirmed for PDA repeated administration. Data from paper and PDA questionnaires were strongly correlated. Lower missed item rates were found in PDA administration. 82.8% of participants preferred using the PDA or had no preference. Mean difficulty/ease ratings indicated that participants found the PDA easy to use. Age did not significantly correlate with preference or difficulty. CONCLUSION: The results confirm the adaptability of the IPSS, IIEF-5, and the PORPUS to PDA administration. Similarly, the findings of this study support the feasibility of using PDA technology for HRQOL serial data capture in the prostate cancer patient population.","Health Qual Life Outcomes, 5(38","Canada",2007,"Any or unknown","Unclear","IPSS,PORPUS,IIEF-5","Patient",null,"Validation","Canada","Patient","Any or unknown","Unclear",null,"Validation","IPSS,PORPUS,IIEF-5","2005:2009","Disease,Complication,Utility"]
[441,"Mazur, D. J. and J. F. Merz (1996). \"How older patients' treatment preferences are influenced by disclosures about therapeutic uncertainty: surgery versus expectant management for localized prostate cancer.\" J Am Geriatr Soc 44(8): 934-937.",null,"Mazur, D. J. and J. F. Merz","How older patients' treatment preferences are influenced by disclosures about therapeutic uncertainty: surgery versus expectant management for localized prostate cancer","OBJECTIVES: There is an ongoing debate about the proper management of localized prostate cancer in older men. We assessed whether older patients differ in their willingness to accept surgery versus expectant management for a hypothetical early stage, low grade, clinically localized prostate carcinoma, and whether patients' current levels or past history of urologic dysfunction (difficulties initiating urination, failing to empty the bladder, urinary dribbling, getting up at night to urinate, and frequency of sexual activity) influence their decisions. We assessed patients' willingness to choose surgery over expectant management by varying the expected survival benefit in years (ESBs-em) of surgery over expectant management. DESIGN: Structured interviews with a consecutive series of male patients. SETTING: A university-based Department of Veterans Affairs Medical Center. PATIENTS: One hundred forty-eight patients seen consecutively in General Medicine Clinic at the Department of Veterans Affairs Medical Center in Portland, Oregon, were enrolled in the study. Mean age of the patients was 66.3 years (SD = 10.3, range = 30-85); mean level of formal education was 12.6 years (SD = 2.7, range = 6-22). MEASUREMENTS: Patients were asked whether they would accept surgery or expectant management in one of 11 treatment comparisons. We varied the ESBs-em in 1-year increments from 0 years to 10 years. As described to patients, surgery carried a mortality risk at the time of treatment of 1 to 2%. Once any patient indicated a willingness to accept surgery at any of the treatment comparisons or if any patient reported preferring expectant management across all treatment comparisons, the elicitation procedure was stopped. All patients were asked to complete a urological and sexual functioning questionnaire to determine the presence of coexisting urological dysfunction and level of sexual activity both at present and in the past. RESULTS: Of the 148 patients enrolled in the study, 43.2% (64/148) preferred surgery with a zero expected life benefit over expectant management (ESBs-em = 0) and a 1 to 2% chance of dying within 1 month of surgery; 24.3% (36/148) rejected surgery as the expected life benefit of surgery was increased (0 < ESBs-em < or = 10 years); 26.4% (39/148) preferred expectant management even when there was a 10-year expected life benefit of surgery; 4.7% (7/148) preferred that their physician make the decision for them; and 1.4% (2/148) of patients reported that they preferred radiation therapy, an option that was not offered to them explicitly. Our results suggest that older patients are more likely to report a preference for expectant management (OR = 1.07). Further, our results suggest that patients who report current urinary dribbling (OR = 9.03) are much more likely to prefer expectant management but that this preference decreases with the amount of time they have had this problem. Similarly, we find that patients who have difficulty with starting urination are much more likely to prefer surgery (OR = 0.13), and this preference is also mediated by the number of years they have experienced this problem. Treatment choice was not associated with formal education, present health status, or the other urological symptoms we assessed. CONCLUSION: Our study in an older male veteran population showed preferences for a variety of options in prostate cancer. Although the majority of men preferred surgery, a significant number preferred expectant management. Our results show that preferences reflect patients' experiences with physical problems associated with disease and that these experiences need to be explored and considered by patients and their providers when making treatment decisions.","J Am Geriatr Soc, 44(8): 934-937","USA",1996,"Local","Radiotherapy,Surgery,Surveillance","Unclear","Patient",null,"Cross-sectional","USA","Patient","Local","Radiotherapy,Surgery,Surveillance",null,"Cross-sectional","Unclear","1960:1999","Complication"]
[442,"Mazzarello Moore, T. H., et al. (2015). \"Supportive care for men with prostate cancer: why are the trials not working? A systematic review and recommendations for future trials.\" Cancer Med 4(8): 1240-1251.",null,"Mazzarello Moore, T. H., et al.","Supportive care for men with prostate cancer: why are the trials not working? A systematic review and recommendations for future trials","Men with prostate cancer are likely to have a long illness and experience psychological distress for which supportive care may be helpful. This systematic review describes the evidence for effectiveness and cost-effectiveness of supportive care for men with prostate cancer, taking into account treatment pathway and components of interventions. MEDLINE, EMBASE, CINAHL, CENTRAL, and Psychinfo were searched from inception--July 2013 for randomized controlled trials and controlled trials. Two authors independently assessed risk of bias and extracted data. Twenty-six studies were included (2740 participants). Interventions were delivered pre and during (n = 12), short-term (n = 8), and longer term (18 months) (n = 5) after primary treatment. No interventions were delivered beyond this time. Few trials recruited ethnic minorities and none recruited men in same sex relationships. Intervention components included information, education, health professional discussion, homework, peer discussion, buddy support, cognitive behavioral therapy, cognitive restructuring, psychoeducation, Reiki and relaxation. Most interventions were delivered for 5-10 weeks. Risk of bias of trials was assessed as unclear for most domains due to lack of information. The majority of trials measuring quality of life and depression found no effect. Relatively few trials measured anxiety, coping skills and self-efficacy, and the majority found no effect. No cost data were available. Trials of supportive care for men with prostate cancer cover a range of interventions but are limited by population diversity, inconsistent measurement and reporting of outcomes, and inability to assess risk of bias. Recommendations on design and conduct of future trials are presented.","Cancer Med, 4(8): 1240-1251","International",2015,"Any or unknown","Various,Psychological","Unclear","Patient",null,"Systematic review","International","Patient","Any or unknown","Various,Psychological",null,"Systematic review","Unclear","2015:2018","General,Comorbidity"]
[443,"McBride, S. M., et al. (2012). \"Hypofractionated stereotactic body radiotherapy in low-risk prostate adenocarcinoma: preliminary results of a multi-institutional phase 1 feasibility trial.\" Cancer 118(15): 3681-3690.",null,"McBride, S. M., et al.","Hypofractionated stereotactic body radiotherapy in low-risk prostate adenocarcinoma: preliminary results of a multi-institutional phase 1 feasibility trial","BACKGROUND: Recent reports using extreme hypofractionated regimens in the treatment of low-risk prostate adenocarcinoma have been encouraging. Here, the authors report on their own multi-institutional experience with extreme hypofractionated stereotactic radiotherapy for early stage disease. METHODS: In total, at 4 centers, 45 patients with National Comprehensive Cancer Network-defined, low-risk prostate adenocarcinoma were enrolled in a phase 1, multi-institutional trial of hypofractionated radiosurgery with a proprietary radiosurgical device (CyberKnife). Thirty-four patients received 7.5 grays (Gy) delivered in 5 fractions, 9 patients received 7.25 Gy delivered in 5 fractions, and 2 patients received other regimens. The variables evaluated were biochemical progression-free survival (bPFS), prostate-specific antigen (PSA) bounce, and toxicities. Health-related quality of life was evaluated using the Sexual Health Inventory for Men (SHIM), American Urological Association (AUA), and Expanded Prostate Cancer Index Composite (EPIC) questionnaires. RESULTS: The median follow-up for surviving patients was 44.5 months (range, 0-62 months). The bPFS rate at 3 years was 97.7%. The median PSA declined from 4.9 ng/mL at diagnosis to 0.2 ng/mL at last follow-up, and the median percentage PSA decline at 12 months was 80%. Nine patients experienced at least 1 PSA bounce >/=0.4 ng/mL, and 4 patients experienced 2 PSA bounces. The median time to first PSA bounce was 11.6 months (range, 7.2-18.2 months), and the mean percentage PSA bounce was 1.07 ng/mL. There was 1 episode of late grade 3 urinary obstruction, and there were 2 episodes of late grade 3 proctitis. There was a significant late decline in SHIM and EPIC sexual scores and a small, late decline in the EPIC Bowel domain score. CONCLUSIONS: In a select population, extreme hypofractionation with stereotactic radiosurgery was safe and effective for the treatment of low-risk prostate adenocarcinoma.","Cancer, 118(15): 3681-3690","USA",2012,"Local","Radiotherapy","EPIC,SHIM,AUA-SI","Patient",null,"Clinical trial","USA","Patient","Local","Radiotherapy",null,"Clinical trial","EPIC,SHIM,AUA-SI","2010:2014","Disease,Symptom"]
[444,"McCammon, K. A., et al. (1999). \"Comparative quality-of-life analysis after radical prostatectomy or external beam radiation for localized prostate cancer.\" Urology 54(3): 509-516.",null,"McCammon, K. A., et al.","Comparative quality-of-life analysis after radical prostatectomy or external beam radiation for localized prostate cancer","OBJECTIVES: To determine and compare quality-of-life (QOL) evaluations from patients who received external beam radiation therapy or radical prostatectomy for the treatment of localized prostate cancer, and to compare differences in QOL assessments for urinary and sexual function after radical prostatectomy as reported by patient and physician. METHODS: Two hundred three patients treated by radical prostatectomy and 257 patients treated by external beam irradiation, all beyond 12-month follow-up after therapy, responded to a QOL questionnaire. The difference in responses with regard to bladder, bowel, and sexual function, overall satisfaction with treatment, and choice of the same treatment were assessed. Satisfaction with and choice of the same treatment were also specifically assessed according to bowel and bladder function and current disease status. The medical records of patients treated by radical prostatectomy were reviewed by an independent data manager to record the physician's assessment of continence and sexual function for comparison with that patient's assessment as noted in the questionnaire. RESULTS: Problems with urinary continence were more frequent among patients treated by radical prostatectomy; problems with gastrointestinal function were more frequent after irradiation. Sexual dysfunction was similar in both groups, although surgical patients experienced a greater impact on sexual relationships. The physician estimates of urinary continence were more favorable than the patient-reported outcomes. However, the physician estimate of sexual function closely approximated that of the patient. Preservation of sexual function among patients who underwent nerve-sparing surgery was disappointingly low. Only for the response to the question dealing with difficulty in achieving an erection was there a statistically significant benefit for patients receiving nerve-sparing versus non-nerve-sparing procedures. Patient satisfaction with and choice of the same treatment varied according to function and current disease status. Patients who had incontinence or bowel dysfunction or had evidence of recurrent disease were statistically less likely to choose the same treatment again when compared with functional and disease-free counterparts. Because irradiated patients were on average 6 years older than surgical patients, responses were adjusted for age; adjustment for age did not alter results. CONCLUSIONS: QOL is determined by the treatment received, by the assessment source, and by the patient's function and disease status at the time of assessment. Prospective and longitudinal studies will more accurately quantify immediate and chronic alterations in QOL. Uniformity of evaluation through consolidation of QOL instruments will permit more accurate cross-series and cross-treatment comparisons.","Urology, 54(3): 509-516","USA",1999,"Local","Surgery,Radiotherapy","Unclear","HCP,Patient",null,"Cross-sectional","USA","HCP,Patient","Local","Surgery,Radiotherapy",null,"Cross-sectional","Unclear","1960:1999","General,Complication"]
[445,"McGovern, P. M., et al. (2004). \"False-positive cancer screens and health-related quality of life.\" Cancer Nurs 27(5): 347-352.",null,"McGovern, P. M., et al.","False-positive cancer screens and health-related quality of life","By design, screening tests are imperfect-unresponsive to some cancers (false negatives) while occasionally raising suspicion of cancer where none exists (false positives). This pilot study describes patients' responses to having a false-positive screening test for cancer, and identifies screening effects on health-related quality of life (HRQoL). The pilot findings suggest issues important for incorporation in future evaluations of the impact of screening for prostate, lung, colon, or ovarian (PLCO) cancers. Seven focus groups were conducted to identify the nature and meaning of all phases of PLCO screening. Minnesota participants in the Prostate, Lung, Colorectal and Ovarian Cancer Screening Trial who had completed screening, with at least 1 false-positive screen, participated (N = 47). Participants' reactions to abnormal screens and diagnostic work-ups were primarily emotional (eg, anxiety and distress), not physical, and ultimately positive for the majority. Health distress and fear of cancer and death were the major negative aspects of HRQoL identified. These concepts are not typically included in generic HRQoL questionnaires like the SF-36, but are highly relevant to PLCO screening. Clinicians were regarded as underestimating the discomfort of follow-up diagnostic testing. However, relief and assurance appeared to eventually outweigh the negative emotions for most participants. Implications for oncology nurses include the need to consider the emotional consequences of screening in association with screen reliability and validity.","Cancer Nurs, 27(5): 347-352","USA",2004,"At risk","Screening","Interview","General population",null,"Cross-sectional","USA","General population","At risk","Screening",null,"Cross-sectional","Interview","2000:2004","Views"]
[446,"McNaughton-Collins, M., et al. (2004). \"Health-related quality of life, satisfaction, and economic outcome measures in studies of prostate cancer screening and treatment, 1990-2000.\" J Natl Cancer Inst Monogr (33): 78-101.",null,"McNaughton-Collins, M., et al.","Health-related quality of life, satisfaction, and economic outcome measures in studies of prostate cancer screening and treatment, 1990-2000","Prostate cancer outcomes research incorporates a broad spectrum of endpoints, from clinical or intermediate endpoints, such as tumor shrinkage or patient compliance, to final endpoints, such as survival or disease-free survival. Three types of nontraditional endpoints that are of growing interest-health-related quality of life (QOL), satisfaction with care, and economic cost impact-hold the promise of improving our ability to understand the full burden of prostate cancer screening and treatment. In this article we review the last decade's published literature regarding the health-related QOL, satisfaction, and economic outcomes of prostate cancer screening and treatment to determine the \"state of the science\" of outcomes measurement. The focus is the enumeration of the types of outcome measurement used in the studies not the determination of the results of the studies. Studies were identified by searching Medline (1990-2000). Articles were included if they presented original data on any patient-centered outcome (including costs or survival alone) for men screened and treated for prostate cancer. Review papers were excluded unless they were quantitative syntheses of the results of other primary studies. Economic and decision analytic papers were included if they presented information on outcomes of real or hypothetical patient cohorts. Each retrieved article was reviewed by one of the authors. Included papers were assigned one primary, mutually exclusive study design. For the \"primary data\" studies, information was abstracted on care setting, dates of the study, sample size, racial distribution, age, tumor differentiation, tumor stage, survival, statistical power, and types of outcomes measures (QOL-generic, QOL-cancer specific, QOL-prostate cancer specific, satisfaction, costs, utilities, and other). For the \"economic and decision analytic\" papers, information was abstracted on stage of disease, age range, outcomes, costs, and whether utilities were measured. Of the 198 included papers, there were 161 primary data papers categorized as follows: randomized trial (n = 28), nonrandomized trial (n = 13), prospective or retrospective cohort study (n = 55), case-control study (n = 0), cross-sectional study (n = 63), and meta-analysis (n = 2). The remaining 37 papers were economic and decision analytic papers. Among the 149 primary data papers that contained patient outcome data, there were 42 standard instruments used, accounting for 44% (179 of 410) of the measures overall. Almost three-quarters (71%) of papers included one, two, or three outcomes measures of all types (standard and nonstandard); three papers included seven outcomes measures, and one paper included nine. Over the 11-year time period, there was a nonstatistically significant trend toward more frequent use of standardized QOL instruments and a statistically significant trend toward increased reporting of race (P = .003). Standardization of measurement of health-related QOL, satisfaction with care, and economic cost effect among men screened and treated for prostate cancer is needed. A core set of similar questions, both generic and disease-specific, should ideally be asked in every study, although investigators should be encouraged to include additional question sets as appropriate to individual studies to get a more complete picture of how patients screened and treated for this condition are doing over time.","J Natl Cancer Inst Monogr, 33): 78-101","International",2004,"At risk,Any or unknown","Screening,Unclear","Unclear","General population,Patient",null,"Systematic review","International","General population,Patient","At risk,Any or unknown","Screening,Unclear",null,"Systematic review","Unclear","2000:2004","General"]
[447,"McNaughton-Collins, M., et al. (2004). \"Psychological effects of a suspicious prostate cancer screening test followed by a benign biopsy result.\" Am J Med 117(10): 719-725.",null,"McNaughton-Collins, M., et al.","Psychological effects of a suspicious prostate cancer screening test followed by a benign biopsy result","PURPOSE: To evaluate the psychological implications of an apparently false-positive screening result for prostate cancer. METHODS: The sample comprised 167 men with a benign biopsy result in response to a suspicious screening test result (biopsy group) and 233 men with a normal prostate-specific antigen (PSA) test result (control group). The men responded to a questionnaire within about 6 weeks of their biopsy or PSA results. They were asked about demographic characteristics, medical history, psychological effects, biopsy experience, and prostate cancer knowledge. RESULTS: The survey response rate was 85% (400/471). The mean (+/- SD) age of respondents was 60 +/- 9 years (range, 40 to 88 years); 88% (n = 350) were white. Forty-nine percent (81/167) of men in the biopsy group reported having thought about prostate cancer either \"a lot\" or \"some of the time\", compared with 18% (42/230) in the control group (P < 0.001). In addition, 40% (67/167) in the biopsy group reported having worried \"a lot\" or \"some of the time\" that they may develop prostate cancer, compared with 8% (18/231) in the control group (P < 0.001). CONCLUSION: Men who underwent prostate biopsy more often reported having thought and worried about prostate cancer, despite having received a benign result. This underrecognized human cost of screening should be considered in the debate about the benefits and harms of prostate cancer screening.","Am J Med, 117(10): 719-725","USA",2004,"At risk","Screening","Unclear","General population",null,"Cross-sectional","USA","General population","At risk","Screening",null,"Cross-sectional","Unclear","2000:2004","Knowledge,Views"]
[448,"Melmed, G. Y., et al. (2002). \"Quality of life at the end of life: trends in patients with metastatic prostate cancer.\" Urology 59(1): 103-109.",null,"Melmed, G. Y., et al.","Quality of life at the end of life: trends in patients with metastatic prostate cancer","OBJECTIVES: To identify the rates of decline in health-related quality of life during the year before death in men with prostate cancer. METHODS: We studied men in a subset analysis within a longitudinal, observational cohort of patients with metastatic prostate cancer at the University of California, Los Angeles, Center for Health Sciences. The analysis included 23 patients who died and had submitted at least two health-related quality-of-life surveys in the final months before death. The outcomes were measured with the RAND 36-Item Health Survey, an established, validated instrument that includes physical and emotional domains. To gauge the effect of marital status, education, and income, we dichotomized these demographic variables. RESULTS: Most domains showed declines, many of them substantial. Patients who had a slower rate of decline in the physical domains tended to be married, better educated, and more affluent. We noted a trend toward a slower deterioration in the mental composite scores among patients who had less than a college degree and an annual household income of $30,000 or less. CONCLUSIONS: Patients dying of metastatic prostate cancer appear to experience declines in health-related quality of life during their final year of life. Further investigation may help identify specific patient characteristics associated with more rapid declines; this will help focus attention on enhancing patients' quality of life as death approaches.","Urology, 59(1): 103-109","USA",2002,"End of life","None","SF-36","Patient",null,"Cohort","USA","Patient","End of life","None",null,"Cohort","SF-36","2000:2004","Utility"]
[449,"Menon, M., et al. (2005). \"Laparoscopic radical prostatectomy: conventional and robotic.\" Urology 66(5 Suppl): 101-104.",null,"Menon, M., et al.","Laparoscopic radical prostatectomy: conventional and robotic","By 2015, prostate cancer will become the most commonly diagnosed cancer in men. Radical prostatectomy reduces disease-specific mortality in patients with localized prostate cancer; however, the invasiveness of surgery and its resultant side effects cause many men to seek other treatments. In 2000, laparoscopic radical prostatectomy emerged as a minimally invasive alternative to open surgery; it has been refined recently by the addition of robotic technology. To examine the outcomes of robotic radical prostatectomy and compare them with those from open and conventional laparoscopic radical prostatectomy, we prospectively collected baseline demographic data on all patients undergoing surgery for prostate cancer over a 4-year period at our center. Urinary function and sexual function were evaluated using standardized criteria as well as a questionnaire preoperatively and at 1, 3, 6, 12, and 18 months after their procedure. Operative and postoperative outcomes were compared using values for open radical prostatectomy as the reference standard. A total of 100 men underwent open radical prostatectomy with conventional laparoscopic radical prostatectomy (n = 50) and robotic radical prostatectomy (n = 500). The odds ratios for operative times, blood loss, postoperative pain, complications, and median times to urinary continence and resumption of sexual activity all were lower for robotic than for open or laparoscopic radical prostatectomy. It appears safe to conclude that conventional laparoscopic radical prostatectomy is a reasonable alternative to open radical prostatectomy in the surgical treatment of patients with clinically localized prostate cancer. The incorporation of robotics may result in even better surgical outcomes than conventional laparoscopy. However, the surgical robot is expensive; few centers have access to the technology and even fewer have expertise in the technique. For robotic radical prostatectomy to become the standard of care for the treatment of localized prostate cancer will require economies of cost, dissemination of surgical expertise, and data from randomized trials.","Urology, 66(5 Suppl): 101-104","USA",2005,"Local","Surgery","Unclear","Patient",null,"Cohort","USA","Patient","Local","Surgery",null,"Cohort","Unclear","2005:2009","Complication"]
[450,"Merrick, G. S., et al. (2000). \"Rectal function following prostate brachytherapy.\" Int J Radiat Oncol Biol Phys 48(3): 667-674.",null,"Merrick, G. S., et al.","Rectal function following prostate brachytherapy","PURPOSE: Quality of life following therapeutic intervention for carcinoma of the prostate gland has not been well documented. In particular, a paucity of data has been published regarding bowel function following prostate brachytherapy. This study evaluated late bowel function in 209 consecutive prostate brachytherapy patients via a one-time questionnaire administered 16-55 months postimplant. MATERIALS AND METHODS: Two hundred nineteen consecutive patients underwent permanent prostate brachytherapy from April 1995 through February 1998 using either (125)I or (103)Pd for clinical T1c-T3a carcinoma of the prostate gland. Of the 219 patients, 7 had expired. Of the remaining 212 patients (median follow-up, 28 months), each patient was mailed a self-administered questionnaire (10 questions) with a prestamped return envelope; 209 (98.6%) surveys were returned. Clinical parameters evaluated for bowel dysfunction included patient age, diabetes, hypertension, history of tobacco consumption, clinical T-stage, elapsed time since implant, and prostate ultrasound volume. Treatment parameters included utilization of neoadjuvant hormonal manipulation, utilization of moderate dose external beam radiation therapy prior to implantation, choice of isotope ((125)I vs. (103)Pd), rectal dose (average, median and maximum doses), total implanted seed strength, values of the minimum dose received by 90% of the prostate gland (D(90)), and the percent prostate volume receiving 100%, 150%, and 200% of the prescribed minimum peripheral dose (V(100), V(150) and V(200), respectively). Because detailed baseline bowel function was not available for these patients, a cross-sectional survey was performed in which 30 newly diagnosed prostate cancer patients of comparable demographics served as controls. RESULTS: The total rectal function scores for the brachytherapy and control patients were 4.3 and 1.6, respectively, out of a total 27 points (p < 0.001). Of the evaluated clinical parameters, only the preimplant number of bowel movements per day were correlated with the total survey score (p < 0.01). None of the treatment parameters were significantly correlated with the total survey score. Despite the fact that implantation with (103)Pd resulted in lower radiation doses to the rectum, the choice of isotope was not predictive of bowel function scores. A trend toward increased rectal scores was noted for older patients, and a nonsignificant improvement in rectal survey scores was noted with elapsed time from implantation. Only 19.2% (40/208) of the treatment group reported a worsening of bowel function following implantation. Patient perception of overall rectal quality of life, however, was inversely related to the utilization of external beam radiation therapy (p = 0.034). CONCLUSION: To date, no severe changes in late bowel function have been noted following prostate brachytherapy. Although the survey scores indicate bowel function is worse after an implant, the minor changes are not significant enough to bother most individuals. Less than 20% of patients reported that their bowel function was worse following prostate brachytherapy.","Int J Radiat Oncol Biol Phys, 48(3): 667-674","USA",2000,"Local,Advanced","Brachytherapy","Unclear","Patient",null,"Cross-sectional","USA","Patient","Local,Advanced","Brachytherapy",null,"Cross-sectional","Unclear","2000:2004","Complication"]
[451,"Merrick, G. S., et al. (2002). \"Erectile function after permanent prostate brachytherapy.\" Int J Radiat Oncol Biol Phys 52(4): 893-902.",null,"Merrick, G. S., et al.","Erectile function after permanent prostate brachytherapy","PURPOSE: To determine the incidence of potency preservation after permanent prostate brachytherapy using a validated patient-administered questionnaire and to evaluate the effect of multiple clinical and treatment parameters on penile erectile function. MATERIALS AND METHODS: Four hundred twenty-five patients underwent permanent prostate brachytherapy from April 1995 to October 1999. Two hundred nine patients who were potent before brachytherapy and who at the time of the survey were not receiving hormonal therapy were mailed the specific erectile questions of the International Index of Erectile Function (IIEF) questionnaire with a self-addressed stamped envelope. The questionnaire consisted of 5 questions, with a maximal score of 25. Of the 209 patients, 181 (87%) completed and returned the questionnaire. The mean and median follow-up was 40.4 +/- 14.9 and 40.6 months, respectively (range 19-75). Preimplant erectile function was assigned using a three-tiered scoring system (2 = erections always or nearly always sufficient for vaginal penetration; 1 = erections sufficient for vaginal penetration but considered suboptimal; 0 = the inability to obtain erections and/or erections inadequate for vaginal penetration). Postimplant potency was defined as an IIEF score >/=11. The clinical parameters evaluated for erectile function included patient age, preimplant potency, clinical T-stage, pretreatment prostate-specific antigen level, Gleason score, elapsed time after implantation, hypertension, diabetes mellitus, and tobacco consumption. Treatment parameters included radiation dose to the prostate gland, use of hormonal manipulation, use of supplemental external beam radiotherapy (EBRT), choice of isotope, prostate volume, and planning volume. The efficacy of sildenafil citrate in brachytherapy-induced erectile dysfunction (ED) was also evaluated. RESULTS: Pretreatment erectile function scores of 2 and 1 were assigned to 125 and 56 patients, respectively. With a 6-year follow-up, 39% of patients maintained potency after prostate brachytherapy, with a plateau on the potency preservation curve. Postimplant preservation of potency (IIEF >/=11) correlated with preimplant erectile function (50.4% vs. 13.2% for preimplant scores of 2 and 1, respectively, p <0.001), patient age (57.4%, 38.2%, and 21.9% for patients <60, 60-69, and >/=70 years old, respectively, p <0.004), use of supplemental EBRT (52.0% vs. 26.4% for patients without and with EBRT, p <0.001), and a history of diabetes mellitus (41.4% vs. 0% for patients without and with diabetes, respectively, p = 0.017). In multivariate analysis, clinical stage, radiation dose to the prostate gland, hormonal manipulation, choice of isotope, history of hypertension, and tobacco consumption had no effect on the ultimate preservation of potency. Only the preimplant potency score, use of supplemental EBRT, and diabetes maintained statistical significance. Sixty-two patients used sildenafil, with 53 (85%) reporting a favorable response. When potent patients were grouped with the ED patients who used sildenafil, the 6-year actuarial rate of potency preservation was 92%. Including the 70 impotent patients who never used sildenafil, the actuarial 6-year rate of potency preservation with and without pharmacologic support was 54% and 39%, respectively. CONCLUSION: Our results suggest that brachytherapy-induced ED is more common than previously reported and may be the result of obtaining patient information by means of a validated quality-of-life instrument by mail and not by personal interview. In multivariate analysis, only pretreatment potency, supplemental EBRT, and diabetes maintained statistical significance. Most patients with brachytherapy-induced ED responded favorably to sildenafil. Although the 6-year actuarial incidence of potency preservation was 39%, 52% of patients not receiving supplemental EBRT maintained potency. In addition, with pharmacologic support, 92% of patients maintained potency.","Int J Radiat Oncol Biol Phys, 52(4): 893-902","USA",2002,"Any or unknown","Brachytherapy","IIEF-5","Patient",null,"Cross-sectional","USA","Patient","Any or unknown","Brachytherapy",null,"Cross-sectional","IIEF-5","2000:2004","Complication"]
[452,"Merrick, G. S., et al. (2002). \"The importance of radiation doses to the penile bulb vs. crura in the development of postbrachytherapy erectile dysfunction.\" Int J Radiat Oncol Biol Phys 54(4): 1055-1062.",null,"Merrick, G. S., et al.","The importance of radiation doses to the penile bulb vs. crura in the development of postbrachytherapy erectile dysfunction","PURPOSE: Recent studies have implicated the proximal penis as a potential site-specific structure for radiation-related erectile dysfunction (ED). In this study, we evaluated by means of a validated patient-administered questionnaire whether radiation doses to the bulb of the penis and/or the proximal corporeal bodies were predictive for the development of brachytherapy-induced ED. METHODS AND MATERIALS: Thirty patients who underwent permanent prostate brachytherapy between April 1995 and October 1999 and developed brachytherapy-induced ED were paired with 30 similar men who maintained potency after implantation. None of the 60 patients received supplemental external beam radiation therapy, either before or after implantation. Potency was assessed by patient self-administration of the specific erectile questions of the International Index of Erectile Function. The questionnaire consisted of 5 questions with a maximum score of 25. Postimplant potency was defined as an International Index of Erectile Function score > or =11. Mean and median follow-up was 48.3 +/- 14.4 months and 48.0 months, respectively (range: 26.6-79.3 months). The bulb of the penis and the proximal crura were outlined at 0.5-cm intervals on the Day 0 postimplant CT scan. The radiation dose distribution to the bulb of the penis and adjacent crura was defined in terms of the minimum dose delivered to 25%, 50%, 70%, 75%, 90%, and 95% of the bulb (D(25), D(50), D(70), D(75), D(90), and D(95)). RESULTS: The radiation dose delivered to the bulb of the penis and the proximal crura in men with brachytherapy-induced ED was statistically greater for all evaluated dosimetric parameters (D(25), D(50), D(70), D(75), D(90), and D(95)). Stepwise linear regression analysis indicated that penile bulb dose parameter D(50), the postimplant prostate CT volume, and patient age at implant were predictive of postimplant ED, whereas the crura dose D(25) approached statistical significance. Seventy-five percent of the impotent men had a bulb D(25) >60% of prescribed minimum peripheral dose (mPD), whereas 80% of potent men had a bulb D(25) < or =60% mPD. Using the D(50) bulb parameter, 70% of ED men had a dose >40% mPD, whereas 90% of potent men had a dose < or =40% mPD. Similar cut points for D(25) and D(50) crura doses were 40% and 28% mPD. The crura D(25) cut point was exceeded by 50% of the ED patients and only 7% of the potent patients. CONCLUSION: This is the first study to evaluate potency preservation and radiation doses to the proximal penis by means of a validated patient-administered quality-of-life instrument. Our data confirm prior reports that radiation doses to the proximal penis are predictive of brachytherapy-induced ED. In a stepwise linear regression analysis, the strongest predictors of potency preservation were bulb D(50), postimplant prostate CT volume, and patient age. With Day 0 dosimetric evaluation, the penile bulb D(50) and D(25) should be maintained below 40% and 60% mPD, respectively, whereas the crura D(50) and D(25) should be maintained below 40% and 28% mPD, respectively, to maximize posttreatment potency.","Int J Radiat Oncol Biol Phys, 54(4): 1055-1062","USA",2002,"Any or unknown","Brachytherapy","IIEF-5","Patient",null,"Case-control","USA","Patient","Any or unknown","Brachytherapy",null,"Case-control","IIEF-5","2000:2004","Complication"]
[453,"Merrick, G. S., et al. (2003). \"Long-term urinary quality of life after permanent prostate brachytherapy.\" Int J Radiat Oncol Biol Phys 56(2): 454-461.",null,"Merrick, G. S., et al.","Long-term urinary quality of life after permanent prostate brachytherapy","PURPOSE: To evaluate late urinary function after permanent prostate brachytherapy using a validated, patient-administered quality-of-life instrument. METHODS AND MATERIALS: A total of 225 consecutive patients underwent prostate brachytherapy between April 1995 and March 1998. Of the 225 patients, 17 had died and 3 had been institutionalized secondary to Alzheimer's disease. Of the remaining 205 patients, each was mailed a self-administered questionnaire (the urinary function component of the Expanded Prostate Cancer Index [EPIC] and the International Prostate Symptom Score [IPSS]). Of the 205 surveys mailed, 195 (95.1%) were returned. The mean and median follow-up was 66.3 and 64.0 months, respectively. The clinical parameters evaluated included age, pretreatment prostate-specific antigen level, Gleason score, stage, risk group, prostate volume, presence of diabetes and hypertension, and tobacco consumption. The treatment parameters included the ultrasound planning volume, hormonal status, use of supplemental external beam radiotherapy, isotope, and follow-up. The dosimetric parameters included values of the minimal dose received by 90% of the prostate gland and the percentage of prostate volume receiving 100%, 150%, and 200% of the prescribed minimal peripheral dose. Because detailed baseline urinary function was not available, a cross-sectional survey was performed in which 51 newly diagnosed prostate cancer patients of comparable demographics served as controls. RESULTS: When the survey scores for the implant patients were compared with the control group, no significant differences in either the IPSS or function, bother, incontinence, or irritation/obstruction subscales of the urinary EPIC were discernible. In addition, no significant difference was observed between the implant and control groups when the EPIC and IPSS surveys were evaluated by each individual question. Of all the evaluated parameters, the use of tobacco was the best predictive variable for diminished quality of life. CONCLUSION: No significant difference was noted in the overall long-term urinary quality of life when brachytherapy patients were compared with a group of newly diagnosed prostate cancer patients of comparable demographics. Of all parameters evaluated, tobacco consumption was the single strongest predictor of late urinary function.","Int J Radiat Oncol Biol Phys, 56(2): 454-461","USA",2003,"Any or unknown","Brachytherapy","EPIC,IPSS","Patient",null,"Cross-sectional","USA","Patient","Any or unknown","Brachytherapy",null,"Cross-sectional","EPIC,IPSS","2000:2004","Disease"]
[454,"Merrick, G. S., et al. (2004). \"Effect of transurethral resection on urinary quality of life after permanent prostate brachytherapy.\" Int J Radiat Oncol Biol Phys 58(1): 81-88.",null,"Merrick, G. S., et al.","Effect of transurethral resection on urinary quality of life after permanent prostate brachytherapy","PURPOSE: To determine the effect of transurethral resection on urinary function after permanent prostate brachytherapy using a validated, patient-administered, quality-of-life (QOL) instrument. METHODS AND MATERIALS: Twenty-seven consecutive brachytherapy patients with clinical T1b-T2b (1997 American Joint Commission on Cancer) prostate cancer and a history of either preimplant or postimplant transurethral resection of the prostate (TURP) were evaluated. Of the 27 patients, 1 continued to be catheter dependent and was excluded from analysis. Of the remaining 26 patients, each was mailed the urinary function component of the Expanded Prostate Cancer Index (EPIC) and the International Prostate Symptom Score (IPSS). Twenty-six surveys (100%) were returned. The mean and median follow-up was 44.8 and 39.8 months, respectively. The clinical, treatment, and dosimetric parameters evaluated included age, pretreatment prostate-specific antigen level, Gleason score, stage, risk group, prostate volume, presence of diabetes and hypertension, tobacco consumption, number of TURPs, number of grams resected, ultrasound planning volume, hormonal status, supplemental external beam radiotherapy, isotope, follow-up (in months), minimal dose received by 90% of the prostate gland, percentage of prostate volume receiving 100%, 150%, and 200% of the prescribed minimal peripheral dose, and the average and maximal urethral dose. Because baseline IPSSs, but not EPIC scores, were available, a cross-sectional survey was performed in which 51 newly diagnosed prostate cancer patients yet to receive any therapeutic intervention and 195 non-TURP brachytherapy patients served as controls. RESULTS: For all evaluated parameters, superior urinary scores were noted in the preimplant TURP group, with intermediate scores in the postimplant TURP patients and poor urinary QOL scores in the pre- and postimplant TURP patients. With time, the EPIC scores improved in the pre- and postimplant TURP cohorts. In multivariate linear regression analysis of the EPIC urinary summary score, the number of TURPs and supplemental external beam radiotherapy were the strongest predictors for diminished QOL. CONCLUSION: TURP results in diminished urinary QOL after brachytherapy. However, patients who underwent preimplant TURP had urinary QOL approaching that of non-TURP brachytherapy patients. Significant urinary dysfunction was noted in approximately one-half of patients who underwent postimplant TURP (especially pre- and postimplant TURP). Because most patients with brachytherapy-related urinary obstruction will eventually spontaneously void, TURP should be approached with extreme caution and only after substantial time has transpired.","Int J Radiat Oncol Biol Phys, 58(1): 81-88","USA",2004,"Local","Brachytherapy","EPIC,IPSS","Patient",null,"Cross-sectional","USA","Patient","Local","Brachytherapy",null,"Cross-sectional","EPIC,IPSS","2000:2004","Disease"]
[455,"Merrick, G. S., et al. (2004). \"Influence of hormonal therapy on late rectal function after permanent prostate brachytherapy with or without supplemental external beam radiotherapy.\" Int J Radiat Oncol Biol Phys 58(1): 68-74.",null,"Merrick, G. S., et al.","Influence of hormonal therapy on late rectal function after permanent prostate brachytherapy with or without supplemental external beam radiotherapy","PURPOSE: Recent clinical studies have reported a relationship between the use of hormonal therapy and degradation in rectal function after external beam radiotherapy. Using a patient-administered quality-of-life instrument, we evaluated the effect of hormonal therapy on late rectal function after permanent prostate brachytherapy with or without supplemental external beam radiotherapy. METHODS AND MATERIALS: A total of 189 patients were mailed the Rectal Function Assessment Score (R-FAS), which consists of nine questions (score range 0-27, with higher scores indicative of poorer bowel function). Of the 189 surveys sent out, 187 (98.4%) were returned. Of the 187 patients, 149 (79.7%) were hormone naive, and 38 (20.3%) had received hormonal manipulation (median duration 4 months, range 3-36). The median follow-up for the entire group was 66.3 months. The effect of hormonal therapy on bowel function was evaluated by comparing the R-FAS scores across time, by each of the individual nine questions, and by means of a summary question evaluating the patient's perception of overall bowel function. The two groups were also evaluated in terms of clinical, treatment, and dosimetric parameters, including follow-up, age, Gleason score, clinical stage, pretreatment prostate-specific antigen level, number of pretreatment bowel movements/d, prostate volume, and rectal dosimetry. RESULTS: The two groups were well matched in all clinical, treatment, and dosimetric parameters, except the patients receiving hormonal therapy had a statistically shorter follow-up (63.9 vs. 69.4 months, p <0.001) and higher pretreatment prostate-specific antigen level (12.0 vs. 9.8 ng/mL, p = 0.024). The R-FAS scores for the hormone-naive and hormonally manipulated patients were comparable (3.76 vs. 4.55, p = 0.083). In terms of the nine individual R-FAS questions, no statistically significant difference was reported for any question when stratified by hormonal status, including rectal bleeding (p = 0.735). Only 12% and 13% of hormone-naive and hormonally manipulated patients, respectively, reported bowel function to be worse after implantation. With time, a trend for improvement in the R-FAS was noted in both cohorts. CONCLUSION: After permanent prostate brachytherapy, no statistically significant difference in bowel habits was discerned when stratified by hormonal status. In addition, only 12% of brachytherapy patients reported deterioration in bowel function after implantation.","Int J Radiat Oncol Biol Phys, 58(1): 68-74","USA",2004,"Any or unknown","Radiotherapy,Hormonal,Brachytherapy","R-FAS","Patient",null,"Cross-sectional","USA","Patient","Any or unknown","Radiotherapy,Hormonal,Brachytherapy",null,"Cross-sectional","R-FAS","2000:2004","Complication"]
[456,"Metz, J. M., et al. (2003). \"A multi-institutional study of Internet utilization by radiation oncology patients.\" Int J Radiat Oncol Biol Phys 56(4): 1201-1205.",null,"Metz, J. M., et al.","A multi-institutional study of Internet utilization by radiation oncology patients","PURPOSE: Studies describing the use of the Internet by radiation oncology patients are lacking. This multi-institutional study of cancer patients presenting to academic (AC), community (CO), and veterans (VA) radiation oncology centers was designed to analyze the use of the Internet, demographic factors related to utilization, and barriers to access to the Internet. METHODS AND MATERIALS: A questionnaire evaluating the use of the Internet was administered to 921 consecutive patients presenting to radiation oncology centers at AC, CO, and VA medical centers. The study included 436 AC patients (47%), 284 CO patients (31%), and 201 VA patients (22%). A computer was available at home to 427 patients (46%), and 337 patients (37%) had E-mail access. The mean age of the patient population was 64 (range = 14-93). Males represented 70% of the patient population. The most common diagnoses included prostate cancer (33%), breast cancer (13%), and lung cancer (11%). RESULTS: Overall, 265/921 patients (29%) were using the Internet to find cancer-related information. The Internet was used by 42% of AC patients, 25% of CO patients, and only 5% of VA patients (p < 0.0001). A computer was available at home in 62% AC vs. 45% CO vs. 12% VA patients (p < 0.0001). Patients < 60 years were much more likely to use the Internet than older patients (p < 0.0001). Most of the Internet users considered the information either very reliable (22%) or somewhat reliable (70%). Unconventional medical therapies were purchased over the Internet by 12% of computer users. CONCLUSIONS: A significant number of cancer patients seen in radiation oncology departments at academic and community medical centers utilize the Internet to obtain information about cancer. Radiation oncologists must familiarize themselves with this resource because of the large number of patients using the Internet. Veterans lack the computerized access to this information and are thus underserved by this important resource.","Int J Radiat Oncol Biol Phys, 56(4): 1201-1205","USA",2003,"Any or unknown","Radiotherapy","Unclear","Patient",null,"Cross-sectional","USA","Patient","Any or unknown","Radiotherapy",null,"Cross-sectional","Unclear","2000:2004","Knowledge,Views"]
[457,"Meulenbeld, H. J., et al. (2012). \"Randomised phase II/III study of docetaxel with or without risedronate in patients with metastatic Castration Resistant Prostate Cancer (CRPC), the Netherlands Prostate Study (NePro).\" Eur J Cancer 48(16): 2993-3000.",null,"Meulenbeld, H. J., et al.","Randomised phase II/III study of docetaxel with or without risedronate in patients with metastatic Castration Resistant Prostate Cancer (CRPC), the Netherlands Prostate Study (NePro)","BACKGROUND: This multicentre, randomised, open label, phase II/III study aimed to investigate the potential benefit of adding risedronate (R) to docetaxel (D) in patients with metastatic Castration Resistant Prostate Cancer (CRPC). PATIENTS AND METHODS: CRPC patients with bone metastasis were randomly assigned to receive D 75 mg/m(2) every 3 weeks and prednisone as first line chemotherapy, with or without R 30 mg oral once daily. The primary end-point was time to progression (TTP). A composite end-point of objective progression by RECIST criteria, PSA progression, or pain progression, whichever occurred first, was applied. The study had 80% power to detect an improvement of 30% in median TTP in the DR group (two-sided alpha=0.05). RESULTS: Five hundred and ninety-two men (301 D versus 291 DR) were randomised. TTP was 7.4 [D] versus 6.5 [DR] months (p=0.75). PSA and pain response rates were similar, 66.3% [D] versus 65.9% [DR] and 27.9% [D] versus 31.2% [DR], respectively. Median overall survival (OS) was 18.4 [D] versus 19.2 [DR] months (p=0.33). There were no differences in toxicity. CONCLUSION: The addition of the third generation bisphosphonate, risedronate, in the setting of effective first line docetaxel based chemotherapy did not increase efficacy, as indicated by the lack of improvement in TTP, OS, PSA- and pain response.","Eur J Cancer, 48(16): 2993-3000","Netherlands",2012,"Metastatic","Taxane,Bisphosphonate","Unclear","Patient",null,"Clinical trial","Netherlands","Patient","Metastatic","Taxane,Bisphosphonate",null,"Clinical trial","Unclear","2010:2014","Symptom"]
[458,"Meyer, J. P., et al. (2003). \"The effect of erectile dysfunction on the quality of life of men after radical prostatectomy.\" BJU Int 92(9): 929-931.",null,"Meyer, J. P., et al.","The effect of erectile dysfunction on the quality of life of men after radical prostatectomy","OBJECTIVE: To report on the first use of a quality-of-life (QoL) measure specific for erectile dysfunction (ED), the 'ED effect on QoL' (ED-EQoL), to assess the effect of ED on QoL after radical prostatectomy (RP). PATIENTS AND METHODS: We retrospectively identified 89 patients who had undergone RP at one institution. Each was sent the ED-EQoL and a second questionnaire asking whether they had been counselled before RP about possible ED afterward. RESULTS: The response rate was 91% and the median time since RP 92 months; 76% of those who were potent before RP were impotent afterward. The overall results showed that the QoL of 72% of patients was moderately or severely affected. For each question, on average a third of the patients reported that their QoL was affected either 'quite a lot' or 'a great deal'. CONCLUSIONS: This study shows that ED after RP has a profound effect on QoL; it is therefore important when assessing ED to use an ED-specific QoL questionnaire such as the ED-EQoL to measure the psychosocial effect of ED, in addition to using an instrument such as the International Index of Erectile Function to measure the functional aspects of ED.","BJU Int, 92(9): 929-931","UK",2003,"Any or unknown","Surgery","ED-EQoL","Patient",null,"Cross-sectional","UK","Patient","Any or unknown","Surgery",null,"Cross-sectional","ED-EQoL","2000:2004","Complication"]
[459,"Miles, B. J., et al. (1999). \"Recall and attitudes in patients with prostate cancer.\" Urology 53(1): 169-174.",null,"Miles, B. J., et al.","Recall and attitudes in patients with prostate cancer","OBJECTIVES: To assess the ability of men with adenocarcinoma of the prostate to recall aspects of testing leading to their diagnosis, recall of the informed consent process, and their satisfaction with treatment and that treatment's impact on their lives. METHODS: A Gallup Organization telephone survey of a national sample of 421 men with known prostate cancer randomly selected from a pool of men identified during \"National Prostate Cancer Awareness Week\" was performed from November 1995 to January 1996. Men were queried about diagnostic tests performed to make the diagnosis of prostate cancer, reasons for being \"tested,\" sources of importance in helping men make an informed treatment decision, informed consent discussions, treatment satisfaction, treatment-related quality of life, and the quality of ongoing physicians' care. RESULTS: Patients' recall of procedures performed to diagnose prostate cancer is poor; less than 20% remember having a \"biopsy.\" More than 80% depended entirely on their attending urologist for informed consent and education about prostate cancer management. Forty percent sustained a complication as a result of their treatment, primarily impacting their sexual or urinary function. Ongoing follow-up care provided by physicians was reported as poor in the management of sexual or urinary problems by 50% and 33% of patients, respectively. CONCLUSIONS: Patients are generally satisfied with the care process for prostate cancer. However, the lack of patient recall for diagnostic procedures makes the adequacy of the current informed consent process questionable and suggests the need for increased efforts at improving patient education.","Urology, 53(1): 169-174","USA",1999,"Any or unknown","None","Interview","Patient",null,"Cross-sectional","USA","Patient","Any or unknown","None",null,"Cross-sectional","Interview","1960:1999","Views"]
[460,"Miller, J., et al. (2007). \"Prospective evaluation of short-term impact and recovery of health related quality of life in men undergoing robotic assisted laparoscopic radical prostatectomy versus open radical prostatectomy.\" J Urol 178(3 Pt 1): 854-858; discussion 859.",null,"Miller, J., et al.","Prospective evaluation of short-term impact and recovery of health related quality of life in men undergoing robotic assisted laparoscopic radical prostatectomy versus open radical prostatectomy","PURPOSE: In the last few years there have been increasing claims that robotic assisted laparoscopic radical prostatectomy decreases short-term morbidity in patients undergoing surgical treatment for prostate cancer. However, there is surprisingly little objective evidence to support this point, which is often used to market the procedure to patients. To address this issue we prospectively evaluated patients undergoing open and robotic assisted laparoscopic radical prostatectomy at baseline and weekly through the postoperative period using a validated questionnaire. MATERIALS AND METHODS: A total of 162 men undergoing radical prostatectomy, including open radical prostatectomy in 120 and robotic assisted laparoscopic radical prostatectomy in 42, for clinically localized prostate cancer completed the SF-12, version 2 Physical and Mental Health Survey Acute Form preoperatively and each week postoperatively for 6 weeks. Physical and Mental Component Scores were calculated from the questionnaires at each time point. Comparisons between the 2 surgical approaches were made at each time point. RESULTS: No significant differences were seen between the open and robotic assisted laparoscopic radical prostatectomy groups with regard to patient age, clinical stage or preoperative prostate specific antigen. Mean surgical blood loss was significantly higher in the open group compared to that in the robotic assisted laparoscopic group. Physical Component Scores in the robotic assisted laparoscopic group were significantly higher than those in the open cohort beginning postoperative week 1 and extending through week 6. On statistical extrapolation Physical Component Scores returned to baseline between weeks 5 and 6 postoperatively in the robotic assisted laparoscopic group and between weeks 6 and 7 in the open group. Mental Component Score scores were not statistically different between the groups except preoperatively. CONCLUSIONS: This study helps prospectively define short-term health related quality of life in patients undergoing robotic assisted laparoscopic vs open radical prostatectomy. Higher physical scores were seen in the robotic assisted laparoscopic group than the open group beginning postoperative week 1 and continuing weekly throughout the 6-week study period. Physical Component Score scores returned to baseline sooner in the robotic assisted laparoscopic group than in the open group.","J Urol, 178(3 Pt 1): 854-858; discussion 859","USA",2007,"Local","Surgery","SF-12","Patient",null,"Clinical trial","USA","Patient","Local","Surgery",null,"Clinical trial","SF-12","2005:2009","Utility"]
[461,"Miller, N. L., et al. (2003). \"Impact of a novel neoadjuvant and adjuvant hormone-deprivation approach on quality of life, voiding function, and sexual function after prostate brachytherapy.\" Cancer 97(5): 1203-1210.",null,"Miller, N. L., et al.","Impact of a novel neoadjuvant and adjuvant hormone-deprivation approach on quality of life, voiding function, and sexual function after prostate brachytherapy","BACKGROUND: Data demonstrate a benefit from neoadjuvant and adjuvant hormone-deprivation therapy with luteinizing hormone-releasing hormone agonists in patients who are treated with radiotherapy for localized prostate carcinoma; however, this approach has detrimental effects on quality of life (QOL). A cross-sectional study was undertaken to evaluate the impact on QOL, voiding function, and sexual function of an alternative hormone-deprivation approach. METHODS: Three hundred fifty patients with clinical T1c-T2b prostate carcinoma were treated from March 1997 to August 2000 either with palladium 103 brachytherapy (BTM) without hormone therapy or with 8 months of adjuvant and neoadjuvant hormone-deprivation therapy with an antiandrogen and finasteride (BTM+H), were mailed the Functional Assessment of Cancer Therapy (FACT) global well being QOL instrument (FACT-G), the American Urological Association symptom score (AUASS), and specific items addressing urinary control and sexual function from validated instruments. Differences between treatment groups were assessed as a function of time since treatment. RESULTS: Seventy-two percent of patients responded to the questionnaire. No differences in overall FACT-G scores, AUASS scores, or AUASS subscale scores between the BTM group and the BTM+H group were found. The BTM+H group initially had lower personal well being FACT-G subscale scores, more urinary incontinence, and lower odds of attaining an erection sufficient for intercourse initially, although these differences disappeared with longer follow-up. CONCLUSIONS: The use of neoadjuvant and adjuvant antiandrogen and finasteride with brachytherapy is associated with QOL equal to that of brachytherapy alone for the treatment of patients with localized prostate carcinoma, allowing the advantages of hormone manipulation in terms of tumor control without its downside.","Cancer, 97(5): 1203-1210","USA",2003,"Local","Brachytherapy,Hormonal","FACT-G,AUA-SI","Patient",null,"Cross-sectional","USA","Patient","Local","Brachytherapy,Hormonal",null,"Cross-sectional","FACT-G,AUA-SI","2000:2004","General,Symptom"]
[462,"Mishra, S. I., et al. (2012). \"Exercise interventions on health-related quality of life for people with cancer during active treatment.\" Cochrane Database Syst Rev 8: Cd008465.",null,"Mishra, S. I., et al.","Exercise interventions on health-related quality of life for people with cancer during active treatment","BACKGROUND: People with cancer undergoing active treatment experience numerous disease- and treatment-related adverse outcomes and poorer health-related quality of life (HRQoL). Exercise interventions are hypothesized to alleviate these adverse outcomes. HRQoL and its domains are important measures of cancer survivorship, both during and after the end of active treatment for cancer. OBJECTIVES: To evaluate the effectiveness of exercise on overall HRQoL outcomes and specific HRQoL domains among adults with cancer during active treatment. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), PubMed MEDLINE, EMBASE, CINAHL, PsycINFO, PEDRO, LILACS, SIGLE, SportDiscus, OTSeeker, Sociological Abstracts from inception to November 2011 with no language or date restrictions. We also searched citations through Web of Science and Scopus, PubMed's related article feature, and several websites. We reviewed reference lists of included trials and other reviews in the field. SELECTION CRITERIA: We included all randomized controlled trials (RCTs) and quasi-randomized controlled clinical trials (CCTs) comparing exercise interventions with usual care or other type of non-exercise comparison intervention to maintain or enhance, or both, overall HRQoL or at least one distinct domain of HRQoL. Included trials tested exercise interventions that were initiated when adults with cancer were undergoing active cancer treatment or were scheduled to initiate treatment. DATA COLLECTION AND ANALYSIS: Five paired review authors independently extracted information on characteristics of included trials, data on effects of the intervention, and assessed risk of bias based on predefined criteria. Where possible, we performed meta-analyses for HRQoL and HRQoL domains for the reported difference between baseline values and follow-up values using standardized mean differences (SMDs) and a random-effects model by length of follow-up. We also reported the SMD at follow-up between the exercise and control groups. Because investigators used many different HRQoL and HRQoL domain instruments and often more than one for the same domain, we selected the more commonly used instrument to include in the SMD meta-analyses. We also report the mean difference for each type of instrument separately. MAIN RESULTS: We included 56 trials with 4826 participants randomized to an exercise (n = 2286) or comparison (n = 1985) group. Cancer diagnoses in trial participants included breast, prostate, gynecologic, hematologic, and other. Thirty-six trials were conducted among participants who were currently undergoing active treatment for their cancer, 10 trials were conducted among participants both during and post active cancer treatment, and the remaining 10 trials were conducted among participants scheduled for active cancer treatment. Mode of exercise intervention differed across trials and included walking by itself or in combination with cycling, resistance training, or strength training; resistance training; strength training; cycling; yoga; or Qigong. HRQoL and its domains were assessed using a wide range of measures.The results suggest that exercise interventions compared with control interventions have a positive impact on overall HRQoL and certain HRQoL domains. Exercise interventions resulted in improvements in: HRQoL from baseline to 12 weeks' follow-up (SMD 0.33; 95% CI 0.12 to 0.55) or when comparing difference in follow-up scores at 12 weeks (SMD 0.47; 95% CI 0.16 to 0.79); physical functioning from baseline to 12 weeks' follow-up (SMD 0.69; 95% CI 0.16 to 1.22) or 6 months (SMD 0.28; 95% CI 0.00 to 0.55); or when comparing differences in follow-up scores at 12 weeks (SMD 0.28; 95% CI 0.11 to 0.45) or 6 months (SMD 0.29; 95% CI 0.07 to 0.50); role function from baseline to 12 weeks' follow-up (SMD 0.48; 95% CI 0.07 to 0.90) or when comparing differences in follow-up scores at 12 weeks (SMD 0.17; 95% CI 0.00 to 0.34) or 6 months (SMD 0.32; 95% CI 0.03 to 0.61); and, in social functioning at 12 weeks' follow-up (SMD 0.54; 95% CI 0.03 to 1.05) or when comparing differences in follow-up scores at both 12 weeks (SMD 0.16; 95% CI 0.04 to 0.27) and 6 months (SMD 0.24; 95% CI 0.03 to 0.44). Further, exercise interventions resulted in a decrease in fatigue from baseline to 12 weeks' follow-up (SMD -0.38; 95% CI -0.57 to -0.18) or when comparing difference in follow-up scores at follow-up of 12 weeks (SMD -0.73; 95% CI -1.14 to -0.31). Since there is consistency of findings on both types of measures (change scores and difference in follow-up scores) there is greater confidence in the robustness of these findings.When examining exercise effects by subgroups, exercise interventions had significantly greater reduction in anxiety for survivors with breast cancer than those with other types of cancer. Further, there was greater reduction in depression, fatigue, and sleep disturbances, and improvement in HRQoL, emotional wellbeing (EWB), physical functioning, and role function for cancer survivors diagnosed with cancers other than breast cancer but not for breast cancer. There were also greater improvements in HRQoL and physical functioning, and reduction in anxiety, fatigue, and sleep disturbances when prescribed a moderate or vigorous versus a mild exercise program.Results of the review need to be interpreted cautiously owing to the risk of bias. All the trials reviewed were at high risk for performance bias. In addition, the majority of trials were at high risk for detection, attrition, and selection bias. AUTHORS' CONCLUSIONS: This systematic review indicates that exercise may have beneficial effects at varying follow-up periods on HRQoL and certain HRQoL domains including physical functioning, role function, social functioning, and fatigue. Positive effects of exercise interventions are more pronounced with moderate- or vigorous-intensity versus mild-intensity exercise programs. The positive results must be interpreted cautiously because of the heterogeneity of exercise programs tested and measures used to assess HRQoL and HRQoL domains, and the risk of bias in many trials. Further research is required to investigate how to sustain positive effects of exercise over time and to determine essential attributes of exercise (mode, intensity, frequency, duration, timing) by cancer type and cancer treatment for optimal effects on HRQoL and its domains.","Cochrane Database Syst Rev, 8(Cd008465","International",2012,"Any or unknown","Various","Unclear","Patient",null,"Systematic review","International","Patient","Any or unknown","Various",null,"Systematic review","Unclear","2010:2014","General"]
[463,"Miyake, H., et al. (2016). \"Prospective assessment of time-dependent changes in quality of life of Japanese patients with prostate cancer following robot-assisted radical prostatectomy.\" J Robot Surg 10(3): 201-207.",null,"Miyake, H., et al.","Prospective assessment of time-dependent changes in quality of life of Japanese patients with prostate cancer following robot-assisted radical prostatectomy","The objective of this study was to characterize changes in the quality of life (QOL) of Japanese patients following robot-assisted radical prostatectomy (RARP). This study included 298 consecutive localized prostate cancer (PC) patients undergoing RARP. The health-related QOL and disease-specific QOL were assessed using The Medical Outcomes Study 8-Item Short Form (SF-8) and The Extended Prostate Cancer Index Composite (EPIC), respectively, before and 1, 3, 6, 12 and 24 months after RARP. At 1 month after RARP, four (physical function, role limitations because of physical health problems, social function and role limitations because of emotional problems) of the eight scores in SF-8 were significantly impaired compared with those of baseline scores. However, all eight scores on all postoperative assessments, except for at 1 month after RARP, showed no significant differences from baseline scores. Although there were no significant differences in the bowel function, bowel bother, sexual bother, hormonal function or hormonal bother between baseline and postoperative assessments of EPIC at all time points, the urinary function, urinary incontinence and sexual function scores at 1, 3 and 6 months after RARP were significantly inferior to those of baseline scores, and urinary bother and urinary irritation/obstruction scores at 1 month after RARP were significantly impaired compared with those of baseline scores. These findings suggest that the health-related QOL of Japanese PC patients undergoing RARP may not be markedly deteriorated following RARP; however, as for the disease-specific QOL, urinary and sexual functions, particularly those early after RARP, appeared to be significantly impaired.","J Robot Surg, 10(3): 201-207","Japan",2016,"Local","Surgery","EPIC,SF-8","Patient",null,"Cohort","Japan","Patient","Local","Surgery",null,"Cohort","EPIC,SF-8","2015:2018","Disease,Utility"]
[464,"Moinpour, C. M., et al. (1998). \"Quality of life in advanced prostate cancer: results of a randomized therapeutic trial.\" J Natl Cancer Inst 90(20): 1537-1544.",null,"Moinpour, C. M., et al.","Quality of life in advanced prostate cancer: results of a randomized therapeutic trial","BACKGROUND: For patients with metastatic prostate cancer, treatment is primarily palliative, relying mainly on the suppression of systemic androgen hormone levels. To help document the achievement of palliation and to characterize positive and negative effects of treatment, we evaluated quality-of-life (QOL) parameters in patients with metastatic prostate cancer who were randomly assigned to two methods of androgen deprivation. METHODS: Patients (n = 739) with stage M1 (bone or soft tissue metastasis) prostate cancer were enrolled in a QOL protocol that was a companion to Southwest Oncology Group INT-0105, a randomized double-blind trial comparing treatment with bilateral orchiectomy (surgical castration) plus either flutamide or placebo. Patients completed a comprehensive battery of QOL questionnaires at random assignment to treatment and at 1, 3, and 6 months later. Data were collected on three treatment-specific symptoms (diarrhea, gas pain, and body image), on physical functioning, and on emotional functioning. All P values are two-sided. RESULTS: Questionnaire return rates for this study never dropped below 80%; only 2% of the patients did not submit baseline QOL assessments. Cross-sectional analyses (corrected for multiple testing) identified statistically significant differences that favored orchiectomy plus placebo for two of the five primary QOL parameters as follows: patients receiving flutamide reported more diarrhea at 3 months (P = .001) and worse emotional functioning at 3 and 6 months (both P<.003). Longitudinal analyses replicated these findings. Other analyzed QOL parameters favored the group receiving placebo but were not statistically significant after adjustment for multiple testing. CONCLUSIONS: We found a consistent pattern of better QOL outcomes at each follow-up assessment during the first 6 months of treatment for orchiectomized patients with metastatic prostate cancer who received placebo versus flutamide. Improvement over time was evident in both treatment groups but more so for patients receiving placebo.","J Natl Cancer Inst, 90(20): 1537-1544","USA",1998,"Metastatic","Hormonal,Surgery","Unclear","Patient",null,"Clinical trial","USA","Patient","Metastatic","Hormonal,Surgery",null,"Clinical trial","Unclear","1960:1999","General,Symptom"]
[465,"Moinpour, C. M., et al. (2008). \"Health-related quality of life results in pathologic stage C prostate cancer from a Southwest Oncology Group trial comparing radical prostatectomy alone with radical prostatectomy plus radiation therapy.\" J Clin Oncol 26(1): 112-120.",null,"Moinpour, C. M., et al.","Health-related quality of life results in pathologic stage C prostate cancer from a Southwest Oncology Group trial comparing radical prostatectomy alone with radical prostatectomy plus radiation therapy","PURPOSE: To compare short- and long-term effects of adjuvant treatment versus observation after surgery on health-related quality of life (HRQL) of prostate cancer patients. PATIENTS AND METHODS: The Southwest Oncology Group (SWOG) intergroup trial compared radical prostatectomy (RP) plus observation versus RP plus adjuvant radiation therapy (RT). Two-hundred seventeen of 425 therapeutic trial patients were eligible and registered to the HRQL study. Patients completed the SWOG Quality of Life Questionnaire (emotional, physical, social, and role function; general symptom status; treatment/disease-specific symptoms; and global HRQL [GHRQL]) at baseline, 6 weeks, 6 months, and annually for 5 years. Prespecified outcomes were three genitourinary symptoms (bowel function tenderness, frequent urination, and erectile dysfunction [ED]) and measures of physical and emotional function. Adjustments were made for the baseline score. RESULTS: Patients receiving adjuvant RT reported worse bowel function (through approximately 2 years) and worse urinary function. There were no statistically significant differences for ED. GHRQL was initially worse for the RP+RT arm but improved over time and was better at the end of the period than the GHRQL reported for RP alone (treatment arm x time interaction, P = .0004). Symptom distress was significantly worse for the RP+RT arm compared with the RP alone arm, but the treatment arms did not differ with respect to other general measures of HRQL. CONCLUSION: The addition of RT to surgery resulted in more frequent urination, as well as early report of more bowel dysfunction, although bowel function differences disappeared over the 5-year period. The addition of RT did not negatively impact ED.","J Clin Oncol, 26(1): 112-120","USA",2008,"Advanced","Surgery,Radiotherapy","SWOG-QLQ","Patient",null,"Clinical trial","USA","Patient","Advanced","Surgery,Radiotherapy",null,"Clinical trial","SWOG-QLQ","2005:2009","General"]
[466,"Moinpour, C. M., et al. (2009). \"Chemotherapeutic impact on pain and global health-related quality of life in hormone-refractory prostate cancer: Dynamically Modified Outcomes (DYNAMO) analysis of a randomized controlled trial.\" Qual Life Res 18(2): 147-155.",null,"Moinpour, C. M., et al.","Chemotherapeutic impact on pain and global health-related quality of life in hormone-refractory prostate cancer: Dynamically Modified Outcomes (DYNAMO) analysis of a randomized controlled trial","PURPOSE: This paper applies the Dynamically Modified Outcomes (DYNAMO) model to a clinical trial of two chemotherapeutic regimens on global health-related quality of life (GHRQL) in hormone-refractory prostate cancer. METHODS: DYNAMO identifies the causal influences operating in a clinical trial and their mediation, moderation, and modulation by uncontrolled variables. The Southwest Oncology Group trial S9916 randomized assignment to mitoxantrone plus prednisone (M + P) versus docetaxel plus estramustine (D + E) treatments. In this application, we examine baseline-adjusted impacts of worst pain (McGill Pain Questionnaire) on GHRQL (EORTC Quality of Life Questionnaire-C30) at 10 weeks. RESULTS: The average treatment levels of pain did not differ, hence, the average mediated effect of treatment on GHRQL was zero. Nonetheless, M + P reduced the impact (the relational outcome) of pain on GHRQL by 54% relative to D + E. Individual variation in the relational outcome (modulation) was of the same magnitude as the average difference between the groups. Performance status moderated the direct effects of treatment, with D + E being more effective in good, but not poor, performance strata. CONCLUSIONS: The DYNAMO approach comprehensively accounted for treatment effects. Rather than a single average effect, there were three distinct treatment effects: one direct effect for each performance status level and a direct effect on the relationship between pain and GHRQL.","Qual Life Res, 18(2): 147-155","USA",2009,"Any or unknown","Taxane,Chemotherapy","EORTC QLQ-C30,MPQ","Patient",null,"Clinical trial","USA","Patient","Any or unknown","Taxane,Chemotherapy",null,"Clinical trial","EORTC QLQ-C30,MPQ","2005:2009","General,Symptom"]
[467,"Moinpour, C. M., et al. (2000). \"Profile of men randomized to the prostate cancer prevention trial: baseline health-related quality of life, urinary and sexual functioning, and health behaviors.\" J Clin Oncol 18(9): 1942-1953.",null,"Moinpour, C. M., et al.","Profile of men randomized to the prostate cancer prevention trial: baseline health-related quality of life, urinary and sexual functioning, and health behaviors","PURPOSE: To describe men who agreed to be randomized to the Prostate Cancer Prevention Trial (PCPT), a 7-year, double-blind placebo-controlled study of the efficacy of finasteride in preventing prostate cancer. METHODS: Comprehensive health-related quality-of-life data are presented for 18,882 randomized PCPT participants. RESULTS: PCPT participants are highly educated, middle to upper income, and primarily white (92%). Participants reported healthy lifestyles. The mean American Urological Association Symptom Index score was well below the maximum entry score of less than 19; existing urinary symptoms were generally not bothersome. The scores for two sexual functioning scales could range from 0 to 100, with higher scores reflecting worse sexual functioning. The mean score for the Sexual Problem Scale was 19.2 out of 100, and the mean Sexual Activities Scale was 44.1 out of 100. Scores for seven of the eight Medical Outcomes Study 36-item Short-Form Health Survey scales (higher scores are better) were 10 to 20 points higher than those reported by a general population sample and differed minimally by race but not by age. Previously reported associations between sexual dysfunction and hypertension, diabetes, and depression were also observed. Men who never smoked reported less sexual dysfunction than did those who either had quit or still smoked. CONCLUSION: Individuals who are likely to enroll in primary prevention trials have a high socioeconomic status, healthy lifestyle behaviors, and better health than the general population. These data help oncologists design chemoprevention trials with respect to the selection of health-related quality-of-life assessments and recruitment strategies.","J Clin Oncol, 18(9): 1942-1953","USA",2000,"At risk","Various","AUA-SI,SF-36","General population",null,"Clinical trial","USA","General population","At risk","Various",null,"Clinical trial","AUA-SI,SF-36","2000:2004","Symptom,Utility"]
[468,"Moinpour, C. M., et al. (2012). \"Health-related quality-of-life findings for the prostate cancer prevention trial.\" J Natl Cancer Inst 104(18): 1373-1385.",null,"Moinpour, C. M., et al.","Health-related quality-of-life findings for the prostate cancer prevention trial","BACKGROUND: The Prostate Cancer Prevention Trial (PCPT)-a randomized placebo-controlled study of the efficacy of finasteride in preventing prostate cancer-offered the opportunity to prospectively study effects of finasteride and other covariates on the health-related quality of life of participants in a multiyear trial. METHODS: We assessed three health-related quality-of-life domains (measured with the Health Survey Short Form-36: Physical Functioning, Mental Health, and Vitality scales) via questionnaires completed by PCPT participants at enrollment (3 months before randomization), at 6 months after randomization, and annually for 7 years. Covariate data obtained at enrollment from patient-completed questionnaires were included in our model. Mixed-effects model analyses and a cross-sectional presentation at three time points began at 6 months after randomization. All statistical tests were two-sided. RESULTS: For the physical function outcome (n = 16 077), neither the finasteride main effect nor the finasteride interaction with time were statistically significant. The effects of finasteride on physical function were minor and accounted for less than a 1-point difference over time in Physical Functioning scores (mixed-effect estimate = 0.07, 95% confidence interval [CI] = -0.28 to 0.42, P = .71). Comorbidities such as congestive heart failure (estimate = -5.64, 95% CI = -7.96 to -3.32, P < .001), leg pain (estimate = -2.57, 95% CI = -3.04 to -2.10, P < .001), and diabetes (estimate = -1.31, 95% CI = -2.04 to -0.57, P < .001) had statistically significant negative effects on physical function, as did current smoking (estimate = -2.34, 95% CI = -2.97 to -1.71, P < .001) and time on study (estimate = -1.20, 95% CI = -1.36 to -1.03, P < .001). Finasteride did not have a statistically significant effect on the other two dependent variables, mental health and vitality, either in the mixed-effects analyses or in the cross-sectional analysis at any of the three time points. CONCLUSION: Finasteride did not negatively affect SF-36 Physical Functioning, Mental Health, or Vitality scores.","J Natl Cancer Inst, 104(18): 1373-1385","USA",2012,"At risk","Various","SF-36","General population",null,"Clinical trial","USA","General population","At risk","Various",null,"Clinical trial","SF-36","2010:2014","Utility"]
[469,"Mold, J. W., et al. (1998). \"Outcomes of an insurance company-sponsored multichannel chemistry screening initiative.\" J Fam Pract 47(2): 110-117.",null,"Mold, J. W., et al.","Outcomes of an insurance company-sponsored multichannel chemistry screening initiative","BACKGROUND: The use of serum chemistry panels as screening tests has been studied in a variety of clinical and nonclinical settings. None of the studies, however, has attempted to carefully examine any potential harm done to participants, and none has measured the impact on health-related quality of life. METHODS: Consenting participants in an insurance company-sponsored screening initiative completed a questionnaire before and 6 months after having blood drawn for a 25-item chemistry panel and a lipid profile; for men older than 50, a prostate-specific antigen (PSA) test was also done. The prescreening questionnaire included demographic and health information. The postscreening questionnaire included questions about specific outcomes. Included in both questionnaires were single-item measures of self-rated health and self-rated worry about health, and the 17-item Duke Health Profile (DUKE), a measure of health-related quality of life. Various outcomes were examined, including the numbers of new diagnoses, numbers and types of new treatment recommendations, change in self-reported health and worry, and change in DUKE subscale scores. Participants who were potentially helped and those who were potentially harmed by the serum chemistry panels screening program were identified and further characterized. RESULTS: Of the 2249 subjects who satisfactorily completed both questionnaires, 2012 (89%) had at least one abnormal test result, but only 985 of these (49%) remembered having discussed their test results with a physician. A total of 342 individuals received new treatment advice. However, 29 (10%) of them indicated that they would be \"somewhat unlikely\" to \"very unlikely\" to follow it. Following the intervention questionnaire, there were statistically significant average decrements in the General Health, Physical Health, and Pain subscales of the DUKE for participants with abnormal results. Self-rated health status did not change but level of worry about health increased significantly. At least 250 (11%) subjects were potentially helped by the screening initiative, but at least 574 (26%) were potentially harmed by it. CONCLUSIONS: The use of serum chemistry panels as screening tests in nonclinical settings should probably be discouraged, since health-related quality of life is not improved and the intervention may harm more individuals than it benefits.","J Fam Pract, 47(2): 110-117","USA",1998,"At risk","Screening","DUKE","General population",null,"Cohort","USA","General population","At risk","Screening",null,"Cohort","DUKE","1960:1999","General"]
[470,"Mols, F., et al. (2009). \"Health-related quality of life in I-125 prostate brachytherapy patients treated with and without volume-reducing hormone therapy: results of a short-term prospective study.\" J Endourol 23(1): 153-159.",null,"Mols, F., et al.","Health-related quality of life in I-125 prostate brachytherapy patients treated with and without volume-reducing hormone therapy: results of a short-term prospective study","PURPOSE: This study describes the differences in short-term effects of health-related quality of life (HRQOL) in I-125 prostate brachytherapy patients who were treated with and without volume-reducing hormone therapy. PATIENTS AND METHODS: Prostate cancer patients (N = 312) filled out questionnaires on HRQOL (European Organization of Research and Treatment of Cancer Quality of Life Questionnaire [EORTC-QLQ]-C30 and EORTC-QLQ-PR25) before treatment and 6 weeks and 3 months after treatment. HRQOL was compared between the two groups: Patients who were receiving brachytherapy (n = 233) and patients who were receiving brachytherapy with volume-reducing hormone therapy (n = 79). Duration of androgen ablation was 9 months, starting 3 months before I-125 implantation. RESULTS: After treatment, patients reported significant and clinically relevant decreased scores on the following subscales: Global health status, role functioning, social functioning, pain, insomnia, bowel symptoms and functioning, and treatment-related functions, regardless of the therapy they received. Results showed that prostate cancer patients receiving brachytherapy with volume-reducing hormone therapy also experienced lower treatment-related functions and lower sexual function. Significant time by treatment interaction effects were found for treatment-related functions. The subscale treatment-related functions was the only scale that showed a difference over time, between treatments, and time by treatment. CONCLUSIONS: The differences in HRQOL between brachytherapy and brachytherapy with volume-reducing hormone therapy are small; they both decrease HRQOL and increase treatment-related problems. A long-term prospective study on long-term effects on HRQOL is needed to obtain a more comprehensive view of the consequences of a specific treatment modality over time. Our results can help to identify the problems patients face after brachytherapy with or without hormone therapy; these problems deserve additional attention during the period of recovery.","J Endourol, 23(1): 153-159","Netherlands",2009,"Any or unknown","Brachytherapy,Hormonal","EORTC QLQ-C30,EORTC QLQ-PR25","Patient",null,"Clinical trial","Netherlands","Patient","Any or unknown","Brachytherapy,Hormonal",null,"Clinical trial","EORTC QLQ-C30,EORTC QLQ-PR25","2005:2009","Disease,General"]
[471,"Moore, M. J., et al. (1994). \"Use of palliative end points to evaluate the effects of mitoxantrone and low-dose prednisone in patients with hormonally resistant prostate cancer.\" J Clin Oncol 12(4): 689-694.",null,"Moore, M. J., et al.","Use of palliative end points to evaluate the effects of mitoxantrone and low-dose prednisone in patients with hormonally resistant prostate cancer","PURPOSE: This phase II study was designed to assess the effects of mitoxantrone with prednisone in patients with metastatic prostate cancer who had progressed on hormonal therapy. The methods of assessment included quality-of-life analyses, pain indices, analgesic scores, and the National Prostatic Cancer Project (NPCP) criteria. PATIENTS AND METHODS: Patients received mitoxantrone 12 mg/m2 intravenously every 3 weeks plus prednisone 10 mg orally daily. All had a castrate serum testosterone and Eastern Cooperation Oncology Group (ECOG) performance status < or = 3, and had not received prior chemotherapy. Every 3 weeks, analgesic intake was scored, and a present pain intensity (PPI) record and visual analog scale (VAS) describing pain were collected. Every 6 weeks, the European Organization for Research and Treatment of Cancer (EORTC) core quality-of-life questionnaire plus a prostate-specific module were completed. A palliative response was defined as a decrease in analgesic score by > or = 50% or a decrease in PPI by > or = two integers without any increase in the other. RESULTS: Twenty-seven patients were entered onto the study. Nine of 25 (36%) assessable patients achieved a palliative response maintained for > or = two cycles (range, two to eight or more). Improvements in mean PPI and VAS pain scores after each cycle of therapy (P < .05) were seen. Quality-of-life analysis showed improvements in social and emotional functioning, and in pain and anorexia. Using NPCP criteria, one patient achieved a partial response (PR) and 12 had stable disease; one of seven patients with measurable disease had a PR. No serious nonhematologic toxicity was experienced, and there were no episodes of febrile neutropenia. CONCLUSION: Mitoxantrone with low-dose prednisone is a well-tolerated treatment regimen that has some beneficial effects on disease-related symptoms and quality of life for patients with advanced prostate cancer.","J Clin Oncol, 12(4): 689-694","Canada",1994,"Metastatic","Chemotherapy","VAS,EORTC QLQ-C30,EORTC QLQ-PR25,MPQ","Patient",null,"Clinical trial","Canada","Patient","Metastatic","Chemotherapy",null,"Clinical trial","VAS,EORTC QLQ-C30,EORTC QLQ-PR25,MPQ","1960:1999","General,Disease,Symptom"]
[472,"Morgan, M. S., et al. (2016). \"An Assessment of Patient Comfort and Morbidity After Robot-Assisted Radical Prostatectomy with Suprapubic Tube Versus Urethral Catheter Drainage.\" J Endourol 30(3): 300-305.",null,"Morgan, M. S., et al.","An Assessment of Patient Comfort and Morbidity After Robot-Assisted Radical Prostatectomy with Suprapubic Tube Versus Urethral Catheter Drainage","OBJECTIVE: Robot-assisted laparoscopic prostatectomy (RALP) with suprapubic tube (SPT), compared to urethral catheter (UC) drainage, has been proposed to improve patient comfort and recovery. We sought to compare short-term outcomes for pain and morbidity after RALP with SPT vs UC drainage. METHODS: Between August 2012 and 2014, 159 men underwent a RALP and prospectively completed a questionnaire addressing postoperative pain and satisfaction. Group 1 (n = 94) underwent a RALP by one surgeon who placed a UC and removed it between postoperative day (POD) 7 and 10. Group 2 (n = 65) underwent a RALP by a different surgeon who placed an SPT and UC. On POD 1, the UC was removed. On POD 9, the SPT was capped and removed on POD 11 if the patient was voiding adequately. Preoperative and intraoperative data, complications, questionnaires, and patient-reported morbidity, including unplanned telephone calls and emergency department (ED) visits, were compared between groups. RESULTS: Patient characteristics were similar between groups. One week after surgery, the penile pain score was statistically significantly lower in Group 2 compared to Group 1 (56.9% and 79.8%, respectively, reported minimal-to-moderate pain, p = 0.003). Bladder spasms and overall pain were not significantly higher for Group 1 compared to Group 2 (p > 0.05). When asked \"How big a problem has your urine storage device been?,\" 20.2% of patients in Group 1 reported it as a \"moderate-to-big\" problem compared to 10.8% in Group 2 (p > 0.05). The number of catheter-related unplanned telephone encounters did not differ between the two groups (p = 0.7), however, although not statistically significant, 4.6% of patients in Group 2 presented to the ED with catheter-related issues (p = 0.07). CONCLUSION: SPT after RALP was associated with less penile pain compared to UC drainage, and modestly better patient satisfaction. There were no significant differences in bladder spasms, overall pain, and patient-reported morbidity between groups.","J Endourol, 30(3): 300-305","USA",2016,"Any or unknown","Surgery","Unclear","Patient",null,"Clinical trial","USA","Patient","Any or unknown","Surgery",null,"Clinical trial","Unclear","2015:2018","Symptom,Satisfaction"]
[473,"Morton, G. C., et al. (2011). \"Health-related quality of life after single-fraction high-dose-rate brachytherapy and hypofractionated external beam radiotherapy for prostate cancer.\" Int J Radiat Oncol Biol Phys 80(5): 1299-1305.",null,"Morton, G. C., et al.","Health-related quality of life after single-fraction high-dose-rate brachytherapy and hypofractionated external beam radiotherapy for prostate cancer","PURPOSE: To investigate the change in health-related quality of life for men after high-dose-rate brachytherapy and external beam radiotherapy for prostate cancer and the factors associated with this change. METHODS AND MATERIALS: Eligible patients had clinically localized intermediate-risk prostate cancer. The patients received high-dose-rate brachytherapy as a single 15-Gy implant, followed by external beam radiotherapy to 37.5 Gy in 15 fractions. The patients were monitored prospectively for toxicity (Common Terminology Criteria for Adverse Events, version 3.0) and health-related quality of life (Expanded Prostate Cancer Index Composite [EPIC]). The proportion of patients developing a clinically significant difference in the EPIC domain score (minimally important difference of >0.5 standard deviation) was determined and correlated with the baseline clinical and dosimetric factors. The study accrued 125 patients, with a median follow-up of 24 months. RESULTS: By 24 months, 23% had Grade 2 urinary toxicity and only 5% had Grade 2 bowel toxicity, with no Grade 3 toxicity. The proportion of patients reporting a significant decrease in EPIC urinary, bowel, sexual, and hormonal domain scores was 53%, 51%, 45%, and 40% at 12 months and 57%, 65%, 51%, and 30% at 24 months, respectively. The proportion with a >1 standard deviation decrease in the EPIC urinary, bowel, sexual, and hormonal domain scores was 38%, 36%, 24%, and 20% at 12 months and 46%, 48%, 19%, and 8% at 24 months, respectively. On multivariate analysis, the dose to 10% of the urethra was associated with a decreasing EPIC urinary domain score (p = .0089) and, less strongly (p = .0312) with a decreasing hormonal domain score. No association was found between the prostate volume, bladder dose, or high-dose volume and urinary health-related quality of life. A high baseline International Index of Erectile Function score was associated (p = .0019) with a decreasing sexual domain score. The optimal maximal dose to 10% of the urethra cutpoint for urinary health-related quality of life was 120% of the prescription dose. CONCLUSION: EPIC was a more sensitive tool for detecting the effects on function and bother than were the generic toxicity scales. The urethral dose had the strongest association with a deteriorating urinary quality of life.","Int J Radiat Oncol Biol Phys, 80(5): 1299-1305","Canada",2011,"Local","Radiotherapy,Brachytherapy","EPIC,CTCAE","Patient",null,"Cohort","Canada","Patient","Local","Radiotherapy,Brachytherapy",null,"Cohort","EPIC,CTCAE","2010:2014","Disease,Treatment"]
[474,"Mottet, N., et al. (1998). \"Artificial urinary sphincter AMS 800 for urinary incontinence after radical prostatectomy: the French experience.\" Urol Int 60 Suppl 2: 25-29; discussion 35.",null,"Mottet, N., et al.","Artificial urinary sphincter AMS 800 for urinary incontinence after radical prostatectomy: the French experience","Post-radical prostatectomy urinary incontinence (PRP-UI) has a major negative impact on the patient's quality of life with the incidence accounting for over 30% on a patient questionnaire basis. In 1995 the French Urological Association started a prospective survey to investigate the efficacy and safety of the AMS 800 artificial urinary sphincter (AUS) in PRP-UI, and preliminary results are presented for the 103 men enrolled in the study in whom bulbar urethral cuff placement was used exclusively. Surgical revision was necessary in 22 patients (21%). Infection and erosion accounted for 12 non-mechanical revisions leading to complete removal of 6 AUS and to eventual replacement of 6 devices with new ones. Mechanical malfunction accounted for revision in l0 patients (9.7%). Fifty-nine patients (61.45%) reported no leakage for the 96 working devices. Twenty-seven patients (28%) wore no pads, 3 patients used 1 pad and 4 patients used 2 pads/day, and all these patients reported improvement, with only 3 patients (3%) having had more than 2 pads/day. Currently, no non-prosthetic procedure reliably affords such good objective results. Insertion of the AMS 800 AUS no doubt represents an attractive treatment modality available for male urinary incontinence following radical prostatectomy.","Urol Int, 60 Suppl 2(25-29; discussion 35","France",1998,"Any or unknown","Various,Surgery","Unclear","Patient",null,"Clinical trial","France","Patient","Any or unknown","Various,Surgery",null,"Clinical trial","Unclear","1960:1999","Complication"]
[475,"Mottet, N., et al. (2012). \"Intermittent hormonal therapy in the treatment of metastatic prostate cancer: a randomized trial.\" BJU Int 110(9): 1262-1269.",null,"Mottet, N., et al.","Intermittent hormonal therapy in the treatment of metastatic prostate cancer: a randomized trial","Study Type - Therapy (RCT) Level of Evidence 1b. What's known on the subject? and What does the study add? Intermittent androgen deprivation therapy (ADT) involves cycling ADT, allowing hormonal recovery during off-treatment periods. This could lead to a better quality of life during off-treatment periods and could delay progression to castration resistance. Safety and feasibility of intermittent ADT have been shown but tolerability and health-related quality of life improvement have been suggested but questioned by others. Results from randomized trials, including relapsing or mixed populations, have suggested intermittent ADT to be as effective as continuous ADT. In this study of only metastatic patients, no statistical difference in either overall survival or progression-free survival was shown between intermittent and continuous ADT and suggests that intermittent might be as safe as continuous castration. It could be an option in highly responding and well-informed metastatic patients even if no clear benefit in health-related quality of life was shown. This intermittent modality could be of interest in metastatic patients with significant treatment-induced side-effects. OBJECTIVE: * To compare intermittent androgen deprivation therapy (ADT) and continuous ADT after 6 months of induction of ADT in patients with metastatic prostate cancer (PCa). PATIENTS AND METHODS: * This is an open-label randomized multi-centre study conducted in 58 centres in Europe. * Patients with metastatic PCa and prostate-specific antigen (PSA) level >20 ng/mL at selection were randomized after 6 months of induction of ADT (leuprorelin and flutamide) if PSA level had decreased below 4 ng/mL. * Patients received either continuous or intermittent ADT. All patients were treated until signs of disease progression under treatment or until study end with a monthly central PSA determination and follow-up visits were performed every 3 months. * The primary endpoint was overall survival. Secondary endpoints included progression-free survival, health-related quality of life (QLQ C30 questionnaire) and safety criteria. RESULTS: * Of 383 selected patients, 173 had a PSA level below 4 ng/mL after 6 months of induction of ADT and were randomized. Median overall survival (52 vs 42 months, P= 0.75) and median progression-free survival (15.1 vs 20.7 months, P= 0.74) were not significantly different between continuous and intermittent ADT. * Although some differences in quality of life were observed, most of the functional and symptom scales showed no significant difference between the two groups. * Significantly fewer treatment-emergent adverse events occurred in the intermittent group (P= 0.042), with the incidence of headache and hot flushes also lower. CONCLUSIONS: * This first randomized trial comparing continuous with intermittent ADT in metastatic PCa suggests that intermittent ADT might be as safe as continuous ADT. * It could be an option in highly responding and well-informed patients even if no clear benefit in health-related quality of life was shown.","BJU Int, 110(9): 1262-1269","France",2012,"Metastatic","Hormonal","EORTC QLQ-C30","Patient",null,"Clinical trial","France","Patient","Metastatic","Hormonal",null,"Clinical trial","EORTC QLQ-C30","2010:2014","General"]
[476,"Movsas, B., et al. (2014). \"Can electronic web-based technology improve quality of life data collection? Analysis of Radiation Therapy Oncology Group 0828.\" Pract Radiat Oncol 4(3): 187-191.",null,"Movsas, B., et al.","Can electronic web-based technology improve quality of life data collection? Analysis of Radiation Therapy Oncology Group 0828","PURPOSE: Missing data are a significant problem in clinical trials, particularly for quality of life (QOL), which cannot be obtained retrospectively. The purpose of this study was to evaluate the feasibility of an electronic web-based strategy for QOL data collection in a cooperative group radiation oncology trial setting. METHODS AND MATERIALS: Radiation Therapy Oncology Group (RTOG) 0828 was a prospective National Cancer Institute cooperative group companion study of RTOG-0415, a randomized study of conventional versus hypofractionated radiation. Forty-nine English-speaking patients with favorable risk prostate cancer who enrolled on RTOG-0415 consented to using web-based technology for completing QOL. In RTOG-0415, using paper forms, the 6-month QOL compliance rate was 52%. The purpose of RTOG-0828 was to test the feasibility of a web-based strategy with the goal of increasing the 6-month QOL completion rate by 25% (from 52% to 77%) for a relative improvement of ~50%. The web-based tool used in this study was VisionTree Optimal Care (VTOC; VisionTree Software, Inc, San Diego, CA), a Health-Insurance-Portability-Accountability-Act secure, online technology that allows real-time tracking and e-mail reminders. The primary endpoint was the 6-month compliance rate for the validated QOL instrument, Expanded Prostate Index Composite. RESULTS: The QOL completion rate at baseline was 98%. Compared with the prior 52% QOL completion rate at 6 months using paper forms, the QOL web-based completion rate at 6 months was 90% (2-sided P value < .001). At 12 months, the EPIC completion rate was 82% (compared with 36% using paper forms). CONCLUSIONS: This RTOG study suggests that a web-based strategy to collect QOL appears to be feasible in the cooperative group radiation oncology trial setting and is associated with an increase in the 6-month QOL compliance rate compared with the prior method of using paper forms. The RTOG plans to further test this strategy in a head-and-neck cancer trial across all participating RTOG sites.","Pract Radiat Oncol, 4(3): 187-191","USA,Canada",2014,"Any or unknown","Radiotherapy","EPIC","Patient",null,"Clinical trial","USA,Canada","Patient","Any or unknown","Radiotherapy",null,"Clinical trial","EPIC","2010:2014","Disease"]
[477,"Moyad, M. A., et al. (1999). \"Use of PC-SPES, a commercially available supplement for prostate cancer, in a patient with hormone-naive disease.\" Urology 54(2): 319-323; discussion 323-314.",null,"Moyad, M. A., et al.","Use of PC-SPES, a commercially available supplement for prostate cancer, in a patient with hormone-naive disease","OBJECTIVES: PC-SPES, an over-the-counter supplement, is actually a combination of eight different herbs. It is being used by patients to treat cancer of the prostate at different stages of the disease and has been commercially available since November 1996. It has been observed to dramatically decrease prostate-specific antigen (PSA) values in several patients; however, its out-of-pocket cost ($162 to $486/mo) and potential side effects must be weighed against its potential objective benefits. We reviewed its use in 1 patient. METHODS: A patient with clinically localized prostate cancer (T1c) with a PSA of 8.8 ng/mL, who decided to delay any conventional treatment, began treatment with 9 PC-SPES capsules/day. RESULTS: After 3 weeks, his PSA dropped to 1.4 ng/mL and after a total of 8 weeks, his PSA was less than 0.1 ng/mL (undetectable). He has continued on a maintenance dose of 6 capsules per day, decreasing to 4 capsules per day, with a continuing undetectable PSA. During this time the patient also experienced a number of strong estrogenic effects: loss of libido, erectile dysfunction, extreme breast enlargement and tenderness, reduction in overall body hair, pitting edema, and a significant drop in his lipoprotein (a) level (from 46 to 11 mg/dL). CONCLUSIONS: PC-SPES may provide additive advantages (or disadvantages) over prescribed hormonal treatments but must be compared with other hormonal and nonhormonal treatments in clinical trials with hormone-sensitive and -insensitive patients with prostate cancer to determine its future use or nonuse.","Urology, 54(2): 319-323; discussion 323-314","USA",1999,"Local","Various","Unclear","Patient",null,"Case study","USA","Patient","Local","Various",null,"Case study","Unclear","1960:1999","Treatment"]
[478,"Mulholland, T. L., et al. (2006). \"Urinary incontinence after radical retropubic prostatectomy is not related to patient body mass index.\" Prostate Cancer Prostatic Dis 9(2): 153-159.",null,"Mulholland, T. L., et al.","Urinary incontinence after radical retropubic prostatectomy is not related to patient body mass index","To determine if a relationship exists between patient body habitus and urinary incontinence after radical retropubic prostatectomy (RRP) for clinically localized prostate cancer. A questionnaire developed by combining parts of lower urinary tract symptom questionnaires concerning voiding symptoms after RRP was mailed to 268 consecutive patients who underwent RRP over a 2-year period. The interval between surgery and questionnaire administration was greater than 24 months for each patient. No interval was greater than 54 months. The questionnaire attempted to overcome the subjectivity of patient documented urinary incontinence by probing different aspects of each patient's voiding symptoms. Body mass index (BMI), obtained from preoperative anesthesia records, was used as the measurement for body habitus. Pearson correlations were used to determine relationships between BMI and responses and the independent t-test was used to determine differences between grouped responses and BMI. One hundred and eighty-two of 268 (68%) questionnaires were returned. No relationship was detected between BMI and patient estimates of urinary control, QOL relating to urinary symptoms, severity of stress incontinence, or use of protection (pad use). As well, no statistically significant relationship was found between BMI and a patient's willingness to undergo RRP again, based on his voiding symptoms, if given the choice. In conclusion, although patient body habitus may be related to other clinical outcomes following RRP, there does not appear to be a relationship of BMI to post-RRP urinary incontinence.","Prostate Cancer Prostatic Dis, 9(2): 153-159","USA",2006,"Local","Surgery","Unclear","Patient",null,"Cross-sectional","USA","Patient","Local","Surgery",null,"Cross-sectional","Unclear","2005:2009","Complication"]
[479,"Naccarato, A. M., et al. (2016). \"Psychotherapy and phosphodiesterase-5 inhibitor in early rehabilitation after radical prostatectomy: a prospective randomised controlled trial.\" Andrologia 48(10): 1183-1187.",null,"Naccarato, A. M., et al.","Psychotherapy and phosphodiesterase-5 inhibitor in early rehabilitation after radical prostatectomy: a prospective randomised controlled trial","The aim of this study was to evaluate the impact of group psychotherapy and the use of a phosphodiesterase-5 inhibitor (PDE-5i) in the early rehabilitation stage of patients with prostate cancer undergoing radical prostatectomy (RP). Fifty-six patients undergoing RP for prostate cancer were randomised into four groups, and 53 completed the protocol: Group 1 - control (n = 11), Group 2 - group psychotherapy (n = 16), Group 3 - lodenafil 80 mg/one tablet per week (n = 12) and Group 4 - group psychotherapy + lodenafil 80 mg/one tablet per week (n = 14). The groups were individually evaluated for erectile function (IIEF-5) and quality of life - QoL (SF-36) weekly, with two meetings held a week apart before the RP and 12 weekly meetings after surgery. The ages ranged from 39 to 76 years, average 61.84. There were no significant medication side effects. Only Group 4 showed improvement in intimacy with a partner and satisfaction with their sex life (P = 0.045 and P = 0.013 respectively), and with no significant worsening of the IIEF-5 (P = 0.250) reported. All groups showed worsening in the final result of the role limitations caused by physical problems (P = 0.009) and role limitations caused by emotional problems (P = 0.002) of the SF-36, but Group 4 had a significantly higher score for the role limitations caused by physical problems (P = 0.009) than the other groups. In conclusion, precocious integral treatment involving group psychotherapy and PDE-5i before and after RP led to less deterioration of erectile function and other domains related to physical aspects (SF-36), with improvement in intimacy with their partner and satisfaction in their sex life, being superior to single treatments.","Andrologia, 48(10): 1183-1187","Brazil",2016,"Any or unknown","Surgery,Psychological,PDEi","IIEF-5,SF-36","Patient",null,"Clinical trial","Brazil","Patient","Any or unknown","Surgery,Psychological,PDEi",null,"Clinical trial","IIEF-5,SF-36","2015:2018","Complication,Utility"]
[480,"Nag, S., et al. (2002). \"American Brachytherapy Society recommendations for reporting morbidity after prostate brachytherapy.\" Int J Radiat Oncol Biol Phys 54(2): 462-470.",null,"Nag, S., et al.","American Brachytherapy Society recommendations for reporting morbidity after prostate brachytherapy","PURPOSE: To standardize the reporting of brachytherapy-related prostate morbidity to guide ongoing clinical practice and future investigations. METHODS: Members of the American Brachytherapy Society (ABS) with expertise in prostate brachytherapy performed a literature review and, guided by their clinical experience, formulated specific recommendations for reporting on morbidity related to prostate brachytherapy. RESULTS: The ABS recommends using validated, patient-administered health-related quality-of-life instruments for the determination of baseline and follow-up data regarding bowel, urinary, and sexual function. Both actuarial and crude incidences should be reported, along with the temporal resolution of specific complications, and correlated with the doses to the normal tissues. The International Prostate Symptom Score is recommended to assess urinary morbidity, and any dysuria, gross hematuria, urinary retention, incontinence, or medication use should be quantified. Likewise, the \"Sexual Health Inventory for Men,\" which includes the specific erectile questions of the International Index of Erectile Function, is the preferred instrument for reporting sexual function, and the loss of sexual desire, incidence of hematospermia, painful orgasm (orgasmalgia), altered orgasm intensity, decreased ejaculatory volume, use of erectile aids, and use of hormones for androgen deprivation should be quantified. The ABS recommends adoption of the Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer acute and late radiation morbidity scoring scheme for reporting rectal morbidity and noting the incidence of rectal steroid, laser, or antidiarrheal use. CONCLUSION: It is important to focus on health-related quality-of-life issues in the treatment of prostate cancer, because the control rates are very similar between appropriate treatment modalities. The ABS recommends using the International Prostate Symptom Score, International Index of Erectile Function, and Radiation Therapy Oncology Group toxicity grading criteria for the determination of urinary, sexual, and bowel function, respectively. Additional parameters for reporting urinary, rectal, and sexual morbidities are presented. These morbidities should be correlated with the doses to the normal tissues. Some of these specific recommendations may be modified if and when new data become available.","Int J Radiat Oncol Biol Phys, 54(2): 462-470","USA",2002,"Any or unknown","Brachytherapy","IIEF-5,SHIM,RTOG-EORTC-SS","Patient",null,"Systematic review","USA","Patient","Any or unknown","Brachytherapy",null,"Systematic review","IIEF-5,SHIM,RTOG-EORTC-SS","2000:2004","Treatment,Complication"]
[481,"Namiki, S., et al. (2003). \"Health-related quality of life after radical prostatectomy in Japanese men with localized prostate cancer.\" Int J Urol 10(12): 643-650.",null,"Namiki, S., et al.","Health-related quality of life after radical prostatectomy in Japanese men with localized prostate cancer","PURPOSE: We evaluated retrospectively health-related quality of life (HRQOL) after radical prostatectomy (RP) in Japanese men with localized prostate cancer. METHODS: The study was based on self-reported HRQOL of 280 patients. Patients were divided into seven groups: time 0 (T0), baseline before operation; T1, 1-3 months after RP; T2, 4-6 months after RP; T3, 7-12 months after RP; T4, 13-24 months after RP; T5, 25-36 months after RP; and T6, more than 36 months after RP. We measured the general and disease-specific HRQOL using the RAND 36-item Health Survey 1.0 (SF-36) and the University of California, Los Angeles Prostate Cancer Index (UCLA PCI). RESULTS: The general HRQOL of the postoperative groups was assessed by SF-36. The postoperative groups showed almost the same or higher scores than those of the baseline group. Urinary function scores decreased substantially after surgery. In contrast, there was no difference in urinary bother between the baseline and postoperative groups. Sexual function deteriorated substantially in all postoperative groups. Similarly, the sexual bother score significantly deteriorated after RP. The sexual bother score of men aged 65-years or younger was significantly worse than that of their counterparts in the T1-2 groups. CONCLUSION: Despite reports of problems with sexual activity and urinary continence, general HRQOL was mostly unaffected by RP. Although there was a substantial decrease in urinary function, recovery from urinary bother was rapid. Since the deterioration of sexual function was marked through the postoperative period, careful attention should be paid to this issue during preoperative counseling, especially for younger patients.","Int J Urol, 10(12): 643-650","Japan",2003,"Local","Surgery","SF-36,UCLA-PCI","Patient",null,"Cohort","Japan","Patient","Local","Surgery",null,"Cohort","SF-36,UCLA-PCI","2000:2004","Disease,Utility"]
[482,"Namiki, S., et al. (2004). \"Health related quality of life in Japanese men after radical prostatectomy or radiation therapy for localized prostate cancer.\" Int J Urol 11(8): 619-627.",null,"Namiki, S., et al.","Health related quality of life in Japanese men after radical prostatectomy or radiation therapy for localized prostate cancer","BACKGROUND: We performed a retrospective survey of general and disease specific health-related quality of life (HRQOL) after radical prostatectomy (RP) and external beam radiotherapy (XRT) in Japanese men. METHODS: A total of 186 patients underwent RP and 78 underwent XRT for clinically localized prostate cancer between 2000 and 2002. We measured the general and disease specific HRQOL with the MOS 36-Item Health Survey and the University of California, Los Angeles Prostate Cancer Index, respectively. Each treatment group was further divided into four subgroups according to the time scale. RESULTS: Patients from the RP group were significantly younger than those from the XRT group. The tumor characteristics differed significantly in their distributions among the treatment groups. Patients undergoing XRT had low scores in most of the general measures of HRQOL just after treatment, but after 6 months there were no differences between the treatment groups, except for the physical domains. The RP group was associated with worse urinary function, whereas the XRT group had worse bowel function and bother during the first 6 months after treatment. Thereafter, however, urinary and bowel domain did not differ between the groups. Both groups reported poor sexual function, although the RP group scored lower sexual bother. CONCLUSION: The patients who underwent RP had significantly worse urinary and better bowel function than those treated with XRT. Both treatment groups had decrements in sexual function throughout the post-treatment period; careful attention should be paid to this side-effect in preoperative counselling, especially in younger patients, regardless of the primary treatments.","Int J Urol, 11(8): 619-627","Japan",2004,"Local","Surgery,Radiotherapy","SF-36,UCLA-PCI","Patient",null,"Cohort","Japan","Patient","Local","Surgery,Radiotherapy",null,"Cohort","SF-36,UCLA-PCI","2000:2004","Disease,Utility"]
[483,"Namiki, S., et al. (2004). \"Recovery of health related quality of life after radical prostatectomy in japanese men: a longitudinal study.\" Int J Urol 11(9): 742-749.",null,"Namiki, S., et al.","Recovery of health related quality of life after radical prostatectomy in japanese men: a longitudinal study","BACKGROUND: We performed a longitudinal survey of health related quality of life (HRQOL) after radical retropubic prostatectomy (RP) in Japanese men with localized prostate cancer. METHODS: The present study started with self-reported HRQOL assessments provided by 72 patients who received only RP. The RAND 36-Item Health Survey and the University of California, Los Angeles Prostate Cancer Index were administered before and 3, 6 and 12 months after RP. RESULTS: Patients who underwent RP showed problems in some domains of general HRQOL, but these problems diminished over time. Urinary function declined substantially at 3 months and continued to recover at 6 and 12 months, but scored lower than the baseline. Urinary bother at 3 months had a significant decrease, but at six months it turned out to be the same as the baseline. The data of sexual function and bother showed a substantially lower score after RP. The sexual bother score of the younger men was significantly worse than that of the older men. Those who underwent nerve sparing procedures experienced significantly better recovery of urinary and sexual functions than the non-nerve sparing group. CONCLUSION: Despite reports of problems with sexuality and urinary continence, general HRQOL was mostly unaffected by RP after 6 months. Although there was a substantial decrease in urinary function, recovery from urinary bother was rapid. Deterioration of the sexual domain was remarkable throughout the postoperative period. Therefore, careful attention should be given to preoperative counseling, especially for younger patients.","Int J Urol, 11(9): 742-749","Japan",2004,"Local","Surgery","SF-36,UCLA-PCI","Patient",null,"Cohort","Japan","Patient","Local","Surgery",null,"Cohort","SF-36,UCLA-PCI","2000:2004","Disease,Utility"]
[484,"Namiki, S., et al. (2005). \"An evaluation of urinary function after radical prostatectomy in Japanese men: concordance with definitions of urinary continence.\" BJU Int 95(4): 530-533.",null,"Namiki, S., et al.","An evaluation of urinary function after radical prostatectomy in Japanese men: concordance with definitions of urinary continence","OBJECTIVE: To determine how well various definitions of continence outcome after radical retropubic prostatectomy (RP) corresponded with each other, using published health-related quality-of-life (HRQoL) questionnaires. PATIENTS AND METHODS: In all, 198 patients undergoing RP alone were enrolled in a study between November 2000 and June 2003. The baseline interview was conducted before RP and 3, 6 and 12 months afterward. The disease-specific HRQoL was assessed using the University of California-Los Angeles Prostate Cancer Index; the correspondence among definitions of incontinence was investigated. RESULTS: The urinary function score substantially declined at 3 months, continued to recover at 6 and 12 months, but remained lower than at baseline (P < 0.001). The correspondence among definitions of continence varied widely; 97% of men who did not have urine leakage at all claimed to use no pads, but only 63% of those claiming no use of pads had no urine leakage at all. Interestingly, this concordance rate progressively changed from 46% at 3 months to 60% at 12 months, whereas it was 82% at baseline. CONCLUSIONS: Based on self-reported questionnaire data, different definitions of continence gave different results when applied to the same patients at the same time. The correspondence among definitions may vary with time after RP. No single question adequately assesses the urinary HRQoL outcome after treatment for prostate cancer.","BJU Int, 95(4): 530-533","Japan",2005,"Any or unknown","Surgery","UCLA-PCI","Patient",null,"Cohort","Japan","Patient","Any or unknown","Surgery",null,"Cohort","UCLA-PCI","2005:2009","Disease"]
[485,"Namiki, S., et al. (2006). \"Health-related quality of life after intensity modulated radiation therapy for localized prostate cancer: comparison with conventional and conformal radiotherapy.\" Jpn J Clin Oncol 36(4): 224-230.",null,"Namiki, S., et al.","Health-related quality of life after intensity modulated radiation therapy for localized prostate cancer: comparison with conventional and conformal radiotherapy","OBJECTIVE: No previous studies have reported the longitudinal health-related quality of life (HRQOL) for intensity modulated radiation therapy (IMRT). We compared HRQOL after IMRT with that after conventional and after conformal radiation therapy (XRT). METHODS: A total of 110 patients underwent XRT (34 patients underwent conventional radiation therapy and 76 underwent conformal radiation therapy) and 30 underwent IMRT for clinically localized prostate cancer between 2000 and 2002. We measured the general and disease-specific HRQOL using the Medical Outcomes Study 36-Item Health Survey and University of California, Los Angeles, Prostate Cancer Index, respectively. RESULTS: There were no significant differences in the preoperative characteristics and HRQOL scores of the two groups. Repeated measure analyses of variance revealed significantly different patterns of alteration in several general HRQOL domains between XRT and the IMRT groups. In the urinary domain, there was no difference in the alteration patterns between the two groups. The XRT group suffered worse bowel function at 3 and 6 months than the IMRT group (P < 0.05). In the XRT group, sexual function decreased at 3 months and remained substantially lower than the baseline level. However, the IMRT group showed no significant difference from the baseline level at any of the observation periods. At 18 months the XRT group showed worse sexual function than the IMRT group. CONCLUSION: The two approaches showed different longitudinal profiles regarding general and disease-specific HRQOL during the first 2 years after treatment. The IMRT approach produced little impairment in bowel and sexual function.","Jpn J Clin Oncol, 36(4): 224-230","Japan",2006,"Local","Radiotherapy","SF-36,UCLA-PCI","Patient",null,"Clinical trial","Japan","Patient","Local","Radiotherapy",null,"Clinical trial","SF-36,UCLA-PCI","2005:2009","Disease,Utility"]
[486,"Namiki, S., et al. (2007). \"Impact of salvage therapy for biochemical recurrence on health-related quality of life following radical prostatectomy.\" Int J Urol 14(3): 186-191.",null,"Namiki, S., et al.","Impact of salvage therapy for biochemical recurrence on health-related quality of life following radical prostatectomy","OBJECTIVE: To determine the impact of salvage therapy for prostate-specific antigen (PSA) recurrence on the health-related quality of life (HRQOL) of patients after radical retropubic prostatectomy (RP). METHODS: Between January 2000 and December 2003, a total of 249 patients who underwent RP were available for 2-year follow up. Of the respondents, 203 men did not show evidence of recurrence (group A), and 46 men received salvage hormonal therapy and/or radiotherapy after RP because of a rise in PSA (group B). The general and prostate-target HRQOL was assessed with the Medical Outcomes Study 36-Item Short Form and University of California, Los Angeles Prostate Cancer Index, respectively. Patients completed the HRQOL instruments by mail at baseline and at 24 months after RP. RESULTS: All of the patients completed both questionnaires. At baseline no significant differences were found between the two groups in any of the HRQOL domains. There were significant improvements in mental health and social function for the patients without biochemical recurrence postoperatively. Repeated measure anova revealed significantly different patterns of alteration in several general HRQOL domains among the treatment groups. The urinary and bowel domains were equivalent between the two treatment groups at baseline and 24 months after RP. The patients treated with salvage hormonal therapy tended to show delayed recovery of sexual function. CONCLUSION: Using a self-administered questionnaire, biochemical recurrence following RP was found to impose a substantial burden in patients with localized prostate cancer.","Int J Urol, 14(3): 186-191","Japan",2007,"Any or unknown","Surgery,Hormonal,Radiotherapy","SF-36,UCLA-PCI","Patient",null,"Cohort","Japan","Patient","Any or unknown","Surgery,Hormonal,Radiotherapy",null,"Cohort","SF-36,UCLA-PCI","2005:2009","Disease,Utility"]
[487,"Namiki, S., et al. (2007). \"Psychological distress in Japanese men with localized prostate cancer.\" Int J Urol 14(10): 924-929.",null,"Namiki, S., et al.","Psychological distress in Japanese men with localized prostate cancer","OBJECTIVE: To investigate: (i) the level of psychological distress; and (ii) the relationships between the level of psychological distress and general or disease-specific HRQOL of Japanese men with localized prostate cancer following surgery or radiotherapy. PATIENTS AND METHODS: The study was a retrospective cross-sectional survey of 253 men with localized prostate cancer treated with radical prostatectomy and 87 with external beam radiotherapy were collected. The measures used four questionnaires including: (i) the Medical Outcomes Study 36-Item Health Survey; (ii) The University of California, Los Angeles Prostate Cancer Index; (iii) International Prostate Symptom Score; and (iv) Hospital Anxiety and Depression Scale (HADS). RESULTS: Mean anxiety and depression scores were 4.0 and 4.7, respectively (standard deviation, 3.3 and 3.7). On the anxiety section of HADS, 291 patients (85%) scored 7 points or less; and on the depression scale, 183 (54%) patients scored 4 points or less. Those 'cases' (HADS total, >10) with psychological distress scored lower in all domains of the general and disease related health-related quality of life (HRQOL) than the 'non-cases' (HADS total, <or=10) except for sexual domains. Logistic regression modeling suggested that the men who tended to experience moderate to high distress suffered from worse urinary and bowel symptoms. CONCLUSION: Most patients who underwent radical prostatectomy or external beam radiotherapy for localized prostate cancer experienced low levels of psychological distress after treatment. However, men who were experiencing urinary and bowel symptoms tended to suffer from moderate to higher distress compared with men reporting no or fewer such symptoms.","Int J Urol, 14(10): 924-929","Japan",2007,"Local","Surgery,Radiotherapy","UCLA-PCI,HADS,IPSS,SF-36","Patient",null,"Cross-sectional","Japan","Patient","Local","Surgery,Radiotherapy",null,"Cross-sectional","UCLA-PCI,HADS,IPSS,SF-36","2005:2009","Disease,Comorbidity,Utility"]
[488,"Namiki, S., et al. (2009). \"Association of lower urinary tract symptoms with sexual dysfunction: a cross-cultural study between Japanese and American men with localized prostate cancer.\" BJU Int 104(8): 1071-1076.",null,"Namiki, S., et al.","Association of lower urinary tract symptoms with sexual dysfunction: a cross-cultural study between Japanese and American men with localized prostate cancer","OBJECTIVE: To assess the association of lower urinary tract symptoms (LUTS) with sexual function, and estimate the correlates of LUTS among Japanese and American men with localized prostate cancer. PATIENTS AND METHODS: In all, 343 Japanese men and 307 American men with prostate cancer were enrolled in the study. Sexual function and sexual bother were measured separately with the University of California-Los Angeles Prostate Cancer Index and obstructive/irritative voiding symptoms were measured with the American Urological Association Symptom Index (AUA SI). RESULTS: Japanese men had worse sexual function scores than the American men before treatment, whereas no differences were reported between Japanese and American men in sexual bother scores. Japanese and American men also did not differ meaningfully in AUA SI. However, those with moderate to severe LUTS reported significantly worse sexual bother scores than those with mild symptoms in both Japanese and American men (P = 0.004 and <0.001, respectively). The Japanese men were more likely to have LUTS than were American men (odds ratio 1.60, P = 0.029). Age and sexual function were highly associated with LUTS (odds ratio 1.35, P = 0.027; and 0.652, P = 0.001, respectively). The comorbidity count was independently associated with worse urinary symptoms (odds ratio 1.23, P = 0.015). CONCLUSIONS: We posit that cultural differences in the meaning or salience of sexual functioning, and the interpretation of the questionnaire in quality-of-life surveys, might explain the different profiles in the association of LUTS with sexual activity in Japanese and American men with localized prostate cancer.","BJU Int, 104(8): 1071-1076","Japan",2009,"Local","None","AUA-SI,UCLA-PCI","Patient",null,"Cross-sectional","Japan","Patient","Local","None",null,"Cross-sectional","AUA-SI,UCLA-PCI","2005:2009","Disease,Symptom"]
[489,"Namiki, S., et al. (2009). \"Distress and social dysfunction following prostate cancer treatment: a longitudinal cross-cultural comparison of Japanese and American men.\" Prostate Cancer Prostatic Dis 12(1): 67-71.",null,"Namiki, S., et al.","Distress and social dysfunction following prostate cancer treatment: a longitudinal cross-cultural comparison of Japanese and American men","We assessed the impact of bother with urinary and bowel dysfunction on social activities among men in Japan and the United States following primary therapy for localized prostate cancer. In paired longitudinal outcomes studies, we measured general and disease-specific health-related quality of life in 400 Japanese and 427 American men who underwent radical prostatectomy or brachytherapy for localized prostate cancer. Outcomes included the social function domain of the Medical Outcomes Study Short Form-36 and the University of California, Los Angeles Prostate Cancer Index, all of which are scored 0-100. Participants completed the questionnaires before and 1, 12 and 24 months after treatment. Among men who reported any urinary bother, Japanese men had slightly better urinary function than American men (84 vs 77, P<0.01). Before brachytherapy, urinary bother was weakly correlated with social function in both the countries; after brachytherapy, urinary bother was strongly correlated with social function in American but not Japanese men. After brachytherapy, bowel dysfunction had a stronger correlation with social function in American than Japanese men (P<0.05). The bother associated with urinary and bowel dysfunction after surgery or brachytherapy for prostate cancer has a greater impact on social function in American men than in Japanese men.","Prostate Cancer Prostatic Dis, 12(1): 67-71","USA",2009,"Local","Surgery,Brachytherapy","SF-36,UCLA-PCI","Patient",null,"Cohort","USA","Patient","Local","Surgery,Brachytherapy",null,"Cohort","SF-36,UCLA-PCI","2005:2009","Disease,Utility"]
[490,"Namiki, S., et al. (2010). \"Quality of life among elderly men treated for prostate cancer with either radical prostatectomy or external beam radiation therapy.\" J Cancer Res Clin Oncol 136(3): 379-386.",null,"Namiki, S., et al.","Quality of life among elderly men treated for prostate cancer with either radical prostatectomy or external beam radiation therapy","PURPOSE: We evaluated the changes of health-related quality of life (HRQOL) during the first 2 years after radical prostatectomy (RP) or external beam radiation therapy (EBRT) in elderly men (70 years old or older) treated for prostate cancer. PATIENTS AND METHODS: Between 2002 and 2005, a total of 319 elderly men who underwent RP or EBRT participated in our study. Patients completed the general and disease-specific HRQOL with the Short Form-36 (SF-36) and University of California, Los Angeles Prostate Cancer Index, respectively. The participants were asked to complete the questionnaire before and 3, 6, 12, 18 and 24 months after treatment. RESULTS: The RP group was younger and had more favorable tumor characteristics than the EBRT group. When compared with the EBRT group, the RP group had higher scores for several SF-36 subscales and sexual function, whereas other domains were comparable. In the EBRT group, there were no significant differences in the general HRQOL scores between the baseline and any of the observation periods. The RP group had a significantly worse urinary function and bother scores postoperatively than the EBRT group. The score for sexual function declined over the 24 months, but more so in the RP group. Similarly, sexual bother scores were significantly lower at each postoperative time point for the RP group. CONCLUSIONS: Both aggressive treatments can offer satisfactory functional outcomes from the perspective of HRQOL for selected elderly subjects with localized prostate cancer.","J Cancer Res Clin Oncol, 136(3): 379-386","Japan",2010,"Any or unknown","Surgery,Radiotherapy","SF-36,UCLA-PCI","Patient",null,"Cohort","Japan","Patient","Any or unknown","Surgery,Radiotherapy",null,"Cohort","SF-36,UCLA-PCI","2010:2014","Disease,Utility"]
[491,"Naoe, M., et al. (2006). \"Pilot evaluation of selective serotonin reuptake inhibitor antidepressants in hot flash patients under androgen-deprivation therapy for prostate cancer.\" Prostate Cancer Prostatic Dis 9(3): 275-278.",null,"Naoe, M., et al.","Pilot evaluation of selective serotonin reuptake inhibitor antidepressants in hot flash patients under androgen-deprivation therapy for prostate cancer","PURPOSE: Hot flash (HF) is a common side effect in prostate cancer patient undergoing androgen-deprivation therapy (ADT). In this study, we evaluated the efficacy of paroxetine (selective serotonin reuptake inhibitors (SSRIs)) for HF. PATIENTS AND METHODS: In total, 10 men with prostate cancer under ADH who were suffering with HF entered this study. Self-report questionnaire was used for the evaluation. RESULTS: The average rating for HF frequency decreased (P=0.009) and HF severity decreased (P=0.0332) also, reported QOL score increased (P=0.0218). CONCLUSION: These preliminary data suggest that low dose (10 mg/day) of antidepressant paroxetine can be helpful in the treatment of HFs in patients under ADT for prostate cancer. Further controlled studies are needed to more fully evaluate the efficacy of the SSRIs.","Prostate Cancer Prostatic Dis, 9(3): 275-278","Japan",2006,"Any or unknown","Hormonal,Various","Unclear","Patient",null,"Clinical trial","Japan","Patient","Any or unknown","Hormonal,Various",null,"Clinical trial","Unclear","2005:2009","Treatment"]
[492,"Nascimento, M., et al. (2014). \"Efficacy of synbiotics to reduce acute radiation proctitis symptoms and improve quality of life: a randomized, double-blind, placebo-controlled pilot trial.\" Int J Radiat Oncol Biol Phys 90(2): 289-295.",null,"Nascimento, M., et al.","Efficacy of synbiotics to reduce acute radiation proctitis symptoms and improve quality of life: a randomized, double-blind, placebo-controlled pilot trial","PURPOSE: To evaluate whether the daily intake of synbiotics interferes in radiation-induced acute proctitis symptoms and in quality of life in patients with prostate cancer. METHODS AND MATERIALS: Twenty patients who underwent 3-dimensional conformal radiation therapy for prostate cancer were randomized to intake either a synbiotic powder containing Lactobacillus reuteri 10(8) colony-forming units and 4.3 g of soluble fiber (Nestle) or placebo. The questionnaire EORTC QLQ-PRT23 was applied before the beginning of radiation therapy and in every week for the first 4 weeks of treatment. The sum of both the complete (proctitis symptoms plus quality of life) and partial (proctitis symptoms) scores of the EORTC QLQ-PRT23 (European Organization for Research and Treatment of Cancer Quality of Life Module for Proctitis-23 items) questionnaire were the main endpoints. RESULTS: This pilot study showed that the complete questionnaire score (median [range]) was higher in the second (23 [21-30] vs 26.5 [22-34], P<.05) and third (23 [21-32] vs 27.5 [24-33], P<.01) weeks in the placebo group. Proctitis symptoms were highest scored in the placebo group in both the second (19.5 [16-25]) and third (19 [17-24]) weeks than in the synbiotic group (week 2: 16.5 [15-20], P<.05; week 3: 17 [15-23], P<.01). In both scores the placebo group had a significantly higher result (P<.01) than the synbiotic group (repeated-measures analysis of variance). CONCLUSIONS: Synbiotics reduce proctitis symptoms and improve quality of life in radiation-induced acute proctitis during radiation therapy for prostate cancer.","Int J Radiat Oncol Biol Phys, 90(2): 289-295","Brazil",2014,"Any or unknown","Radiotherapy,Various","EORTC-QLQ-PRT23","Patient",null,"Clinical trial","Brazil","Patient","Any or unknown","Radiotherapy,Various",null,"Clinical trial","EORTC-QLQ-PRT23","2010:2014","Complication"]
[493,"Naughton, C. K., et al. (2001). \"Impact of transrectal ultrasound guided prostate biopsy on quality of life: a prospective randomized trial comparing 6 versus 12 cores.\" J Urol 165(1): 100-103.",null,"Naughton, C. K., et al.","Impact of transrectal ultrasound guided prostate biopsy on quality of life: a prospective randomized trial comparing 6 versus 12 cores","PURPOSE: Recent studies advocating an increase in the number of cores of sextant transrectal ultrasound guided biopsy of the prostate to improve the cancer detection rate often have not addressed the impact on quality of life. We performed a prospective randomized trial comparing 6 to 12 prostate biopsy cores to determine the impact on the cancer detection rate, pain and morbidity, and quality of life. We report the impact on health related and screening specific quality of life in men undergoing 6 versus 12 core transrectal ultrasound guided prostate biopsy. MATERIALS AND METHODS: We prospectively randomized 244 men with a mean age plus or minus standard deviation of 65 +/- 8 years, serum total prostate specific antigen between 2.5 and 20.0 ng./ml., and/or digital rectal examination findings suspicious of cancer to undergo 6 or 12 core peripheral zone tissue biopsy. Of the men 71 (29%) were black. All patients completed a self-administered questionnaire before, and 2 questionnaires 2 and 4 weeks after the procedure. Health related quality of life was measured using 2 subscales (emotional well-being and role limitation due to physical health) of the short form 36-Item Health Survey. Screening specific quality of life was addressed by questions on the functional consequences of the procedure (return to daily activity, work-employment and sports-exercise). Health related and screening specific quality of life responses were compared in the groups. RESULTS: After controlling for cancer diagnosis, patient age, race, education, report of pain and baseline emotional well-being there was no significant difference in the mean change in emotional well-being scores at 2 and 4 weeks in the 6 and 12 core groups (p = 0.7 and 0.3, respectively). Similarly after controlling for these factors and baseline role limitation due to physical health there was no significant difference in the mean change in role limitation due to physical health scores at 2 and 4 weeks in the 2 groups (p = 0.3 and 0.5, respectively). There was no difference in the percent of men returning to routine daily activity (p = 0.6), work-employment (p = 0.5) or sports-exercise (p = 0.3) at 0 to 1, 2 to 3 and 4 to 7 days or longer than 1 week after the procedure in the groups. CONCLUSIONS: Doubling the sextant biopsy does not affect the quality of life in regard to emotional well-being, role limitation due to physical health, or return to routine daily activity, work-employment or sports-exercise.","J Urol, 165(1): 100-103","USA",2001,"At risk","Screening","SF-36","General population",null,"Clinical trial","USA","General population","At risk","Screening",null,"Clinical trial","SF-36","2000:2004","Utility"]
[494,"Navon, L. and A. Morag (2003). \"Advanced prostate cancer patients' relationships with their spouses following hormonal therapy.\" Eur J Oncol Nurs 7(2): 73-80; discussion 81-72.",null,"Navon, L. and A. Morag","Advanced prostate cancer patients' relationships with their spouses following hormonal therapy","The paper analyses the adverse impact of the hormonal therapy's side-effects on advanced prostate cancer patients' capacity for maintaining their pre-treatment spousal relationships, the pros and cons of their ways of coping with the difficulties involved, and the implications of these issues for oncology nursing interventions. In-depth interviews were conducted with 15 Israeli prostate cancer patients, and the data were processed according to the constant comparative analysis method. The findings show that partners' supportive attitude and patients' attempts to stage resilience led to pre-treatment relationships' maintenance, and that, accordingly, patients' rejection by their partners and resignation to this difficulty resulted in spousal ties' disruption. However, whereas the relationships' maintenance came at the cost of burdensome constant pretence, their disruption was eventually reconstructed by the patients in positive terms. These findings are analysed against the backdrop of the constraints imposed by the hormonal therapy on patients' general coping competence and ability to enjoy non-sexual activities, which impair their capability to solve their marital problems more effectively. They would thus benefit from training oncology nurses who specialize in the unique difficulties facing them and their partners, and from oncology nursing interventions that focus on relevant information provision and counselling.","Eur J Oncol Nurs, 7(2): 73-80; discussion 81-72","Israel",2003,"Advanced","Hormonal","Interview","Patient",null,"Cross-sectional","Israel","Patient","Advanced","Hormonal",null,"Cross-sectional","Interview","2000:2004","Social"]
[495,"Neumann, P. J., et al. (2012). \"Willingness-to-pay for predictive tests with no immediate treatment implications: a survey of US residents.\" Health Econ 21(3): 238-251.",null,"Neumann, P. J., et al.","Willingness-to-pay for predictive tests with no immediate treatment implications: a survey of US residents","We assessed how much, if anything, people would pay for a laboratory test that predicted their future disease status. A questionnaire was administered via an internet-based survey to a random sample of adult US respondents. Each respondent answered questions about two different scenarios, each of which specified: one of four randomly selected diseases (Alzheimer's, arthritis, breast cancer, or prostate cancer); an ex ante risk of developing the disease (randomly designated 10 or 25%); and test accuracy (randomly designated perfect or 'not perfectly accurate'). Willingness-to-pay (WTP) was elicited with a double-bounded, dichotomous-choice approach. Of 1463 respondents who completed the survey, most (70-88%, depending on the scenario) were inclined to take the test. Inclination to take the test was lower for Alzheimer's and higher for prostate cancer compared with arthritis, and rose somewhat with disease prevalence and for the perfect versus imperfect test [Correction made here after initial online publication.]. Median WTP varied from $109 for the imperfect arthritis test to $263 for the perfect prostate cancer test. Respondents' preferences for predictive testing, even in the absence of direct treatment consequences, reflected health and non-health related factors, and suggests that conventional cost-effectiveness analyses may underestimate the value of testing.","Health Econ, 21(3): 238-251","USA",2012,"At risk","Screening","WTP","General population",null,"Cross-sectional","USA","General population","At risk","Screening",null,"Cross-sectional","WTP","2010:2014","Utility"]
[496,"Newton, F. J., et al. (2006). \"Disease-specific quality of life among patients with localized prostate cancer: an Australian perspective.\" BJU Int 97(6): 1179-1183.",null,"Newton, F. J., et al.","Disease-specific quality of life among patients with localized prostate cancer: an Australian perspective","OBJECTIVES: To examine differences in sexual, urinary and bowel function, and bother, in patients with prostate cancer after treatment with radical prostatectomy (RP) or external beam radiation (EBRT), compared to a convenience sample of men with no diagnosis of prostate cancer, as little is known about the disease-specific health-related quality of life (HRQoL) of men in Australia after treatment for clinically localized prostate cancer. PATIENTS AND METHODS: The study was a retrospective cross-sectional survey of 95 controls, 82 men with localized prostate cancer treated with RP and 39 with EBRT at > or = 2 years before data were collected. Disease-specific HRQoL was assessed using the University of California Los Angeles Prostate Cancer Index, a validated measure that includes six subscales addressing sexual, urinary and bowel symptoms, and level of bother associated with the symptoms. Univariate analyses were conducted to ascertain differences in disease-specific HRQoL among the three groups. To minimize the influence of other factors, age and comorbid medical conditions were included as covariates. RESULTS: Men treated with RP had more sexual and urinary symptoms (both P < 0.001) than those treated with EBRT, and more sexual bother (P < 0.001). Men treated with EBRT reported significantly worse bowel function (P = 0.02) and more bother (P < 0.001) with these symptoms than those who had RP. CONCLUSIONS: Except for bowel dysfunction and the bother associated with these symptoms, disease-specific HRQoL was generally worse after RP than EBRT.","BJU Int, 97(6): 1179-1183","Australia",2006,"Local","Surgery,Radiotherapy","UCLA-PCI","Patient,General population",null,"Cross-sectional","Australia","Patient,General population","Local","Surgery,Radiotherapy",null,"Cross-sectional","UCLA-PCI","2005:2009","Disease"]
[497,"Nguyen, L. N., et al. (1998). \"Late effects after radiotherapy for prostate cancer in a randomized dose-response study: results of a self-assessment questionnaire.\" Urology 51(6): 991-997.",null,"Nguyen, L. N., et al.","Late effects after radiotherapy for prostate cancer in a randomized dose-response study: results of a self-assessment questionnaire","OBJECTIVES: To evaluate the late effects more than 2 years after radiotherapy using a patient-reported questionnaire in patients with prostate cancer enrolled in a randomized dose-response study comparing 70 Gy (conventional) and 78 Gy (conformal) radiotherapy (RT). METHODS: The first 112 patients in the study were sent questionnaires to evaluate late bladder, rectal, and sexual function. There were 101 evaluable responses, with 50 in the conventional (Conven-RT) arm and 51 in the conformal (3DCRT) arm. RESULTS: The overall rate of persistent incontinence was 29%, with 36% reporting urgency-related and 8% stress-related incontinence at some time after radiation. Use of a urinary protective device was required in 2%. The majority noticed leakage less than once per day (52%). In comparing the Conven-RT group with the 3DCRT group, similar incontinence rates were seen. However, fewer of those who received 3DCRT reported daily leakage of urine (33% versus 63%, P = 0.044). The majority (78%) of patients experienced no or mild change in bowel function after RT. Urgency of bowel movements (BMs) was of concern for 27% of patients; however, 90% reported their BMs were controlled without accidents, and 1% were taking antidiarrheal medications once a week or daily. The Conven-RT group had more moderate or major changes in bowel function than the 3DCRT group (34% versus 10%), more frequent BMs (47% versus 27%), and more urgent BMs (37% versus 18%) (P < or = 0.040 for all three comparisons). Hematochezia was uncommon, occurring once a week in 7% and daily in 4% of patients. Before RT, 80% of patients were potent, with erections adequate for intercourse at least a few times over the prior year. After RT, potency was decreased to 51%, with erections adequate for intercourse at least a few times since the completion of RT. CONCLUSIONS: The overall rates of significant complications were extremely low. Although 30% reported incontinence, relatively few patients (2%) required pads. This rate compares favorably with the 31% of patients requiring protection after radical prostatectomy reported previously. Despite the higher treatment doses in the 3DCRT arm, slightly fewer long-term bowel side effects were noted. These data indicate that 78 Gy may safely be delivered using the conformal RT boost treatment technique described.","Urology, 51(6): 991-997","USA",1998,"Any or unknown","Radiotherapy","Unclear","Patient",null,"Clinical trial","USA","Patient","Any or unknown","Radiotherapy",null,"Clinical trial","Unclear","1960:1999","Complication"]
[498,"Nguyen, P. L., et al. (2009). \"Patient-reported quality of life after salvage brachytherapy for radio-recurrent prostate cancer: A prospective Phase II study.\" Brachytherapy 8(4): 345-352.",null,"Nguyen, P. L., et al.","Patient-reported quality of life after salvage brachytherapy for radio-recurrent prostate cancer: A prospective Phase II study","BACKGROUND: Patient-reported quality of life (QOL) after salvage brachytherapy for radiorecurrent prostate cancer has not been well-characterized prospectively. METHODS: We examined 25 men who recurred after primary radiotherapy for prostate cancer and received MRI-guided salvage brachytherapy as part of a prospective Phase II study. These patients received prospectively a validated patient-reported QOL questionnaire to fill out at baseline, as well as 3, 15, and 27 months after re-irradiation to determine the degree of sexual, bowel, and urinary dysfunction (maximum dysfunction score=100). RESULTS: On average, sexual function continued to decline with time, and patients had significantly worse sexual function scores at 27 months than baseline (p=0.01). Although bowel and urinary symptoms worsened acutely at 3 or 15 months, they showed on average some improvement by 27 months, and there were no significant differences between baseline and 27-month urinary or bowel scores. An interval to re-irradiation less than 4.5 years and prior brachytherapy were each associated significantly with the largest decrements in bowel function (p=0.035). CONCLUSION: Similar to the patterns seen in the de novo setting, patients who receive salvage brachytherapy report a worsening of bowel and urinary symptoms followed by some improvement by 27 months, while sexual function steadily declines over time. Interval to re-irradiation and type of prior radiation received may be used to counsel and optimize selection of men for salvage brachytherapy with regard to QOL endpoints.","Brachytherapy, 8(4): 345-352","USA",2009,"Recurrent","Radiotherapy,Brachytherapy","Unclear","Patient",null,"Clinical trial","USA","Patient","Recurrent","Radiotherapy,Brachytherapy",null,"Clinical trial","Unclear","2005:2009","Complication"]
[499,"Nguyen, P. L., et al. (2010). \"Rectal dose-volume histogram parameters are associated with long-term patient-reported gastrointestinal quality of life after conventional and high-dose radiation for prostate cancer: a subgroup analysis of a randomized trial.\" Int J Radiat Oncol Biol Phys 78(4): 1081-1085.",null,"Nguyen, P. L., et al.","Rectal dose-volume histogram parameters are associated with long-term patient-reported gastrointestinal quality of life after conventional and high-dose radiation for prostate cancer: a subgroup analysis of a randomized trial","PURPOSE: We examined whether rectal dose-volume histogram (DVH) parameters were associated with long-term patient-reported gastrointestinal (GI) quality of life (QOL) after conventional (70.2 GyE) or high-dose (79.2 GyE) radiation for prostate cancer. METHODS AND MATERIALS: Of 64 men with localized prostate cancer alive with a minimum 7-year follow-up after treatment as part of a randomized trial with either 70.2 GyE or 79.2 GyE of external beam radiation at Massachusetts General Hospital, 56 men (88%) returned a QOL questionnaire, and 50 of those men had DVH information. The DVH parameters of the anterior rectal wall were correlated with patient-reported long-term GI QOL using Pearson correlation and t tests. RESULTS: There was a trend toward an association between increased long-term GI dysfunction and higher V60 (p = 0.07), V65 (p = 0.06), V70 (p = 0.09), and V75 (p = 0.09). When dichotomized by their medians, a V60 > 54% (p = 0.04), V70 > 44% (p = 0.06), and V75 > 39% (p = 0.06) were associated with increased long-term GI dysfunction. There was no difference in long-term GI dysfunction between men on the conventional vs. high-dose arms (p = 0.49). CONCLUSIONS: Dose-volume histogram parameters of the anterior rectal wall were associated with long-term patient-reported GI QOL after prostate radiation, whereas the dose prescribed to the prostate was not, suggesting that DVH constraints, rather than total prescribed dose, may have the greatest impact on long-term bowel dysfunction, and therefore that continued dose escalation may be feasible if appropriate dose-volume constraints are met.","Int J Radiat Oncol Biol Phys, 78(4): 1081-1085","USA",2010,"Local","Radiotherapy","Unclear","Patient",null,"Clinical trial","USA","Patient","Local","Radiotherapy",null,"Clinical trial","Unclear","2010:2014","Complication"]
[500,"Nielsen, O. S., et al. (1998). \"Randomized trial of single dose versus fractionated palliative radiotherapy of bone metastases.\" Radiother Oncol 47(3): 233-240.",null,"Nielsen, O. S., et al.","Randomized trial of single dose versus fractionated palliative radiotherapy of bone metastases","PURPOSE: Data in the literature suggest that for painful bone metastases a single dose is as effective as fractionated radiotherapy. In the present multicentre prospective trial, the effects of 8 Gy x1 and 5 Gy x4 were compared. PATIENTS AND METHODS: A total of 241 patients were randomized to 8 Gy (122 patients) or 20 Gy (119 patients). The primary tumour was in the breast in 39% of patients, in the prostate in 34% of patients, in the lung in 13% of patients and in other locations in 14% of patients. Outcome measures were pain relief as measured by VAS and in half of the patients also by a five-point categorical pain scale, global quality of life (QoL) and analgesic consumption. Evaluation was performed before and 4, 8, 12 and 20 weeks after treatment. RESULTS: A total of 239 patients were evaluable for response. The two groups did not differ with respect to age, sex, primary tumour, metastasis localization, analgesic consumption (type and dose), performance status, prior systemic treatment, degree of pain and QoL. The treatment was completed as planned in 98% of patients. The degree of pain relief did not differ between the two treatment groups. At 4 weeks the difference in pain relief was 6% (95% CI 7, 20%) and at 8 weeks the difference was 13% (95% CI 3, 28%). Neither was there any significant difference in the duration of pain relief, the number of new painful sites and the need for reirradiation and toxicity was minor. CONCLUSION: The present randomized study showed that a single fraction of 8 Gy was as effective as 5 Gy x4 in relieving pain from bone metastasis.","Radiother Oncol, 47(3): 233-240","Denmark",1998,"Metastatic","Radiotherapy","VAS","Patient",null,"Clinical trial","Denmark","Patient","Metastatic","Radiotherapy",null,"Clinical trial","VAS","1960:1999","Symptom"]
[501,"Nilsen, T. S., et al. (2015). \"Effects of strength training on body composition, physical functioning, and quality of life in prostate cancer patients during androgen deprivation therapy.\" Acta Oncol 54(10): 1805-1813.",null,"Nilsen, T. S., et al.","Effects of strength training on body composition, physical functioning, and quality of life in prostate cancer patients during androgen deprivation therapy","BACKGROUND: Androgen deprivation therapy (ADT) increases survival rates in prostate cancer (PCa) patients with locally advanced disease, but is associated with side effects that may impair daily function. Strength training may counteract several side effects of ADT, such as changes in body composition and physical functioning, which in turn may affect health-related quality of life (HRQOL). However, additional randomised controlled trials are needed to expand this knowledge. MATERIAL AND METHODS: Fifty-eight PCa patients on ADT were randomised to either 16 weeks of high-load strength training (n = 28) or usual care (n = 30). The primary outcome was change in total lean body mass (LBM) assessed by dual x-ray absorptiometry (DXA). Secondary outcomes were changes in regional LBM, fat mass, and areal bone mineral density (aBMD) measured by DXA; physical functioning assessed by 1-repetition maximum (1RM) tests, sit-to-stand test, stair climbing test and Shuttle walk test; and HRQOL as measured by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30. RESULTS AND CONCLUSION: No statistically significant effect of high-load strength training was demonstrated on total LBM (p = 0.16), but significant effects were found on LBM in the lower and upper extremities (0.49 kg, p < 0.01 and 0.15 kg, p < 0.05, respectively). Compared to usual care, high-load strength training showed no effect on fat mass, aBMD or HRQOL, but beneficial effects were observed in all 1RM tests, sit-to-stand test and stair climbing tests. Adherence to the training program was 88% for lower body exercises and 84% for upper body exercises. In summary, high-load strength training improved LBM in extremities and physical functioning, but had no effect on fat mass, aBMD, or HRQOL in PCa patients on ADT.","Acta Oncol, 54(10): 1805-1813","Norway,Canada",2015,"Advanced","Various,Hormonal","EORTC QLQ-C30","Patient",null,"Clinical trial","Norway,Canada","Patient","Advanced","Various,Hormonal",null,"Clinical trial","EORTC QLQ-C30","2015:2018","General"]
[502,"Nilssen, S. R., et al. (2012). \"Does physiotherapist-guided pelvic floor muscle training increase the quality of life in patients after radical prostatectomy? A randomized clinical study.\" Scand J Urol Nephrol 46(6): 397-404.",null,"Nilssen, S. R., et al.","Does physiotherapist-guided pelvic floor muscle training increase the quality of life in patients after radical prostatectomy? A randomized clinical study","OBJECTIVE: The aim of this study was to study the effect of postoperative physiotherapist-guided pelvic floor muscle training (PFMT) on health-related quality of life (HRQoL) parameters in patients treated with radical prostatectomy (RP). MATERIAL AND METHODS: A prospective randomized controlled trial was conducted at St. Olavs Hospital, Trondheim University Hospital, Norway. Eighty-five men were randomized into two intervention groups (A and B). patients in group A (n = 42) were offered physiotherapist-guided PFMT (in groups or by DVD) once weekly throughout the first 12 months after RP, while those in group B (n = 43) trained on their own. HRQoL data were assessed using the University of California, Los Angeles Prostate Cancer Index (UCLA-PCI) and the Short Form-12 (SF-12) health survey. The physical component summary (PCS) and mental component summary (MCS) scores of the SF-12 plus the urinary, sexual and bowel function and bother of the UCLA-PCI make up the eight quality of life outcomes used in this study. Data were obtained preoperatively (baseline), 6 weeks, and 3, 6 and 12 months postoperatively. RESULTS: Eighty patients completed at least one follow-up assessment, 38 in group A and 42 in group B, giving a dropout rate of 5.9%. The overall response rates were 96% at baseline, 83% at 6 weeks, 90% at 3 months, 88% at 6 months and 68% at 12 months. No statistically significant difference in HRQoL was found between groups A and B. CONCLUSIONS: Even though physiotherapist-guided training of the pelvic floor muscles after RP improved postoperative urinary incontinence significantly compared to those patients receiving standard care/training, this was not reflected in better outcome in HRQoL parameters.","Scand J Urol Nephrol, 46(6): 397-404","Norway",2012,"Any or unknown","Surgery,Various","SF-12,UCLA-PCI","Patient",null,"Clinical trial","Norway","Patient","Any or unknown","Surgery,Various",null,"Clinical trial","SF-12,UCLA-PCI","2010:2014","Disease,Utility"]
[503,"Nilsson, S., et al. (2016). \"Patient-reported quality-of-life analysis of radium-223 dichloride from the phase III ALSYMPCA study.\" Ann Oncol 27(5): 868-874.",null,"Nilsson, S., et al.","Patient-reported quality-of-life analysis of radium-223 dichloride from the phase III ALSYMPCA study","BACKGROUND: Radium-223 dichloride (radium-223), a first-in-class alpha-emitting radiopharmaceutical, is recommended in both pre- and post-docetaxel settings in patients with castration-resistant prostate cancer (CRPC) and symptomatic bone metastases based on overall survival benefit demonstrated in the phase III ALSYMPCA study. ALSYMPCA included prospective measurements of health-related quality of life (QOL) using two validated instruments: the general EuroQoL 5D (EQ-5D) and the disease-specific Functional Assessment of Cancer Therapy-Prostate (FACT-P). PATIENTS AND METHODS: Analyses were conducted to determine treatment effects of radium-223 plus standard of care (SOC) versus placebo plus SOC on QOL using FACT-P and EQ-5D. Outcomes assessed were percentage of patients experiencing improvement, percentage of patients experiencing worsening, and mean QOL scores during the study. RESULTS: Analyses were carried out on the intent-to-treat population of patients randomized to receive radium-223 (n = 614) or placebo (n = 307). The mean baseline EQ-5D utility and FACT-P total scores were similar between treatment groups. A significantly higher percentage of patients receiving radium-223 experienced meaningful improvement in EQ-5D utility score on treatment versus placebo {29.2% versus 18.5%, respectively; P = 0.004; odds ratio (OR) = 1.82 [95% confidence interval (CI) 1.21-2.74]}. Findings were similar for FACT-P total score [24.6% versus 16.1%, respectively; P = 0.020; OR = 1.70 (95% CI 1.08-2.65)]. A lower percentage of patients receiving radium-223 experienced meaningful worsening versus placebo measured by EQ-5D utility score and FACT-P total score. Prior docetaxel use and current bisphosphonate use did not affect these findings. Treatment was a significant predictor of EQ-5D utility score, with radium-223 associated with higher scores versus placebo (0.56 versus 0.50, respectively; P = 0.002). Findings were similar for FACT-P total score (99.08 versus 95.22, respectively; P = 0.004). CONCLUSIONS: QOL data from ALSYMPCA demonstrated that improved survival with radium-223 is accompanied by significant QOL benefits, including a higher percentage of patients with meaningful QOL improvement and a slower decline in QOL over time in patients with CRPC.","Ann Oncol, 27(5): 868-874","USA,UK",2016,"Metastatic","Radiotherapy","FACT-P,EQ-5D","Patient",null,"Clinical trial","USA,UK","Patient","Metastatic","Radiotherapy",null,"Clinical trial","FACT-P,EQ-5D","2015:2018","Disease,Utility"]
[504,"Nishiyama, T., et al. (2004). \"Influence of hot flashes on quality of life in patients with prostate cancer treated with androgen deprivation therapy.\" Int J Urol 11(9): 735-741.",null,"Nishiyama, T., et al.","Influence of hot flashes on quality of life in patients with prostate cancer treated with androgen deprivation therapy","BACKGROUND: We surveyed patients with prostate cancer treated with androgen deprivation therapy to examine the influence of hot flashes on quality of life (QOL). METHODS: Fifty-five outpatients with prostate cancer (M0, 39; M1, 16) treated with androgen deprivation therapy (castration, 15; castration and antiandrogen, 40) were enrolled in this study. Mean duration of androgen deprivation therapy was 21 months (2-91 months). The patients were still being treated with androgen deprivation therapy at the time of the survey. The functional assessment of cancer therapy (FACT) was used as a QOL questionnaire for outpatients with prostate cancer treated with androgen deprivation therapy. Hot flash assessments were used to document the number and severity (mild, moderate, and severe) of daily hot flashes. The patients prescribed fluvoxamine maleate were reassessed for hot flashes 2 weeks after the prescription. RESULTS: Thirty-two of the 55 patients (58.2%) suffered from hot flashes. Hot flashes deteriorated the physical well-being subscale of QOL in patients with prostate cancer treated with androgen deprivation therapy (P = 0.043). There was a significant relationship between the desire to be treated for hot flashes and the hot flash assessments (P = 0.038). Fluvoxamine maleate was significantly effective in reducing hot flashes (P = 0.001). CONCLUSIONS: Hot flashes had adverse effects on the patients' physical status and deteriorated the patients' QOL. New treatment options such as fluvoxamine maleate might help simplify the often difficult management of hot flashes in patients with prostate cancer treated with androgen deprivation therapy.","Int J Urol, 11(9): 735-741","Japan",2004,"Any or unknown","Hormonal,Surgery","FACT-G","Patient",null,"Cross-sectional","Japan","Patient","Any or unknown","Hormonal,Surgery",null,"Cross-sectional","FACT-G","2000:2004","Treatment"]
[505,"Noale, M., et al. (2017). \"Pros-IT CNR: an Italian prostate cancer monitoring project.\" Aging Clin Exp Res 29(2): 165-172.",null,"Noale, M., et al.","Pros-IT CNR: an Italian prostate cancer monitoring project","AIMS: The Pros-IT CNR project aims to monitor a sample of Italian males >/=18 years of age who have been diagnosed in the participating centers with incident prostate cancer, by analyzing their clinical features, treatment protocols and outcome results in relation to quality of life. METHODS: Pros-IT CNR is an observational, prospective, multicenter study. The National Research Council (CNR), Neuroscience Institute, Aging Branch (Padua) is the promoting center. Ninety-seven Italian centers located throughout Italy were involved. The field study began in September 1, 2014. Subjects eligible were diagnosed with biopsy-verified prostate cancer, naive. A sample size of 1500 patients was contemplated. A baseline assessment including anamnestic data, clinical history, risk factors, the initial diagnosis, cancer staging information and quality of life (Italian UCLA Prostate Cancer Index; SF-12 Scale) was completed. Six months after the initial diagnosis, a second assessment evaluating the patient's health status, the treatment carried out, and the quality of life will be made. A third assessment, evaluating the treatment follow-up and the quality of life, will be made 12 months after the initial diagnosis. The 4th, 5th, 6th and 7th assessments, similar to the third, will be completed 24, 36, 48 and 60 months after the initial diagnosis, respectively, and will include also a Food Frequency Questionnaire and the Physical Activity Scale for the Elderly. DISCUSSION: The study will provide information on patients' quality of life and its variations over time in relation to the treatments received for the prostate cancer.","Aging Clin Exp Res, 29(2): 165-172","Italy",2017,"Any or unknown","None","UCLA-PCI,SF-12","Patient",null,"Protocol","Italy","Patient","Any or unknown","None",null,"Protocol","UCLA-PCI,SF-12","2015:2018","Disease,Utility"]
[506,"Noguchi, M., et al. (2004). \"Early catheter removal 3 days after radical retropubic prostatectomy.\" Int J Urol 11(11): 983-988.",null,"Noguchi, M., et al.","Early catheter removal 3 days after radical retropubic prostatectomy","AIM: We investigated the feasibility and safety of the early removal of urethral catheters 3 days after radical retropubic prostatectomy. METHODS: Seventy consecutive patients underwent radical retropubic prostatectomy with the intent of early catheter removal on postoperative day (POD) 3. Catheter removal was based on postoperative cystograms performed on POD 2. Patients were analyzed using a validated prostate cancer specific questionnaire (University of California, Los Angeles Prostate Cancer Symptom Index) to determine quality of life outcomes. Multiple logistic regression analysis was also used to evaluate if any of the preoperative or intraoperative parameters were able to predict the success of early catheter removal after radical retropubic prostatectomy. RESULTS: The catheter was removed on POD 3 in 67 of 70 patients (97%) excluding three patients with moderate or severe extravasation on postoperative cystograms. Of the 67 patients, 53 (76%) were successful in early catheter removal, but the remaining 14 (24%) patients experienced urinary retention within 48 h and were treated with simple catheter replacement for 1 or 2 days. Two patients developed anastomotic strictures 3 and 4 months postoperatively, which were managed by dilation alone. Multiple logistic regression analysis showed that no leak during an intraoperative leak test was the only independent predictor of success for early catheter removal (P = 0.0069; odds ratio, 6.667; 95% confidence interval, 1.682-26.428). CONCLUSION: The present study revealed that early catheter removal 3 days after radical retropubic prostatectomy is feasible in patients who show a negative intraoperative leak test. Postoperative monitoring of more patients is needed to determine if the early catheter removal is widely applicable.","Int J Urol, 11(11): 983-988","Japan",2004,"Any or unknown","Surgery","UCLA-PCI","Patient",null,"Clinical trial","Japan","Patient","Any or unknown","Surgery",null,"Clinical trial","UCLA-PCI","2000:2004","Disease"]
[507,"Noldus, J., et al. (2002). \"Patient-reported sexual function after nerve-sparing radical retropubic prostatectomy.\" Eur Urol 42(2): 118-124.",null,"Noldus, J., et al.","Patient-reported sexual function after nerve-sparing radical retropubic prostatectomy","OBJECTIVE: Improved selection criteria have lead to an increasing number of nerve-sparing radical retropubic prostatectomies (RRP) in patients with clinically localised prostate cancer (PCA). Patient questionnaire based outcome analysis on post-operative erectile function after uni- or bilateral nerve-sparing RRP is described. METHODS: Between January 1992 and March 1999, 366 patients (mean age 62.5 years) underwent uni- or bilateral nerve-sparing RRP at our institution. Indication for nerve-sparing procedure was based on the results of a multivariate classification and regression tree analysis (CART). For evaluation of post-operative patient-reported rates of sexual and erectile function non-validated and validated questionnaires (IIEF 5) were administered after a follow-up of 12 months. Data of five operation periods were analysed. RESULTS: The unilateral procedure resulted in rates of 13-29% of erections sufficient for unassisted intercourse. Some degree of tumescence was reported by 37-73% of the remaining patients. Bilateral nerve-sparing procedures were almost exclusively performed in periods 3-5, only four patients of period 2 received the bilateral procedure. Here, rates of erections sufficient for intercourse were 25% (period 2), 61% (period 3), 50% (period 4), and 52% (period 5), respectively. Patients with grades 4 and 5 erections had IIEF scores of 19.2 and 20.2 and patients without rigidity or tumescence had scores of 5.7 and 7.0 after uni- and bilateral nerve-sparing procedure, respectively. Patients <60 years of age had better erections than those > or =60 (unilateral: 19% versus 13%, bilateral 45% versus 38%). CONCLUSION: Compared to a unilateral nerve-sparing procedure, the bilateral nerve-sparing technique revealed much better results inasmuch as about 50% of the patients reported recovery of erections sufficient for sexual intercourse without use of sexual aids.","Eur Urol, 42(2): 118-124","Germany",2002,"Local","Surgery","IIEF-5","Patient",null,"Cross-sectional","Germany","Patient","Local","Surgery",null,"Cross-sectional","IIEF-5","2000:2004","Complication"]
[508,"Norkus, D., et al. (2013). \"A randomized hypofractionation dose escalation trial for high risk prostate cancer patients: interim analysis of acute toxicity and quality of life in 124 patients.\" Radiat Oncol 8: 206.",null,"Norkus, D., et al.","A randomized hypofractionation dose escalation trial for high risk prostate cancer patients: interim analysis of acute toxicity and quality of life in 124 patients","BACKGROUND: The alpha/beta ratio for prostate cancer is postulated being in the range of 0.8 to 2.2 Gy, giving rise to the hypothesis that there may be a therapeutic advantage to hypofractionation. To do so, we carried out a randomized trial comparing hypofractionated and conventionally fractionated image-guided intensity modulated radiotherapy (IG-IMRT) in high-risk prostate cancer. Here, we report on acute toxicity and quality of life (QOL) for the first 124 randomized patients. METHODS: The trial compares 76 Gy in 38 fractions (5 fractions/week) (Arm 1) to 63 Gy in 20 fractions (4 fractions/week) (Arm 2) (IG-IMRT). Prophylactic pelvic lymph node irradiation with 46 Gy in 23 fractions sequentially (Arm 1) and 44 Gy in 20 fractions simultaneously (Arm 2) was applied. All patients had long term androgen deprivation therapy (ADT) started before RT. Both physician-rated acute toxicity and patient-reported QOL using EPIC questionnaire are described. RESULTS: There were no differences in overall maximum acute gastrointestinal (GI) or genitourinary (GU) toxicity. Compared to conventional fractionation (Arm 1), GI and GU toxicity both developed significantly earlier but also disappeared earlier in the Arm 2, reaching significant differences from Arm 1 at week 8 and 9. In multivariate analyses, only parameter shown to be related to increased acute Grade >/=1 GU toxicity was the study Arm 2 (p = 0.049). There were no statistically significant differences of mean EPIC scores in any domain and sub-scales. The clinically relevant decrease (CRD) in EPIC urinary domain was significantly higher in Arm 2 at month 1 with a faster recovery at month 3 as compared to Arm 1. CONCLUSIONS: Hypofractionation at 3.15 Gy per fraction to 63 Gy within 5 weeks was well tolerated. The GI and GU physician-rated acute toxicity both developed earlier but recovered faster using hypofractionation. There was a correlation between acute toxicity and bowel and urinary QOL outcomes. Longer follow-up is needed to determine the significance of these associations with late toxicity.","Radiat Oncol, 8(206","Lithuania",2013,"Any or unknown","Radiotherapy,Hormonal","EPIC","HCP,Patient",null,"Clinical trial","Lithuania","HCP,Patient","Any or unknown","Radiotherapy,Hormonal",null,"Clinical trial","EPIC","2010:2014","Disease,Treatment"]
[509,"Nussbaum, N., et al. (2016). \"Patient experience in the treatment of metastatic castration-resistant prostate cancer: state of the science.\" Prostate Cancer Prostatic Dis 19(2): 111-121.",null,"Nussbaum, N., et al.","Patient experience in the treatment of metastatic castration-resistant prostate cancer: state of the science","BACKGROUND: Contemporary therapies for metastatic castration-resistant prostate cancer (mCRPC) have shown survival improvements, which do not account for patient experience and health-related quality of life (HRQoL). METHODS: This literature review included a search of MEDLINE for randomized clinical trials enrolling 50 patients with mCRPC and reporting on patient-reported outcomes (PROs) since 2010. RESULTS: Nineteen of 25 publications describing seven treatment regimens (10 clinical trials and nine associated secondary analyses) met the inclusion criteria and were critically appraised. The most commonly used measures were the Functional Assessment of Cancer Therapy-Prostate (n=5 trials) and Brief Pain Inventory Short Form (n=4 trials) questionnaires. The published data indicated that HRQoL and pain status augmented the clinical efficacy data by providing a better understanding of treatment impact in mCRPC. Abiraterone acetate and prednisone, enzalutamide, radium-223 dichloride and sipuleucel-T offered varying levels of HRQoL benefit and/or pain mitigation versus their respective comparators, whereas three treatments (mitoxantrone, estramustine phosphate and docetaxel, and cabazitaxel) had no meaningful impact on HRQoL or pain. The main limitation of the data were that the PROs utilized were not developed for use in mCRPC patients and hence may not have comprehensively captured symptoms important to this population. CONCLUSIONS: Recently published randomized clinical trials of new agents for mCRPC have captured elements of the patient experience while on treatment. Further research is required to standardize methods for measuring, quantifying and reporting on HRQoL and pain in patients with mCRPC in the clinical practice setting.","Prostate Cancer Prostatic Dis, 19(2): 111-121","International",2016,"Metastatic","Taxane,Chemotherapy,Brachytherapy,Abiraterone","FACT-P,BPI","Patient",null,"Systematic review","International","Patient","Metastatic","Taxane,Chemotherapy,Brachytherapy,Abiraterone",null,"Systematic review","FACT-P,BPI","2015:2018","Disease,Symptom"]
[510,"Nyarangi-Dix, J. N., et al. (2013). \"Impact of complete bladder neck preservation on urinary continence, quality of life and surgical margins after radical prostatectomy: a randomized, controlled, single blind trial.\" J Urol 189(3): 891-898.",null,"Nyarangi-Dix, J. N., et al.","Impact of complete bladder neck preservation on urinary continence, quality of life and surgical margins after radical prostatectomy: a randomized, controlled, single blind trial","PURPOSE: We investigated the influence of bladder neck preservation on urinary continence, quality of life and surgical margins after radical prostatectomy. MATERIALS AND METHODS: A total of 208 men who presented for radical prostatectomy were randomized to complete bladder neck preservation with subsequent urethro-urethral anastomosis or to no preservation as controls. Patients with failed bladder neck preservation were not included in study. We documented objective continence by the 24-hour pad test, social continence by the number of pads per day and quality of life outcomes by the validated Incontinence Quality of Life questionnaire in a single blind setting. Cancer resection was assessed by surgical margin status. RESULTS: At 0, 3, 6 and 12 months mean urine loss in the control vs the bladder neck preservation group was 713.3 vs 237.0, 49.6 vs 15.6, 44.4 vs 5.5 and 25.4 vs 3.1 gm, respectively (each p <0.001). At 3, 6 and 12 months in the control vs the preservation group the social continence rate was 55.3% vs 84.2% (p <0.001), 74.8% vs 89.5% (p = 0.05) and 81.4% vs 94.7% (p = 0.027), and the quality of life score was 80.4 vs 90.3 (p <0.001), 85.4 vs 91.7 (p = 0.016) and 86.0 vs 93.8 (p = 0.001), respectively. We noted significantly less urine loss, higher objective and social continence rates, and higher quality of life scores after complete bladder neck preservation at all followup points. On multiple logistic regression analysis complete bladder neck preservation was an independent positive predictor of continence. No significant difference was found in surgical margin status between the control and bladder neck preservation groups (12.5% vs 14.7%, p = 0.65). CONCLUSIONS: In what is to our knowledge the first prospective, randomized, controlled, single blind trial complete bladder neck preservation during radical prostatectomy was associated with a significantly higher urinary continence rate and increased patient satisfaction without compromising resection margins.","J Urol, 189(3): 891-898","Germany",2013,"Any or unknown","Surgery","I-QoL","Patient",null,"Clinical trial","Germany","Patient","Any or unknown","Surgery",null,"Clinical trial","I-QoL","2010:2014","Complication"]
[511,"Nygard, R., et al. (2001). \"Goserelin (Zoladex) or orchiectomy in metastatic prostate cancer? A quality of life and cost-effectiveness analysis.\" Anticancer Res 21(1b): 781-788.",null,"Nygard, R., et al.","Goserelin (Zoladex) or orchiectomy in metastatic prostate cancer? A quality of life and cost-effectiveness analysis","BACKGROUND: We have today two treatment alternatives (orchiectomy or LHRH-analogue) in metastatic prostate cancer offering the same expectations of survival. This study documents the quality of life (QoL) and cost-effectiveness of these alternatives. PATIENTS AND METHODS: 65 consecutive patients treated at the University Hospital of Tromso (UHT), Norway, between 1994 and 1999 were registered. At evaluation, 45 patients (LHRH-analogue--15 patients, orchiectomy--30 patients) were alive and included in the QoL-study (EORTC QLQ C-30, QoL 15D). 45 patients were followed-up at the UHT and included in the cost-analysis. Costs were calculated for a 36-month interval and converted to British pounds (1 Pound = 13 NOK). A 5% d.r. was employed. RESULTS: The mean QoL (15D) was 76.4 (orchiectomy) and 72 (LHRH) (0-100 scale). Constipation, urinating problems, fatigue, pain and loss of sexual functioning were the dominant symptoms. The treatment costs per patient treated were 8,895 Pounds (orchiectomy) and 10,937 Pounds (LHRH-analogue). The crossover in cost was located at 25 months. A sensitivity analysis varying discount rate (0-10%), drug charges (25-50% off) and treatment time (12-18 months) did not alter the conclusion. CONCLUSION: Orchiectomy is the treatment of choice when life expectancy is more than two years.","Anticancer Res, 21(1b): 781-788","Norway",2001,"Metastatic","Hormonal,Surgery","EORTC QLQ-C30,15D","Patient",null,"Economic model","Norway","Patient","Metastatic","Hormonal,Surgery",null,"Economic model","EORTC QLQ-C30,15D","2000:2004","General,Utility"]
[512,"O'Callaghan, M. E., et al. (2017). \"Patient-Reported Outcomes After Radiation Therapy in Men With Prostate Cancer: A Systematic Review of Prognostic Tool Accuracy and Validity.\" Int J Radiat Oncol Biol Phys 98(2): 318-337.",null,"O'Callaghan, M. E., et al.","Patient-Reported Outcomes After Radiation Therapy in Men With Prostate Cancer: A Systematic Review of Prognostic Tool Accuracy and Validity","PURPOSE: To identify, through a systematic review, all validated tools used for the prediction of patient-reported outcome measures (PROMs) in patients being treated with radiation therapy for prostate cancer, and provide a comparative summary of accuracy and generalizability. METHODS AND MATERIALS: PubMed and EMBASE were searched from July 2007. Title/abstract screening, full text review, and critical appraisal were undertaken by 2 reviewers, whereas data extraction was performed by a single reviewer. Eligible articles had to provide a summary measure of accuracy and undertake internal or external validation. Tools were recommended for clinical implementation if they had been externally validated and found to have accuracy >/=70%. RESULTS: The search strategy identified 3839 potential studies, of which 236 progressed to full text review and 22 were included. From these studies, 50 tools predicted gastrointestinal/rectal symptoms, 29 tools predicted genitourinary symptoms, 4 tools predicted erectile dysfunction, and no tools predicted quality of life. For patients treated with external beam radiation therapy, 3 tools could be recommended for the prediction of rectal toxicity, gastrointestinal toxicity, and erectile dysfunction. For patients treated with brachytherapy, 2 tools could be recommended for the prediction of urinary retention and erectile dysfunction. CONCLUSIONS: A large number of tools for the prediction of PROMs in prostate cancer patients treated with radiation therapy have been developed. Only a small minority are accurate and have been shown to be generalizable through external validation. This review provides an accessible catalogue of tools that are ready for clinical implementation as well as which should be prioritized for validation.","Int J Radiat Oncol Biol Phys, 98(2): 318-337","International",2017,"Any or unknown","Radiotherapy","Unclear","Patient",null,"Systematic review,Validation","International","Patient","Any or unknown","Radiotherapy",null,"Systematic review,Validation","Unclear","2015:2018","Complication"]
[513,"Oefelein, M. (2003). \"Health related quality of life using serum testosterone as the trigger to re-dose long acting depot luteinizing hormone-releasing hormone agonists in patients with prostate cancer.\" J Urol 169(1): 251-255.",null,"Oefelein, M.","Health related quality of life using serum testosterone as the trigger to re-dose long acting depot luteinizing hormone-releasing hormone agonists in patients with prostate cancer","PURPOSE: Health related quality of life was assessed in patients with prostate cancer on androgen suppression therapy re-dosed based on serum testosterone, and observations were confirmed regarding the safety, efficacy and cost per patient treated with this method of re-dosing luteinizing hormone-releasing hormone agonists. MATERIALS AND METHODS: The study comprised 22 patients with prostate cancer prospectively enrolled in a control-crossover designed trial of dosing depot luteinizing hormone-releasing hormone agonist based on serum testosterone. Health related quality of life using the Expanded Prostate Index Composite and SF-36 instruments was the primary outcome assessed. RESULTS: Median duration of castrate testosterone was 5.5 months (range 3.5 to 10). Longer durations of castrate testosterone significantly correlated with lower pretreatment serum testosterone and smaller body mass index. No significant change from nadir prostate specific antigen was observed during castrate duration. The yearly cost of care was significantly decreased using the method of re-dosing based on serum testosterone ($3,567.90 versus $7,135.80). Short-term overall health related quality of life and patient satisfaction were significantly improved over baseline measurements. However, by study completion overall health related quality of life was equivalent regardless of the dosing method. CONCLUSIONS: Patient assessed health related quality of life improved in the short term and the cost of care decreased with no loss in the quality of care or patient satisfaction using serum testosterone as the trigger to re-dose 10.8 mg. goserelin in patients with prostate cancer on androgen suppression therapy.","J Urol, 169(1): 251-255","USA",2003,"Any or unknown","Hormonal","SF-36,EPIC","Patient",null,"Clinical trial","USA","Patient","Any or unknown","Hormonal",null,"Clinical trial","SF-36,EPIC","2000:2004","Disease,Utility"]
[514,"Oefelein, M. G. (2004). \"Prospective predictors of urinary continence after anatomical radical retropubic prostatectomy: a multivariate analysis.\" World J Urol 22(4): 267-271.",null,"Oefelein, M. G.","Prospective predictors of urinary continence after anatomical radical retropubic prostatectomy: a multivariate analysis","The aim of this work was to evaluate variables that predict time to pad-free urinary continence after anatomical radical prostatectomy (ARP). Sixty consecutive prostate cancer patients who underwent ARP by one surgeon were studied. Pad-free urinary continence was prospectively determined by patient interviews and confirmed on physical examination and by the urinary domain of the Extended Prostate Inventory Composite (EPIC) Health Related Quality of Life questionnaire. A time-dependent Cox multivariate regression analysis was performed to determine which variables significantly correlated with time to pad-free urinary continence. Increasing prostate size (cc), increasing prostate urethral length (cm) and surgical technique (wide excision of the neuro-vascular bundle) correlated with a significantly (P<0.05) prolonged time to achieve pad-free urinary continence. In conclusion, prostate size and surgical technique were the most useful variables in predicting time to pad-free urinary continence after ARP.","World J Urol, 22(4): 267-271","USA",2004,"Any or unknown","Surgery","EPIC","Patient",null,"Cohort","USA","Patient","Any or unknown","Surgery",null,"Cohort","EPIC","2000:2004","Disease"]
[515,"Okihara, K., et al. (2012). \"Quantitative evaluation of lower urinary tract symptoms using a visual analog scale in men undergoing permanent brachytherapy.\" Brachytherapy 11(4): 265-270.",null,"Okihara, K., et al.","Quantitative evaluation of lower urinary tract symptoms using a visual analog scale in men undergoing permanent brachytherapy","PURPOSE: A previous study showed that a visual analog scale (VAS) that measures quality of life (QOL) in relation to each of the seven items on the International Prostate Symptom Score (IPSS) was found to be significantly more able to identify a patient's chief complaint. The aim of this study was to assess the two questionnaires with special reference to the symptom that the patient most wants treated via the concomitant use of the IPSS and VAS after permanent brachytherapy (PBT). METHODS AND MATERIALS: A total of 156 men undergoing PBT were enrolled. The IPSS and VAS were evaluated at the preimplantation stage and at 1-3 months, 6-9 months, and 1 year after PBT. The correlations between the IPSS-QOL score and the total for the 14 symptoms questions included in the IPSS and VAS were statistically calculated. Multivariate analysis was used to investigate which factors could be used to predict the IPSS-QOL after PBT. RESULTS: The correlation coefficients between the IPSS-QOL score and the seven questions on the VAS were higher than those between the IPSS-QOL and the seven questions on the IPSS. Multivariate analysis showed that the strongest factor for determining IPSS-QOL at each time point was nocturia on the VAS. CONCLUSIONS: The VAS scale reflected the change in the patients' QOL more precisely than the IPSS, which examines the frequency of lower urinary tract symptoms. Nocturia plays a key role in determining QOL. VAS could be a promising tool for assessing satisfaction in patients with lower urinary tract symptoms after PBT.","Brachytherapy, 11(4): 265-270","Japan",2012,"Any or unknown","Brachytherapy","VAS,IPSS","Patient",null,"Validation","Japan","Patient","Any or unknown","Brachytherapy",null,"Validation","VAS,IPSS","2010:2014","Disease"]
[516,"O'Leary, E., et al. (2015). \"Psychometric evaluation of the EORTC QLQ-PR25 questionnaire in assessing health-related quality of life in prostate cancer survivors: a curate's egg.\" Qual Life Res 24(9): 2219-2230.",null,"O'Leary, E., et al.","Psychometric evaluation of the EORTC QLQ-PR25 questionnaire in assessing health-related quality of life in prostate cancer survivors: a curate's egg","PURPOSE: The EORTC QLQ-PR25 was primarily developed to measure disease-specific health-related quality of life (HRQoL) of prostate cancer (PCa) patients undergoing active treatment. The growing number of cancer survivors has focussed interest on assessing survivors' HRQoL. We evaluated psychometric properties of the EORTC QLQ-PR25 questionnaire amongst PCa survivors. METHODS: A postal questionnaire, including the QLQ-PR25, was administered to 6559 PCa survivors 2-18 years post-diagnosis, identified through population-based cancer registries in Ireland; 3348 participated. The QLQ-PR25 has been suggested to have five multi-item subscales measuring urinary (US), bowel (BS) and hormone treatment-related symptoms (TS), sexual activity (SA) and sexual functioning (SF), and a single item measuring bother due to using incontinence aids (IA). Reliability analysis, divergent validity, discriminant validity (compared to EORTC QLQ-C30, DASS-21 and EuroQoL EQ-5D-5L), and exploratory and confirmatory factor analysis (EFA, CFA) were undertaken. RESULTS: The percentage of survivors completing QLQ-PR25 subscales was: US-79 %; IA-20 %; BS-83 %; TS-86 %; SA-87 %; and SF-26 %. Reliability was acceptable (Cronbach's alpha > 0.7) for three subscales (US, SA, SF). The instrument discriminated well between clinically distinct groups, especially those defined by primary treatment(s) and stage at diagnosis. The SA and SF subscales showed good discriminant validity compared to QLQ-C30, DASS-21 and EQ-5D-5L; other subscales did not. EFA reproduced a near fit to the proposed factor structure. CFA confirmed this. CONCLUSION: This is the largest ever QLQ-PR25 validation study. When used in PCa survivors, although the proposed factor structure was confirmed, some of the subscales (e.g. BS and TS) showed poor reliability, a lack of discriminant validity and moderate levels of item non-response.","Qual Life Res, 24(9): 2219-2230","Ireland",2015,"Survivors","None","EORTC QLQ-PR25,EORTC QLQ-C30,EQ-5D,DASS-21","Patient",null,"Validation","Ireland","Patient","Survivors","None",null,"Validation","EORTC QLQ-PR25,EORTC QLQ-C30,EQ-5D,DASS-21","2015:2018","Disease,General,Comorbidity"]
[517,"Organ, M., et al. (2013). \"Intermittent LHRH therapy in the management of castrate-resistant prostate cancer (CRPCa): results of a multi-institutional randomized prospective clinical trial.\" Am J Clin Oncol 36(6): 601-605.",null,"Organ, M., et al.","Intermittent LHRH therapy in the management of castrate-resistant prostate cancer (CRPCa): results of a multi-institutional randomized prospective clinical trial","BACKGROUND: Patients who develop castration-resistant prostate cancer (CRPCa) typically continue on androgen deprivation therapy (ADT). Whether these patients need to remain on ADT has not been well studied. We conducted a multicenter randomized trial to compare an intermittent versus continuous approach to ADT in CRPCa patients. Overall survival, health-related quality of life (QOL), and cost were the main endpoints. METHODS: CRPCa patients were randomized 2:1 to intermittent or continuous luteinizing hormone-releasing hormone agonists (LHRHa). Patients were followed with clinical assessments, laboratory investigations, and QOL questionnaires (EORTC QLQ-C30 or PROSQOLI) every 2 months. If the serum testosterone rose above castrate levels (1.75 nmol/L), LHRHa were reinitiated. The study was designed to close if >50% of patients needed to restart ADT in the intermittent arm. RESULTS: Thirty-one patients were followed with a median follow-up of 26.8 months-18 in the intermittent arm and 13 in the continuous. Twelve of 18 patients on the intermittent arm were reinitiated on LHRHa at a median time of 17.9 months. There was no difference in overall or cancer-specific survival between the 2 arms. There was no statistically significant difference in QOL between the 2 arms at 0 and 12 months. The total mean costs at 24 months were significantly lower in the intermittent arm ($3135 vs. $8253 Canadian dollars, P=0.0167) compared with the continuous. The main limitation of this study is the small sample size. CONCLUSIONS: We have observed that intermittent ADT in patients with CRPCa, using a testosterone of >1.75 ngmol/L as a trigger to reinitiate LHRHa, results in a substantial cost savings with no negative impact on oncologic and QOL outcomes.","Am J Clin Oncol, 36(6): 601-605","Canada",2013,"Any or unknown","Hormonal","EORTC QLQ-C30,PROSQOLI","Patient",null,"Clinical trial","Canada","Patient","Any or unknown","Hormonal",null,"Clinical trial","EORTC QLQ-C30,PROSQoLI","2010:2014","Disease,General"]
[518,"O'Shaughnessy, P. K., et al. (2013). \"Differences in self-reported outcomes of open prostatectomy patients and robotic prostatectomy patients in an international web-based survey.\" Eur J Oncol Nurs 17(6): 775-780.",null,"O'Shaughnessy, P. K., et al.","Differences in self-reported outcomes of open prostatectomy patients and robotic prostatectomy patients in an international web-based survey","OBJECTIVES: To compare patient reported outcomes between robotic assisted surgery and non-robotic assisted surgery. METHODS: This was an international web-based survey based on a qualitative research and literature review, an internet-based questionnaire was developed with approximately 70 items. The questionnaire included both closed and open-ended questions. RESULTS: Responses were received from 193 men of whom 86 had received either open (OP) or robotic (RALP) surgery. A statistically significant (p=0.027), ranked analysis of covariance was found demonstrating higher recent distress in the robotic (RALP) surgery group. Although not statistically significant, there was a pattern of men having robotic (RALP) surgery reporting fewer urinary and bowel problems, but having a greater rate of sexual dysfunction. CONCLUSIONS: Men who opt for robotic surgery may have higher expectations for robotic (RALP) surgery, when these expectations are not fully met they may be less likely to accept the consequences of this major cancer surgery. Information regarding surgical choice needs to be tailored to ensure that men diagnosed with prostate cancer are fully informed of not only short term surgical and physical outcomes such as erectile dysfunction and incontinence, but also of potential issues with regards to masculinity, lifestyle and sexual health.","Eur J Oncol Nurs, 17(6): 775-780","Australia",2013,"Any or unknown","Surgery","Unclear","Patient",null,"Cross-sectional","Australia","Patient","Any or unknown","Surgery",null,"Cross-sectional","Unclear","2010:2014","Complication"]
[519,"Osoba, D., et al. (1999). \"Health-related quality of life in men with metastatic prostate cancer treated with prednisone alone or mitoxantrone and prednisone.\" J Clin Oncol 17(6): 1654-1663.",null,"Osoba, D., et al.","Health-related quality of life in men with metastatic prostate cancer treated with prednisone alone or mitoxantrone and prednisone","PURPOSE: A combination of mitoxantrone plus prednisone is preferable to prednisone alone for reduction of pain in men with metastatic, hormone-resistant, prostate cancer. The purpose of this study was to assess the effects of these treatments on health-related quality of life (HQL). PATIENTS AND METHODS: Men with metastatic prostate cancer (n = 161) were randomized to receive either daily prednisone alone or mitoxantrone (every 3 weeks) plus prednisone. Those who received prednisone alone could have mitoxantrone added after 6 weeks if there was no improvement in pain. HQL was assessed before treatment initiation and then every 3 weeks using the European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire C30 (EORTC QLQ-C30) and the Quality of Life Module-Prostate 14 (QOLM-P14), a trial-specific module developed for this study. An intent-to-treat analysis was used to determine the mean duration of HQL improvement and differences in improvement duration between groups of patients. RESULTS: At 6 weeks, both groups showed improvement in several HQL domains, and only physical functioning and pain were better in the mitoxantrone-plus-prednisone group than in the prednisone-alone group. After 6 weeks, patients taking prednisone showed no improvement in HQL scores, whereas those taking mitoxantrone plus prednisone showed significant improvements in global quality of life (P =.009), four functioning domains, and nine symptoms (.001 < P <. 01), and the improvement (> 10 units on a scale of 0 to100) lasted longer than in the prednisone-alone group (.004 < P <.05). The addition of mitoxantrone to prednisone after failure of prednisone alone was associated with improvements in pain, pain impact, pain relief, insomnia, and global quality of life (.001 < P <.003). CONCLUSION: Treatment with mitoxantrone plus prednisone was associated with greater and longer-lasting improvement in several HQL domains and symptoms than treatment with prednisone alone.","J Clin Oncol, 17(6): 1654-1663","Canada",1999,"Metastatic","Chemotherapy","EORTC QLQ-C30,QOLM-P14","Patient",null,"Clinical trial","Canada","Patient","Metastatic","Chemotherapy",null,"Clinical trial","EORTC QLQ-C30,QOLM-P14","1960:1999","Disease,General"]
[520,"Ott, C. and M. K. Fulton (2005). \"Osteoporosis risk and interest in strength training in men receiving androgen ablation therapy for locally advanced prostate cancer.\" J Am Acad Nurse Pract 17(3): 113-122.",null,"Ott, C. and M. K. Fulton","Osteoporosis risk and interest in strength training in men receiving androgen ablation therapy for locally advanced prostate cancer","PURPOSE: The overall purpose of this preliminary study to a clinical trial is to explore the feasibility of recruiting men receiving androgen ablation therapy (AAT) for locally advanced prostate cancer to a future strength training study for the prevention of osteoporosis. The threefold specific purpose of this comparative and correlational study is to (a) describe the prevalence of risk factors for osteoporosis, (b) compare functional status and symptom distress between those interested and not interested in a future strength training study, and (c) examine relationships among self-efficacy for strength training, functional status, symptom distress, years since cancer diagnosis, and cumulative dose of AAT in this at-risk population. METHOD: Data were obtained from 40 Caucasian men (mean age = 75.8 years) with locally advanced prostate cancer, capable of self-care, and receiving AAT. The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ) EORTC QLQ-C30 and EORTC QLQ-PR25 (prostate cancer specific) were used to measure functional status and symptom distress. A 6-item, investigator-developed questionnaire was used to measure self-efficacy for learning and overcoming barriers to strength training. CONCLUSIONS: The majority of these men had multiple risk factors for osteoporosis, in addition to receiving AAT, and had not completed bone mineral density (BMD) testing. A high percentage (67.5%) expressed interest in a future strength training protocol for osteoporosis prevention; functional status and symptom distress did not appear to influence this interest. Several aspects of functional status and symptom distress were significantly related to self-efficacy for learning and overcoming barriers to strength training. Years since cancer diagnosis and cumulative dose of AAT were not significantly related to self-efficacy for strength training, but age was related. This study informs a planned future experimental study by establishing the recruitment potential and the decreased likelihood of symptom distress interfering with self-efficacy for participation in strength training. IMPLICATIONS FOR PRACTICE: Advanced practice nurses should complete assessments for osteoporosis risk factors, monitor height loss, order BMD testing and bone enhancing medications, and discuss lifestyle modifications including strength training to improve bone health in men receiving AAT for prostate cancer.","J Am Acad Nurse Pract, 17(3): 113-122","USA",2005,"Advanced","Hormonal","EORTC QLQ-C30,EORTC QLQ-PR25","Patient",null,"Cross-sectional","USA","Patient","Advanced","Hormonal",null,"Cross-sectional","EORTC QLQ-C30,EORTC QLQ-PR25","2005:2009","Disease,General"]
[521,"Pannek, J., et al. (1997). \"Quality of life of patients with renal cell carcinoma or prostate cancer after radical surgery.\" Int Urol Nephrol 29(6): 637-643.",null,"Pannek, J., et al.","Quality of life of patients with renal cell carcinoma or prostate cancer after radical surgery","OBJECTIVES: To study the impact of radical tumour surgery in prostate and renal cell cancer patients on quality of life (QOL). METHODS: In 38 male patients suffering from organ-confined prostate or renal cell cancer, a prospective study was performed. For the evaluation of QOL, we used the EMPK (Erfassung multipler psychischer Konstrukte). Urologic symptoms were evaluated with a specially designed symptom score. The test instrument was filled out the day before surgery and one year after operation. RESULTS: The EMPK was able to detect and describe significant changes in certain aspects of QOL in renal cell cancer and prostate cancer patients. Moreover, there seems to be a difference between the two groups. A direct relation between QOL and the different quality and quantity of operation-related symptoms, however, could not be proven. CONCLUSIONS: In this pilot study, radical surgical therapy did not significantly change QOL in prostate cancer patients, but seemed to have a positive influence on the QOL of renal cell cancer patients.","Int Urol Nephrol, 29(6): 637-643","Germany",1997,"Any or unknown","Surgery","EMPK","Patient",null,"Cohort","Germany","Patient","Any or unknown","Surgery",null,"Cohort","EMPK","1960:1999","General"]
[522,"Papatheofanis, F. J., et al. (2009). \"Improvement in sensory pain rating after palliative systemic radionuclide therapy in patients with advanced prostate cancer.\" Am J Ther 16(2): 127-132.",null,"Papatheofanis, F. J., et al.","Improvement in sensory pain rating after palliative systemic radionuclide therapy in patients with advanced prostate cancer","This study assessed whether baseline and short-term patient-reported quality of life (QOL) differs in patients with symptomatic metastatic prostate cancer undergoing palliative management using opioids, nonsteroidal anti-inflammatory agents (NSAIDs), (89)strontium chloride ((89)Sr), and samarium-lexidronam ((153)Sm). Males were grouped according to primary palliative intervention: opioids (n = 40), NSAIDs (n = 40), (89)Sr chloride (n = 25), and (153)Sm (n = 25). The short form of the self-administered McGill Pain Questionnaire was used to measure QOL at baseline, 4 and 8 weeks after initiation of treatment. Clinical data were collected from patients' medical records. Statistical analyses were conducted using descriptive methods and the Student t test. A significant increase in the sensory pain rating was observed in the patients treated by NSAIDs ([upward arrow]21%) and (89)Sr ([upward arrow]46%), whereas those treated by opioids ([downward arrow]27%) and (153)Sm ([downward arrow]27%) demonstrated a significant (P < 0.05) decrease in this subscore. There was a longitudinal decrease in QOL over time in patients treated by NSAIDs and (89)Sr as measured by the total pain rating score, whereas those treated with the other agents experienced improved QOL. This study demonstrates improvement in QOL achieved using (153)Sm, which is comparable to that achieved with the use of opioids during this observation interval.","Am J Ther, 16(2): 127-132","USA",2009,"Metastatic","Palliative care","MPQ","Patient",null,"Clinical trial","USA","Patient","Metastatic","Palliative care",null,"Clinical trial","MPQ","2005:2009","Symptom"]
[523,"Park, J., et al. (2013). \"Cross-cultural application of the Korean version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for patients with prostate cancer - EORTC QLQ-PR25.\" Oncology 85(5): 299-305.",null,"Park, J., et al.","Cross-cultural application of the Korean version of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire for patients with prostate cancer - EORTC QLQ-PR25","OBJECTIVE: We evaluated the psychometric properties of the Korean version of the European Organization for Research and Treatment of Cancer QLQ-PR25 when applied to Korean prostate cancer (PC) patients. METHODS: A total of 172 patients who underwent curative radical prostatectomy (RP) with or without adjuvant androgen deprivation therapy were asked to complete the Korean version of the EORTC QLQ-C30 and PR25 questionnaires 3 times (before and 3 and 6 months after RP). Psychometric evaluation of the questionnaire was conducted. RESULTS: Multitrait scaling analysis showed satisfactory construct validity in most scales except for bowel symptoms and hormonal treatment-related symptoms. Internal consistency tested by Cronbach's alpha coefficient met the 0.70 criterion for the urinary symptom, sexual activity and sexual functioning scales at the all 3 time points. Known-group comparison analyses showed better quality-of-life (QOL) scores in patients with higher performance status, and higher hormonal treatment-related symptom scores in patients on hormonal treatment. Responsiveness to changes was in line with clinical implications over time after RP. CONCLUSIONS: Our results show that the EORTC QLQ-PR25 questionnaire has adequate levels in cross-cultural validity. The Korean version of the EORTC QLQ-PR25 is a generally reliable and robust instrument for the assessment of various QOL aspects that can be self-administered to Korean PC patients undergoing RP.","Oncology, 85(5): 299-305","Korea",2013,"Any or unknown","Surgery,Hormonal","EORTC QLQ-C30,EORTC QLQ-PR25","Patient",null,"Validation","Korea","Patient","Any or unknown","Surgery,Hormonal",null,"Validation","EORTC QLQ-C30,EORTC QLQ-PR25","2010:2014","Disease,General"]
[524,"Park, S. W., et al. (2012). \"Recovery of overall exercise ability, quality of life, and continence after 12-week combined exercise intervention in elderly patients who underwent radical prostatectomy: a randomized controlled study.\" Urology 80(2): 299-305.",null,"Park, S. W., et al.","Recovery of overall exercise ability, quality of life, and continence after 12-week combined exercise intervention in elderly patients who underwent radical prostatectomy: a randomized controlled study","OBJECTIVE: To examine the changes from a combined exercise intervention after radical prostatectomy (RP) in elderly patients with prostate cancer, because randomized controlled trials addressing exercise intervention after RP have been lacking. METHODS: From May 2009 to May 2010, all patients who underwent laparoscopic RP were assessed for eligibility. A total of 66 patients were randomized to an exercise or a control group. The exercise group received a combined exercise intervention (resistance, flexibility, and Kegel exercises) twice a week for 12 weeks, and the control group received only Kegel exercises. The primary outcome was physical function, and the secondary outcomes were continence status and quality of life after the exercise intervention. RESULTS: A total of 49 patients completed follow-up to the end of study. After the 12-week exercise intervention, except for grip strength, all physical functions were better in the exercise group than in the control group. The 24-hour pad test results (12.2 g in the exercise group, 46.2 g in the control group) and continence rate (73.1% in exercise group, 43.5% in the control group) recovered more promptly in the exercise group. On a questionnaire study using the International Consultation on Incontinence questionnaire, Beck Depression Inventory, and Medical Outcomes Study 36-item short-form health survey, only the exercise group showed improvement at the last follow-up visit. CONCLUSION: A 12-week combined exercise intervention after RP results in improvement of physical function, continence rate, and quality of life. These results could help with prompt recovery of daily activities.","Urology, 80(2): 299-305","Korea",2012,"Any or unknown","Surgery,Various","ICIQ,BDI,SF-36","Patient",null,"Clinical trial","Korea","Patient","Any or unknown","Surgery,Various",null,"Clinical trial","ICIQ,BDI,SF-36","2010:2014","Complication,Comorbidity,Utility"]
[525,"Parker, C. C., et al. (2013). \"A randomized, double-blind, dose-finding, multicenter, phase 2 study of radium chloride (Ra 223) in patients with bone metastases and castration-resistant prostate cancer.\" Eur Urol 63(2): 189-197.",null,"Parker, C. C., et al.","A randomized, double-blind, dose-finding, multicenter, phase 2 study of radium chloride (Ra 223) in patients with bone metastases and castration-resistant prostate cancer","BACKGROUND: Patients with castration-resistant prostate cancer (CRPC) and bone metastases have an unmet clinical need for effective treatments that improve quality of life and survival with a favorable safety profile. OBJECTIVE: To prospectively evaluate the efficacy and safety of three different doses of radium chloride (Ra 223) in patients with CRPC and bone metastases. DESIGN, SETTING, AND PARTICIPANTS: In this phase 2 double-blind multicenter study, 122 patients were randomized to receive three injections of Ra 223 at 6-wk intervals, at doses of 25 kBq/kg (n=41), 50 kBq/kg (n=39), or 80 kBq/kg (n=42). The study compared the proportion of patients in each dose group who had a confirmed decrease of >/= 50% in baseline prostate-specific antigen (PSA) levels. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Efficacy was evaluated using blood samples to measure PSA and other tumor markers, recorded skeletal-related events, and pain assessments. Safety was evaluated using adverse events (AEs), physical examination, and clinical laboratory tests. The Jonckheere-Terpstra test assessed trends between groups. RESULTS AND LIMITATIONS: The study met its primary end point with a statistically significant dose-response relationship in confirmed >/= 50% PSA declines for no patients (0%) in the 25-kBq/kg dose group, two patients (6%) in the 50-kBq/kg dose group, and five patients (13%) in the 80-kBq/kg dose group (p=0.0297). A >/= 50% decrease in bone alkaline phosphatase levels was identified in six patients (16%), 24 patients (67%), and 25 patients (66%) in the 25-, 50-, and 80-kBq/kg dose groups, respectively (p<0.0001). The most common treatment-related AEs (>/= 10%) occurring up to week 24 across all dose groups were diarrhea (21%), nausea (16%), and anemia (14%). No difference in incidence of hematologic events was seen among dose groups. Potential limitations include small patient numbers and differences among dose groups at baseline. CONCLUSIONS: Ra 223 had a dose-dependent effect on serum markers of CRPC activity, suggesting that control of bone disease with Ra 223 may affect cancer-related outcomes. Ra 223 was well tolerated at all doses. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00337155.","Eur Urol, 63(2): 189-197","UK",2013,"Metastatic","Radiotherapy","Unclear","Patient",null,"Clinical trial","UK","Patient","Metastatic","Radiotherapy",null,"Clinical trial","Unclear","2010:2014","Symptom"]
[526,"Parker, P. A., et al. (2009). \"The effects of a presurgical stress management intervention for men with prostate cancer undergoing radical prostatectomy.\" J Clin Oncol 27(19): 3169-3176.",null,"Parker, P. A., et al.","The effects of a presurgical stress management intervention for men with prostate cancer undergoing radical prostatectomy","PURPOSE This study assessed the short-term and long-term efficacy of a presurgical stress management intervention at reducing mood disturbance and improving quality of life (QOL) in men undergoing radical prostatectomy (RP) for prostate cancer. PATIENTS AND METHODS One hundred fifty-nine men were randomly assigned to a two-session (plus two boosters) presurgical stress management intervention (SM), a two-session (plus two boosters) supportive attention group (SA), or a standard care group (SC). Assessments occurred 1 month before surgery; 1 week before surgery; the morning of surgery; 6 weeks after surgery, and 6 and 12 months after surgery. Results Results indicated significant group differences in mood disturbance before surgery (P = .02), such that men in the SM group had significantly less mood disturbance than men in the SC group (P = .006), with no significant differences between the SM and SA or SA and SC groups. In the year after surgery, there were significant group differences on Medical Outcomes Study 36-item short form survey (SF-36) physical component summary (PCS) scores (P = .004); men in the SM group had significantly higher PCS scores than men in the SC group (P = .0009), and there were no significant differences between the SM and SA or SA and SC groups. There were no group effects on prostate-specific QOL or SF-36 mental health scores. CONCLUSION These findings demonstrate the efficacy of a brief presurgical stress management intervention in improving some short-term and long-term outcomes. If these results are replicated, it may be a useful adjunct to standard care for men with prostate cancer undergoing surgery.","J Clin Oncol, 27(19): 3169-3176","USA",2009,"Any or unknown","Surgery,Psychological","SF-36","Patient",null,"Clinical trial","USA","Patient","Any or unknown","Surgery,Psychological",null,"Clinical trial","SF-36","2005:2009","Utility"]
[527,"Partin, M. R., et al. (2004). \"Randomized trial examining the effect of two prostate cancer screening educational interventions on patient knowledge, preferences, and behaviors.\" J Gen Intern Med 19(8): 835-842.",null,"Partin, M. R., et al.","Randomized trial examining the effect of two prostate cancer screening educational interventions on patient knowledge, preferences, and behaviors","OBJECTIVE: To assess the effect of video and pamphlet interventions on patient prostate cancer (CaP) screening knowledge, decision-making participation, preferences, and behaviors. DESIGN: Randomized, controlled trial. SETTING: Four midwestern Veterans Affairs medical facilities. PATIENTS/PARTICIPANTS: One thousand, one hundred fifty-two male veterans age 50 and older with primary care appointments at participating facilities were randomized and 893 completed follow-up. INTERVENTIONS: Patients were randomized to mailed pamphlet, mailed video, or usual care/control. MEASUREMENTS AND MAIN RESULTS: Outcomes assessed by phone survey 2 weeks postintervention included a 10-item knowledge index; correct responses to questions on CaP natural history, treatment efficacy, the prostate-specific antigen (PSA)'s predictive value, and expert disagreement about the PSA; whether screening was discussed with provider; screening preferences; and PSA testing rates. Mean knowledge index scores were higher for video (7.44; P = .001) and pamphlet (7.26; P = .03) subjects versus controls (6.90). Video and pamphlet subjects reported significantly higher percentages of correct responses relative to controls to questions on CaP natural history (63%, 63%, and 54%, respectively); treatment efficacy (19%, 20%, and 5%), and expert disagreement (28%, 19%, and 8%), but not PSA accuracy (28%, 22%, and 22%). Pamphlet subjects were more likely than controls to discuss screening with their provider (41% vs 32%; P = .03) but video subjects were not (35%; P = .33). Video and pamphlet subjects were less likely to intend to have a PSA, relative to controls (63%, 65%, and 74%, respectively). PSA testing rates did not differ significantly across groups. CONCLUSIONS: Mailed interventions enhance patient knowledge and self-reported participation in decision making, and alter screening preferences. The pamphlet and video interventions evaluated are comparable in effectiveness. The lower-cost pamphlet approach is an attractive option for clinics with limited resources.","J Gen Intern Med, 19(8): 835-842","USA",2004,"At risk","Various,Screening","Interview","General population",null,"Clinical trial","USA","General population","At risk","Various,Screening",null,"Clinical trial","Interview","2000:2004","Knowledge"]
[528,"Pastore, A. L., et al. (2014). \"Are early continence recovery and oncologic outcomes influenced by use of different devices in prostatic apex dissection during laparoscopic radical prostatectomy?\" J Endourol 28(11): 1313-1319.",null,"Pastore, A. L., et al.","Are early continence recovery and oncologic outcomes influenced by use of different devices in prostatic apex dissection during laparoscopic radical prostatectomy?","BACKGROUND AND PURPOSE: Treatment of patients with prostate cancer has evolved considerably in the last decade, especially in terms of minimization of the negative impacts on erectile function and continence to ensure good quality of life for treated patients. New surgical devices, such as dissectors and hemostatic scalpels, allow precise definition of the surgical field with finer dissection of the anatomic structures, with subsequent reductions in operative times and better oncologic and functional outcomes. Although monopolar scissors (MS) are still widely used, radiofrequency (RF) and ultrasound (US) scalpels have been introduced recently in laparoscopic radical prostatectomy (LRP). Despite the widespread use of these scalpels, however, few studies have compared these devices in terms of oncologic and functional outcomes after radical prostatectomy. The present study aimed to prospectively assess the impact of MS, RF, and US scalpels on margin status at apex, and recovery of urinary continence and erectile function in patients undergoing extraperitoneal LRP. PATIENTS AND METHODS: A total of 150 men were prospectively enrolled between September 2009 and April 2013 and postoperatively evaluated for continence and clinical factors. RESULTS: There were no differences in terms of operative times (P=0.9433), blood loss (P=0.9681), apical margin positivity (P=0.3965) or postoperative hospital stay (P=0.9257) among the groups. Moreover, no differences in the functional outcome scores, as evaluated by the International Consultation on Incontinence self-administered Questionnaire, at 1, 3, and 6 months postsurgery were observed. CONCLUSION: Our study represents the first evaluation of continence recovery in LRP with respect to different devices used for prostatic apex dissection. We found that the oncologic, functional, and operative outcomes were similar between these different devices during LRP, with no scalpel demonstrating superiority in continence recovery.","J Endourol, 28(11): 1313-1319","Italy",2014,"Any or unknown","Surgery,Various","ICIQ","Patient",null,"Clinical trial","Italy","Patient","Any or unknown","Surgery,Various",null,"Clinical trial","ICIQ","2010:2014","Complication"]
[529,"Patel, V. R., et al. (2005). \"Robotic radical prostatectomy in the community setting--the learning curve and beyond: initial 200 cases.\" J Urol 174(1): 269-272.",null,"Patel, V. R., et al.","Robotic radical prostatectomy in the community setting--the learning curve and beyond: initial 200 cases","PURPOSE: The introduction of robotic assistance has the potential to improve surgical outcomes and reduce the steep learning curve associated with conventional laparoscopic radical prostatectomy. We report on our experience with robotic radical prostatectomy in the community setting. MATERIALS AND METHODS: A total of 200 patients underwent robotic radical prostatectomy during 18 months. Prospective data collection included a quality of life (Expanded Prostate Cancer Index Composite) questionnaire, basic demographics, prostate specific antigen (PSA), clinical stage and Gleason grade. Operative outcome measures included operative time, estimated blood loss and complications. Postoperative outcome measures included hospital stay, catheter time, pathology, PSA and return of continence. RESULTS: Average operative time was 141 minutes with an estimated blood loss of 75 cc. The intraoperative complication rate was 1% with no mortality, reexploration or transfusion. Of the patients 95% were discharged home on postoperative day 1 (1 to 3) with hematocrit averaging 34.5 (range 25 to 45). The average difference in preoperative and postoperative hematocrit was 3 points (range -2 to 15). Average catheter time was 7.2 days (range 5 to 15). The positive margin rate was 10.5% for the entire series, 5.7% for T2 tumors, 28.5% (T3a), 20% (T3b) and 33% (T4a). Of the patients 95% had undetectable PSA (less than 0.1 ng/ml) at average followup of 9.7 months. Continence at 1, 3, 6, 9 and 12 months was 47%, 78%, 89%, 92% and 98%, respectively. CONCLUSIONS: Our initial experience with robotic radical prostatectomy is promising. The learning curve was approximately 20 to 25 cases. With a structured methodical approach we were able to implement robotics safely and effectively into our community practice with minimal patient morbidity, and good oncological and functional outcomes.","J Urol, 174(1): 269-272","USA",2005,"Local,Advanced","Surgery","EPIC","Patient",null,"Cohort","USA","Patient","Local,Advanced","Surgery",null,"Cohort","EPIC","2005:2009","Disease"]
[530,"Patterson, R. E., et al. (2002). \"Types of alternative medicine used by patients with breast, colon, or prostate cancer: predictors, motives, and costs.\" J Altern Complement Med 8(4): 477-485.",null,"Patterson, R. E., et al.","Types of alternative medicine used by patients with breast, colon, or prostate cancer: predictors, motives, and costs","OBJECTIVE: Assess predictors and costs of various types of alternative medicine used by adult patients with cancer. DESIGN, LOCATION, SUBJECTS: Telephone survey of 356 patients with colon, breast, or prostate cancer identified from the population-based Cancer Surveillance System of western Washington. RESULTS: Overall, 70.2% of patients used at least one type of alternative medicine, with 16.6% seeing alternative providers, 19.1% using mental/other therapy, and 64.6% taking dietary supplements. Compared to males, females were five times more likely to see an alternative provider and about twice as likely to use mental therapies or supplements (p < 0.05 for all). Older patients were less likely to use mental/other therapy. Higher education (but not income) was associated with use of all types of alternative medicine. Patients with multiple medical treatments were two times more likely to take dietary supplements compared to patients having only surgery (p < 0.01). Varying by the type of alternative therapy, 83%-97% of patients reported that they used alternative medicine for general health and well-being while 8% to 56% reported use for treatment of cancer. Almost all patients reported that the alternative therapy improved their well-being. Expenditures for alternative medicine averaged $68 per user per year, but ranged from $4 to $14,659. CONCLUSIONS: Given the high prevalence of use and that patients believed that alternative medicine improved their well-being, clinicians should show an open mind toward these treatment choices and encourage frank discussion. Familiarity and some knowledge regarding use of alternative medicine is important in cases where interactions between conventional and alternative medicine may occur. It is also important to identify potential patient needs for mental health support beyond conventional care and support patients who want to make healthful lifestyle changes. Longitudinal investigations are urgently needed to investigate associations of alternative medicine use with survival and quality of life in patients with cancer.","J Altern Complement Med, 8(4): 477-485","USA",2002,"Any or unknown","Various","Interview","Patient",null,"Cross-sectional","USA","Patient","Any or unknown","Various",null,"Cross-sectional","Interview","2000:2004","General"]
[531,"Pearce, A., et al. (2006). \"Effect of combined treatment with salvage radiotherapy plus androgen suppression on quality of life in patients with recurrent prostate cancer after radical prostatectomy.\" Int J Radiat Oncol Biol Phys 65(1): 78-83.",null,"Pearce, A., et al.","Effect of combined treatment with salvage radiotherapy plus androgen suppression on quality of life in patients with recurrent prostate cancer after radical prostatectomy","PURPOSE: To examine the effect of salvage radiotherapy (RT) plus 2-year androgen suppression (AS) on quality of life (QOL). METHODS AND MATERIALS: A total of 74 patients with biopsy-proven local recurrence or PSA relapse after radical prostatectomy were treated with salvage RT plus 2-year AS, as per a phase II study. Quality of life was prospectively assessed with the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30-Item Version 3.0 with the added prostate cancer-specific module at baseline and predefined follow-up visits. RESULTS: Patients experienced a significant increase in bowel dysfunction (23%) by the end of RT (p < 0.0001). This bowel dysfunction improved after RT but remained slightly elevated (5-10%) throughout the 2-year AS period. This extent of residual bowel dysfunction would be considered of minimal clinical importance. A similar, but less pronounced, pattern of change did occur for urinary dysfunction. Erectile function showed no change during RT, but had an abrupt decline (10%) with initiation of AS that was of moderate clinical significance (p < 0.01). None of the other QOL domains demonstrated a persistent, significant change from baseline that would be considered of major clinical significance. CONCLUSION: The combined treatment with salvage RT plus 2-year AS had relatively minor long-term effects on QOL.","Int J Radiat Oncol Biol Phys, 65(1): 78-83","Canada",2006,"Recurrent","Surgery,Radiotherapy,Hormonal","EORTC QLQ-C30,EORTC QLQ-PR25","Patient",null,"Clinical trial","Canada","Patient","Recurrent","Surgery,Radiotherapy,Hormonal",null,"Clinical trial","EORTC QLQ-C30,EORTC QLQ-PR25","2005:2009","Disease,General"]
[532,"Pearse, M., et al. (2014). \"A Phase III trial to investigate the timing of radiotherapy for prostate cancer with high-risk features: background and rationale of the Radiotherapy -- Adjuvant Versus Early Salvage (RAVES) trial.\" BJU Int 113 Suppl 2: 7-12.",null,"Pearse, M., et al.","A Phase III trial to investigate the timing of radiotherapy for prostate cancer with high-risk features: background and rationale of the Radiotherapy -- Adjuvant Versus Early Salvage (RAVES) trial","OBJECTIVES: To test the hypothesis that observation with early salvage radiotherapy (SRT) is not inferior to 'standard' treatment with adjuvant RT (ART) with respect to biochemical failure in patients with pT3 disease and/or positive surgical margins (SMs) after radical prostatectomy (RP). To compare the following secondary endpoints between the two arms: patient-reported outcomes, adverse events, biochemical failure-free survival, overall survival, disease-specific survival, time to distant failure, time to local failure, cost utility analysis, quality adjusted life years and time to androgen deprivation. PATIENTS AND METHODS: The Radiotherapy - Adjuvant Versus Early Salvage (RAVES) trial is a phase III multicentre randomised controlled trial led by the Trans Tasman Radiation Oncology Group (TROG), in collaboration with the Urological Society of Australia and New Zealand (USANZ), and the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP). In all, 470 patients are planned to be randomised 1:1 to either ART commenced at </=4 months of RP (standard of care) or close observation with early SRT triggered by a PSA level of >0.20 ng/mL (experimental arm). Eligible patients have had a RP for adenocarcinoma of the prostate with at least one of the following risk factors: positive SMs +/- extraprostatic extension +/- seminal vesicle involvement. The postoperative PSA level must be </=0.10 ng/mL. Rigorous investigator credentialing and a quality assurance programme are designed to promote consistent RT delivery among patients. RESULTS: Trial is currently underway, with 258 patients randomised as of 31 October 2013. International collaborations have developed, including a planned meta-analysis to be undertaken with the UK Medical Research Council/National Cancer Institute of Canada Clinical Trials Group RADICALS (Radiotherapy and Androgen Deprivation In Combination with Local Surgery) trial and an innovative psycho-oncology sub-study to investigate a patient decision aid resource. CONCLUSION: On the current evidence available, it remains unclear if ART is equivalent or superior to observation with early SRT.","BJU Int, 113 Suppl 2(7-12","New Zealand",2014,"Advanced","Radiotherapy","Unclear","Patient",null,"Protocol","New Zealand","Patient","Advanced","Radiotherapy",null,"Protocol","Unclear","2010:2014","Unclear"]
[533,"Pedersen, K. V., et al. (1990). \"Screening for carcinoma of the prostate by digital rectal examination in a randomly selected population.\" Bmj 300(6731): 1041-1044.",null,"Pedersen, K. V., et al.","Screening for carcinoma of the prostate by digital rectal examination in a randomly selected population","OBJECTIVE: To study the acceptability, costs, psychosocial consequences, and organisation of screening for carcinoma of the prostate. DESIGN: A randomly selected population was personally invited for digital rectal examination by a urologist and a general practitioner. Further examinations were performed if induration was felt. Each man completed a questionnaire on his response to the examination. SETTING: General practices in the area of Norrkoping. PATIENTS: 1494 Men aged 50-69 randomly selected from a population of 9026. MAIN OUTCOME MEASURE: Prostates having a firm nodular consistency. RESULTS: Carcinoma of the prostate was suspected in 45 of 1163 patients examined; in 10 by the general practitioners, in 10 by the urologists, and in 25 by both. Forty four men had a fine needle aspiration biopsy, and carcinomas were found in 13 cases. Of these, one had been suspected by the general practitioner, four by urologists, and eight by both. The cost for each man was 11.60 pounds, and the cost for each case of carcinoma detected and treated by potentially curative methods was 2477 pounds. Of the 13 men with carcinoma, 10 underwent radical prostatectomy and one radiotherapy. One man had advanced disease and was given endocrine treatment, another was not treated. Only 193 men felt distress during the initial examination. Of the 44 men who had an aspiration biopsy, 25 experienced anxiety. CONCLUSIONS: Screening for carcinoma of the prostate by a urologist or a general practitioner using digital rectal examination is a cost effective method of early diagnosis. Whether such screening leads to prolonged survival, however, remains doubtful.","Bmj, 300(6731): 1041-1044","Sweden",1990,"At risk","Screening","Unclear","General population",null,"Cross-sectional","Sweden","General population","At risk","Screening",null,"Cross-sectional","Unclear","1960:1999","Views"]
[534,"Penson, D. F., et al. (2001). \"The association between socioeconomic status, health insurance coverage, and quality of life in men with prostate cancer.\" J Clin Epidemiol 54(4): 350-358.",null,"Penson, D. F., et al.","The association between socioeconomic status, health insurance coverage, and quality of life in men with prostate cancer","The objective of this study was to examine the effect of socioeconomic status and insurance status on health-related quality of life (HRQOL) outcomes in men with prostate cancer. The design was a retrospective cohort study using multiple sites, including both academic and private practice settings. A cohort of 860 men with newly diagnosed, biopsy-proven prostate cancer of any stage was identified within CaPSURE, a longitudinal disease registry of prostate cancer patients. HRQOL was assessed with validated instruments, including the RAND 36-item Health Survey (SF-36) and the UCLA Prostate Cancer Index. Covariates included insurance status, education level, annual income, age, stage, comorbidity, Gleason grade, baseline PSA, marital status, ethnicity and primary treatment. HRQOL measurements were taken at 3-6-month intervals. Analysis of covariance was used to determine the effect of SES and insurance status on the HRQOL domains at baseline and over time. Patients with lower annual income had significantly lower baseline HRQOL scores in the all of the domains of the SF-36 and four of eight disease-specific HRQOL domains. No relationship was seen between annual income and HRQOL outcomes over time. Conversely, health insurance status was associated with HRQOL over time, but not at baseline. Health insurance status appears to have a unique effect on general HRQOL outcomes in men after treatment for prostate cancer. This study confirms the commonly held belief that patients of lower SES tend to have worse quality of life at baseline and following treatment for their disease. These findings have important ramifications for clinicians, researchers and policy makers.","J Clin Epidemiol, 54(4): 350-358","USA",2001,"Any or unknown","Unclear","SF-36,UCLA-PCI","Patient",null,"Cohort","USA","Patient","Any or unknown","Unclear",null,"Cohort","SF-36,UCLA-PCI","2000:2004","Disease,Utility,Costs"]
[535,"Penson, D. F., et al. (2003). \"General quality of life 2 years following treatment for prostate cancer: what influences outcomes? Results from the prostate cancer outcomes study.\" J Clin Oncol 21(6): 1147-1154.",null,"Penson, D. F., et al.","General quality of life 2 years following treatment for prostate cancer: what influences outcomes? Results from the prostate cancer outcomes study","PURPOSE: The goal of this study was to determine the relationship between primary treatment, urinary dysfunction, sexual dysfunction, and general health-related quality of life (HRQOL) in prostate cancer. METHODS: A sample of men with newly diagnosed prostate cancer between 1994 and 1995 was randomly selected from six population-based Surveillance, Epidemiology, and End Results registries. A baseline survey was completed by 2,306 men within 6 to 12 months of diagnosis, and these men also completed a follow-up HRQOL survey 2 years after diagnosis. Logistic regression models were used to determine whether primary treatment, urinary dysfunction, and sexual dysfunction were independently associated with general HRQOL outcomes approximately 2 years after diagnosis as measured by the Medical Outcomes Study 36-item Short Form Health Survey. The magnitude of this effect was estimated using least square means models. RESULTS: After adjustment for potential confounders, primary treatment was not associated with 2-year general HRQOL outcomes in men with prostate cancer. Urinary function and bother were independently associated with worse general HRQOL in all domains. Sexual function and bother were also independently associated with worse general HRQOL, although the relationship was not as strong as in the urinary domains. CONCLUSION: Primary treatment is not associated with 2-year general HRQOL outcomes in prostate cancer. Although both sexual and urinary function and bother are associated with quality of life, men who are more bothered by their urination or impotence are more likely to report worse quality of life. This implies that future research should be directed toward finding ways to improve treatment-related outcomes or help patients better cope with their posttreatment urinary or sexual dysfunction.","J Clin Oncol, 21(6): 1147-1154","USA",2003,"Any or unknown","Unclear","SF-36","Patient",null,"Cohort","USA","Patient","Any or unknown","Unclear",null,"Cohort","SF-36","2000:2004","Utility"]
[536,"Perkins, J. J., et al. (1998). \"An exploration of screening practices for prostate cancer and the associated community expenditure.\" Br J Urol 82(4): 524-529.",null,"Perkins, J. J., et al.","An exploration of screening practices for prostate cancer and the associated community expenditure","OBJECTIVES: To determine: (i) the prevalence, reasons for, and demographic and psychosocial predictors of prostate cancer screening among a randomly selected sample of men; and (ii) to estimate the community expenditure involved in the screening of asymptomatic men. SUBJECTS AND METHODS: A random sample of men aged 40-79 years was selected from the State Electoral Register of New South Wales, Australia, and asked to complete a computer-assisted telephone interview. The questions determined their demographic characteristics, their subjective health rating compared with others of the same age (5-point scale), the prevalence and reasons for any screening for prostate cancer ('ever screened' and 'screened within the last 12 months'), whether they had undergone a digital rectal examination (DRE), a blood test for prostate-specific antigen (PSA) or transrectal ultrasonography (TRUS), and the prevalence of urinary symptoms. Those who had been screened were then asked to nominate the single most important factor in the decision to undergo prostate cancer screening. To estimate community expenditure, the costs for prostate cancer screening were estimated by applying Medicare schedule charges to the screening and subsequent diagnostic tests performed. Two scenarios were developed to estimate costs: the first used guidelines which do not recommend the use of routine screening for all asymptomatic men, and the second was based on guidelines where the routine use of PSA or TRUS as part of a periodic health examination is not recommended, but the use of DRE in asymptomatic men aged 50-70 years is. RESULTS: Of the 551 eligible participants, 86% completed the interview; 44% of participants reported that they had 'ever' been screened, whilst 23% had been screened in the year before the study. Among those who had been screened, the reason reported most often for screening, apart from symptoms and family history, was the doctor's recommendation after a medical assessment of their prostate cancer risk status. Screening status was predicted both by the age of the man and his symptom score. As a result, the community expenditure in New South Wales for screening among asymptomatic men was estimated to be A$6.4 million and A$5.2 million for the first and second scenarios, respectively. CONCLUSIONS: The results of this study suggest that, despite the recommendations of primary bodies that asymptomatic men not be screened for prostate cancer, screening is occurring at a high level and with significant costs to the healthcare system.","Br J Urol, 82(4): 524-529","Australia",1998,"At risk","Screening","Interview","General population",null,"Cross-sectional","Australia","General population","At risk","Screening",null,"Cross-sectional","Interview","1960:1999","Views"]
[537,"Petersen, S. E., et al. (2014). \"Development and validation of a scoring system for late anorectal side-effects in patients treated with radiotherapy for prostate cancer.\" Radiother Oncol 111(1): 94-99.",null,"Petersen, S. E., et al.","Development and validation of a scoring system for late anorectal side-effects in patients treated with radiotherapy for prostate cancer","PURPOSE: To develop and validate a scoring system for evaluation of long term anorectal dysfunction following radiotherapy for prostate cancer. MATERIALS AND METHODS: Patients treated for prostate cancer with radiotherapy filled in questionnaires on anorectal function and quality of life. Items for the condensed anorectal dysfunction score (RT-ARD) were identified and weighted by binomial regression analysis. The score was tested in a separate patient material by receiver operating characteristic (ROC) analysis and correlations to quality of life domains. RESULTS: A total of 309 patients participated in the study. The items selected were \"incontinence for solid stool\", \"ability to defer defecation\", \"unproductive call to stool\", \"clustering of stool\", and \"mucus in stool.\" Patients were grouped into three categories according to the RT-ARD score; 0-8 (no RT-ARD), 9-23 (minor RT-ARD), 24-45 (major RT-ARD). ROC analyses revealed high sensitivity (91%) and specificity (85%) for major RT-ARD. The prediction model demonstrated a perfect fit in 60%, moderate fit in 36% and no fit in 4%. There was good correlation between the RT-ARD score and quality of life. CONCLUSIONS: The RT-ARD score is a validated and simple instrument for evaluation of anorectal dysfunction following radiotherapy for prostate cancer, and the RT-ARD score correlates to the patient's quality of life.","Radiother Oncol, 111(1): 94-99","Denmark",2014,"Any or unknown","Radiotherapy","RT-ARD","Patient",null,"Validation","Denmark","Patient","Any or unknown","Radiotherapy",null,"Validation","RT-ARD","2010:2014","Complication"]
[538,"Petrylak, D. P., et al. (2004). \"Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer.\" N Engl J Med 351(15): 1513-1520.",null,"Petrylak, D. P., et al.","Docetaxel and estramustine compared with mitoxantrone and prednisone for advanced refractory prostate cancer","BACKGROUND: Mitoxantrone-based chemotherapy palliates pain without extending survival in men with progressive androgen-independent prostate cancer. We compared docetaxel plus estramustine with mitoxantrone plus prednisone in men with metastatic, hormone-independent prostate cancer. METHODS: We randomly assigned 770 men to one of two treatments, each given in 21-day cycles: 280 mg of estramustine three times daily on days 1 through 5, 60 mg of docetaxel per square meter of body-surface area on day 2, and 60 mg of dexamethasone in three divided doses before docetaxel, or 12 mg of mitoxantrone per square meter on day 1 plus 5 mg of prednisone twice daily. The primary end point was overall survival; secondary end points were progression-free survival, objective response rates, and post-treatment declines of at least 50 percent in serum prostate-specific antigen (PSA) levels. RESULTS: Of 674 eligible patients, 338 were assigned to receive docetaxel and estramustine and 336 to receive mitoxantrone and prednisone. In an intention-to-treat analysis, the median overall survival was longer in the group given docetaxel and estramustine than in the group given mitoxantrone and prednisone (17.5 months vs. 15.6 months, P=0.02 by the log-rank test), and the corresponding hazard ratio for death was 0.80 (95 percent confidence interval, 0.67 to 0.97). The median time to progression was 6.3 months in the group given docetaxel and estramustine and 3.2 months in the group given mitoxantrone and prednisone (P<0.001 by the log-rank test). PSA declines of at least 50 percent occurred in 50 percent and 27 percent of patients, respectively (P<0.001), and objective tumor responses were observed in 17 percent and 11 percent of patients with bidimensionally measurable disease, respectively (P=0.30). Grade 3 or 4 neutropenic fevers (P=0.01), nausea and vomiting (P<0.001), and cardiovascular events (P=0.001) were more common among patients receiving docetaxel and estramustine than among those receiving mitoxantrone and prednisone. Pain relief was similar in both groups. CONCLUSIONS: The improvement in median survival of nearly two months with docetaxel and estramustine, as compared with mitoxantrone and prednisone, provides support for this approach in men with metastatic, androgen-independent prostate cancer.","N Engl J Med, 351(15): 1513-1520","USA",2004,"Metastatic","Taxane,Chemotherapy","Unclear","Patient",null,"Clinical trial","USA","Patient","Metastatic","Taxane,Chemotherapy",null,"Clinical trial","Unclear","2000:2004","Symptom"]
[539,"Pettersson, A., et al. (2012). \"Effects of a dietary intervention on acute gastrointestinal side effects and other aspects of health-related quality of life: a randomized controlled trial in prostate cancer patients undergoing radiotherapy.\" Radiother Oncol 103(3): 333-340.",null,"Pettersson, A., et al.","Effects of a dietary intervention on acute gastrointestinal side effects and other aspects of health-related quality of life: a randomized controlled trial in prostate cancer patients undergoing radiotherapy","PURPOSE: To study the effect of a dietary intervention on acute gastrointestinal side effects and other aspects of health-related quality of life (HRQOL) in prostate cancer patients referred to radiotherapy. MATERIALS AND METHODS: A total of 130 patients were randomly assigned to one of two groups: an intervention group (IG, n=64), instructed to reduce their intake of insoluble dietary fibres and lactose, a standard care group (SC, n=66), instructed to continue their normal diet. Gastrointestinal side effects and other aspects of HRQOL were evaluated from baseline up to 2 months after completed radiotherapy, using the EORTC QLQ-C30 and QLQ-PR25 and the study-specific Gastrointestinal Side Effects Questionnaire (GISEQ). A scale indicating adherence to dietary instructions was developed from a Food Frequency Questionnaire (FFQ), with lower scores representing better compliance. Descriptive and inferential statistical analyses were conducted. RESULTS: There was an interaction effect between randomization and time in the FFQ Scores (p<0.001), indicating that both groups followed their assigned dietary instructions. The dietary intervention had no effect on gastrointestinal side effects or other aspects of HRQOL. During radiotherapy, the percentage of patients with bowel symptoms and bloated abdomen was lower in IG compared to SC, but the between-group differences were not statistically significant. During radiotherapy, the percentage of patients with bowel symptoms, urinary symptoms, pain, fatigue and diminished physical and role functioning increased in both groups. CONCLUSIONS: The dietary intervention had no effect on gastrointestinal side effects or other aspects of HRQOL. The tendency towards lower prevalence of bowel symptoms in IG may indicate some positive effect of the dietary intervention, but methodological refinements, clearer results and longer follow-up are needed before the value of diet change can be established with certainty.","Radiother Oncol, 103(3): 333-340","Sweden",2012,"Any or unknown","Various,Radiotherapy","EORTC QLQ-C30,EORTC QLQ-PR25,GISEQ,FFQ","Patient",null,"Clinical trial","Sweden","Patient","Any or unknown","Various,Radiotherapy",null,"Clinical trial","EORTC QLQ-C30,EORTC QLQ-PR25,GISEQ,FFQ","2010:2014","Disease,General,Complication,Treatment"]
[540,"Pickard, A. S., et al. (2009). \"Proxy assessment of health-related quality of life in african american and white respondents with prostate cancer: perspective matters.\" Med Care 47(2): 176-183.",null,"Pickard, A. S., et al.","Proxy assessment of health-related quality of life in african american and white respondents with prostate cancer: perspective matters","OBJECTIVES: An emerging issue in the proxy literature is whether specifying different proxy viewpoints contributes to different health-related quality of life (HRQL) assessments, and if so, how might each perspective be informative in medical decision making. The aims of this study were to determine if informal caregiver assessments of patients with prostate cancer differed when prompted from both the patient perspective (proxy-patient) and their own viewpoint (proxy-proxy), and to identify factors associated with differences in proxy perspectives (ie, the intraproxy gap). RESEARCH DESIGN AND METHODS: Using a cross-sectional design, prostate cancer patients and their informal caregivers were recruited from urology clinics in the Jesse Brown Veterans Affairs Healthcare System in Chicago. Dyads assessed HRQL using the EQ-5D visual analog scale (VAS) and EORTC QLQ-C30. RESULTS: Of 87 dyads, most caregivers were female (83%) and were spouses/partners (58%). Mean difference scores between proxy-patient and proxy-proxy perspectives were statistically significant for QLQ-C30 physical and emotional functioning, and VAS (all P < 0.05), with the proxy-patient perspective closer to patient self-report. Emotional functioning had the largest difference, mean 6.0 (SD 12.8), an effect size = 0.47. Factors weakly correlated with the intraproxy gap included relationship (spouse) and proxy gender for role functioning, and health literacy (limited/functional) for physical functioning (all P < 0.05, 0.20 < r < 0.35). CONCLUSIONS: Meaningful differences between proxy-patient and proxy-proxy perspectives on mental health were consistent with a conceptual framework for understanding proxy perspectives. Prompting different proxy viewpoints on patient health could help clinicians identify patients who may benefit from clinical intervention.","Med Care, 47(2): 176-183","USA",2009,"Any or unknown","None","EQ-5D,EORTC QLQ-C30","Caregiver,Patient",null,"Validation","USA","Caregiver,Patient","Any or unknown","None",null,"Validation","EQ-5D,EORTC QLQ-C30","2005:2009","General,Disease"]
[541,"Pietrow, P. K., et al. (2001). \"Health related quality of life assessment after radical prostatectomy in men with prostate specific antigen only recurrence.\" J Urol 166(6): 2286-2290.",null,"Pietrow, P. K., et al.","Health related quality of life assessment after radical prostatectomy in men with prostate specific antigen only recurrence","PURPOSE: The health related quality of life assessment is becoming increasingly important among patients with prostate cancer. Meanwhile, treatment of patients with increasing prostate specific antigen (PSA) after radical retropubic prostatectomy remains controversial. We attempt to define the impact of PSA recurrence on the health related quality of life of patients after radical retropubic prostatectomy. MATERIALS AND METHODS: Of 604 consecutive patients who underwent radical retropubic prostatectomy between March 1991 and September 1998, 510 (84%) were available for followup. Each patient was mailed the RAND 36-Item Health Survey and University of California, Los Angeles, Prostate Cancer Index questionnaire. A total of 348 (70%) questionnaires were returned. Health related quality of life scores were then compared between patients with and without PSA recurrence. A multivariate analysis was also performed to elucidate further the cause of differences between the groups. RESULTS: Overall, 88 (25%) patients had PSA recurrence. In regard to health related quality of life there were small (less than 10%) but statistically significant differences in 2 of 4 physical health domains (RAND 36-Item Health Survey). There was a significant decrease in only 1 category of the mental health domain for patients with PSA recurrence. Only sexual function was statistically lower on the University of California, Los Angeles, Prostate Cancer Index. This result reflects the lower incidence of nerve sparing in these patients, as confirmed by the multivariate analysis. Overall patient satisfaction was similar between those with and without PSA recurrence (76% and 79%, respectively). CONCLUSIONS: Our study demonstrates small health related quality of life differences in patients with biochemical PSA recurrence versus those without. These findings provide a baseline assessment of general and disease specific health related quality of life domains among these patients. Future studies should focus on differences in the measure of cancer anxiety before and after administration of adjuvant therapy in these asymptomatic patients.","J Urol, 166(6): 2286-2290","USA",2001,"Recurrent","Surgery","SF-36,UCLA-PCI","Patient",null,"Cross-sectional","USA","Patient","Recurrent","Surgery",null,"Cross-sectional","SF-36,UCLA-PCI","2000:2004","Disease,Utility"]
[542,"Pinkawa, M., et al. (2009). \"Health-related quality of life after permanent I-125 brachytherapy and conformal external beam radiotherapy for prostate cancer--a matched-pair comparison.\" Radiother Oncol 91(2): 225-231.",null,"Pinkawa, M., et al.","Health-related quality of life after permanent I-125 brachytherapy and conformal external beam radiotherapy for prostate cancer--a matched-pair comparison","BACKGROUND AND PURPOSE: The aim of the study was to compare quality of life after permanent I-125 brachytherapy (BT) and external beam radiotherapy (EBRT) for prostate cancer. MATERIALS AND METHODS: A group of 104 patients (52 in each group) have been surveyed prospectively before EBRT/BT (time A), at the last day of EBRT (70.2-72.0 Gy) or one month after BT (time B), and a median time of 16 months after EBRT/BT (time C) using a validated questionnaire (Expanded Prostate Cancer Index Composite). Pairs were matched according to the following criteria: age +/-5 years, prostate volume +/-10 cc, use of antiandrogens, and erectile function. RESULTS: Urinary function/bother scores decreased significantly more after BT both at time B and time C. Bowel function/bother scores tended to be higher after BT, with a lower percentage of patients with painful bowel movements (BT: 12%/27%/15%; EBRT: 19%/52%/35% at time A/B/C; p<0.05 for differences at times B/C) and rectal bleeding (BT: 12%/12%/12%; EBRT: 8%/14%/17%). No difference concerning erectile dysfunction was found (67% vs. 61% with preserved erections firm enough for intercourse after BT vs. EBRT at time C). CONCLUSIONS: BT was associated with higher urinary, but lower rectal toxicity. The risk of treatment-associated erectile dysfunction did not differ between these methods.","Radiother Oncol, 91(2): 225-231","Germany",2009,"Any or unknown","Radiotherapy,Brachytherapy","EPIC","Patient",null,"Case-control","Germany","Patient","Any or unknown","Radiotherapy,Brachytherapy",null,"Case-control","EPIC","2005:2009","Disease"]
[543,"Pinkawa, M., et al. (2009). \"Impact of the target volume (prostate alone vs. prostate with seminal vesicles) and fraction dose (1.8 Gy vs. 2.0 Gy) on quality of life changes after external-beam radiotherapy for prostate cancer.\" Strahlenther Onkol 185(11): 724-730.",null,"Pinkawa, M., et al.","Impact of the target volume (prostate alone vs. prostate with seminal vesicles) and fraction dose (1.8 Gy vs. 2.0 Gy) on quality of life changes after external-beam radiotherapy for prostate cancer","PURPOSE: To evaluate the impact of the clinical target volume (CTV) and fraction dose on quality of life (QoL) after external-beam radiotherapy (EBRT) for prostate cancer. PATIENTS AND METHODS: A group of 283 patients has been surveyed prospectively before, at the last day, at a median time of 2 months and 15 months after EBRT (70.2-72 Gy) using a validated questionnaire (Expanded Prostate Cancer Index Composite). EBRT of prostate alone (P, n = 70) versus prostate with seminal vesicles (PS, n = 213) was compared. Differences of fraction doses (1.8 Gy, n = 80, vs. 2.0 Gy, n = 69) have been evaluated in the patient group receiving a total dose of 72 Gy. RESULTS: Significantly higher bladder and rectum volumes were found at all dose levels for the patients with PS versus P within the CTV (p < 0.001). Similar volumes resulted in the groups with different fraction doses. Paradoxically, bowel function scores decreased significantly less 2 and 15 months after EBRT of PS versus P. 2 months after EBRT, patients with a fraction dose of 2.0 Gy versus 1.8 Gy reported pain with urination (> or = once a day in 12% vs. 3%; p = 0.04) and painful bowel movements (> or = rarely in 46% vs. 29%; p = 0.05) more frequently. No long-term differences were found. CONCLUSION: The risk of adverse QoL changes after EBRT for prostate cancer cannot be derived from the dose-volume histogram alone. Seminal vesicles can be included in the CTV up to a moderate total dose without adverse effects on QoL. Apart from a longer recovery period, higher fraction doses were not associated with higher toxicity.","Strahlenther Onkol, 185(11): 724-730","Germany",2009,"Any or unknown","Radiotherapy","EPIC","Patient",null,"Cohort","Germany","Patient","Any or unknown","Radiotherapy",null,"Cohort","EPIC","2005:2009","Disease"]
[544,"Pinkawa, M., et al. (2009). \"Neoadjuvant hormonal therapy and external-beam radiotherapy versus external-beam irradiation alone for prostate cancer. A quality-of-life analysis.\" Strahlenther Onkol 185(2): 101-108.",null,"Pinkawa, M., et al.","Neoadjuvant hormonal therapy and external-beam radiotherapy versus external-beam irradiation alone for prostate cancer. A quality-of-life analysis","PURPOSE: To evaluate the impact of neoadjuvant hormonal therapy (NHT) on quality of life after external-beam radiotherapy (EBRT) for prostate cancer. PATIENTS AND METHODS: A group of 170 patients (85 with and 85 without NHT) has been surveyed prospectively before EBRT (70.2-72 Gy), at the last day of EBRT, a median time of 2 months and 15 months after EBRT using a validated questionnaire (Expanded Prostate Cancer Index Composite). Pairs with and without NHT (median treatment time of 3.5 months before EBRT) were matched according to the respective planning target volume and prostate volume. RESULTS: Before EBRT, significantly lower urinary function/bother, sexual function and hormonal function/bother scores were found for patients with NHT. More than 1 year after EBRT, only sexual function scores remained lower. In a multivariate analysis, NHT and adjuvant hormonal therapy (HT) versus NHT only (hazard ratio 14; 95% confidence interval 2.7-183; p = 0.02) and luteinizing hormone-releasing hormone (LHRH) agonists versus antiandrogens (hazard ratio 3.6; 95% confidence interval 1.1-12; p = 0.04) proved to be independent risk factors for long-term erectile dysfunction (no or very poor ability to have an erection). CONCLUSION: With the exception of sexual function (additional adjuvant HT and application of LHRH analog independently adverse), short-term NHT was not found to decrease quality of life after EBRT for prostate cancer.","Strahlenther Onkol, 185(2): 101-108","Germany",2009,"Any or unknown","Hormonal,Radiotherapy","EPIC","Patient",null,"Cohort","Germany","Patient","Any or unknown","Hormonal,Radiotherapy",null,"Cohort","EPIC","2005:2009","Disease"]
[545,"Pinkawa, M., et al. (2010). \"Rectal morbidity after permanent interstitial brachytherapy for prostate cancer--impact of day 1 vs. day 30 computed tomography-based postimplant dosimetry.\" Brachytherapy 9(1): 1-7.",null,"Pinkawa, M., et al.","Rectal morbidity after permanent interstitial brachytherapy for prostate cancer--impact of day 1 vs. day 30 computed tomography-based postimplant dosimetry","PURPOSE: The aim of the study was to evaluate bowel quality-of-life changes after prostate brachytherapy and the impact of Day 1 vs. Day 30 postimplant dosimetry. METHODS AND MATERIALS: In 61 patients, computed tomography (CT) scans were performed at Days 1 and 30 after (125)I brachytherapy. The patients have been surveyed prospectively before (time A), 1 month (time B), and >1 year after treatment (time C) using a validated questionnaire (Expanded Prostate Cancer Index Composite). Different parameters were tested for their predictive value on bowel quality-of-life changes (bowel bother score decrease >20 points at time B=BB20; bowel bother score decrease >10 points at time C=BC10), including seed displacements. RESULTS: Mean bowel function/bother score decreased 13/13 points at time B (p<0.01) and 1/4 points at time C (change not significant). BB20 and BC10 were found in 25% and 20% of patients, respectively. Bowel bother score declines at time B correlated well with declines at time C (r=0.53; p<0.01). Prostate volume before implantation and the number of seeds per cubic centimeters were found to be predictive for BB20 and BC10. Smaller rectal wall volumes covered by the 60-100% isodoses at Day 1 were (paradoxically) found to be significantly predictive for BC10. Larger posterior seed displacements between Days 1 and 30 were significantly associated with BB20. CONCLUSIONS: Quality-of-life scores have not been found to change significantly >1 year after brachytherapy. Larger rectal wall volumes within higher isodoses at Day 1 or 30 were not found to be predisposing for adverse quality-of-life changes.","Brachytherapy, 9(1): 1-7","Germany",2010,"Any or unknown","Brachytherapy","EPIC","Patient",null,"Cohort","Germany","Patient","Any or unknown","Brachytherapy",null,"Cohort","EPIC","2010:2014","Disease"]
[546,"Pinkawa, M., et al. (2011). \"Combination of dose escalation with technological advances (intensity-modulated and image-guided radiotherapy) is not associated with increased morbidity for patients with prostate cancer.\" Strahlenther Onkol 187(8): 479-484.",null,"Pinkawa, M., et al.","Combination of dose escalation with technological advances (intensity-modulated and image-guided radiotherapy) is not associated with increased morbidity for patients with prostate cancer","PURPOSE: The aim was to evaluate treatment-related morbidity after intensity-modulated (IMRT) and image-guided (IGRT) radiotherapy with a total dose of 76 Gy in comparison to conventional conformal radiotherapy (3DCRT) up to 70.2-72 Gy for patients with prostate cancer. PATIENTS AND METHODS: All patients were prospectively surveyed prior to, on the last day, as well as after a median time of 2 and 16 months after RT using a validated questionnaire (Expanded Prostate Cancer Index Composite). Criteria for the 78 matched pairs after IMRT vs. 3DCRT were patient age, use of antiandrogens, treatment volume (+/- whole pelvis), prognostic risk group, and urinary/bowel/sexual quality of life (QoL) before treatment. RESULTS: QoL changes after dose-escalated IMRT were found to be similar to QoL changes after 3DCRT in all domains. Only sexual function scores more than 1 year after RT decreased slightly more after 3DCRT in comparison to IMRT (mean 9 vs. 6 points; p = 0.04), with erections firm enough for intercourse in 14% vs. 30% (p = 0.03). Painful bowel movements were reported more frequently after 3DCRT vs. IMRT 2 months after treatment (>/= once a day in 10% vs. 1%; p = 0.03), but a tendency for higher rectal bleeding rates was found after IMRT vs. 3DCRT more than 1 year after RT (>/= rarely in 20% vs. 9%; p = 0.06). CONCLUSION: Combination of dose escalation with technological advances (IMRT and IGRT) is not associated with increased morbidity for patients with prostate cancer.","Strahlenther Onkol, 187(8): 479-484","Germany",2011,"Any or unknown","Radiotherapy","EPIC","Patient",null,"Cohort","Germany","Patient","Any or unknown","Radiotherapy",null,"Cohort","EPIC","2010:2014","Disease"]
[547,"Pinkawa, M., et al. (2012). \"Quality of life after intensity-modulated radiotherapy for prostate cancer with a hydrogel spacer. Matched-pair analysis.\" Strahlenther Onkol 188(10): 917-925.",null,"Pinkawa, M., et al.","Quality of life after intensity-modulated radiotherapy for prostate cancer with a hydrogel spacer. Matched-pair analysis","BACKGROUND: Hydrogel spacer is an innovative method to protect the rectal wall during prostate cancer radiotherapy. Clinical effects are not well known. METHODS: Patients have been surveyed before, at the last day, and 2-3 months after radiotherapy using a validated questionnaire (Expanded Prostate Cancer Index Composite). Median dose to the prostate in the spacer subgroup (SP) was 78 Gy in 2 Gy fractions. The results were independently compared with two matched-pair subgroups (treated conventionally without spacer): 3D conformal 70.2 Gy in 1.8 Gy fractions (3DCRT) and intensity-modulated radiotherapy (IMRT) 76 Gy in 2 Gy fractions. There were 28 patients in each of the three groups. RESULTS: Baseline mean bowel bother scores were 96 points in all subgroups. Similar mean changes (SP 16, 3DCRT 14, IMRT 17 points) were observed at the end of radiotherapy. The smallest difference resulted in the spacer subgroup 2-3 months after radiotherapy (SP 2, 3DCRT 8, IMRT 6 points). Bowel bother scores were only significantly different in comparison to baseline levels in the spacer subgroup. The percentage of patients reporting moderate/big bother with specific symptoms did not increase for any item (urgency, frequency, diarrhoea, incontinence, bloody stools, pain). CONCLUSION: Moderate bowel quality-of-life changes can be expected during radiotherapy irrespective of spacer application or total dose. Advantages with a spacer can be expected a few weeks after treatment.","Strahlenther Onkol, 188(10): 917-925","Germany",2012,"Any or unknown","Radiotherapy,Various","EPIC","Patient",null,"Cohort","Germany","Patient","Any or unknown","Radiotherapy,Various",null,"Cohort","EPIC","2010:2014","Disease"]
[548,"Pinkawa, M., et al. (2014). \"Transurethral resection of the prostate after radiotherapy for prostate cancer: impact on quality of life.\" Int J Urol 21(9): 899-903.",null,"Pinkawa, M., et al.","Transurethral resection of the prostate after radiotherapy for prostate cancer: impact on quality of life","OBJECTIVES: To evaluate the impact of transurethral resection of the prostate on quality of life after radiotherapy for prostate cancer. METHODS: A group of 49 consecutive patients with and 487 without prior transurethral resection of the prostate responded to the Expanded Prostate Cancer Index Composite questionnaire before, on the last day, and a median time of 2 months and 16 months after external beam radiotherapy (70-78 Gy). A matched-pair analysis was used to avoid the influence of treatment-associated confounding factors, including dose, treatment volume and hormonal therapy. RESULTS: Significantly smaller acute urinary score changes relative to baseline levels resulted with versus without prior transurethral resection of the prostate (mean function/bother score decrease of 3/6 vs 18/21 points at the end of radiotherapy; P < 0.01), affecting urinary incontinence (pads to control urinary leakage in 4% vs 24%; P = 0.03) and irritative/obstructive symptoms (big/moderate problem with weak urinary stream in 11% vs 37%; P = 0.02). As opposed to acute changes, transurethral resection of the prostate was a significant predisposing factor for a long-term urinary function score decrease >10 points (20% vs 6% of patients with vs without prior resection; P = 0.04). Urinary incontinence risk was higher for patients with a longer time from resection to radiotherapy. CONCLUSIONS: Transurethral resection of the prostate significantly affects acute (considerably fewer symptoms) and long-term (relevant toxicity in some cases) urinary quality of life after radiotherapy for prostate cancer.","Int J Urol, 21(9): 899-903","Germany",2014,"Any or unknown","Radiotherapy,Surgery","EPIC","Patient",null,"Cohort","Germany","Patient","Any or unknown","Radiotherapy,Surgery",null,"Cohort","EPIC","2010:2014","Disease"]
[549,"Pinkawa, M., et al. (2017). \"Hydrogel injection reduces rectal toxicity after radiotherapy for localized prostate cancer.\" Strahlenther Onkol 193(1): 22-28.",null,"Pinkawa, M., et al.","Hydrogel injection reduces rectal toxicity after radiotherapy for localized prostate cancer","PURPOSE: Injection of a hydrogel spacer before prostate cancer radiotherapy (RT) is known to reduce the dose to the rectal wall. Clinical results from the patient's perspective are needed to better assess a possible benefit. METHODS: A group of 167 consecutive patients who received prostate RT during the years 2010 to 2013 with 2Gy fractions up to 76 Gy (without hydrogel, n = 66) or 76-80 Gy (with hydrogel, n = 101) were included. The numbers of interventions resulting from bowel problems during the first 2 years after RT were compared. Patients were surveyed prospectively before RT, at the last day of RT, and at a median of 2 and 17 months after RT using a validated questionnaire (Expanded Prostate Cancer Index Composite). RESULTS: Baseline patient characteristics were well balanced. Treatment for bowel symptoms (0 vs. 11 %; p < 0.01) and endoscopic examinations (3 vs. 19 %; p < 0.01) were performed less frequently with a spacer. Mean bowel function scores did not change for patients with a spacer in contrast to patients without a spacer (mean decrease of 5 points) >1 year after RT in comparison to baseline, with 0 vs. 12 % reporting a new moderate/big problem with passing stools (p < 0.01). Statistically significant differences were found for the items \"loose stools\", \"bloody stools\", \"painful bowel movements\" and \"frequency of bowel movements\". CONCLUSION: Spacer injection is associated with a significant benefit for patients after prostate cancer RT.","Strahlenther Onkol, 193(1): 22-28","Germany",2017,"Local","Radiotherapy,Various","EPIC","Patient",null,"Clinical trial","Germany","Patient","Local","Radiotherapy,Various",null,"Clinical trial","EPIC","2015:2018","Disease"]
[550,"Pistevou-Gombaki, K., et al. (2003). \"Octreotide for palliative treatment of hepatic metastases from non-neuroendocrine primary tumours: evaluation of quality of life using the EORTC QLQ-C30 questionnaire.\" Palliat Med 17(3): 257-262.",null,"Pistevou-Gombaki, K., et al.","Octreotide for palliative treatment of hepatic metastases from non-neuroendocrine primary tumours: evaluation of quality of life using the EORTC QLQ-C30 questionnaire","BACKGROUND AND AIM: While octreotide has been used in palliative treatment of hepatocellular carcinoma and neuroendocrine tumours with good results, little is known about the possible role of this in palliative treatment of hepatic metastases. MATERIAL AND METHODS: We present our experience from the use of octreotide in palliative treatment of symptomatic liver metastases in 16 patients (11 males, five females, age ranged 43-69 years) with proven hepatic metastases from different primary tumours (six with non-small lung cancer, four with colon carcinoma, two with primary pancreatic head carcinoma, two with prostate cancer and two with adenocarcinoma of the stomach). All patients were administered 20 mg long-acting octreotide IM (octreotide LAR) once the first day, octreotide SC 0.5 mg three times daily on days 2-14 and then 20 mg long-acting octreotide IM every month. Quality of life was assessed by using the European Organization for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30). Tumour response was evaluated by using ultrasonography. RESULTS: One month after baseline, octreotide resulted in significant (P < 0.01, Wilcoxon test) improvement and stabilization of all major related EORTC QLQ-C30 parameters such as global quality of life, pain, fatigue, insomnia, appetite loss as well as physical, emotional, cognitive, social and role functioning. Except for mild hyperglycaemia in six out of 16 patients and mild gastrointestinal complications in one patient, no other severe side effect due to octreotide was reported. Two patients died two months after the initiation of the study due to generalized metastatic disease, while the remaining 14 patients were still alive seven months after the initiation of the study. The hepatic metastases were stabilized and no new lesions were detected by ultrasonography. CONCLUSIONS: Although further studies are warranted, we consider the use of octreotide a good alternative in palliative treatment of symptomatic liver metastases in patients with end-stage malignant disease.","Palliat Med, 17(3): 257-262","Greece",2003,"Metastatic","Various","EORTC QLQ-C30","Patient",null,"Clinical trial","Greece","Patient","Metastatic","Various",null,"Clinical trial","EORTC QLQ-C30","2000:2004","General"]
[551,"Pommier, P., et al. (2007). \"Is there a role for pelvic irradiation in localized prostate adenocarcinoma? Preliminary results of GETUG-01.\" J Clin Oncol 25(34): 5366-5373.",null,"Pommier, P., et al.","Is there a role for pelvic irradiation in localized prostate adenocarcinoma? Preliminary results of GETUG-01","PURPOSE: To assess the benefit and toxicity and quality-of-life (QOL) outcomes of pelvic nodes irradiation in nonmetastatic prostate carcinoma patients. PATIENTS AND METHODS: Between December 1998 and June 2004, 444 patients with T1b-T3, N0 pNx, M0 prostate carcinoma were randomly assigned to either pelvic and prostate radiotherapy or prostate radiotherapy only. Patients were stratified according to the prognostic factor of lymph node involvement (LNI). Short-term 6-month neoadjuvant and concomitant hormonal therapy was allowed only for patients in the high-risk group. The pelvic dose was 46 Gy. The total dose recommended to the prostate was changed during the course of the study from 66 Gy to 70 Gy. Criteria for progression-free survival (PFS) included biologic prostate-specific antigen recurrences or a local or metastatic evolution. Acute and late toxicities were recorded according to the Radiation Therapy Oncology Group and Late Effects in Normal Tissues Subjective, Objective, Management, and Analytic scales, respectively. The QOL outcome was recorded with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C30, the International Prostatic Symptom Score, and the Sexual Function Index scales. RESULTS: With a 42.1-month median follow-up time, the 5-year PFS and overall survival were similar in the two treatment arms for the whole series and for each stratified group. On multivariate analysis, low LNI risk and hormonal therapy were statistically associated with increased PFS. However, subgroup analyses based on these factors did not show any benefit for pelvic irradiation. There were no significant differences in acute and late digestive toxicities and in QOL outcomes. CONCLUSION: Pelvic node irradiation was well tolerated but did not improve PFS.","J Clin Oncol, 25(34): 5366-5373","France",2007,"Advanced,Local","Radiotherapy","RTOG-EORTC-SS,LENT-SOMA,EORTC QLQ-C30,IPSS,SFI","Patient",null,"Clinical trial","France","Patient","Advanced,Local","Radiotherapy",null,"Clinical trial","RTOG-EORTC-SS,LENT-SOMA,EORTC QLQ-C30,IPSS,SFI","2005:2009","General,Disease,Treatment,Complication"]
[552,"Ponholzer, A., et al. (2003). \"Frequent use of complementary medicine by prostate cancer patients.\" Eur Urol 43(6): 604-608.",null,"Ponholzer, A., et al.","Frequent use of complementary medicine by prostate cancer patients","OBJECTIVES: To assess the use of complementary and alternative medicine (CAM) by prostate cancer patients and to characterize CAM-users in this population. METHODS: Prostate cancer patients who underwent routine follow-up at urological practices completed an anonymous, self-administered questionnaire on lower urinary tract function, sexuality, quality of life and use of CAM. All patients with biopsy proven cancer irrespective of age, stage and therapy were eligible. RESULTS: 822 men (69+/-8.5 years; range: 45-95) entered this survey. 245 men (29.8%) used at least one form of CAM, most frequent forms were fat-reduced diet (13.3%), selenium (10.8%) and vitamin E (9.3%). CAM-users did not differ regarding age (68.6 vs. 69.2 years), time interval between diagnosis and current evaluation (4.4 vs. 3.8 years) and PSA at diagnosis (24.9 vs. 18.5 ng/ml) from non-users. CAM-use was dependent on primary therapy (radical prostatectomy: 23.3%, radiotherapy: 31.6%, endocrine therapy: 38.8%) and disease progression. CAM-users were generally less satisfied with their treatment and rated health status and quality of life lower than those not using CAM (all p<0.001). CONCLUSIONS: CAM is used by almost 1/3 of prostate cancer patients in Austria, particularly by those with disease progression, impaired quality of life and treatment satisfaction. Urologists have to be aware of this fact and require a detailed knowledge on this issue to provide objective and evidence-based information.","Eur Urol, 43(6): 604-608","Austria",2003,"Any or unknown","Various","Unclear","Patient",null,"Cross-sectional","Austria","Patient","Any or unknown","Various",null,"Cross-sectional","Unclear","2000:2004","General,Complication"]
[553,"Ponholzer, A., et al. (2006). \"Lower urinary tract symptoms, urinary incontinence, sexual function and quality of life after radical prostatectomy and external beam radiation therapy: real life experience in Austria.\" World J Urol 24(3): 325-330.",null,"Ponholzer, A., et al.","Lower urinary tract symptoms, urinary incontinence, sexual function and quality of life after radical prostatectomy and external beam radiation therapy: real life experience in Austria","The objective of this study was to assess lower urinary tract symptoms (LUTS), urinary incontinence (UI), erectile dysfunction (ED) and quality of life after radical prostatectomy (RPE) and external beam radiation therapy (EBRT) in a \"real-life\" setting. A consecutive series of patients undergoing routine follow-up after RPE and EBRT at 28 Austrian institutions were analyzed. Men who received adjuvant therapy were excluded. All patients completed a questionnaire on (a) LUTS and UI, (b) sexual function and (c) quality of life. A total of 364 patients following RPE and 82 after EBRT entered this study and were compared in a matched pair analysis (1:1) based on age, PSA at diagnosis and follow-up (RPE: n=82; EBRT: n=82). Mean time-interval between treatment and current investigation was 4.6 years for RPE and 4.4 years for EBRT (n.s.). UI was reported by 41.3% after RPE and 18.8% after EBRT (P=0.001). Urgency was more frequent after EBRT, this difference, however, did not reach statistical significance. Moderate to severe ED (IIEF-5, <17) was present in 80.0% after RPE and in 80.8% after EBRT (n.s.). On a ten-point scale, RPE-patients rated their quality of life higher (7.3) than after EBRT (6.7) (P=0.01). In this \"real-life\" setting, RPE and EBRT had significant, yet divergent effects on LUTS, UI and sexual function. The respective numbers were substantially higher than those usually reported by physician-directed studies and centers of excellence.","World J Urol, 24(3): 325-330","Austria",2006,"Any or unknown","Surgery,Radiotherapy","IIEF-5","Patient",null,"Cross-sectional","Austria","Patient","Any or unknown","Surgery,Radiotherapy",null,"Cross-sectional","IIEF-5","2005:2009","General,Complication"]
[554,"Portenoy, R. K., et al. (1994). \"Symptom prevalence, characteristics and distress in a cancer population.\" Qual Life Res 3(3): 183-189.",null,"Portenoy, R. K., et al.","Symptom prevalence, characteristics and distress in a cancer population","Despite the importance of symptom control in the cancer population, few studies have systematically assessed the prevalence and characteristics of symptoms or the interactions between various symptom characteristics and other factors related to quality of life (QOL). As part of a validation study of a new symptom assessment instrument, inpatients and outpatients with prostate, colon, breast or ovarian cancer were evaluated using the Memorial Symptom Assessment Scale and other measures of psychological condition, performance status, symptom distress and overall quality of life. The mean age of the 243 evaluable patients was 55.5 years (range 23-86 years); over 60% were women and almost two-thirds had metastatic disease. The Karnofsky Performance Status (KPS) score was < or = 80 in 49.8% and 123 were inpatients at the time of assessment. Across tumour types, 40-80% experienced lack of energy, pain, feeling drowsy, dry mouth, insomnia, or symptoms indicative of psychological distress. Although symptom characteristics were variable, the proportion of patients who described a symptom as relatively intense or frequent always exceeded the proportion who reported it as highly distressing. The mean (+/- SD range) number of symptoms per patient was 11.5 +/- 6.0 (0-25); inpatients had more symptoms than outpatients (13.5 +/- 5.4 vs. 9.7 +/- 6.0, p < 0.002) and those with KPS < or = 80 had more symptoms than those with KPS > 80 (14.8 +/- 5.5 vs. 9.2 +/- 4.9, p < 0.0001).(ABSTRACT TRUNCATED AT 250 WORDS)","Qual Life Res, 3(3): 183-189","USA",1994,"Any or unknown","None","MSAS","Patient",null,"Cross-sectional","USA","Patient","Any or unknown","None",null,"Cross-sectional","MSAS","1960:1999","Symptom"]
[555,"Portenoy, R. K., et al. (1994). \"The Memorial Symptom Assessment Scale: an instrument for the evaluation of symptom prevalence, characteristics and distress.\" Eur J Cancer 30a(9): 1326-1336.",null,"Portenoy, R. K., et al.","The Memorial Symptom Assessment Scale: an instrument for the evaluation of symptom prevalence, characteristics and distress","The Memorial Symptom Assessment Scale (MSAS) is a new patient-rated instrument that was developed to provide multidimensional information about a diverse group of common symptoms. This study evaluated the reliability and validity of the MSAS in the cancer population. Randomly selected inpatients and outpatients (n = 246) with prostate, colon, breast or ovarian cancer were assessed using the MSAS and a battery of measures that independently evaluate phenomena related to quality of life. Symptom prevalence in the 218 evaluable patients ranged from 73.9% for lack of energy to 10.6% for difficulty swallowing. Based on a content analysis, three symptoms were deleted and two were added; the revised scale evaluates 32 physical and psychological symptoms. A factor analysis of variance yielded two factors that distinguished three major symptom groups and several subgroups. The major groups comprised psychological symptoms (PSYCH), high prevalence physical symptoms (PHYS H), and low prevalence physical symptoms (PHYS L). Internal consistency was high in the PHYS H and PSYCH groups (Cronback alpha coefficients of 0.88 and 0.83, respectively), and moderate in the PHYS L group (alpha = 0.58). Although the severity, frequency and distress dimensions were highly intercorrelated, canonical correlations and other analyses demonstrated that multidimensional assessment (frequency and distress) augments information about the impact of symptoms. High correlations with clinical status and quality of life measures support the validity of the MSAS and indicate the utility of several subscale scores, including PSYCH, PHYS, and a brief Global Distress Index. The MSAS is a reliable and valid instrument for the assessment of symptom prevalence, characteristics and distress. It provides a method for comprehensive symptom assessment that may be useful when information about symptoms is desirable, such as clinical trials that incorporate quality of life measures or studies of symptom epidemiology.","Eur J Cancer, 30a(9): 1326-1336","USA",1994,"Any or unknown","None","MSAS","Patient",null,"Validation","USA","Patient","Any or unknown","None",null,"Validation","MSAS","1960:1999","Symptom"]
[556,"Prezioso, D., et al. (2007). \"Quality of life evaluation by the EORTC QLQ-C30 questionnaire in patients treated with hormonal treatment in Italy. A QuABIOS group study.\" Arch Ital Urol Androl 79(3): 99-103.",null,"Prezioso, D., et al.","Quality of life evaluation by the EORTC QLQ-C30 questionnaire in patients treated with hormonal treatment in Italy. A QuABIOS group study","OBJECTIVES: An observational study was planned by the QuABIOS group, to survey the hormonal treatment administered to prostate cancer patients in Italy within a time window of 12 months. We report here a prospective quality of life (QOL) evaluation over time and by hormonal treatment modalities. METHODS: Patients with diagnosis of prostate cancer and treated with hormonal therapy were eligible for this study. The EORTC QLQ-C30 v.3 questionnaire was administered at enrolment, after 6 months and after 12 months from enrolment. RESULTS: 587 patients were enrolled by 33 urological centers. When 1518 visits were considered together independently of time, antiandrogen monotherapy was associated with a significantly better QOL than LHRH-analogue containing treatment modalities in almost all functional scales; cyproterone acetate demonstrated a better physical function and general health status than bicalutamide. When QOL was analyzed in a prospective 12-month window, a worsening of physical function and general health status was observed, notwithstanding, antiandrogens remained significantly associated to a better QOL than LHRH-analogue therapies also over time: a favourable physical function and general health status appeared again to be related to cyproterone acetate than bicalutamide. CONCLUSIONS: Androgen deprivation therapy is associated with decline in QOL, particularly in the domains of physical function, energy, and general health status. This survey demonstrated that antiandrogens had a better QOL profile than LHRH-analogue containing therapies;furthermore, a more favourable tolerability for cyproterone acetate as compared to bicalutamide is suggested.","Arch Ital Urol Androl, 79(3): 99-103","Italy",2007,"Any or unknown","Hormonal","EORTC QLQ-C30","Patient",null,"Cohort","Italy","Patient","Any or unknown","Hormonal",null,"Cohort","EORTC QLQ-C30","2005:2009","General"]
[557,"Protopapa, E., et al. (2017). \"Patient-reported outcome (PRO) questionnaires for men who have radical surgery for prostate cancer: a conceptual review of existing instruments.\" BJU Int 120(4): 468-481.",null,"Protopapa, E., et al.","Patient-reported outcome (PRO) questionnaires for men who have radical surgery for prostate cancer: a conceptual review of existing instruments","To critically review conceptual frameworks for available patient-reported outcome (PRO) questionnaires in men having radical prostatectomy (RP), psychometrically evaluate each questionnaire, and identify whether each is appropriate for use at the level of the individual patient. We searched PubMed, the Reports and Publications database of the University of Oxford Patient-Reported Outcomes Measurement Group and the website of the International Consortium for Health Outcomes Measurement (ICHOM) for psychometric reviews of prostate cancer-specific PRO questionnaires. From these we identified relevant questionnaires and critically appraised the conceptual content, guided by the Wilson and Cleary framework and psychometric properties, using well established criteria. The searches found four reviews and one recommendation paper. We identified seven prostate cancer-specific PROs: the Expanded Prostate Cancer Index Composite-26 (EPIC-26), Expanded Prostate Cancer Index Composite-50 (EPIC-50), University of California-Los Angeles Prostate Cancer Index (UCLA-PCI), Functional Assessment of Cancer Therapy - Prostate Cancer Subscale (FACT-P PCS), European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - prostate specific 25-item (EORTC QLQ-PR25), Prostate Cancer - Quality of Life (PC-QoL), and Symptom Tracking and Reporting (STAR). Six out of seven measures purported to measure health-related quality of life (HRQL), but items focused strongly on urinary and sexual symptoms/functioning. The remaining questionnaire (STAR) claimed to assess functional recovery after RP. The psychometric evidence for these questionnaires was incomplete and variable in quality; none had evidence that they were appropriate for use with individual patients. Several questionnaires provide the basis of measures of urinary and/or sexual symptoms/functioning. Further work should explore other aspects of HRQL that are important for men having RP. Further psychometric work is also needed to determine whether they can be used at the individual level.","BJU Int, 120(4): 468-481","International",2017,"Any or unknown","Surgery","EPIC,UCLA-PCI,FACT-P,EORTC QLQ-PR25,PC-QoL,STAR","Patient",null,"Systematic review","International","Patient","Any or unknown","Surgery",null,"Systematic review","EPIC,UCLA-PCI,FACT-P,EORTC QLQ-PR25,PC-QoL,STAR","2015:2018","Disease,Symptom"]
[558,"Punnen, S., et al. (2012). \"Among potent men post radical prostatectomy, does the need for phosphodiesterase inhibitors have an impact on sexual bother scores?\" BJU Int 109(10): 1520-1524.",null,"Punnen, S., et al.","Among potent men post radical prostatectomy, does the need for phosphodiesterase inhibitors have an impact on sexual bother scores?","Study Type - Therapy (case series) Level of Evidence 4. What's known on the subject? and What does the study add? Although phosphodiesterase inhibitor use post radical prostatectomy improves potency, little is known about its affects on sexual bother. We found no difference in sexual bother scores between patients who use and do not use phosphodiesterase inhibitors. This suggests that the current definition of potency, inclusive of medication use, is valid with respect to sexual bother. OBJECTIVE: To determine whether the current definition of potency, inclusive of phosphodiesterase inhibitor (PDEi) use, is valid with respect to sexual bother (SB). This will be assessed by characterizing the effect of PDEi use on SB scores in men who are potent post radical prostatectomy. PATIENTS AND METHODS: The study population consisted of patients who were potent both before and after radical prostatectomy, with at least 2 years of follow-up. Disease-specific quality of life data were evaluated by the University of California, Los Angeles, Prostate Cancer Index (PCI) survey. The relationships between changes in sexual function (SF) and SB and use of PDEi over time were evaluated by mixed model analysis controlling for age, clinical risk group, marital status, and time of PCI assessment. RESULTS: Of the 246 patients who met the study criteria, 39% reported PDEi use at some point after treatment. PDEi use was not associated with improved SF (P= 0.81). Furthermore, PDEi use was not associated with a change in SB (P= 0.36). Both SF and SB were significantly associated with time of assessment and age, and SF and SB each improved over time. In addition, SB was significantly associated with marital status. CONCLUSIONS: In this analysis, there was no difference in SF scores between men who were potent with or without the use of PDEi. Furthermore, there was no difference in SB scores between men who were potent with or without the use of PDEi. This suggests that the current, inclusive, definition of potency is valid with respect to SB.","BJU Int, 109(10): 1520-1524","USA",2012,"Any or unknown","Surgery,PDEi","UCLA-PCI","Patient",null,"Cohort","USA","Patient","Any or unknown","Surgery,PDEi",null,"Cohort","UCLA-PCI","2010:2014","Disease"]
[559,"Purohit, O. P., et al. (1994). \"High-dose intravenous pamidronate for metastatic bone pain.\" Br J Cancer 70(3): 554-558.",null,"Purohit, O. P., et al.","High-dose intravenous pamidronate for metastatic bone pain","The bisphosphonates are able to relieve pain from metastatic bone disease and, when given intravenously, may promote bone healing of lytic metastases. In this study, the aim was to assess the acute effects of a single 'high-dose' intravenous treatment with pamidronate on pain, mobility, analgesic consumption and quality of life (QOL). Thirty-four normocalcaemic patients with painful progressing bone metastases (22 from breast, five prostate and seven others) received a single intravenous infusion of 120 mg of pamidronate as palliative therapy. No other systemic therapy or drugs known to influence bone metabolism were administered during the study. Patients' subjective response to treatment was assessed weekly with a pain questionnaire recording a composite of pain intensity, mobility, performance status and analgesic consumption. In addition, patients completed the Rotterdam Symptom Check List (RSCL) for measurement of QOL and a mobility questionnaire. The mean reduction in the pain questionnaire score (recorded on at least two occasions) was 25% [standard error (s.e.) 3%, range 0-75%]. Twenty patients (59%) showed a > or = 20% improvement and were classified as responders. The median duration of symptomatic response was 12 (range 4-24 +) weeks. The responding patients showed a reduction in RSCL score (improvement in QOL) from 35% before treatment to 27% at 6 weeks, but no significant improvement was noted in non-responders. Twenty-one patients were retreated with pamidronate when their symptoms deteriorated again. Eight out of 15 responders showed a second reduction in pain score of > or = 20%, but this was not seen in any of the six non-responders. Five patients have remained well with no additional treatment for their disease other than repeat infusions of pamidronate every 3-6 months. Treatment was well tolerated. Eight (24%) experienced fever after the first treatment only, and four had asymptomatic, biochemical evidence of hypocalcaemia. The acute inhibition of osteoclastic bone resorption induced by a single high-dose treatment with pamidronate can provide useful palliation for patients with bone metastases. Responding patients may be retreated as symptoms dictate to good effect. We are currently running a phase III double-blind trial with high-dose pamidronate for progressive painful metastatic bone disease to exclude any placebo effect and observer bias.","Br J Cancer, 70(3): 554-558","UK",1994,"Metastatic","Bisphosphonate","RSCL","Patient",null,"Clinical trial","UK","Patient","Metastatic","Bisphosphonate",null,"Clinical trial","RSCL","1960:1999","Symptom"]
[560,"Quattrone, C., et al. (2015). \"Retropubic, laparoscopic and mini-laparoscopic radical prostatectomy: a prospective assessment of patient scar satisfaction.\" World J Urol 33(8): 1181-1187.",null,"Quattrone, C., et al.","Retropubic, laparoscopic and mini-laparoscopic radical prostatectomy: a prospective assessment of patient scar satisfaction","PURPOSE: To compare patient scar satisfaction after retropubic, standard laparoscopic, mini-laparoscopic (ML) and open radical prostatectomy (RP). METHODS: Patients undergoing RP for a diagnosis of localized prostate cancer at a single academic hospital between September 2012 and December 2013 were enrolled in this prospective nonrandomized study. The patients were included in three study arms: open surgery, VLP and ML. A skin stapler was used for surgical wound closure in all cases. Demographic and main surgical outcomes, including perioperative complications, were analyzed. Surgical scar satisfaction was measured using the Patient and Observer Scar Assessment Questionnaire (POSAS) and the two Body Image Questionnaire (BIQ) scales, respectively, recorded at skin clips removal and either at 6 months after surgery. RESULTS: Overall, 32 patients were enrolled and completed the 6 month of follow-up. At clips removal, laparoscopic approaches offered better scar result than open surgery according to the POSAS. However, at 6 months, no differences were detected between VLP and open, whereas ML was still associated with a better scar outcome (p = 0.001). This finding was also confirmed by both BIQ scales, including the body image score (ML 9.8 +/- 1.69, open 15.73 +/- 3.47, VLP 13.27 +/- 3.64; p = 0.001) and the cosmetic score (ML 16.6 +/- 4.12, open 10 +/- 1.9, LP 12.91 +/- 3.59; p = 0.001). Small sample size and lack of randomization represent the main limitations of this study. CONCLUSIONS: ML RP offers a better cosmetic outcome when compared to both open and standard laparoscopic RP, representing a step toward minimal surgical scar. The impact of scar outcome on RP patients' quality of life remains to be determined.","World J Urol, 33(8): 1181-1187","Italy",2015,"Local","Surgery","BIS,POSAS","Patient",null,"Clinical trial","Italy","Patient","Local","Surgery",null,"Clinical trial","BIS,POSAS","2015:2018","General,Satisfaction"]
[561,"Quon, H., et al. (2012). \"Quality of life after hypofractionated concomitant intensity-modulated radiotherapy boost for high-risk prostate cancer.\" Int J Radiat Oncol Biol Phys 83(2): 617-623.",null,"Quon, H., et al.","Quality of life after hypofractionated concomitant intensity-modulated radiotherapy boost for high-risk prostate cancer","PURPOSE: To evaluate the change in health-related quality of life (QOL) of patients with high-risk prostate cancer treated using hypofractionated radiotherapy combined with long-term androgen deprivation therapy. METHODS AND MATERIALS: A prospective Phase I-II study enrolled patients with any of the following: clinical Stage T3 disease, prostate-specific antigen level >/=20 ng/mL, or Gleason score 8-10. Radiotherapy consisted of 45 Gy (1.8 Gy per fraction) to the pelvic lymph nodes with a concomitant 22.5 Gy intensity-modulated radiotherapy boost to the prostate, for a total of 67.5 Gy (2.7 Gy per fraction) in 25 fractions over 5 weeks. Daily image guidance was performed using three gold seed fiducials. Quality of life was measured using the Expanded Prostate Cancer Index Composite (EPIC), a validated tool that assesses four primary domains (urinary, bowel, sexual, and hormonal). RESULTS: From 2004 to 2007, 97 patients were treated. Median follow-up was 39 months. Compared with baseline, at 24 months there was no statistically significant change in the mean urinary domain score (p = 0.99), whereas there were decreases in the bowel (p < 0.01), sexual (p < 0.01), and hormonal (p < 0.01) domains. The proportion of patients reporting a clinically significant difference in EPIC urinary, bowel, sexual, and hormonal scores at 24 months was 27%, 31%, 55%, and 60%, respectively. However, moderate and severe distress related to these symptoms was minimal, with increases of only 3% and 5% in the urinary and bowel domains, respectively. CONCLUSIONS: Hypofractionated radiotherapy combined with long-term androgen deprivation therapy was well tolerated. Although there were modest rates of clinically significant patient-reported urinary and bowel toxicity, most of this caused only mild distress, and moderate and severe effects on QOL were limited. Additional follow-up is ongoing to characterize long-term QOL.","Int J Radiat Oncol Biol Phys, 83(2): 617-623","Canada",2012,"Advanced","Radiotherapy,Hormonal","EPIC","Patient",null,"Clinical trial","Canada","Patient","Advanced","Radiotherapy,Hormonal",null,"Clinical trial","EPIC","2010:2014","Disease"]
[562,"Rago, R. P., et al. (2003). \"Safety and efficacy of the MDR inhibitor Incel (biricodar, VX-710) in combination with mitoxantrone and prednisone in hormone-refractory prostate cancer.\" Cancer Chemother Pharmacol 51(4): 297-305.",null,"Rago, R. P., et al.","Safety and efficacy of the MDR inhibitor Incel (biricodar, VX-710) in combination with mitoxantrone and prednisone in hormone-refractory prostate cancer","PURPOSE: VX-710 (biricodar, Incel) restores drug sensitivity to cells expressing P-glycoprotein (P-gp) and multidrug resistance-associated protein (MRP1). MRP1 is expressed in a high proportion of prostate tumors while P-gp expression is variable. Since mitoxantrone (M) and prednisone (P) are substrates for MDR transporters, we initiated a study to evaluate the safety, pharmacokinetics, and efficacy of VX-710 plus M/P in patients with hormone-refractory prostate cancer (HRPC). PATIENTS AND METHODS: Eligible patients had progressive HRPC (defined as new lesions, new disease-related pain, or 50% increase in PSA within 6 weeks of entry), testosterone <30 ng/ml, no prior chemotherapy, ECOG performance status of 0-3, and adequate organ function. Patients received VX-710 (120 mg/m(2) per h) as a 72-h continuous intravenous infusion with intravenous bolus mitoxantrone (12 mg/m(2)) administered 4 h after VX-710 was started and prednisone (5 mg twice daily) administered throughout the study treatment. Endpoints included serum PSA response, PSA response duration, time to PSA progression, pain reduction, and quality of life measures. RESULTS: Enrolled in the study were 40 patients and 184 courses of VX-710 plus M/P were administered. Intensive pharmacokinetics, which were performed on six patients who received one cycle of M/P alone, followed by VX-710 plus M/P for all other cycles, showed that VX-710 did not alter mitoxantrone clearance. VX-710 blood concentration at the time of mitoxantrone administration averaged 4.52 microg/ml. VX-710 plus M/P was well tolerated. Transient nausea/vomiting and mild neutropenia were the principal treatment toxicities. Five patients experienced an uncomplicated febrile neutropenic episode (12%), three had severe nausea/vomiting, and two experienced transient moderate to severe ataxia. Of the 40 patients, 12 (30%, 95% confidence interval 16-44%) had a reduction in PSA of >/=50% and 9 of the 12 patients (23% overall, 95% CI 10-35%) achieved a reduction in PSA of >/=80% that was sustained for the duration of treatment with M/P plus VX-710. The median time to PSA progression was 41 weeks (95% CI 34-68 weeks). Of the 40 patients, 15 completed treatment with stable disease and 13 had progressive disease with increasing serum PSA during study treatment. Median survival was 48 weeks for the intent-to-treat population of 40 patients. CONCLUSIONS: The addition of VX-710 to M/P therapy did not appear to increase the proportion of patients with significant serum PSA reductions compared to M/P alone. However, the duration of PSA response observed for the 12 PSA responders suggests that MDR inhibition may benefit some patients with HRPC. In addition to MRP1 or P-gp expression, other mechanisms of drug resistance are probably associated with the relative insensitivity of HRPC to cytotoxic therapy.","Cancer Chemother Pharmacol, 51(4): 297-305","USA",2003,"Any or unknown","Chemotherapy","Unclear","Patient",null,"Clinical trial","USA","Patient","Any or unknown","Chemotherapy",null,"Clinical trial","Unclear","2000:2004","General,Symptom"]
[563,"Ramachandra, P., et al. (2009). \"A brief self-administered psychological intervention to improve well-being in patients with cancer: results from a feasibility study.\" Psychooncology 18(12): 1323-1326.",null,"Ramachandra, P., et al.","A brief self-administered psychological intervention to improve well-being in patients with cancer: results from a feasibility study","BACKGROUND: Patients with cancer have relatively high rates of anxiety and distress, adversely affecting their well-being and quality of life. Recent studies indicate that addressing these symptoms could result in better response to cancer treatment. Researchers have found that interventions that focus on increasing mental awareness and the frequency of positive experiences may have a greater impact on reducing psychological morbidity and increasing quality of life than interventions that target relief of psychological symptoms. AIM: To develop and test a brief, easy to use intervention that could improve well-being and quality of life in cancer patients. METHODS: We developed a simple well-being intervention that made few demands on patient time and required little training resource. Participants were randomly assigned to an intervention group or a deferred entry group. Measures of anxiety, depression, well-being and quality of life were administered at baseline and at follow-ups. RESULTS: Twenty-two women with metastatic breast cancer and 24 men with metastatic prostate cancer were recruited from oncology clinics. Thirteen women and 14 men completed the study. Both qualitative and quantitative data showed that the intervention was acceptable to users. There was statistically significant improvement in quality of life scores on WHOQOL-BREF post-intervention (p=0.046). Compliance with the intervention was good. CONCLUSIONS: This brief well-being intervention appears to be a promising technique for improving quality of life of cancer patients, without making undue demands on staff resources or patient time. If further studies confirm its effectiveness, it could prove to be a cost-effective intervention.","Psychooncology, 18(12): 1323-1326","UK",2009,"Metastatic","Psychological","WHOQOL-BREF","Patient",null,"Clinical trial","UK","Patient","Metastatic","Psychological",null,"Clinical trial","WHOQOL-BREF","2005:2009","General"]
[564,"Ramsay, C. R., et al. (2015). \"Ablative therapy for people with localised prostate cancer: a systematic review and economic evaluation.\" Health Technol Assess 19(49): 1-490.",null,"Ramsay, C. R., et al.","Ablative therapy for people with localised prostate cancer: a systematic review and economic evaluation","BACKGROUND: For people with localised prostate cancer, active treatments are effective but have significant side effects. Minimally invasive treatments that destroy (or ablate) either the entire gland or the part of the prostate with cancer may be as effective and cause less side effects at an acceptable cost. Such therapies include cryotherapy, high-intensity focused ultrasound (HIFU) and brachytherapy, among others. OBJECTIVES: This study aimed to determine the relative clinical effectiveness and cost-effectiveness of ablative therapies compared with radical prostatectomy (RP), external beam radiotherapy (EBRT) and active surveillance (AS) for primary treatment of localised prostate cancer, and compared with RP for salvage treatment of localised prostate cancer which has recurred after initial treatment with EBRT. DATA SOURCES: MEDLINE (1946 to March week 3, 2013), MEDLINE In-Process & Other Non-Indexed Citations (29 March 2013), EMBASE (1974 to week 13, 2013), Bioscience Information Service (BIOSIS) (1956 to 1 April 2013), Science Citation Index (1970 to 1 April 2013), Cochrane Central Register of Controlled Trials (CENTRAL) (issue 3, 2013), Cochrane Database of Systematic Reviews (CDSR) (issue 3, 2013), Database of Abstracts of Reviews of Effects (DARE) (inception to March 2013) and Health Technology Assessment (HTA) (inception to March 2013) databases were searched. Costs were obtained from NHS sources. REVIEW METHODS: Evidence was drawn from randomised controlled trials (RCTs) and non-RCTs, and from case series for the ablative procedures only, in people with localised prostate cancer. For primary therapy, the ablative therapies were cryotherapy, HIFU, brachytherapy and other ablative therapies. The comparators were AS, RP and EBRT. For salvage therapy, the ablative therapies were cryotherapy and HIFU. The comparator was RP. Outcomes were cancer related, adverse effects (functional and procedural) and quality of life. Two reviewers extracted data and carried out quality assessment. Meta-analysis used a Bayesian indirect mixed-treatment comparison. Data were incorporated into an individual simulation Markov model to estimate cost-effectiveness. RESULTS: The searches identified 121 studies for inclusion in the review of patients undergoing primary treatment and nine studies for the review of salvage treatment. Cryotherapy [3995 patients; 14 case series, 1 RCT and 4 non-randomised comparative studies (NRCSs)], HIFU (4000 patients; 20 case series, 1 NRCS) and brachytherapy (26,129 patients; 2 RCTs, 38 NRCSs) studies provided limited data for meta-analyses. All studies were considered at high risk of bias. There was no robust evidence that mortality (4-year survival 93% for cryotherapy, 99% for HIFU, 91% for EBRT) or other cancer-specific outcomes differed between treatments. For functional and quality-of-life outcomes, the paucity of data prevented any definitive conclusions from being made, although data on incontinence rates and erectile dysfunction for all ablative procedures were generally numerically lower than for non-ablative procedures. The safety profiles were comparable with existing treatments. Studies reporting the use of focal cryotherapy suggested that incontinence rates may be better than for whole-gland treatment. Data on AS, salvage treatment and other ablative therapies were too limited. The cost-effectiveness analysis confirmed the uncertainty from the clinical review and that there is no technology which appears superior, on the basis of current evidence, in terms of average cost-effectiveness. The probabilistic sensitivity analyses suggest that a number of ablative techniques are worthy of further research. LIMITATIONS: The main limitations were the quantity and quality of the data available on cancer-related outcomes and dysfunction. CONCLUSIONS: The findings indicate that there is insufficient evidence to form any clear recommendations on the use of ablative therapies in order to influence current clinical practice. Research efforts in the use of ablative therapies in the management of prostate cancer should now be concentrated on the performance of RCTs and the generation of standardised outcomes. STUDY REGISTRATION: This study is registered as PROSPERO CRD42012002461. FUNDING: The National Institute for Health Research Health Technology Assessment programme.","Health Technol Assess, 19(49): 1-490","International",2015,"Local","Surgery,Radiotherapy,Surveillance,HIFU,Brachytherapy,Various","Unclear","Patient",null,"Systematic review","International","Patient","Local","Surgery,Radiotherapy,Surveillance,HIFU,Brachytherapy,Various",null,"Systematic review","Unclear","2015:2018","Complication"]
[565,"Ravasco, P., et al. (2003). \"Does nutrition influence quality of life in cancer patients undergoing radiotherapy?\" Radiother Oncol 67(2): 213-220.",null,"Ravasco, P., et al.","Does nutrition influence quality of life in cancer patients undergoing radiotherapy?","PURPOSE: To investigate in cancer patients referred for radiotherapy (RT): (1) quality of life (QoL), nutritional status and nutrient intake, at the onset and at the end of RT; (2) whether individualised nutritional counselling, despite symptoms, was able to enhance nutrient intake over time and whether the latter influenced the patient's QoL; and (3) which symptoms may anticipate poorer QoL and/or reduced nutritional intake. MATERIAL AND METHODS: One hundred and twenty-five patients with tumours of the head-neck/gastrointestinal tract (high-risk: HR), prostate, breast, lung, brain, gallbladder, uterus (low-risk: LR) were evaluated before and at the end of RT. Nutritional status was evaluated by Ottery's Subjective Global Assessment, nutritional intake by a 24-h recall food questionnaire and QoL by two instruments: EUROQOL and the European Organisation for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30. RESULTS: Baseline malnutrition was prevalent in HR vs. LR (P=0.02); nutritional intake was associated with nutritional status (P=0.007); the latter did not change significantly during RT. In LR, baseline energy intake was higher than EER (P=0.001), and higher than HR' intake (P=0.002); the latter increased (P<0.03), in spite of symptom increase anew and/or in severity (P=0.0001). According to both instruments, QoL was always better in LR vs. HR (P=0.01); at the end of RT, QoL improvement in HR was correlated with increased nutritional intake (P=0.001), both remained stable in LR. CONCLUSIONS: Individualised nutritional counselling accounting for nutritional status and clinical condition, was able to improve nutritional intake and patients' QoL, despite self-reported symptoms.","Radiother Oncol, 67(2): 213-220","Portugal",2003,"Any or unknown","Radiotherapy,Various","EORTC QLQ-C30,EQ-5D,OSGA,FFQ","Patient",null,"Cohort","Portugal","Patient","Any or unknown","Radiotherapy,Various",null,"Cohort","EORTC QLQ-C30,EQ-5D,OSGA,FFQ","2000:2004","General,Utility"]
[566,"Reddy, S. M., et al. (1997). \"Patient self-assessment of complications and quality of life after conformal neutron and photon irradiation for localized prostate cancer.\" Radiat Oncol Investig 5(5): 252-256.",null,"Reddy, S. M., et al.","Patient self-assessment of complications and quality of life after conformal neutron and photon irradiation for localized prostate cancer","Although neutron irradiation for prostate cancer has been associated with significant morbidity, pilot data in patients with early stage disease suggested that conformal neutron and photon irradiation was well tolerated without severe complications. A self-assessment questionnaire was mailed to the first 83 patients treated with conformal neutron and photon irradiation to objectively evaluate the impact on quality of life of this regimen. In total, 75 patients (90%) returned the completed questionnaire. These patients had received either 9 neutron Gy (N Gy) plus 38 photon Gy (50 patients) or 10 N Gy plus 38 photon Gy (33 patients) for stage T1/T2 N0 M0 prostate cancer (Gleason score < or = 7). The irradiated volume included the prostate and seminal vesicles with a 1.5 cm margin. Neutrons were delivered as a boost to the prostate only with a non-axial four field beam arrangement. Approximately 50% of the dose to the prostate was from neutron irradiation. Follow-up ranged from 6 to 25 months (median 13 months). The questionnaire used was a validated quality of life instrument used previously in patients treated with surgery or radiation. Prior to irradiation, 29% of patients reported urinary symptoms and 11% had prostate surgery (TURP). At follow-up, 23% reported persistent urinary symptoms. Of these, 21% dripped a few drops of urine, 3% used pads but none leaked > 1 tablespoon/day. One patient underwent surgery to dilate a urethral stricture. Although 55% of patients had gastrointestinal symptoms during radiation therapy, only 26% had persistent symptoms at the time of questioning. These included minor rectal bleeding in 20% and significant hematochezia in 3%. Of the 85% of patients able to obtain full or partial erections prior to irradiation, 87% maintained their potency. Fifteen percent sought treatment for impotence. Overall, at last follow-up, 84% felt little or no physical discomfort, 91% were very satisfied with their treatment, and 97% would choose radiation therapy again. This patient self-assessment questionnaire confirmed that this regimen of conformal neutron and photon irradiation resulted in levels of chronic toxicity acceptable to the patient.","Radiat Oncol Investig, 5(5): 252-256","USA",1997,"Local","Radiotherapy","Unclear","Patient",null,"Cross-sectional","USA","Patient","Local","Radiotherapy",null,"Cross-sectional","Unclear","1960:1999","General,Complication"]
[567,"Rees, J., et al. (2005). \"The measurement of response shift in patients with advanced prostate cancer and their partners.\" Health Qual Life Outcomes 3: 21.",null,"Rees, J., et al.","The measurement of response shift in patients with advanced prostate cancer and their partners","BACKGROUND: There is increasing evidence to support the phenomenon of response shift (RS) in quality of life (QoL) studies, with many current QoL measures failing to allow for this. If significant response shift occurs amongst prostate cancer patients, it will be necessary to allow for this in the design of future clinical research and to reassess the conclusions of previous studies that have not allowed for this source of bias. This study therefore aimed to assess the presence of RS and psychosocial morbidity in patients with advanced prostate cancer and their partners. METHODS: 55 consecutive advanced prostate cancer patients and their partners completed the Prostate Cancer Patient & Partner questionnaire (PPP), shortly after diagnosis and again at 3 months and 6 months. At the follow-up visits, both patients and partners also completed a then-test in order to assess RS. RESULTS: Partners consistently showed greater psychological morbidity than patients in relation to the prostate cancer. This was most marked on the General Cancer Distress (GCD) subscale (p < 0.001, paired t-test), and regarding worries about treatment (p = 0.01). Significant RS was identified in partners and patients by the use of the then-test technique, particularly on the GCD subscale, the concerns about treatment and the concerns about urinary symptoms items. CONCLUSION: These results suggest the presence of RS in patients with advanced prostate cancer and their partners, with higher levels of psychosocial morbidity noted amongst partners. This is the first study to identify RS in partners and calls into question the interpretation of all studies assessing changes in QoL that fail to allow for this phenomenon.","Health Qual Life Outcomes, 3(21","UK",2005,"Advanced","Unclear","PPP","Patient,Caregiver",null,"Cohort","UK","Patient,Caregiver","Advanced","Unclear",null,"Cohort","PPP","2005:2009","Disease"]
[568,"Reeve, B. B., et al. (2009). \"Impact of cancer on health-related quality of life of older Americans.\" J Natl Cancer Inst 101(12): 860-868.",null,"Reeve, B. B., et al.","Impact of cancer on health-related quality of life of older Americans","BACKGROUND: The impact of cancer on health-related quality of life (HRQOL) is poorly understood because of the lack of baseline HRQOL status before cancer diagnosis. To our knowledge, this is the first population-based study to quantify the nature and extent of HRQOL changes from before to after cancer diagnosis for nine types of cancer patients and to compare their health with individuals without cancer. METHODS: The Surveillance, Epidemiology, and End Results cancer registry data were linked with the Medicare Health Outcomes Survey (MHOS) data; data were collected from Medicare beneficiaries who were aged 65 years and older from 1998 through 2003. Cancer patients (n = 1432; with prostate, breast, colorectal, lung, bladder, endometrial, or kidney cancers; melanoma; or non-Hodgkin lymphoma [NHL]) were selected whose first cancer diagnosis occurred between their baseline and follow-up MHOS assessments. Control subjects without cancer (n = 7160) were matched to cancer patients by use of propensity scores that were estimated from demographics and comorbid medical conditions. Analysis of covariance models were used to estimate changes in HRQOL as assessed with the Medical Outcomes Study Short Form-36 survey (mean score = 50, SD = 10). All statistical tests were two-sided. RESULTS: Patients with all cancer types (except melanoma and endometrial cancer) reported statistically significant declines in physical health (mean scores: prostate cancer = -3.4, 95% confidence interval [CI] = -2.5 to -4.2; breast cancer = -3.5, 95% CI = -2.5 to -4.5; bladder cancer = -4.3, 95% CI = -2.5 to -6.1; colorectal cancer = -4.4, 95% CI = -3.3 to -5.5; kidney cancer = -5.7, 95% CI = -3.2 to -8.2; NHL = -6.7, 95% CI = -4.4 to -9.1; and lung cancer = -7.5, 95% CI = -5.9 to -9.2) compared with the control subjects (mean score = -1.8, 95% CI = -1.6 to -2.0) (all P < .05). However, only lung (mean score = -5.4, 95% CI = -3.5 to -7.2), colorectal (mean score = -3.5, 95% CI = -2.2 to -4.7), and prostate (mean score = -2.8, 95% CI = -1.8 to -3.7) cancer patients showed statistically significant decreases in mental health relative to the mean change of the control subjects (mean score = -1.2, 95% CI = -0.9 to -1.4) (all P < .05). CONCLUSION: These findings provide validation of the specific deleterious effects of cancer on HRQOL and an evidence base for future research and clinical interventions aimed at understanding and remediating these effects.","J Natl Cancer Inst, 101(12): 860-868","USA",2009,"Any or unknown","None","SF-36","Patient",null,"Cohort","USA","Patient","Any or unknown","None",null,"Cohort","SF-36","2005:2009","Utility"]
[569,"Register, S. P., et al. (2013). \"An MRI-based dose--reponse analysis of urinary sphincter dose and urinary morbidity after brachytherapy for prostate cancer in a phase II prospective trial.\" Brachytherapy 12(3): 210-216.",null,"Register, S. P., et al.","An MRI-based dose--reponse analysis of urinary sphincter dose and urinary morbidity after brachytherapy for prostate cancer in a phase II prospective trial","PURPOSE: To compare dose-volume histogram variables for the internal and external urinary sphincters (IUS/EUS) with urinary quality of life after prostate brachytherapy. METHODS AND MATERIALS: Subjects were 42 consecutive men from a prospective study of brachytherapy as monotherapy with (125)I for intermediate-risk localized prostate cancer. No patient received hormonal therapy. Preplanning constraints included prostate V100 higher than 95%, V150 lower than 60%, and V200 lower than 20% and rectal R100 less than 1cm(3). Patients completed the Expanded Prostate Cancer Index Composite quality-of-life questionnaire before and at 1, 4, 8, and 12 months after implantation, and urinary domain scores were analyzed. All structures including the IUS and EUS were contoured on T2-weighted MRI at day 30, and doses received were calculated from identification of seeds on CT. Spearman's (nonparametric) rank correlation coefficient (rho) was used for statistical analyses. RESULTS: Overall urinary morbidity was worst at 1 month after the implant. Urinary function declined when the IUS V285 was 0.4% (rho=-0.32, p=0.04); bother worsened when the IUS V35 was 99% (rho=-0.31, p=0.05) or the EUS V240 was 63% (rho=-0.31, p=0.05); irritation increased when the IUS V35 was 95% (rho=-0.37, p=0.02) and the EUS V265 was 24% (rho=-0.32, p=0.04); and urgency worsened when the IUS V35 was 99.5% (rho=-0.38, p=0.02). Incontinence did not correlate with EUS or IUS dose. CONCLUSIONS: Doses to the IUS and EUS on MRI/CT predicted worse urinary function, with greater bother, irritative symptoms, and urgency. Incorporating MRI-based dose-volume histogram analysis into the treatment planning process may reduce acute urinary morbidity after brachytherapy.","Brachytherapy, 12(3): 210-216","USA",2013,"Local","Brachytherapy","EPIC","Patient",null,"Clinical trial","USA","Patient","Local","Brachytherapy",null,"Clinical trial","EPIC","2010:2014","Disease"]
[570,"Rehman, J., et al. (2004). \"Laparoscopic radical prostatectomy: Washington University initial experience and prospective evaluation of quality of life.\" J Endourol 18(3): 277-287.",null,"Rehman, J., et al.","Laparoscopic radical prostatectomy: Washington University initial experience and prospective evaluation of quality of life","BACKGROUND AND PURPOSE: The laparoscopic approach to radical prostatectomy offers an alternative to the open surgical procedure with less morbidity. We prospectively collected data including a validated quality-of-life questionnaires on our first 38 laparoscopic radical prostatectomies (LRPs). The first 10 patients (group 1), second 10 patients (group II), and the most recent 18 patients (group III) were examined separately to study the learning curve for this procedure. In addition, we determined the pattern of recovery of urinary continence, potency, and quality of life. PATIENTS AND METHODS: Between July 1999 and July 2002, 38 consecutive transperitoneal laparoscopic radical prostatectomies were performed for clinically localized prostate carcinoma. Patients completed quality-of-life questionnaires (Rand 36 Health Survey) before surgery as well as at 1, 3, 6, and 12 months and every 6 months thereafter. The patients were also interviewed by an individual not directly involved in patient care. RESULTS: One patient (the second in our experience) was converted to the open approach because of failure to progress. The average operating time for the whole series was 423 +/- 137.6 minutes (range 215-825 minutes), the last 10 procedures taking 305 +/- 63 minutes (range 215-420 minutes). Complications consisted of one case each of intraoperative bladder injury, transient superficial peroneal nerve palsy, pulmonary embolism, and bladder neck obstruction. The bladder injury was closed laparoscopically without further complication. Bladder neck obstruction was secondary to a bladder wall fold that was treated with transurethral resection 14 months after surgery with good results. Four patients in group 1 had minor anastomotic leaks, while only one patient after that had a leak (group III). Four patients required transfusion, two intraoperatively and two postoperatively. In group III, the urethral catheter remained in place for an average of 8 days (range 6-10 days). With a mean follow-up of 22.8 months (range 9-43 months), 84.8% of the patients had perfect urinary control. Postoperatively, 9 patients (27%) were fully continent on removal of the Foley catheter. At 1, 3, 6, and 9 months postoperatively, diurnal urinary control was reported by 30.3%, 48%, 72.7%, and 84.8% of the patients, respectively. One patient needed an artificial urinary sphincter. Among the incontinent patients, 24.2% had urinary urgency, and one third of these patients reported urge incontinence. CONCLUSIONS: Laparoscopic prostatectomy is a reproducible technique with a steep learning curve. Operating times and the incidence of anastomotic leaks and urinary incontinence decrease significantly after the initial 10 patients.","J Endourol, 18(3): 277-287","USA",2004,"Local","Surgery","SF-36","Patient",null,"Cohort","USA","Patient","Local","Surgery",null,"Cohort","SF-36","2000:2004","Utility"]
[571,"Reidunsdatter, R. J., et al. (2010). \"Validation of the intestinal part of the prostate cancer questionnaire \"QUFW94\": psychometric properties, responsiveness, and content validity.\" Int J Radiat Oncol Biol Phys 77(3): 793-804.",null,"Reidunsdatter, R. J., et al.","Validation of the intestinal part of the prostate cancer questionnaire \"QUFW94\": psychometric properties, responsiveness, and content validity","PURPOSE: Several treatment options are available for patients with prostate cancer. Applicable and valid self-assessment instruments for assessing health-related quality of life (HRQOL) are of paramount importance. The aim of this study was to explore the validity and responsiveness of the intestinal part of the prostate cancer-specific questionnaire QUFW94. METHODS AND MATERIALS: The content of the intestinal part of QUFW94 was examined by evaluation of experienced clinicians and reviewing the literature. The psychometric properties and responsiveness were assessed by analyzing HRQOL data from the randomized study Scandinavian Prostate Cancer Group 7 (SPCG)/Swedish Association for Urological Oncology 3 (SFUO). Subscales were constructed by means of exploratory factor analyses. Internal consistency was assessed by Cronbach's alpha. Responsiveness was investigated by comparing baseline scores with the 4-year posttreatment follow-up. RESULTS: The content validity was found acceptable, but some amendments were proposed. The factor analyses revealed two symptom scales. The first scale comprised five items regarding general stool problems, frequency, incontinence, need to plan toilet visits, and daily activity. Cronbach's alpha at 0.83 indicated acceptable homogeneity. The second scale was less consistent with a Cronbach's alpha at 0.55. The overall responsiveness was found to be very satisfactory. CONCLUSION: Two scales were identified in the bowel dimension of the QUFW94; the first one had good internal consistency. The responsiveness was excellent, and some modifications are suggested to strengthen the content validity.","Int J Radiat Oncol Biol Phys, 77(3): 793-804","Norway",2010,"Any or unknown","Unclear","QUFW94","Patient",null,"Validation","Norway","Patient","Any or unknown","Unclear",null,"Validation","QUFW94","2010:2014","Disease"]
[572,"Reis, F., et al. (2004). \"The impact of prostatectomy and brachytherapy in patients with localized prostate cancer.\" Int Urol Nephrol 36(2): 187-190.",null,"Reis, F., et al.","The impact of prostatectomy and brachytherapy in patients with localized prostate cancer","PURPOSE: to compare urinary incontinence and erectile dysfunction symptoms reflecting quality of life and the willingness to undergo treatment again in patients treated by radical retropubic prostatectomy and low dose radiation (LDR) brachytherapy. MATERIALS AND METHODS: from July 1992 to November 2001, 158 patients with clinical localized prostate cancer were treated by radical retropubic prostatectomy with or without nerve sparring or LDR brachytherapy. To all the 158 patients we mailed a self-reporting questionnaire with 5 questions to access sexual function, 4 questions for urinary continence, and 2 for the satisfaction with the treatment and willingness to undergo treatment again. Patients had no form of adjuvant radiation therapy, or neoadjuvant or adjuvant androgen suppression therapy. A total of 56 patients (43%), 34 of the prostatectomy and 22 patients of the brachytherapy group answered the questionnaire. Questionnaire results were independently analyzed by someone else not involved with patients' treatment. RESULTS: patients self-reported some degree of erectile dysfunction in 84.8% (p = 0.01) in the group treated by prostatectomy and 23.07% (p = 0.86) in the brachytherapy group. Urinary incontinence occurred in 17.6% in the group treated by prostatectomy (p = 0.01) and in 9.5% (p = 0.52) in the brachytherapy group. Urinary incontinence and impotence significantly affected treatment satisfaction. However, considering satisfaction with the treatment and willingness to undergo treatment again, 88.2% of patients would elect surgery again and 95.5% brachytherapy again.","Int Urol Nephrol, 36(2): 187-190","Brazil",2004,"Local","Surgery,Brachytherapy","Unclear","Patient",null,"Cross-sectional","Brazil","Patient","Local","Surgery,Brachytherapy",null,"Cross-sectional","Unclear","2000:2004","Complication,Satisfaction"]
[573,"Richard, P. O., et al. (2015). \"Phase II, randomised, double-blind, placebo-controlled trial of methylphenidate for reduction of fatigue levels in patients with prostate cancer receiving LHRH-agonist therapy.\" BJU Int 116(5): 744-752.",null,"Richard, P. O., et al.","Phase II, randomised, double-blind, placebo-controlled trial of methylphenidate for reduction of fatigue levels in patients with prostate cancer receiving LHRH-agonist therapy","OBJECTIVES: To investigate whether methylphenidate can alleviate fatigue, as measured by the Functional Assessment of Cancer Therapy: Fatigue subscale, in men with prostate cancer (PCa) treated with a luteinizing hormone-releasing hormone (LHRH) for a minimum of 6 months, and to assess changes in global fatigue and quality of life (QoL) as measured by the Bruera Global Fatigue Severity Scale (BFS) and the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36), respectively. PARTICIPANTS AND METHODS: We performed a single-centre, randomised, double-blind, placebo-controlled trial with the aim of recruiting 128 participants. Men treated with a LHRH agonist for PCa were screened between February 2008 and June 2012 for fatigue at our outpatient clinics using the BFS. Participants were randomised to receive either 10 mg daily of methylphenidate or placebo. Change in fatigue levels and in SF-36 scores between both groups were compared using linear regression, adjusted for baseline scores. RESULTS: The study was closed prematurely because of poor accrual. Of the 790 subjects screened, 24 men were randomised to methylphenidate or placebo (12 per group). After 10 weeks, the improvement in mean [sd] fatigue score was greater in the methylphenidate than in the placebo arm (+7.7 [7.7] vs +1.4 [7.6]; P = 0.022). The within-group analysis showed a significant improvement in fatigue scores in the methylphenidate arm (P = 0.008) but not in the placebo arm (P = 0.82). The use of methylphenidate also resulted in a significantly greater improvement in QoL as measured by the physical and mental component summary scores than did the use of placebo (P = 0.04 for both component scores). CONCLUSIONS: Our findings support the beneficial effect of methylphenidate on fatigue and QoL among men with LHRH-induced fatigue. Clinicians should be aware of these benefits and should consider discussing these findings with patients who have high levels of fatigue.","BJU Int, 116(5): 744-752","Canada",2015,"Any or unknown","Hormonal,Various","FACT-F,SF-36,BFS","Patient",null,"Clinical trial","Canada","Patient","Any or unknown","Hormonal,Various",null,"Clinical trial","FACT-F,SF-36,BFS","2015:2018","Symptom,Utility"]
[574,"Riley, B. B., et al. (1998). \"Types of spiritual well-being among persons with chronic illness: their relation to various forms of quality of life.\" Arch Phys Med Rehabil 79(3): 258-264.",null,"Riley, B. B., et al.","Types of spiritual well-being among persons with chronic illness: their relation to various forms of quality of life","OBJECTIVES: Derive a spiritual well-being classification and thereby enhance understanding of the relation between spiritual well-being, quality of life (QOL), and health among persons with chronic illness or disability. DESIGN: Cluster analyses were performed to develop a spiritual well-being classification. Analysis of variance was used to compare cluster groups on various dimensions of QOL. SETTING: Part of a larger QOL study conducted at a midwestern medical center. PATIENTS: A convenience sample of 216 inpatients: amputation (n = 74), postpolio (n = 37), spinal cord injury (n = 34), breast cancer (n = 36), and prostate cancer (n = 35). Minors were excluded from the study. MAIN OUTCOME MEASURES: Spiritual Well-Being Scale (SWBS), Functional Assessment of Cancer Therapy (FACT), Functional Living Index-Cancer (FLIC), Sickness Impact Profile (SIP), Medical Outcome Survey-Short Form (SF-36), and the Satisfaction With Life Scale (SWLS). RESULTS: Three types of spiritual well-being were identified: religious (n = 146), existential (n = 37), and nonspiritual (n = 30). Significant cluster differences (p < .03 to p < .001) were observed across all QOL domains and life satisfaction. Compared with the other cluster groups, the nonspiritual group reported significantly lower levels of QOL and life satisfaction and the highest proportion of health status change with respect to both improvement and decline in health. CONCLUSIONS: Three types of spiritual well-being were empirically identified in this sample. Subtypes differed significantly with respect to various aspects of QOL. Further research is needed to validate this classification and to determine if type of spiritual well-being has a causal effect on treatment outcome or on the recovery process.","Arch Phys Med Rehabil, 79(3): 258-264","USA",1998,"Any or unknown","None","FACT-G,FLIC,SIP,SF-36,SWLS,SWBS","Patient",null,"Cross-sectional","USA","Patient","Any or unknown","None",null,"Cross-sectional","FACT-G,FLIC,SIP,SF-36,SWLS,SWBS","1960:1999","General,Utility"]
[575,"Rnic, K., et al. (2013). \"Measuring symptoms in localized prostate cancer: a systematic review of assessment instruments.\" Prostate Cancer Prostatic Dis 16(2): 111-122.",null,"Rnic, K., et al.","Measuring symptoms in localized prostate cancer: a systematic review of assessment instruments","It is critical for prostate cancer researchers and clinicians to have access to comprehensive, sensitive and simple-to-use symptom measures that allow them to understand and quantify the subjective patient experience. The purpose of the current review is to provide a comprehensive review, detailed tool descriptions and objectively defined quality criteria to facilitate tool choices for patients with localized prostate cancer. Using a systematic web-based literature search, we found n=29 prostate symptom measures described in n=35 validation studies. To be recommended, tools needed to meet four criteria: broad domain coverage, ability to differentiate objective and subjective experience, good internal consistency and validation in at least two populations and/or having achieved two types of validations. Of the 29 tools reviewed, n=7 meet our criteria for recommendation, and three in particular (the EPIC-26 (Expanded Prostate Cancer Index Composite)-26, PC-QOL (Prostate Cancer-Quality of Life) and the UCLA-PCI (UCLA Prostate Cancer Index)) showed the strongest psychometrics. There is a reasonable number of measures to choose from that meet criteria for good psychometrics.","Prostate Cancer Prostatic Dis, 16(2): 111-122","International",2013,"Local","None","EPIC,PC-QOL,UCLA-PCI","Patient",null,"Systematic review,Validation","International","Patient","Local","None",null,"Systematic review,Validation","EPIC,PC-QoL,UCLA-PCI","2010:2014","Disease"]
[576,"Roach, M., 3rd, et al. (1996). \"A pilot survey of sexual function and quality of life following 3D conformal radiotherapy for clinically localized prostate cancer.\" Int J Radiat Oncol Biol Phys 35(5): 869-874.",null,"Roach, M., 3rd, et al.","A pilot survey of sexual function and quality of life following 3D conformal radiotherapy for clinically localized prostate cancer","PURPOSE: To assess the impact of high dose three-dimensional conformal radiotherapy (3D CRT) for prostate cancer on the sexual function-related quality of life of patients and their partners. METHODS AND MATERIALS: Sixty of 124 consecutive patients (median age 72.3 years) treated with 3D CRT for localized prostate cancer were surveyed and reported being potent prior to treatment. The answers to survey questions assessing the impact of quality of life related to sexual function from these 60 patients and their partners forms the basis for this retrospective analysis. RESULTS: Following 3D CRT, 37 of 60 patients (62%) retained sexual function sufficient for intercourse. Intercourse at least once per month was reduced from 71 to 40%, whereas intercourse less than once per year increased from 12 to 35%. Following treatment, 25% of patients reported that the change in sexual dysfunction negatively affected their relationship or resulted in poor self-esteem. This outcome was associated with impotence following treatment (p < 0.01). Patients who had partners and satisfactory sexual function appeared to be at a higher risk of having a negatively affected relationship or losing self-esteem if they become impotent (p < 0.05). Partners of patients who reported a negatively affected relationship or loss of self-esteem appear to be less likely to return the survey instrument used (p = 0.02). CONCLUSIONS: More work is needed to evaluate the impact of radiotherapy and other treatments on the quality of life of patients and their partners to allow adequate informed consent to be given.","Int J Radiat Oncol Biol Phys, 35(5): 869-874","USA",1996,"Local","Radiotherapy","Unclear","Patient",null,"Cohort","USA","Patient","Local","Radiotherapy",null,"Cohort","Unclear","1960:1999","Complication"]
[577,"Robertson, J. M., et al. (2014). \"Exploring the feasibility and acceptability of couple-based psychosexual support following prostate cancer surgery: study protocol for a pilot randomised controlled trial.\" Trials 15: 183.",null,"Robertson, J. M., et al.","Exploring the feasibility and acceptability of couple-based psychosexual support following prostate cancer surgery: study protocol for a pilot randomised controlled trial","BACKGROUND: Men who undergo surgery for prostate cancer frequently experience significant side-effects including urinary and sexual dysfunction. These difficulties can lead to anxiety, depression and reduced quality of life. Many partners also experience psychological distress. An additional impact can be on the couple relationship, with changes to intimacy, and unmet psychosexual supportive needs in relation to sexual recovery and rehabilitation. The aim of this exploratory randomised controlled trial pilot study is to determine the feasibility and acceptability of a novel family-relational-psychosexual intervention to support intimacy and reduce distress among couples following prostate cancer surgery and to estimate the efficacy of this intervention. METHODS/DESIGN: The intervention will comprise six sessions of psychosexual and relationship support delivered by experienced couple-support practitioners. Specialist training in delivering the intervention will be provided to practitioners and they will be guided by a detailed treatment manual based on systemic principles. Sixty-eight couples will be randomised to receive either the intervention or standard care (comprising usual follow-up hospital appointments). A pre-test, post-test design will be used to test the feasibility of the intervention (baseline, end of intervention and six-month follow-up) and its acceptability to couples and healthcare professionals (qualitative interviews). Both individual and relational outcome measures will assess sexual functioning, anxiety and depression, couple relationship, use of health services and erectile dysfunction medication/technologies. An economic analysis will estimate population costs of the intervention, compared to usual care, using simple modelling to evaluate the affordability of the intervention. DISCUSSION: Given the increasing incidence and survival of post-operative men with prostate cancer, it is timely and appropriate to determine the feasibility of a definitive trial through a pilot randomised controlled trial of a family-relational-psychosexual intervention for couples. The study will provide evidence about the components of a couple-based intervention, its acceptability to patients and healthcare professionals, and its influence on sexual and relational functioning. Data from this study will be used to calculate sample sizes required for any definitive trial. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01842438.Registration date: 24 April 2013; Randomisation of first patient: 13 May 2013.","Trials, 15(183","UK",2014,"Any or unknown","Psychological,Surgery","Interview","Patient",null,"Protocol","UK","Patient","Any or unknown","Psychological,Surgery",null,"Protocol","Interview","2010:2014","Complication"]
[578,"Robinson, J. P., et al. (2007). \"Psychometric properties of the Male Urogenital Distress Inventory (MUDI) and Male Urinary Symptom Impact Questionnaire (MUSIQ) in patients following radical prostatectomy.\" Urol Nurs 27(6): 512-518.",null,"Robinson, J. P., et al.","Psychometric properties of the Male Urogenital Distress Inventory (MUDI) and Male Urinary Symptom Impact Questionnaire (MUSIQ) in patients following radical prostatectomy","INTRODUCTION: Research instruments can be used to assess the impact of lower urinary tract symptoms on health-related quality of life. Evaluating the reliability, validity, and sensitivity of two of these instruments provides evidence concerning their readiness for use in research and clinical settings. OBJECTIVE: The researchers evaluated psychometric properties of the Male Urogenital Distress Inventory and Male Urinary Symptom Impact Questionnaire in men suffering from lower urinary tract symptoms following radical prostatectomy. METHOD: The internal consistency reliability, concurrent validity, construct validity, and sensitivity of both instruments were evaluated in a cohort of men who participated in a larger study of nursing's impact on quality of life post-prostatectomy. RESULTS: The reliability, validity, and sensitivity of both instruments were supported in this population. CONCLUSIONS: Initial support is provided for use of the instruments to measure the effect of interventions for lower urinary tract symptoms and urine leakage on health-related quality of life during the first 6 months of recovery from radical prostatectomy; however, further research with a larger and more diverse sample is needed prior to using the instruments in clinical settings.","Urol Nurs, 27(6): 512-518","USA",2007,"Any or unknown","Surgery","MUDI,MUSIQ","Patient",null,"Validation","USA","Patient","Any or unknown","Surgery",null,"Validation","MUDI,MUSIQ","2005:2009","Complication"]
[579,"Robinson, J. W., et al. (2002). \"Quality of life and sexuality of men with prostate cancer 3 years after cryosurgery.\" Urology 60(2 Suppl 1): 12-18.",null,"Robinson, J. W., et al.","Quality of life and sexuality of men with prostate cancer 3 years after cryosurgery","The current study was designed to describe the long-term life quality and sexuality of men enrolled in a phase 2 clinical trial of cryosurgery for the treatment of localized prostate cancer. A total of 75 men were administered the Functional Assessment of Cancer Treatment-Prostate (FACT-P) before treatment and after treatment at 6 weeks, and at 3, 6, 12, 24, and 36 months. Additionally, these men completed a Sexuality Follow-Up Questionnaire (SFQ) 3 years after cryosurgery. By 12 months after cryosurgery, most FACT-P subscales had returned to pretreatment levels. Quality of life remained stable over the subsequent 2 years. The only exception to this general trend was persistent impairment in measures of social/family well-being. At 36 months, 13% (5 of 38) of patients had regained erectile functioning, and an additional 34% (13 of 38) of patients were sexually active with the help of aids. The 3-year quality-of-life outcomes support the renewed interest in cryosurgery. No late complications were observed. Whereas improvements in erectile function were observed between years 1 and 3 for some patients, most continue to experience erectile dysfunction. For these patients, aids are an important adjunct to the treatment of their erectile dysfunction.","Urology, 60(2 Suppl 1): 12-18","Canada",2002,"Local","Various","FACT-P,SFQ","Patient",null,"Clinical trial","Canada","Patient","Local","Various",null,"Clinical trial","FACT-P,SFQ","2000:2004","Disease,Complication"]
[580,"Rodda, S., et al. (2017). \"ASCENDE-RT: An Analysis of Health-Related Quality of Life for a Randomized Trial Comparing Low-Dose-Rate Brachytherapy Boost With Dose-Escalated External Beam Boost for High- and Intermediate-Risk Prostate Cancer.\" Int J Radiat Oncol Biol Phys 98(3): 581-589.",null,"Rodda, S., et al.","ASCENDE-RT: An Analysis of Health-Related Quality of Life for a Randomized Trial Comparing Low-Dose-Rate Brachytherapy Boost With Dose-Escalated External Beam Boost for High- and Intermediate-Risk Prostate Cancer","PURPOSE: To report the patient-reported health-related quality of life (HR-QoL) outcomes for a multicenter randomized trial evaluating the safety and efficacy of 2 different techniques for dose escalation. METHODS AND MATERIALS: A total of 357 men with intermediate- and high-risk prostate cancer were stratified by risk group and randomized (1:1) to either a dose-escalated external beam (DE-EBRT) boost (n=177) or a low-dose-rate prostate brachytherapy (LDR-PB) boost (n=180) as part of combined modality therapy. The HR-QoL was assessed using the SF36v2 questionnaire, with additional scales for urinary, bowel, and sexual function. Date of starting androgen deprivation therapy was considered time zero, the median follow-up of 6 years. Scales were scored from 0 to 100; a decline in a mean score >/=10 compared with baseline was considered a clinically significant decline. This was an intent-to-treat analysis. RESULTS: Mean domain scores at baseline were well balanced between the 2 treatment arms. A clinically significant decline in mean scores in both the arms compared with baseline was noted for role physical (DE-EBRT [-11.4] and LDR-PB [-15.3]) and sexual function scale (DE-EBRT [-15.1] and LDR-PB [-19.2]). There was a significantly larger drop in mean scores in the LDR-PB group compared with the DE-EBRT group for physical function (-15.3 vs -6.9; P=.03), urinary function (-3.6 vs -0.5; P=.04). CONCLUSION: At 6 years' follow up, there were no significant differences in mean scores in 9 of 11 scales compared with baseline in both arms. A clinically significant decline in mean scores was noted in both arms for role physical and sexual function scales. There was a statistically significant decline in physical function and urinary function scales in the LDR-PB arm compared with the DE-EBRT arm.","Int J Radiat Oncol Biol Phys, 98(3): 581-589","Canada",2017,"Any or unknown","Radiotherapy,Brachytherapy","SF-36","Patient",null,"Clinical trial","Canada","Patient","Any or unknown","Radiotherapy,Brachytherapy",null,"Clinical trial","SF-36","2015:2018","Utility"]
[581,"Rodrigues, G., et al. (2004). \"The relationship of changes in EORTC QLQ-C30 scores to ratings on the Subjective Significance Questionnaire in men with localized prostate cancer.\" Qual Life Res 13(7): 1235-1246.",null,"Rodrigues, G., et al.","The relationship of changes in EORTC QLQ-C30 scores to ratings on the Subjective Significance Questionnaire in men with localized prostate cancer","PURPOSE: To examine the relationship between changes in health-related quality-of-life (HRQOL) on the EORTC Quality of Life Questionnaire (QLQ-C30), and patients' perceptions of HRQOL changes as measured by the Subjective Significance Questionnaire (SSQ). PATIENTS AND METHODS: A total of 101 patients completed the QLQ-C30 on weeks 1, 4 and 7 of radical external-beam radiation therapy (RT) for localized cancer of the prostate. Patients rated their change in physical functioning, emotional functioning, social functioning, and overall/global quality of life (QOL) by completing a seven-category SSQ at weeks 4 and 7. The association between changes in the QLQ-C30 change and the corresponding SSQ ratings were determined by calculation of mean change scores for each SSQ category and by Spearman rank correlation coefficient analysis. RESULTS: Patients' completion of the QLQ-C30 and SSQ exceeded 95%. Statistically significant changes in fatigue, pain, appetite, diarrhea, and global QOL scores were detected during RT. For patients reporting 'a little' change in global QOL on the SSQ, absolute mean QLQ-C30 change scores ranged between 0 to 15 points with 12/16 mean change scores between 2.5 and 8.5 points. In the entire study sample, correlations between SSQ patient ratings and QLQ-C30 change scores were lower than previously reported, ranging between 0.15 and 0.24 for the four different domains, but were higher when QOL scores producing ceiling effects were omitted. CONCLUSION: The SSQ and QLQ-C30 may measure related concepts that could assist in the interpretation of changes in scores and in the calibration of the QLQ-C30. However, the nature of this relationship could not be elucidated in this data set because of a lack of variance in HRQOL scores in the study sample. Further investigation should be carried out in study samples with sufficient variance to allow more robust conclusions.","Qual Life Res, 13(7): 1235-1246","UK",2004,"Local","Radiotherapy","EORTC QLQ-C30,SSQ","Patient",null,"Validation","UK","Patient","Local","Radiotherapy",null,"Validation","EORTC QLQ-C30,SSQ","2000:2004","General"]
[582,"Rodrigues, G., et al. (2007). \"Psychometric properties of a prostate cancer radiation late toxicity questionnaire.\" Health Qual Life Outcomes 5: 29.",null,"Rodrigues, G., et al.","Psychometric properties of a prostate cancer radiation late toxicity questionnaire","BACKGROUND: To construct a short prostate cancer radiation late toxicity (PCRT) questionnaire with health-related quality-of-life (HRQoL) domains. METHODS: The PCRT was developed by item generation, questionnaire construction (n = 7 experts, n = 8 focus group patients), pilot testing (n = 37), item reduction (n = 100), reliability testing (n = 237), and validity testing (n = 274). RESULTS: Reliability of the three item-reduced subscales demonstrated intraclass correlation coefficients (CC) of 0.811 (GU), 0.842 (GI), and 0.740 (sexual). Discriminant validity demonstrated Pearson CC of 0.449 (GU-GI), 0.200 (sexual-GU), and 0.09 (sexual-GI). Content validity correlations between PCRT-PCQoL were 0.35-0.78, PCRT-FACT-G(c) were 0.19-0.39, and PCRT-SF-36(R) were 0.03-0.34. CONCLUSION: We successfully generated a PCRT HRQoL questionnaire including subscales with very good psychometric properties.","Health Qual Life Outcomes, 5(29","Canada",2007,"Any or unknown","Radiotherapy","PCRT,FACT-G,SF-36,PC-QoL","Patient",null,"Validation,Mapping to utility","Canada","Patient","Any or unknown","Radiotherapy",null,"Validation,Mapping to utility","PCRT,FACT-G,SF-36,PC-QoL","2005:2009","Treatment,Utility,Disease"]
[583,"Rodrigues, G., et al. (2011). \"Cross validation of the prostate cancer radiotherapy late toxicity (PCRT) questionnaire with the expanded prostate cancer index composite (EPIC) instrument.\" Can J Urol 18(4): 5802-5810.",null,"Rodrigues, G., et al.","Cross validation of the prostate cancer radiotherapy late toxicity (PCRT) questionnaire with the expanded prostate cancer index composite (EPIC) instrument","INTRODUCTION: A 29-item prostate cancer radiotherapy (PCRT) questionnaire with genitourinary (GU), gastrointestinal (GI), and sexual (S) domains has been previously validated for the assessment of late toxicity health-related quality of life (HRQoL) effects. The study objective was to cross-validate the PCRT domains versus the expanded prostate cancer index composite (EPIC) questionnaire urinary (U), bowel (B), hormonal (H), and S subscales. METHODS AND MATERIALS: A single-institution cross-sectional PCRT patient cohort was surveyed. Descriptive and intra- and inter-class correlation coefficient statistics for the various EPIC and PCRT HRQoL domain scores were generated. Univariable and multivariable Cox and logistic regressions were performed depending on the HRQoL endpoint being assessed. RESULTS: A total of 189/276 patients (68%) completed questionnaires with EPIC and PCRT missing data rates of 9% and 4%, respectively. Mean age was 75.8 years (SD 5.5) and the mean time of questionnaire completion after radiotherapy was 852 days (range 212-1454 days). Mean EPIC urinary (85.1 SD 12.9), bowel (84.1 SD 15.8), sexual (21.8 SD 20.7), and hormonal (85.3 SD 13.7) as well as PCRT genitourinary (66.1 SD 15.3), gastrointestinal (83.6 SD 14.3), and sexual (39.4 SD 21.6) domain scores were calculated. Intraclass correlation coefficients comparing corresponding EPIC/PCRT domains ranged from 0.50-0.88. Interclass correlation coefficients for non-corresponding EPIC/PCRT domains ranged from 0.16-0.43 and 0.23-0.30, respectively. EPIC B/U, PCRT GI/GU and PCRT S required arcsin square root transformation and EPIC S/H domains required dichotomous transformations prior to univariable/multivariable analyses. Multivariable analysis demonstrated novel associations between predictive variables and HRQoL domains including between the PTV-bladder overlap volume and PCRT GU score. CONCLUSIONS: The PCRT is a compact, valid, and HRQoL instrument with very high questionnaire compliance rates and similar statistical properties to the EPIC instrument. However, dichotomization of the PRCT S data was not required which suggests some potential statistical advantage to the PCRT.","Can J Urol, 18(4): 5802-5810","Canada",2011,"Any or unknown","Radiotherapy","PCRT,EPIC","Patient",null,"Validation","Canada","Patient","Any or unknown","Radiotherapy",null,"Validation","PCRT,EPIC","2010:2014","Disease,Treatment"]
[584,"Rondorf-Klym, L. M. and J. Colling (2003). \"Quality of life after radical prostatectomy.\" Oncol Nurs Forum 30(2): E24-32.",null,"Rondorf-Klym, L. M. and J. Colling","Quality of life after radical prostatectomy","PURPOSE/OBJECTIVES: To examine physical and psychosocial factors that affect the quality of life (QOL) for men 12-24 months after radical prostatectomy treatment for prostate cancer. DESIGN: Cross-sectional survey. SETTING: An entire population from one tumor registry. SAMPLE: Of the 132 men meeting inclusion criteria, 97 men responded, with 91 meeting analysis requirements. Analysis was completed on the Caucasian sample (n = 88) with a mean age of 66 years. Most men were married, lived with a spouse or partner, and had a high level of education. METHODS: A survey was developed to assess men 12-24 months prostatectomy. The tumor registry mailed the survey, which was completed at home, and participants returned it in a prestamped, addressed envelope. MAIN RESEARCH VARIABLES: Major hypotheses in the causal model were that age, sexual function, urinary function, and sexual appraisal would only have indirect effects on QOL, whereas urinary function appraisal, self-esteem, anger suppression, perceived social support, depression, and health locus of control would directly affect QOL. FINDINGS: As analyzed by path analytic techniques, the hypothesized causal model explained 72% variance in the QOL variable. Perceived social support, self-esteem, and health locus of control were significant predictors of QOL. Urinary function appraisal contributed indirectly through health locus of control. Contrary to the hypotheses, anger suppression and depression were not significant predictors of QOL. CONCLUSIONS: After radical prostatectomy for prostate cancer, perceived social support, self-esteem, and health locus of control may influence men's QOL. Future research is needed to increase understanding about the adaptation trajectory of men's response to the impact of prostate cancer. IMPLICATIONS FOR NURSING: Nurses can help patients by providing a thorough assessment of each patient's values that may affect QOL before any intervention begins, using research-based evidence regarding potential side effects of interventions, clear and concise information from a variety of sources that addresses the possible concerns of men and their spouses, and focused counseling that addresses patient-specific problems.","Oncol Nurs Forum, 30(2): E24-32","USA",2003,"Any or unknown","Surgery","Unclear","Patient",null,"Cross-sectional","USA","Patient","Any or unknown","Surgery",null,"Cross-sectional","Unclear","2000:2004","General,Complication"]
[585,"Rosario, D. J., et al. (2012). \"Short term outcomes of prostate biopsy in men tested for cancer by prostate specific antigen: prospective evaluation within ProtecT study.\" Bmj 344: d7894.",null,"Rosario, D. J., et al.","Short term outcomes of prostate biopsy in men tested for cancer by prostate specific antigen: prospective evaluation within ProtecT study","OBJECTIVES: To measure the effect of the adverse events within 35 days of transrectal ultrasound guided biopsy from the perspective of asymptomatic men having prostate specific antigen (PSA) testing; to assess early attitude to re-biopsy; to estimate healthcare resource use associated with adverse events due to biopsy; and to develop a classification scheme for reporting adverse events after prostate biopsy. DESIGN: Prospective cohort study (Prostate Biopsy Effects: ProBE) nested within Prostate Testing for Cancer and Treatment (ProtecT) study. Participants Between 1999 and 2008, 227,000 community dwelling men aged 50-69 years were identified at 352 practices and invited to counselling about PSA testing. 111,148 attended a nurse led clinic in the community, and 10,297 with PSA concentrations of 3-20 ng/mL were offered biopsy within ProtecT. Between February 2006 and May 2008, 1147/1753 (65%) eligible men (mean age 62.1 years, mean PSA 5.4 ng/mL) having 10 core transrectal ultrasound guided biopsy under antibiotic cover in the context of ProtecT were recruited to the ProBE study. OUTCOME MEASURES: Purpose designed questionnaire administered at biopsy and 7 and 35 days after the procedure to measure frequency and effect of symptoms related to pain, infection, and bleeding; patients' attitude to repeat biopsy assessed immediately after biopsy and 7 days later; participants' healthcare resource use within 35 days of biopsy evaluated by questionnaire, telephone follow-up, and medical note review; each man's adverse event profile graded according to symptoms and healthcare use. RESULTS: Pain was reported by 429/984 (43.6%), fever by 172/985 (17.5%), haematuria by 642/976 (65.8%), haematochezia by 356/967 (36.8%), and haemoejaculate by 605/653 (92.6%) men during the 35 days after biopsy. Fewer men rated these symptoms as a major/moderate problem-71/977 (7.3%) for pain, 54/981 (5.5%) for fever, 59/958 (6.2%) for haematuria, 24/951 (2.5%) for haematochezia, and 172/646 (26.6%) for haemoejaculate. Immediately after biopsy, 124/1142 (10.9%, 95% confidence interval 9.2 to 12.8) men reported that they would consider further biopsy a major or moderate problem: seven days after biopsy, this proportion had increased to 213/1085 (19.6%, 17.4% to 22.1%). A negative attitude to repeat biopsy was associated with unfavourable experience after the first biopsy, particularly pain at biopsy (odds ratio 8.2, P<0.001) and symptoms related to infection (7.9, P<0.001) and bleeding (4.2, P<0.001); differences were evident between centres (P<0.001). 119/1147 (10.4%, 8.7% to 12.3%) men reported consultation with a healthcare professional (usually their general practitioner), most commonly for infective symptoms. Complete data for all index symptoms at all time points were available in 851 participants. Symptoms and healthcare use could be used to grade these men as follows: grade 0 (no symptoms/contact) 18 (2.1%, 1.3% to 3.3%); grade 1 (minor problem/no contact) 550 (64.6%, 61.4% to 67.8%); grade 2 (moderate/major problem or contact) 271 (31.8%, 28.8% to 35.1%); grade 3 (hospital admission) 12 (1.4%, 0.8% to 2.4%); and grade 4 (death) 0. Grade of adverse event was associated with an unfavourable attitude to repeat biopsy (Kendall's tau-b ordinal by ordinal 0.29, P<0.001). CONCLUSION: This study with a high response rate of 89% at 35 days in men undergoing biopsy in the context of a randomised controlled trial has shown that although prostate biopsy is well tolerated by most men, it is associated with significant symptoms in a minority and affects attitudes to repeat biopsy and primary care resource use. These findings will inform men who seek PSA testing for detection of prostate cancer and assist their physicians during counselling about the potential risks and effect of biopsy. Variability in the adverse event profile between centres suggests that patients' outcomes could be improved and healthcare use reduced with more effective administration of local anaesthetic and antibiotics. Trial registration Current Controlled Trials ISRCTN20141297.","Bmj, 344(d7894","UK",2012,"At risk","Screening","Unclear","Patient",null,"Cohort","UK","Patient","At risk","Screening",null,"Cohort","Unclear","2010:2014","Complication"]
[586,"Ross, P. L., et al. (2003). \"Paper standard gamble: a paper-based measure of standard gamble utility for current health.\" Int J Technol Assess Health Care 19(1): 135-147.",null,"Ross, P. L., et al.","Paper standard gamble: a paper-based measure of standard gamble utility for current health","OBJECTIVES: To develop and validate a paper-based instrument that is simple to administer and produces a reliable estimate of patient standard gamble (SG) utilities for current health status. METHODS: A 1-page paper questionnaire instrument, paper standard gamble (PSG), was designed to estimate SG utilities. We performed two studies to assess the validity of PSG. First we compared PSG and SG utilities for current health in patients with prostate cancer. They randomly received either PSG followed by SG or vice versa, always with an intervening SF-12. In the second validity study, we assessed the test-retest reliability of PSG by administering it to prostate cancer patients twice, at least 2 weeks apart. RESULTS: In the first study, utilities were assessed in 64 men (32 per SG/PSG order group). A paired-comparison t test suggested no difference between SG and PSG (mean difference = -0.007; 95% confidence interval (Cl), -0.022 to 0.008). The concordance correlation coefficient was 0.92 (95% Cl, 0.79 to 0.99). In the second study, test and retest PSGs were available for 184 patients. The concordance correlation coefficient was 0.88 (95% Cl, 0.73 to 0.94). CONCLUSIONS: These data suggest that PSG may serve as a reliable substitute for SG when current health utility is of interest. PSG may have particular advantages for acquisition of health-related quality-of-life data in longitudinal studies.","Int J Technol Assess Health Care, 19(1): 135-147","USA",2003,"Any or unknown","None","SF-12,SG","Patient",null,"Validation","USA","Patient","Any or unknown","None",null,"Validation","SF-12,SG","2000:2004","Utility"]
[587,"Rossetti, S. R. and C. Terrone (1996). \"Quality of life in prostate cancer patients.\" Eur Urol 30 Suppl 1: 44-48; discussion 49.",null,"Rossetti, S. R. and C. Terrone","Quality of life in prostate cancer patients","INTRODUCTION: Quality of life (QL) assessment should be an essential part of clinical practice and should also be included in every clinical trial of prostate cancer. The term QL describes a person's overall well-being comprising not only physical functioning but also psychological and social dimensions. It is important to remember that QL can be affected by the disease as well as by the therapeutic treatment adopted. OBJECTIVES: To measure the impact on QL in 161 patients treated by radical prostatectomy performed from January 1980 to June 1995. To describe the QL results from a national epidemiological study on prostate cancer, and to review the assessment of QL in this setting. CONCLUSIONS: We found radical prostatectomy to have minimal overall impact on QL in patients informed of, and involved with all therapeutic decisions. Maintenance of sexual activity was considered to be of less importance than the attempt to cure the disease. The best method of assessment remains unclear but, minimally, a general questionnaire supplemented by specific questions on urinary-sexual symptoms should be administered at follow-up.","Eur Urol, 30 Suppl 1(44-48; discussion 49","Italy",1996,"Any or unknown","Surgery","Unclear","Patient",null,"Cross-sectional","Italy","Patient","Any or unknown","Surgery",null,"Cross-sectional","Unclear","1960:1999","General"]
[588,"Rubio-Briones, J., et al. (2016). \"Preliminary results of the Spanish Association of Urology National Registry in Active Surveillance for prostate cancer.\" Actas Urol Esp 40(1): 3-10.",null,"Rubio-Briones, J., et al.","Preliminary results of the Spanish Association of Urology National Registry in Active Surveillance for prostate cancer","OBJECTIVES: To present a National Registry of patients with prostate cancer as monitored through active surveillance, with the intention of testing the hypothesis that cancer-specific mortality in very low-risk and low-risk patients is less than 5% at 15 years. MATERIAL AND METHODS: A multicentre observational study (AEU-PIEM/2014/0001) sponsored by the Spanish Association of Urology was conducted using their platform for multicentre studies. The clinical-pathological inclusion criteria were as follows: cT1a-cT3a, PSA </= 20 ng/ml, initial minimum biopsy of 10 cores, number of affected cores </= 3, 1st Gleason score of 3 and 2nd Gleason score </= 4 and a known prostate volume (in cc). A unified follow-up was not established for all recruiting centres; however, a survey was conducted that reflects the follow-up characteristics based on a number of tangible parameters that allow for their comparison. With the same philosophy of flexibility, the use of certain biomarkers and multiparametric MRI was not considered necessary for inclusion. RESULTS: We describe the Registry's characteristics and possibilities, as well as the preliminary results from the 324 patients included in its first 5 months of operation in the 15 recruiting centres. We also report the clinical-pathological variables, biomarkers, radiodiagnosis technique and quality-of-life questionnaires considered for the database, as well as the possibilities for indefinite follow-up, remaining open to any active treatment recognized in clinical guidelines. CONCLUSIONS: The AEU-PIEM/2014/0001 represents an extremely useful tool for all Spanish urologists for multicentre clinical research. The registry will undoubtedly enable the dissemination of active surveillance of our patients in a more coordinated manner, thus maintaining the advantages of optimised opportunistic screening for prostate cancer without resulting in overtreatment.","Actas Urol Esp, 40(1): 3-10","Spain",2016,"Local,Advanced","Surveillance","Unclear","Patient",null,"Protocol","Spain","Patient","Local,Advanced","Surveillance",null,"Protocol","Unclear","2015:2018","General"]
[589,"Ruiz-Deya, G., et al. (2001). \"Outpatient radical prostatectomy: impact of standard perineal approach on patient outcome.\" J Urol 166(2): 581-586.",null,"Ruiz-Deya, G., et al.","Outpatient radical prostatectomy: impact of standard perineal approach on patient outcome","PURPOSE: As managed care becomes more prevalent, urologists must critically evaluate the economic aspect of and patient satisfaction with urological practice patterns. We have previously reported the advantages of radical perineal prostatectomy, which decreases hospitalization and morbidity, and provides a more rapid return to normal activity, translating into cost savings. We have since evaluated the satisfaction of patients who underwent outpatient radical prostatectomy with and without laparoscopic pelvic lymph node dissection. MATERIALS AND METHODS: We evaluated the charts of 250 consecutive patients who underwent outpatient radical perineal prostatectomy with less than 24 hours of hospitalization from 1992 to 1997. Complications, pain management, blood transfusion, and bowel and urinary dysfunction were assessed. Validated quality of life questionnaires were mailed to 200 patients several months postoperatively and a 62% response rate was achieved. RESULTS: Mean followup in the series was 30 months. In the perioperative period there were rectal perforation in less than 2% of patients, anastomotic stricture in 3%, perineal fistula in 0.4% and blood transfusion in 11%. Some problems with bowel movements immediately after the procedure, such as diarrhea, constipation or soiled underwear, developed in 17% of patients, of whom up to 20% had had some bowel dysfunction before surgery. In the majority bowel problems resolved in an average of 7.3 weeks. Persistent new onset bowel trouble developed in 9 of the 124 patients (7%). The questionnaire demonstrated persistent significant urinary incontinence in 8 cases (7%). Nerve sparing was attempted in 54 patients, including 22 (41%) who achieve erection sufficient for vaginal penetration and are satisfied with sexual function. Of the patients 17% reported problems after hospital discharge that were mostly related to Foley catheter management. Overall 94.8% of patients were satisfied with treatment. Physical and social/family well-being appeared to be excellent according to the questionnaire. Only 12% of patients would have preferred longer hospitalization. The preferred method of pain control was nonsteroidal anti-inflammatory drugs. CONCLUSIONS: Radical perineal prostatectomy is a low morbidity alternative for localized prostate cancer. Outpatient radical perineal prostatectomy may be performed with good patient satisfaction and safety. There appear to be few bowel problems after long-term followup.","J Urol, 166(2): 581-586","USA",2001,"Any or unknown","Surgery","Unclear","Patient",null,"Cross-sectional","USA","Patient","Any or unknown","Surgery",null,"Cross-sectional","Unclear","2000:2004","Complication,Satisfaction"]
[590,"Ruland, C. M., et al. (2013). \"Effects of an internet support system to assist cancer patients in reducing symptom distress: a randomized controlled trial.\" Cancer Nurs 36(1): 6-17.",null,"Ruland, C. M., et al.","Effects of an internet support system to assist cancer patients in reducing symptom distress: a randomized controlled trial","BACKGROUND: Cancer patients experience many physical and psychosocial problems for which they need support. WebChoice is an Internet-based, interactive health communication application that allows cancer patients to monitor their symptoms and problems, provides individually tailored information and self-management support, e-communication with expert cancer nurses, and an e-forum for group discussion with other patients. OBJECTIVE: The objective of this study was to examine the effects of WebChoice on symptom distress (primary outcome), depression, self-efficacy, health-related quality of life, and social support (secondary outcomes). METHODS: In this 1-year repeated-measures randomized controlled trial, 325 breast and prostate cancer patients were randomized into 1 experimental group with access to WebChoice and 1 control group who received URLs of publicly available cancer Web sites. RESULTS: Group differences on symptom distress were significant only for the global symptom distress index on the Memorial Symptom Assessment Scale (slope estimate, -0.052 [95% confidence interval, -0.101 to -0.004]; t = 4.42; P = .037). There were no significant group differences on secondary outcomes. Additional analyses showed significant within-group improvements in depression in the experimental group only. In the control group, self-efficacy and health-related quality of life deteriorated significantly over time. CONCLUSION: This randomized controlled trial is one of the first to evaluate effects of an interactive health communication application to support cancer patients in illness management on symptoms. Although only 1 hypothesis was partially supported, the combined results show a clear trend toward better scores in the intervention group on most outcome measures. IMPLICATIONS FOR PRACTICE: If findings can be supported with additional research, WebChoice may become an important tool to support nursing care that can equip cancer patients to better manage their illness.","Cancer Nurs, 36(1): 6-17","Norway",2013,"Any or unknown","Various","MSAS","Patient",null,"Clinical trial","Norway","Patient","Any or unknown","Various",null,"Clinical trial","MSAS","2010:2014","Symptom"]
[591,"Sadetsky, N., et al. (2008). \"Insurance and quality of life in men with prostate cancer: data from the Cancer of the Prostate Strategic Urological Research Endeavor.\" BJU Int 101(6): 691-697.",null,"Sadetsky, N., et al.","Insurance and quality of life in men with prostate cancer: data from the Cancer of the Prostate Strategic Urological Research Endeavor","OBJECTIVE: To evaluate the effect of medical insurance coverage on health-related quality of life (HRQoL) outcomes in men newly diagnosed with prostate cancer, as insurance status has been shown to be related to clinical presentation, and types of treatments received for localized prostate cancer, but the relationship of insurance and QoL has not been explored sufficiently. PATIENTS AND METHODS: Data from the Cancer of the Prostate Strategic Urological Research Endeavor (CaPSURE), a national longitudinal database registry of men with prostate cancer, were used for this study. Men who were newly diagnosed at entry to CaPSURE and completed one questionnaire before treatment, and one or more afterwards, were included. Insurance groups specific to age distribution of the study population were assessed, i.e. Medicare, preferred provider organizations (PPOs), health maintenance organizations (HMOs), fee for service (FFS), and the Veterans Administration (VA) for the younger group, and Medicare only, Medicare plus supplement (+S), and HMO/PPO for the older group. Associations between patients' clinical and sociodemographic characteristics and insurance status were evaluated by chi-square and analysis of variance. Relationships between insurance status and HRQoL outcomes over time were evaluated by multivariate mixed model. RESULTS: Of 2258 men who met the study criteria, 1259 were younger and 999 were older than 65 years. More than half of the younger patients belonged to an HMO or PPO (42.2% and 32.5%, respectively), with the remainder distributed between Medicare, FFS and VA. In the older group most men belonged to Medicare only and the Medicare +S groups (22.4% and 58.8%, respectively). There was greater variation in clinical risk categories at presentation by insurance groups in the younger group. In the multivariate analysis, insurance status was significantly associated with changes in most HRQoL outcomes over time in the younger group, while in the older patients the effect of insurance diminished. Men in the VA and Medicare systems had lower scores at baseline and a steeper decline in Physical Function, Role Physical, Role Emotional, Social Function, Bodily Pain, Vitality, and General Health domains over time, controlling for type of initial treatment received, timing of HRQoL assessment, number of comorbidities, clinical risk at presentation, and income. CONCLUSION: Insurance was independently related to changes in a wide range of HRQoL outcomes in men aged <65 years treated for prostate cancer. With the latest advances in early diagnosis and treatment of prostate cancer, clinicians and researchers should be aware of the specific groups of patients who are more vulnerable to the adverse effects of treatment and subsequent decline in functioning. The present findings could provide important tools for understanding the process of recovery after treatment for prostate cancer, and identifying needs for specific services.","BJU Int, 101(6): 691-697","USA",2008,"Local","Unclear","Unclear","Patient",null,"Cohort","USA","Patient","Local","Unclear",null,"Cohort","Unclear","2005:2009","General"]
[592,"Saigal, C. S., et al. (2001). \"Predictors of utilities for health states in early stage prostate cancer.\" J Urol 166(3): 942-946.",null,"Saigal, C. S., et al.","Predictors of utilities for health states in early stage prostate cancer","PURPOSE: When faced with treatment choices for early stage prostate cancer, patients must balance the survival benefit of a treatment with its morbidity. Little is known about how patients balance these trade-offs. To further our understanding of patient decision making we assessed patient utilities for prostate cancer treatment related morbidities. We determined whether patient utilities were predicted by sociodemographic characteristics or baseline genitourinary function. MATERIALS AND METHODS: We evaluated 401 men undergoing prostate needle biopsy for suspicion of prostate cancer at university, Veterans Affairs and public hospitals. Study design included a prospective cross-sectional cohort with correlation and multivariate analysis. Subjects were studied with 2 established health related quality of life instruments. Patient utilities were assessed with an interactive software application. RESULTS: On multivariate analysis utility for current general health was a significant predictor of utilities for treatment related morbidities. Surprisingly baseline urinary, sexual and bowel function scores did not correlate well with respective utilities for potential incontinence, impotence or radiation proctitis. In other words, men with good and imperfect baseline function were equally willing to risk impairment to preserve life. CONCLUSIONS: Men who perceived that general health was better appear to place higher value on quantity of life, while those who already are suffering from poor general health place higher value on quality of life. Ethnicity appears to modify some effects of other variables on patient preference. Utility assessment provides a quantitative tool to aid physicians in counseling patients when making treatment decisions for localized prostate cancer.","J Urol, 166(3): 942-946","USA",2001,"Local","Unclear","Unclear","Patient",null,"Cross-sectional","USA","Patient","Local","Unclear",null,"Cross-sectional","Unclear","2000:2004","Utility"]
[593,"Sakai, H., et al. (2009). \"Hot flashes during androgen deprivation therapy with luteinizing hormone-releasing hormone agonist combined with steroidal or nonsteroidal antiandrogen for prostate cancer.\" Urology 73(3): 635-640.",null,"Sakai, H., et al.","Hot flashes during androgen deprivation therapy with luteinizing hormone-releasing hormone agonist combined with steroidal or nonsteroidal antiandrogen for prostate cancer","OBJECTIVES: To investigate hot flashes and quality of life during combined androgen blockade (CAB) therapy using steroidal or nonsteroidal antiandrogens. METHODS: A total of 151 patients with prostate cancer, who were enrolled into this study from May 2001 to June 2003, were randomized to receive CAB therapy using a luteinizing hormone-releasing hormone agonist (leuprorelin) combined with a steroidal antiandrogen (chlormadinone) or a nonsteroidal antiandrogen (bicalutamide). The incidence of, frequency of, and distress due to hot flashes were evaluated with a self-administered questionnaire during a 2-year period. The general and disease-specific quality-of-life outcomes were also measured using the Functional Assessment of Cancer Therapy-Prostate questionnaire. RESULTS: Data were available for analysis from 124 patients. Although the incidence of hot flashes largely tended to be greater in the bicalutamide group than in the chlormadinone group, no significant difference was noted in the cumulative incidence of hot flashes at 2 years. The median frequency of hot flashes daily was 1.3 and 2.2 for warmth/flushing (P = .16) and 1.0 and 3.6 for sweating (P = .021) in the chlormadinone and bicalutamide groups, respectively. Patients in the chlormadinone group were significantly less likely to be distressed by warmth/flushing (odds ratio 0.47, P < .001) and sweating (odds ratio 0.61, P = .01) than were those in the bicalutamide group. The Functional Assessment of Cancer Therapy-Prostate scores over time showed no intergroup differences. CONCLUSIONS: Our results suggest that CAB using a steroidal antiandrogen such as chlormadinone might induce fewer and less-distressing hot flashes than CAB with bicalutamide.","Urology, 73(3): 635-640","Japan",2009,"Any or unknown","Hormonal","FACT-P","Patient",null,"Clinical trial","Japan","Patient","Any or unknown","Hormonal",null,"Clinical trial","FACT-P","2005:2009","Disease"]
[594,"Salonen, A. J., et al. (2013). \"Advanced prostate cancer treated with intermittent or continuous androgen deprivation in the randomised FinnProstate Study VII: quality of life and adverse effects.\" Eur Urol 63(1): 111-120.",null,"Salonen, A. J., et al.","Advanced prostate cancer treated with intermittent or continuous androgen deprivation in the randomised FinnProstate Study VII: quality of life and adverse effects","BACKGROUND: Intermittent dosing may reduce the adverse events (AEs) of androgen-deprivation therapy (ADT). OBJECTIVE: To compare intermittent androgen deprivation (IAD) and continuous androgen deprivation (CAD) with regard to health-related quality of life (QoL). DESIGN, SETTING, AND PARTICIPANTS: A total of 852 men with advanced prostate cancer (PCa) were enrolled to receive goserelin acetate 3.6 mg every 28 d for 24 wk. A total of 554 patients whose prostate-specific antigen (PSA) decreased to <10 ng/ml or by >/=50% (<20 ng/ml at baseline) were randomised to IAD or CAD. INTERVENTION: In the IAD arm, ADT was resumed for at least 24 wk whenever PSA increased >20 ng/ml or above baseline. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: QoL was monitored with a validated Cleary 30-item questionnaire and analysed by the Mann-Whitney U test, 0.5 standard deviation rule, and repeated measures analysis of variance. AEs and adverse drug reactions (ADRs) were analysed by the chi-square test. RESULTS AND LIMITATIONS: Median follow-up was 65 mo. Significant differences in QoL emerged in activity limitation, physical capacity, and sexual functioning, favouring IAD. No significant differences emerged in the prevalence of AEs: 87 patients in the IAD arm (31.8%) and 95 in the CAD arm (33.9%) had cardiovascular (CV) AEs (p=0.59), with 25 (9.1%) and 29 (10.4%) withdrawn (p=0.62), and 21 (7.7%) and 24 (8.6%) dying because of a CV event (p=0.70), respectively; bone fractures occurred in 19 (6.9%) and 15 (5.4%) patients (p=0.44), respectively. Hot flushes or night sweats were the most common ADRs (47.1% vs 50.4%; p=0.44). Erectile dysfunction (15.7% vs 7.9%; p=0.042) and depressed mood (2.2 vs 0%; p=0.032) were more common in the IAD arm. CONCLUSIONS: IAD showed benefits in the treatment of advanced PCa with respect to QoL. The prevalence of AEs was not significantly lower with IAD. TRIAL REGISTRATION: ClinicalTrials.gov, NCT00293670.","Eur Urol, 63(1): 111-120","Finland",2013,"Advanced","Hormonal","Cleary-30","Patient",null,"Clinical trial","Finland","Patient","Advanced","Hormonal",null,"Clinical trial","Cleary-30","2010:2014","General"]
[595,"Sammon, J., et al. (2011). \"Robotic radical prostatectomy: a critical analysis of surgical quality.\" Curr Opin Urol 21(3): 195-199.",null,"Sammon, J., et al.","Robotic radical prostatectomy: a critical analysis of surgical quality","PURPOSE OF REVIEW: To review the ways in which the quality of radical prostatectomy and robot-assisted radical prostatectomy have been assessed, including quality-of-life (QoL) assessment, combined outcomes reporting, and patient utilities. RECENT FINDINGS: Superlative survival expectations following radical prostatectomy have shifted the paradigm of assessing surgical quality toward the prospective evaluation of QoL outcomes and combined outcomes reporting. Several high quality multi-institutional studies have compared QoL outcomes between the common treatment modalities for prostate cancer. Single-institution combined outcomes 'Trifecta' studies provide a convenient presentation of outcomes most important to the surgeon but have many associated limitations. The assessment of patient preferences for treatment outcomes is an underexplored area within the urologic literature and can provide an insight into a patient's perception of surgical quality as seen in a pilot study performed at our institution. SUMMARY: Advances in the use of validated QoL instruments allow patients and clinicians to select treatment based on the perceived risk of adverse QoL impact but do not provide an insight into what the individual patient considers important. Combined outcomes reports also fail to address key patient concerns. A phenomenologic assessment of robot-assisted radical prostatectomy surgical quality does not exist, but will be necessary to properly evaluate surgical quality.","Curr Opin Urol, 21(3): 195-199","USA",2011,"Any or unknown","Surgery","Unclear","Patient",null,"Narrative review","USA","Patient","Any or unknown","Surgery",null,"Narrative review","Unclear","2010:2014","General"]
[596,"Sampurno, F., et al. (2016). \"Comparison of Patient-Reported Quality-of-Life and Complications in Men With Prostate Cancer, Between Two Modes of Administration.\" Clin Genitourin Cancer 14(4): 284-289.",null,"Sampurno, F., et al.","Comparison of Patient-Reported Quality-of-Life and Complications in Men With Prostate Cancer, Between Two Modes of Administration","INTRODUCTION: Our purpose was to: (1) assess the level of consistency between the quality-of-life (QOL) scores of men with prostate cancer for urinary/bowel/sexual bother, collected via telephone versus self-administered survey; (2) determine factors associated with variation in level of agreement; and (3) assess the efficacy of telephone interview as a mode of administration against the \"gold standard\" tool, EPIC-26. METHODS: Cohen's Kappa coefficients were calculated to investigate test-retest reliability across modes of administration. Logistic regression models explored patients' characteristics associated with the magnitude of urinary/bowel/sexual problem. Sensitivities and specificities of the telephone mode in reference to \"gold standard\" were further measured. RESULTS: From 221 men who agreed to participate in the study, 168 (76.0%) returned completed surveys. Kappa-linear model resulted in a moderate agreement across the urinary/bowel/sexual bother scores for both modes of administration; with greatest concordance recorded for bowel bother (90%). Patient's age (<75 years), disease risk, and active treatment type determined a moderate-to-good level of agreement between administration modalities with a Kappa varying between 0.44 and 0.73; chi(2), 8.18; P = .042. Sensitivity tests revealed that 68% of men with a moderate/big problem during the phone interviews would respond to suffering from a moderate/big sexual problem. CONCLUSION: Results of this pilot study revealed that QOL outcomes from this registry will likely underestimate the true bother experienced by men. More research is required to determine the differences between self-administered and telephone interviews in men with prostate cancer.","Clin Genitourin Cancer, 14(4): 284-289","Australia",2016,"Any or unknown","None","EPIC","Patient",null,"Validation","Australia","Patient","Any or unknown","None",null,"Validation","EPIC","2015:2018","Disease"]
[597,"Sanchez-Ortiz, R. F., et al. (2000). \"Erectile function and quality of life after interstitial radiation therapy for prostate cancer.\" Int J Impot Res 12 Suppl 3: S18-24.",null,"Sanchez-Ortiz, R. F., et al.","Erectile function and quality of life after interstitial radiation therapy for prostate cancer","Few studies have evaluated erectile function after interstitial radiation therapy for localized prostate cancer. Using a validated quality of life questionnaire, we assessed post-treatment erectile function and its relationship to treatment satisfaction and quality of life. We retrospectively reviewed the records of 171 consecutive patients who underwent Pd-103 or I-125 brachytherapy for prostate cancer between December 1992 and June 1998. Seventy percent of patients received neoadjuvant androgen deprivation therapy. All patients were mailed a validated questionnaire assessing sexual function and overall quality of life (UCLA Prostate Cancer Index and SF-36). Sixty-seven percent of all questionnaires were available for evaluation (114/171). The mean age was 69.1 y with a mean follow-up of 23 months (range 4-72, median 24). Seventy-one percent of patients (81/114) had pre-treatment erections sufficient for sustained vaginal penetration. Of these patients, potency was maintained in 49% of men (40/81). An additional 26% had erections firm enough for foreplay but not penetration (21/81). Erectile dysfunction rates were significantly lower in younger patients (48%) vs older patients (55%). There was no difference in post-treatment potency between men who received neoadjuvant hormonal therapy and those who did not (P>0.05). In addition, there were no differences in physical function (86, scale 0-100), general health perception (78), emotional well-being (83), energy/fatigue (74), and overall satisfaction (84) between men with erectile dysfunction and those without. In summary, two years following brachytherapy 25% of patients complained of complete (20/81) or partial (26%, 21/81) erectile dysfunction, for an overall rate of 51% (41/81). Short-term neoadjuvant hormonal therapy (<3-6 months) did not increase the likelihood of post-treatment erectile dysfunction. Interestingly, overall satisfaction rates among brachytherapy patients were high (84/100) and surprisingly did not correlate with post-treatment sexual function.","Int J Impot Res, 12 Suppl 3(S18-24","USA",2000,"Local","Brachytherapy,Hormonal","UCLA-PCI,SF-36","Patient",null,"Cross-sectional","USA","Patient","Local","Brachytherapy,Hormonal",null,"Cross-sectional","UCLA-PCI,SF-36","2000:2004","Disease,Utility"]
[598,"Sandblom, G., et al. (2001). \"Pain and health-related quality of life in a geographically defined population of men with prostate cancer.\" Br J Cancer 85(4): 497-503.",null,"Sandblom, G., et al.","Pain and health-related quality of life in a geographically defined population of men with prostate cancer","In order to provide baseline data on pain and health-related quality of life, to explore factors predicting pain and reduced quality of life, and to find potentially undertreated cases in men with prostate cancer, we undertook a population-based questionnaire study. The questionnaire, which included the EuroQo1 instrument, the Brief Pain Inventory form and 8 specially designed questions, was sent to all men with prostate cancer in the county of Ostergotland, Sweden. Of the 1442 men included in the study, 1243 responded to the questionnaire. Altogether 42% had perceived pain during the previous week and 26% stated their quality of life to be 50% or lower on a visual analogue scale. A high rating of health care availability and short time since diagnosis were found to significantly predict lower ratings of pain (P< 0.05). Pain was found to be a significant predictive factor for decreased quality of life together with high age, low rating of health care availability and palliative treatment (P< 0.05). In conclusion, assessment and treatment of pain is essential for a good quality of life in men with prostate cancer. The monitoring of prostate cancer patients should be individualized to fit the demands of the groups with the greatest need for support.","Br J Cancer, 85(4): 497-503","Sweden",2001,"Any or unknown","None","EQ-5D,BPI,VAS","Patient",null,"Cross-sectional","Sweden","Patient","Any or unknown","None",null,"Cross-sectional","EQ-5D,BPI,VAS","2000:2004","Symptom,Utility"]
[599,"Sandblom, G., et al. (2004). \"A population-based study of pain and quality of life during the year before death in men with prostate cancer.\" Br J Cancer 90(6): 1163-1168.",null,"Sandblom, G., et al.","A population-based study of pain and quality of life during the year before death in men with prostate cancer","In order to explore how health-related quality of life changes towards the end of life, a questionnaire including the EuroQOl form and the Brief Pain Inventory form was sent to all men with prostate cancer in the county of Ostergotland, Sweden, in September 1999. Responders who had died prior to 1 January 2001 were later identified retrospectively. Of the 1442 men who received the questionnaire, 1243 responded (86.2%). In the group of responders, 167 had died within the study period, 66 of prostate cancer. In multivariate analysis, pain as well as death within the period of study were found to predict decreased quality of life significantly. Of those who died of prostate cancer, 29.0% had rated their worst pain the previous week as severe. The same figure for those still alive was 10.5%. On a visual analogue scale (range 0-100), the mean rating of quality of life for those who subsequently died of prostate cancer was 54.0 (95% confidence interval +/-5.2) and those still alive was 70.0 (+/-1.2). In conclusion, health-related quality of life gradually declines during the last year of life in men with prostate cancer. This decline may partly be avoided by an optimised pain management.","Br J Cancer, 90(6): 1163-1168","Sweden",2004,"End of life","None","EQ-5D,BPI,VAS","Patient",null,"Cross-sectional","Sweden","Patient","End of life","None",null,"Cross-sectional","EQ-5D,BPI,VAS","2000:2004","Symptom,Utility"]
[600,"Sato, K., et al. (2003). \"Total cystoprostatectomy in the treatment of locally advanced prostate carcinoma.\" Aktuelle Urol 34(4): 259-261.",null,"Sato, K., et al.","Total cystoprostatectomy in the treatment of locally advanced prostate carcinoma","OBJECTIVE: Locally advanced prostate carcinoma frequently causes lower urinary tract symptoms and is a clinical challenge when radiation and/or hormone therapy fail. We investigated whether cystoprostatectomy with urinary diversion benefits patients with locally advanced prostate carcinoma in terms of quality of life and prognostic outcome. PATIENTS AND METHODS: Between 1989 and 2001, we performed 15 cystoprostatectomies for stage C-D1 prostate carcinoma with bladder neck involvement. Of these patients, 5 underwent ileal conduit, 8 rectal bladder, 1 Koch pouch, and 1 ureterocutaneostomy. All the patients received neoadjuvant and/or adjuvant hormonal therapy. In the same period, 28 patients underwent retropubic prostatectomies and 15 patients received hormone therapy alone for stage C-Dl disease. These patients were included as references. RESULTS: Lower urinary tract symptoms caused by bladder involvement were controlled well until the end of follow-up for all the patients in the cystoprostatectomy group. There was no statistically significant difference in QOL score assessed with the EORTC QLQ-C30 questionnaire between the prostatectomy group and the cystoprostatectomy group, while that in the hormone therapy group was lower than those in the surgery groups. There was no statistically significant difference in 5-year PSA-relapse-free survival among cystoprostatectomy, prostatectomy, and hormone therapy groups. Patients in the hormone therapy group died earlier than those in the prostatectomy group (p = 0.02), while those in the cystoprostatectomy group did not. CONCLUSION: These results suggest that total cystoprostatectomy with urinary diversion is a valid option, in terms of disease control and QOL, for prostate cancer patients whose tumor is infiltrating into the bladder.","Aktuelle Urol, 34(4): 259-261","Japan",2003,"Advanced","Surgery,Hormonal","EORTC QLQ-C30","Patient",null,"Cohort","Japan","Patient","Advanced","Surgery,Hormonal",null,"Cohort","EORTC QLQ-C30","2000:2004","General"]
[601,"Sato, N., et al. (2004). \"Intermittent androgen suppression for locally advanced and metastatic prostate cancer: preliminary report of a prospective multicenter study.\" Urology 64(2): 341-345.",null,"Sato, N., et al.","Intermittent androgen suppression for locally advanced and metastatic prostate cancer: preliminary report of a prospective multicenter study","OBJECTIVES: To clarify the effect of intermittent androgen suppression on the time to androgen-independent progression and changes in quality of life (QOL). METHODS: Patients with locally advanced or metastatic prostate cancer were treated with a combination of leuprolide acetate and flutamide for 36 weeks. When the serum prostate-specific antigen (PSA) levels at 24 and 32 weeks were less than 4.0 ng/mL, treatment was withheld until the PSA level reached 15 ng/mL or the pretreatment level. This cycle of on-treatment and off-treatment was repeated until PSA failure (three consecutive increases in PSA level greater than 4.0 ng/mL during the on-treatment period) or symptomatic progression was observed. Changes in QOL were assessed by a self-assessment questionnaire. RESULTS: Forty-nine patients (26 with T3N0M0, 8 with T2-T3N1M0, 2 with T4N0M0, and 13 with T2-T3N0M1) were enrolled. The mean follow-up period was 136.5 weeks. Thirty-one patients finished cycle 1, six finished cycle 2, and three finished cycle 3. The mean off-treatment duration in cycles 1, 2, and 3 was 46.1, 36.9, and 23.3 weeks, respectively. In the off-treatment period, statistically significant improvements in the QOL score were observed in the categories of potency (11.4 versus 2.4) and social/family well-being (20.3 versus 16.1) compared with those in the on-treatment period. PSA failure occurred in 6 patients (3 with T3N0M0 and 3 with T2-T3N1M0), and all patients were alive at last follow-up. CONCLUSIONS: Our interim analysis indicated that QOL is remarkably improved during the off-treatment period. Intermittent androgen suppression would be a viable option for treatment of advanced prostate cancer, although a randomized controlled study is required to determine whether intermittent androgen suppression prolongs the time to androgen-independent cancer. We will continue follow-up in this study to a minimum of 3 years.","Urology, 64(2): 341-345","Japan",2004,"Advanced,Metastatic","Hormonal","Unclear","Patient",null,"Clinical trial","Japan","Patient","Advanced,Metastatic","Hormonal",null,"Clinical trial","Unclear","2000:2004","General"]
[602,"Scalliet, P. G., et al. (2004). \"Retrospective analysis of results of p(65)+Be neutron therapy for treatment of prostate adenocarcinoma at the cyclotron of Louvain-la-Leuve. Part II: Side effects and their influence on quality of life measured with QLQ-C30 of EORTC.\" Int J Radiat Oncol Biol Phys 58(5): 1549-1561.",null,"Scalliet, P. G., et al.","Retrospective analysis of results of p(65)+Be neutron therapy for treatment of prostate adenocarcinoma at the cyclotron of Louvain-la-Leuve. Part II: Side effects and their influence on quality of life measured with QLQ-C30 of EORTC","PURPOSE: Between 1978 and 1998, 533 prostate adenocarcinoma patients were treated with mixed photon-neutron radiotherapy. We report on a retrospective series of patients for whom the side effects of the treatment and their impact on quality of life were assessed by a mailed questionnaire. METHODS AND MATERIALS: The European Organization for Research and Treatment of Cancer quality-of-life core questionnaire and a prostate-specific questionnaire were used. Between 1990 and 1996, 308 consecutive patients were treated. Two protocols were used: pelvic fields (50 Gy equivalent photons, 2 Gy/fraction) followed by a prostate boost (66 Gy) or prostate alone. The neutron/photon ratio varied. The questionnaire was mailed to 262 patients presumed to be alive. RESULTS: Of the 262 patients, 230 replied. Of the 230 patients, 73% had no trouble doing strenuous activities and 4% had trouble with taking a short walk. The overall physical condition and quality-of-life questions received a mean score of 5.2 and 5.3 on a 7-point scale, respectively. Twenty-two percent had bowel movements at least four times daily, and 6% did so six times or more. Retaining stool was a problem in 26%, and only 38% reported full continence; 17% urinated four times or more nightly. Urinary incontinence was scored as \"quite a bit\" or \"very much\" in 11% and 5%, respectively. Hematuria and dysuria (pain) were reported by 7% and 16%, respectively, mainly as moderate. Only 28% reported easy erections, but 75% judged the sexual change acceptable. A greater neutron/photon ratio was significantly associated with more bowel problems (p = 0.003). CONCLUSION: Mixed photon-neutron therapy for prostate cancer was associated with significant patient-reported side effects. Their significant effect on patients' quality of life is described.","Int J Radiat Oncol Biol Phys, 58(5): 1549-1561","Belgium",2004,"Any or unknown","Radiotherapy","EORTC QLQ-C30,EORTC QLQ-PR25","Patient",null,"Cross-sectional","Belgium","Patient","Any or unknown","Radiotherapy",null,"Cross-sectional","EORTC QLQ-C30,EORTC QLQ-PR25","2000:2004","Disease,General"]
[603,"Schaake, W., et al. (2014). \"The impact of gastrointestinal and genitourinary toxicity on health related quality of life among irradiated prostate cancer patients.\" Radiother Oncol 110(2): 284-290.",null,"Schaake, W., et al.","The impact of gastrointestinal and genitourinary toxicity on health related quality of life among irradiated prostate cancer patients","PURPOSE: To determine the impact of late radiation-induced toxicity on health-related quality of life (HRQoL) among patients with prostate cancer. PATIENTS AND METHODS: The study sample was composed of 227 patients, treated with external beam radiotherapy. Common Terminology Criteria for Adverse Events version 3.0 were used to grade late genitourinary and gastrointestinal toxicity. The European Organization for Research and Treatment of Cancer Quality of life Questionnaire C30 (EORTC QLQ-C30) was used to assess HRQoL at baseline, and 6, 12 and 24 months after completion of radiotherapy. Statistical analysis was performed using a multivariate analysis of variance (MANOVA). RESULTS: Urinary incontinence and rectal discomfort significantly affected HRQoL. The impact of urinary incontinence on HRQoL was most pronounced 6 months after radiotherapy and gradually decreased over time. The impact of rectal discomfort on HRQoL was predominant at 6 months after radiotherapy, decreased at 12 months and increased again 2 years after radiotherapy. No significant impact on HRQoL was observed for any of the other toxicity endpoints, or non-toxicity related factors such as hormonal therapy, radiotherapy technique or age. CONCLUSION: Urinary incontinence and rectal discomfort have a significant impact on HRQoL. Prevention of these side effects may likely improve quality of life of prostate cancer patients after completion of treatment.","Radiother Oncol, 110(2): 284-290","Netherlands",2014,"Any or unknown","Radiotherapy","EORTC QLQ-C30,CTCAE","Patient",null,"Clinical trial","Netherlands","Patient","Any or unknown","Radiotherapy",null,"Clinical trial","EORTC QLQ-C30,CTCAE","2010:2014","General,Treatment"]
[604,"Schafer, J. W., et al. (2008). \"Long-term health-related quality-of-life outcomes after permanent prostate brachytherapy.\" Onkologie 31(11): 599-603.",null,"Schafer, J. W., et al.","Long-term health-related quality-of-life outcomes after permanent prostate brachytherapy","BACKGROUND: We evaluated the long-term health-related quality of life (HRQoL) after modern prostate brachytherapy (PB). PATIENTS AND METHODS: The European Organization for Research and Treatment of Cancer (EORTC) prostate cancer quality-of-life questionnaire, QLQ-PR25, and the modified International Continence Society (ICS) male questionnaire were sent to 296 men treated with PB at the University Medical Center Mannheim. To evaluate the influence of age, we subclassified two groups: group 1 <65 years, group 2 > or =65 years. 258 of the 296 patients were alive at the time of assessment. Of 238 questionnaires (92% response rate), 231 were suitable for analysis. Median follow-up was 51 months. RESULTS: Of group 1 77.8% and of group 2 73.4% of the men were in good, very good or excellent health. There was a low rate of moderate (10.4%) or strong (1.0%) symptoms regarding urinary functioning. Stress incontinence was uncommon. Only 28.2% reported moderate or strong (up to 17.6%) symptoms regarding sexual functioning. In group 1 48.6% and in group 2 25.0% of patients reported no or minor erectile dysfunction (p < 0.007). There was no severe overall rectal dysfunction (<2%). CONCLUSION: Our data substantiate the favorable long-term HRQoL outcomes associated with modern PB techniques. Significant age differences were observed in sexual symptoms and less pronounced age differences in urinary symptoms. We found a low rate of urinary symptoms and no evidence of severe rectal dysfunction.","Onkologie, 31(11): 599-603","Germany",2008,"Any or unknown","Brachytherapy","EORTC QLQ-PR25,ICSQ","Patient",null,"Cross-sectional","Germany","Patient","Any or unknown","Brachytherapy",null,"Cross-sectional","EORTC QLQ-PR25,ICSQ","2005:2009","Disease,Complication"]
[605,"Schapira, M. M., et al. (2001). \"Effect of treatment on quality of life among men with clinically localized prostate cancer.\" Med Care 39(3): 243-253.",null,"Schapira, M. M., et al.","Effect of treatment on quality of life among men with clinically localized prostate cancer","BACKGROUND: Quality-of-life outcomes are an important consideration for patients evaluating therapeutic options for localized prostate cancer. OBJECTIVES: The objective of this study was to describe the effect of treatment choice on change in health-related quality of life (HRQOL) among men with clinically localized prostate cancer. RESEARCH DESIGN: This was a prospective observational study. SUBJECTS: The study subjects were 122 men with clinically localized adenocarcinoma of the prostate. Forty-two subjects (34%) underwent radical prostatectomy, 51 (42%) underwent radiation therapy, and 29 (24%) were followed with expectant management. MEASURES: The University of California at Los Angeles Prostate Cancer Quality of Life Inde- and the Medical Outcomes Study Short Form-36 were administered before and 3 and 12 months after initial treatment. The study used an analysis of covariance model adjusted for baseline differences in clinical and demographic factors. RESULTS: Men who underwent radical prostatectomy experienced significant declines in urinary and sexual function and bother that persisted at 12 months after treatment. Men treated with radiation therapy experienced smaller but significant declines in sexual function and a decline in social function. Expectant management patients did not have a significant change in disease-targeted or generic HRQOL domains. Differential rates of change in urinary and sexual function between treatment groups persisted after adjustment for differences in pretreatment clinical and demographic factors. CONCLUSIONS: Men undergoing radical prostatectomy have substantial declines in urinary and sexual function, and men undergoing radiotherapy have declines in sexual function. Men undergoing expectant management have no change in disease-specific or general HRQOL in the first year after treatment.","Med Care, 39(3): 243-253","USA",2001,"Local","Surgery,Radiotherapy,Surveillance","SF-36,UCLA-PCI","Patient",null,"Cohort","USA","Patient","Local","Surgery,Radiotherapy,Surveillance",null,"Cohort","SF-36,UCLA-PCI","2000:2004","Disease,Utility"]
[606,"Schellhammer, P., et al. (1995). \"A controlled trial of bicalutamide versus flutamide, each in combination with luteinizing hormone-releasing hormone analogue therapy, in patients with advanced prostate cancer. Casodex Combination Study Group.\" Urology 45(5): 745-752.",null,"Schellhammer, P., et al.","A controlled trial of bicalutamide versus flutamide, each in combination with luteinizing hormone-releasing hormone analogue therapy, in patients with advanced prostate cancer. Casodex Combination Study Group","OBJECTIVES: To compare the efficacy and safety of bicalutamide and flutamide, each used in combination with luteinizing hormone-releasing analogue (LHRH-A) therapy, in patients with untreated metastatic (Stage D2) prostate cancer. METHODS: Randomized, double-blind (for antiandrogen therapy), multicenter study with a 2 x 2 factorial design. Eight hundred thirteen patients were allocated 1:1 to bicalutamide (50 mg once daily) and flutamide (250 mg three times daily) and 2:1 to goserelin acetate (3.6 mg every 28 days) and leuprolide acetate (7.5 mg every 28 days). RESULTS: With a median duration of follow-up of 49 weeks, time to treatment failure, the primary endpoint, was significantly (P = 0.005) better for the bicalutamide plus LHRH-A group than for the flutamide plus LHRH-A group. Patients in the flutamide plus LHRH-A group were 34% more likely to fail treatment over the given time period, as indicated by the hazard ratio of 0.749 (95% confidence interval, 0.61 to 0.92) for bicalutamide plus LHRH-A to flutamide plus LHRH-A. Results for secondary endpoints (survival, quality of life, and subjective response) were similar between groups. Diarrhea occurred in 24% of patients in the flutamide plus LHRH-A group, compared with 10% of patients in the bicalutamide plus LHRH-A group (P < 0.001). CONCLUSIONS: In patients with metastatic prostate cancer, bicalutamide plus LHRH-A is well tolerated and provides superior efficacy to flutamide plus LHRH-A with respect to time to treatment failure. Assessment of the effects of these regimens on longer term survival requires additional time for follow-up.","Urology, 45(5): 745-752","USA",1995,"Metastatic","Hormonal","Unclear","Patient",null,"Clinical trial","USA","Patient","Metastatic","Hormonal",null,"Clinical trial","Unclear","1960:1999","General"]
[607,"Schlenk, E. A., et al. (1998). \"Health-related quality of life in chronic disorders: a comparison across studies using the MOS SF-36.\" Qual Life Res 7(1): 57-65.",null,"Schlenk, E. A., et al.","Health-related quality of life in chronic disorders: a comparison across studies using the MOS SF-36","The purpose of this report is to examine health-related quality of life (HRQoL) as measured by the Medical Outcomes Study Short Form-36, across patient populations with chronic disorders and to compare quality of life (QoL) in these subjects with normative data on healthy persons. Six studies, within the Center for Research in Chronic Disorders at the University of Pittsburgh School of Nursing, in patients with urinary incontinence, prostate cancer, chronic obstructive pulmonary disease (COPD), acquired immune deficiency syndrome (AIDS), fibromyalgia and hyperlipidaemia provided the data for analysis. The results demonstrated that not only did the prostate cancer and hyperlipidaemia patients have the highest QoL across the chronic disorders, but their QoL was comparable to normative data on healthy persons. Homebound, elderly, incontinent patients had the lowest QoL for physical functioning, whereas patients hospitalized with AIDS had the lowest QoL in general health and social functioning. Patients with COPD had the lowest QoL in role-physical, role-emotional and mental health. Patients with fibromyalgia had the lowest QoL in bodily pain and vitality. Compared to normative data, patients with urinary incontinence, COPD, AIDS and fibromyalgia generally had lower QoL. Prostate cancer and hyperlipidaemia patients had QoL comparable to normative data. Compared to normative data, patients with urinary incontinence, COPD, AIDS and fibromyalgia had more variability for role-emotional. AIDS patients had more variability on physical functioning, bodily pain and social functioning compared to the normative data. These data suggest that patients with various chronic disorders may have QoL that is lower in most domains compared to a healthy population. However, there may be differences in the domains affected as well as the extent of variation across specific chronic disorders.","Qual Life Res, 7(1): 57-65","USA",1998,"Any or unknown","None","SF-36","Patient",null,"Cross-sectional","USA","Patient","Any or unknown","None",null,"Cross-sectional","SF-36","1960:1999","Utility"]
[608,"Schmid, S., et al. (2015). \"Assessment of anticancer-treatment outcome in patients with metastatic castration-resistant prostate cancer-going beyond PSA and imaging, a systematic literature review.\" Ann Oncol 26(11): 2221-2247.",null,"Schmid, S., et al.","Assessment of anticancer-treatment outcome in patients with metastatic castration-resistant prostate cancer-going beyond PSA and imaging, a systematic literature review","BACKGROUND: In the past years, there has been significant progress in anticancer drug development for patients with metastatic castration-resistant prostate cancer (CRPC). However, the current instruments to assess clinical treatment response have limitations and may not sufficiently reflect patient benefit. Our objective was to systematically identify tools to evaluate both patient benefit and clinical anticancer-treatment response as basis for an international consensus process and development of a specific pragmatic instrument for men with CRPC. METHODS: PubMed, Embase and CINAHL were searched to identify currently available tools to assess anticancer-treatment benefit, other than standard imaging procedures and prostate-specific antigen measurements, namely quality of life (QoL), detailed pain assessment, physical function and objective measures of other complex cancer-related syndromes in patients with CRPC. Additionally, all CRPC phase III trials published in the last 5 years were reviewed as well as studies using physical function tools in a general cancer population. The PRIMSA statement was followed for the systematic review process. RESULTS: The search generated 1096 hits, 185 full-text papers were screened and finally 73 publications were included. Additional 89 publications were included by hand-search. We identified a total of 98 tools used in CRPC trials and grouped these into three categories: 22 tools assessing QoL domains and subgroups, 47 tools for pain assessment and 29 tools for objective measures, mainly physical function and assessment of skeletal disease burden. CONCLUSION: A wide variety of assessment tools and also efforts to standardize and harmonize patient-reported outcomes and pain assessment were identified. However, the specific needs of the increasing CRPC population living longer with their incurable cancer are insufficiently captured and objective physical outcome measures are under-represented. In the age of new anticancer drug targets and principles, new methods to monitor patient relevant outcomes of antineoplastic therapy are of utmost importance.","Ann Oncol, 26(11): 2221-2247","International",2015,"Metastatic","Unclear","Unclear","Patient",null,"Systematic review","International","Patient","Metastatic","Unclear",null,"Systematic review","Unclear","2015:2018","General,Symptom"]
[609,"Schmidt, S., et al. (2014). \"Assessing quality of life in patients with prostate cancer: a systematic and standardized comparison of available instruments.\" Qual Life Res 23(8): 2169-2181.",null,"Schmidt, S., et al.","Assessing quality of life in patients with prostate cancer: a systematic and standardized comparison of available instruments","PURPOSE: The objective was to obtain a standardized evaluation of available prostate cancer-specific quality of life instruments used in patients with early-stage disease. METHODS: We carried out systematic literature reviews in the PubMed database to identify manuscripts which contained information regarding either the development process or metric properties of prostate cancer-specific quality of life instruments. Each instrument was evaluated by two experts, independently, using the Evaluating Measures of Patient-Reported Outcomes (EMPRO) tool. An overall and seven attribute-specific EMPRO scores were calculated (range 0-100, worst to best): measurement model, reliability, validity, responsiveness, interpretability, burden and alternative forms. RESULTS: Eight instruments and 57 manuscripts (2-15 per instrument) were identified. The Expanded Prostate Cancer Index Composite (EPIC) was the best rated (overall EMPRO score 83.1 points). Good results were also obtained by University of California Los Angeles-Prostate Cancer Index (UCLA-PCI), Patient-Oriented Prostate Utility Scale (PORPUS) and Prostate Cancer Quality of Life Instrument (PC-QoL) with 77.3, 70.5 and 64.8 points, respectively. These four instruments passed with distinction the validity and responsiveness evaluation. Insufficient reliability results were observed for UCLA-PCI and PORPUS. CONCLUSIONS: Current evidence supports the choice of EPIC, PORPUS or PC-QoL. Attribute-specific EMPRO results facilitate selecting the adequate instrument for every purpose. For longitudinal studies or clinical trials, where responsiveness is the priority, EPIC or PC-QoL should be considered. We recommend the PORPUS for economic evaluations because it allows cost-utility analysis, and EPIC short versions to minimize administration burden.","Qual Life Res, 23(8): 2169-2181","Spain",2014,"Local","None","EPIC,PORPUS,PC-QoL,UCLA-PCI","Patient",null,"Validation","Spain","Patient","Local","None",null,"Validation","EPIC,PORPUS,PC-QoL,UCLA-PCI","2010:2014","Disease,Utility"]
[610,"Schofield, P., et al. (2016). \"Nurse-led group consultation intervention reduces depressive symptoms in men with localised prostate cancer: a cluster randomised controlled trial.\" BMC Cancer 16: 637.",null,"Schofield, P., et al.","Nurse-led group consultation intervention reduces depressive symptoms in men with localised prostate cancer: a cluster randomised controlled trial","BACKGROUND: Radiotherapy for localised prostate cancer has many known and distressing side effects. The efficacy of group interventions for reducing psychological morbidity is lacking. This study investigated the relative benefits of a group nurse-led intervention on psychological morbidity, unmet needs, treatment-related concerns and prostate cancer-specific quality of life in men receiving curative intent radiotherapy for prostate cancer. METHODS: This phase III, two-arm cluster randomised controlled trial included 331 men (consent rate: 72 %; attrition: 5 %) randomised to the intervention (n = 166) or usual care (n = 165). The intervention comprised four group and one individual consultation all delivered by specialist uro-oncology nurses. Primary outcomes were anxious and depressive symptoms as assessed by the Hospital Anxiety and Depression Scale. Unmet needs were assessed with the Supportive Care Needs Survey-SF34 Revised, treatment-related concerns with the Cancer Treatment Scale and quality of life with the Expanded Prostate Cancer Index -26. Assessments occurred before, at the end of and 6 months post-radiotherapy. Primary outcome analysis was by intention-to-treat and performed by fitting a linear mixed model to each outcome separately using all observed data. RESULTS: Mixed models analysis indicated that group consultations had a significant beneficial effect on one of two primary endpoints, depressive symptoms (p = 0.009), and one of twelve secondary endpoints, procedural concerns related to cancer treatment (p = 0.049). Group consultations did not have a significant beneficial effect on generalised anxiety, unmet needs and prostate cancer-specific quality of life. CONCLUSIONS: Compared with individual consultations offered as part of usual care, the intervention provides a means of delivering patient education and is associated with modest reductions in depressive symptoms and procedural concerns. Future work should seek to confirm the clinical feasibility and cost-effectiveness of group interventions. TRIAL REGISTRATION: Australian and New Zealand Clinical Trials Registry ANZCTRN012606000184572 . 1 March 2006.","BMC Cancer, 16(637","Australia",2016,"Local","Various,Radiotherapy","HADS,EPIC,SCN-SF34,CTS","Patient",null,"Clinical trial","Australia","Patient","Local","Various,Radiotherapy",null,"Clinical trial","HADS,EPIC,SCN-SF34,CTS","2015:2018","Disease,Comorbidity,Treatment,Social"]
[611,"Schroder, F. H., et al. (2000). \"Prostate cancer treated by anti-androgens: is sexual function preserved? EORTC Genitourinary Group. European Organization for Research and Treatment of Cancer.\" Br J Cancer 82(2): 283-290.",null,"Schroder, F. H., et al.","Prostate cancer treated by anti-androgens: is sexual function preserved? EORTC Genitourinary Group. European Organization for Research and Treatment of Cancer","This paper reports on results of the EORTC protocol 30892, an open, prospective, randomized study of 310 patients with previously untreated metastatic prostate cancer with favourable prognostic factors who were treated by either flutamide (FLU) or cyproterone acetate (CPA) monotherapy. The final analysis with regard to the main end points, time to progression and survival are still pending. Final results related to the evaluation of sexual functioning prior to and under treatment are reported here. Of 310 randomized patients 294 were eligible for evaluation within this side study. The median age was 71 years (range 48-85). Potential risk factors related to age, general health and prostate cancer were evaluated. For evaluation of sexual functions a five-item questionnaire was used which was administered by the investigator. The protocol allowed time dependent observations at 3-monthly follow-up visits. Sexual functioning was dependent on age but not on prostate cancer-related parameters. Sexual functions at entry were similar within the two treatment groups, spontaneous (nightly) erections and sexual activity were seen in 43-51% and 29-35% of cases. Under treatment, sexual functions under FLU and CPA declined slowly with median times of 12.9 and 5.8 months versus 13.7 and 8.9 months respectively for spontaneous erections and sexual activity. Eventually, with an average observation time in excess of 2 years, loss of spontaneous erections and of sexual activity occurred in 80% versus 92% and in 78% versus 88% of men under FLU versus CPA treatment respectively. None of these differences reached statistical significance. Maintenance of potency under treatment with FLU as reported in the literature is not confirmed in this study. However, loss of sexual functions under monotherapy with both antiandrogens is slow and 10-20% of men retain sexual activity after 2-6 years of treatment. This observation can be exploited in new treatment schemes and is likely to lead to improved quality of life. The advantage of FLU in time and total preservation of sexual functions is statistically not significant and must be balanced against the side effects of FLU and other pure antiandrogens, which may exceed those of CPA especially with respect to gynaecomastia. Hepatic toxicity may limit the long-term use of both drugs.","Br J Cancer, 82(2): 283-290","Netherlands",2000,"Metastatic","Hormonal","Unclear","Patient",null,"Clinical trial","Netherlands","Patient","Metastatic","Hormonal",null,"Clinical trial","Unclear","2000:2004","Complication"]
[612,"Schulman, C., et al. (2016). \"Intermittent Versus Continuous Androgen Deprivation Therapy in Patients with Relapsing or Locally Advanced Prostate Cancer: A Phase 3b Randomised Study (ICELAND).\" Eur Urol 69(4): 720-727.",null,"Schulman, C., et al.","Intermittent Versus Continuous Androgen Deprivation Therapy in Patients with Relapsing or Locally Advanced Prostate Cancer: A Phase 3b Randomised Study (ICELAND)","BACKGROUND: Intermittent androgen deprivation (IAD) has received increasing attention; however, the current literature is still limited, especially in nonmetastatic prostate cancer (PCa), and the relative efficacy and safety benefits of IAD versus continuous androgen deprivation (CAD) remain unclear. OBJECTIVE: To add to the knowledge base regarding efficacy and potential benefits, including reduced side effects and improved quality of life (QoL), of IAD versus CAD in patients with nonmetastatic relapsing or locally advanced PCa. DESIGN, SETTING, AND PARTICIPANTS: A 42-mo phase 3b open-label randomised study in 933 patients from 20 European countries. INTERVENTION: Following a 6-mo induction with leuprorelin acetate (Eligard) 22.5mg 3-mo depot, patients were randomised to CAD or IAD with leuprorelin for 36 mo. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary end point was time to prostate-specific antigen (PSA) progression while receiving luteinising hormone-releasing hormone agonist, defined as three consecutive increasing PSA values >/= 4 ng/ml >/= 2 wk apart. Secondary end points included PSA progression-free survival (PFS), overall survival (OS), testosterone levels, performance status, and QoL. RESULTS AND LIMITATIONS: A total of 933 patients entered the induction phase; 701 were randomised. The median number of injections administered after randomisation was 12 (range: 1-12) for the CAD group and 3 (range: 1-10) for the IAD group. There were no statistically significant or clinically relevant differences between the groups for time to PSA progression, PSA PFS, OS, mean PSA levels over time, or QoL. A similar number of adverse events was observed in each group; the most common were hot flushes and hypertension. Study limitations include the open-label design and absence of formal testosterone recovery assessment. CONCLUSIONS: IAD and CAD demonstrated similar efficacy, tolerability, and QoL in men with nonmetastatic PCa. The principal benefit of IAD compared with CAD is a potential cost reduction with comparable OS rates. There are no apparent QoL benefits. PATIENT SUMMARY: This randomised trial showed that both intermittent and continuous hormone therapy had similar efficacy, tolerability, and quality-of-life profiles in patients with relapsing M0 or locally advanced prostate cancer. Intermittent therapy may be a valid option for selected patients. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT00378690.","Eur Urol, 69(4): 720-727","Europe",2016,"Advanced,Refractory","Hormonal","Unclear","Patient",null,"Clinical trial","Europe","Patient","Advanced,Refractory","Hormonal",null,"Clinical trial","Unclear","2015:2018","General,Treatment"]
[613,"Schweizer, M. T., et al. (2016). \"Bipolar Androgen Therapy for Men With Androgen Ablation Naive Prostate Cancer: Results From the Phase II BATMAN Study.\" Prostate 76(13): 1218-1226.",null,"Schweizer, M. T., et al.","Bipolar Androgen Therapy for Men With Androgen Ablation Naive Prostate Cancer: Results From the Phase II BATMAN Study","BACKGROUND: We have previously documented a paradoxical anti-tumor effect when castration-resistant prostate cancer patients were treated with intermittent, high-dose testosterone (i.e., Bipolar Androgen Therapy; BAT). Because, an adaptive increase in androgen receptor expression following chronic androgen deprivation therapy (ADT) may underlie this effect, we tested whether men with hormone-sensitive (HS) prostate cancer (PC) would also respond to BAT if given following a 6-month ADT lead-in. METHODS: Asymptomatic HS PC patients with low metastatic burden or non-metastatic biochemically recurrent disease were enrolled. Following 6-month of ADT, those with a PSA <4 ng/ml went on to receive alternating 3-month cycles of BAT and ADT. BAT was administered as intramuscular testosterone (T) cypionate or enanthate 400 mg on Days (D) 1, 29, and 57. ADT was continued throughout the study to allow rapid cycling from near castrate to supraphysiologic range T following T injections. The primary endpoint was the percent of patients with a PSA <4 ng/ml after 18 months. Secondary endpoints included radiographic response and quality of life (QoL). RESULTS: Twenty-nine of 33 patients received BAT following the ADT lead-in. The primary endpoint was met, with 17/29 men (59%, 90% confidence interval: 42-74%) having a PSA <4 ng/ml at 18 months. Ten patients receiving BAT had RECIST evaluable disease, and eight (80%) objective responses were observed (four complete; four partial). Three patients progressed per RECIST criteria and three had unconfirmed progression on bone scan. Men treated with 6-month of ADT had improved QoL following the first cycle of BAT as measured by the SF-36, FACT-P, and IIEF surveys. CONCLUSIONS: BAT demonstrated preliminary efficacy in men with HS PC following 6-month of ADT. BAT may improve QoL in men treated with ADT. Prostate 76:1218-1226, 2016. (c) 2016 Wiley Periodicals, Inc.","Prostate, 76(13): 1218-1226","USA",2016,"Any or unknown","Hormonal","SF-36,FACT-P,IIEF-5","Patient",null,"Clinical trial","USA","Patient","Any or unknown","Hormonal",null,"Clinical trial","SF-36,FACT-P,IIEF-5","2015:2018","Disease,Complication,Utility"]
[614,"Sciarra, A., et al. (2013). \"Intermittent androgen-deprivation therapy in prostate cancer: a critical review focused on phase 3 trials.\" Eur Urol 64(5): 722-730.",null,"Sciarra, A., et al.","Intermittent androgen-deprivation therapy in prostate cancer: a critical review focused on phase 3 trials","CONTEXT: Intermittent androgen deprivation (IAD) in prostate cancer (PCa) patients has been proposed to delay development of castration resistance and to reduce the side effects and costs of androgen deprivation therapy (ADT). OBJECTIVE: This review analyzes (1) the oncologic and quality of life (QoL) results from randomized phase 3 trials comparing IAD and continuous ADT and (2) the prognostic parameters for IAD. EVIDENCE ACQUISITION: We searched the Medline and Cochrane Library databases (primary fields: prostate neoplasm and intermittent androgen deprivation; secondary fields: randomized trials, survival, quality of life, predictors) without language restriction. EVIDENCE SYNTHESIS: We found seven extensively described phase 3 trials randomizing 4675 patients to IAD versus continuous ADT. Other randomized trials investigating IAD have been performed, but available data are limited and have been published only in preliminary fashion. In all seven trials, patients spent most of their time on, rather than off, ADT. The induction periods ranged from 3 mo to 8 mo; in all but one trial, the PSA level designated for ADT discontinuation was <4 ng/ml. Mean follow-up ranged from 40-108 mo. Collectively, these trials support the concept that, mainly in metastatic cases, IAD can produce oncologic results similar to continuous ADT. In terms of overall survival, the hazard ratios for IAD and continuous ADT were very similar (range: 0.98-1.08). The QoL benefit of IAD appears to be modest at best. With IAD, QoL is likely influenced by the duration of the off-treatment periods and by the rate of testosterone recovery. CONCLUSIONS: The evidence indicates that IAD is not inferior to continuous ADT. Data are insufficient to determine whether IAD is able to prevent the long-term complications of ADT. More comparative analysis focused on QoL is warranted.","Eur Urol, 64(5): 722-730","International",2013,"Any or unknown","Hormonal","Unclear","Patient",null,"Systematic review","International","Patient","Any or unknown","Hormonal",null,"Systematic review","Unclear","2010:2014","General"]
[615,"Scorsetti, M., et al. (2014). \"Stereotactic body radiotherapy with flattening filter-free beams for prostate cancer: assessment of patient-reported quality of life.\" J Cancer Res Clin Oncol 140(10): 1795-1800.",null,"Scorsetti, M., et al.","Stereotactic body radiotherapy with flattening filter-free beams for prostate cancer: assessment of patient-reported quality of life","PURPOSE: Stereotactic body radiotherapy (SBRT) is an emerging treatment approach reported as safe and effective strategy for low- and intermediate-risk prostate cancer patients. End point of the current study is to appraise the patient-reported quality of life according to the expanded prostate cancer index composite (EPIC) questionnaire. METHODS: In the framework of a prospective mono-institutional phase II trial, EPIC questionnaire was dispensed (up to 1 year after treatment) to a cohort of 46 patients of 72 treated with 5 fractions of 7 Gy each to the prostate. SBRT was delivered with RapidArc VMAT with 10 MV flattening filter-free photon beams. RESULTS: Median follow-up of patients was 14.5 months (range: 6-23). Acute rectal toxicity was mild (only 23/72 cases with G1-2 and no G3-4) as well as urinary (50/72 G1-2 and no G3-4). At the moment, four cases of G1 late rectal toxicity and 22 cases of G1 urinary (1 of G2) were reported. Urinary, rectal, sexual, and hormonal scores resulted stable over time: 1 year scores resulted, respectively, in -0.3, +2.8, -1.7, and -2.8 % variations with respect to baseline. No significant differences were observed also when data were stratified according to functional and bother sub-scales. CONCLUSIONS: Stereotactic body radiotherapy (SBRT) treatment of prostate with RapidArc and high-intensity photon beams resulted to be well tolerated by patients with mild toxicity profiles and good patient-reported quality of life perception for the first year after treatment. Longer follow-up in the trial cohort is in progress.","J Cancer Res Clin Oncol, 140(10): 1795-1800","Italy",2014,"Any or unknown","Radiotherapy","EPIC","Patient",null,"Clinical trial","Italy","Patient","Any or unknown","Radiotherapy",null,"Clinical trial","EPIC","2010:2014","Disease"]
[616,"Sebrow, D., et al. (2012). \"Monitoring validated quality of life outcomes after prostatectomy: initial description of novel online questionnaire.\" Urology 79(2): 314-319.",null,"Sebrow, D., et al.","Monitoring validated quality of life outcomes after prostatectomy: initial description of novel online questionnaire","OBJECTIVES: To describe a novel, low-cost, online health-related quality of life (HRQOL) survey that allows for automated follow-up and convenient access for patients in geographically diverse locations. Clinicians and investigators have been encouraged to use validated HRQOL instruments when reporting outcomes after radical prostatectomy. METHODS: The institutional review board approved our protocol and the use of a secure web site (http://www.SurveyMonkey.com) to send patients a collection of validated postprostatectomy HRQOL instruments by electronic mail. To assess compliance with the electronic mail format, a pilot study of cross-sectional surveys was sent to patients who presented for follow-up after robotic-assisted laparoscopic prostatectomy. The response data were transmitted in secure fashion in compliance with the Health Insurance Portability and Accountability Act. RESULTS: After providing written informed consent, 514 patients who presented for follow-up after robotic-assisted laparoscopic prostatectomy from March 2010 to February 2011 were sent the online survey. A total of 293 patients (57%) responded, with an average age of 60 years and a median interval from surgery of 12 months. Of the respondents, 75% completed the survey within 4 days of receiving the electronic mail, with a median completion time of 15 minutes. The total survey administration costs were limited to the web site's $200 annual fee-for-service. CONCLUSIONS: An online survey can be a low-cost, efficient, and confidential modality for assessing validated HRQOL outcomes in patients who undergo treatment of localized prostate cancer. This method could be especially useful for those who cannot return for follow-up because of geographic reasons.","Urology, 79(2): 314-319","USA",2012,"Any or unknown","Surgery","Unclear","Patient",null,"Cross-sectional","USA","Patient","Any or unknown","Surgery",null,"Cross-sectional","Unclear","2010:2014","General"]
[617,"See, D., et al. (2002). \"Increased tumor necrosis factor alpha (TNF-alpha) and natural killer cell (NK) function using an integrative approach in late stage cancers.\" Immunol Invest 31(2): 137-153.",null,"See, D., et al.","Increased tumor necrosis factor alpha (TNF-alpha) and natural killer cell (NK) function using an integrative approach in late stage cancers","Natural products may increase cytotoxic activity of Natural Killer Cells (NK) Tumor Necrosis Factor alpha (TNF-alpha) while decreasing DNA damage in patients with late-stage cancer. Pilot studies have suggested that a combination of Nutraceuticals can raise NK cell function and TNF-alpha alpha activity and result in improved clinical outcomes in patients with late stage cancer. The objective of the study is to determine if Nutraceuticals can significantly raise NK function and TNF levels in patients with late stage cancer. After informed consent was obtained, 20 patients with stage IV, end-stage cancer were evaluated (one bladder, five breast, two prostate, one neuroblastoma, two non-small cell lung, three colon, 1 mesothelioma, two lymphoma, one ovarian, one gastric, one osteosarcoma). Transfer Factor Plus (TFP+, 3 tablets 3 times per day), IMUPlus (non denatured milk whey protein, 40 gm/day); Intravenous (50 to 100 gm/day) and oral (1-2 gm/day) ascorbic acid; Agaricus Blazeii Murill teas (10 gm/day); Immune Modulator Mix (a combination of vitamin, minerals, antioxidants and immune-enhancing natural products); nitrogenated soy extract (high levels of genistein and dadzein) and Andrographis Paniculata (500 mg twice, daily) were used. Baseline NK function by standard 4 h 51Cr release assay and TNF alpha and receptor levels were measured by ELISA from resting and phytohemagglutinin (PHA) stimulated adherent and non-adherent Peripheral Blood Mononuclear Cell (PBMC). Total mercaptans and glutathione in plasma were taken and compared to levels measured 6 months later. Complete blood counts and chemistry panels were routinely monitored. As of a mean of 6 months, 16/20 patients were still alive. The 16 survivors had significantly higher NK function than baseline (p < .01 for each) and TNF-alpha levels in all four cell populations studied (p < .01 for each). Total mercaptans (p < .01) and TNF-alpha receptor levels were significantly reduced (p < .01). It was also observed that hemoglobin, hematocrit and glutathione levels were significantly elevated. The only toxicity noted was occasional diarrhea and nausea. The quality of life improved for all survivors by SF-36 form evaluation. An aggressive combination of immunoactive Nutraceuticals was effective in significantly increasing NK function, other immune parameters and hemoglobin from PBMC or plasma in patients with late stage cancers. Nutraceutical combinations may be effective in late stage cancers. Clinical outcomes evaluations are ongoing.","Immunol Invest, 31(2): 137-153","USA",2002,"Metastatic","Various","SF-36","Patient",null,"Clinical trial","USA","Patient","Metastatic","Various",null,"Clinical trial","SF-36","2000:2004","Utility"]
[618,"Seidenfeld, J., et al. (1999). \"Relative effectiveness and cost-effectiveness of methods of androgen suppression in the treatment of advanced prostate cancer.\" Evid Rep Technol Assess (Summ) (4): i-x, 1-246, I241-236, passim.",null,"Seidenfeld, J., et al.","Relative effectiveness and cost-effectiveness of methods of androgen suppression in the treatment of advanced prostate cancer","OBJECTIVES: With 184,500 new cases and 39,200 deaths anticipated in 1998, prostate cancer is second only to lung cancer in cancer mortality for men. This report is a systematic review of the evidence from randomized controlled trials on the relative effectiveness of alternative strategies for androgen suppression as treatment of advanced prostate cancer. Three key issues are addressed: (1) the relative effectiveness of the available methods for monotherapy (orchiectomy, luteinizing hormone-releasing hormone [LHRH] agonists, and antiandrogens), (2) the effectiveness of combined androgen blockade compared to monotherapy, and (3) the effectiveness of immediate androgen suppression compared to androgen suppression deferred until clinical progression. Outcomes of interest are overall, cancer-specific, and progression-free survival; time to treatment failure; adverse effects; and quality of life. Two supplementary analyses were conducted for each key question: (1) meta-analysis of overall survival at 2 years (questions 1 and 2) and 5 years (questions 2 and 3), and (2) cost-effectiveness analysis. SEARCH STRATEGY: The MEDLINE, CANCERLIT, and EMBASE databases were searched from 1966 to March 1998, and Current Contents to August 24, 1998, for the terms: leuprolide (Lupron); goserelin (Zoladex); buserelin (Suprefact); flutamide (Eulexin); nilutamide (Anandron, Nilandron); bicalutamide (Casodex); cyproterone acetate (Androcur); diethylstilbestrol (DES); and orchiectomy (castration, orchidectomy). The search was then limited to human studies indexed under the MeSH term \"prostatic neoplasms\" and by the UK Cochrane Center search strategy for randomized controlled trials. Total yield was 1,477 references. SELECTION CRITERIA: We Reports of efficacy outcomes were limited to randomized controlled trials. Phase II studies that reported on withdrawals from therapy and all studies reporting on quality of life were also included. DATA COLLECTION AND ANALYSIS: The systematic review used a prospectively designed protocol conducted by two independent reviewers, with disagreements resolved by consensus. The meta-analysis combined data on overall survival using a random effects model. The cost-effectiveness analysis used a decision analysis model of advanced prostate cancer with health states and transitions derived from the literature and estimates of effectiveness derived from the meta-analysis. The cost-effectiveness analysis is conducted from a societal perspective, consistent with the guidelines of the U.S. Public Health Service Panel on Cost-Effectiveness in Health and Medicine. MAIN RESULTS: Survival after treatment with an LHRH agonist is equivalent to survival after orchiectomy. The available LHRH agonists are equally effective, and no LHRH agonist is superior to the other when adverse effects are considered. Survival may be somewhat lower with use of a nonsteroidal antiandrogen. There is no statistically significant difference in survival at 2 years between patients treated with combined androgen blockade or monotherapy. Meta-analysis of the limited data available shows a statistically significant difference in survival at 5 years that favors combined androgen blockade. However, the magnitude of this difference is of questionable clinical significance. For the subgroup of patients with good prognosis, there is no statistically significant difference in survival. Adverse effects leading to withdrawal from therapy occurred more often with combined androgen blockade. No evidence is yet available from randomized controlled trials of androgen suppression initiated at prostate-specific antigen (PSA) rise after definitive therapy for clinically localized disease. For patients who are newly diagnosed with locally advanced or asymptomatic metastatic disease, the evidence is insufficient to determine whether primary androgen suppression initiated at diagnosis improves outcomes. (ABSTRACT TRUNCATED)","Evid Rep Technol Assess (Summ), 4): i-x, 1-246, I241-236, passim","USA",1999,"Advanced","Hormonal,Surgery","Unclear","Patient",null,"Systematic review,Economic model","USA","Patient","Advanced","Hormonal,Surgery",null,"Systematic review,Economic model","Unclear","1960:1999","Utility"]
[619,"Selek, U., et al. (2004). \"Erectile dysfunction and radiation dose to penile base structures: a lack of correlation.\" Int J Radiat Oncol Biol Phys 59(4): 1039-1046.",null,"Selek, U., et al.","Erectile dysfunction and radiation dose to penile base structures: a lack of correlation","PURPOSE: To evaluate the relationship between the dose and volume of radiation to proximal penile structures and the development of erectile dysfunction after external beam radiotherapy (RT) for localized prostate adenocarcinoma. METHODS AND MATERIALS: The study cohort comprised 28 patients who were enrolled our in-house three-dimensional conformal RT dose escalation protocol. The patients were treated to 78 Gy between 1995 and 1998. This protocol included a planned quality-of-life questionnaire to assess sexual function 2 years after completing RT. All the study patients were potent before RT. The median follow-up was 66 months (range 39-95). Penile base contents were outlined retrospectively in restored treatment plans. The dose-volume histograms (DVHs) for the corpus spongiosum (penile bulb), corpora cavernosum and crura, and total penile structure (corpus spongiosum plus corpora cavernosum and crura) were calculated. Statistical significance was defined as p < 0.05. The Bonferroni correction was used to adjust for multiple comparisons. Power calculations showed that our study sample would detect radiation- induced impotence with a very high power. We also estimated that a relatively small difference of 10-15% in the DVHs between the potent and impotent patients could be detected. RESULTS: At 2 years after RT, 10 patients (35.7%) reported new-onset erectile dysfunction and were unable to attain firm enough erections to have intercourse. Only hypertension was observed to affect erectile dysfunction after external beam RT. We found no statistically significant correlation among age, diabetes, or heavy alcohol consumption and post-RT potency. The mean radiation dose +/- standard deviation delivered to the corpus spongiosum, corpora cavernosa and crura, and total penile structure was, respectively, 42.2 +/- 8.4 Gy, 36.3 +/- 8.0 Gy, and 38.2 +/- 7.5 Gy. t test comparisons were performed between DVHs of post-RT potent and impotent patients on multiple cutpoints. No dose-volume effect was found. Analysis of the DVHs when the patients were subdivided into normotensive and hypertensive groups also showed no dose-volume response. CONCLUSION: Our analysis did not show statistically significant correlations between potency preservation and radiation dose to the proximal penis. The entire etiology of radiation- induced erectile dysfunction remains unclear and further research is needed.","Int J Radiat Oncol Biol Phys, 59(4): 1039-1046","USA",2004,"Local","Radiotherapy","Unclear","Patient",null,"Cohort","USA","Patient","Local","Radiotherapy",null,"Cohort","Unclear","2000:2004","Complication"]
[620,"Selli, C., et al. (2004). \"Role of bladder neck preservation in urinary continence following radical retropubic prostatectomy.\" Scand J Urol Nephrol 38(1): 32-37.",null,"Selli, C., et al.","Role of bladder neck preservation in urinary continence following radical retropubic prostatectomy","OBJECTIVE: To report our experience of the influence of bladder neck preservation on patient continence. MATERIAL AND METHODS: Radical retropubic prostatectomy with bladder neck preservation was performed in 131 patients (age range 48-73 years; mean 64.5 years). Urinary continence was evaluated using a validated questionnaire at follow-up visits and telephone interviews. All patients reporting incontinence were studied using a pad test and urodynamics. RESULTS: After a mean follow-up period of 21.7 months (range 4-47 months), 115 patients were continent (87%) and 16 incontinent. According to the International Continence Society criteria, three had severe, three moderate and 10 mild incontinence. Urodynamics revealed sphincter deficiency in 15 cases, which was associated with decreased bladder compliance in four, while decreased compliance was the only abnormality in one. Continence was recovered 0-27 months after surgery (mean 3.2 months): 40% of men were continent within the first month and 74% within the third. Histopathology revealed positive margins in 30/131 patients (22%), but exclusively at the bladder neck level in only seven (5%), and two also had positive nodes. Six patients (4.5%) presented bladder neck stenosis requiring transurethral incision. No statistically significant differences were found between the ages of continent and incontinent men or between the time to continence recovery with two different techniques of retropubic hemostasis; however, use of a nerve-sparing technique significantly reduced the time to continence recovery. CONCLUSIONS: Bladder neck preservation during radical retropubic prostatectomy does not improve the long-term results of urinary continence but does contribute substantially to its earlier recovery, thus improving the quality of life. With proper patient selection the risk of positive margins at the bladder neck level only is reasonably low.","Scand J Urol Nephrol, 38(1): 32-37","Italy",2004,"Any or unknown","Surgery","ICSQ","Patient",null,"Cohort","Italy","Patient","Any or unknown","Surgery",null,"Cohort","ICSQ","2000:2004","Complication"]
[621,"Seo, P. H., et al. (2004). \"Assessing a prostate cancer brachytherapy technique using early patient-reported symptoms: a potential early indicator for technology assessment?\" Clin Prostate Cancer 3(1): 38-42.",null,"Seo, P. H., et al.","Assessing a prostate cancer brachytherapy technique using early patient-reported symptoms: a potential early indicator for technology assessment?","Brachytherapy for early prostate cancer can cause long-term urinary, bowel, and sexual dysfunction. Modifying technique may mitigate complications, but definitive outcome assessment requires long-term follow-up. Although radiation dose plausibly mediates all treatment-related toxicity, short-term symptoms may indicate long-term outcomes. We sought an early indication of whether a modified brachytherapy technique successfully decreased toxicity in the anticipated direction by assessing changes in symptoms and symptom distress 3 months after treatment. In a prospective study of clinically localized prostate cancer using a validated, patient-reported questionnaire, we assessed 85 men, whose primary treatment was brachytherapy alone, prior to treatment and 3 months after the procedure. Twenty-two men received standard ultrasound-guided brachytherapy (SB), and 63 men received magnetic resonance imaging-guided brachytherapy (MB), a technique intended to decrease urinary toxicity by reducing urethral irradiation. Patient age and other sociodemographic variables were similar in the 2 groups. The MB group experienced a greater increase in urinary obstruction/irritation symptoms (P = 0.02) and sexual function distress, but not sexual dysfunction (P = 0.22), whereas the SB group reported a smaller increase in bowel symptoms (P = 0.04) and bowel distress (P = 0.02). We found reduced short-term urinary obstruction/irritation and increased bowel problems after MB consistent with the hypothesized effects of the modified technique, although no obvious mechanism explains the decreased sexual function distress in MB patients. Whether these short-term changes predict long-term outcome differences will require much longer follow-up. However, these results suggest that measuring early symptoms may indicate whether an altered brachytherapy treatment technique has intended favorable consequences, potentially accelerating technology assessment.","Clin Prostate Cancer, 3(1): 38-42","USA",2004,"Local","Brachytherapy","Unclear","Patient",null,"Cohort","USA","Patient","Local","Brachytherapy",null,"Cohort","Unclear","2000:2004","Complication"]
[622,"Shaikh, T., et al. (2017). \"Long-Term Patient-Reported Outcomes From a Phase 3 Randomized Prospective Trial of Conventional Versus Hypofractionated Radiation Therapy for Localized Prostate Cancer.\" Int J Radiat Oncol Biol Phys 97(4): 722-731.",null,"Shaikh, T., et al.","Long-Term Patient-Reported Outcomes From a Phase 3 Randomized Prospective Trial of Conventional Versus Hypofractionated Radiation Therapy for Localized Prostate Cancer","PURPOSE: To assess the long-term quality of life (QoL) outcomes from a phase 3 trial comparing 2 modes of intensity modulated radiation therapy (IMRT): conventional IMRT (CIMRT) versus hypofractionated IMRT (HIMRT) in patients with localized prostate cancer. METHODS AND MATERIALS: Between 2002 and 2006, 303 men with low-risk to high-risk prostate cancer were randomized to 76 Gy in 38 fractions (CIMRT) versus 70.2 Gy in 26 fractions (HIMRT). QoL was compared by use of the Expanded Prostate Cancer Index Composite (EPIC), the International Prostate Symptom Score (IPSS), and EuroQoL (EQ5D) questionnaires. The primary outcome of the QoL analysis was a minimum clinically important difference defined as a 0.5 standard deviation change from baseline for each respective QoL parameter. Treatment effects were evaluated with the use of logistic mixed effects regression models. RESULTS: A total of 286, 299, and 218 patients had baseline EPIC, IPSS, or EQ5D data available and were included in the analysis. Overall, there was no statistically significant difference between the 2 treatment arms in terms of EPIC, IPSS, or EQ5D scores over time, although there was a trend toward lower EPIC urinary incontinence scores in the HIMRT arm. More patients in the HIMRT arm had a lower EPIC urinary incontinence score relative to baseline versus patients in the CIMRT arm with long-term follow-up. On multivariable analysis, there was no association between radiation fractionation scheme and any QoL parameter. When other clinical factors were examined, lymph node radiation was associated with worse EPIC hormonal scores versus patients receiving no lymph node radiation. In general, QoL outcomes were generally stable over time, with the exception of EPIC hormonal and EQ5D scores. CONCLUSIONS: In this randomized prospective study, there were stable QoL changes in patients receiving HIMRT or CIMRT. Our results add to the growing body of literature suggesting that HIMRT may be an acceptable treatment modality in clinically localized prostate cancer.","Int J Radiat Oncol Biol Phys, 97(4): 722-731","USA",2017,"Local","Radiotherapy","EPIC,IPSS,EQ-5D","Patient",null,"Clinical trial","USA","Patient","Local","Radiotherapy",null,"Clinical trial","EPIC,IPSS,EQ-5D","2015:2018","Disease,Utility"]
[623,"Shamash, J., et al. (2011). \"A multi-centre randomised phase III trial of Dexamethasone vs Dexamethasone and diethylstilbestrol in castration-resistant prostate cancer: immediate vs deferred Diethylstilbestrol.\" Br J Cancer 104(4): 620-628.",null,"Shamash, J., et al.","A multi-centre randomised phase III trial of Dexamethasone vs Dexamethasone and diethylstilbestrol in castration-resistant prostate cancer: immediate vs deferred Diethylstilbestrol","BACKGROUND: The role of further hormone therapy in castration-resistant prostate cancer (CRPC) remains unclear. We performed a multi-centre randomised phase III study comparing the use of Dexamethasone, Aspirin, and immediate addition of Diethylstilbestrol (DAiS) vs Dexamethasone, Aspirin, and deferred (until disease progression) addition of Diethylstilbestrol (DAdS). METHODS: From 2001 to 2008, 270 men with chemotherapy-naive CRPC were randomly assigned, in a 1 : 1 ratio, to receive either DAiS or DAdS. They were stratified for performance status, presence of bone metastases, and previous normalisation of prostate-specific antigen (PSA) to androgen deprivation. The study end points were the proportion of patients achieving a 50% PSA response, progression-free survival (PFS), overall survival, and quality of life. Intention-to-treat analysis was carried out. The effect of treatment was studied first by Kaplan-Meier curves and log-rank test, and finally through multivariable stratified Cox's proportional hazards model adjusting for the effects of possible baseline prognostic factors. Quality of life was analysed using multivariate analysis of variance. RESULTS: At study entry, the median age was 76 years (inter-quartile range: 70-80 years), the median PSA was 79 ng ml(-1), and 76% of the cohort had metastatic disease. The response rates for DAiS (68%) and DAdS (64%) were not significantly different (P=0.49). Similar to the response rate, neither the PFS (median=8.1 months for both arms) nor the overall survival (19.4 vs 18.8 months) differed significantly between the DAiS and DAdS groups (P>0.20). However, the response rate for the DAiS (68%) was significantly higher than the response rate of DA (before adding Diethylstilbestrol) (50%) (P=0.002). Similarly, the median time to progression for DAiS (8.6 months) was significantly longer than that of DA (4.5 months) (P<0.001). Multivariable analysis showed that patients with previous haemoglobin >/=11 g dl(-1) decreased the risk of death significantly (hazard ratio: 0.44, 95% CI: 0.25-0.77). Patients treated with previous anti-androgens alone had more than 5 times more risk of death compared with patients treated with gonadorelin analogues throughout their castration-sensitive phase. Treatment sequencing did not affect the quality of life but pre-treatment performance status did. The incidence of veno-thromboembolic events was 22% (n=28) in DAiS and 11% (n=14) in the DA arm (P=0.02). Painful gynaecomastia occurred in only 1% on DA, whereas in 40% on DAiS (P=0.001). CONCLUSION: Dexamethasone and immediate Diethylstilbestrol resulted in neither higher PSA response rate nor higher PFS compared with Dexamethasone with deferred Diethylstilbestrol. There was no suggestion of significantly improved overall survival or quality of life. Given the significantly higher toxicity of Diethylstilbestrol, deferring Diethylstilbestrol until failure of Dexamethasone is the preferred strategy when using these agents in CRPC.","Br J Cancer, 104(4): 620-628","UK",2011,"Any or unknown","Hormonal","Unclear","Patient",null,"Clinical trial","UK","Patient","Any or unknown","Hormonal",null,"Clinical trial","Unclear","2010:2014","General"]
[624,"Sharma, P., et al. (2016). \"Evaluation of point-of-care PRO assessment in clinic settings: integration, parallel-forms reliability, and patient acceptability of electronic QOL measures during clinic visits.\" Qual Life Res 25(3): 575-583.",null,"Sharma, P., et al.","Evaluation of point-of-care PRO assessment in clinic settings: integration, parallel-forms reliability, and patient acceptability of electronic QOL measures during clinic visits","PURPOSE: Assessment of patient-reported outcomes (PROs), such as health-related quality of life, has become an important component of healthcare that measures the impact of disease and medical treatment on patient health. Collecting PROs during point-of-care assessments and integrating them into the clinical setting, however, remains challenging. The objective of this pilot study was to evaluate the reliability, usability, and acceptability of point-of-care electronic PRO assessments implemented in a prostate cancer clinic. METHODS: Fifty subjects completed paper-pencil and computerized formats of the Expanded Prostate Cancer Index Composite (EPIC), a validated, condition-specific QOL instrument, at separate times before treatment. Parallel-forms reliability was evaluated by comparing mean scores, variations in response distribution, and correlations between administration formats. Correlation coefficients of at least 0.70 were used for reliability testing. Differences between administration forms, indicating potential bias, were compared using the signed-rank test. A 6-item acceptability scale was also used to evaluate patient acceptability and satisfaction with the electronic format. RESULTS: Mean scores and standard deviations were similar between the paper-pencil and electronic forms across all EPIC instrument domains, and no assessment bias was found. Each EPIC domain demonstrated a high reliability between administration formats (correlation coefficients: 0.70-0.98). The majority (>90 %) of respondents found that the computerized QOL format was user friendly and simple to use. CONCLUSIONS: Point-of-care computerized QOL assessments were reliable and acceptable to patients in this study, supporting the feasibility of PRO integration at the point-of-care in clinical settings.","Qual Life Res, 25(3): 575-583","USA",2016,"Any or unknown","None","EPIC","Patient",null,"Validation","USA","Patient","Any or unknown","None",null,"Validation","EPIC","2015:2018","Disease"]
[625,"Sharp, L. K., et al. (1999). \"Quality of life in low-income patients with metastatic prostate cancer: divergent and convergent validity of three instruments.\" Qual Life Res 8(5): 461-470.",null,"Sharp, L. K., et al.","Quality of life in low-income patients with metastatic prostate cancer: divergent and convergent validity of three instruments","Few studies have evaluated Quality Of Life (QOL) among low-income patients with cancer. Information is needed about the feasibility and psychometric characteristics of QOL instruments in these populations. The purpose of this study was to examine the convergent and discriminant relationships between scales of three QOL instruments: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC), Functional Assessment of Cancer Therapy--General (FACT), and Quality of Life Index (QLI). Participants included 110 men with metastatic prostate cancer of whom 94% were low income and 62% were African-American. Interviewers administered the questionnaires. Cronbach alpha internal consistency reliabilities were 0.57 to 0.90 for the EORTC, 0.65 to 0.86 for the FACT, and 0.63 for the QLI. Convergent validity was supported for the EORTC and FACT scales measuring emotional, physical, and role/functional dimensions (r = 0.54 to 0.72), but not on scales measuring social function (r = 0.12). Divergent validity was supported between dissimilar scales (r = 0.14 to 0.38). Analysis with receiver operating characteristics curves provided empirical support for the EORTC and FACT as multidimensional measures. These findings suggest that, even in busy clinical settings with low literacy patients, interviewer-administered EORTC and FACT QOL instruments can provide valid and reliable information.","Qual Life Res, 8(5): 461-470","USA",1999,"Metastatic","None","EORTC QLQ-C30,FACT-G,QLI","Patient",null,"Validation","USA","Patient","Metastatic","None",null,"Validation","EORTC QLQ-C30,FACT-G,QLI","1960:1999","General,Treatment"]
[626,"Shelfo, S. W., et al. (1998). \"Update on bladder neck preservation during radical retropubic prostatectomy: impact on pathologic outcome, anastomotic strictures, and continence.\" Urology 51(1): 73-78.",null,"Shelfo, S. W., et al.","Update on bladder neck preservation during radical retropubic prostatectomy: impact on pathologic outcome, anastomotic strictures, and continence","OBJECTIVES: To preserve the bladder neck during radical prostatectomy in an attempt to maintain continence and decrease the incidence of anastomotic stricture without compromising the removal of cancer. METHODS: A retrospective analysis of 365 consecutive radical prostatectomies performed from December 1991 through January 1997 was carried out. The records were reviewed in regard to the pathology of the prostate. In addition, the incidence of anastomotic strictures was determined. Urinary function and continence was evaluated in 195 patients by a quality of life questionnaire. RESULTS: (1) Pathology: positive margins were found in 119 patients (32%). The bladder neck margin was positive in 27 (7%), but the bladder neck was the only positive margin in only 2 patients (0.5%). The mean Gleason score for patients with negative margins was 6.4, for those with positive margins 7.2, and for all those with bladder neck margin positive 7.7. The mean Gleason score for the 2 patients with a solitary positive margin at the bladder neck was 9.0. Of patients with a Gleason score less than 7, 81% had a negative margin, 19% had a positive margin, and 1% had tumor at the bladder neck. Of patients with a Gleason score 7 or more, 58% had a negative margin, 42% had a positive margin, and 11% had a positive bladder neck. Patients with a prostate-specific antigen value of less than 10 ng/mL were more likely to have a favorable pathology. (2) Anastomotic stricture: an anastomotic stricture occurred in 5 patients (1%). Three had a previous transurethral resection of the prostate (TURP) and therefore bladder neck preservation was not possible. (3) Urinary function: 88% of all responders did not wear pads 6 months or more after surgery. Seventy percent of patients did not wear pads less than 6 months after surgery. Ninety percent of patients believed that urinary function did not limit social, physical, or occupational activities. CONCLUSIONS: We believe that bladder neck preservation during radical prostatectomy does not compromise surgical margins. The incidence of anastomotic strictures is less than 1% in patients who have not had a previous TURP. The quality of life questionnaire indicates a high level of continence that may be related in part to preservation of the bladder neck.","Urology, 51(1): 73-78","USA",1998,"Any or unknown","Surgery","Unclear","Patient",null,"Cohort","USA","Patient","Any or unknown","Surgery",null,"Cohort","Unclear","1960:1999","Complication"]
[627,"Sherman, E. J., et al. (2001). \"The Collection of Indirect and Nonmedical Direct Costs (COIN) form: a new tool for collecting the invisible costs of androgen independent prostate carcinoma.\" Cancer 91(4): 841-853.",null,"Sherman, E. J., et al.","The Collection of Indirect and Nonmedical Direct Costs (COIN) form: a new tool for collecting the invisible costs of androgen independent prostate carcinoma","BACKGROUND: There are limited data available regarding the cost of care in patients with androgen independent prostate carcinoma (AIPC), and there are no data on the impact of direct nonmedical and indirect costs (DNM/IC). This lack of data, along with the feasibility of collecting DNM/IC, was examined in patients with AIPC who took part in a randomized trial using a newly developed questionnaire, the Collection of Indirect and Nonmedical Direct Costs (COIN) form. METHODS: Patients with AIPC were randomized to one of three treatment arms: 1) strontium only (strontium 4 Mci in Week 1 and Week 12) (STRONT); 2) vinblastine 4 mg/m(2) per week for 3 weeks then 1 week off and estramustine, 10 mg/kg per day (CHEMO); or 3) a combination of treatments outlined in the arms for CHEMO and STRONT (CHEMO/STRONT). Direct medical costs were collected through the hospital billing system. DNM/IC data were obtained prospectively using the COIN form. Cost data were analyzed for a period of 6 months. RESULTS: Twenty-nine patients were randomized, after which the protocol was closed because of poor accrual. The median survival of the patients was 22.3 months. The mean and median total costs for the 20 of 29 patients with complete cost information were $12,647 and $11,257 over 6 months, respectively. DNM/IC represented 11% of the total cost (range, from < 1% to 42%); in 20% of participating individuals, these costs accounted for 35-42% of total costs. Failure to collect complete cost information was due to early death, administrative difficulties, and loss to follow-up. CONCLUSIONS: In this pilot project, the collection of these cost data using the COIN form was feasible and practical and was limited primarily by logistic, not form specific, issues. DNM/IC were found to be a significant proportion of total costs (up to 42%) in selected patients, and this information proved to be a useful addition to the cost analysis. Approximately 98 patients would be required to detect a 20% difference in total costs between arms in a properly powered, randomized trial. Considering the potentially significant impact on total costs, DNM/IC data should be included in future cost-analysis studies of patients with AIPC and other diseases.","Cancer, 91(4): 841-853","USA",2001,"Any or unknown","None","COIN","Patient",null,"Clinical trial","USA","Patient","Any or unknown","None",null,"Clinical trial","COIN","2000:2004","Costs"]
[628,"Shim, M., et al. (2015). \"The therapeutic effect of solifenacin succinate on the recovery from voiding dysfunction after radical prostatectomy in men with clinically localized prostate cancer: a prospective, randomized, controlled study.\" Urology 85(5): 1123-1129.",null,"Shim, M., et al.","The therapeutic effect of solifenacin succinate on the recovery from voiding dysfunction after radical prostatectomy in men with clinically localized prostate cancer: a prospective, randomized, controlled study","OBJECTIVE: To evaluate whether anticholinergic medication contributes to early recovery of continence and improvement of other voiding symptoms after radical prostatectomy (RP). PATIENTS AND METHODS: A total of 78 patients with clinically localized prostate cancer who had incontinence at 1 week after RP were enrolled prospectively. The patients were allocated to one of the 2 groups: group 1 (alpha-adrenergic agonist [midodrine] plus an anticholinergic [solifenacin]) or group 2 (alpha-adrenergic agonist only). A urodynamic study and the International Continence Society male Short Form questionnaire were completed preoperatively and 4 months after RP. One-hour pad test and 3-day frequency volume chart at 1 and 4 months after medication were also analyzed. RESULTS: The rate of continence, defined as being pad free, did not differ between the groups at 4 months (both 71.8%; P >.05). However, the decreased value of mean weight of daily pads worn by groups 1 and 2 were 51.5 vs 11.7 g, respectively (P = .005). The incontinence (P = .008) and quality of life (P = .044) subscale scores significantly worsened in group 2, whereas they remained unchanged in group 1. Maximal detrusor pressure and maximal urethral closure pressure significantly decreased in both groups, whereas maximal cystometric capacity increased significantly in group 1 only (290.8-332.0 cm H2O; P <.001). CONCLUSION: Anticholinergics may facilitate early recovery from incontinence and prevent worsening of quality of life, which might be attributed to increased cystometric capacity after their use.","Urology, 85(5): 1123-1129","Korea",2015,"Local","Surgery,Various","ISCQ","Patient",null,"Clinical trial","Korea","Patient","Local","Surgery,Various",null,"Clinical trial","ISCQ","2015:2018","Complication"]
[629,"Shrader-Bogen, C. L., et al. (1997). \"Quality of life and treatment outcomes: prostate carcinoma patients' perspectives after prostatectomy or radiation therapy.\" Cancer 79(10): 1977-1986.",null,"Shrader-Bogen, C. L., et al.","Quality of life and treatment outcomes: prostate carcinoma patients' perspectives after prostatectomy or radiation therapy","BACKGROUND: Of the estimated 317,000 men in the United States diagnosed with prostate carcinoma in 1996, 57% will have localized disease, and their 5-year relative survival rate will be 98%. Limited information exists on patient-reported quality of life (QOL) and the incidence and severity of treatment-related side effects. The purpose of this study was to identify and compare patients' self-reported QOL and treatment side effects 1-5 years after radical prostatectomy or radiotherapy. METHODS: Data collection for this cross-sectional study included a mailed, self-administered survey with three parts: a demographic survey, the Functional Assessment of Cancer Therapy-General (FACT-G), and a newly developed Prostate Cancer Treatment Outcome Questionnaire (PCTO-Q). The FACT-G measured the effect of prostate carcinoma on overall QOL in the two treatment groups. The PCTO-Q assessed the patients' perceptions of the incidence and severity of specific changes in bowel, urinary, and sexual functions. The test-retest reliability of the PCTO-Q in a pilot study was 91.2%. RESULTS: Two hundred seventy-four eligible men completed the questionnaires; 132 (48%) reported having undergone prostatectomy and 142 (52%) reported having undergone radiotherapy. After age adjustment, the radiotherapy group reported more bowel dysfunction (P = 0.001), whereas the prostatectomy group reported more urinary problems (P = 0.03) and more sexual dysfunction (P = 0.001). Scores for the FACT-G were similar in the two treatment groups. CONCLUSIONS: Men undergoing treatment for clinically localized prostate carcinoma continue to experience difficulty long after treatment. In this study, the prostatectomy group fared worse in regard to sexual and urinary functions, whereas the radiotherapy group experienced more bowel dysfunction. Survivor-reported QOL and treatment outcomes can assist physicians in counseling patients in the selection of the preferred course of treatment.","Cancer, 79(10): 1977-1986","USA",1997,"Local","Surgery,Radiotherapy","FACT-G,PCTO-Q","Patient",null,"Cross-sectional","USA","Patient","Local","Surgery,Radiotherapy",null,"Cross-sectional","FACT-G,PCTO-Q","1960:1999","Treatment"]
[630,"Simard, S. and J. Savard (2009). \"Fear of Cancer Recurrence Inventory: development and initial validation of a multidimensional measure of fear of cancer recurrence.\" Support Care Cancer 17(3): 241-251.",null,"Simard, S. and J. Savard","Fear of Cancer Recurrence Inventory: development and initial validation of a multidimensional measure of fear of cancer recurrence","BACKGROUND: Despite the fact that the fear of cancer recurrence is to varying degrees almost universal in cancer survivors, there is a lack of validated multidimensional instruments to evaluate this issue specifically. PURPOSE: The goal of this study was to develop and empirically validate a multidimensional self-report scale for assessing the fear of cancer recurrence, the Fear of Cancer Recurrence Inventory (FCRI). METHODS: A provincial medical databank was used to randomly select a pool of 1,704 French-Canadian patients who had been treated for breast, prostate, lung, and colorectal cancer within the past 10 years. Of these, 300 patients were asked to complete the FCRI on two occasions. RESULTS: The factorial analysis conducted on the final 42-item scale revealed a seven-component solution (64% of the variance) including the following factors: triggers, severity, psychological distress, coping strategies, functioning impairments, insight, and reassurance. The results also supported the internal consistency (alpha = 0.95) and the temporal stability (r = 0.89) of the FCRI, as well as its construct validity with other self-report scales assessing fear of cancer recurrence (r = 0.68 to 0.77) or related constructs such as psychological distress (r = 0.43 to 0.77) and quality of life (r = -0.20 to -0.36). CONCLUSIONS: This study suggests that the French-Canadian version of the FCRI is a reliable and valid instrument for evaluating the multidimensional aspects of the fear of cancer recurrence.","Support Care Cancer, 17(3): 241-251","Canada",2009,"Survivors","None","FCRI","Patient",null,"Validation","Canada","Patient","Survivors","None",null,"Validation","FCRI","2005:2009","Disease"]
[631,"Sini, C., et al. (2017). \"Patient-reported intestinal toxicity from whole pelvis intensity-modulated radiotherapy: First quantification of bowel dose-volume effects.\" Radiother Oncol 124(2): 296-301.",null,"Sini, C., et al.","Patient-reported intestinal toxicity from whole pelvis intensity-modulated radiotherapy: First quantification of bowel dose-volume effects","BACKGROUND AND PURPOSE: Intestinal toxicity is commonly experienced during whole-pelvis intensity-modulated radiotherapy (WPRT) for prostate cancer. The aim of the current study was to assess bowel dose-volume relationships for acute patient-reported intestinal symptoms of patients treated with WPRT for prostate cancer. MATERIALS AND METHODS: Complete data of 206 patients were available; the median dose to pelvic nodes was 51.8Gy (range 50.4-54.4, 1.7-2Gy/fr). Intestinal symptoms were assessed as changes in the Inflammatory Bowel Disease Questionnaire scores relative to the Bowel Domain (IBDQ-B) between baseline and radiotherapy mid-point/end. The 25th percentiles of the most severe worsening from baseline (DeltaIBDQ-B) were set as end-points. The impact of bowel loops and sigmoid colon dose-volume/surface parameters as well as selected clinical parameters were investigated using multivariate logistic regression. RESULTS: Analyses were focused on the four questions showing a median DeltaIBDQ-B>0. No dose volume/surface parameters were predictive, other than DeltaIBDQ5>/=3 (loose stools): when grouping patients according to bowel DVHs (high risk: V20>470cc, V30>245cc, V42>110cc; low risk: all the remaining patients), a two-variable model including high-risk DVH-shape (OR: 9.3) and age (protective, OR: 0.94) was assessed. The model showed good calibration (slope: 1.003, R(2)=0.92) and was found to be robust after bootstrap-based internal validation. CONCLUSIONS: Constraining the bowel loops may reduce the risk of loose stools. The risk is higher for younger patients.","Radiother Oncol, 124(2): 296-301","Italy",2017,"Any or unknown","Radiotherapy","IBDQ","Patient",null,"Cohort","Italy","Patient","Any or unknown","Radiotherapy",null,"Cohort","IBDQ","2015:2018","Complication"]
[632,"Siston, A. K., et al. (2003). \"Quality of life after a diagnosis of prostate cancer among men of lower socioeconomic status: results from the Veterans Affairs Cancer of the Prostate Outcomes Study.\" Urology 61(1): 172-178.",null,"Siston, A. K., et al.","Quality of life after a diagnosis of prostate cancer among men of lower socioeconomic status: results from the Veterans Affairs Cancer of the Prostate Outcomes Study","OBJECTIVES: To evaluate prospectively the health-related and disease-specific quality of life (QOL) at diagnosis and during the first year thereafter for patients with newly diagnosed prostate cancer who received care at Veterans Affairs Medical Centers. METHODS: Interviewers administered the European Organization for Research and Treatment of Cancer-QOL Questionnaire, a valid and reliable measure of health status, to 140 patients with prostate cancer at baseline (at diagnosis, before the initiation of treatment) and at 3 and 12 months thereafter at five Veterans Affairs Medical Centers. The mean changes from baseline values were analyzed statistically for patients with localized disease stratified by treatment group and separately for patients with metastatic disease. RESULTS: Among the 98 men with localized prostate cancer, significant disease-specific QOL changes noted at 3 and 12 months included worsening of urinary and sexual function among men treated with radical prostatectomy or radiotherapy and worsening of urinary function among those who opted for watchful waiting (each P <0.05). Among the 42 men with metastatic prostate cancer, significant decrements in role and social and sexual function were noted at 3 months, but had resolved on average by 12 months of follow-up. CONCLUSIONS: At 12 months, disease-specific QOL decrements persisted for patients with localized disease, but for patients with metastatic disease, disease-specific QOL appeared to return to near baseline (at diagnosis, before treatment initiation) function. Our study, among the first to assess the QOL at baseline before treatment, provides meaningful information on general treatment effects, which are directly relevant to clinicians when discussing treatment options with patients.","Urology, 61(1): 172-178","USA",2003,"Local,Metastatic","Surgery,Radiotherapy,Surveillance","EORTC QLQ-C30","Patient",null,"Cohort","USA","Patient","Local,Metastatic","Surgery,Radiotherapy,Surveillance",null,"Cohort","EORTC QLQ-C30","2000:2004","General"]
[633,"Skaltsa, K., et al. (2014). \"Mapping the FACT-P to the preference-based EQ-5D questionnaire in metastatic castration-resistant prostate cancer.\" Value Health 17(2): 238-244.",null,"Skaltsa, K., et al.","Mapping the FACT-P to the preference-based EQ-5D questionnaire in metastatic castration-resistant prostate cancer","OBJECTIVES: To develop a mapping algorithm for estimating EuroQol five-dimensional (EQ-5D) questionnaire values from the prostate cancer-specific health-related quality-of-life (HRQOL) instrument Functional Assessment of Cancer Therapy-Prostate (FACT-P) instrument. METHODS: The EQ-5D questionnaire and FACT-P instrument data were collected for a subset of patients with metastatic castration-resistant prostate cancer in a multicenter, randomized, double-blind, placebo-controlled phase 3 trial. We compared three statistical techniques to estimate patients' EQ-5D questionnaire index scores determined by using the UK tariff: 1) generalized estimating equations, 2) two-part model combining logistic regression and generalized estimating equation, and 3) separate mapping algorithms for patients with poor health defined as a FACT-P score of 76 or less (group-specific model). Four different sets of explanatory variables were compared. The models were cross-validated by using a 10-fold in-sample cross-validation. RESULTS: Values for both instruments were available for 236 patients with metastatic castration-resistant prostate cancer. The group-specific model including the FACT-P subscale scores and baseline variables had the best predictive performance with R(2) 0.718, root mean square error 0.162, and mean absolute error 0.117. The two-part model and the generalized estimating equation model including the FACT-P subdomain scores and baseline variables also had good predictive performance. CONCLUSIONS: The developed algorithms for mapping the FACT-P instrument to the EQ-5D questionnaire enable the estimation of preference-based health-related quality-of-life scores for use in cost-effectiveness analyses when directly elicited EQ-5D questionnaire data are missing.","Value Health, 17(2): 238-244","Netherlands",2014,"Metastatic","Unclear","EQ-5D,FACT-P","Patient",null,"Mapping to utility","Netherlands","Patient","Metastatic","Unclear",null,"Mapping to utility","EQ-5D,FACT-P","2010:2014","Disease,Utility"]
[634,"Skolarus, T. A., et al. (2012). \"Monitoring quality of life among prostate cancer survivors: the feasibility of automated telephone assessment.\" Urology 80(5): 1021-1026.",null,"Skolarus, T. A., et al.","Monitoring quality of life among prostate cancer survivors: the feasibility of automated telephone assessment","OBJECTIVE: To examine the feasibility of using automated interactive voice response calls to assess prostate cancer survivor quality of life (QOL). In light of an increasing focus on patient-centered outcomes, innovative and efficient approaches to monitor QOL among prostate cancer survivors are increasingly valuable. METHODS: Forty prostate cancer survivors less than 1 year post-treatment were enrolled at a university-based cancer center clinic from July through August 2011. We adapted the Expanded Prostate Cancer Index Composite (EPIC) survey, a prostate cancer-specific QOL instrument, for use via personal telephone with interactive voice response. We compared written vs interactive voice response EPIC scores across urinary, sexual, bowel, and vitality domains. RESULTS: The median age of respondents was 63 years (range, 41-76 years) and the majority had undergone surgery (97.5%). The entire interactive voice response call was completed by 35 participants (87.5%). Over half of all interactive voice response calls were answered after 2 attempts with a median length of 11.3 minutes. On average, interactive voice response EPIC scores were slightly lower than written scores (-2.1 bowel, P = .05; -4.6 urinary incontinence, P < .01). Test-retest reliability was very high for urinary incontinence (r = .97) and sexual function domains (r = .96). Although mean scores were similar for other domains, their distributions had significant ceiling effects limiting our reliability measure interpretation. CONCLUSION: Automated interactive voice response calls are a feasible strategy for assessing prostate cancer survivor QOL. Interactive voice response could provide a low cost, sustainable, and systematic approach to measuring patient-centered outcomes, conducting comparative effectiveness research, and monitoring the quality of prostate cancer care.","Urology, 80(5): 1021-1026","USA",2012,"Survivors","None","EPIC","Patient",null,"Cross-sectional","USA","Patient","Survivors","None",null,"Cross-sectional","EPIC","2010:2014","Disease"]
[635,"Small, E. J., et al. (2000). \"Suramin therapy for patients with symptomatic hormone-refractory prostate cancer: results of a randomized phase III trial comparing suramin plus hydrocortisone to placebo plus hydrocortisone.\" J Clin Oncol 18(7): 1440-1450.",null,"Small, E. J., et al.","Suramin therapy for patients with symptomatic hormone-refractory prostate cancer: results of a randomized phase III trial comparing suramin plus hydrocortisone to placebo plus hydrocortisone","PURPOSE: Suramin is a novel agent that has demonstrated preliminary evidence of antitumor activity in hormone-refractory prostate cancer (HRPC). A prospective randomized clinical trial was designed to evaluate pain and opioid analgesic intake as surrogates for antitumor response in HRPC patients with significant, opioid analgesic-dependent pain. PATIENTS AND METHODS: A double-blind, placebo-controlled trial randomized patients to receive a 78-day, outpatient regimen of either suramin plus hydrocortisone (HC, 40 mg/d) or placebo plus HC. Treatment assignment was unblinded when either disease progression or dose-limiting toxicity occurred; placebo patients were allowed to cross-over to open-label suramin plus HC. In addition to pain and opioid analgesic intake, prostate-specific antigen (PSA) response, time to disease progression, quality of life, performance status, and survival were compared. RESULTS: Overall mean reductions in combined pain and opioid analgesic intake were greater for suramin plus HC (rank sum P =.0001). Pain response was achieved in a higher proportion of patients receiving suramin than placebo (43% v 28%; P =.001), and duration of response was longer for suramin responders (median, 240 v 69 days; P =.0027). Time to disease progression was longer (relative risk = 1.5; 95% confidence interval, 1.2 to 1.9) and the proportion of patients with a greater than 50% decline in PSA was higher (33% v 16%; P =.01) in patients who received suramin. Neither quality of life nor performance status was decreased by suramin treatment, and overall survival was similar. Most adverse events were of mild or moderate intensity and were easily managed medically. CONCLUSION: Outpatient treatment with suramin plus HC is well tolerated and provides moderate palliative benefit and delay in disease progression for patients with symptomatic HRPC.","J Clin Oncol, 18(7): 1440-1450","USA",2000,"Any or unknown","Various","Unclear","Patient",null,"Clinical trial","USA","Patient","Any or unknown","Various",null,"Clinical trial","Unclear","2000:2004","General"]
[636,"Smith, D. S., et al. (2000). \"Quality-of-life outcomes for men with prostate carcinoma detected by screening.\" Cancer 88(6): 1454-1463.",null,"Smith, D. S., et al.","Quality-of-life outcomes for men with prostate carcinoma detected by screening","BACKGROUND: There is limited information on outcomes of prostate carcinoma treatments given to screened patient populations for whom cancer is usually detected at an earlier stage. METHODS: The authors conducted a cross-sectional evaluation of quality-of-life outcomes for men with prostate carcinoma detected in screening studies at a university center. Of 2234 men diagnosed with prostate carcinoma between 1989 and 1997, 74% responded to the questionnaire. Primary management included radical prostatectomy (76%), radiotherapy (11%), observation (7%), hormonal therapy (4%), and cryoablation (2%). Main outcome measures included validated measurements of quality of life, urinary and sexual functioning, and bother (36-item RAND Health Survey, UCLA Prostate Cancer Index). RESULTS: After controlling for demographic factors, differences among treatment groups were found for all general quality-of-life outcomes, with increased impairment in men who underwent hormonal therapy (all P values <0.05). Urinary and sexual function and bother were also significantly related to treatment. However, among men followed for > or =12 months, only 9% reported a moderate or major problem with urinary control. Sexual functioning was a moderate or major problem following treatment for 58% treated with prostatectomy, 48% treated with radiotherapy, 64% treated with hormonal therapy, 45% treated with cryoablation, and 30% managed with observation. Approximately one-third of the men younger than 70 years who underwent radical prostatectomy maintained adequate sexual functioning posttreatment. CONCLUSIONS: Up to 6 years after diagnosis, the majority of men with prostate carcinoma detected by screening were bothered by their current sexual function, regardless of treatment. In contrast, most men were not bothered by their current urinary function.","Cancer, 88(6): 1454-1463","USA",2000,"Any or unknown","Surgery,Radiotherapy,Surveillance,Hormonal,Various","UCLA-PCI,SF-36","Patient",null,"Cross-sectional","USA","Patient","Any or unknown","Surgery,Radiotherapy,Surveillance,Hormonal,Various",null,"Cross-sectional","UCLA-PCI,SF-36","2000:2004","Disease,Utility"]
[637,"Smith, D. S., et al. (2002). \"Patient preferences for outcomes associated with surgical management of prostate cancer.\" J Urol 167(5): 2117-2122.",null,"Smith, D. S., et al.","Patient preferences for outcomes associated with surgical management of prostate cancer","PURPOSE: We used utility assessment to evaluate patient preferences for current urinary and sexual function after radical prostatectomy. MATERIALS AND METHODS: We measured preferences in 209 community volunteers enrolled in a prostate cancer screening study who underwent radical prostatectomy between 1994 and 1998. We compared preferences in 3 outcome groups, namely men bothered by current urinary and sexual functioning, only bothered by current sexual functioning and not bothered by current sexual or urinary functioning. Preferences were assessed via a computer based interview using time trade-off and standard gamble methods. Current functioning was assessed via a standardized questionnaire. RESULTS: Median time trade-off and standard gamble utilities were high at 0.9 across outcome groups, indicating that men were not willing to give up many remaining life years (10% of remaining life expectancy) with current functioning to achieve ideal functioning. However, mean time trade-off and standard gamble scores significantly decreased as the burden increased in men bothered by current sexual and urinary function (0.77 and 0.82), bothered by current sexual function only (0.87 and 0.89) and not bothered by sexual or urinary function (0.92 and 0.96, respectively). CONCLUSIONS: Health related quality of life was generally good in this observational study of patients treated for prostate cancer with radical prostatectomy. In addition, those bothered by urinary and/or sexual function would not be willing to trade much of the remaining life span to achieve perfect functioning. However, the perception of side effects was bothersome enough in some men to warrant appropriate patient counseling regarding the potential risks and benefits.","J Urol, 167(5): 2117-2122","USA",2002,"Any or unknown","Surgery","TTO,SG","Patient",null,"Cross-sectional","USA","Patient","Any or unknown","Surgery",null,"Cross-sectional","TTO,SG","2000:2004","Utility"]
[638,"Smith, R. P., et al. (2003). \"Internet use by patients with prostate cancer undergoing radiotherapy.\" Urology 62(2): 273-277.",null,"Smith, R. P., et al.","Internet use by patients with prostate cancer undergoing radiotherapy","OBJECTIVES: To analyze the amount of Internet use, type of Internet use, and factors that predict Internet use by patients with prostate cancer. METHODS: A questionnaire evaluating the use of the Internet was given to 295 patients undergoing radiotherapy for prostate cancer in three different settings: an academic center (AC), a Veterans Affairs center (VA), and a community hospital. The study included 171 AC patients (58%), 104 VA patients (35%), and 20 community hospital patients (7%). RESULTS: The response rate to the questionnaire was greater than 99%. Overall, 128 (43%) of 295 patients had a home computer. This differed among the institutions, with 64% of AC patients and only 5% of VA patients having a home computer (P <0.0001). Overall, 94 (32%) of 295 patients used the Internet to access cancer information, with 48% of AC patients and 8% of VA patients using the Internet (P <0.0001). Seventeen percent of black patients (n = 113) had a home computer compared with 62% of white patients (n = 175; P <0.0001). Equal access to computers did not influence Internet use because, among those patients who had access to computers, black patients used the Internet less than did white patients (32% versus 61%, P <0.0001). Men 65 years of age or younger were more likely to use the Internet (45%) than those older than 65 years (28%; P = 0.004). Patients used many sites to access different types of information. CONCLUSIONS: A significant number of patients with prostate cancer access the Internet to obtain cancer information. Urologists and radiation oncologists should be familiar with this important resource to help patients access appropriate material.","Urology, 62(2): 273-277","USA",2003,"Any or unknown","Radiotherapy","Unclear","Patient",null,"Cross-sectional","USA","Patient","Any or unknown","Radiotherapy",null,"Cross-sectional","Unclear","2000:2004","Knowledge"]
[639,"Sneeuw, K. C., et al. (2001). \"Comparison of patient and spouse assessments of health related quality of life in men with metastatic prostate cancer.\" J Urol 165(2): 478-482.",null,"Sneeuw, K. C., et al.","Comparison of patient and spouse assessments of health related quality of life in men with metastatic prostate cancer","PURPOSE: We examined the extent of agreement in health related quality of life ratings provided by patients with metastatic prostate cancer and their spouses. This agreement is important for determining the feasibility of using spouses as potential proxy raters in quality of life studies in this patient population. MATERIALS AND METHODS: The study sample consisted of 72 pairs of patients with metastatic prostate cancer in remission or progression and their spouses. Patients and spouses independently completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 and a prostate cancer specific questionnaire module. Together the 2 questionnaires assess a wide range of symptoms and functional limitations for a total of 21 quality of life outcomes. RESULTS: For 5 of the 21 patient-proxy comparisons we noted systematic differences in the mean score with spouses rating more impairment in patients than patients indicated. Most patient-proxy correlations were 0.40 to 0.75, indicating moderate to good agreement in patient and spouse ratings. A low patient-proxy correlation of less than 0.40 was noted only for the 2 measures of sexual function. CONCLUSIONS: Our findings suggest that the spouses of men with metastatic prostate cancer evaluate with a fair degree of accuracy how patients experience physical and psychosocial functioning, symptoms and overall quality of life. However, caution should be exercised when relying on proxy raters for assessing sexual functioning and satisfaction.","J Urol, 165(2): 478-482","Netherlands",2001,"Metastatic","None","EORTC QLQ-C30,EORTC QLQ-PR25","Patient,Caregiver",null,"Validation","Netherlands","Patient,Caregiver","Metastatic","None",null,"Validation","EORTC QLQ-C30,EORTC QLQ-PR25","2000:2004","Disease,General"]
[640,"So, W. K., et al. (2013). \"Comparison of health-related quality of life and emotional distress among Chinese cancer survivors.\" Int J Nurs Pract 19(3): 306-317.",null,"So, W. K., et al.","Comparison of health-related quality of life and emotional distress among Chinese cancer survivors","The purpose of this study is to compare health-related quality of life (HRQoL) and emotional distress among diverse cancer survivors who had completed all treatment within the previous year. A convenience sample of 353 cancers survivors (lung, head and neck, breast and prostate cancers) were recruited to complete a survey, which consisted of (i) Hospital Anxiety and Depression Scales; (ii) Chinese version of the Functional Assessment of Cancer Therapy-General version; and (iii) demographic and clinical data. The HRQoL scores were similar among the four types of survivors. Mild anxiety and depression levels were reported, but no significant difference was noted. Younger females with financial burdens and uncertain prognosis were particularly associated with HRQoL and emotional distress. Further studies are essential to identify specific problems that cancer patients experience after cancer diagnosis that might lead to the early detection of those most at risk of ongoing problems.","Int J Nurs Pract, 19(3): 306-317","China",2013,"Survivors","None","HADS,FACT-G","Patient",null,"Cross-sectional","China","Patient","Survivors","None",null,"Cross-sectional","HADS,FACT-G","2010:2014","Comorbidity,Treatment"]
[641,"Soderdahl, D. W., et al. (2005). \"Prospective longitudinal comparative study of health-related quality of life in patients undergoing invasive treatments for localized prostate cancer.\" J Endourol 19(3): 318-326.",null,"Soderdahl, D. W., et al.","Prospective longitudinal comparative study of health-related quality of life in patients undergoing invasive treatments for localized prostate cancer","BACKGROUND AND PURPOSE: Health-related quality of life (QoL) concerns are important for patients selecting treatment options for clinically localized prostate cancer and are critical in evaluating outcomes. We report pretreatment and post-treatment general and disease-specific QoL for the following invasive interventions: open radical prostatectomy (ORP), laparoscopic radical prostatectomy (LRP), and palladium-103 ((103)Pd) brachytherapy. PATIENTS AND METHODS: We performed a prospective longitudinal survey of 452 patients with newly diagnosed prostate cancer treated at a single medical center between 2001 and 2003. An Institutional Review Board-approved questionnaire comprised of validated QoL instruments was sent to patients scheduled to undergo ORP (N = 186), LRP (N = 116), or brachytherapy (N = 150). The same questionnaire was sent out 1, 3, 6, 9, and 12 months after therapy. Comparisons were made between the groups to determine if the choice of therapy resulted in differences in QoL. RESULTS: General QoL scores were minimally affected by the choices; however, the disease-specific domains of bowel, urinary, and sexual function were adversely affected by all modalities. The ORP and LRP groups were similar among disease-specific domains and received lower post-treatment urinary and sexual scores than the (103)Pd patients. At 12 months, 38% of ORP and 46% of LRP patients had returned to baseline urinary function compared with 75% of (103)Pd patients. At 12 months, 63% of (103)Pd patients had returned to baseline sexual function compared with 19% of both the LRP and ORP patients. CONCLUSIONS: Invasive treatments for localized prostate cancer have little impact on general QoL but significantly affect disease-specific domains. Both ORP and LRP have a greater initial negative impact on urinary and sexual function than (103)Pd. The differences among the treatments with regard to QoL provide information to patients faced with choosing a treatment.","J Endourol, 19(3): 318-326","USA",2005,"Local","Surgery,Brachytherapy","Unclear","Patient",null,"Cohort","USA","Patient","Local","Surgery,Brachytherapy",null,"Cohort","Unclear","2005:2009","General"]
[642,"Solberg, A., et al. (2011). \"Side-effects of post-treatment biopsies in prostate cancer patients treated with endocrine therapy alone or combined with radical radiotherapy in the Scandinavian Prostate Cancer Group-7 randomized trial.\" Scand J Urol Nephrol 45(4): 233-238.",null,"Solberg, A., et al.","Side-effects of post-treatment biopsies in prostate cancer patients treated with endocrine therapy alone or combined with radical radiotherapy in the Scandinavian Prostate Cancer Group-7 randomized trial","OBJECTIVE: Post-treatment prostate biopsy side-effects were evaluated in patients with locally advanced prostate cancer on endocrine therapy alone or combined with radiotherapy in the Scandinavian Prostate Cancer Group-7 randomized trial. MATERIAL AND METHODS: One-hundred and twenty patients underwent transrectalultrasound-guided biopsy, and were requested to complete a questionnaire on side-effects occurring within 7 days' follow-up. RESULTS: The questionnaire was returned by 109 patients (91%) (endocrine therapy only 52%, combined endocrine therapy and radiotherapy 48%). Previous therapy had no significant influence on pain, urinary flow, haematuria or haematospermia. Pain at biopsy was reported in 63% (mild, 57%; moderate, 5.6%; severe, one patient) and pain at follow-up in 31% (mild, 27%; moderate, four patients). Haematuria (mean duration 2.2 days) was reported in 41%, and reduced urinary flow in 20% (mild, 18%; severe: four patients; no patient had urinary retention). Haematospermia was scarce. No patient reported urinary tract infection. Rectal bleeding occurred in 18% in the endocrine and 35% in the combined therapy group (p = 0.047), with a mean duration of 1.6 and 2.2 days, respectively (p = 0.031). In logistic regression analysis, a trend towards increased rectal bleeding was found in patients on combined endocrine therapy and radiotherapy (odds ratio 2.4, p = 0.050). CONCLUSION: Patient-reported post-treatment prostate biopsy side-effects were mild and self-limiting.","Scand J Urol Nephrol, 45(4): 233-238","Norway",2011,"Advanced","Radiotherapy,Hormonal","Unclear","Patient",null,"Clinical trial","Norway","Patient","Advanced","Radiotherapy,Hormonal",null,"Clinical trial","Unclear","2010:2014","Treatment"]
[643,"Sommers, S. D. and S. D. Ramsey (1999). \"A review of quality-of-life evaluations in prostate cancer.\" Pharmacoeconomics 16(2): 127-140.",null,"Sommers, S. D. and S. D. Ramsey","A review of quality-of-life evaluations in prostate cancer","Prostate cancer is a highly prevalent malignancy in older men. Because the disease and its treatments have the potential to cause substantial morbidity in affected individuals, prostate cancer has been the subject of great interest for quality-of-life (QOL) researchers. In this article, we review published QOL studies that have focused on individuals with prostate cancer. Generic survey instruments have generally been found to be insensitive to changes in health-related quality of life (HR-QOL) related to prostate cancer and its treatments. Domain-specific survey instruments (such as those focusing on sexual function) have been more sensitive, but fail to capture all relevant impacts. At least 9 disease-specific instruments have been developed to measure the HR-QOL impact of prostate cancer. These instruments generally focus on specific symptoms related to the disease and its treatment--urinary function, bowel function, sexual function, physical function, psychological function and pain--however, the domains covered are not consistent from instrument to instrument, and the domains of emphasis within each instrument are rarely the same. In addition, no single instrument has been applied to all major therapies for prostate cancer across men at different ages and stages of disease. Finally, HR-QOL evaluations in some patient groups, such as those with advanced disease, have received relatively little attention to date. As a result of the proliferation of prostate cancer-specific survey instruments and inconsistencies in their design and application, decision-makers face great difficulties evaluating HR-QOL across disease stages and comparing the HR-QOL impacts of alternative therapies, including conservative management ('watchful waiting'). In order for these tools to be useful for patient management and policy-making, coordination of instrument development efforts with the goal of consolidating the number of measures used is urgently needed.","Pharmacoeconomics, 16(2): 127-140","USA",1999,"Any or unknown","None","Unclear","Patient",null,"Narrative review","USA","Patient","Any or unknown","None",null,"Narrative review","Unclear","1960:1999","Unclear"]
[644,"Sonn, G. A., et al. (2013). \"Differing perceptions of quality of life in patients with prostate cancer and their doctors.\" J Urol 189(1 Suppl): S59-65; discussion S65.",null,"Sonn, G. A., et al.","Differing perceptions of quality of life in patients with prostate cancer and their doctors","PURPOSE: As the number of prostate cancer survivors increases, urologists must recognize their quality of life impairment. In the past physician ratings of patient symptoms did not correlate with patient self-assessments. We determined if urologists have improved their reporting of patient health related quality of life. We also investigated if urologists assessed health related quality of life more accurately in the short or long term. MATERIALS AND METHODS: We identified 1,366 men from CaPSURE, a national, prospective cohort, who had undergone prostatectomy, brachytherapy or external beam radiation therapy. At each visit urologists assessed fatigue, pain, and sexual, urinary and bowel dysfunction. Participants independently completed the SF-36 and the UCLA-PCI. We contrasted the frequency of impairment reported by physicians and participants in select health related quality of life domains in the short (less than 1 year) and long (greater than 2 years) term. We also compared physician-patient concordance between the periods 1995 to 2000 and 2001 to 2007. RESULTS: In short-term and long-term followup, and for the 1995 to 2000 and 2001 to 2007 cohorts, physician and participant assessments differed in all analyzed domains. Urologists noted impairment in urinary and sexual function more often than fatigue or pain. Disagreement between physician and participant ratings did not vary dramatically from short-term to long-term followup, or from the earlier to the later cohort. CONCLUSIONS: In men treated for localized prostate cancer physician ratings of symptoms do not correlate well with patient self-assessments of health related quality of life. Physician reporting did not improve over time. It is increasingly important to recognize and address impairments in quality of life from prostate cancer and its treatment.","J Urol, 189(1 Suppl): S59-65; discussion S65","USA",2013,"Any or unknown","Surgery,Radiotherapy,Brachytherapy","SF-36,UCLA-PCI","HCP,Patient",null,"Validation","USA","HCP,Patient","Any or unknown","Surgery,Radiotherapy,Brachytherapy",null,"Validation","SF-36,UCLA-PCI","2010:2014","Disease,Utility"]
[645,"Souchek, J., et al. (2000). \"A trial for comparing methods for eliciting treatment preferences from men with advanced prostate cancer: results from the initial visit.\" Med Care 38(10): 1040-1050.",null,"Souchek, J., et al.","A trial for comparing methods for eliciting treatment preferences from men with advanced prostate cancer: results from the initial visit","OBJECTIVE: The objective of this study was to evaluate the convergent validity of 3 types of utility measures: standard gamble, time tradeoff, and rating scale. RESEARCH DESIGN: A prospective cohort of 120 men with advanced prostate cancer were first asked to rank order 8 health states, and then utility values were obtained from each participant for each of the 8 health states through 2 of the 3 techniques evaluated (standard gamble, time tradeoff and rating scale). Participants were randomly assigned to 1 of 3 possible pairs of techniques. The validity of the 3 methods, as measured by the convergence and raw score differences of the techniques, was assessed with ANOVA. The ability of the techniques to differentiate health states was determined. The inconsistencies between rankings and utility values were also measured. Proportions of illogical utility responses were assessed as the percent of times when states with more symptoms were given higher or equal utility values than states with fewer symptoms. RESULTS: There were significant differences in raw scores between techniques, but the values were correlated across health states. Utility values were often inconsistent with the rank order of health states. In addition, utility assessment did not differentiate the health states as well as the rank order. Furthermore, utility values were often illogical in that states with more symptoms received equal or higher utility values than states with fewer symptoms. CONCLUSIONS: Use of the utility techniques in cost-effectiveness analysis and decision making has been widely recommended. The results of this study raise serious questions as to the validity and usefulness of the measures.","Med Care, 38(10): 1040-1050","USA",2000,"Advanced","None","SG,TTO,RatingS","Patient",null,"Validation","USA","Patient","Advanced","None",null,"Validation","SG,TTO,RatingS","2000:2004","Utility"]
[646,"Soumarova, R., et al. (2006). \"Acute toxicity of conformal high dose interstitial brachytherapy boost in prostate cancer.\" Neoplasma 53(5): 410-417.",null,"Soumarova, R., et al.","Acute toxicity of conformal high dose interstitial brachytherapy boost in prostate cancer","Over the past few years, brachytherapy has become more and more common in the treatment of prostate cancer, largely thanks to the reduced amount of acute and chronic side effects. At the same time, brachytherapy also allows dose escalation, resulting in significant improvements in the treatment results. From August 2004 to June 2005, we irradiated 40 patients suffering from T1c-T3a prostate cancer. All of the patients underwent external beam radiotherapy with a median dose of 45-50.4 Gy and a conformal high dose interstitial brachytherapy boost (two fractions, 8 Gy per fraction). The patients were divided into three groups: low risk of recurrence (11 patients - 27.5%), intermediate risk (14 patients - 35%) and high risk (15 patients - 37.5%). The medium age of the patients was 68.7 years (between 55 and 77). Hormonal treatment was carried out 17 patients (42.5%). We evaluated the quality of each implantation, including the maximum urethral and rectal dose. The calculated doses were compared with measurements by in vivo dosimetry. Acute toxicity was evaluated in all of the patients according to the Radiation Therapy Oncology Group (RTOG) scale. Each of the patients completed an International Prostatic Symptom Score (IPSS) questionnaire. Acute genitourinary morbidity grade 1 was recorded in 37.5% of patients; grade 2 in 15% of patients. Urine retention in one of the patients resulted in the need to perform an epicystostomy. According to the IPSS score, the majority of patients (90%) experienced an improvement in symptoms related to quality of life. Grade 1 acute gastrointestinal toxicity was recorded in 40% of the patients. Grades 2-4 were not recorded. Here, we show that the combination of external beam radiotherapy and high dose rate (HDR) brachytherapy in the treatment of early prostate cancer to be feasible and well tolerated. Acute toxicity was low and scarcely influenced the quality of life. Among the risk factors of genitourinary toxicity was the volume of the prostate. For gastrointestinal toxicity, risk factors included the combination of HDR brachytherapy and external beam radiotherapy to the pelvis, as well as hormonal treatment.","Neoplasma, 53(5): 410-417","Czech Republic",2006,"Local,Advanced","Radiotherapy,Brachytherapy","IPSS,RTOG-EORTC-SS","Patient",null,"Clinical trial","Czech Republic","Patient","Local,Advanced","Radiotherapy,Brachytherapy",null,"Clinical trial","IPSS,RTOG-EORTC-SS","2005:2009","Disease,Treatment"]
[647,"Staff, I., et al. (2003). \"Disease-specific symptoms and general quality of life of patients with prostate carcinoma before and after primary three-dimensional conformal radiotherapy.\" Cancer 98(11): 2335-2343.",null,"Staff, I., et al.","Disease-specific symptoms and general quality of life of patients with prostate carcinoma before and after primary three-dimensional conformal radiotherapy","BACKGROUND: Approximately 189,000 men are diagnosed with prostate carcinoma each year and more than 1 million are living with the disease. Good prognoses and undesirable sequelae accompany each of several available primary and adjuvant treatment options. The current study explored the effects of primary three-dimensional conformal radiotherapy with or without neoadjuvant hormonal therapy on urinary, bowel, and sexual symptoms and health-related quality of life (HRQOL). METHODS: A prospective, repeated-measures design study included 100 patients. Data from the Medical Outcomes Study Short Form Health Survey (a measure of general HRQOL) and a 12-item symptom questionnaire were collected before the start of radiotherapy, approximately 1-3 months after completion of treatment, and again approximately 5-10 months after completion of treatment for follow-up. RESULTS: Patients reported few urinary symptoms after treatment. Bowel frequency and urgency were reported more frequently posttreatment and at follow-up. Erectile difficulties, which were common pretreatment, were reported with increased frequency posttreatment and at follow-up. General HRQOL scores were higher than age-related general population norms for men at all three data collection times, but there were significant losses posttreatment for patients' physical functioning and vitality. At the 5-10-month follow-up, physical functioning remained lower but vitality scores regained some of the losses. A more extended follow-up is needed. Neoadjuvant therapy, which was received before the pretreatment data collection, had a deleterious effect on erectile functioning but no interactive effects with the radiotherapy on symptoms or HRQOL. CONCLUSIONS: Although patients with a diagnosis of prostate carcinoma experienced increased bowel and sexual dysfunction and decreased vitality after radiotherapy, their HRQOL scores remained at or above age-related general population norms.","Cancer, 98(11): 2335-2343","USA",2003,"Any or unknown","Radiotherapy,Hormonal","SF-36","Patient",null,"Cohort","USA","Patient","Any or unknown","Radiotherapy,Hormonal",null,"Cohort","SF-36","2000:2004","Utility,Symptom"]
[648,"Stafford, R. S. and P. L. Cyr (1997). \"The impact of cancer on the physical function of the elderly and their utilization of health care.\" Cancer 80(10): 1973-1980.",null,"Stafford, R. S. and P. L. Cyr","The impact of cancer on the physical function of the elderly and their utilization of health care","BACKGROUND: Controversy about whether cancer has an independent impact on patient quality of life led the authors to evaluate the effects of cancer on a range of quality-of-life and health care utilization measures within an elderly population. METHODS: The authors analyzed a nationally representative sample of 9745 elderly community-based Medicare beneficiaries sampled in the 1991 Medicare Current Beneficiary Survey. Of these, 1647 reported being diagnosed by a physician as having a malignancy that was not of the skin. Multiple logistic regression was used to identify the independent predictors of functional limitation, poor health status, health care utilization, and patient satisfaction with medical care. RESULTS: Cancer was reported by 17% of the elderly. Individuals with cancer reported poorer health, more limitations of the activities of daily living (ADLs) and the instrumental activities of daily living (IADLs), and greater health care utilization than individuals without cancer. For individuals with cancer, difficulty walking (38%) and getting out of a chair (21%) were the most commonly reported ADL limitations, whereas difficulty completing heavy housework (34%) and shopping (17%) were the most common IADL limitations. Carcinomas of the lung, prostate, and colon independently predicted poorer health status. Lung carcinoma was independently associated with more ADL limitations. Lung, bladder, and prostate carcinomas predicted increased health care utilization. Overall, cancer patients were at least as satisfied with their medical care as those without cancer. CONCLUSIONS: Cancer increased the use of health care resources and modestly reduced physical function. By identifying specific connections between cancer and physical function, these findings have implications for improving cancer care.","Cancer, 80(10): 1973-1980","USA",1997,"Any or unknown","None","Unclear","Patient",null,"Cross-sectional","USA","Patient","Any or unknown","None",null,"Cross-sectional","Unclear","1960:1999","Satisfaction,General"]
[649,"Stanciu, M. A., et al. (2015). \"A pilot randomised controlled trial of personalised care after treatment for prostate cancer (TOPCAT-P): nurse-led holistic-needs assessment and individualised psychoeducational intervention: study protocol.\" BMJ Open 5(6): e008470.",null,"Stanciu, M. A., et al.","A pilot randomised controlled trial of personalised care after treatment for prostate cancer (TOPCAT-P): nurse-led holistic-needs assessment and individualised psychoeducational intervention: study protocol","INTRODUCTION: Prostate cancer is common and the incidence is increasing, but more men are living longer after diagnosis, and die with their disease rather than of it. Nonetheless, specific and substantial physical, sexual, emotional and mental health problems often lead to a poor quality of life. Urology services increasingly struggle to cope with the demands of follow-up care, and primary care is likely to play the central role in long-term follow-up. The present phase II trial will evaluate the feasibility and acceptability of a nurse-led, person-centred psychoeducational intervention, delivered in community or primary care settings. METHODS AND ANALYSIS: Prostate cancer survivors diagnosed in the past 9-48 months and currently biochemically stable will be identified from hospital records by their treating clinician. Eligible men would have either completed radical treatment, or would be followed up with prostate specific antigen monitoring and symptom reporting. We will recruit 120 patients who will be randomised to receive either an augmented form of usual care, or an additional nurse-led intervention for a period of 36 weeks. Following the health policy in Wales, the intervention is offered by a key worker, is promoting prudent healthcare and is using a holistic needs assessment. Outcome measures will assess physical symptoms, psychological well-being, confidence in managing own health and quality of life. Healthcare service use will be measured over 36 weeks. Feedback interviews with patients and clinicians will further inform the acceptability of the intervention. Recruitment, attrition, questionnaire completion rates and outcome measures variability will be assessed, and results will inform the design of a future phase III trial and accompanying economic evaluation. ETHICS AND DISSEMINATION: Ethics approval was granted by Bangor University and North Wales REC (13/WA/0291). Results will be reported in peer-reviewed publications, at scientific conferences, and directly through national cancer and primary care networks. TRIAL REGISTRATION NUMBER: ISRCTN 34516019.","BMJ Open, 5(6): e008470","UK",2015,"Survivors","Various,Psychological","Unclear","Patient",null,"Protocol","UK","Patient","Survivors","Various,Psychological",null,"Protocol","Unclear","2015:2018","General,Symptom"]
[650,"Steenland, E., et al. (1999). \"The effect of a single fraction compared to multiple fractions on painful bone metastases: a global analysis of the Dutch Bone Metastasis Study.\" Radiother Oncol 52(2): 101-109.",null,"Steenland, E., et al.","The effect of a single fraction compared to multiple fractions on painful bone metastases: a global analysis of the Dutch Bone Metastasis Study","PURPOSE: To answer the question whether a single fraction of radiotherapy that is considered more convenient to the patient is as effective as a dose of multiple fractions for palliation of painful bone metastases. PATIENTS: 1171 patients were randomised to receive either 8 Gy x 1 (n = 585) or 4 Gy x 6 (n = 586). The primary tumour was in the breast in 39% of the patients, in the prostate in 23%, in the lung in 25% and in other locations in 13%. Bone metastases were located in the spine (30%), pelvis (36%), femur (10%), ribs (8%), humerus (6%) and other sites (10%). METHOD: Questionnaires were mailed to collect information on pain, analgesics consumption, quality of life and side effects during treatment. The main endpoint was pain measured on a pain scale from 0 (no pain at all) to 10 (worst imaginable pain). Costs per treatment schedule were estimated. RESULTS: On average, patients participated in the study for 4 months. Median survival was 7 months. Response was defined as a decrease of at least two points as compared to the initial pain score. The difference in response between the two treatment groups proved not significant and stayed well within the margin of 10%. Overall, 71% experienced a response at some time during the first year. An analysis of repeated measures confirmed that the two treatment schedules were equivalent in terms of palliation. With regard to pain medication, quality of life and side effects no differences between the two treatment groups were found. The total number of retreatments was 188 (16%). This number was 147 (25%) in the 8 Gy x 1 irradiation group and 41 (7%) in the 4 Gy x 6 group. It was shown that the level of pain was an important reason to retreat. There were also indications that doctors were more willing to retreat patients in the single fraction group because time to retreatment was substantially shorter in this group and the preceding pain score was lower. Unexpectedly, more pathological fractures were observed in the single fraction group, but the absolute percentage was low. In a cost-analysis, the costs of the 4 Gy x 6 and the 8 Gy x 1 treatment schedules were calculated at 2305 and 1734 Euro respectively. Including the costs of retreatment reduced this 25% cost difference to only 8%. The saving of radiotherapy capacity, however, was considered the major economic advantage of the single dose schedule. CONCLUSION: The global analysis of the Dutch study indicates the equality of a single fraction as compared to a 6 fraction treatment in patients with painful bone metastases provided that 4 times more retreatments are accepted in the single dose group. This equality is also shown in long term survivors. A more detailed analysis of the study is in progress.","Radiother Oncol, 52(2): 101-109","Netherlands",1999,"Metastatic","Radiotherapy","NPS","Patient",null,"Clinical trial","Netherlands","Patient","Metastatic","Radiotherapy",null,"Clinical trial","NPS","1960:1999","Symptom"]
[651,"Steineck, G., et al. (2002). \"Quality of life after radical prostatectomy or watchful waiting.\" N Engl J Med 347(11): 790-796.",null,"Steineck, G., et al.","Quality of life after radical prostatectomy or watchful waiting","BACKGROUND: We evaluated symptoms and self-assessments of quality of life in men with localized prostate cancer who participated in a randomized comparison between radical prostatectomy and watchful waiting. METHODS: Between 1989 and 1999, a group of Swedish urologists randomly assigned men with localized prostate cancer to radical prostatectomy or watchful waiting. In this follow-up study, we obtained information from 326 of 376 eligible men (87 percent) concerning certain symptoms, symptom-induced distress, well-being, and the subjective assessment of quality of life by means of a mailed questionnaire. RESULTS: Erectile dysfunction (80 percent vs. 45 percent) and urinary leakage (49 percent vs. 21 percent) were more common after radical prostatectomy, whereas urinary obstruction (e.g., 28 percent vs. 44 percent for weak urinary stream) was less common. Bowel function, the prevalence of anxiety, the prevalence of depression, well-being, and the subjective quality of life were similar in the two groups. CONCLUSIONS: The assignment of patients to watchful waiting or radical prostatectomy entails different risks of erectile dysfunction, urinary leakage, and urinary obstruction, but on average, the choice has little if any influence on well-being or the subjective quality of life after a mean follow-up of four years.","N Engl J Med, 347(11): 790-796","Sweden",2002,"Local","Surgery,Surveillance","Unclear","Patient",null,"Clinical trial","Sweden","Patient","Local","Surgery,Surveillance",null,"Clinical trial","Unclear","2000:2004","General,Symptom"]
[652,"Stephens, R. J., et al. (2007). \"The quality of life of men with locally advanced prostate cancer during neoadjuvant hormone therapy: data from the Medical Research Council RT01 trial (ISRCTN 47772397).\" BJU Int 99(2): 301-310.",null,"Stephens, R. J., et al.","The quality of life of men with locally advanced prostate cancer during neoadjuvant hormone therapy: data from the Medical Research Council RT01 trial (ISRCTN 47772397)","OBJECTIVE: To explore patients' quality of life (QoL) during neoadjuvant hormone therapy (HT) using data from the Medical Research Council RT01 trial of standard- (64 Gy/32-fraction) and high- (74 Gy/37-fraction) dose radiotherapy (RT, both given conformally). PATIENTS AND METHODS: Of the 843 patients randomized to the RT01 trial, 316 completed the Functional Assessment Of Cancer Therapy core questionnaire with its additional prostate subscale, and the Short Form-36 Health Survey questionnaire with the University of California-Los Angeles Prostate Cancer Index before HT and again before starting RT. Three predefined QoL hypotheses were generated to focus the analyses. RESULTS: For the three primary QoL analyses there was evidence that sexual functioning deteriorated, urinary function did not change, and there was a slight decline in physical well-being after > or = 3 months of HT. Sensitivity analyses confirmed these findings. Exploratory analyses also suggested that role functioning deteriorated, sleep was more disturbed, and there was an increase in fatigue. However, overall QoL was not reported to be affected and patients indicated an improvement in attitude and satisfaction with treatment. CONCLUSIONS: In this group of men, many of whom reported reduced sexual functioning before treatment, the additional decline during HT seemed to be generally accepted as the price to pay for an appropriate cancer treatment. Nevertheless, these changes need to be discussed with patients before HT is commenced.","BJU Int, 99(2): 301-310","UK",2007,"Advanced","Hormonal,Radiotherapy","SF-36,UCLA-PCI,FACT-G,FACT-P","Patient",null,"Clinical trial","UK","Patient","Advanced","Hormonal,Radiotherapy",null,"Clinical trial","SF-36,UCLA-PCI,FACT-G,FACT-P","2005:2009","Disease,Treatment,Utility"]
[653,"Stewart, S. T., et al. (2005). \"Utilities for prostate cancer health states in men aged 60 and older.\" Med Care 43(4): 347-355.",null,"Stewart, S. T., et al.","Utilities for prostate cancer health states in men aged 60 and older","PURPOSE: We sought to measure utilities for prostate cancer health states in older men. METHODS: A total of 162 men aged 60 years or older (52% of whom had been diagnosed with prostate cancer) provided standard gamble utilities for 19 health states associated with prostate cancer or its treatment using an interactive, computer-based utility assessment program. Demographics and experience with specific health states were examined as predictors of ratings using ordinary least squares regression analysis. RESULTS: Mean utilities ranged from 0.67 to 0.84 for living with symptom-free cancer under conservative management (\"watchful waiting\") and from 0.71 to 0.89 for symptoms occurring with treatment (prostatectomy, radiation, and hormone ablation). For long-term treatment complications, bowel problems (0.71) were rated as significantly worse than impotence (0.89), urinary difficulty (0.88), or urinary incontinence (0.83). Combinations of these conditions were rated as significantly worse than individual component states. Men who had experienced impotence or urinary incontinence rated these states as slightly better than men who had not experienced the specific problems. CONCLUSIONS: Both \"watchful waiting\" and treatment complications from prostate cancer treatments can have large impacts on quality of life. Mean ratings are important for use in policy-making and cost-effectiveness analyses. Variation in ratings across patients suggests that mean scores do not reflect individual preferences and that shared decision-making may be best for clinical decisions.","Med Care, 43(4): 347-355","USA",2005,"Any or unknown","Hormonal,Radiotherapy,Surgery","SG","Patient,General population",null,"Cross-sectional","USA","Patient,General population","Any or unknown","Hormonal,Radiotherapy,Surgery",null,"Cross-sectional","SG","2005:2009","Utility"]
[654,"Stier, D. M., et al. (1999). \"Quantifying comorbidity in a disease-specific cohort: adaptation of the total illness burden index to prostate cancer.\" Urology 54(3): 424-429.",null,"Stier, D. M., et al.","Quantifying comorbidity in a disease-specific cohort: adaptation of the total illness burden index to prostate cancer","OBJECTIVES: Numerous studies have demonstrated the importance of comorbid illness when analyzing medical outcomes. The purpose of this study was to adapt a generic comorbidity index, the Total Illness Burden Index (TIBI), for use in men with prostate cancer, and to evaluate the usefulness of the new instrument in adjusting for the impact of comorbidity on functional outcomes in a prostate cancer cohort. METHODS: The TIBI uses patients' self-report of symptoms and diagnoses to determine not only the presence but also the severity of comorbidities in each of 16 body system domains. To create the TIBI-P (prostate cancer modification), some domains were added and others were modified according to clinical criteria. The TIBI-P was completed by 1638 men with prostate cancer followed up longitudinally in 29 urology practices in the United States. TIBI-P scores were calculated for each patient and analyzed with scores on the SF-36 quality-of-life questionnaire and with patient report of days confined to bed. RESULTS: After adjusting for age and income, lower SF-36 scale scores and increases in confinement to bed were associated with a greater burden of comorbid illness as measured by the TIBI-P, independent of the extent of prostate cancer. The TIBI-P explained 24% of the variance in the SF-36 physical functioning domain score. CONCLUSIONS: The TIBI-P is a powerful measure of the impact of comorbid illness on the quality of life and functioning among patients with prostate cancer. This index may prove valuable in research on clinical and economic outcomes of prostate cancer.","Urology, 54(3): 424-429","USA",1999,"Any or unknown","None","SF-36,TIBI-P","Patient",null,"Mapping to utility,Validation","USA","Patient","Any or unknown","None",null,"Mapping to utility,Validation","SF-36,TIBI-P","1960:1999","Comorbidity,Utility"]
[655,"Stockler, M. R., et al. (1998). \"Responsiveness to change in health-related quality of life in a randomized clinical trial: a comparison of the Prostate Cancer Specific Quality of Life Instrument (PROSQOLI) with analogous scales from the EORTC QLQ-C30 and a trial specific module. European Organization for Research and Treatment of Cancer.\" J Clin Epidemiol 51(2): 137-145.",null,"Stockler, M. R., et al.","Responsiveness to change in health-related quality of life in a randomized clinical trial: a comparison of the Prostate Cancer Specific Quality of Life Instrument (PROSQOLI) with analogous scales from the EORTC QLQ-C30 and a trial specific module. European Organization for Research and Treatment of Cancer","INTRODUCTION: The Prostate Cancer Specific Quality of Life Instrument (PROSQOLI) was developed to be a pragmatic outcome measure for clinical trials in symptomatic men with advanced hormone-resistant prostate cancer. DESIGN AND SETTING: A comparative assessment of responsiveness was made with longitudinal data from a positive multicenter randomized trial of palliative chemotherapy in 161 symptomatic men with advanced hormone-resistant prostate cancer. INSTRUMENTS: The PROSQOLI, the European Organisation for Research and Treatment of Cancer (EORTC) core quality of life questionnaire (QLQ-C30), and a specific quality of life module for advanced prostate cancer [QLM-P14] were administered every 3 weeks while patients received their allocated treatment. FINDINGS: Sixteen of the 19 health-related quality of life (HRQL) scales demonstrated improvements in palliative responders. All three pain scales detected a beneficial effect of palliative chemotherapy. The relative efficiency statistics favored the PROSQOLI for physical symptoms and physical function but the QLQ-C30 for emotional function, social function, and global perceptions. The PROSQOLI linear analog scale was the most responsive measure of pain. Bootstrap confidence intervals for the relative efficiency statistics were wide. CONCLUSIONS: Both the PROSQOLI and the analogous scales from the QLQ-C30 were responsive to improvements in HRQL. Differences between the instruments were generally subtle. The PROSQOLI is a short, simple, responsive measure of HRQL in men receiving systemic treatment for advanced hormone-resistant prostate cancer.","J Clin Epidemiol, 51(2): 137-145","Canada",1998,"Advanced","Chemotherapy,Palliative care","EORTC QLQ-C30,PROSQoLI,QOLM-P14","Patient",null,"Validation","Canada","Patient","Advanced","Chemotherapy,Palliative care",null,"Validation","EORTC QLQ-C30,PROSQoLI,QOLM-P14","1960:1999","Disease,General"]
[656,"Stockler, M. R., et al. (1999). \"Convergent discriminitive, and predictive validity of the Prostate Cancer Specific Quality of Life Instrument (PROSQOLI) assessment and comparison with analogous scales from the EORTC QLQ-C30 and a trial-specific module. European Organisation for Research and Treatment of Cancer. Core Quality of Life Questionnaire.\" J Clin Epidemiol 52(7): 653-666.",null,"Stockler, M. R., et al.","Convergent discriminitive, and predictive validity of the Prostate Cancer Specific Quality of Life Instrument (PROSQOLI) assessment and comparison with analogous scales from the EORTC QLQ-C30 and a trial-specific module. European Organisation for Research and Treatment of Cancer. Core Quality of Life Questionnaire","The Prostate Cancer Specific Quality of Life Instrument (PROSQOLI) is a measure of health-related quality of life (HRQL) that was designed to be an outcome measure for clinical trials in advanced hormone-resistant prostate cancer. The cross-sectional validity of the PROSQOLI was assessed using baseline data from a randomized trial in which HRQL was also assessed with the European Organisation for Research and Treatment of Cancer (EORTC) Core Quality of Life Questionnaire (QLQ-C30) and a trial-specific quality of life module (QLM-P14). Convergent validity was assessed with the multitrait-multimethod matrix approach; discriminative validity was assessed according to conventional clinical criteria; and predictive validity was assessed by the ability to predict survival duration. These assessments provided strong support for the validity of all PROSQOLI scales except those for family/marriage relationships and passing urine; modifications of these two scales are under evaluation. The strength, consistency, and independence of the prognostic information provided by the HRQL scales were striking. Differences between the instruments were generally subtle. These data support validity of the PROSQOLI and the analogous scales from the QLQ-C30 and QLM-P14 in symptomatic men with advanced hormone resistant prostate cancer. The PROSQOLI is a short, simple, and valid measure of HRQL in this setting.","J Clin Epidemiol, 52(7): 653-666","Canada",1999,"Advanced","Unclear","EORTC QLQ-C30,QOLM-P14,PROSQoLI","Patient",null,"Validation","Canada","Patient","Advanced","Unclear",null,"Validation","EORTC QLQ-C30,QOLM-P14,PROSQoLI","1960:1999","Disease,General"]
[657,"Stone, P., et al. (2001). \"Fatigue in patients with cancers of the breast or prostate undergoing radical radiotherapy.\" J Pain Symptom Manage 22(6): 1007-1015.",null,"Stone, P., et al.","Fatigue in patients with cancers of the breast or prostate undergoing radical radiotherapy","To determine the prevalence, severity, and correlates of fatigue among patients with cancers of the prostate or breast receiving high dose radiotherapy with curative intent, a prospective, questionnaire-based study evaluated a convenience sample of 62 patients who were about to start a course of radiotherapy. Patients were assessed immediately prior to treatment, and again within a week of finishing. Fatigue was assessed using the Fatigue Severity Scale (FSS) and the Bidimensional Fatigue Scale (BFS). Quality of life was assessed using the European Organisation for Research and Treatment of Cancer 30-item Quality of Life Questionnaire (EORTC QLQc30). Psychological distress was assessed using the Hospital Anxiety and Depression Scale (HADS). Personality Traits were assessed using the Eysenck Personality Inventory (EPI). Fatigue severity increased significantly on 3 out of the 5 assessment instruments used. Radiotherapy was associated with a decline in global quality of life, role, cognitive and social functioning, and an increase in nausea/vomiting, pain, insomnia, diarrhea, and financial difficulty. At baseline, 39% of the variation in fatigue scores among the patients could be explained by a combination of measures of their global quality of life and physical functioning. A combination of fatigue and anxiety scores at baseline was able to predict 54% of the variation in fatigue scores at the completion of radiotherapy. These data indicate that fatigue is a significant problem for patients receiving radical radiotherapy, although its severity is relatively modest.","J Pain Symptom Manage, 22(6): 1007-1015","UK",2001,"Any or unknown","Radiotherapy","EORTC QLQ-C30,HADS,FSS,EPInv,BiFS","Patient",null,"Cohort","UK","Patient","Any or unknown","Radiotherapy",null,"Cohort","EORTC QLQ-C30,HADS,FSS,EPInv,BiFS","2000:2004","General,Comorbidity,Symptom"]
[658,"Sullivan, P. W., et al. (2007). \"Quality of life findings from a multicenter, multinational, observational study of patients with metastatic hormone-refractory prostate cancer.\" Qual Life Res 16(4): 571-575.",null,"Sullivan, P. W., et al.","Quality of life findings from a multicenter, multinational, observational study of patients with metastatic hormone-refractory prostate cancer","BACKGROUND: The assessment of health-related quality of life (HRQL) for patients with hormone-refractory prostate cancer (HRPC) is of paramount importance because new treatments have a modest impact on survival but side effects of treatment and disease symptoms can significantly impact HRQL. METHODS: This was an observational, non-interventional, multi-center, multi-national cohort study of patients with metastatic HRPC. Health-related quality of life was assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ C30), the Functional Assessment of Cancer Therapy-Prostate (FACT-P) and the EQ-5D index. Mean changes from baseline to month 3, 6, and 9 were computed and tested using paired t-tests. RESULTS: FACT-P PCS, EQ-5D index and 10 of 14 EORTC domains were statistically significantly lower (P < 0.05) than the baseline scores at the 3, 6 and 9 month visits. The domains that did not reach statistical significance were cognitive functioning, insomnia, diarrhea and financial difficulties. CONCLUSIONS: These data demonstrate that patients with metastatic HRPC experience rapid, significant deterioration in HRQL, highlighting the need for effective palliative therapy for men with HRPC.","Qual Life Res, 16(4): 571-575","USA",2007,"Metastatic","None","EORTC QLQ-C30,FACT-P,EQ-5D","Patient",null,"Cohort","USA","Patient","Metastatic","None",null,"Cohort","EORTC QLQ-C30,FACT-P,EQ-5D","2005:2009","General,Disease,Utility"]
[659,"Sundberg, K., et al. (2015). \"Feasibility of an interactive ICT-platform for early assessment and management of patient-reported symptoms during radiotherapy for prostate cancer.\" Eur J Oncol Nurs 19(5): 523-528.",null,"Sundberg, K., et al.","Feasibility of an interactive ICT-platform for early assessment and management of patient-reported symptoms during radiotherapy for prostate cancer","PURPOSE: The aim of this study was to test the feasibility and acceptability of an Information and Communication Technology platform for assessing and managing patient reported symptoms during radiotherapy for prostate cancer. METHODS: In cooperation with a health management company, using a patient experience co-design, we developed the platform operated by an interactive application for reporting and managing symptoms in real time. Nine patients diagnosed with prostate cancer and receiving radiotherapy were recruited from two university hospitals in Sweden. Evidence-based symptoms and related self-care advice specific to prostate cancer were implemented in the application based on a literature review and interviews with patients and health care professionals. In the test of the platform the patients reported symptoms, via a mobile phone, daily for two weeks and were afterwards interviewed about their experiences. RESULTS: Overall, the patients found the symptom questionnaire and the self-care advice relevant and the application user friendly. The alert system was activated on several occasions when the symptoms were severe leading to a nurse contact and support so the patients felt safe and well cared for. CONCLUSIONS: The platform enabled increased patient involvement and facilitated symptom assessment and communication between the patient and the health care provider. The study's results support further development of the platform, as well as tests in full-scale studies and in other populations.","Eur J Oncol Nurs, 19(5): 523-528","Sweden",2015,"Any or unknown","Radiotherapy","Unclear","Patient",null,"Validation","Sweden","Patient","Any or unknown","Radiotherapy",null,"Validation","Unclear","2015:2018","Symptom"]
[660,"Syndikus, I., et al. (2010). \"Late gastrointestinal toxicity after dose-escalated conformal radiotherapy for early prostate cancer: results from the UK Medical Research Council RT01 trial (ISRCTN47772397).\" Int J Radiat Oncol Biol Phys 77(3): 773-783.",null,"Syndikus, I., et al.","Late gastrointestinal toxicity after dose-escalated conformal radiotherapy for early prostate cancer: results from the UK Medical Research Council RT01 trial (ISRCTN47772397)","PURPOSE: In men with localized prostate cancer, dose-escalated conformal radiotherapy (CFRT) improves efficacy outcomes at the cost of increased toxicity. We present a detailed analysis to provide further information about the incidence and prevalence of late gastrointestinal side effects. METHODS AND MATERIALS: The UK Medical Research Council RT01 trial included 843 men with localized prostate cancer, who were treated for 6 months with neoadjuvant radiotherapy and were randomly assigned to either 64-Gy or 74-Gy CFRT. Toxicity was evaluated before CFRT and during long-term follow-up using Radiation Therapy Oncology Group (RTOG) grading, the Late Effects on Normal Tissue: Subjective, Objective, Management (LENT/SOM) scale, and Royal Marsden Hospital assessment scores. Patients regularly completed Functional Assessment of Cancer Therapy--Prostate (FACT-P) and University of California, Los Angeles, Prostate Cancer Index (UCLA-PCI) questionnaires. RESULTS: In the dose-escalated group, the hazard ratio (HR) for rectal bleeding (LENT/SOM grade >or=2) was 1.55 (95% CI, 1.17-2.04); for diarrhea (LENT/SOM grade >or=2), the HR was 1.79 (95% CI, 1.10-2.94); and for proctitis (RTOG grade >or=2), the HR was 1.64 (95% CI, 1.20-2.25). Compared to baseline scores, the prevalence of moderate and severe toxicities generally increased up to 3 years and than lessened. At 5 years, the cumulative incidence of patient-reported severe bowel problems was 6% vs. 8% (standard vs. escalated, respectively) and severe distress was 4% vs. 5%, respectively. CONCLUSIONS: There is a statistically significant increased risk of various adverse gastrointestinal events with dose-escalated CFRT. This remains at clinically acceptable levels, and overall prevalence ultimately decreases with duration of follow-up.","Int J Radiat Oncol Biol Phys, 77(3): 773-783","UK",2010,"Local","Radiotherapy","FACT-P,UCLA-PCI,RTOG-EORTC-SS,LENT-SOMA,RMS","Patient",null,"Clinical trial","UK","Patient","Local","Radiotherapy",null,"Clinical trial","FACT-P,UCLA-PCI,RTOG-EORTC-SS,LENT-SOMA,RMS","2010:2014","Disease,Treatment"]
[661,"Szymanski, K. M., et al. (2010). \"Development and validation of an abbreviated version of the expanded prostate cancer index composite instrument for measuring health-related quality of life among prostate cancer survivors.\" Urology 76(5): 1245-1250.",null,"Szymanski, K. M., et al.","Development and validation of an abbreviated version of the expanded prostate cancer index composite instrument for measuring health-related quality of life among prostate cancer survivors","OBJECTIVES: Widespread implementation of health-related quality-of-life (HRQOL) measurement in prostate cancer practice and research requires concise instruments. With 50 questions, the full-length Expanded Prostate Cancer Index Composite (EPIC) is cumbersome to administer outside of studies focusing exclusively on HRQOL. To facilitate HRQOL measurement in a broad range of prostate cancer research and practice settings, we developed and validated an abbreviated version of the EPIC. METHODS: The 50 questions that constitute the full-length EPIC-50 were evaluated to identify the items suitable for elimination while retaining the ability to measure the 5 prostate cancer-specific HRQOL domains of the EPIC-50. The resulting abbreviated version (EPIC-26) was validated using question responses from 252 subjects who had undergone brachytherapy, external beam radiotherapy, or prostatectomy for prostate cancer. The EPIC-26 internal consistency was measured by Cronbach's alpha coefficient and reliability using test-retest correlation. RESULTS: Using the high item-scale correlations, clinically relevant content, and preservation of domain psychometrics, 26 items were retained in the EPIC-26 from the 50 questions in the full-length EPIC-50. A high correlation was observed between the EPIC-50 and EPIC-26 versions for the urinary incontinence, urinary irritation/obstruction, bowel, sexual, and vitality/hormonal domain scores (all r >/= 0.96). The correlations between the different domains were low, confirming that EPIC-26 retained the ability to discern the 5 distinct HRQOL domains. The internal consistency and test-retest reliability for EPIC-26 (Cronbach's alpha >/= 0.70 and r >/= 0.69, respectively for all 5 HRQOL domains) supported its validity. CONCLUSIONS: EPIC-26 is a brief, valid, and reliable subjective measure of health quality among patients with prostate cancer and is suitable for measuring the HRQOL among patients undergoing treatment of early-stage prostate cancer.","Urology, 76(5): 1245-1250","Canada",2010,"Survivors","Surgery,Radiotherapy,Brachytherapy","EPIC","Patient",null,"Validation","Canada","Patient","Survivors","Surgery,Radiotherapy,Brachytherapy",null,"Validation","EPIC","2010:2014","Disease"]
[662,"Talcott, J. A., et al. (1997). \"Patient-reported impotence and incontinence after nerve-sparing radical prostatectomy.\" J Natl Cancer Inst 89(15): 1117-1123.",null,"Talcott, J. A., et al.","Patient-reported impotence and incontinence after nerve-sparing radical prostatectomy","BACKGROUND: The age-adjusted rate of radical prostatectomy, the most common treatment of early (nonmetastatic) prostate cancer, increased almost sixfold between 1984 and 1990. This increase was due in part to reported improvements in postoperative sexual potency after the use of newly developed \"nerve-sparing\" procedures. However, published estimates from physicians of impotence following various types of radical prostatectomy may be low, since not all patients may report treatment-related complications accurately and completely to their doctors. In contrast, direct surveys of patients indicate much higher rates of postoperative sexual and urinary dysfunction. One problem with most physician and patient surveys is that they have been performed retrospectively, and pretreatment impotence and incontinence prevalent in older men cannot be assessed accurately in retrospective studies. PURPOSE: This study was initiated in a cohort of men before they underwent radical prostatectomy to assess treatment-related effects on impotence and incontinence. METHODS: The study population consisted of 94 men enrolled in a cohort study of treatment for early prostate cancer. The patients completed questionnaires about sexual and urinary functions before surgery and at 3 and 12 months after surgery and had adequate information to assess the type of surgical technique used (non-nerve-sparing, unilateral nerve-sparing, or bilateral nerve-sparing). Because items assessing sexual function were inadvertently omitted from the questionnaire in the initial months of the study, information on sexual function for all time periods was available for only 49 men. RESULTS: Compared with men who had not been treated with a nerve-sparing procedure, men who underwent nerve-sparing radical prostatectomy, particularly of the bilateral type, were younger and had better prognostic features, indicating less advanced cancers. Before surgery, nine (75%) of 12 men not treated with a nerve-sparing procedure reported erections that were usually inadequate for sexual intercourse compared with six (33%) of 18 men and one (5%) of 19 men who underwent unilateral and bilateral nerve-sparing prostatectomies, respectively. At 12 months after surgery, most men reported inadequate erections, including 15 (79%) of the 19 men who had bilateral nerve-sparing surgery; unilateral nerve preservation provided no apparent benefit. In general, nerve-sparing surgery was associated with more use of absorbent pads at 3 and 12 months following treatment, and this approach was associated with substantial urinary incontinence at 3 months but not at 12 months following surgery. CONCLUSIONS: Nerve-sparing prostatectomy, particularly when performed unilaterally, improves postoperative sexual function to a lesser extent than previously reported. Because men with preoperative impotence and more advanced cancers receive nerve-sparing surgery less often, some of the previously reported benefit of nerve preservation may be the result of patient selection and not of the technique per se.","J Natl Cancer Inst, 89(15): 1117-1123","USA",1997,"Local","Surgery","Unclear","Patient",null,"Cohort","USA","Patient","Local","Surgery",null,"Cohort","Unclear","1960:1999","Complication"]
[663,"Talcott, J. A., et al. (2010). \"Patient-reported long-term outcomes after conventional and high-dose combined proton and photon radiation for early prostate cancer.\" Jama 303(11): 1046-1053.",null,"Talcott, J. A., et al.","Patient-reported long-term outcomes after conventional and high-dose combined proton and photon radiation for early prostate cancer","CONTEXT: Increased radiation doses improve prostate cancer control but also increase toxicity to adjacent normal tissue. Proton radiation may attenuate adverse effects. OBJECTIVE: To determine long-term, patient-reported, dose-related toxicity. DESIGN, SETTING, AND PATIENTS: We performed a post hoc cross-sectional survey of surviving participants in the Proton Radiation Oncology Group (PROG) 9509--a randomized trial comparing 70.2 Gy vs 79.2 Gy of combined photon and proton radiation for 393 men with clinically localized prostate cancer (stage T1b-T2b, prostate-specific antigen <15 ng/mL, and no radiographic evidence of metastasis). The estimated 10-year biochemical progression rate for patients receiving standard dose was 32% (95% confidence interval, 26%-39%) compared with 17% (95% confidence interval, 11%-23%) for patients receiving high dose (P < .001). We surveyed 280 of the surviving 337 patients (83%) from April 2007 to September 2008. MAIN OUTCOME MEASURES: Prostate Cancer Symptom Indices, a validated measure of urinary incontinence, urinary obstruction and irritation, bowel problems, and sexual dysfunction, and related quality-of-life instruments. RESULTS: At a median of 9.4 years after treatment (range, 7.4-12.1 years), participants' demographic and clinical characteristics were similar. Patient-reported outcomes were reported as mean (SD) scale score for standard dose vs high dose: urinary obstruction/irritation (23.3 [13.7] vs 24.6 [14.0]; P = .36), urinary incontinence (10.6 [17.7] vs 9.7 [15.8]; P = .99), bowel problems (7.7 [7.8] vs 7.9 [9.1]; P = .70), sexual dysfunction (68.2 [34.6] vs 65.9 [34.7]; P = .65), and most other outcomes were also similar, although patients receiving standard dose whose cancers had more often progressed expressed less confidence that their cancers were under control (mean [SD] scale score for standard dose, 76.0 [25.4] vs high dose, 86.2 [17.9]; P < .001). Many patients characterized their urinary and bowel function as normal despite reporting symptoms that, for other prostate cancer patients before and early after cancer treatment, caused substantial distress. CONCLUSION: Among men with clinically localized prostate cancer, treatment with higher-dose radiation compared with standard dose was not associated with an increase in patient-reported prostate cancer symptoms after a median of 9.4 years.","Jama, 303(11): 1046-1053","USA",2010,"Local","Radiotherapy","PCSI","Patient",null,"Cross-sectional","USA","Patient","Local","Radiotherapy",null,"Cross-sectional","PCSI","2010:2014","Symptom"]
[664,"Talcott, J. A., et al. (2014). \"Using patient-reported outcomes to assess and improve prostate cancer brachytherapy.\" BJU Int 114(4): 511-516.",null,"Talcott, J. A., et al.","Using patient-reported outcomes to assess and improve prostate cancer brachytherapy","OBJECTIVE: To describe a successful quality improvement process that arose from unexpected differences in control groups' short-term patient-reported outcomes (PROs) within a comparative effectiveness study of a prostate brachytherapy technique intended to reduce urinary morbidity. PATIENTS AND METHODS: Patients planning prostate brachytherapy at one of three institutions were enrolled in a prospective cohort study. Patients were surveyed using a validated instrument to assess treatment-related toxicity before treatment and at pre-specified intervals. Unexpectedly, urinary PROs were worse in one of two standard brachytherapy technique control populations (US-BT1 and US-BT2 ). Therefore, we collaboratively reviewed treatment procedures, identified a discrepancy in technique, made a corrective modification, and evaluated the change. RESULTS: The patient groups were demographically and clinically similar. In the first preliminary analysis, US-BT2 patients reported significantly more short-term post-treatment urinary symptoms than US-BT1 patients. The study's treating physicians reviewed the US-BT1 and US-BT2 treatment protocols and found that they differed in whether they used an indwelling urinary catheter. After adopting the US-BT1 approach, short-term urinary morbidity in US-BT2 patients decreased significantly. Brachytherapy procedures were otherwise unchanged. CONCLUSION: Many procedures in cancer treatments are not evaluated, resulting in practice variation and suboptimal outcomes. Patients, the primary medical consumers, provide little direct input in evaluations of their care. We used PROs, a sensitive and valid measure of treatment-related toxicity, for quality assessment and quality improvement (QA/QI) of prostate brachytherapy. This serendipitous patient-centred QA/QI process may be a useful model for empirically evaluating complex cancer treatment procedures and for screening for substandard care.","BJU Int, 114(4): 511-516","USA",2014,"Any or unknown","Brachytherapy","Unclear","Patient",null,"Cohort","USA","Patient","Any or unknown","Brachytherapy",null,"Cohort","Unclear","2010:2014","Treatment"]
[665,"Tannock, I. F., et al. (1996). \"Chemotherapy with mitoxantrone plus prednisone or prednisone alone for symptomatic hormone-resistant prostate cancer: a Canadian randomized trial with palliative end points.\" J Clin Oncol 14(6): 1756-1764.",null,"Tannock, I. F., et al.","Chemotherapy with mitoxantrone plus prednisone or prednisone alone for symptomatic hormone-resistant prostate cancer: a Canadian randomized trial with palliative end points","PURPOSE: To investigate the benefit of chemotherapy in patients with symptomatic hormone-resistant prostate cancer using relevant end points of palliation in a randomized controlled trial. PATIENTS AND METHODS: We randomized 161 hormone-refractory patients with pain to receive mitoxantrone plus prednisone or prednisone alone (10 mg daily). Nonresponding patients on prednisone could receive mitoxantrone subsequently. The primary end point was a palliative response defined as a 2-point decrease in pain as assessed by a 6-point pain scale completed by patients (or complete loss of pain if initially 1 +) without an increase in analgesic medication and maintained for two consecutive evaluations at least 3 weeks apart. Secondary end points were a decrease of > or = 50% in use of analgesic medication without an increase in pain, duration of response, and survival. Health-related quality of life was evaluated with a series of linear analog self-assessment scales (LASA and the Prostate Cancer-Specific Quality-of-Life Instrument [PROSQOLI]), the core questionnaire of the European Organization for Research and Treatment of Cancer (EORTC), and a disease-specific module. RESULTS: Palliative response was observed in 23 of 80 patients (29%; 95% confidence interval, 19% to 40%) who received mitoxantrone plus prednisone, and in 10 of 81 patients (12%; 95% confidence interval, 6% to 22%) who received prednisone alone (P = .01). An additional seven patients in each group reduced analgesic medication > or = 50% without an increase in pain. The duration of palliation was longer in patients who received chemotherapy (median, 43 and 18 weeks; P < .0001, log-rank). Eleven of 50 patients randomized to prednisone treatment responded after addition of mitoxantrone. There was no difference in overall survival. Treatment was well tolerated, except for five episodes of possible cardiac toxicity in 130 patients who received mitoxantrone. Most responding patients had an improvement in quality-of-life scales and a decrease in serum prostate-specific antigen (PSA) level. CONCLUSION: Chemotherapy with mitoxantrone and prednisone provides palliation for some patients with symptomatic hormone-resistant prostate cancer.","J Clin Oncol, 14(6): 1756-1764","Canada",1996,"Any or unknown","Chemotherapy","PROSQoLI,EORTC QLQ-C30,NPS,LASA","Patient",null,"Clinical trial","Canada","Patient","Any or unknown","Chemotherapy",null,"Clinical trial","PROSQoLI,EORTC QLQ-C30,NPS,LASA","1960:1999","Disease,General,Symptom"]
[666,"Tannock, I. F., et al. (2004). \"Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer.\" N Engl J Med 351(15): 1502-1512.",null,"Tannock, I. F., et al.","Docetaxel plus prednisone or mitoxantrone plus prednisone for advanced prostate cancer","BACKGROUND: Mitoxantrone plus prednisone reduces pain and improves the quality of life in men with advanced, hormone-refractory prostate cancer, but it does not improve survival. We compared such treatment with docetaxel plus prednisone in men with this disease. METHODS: From March 2000 through June 2002, 1006 men with metastatic hormone-refractory prostate cancer received 5 mg of prednisone twice daily and were randomly assigned to receive 12 mg of mitoxantrone per square meter of body-surface area every three weeks, 75 mg of docetaxel per square meter every three weeks, or 30 mg of docetaxel per square meter weekly for five of every six weeks. The primary end point was overall survival. Secondary end points were pain, prostate-specific antigen (PSA) levels, and the quality of life. All statistical comparisons were against mitoxantrone. RESULTS: As compared with the men in the mitoxantrone group, men in the group given docetaxel every three weeks had a hazard ratio for death of 0.76 (95 percent confidence interval, 0.62 to 0.94; P=0.009 by the stratified log-rank test) and those given weekly docetaxel had a hazard ratio for death of 0.91 (95 percent confidence interval, 0.75 to 1.11; P=0.36). The median survival was 16.5 months in the mitoxantrone group, 18.9 months in the group given docetaxel every 3 weeks, and 17.4 months in the group given weekly docetaxel. Among these three groups, 32 percent, 45 percent, and 48 percent of men, respectively, had at least a 50 percent decrease in the serum PSA level (P<0.001 for both comparisons with mitoxantrone); 22 percent, 35 percent (P=0.01), and 31 percent (P=0.08) had predefined reductions in pain; and 13 percent, 22 percent (P=0.009), and 23 percent (P=0.005) had improvements in the quality of life. Adverse events were also more common in the groups that received docetaxel. CONCLUSIONS: When given with prednisone, treatment with docetaxel every three weeks led to superior survival and improved rates of response in terms of pain, serum PSA level, and quality of life, as compared with mitoxantrone plus prednisone.","N Engl J Med, 351(15): 1502-1512","Canada",2004,"Metastatic","Taxane,Chemotherapy","Unclear","Patient",null,"Clinical trial","Canada","Patient","Metastatic","Taxane,Chemotherapy",null,"Clinical trial","Unclear","2000:2004","General,Symptom"]
[667,"Tannock, I., et al. (1989). \"Treatment of metastatic prostatic cancer with low-dose prednisone: evaluation of pain and quality of life as pragmatic indices of response.\" J Clin Oncol 7(5): 590-597.",null,"Tannock, I., et al.","Treatment of metastatic prostatic cancer with low-dose prednisone: evaluation of pain and quality of life as pragmatic indices of response","Thirty-seven men with symptomatic bone metastases from prostate cancer that had progressed following earlier treatment with estrogens and/or orchidectomy were treated with low-dose prednisone (7.5 to 10 mg daily). The rationale for this treatment was that some patients might still have hormone-sensitive disease that was stimulated by weak androgens of adrenal origin, and that these androgens could be suppressed by prednisone through its negative feedback on secretion of adrenocorticotrophic hormone (ACTH). Response to treatment was assessed by requirement for analgesics, by the McGill-Melzack pain questionnaire, and by a series of 17 linear analog self-assessment (LASA) scales relating to pain and to various aspects of quality of life. Fourteen patients (38%) had improvement in indices used to assess pain at 1 month after starting prednisone, and seven patients (19%) maintained this improvement for 3 to 30 months (median, 4 months). Reduction in pain was associated with improvement in other dimensions of quality of life, and in the scale for overall well-being. Prednisone treatment led to a decrease in the concentration of serum testosterone in seven of nine patients where it was not initially suppressed below 2 nmol/L, and caused a decrease in serum levels of androstenedione and dehydroepiandrosterone sulfate in more than 50% of patients. Symptomatic response was associated with a decrease in serum concentration of adrenal androgens. We conclude that (1) low-dose prednisone may cause useful relief of pain in some patients with advanced prostatic cancer; (2) relief of pain was associated with suppression of adrenal androgens; and (3) measures of pain and quality of life can be used to assess possible benefits of systemic therapy in patients with metastatic prostate cancer.","J Clin Oncol, 7(5): 590-597","Canada",1989,"Metastatic","Hormonal","LASA,MPQ","Patient",null,"Cohort","Canada","Patient","Metastatic","Hormonal",null,"Cohort","LASA,MPQ","1960:1999","General,Symptom"]
[668,"Tate, D. G., et al. (1997). \"Quality of life issues among women with physical disabilities or breast cancer.\" Arch Phys Med Rehabil 78(12 Suppl 5): S18-25.",null,"Tate, D. G., et al.","Quality of life issues among women with physical disabilities or breast cancer","OBJECTIVE: The purpose of this study was to assess quality of life (QOL) and life satisfaction among women with physical disabilities or breast cancer, and to identify factors predictive of QOL and life satisfaction for women and men. QOL and life satisfaction differences were examined between women and men with physical disabilities and cancer, and between women with traumatic and chronic physical conditions. DESIGN: A cross-sectional design employing several QOL and life satisfaction measures was used. SAMPLE: Two hundred sixteen outpatient subjects (99 women, 117 men) with physical disabilities or cancer were studied. INSTRUMENTS: The Health Status Questionnaire-Short-Form 36 (SF-36), Functional Assessment of Cancer Therapy (FACT), Functional Living Index-Cancer (FLIC), and the Satisfaction With Life Scale (SWLS). RESULTS: Women with traumatic conditions (amputation, spinal cord injury) reported poorer physical functioning and well-being, whereas women in the chronic (postpolio, breast cancer) group reported poorer health status. No significant gender differences were found with respect to QOL or life satisfaction. Whereas functional and emotional well-being were the strongest predictors of overall QOL for both men and women, self-perceived general health significantly predicted QOL for women (p < .05) and social well-being significantly predicted QOL for men (p < .01). Among men, life satisfaction was best predicted by marital status (p < .05), general health (p < .05), and social well-being (p < .01). The resulting QOL models had adjusted R2 values of .77 and .76 for women and men, respectively. Among women with traumatic conditions, functional well-being best predicted QOL (p < .01). Life satisfaction for women with chronic conditions was best predicted by age, education, and spiritual well-being. CONCLUSION: QOL as measured by the impact of illness on an individual is best predicted by physical and functional well-being. Satisfaction with one's life was best predicted by functional ability. Although functional and physical ability were the best predictors for both QOL and life satisfaction, social functioning made significant and substantive contributions to these constructs. Spinal cord injury had the most impact on physical functioning, whereas prostate cancer had the least. Psychosocial functioning was most affected by amputation and least affected by prostate cancer.","Arch Phys Med Rehabil, 78(12 Suppl 5): S18-25","USA",1997,"Any or unknown","None","SF-36,FACT-G,FLIC,SWLS","Patient",null,"Cross-sectional","USA","Patient","Any or unknown","None",null,"Cross-sectional","SF-36,FACT-G,FLIC,SWLS","1960:1999","General,Treatment,Utility"]
[669,"Taussky, D., et al. (2003). \"Patient-reported toxicity correlated to dose-volume histograms of the rectum in radiotherapy of the prostate.\" Am J Clin Oncol 26(5): e144-149.",null,"Taussky, D., et al.","Patient-reported toxicity correlated to dose-volume histograms of the rectum in radiotherapy of the prostate","We studied 73 patients treated with 3-dimensional conformal radiotherapy for prostate cancer to determine whether there is a correlation between dose per volume to either the whole rectum, rectal wall, rectal surface, or anal canal and the development of late rectal complications measured with prostate-specific quality-of-life (QOL) questionnaires. Given doses were 66.6 to 72 Gy. The prostate cancer modules used were the UCLA-Prostate Cancer Index module (UCLA-PCI) (5 questions), the Functional Assessment of Cancer Therapy-Prostate module (FACT-P) (1 question), and the European Organization for Research and Treatment of Cancer prostate cancer module (EORTC QLQ-PR25) (4 questions). A Spearman correlation analysis between the total toxicity score and the dose-volume histograms (DVHs) was performed. All statistical tests were 2-sided. Sixty-five (89%) patients returned the questionnaire, and 18 (28%) underwent endoscopy for rectal bleeding. We found that only patients who had had an endoscopy showed a correlation between rectal toxicity and dose per volume, as compared with the other patients who showed none. Correlation between rectal toxicity and dose per volume for all 4 structures was stronger for higher doses. For 70 Gy, all contours, except the anal canal, showed a significant dose-volume correlation. Our results indicate that only in cases of pronounced rectal toxicity is there a dose-volume correlation, especially for doses of 70 Gy or more. DVHs of the whole rectum, wall, or surface, but not the anal canal, are all equivalent in predicting late rectal toxicity.","Am J Clin Oncol, 26(5): e144-149","Switzerland",2003,"Any or unknown","Radiotherapy","FACT-P,EORTC QLQ-PR25,UCLA-PCI","Patient",null,"Cross-sectional","Switzerland","Patient","Any or unknown","Radiotherapy",null,"Cross-sectional","FACT-P,EORTC QLQ-PR25,UCLA-PCI","2000:2004","Disease"]
[670,"Tefilli, M. V., et al. (1998). \"Quality of life in patients undergoing salvage procedures for locally recurrent prostate cancer.\" J Surg Oncol 69(3): 156-161.",null,"Tefilli, M. V., et al.","Quality of life in patients undergoing salvage procedures for locally recurrent prostate cancer","BACKGROUND AND OBJECTIVES: As patients are being treated for prostate cancer at a younger age, a significant number of them will ultimately fail the primary treatment and will be candidates for potentially curative salvage therapy. The purpose of this study was to evaluate the impact of salvage therapy for locally recurrent prostate cancer upon the patients' quality of life. METHODS: A cohort of 68 men with locally recurrent prostate cancer undergoing salvage treatment was included in this analysis. Data were collected for the study by mailing the subjects a self-administered questionnaire that included a General Functional Assessment of Cancer Therapy (FACT-G) and a Prostate Cancer Treatment Outcome Questionnaire (FACT-P). Group comparisons were conducted using one-way analysis of variance (ANOVA). RESULTS: Overall, 50% and 88.6% of patients were free of biochemical recurrence in the salvage surgery (SS) and salvage radiotherapy (SRt) group, respectively (P=0.4). The physical well-being (PWB) subscale of FACT-G was significantly higher for the SRt patients (P=0.008). Using the Trial Outcome Index Prostate subscale, the Trial Outcome Index Incontinence Urinary scores, and the Functional Assessment of Incontinence Therapy-Urinary score group comparisons, patients in the SRt group had a higher quality of life than patients in the SS group (P=0.038, P=0.001, and P=0.001, respectively). CONCLUSIONS: In the current study, patients with clinically localized prostate cancer who are at high risk for local disease recurrence may have a trend toward better disease-free survival and a better urinary continence rates if the primary treatment is radical prostatectomy rather than radiation therapy.","J Surg Oncol, 69(3): 156-161","USA",1998,"Recurrent","Surgery,Radiotherapy","FACT-G,FACT-P,TOI,FAIT-U","Patient",null,"Clinical trial","USA","Patient","Recurrent","Surgery,Radiotherapy",null,"Clinical trial","FACT-G,FACT-P,TOI,FAIT-U","1960:1999","Treatment,Disease,Complication"]
[671,"Templeton, H. and V. Coates (2004). \"Evaluation of an evidence-based education package for men with prostate cancer on hormonal manipulation therapy.\" Patient Educ Couns 55(1): 55-61.",null,"Templeton, H. and V. Coates","Evaluation of an evidence-based education package for men with prostate cancer on hormonal manipulation therapy","Prostate cancer has become a public health problem worldwide with considerable social and economic consequences. Many men have extraprostatic spread at diagnosis, and treatment usually involves hormonal manipulation therapy, which can challenge the stereotypical male image. It is often assumed that merely the provision of educational material for patients in an accessible form is sufficient to address informational needs. However, with the increasing emphasis on evidence-based practice, an essential element of the patient education process is evaluation of the impact of educational interventions. In this study, a randomised controlled trial was used to evaluate the effect of an evidence-based education package on the knowledge of disease and treatment, quality of life, coping and satisfaction of a sample (n=55) of men with prostate cancer on hormonal manipulation therapy in the UK. The men were randomly assigned to experimental (n=28) and control group (n=27). Established instruments with satisfactory reliability and validity were used to measure the dependent variables. The independent variable, namely the education package, had been developed following the results of a previous study, which assessed the informational needs of this client group. This package consisted of an information booklet supplemented by the verbal teaching of a urology nurse. Results demonstrated that delivery of the education package had a significant effect on knowledge, quality of life and satisfaction with care, but not on coping. This study has contributed to the evidence-base for practice in urological nursing. This education package should become a routine, and not merely incidental aspect of care for this client group.","Patient Educ Couns, 55(1): 55-61","UK",2004,"Any or unknown","Hormonal,Various","Unclear","Patient",null,"Clinical trial","UK","Patient","Any or unknown","Hormonal,Various",null,"Clinical trial","Unclear","2000:2004","General,Knowledge"]
[672,"Thiel, D. D., et al. (2015). \"Comparison of patient-reported quality of life outcome questionnaire response rates between patients treated surgically for renal cell carcinoma and prostate carcinoma.\" BMC Urol 15: 58.",null,"Thiel, D. D., et al.","Comparison of patient-reported quality of life outcome questionnaire response rates between patients treated surgically for renal cell carcinoma and prostate carcinoma","BACKGROUND: We sought to examine differences in response rates to quality of life (QoL) surveys in patients treated surgically for renal cell carcinoma (RCC) and prostate cancer (PCa) and to analyze factors associated with non-response of the surveys. METHODS: Patients who underwent surgery for RCC or PCa between 2006 and 2012 were offered enrollment in respective prospective cancer registries that included baseline and annual QoL assessments. We identified 201 RCC patients and 616 PCa patients who completed a baseline QoL survey and were mailed annual QoL surveys [RCC: SF-36, FACT-G (73 questions), PCa: EPIC, IIEF, Max-PC (80 questions)]. We compared patient characteristics between responders and non-responders using a Wilcoxon rank-sum test for continuous variables and a Fisher's Exact test for categorical variables. RESULTS: The overall response rates for the PCa and RCC groups were 63 and 48% (p < 0.001), respectively. This difference in response rates remained when we limited analysis to only those with early stage disease (pT2 for PCa and pT1 RCC, 62% vs. 52%; p = 0.03). PCa characteristics associated with response included older age (64.1 vs 62.6 years, p = 0.032) and robotic versus open surgery (56% vs 44%; p = 0.009). There were no characteristics that were associated with response in RCC patients. CONCLUSIONS: Surgically treated PCa patients have higher QoL mail-based survey response rates compared to patients treated surgically for RCC. This difference holds true for clinically localized cancers as well.","BMC Urol, 15(58","USA",2015,"Any or unknown","Surgery","EPIC,IIEF-5,MASPC","Patient",null,"Cohort","USA","Patient","Any or unknown","Surgery",null,"Cohort","EPIC,IIEF-5,MASPC","2015:2018","Disease,Comorbidity,Complication"]
[673,"Thong, M. S., et al. (2010). \"Prostate cancer survivors who would be eligible for active surveillance but were either treated with radiotherapy or managed expectantly: comparisons on long-term quality of life and symptom burden.\" BJU Int 105(5): 652-658.",null,"Thong, M. S., et al.","Prostate cancer survivors who would be eligible for active surveillance but were either treated with radiotherapy or managed expectantly: comparisons on long-term quality of life and symptom burden","OBJECTIVE: To assess and identify factors associated with the long-term health-related quality of life (HRQL) of prostate cancer survivors managed expectantly, as patients with low-risk prostate cancer can be managed with active surveillance (AS), but research on associated long-term HRQL is scarce. PATIENTS AND METHODS: From the population-based Eindhoven Cancer Registry, 71 men managed with AS were matched with 71 survivors who had similar demographic and clinical characteristics but treated with external beam radiotherapy (RT). All were diagnosed between 1994 and 1998. HRQL data were collected 5-10 years after diagnosis. Patients completed generic- (Short Form-36) and cancer-specific (Quality of Life - Cancer Survivors) HRQL instruments, and symptom burden (Expanded Prostate Cancer Index, Sexual Activity) questionnaires. RESULTS: Patients on AS were comparable to those treated with RT for most generic- and disease-specific HRQL dimensions. Patients treated with RT had poorer mean (sd) bowel function scores, of 87.1 (13.1) vs 92.8 (10.7) (P < 0.001), more bother with bowel function, at 85.0 (16.4) vs 93.7 (10.1) (P < 0.001), and more problems with getting an erection (68% vs 47%, P = 0.005). Multivariate regression analyses (corrected for comorbidity and clinical disease progression) indicated that the management strategy independently predicted differences in physical functioning, bodily pain, spiritual and total well-being, and bowel function and bowel bother. CONCLUSIONS: Patients managed expectantly at initial diagnosis (AS) have comparable HRQL and a lower symptom burden than patients treated with RT up to 10 years after the diagnosis.","BJU Int, 105(5): 652-658","Netherlands",2010,"Survivors","Radiotherapy,Surveillance","SF-36,EPIC,SActQ,QOL-CS","Patient",null,"Case-control","Netherlands","Patient","Survivors","Radiotherapy,Surveillance",null,"Case-control","SF-36,EPIC,SActQ,QOL-CS","2010:2014","Disease,Complication,Utility"]
[674,"Thorsteinsdottir, T., et al. (2011). \"LAPPRO: a prospective multicentre comparative study of robot-assisted laparoscopic and retropubic radical prostatectomy for prostate cancer.\" Scand J Urol Nephrol 45(2): 102-112.",null,"Thorsteinsdottir, T., et al.","LAPPRO: a prospective multicentre comparative study of robot-assisted laparoscopic and retropubic radical prostatectomy for prostate cancer","OBJECTIVE: This study describes the study design and procedures for a prospective, non-randomized trial comparing open retropubic and robot-assisted laparoscopic radical prostatectomy regarding functional and oncological outcomes. MATERIAL AND METHODS: The aim was to achieve a detailed prospective registration of symptoms experienced by patients using validated questionnaires in addition to documentation of surgical details, clinical examinations, medical facts and resource use. Four patient questionnaires and six case-report forms were especially designed to collect data before, during and after surgery with a follow-up time of 2 years. The primary endpoint is urinary leakage 1 year after surgery. Secondary endpoints include erectile dysfunction, oncological outcome, quality of life and cost-effectiveness at 3, 12 and 24 months after surgery. RESULTS: The study started in September 2008 with accrual continuing to October 2011. Twelve urological departments in Sweden well established in performing radical prostatectomy are participating. Personal contact with the participating departments and patients was established to ascertain a high response rate. To reach 80% statistical power to detect a difference of 5 absolute per cent in incidence of urinary leakage, 700 men in the retropubic group and 1400 in the robotic group are needed. CONCLUSIONS: The Swedish healthcare context is well suited to performing multicentre long-term prospective clinical trials. The similar care protocols and congruent specialist training are particularly favourable. The LAPPRO trial aims to compare the two surgical techniques in aspects of short- and long-term functional and oncological outcome, cost effectiveness and quality of life, supplying new knowledge to support future decisions in treatment strategies for prostate cancer.","Scand J Urol Nephrol, 45(2): 102-112","Sweden",2011,"Any or unknown","Surgery","Unclear","Patient",null,"Protocol","Sweden","Patient","Any or unknown","Surgery",null,"Protocol","Unclear","2010:2014","General,Complication"]
[675,"Thrasher, J. B., et al. (2000). \"Comparative study of the clinical efficacy of two dosing regimens of flutamide.\" Mol Urol 4(3): 259-263;discussion 265.",null,"Thrasher, J. B., et al.","Comparative study of the clinical efficacy of two dosing regimens of flutamide","PURPOSE: We performed a randomized trial to compare the efficacy and toxicity of a new dose of flutamide (500 mg QD) with the currently recommended dose (250 mg q8h) in the treatment of advanced prostate cancer. The primary endpoints were percent of patients having normalization of prostate specific antigen (PSA), time to normalization, and percent change from baseline. Secondary endpoints were quality of life and toxicity. PATIENTS: Altogether, 440 men aged 46 to 94 years (mean 71 years) with confirmed stage M(1) disease, documented PSA rise >0.2 ng/mL, ECOG status 0 to 2, no second neoplasm, no liver function tests > or = 1.5-fold normal values, and no previous treatment for metastatic disease were entered in the trial. RESULTS: The PSA normalized by week 12 in 71% of the patients receiving 500-mg dose and 75% of those receiving the standard dose. The percent change in PSA was 89% and 96%, respectively. The treatment groups were not significantly different with respect to the incidence of adverse events: 71% v 68% in the 500-mg and 250-mg arms, respectively (P = 0.337). CONCLUSIONS: When combined with castration, 500 mg of flutamide appears to be equally effective in lowering serum PSA and is not significantly more toxic than conventional dosing. The use of 500 mg QD instead of the standard 250 mg q8h would result in a cost savings of 30%.","Mol Urol, 4(3): 259-263;discussion 265","USA",2000,"Advanced","Hormonal","Unclear","Patient",null,"Clinical trial","USA","Patient","Advanced","Hormonal",null,"Clinical trial","Unclear","2000:2004","General,Treatment"]
[676,"Tienforti, D., et al. (2012). \"Efficacy of an assisted low-intensity programme of perioperative pelvic floor muscle training in improving the recovery of continence after radical prostatectomy: a randomized controlled trial.\" BJU Int 110(7): 1004-1010.",null,"Tienforti, D., et al.","Efficacy of an assisted low-intensity programme of perioperative pelvic floor muscle training in improving the recovery of continence after radical prostatectomy: a randomized controlled trial","Study Type - Therapy (RCT) Level of Evidence 1b. What's known on the subject? and What does the study add? Peri-operative pelvic floor muscle training reduces urinary incontinence for men undergoing radical prostatectomy (RP). A preoperative biofeedback session, combined with postoperative pelvic floor muscle training, and assisted sessions on a monthly basis only, is an effective low-intensity programme to improve recovery of continence in patients undergoing RP. OBJECTIVE: To evaluate the efficacy of preoperative biofeedback (BFB) combined with an assisted low-intensity programme of postoperative perineal physiokinesitherapy in reducing the incidence, duration and severity of urinary incontinence (UI) in patients undergoing radical prostatectomy (RP). PATIENTS AND METHODS: A prospective, single-centre, randomized controlled clinical study was designed. * The intervention group received a training session with BFB, supervised oral and written instructions on Kegel exercises and a structured programme of postoperative exercises on the day before open RP. After RP, patients received control visits, including a session of BFB, at monthly intervals only. * The control group received, after catheter removal, only oral and written instructions on Kegel exercises to be performed at home. Patients received control visits at 1, 3 and 6 months after catheter removal. * At each visit the number of incontinence episodes, the number of pads used and patient-reported outcome measures (International Consultation on Incontinence Questionnaire on Urinary Incontinence [ICIQ-UI], [ICIQ]-Overactive Bladder [OAB], University of California, Los Angeles-Prostate Cancer Index [UCLA-PCI], International Prostate Symptom Score-Quality of Life [IPSS-QoL]) were assessed in both groups. All patients were followed-up for a period of at least 6 months after catheter removal. * The primary outcome was the recovery of continence, strictly defined as a ICIQ-UI score of zero. RESULTS: Overall, 34 consecutive patients were eligible and 32 were available for the final analysis: 16 patients for each study group. The two groups were homogeneous for all pre- and intraoperative features examined. * In the intervention group, continence had been achieved by six, eight and 10 patients at 1-, 3- and 6-month follow-ups, respectively, vs no patients (P= 0.02), one patient (P= 0.01) and one patient (P= 0.002) in the control group at each follow-up, respectively. * The analysis of the UCLA-PCI and ICIQ-OAB scores, the number of incontinence episodes per week and the number of pads per week showed significant differences in favour of patients in the intervention group at 3 and 6 months. * Patients in the intervention group reported better IPSS-QoL scores at all follow-up times but the difference did not reach statistical significance. CONCLUSIONS: Preoperative BFB combined with a postoperative programme of perineal physiokinesitherapy and assisted sessions on a monthly basis only, is a treatment strategy significantly more effective than the standard care in improving recovery of continence in patients undergoing RP. * The impact on QoL appeared less evident, although a trend for a better QoL was observed in the intervention group.","BJU Int, 110(7): 1004-1010","Italy",2012,"Any or unknown","Surgery,Various","IPSS, ICIQ,UCLA-PCI","Patient",null,"Clinical trial","Italy","Patient","Any or unknown","Surgery,Various",null,"Clinical trial","IPSS,UCLA-PCI","2010:2014","Disease,Complication"]
[677,"Torvinen, S., et al. (2016). \"USE OF PATIENT ASSESSED HEALTH-RELATED QUALITY OF LIFE INSTRUMENTS IN PROSTATE CANCER RESEARCH: A SYSTEMATIC REVIEW OF THE LITERATURE 2002-15.\" Int J Technol Assess Health Care 32(3): 97-106.",null,"Torvinen, S., et al.","USE OF PATIENT ASSESSED HEALTH-RELATED QUALITY OF LIFE INSTRUMENTS IN PROSTATE CANCER RESEARCH: A SYSTEMATIC REVIEW OF THE LITERATURE 2002-15","OBJECTIVES: The objectives of this study were to identify and qualitatively describe, in a systematic literature review, published studies that collected prostate cancer patients' health-related quality of life (HRQoL) estimates by using validated, generic instruments. METHODS: Systematic searches of the literature were made using the Medline, Cochrane Library, PsycINFO, and CINAHL electronic databases from 2002 to 2015. RESULTS: The search identified 2,171 references, of which 237 were obtained for full-text assessment; thirty-three of these articles were deemed relevant and included in the systematic review. An indirect valuation method was used in 73 percent (n = 24) of the studies. The most commonly used HRQoL instrument with an indirect valuation method was the EuroQol (EQ-5D; n = 21), and the second most common was the 15D (n = 5). A direct valuation method was used in 48 percent (n = 16) of the studies. Of these, the Visual Analogue Scale (VAS) was the most often used (n = 10), followed by the Time-Trade-Off (n = 6). HRQoL scores varied in localized and early stage disease between 0.63 and 0.91, and in advanced or metastatic disease stage between 0.50 and 0.87. There was also variance in the HRQoL instruments and study methods used, which explains the large variance in HRQoL scores between the various disease stages. CONCLUSIONS: Although utility and quality-adjusted life-years gained are considered important measures of effectiveness in health care, the number of studies in which utilities of prostate cancer patients have been estimated using generic HRQoL instruments, based on either direct or indirect measurement of HRQoL, is fairly small.","Int J Technol Assess Health Care, 32(3): 97-106","International",2016,"Any or unknown","None","EQ-5D,VAS,TTO,15D","Patient",null,"Systematic review","International","Patient","Any or unknown","None",null,"Systematic review","EQ-5D,VAS,TTO,15D","2015:2018","Utility"]
[678,"Touijer, K., et al. (2008). \"Comprehensive prospective comparative analysis of outcomes between open and laparoscopic radical prostatectomy conducted in 2003 to 2005.\" J Urol 179(5): 1811-1817; discussion 1817.",null,"Touijer, K., et al.","Comprehensive prospective comparative analysis of outcomes between open and laparoscopic radical prostatectomy conducted in 2003 to 2005","PURPOSE: In a nonrandomized prospective fashion we compared the oncological, functional and morbidity outcomes after laparoscopic and retropubic radical prostatectomy. MATERIALS AND METHODS: Between January 2003 and December 2005 a total of 1,430 consecutive men with clinically localized prostate cancer underwent radical prostatectomy, laparoscopic in 612 and retropubic in 818. The surgical approach was selected by the patient. Preoperative staging, respective surgical techniques, pathological examination and followup were uniform. Functional outcome was measured by patient completed health related quality of life questionnaire. RESULTS: Positive surgical margin rates (11%) and freedom from progression (median followup 18 months) were comparable between laparoscopic and retropubic radical prostatectomy (HR 0.99 for laparoscopic vs retropubic radical prostatectomy, p = 0.9). We found no significant association between operation type and time to postoperative potency (HR 1.04 for laparoscopic vs retropubic radical prostatectomy; 95% CI 0.74, 1.46; p = 0.8). Patients who underwent laparoscopic radical prostatectomy were less likely to become continent than those treated with retropubic radical prostatectomy (HR 0.56 for laparoscopic vs retropubic radical prostatectomy; 95% CI 0.44, 0.70; p <0.0005). Laparoscopic radical prostatectomy was associated with less blood loss (mean ml +/- SD 315 +/- 186 vs 1,267 +/- 660) and lower overall transfusion rate (3% vs 49%). No significant difference was noted in cardiovascular, thromboembolic and urinary complications. Emergency room visits and readmissions were higher after laparoscopic radical prostatectomy (15% vs 11% and 4.6% vs 1.2%, respectively). CONCLUSIONS: At our institution and during the study period laparoscopic radical prostatectomy and retropubic radical prostatectomy provided comparable oncological efficacy. Laparoscopic radical prostatectomy was associated with less blood loss and a lower transfusion rate, and higher postoperative hospital visits and readmission rate. While the recovery of potency was equivalent, that of continence was superior after retropubic radical prostatectomy.","J Urol, 179(5): 1811-1817; discussion 1817","USA",2008,"Local","Surgery","Unclear","Patient",null,"Clinical trial","USA","Patient","Local","Surgery",null,"Clinical trial","Unclear","2005:2009","General"]
[679,"Turini, M., et al. (2003). \"Quality of life and economic considerations in the management of prostate cancer.\" Pharmacoeconomics 21(8): 527-541.",null,"Turini, M., et al.","Quality of life and economic considerations in the management of prostate cancer","The purpose of this article was to provide an overview of the morbidity and mortality of prostate cancer, QOL issues and the economic impact of the disease. We searched Medline (from 1990 onwards) for all studies dealing with prostate cancer epidemiology, treatment, screening and staging, and critically reviewed the most relevant articles, focusing on pharmacoeconomic issues. Prostate cancer is the most common cancer in men. In the US, new estimated cases of prostate cancer represented 14.8% of all new cancer cases for 2000, with estimated deaths from prostate cancer comprising 5.8% of all deaths from cancer. Current options for prostate cancer management include radical prostatectomy, cryosurgery, radiotherapy, hormone therapy and watchful waiting. Many of the long-term effects of treatment, such as urinary incontinence, impotence and radiation-induced proctitis, have a large impact on patients' quality of life and, in some patients, may offset the clinical benefits. Regulatory bodies and managed care organisations are assigning increasing importance to the evaluation of QOL benefits as an independent clinical endpoint and a measure of patient satisfaction. Several screening programmes for early detection of prostate cancer, mostly based on prostate-specific antigen (PSA) measurement or digital rectal examination, have been proposed, but their routine implementation in all asymptomatic elderly men has been questioned. There is still no definite proof that patient outcomes are improved by extensive PSA screening. Furthermore, the total cost of a screening programme is difficult to define since it extends well beyond the initial test. Several instruments are used for QOL assessment in prostate cancer, some of which have been specifically developed for, or adapted to, patients with this disease, such as the Functional Assessment Cancer Therapy (FACT) tool, Prostate Cancer Treatment Outcome Questionnaire (PCTO-Q) and Prostate Cancer Specific Quality of Life Instrument (PROSQOLI). More than 50% of treatment costs for prostate cancer are accrued during the patient's last year of life, and total initial care costs decrease with increasing age. In the US, initial average inpatient costs were estimated at $US 2253, in 1995, for men aged > or =80 years, compared with $US 4540 for men aged 35-64 years. In recent years, treatments based on combined modalities (i.e. radiotherapy/prostatectomy plus hormonal therapies) have emerged. Although cost-effectiveness analyses of various treatment options have been attempted, the strength of their conclusions appears to be limited by the lack of homogeneous literature data on the effects of such interventions on survival and morbidity.","Pharmacoeconomics, 21(8): 527-541","International",2003,"Any or unknown","Surgery,Radiotherapy,Hormonal,Surveillance","FACT-G,PCTO-Q,PROSQoLI","Patient",null,"Systematic review","International","Patient","Any or unknown","Surgery,Radiotherapy,Hormonal,Surveillance",null,"Systematic review","FACT-G,PCTO-Q,PROSQoLI","2000:2004","General,Disease,Treatment"]
[680,"Turner, S. L., et al. (2001). \"Less pain does equal better quality of life following strontium-89 therapy for metastatic prostate cancer.\" Br J Cancer 84(3): 297-302.",null,"Turner, S. L., et al.","Less pain does equal better quality of life following strontium-89 therapy for metastatic prostate cancer","93 patients with hormone refractory metastatic prostate cancer were entered on a prospective study to measure reduction in pain and changes in quality of life (QoL) after the administration of 150 MegaBequerel (MBq) Strontium-89 (Sr-89). QoL was assessed using a validated instrument, the Functional Living Index - Cancer (FLIC) questionnaire. Pain response was measured using the Radiation Therapy Oncology Group scoring system. Overall there was limited QoL improvement over 3 months following Sr-89. However, in the 53 patients (63%) achieving pain responses, QoL did significantly improve within 6 weeks of receiving Sr-89 compared to patients with stable or worsening bone pain, and this was independent of other parameters that might influence QoL outcomes, such as performance status, baseline PSA and extent of skeletal disease (P = 0.004). PSA 'response' occurred in 30 patients (37%) over 4 months after Sr-89. This did not appear to correlate with clinical improvement. This study supports the presumption that improvement in pain following Sr-89 is accompanied by better QoL. The lack of correlation of PSA response and clinical parameters indicates that in the palliative setting, PSA may not provide a useful surrogate for treatment outcome.","Br J Cancer, 84(3): 297-302","Australia",2001,"Metastatic","Brachytherapy","FLIC,RTOG-EORTC-SS","Patient",null,"Cohort","Australia","Patient","Metastatic","Brachytherapy",null,"Cohort","FLIC,RTOG-EORTC-SS","2000:2004","General,Treatment"]
[681,"Tyrrell, C. J. (1994). \"Tolerability and quality of life aspects with the anti-androgen Casodex (ICI 176,334) as monotherapy for prostate cancer. International Casodex Investigators.\" Eur Urol 26 Suppl 1: 15-19.",null,"Tyrrell, C. J.","Tolerability and quality of life aspects with the anti-androgen Casodex (ICI 176,334) as monotherapy for prostate cancer. International Casodex Investigators","Over 3,000 men, the majority of whom were patients with prostate cancer, were treated with Casodex (ICI 176,334), an oral anti-androgen, at doses ranging from 10 to 200 mg daily, corresponding to a total exposure to the drug of over 1,500 patient-years. Over this period, the tolerability of Casodex and its effect on quality of life were closely studied. Information on tolerability is presented from three large randomized trials of Casodex, 50 mg/day, in patients with prostate cancer, two large randomized trials of Casodex, 150 mg/day, in patients with prostate cancer and three double-blind, placebo-controlled trials of Casodex, 50 mg/day, in patients with benign prostatic hyperplasia (BPH). Information on quality of life and assessment of sexual functioning is presented from the trials using Casodex, 50 mg/day, for both prostate cancer and BPH. The most commonly reported adverse events were those that would be expected with an anti-androgen (i.e. breast tenderness, gynaecomastia and hot flushes). Overall, Casodex was well tolerated; there were no reports of light/dark adaptation problems or pulmonary fibrosis, and only one case of alcohol intolerance, which was not considered by the investigator to be treatment related. Only 0.3% of patients in the whole trial programme had to be withdrawn because of changes in liver function, and there were no clinically significant changes in mean liver function tests. Although there were no consistent differences between treatments for other aspects of quality of life, there was evidence of benefit from treatment with Casodex in maintaining both sexual interest and functioning.","Eur Urol, 26 Suppl 1(15-19","UK",1994,"Any or unknown","Hormonal","Unclear","Patient",null,"Narrative review","UK","Patient","Any or unknown","Hormonal",null,"Narrative review","Unclear","1960:1999","General,Treatment"]
[682,"Tyrrell, C. J., et al. (1998). \"A randomised comparison of 'Casodex' (bicalutamide) 150 mg monotherapy versus castration in the treatment of metastatic and locally advanced prostate cancer.\" Eur Urol 33(5): 447-456.",null,"Tyrrell, C. J., et al.","A randomised comparison of 'Casodex' (bicalutamide) 150 mg monotherapy versus castration in the treatment of metastatic and locally advanced prostate cancer","OBJECTIVES: To evaluate the efficacy and tolerability of 'Casodex' monotherapy (150 mg daily) for metastatic and locally advanced prostate cancer. METHODS: A total of 1,453 patients with either confirmed metastatic disease (M1), or T3/T4 non-metastatic disease with elevated prostate-specific antigen (M0) were recruited into one of two identical, multicentre, randomised studies to compare 'Casodex' 150 mg/day with castration. The protocols allowed for combined analysis. RESULTS: At a median follow-up period of approximately 100 weeks for both studies, 'Casodex' 150 mg was found to be less effective than castration in patients with metastatic disease (M1) at entry (hazard ratio of 1.30 for time to death) with a difference in median survival of 6 weeks. In symptomatic M1 patients, 'Casodex' was associated with a statistically significant improvement in subjective response (70%) compared with castration (58%). Analysis of a validated quality-of-life questionnaire proved an advantage for 'Casodex' in sexual interest and physical capacity. 'Casodex' had a substantially lower incidence of hot flushes compared to castration (6-13% compared with 39-44%) and the most commonly reported adverse events were those expected for a potent antiandrogen. However, in patients with M0 disease at entry, the data are still immature with only 13% of M0 patients having died. An initial analysis of this immature data has suggested that the results in these patients may be different to those obtained in patients with M1 disease. A further survival analysis in patients with M0 disease is therefore planned when the data are more mature. CONCLUSIONS: 'Casodex' 150 mg is less effective than castration in patients with M1 disease. However, 'Casodex' has shown a benefit in terms of quality of life and subjective response when compared to castration and has an acceptable tolerability profile. Thus 'Casodex' 150 mg monotherapy is an option for patients with M1 prostate cancer for whom surgical or medical castration is not indicated or is not acceptable.","Eur Urol, 33(5): 447-456","UK",1998,"Advanced,Metastatic","Hormonal,Surgery","Unclear","Patient",null,"Clinical trial","UK","Patient","Advanced,Metastatic","Hormonal,Surgery",null,"Clinical trial","Unclear","1960:1999","General,Complication"]
[683,"Uchida, T., et al. (2005). \"Transrectal high-intensity focused ultrasound in the treatment of localized prostate cancer: a multicenter study.\" Hinyokika Kiyo 51(10): 651-658.",null,"Uchida, T., et al.","Transrectal high-intensity focused ultrasound in the treatment of localized prostate cancer: a multicenter study","We report a multicenter trial with transrectal high-intensity focused ultrasound (HIFU) in the treatment of localized prostate cancer. A total of 72 consecutive patients with stage T1c-2NOM0 prostate cancer were treated using the Sonablate 500TM HIFU device (Focus Surgery, Indianapolis, USA). Biochemical recurrence was defined according to the criteria recommended by the American Society for Therapeutic Radiology and Oncology Consensus Panel. The median age and prostate specific antigen (PSA) level were 72 years and 8.10 ng/ml, respectively. The median follow-up period for all patients was 14.0 months. Biochemical disease-free survival rates in all patients at 1 and 2 years were 78% and 76%, respectively. Biochemical disease-free survival rates in patients with stage T1c, T2a and T2b groups at 2 years were 89, 67% and 40% (p = 0.0817). Biochemical disease-free survival rates in patients with Gleason scores of 2-4, 5-7 and 8-10 at 2 years were 88, 72% and 80% (p = 0.6539). Biochemical disease-free survival rates in patients with serum PSA of less than 10 ng/ml and 10-20 ng/ml were 75% and 78% (p = 0.6152). No viable tumor cells were noted in 68% of patients by postoperative prostate needle biopsy. Prostatic volume was decreased from 24.2 ml to 14.0 ml at 6 months after HIFU (p < 0.01). No statistically significant differences were noted in International Prostate Symptom Score, maximum urinary flow rate and quality of life analysis with Functional Assessment of Cancer Therapy. HIFU therapy appears to be minimally invasive, efficacious and safe for patients with localized prostate cancer with pretreatment PSA levels less than 20 ng/ml.","Hinyokika Kiyo, 51(10): 651-658","Japan",2005,"Local","HIFU","FACT-G,IPSS","Patient",null,"Clinical trial","Japan","Patient","Local","HIFU",null,"Clinical trial","FACT-G,IPSS","2005:2009","Treatment,Disease"]
[684,"Vainshtein, J., et al. (2012). \"Randomized phase II trial of urethral sparing intensity modulated radiation therapy in low-risk prostate cancer: implications for focal therapy.\" Radiat Oncol 7: 82.",null,"Vainshtein, J., et al.","Randomized phase II trial of urethral sparing intensity modulated radiation therapy in low-risk prostate cancer: implications for focal therapy","BACKGROUND: Low-risk prostate cancer (PCa) patients have excellent outcomes, with treatment modality often selected by perceived effects on quality of life. Acute urinary symptoms are common during external beam radiotherapy (EBRT), while chronic symptoms have been linked to urethral dose. Since most low-risk PCa occurs in the peripheral zone (PZ), we hypothesized that EBRT using urethral sparing intensity modulated radiation therapy (US-IMRT) could improve urinary health-related quality of life (HRQOL) while maintaining high rates of PCa control. METHODS: Patients with National Comprehensive Cancer Network (NCCN) defined low-risk PCa with no visible lesion within 5 mm of the prostatic urethra on MRI were randomized to US-IMRT or standard (S-) IMRT. Prescription dose was 75.6 Gy in 41 fractions to the PZ + 3-5 mm for US-IMRT and to the prostate + 3 mm for S-IMRT. For US-IMRT, mean proximal and distal urethral doses were limited to 65 Gy and 74 Gy, respectively. HRQOL was assessed using the Expanded Prostate Cancer Index (EPIC) Quality of Life questionnaire. The primary endpoint was change in urinary HRQOL at 3 months. RESULTS: From June 2004 to November 2006, 16 patients were randomized, after which a futility analysis concluded that continued accrual was unlikely to demonstrate a difference in the primary endpoint. Mean change in EPIC urinary HRQOL at 3 months was -0.5 +/- 11.2 in the US-IMRT arm and +3.9 +/- 15.3 in the S-IMRT arm (p = 0.52). Median PSA nadir was higher in the US-IMRT arm (1.46 vs. 0.78, p = 0.05). At 4.7 years median follow-up, three US-IMRT and no S-IMRT patients experienced PSA failure (p = 0.06; HR 8.8, 95% CI 0.9-86). Two out of 3 patients with PSA failure had biopsy-proven local failure, both located contralateral to the original site of disease. CONCLUSIONS: Compared with S-IMRT, US-IMRT failed to improve urinary HRQOL and resulted in higher PSA nadir and inferior biochemical control. The high rate of PSA failure and contralateral local failures in US-IMRT patients, despite careful selection of MRI-screened low-risk patients, serve as a cautionary tale for focal PCa treatments.","Radiat Oncol, 7(82","USA",2012,"Local","Radiotherapy","EPIC","Patient",null,"Clinical trial","USA","Patient","Local","Radiotherapy",null,"Clinical trial","EPIC","2010:2014","Disease"]
[685,"Valdimarsdottir, U., et al. (2002). \"The unrecognised cost of cancer patients' unrelieved symptoms:a nationwide follow-up of their surviving partners.\" Br J Cancer 86(10): 1540-1545.",null,"Valdimarsdottir, U., et al.","The unrecognised cost of cancer patients' unrelieved symptoms:a nationwide follow-up of their surviving partners","We investigated if a cancer patient's unrelieved symptoms during the last 3 months of life increase the risk of long-term psychological morbidity of the surviving partner. All women (n=506) living in Sweden under 80 years of age, who lost their husband/partner owing to cancer of the prostate in 1996 or of the urinary bladder in 1995 or 1996 were asked to answer an anonymous postal questionnaire, 2-4 years after their loss. The widows' psychological morbidity was associated with the patient's unrelieved mental symptoms. When the patient was perceived to have been very anxious during last three months of life (compared to no observed symptoms) the relative risks for the widows' psychological morbidity were: 2.5 (1.4-4.3) for depression and 3.4 (1.4-8.2) for anxiety. When comparing reports of the patient's pain (much vs no), the relative risks were 0.8 (0.5-1.2) for widowhood depression, and 0.8 (0.4-1.7) for widowhood anxiety. The patients were found to have had adequate access to physical pain control but poor access to psychological symptom control. Efficiency in diagnosing and treating psychological complications of terminally ill cancer patients may not only improve their quality of life but possibly also prevent long-term psychological morbidity of their surviving partners.","Br J Cancer, 86(10): 1540-1545","Sweden",2002,"End of life","None","Unclear","Caregiver",null,"Cross-sectional","Sweden","Caregiver","End of life","None",null,"Cross-sectional","Unclear","2000:2004","Comorbidity"]
[686,"van Andel, G. and K. H. Kurth (2003). \"The impact of androgen deprivation therapy on health related quality of life in asymptomatic men with lymph node positive prostate cancer.\" Eur Urol 44(2): 209-214.",null,"van Andel, G. and K. H. Kurth","The impact of androgen deprivation therapy on health related quality of life in asymptomatic men with lymph node positive prostate cancer","PURPOSE: To evaluate the impact of androgen deprivation on health related quality of life (HRQOL) in patients with asymptomatic lymph node positive prostatic carcinoma (LPPC). MATERIALS AND METHODS: HRQOL domains were measured, using standard instruments in 91 patients with histologically proven LPPC. Most patients were randomized for immediate or deferred hormonal treatment until progression was observed. For analyses concerning the time to progression and survival the Kaplan-Meier method was used. RESULTS: Patients treated with androgen deprivation showed a significantly worse sexual, emotional, and physical function, experienced more hot flushes and a worse overall HRQOL, compared with patients receiving no therapy. Time to progression was significantly shorter in the deferred treated patients in comparison with the immediately treated patients (33 vs. 62 months, p<0.001). No significant differences were found with respect to the duration of survival. CONCLUSION: Hormonally treated patients with asymptomatic LPPC have a worse HRQOL compared with patients receiving no therapy. The duration of survival was similar, whether patients received immediate or deferred hormonal treatment. Nowadays, with patients' preferences playing an increasingly important role in therapeutic decision making, physicians should be aware of this negative impact and ought to inform the patients on this.","Eur Urol, 44(2): 209-214","Netherlands",2003,"Advanced","Hormonal","Unclear","Patient",null,"Clinical trial","Netherlands","Patient","Advanced","Hormonal",null,"Clinical trial","Unclear","2000:2004","General,Complication"]
[687,"van Andel, G., et al. (1997). \"Quality of life in patients with prostatic carcinoma: a review and results of a study in N+ disease. Prostate-specific antigen as predictor of quality of life.\" Urol Res 25 Suppl 2: S79-88.",null,"van Andel, G., et al.","Quality of life in patients with prostatic carcinoma: a review and results of a study in N+ disease. Prostate-specific antigen as predictor of quality of life","Clinical evaluation in oncology has typically focused on outcome indicators, while less attention has been paid to how treatment affects quality of life (QOL) of the patient. In this article some general aspects of quality of life are discussed, a short review of published data on QOL in patients with prostate cancer is given and results of a QOL study executed by the authors on patients with lymph node positive prostatic cancer are presented. The purpose of the study was to examine the impact of immediate or delayed treatment (after objective progression) in patients with prostatic carcinoma (T1-3 N1-3 M0) on quality of life parameters. To this end an extended questionnaire was constructed. Fifty-five patients participated. Assessment was performed twice, in 1994 and 1995. The comparison between patients with and patients without treatment showed in 1994 as well as in 1995 significant differences for hormonal treatment side effects such as sexual functioning and hot flushes, all of which were experienced more frequently by treated patients. In 1994 the treated patients experienced more psychological distress while in 1995 they showed worse physical function, less energy and more fatigue when compared to patients under surveillance. The premise that active treatment would improve the psychological quality of life was not sustained. In addition global health status and quality of life were identified as independent factors for progression in untreated patients with lymph node positive prostate cancer. Finally, an increase in prostate-specific antigen (PSA) in hormonally treated patients not only indicated hormonal escape but also a decrease in QOL.","Urol Res, 25 Suppl 2(S79-88","Netherlands",1997,"Advanced","None","Unclear","Patient",null,"Cross-sectional","Netherlands","Patient","Advanced","None",null,"Cross-sectional","Unclear","1960:1999","Complication"]
[688,"van Andel, G., et al. (2000). \"Quality of life assessment in patients with hormone-resistant prostate cancer treated with epirubicin or with epirubicin plus medroxy progesterone acetate - is it feasible?\" Eur Urol 38(3): 259-264.",null,"van Andel, G., et al.","Quality of life assessment in patients with hormone-resistant prostate cancer treated with epirubicin or with epirubicin plus medroxy progesterone acetate - is it feasible?","OBJECTIVES: The optimal palliative treatment in patients with advanced hormone-resistant prostate cancer (AHRPC) is still under investigation. We studied the effect of epirubicin, alone or combined with medroxy progesterone acetate (MPA), in this particular patient group. The aim of the study was to investigate the feasibility of quality of life (QOL) measurement and to ascertain whether MPA added to epirubicin produces a better QOL than epirubicin alone. METHODS: Of 28 randomized patients with symptomatic AHRPC, 26 were eligible for the study. Fourteen of them received epirubicin (100 mg/m(2) i.v.) every 3 weeks in combination with an oral dose of 500 mg of MPA twice daily. Twelve patients received epirubicin alone. For the QOL assessment, the Rotterdam Symptom Checkliste was used. Toxic side effects of chemotherapy were assed by the WHO criteria. Subjective responses included performance status and pain score. RESULTS: Compliance in completing QOL questionnaires was high (87.5%). In none of the QOL domains studied did any of the patients, irrespective of their treatment, experience an improvement in their QOL. Moreover, after 12 and 24 weeks, patients in both treatment arms experienced a significant worsening of physical symptom distress when compared to study entry. Toxicity was moderate to severe. A biochemical response (drop in prostate-specific antigen of more than 50%) was observed in 5 out of 26 patients (19.1%) and a subjective response in 7 out of 26 patients (26.9%). The median survival for all patients was 30 weeks. There was no statistically significant difference between the two arms. Performance status and the global QOL as judged by the patients themselves were associated with the duration of survival. No relation was found between the initial observed subjective response and survival. CONCLUSIONS: The feasibility of measuring QOL in patients with symptomatic AHRPC is demonstrated in the present study. Subjective and biochemical responses were observed in both treatment arms, but these were not translatable as improved measured QOL domains.","Eur Urol, 38(3): 259-264","Netherlands",2000,"Advanced","Chemotherapy,Palliative care","RSCL","Patient",null,"Clinical trial","Netherlands","Patient","Advanced","Chemotherapy,Palliative care",null,"Clinical trial","RSCL","2000:2004","Symptom"]
[689,"van Andel, G., et al. (2003). \"A randomized study comparing epirubicin in a 4-weekly versus a weekly intravenous regimen in patients with metastatic, hormone resistant, prostatic carcinoma: effects on health related quality of life.\" World J Urol 21(3): 177-182.",null,"van Andel, G., et al.","A randomized study comparing epirubicin in a 4-weekly versus a weekly intravenous regimen in patients with metastatic, hormone resistant, prostatic carcinoma: effects on health related quality of life","The treatment of hormone resistant prostate cancer) with epirubicin 25 mg/m(2)(Epi25) on a weekly intravenous regimen may be better in terms of health related quality of life (HRQOL) than with 100 mg/m(2)(Epi100) on a 4-weekly regimen. A total of 79 patients who filled out the EORTC-QLQ-C30 questionnaire for the assessment of HRQOL could be evaluated. Compared with the baseline, no changes in HRQOL function scales or significant changes in the following HRQOL symptom scales were found. The Epi25 group reported less pain during the first 3 months and the Epi100 group more dyspnoea after 4 weeks and less pain and less insomnia but more loss of appetite after 8 weeks. In both groups, toxicity was comparable, except for World Health Organisation grade II-III alopecia occurring in 82% in the Epi100 versus 31% in the Epi25 group. There were no significant differences between groups in response rates and survival. In this study, HRQOL was not improved which is in line with other studies using only epirubicine. Epirubicin as single agent therapy should not be used in future treatment of patients with HRPC.","World J Urol, 21(3): 177-182","Netherlands",2003,"Metastatic","Chemotherapy","EORTC QLQ-C30","Patient",null,"Clinical trial","Netherlands","Patient","Metastatic","Chemotherapy",null,"Clinical trial","EORTC QLQ-C30","2000:2004","General"]
[690,"Van Andel, G., et al. (2003). \"Health-related quality of life and psychosocial factors in patients with prostate cancer scheduled for radical prostatectomy or external radiation therapy.\" BJU Int 92(3): 217-222.",null,"Van Andel, G., et al.","Health-related quality of life and psychosocial factors in patients with prostate cancer scheduled for radical prostatectomy or external radiation therapy","OBJECTIVE: To assess whether baseline health-related quality of life (HRQOL) and psychosocial profiles differ in patients with prostate cancer scheduled for radical prostatectomy (RP) or external radiation therapy (ERT), as there is evidence that HRQOL is influenced by psychosocial factors (PFs), so that any variation at baseline should be considered when comparing the effect of therapy on HRQOL. PATIENTS AND METHODS: Before receiving therapy, HRQOL and PFs were assessed in 65 patients scheduled for RP and in 73 scheduled for ERT. To measure HRQOL (generic and disease-specific) and PFs, an extended questionnaire was constructed, using validated and standardized instruments. Clinical data were collected from patients' medical records. Comparisons adjusted for age and socio-economic status (SES) were analysed using Student's t-test and univariate analyses of variance and covariance. RESULTS: Patients scheduled for ERT were 7.9 years older and had a lower SES (both P < 0.001), more often had stage T3 and T4 disease, had poorer histopathological differentiation and higher levels of prostate-specific antigen (all P < 0.01). They also reported a worse physical, role, cognitive and social function, more fatigue, more pain, a lower overall HRQOL and worse sexual function than patients scheduled for RP. There were no differences in urinary and bowel function, nor in the PFs assessed. CONCLUSION: The baseline HRQOL profile of patients scheduled for RP is better than in those scheduled for ERT. These results are in line with those from the few other studies on this subject. Knowing the impact of RP and ERT on HRQOL should therefore be based mainly on longitudinal studies including baseline measures, the analyses of which should be adjusted for age and SES. In the present small study, baseline PFs did not differ between the treatments.","BJU Int, 92(3): 217-222","Netherlands",2003,"Any or unknown","Surgery,Radiotherapy","Unclear","Patient",null,"Cross-sectional","Netherlands","Patient","Any or unknown","Surgery,Radiotherapy",null,"Cross-sectional","Unclear","2000:2004","General,Disease"]
[691,"van Andel, G., et al. (2004). \"A prospective longitudinal study comparing the impact of external radiation therapy with radical prostatectomy on health related quality of life (HRQOL) in prostate cancer patients.\" Prostate 58(4): 354-365.",null,"van Andel, G., et al.","A prospective longitudinal study comparing the impact of external radiation therapy with radical prostatectomy on health related quality of life (HRQOL) in prostate cancer patients","BACKGROUND: The objective of the present study is to compare the impact on the general and disease-specific health related quality of life (HRQOL) of external radiation therapy (ERT) with radical prostatectomy (RP) in patients with localized prostate cancer, and to explore which factors, and to what extent, contribute to the assessed changes in HRQOL. METHODS: One hundred and thirty eight patients participated in this prospective longitudinal study. They completed before treatment (T0) and after 12 months (T1) a questionnaire constructed of validated instruments, measuring HRQOL and several psychosocial factors (PF). Among other things, multiple regression analyses including all baseline characteristics, HRQOL and PF were executed in order to meet the objectives. RESULTS: RP patients showed significantly more improvement in their emotional function, while they reported more incontinence and a worse sexual function. There was significantly more improvement in the overall HRQOL of ERT patients, while the changes in the gastrointestinal function of these patients were significantly worse. Only the differences with respect to incontinence can be attributed to the treatment itself. Almost all HRQOL change scores are primarily influenced by their own baseline score. The influence of other factors, like age, socioeconomic status, and several PF, is limited. CONCLUSIONS: The impact on HRQOL of ERT is similar to that of RP, except for incontinence. RP patients suffer more from incontinence than ERT patients. Changes in the assessed HRQOL are mainly influenced by the pre-treatment HRQOL scores.","Prostate, 58(4): 354-365","Netherlands",2004,"Local","Surgery,Radiotherapy","Unclear","Patient",null,"Cohort","Netherlands","Patient","Local","Surgery,Radiotherapy",null,"Cohort","Unclear","2000:2004","General,Disease"]
[692,"van Andel, G., et al. (2008). \"An international field study of the EORTC QLQ-PR25: a questionnaire for assessing the health-related quality of life of patients with prostate cancer.\" Eur J Cancer 44(16): 2418-2424.",null,"van Andel, G., et al.","An international field study of the EORTC QLQ-PR25: a questionnaire for assessing the health-related quality of life of patients with prostate cancer","AIM: To evaluate the psychometrics of the EORTC QLQ-PR25, a questionnaire assessing the health-related quality of life of prostate cancer patients. METHODS: The QLQ-PR25 and the QLQ-C30 were administered to 642 prostate cancer patients from 13 countries treated with curative or palliative intent. The QLQ-PR25 assesses urinary, bowel and sexual symptoms and functioning, and the side-effects of hormonal treatment. RESULTS: Five hundred and nine patients were available for the final analysis. Multitrait scaling analyses confirmed the hypothesised scale structure of the QLQ-PR25. Internal consistency reliability was good (coefficient alpha=0.70-0.86) for the urinary symptoms and sexual function scales, but lower for the bowel function and side-effects of hormonal treatment scales (alpha<0.70). The module discriminated clearly between clinically distinct patient subgroups, and was responsive to changes in health status over time. CONCLUSION: In general, the QLQ-PR25 demonstrates acceptable psychometric properties and clinical validity. Some caution should be used in interpreting the bowel function and side-effects of hormonal therapy scales; results can be reported at the individual item and scale level.","Eur J Cancer, 44(16): 2418-2424","Netherlands",2008,"Any or unknown","Hormonal","EORTC QLQ-PR25,EORTC QLQ-C30","Patient",null,"Validation","Netherlands","Patient","Any or unknown","Hormonal",null,"Validation","EORTC QLQ-PR25,EORTC QLQ-C30","2005:2009","Disease,General"]
[693,"van Brussel, J. P., et al. (2000). \"A phase II study of temozolomide in hormone-refractory prostate cancer.\" Cancer Chemother Pharmacol 45(6): 509-512.",null,"van Brussel, J. P., et al.","A phase II study of temozolomide in hormone-refractory prostate cancer","INTRODUCTION: Hormone-refractory disseminated prostate cancer is a major oncological problem. Preclinical studies with temozolomide, an oral alkylating agent, in prostate cancer have shown encouraging results. In phase I studies the safety of temozolomide in non-prostate cancer patients has been demonstrated. Based on these results, a phase II study of temozolomide in patients with metastatic disease who had developed progressive symptomatic disease while on antiandrogen therapy, was initiated. METHODS: A group of 18 patients started a 5-day temozolomide regimen, with a 28-day treatment cycle. Response parameters (prostate-specific antigen, bone scan, quality of life questionnaire) and toxicity (common toxicity criteria for international studies) were recorded at regular intervals. RESULTS: Of the 18 patients, 16 were evaluable by completing two or three cycles. All patients developed progressive disease within two cycles, except one who had progressive disease at the end of cycle 3. Of the 16 evaluable patients, 11 developed new bone metastases (bone scan), 1 developed lung metastases, 4 had progressive disease as reflected by a 25% increase in serum PSA together with subjective progression, and 7 and 5 had progressive disease as reflected by decreased quality of life and increased pain score, respectively. Toxicity was limited to nausea and vomiting, which was effectively treated with antiemetic medication, and anemia and thrombocytopenia, which returned to normal values within 1 week. DISCUSSION: Treatment with temozolomide was generally well tolerated, with occasionally moderate toxicity. As all patients developed progressive disease the results are rather discouraging. Temozolomide is ineffective for the treatment of patients with symptomatic progressive hormone-refractory prostate cancer.","Cancer Chemother Pharmacol, 45(6): 509-512","Netherlands",2000,"Metastatic","Chemotherapy","Unclear","Patient",null,"Clinical trial","Netherlands","Patient","Metastatic","Chemotherapy",null,"Clinical trial","Unclear","2000:2004","General"]
[694,"van Dis, F. W., et al. (2006). \"A validation study of the Dutch version of the Quality of Life-Cancer Survivor (QOL-CS) questionnaire in a group of prostate cancer survivors.\" Qual Life Res 15(10): 1607-1612.",null,"van Dis, F. W., et al.","A validation study of the Dutch version of the Quality of Life-Cancer Survivor (QOL-CS) questionnaire in a group of prostate cancer survivors","The primary objective of this study was to validate the Dutch version of the Quality of Life-Cancer Survivor (QOL-CS) questionnaire using a group of Dutch prostate cancer survivors. The QOL-CS was specifically designed to measure the quality of life of long-term cancer survivors. We performed a population-based, cohort study of 784 prostate cancer survivors who were diagnosed with prostate cancer between 1994 and 1998. To determine the test-retest reliability, second questionnaires were sent to 109 participants, of whom 103 (94%) returned the forms. The quality of life in Dutch long-term prostate cancer survivors was adequately measured by the physical, psychological and social well-being subscale and can be used in order to measure the specific aspects of quality of life important to cancer survivors. However, as the subscale spiritual well-being showed a low internal consistency, which could be related to cultural background, it seems to be appropriate to evaluate the validity and reliability of the QOL-CS in other cultural settings.","Qual Life Res, 15(10): 1607-1612","Netherlands",2006,"Survivors","None","QOL-CS","Patient",null,"Validation","Netherlands","Patient","Survivors","None",null,"Validation","QOL-CS","2005:2009","General"]
[695,"van Gysen, K. L., et al. (2013). \"Health-related quality of life using intensity-modulated radiation therapy for post-prostatectomy radiotherapy.\" J Med Imaging Radiat Oncol 57(1): 89-96.",null,"van Gysen, K. L., et al.","Health-related quality of life using intensity-modulated radiation therapy for post-prostatectomy radiotherapy","INTRODUCTION: Post-prostatectomy radiotherapy (PPRT) with intensity-modulated radiation therapy (IMRT) has the potential to decrease toxicity by reducing dose to surrounding structures. We assessed its impact on health-related quality of life (HRQoL). METHODS: PPRT patients were enrolled in a prospective HRQoL database. To be eligible, patients were required to be treated with IMRT and have a minimum of 15-month follow up. HRQoL was assessed at baseline, 3, 9 and 15-24 months using the Expanded Prostate Cancer Index Composite questionnaire. Higher scores reflected better HRQoL. Results were analysed as both population means and as individual scores where a moderate change was 10-20 points and a substantial change was >20 points. RESULTS: There were 64 patients eligible and 83% of the cohort received salvage radiotherapy. Prescribed dose was 64 Gy in 32 fractions for adjuvant and 66 Gy in 33 fractions for salvage IMRT. Mean function scores for urinary, bowel and sexual domains were similar at baseline and 15 months (83.5, 94.2 and 16.9 vs. 82.2, 93.1 and 14.3, respectively). Mean global physical functioning (51.0 vs. 48.1) and mental functioning (51.6 vs. 54.2) showed no difference over time. Individual patient scores by 2 years showed a >20-point deterioration in urinary (12.5%), bowel (1.6%), sexual function (9.4%), physical functioning (3.1%) and mental functioning (1.6%). CONCLUSION: This report on HRQoL following post-prostatectomy IMRT demonstrates no variation in mean scores in any domain and only 1.6% of patients reporting a greater than 20-point deterioration between baseline and 15-24 months in bowel function.","J Med Imaging Radiat Oncol, 57(1): 89-96","Australia",2013,"Any or unknown","Surgery,Radiotherapy","EPIC","Patient",null,"Cohort","Australia","Patient","Any or unknown","Surgery,Radiotherapy",null,"Cohort","EPIC","2010:2014","Disease"]
[696,"van Leeuwen, M., et al. (2014). \"Recruiting long-term survivors of European Organisation for Research and Treatment of Cancer phase III clinical trials into quality of life studies: challenges and opportunities.\" Eur J Cancer 50(11): 1957-1963.",null,"van Leeuwen, M., et al.","Recruiting long-term survivors of European Organisation for Research and Treatment of Cancer phase III clinical trials into quality of life studies: challenges and opportunities","OBJECTIVES: In this pilot study we evaluated the feasibility of and methods for assessing the quality of life of long term survivors of European Organisation for Research and Treatment of Cancer (EORTC) phase III clinical trials. Here we report the results pertaining to the feasibility of conducting such research. METHODS: In this cross-sectional study, we recruited long-term, disease-free survivors from two mature EORTC clinical trials in testicular and prostate cancer from centres in Northern and Southern Europe, and the United Kingdom (UK). RESULTS: A number of challenges were encountered in recruiting participating centres, obtaining medical ethical approval and in recruiting survivors and collecting the health-related quality of life (HRQoL) data in a timely manner. The efficiency with which the study could be conducted varied widely across centres and countries. Time to obtain medical ethical approval for the study ranged from 1.5 to 25 months. We encountered most problems with ethical approval in the UK, Italy and Belgium. In most cases, data collection was completed within 3 months (range 10 weeks-1 year). Completed questionnaires were obtained from 68% and 56%, respectively, of the testicular and prostate cancer survivors who were approached. CONCLUSIONS: HRQoL research among long-term survivors of EORTC phase III clinical trials is possible, but the process of ethical approval and data collection is a lengthy one. To minimise many of the logistical problems, long-term follow-up of patients should be an integral part of future clinical trials. Moreover, regulations governing medical ethical approval for clinical research within the EU should be carefully evaluated to facilitate long-term follow-up of cancer survivors in Europe.","Eur J Cancer, 50(11): 1957-1963","Netherlands,France,Italy,Austria,Belgium,UK,Norway",2014,"Survivors","None","Unclear","Patient",null,"Cross-sectional","Netherlands,France,Italy,Austria,Belgium,UK,Norway","Patient","Survivors","None",null,"Cross-sectional","Unclear","2010:2014","General"]
[697,"van Leeuwen, M., et al. (2017). \"International evaluation of the psychometrics of health-related quality of life questionnaires for use among long-term survivors of testicular and prostate cancer.\" Health Qual Life Outcomes 15(1): 97.",null,"van Leeuwen, M., et al.","International evaluation of the psychometrics of health-related quality of life questionnaires for use among long-term survivors of testicular and prostate cancer","BACKGROUND: Understanding of the physical, functional and psychosocial health problems and needs of cancer survivors requires cross-national and cross-cultural standardization of health-related quality of life (HRQoL) questionnaires that capture the full range of issues relevant to cancer survivors. To our knowledge, only one study has investigated in a comprehensive way whether a questionnaire used to evaluate HRQoL in cancer patients under active treatment is also reliable and valid when used among (long-term) cancer survivors. In this study we evaluated, in an international context, the psychometrics of HRQoL questionnaires for use among long-term, disease-free, survivors of testicular and prostate cancer. METHODS: In this cross-sectional study, we recruited long-term survivors of testicular and prostate cancer from Northern and Southern Europe and from the United Kingdom who had participated in two phase III EORTC clinical trials. Participants completed the SF-36 Health Survey, the EORTC QLQ-C30 questionnaire, the QLQ-PR25 (for prostate cancer) or the QLQ-TC26 (for testicular cancer) questionnaires, and the Impact of Cancer questionnaire. Testicular cancer survivors also completed subscales from the Nordic Questionnaire for Monitoring the Age Diverse Workforce. RESULTS: Two hundred forty-two men (66% response rate) were recruited into the study. The average time since treatment was more than 10 years. Overall, there were few missing questionnaire data, although scales related to sexuality, satisfaction with care and relationship concerns of men without partners were missing in more than 10% of cases. Debriefing showed that in general the questionnaires were accepted well. Many of the survivors scored at the upper extremes of the questionnaires, resulting in floor and ceiling effects in 64% of the scales. All of the questionnaires investigated met the threshold of 0.70 for group level reliability, with the exception of the QLQ-TC26 (mean reliability .64) and the QLQ-PR25 (mean reliability .69). The questionnaires were able to discriminate clearly between patients with and without comorbid conditions. CONCLUSIONS: The currently available HRQoL questionnaires exhibit acceptable psychometric properties and were well received by patients, but additional efforts are needed to ensure that the full range of survivor-specific issues is assessed.","Health Qual Life Outcomes, 15(1): 97","Netherlands,Italy,France,Norway,Austria,Belgium",2017,"Survivors","Unclear","SF-36,EORTC QLQ-C30,EORTC QLQ-PR25","Patient",null,"Validation","Netherlands,Italy,France,Norway,Austria,Belgium","Patient","Survivors","Unclear",null,"Validation","SF-36,EORTC QLQ-C30,EORTC QLQ-PR25","2015:2018","Disease,General,Utility"]
[698,"Van Vulpen, M., et al. (2003). \"A prospective quality of life study in patients with locally advanced prostate cancer, treated with radiotherapy with or without regional or interstitial hyperthermia.\" Int J Hyperthermia 19(4): 402-413.",null,"Van Vulpen, M., et al.","A prospective quality of life study in patients with locally advanced prostate cancer, treated with radiotherapy with or without regional or interstitial hyperthermia","INTRODUCTION: The aim of this prospective study was to describe quality of life (QoL) in patients with locally advanced prostate carcinoma treated with conventional radiotherapy and to evaluate the influence of adding regional or interstitial hyperthermia. MATERIALS AND METHODS: All patients were irradiated using a CT-planned conventional three field technique, administering 70 Gy to prostate and vesicles. In two different phase I studies, hyperthermia was added to the radiotherapy. Twelve patients were treated with one interstitial hyperthermia treatment, lasting 60 min. Fourteen patients have been treated with five regional hyperthermia treatments, lasting 75 min each. In both hyperthermia studies, the body, bladder and rectum temperatures remained below safety limits. Patients treated with radiotherapy alone (n = 58) or combined with regional (n = 8) or interstitial hyperthermia (n = 12) completed the European Organization for Research and Treatment of Cancer (EORTC) core questionnaire (C30 + 3), the EORTC prostate cancer module (PR25) and the Rand 36 health survey before treatment and 1 and 6 months after completion of treatment. Analysis of Variance (ANOVA) for repeated measurements has been performed to describe the data. RESULTS: All patient groups were comparable concerning patient characteristics. No significant interaction or difference in QoL has been noticed between the two hyperthermia patient groups and the patient group without hyperthermia. Therefore, all groups were analysed together (n = 78) to detect QoL changes in time. A deterioration of QoL has been measured from baseline to 1 month after treatment. Fatigue, pain, urinary symptoms, bowel symptoms and financial difficulties increased significantly. Social, physical and role functioning worsened significantly. No differences in QoL were measured 6 months after treatment compared to the baseline measurement, except for a decrease in sexual activity. CONCLUSIONS: After radiotherapy with or without hyperthermia only a temporary deterioration of QoL occurs, concerning social, psychological and disease related symptoms. Additional hyperthermia does not seem to decrease QoL.","Int J Hyperthermia, 19(4): 402-413","Netherlands",2003,"Advanced","Radiotherapy,Various","EORTC QLQ-C30,EORTC QLQ-PR25,SF-36","Patient",null,"Clinical trial","Netherlands","Patient","Advanced","Radiotherapy,Various",null,"Clinical trial","EORTC QLQ-C30,EORTC QLQ-PR25,SF-36","2000:2004","Disease,General,Utility"]
[699,"Vandecasteele, K., et al. (2012). \"Evaluation of the efficacy and safety of Salvia officinalis in controlling hot flashes in prostate cancer patients treated with androgen deprivation.\" Phytother Res 26(2): 208-213.",null,"Vandecasteele, K., et al.","Evaluation of the efficacy and safety of Salvia officinalis in controlling hot flashes in prostate cancer patients treated with androgen deprivation","The purpose of this pilot study was to evaluate the efficacy and safety of Salvia officinalis in controlling hot flashes in prostate cancer patients treated with androgen deprivation therapy (ADT). Ten patients experiencing hot flashes were included in a single-centre prospective pilot study. Treatment consisted of 150 mg of Salvia officinalis extract taken orally three times daily. A diary questionnaire scoring hot flashes, subjective side effects and quality of life (QOL) had to be completed. Clinical examination was performed at every visit and the concentration of ADT-linked hormones, haemoglobin and cholesterol was measured before, during and after ending treatment. Before the start of treatment, a 1 week baseline registration was performed. An analysis of variance with time of measurement as a within-subject factor was performed. When analysing the hot flashes score, one patient was excluded due to insufficient diary notes. The mean weekly score declined from 112 (SD = 71) at baseline to 59 (SD = 54) at the end of treatment (p = 0.002). Hot flashes diminished significantly from the first week up to and including week 3. This was maintained during treatment. There was no effect on QOL. There were no side effects. It is concluded that Salvia officinalis is efficient and safe in the treatment hot flashes, without improving QOL.","Phytother Res, 26(2): 208-213","Belgium",2012,"Any or unknown","Hormonal,Various","Diary","Patient",null,"Clinical trial","Belgium","Patient","Any or unknown","Hormonal,Various",null,"Clinical trial","Diary","2010:2014","General,Symptom"]
[700,"Vasarainen, H., et al. (2013). \"Effects of prostate cancer screening on health-related quality of life: results of the Finnish arm of the European randomized screening trial (ERSPC).\" Acta Oncol 52(8): 1615-1621.",null,"Vasarainen, H., et al.","Effects of prostate cancer screening on health-related quality of life: results of the Finnish arm of the European randomized screening trial (ERSPC)","BACKGROUND: As prostate cancer (PC) mortality reduction results are not unequivocal, a special emphasis has to be put on other aspects of the prostate-specific antigen (PSA) screening, including effects on quality of life. In the present study we describe the short-term effects of various phases of PC screening on health-related quality of life (HRQL). MATERIAL AND METHODS: The study participants were randomized into the screening arm within the Finnish component of the European Randomized Study on Screening for Prostate Cancer (ERSPC). The RAND 36-Item Health Survey on HRQL and questionnaires on sociodemographic and behavioral factors were delivered to participants at various phases of the first screening round: 1) 500 participants at invitation; 2) 500 after screening; 3) 500 after obtaining the PSA result; 4) to 300 participants after undergoing digital rectal examination (DRE) (but prior to being informed of its result); and 5) approximately 300 after prostate biopsy. At each stage, a new sample of participants was recruited. RESULTS: Response rates were 59% at invitation, 77% after PSA blood test, 54% after PSA result and 69% after DRE. The men recruited at each stage were comparable in respect to socioeconomic variables. The HRQL scores in RAND-36 subscales showed little variation in the different phases of the screening process. Compared with the previous phase, the social function score was slightly lower after obtaining the PSA result than after blood test, the emotional role score lower after DRE than after PSA result and the pain-related score lower after DRE than after TRUS and biopsy. The screening participants were comparable to the general population as their HRQL scores were similar to an age-stratified general Finnish male population. CONCLUSION: Short-term HRQL effects of prostate cancer screening appear minor and transient.","Acta Oncol, 52(8): 1615-1621","Finland",2013,"At risk","Screening","SF-36","General population",null,"Clinical trial","Finland","General population","At risk","Screening",null,"Clinical trial","SF-36","2010:2014","Utility"]
[701,"Verma, V., et al. (2018). \"Quality of Life and Patient-Reported Outcomes Following Proton Radiation Therapy: A Systematic Review.\" J Natl Cancer Inst 110(4).",null,"Verma, V., et al.","Quality of Life and Patient-Reported Outcomes Following Proton Radiation Therapy: A Systematic Review","Background: As costs of cancer care rise, the importance of documenting value in oncology increases. Proton beam radiotherapy (PBT) has the potential to reduce toxicities in cancer patients, but is relatively expensive and unproven. Evaluating quality of life (QOL) and patient-reported outcomes (PROs) is essential to establishing PBT's \"value\" in oncologic therapy. The goal of this systematic review was to assess QOL and PROs in patients treated with PBT. Methods: Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)-guided systematic searches were conducted. The PubMed search engine was the primary data source, along with publications found from references of selected articles, and articles known to the authors published through 2017. Seventeen original investigations were found to have sufficient focus and relevance to be incorporated into the systematic review. Results: Studies of skull base (n = 1), brain (n = 1), head/neck (n = 1), lung (n = 1), breast (n = 2), prostate (n = 8), and pediatric (n = 3) malignancies treated with PBT that met eligibility criteria were included. QOL did not deteriorate during PBT for skull base and after PBT for brain tumors, respectively. PROs were higher for PBT than photon-based radiotherapy for both head/neck and lung cancer. Patient-reported breast cosmesis was appropriate after PBT and comparable to photon modalities. PBT in various settings of prostate cancer displayed an expected post-therapy decline; one study showed improved PROs (rectal urgency, bowel frequency) for PBT, and two others showed PROs/QOL comparable with other modalities. Pediatric studies demonstrated improvements in QOL during therapy, with additional increases thereafter. Conclusions: Based on limited data, PBT provides favorable QOL/PRO profiles for select brain, head/neck, lung, and pediatric cancers; measures for prostate and breast cancers were more modest. These results have implications for cost-effective cancer care and prudently designed QOL evaluation in ongoing trials, which are discussed. Future data could substantially change the conclusions of this review.","J Natl Cancer Inst, 110(4): ","International",2018,"Any or unknown","Radiotherapy","Unclear","Patient",null,"Systematic review","International","Patient","Any or unknown","Radiotherapy",null,"Systematic review","Unclear","2015:2018","Complication"]
[702,"Vickers, A. J., et al. (2010). \"Validation study of a web-based assessment of functional recovery after radical prostatectomy.\" Health Qual Life Outcomes 8: 82.",null,"Vickers, A. J., et al.","Validation study of a web-based assessment of functional recovery after radical prostatectomy","BACKGROUND: Good clinical care of prostate cancer patients after radical prostatectomy depends on careful assessment of post-operative morbidities, yet physicians do not always judge patient symptoms accurately. Logistical problems associated with using paper questionnaire limit their use in the clinic. We have implemented a web-interface (\"STAR\") for patient-reported outcomes after radical prostatectomy. METHODS: We analyzed data on the first 9 months of clinical implementation to evaluate the validity of the STAR questionnaire to assess functional outcomes following radical prostatectomy. We assessed response rate, internal consistency within domains, and the association between survey responses and known predictors of sexual and urinary function, including age, time from surgery, nerve sparing status and co-morbidities. RESULTS: Of 1581 men sent an invitation to complete the instrument online, 1235 responded for a response rate of 78%. Cronbach's alpha was 0.84, 0.86 and 0.97 for bowel, urinary and sexual function respectively. All known predictors of sexual and urinary function were significantly associated with survey responses in the hypothesized direction. CONCLUSIONS: We have found that web-based assessment of functional recovery after radical prostatectomy is practical and feasible. The instrument demonstrated excellent psychometric properties, suggested that validity is maintained when questions are transferred from paper to electronic format and when patients give responses that they know will be seen by their doctor and added to their clinic record. As such, our system allows ready implementation of patient-reported outcomes into routine clinical practice.","Health Qual Life Outcomes, 8(82","USA",2010,"Any or unknown","Surgery","STAR","Patient",null,"Validation","USA","Patient","Any or unknown","Surgery",null,"Validation","STAR","2010:2014","Symptom"]
[703,"Vieira, I., et al. (2014). \"Prostate cancer follow-up needs: do patients and professionals agree?\" Br J Nurs 23(9): S12, s14-19.",null,"Vieira, I., et al.","Prostate cancer follow-up needs: do patients and professionals agree?","BACKGROUND: With recent changes in the economy and the drive for cost-effective health care, current practices in the NHS need to be reviewed and revised. In light of this, the aim of this study is to investigate the perceived benefits of routine follow-up of patients with prostate cancer and to examine perceptions of prostate cancer patients and health professionals about who should follow-up patients and where and when this should take place. METHODS: A service evaluation was carried out on a sample of patients receiving follow-up assessment following radical treatment for prostate cancer and health professionals in a specialist cancer urology unit in an acute NHS trust in south-east England. Data were collected through patient (n=47) and health professional (n=17) questionnaires and through a group discussion with a sample of patients (n=52). RESULTS: There was agreement between patients and professionals that the main purpose of follow-up consultation was to review the prostate-specific antigen (PSA) blood test and assess urinary symptoms. The majority of patients and professionals wanted follow-up in the hospital with face-to-face consultation. There was general agreement that assessments should be carried out every six months. An overwhelming majority of patients (95%) felt that it was important to have easy access to the urology cancer nurses and doctors. CONCLUSION: Patients want to maintain the traditional model of hospital based follow-up in specialist urology cancer clinics. However, this approach is not economically sustainable. If this is to change we need to work with our patients to develop a service that meets their needs. For a new approach to follow-up to meet the needs of patients, they need to be confident that they have access to expert advice and support, and are assured of referral back to the urology team if required. Nurses are ideally placed to play a key role in the development of such a service.","Br J Nurs, 23(9): S12, s14-19","UK",2014,"Any or unknown","None","Unclear","Patient,HCP",null,"Cross-sectional","UK","Patient,HCP","Any or unknown","None",null,"Cross-sectional","Unclear","2010:2014","Views"]
[704,"Viers, B. R., et al. (2015). \"Efficiency, satisfaction, and costs for remote video visits following radical prostatectomy: a randomized controlled trial.\" Eur Urol 68(4): 729-735.",null,"Viers, B. R., et al.","Efficiency, satisfaction, and costs for remote video visits following radical prostatectomy: a randomized controlled trial","BACKGROUND: Telemedicine in an ambulatory surgical population remains incompletely evaluated. OBJECTIVE: To investigate patient encounters in the outpatient setting using video visit (VV) technology compared to traditional office visits (OVs). DESIGN, SETTING, AND PARTICIPANTS: From June 2013 to March 2014, 55 prescreened men with a history of prostate cancer were prospectively randomized. VVs, with the patient at home or at work, were included in the outpatient clinic calendar of urologists. INTERVENTION: Remote VV versus traditional OV. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: An equivalence analysis was used to assess the primary outcome, visit efficiency as measured by time studies. Secondary outcomes were patient/provider satisfaction and costs. RESULTS AND LIMITATIONS: There were 28 VVs and 27 OVs. VVs were equivalent in efficiency to relative to OVs, as measured by patient-provider face time (mean 14.5 vs 14.3min; p=0.96), patient wait time (18.4 vs 13.0min; p=0.20), and total time devoted to care (17.9 vs 17.8min; p=0.97). There were no significant differences in patient perception of visit confidentiality, efficiency, education quality, or overall satisfaction. VVs incurred lower costs, including distance traveled (median 0 vs 95 miles), travel time (0 vs 95min), missed work (0 vs 1 d), and money spent on travel ($0 vs $48; all p<0.0001). There was a high level of urologist satisfaction for both VVs (88%) and OVs (90%). The major limitation was sample size. CONCLUSIONS: VV in the ambulatory postprostatectomy setting may have a future role in health care delivery models. We found equivalent efficiency, similar satisfaction, but significantly reduced patient costs for VV compared to OV. Further prospective analyses are warranted. PATIENT SUMMARY: Among men with surgically treated prostate cancer, we evaluated the utility of remote video visits compared to office visits for outpatient consultation with a urologist. Video visits were associated with equivalent efficiency, similar satisfaction, and significantly lower patient costs when compared to office visits. We conclude that video visits may have a future role in health care delivery models.","Eur Urol, 68(4): 729-735","USA",2015,"Any or unknown","Surgery,Various","Unclear","Patient",null,"Clinical trial","USA","Patient","Any or unknown","Surgery,Various",null,"Clinical trial","Unclear","2015:2018","Satisfaction,Costs"]
[705,"Visser, A., et al. (2003). \"Changes in health-related quality of life of men with prostate cancer 3 months after diagnosis: the role of psychosocial factors and comparisment with benign prostate hyperplasia patients.\" Patient Educ Couns 49(3): 225-232.",null,"Visser, A., et al.","Changes in health-related quality of life of men with prostate cancer 3 months after diagnosis: the role of psychosocial factors and comparisment with benign prostate hyperplasia patients","The objective of the pilot study is to measure the changes in health-related quality of life (HRQOL, general and prostate specific) 3 months after the disease has been diagnosed in men with prostate cancer. The results are compared with benign prostate hyperplasia (BPH) patients. Also the influence of psychosocial factors (distress, coping and social support) on the experienced changes in health-related quality of life is studied for both patient groups. The sample consists of 61 patients who filled in the questionnaire before the diagnosis was know to them and after 3 months (38 benign prostate hyperplasia and 23 prostate cancer patients). The measures consist of: quality of life, micturation symptoms, sexual functioning, coping style, psychological distress, life events, social support, social desirability, and health behavior. The results show a decrease in quality of life for prostate cancer patient after three moments, while the quality of life measure for BPH patients are stable over time. For both patient groups, the psychosocial factors do not change after 3 months. The psychosocial factors contribute only marginal to the changes in quality of life. Conclusions are drawn concerning the need and the content of psychosocial support and education for prostate cancer patients.","Patient Educ Couns, 49(3): 225-232","Netherlands",2003,"Any or unknown","None","Unclear","Patient",null,"Cohort","Netherlands","Patient","Any or unknown","None",null,"Cohort","Unclear","2000:2004","General,Symptom,Social,Comorbidity"]
[706,"Voerman, B., et al. (2006). \"Health-related quality of life in Dutch men with prostate cancer.\" J Psychosoc Oncol 24(2): 49-64.",null,"Voerman, B., et al.","Health-related quality of life in Dutch men with prostate cancer","Prostate cancer is the most prevalent solid malignancy in men in the Netherlands. With regard to treatment, the focus of attention has shifted in the last decade from pure survival rates to health-related quality of life. HRQOL is affected differently by different treatments. The objective of this study is to assess the HRQOL related to treatment regime and time since diagnosis in Dutch men with prostate cancer. We conducted a cross-sectional study among 238 men with prostate cancer in a heterogeneous sample who filled in a general health-related quality-of-life measure (EORTC-QLQ-C30) and a prostate cancer specific quality-of-life instrument (the EORTC-QLQ-PR25) and a Joy-of-Life questionnaire. Men on hormonal treatment are doing worse compared with other treatments with respect to physical functioning, role functioning, fatigue, pain and sexual functioning. No differences were found between radical prostatectomy and radiation therapy on any of the HRQOL dimensions nor for time since diagnosis. In hormonal therapy, men who are diagnosed longer than two years ago report a worse cognitive functioning and more burdens from urinary problems.","J Psychosoc Oncol, 24(2): 49-64","Netherlands",2006,"Any or unknown","Surgery,Radiotherapy,Hormonal","EORTC QLQ-C30,EORTC QLQ-PR25,JOL","Patient",null,"Cross-sectional","Netherlands","Patient","Any or unknown","Surgery,Radiotherapy,Hormonal",null,"Cross-sectional","EORTC QLQ-C30,EORTC QLQ-PR25,JOL","2005:2009","Disease,General"]
[707,"Volk, R. J., et al. (2004). \"Preferences of husbands and wives for outcomes of prostate cancer screening and treatment.\" J Gen Intern Med 19(4): 339-348.",null,"Volk, R. J., et al.","Preferences of husbands and wives for outcomes of prostate cancer screening and treatment","OBJECTIVE: To explore the preferences of male primary care patients and their spouses for the outcomes of prostate cancer screening and treatment, and quality of life with metastatic prostate cancer. DESIGN: Cross-sectional design. SETTING: Primary care clinics in Galveston County, Texas. PATIENTS: One hundred sixty-eight couples in which the husband was a primary care patient and a candidate for prostate cancer screening. MEASUREMENTS AND MAIN RESULTS: Preferences were measured as utilities for treatment outcomes and quality of life with metastatic disease by the time trade-off method for the husband and the wife individually and then conjointly for the couple. For each health state considered, husbands associated lower utilities for the health states than did their wives. Couples' utilities fell between those of husbands and wives (all comparisons were significant at P <.01). For partial and complete impotence and mild-to-moderate incontinence, the median utility value for the wives was 1.0, indicating that most wives did not associate disutility with their husbands having to experience these treatment complications. CONCLUSIONS: Male primary care patients who are candidates for prostate cancer screening evaluate the outcomes of prostate cancer treatment and life with advanced prostate cancer as being far worse than do their wives. Because the choice between quantity and quality of life is a highly individualistic one, both the patient and his partner should be involved in making decisions about prostate cancer screening. J","J Gen Intern Med, 19(4): 339-348","USA",2004,"At risk","Screening","TTO","Patient,Caregiver",null,"Validation","USA","Patient,Caregiver","At risk","Screening",null,"Validation","TTO","2000:2004","Utility"]
[708,"Vordermark, D., et al. (2006). \"3-D conformal treatment of prostate cancer to 74 Gy vs. high-dose-rate brachytherapy boost: a cross-sectional quality-of-life survey.\" Acta Oncol 45(6): 708-716.",null,"Vordermark, D., et al.","3-D conformal treatment of prostate cancer to 74 Gy vs. high-dose-rate brachytherapy boost: a cross-sectional quality-of-life survey","The effects of two modalities of dose-escalated radiotherapy on health-related quality of life (HRQOL) were compared. Forty-one consecutive patients were treated with a 3-D conformal (3-DC) boost to 74 Gy, and 43 with high-dose rate (HDR) brachytherapy boost (2x9 Gy), following 3-D conformal treatment to 46 Gy. Median age was 70 years in both groups, median initial PSA was 7.9 microg/l in 3-DC boost patients and 8.1 microg/l in HDR boost patients. Stage was <or=T2 in 66% and 67% and Gleason score was >or=7 in 52% and 47%, respectively. HRQOL was assessed cross-sectionally using EORTC QLQ-C30 and organ-specific PR25 modules 3--32 (median 19) and 4--25 (median 14) months after treatment, respectively. Questionnaires were completed by 93% and 97% of patients, respectively. Diarrhea and insomnia scores were significantly increased in both groups. In the PR25 module, scores of 3-DC boost and HDR boost patients for urinary, bowel and treatment-related symptoms were similar. Among responders, 34% of 3-DC boost patients and 86% of HDR boost patients had severe erectile problems. Dose escalation in prostate cancer by either 3-DC boost to 74 Gy or HDR brachytherapy boost appears to result in similar HRQOL profiles.","Acta Oncol, 45(6): 708-716","Germany",2006,"Any or unknown","Radiotherapy,Brachytherapy","EORTC QLQ-C30,EORTC QLQ-PR25","Patient",null,"Cross-sectional","Germany","Patient","Any or unknown","Radiotherapy,Brachytherapy",null,"Cross-sectional","EORTC QLQ-C30,EORTC QLQ-PR25","2005:2009","Disease,General"]
[709,"Wahlgren, T., et al. (2004). \"Health-related quality of life in men after treatment of localized prostate cancer with external beam radiotherapy combined with (192)ir brachytherapy: a prospective study of 93 cases using the EORTC questionnaires QLQ-C30 and QLQ-PR25.\" Int J Radiat Oncol Biol Phys 60(1): 51-59.",null,"Wahlgren, T., et al.","Health-related quality of life in men after treatment of localized prostate cancer with external beam radiotherapy combined with (192)ir brachytherapy: a prospective study of 93 cases using the EORTC questionnaires QLQ-C30 and QLQ-PR25","PURPOSE: To describe prospectively the long-term health-related quality of life (HRQOL) and treatment-related symptoms in patients with localized prostate cancer treated with neoadjuvant androgen deprivation therapy and radical radiotherapy (RT), including external beam RT and iridium high-dose-rate brachytherapy, and to compare them with age-matched normative data. METHODS AND MATERIALS: A total of 93 patients with T1-T3a tumors consecutively treated with definitive RT at our institution completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ)-C30 and QLQ-prostate specific 25-item (PR25) module twice at an 18-month interval 0-18 months after RT. Subgroups were analyzed regarding acute and late effects on symptoms and quality of life. RESULTS: The main analysis included 80 patients who were disease free at the final assessment. The levels of HRQOL were generally high, did not change over time, and were comparable to the normative data. Symptom development (urinary, bowel, and sexual) correlated well with the known acute and late effects of radical RT and neoadjuvant androgen deprivation therapy. CONCLUSION: Combining external beam RT and HDR brachytherapy when treating prostate cancer did not appear to impair HRQOL and was comparable to that of other brachytherapy methods. The negative contribution from late neoadjuvant androgen deprivation therapy on symptom development seemed to be substantial but mostly transitory. Additional research is needed to determine the long-term HRQOL (3-5 years), and interventional randomized studies are suggested.","Int J Radiat Oncol Biol Phys, 60(1): 51-59","Sweden",2004,"Local","Radiotherapy,Brachytherapy","EORTC QLQ-C30,EORTC QLQ-PR25","Patient",null,"Cohort","Sweden","Patient","Local","Radiotherapy,Brachytherapy",null,"Cohort","EORTC QLQ-C30,EORTC QLQ-PR25","2000:2004","Disease,General"]
[710,"Wakatsuki, M., et al. (2008). \"Quality of life in men treated with carbon ion therapy for prostate cancer.\" Int J Radiat Oncol Biol Phys 72(4): 1010-1015.",null,"Wakatsuki, M., et al.","Quality of life in men treated with carbon ion therapy for prostate cancer","PURPOSE: To prospectively assess patient quality of life (QOL) after carbon ion radiotherapy (C-ion RT) for prostate cancer, using established questionnaires. METHODS AND MATERIAL: The subjects were 150 patients who underwent C-ion RT. Of these, 25 patients with low-risk prostate cancer received C-ion RT alone, whereas the remaining 125 patients with a high-risk tumor also received androgen deprivation therapy. Quality of life was assessed using the self-administered Functional Assessment of Cancer Therapy-Prostate (FACT-P) questionnaire in all patients three times. In addition, the University of California-Los Angeles Prostate Cancer Index (UCLA-PCI) was conducted in the low-risk patients. RESULTS: The FACT-General (FACT-G) and FACT-P scores at 12 months after treatment averaged over all 150 patients showed no significant change compared with those before C-ion RT. In FACT-P subscales, emotional well-being increased significantly just after and 12 months after treatment. In contrast, physical well-being (PWB) and social/family well-being (S/FWB) decreased significantly at 12 months, whereas the prostate cancer subscale (PCS) decreased significantly just after treatment. Average scores for FACT-G, FACT-P, PWB, S/FWB, and PCS for the 125 patients receiving hormone therapy showed substantial detrimental changes at 12 months. In contrast, those of the 25 low-risk patients who had no hormone therapy showed no significant change. Similarly no significant change in the average of the UCLA-PCI scores in the low-risk patients was seen at 12 months. CONCLUSIONS: Average QOL parameters reported by patients with localized prostate cancer treated with C-ion RT, in the absence of hormone therapy, showed no significant decrease 12 months after C-ion RT.","Int J Radiat Oncol Biol Phys, 72(4): 1010-1015","Japan",2008,"Any or unknown","Radiotherapy,Hormonal","FACT-P,FACT-G,UCLA-PCI","Patient",null,"Clinical trial","Japan","Patient","Any or unknown","Radiotherapy,Hormonal",null,"Clinical trial","FACT-P,FACT-G,UCLA-PCI","2005:2009","Disease,Treatment"]
[711,"Waldmann, A., et al. (2009). \"Measuring prostate-specific quality of life in prostate cancer patients scheduled for radiotherapy or radical prostatectomy and reference men in Germany and Canada using the Patient Oriented Prostate Utility Scale-Psychometric (PORPUS-P).\" BMC Cancer 9: 295.",null,"Waldmann, A., et al.","Measuring prostate-specific quality of life in prostate cancer patients scheduled for radiotherapy or radical prostatectomy and reference men in Germany and Canada using the Patient Oriented Prostate Utility Scale-Psychometric (PORPUS-P)","BACKGROUND: The PORPUS-P is a short questionnaire for measuring prostate-specific quality of life (QoL), which was designed in Canada for use in prostate cancer (PC) patients. We aimed to generate a German version and compare PORPUS-P scores of German reference men from the general population, and German and Canadian patients with newly diagnosed PC who were scheduled to receive radical prostatectomy (RP) or radiotherapy (RT). METHODS: The study sample consisted of 988 reference men, 121 German and 66 Canadian PC patients scheduled for RT, and 371 German and 68 Canadian PC patients scheduled for RP. All men completed the PORPUS-P (German postal questionnaire, Canada personal interview). Data were gathered from PC patients before the start of therapy. RESULTS: Canadian patients were better educated than the German patients, and fewer were retired. Patients scheduled to receive RT were older and more were retired. German RT patients had lower D'Amico risk scores and pre-treatment Gleason scores than RP patients, and Canadian RT patients had higher pre-treatment PSA than RP patients. Urinary and sexual dysfunction were seen in PC patients (especially RT patients), but were also common in the German reference men. Crude mean PORPUS-P scores differed statistically significant between German RT and RP and Canadian RP and RT patients, with RT patients having higher QoL scores. The differences in age-adjusted mean PORPUS-P scores between reference men and RP patients were not clinically significant, while RT patients had (clinically) significantly lower scores than the reference men. CONCLUSION: The German translation of the PORPUS-P appears to be a short and feasible tool for assessing prostate-specific QoL. Although we found a similar response pattern, Canadian and German PC patients scheduled to receive RT or RP rated their pre-treatment quality of life on different levels, which reveals the need for national reference data. Problems in several QoL domains exist before treatment, and differ between PC patients scheduled for RT and RP.","BMC Cancer, 9(295","Germany,Canada",2009,"Any or unknown","Surgery,Radiotherapy","PORPUS","Patient,General population",null,"Validation","Germany,Canada","Patient,General population","Any or unknown","Surgery,Radiotherapy",null,"Validation","PORPUS","2005:2009","Utility"]
[712,"Wallace, M. (2003). \"Uncertainty and quality of life of older men who undergo watchful waiting for prostate cancer.\" Oncol Nurs Forum 30(2): 303-309.",null,"Wallace, M.","Uncertainty and quality of life of older men who undergo watchful waiting for prostate cancer","PURPOSE/OBJECTIVES: To explore uncertainty, anxiety, and the personal manner in which uncertainty is understood, and explain the health-related and affective quality of life (QOL) of men who undergo watchful waiting for prostate cancer. DESIGN: Descriptive, quantitative, survey approach. SETTING: United States. SAMPLE: A national sample of 21 men diagnosed with prostate cancer (mean age = 76 years) who had elected to receive no treatment for their disease. METHODS: 19 subjects who met the criteria contacted the researcher and completed the mailed questionnaire. MAIN RESEARCH VARIABLES: Uncertainty and QOL. FINDINGS: Moderate yet significant relationships were found between each of the independent variables. Significant relationships were found among uncertainty, anxiety, and the perception of danger (a dimension of QOL). Using hierarchical multiple regression, a model was built to explain 60% of the variance in this QOL dimension. CONCLUSIONS: This study supports that men who undergo watchful waiting are uncertain and that this uncertainty results in their perception of danger and influences their affective health-functioning QOL. This study lends further support for the Uncertainty in Illness Model in the watchful waiting population. IMPLICATIONS FOR NURSING: The findings of this study imply that increased teaching and patient care management regarding watchful waiting are needed both before and after the treatment decision has been made. This study provides the framework for further study on interventions to improve the QOL of this population.","Oncol Nurs Forum, 30(2): 303-309","USA",2003,"Local","Surveillance","Unclear","Patient",null,"Cross-sectional","USA","Patient","Local","Surveillance",null,"Cross-sectional","Unclear","2000:2004","General"]
[713,"Wallerstedt, A., et al. (2015). \"Short-term results after robot-assisted laparoscopic radical prostatectomy compared to open radical prostatectomy.\" Eur Urol 67(4): 660-670.",null,"Wallerstedt, A., et al.","Short-term results after robot-assisted laparoscopic radical prostatectomy compared to open radical prostatectomy","BACKGROUND: Robot-assisted laparoscopic radical prostatectomy has become a widespread technique despite a lack of randomised trials showing its superiority over open radical prostatectomy. OBJECTIVE: To compare in-hospital characteristics and patient-reported outcomes at 3 mo between robot-assisted laparoscopic and open retropubic radical prostatectomy. DESIGN, SETTING, AND PARTICIPANTS: A prospective, controlled trial was performed of all men who underwent radical prostatectomy at 14 participating centres. Validated patient questionnaires were collected at baseline and after 3 mo by independent health-care researchers. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The difference in outcome between the two treatment groups were analysed using logistic regression analysis, with adjustment for identified confounders. RESULTS AND LIMITATIONS: Questionnaires were received from 2506 (95%) patients. The robot-assisted surgery group had less perioperative bleeding (185 vs 683 ml, p<0.001) and shorter hospital stay (3.3 vs 4.1 d, p<0.001) than the open surgery group. Operating time was shorter with the open technique (103 vs 175 min, p<0.001) compared with the robot-assisted technique. Reoperation during initial hospital stay was more frequent after open surgery after adjusting for tumour characteristics and lymph node dissection (1.6% vs 0.7%, odds ratio [OR] 0.31, 95% confidence interval [CI 95%] 0.11-0.90). Men who underwent open surgery were more likely to seek healthcare (for one or more of 22 specified disorders identified prestudy) compared to men in the robot-assisted surgery group (p=0.03). It was more common to seek healthcare for cardiovascular reasons in the open surgery group than in the robot-assisted surgery group, after adjusting for nontumour and tumour-specific confounders, (7.9% vs 5.8%, OR 0.63, CI 95% 0.42-0.94). The readmittance rate was not statistically different between the groups. A limitation of the study is the lack of a standardised tool for the assessment of the adverse events. CONCLUSIONS: This large prospective study confirms previous findings that robot-assisted laparoscopic radical prostatectomy is a safe procedure with some short-term advantages compared to open surgery. Whether these advantages also include long-term morbidity and are related to acceptable costs remain to be studied. PATIENT SUMMARY: We compare patient-reported outcomes between two commonly used surgical techniques. Our results show that the choice of surgical technique may influence short-term outcomes.","Eur Urol, 67(4): 660-670","Sweden,Iceland",2015,"Any or unknown","Surgery","Unclear","Patient",null,"Clinical trial","Sweden,Iceland","Patient","Any or unknown","Surgery",null,"Clinical trial","Unclear","2015:2018","Costs"]
[714,"Wallner, K. (2002). \"Prostate brachytherapy under local anesthesia; lessons from the first 600 patients.\" Brachytherapy 1(3): 145-148.",null,"Wallner, K.","Prostate brachytherapy under local anesthesia; lessons from the first 600 patients","PURPOSE: Local anesthesia for prostate brachytherapy was instituted at the Puget Sound Veterans Hospital in 1999, peforming the procedure in our own department without anesthesia personnel in attendance. MATERIALS AND METHODS: The patient is brought into the simulator suite in the radiation oncology department, an i.v. line is started, a cardiac monitor attached, and a urinary catheter is inserted. He is then placed in the lithotomy position, using stirrups attached to the simulator table. A 6-8 cm patch of perineal skin and subcutaneous tissue is anesthetized by local infiltration of 1% lidocaine. The transrectal ultrasound (TRUS) probe is then inserted and positioned to reproduce the planning images. A 3.0 inch 22-gauge spinal needle is used to inject lidocaine up to the prostatic apex, in a pattern around the periphery of the prostate. Once the pelvic floor and prostatic apex are anesthetized, a 7.0-inch, 22-gauge spinal needle is inserted through an 18-gauge 3 inch spinal needle into the peripheral planned needle tracks, monitored by TRUS. As the needles are advanced to the prostatic base, about 1.0 cc of lidocaine solution is injected in the intraprostatic track. A total of 200 to 500 mg of lidocaine is used. RESULTS: As of December 2000, more than 600 patients have received implants under local anesthesia at Seattle, WA. Patients tolerate brachytherapy under local anesthesia surprisingly well. Post-implant CT-defined target coverage has ranged from 80% to 95%, well within published criteria for technical adequacy. Patients' typical implant pain score is 3, on a scale of 0-10. After a series of patient acceptance quality studies, we have abandoned the routine use of sedation, and relied instead on local lidocaine infiltration alone. CONCLUSION: In addition to a high degree of patient satisfaction, performing implants under local anesthesia allows for phenomenal logistical efficiencies and cost advantages.","Brachytherapy, 1(3): 145-148","USA",2002,"Any or unknown","Brachytherapy","NPS","Patient",null,"Cross-sectional","USA","Patient","Any or unknown","Brachytherapy",null,"Cross-sectional","NPS","2000:2004","Symptom"]
[715,"Walsh, P. C., et al. (2000). \"Patient-reported urinary continence and sexual function after anatomic radical prostatectomy.\" Urology 55(1): 58-61.",null,"Walsh, P. C., et al.","Patient-reported urinary continence and sexual function after anatomic radical prostatectomy","OBJECTIVES: After radical prostatectomy, the rates for recovery of urinary continence and sexual function reported by experienced surgeons are much higher than the patient-reported outcomes from other centers. It is uncertain whether this represents differences in surgical technique or in the collection of data. This study was performed to determine patient-reported rates of continence and potency after radical prostatectomy performed by an experienced surgeon at a high-volume referral center for the treatment of localized prostate cancer. METHODS: Sixty-four men with localized prostate cancer who were potent preoperatively and who had sexual partners underwent anatomic radical prostatectomy between March 1997 and January 1998. A validated disease-targeted quality-of-life survey that assesses function and bother in two organ systems (urinary and sexual) was administered preoperatively and at 3, 6, 12, and 18 months postoperatively. RESULTS: Urinary continence, which was defined as wearing no pads, gradually improved during the first 12 months after surgery, and at 1 2 and 18 months, 93% of the patients were dry. Throughout the study, 93% to 98% of the patients characterized their urinary bother as none or small. Potency, defined as the ability to have unassisted intercourse with or without the use of sildenafil, improved gradually, and by 18 months, 86% of patients were potent and 84% considered sexual bother as none or small. Although one third of patients at 18 months were using sildenafil intermittently, only 2 patients were not able to have intercourse without its use. CONCLUSIONS: Patient-reported rates of continence and potency after radical prostatectomy performed by an experienced surgeon are high.","Urology, 55(1): 58-61","USA",2000,"Local","Surgery","Unclear","Patient",null,"Cohort","USA","Patient","Local","Surgery",null,"Cohort","Unclear","2000:2004","General"]
[716,"Wang, H., et al. (2000). \"Self-assessed health-related quality of life in men who have completed radiotherapy for prostate cancer: instrument validation and its relation to patient-assessed bother of symptoms.\" Int J Cancer 90(3): 163-172.",null,"Wang, H., et al.","Self-assessed health-related quality of life in men who have completed radiotherapy for prostate cancer: instrument validation and its relation to patient-assessed bother of symptoms","The purpose of this study was to develop a psychometrically reliable and valid questionnaire to assess the disease-specific dimensions of health-related quality of life (HRQOL) in the urinary function (UF), bowel function (BF), and sexual function (SF) domains of prostate cancer (PCa) patients treated with radiation therapy. Patients were given a six-page questionnaire using Likert-type questions assessing three HRQOL dimensions during their follow-up visits after completing radiotherapy. Scales created from an earlier study were utilized and tested for reliability and validity. In addition, we assessed the relationship between these dimensions and the degree to which a decreased HRQOL increases the degree to which patients feel bothered about their symptoms. There are two scales within each dimension: BF, Urgency and Daily Living; UF, Urgency and Weakness of Stream; SF, Interest/Satisfaction and Impotence. Internal-consistency reliability coefficients (Cronbach's alpha) for the proposed scales range from 0.48 to 0.92, and all item-scale correlations and divergence correlations validate the use of the scales, ranging from 0.49 to 0.89. The validity of these scales is also confirmed by the rising median scores with rising reported levels of patient-perceived \"bother.\" The different dimensions have differing quantitative influences on patients. We have developed a prostate-specific HRQOL instrument that is an adequate and suitable tool for measuring HRQOL along three distinct dimensions for patients who have completed radiotherapy for PCa. Psychometric standards for reliability and validity were met for the proposed scales. Moreover, positive correlations were found between these dimensions and how bothered patients were by their symptoms, suggesting important relationships that should be followed in PCa patients after radiotherapy. Certain scales have strong influences on patient-perceived \"bothersomeness\" of symptoms, such as loss of control of BF, urgency of BF, urgency of urination, and level of interest/satisfaction in sex. Compared to our earlier study on patients being treated with radiotherapy for PCa, this study produced very similar results. With some modification, the same questionnaire could be used for both groups of patients. Int. J. Cancer (Radiat. Oncol. Invest.) 90, 163-172 (2000).","Int J Cancer, 90(3): 163-172","USA",2000,"Any or unknown","Radiotherapy","Unclear","Patient",null,"Validation","USA","Patient","Any or unknown","Radiotherapy",null,"Validation","Unclear","2000:2004","Symptom,Complication"]
[717,"Watkins-Bruner, D., et al. (1995). \"RTOG's first quality of life study--RTOG 90-20: a phase II trial of external beam radiation with etanidazole for locally advanced prostate cancer.\" Int J Radiat Oncol Biol Phys 33(4): 901-906.",null,"Watkins-Bruner, D., et al.","RTOG's first quality of life study--RTOG 90-20: a phase II trial of external beam radiation with etanidazole for locally advanced prostate cancer","PURPOSE: To assess institutional and patient compliance with quality of life (QL) instruments in RTOG clinical trials. To assess feasibility of using the Functional Assessment Cancer Therapy (FACT), Sexual Adjustment Questionnaire (SAQ), and Changes in Urinary Function (CUF) QL instruments in a prostate clinical trial and to compare patient self-report of symptoms to medical professional ratings of the same symptoms using the RTOG acute toxicity rating scales. METHODS AND MATERIALS: Three self-assessment QL instruments, the FACT, the SAQ, and CUF, were to be administered to patients on a Phase II locally advanced prostate trial at specified time points. Specific instructions for both data managers and for patients on when, how, and why to fill out the questionnaires were included. RESULTS: Sixty-seven percent (24 out of 36) of patients accrued to RTOG 90-20 completed both the initial FACT and SAQ. Eighty-five percent completed FACT at end of RT and 73% at 3 months. Eighty-one percent completed SAQ at end of treatment, while 69% completed this form at 3 months. Compliance drops off thereafter. Seventy-five percent of patients who had their symptom of dysuria rated by a medical professional as 0 on the RTOG toxicity rating scale self-reported the same. Only 56% of patient self-reports on FACT regarding diarrhea were in agreement with the medical professional's RTOG rating of 0 toxicity. The measures were determined to be in moderate agreement when the patient evaluated a symptom as a 1 on the FACT and the medical professional rated the same symptom as a 0 on the RTOG toxicity rating scale. There was moderate agreement in 13% of patients with dysuria and 31% of patients with diarrhea. Low agreement occurred when the patient evaluated a symptom as a 2 or 3 on the FACT and the medical professional rated the same symptom as a 0 on the RTOG scale. Low agreement occurred in 13% of both patients reporting dysuria and diarrhea. Differences between how medical professionals and patients were able to rate erectile function make direct comparisons difficult, but the trend towards significant discrepancies is still noteworthy. CONCLUSIONS: Quality of life assessments are necessary and attainable in RTOG clinical trials. Compliance rates for both institutional and patient participation were acceptable at initial and 3 month follow-up. Reasons for noncompliance were predominantly institution related and not patient related. Strategies to address both institution and patient compliance have been developed and implemented within the RTOG. Serious disagreement between patient self-reports of symptoms on the FACT QL scale and medical professional ratings on the RTOG acute toxicity rating scales of the same symptoms was 13% at 3 months follow-up. This warrants continued use of QL self-assessments in clinical trials.","Int J Radiat Oncol Biol Phys, 33(4): 901-906","USA",1995,"Advanced","Radiotherapy,Various","FACT-G,SAQ,CUF","Patient",null,"Validation","USA","Patient","Advanced","Radiotherapy,Various",null,"Validation","FACT-G,SAQ,CUF","1960:1999","Treatment,Complication,Symptom"]
[718,"Watson, E., et al. (2006). \"Informed decision making and prostate specific antigen (PSA) testing for prostate cancer: a randomised controlled trial exploring the impact of a brief patient decision aid on men's knowledge, attitudes and intention to be tested.\" Patient Educ Couns 63(3): 367-379.",null,"Watson, E., et al.","Informed decision making and prostate specific antigen (PSA) testing for prostate cancer: a randomised controlled trial exploring the impact of a brief patient decision aid on men's knowledge, attitudes and intention to be tested","OBJECTIVE: To examine the impact of a brief patient decision aid (pDA) on men's knowledge, attitudes and intention to have a prostate specific antigen (PSA) test. To explore the important predictors of intention to be tested in men who received the brief pDA. METHODS: A brief pDA designed to facilitate informed decision-making for men considering PSA testing was developed for the NHS Prostate Cancer Risk Management Programme. Men aged 40-75 years selected from 11 General Practices in England and Wales were randomised to receive either a mailed copy of the brief pDA and a questionnaire (intervention group), or a questionnaire alone (control group). The questionnaire assessed knowledge, attitudes, perceived risk and intention to have a PSA test and, for the intervention group, their perceptions of the brief pDA. RESULTS: Nine hundred and ninety of the men who were eligible for the study returned completed questionnaires (response rate=54%). Men who received the brief pDA had significantly higher knowledge scores (p<0.0001) and less positive attitudes (p<0.0001) regarding PSA testing than men in the control group. There was no significant difference between the two groups in intention to be tested within the next 12 months. 87% of men found the brief pDA was easy to read, 94% considered it contained about the right amount of detail and 94% felt the information was presented in a balanced way. Multivariate analysis identified perceived risk (p<0.0001), perceived benefits of PSA testing (p<0.0001), knowledge (p=0.004), attitude (p=0.007) and age (p=0.01) as the most important independent predictors of intention to be tested amongst men in the intervention group. CONCLUSION: The brief pDA was shown to dramatically increase men's knowledge of the benefits and risks of the PSA test. Men who received the brief pDA were significantly less positive about the PSA test, although there was no difference between the two groups regarding their intention to be tested within the next year. PRACTICE IMPLICATIONS: This brief pDA could serve as an acceptable and low cost adjunct to counselling by the General Practitioner (GP), and should promote informed decision making regarding the PSA test. Further research is required to ascertain the utility of the decision aid during the consultation.","Patient Educ Couns, 63(3): 367-379","UK",2006,"At risk","Various,Screening","Unclear","General population",null,"Clinical trial","UK","General population","At risk","Various,Screening",null,"Clinical trial","Unclear","2005:2009","Knowledge"]
[719,"Watts, S., et al. (2015). \"A quantitative analysis of the prevalence of clinical depression and anxiety in patients with prostate cancer undergoing active surveillance.\" BMJ Open 5(5): e006674.",null,"Watts, S., et al.","A quantitative analysis of the prevalence of clinical depression and anxiety in patients with prostate cancer undergoing active surveillance","OBJECTIVE: To quantitatively determine the prevalence of anxiety and depression in men on active surveillance (AS). DESIGN: Cross-sectional questionnaire survey. SETTING: Secondary care prostate cancer (PCa) clinics across South, Central and Western England. PARTICIPANTS: 313 men from a total sample of 426 with a histological diagnosis of PCa currently managed with AS were identified from seven UK urology departments. The mean age of respondents was 70 (51-86) years with the majority (76%) being married or in civil partnerships. 94% of responders were of white British ethnicity. PRIMARY OUTCOME MEASURES: The prevalence of clinically meaningful depression and anxiety as assessed by the Hospital Anxiety and Depression Scale (HADS; score >/=8/21). SECONDARY OUTCOME MEASURES: Patient demographic data (age, employment, relationship, ethnic and educational status). Each demographic variable was cross-tabulated against patients identified as depressed or anxious to allow for the identification of variables that were significantly associated with depression and anxiety. In order to determine predictors for depression and anxiety among the demographic variables, logistic regression analyses were conducted, with p<0.05 considered as indicating statistical significance. RESULTS: The prevalence of clinical anxiety and depression as determined via the HADS (HADS >/=8) was 23% (n=73) and 12.5% (n=39), respectively. Published data from men in the general population of similar age has shown prevalence rates of 8% and 6%, respectively, indicating a twofold increase in depression and a threefold increase in anxiety among AS patients. Our findings also suggest that AS patients experience substantially greater levels of anxiety than patients with PCa treated radically. The only demographic predictor for anxiety or depression was divorce. CONCLUSIONS: Patients with PCa managed with AS experienced substantially higher rates of anxiety and depression than that expected in the general population. Strategies to address this are needed to improve the management of this population and their quality of life.","BMJ Open, 5(5): e006674","UK",2015,"Any or unknown","Surveillance","HADS","Patient",null,"Cross-sectional","UK","Patient","Any or unknown","Surveillance",null,"Cross-sectional","HADS","2015:2018","Comorbidity"]
[720,"Wei, J. T. and J. E. Montie (2000). \"Comparison of patients' and physicians' rating of urinary incontinence following radical prostatectomy.\" Semin Urol Oncol 18(1): 76-80.",null,"Wei, J. T. and J. E. Montie","Comparison of patients' and physicians' rating of urinary incontinence following radical prostatectomy","One of the most important endpoints following a radical prostatectomy focuses on the recovery of urinary continence; however, the reported incontinence rates have been quite variable. In men with prostate cancer, it has been found that the physician's assessment of a patient's symptom does not correlate with the patient's own assessment. To further explore the differences in the reported outcomes between physicians and patients, we evaluated the assessment of urinary incontinence in a cohort of men undergoing radical prostatectomy. A total of 145 individuals completed a brief urinary continence questionnaire postoperatively at the 1-year anniversary of their operation and also had the physicians' assessment of incontinence documented in the medical record. Patient-reported incontinence rates varied from 13% to 65% depending on the definition of incontinence applied and the greatest agreement was seen when the physicians' assessment of incontinence was compared with the patient's report of pad use and urinary bother. These comparisons resulted in only moderate to good levels of agreement, which suggests that a more reliable and accurate means to evaluate urinary incontinence following radical prostatectomy needs to be developed.","Semin Urol Oncol, 18(1): 76-80","USA",2000,"Any or unknown","Surgery","Unclear","HCP,Patient",null,"Validation","USA","HCP,Patient","Any or unknown","Surgery",null,"Validation","Unclear","2000:2004","Complication"]
[721,"Wei, J. T., et al. (2000). \"Development and validation of the expanded prostate cancer index composite (EPIC) for comprehensive assessment of health-related quality of life in men with prostate cancer.\" Urology 56(6): 899-905.",null,"Wei, J. T., et al.","Development and validation of the expanded prostate cancer index composite (EPIC) for comprehensive assessment of health-related quality of life in men with prostate cancer","OBJECTIVES: Health-related quality of life (HRQOL) is an increasingly important endpoint in prostate cancer care. However, pivotal issues that are not fully assessed in existing HRQOL instruments include irritative urinary symptoms, hormonal symptoms, and multi-item scores quantifying bother between urinary, sexual, bowel, and hormonal domains. We sought to develop a novel instrument to facilitate more comprehensive assessment of prostate cancer-related HRQOL. METHODS: Instrument development was based on advice from an expert panel and prostate cancer patients, which led to expanding the 20-item University of California-Los Angeles Prostate Cancer Index (UCLA-PCI) to the 50-item Expanded Prostate Index Composite (EPIC). Summary and subscale scores were derived by content and factor analyses. Reliability and validity were assessed by test-retest correlation, Cronbach's alpha coefficient, interscale correlation, and EPIC correlation with other validated instruments. RESULTS: Test-retest reliability and internal consistency were high for EPIC urinary, bowel, sexual, and hormonal domain summary scores (each r >/=0.80 and Cronbach's alpha >/=0.82) and for most domain-specific subscales. Correlations between function and bother subscales within domains were high (r >0.60). Correlations between different primary domains were consistently lower, indicating that these domains assess distinct HRQOL components. EPIC domains had weak to modest correlations with the Medical Outcomes Study 12-item Short-Form Health Survey (SF-12), indicating rationale for their concurrent use. Moderate agreement was observed between EPIC domains relevant to the Functional Assessment of Cancer Therapy Prostate module (FACT-P) and the American Urological Association Symptom Index (AUA-SI), providing criterion validity without excessive overlap. CONCLUSIONS: EPIC is a robust prostate cancer HRQOL instrument that complements prior instruments by measuring a broad spectrum of urinary, bowel, sexual, and hormonal symptoms, thereby providing a unique tool for comprehensive assessment of HRQOL issues important in contemporary prostate cancer management.","Urology, 56(6): 899-905","USA",2000,"Any or unknown","None","EPIC,SF-12,FACT-P,AUA-SI","Patient",null,"Validation","USA","Patient","Any or unknown","None",null,"Validation","EPIC,SF-12,FACT-P,AUA-SI","2000:2004","Disease,Utility,Symptom"]
[722,"Wei, J. T., et al. (2000). \"Prospective assessment of patient reported urinary continence after radical prostatectomy.\" J Urol 164(3 Pt 1): 744-748.",null,"Wei, J. T., et al.","Prospective assessment of patient reported urinary continence after radical prostatectomy","PURPOSE: Reported urinary continence rates after radical prostatectomy vary. Although modifications of radical prostatectomy meant to improve outcome, such as nerve sparing or bladder neck preservation, are in widespread use, to our knowledge evidence to support these practices based on patient report is scant. We evaluated the potential effects of nerve sparing and bladder neck preservation on urinary continence after radical prostatectomy, and assessed the impact of various urinary continence definitions on the observed outcome. MATERIALS AND METHODS: We prospectively evaluated a cohort of men with prostate cancer who elected surgery with and without nerve sparing, and bladder neck preservation as primary therapy. A total of 482 men completed a brief urinary continence questionnaire preoperatively and postoperatively at a median followup of 18 months. Urinary continence was followed prospectively using the questionnaire and patient reported urinary continence recovery was based on 3 definitions of continence. RESULTS: Median time to continence recovery based on patient reporting was significantly shorter in the nerve sparing than in the nonnerve sparing group when continence was defined as no urinary leakage (5.3 versus 10.9 months, p <0.01). A multivariate model controlling for baseline factors revealed that significant predictors of continence outcome were preoperative continence, patient age, nerve sparing and the interaction of nerve sparing with age (p <0.05). The definition of urinary continence also affected outcome. CONCLUSIONS: The nerve sparing technique of radical prostatectomy was associated with improved recovery of urinary continence in an age dependent manner, whereas bladder neck preservation was not beneficial. Patient age and the sensitivity of the incontinence definitions, as reflected by the associated variable rates of preoperative baseline incontinence, are significant contexts for interpreting urinary function data after radical prostatectomy. These factors may partially explain the variation in continence rates in the literature.","J Urol, 164(3 Pt 1): 744-748","USA",2000,"Any or unknown","Surgery","Unclear","Patient",null,"Cohort","USA","Patient","Any or unknown","Surgery",null,"Cohort","Unclear","2000:2004","Complication"]
[723,"Wei, J. T., et al. (2002). \"Comprehensive comparison of health-related quality of life after contemporary therapies for localized prostate cancer.\" J Clin Oncol 20(2): 557-566.",null,"Wei, J. T., et al.","Comprehensive comparison of health-related quality of life after contemporary therapies for localized prostate cancer","PURPOSE: Health-related quality-of-life (HRQOL) concerns are pivotal in choosing prostate cancer therapy. However, concurrent HRQOL comparison between brachytherapy, external radiation, radical prostatectomy, and controls is hitherto lacking. HRQOL effects of hormonal adjuvants and of cancer control after therapy also lack prior characterization. PATIENTS AND METHODS: A cross-sectional survey was administered to patients who underwent brachytherapy, external-beam radiation, or radical prostatectomy during 4 years at an academic medical center and to age-matched controls. HRQOL among controls was compared with therapy groups. Comparison between therapy groups was performed using regression models to control covariates. HRQOL effects of cancer progression were evaluated. RESULTS: One thousand fourteen subjects participated. Compared with controls, each therapy group reported bothersome sexual dysfunction; radical prostatectomy was associated with adverse urinary HRQOL; external-beam radiation was associated with adverse bowel HRQOL; and brachytherapy was associated with adverse urinary, bowel, and sexual HRQOL (P < or =.0002 for each). Hormonal adjuvant symptoms were associated with significant impairment (P <.002). More than 1 year after therapy, several HRQOL outcomes were less favorable among subjects after brachytherapy than after external radiation or radical prostatectomy. Progression-free subjects reported better sexual and hormonal HRQOL than subjects with increasing prostate-specific antigen (P <.0001). CONCLUSION: Long-term HRQOL after prostate brachytherapy showed no benefit relative to radical prostatectomy or external-beam radiation and may be less favorable in some domains. Hormonal adjuvants can be associated with significant impairment. Progression-free survival is associated with HRQOL benefits. These findings facilitate patient counseling regarding HRQOL expectations and highlight the need for prospective studies sensitive to urinary irritative and hormonal concerns in addition to incontinence, sexual, and bowel HRQOL domains.","J Clin Oncol, 20(2): 557-566","USA",2002,"Local","Surgery,Radiotherapy,Brachytherapy","Unclear","Patient",null,"Case-control","USA","Patient","Local","Surgery,Radiotherapy,Brachytherapy",null,"Case-control","Unclear","2000:2004","Complication"]
[724,"Weinfurt, K. P., et al. (2005). \"The significance of skeletal-related events for the health-related quality of life of patients with metastatic prostate cancer.\" Ann Oncol 16(4): 579-584.",null,"Weinfurt, K. P., et al.","The significance of skeletal-related events for the health-related quality of life of patients with metastatic prostate cancer","BACKGROUND: We examined the clinical relevance of skeletal-related events (SREs) for health state preferences, pain and health-related quality of life in patients with advanced prostate cancer and a history of bone metastases. PATIENTS AND METHODS: Data were from a clinical trial of zoledronic acid versus placebo in the treatment of SREs associated with advanced prostate cancer metastatic to bone. Patients (n=248) were included if they experienced an SRE during the study. Outcome measures were assessed at fixed intervals. We used mixed-effects models to estimate changes in outcomes after each patient's first SRE. RESULTS: There were clinically meaningful and statistically significant declines in physical well-being after: radiation and pathologic fractures; functional well-being after radiation; and emotional well-being after radiation and pathologic fractures. There also were meaningful and significant declines in preference and utility scores after radiation and fracture. Pain intensity declined after radiation, but not after other SREs; no other pain measure changed substantively. CONCLUSIONS: SREs have important and significant effects on measures of health-related quality of life in men with prostate cancer. Treatments that prevent SREs may not demonstrate corresponding effects on outcomes if the effects of SREs occur between scheduled outcome assessments. Implications for trial design are discussed.","Ann Oncol, 16(4): 579-584","USA",2005,"Metastatic","Bisphosphonate","Unclear","Patient",null,"Clinical trial","USA","Patient","Metastatic","Bisphosphonate",null,"Clinical trial","Unclear","2005:2009","Utility"]
[725,"Weinrich, S. P., et al. (1998). \"The impact of prostate cancer knowledge on cancer screening.\" Oncol Nurs Forum 25(3): 527-534.",null,"Weinrich, S. P., et al.","The impact of prostate cancer knowledge on cancer screening","PURPOSE/OBJECTIVES: To test the effect of knowledge on participation in prostate cancer screening. DESIGN: Quasi-experimental design; PRECEDE framework. SAMPLE: 319 men, 82% African American. METHODS: Prostate cancer knowledge was measured with a Prostate Cancer Knowledge Questionnaire prior to a community-based educational program. Men were referred to their personal physicians for a free prostate cancer screening. Results were sent to the Prostate Cancer Project. MAIN RESEARCH VARIABLES: Prostate cancer knowledge and participation in free prostate screening with a digital rectal examination and prostate specific antigen. FINDINGS: Prostate cancer knowledge was a predictor in participation in screening (p = 0.05). IMPLICATIONS FOR NURSING PRACTICE: Nurses need to target educational interventions for African American men, who have the highest incidence of and mortality rates for prostate cancer, to significantly reduce mortality rates. This study documented the importance of providing educational programs to increase participation in prostate cancer screening.","Oncol Nurs Forum, 25(3): 527-534","USA",1998,"At risk","Screening","PCKQ","General population",null,"Cross-sectional","USA","General population","At risk","Screening",null,"Cross-sectional","PCKQ","1960:1999","Knowledge"]
[726,"Weitzner, M. A., et al. (1999). \"The Caregiver Quality of Life Index-Cancer (CQOLC) scale: development and validation of an instrument to measure quality of life of the family caregiver of patients with cancer.\" Qual Life Res 8(1-2): 55-63.",null,"Weitzner, M. A., et al.","The Caregiver Quality of Life Index-Cancer (CQOLC) scale: development and validation of an instrument to measure quality of life of the family caregiver of patients with cancer","Family caregivers have become increasingly responsible for providing home care for cancer patients. Research has documented the distress of family caregivers; however, little has been done to evaluate the broader impact of caregiving on quality of life (QoL). The objectives of this study were to evaluate the reliability and validity of the Caregiver Quality of Life Index-Cancer (CQOLC), a new self-report instrument. Two hundred and sixty-three family caregivers of patients with lung, breast or prostate neoplasms participated. Test-retest reliability was 0.95 and internal consistency was 0.91. As expected, there were moderate correlations with overall mental health (r = 0.64), emotional distress (r = -0.50 to -0.52), burden (r = -0.65) and patient's performance status (r = -0.47) and low correlations with overall physical health (r = 0.13), social support (r = 0.22) and social desirability (r = 0.08). These results show that increased overall mental health is associated with better QoL, while more emotional distress and worsening patient performance status are associated with poorer QoL. Thus, the CQOLC appears to possess adequate validity, test-retest reliability and internal consistency. Future directions include further evaluation of sensitivity to change and factor analysis to determine the principal health-related QoL domains evaluated by the CQOLC.","Qual Life Res, 8(1-2): 55-63","USA",1999,"Any or unknown","None","CQOLC","Caregiver",null,"Validation","USA","Caregiver","Any or unknown","None",null,"Validation","CQOLC","1960:1999","Carer"]
[727,"Westhoff, P. G., et al. (2014). \"An easy tool to predict survival in patients receiving radiation therapy for painful bone metastases.\" Int J Radiat Oncol Biol Phys 90(4): 739-747.",null,"Westhoff, P. G., et al.","An easy tool to predict survival in patients receiving radiation therapy for painful bone metastases","PURPOSE: Patients with bone metastases have a widely varying survival. A reliable estimation of survival is needed for appropriate treatment strategies. Our goal was to assess the value of simple prognostic factors, namely, patient and tumor characteristics, Karnofsky performance status (KPS), and patient-reported scores of pain and quality of life, to predict survival in patients with painful bone metastases. METHODS AND MATERIALS: In the Dutch Bone Metastasis Study, 1157 patients were treated with radiation therapy for painful bone metastases. At randomization, physicians determined the KPS; patients rated general health on a visual analogue scale (VAS-gh), valuation of life on a verbal rating scale (VRS-vl) and pain intensity. To assess the predictive value of the variables, we used multivariate Cox proportional hazard analyses and C-statistics for discriminative value. Of the final model, calibration was assessed. External validation was performed on a dataset of 934 patients who were treated with radiation therapy for vertebral metastases. RESULTS: Patients had mainly breast (39%), prostate (23%), or lung cancer (25%). After a maximum of 142 weeks' follow-up, 74% of patients had died. The best predictive model included sex, primary tumor, visceral metastases, KPS, VAS-gh, and VRS-vl (C-statistic = 0.72, 95% CI = 0.70-0.74). A reduced model, with only KPS and primary tumor, showed comparable discriminative capacity (C-statistic = 0.71, 95% CI = 0.69-0.72). External validation showed a C-statistic of 0.72 (95% CI = 0.70-0.73). Calibration of the derivation and the validation dataset showed underestimation of survival. CONCLUSION: In predicting survival in patients with painful bone metastases, KPS combined with primary tumor was comparable to a more complex model. Considering the amount of variables in complex models and the additional burden on patients, the simple model is preferred for daily use. In addition, a risk table for survival is provided.","Int J Radiat Oncol Biol Phys, 90(4): 739-747","Netherlands",2014,"Metastatic","Radiotherapy","VAS,VRS","Patient",null,"Cohort","Netherlands","Patient","Metastatic","Radiotherapy",null,"Cohort","VAS,VRS","2010:2014","General"]
[728,"Westhoff, P. G., et al. (2015). \"Quality of Life in Relation to Pain Response to Radiation Therapy for Painful Bone Metastases.\" Int J Radiat Oncol Biol Phys 93(3): 694-701.",null,"Westhoff, P. G., et al.","Quality of Life in Relation to Pain Response to Radiation Therapy for Painful Bone Metastases","PURPOSE: To study quality of life (QoL) in responders and nonresponders after radiation therapy for painful bone metastases; and to identify factors predictive for a pain response. PATIENTS AND METHODS: The prospectively collected data of 956 patients with breast, prostate, and lung cancer within the Dutch Bone Metastasis Study were used. These patients, irradiated for painful bone metastases, rated pain, QoL, and overall health at baseline and weekly afterward for 12 weeks. Using generalized estimating equations analysis, the course of QoL was studied, adjusted for primary tumor. To identify predictive variables, proportional hazard analyses were performed, taking into account death as a competing risk, and C-statistics were calculated for discriminative value. RESULTS: In total, 722 patients (76%) responded to radiation therapy. During follow-up, responders had a better QoL in all domains compared with nonresponders. Patients with breast or prostate cancer had a better QoL than patients with lung cancer. In multivariate analysis, baseline predictors for a pain response were breast or prostate cancer as primary tumor, younger age, good performance status, absence of visceral metastases, and using opioids. The discriminative ability of the model was low (C-statistic: 0.56). CONCLUSIONS: Responding patients show a better QoL after radiation therapy for painful bone metastases than nonresponders. Our model did not have enough discriminative power to predict which patients are likely to respond to radiation therapy. Therefore, radiation therapy should be offered to all patients with painful bone metastases, aiming to decrease pain and improve QoL.","Int J Radiat Oncol Biol Phys, 93(3): 694-701","Netherlands",2015,"Metastatic","Radiotherapy","Unclear","Patient",null,"Cohort","Netherlands","Patient","Metastatic","Radiotherapy",null,"Cohort","Unclear","2015:2018","General,Symptom"]
[729,"Wheat, J. C., et al. (2009). \"Clinical interpretation of the Expanded Prostate Cancer Index Composite-Short Form sexual summary score.\" J Urol 182(6): 2844-2849.",null,"Wheat, J. C., et al.","Clinical interpretation of the Expanded Prostate Cancer Index Composite-Short Form sexual summary score","PURPOSE: The Expanded Prostate Cancer Index Composite is a validated health related quality of life instrument that is commonly administered after prostate cancer treatment. We classified Expanded Prostate Cancer Index Composite-Short Form sexual summary scores into clinically meaningful groups. MATERIALS AND METHODS: A development cohort of 561 patients undergoing radical prostatectomy was used to define sexual summary groups by correlation with their responses on the Sexual Health Inventory for Men. A separate validation cohort of 430 patients was used to compare Expanded Prostate Cancer Index Composite-Long Form sexual bother scores among these sexual summary groups. RESULTS: A sexual summary group score of 0 to 33, 34 to 45, 46 to 60, 61 to 75 and greater than 75 correlated with Sexual Health Inventory for Men groups of severe--1 to 7, moderate--8 to 11, mild/moderate--12 to 16, mild--17 to 21 and no erectile dysfunction--22 to 25, respectively. In the validation group mean sexual bother scores in each of the 5 sexual summary groups were significantly different from each other after controlling for patient age, stage, hormone treatment, marital status and nerve sparing (p <0.0001). CONCLUSIONS: Expanded Prostate Cancer Index Composite-Short Form sexual summary scores can be categorized into 5 groups for which excellent correlation is found with similar validated groups based on the Sexual Health Inventory for Men. Also, sexual bother scores are significantly different among the groups, showing that they represent discrete, clinically relevant cutoffs. This will help patients and physicians interpret Expanded Prostate Cancer Index Composite scores and help define potency for comparison among various prostate cancer treatments.","J Urol, 182(6): 2844-2849","USA",2009,"Any or unknown","Surgery,Hormonal","EPIC,SHIM","Patient",null,"Validation","USA","Patient","Any or unknown","Surgery,Hormonal",null,"Validation","EPIC,SHIM","2005:2009","Disease,Complication"]
[730,"Widmark, A., et al. (2003). \"Does prophylactic breast irradiation prevent antiandrogen-induced gynecomastia? Evaluation of 253 patients in the randomized Scandinavian trial SPCG-7/SFUO-3.\" Urology 61(1): 145-151.",null,"Widmark, A., et al.","Does prophylactic breast irradiation prevent antiandrogen-induced gynecomastia? Evaluation of 253 patients in the randomized Scandinavian trial SPCG-7/SFUO-3","OBJECTIVES: To examine the development of antiandrogen-induced gynecomastia and breast tenderness in the first 253 patients in a randomized Scandinavian trial (SPCG-7/SFUO-3) with a 12-month complete follow-up evaluation performed by both doctors and patients. METHODS: In this study, the treating doctor and patient decided whether prophylactic irradiation (RT) of the breast should be given to prevent antiandrogen-induced gynecomastia. At each visit, the doctor evaluated the occurrence of gynecomastia and breast tenderness. Questions about gynecomastia and breast tenderness were also included in the study quality-of-life questionnaire (Prostate Cancer Symptom Scale). RESULTS: Mammary RT with mostly single fraction (12 to 15 Gy) electrons was given to 174 (69%) of the 253 evaluated patients. At the 1-year follow-up visit, the doctor evaluations indicated some form of gynecomastia in 71% and 28% (P <0.001) of the nonirradiated (no-RT) and irradiated (RT) patients, respectively. The patient evaluations at 1 year showed some form of breast enlargement in 78% and 44% (P <0.001) of the no-RT and RT patients, respectively. The doctors reported some form of breast tenderness at 1 year in 75% and 43% (P <0.001) of the no-RT and RT patients, respectively. The patient evaluations of breast tenderness show an expected significant increase in the RT arm at the 3-month follow-up, which was probably due to skin reactions. At 1 year, significantly more patients who marked \"very much\" on the Prostate Cancer Symptom Scale were seen in the no-RT group. A weak correlation between the doctors' and patients' detection of breast problems was observed. CONCLUSIONS: The results show that, with high significance, prophylactic RT of the breast decreases the risk of antiandrogen-induced gynecomastia and breast tenderness.","Urology, 61(1): 145-151","Sweden",2003,"Any or unknown","Radiotherapy,Hormonal","PCSI","HCP,Patient",null,"Clinical trial","Sweden","HCP,Patient","Any or unknown","Radiotherapy,Hormonal",null,"Clinical trial","PCSI","2000:2004","Symptom"]
[731,"Wiegner, E. A. and C. R. King (2010). \"Sexual function after stereotactic body radiotherapy for prostate cancer: results of a prospective clinical trial.\" Int J Radiat Oncol Biol Phys 78(2): 442-448.",null,"Wiegner, E. A. and C. R. King","Sexual function after stereotactic body radiotherapy for prostate cancer: results of a prospective clinical trial","PURPOSE: To study the sexual quality of life for prostate cancer patients after stereotactic body radiotherapy (SBRT). METHODS AND MATERIALS: Using the Expanded Prostate Cancer Index Composite (EPIC)-validated quality-of-life questionnaire, the sexual function of 32 consecutive patients who received prostate SBRT in a prospective Phase II clinical trial were analyzed at baseline, and at median times of 4, 12, 20, and 50 months after treatment. SBRT consisted of 36.25 Gy in five fractions of 7.25 Gy using the Cyberknife. No androgen deprivation therapy was given. The use of erectile dysfunction (ED) medications was monitored. A comprehensive literature review for radiotherapy-alone modalities based on patient self-reported questionnaires served as historical comparison. RESULTS: Median age at treatment was 67.5 years, and median follow-up was 35.5 months (minimum 12 months). The mean EPIC sexual domain summary score, sexual function score, and sexual bother score decreased by 45%, 49%, and 25% respectively at 50 months follow-up. These differences reached clinical relevance by 20 months after treatment. Baseline ED rate was 38% and increased to 71% after treatment (p = 0.024). Use of ED medications was 3% at baseline and progressed to 25%. For patients aged <70 years at follow-up, 60% maintained satisfactory erectile function after treatment compared with only 12% aged >/=70 years (p = 0.008). Penile bulb dose was not associated with ED. CONCLUSIONS: The rates of ED after treatment appear comparable to those reported for other modalities of radiotherapy. Given the modest size of this study and the uncertainties in the physiology of radiotherapy-related ED, these results merit further investigations.","Int J Radiat Oncol Biol Phys, 78(2): 442-448","USA",2010,"Any or unknown","Radiotherapy","EPIC","Patient",null,"Clinical trial","USA","Patient","Any or unknown","Radiotherapy",null,"Clinical trial","EPIC","2010:2014","Disease"]
[732,"Wilkins, A., et al. (2015). \"Hypofractionated radiotherapy versus conventionally fractionated radiotherapy for patients with intermediate-risk localised prostate cancer: 2-year patient-reported outcomes of the randomised, non-inferiority, phase 3 CHHiP trial.\" Lancet Oncol 16(16): 1605-1616.",null,"Wilkins, A., et al.","Hypofractionated radiotherapy versus conventionally fractionated radiotherapy for patients with intermediate-risk localised prostate cancer: 2-year patient-reported outcomes of the randomised, non-inferiority, phase 3 CHHiP trial","BACKGROUND: Patient-reported outcomes (PROs) might detect more toxic effects of radiotherapy than do clinician-reported outcomes. We did a quality of life (QoL) substudy to assess PROs up to 24 months after conventionally fractionated or hypofractionated radiotherapy in the Conventional or Hypofractionated High Dose Intensity Modulated Radiotherapy in Prostate Cancer (CHHiP) trial. METHODS: The CHHiP trial is a randomised, non-inferiority phase 3 trial done in 71 centres, of which 57 UK hospitals took part in the QoL substudy. Men with localised prostate cancer who were undergoing radiotherapy were eligible for trial entry if they had histologically confirmed T1b-T3aN0M0 prostate cancer, an estimated risk of seminal vesicle involvement less than 30%, prostate-specific antigen concentration less than 30 ng/mL, and a WHO performance status of 0 or 1. Participants were randomly assigned (1:1:1) to receive a standard fractionation schedule of 74 Gy in 37 fractions or one of two hypofractionated schedules: 60 Gy in 20 fractions or 57 Gy in 19 fractions. Randomisation was done with computer-generated permuted block sizes of six and nine, stratified by centre and National Comprehensive Cancer Network (NCCN) risk group. Treatment allocation was not masked. UCLA Prostate Cancer Index (UCLA-PCI), including Short Form (SF)-36 and Functional Assessment of Cancer Therapy-Prostate (FACT-P), or Expanded Prostate Cancer Index Composite (EPIC) and SF-12 quality-of-life questionnaires were completed at baseline, pre-radiotherapy, 10 weeks post-radiotherapy, and 6, 12, 18, and 24 months post-radiotherapy. The CHHiP trial completed accrual on June 16, 2011, and the QoL substudy was closed to further recruitment on Nov 1, 2009. Analysis was on an intention-to-treat basis. The primary endpoint of the QoL substudy was overall bowel bother and comparisons between fractionation groups were done at 24 months post-radiotherapy. The CHHiP trial is registered with ISRCTN registry, number ISRCTN97182923. FINDINGS: 2100 participants in the CHHiP trial consented to be included in the QoL substudy: 696 assigned to the 74 Gy schedule, 698 assigned to the 60 Gy schedule, and 706 assigned to the 57 Gy schedule. Of these individuals, 1659 (79%) provided data pre-radiotherapy and 1444 (69%) provided data at 24 months after radiotherapy. Median follow-up was 50.0 months (IQR 38.4-64.2) on April 9, 2014, which was the most recent follow-up measurement of all data collected before the QoL data were analysed in September, 2014. Comparison of 74 Gy in 37 fractions, 60 Gy in 20 fractions, and 57 Gy in 19 fractions groups at 2 years showed no overall bowel bother in 269 (66%), 266 (65%), and 282 (65%) men; very small bother in 92 (22%), 91 (22%), and 93 (21%) men; small bother in 26 (6%), 28 (7%), and 38 (9%) men; moderate bother in 19 (5%), 23 (6%), and 21 (5%) men, and severe bother in four (<1%), three (<1%) and three (<1%) men respectively (74 Gy vs 60 Gy, ptrend=0.64, 74 Gy vs 57 Gy, ptrend=0.59). We saw no differences between treatment groups in change of bowel bother score from baseline or pre-radiotherapy to 24 months. INTERPRETATION: The incidence of patient-reported bowel symptoms was low and similar between patients in the 74 Gy control group and the hypofractionated groups up to 24 months after radiotherapy. If efficacy outcomes from CHHiP show non-inferiority for hypofractionated treatments, these findings will add to the growing evidence for moderately hypofractionated radiotherapy schedules becoming the standard treatment for localised prostate cancer. FUNDING: Cancer Research UK, Department of Health, and the National Institute for Health Research Cancer Research Network.","Lancet Oncol, 16(16): 1605-1616","UK",2015,"Local","Radiotherapy","UCLA-PCI,SF-36,FACT-P,EPIC,SF-12","Patient",null,"Clinical trial","UK","Patient","Local","Radiotherapy",null,"Clinical trial","UCLA-PCI,SF-36,FACT-P,EPIC,SF-12","2015:2018","Disease,Utility"]
[733,"Wilkinson, S., et al. (2002). \"Attitudes and use of complementary medicine in men with prostate cancer.\" J Urol 168(6): 2505-2509.",null,"Wilkinson, S., et al.","Attitudes and use of complementary medicine in men with prostate cancer","PURPOSE: Patients with cancer are increasingly incorporating complementary therapies into the overall treatment. We determine the prevalence and patterns of use of complementary therapies among patients with prostate cancer. MATERIALS AND METHODS: Patients attending 6 urology institutions for prostate cancer management completed a self-administered questionnaire on complementary therapy. All men diagnosed with prostate cancer were eligible, regardless of age, stage of disease or treatment. RESULTS: A total of 1,099 patients returned the questionnaire. The overall response rate was 78.5%. Complementary therapies had previously been or were currently being used by 23.5% (258) and 18.2% (200) of patients, respectively. Higher levels of education and income were associated with greater use of complementary therapy (p <0.002 by logistic regression). Patients with progressive disease or those primarily treated with hormones were most likely to use complementary therapy. Among the patients using complementary therapy 90% believed that it would help them live longer and improve quality of life, 60% believed it would relieve symptoms and 47% expected it to cure disease. CONCLUSIONS: Complementary therapies are used by a large number of patients with prostate cancer, particularly those with progressive disease or who have undergone multiple treatments. Health care providers need to recognize this growing pattern of use of complementary therapy. Among patients who use complementary therapy the perception of benefit is much greater than that supported by scientific data. Future research should aim to unravel the complex psychosocial dynamics that influence the decision to use complementary therapy by men with prostate cancer and to educate patients about the efficacy of such therapies.","J Urol, 168(6): 2505-2509","USA",2002,"Any or unknown","Various","Unclear","Patient",null,"Cross-sectional","USA","Patient","Any or unknown","Various",null,"Cross-sectional","Unclear","2000:2004","Views"]
[734,"Willis, D. L., et al. (2012). \"Comparison of outcomes between pure laparoscopic vs robot-assisted laparoscopic radical prostatectomy: a study of comparative effectiveness based upon validated quality of life outcomes.\" BJU Int 109(6): 898-905.",null,"Willis, D. L., et al.","Comparison of outcomes between pure laparoscopic vs robot-assisted laparoscopic radical prostatectomy: a study of comparative effectiveness based upon validated quality of life outcomes","OBJECTIVE: To compare perioperative, oncological and functional outcomes of laparoscopic radical prostatectomy (LRP) and robot-assisted laparoscopic radical prostatectomy (RALP) with emphasis on health-related quality of life (HRQOL) data as few studies exist. PATIENTS AND METHODS: Patients underwent RALP or LRP by a single, fellowship trained surgeon with a standard clinical care pathway. HRQOL data using the Expanded Prostate Cancer Index Composite (EPIC) were collected at 0, 3, 6 and 12 months after 175 consecutive LRP and 174 RALP procedures. Urinary and sexual function outcomes were compared using two methods: (1) EPIC summary/subscale analyses described as percent return to baseline function and (2) traditional single-question analysis. RESULTS: The two groups were statistically similar with respect to demographics, clinical stage, perioperative outcomes, stage-specific surgical margin rates, and baseline urinary and sexual function scores. There was no statistical difference in postoperative urinary function between RALP and LRP using EPIC or single-question analyses at 3, 6 and 12 months. EPIC questionnaire data showed a greater return to baseline sexual function over time (mixed model analysis) in RALP than in LRP patients who had a bilateral nerve sparing procedure (Sexual Summary Score, P= 0.005; Sexual Function and Bother Subscales, P= 0.007). Using EPIC, RALP patients receiving a bilateral nerve sparing procedure showed improved percent return to baseline potency at 3 and 6 months (P < 0.025) compared with LRP patients, but had similar outcomes at 12 months (73.7% vs 66.2%, P= 0.3). Single-question analysis suggested improved potency after RALP compared with LRP, with a greater percentage of RALP patients reporting successful sexual intercourse in the past 4 weeks (87.5% vs 66.7% at 12 months, P= 0.06). CONCLUSIONS: When comparing surgical techniques, RALP and LRP groups showed statistically similar postoperative urinary function outcomes. RALP patients had an earlier return of sexual function when compared with LRP patients after a bilateral nerve sparing procedure.","BJU Int, 109(6): 898-905","USA",2012,"Any or unknown","Surgery","EPIC","Patient",null,"Clinical trial","USA","Patient","Any or unknown","Surgery",null,"Clinical trial","EPIC","2010:2014","Disease"]
[735,"Wilson, K. A., et al. (2000). \"Perception of quality of life by patients, partners and treating physicians.\" Qual Life Res 9(9): 1041-1052.",null,"Wilson, K. A., et al.","Perception of quality of life by patients, partners and treating physicians","The objective of the study was to determine possible differences in perception of quality of life (QoL) between patients with metastatic breast or prostate cancer, their partners, and the treating physician. Patients with metastatic breast cancer (n = 71), and metastatic prostate cancer (n = 29), a partner, and the physician each completed the same QoL questionnaire indicating how they perceived the patient's QoL. The European organization for research and treatment of cancer (EORTC) QLQ-C30 questionnaire was used to assess patients with breast cancer and the modified prostate cancer specific quality of life instrument (PROSQOLI) for patients with prostate cancer. There was reasonable agreement in mean scores between patients, and physicians or partners, for many domains of QoL; however, there was substantial discordance between scores when considering individual patients. For patients with metastatic breast cancer, physicians systematically underestimated overall QoL (p = 0.0002), social functioning (p = 0.001), and role functioning (p = 0.008), while partners showed better agreement. With prostate cancer physicians tended to underestimate pain, while mean scores for spouses were more concordant. There is substantial variability between ratings of QoL by physicians or partners, as compared to patient ratings. Medical decisions should be based on information about QoL provided by patients using validated methods.","Qual Life Res, 9(9): 1041-1052","Canada",2000,"Metastatic","Unclear","PROSQoLI","HCP,Patient,Caregiver",null,"Validation","Canada","HCP,Patient,Caregiver","Metastatic","Unclear",null,"Validation","PROSQoLI","2000:2004","Disease"]
[736,"Wilt, T. J. and M. K. Brawer (1994). \"The Prostate Cancer Intervention Versus Observation Trial: a randomized trial comparing radical prostatectomy versus expectant management for the treatment of clinically localized prostate cancer.\" J Urol 152(5 Pt 2): 1910-1914.",null,"Wilt, T. J. and M. K. Brawer","The Prostate Cancer Intervention Versus Observation Trial: a randomized trial comparing radical prostatectomy versus expectant management for the treatment of clinically localized prostate cancer","The Prostate Cancer Intervention Versus Observation Trial (PIVOT) is a randomized controlled trial sponsored by the Department of Veterans Affairs and the National Cancer Institute. PIVOT will enroll 2,000 participants from at least 80 Veterans Administration and National Cancer Institute medical centers. The purpose of PIVOT is to determine which of 2 strategies is superior for managing clinically localized prostate cancer (stage T1/T2NXM0) of all histological grades. Patients less than 75 years old will be randomized to either radical prostatectomy with early intervention for disease persistence/recurrence or expectant management with palliative therapy reserved for symptomatic or metastatic disease progression. Participants will be excluded if they have received prior therapy for prostate cancer (except transurethral resection of the prostate) or are judged not to be candidates for radical prostectomy. All patients with newly diagnosed prostate cancer will be recorded on the PIVOT screening log. Registry information will include patient age, race, prostate specific antigen level, clinical stage, histological tumor grade, initial therapy, and vital status. Patients meeting eligibility criteria will watch an information and randomization video tape developed for PIVOT. Participants will be randomized over a 3-year period and followed for a minimum of 12 years. Data collected at followup will include urological symptoms, disease and treatment related morbidity, and disease specific and overall quality of life. Evidence of symptomatic or asymptomatic disease persistence, recurrence or progression will be measured by questionnaire, physical examination, digital rectal examination, prostate specific antigen and annual bone scan. The primary study end point will be all cause mortality. Secondary outcomes will include prostate cancer and treatment specific morbidity and mortality rates, health status, predictors of disease specific outcomes and cost-effectiveness. PIVOT will provide a 90% power to detect a 15% relative decrease in all cause mortality and a 35% relative decrease in prostate cancer specific mortality rate by either treatment strategy.","J Urol, 152(5 Pt 2): 1910-1914","USA",1994,"Local","Surgery,Surveillance","Unclear","Patient",null,"Protocol","USA","Patient","Local","Surgery,Surveillance",null,"Protocol","Unclear","1960:1999","Symptom"]
[737,"Winters-Stone, K. M., et al. (2016). \"Benefits of partnered strength training for prostate cancer survivors and spouses: results from a randomized controlled trial of the Exercising Together project.\" J Cancer Surviv 10(4): 633-644.",null,"Winters-Stone, K. M., et al.","Benefits of partnered strength training for prostate cancer survivors and spouses: results from a randomized controlled trial of the Exercising Together project","BACKGROUND: Prostate cancer can negatively impact quality of life of the patient and his spouse caregiver, but interventions rarely target the health of both partners simultaneously. We tested the feasibility and preliminary efficacy of a partnered strength training program on the physical and mental health of prostate cancer survivors (PCS) and spouse caregivers. METHODS: Sixty-four couples were randomly assigned to 6 months of partnered strength training (Exercising Together, N = 32) or usual care (UC, N = 32). Objective measures included body composition (lean, fat and trunk fat mass (kg), and % body fat) by DXA, upper and lower body muscle strength by 1-repetition maximum, and physical function by the physical performance battery (PPB). Self-reported measures included the physical and mental health summary scales and physical function and fatigue subscales of the SF-36 and physical activity with the CHAMPS questionnaire. RESULTS: Couple retention rates were 100 % for Exercising Together and 84 % for UC. Median attendance of couples to Exercising Together sessions was 75 %. Men in Exercising Together became stronger in the upper body (p < 0.01) and more physically active (p < 0.01) than UC. Women in Exercising Together increased muscle mass (p = 0.05) and improved upper (p < 0.01) and lower body (p < 0.01) strength and PPB scores (p = 0.01) more than UC. CONCLUSIONS: Exercising Together is a novel couples-based approach to exercise that was feasible and improved several health outcomes for both PCS and their spouses. IMPLICATIONS FOR CANCER SURVIVORS: A couples-based approach should be considered in cancer survivorship programs so that outcomes can mutually benefit both partners. TRIAL REGISTRATION: ClinicalTrials.gov NCT00954044.","J Cancer Surviv, 10(4): 633-644","USA",2016,"Survivors","Various","SF-36,CHAMPS","Patient,Caregiver",null,"Clinical trial","USA","Patient,Caregiver","Survivors","Various",null,"Clinical trial","SF-36,CHAMPS","2015:2018","Utility,General"]
[738,"Wiygul, J. B., et al. (2005). \"Early patient self-assessed outcomes of nerve-sparing radical perineal prostatectomy.\" Urology 66(3): 582-586.",null,"Wiygul, J. B., et al.","Early patient self-assessed outcomes of nerve-sparing radical perineal prostatectomy","OBJECTIVES: To compare the early recovery of erectile function and urinary continence in patients undergoing nerve-sparing and non-nerve-sparing radical perineal prostatectomy (RPP) using a validated patient self-assessment instrument. METHODS: Eighty-eight patients who underwent RPP by a single surgeon between January 2002 and July 2003 were given a validated patient self-assessment questionnaire, the Expanded Prostate Cancer Index Composite, preoperatively and subsequently at 3- to 6-month intervals. Of the 88 patients, 40 underwent non-nerve-sparing and 48 nerve-sparing RPP. The time to recover erectile function and urinary continence, as well as sexual and urinary health-related quality of life was analyzed using the Kaplan-Meier method and a multivariate Cox proportional hazards model. RESULTS: Nerve-sparing RPP was a predictor of the time to recover erections sufficient for intercourse (P = 0.013). In a multivariate regression model adjusting for baseline erectile function, age, and prostate size, preservation of the neurovascular bundle (P = 0.007) was an independent predictor of the time to recover erectile function sufficient for intercourse (hazard ratio 5.3; 95% confidence interval 1.2 to 23.1). The median time to recover urinary continence, defined as no pad use, was 4.7 months in the nerve-sparing group compared with 5.6 months in the non-nerve-sparing group (P = 0.021). In multivariate analysis, nerve-sparing status was an independent predictor (P = 0.003) of an earlier recovery of continence (hazard ratio 2.2; 95% confidence interval 1.3 to 3.6). CONCLUSIONS: Patient self-assessed outcomes support a benefit of nerve-sparing RPP for the postoperative recovery of erectile function and urinary continence. Future studies with larger patient numbers and longer follow-up are necessary to validate these findings.","Urology, 66(3): 582-586","USA",2005,"Any or unknown","Surgery","EPIC","Patient",null,"Cohort","USA","Patient","Any or unknown","Surgery",null,"Cohort","EPIC","2005:2009","Disease"]
[739,"Wong, C. K., et al. (2015). \"Psychometric properties of Functional Assessment of Cancer Therapy-Prostate (FACT-P) in Chinese patients with prostate cancer.\" Qual Life Res 24(10): 2397-2402.",null,"Wong, C. K., et al.","Psychometric properties of Functional Assessment of Cancer Therapy-Prostate (FACT-P) in Chinese patients with prostate cancer","PURPOSE: The aim of the study was to assess the validity, reliability and sensitivity of the FACT-P (version 4) in Chinese males with prostate cancer. METHODS: Construct validity was assessed using Spearman's correlation test against the 12-item Short Form Health Survey (SF-12v2). Internal consistency and test-retest reliability were assessed using Cronbach's alpha coefficient and intra-class correlation coefficient, respectively. Sensitivity was determined by performing known-group comparisons by independent t test. RESULTS: FACT-P subscale scores had a moderate correlation with the corresponding SF-12v2 domain score that conceptually measures the similar construct providing evidence for adequate construct validity. Internal consistency was acceptable (alpha: 0.687-0.900) for all subscales aside from the Prostate Cancer Subscale (alpha: 0.505) and Trial Outcome Index (alpha: 0.562). FACT-P subscale and total scores showed good test-retest reliability (range 0.753-0.913). All total scales and most of the subscales were sensitive in detecting differences between patients with different levels of functional impairment but not different cancer stages or levels of prostate-specific antigen. CONCLUSIONS: The measure is a valid and reliable measure to assess the health-related quality of life of Chinese males with prostate cancer. The FACT-P is sensitive to detect difference between patients with varying functional status.","Qual Life Res, 24(10): 2397-2402","China",2015,"Any or unknown","None","SF-12,FACT-P","Patient",null,"Validation,Mapping to utility","China","Patient","Any or unknown","None",null,"Validation,Mapping to utility","SF-12,FACT-P","2015:2018","Disease,Utility"]
[740,"Woolsey, J., et al. (2004). \"Prospective outcomes associated with migration from preoperative to intraoperative planned brachytherapy: a single center report.\" J Urol 172(6 Pt 2): 2528-2531.",null,"Woolsey, J., et al.","Prospective outcomes associated with migration from preoperative to intraoperative planned brachytherapy: a single center report","PURPOSE: Brachytherapy (BT) for prostate cancer can be performed with either preoperative (PO) or intraoperative (IO) planned dosimetry. Potential benefits of intraoperative include fewer procedures for the patient, cost savings and improved accuracy of seed implantation leading to improved tumor control and urinary side effect profile. We report our experience with transition to IO planned BT after performing more than 600 PO planned implants since 1997. MATERIALS AND METHODS: From September 2001 to February 2003, 46 consecutive patients with T1-3N0M0 adenocarcinoma of the prostate underwent BT. IO dosimetry was performed in 23 patients, while PO dosimetry was used in 23 immediately before changing to IO. American Urological Association (AUA) symptom index questionnaires were administered preoperatively and postoperatively. All patients underwent postoperative dosimetry by computerized tomography. Total, irritative and obstructive AUA scores were compared in the 2 groups using analysis of covariance. Models were adjusted for pretreatment variables of symptom scores, type of procedure and time since procedure. RESULTS: Median followup was 47 and 45 days for PO and IO dosimetry, respectively. No differences were observed in seed, needle numbers or prostate size in the 2 groups. Average operative times were higher (47 vs 79 minutes, p <0.01) in the IO group but they decreased to nearly the same levels as PO implants in the first 23 cases so treated. Slopes of operative time over date of procedure differed significantly between methods (p <0.01). Comparing PO to IO dosimetry adjusted estimate of difference was -1.96 for total (95% CI -6.4, 2.5), -0.48 for obstructive (95% CI -3.3, 2.3) and -1.78 for irritative (95% CI -3.9, 0.31) AUA score. These differences were neither statistically nor clinically significant. CONCLUSIONS: Our experience indicates that intraoperative planned BT is easily implemented in clinical practice as a result of a short learning curve. In addition, the approach is not associated with any changes in early postoperative voiding symptoms and, due to only marginally longer operative times, may have a cost advantage by eliminating the preplanning visit and ultrasound.","J Urol, 172(6 Pt 2): 2528-2531","USA",2004,"Local,Advanced","Brachytherapy","AUA-SI","Patient",null,"Clinical trial","USA","Patient","Local,Advanced","Brachytherapy",null,"Clinical trial","AUA-SI","2000:2004","Symptom"]
[741,"Wu, A. W., et al. (2016). \"Improving an electronic system for measuring PROs in routine oncology practice.\" J Cancer Surviv 10(3): 573-582.",null,"Wu, A. W., et al.","Improving an electronic system for measuring PROs in routine oncology practice","PURPOSE: Our aim was to study how patients and their clinicians evaluated the usability of PatientViewpoint, a webtool designed to allow patient-reported outcome (PRO) measures to be used in clinical practice. METHODS: As part of a two-round quality improvement study, breast and prostate cancer patients and their medical and radiation oncology clinicians completed semi-structured interviews about their use of PatientViewpoint. The patient interview addressed different phases of the PRO completion workflow: reminders, completing the survey, and viewing the results. The clinician interviews asked about use of PatientViewpoint, integration with the clinical workflow, barriers to use, and helpful and desired features. Responses were recorded, categorized, and reviewed. After both rounds of interviews, modifications were made to PatientViewpoint. RESULTS: Across the two rounds, 42 unique patients (n = 19 in round 1, n = 23 in round 2) and 12 clinicians (all in both rounds) completed interviews. For patients, median age was 65, 81 % were white, 69 % were college graduates, 80 % had performance status of 0, 69 % had loco-regional disease, and 81 % were regular computer users. In the quality improvement interviews, patients identified numerous strengths of the system, including its ability to flag issues for discussion with their provider. Comments included confusion about how scores were presented and that the value of the system was diminished if the doctor did not look at the results. Requests included tailoring questions to be applicable to the individual and providing more explanation about the score meaning, including having higher scores consistently indicating either better or worse status. Clinicians also provided primarily positive feedback about the system, finding it helpful in some cases, and confirmatory in others. Their primary concern was with impact on their workflow. CONCLUSIONS: Systematically collected feedback from patients and clinicians was useful to identify ways to improve a system to incorporate PRO measures into oncology practice. The findings and evaluation methods should be useful to others in efforts to integrate PRO assessments into ambulatory care. IMPLICATIONS FOR CANCER SURVIVORS: Systems to routinely collect patient-reported information can be incorporated into oncology practices and provide useful information that promote patient and clinician partnership to improve the quality of care.","J Cancer Surviv, 10(3): 573-582","USA",2016,"Any or unknown","None","PVP","Patient",null,"Validation","USA","Patient","Any or unknown","None",null,"Validation","PVP","2015:2018","General"]
[742,"Wu, E. Q., et al. (2007). \"Mapping FACT-P and EORTC QLQ-C30 to patient health status measured by EQ-5D in metastatic hormone-refractory prostate cancer patients.\" Value Health 10(5): 408-414.",null,"Wu, E. Q., et al.","Mapping FACT-P and EORTC QLQ-C30 to patient health status measured by EQ-5D in metastatic hormone-refractory prostate cancer patients","OBJECTIVES: To construct and validate a prediction model of preference-adjusted health status (EQ-5D) for metastatic hormone-refractory prostate cancer (HRPCA) patients using cancer-specific health-related quality of life (HRQoL) measures. METHODS: Data were obtained from a multicenter, multinational observational study of metastatic HRPCA patients conducted during 2002 to 2004. In addition to clinical and resource utilization, preference-adjusted health status (EQ-5D) and HRQoL (Functional Assessment of Cancer Therapy-Prostate [FACT-P] and European Organization for Research and Treatment of Cancer Quality of Life Questionnaire [EORTC QLQ-C30]) data were collected. Predictive validity of ordinary least square (OLS) and median regressions of various model specifications were tested using cross-validation samples. The selected specification was then further refined and tested for alternative model specifications and restrictions. RESULTS: OLS regression with both HRQoL measures as individual components and patient demographics was the best-performing model. It explained 58.2% of the observed EQ-5D variation in the validation sample. A model including only the prostate cancer-specific HRQoL measure, FACT-P, explained 53.5% of the observed EQ-5D variation. CONCLUSIONS: The models developed have good predictive validity. These algorithms enable researchers to translate cancer-specific HRQoL measures to preference-adjusted health status in metastatic HRPCA patients. The findings will help perform health status adjustments in cost-utility analyses.","Value Health, 10(5): 408-414","USA",2007,"Metastatic","None","EQ-5D,FACT-P,EORTC QLQ-C30","Patient",null,"Mapping to utility","USA","Patient","Metastatic","None",null,"Mapping to utility","EQ-5D,FACT-P,EORTC QLQ-C30","2005:2009","Disease,General,Utility"]
[743,"Wust, P., et al. (2004). \"Clinical and physical determinants for toxicity of 125-I seed prostate brachytherapy.\" Radiother Oncol 73(1): 39-48.",null,"Wust, P., et al.","Clinical and physical determinants for toxicity of 125-I seed prostate brachytherapy","BACKGROUND AND PURPOSE: To assess acute as well as long-term toxicity after permanent prostate seed implantation. To find predictive clinical or dosimetric factors for side effects in order to work out strategies for improvement. PATIENTS AND METHODS: A group of 174 patients with localised prostate cancer was treated with permanent seed implantation between 1999 and 2001, either alone (140 patients) or in combination with external radiotherapy (34 patients). For the majority (114/174, i.e. 66%) a CT was performed four weeks after implantation and analysed in the planning system VariSeed. In the postimplant analysis, dosimetric descriptors (doses, volumes) were determined for the prostate and rectum and compared with the intraoperative values. In addition, a questionnaire was sent to all patients to assess and quantify acute and chronic toxicity (urinary, rectal, sexual) and the impact on subjective acceptance and quality of life (return rate of questionnaires 83%). The derived score changes were correlated with clinical and dosimetric factors. RESULTS: In the mono-brachytherapy group 14% (16/140) required a bladder catheter, of them 8% (9/140) with a manifest urinary obstruction. Long-term rectal toxicity (<5%) and impairment of potency (<30%) are moderate and obviously below other treatment options. Urinary toxicity is dominant with an overall long-term dysuria up to 30% (at a mean observation interval of ten months), and a significant trend to decline with follow-up time. Conversely, the erectile function tends to deteriorate with follow-up time. Nevertheless, quality of life is not significantly reduced and acceptance is high. Our analysis suggests that the main factor for urinary toxicity and impaired erectile function is the dose load to larger portions of the prostate (D(50)>240 Gy), which appears to be attributed to unnecessarily high numbers of seeds (for a fixed activity per seed) and needles. The rectal toxicity is correlated with the high dose regions in the rectum (>/=145 Gy). Urinary toxicity is lower for combined-brachytherapy, while rectal toxicity and impairment of potency are slightly higher. CONCLUSIONS: Toxicity spectrum and quality of life after permanent seed implantation for early prostate cancer are acceptable for nearly all patients (98%). To further improve tolerance we should attempt to achieve a better dose homogeneity, i.e. by reducing D(50). Therefore, special attention should be given to D(50) during the real-time planning process. The necessity of more homogeneous dose distributions might imply a reduction of the activity per seed, e.g. from 0.7 mCi down to 0.6 mCi.","Radiother Oncol, 73(1): 39-48","Germany",2004,"Local","Brachytherapy","Unclear","Patient",null,"Cross-sectional","Germany","Patient","Local","Brachytherapy",null,"Cross-sectional","Unclear","2000:2004","Treatment"]
[744,"Yamamoto, S., et al. (2014). \"Longitudinal change in health-related quality of life after intensity-modulated radiation monotherapy for clinically localized prostate cancer.\" Qual Life Res 23(5): 1641-1650.",null,"Yamamoto, S., et al.","Longitudinal change in health-related quality of life after intensity-modulated radiation monotherapy for clinically localized prostate cancer","PURPOSE: The purpose of the study is to assess longitudinal changes in general and disease-specific health-related quality-of-life (HRQOL) indices after intensity-modulated radiotherapy (IMRT) monotherapy for patients with localized prostate cancer (PCA). METHODS: Between 2006 and 2010, 91 patients with localized PCA underwent IMRT monotherapy and were enrolled into this prospective study. At baseline, and at 3, 6, 12, and 24 months after IMRT, the general and prostate-specific HRQOL were estimated using physical (PCS) and mental component summaries (MCS) calculated using the Medical Outcomes Study 8-Item Short Form Health Survey and Expanded Prostate Cancer Index Composite (EPIC). RESULTS: For 2 years, there were no significant changes in EPIC scores in all subscales of urinary domain, hormonal function, and bother. Bowel and sexual function scores decreased after IMRT and did not return to those at baseline (p = 0.006 and < 0.001, respectively). PCS began to decrease at 3 months after IMRT and then returned to the baseline score at 24 months. In contrast, the MCS score began to significantly increase after IMRT, and thereafter the score remained constant until 24 months (p < 0.001). On multivariate logistic regression analysis, urinary (p = 0.003) and sexual functions (p = 0.0005) at baseline were identified as significant predictors of EPIC urinary irritative/obstructive score and sexual function at 24 months after IMRT. CONCLUSION: Urinary function, including irritative/obstruction symptoms and hormonal function, was not affected by IMRT. However, bowel and sexual function decreased after IMRT. These findings will provide important information for PCA patients considering IMRT.","Qual Life Res, 23(5): 1641-1650","Japan",2014,"Local","Radiotherapy","EPIC,SF-8","Patient",null,"Cohort","Japan","Patient","Local","Radiotherapy",null,"Cohort","EPIC,SF-8","2010:2014","Disease,Utility"]
[745,"Yanez, B., et al. (2015). \"Feasibility, acceptability, and preliminary efficacy of a technology-assisted psychosocial intervention for racially diverse men with advanced prostate cancer.\" Cancer 121(24): 4407-4415.",null,"Yanez, B., et al.","Feasibility, acceptability, and preliminary efficacy of a technology-assisted psychosocial intervention for racially diverse men with advanced prostate cancer","BACKGROUND: The utility of psychosocial interventions in reducing symptom burden and improving health-related quality of life (HRQOL) for men with localized prostate cancer has been demonstrated. However, studies have yet to demonstrate the efficacy of interventions in advanced prostate cancer (APC). This study examined the feasibility, acceptability, and preliminary efficacy of a technology-assisted, 10-week, group-based psychosocial intervention for diverse men with APC. METHODS: The participants were 74 men (mean age, 68.84 years; non-Hispanic white, 57%; black, 40.5%) who were randomized to a cognitive-behavioral stress management (CBSM) treatment or health promotion (HP) attention-control condition. The participants were assessed at the baseline, weekly throughout the 10-week program, and 6 months after the baseline. Outcomes were assessed with the Patient-Reported Outcomes Measurement Information System along with established measures of HRQOL, CBSM intervention targets (eg, relaxation skills), and patient-reported acceptability. RESULTS: Feasibility was demonstrated through good retention rates (>85%) and acceptable average attendance rates (>70%), and acceptability was demonstrated through very favorable weekly session evaluations (mean score, 4/5) and exit surveys (mean score, 3.6/4). Men randomized to the CBSM condition reported significant reductions (P < .05) in depressive symptoms and improvements in relaxation self-efficacy (P < .05) at the 6-month follow-up. CBSM participants reported trends for improvement in distress and functional well-being (P < .08) in comparison with those in the HP condition. Effect sizes ranged from medium (0.54) to large (1.87) and, in some instances, were clinically meaningful. CONCLUSIONS: Technology-based CBSM interventions among diverse men with APC may be feasible, acceptable, and efficacious.","Cancer, 121(24): 4407-4415","USA",2015,"Advanced","Psychological","PROMIS","Patient",null,"Clinical trial","USA","Patient","Advanced","Psychological",null,"Clinical trial","PROMIS","2015:2018","Symptom,General"]
[746,"Yarbro, C. H. and C. E. Ferrans (1998). \"Quality of life of patients with prostate cancer treated with surgery or radiation therapy.\" Oncol Nurs Forum 25(4): 685-693.",null,"Yarbro, C. H. and C. E. Ferrans","Quality of life of patients with prostate cancer treated with surgery or radiation therapy","PURPOSE/OBJECTIVES: To compare the quality-of-life (QOL) perceptions of men treated for prostate cancer with surgery to those of men treated for prostate cancer with radiation therapy. DESIGN: A two-group descriptive study. SETTING: Midwestern community cancer center and teaching hospital. SAMPLE: The study group consisted of 121 men: 68 treated by radical prostatectomy and 53 treated with radiation therapy. METHODS: Mailed survey using the Quality of Life Index (QLI) Cancer Version and the University of California at Los Angeles Prostate Cancer Index. MAIN RESEARCH VARIABLES: QOL; level of urinary, bowel, and sexual function; impact of dysfunction on patients' lives. FINDINGS: No significant differences were found between the groups in QLI scores, but significant differences were found in urinary, bowel, and sexual function. Urinary function was superior in the radiation therapy group (p = 0.0002). Patients who had undergone surgery were more likely to leak urine every day (p < 0.001). Only 6% of patients who had undergone radiation therapy needed to use pads or diapers as compared to 32% of patients who had undergone surgery. Bowel function was better in the surgery group (p = 0.05). Both groups reported poor sexual function, although it was worse in the surgery group (p = 0.009). CONCLUSIONS: The patients who were treated with surgery had significantly worse urinary and sexual function and better bowel function than those treated with radiation therapy. QOL scores were consistent with these findings, although they did not differ significantly between groups. IMPLICATIONS FOR NURSING PRACTICE: This information on the problems of survivors of prostate cancer after surgery and radiation therapy and the effects of therapy on QOL will assist nurses in providing patient education, emotional support, and rehabilitative interventions.","Oncol Nurs Forum, 25(4): 685-693","USA",1998,"Any or unknown","Surgery,Radiotherapy","QLI,UCLA-PCI","Patient",null,"Cross-sectional","USA","Patient","Any or unknown","Surgery,Radiotherapy",null,"Cross-sectional","QLI,UCLA-PCI","1960:1999","Disease,General"]
[747,"Yaxley, J. W., et al. (2016). \"Robot-assisted laparoscopic prostatectomy versus open radical retropubic prostatectomy: early outcomes from a randomised controlled phase 3 study.\" Lancet 388(10049): 1057-1066.",null,"Yaxley, J. W., et al.","Robot-assisted laparoscopic prostatectomy versus open radical retropubic prostatectomy: early outcomes from a randomised controlled phase 3 study","The absence of trial data comparing robot-assisted laparoscopic prostatectomy and open radical retropubic prostatectomy is a crucial knowledge gap in uro-oncology. We aimed to compare these two approaches in terms of functional and oncological outcomes and report the early postoperative outcomes at 12 weeks. In this randomised controlled phase 3 study, men who had newly diagnosed clinically localised prostate cancer and who had chosen surgery as their treatment approach, were able to read and speak English, had no previous history of head injury, dementia, or psychiatric illness or no other concurrent cancer, had an estimated life expectancy of 10 years or more, and were aged between 35 years and 70 years were eligible and recruited from the Royal Brisbane and Women's Hospital (Brisbane, QLD). Participants were randomly assigned (1:1) to receive either robot-assisted laparoscopic prostatectomy or radical retropubic prostatectomy. Randomisation was computer generated and occurred in blocks of ten. This was an open trial; however, study investigators involved in data analysis were masked to each patient's condition. Further, a masked central pathologist reviewed the biopsy and radical prostatectomy specimens. Primary outcomes were urinary function (urinary domain of EPIC) and sexual function (sexual domain of EPIC and IIEF) at 6 weeks, 12 weeks, and 24 months and oncological outcome (positive surgical margin status and biochemical and imaging evidence of progression at 24 months). The trial was powered to assess health-related and domain-specific quality of life outcomes over 24 months. We report here the early outcomes at 6 weeks and 12 weeks. The per-protocol populations were included in the primary and safety analyses. This trial was registered with the Australian New Zealand Clinical Trials Registry (ANZCTR), number ACTRN12611000661976. Between Aug 23, 2010, and Nov 25, 2014, 326 men were enrolled, of whom 163 were randomly assigned to radical retropubic prostatectomy and 163 to robot-assisted laparoscopic prostatectomy. 18 withdrew (12 assigned to radical retropubic prostatectomy and six assigned to robot-assisted laparoscopic prostatectomy); thus, 151 in the radical retropubic prostatectomy group proceeded to surgery and 157 in the robot-assisted laparoscopic prostatectomy group. 121 assigned to radical retropubic prostatectomy completed the 12 week questionnaire versus 131 assigned to robot-assisted laparoscopic prostatectomy. Urinary function scores did not differ significantly between the radical retropubic prostatectomy group and robot-assisted laparoscopic prostatectomy group at 6 weeks post-surgery (74.50 vs 71.10; p=0.09) or 12 weeks post-surgery (83.80 vs 82.50; p=0.48). Sexual function scores did not differ significantly between the radical retropubic prostatectomy group and robot-assisted laparoscopic prostatectomy group at 6 weeks post-surgery (30.70 vs 32.70; p=0.45) or 12 weeks post-surgery (35.00 vs 38.90; p=0.18). Equivalence testing on the difference between the proportion of positive surgical margins between the two groups (15 [10%] in the radical retropubic prostatectomy group vs 23 [15%] in the robot-assisted laparoscopic prostatectomy group) showed that equality between the two techniques could not be established based on a 90% CI with a Delta of 10%. However, a superiority test showed that the two proportions were not significantly different (p=0.21). 14 patients (9%) in the radical retropubic prostatectomy group versus six (4%) in the robot-assisted laparoscopic prostatectomy group had postoperative complications (p=0.052). 12 (8%) men receiving radical retropubic prostatectomy and three (2%) men receiving robot-assisted laparoscopic prostatectomy experienced intraoperative adverse events. These two techniques yield similar functional outcomes at 12 weeks. Longer term follow-up is needed. In the interim, we encourage patients to choose an experienced surgeon they trust and with whom they have rapport, rather than a specific surgical approach. Cancer Council Queensland.","Lancet, 388(10049): 1057-1066","Australia",2016,"Local","Surgery","EPIC,IIEF-5","Patient",null,"Clinical trial","Australia","Patient","Local","Surgery",null,"Clinical trial","EPIC,IIEF-5","2015:2018","Disease,Comp-lication"]
[748,"Yoshimura, K., et al. (2003). \"Neoadjuvant flutamide monotherapy for locally confined prostate cancer.\" Int J Urol 10(4): 190-195.",null,"Yoshimura, K., et al.","Neoadjuvant flutamide monotherapy for locally confined prostate cancer","BACKGROUND: We compared the clinical effects and impact on quality of life (QOL) of patients who received a 3-month course of flutamide monotherapy before radical prostatectomy with those who received a 3-month course of luteinizing hormone-releasing hormone (LHRH) agonist monotherapy. METHODS: Thirty-seven patients with non-metastatic prostate cancer were enrolled in this study (19, flutamide; 18, LHRH agonist). The rates of change of serum prostate-specific antigen (PSA) and testosterone levels, downsizing of prostate volume, the rate of organ confined disease, adverse effects and perioperative scores measured using the European Organization for Research and Treatment of Cancer Prostate Cancer Quality of Life Questionnaire (EORTC-P) and the Sapporo Medical University Sexual Function Questionnaire (SMUF) were analyzed. RESULTS: At radical prostatectomy, pathological variables were not significantly different in the two groups. Serum testosterone level was significantly higher (mean 359.2 compared to 10.5, P < 0.001), complete response rate of PSA (13% compared to 57%, P = 0.028) and rate of downsizing of prostate volume (mean, -17.7% compared to -35.4%, P = 0.038) were significantly lower in the flutamide group than in the LHRH group. After neoadjuvant hormone therapy, the scores on the sexual problem domain of EORTC-P (P = 0.033) and sexual desire score of SMUF (P = 0.021) were significantly higher in the flutamide group than in the LHRH group. At a median follow-up of 34 months after prostatectomy, biochemical failure-free survival rate in the flutamide group did not differ from that in the LHRH group. CONCLUSION: This study suggests that flutamide monotherapy can be an acceptable modality as an option for neoadjuvant hormone therapy.","Int J Urol, 10(4): 190-195","Japan",2003,"Local","Surgery,Hormonal","EORTC QLQ-PR25,SFQ","Patient",null,"Clinical trial","Japan","Patient","Local","Surgery,Hormonal",null,"Clinical trial","EORTC QLQ-PR25,SFQ","2000:2004","Disease,Complication"]
[749,"Yoshimura, K., et al. (2003). \"Use of complementary and alternative medicine by patients with localized prostate carcinoma: study at a single institute in Japan.\" Int J Clin Oncol 8(1): 26-30.",null,"Yoshimura, K., et al.","Use of complementary and alternative medicine by patients with localized prostate carcinoma: study at a single institute in Japan","BACKGROUND: The use of complementary/alternative medicine (CAM) has recently received considerable attention throughout the world. We evaluated the prevalence and predictors of CAM use among Japanese patients with localized prostate cancer. METHODS: A total of 177 patients with localized prostate carcinoma underwent radical retropubic prostatecotomy or external beam radiation therapy between January 1994 and January 2001. Of them, 138 (78%) answered a self-administered questionnaire on CAM use and were eligible for this study. The overall prevalence, types of CAM used, and costs of CAM were assessed. The effects of age, prostate-specific antigen (PSA) level, clinical stage, pretreatment Gleason score, patients' income, patients' final educational status, and general health-related quality of life at baseline and 1 year after treatment, as estimated using the European Organization for Research and Treatment of Cancer Prostate Cancer Quality of Life Questionnaire on the prevalence of CAM use, were evaluated. RESULTS: Twenty-seven patients (20%) had once used or had been using some types of CAM. Herbal medicine and vitamins were the most common types of CAM used. Preoperative Gleason score was significantly associated with CAM use, as determined by the chi(2) test ( P = 0.0198), and PSA level and posttreatment physical function domain were marginally associated with CAM use, as determined by the Mann-Whitney U-test ( P = 0.0734 and P = 0.0597, respectively). Patient age, income, and final educational status had no impact on CAM use. CONCLUSION: A relatively small proportion of Japanese patients with localized prostate cancer have tried CAM compared with the proportions of patients described in previous reports from Western countries.","Int J Clin Oncol, 8(1): 26-30","Japan",2003,"Local","Surgery,Radiotherapy,Various","EORTC QLQ-PR25","Patient",null,"Cross-sectional","Japan","Patient","Local","Surgery,Radiotherapy,Various",null,"Cross-sectional","EORTC QLQ-PR25","2000:2004","Disease"]
[750,"Yoshimura, K., et al. (2004). \"A 3-y prospective study of health-related and disease-specific quality of life in patients with nonmetastatic prostate cancer treated with radical prostatectomy or external beam radiotherapy.\" Prostate Cancer Prostatic Dis 7(2): 144-151.",null,"Yoshimura, K., et al.","A 3-y prospective study of health-related and disease-specific quality of life in patients with nonmetastatic prostate cancer treated with radical prostatectomy or external beam radiotherapy","We assessed the longitudinal alteration of the quality of life (QOL) of patients with localized prostate cancer after radical prostatectomy or hormonoradiotherapy during 3-y follow-up. In addition, we examined the impact on QOL of initiation of second treatment after failure of primary treatment. In all, 135 patients with localized prostate cancer who underwent radical retropubic prostatectomy (RP) (N=84) or external beam radiotherapy with neoadjuvant hormone (XRT) (N=51) at our institute and who had a minimum follow-up of 3 y were included in this study. Data were collected prospectively, at baseline, at 3 months after treatment, at 1 y, and annually thereafter. QOL, generic and disease-targeted was evaluated using the European Organization for Research and Treatment of Cancer Prostate Cancer QOL Questionnaire, the Sapporo Medical University Sexual Function Questionnaire, the International Prostate Symptom Index Quality of Life Score and similar questions regarding bowel function. Repeated-measures ANOVA revealed significantly different patterns of alteration in the domains of QOL, with the exception of several domains, between the RP and XRT groups. Rapid decline of sexual function and increase in sexual bothersomeness were followed by slight amelioration throughout follow-up in the RP group, and did not change thereafter in the XRT group. Overall satisfaction with urinary condition significantly improved after treatment and that with bowel condition was stable during follow-up in both of the groups. Failure of primary treatment and initiation of salvage treatment had no impact on QOL. This prospective study revealed longitudinal alteration of QOL status of patients undergoing treatment for localized prostate cancer, but did not yield any conclusions regarding effect of treatment failure and second treatment on QOL due to small sample size. It should be noted that different instruments for assessment of QOL can generate different outcomes.","Prostate Cancer Prostatic Dis, 7(2): 144-151","Japan",2004,"Local","Surgery,Radiotherapy,Hormonal","EORTC QLQ-PR25,SMUF,IPSS","Patient",null,"Cohort","Japan","Patient","Local","Surgery,Radiotherapy,Hormonal",null,"Cohort","EORTC QLQ-PR25,SMUF,IPSS","2000:2004","Disease,Complication"]
[751,"Yoshimura, K., et al. (2005). \"Use of complementary and alternative medicine by patients with urologic cancer: a prospective study at a single Japanese institution.\" Support Care Cancer 13(9): 685-690.",null,"Yoshimura, K., et al.","Use of complementary and alternative medicine by patients with urologic cancer: a prospective study at a single Japanese institution","OBJECTIVES: We prospectively evaluated the prevalence and predictors of complementary medicine (CAM) use among Japanese patients with urologic cancer 1 year after diagnosis. PATIENTS AND METHODS: A total of 349 patients with newly diagnosed urologic cancer answered a self-administered questionnaire on CAM use 1 year after diagnosis. General-health-related quality of life (GHQL) of the patients was also assessed at diagnosis and 1 year after diagnosis using the Medical Outcome Study Short Form-36 (SF-36). The overall prevalence, types of CAM used, and costs of CAM were assessed. The effects of several variables including GHQL at baseline and 1 year after treatment on the prevalence of use of CAM were evaluated. RESULTS: A total of 164 respondents (47%) admitted using some type of CAM, of which 73 (45%) had used multiple types. \"Health food,\" in particular extract from Agaricus blazei, was the most common type of CAM used. CAM users had significantly lower scores for social function, general health perception, and vitality domains than CAM non-users 1 year after diagnosis. This tendency was more marked in users of multiple types of CAM. CONCLUSIONS: \"Health food,\" including extract from A. blazei, was the most commonly used CAM in Japan. The prevalence of CAM use did not differ between patients with prostate cancer and those with urologic cancer other than prostate cancer. CAM users, especially those who used multiple types of CAM, had lower GHQL scores than non-users of CAM.","Support Care Cancer, 13(9): 685-690","Japan",2005,"Any or unknown","Various","SF-36","Patient",null,"Cross-sectional","Japan","Patient","Any or unknown","Various",null,"Cross-sectional","SF-36","2005:2009","Utility"]
[752,"Yoshimura, K., et al. (2007). \"Health-related quality-of-life after external beam radiation therapy for localized prostate cancer: intensity-modulated radiation therapy versus conformal radiation therapy.\" Prostate Cancer Prostatic Dis 10(3): 288-292.",null,"Yoshimura, K., et al.","Health-related quality-of-life after external beam radiation therapy for localized prostate cancer: intensity-modulated radiation therapy versus conformal radiation therapy","We compared health-related quality-of-life (HRQL) after intensity-modulated radiotherapy (IMRT) with statuses obtained after old and new protocols of three-dimensional conformal radiation therapy (3DCRT) for localized prostate cancer. We measured the general and disease specific HRQL using the MOS 36-Item Health Survey (SF-36), and the University of California, Los Angeles Prostate Cancer Index (UCLA PCI), respectively. IMRT resulted in similar profiles of general and disease-specific HRQL to two other methods within the first year after treatment. Moreover, IMRT gave rise to comparable urinary, intestinal and sexual side effects despite the high dose of radiation applied.","Prostate Cancer Prostatic Dis, 10(3): 288-292","Japan",2007,"Local","Radiotherapy","SF-36,UCLA-PCI","Patient",null,"Cohort","Japan","Patient","Local","Radiotherapy",null,"Cohort","SF-36,UCLA-PCI","2005:2009","Disease,utility"]
[753,"You, D., et al. (2010). \"Impacts of leuprolide acetate on quality of life in patients with prostate cancer: a prospective multicenter study.\" Scand J Urol Nephrol 44(6): 399-405.",null,"You, D., et al.","Impacts of leuprolide acetate on quality of life in patients with prostate cancer: a prospective multicenter study","OBJECTIVE: To investigate the impacts of leuprolide acetate on the quality of life (QoL) of patients with prostate cancer. MATERIAL AND METHODS: A total of 104 patients was enrolled in this prospective multicenter study. All patients received subcutaneous injections of 3.75 mg leuprolide acetate at 4 week intervals for a total of 12 weeks. QoL was assessed before treatment and at 12 weeks using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) and an accompanying prostate cancer-specific module (QLQ-PR25). RESULTS: Eighty-nine of 104 patients (85.6%) completed the 12 week study. Eighty-six of 89 patients (96.6%) achieved and maintained medical castration. The results of the EORTC QLQ-C30 indicated that patients experienced an improvement in global health status/QoL (p < 0.001), despite a deterioration in physical and role functioning (p = 0.012 and p = 0.007, respectively). The symptom scales indicated a statistically significant improvement in appetite (p = 0.003). The results of the QLQ-PR25 revealed that patients experienced an increase in hot flushes (p < 0.001) and erection problems and uncomfortable sexual intimacy among the sexual functioning items (p = 0.030 and p = 0.023, respectively), but day-time urinary frequency was improved (p = 0.004). CONCLUSION: The results of this prospective study indicate that leuprolide acetate treatment was accompanied by improvements in global health status/QoL, despite a deterioration in physical, role and sexual function.","Scand J Urol Nephrol, 44(6): 399-405","South Korea",2010,"Any or unknown","Hormonal","EORTC QLQ-C30,EORTC QLQ-PR25","Patient",null,"Clinical trial","South Korea","Patient","Any or unknown","Hormonal",null,"Clinical trial","EORTC QLQ-C30,EORTC QLQ-PR25","2010:2014","Disease,General"]
[754,"Young, M. D., et al. (2003). \"Urinary continence and quality of life in the first year after radical perineal prostatectomy.\" J Urol 170(6 Pt 1): 2374-2378.",null,"Young, M. D., et al.","Urinary continence and quality of life in the first year after radical perineal prostatectomy","PURPOSE: We attempt to characterize the return of urinary continence and urinary domain related quality of life objectively after radical perineal prostatectomy (RPP). MATERIALS AND METHODS: A total of 92 RPP candidates were prospectively enrolled in a quality of life (QOL) survey using a validated assessment tool and evaluated before surgery, and then after surgery at 1 month and subsequent 3-month intervals. The time to regain continence based on 3 different definitions and the time to recover baseline urinary domain related QOL was calculated. RESULTS: Median time to regain continence after RPP ranged from 3.0 to 3.3 months depending on the definition of continence. Median time for patients to regain continence depending on age (younger than 55, 55 to 64 and older than 64) and medical comorbidities (none, 1 and 2 or more) varied between 1.4 +/- 0.3, 3.0 +/- 0.9 and 3.3 +/- 0.4 months, respectively (p = 0.028), and 1.4 +/- 0.2, 3.3 +/- 0.2 and 3.5 +/- 2.6 months, respectively (p = 0.009). Twelve months after RPP 84%, 66% and 82% of patients regained individual baseline urinary summary, function and bother scores, respectively. Postoperative radiation (XRT) represented the only independent predictor of the time to recover baseline urinary domain summary scores in a multivariate analysis (p = 0.042) with a median delay in the XRT (10 patients) and nonXRT group (82 patients) of 8.0 and 6.7 months, respectively. CONCLUSIONS: Based on self-reported questionnaire data, a majority of patients regain urinary continence and urinary domain related QOL within 12 months after RPP. The time course of recovery from radical prostatectomy represents an important outcome criterion that should be shared with patients considering treatment options.","J Urol, 170(6 Pt 1): 2374-2378","USA",2003,"Any or unknown","Surgery","Unclear","Patient",null,"Cohort","USA","Patient","Any or unknown","Surgery",null,"Cohort","Unclear","2000:2004","Complication"]
[755,"Yount, S., et al. (2003). \"Brief assessment of priority symptoms in hormone refractory prostate cancer: the FACT Advanced Prostate Symptom Index (FAPSI).\" Health Qual Life Outcomes 1: 69.",null,"Yount, S., et al.","Brief assessment of priority symptoms in hormone refractory prostate cancer: the FACT Advanced Prostate Symptom Index (FAPSI)","BACKGROUND: The objective of this study was to construct and validate a brief, clinically-relevant symptom index for advanced prostate cancer. METHODS: Questions were extracted from a commonly-used multi-dimensional cancer quality of life instrument with prostate-specific items, the Functional Assessment of Cancer Therapy-Prostate (FACT-P). Surveys of disease-related symptoms were presented to an international sample of 44 expert physicians. Each expert narrowed the list to no more than five of the most important symptoms or concerns to monitor when assessing the value of treatment for advanced prostate cancer. Symptoms/concerns endorsed at a frequency greater than chance probability (17%) were retained for the symptom index and called the FACT Advanced Prostate Symptom Index-8 (FAPSI-8): pain (three items), fatigue, weight loss, urinary difficulties (two items), and concern about the condition becoming worse. The FAPSI-8 was validated using data from a clinical trial of 288 men being treated for hormone refractory prostate cancer. RESULTS: The FAPSI-8 showed good internal consistency (r = 0.67-0.80); association with existing FACT scales (e.g., FACT-P, Physical Well-being, Functional Well-being; r = 0.44-0.85, p <.0001), responsiveness to clinical change (Guyatt's Responsiveness statistic = 1.29), and ability to differentiate patients by performance status (p <.0001). A six-item alternate version of the FAPSI was also evaluated with comparable results. CONCLUSIONS: This project produced a reliable and valid list of the eight most important clinician-rated targets of drug therapy for advanced prostate cancer. These questions perform comparably to the longer derivative questionnaire. Examination of patient agreement with this priority list and the extent to which changes in these 8 targets are related to meaningful clinical benefit to the patient are important next steps for future research.","Health Qual Life Outcomes, 1(69","USA",2003,"Advanced","None","FACT-P,FAPSI-8","Patient",null,"Validation","USA","Patient","Advanced","None",null,"Validation","FACT-P,FAPSI-8","2000:2004","Disease,Symptom"]
[756,"Zebrack, B. J., et al. (2006). \"Assessing the impact of cancer: development of a new instrument for long-term survivors.\" Psychooncology 15(5): 407-421.",null,"Zebrack, B. J., et al.","Assessing the impact of cancer: development of a new instrument for long-term survivors","OBJECTIVE: To develop and evaluate a new instrument that measures aspects of long-term survivorship not measured by existing tools. METHODS: In qualitative interviews, 47 long-term cancer survivors (LTS) detailed ways that cancer has impacted their lives. Content analysis resulted in the creation of 325 candidate items for inclusion in a new Impact of Cancer (IOC) instrument. Following expert review, item reduction and pilot testing, 81 items were administered with other established health status and quality of life (QOL) instruments to 193 LTS of breast, prostate, colorectal cancers and lymphoma. Internal consistency reliability and validity of newly-derived scales was assessed. RESULTS: Factor analysis of items using a priori QOL domains resulted in the derivation of ten new and specific subscales: Health Awareness, Body Changes, Health Worries, Positive and Negative Self-Evaluation, Positive and Negative Life Outlook, Social Life Interferences, Relationships, and Meaning of Cancer. Internal consistency measurements for these subscales ranged from 0.67 to 0.89. Expected associations within and among the IOC subscales and standardized measures of health status and QOL were observed, as were some unexpected findings. CONCLUSIONS: Psychometric analysis indicated that this initial version of the Impact of Cancer instrument measures distinct and relevant constructs for LTS. Future work is necessary to confirm the factor structure, responsiveness and further validation of the instrument.","Psychooncology, 15(5): 407-421","USA",2006,"Survivors","None","IOC","Patient",null,"Validation","USA","Patient","Survivors","None",null,"Validation","IOC","2005:2009","Disease"]
[757,"Zeliadt, S. B., et al. (2013). \"A preliminary exploration of the feasibility of offering men information about potential prostate cancer treatment options before they know their biopsy results.\" BMC Med Inform Decis Mak 13: 19.",null,"Zeliadt, S. B., et al.","A preliminary exploration of the feasibility of offering men information about potential prostate cancer treatment options before they know their biopsy results","BACKGROUND: A small pre-test study was conducted to ascertain potential harm and anxiety associated with distributing information about possible cancer treatment options at the time of biopsy, prior to knowledge about a definitive cancer diagnosis. Priming men about the availability of multiple options before they have a confirmed diagnosis may be an opportunity to engage patients in more informed decision-making. METHODS: Men with an elevated PSA test or suspicious Digital Rectal Examination (DRE) who were referred to a urology clinic for a biopsy were randomized to receive either the clinic's usual care (UC) biopsy instruction sheet (n = 11) or a pre-biopsy educational (ED) packet containing the biopsy instruction sheet along with a booklet about the biopsy procedure and a prostate cancer treatment decision aid originally written for newly diagnosed men that described in detail possible treatment options (n = 18). RESULTS: A total of 62% of men who were approached agreed to be randomized, and 83% of the ED group confirmed they used the materials. Anxiety scores were similar for both groups while awaiting the biopsy procedure, with anxiety scores trending lower in the ED group: 41.2 on a prostate-specific anxiety instrument compared to 51.7 in the UC group (p = 0.13). ED participants reported better overall quality of life while awaiting biopsy compared to the UC group (76.4 vs. 48.5, p = 0.01). The small number of men in the ED group who went on to be diagnosed with cancer reported being better informed about the risks and side effects of each option compared to men diagnosed with cancer in the UC group (p = 0.07). In qualitative discussions, men generally reported they found the pre-biopsy materials to be helpful and indicated having information about possible treatment options reduced their anxiety. However, 2 of 18 men reported they did not want to think about treatment options until after they knew their biopsy results. CONCLUSIONS: In this small sample offering pre-biopsy education about potential treatment options was generally well received by patients, appeared to be beneficial to men who went on to be diagnosed, and did not appear to increase anxiety unnecessarily among those who had a negative biopsy.","BMC Med Inform Decis Mak, 13(19","USA",2013,"At risk","Screening","Unclear","Patient",null,"Clinical trial","USA","Patient","At risk","Screening",null,"Clinical trial","Unclear","2010:2014","Comorbidity"]
[758,"Zenger, M., et al. (2009). \"Health-related quality of life of prostate cancer patients compared to the general German population: age-specific results.\" Urol Int 83(2): 166-170.",null,"Zenger, M., et al.","Health-related quality of life of prostate cancer patients compared to the general German population: age-specific results","OBJECTIVE: The objective of this study was to examine the age-specific health-related quality of life (HRQOL) of prostate cancer patients (PCPs). PATIENTS AND METHODS: 387 PCPs were asked to self-assess their HRQOL with the EORTC QLQ-C30 questionnaire. Patients' data were compared with those of the general German population. RESULTS: The reported global health/QOL scores of the study group and the general German population are nearly equal. However, most of the subdomains of HRQOL are negatively affected in PCPs, especially in younger patients (<or=59 years). CONCLUSION: Medical professionals should pay more attention to the emotional burden of PCPs, because their stress and strains during the time before treatment have a rather more emotional than physical character.","Urol Int, 83(2): 166-170","Germany",2009,"Any or unknown","None","EORTC QLQ-C30","Patient,General population",null,"Cross-sectional","Germany","Patient,General population","Any or unknown","None",null,"Cross-sectional","EORTC QLQ-C30","2005:2009","General"]
[759,"Zhang, A. Y. and A. Z. Fu (2016). \"Cost-effectiveness of a behavioral intervention for persistent urinary incontinence in prostate cancer patients.\" Psychooncology 25(4): 421-427.",null,"Zhang, A. Y. and A. Z. Fu","Cost-effectiveness of a behavioral intervention for persistent urinary incontinence in prostate cancer patients","OBJECTIVE: The aim of this study was to evaluate the cost-effectiveness of a behavioral intervention for urinary incontinence of prostate cancer patients. Study subjects were either participating in or eligible but declined (i.e., nonparticipating) the active intervention study. METHODS: The intervention-participating subjects were randomized into three groups, including two intervention groups (support and telephone groups) and a usual care reference group. Intervention-nonparticipating subjects were concurrently enrolled. Intervention effectiveness was assessed on the EQ-5D measure. The costs included direct healthcare cost from medical billing data, patient out-of-pocket expense, caregiver expense, patient loss-of-work cost, and intervention cost. We calculated incremental cost-effectiveness ratios (ICERs) from societal, provider, and patient perspectives. RESULTS: Two hundred and sixty-seven intervention-participating and 69 intervention-nonparticipating post-cancer treatment patients were included. The support and telephone groups, but not the usual care group, had significantly higher EQ-5D index scores (0.054, p = 0.033, and 0.057, p = 0.026, respectively) than the intervention-nonparticipating group at month 6. Within 6 months, intervention cost per subject was $252 and $484, respectively, for providers, and $564 and $203, respectively, for the support and phone group subjects. The final ICERs were $16,759 per quality-adjusted life year (QALY) and $12,561/QALY for support and telephone groups, compared with those of the intervention-nonparticipating group. These ICERs are much smaller than $50,000/QALY, the consensus threshold to determine cost-effectiveness for society. CONCLUSIONS: The study interventions are cost-effective in consideration of eligible patients who declined the interventions. The interventions can provide meaningful outcome improvement on urinary continence at a low cost. This evidence provides critical information for future health policy decision-making of healthcare providers and payers.","Psychooncology, 25(4): 421-427","USA",2016,"Any or unknown","Psychological","EQ-5D","Patient",null,"Economic model","USA","Patient","Any or unknown","Psychological",null,"Economic model","EQ-5D","2015:2018","Utility"]
[760,"Zhou, T., et al. (2015). \"A multicenter, randomized clinical trial comparing the three-weekly docetaxel regimen plus prednisone versus mitoxantone plus prednisone for Chinese patients with metastatic castration refractory prostate cancer.\" PLoS One 10(1): e0117002.",null,"Zhou, T., et al.","A multicenter, randomized clinical trial comparing the three-weekly docetaxel regimen plus prednisone versus mitoxantone plus prednisone for Chinese patients with metastatic castration refractory prostate cancer","PURPOSE: To explore the feasibility and efficacy of docetaxel plus prednisone for Chinese population with metastatic castration refractory prostate cancer (mCRPC). PATIENTS AND METHODS: A total of 228 patients recruited from 15 centers were randomized to receive 10 cycles of D3P arm (docetaxel: 75 mg/m2, intravenous infusion, every three weeks; Prednisone 10mg orally given daily) or M3P arm (mitoxantrone: 12 mg/m2, intravenous infusion, every three weeks; Prednisone 10mg orally given daily). Primary end point was overall survival, and secondary end points were events progression-free survival (PFS), response rate, response duration. Quality of life (QoL) was also assessed in both treatment groups. RESULTS: The median overall survival was 21.88 months in D3P arm and 13.67 months in M3P arm (P = 0.0011, hazard ratio = 0.63, 95% confidence interval, 0.46-0.86). Subgroup analysis was consistent with the results of overall analysis. Events progression-free survival (pain, PSA, tumor and disease) were significantly improved in D3P arm compared with M3P arm. PSA response rate was 35.11% for patients treated by D3P arm and 19.39% for M3P arm (P = 0.0155). Pain response rate was higher in D3P arm (61.11%, P = 0.0011) than in M3P (23.08%) arm. No statistical differences were found between D3P arm and M3P arm for QoL, tumor response rate and response duration of PSA and pain. The tolerability and overall safety of D3P arm were generally comparable to that of M3P arm. CONCLUSIONS: Compared with M3P arm, D3P arm significantly prolonged overall survival for the Chinese patients with mCRPC and improved the response rate for PSA and pain. TRIAL REGISTRATION: clinicaltrials.gov NCT00436839.","PLoS One, 10(1): e0117002","China",2015,"Metastatic","Taxane,Chemotherapy","Unclear","Patient",null,"Clinical trial","China","Patient","Metastatic","Taxane,Chemotherapy",null,"Clinical trial","Unclear","2015:2018","General"]
[761,"Zimmermann, M., et al. (2016). \"Prospective Phase II Trial of Once-weekly Hypofractionated Radiation Therapy for Low-risk Adenocarcinoma of the Prostate: Late Toxicities and Outcomes.\" Clin Oncol (R Coll Radiol) 28(6): 386-392.",null,"Zimmermann, M., et al.","Prospective Phase II Trial of Once-weekly Hypofractionated Radiation Therapy for Low-risk Adenocarcinoma of the Prostate: Late Toxicities and Outcomes","AIMS: To report the long-term toxicities and sexual quality of life of a once-weekly hypofractionated radiation therapy schedule for low-risk prostate cancer. MATERIALS AND METHODS: A multi-institutional phase II trial was conducted, using a three-dimensional conformal radiation therapy (3D-CRT) approach for low-risk prostate cancer (T1a-T2a, Gleason </= 6 and prostate-specific antigen </= 10 ng/ml). Forty-five Gray (Gy) were delivered in nine fractions of 5 Gy given on a weekly basis. Acute and late genitourinary and gastrointestinal toxicities were graded according to the Radiation Therapy Oncology Group toxicity scale. Sexual function and sexual bother were assessed with the Expanded Prostate Cancer Index Composite (EPIC) questionnaire. RESULTS: Between March 2006 and August 2008, 80 patients were treated, with a median age of 69 years (interquartile range 64-72). The median follow-up was 83 months (interquartile range 73-85 months). At 7 years, overall survival was 88%. No patients died of prostate cancer. Cumulative grade >/=2 genitourinary and gastrointestinal late toxicity was reported for 31.3% and 30% of our patients, respectively. Cumulative grade >/=3 genitourinary and gastrointestinal late toxicity was seen in 3.8% and 12.5% of cases, respectively. Late genitourinary grade 2 toxicity was correlated with the occurrence of acute genitourinary grade 2 toxicity (P = 0.006). The occurrence of late gastrointestinal toxicity was not correlated with acute gastrointestinal toxicity. Pre-treatment EPIC sexual function was low (37.5%) and the mean EPIC sexual function score at 7 years after treatment was 14%. On the other hand, pre-treatment EPIC sexual bother reached 80.5%, meaning little bother, and remained stable during follow-up. CONCLUSIONS: Once-weekly 3D-CRT leads to excellent biochemical disease-free survival and acceptable toxicities. Pre-treatment EPIC sexual function dropped by 42% at 5 years of follow-up. This functional deficit did not bother patients, possibly due to the already low sexual function at baseline.","Clin Oncol (R Coll Radiol), 28(6): 386-392","Canada",2016,"Local","Radiotherapy","EPIC,RTOG-EORTC-SS","Patient",null,"Clinical trial","Canada","Patient","Local","Radiotherapy",null,"Clinical trial","EPIC,RTOG-EORTC-SS","2015:2018","Disease,Treatment"]
[762,"Zorn, K. C., et al. (2012). \"Prospective randomized trial of barbed polyglyconate suture to facilitate vesico-urethral anastomosis during robot-assisted radical prostatectomy: time reduction and cost benefit.\" BJU Int 109(10): 1526-1532.",null,"Zorn, K. C., et al.","Prospective randomized trial of barbed polyglyconate suture to facilitate vesico-urethral anastomosis during robot-assisted radical prostatectomy: time reduction and cost benefit","Study Type - RCT (randomized trial) Level of Evidence 2b. What's known on the subject? and What does the study add? In a previous randomized controlled trial, barbed polyglyconate suture for vesico-urethral anastomosis was associated with more frequent cystogram leaks, longer mean catheterization times and greater suture costs per case. In the current randomized controlled trial, we show that barbed polyglyconate suture is associated with decreased anastomosis time, decreased need to readjust suture tension, cost reduction, and equal continence and early/late urinary complication rates. OBJECTIVE: To examine the effectiveness of barbed polyglyconate suture (V-Loc 180; Covidien, Mansfield, MA, USA) compared with standard monofilament for posterior reconstruction (PR) and vesico-urethral anastomosis (VUA) during robot-assisted radical prostatectomy (RARP). PATIENTS AND METHODS: A prospective randomized controlled trial was conducted in 70 consecutive RARP cases by a single surgeon (K.C.Z.). Standard VUA was performed using three 4-0 poliglecaprone 25 (Monocryl; Ethicon Endosurgery, Cincinnati, OH, USA) sutures secured with absorbable suture clips (LapraTy, Ethicon; one single 6-inch [15.2 cm] for PR and two attached 6-inch [15.2 cm] for VUA). Barbed suture VUA was performed using two 3-0 6-inch (15.2 cm) barbed polyglyconate sutures. Time to complete the suture set-up by the nursing team, anastomosis time and need to adjust suture tension were recorded. Suture-related complications, validated-questionnaire continence and cost were also examined. RESULTS: Compared with a conventional reconstruction technique, there was a significant reduction in mean nurse set-up time (31 vs. 294 s; P < 0.01) and reconstruction time (13.1 vs. 20.8 min; P < 0.01) for the barbed suture technique. Need to readjust suture tension or to place additional suture clips for watertight closure was greater in the standard monofilament group than in the barbed suture group (6% vs. 24%; P= 0.03). * A cost reduction was recorded at our institution (48.05 vs. 70.25 $CAN) with the barbed suture technique. * With a mean follow-up of 6.2 months, no delayed anastomotic leak or bladder neck contracture was observed in either group. * Pad-free continence outcomes for the monofilament suture vs the barbed suture groups at 1 (64 vs. 69%, P= 0.6), 3 (76 vs. 81%, P= 0.5) and 6 months (88 vs. 92%, P= 0.7) were similar. CONCLUSIONS: * Compared with standard monofilament suture, the unidirectional barbed polyglyconate suture appears to provide safe, efficient and cost-effective PR and VUA during RARP. * Use of the interlocked barbed polyglyconate suture technique prevents slippage, precluding the need for assistance, knot-tying and constant reassessment of anastomosis integrity.","BJU Int, 109(10): 1526-1532","Canada",2012,"Any or unknown","Surgery","Unclear","Patient",null,"Clinical trial","Canada","Patient","Any or unknown","Surgery",null,"Clinical trial","Unclear","2010:2014","Complication"]
[763,"Zuber, S., et al. (2015). \"Iodine-125 seed brachytherapy for early stage prostate cancer: a single-institution review.\" Radiat Oncol 10: 49.",null,"Zuber, S., et al.","Iodine-125 seed brachytherapy for early stage prostate cancer: a single-institution review","PURPOSE: We are reporting the five-year biochemical control, toxicity profile and dosimetric parameters using iodine-125 low dose rate brachytherapy (BT) as monotherapy for early stage prostate cancer at a single institution. MATERIAL AND METHODS: Between April 2006 and December 2010, 169 men with early stage prostate cancer were treated with BT. Biochemical failure was defined using the Phoenix definition (nadir + 2 ng/mL). Treatment-related morbidities, including urinary, rectal and sexual function, were measured, applying the International Prostate Symptom Score (IPSS), the 7-grade Quality of Life Scale (QoL) and medical status, the International Consultation on Incontinence Modular Questionnaire (ICIQ), the International Index of Erectile Function (IIEF-5) and the Common Terminology Criteria for Adverse Events (CTCAE v4.03). Seed migration and loss, dosimetric parameters and learning effects were also analyzed. RESULTS: Medium follow-up time was 50 months (range, 1-85 months). The five-year biochemical failure rate was 7%. Acute proctitis rates were 19% (grade 1) and 1% (grade 2), respectively. The overall incidence of incontinence was 19% (mild), 16% (moderate) and < 1% (severe). An increase in IPSS >/= 5 points was detected in 59% of patients, with 38% regaining their baseline. Seed dislocation was found in 24% of patients and correlated with D90 and V100. A learning curve was found for seed migration, D90 and V100. QoL correlated with the general health condition of patient, incontinence symptoms and IPSS. CONCLUSIONS: BT for early stage prostate cancer offers excellent five-year biochemical control with low toxicities. QoL aspects are favorable. A learning curve was detected for procedural aspects but its impact on patient relevant endpoints remains inconclusive.","Radiat Oncol, 10(49","Germany,UK,Switzerland",2015,"Local","Brachytherapy","IPSS,IIEF-5,ICIQ,CTCAE,QOL-7","Patient",null,"Cross-sectional","Germany,UK,Switzerland","Patient","Local","Brachytherapy",null,"Cross-sectional","IPSS,IIEF-5,ICIQ,CTCAE,QOL-7","2015:2018","Disease,Complication,Treatment,General"]

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[null,null,56,null,null,null,null,null,"Unallocated","Case study",null,null,null,null,null,null,null,null,null,"Carer",null,"New names","Existing names",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1960,false,true,1960,1999,{"$f":"IF(CF3<>\"\",_xlfn.CONCAT(CF3,\":\",CG3),\"\")","v":"1960:1999"},{"$f":"OFFSET($CJ$2,0,ROW()-3)","v":"Locations"},"Australia","Abiraterone","Advanced","15D","Caregiver",null,"Case study",null,null,null,null,{"$f":"OFFSET(INDIRECT($CU$1),ROW()-3,0)","v":"Unallocated"}]
[null,"From",null,null,"To",null,null,null,null,"Case study",null,null,null,null,null,null,null,null,null,"Comorbidity",null,"Type of PRO tool","Type of PRO tool","Locations",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"OFFSET($BY$5,domainChoice,0)","v":"studymethodCategories"},null,null,null,1961,false,null,2000,2004,{"$f":"IF(CF4<>\"\",_xlfn.CONCAT(CF4,\":\",CG4),\"\")","v":"2000:2004"},{"$f":"OFFSET($CJ$2,0,ROW()-3)","v":"Interventions"},"Austria","Bisphosphonate","Any or unknown","ABC","General population",null,"Case-control",null,null,null,null,{"$f":"OFFSET(INDIRECT($CU$1),ROW()-3,0)","v":"Case study"}]
[null,{"$f":"IF(CF3=\"\",\"\",CF3)","v":1960},null,null,{"$f":"IF(CG3=\"\",\"\",CG3)","v":1999},null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Complication",null,"C2","C2","Interventions",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1962,false,"Segment count",2005,2009,"2005:2009","Diseases","Belgium","Brachytherapy","At risk","AUA-SI","HCP",null,"Clinical trial",null,null,null,null,"Case-control"]
[null,{"$f":"IF(CF4=\"\",\"\",CF4)","v":2000},null,null,{"$f":"IF(CG4=\"\",\"\",CG4)","v":2004},null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Costs ",null,"C3","C3","Diseases",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"locationCategories",null,null,null,1963,false,null,2010,2014,"2010:2014","PRO tools","Brazil","Chemotherapy","End of life","BAI","Patient",null,"Cohort",null,null,null,null,"Clinical trial"]
[null,2005,null,null,2009,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Disease",null,"C4","C4","Sub-populations",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"interventionCategories",null,null,null,1964,false,null,2015,2018,"2015:2018","subPopulations","Canada","Gefitinib","Local","BDI",null,null,"Cross-sectional",null,null,null,null,"Cohort"]
[null,2010,null,null,2014,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"General",null,"C5","C5","PRO tools",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"diseaseCategories",null,null,null,1965,false,null,null,null,"","Study types","Chile","HIFU","Metastatic","BFS",null,null,"Economic model",null,null,null,null,"Cross-sectional"]
[null,2015,null,null,2018,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Knowledge",null,null,null,"Study types",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"protoolCategories",null,null,null,1966,false,null,null,null,"","Study methodologies","China","Hormonal","Recurrent","BHS",null,null,"Mapping to utility",null,null,null,null,"Economic model"]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Satisfaction",null,null,null,"Study methodologies",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"subpopulationCategories",null,null,null,1967,false,null,null,null,"",null,"Czech Republic","None","Refractory","BIS",null,null,"Narrative review",null,null,null,null,"Mapping to utility"]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Social",null,null,null,"Location categorised",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"studytypeCategories",null,null,null,1968,false,null,null,null,"",null,"Denmark","PDEi","Survivors","BPI",null,null,"Protocol",null,null,null,null,"Narrative review"]
[null,{"$f":"IF(CF10=\"\",\"\",CF10)","v":""},null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Symptom",null,null,null,"Intervention categorised",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"studymethodCategories",null,null,null,1969,false,null,null,null,"",null,"Europe","Palliative care",null,"BSFI",null,null,"Systematic review",null,null,null,null,"Protocol"]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Treatment",null,null,null,"Disease categorised",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1970,false,null,null,null,"",null,"Finland","Psychological",null,"BSI",null,null,"Validation",null,null,null,null,"Systematic review"]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Utility",null,null,null,"Sub-populations categorised",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1971,false,null,null,null,"",null,"France","Radiotherapy",null,"BSP-PC",null,null,null,null,null,null,null,"Validation"]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Views",null,null,null,"PRO tool categorised",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1972,false,null,null,null,"",null,"Germany","Screening",null,"BiFS",null,null,null,null,null,null,null,""]
[null,"",null,null,{"$f":"IF(CG14=\"\",\"\",CG14)","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Study type categorised",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1973,false,null,null,null,"",null,"Greece","Surgery",null,"CARDI",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Study methodology categorised",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1974,false,null,null,null,"",{"$f":"COLUMN()","v":87},"Iceland","Surveillance",null,"CARES-SF",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1975,false,null,null,null,"",null,"Indonesia","Taxane",null,"CARIQ",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1976,false,null,null,null,"",null,"International","Unclear",null,"CAVIPRES-30",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1977,false,null,null,null,"",null,"Ireland","Various",null,"CCCI",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1978,false,null,null,null,"",null,"Israel",null,null,"CCFIS",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1979,false,null,null,null,"",null,"Italy",null,null,"CES-D",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1980,false,null,null,null,"",null,"Japan",null,null,"CHAMPS",null,null,null,null,null,null,null,""]
[null,"",22,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1981,false,null,null,null,"",null,"Korea",null,null,"CHIPS",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1982,false,null,null,null,"",null,"Lithuania",null,null,"CILFS",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1983,false,null,null,null,"",null,"Malaysia",null,null,"CLSS",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1984,false,null,null,null,"",null,"Netherlands",null,null,"COIN",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1985,false,null,null,null,"",null,"New Zealand",null,null,"COPM",null,null,null,null,null,null,null,""]
[null,null,null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1986,false,null,null,null,"",null,"Norway",null,null,"CPQ",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1987,false,null,null,null,"",null,"Portugal",null,null,"CQOLC",null,null,null,null,null,null,null,""]
[null,null,null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1988,false,null,null,null,{"$f":"IF(CF31<>\"\",_xlfn.CONCAT(CF31,\":\",CG31),\"\")","v":""},null,"Serbia",null,null,"CSQ-8",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1989,false,null,null,null,"",null,"Singapore",null,null,"CTCAE",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1990,false,null,null,null,"",null,"South Africa",null,null,"CTS",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1991,false,null,null,null,"",null,"South Korea",null,null,"CUF",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1992,false,null,null,null,"",null,"Spain",null,null,"Cleary-30",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1993,false,null,null,null,"",null,"Sweden",null,null,"DASS-21",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1994,false,null,null,null,"",null,"Switzerland",null,null,"DUKE",null,null,null,null,null,null,null,""]
[null,"",null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1995,false,null,null,null,"",null,"Taiwan",null,null,"Diary",null,null,null,null,null,null,null,""]
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