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Objectives: To report the long-term outcomes from a longitudinal psychosocial study that forms part of the 'Identification of Men with a genetic predisposition to ProstAte Cancer: Targeted Screening in men at higher genetic risk and controls' (IMPACT) study. The IMPACT study is a multi-national study of targeted prostate cancer (PrCa) screening in individuals with a known germline pathogenic variant (GPV) in either the BReast CAncer gene 1 (BRCA1) or the BReast CAncer gene 2 (BRCA2)., Subjects and Methods: Participants enrolled in the IMPACT study were invited to complete a psychosocial questionnaire prior to each annual screening visit for a minimum of 5 years. The questionnaire included questions on sociodemographics and the following measures: Hospital Anxiety and Depression Scale, Impact of Event Scale, 36-item Short-Form Health Survey, Memorial Anxiety Scale for PrCa, Cancer Worry Scale, risk perception and knowledge., Results: A total of 760 participants completed questionnaires: 207 participants with GPV in BRCA1, 265 with GPV in BRCA2 and 288 controls (non-carriers from families with a known GPV). We found no evidence of clinically concerning levels of general or cancer-specific distress or poor health-related quality of life in the cohort as a whole. Individuals in the control group had significantly less worry about PrCa compared with the carriers; however, all mean scores were low and within reported general population norms, where available. BRCA2 carriers with previously high prostate-specific antigen (PSA) levels experience a small but significant increase in PrCa anxiety (P = 0.01) and PSA-specific anxiety (P < 0.001). Cancer risk perceptions reflected information provided during genetic counselling and participants had good levels of knowledge, although this declined over time., Conclusion: This is the first study to report the longitudinal psychosocial impact of a targeted PrCa screening programme for BRCA1 and BRCA2 carriers. The results reassure that an annual PSA-based screening programme does not have an adverse impact on psychosocial health or health-related quality of life in these higher-risk individuals. These results are important as more PrCa screening is targeted to higher-risk groups., (© 2024 The Author(s). BJU International published by John Wiley & Sons Ltd on behalf of BJU International.)

Purpose: To support the development and implementation of exercise programming for people with prostate cancer (PC), we investigated their views on exercise., Methods: Online survey with open recruitment. We collected data on clinical and sociodemographic variables, experiences with exercise advice, outcome expectations, and preferences. We explored determinants of (1) having been counselled about exercise and (2) preferring supervised exercise., Results: The survey was completed by 171 patients (mean age = 70 years, SD = 6.5) from all PC treatment pathways. Sixty-three percent of the respondents reported never having been informed about the potential benefits of exercise. Forty-nine percent preferred exercise to be supervised. Respondents generally reported a positive attitude towards exercise. Seventy-four percent indicated barriers to exercising, including fatigue and lack of access to specific programmes. Outcome expectations were generally positive but moderately strong. Receiving hormonal therapy and younger age were significantly associated with having received exercise advice. Being insured and having higher fatigue levels contributed significantly to the preference for supervised exercise., Conclusion: Dutch people with PC report receiving insufficient effective exercise counselling. Yet, they are open to exercise and expect exercise to improve their health, although they experience various barriers that limit their ability to exercise., Implications for Cancer Survivors: The moderate outcome expectations for exercise of people with PC and their limited recall of exercise counselling highlight the need for better integration of exercise in clinical pathways. The lack of access to specific programming limits the use of evidence-based exercise programmes for people with PC., (© 2023. The Author(s).)

Background: As a local treatment for prostate cancer (PCa), robot-assisted radical prostatectomy (RARP) may have a quality of life (QoL) benefit over open surgery. Recent analyses revealed substantial between-country differences in the function and symptom scale scores for the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), which is typically used to assess patient-reported QoL. Such differences could have implications for multinational studies in PCa., Objective: To examine whether nationality is significantly associated with patient-reported QoL., Design, Setting, and Participants: The study cohort comprised Dutch and German patients with PCa treated with RARP in a single high-volume prostate center from 2006 to 2018. Analyses were restricted to patients who were preoperatively continent with at least one follow-up time point., Outcome Measurements and Statistical Analysis: QoL was measured in terms of the global Quality of Life (QL) scale score and the overall summary score for the EORTC QLQ-C30. Linear mixed models for repeated-measures multivariable analyses (MVAs) were used to examine the association between nationality and both the global QL score and the summary score. MVAs were further adjusted for QLQ-C30 baseline values, age, Charlson comorbidity index, preoperative prostate-specific antigen, surgical expertise, pathological tumor and nodal stage, Gleason grade, degree of nerve-sparing, surgical margin status, 30-d Clavien-Dindo grade complications, urinary continence recovery, and biochemical recurrence/postoperative radiotherapy., Results and Limitations: For Dutch (n = 1938) versus German (n = 6410) men, the mean baseline scores were 82.8 versus 71.9 for the global QL scale score and 93.4 versus 89.7 for the QLQ-C30 summary score. Urinary continence recovery (QL: +8.9, 95% confidence interval [CI] 8.1-9.8; p < 0001) and Dutch nationality (QL: +6.9, 95% CI 6.1-7.6; p < 0001) were the strongest positive contributors to the global QL and summary scores, respectively. The main limitation is the retrospective study design. In addition, our Dutch cohort may not be representative of the general Dutch population and reporting bias cannot be ruled out., Conclusions: Our findings provide observational evidence under specific conditions involving the same setting for patients of two different nationalities suggesting that cross-national patient-reported QoL differences appear to be real and may need to be taken into consideration in multinational studies., Patient Summary: We observed differences in the quality-of-life scores reported by Dutch and German patients with prostate cancer after they underwent robot-assisted removal of the prostate. These findings should be taken into consideration in cross-national studies., (Copyright © 2023 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Purpose: To develop optimal cancer survivorship care programs, this study assessed the quality of prostate cancer follow-up care as experienced by patients shortly after completion of primary treatment., Methods: We surveyed 402 patients with localized prostate cancer participating in a randomized controlled trial comparing specialist versus primary care-based follow-up. For the current study, we used patient-reported data at the time of the first follow-up visit at the hospital, prior to randomization. We assessed patients' ratings of the quality of follow-up care using the Assessment of Patient Experiences of Cancer Care survey. This survey includes 13 scales about different aspects of care and an overall rating of care. Multivariable linear regression analysis was used to identify factors associated with perceived follow-up quality., Results: Patients reported positive experiences at first follow-up for 9 of 13 scales, with mean (M) scores ranging from 79 to 97 (on a 0-100 response scale). Patients reported most frequently (over 70%) suboptimal care regarding symptom management (84%; M = 44, SD = 37), health promotion (75%; M = 45, SD = 39), and physician's knowledge about patients' life (84%; M = 65, SD = 23). Overall, patients' lower quality of follow-up ratings were associated with younger age, higher education level, having more than one comorbid condition, having undergone primary surgery, and experiencing significant symptoms., Conclusion: Patients with prostate cancer are generally positive about their initial, hospital-based follow-up care. However, efforts should be made to improve symptom management, health promotion, and physician's knowledge about patients' life. These findings point to areas where prostate cancer follow-up care can be improved., (© 2022. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Background: Lynch syndrome is a rare familial cancer syndrome caused by pathogenic variants in the mismatch repair genes MLH1, MSH2, MSH6, or PMS2, that cause predisposition to various cancers, predominantly colorectal and endometrial cancer. Data are emerging that pathogenic variants in mismatch repair genes increase the risk of early-onset aggressive prostate cancer. The IMPACT study is prospectively assessing prostate-specific antigen (PSA) screening in men with germline mismatch repair pathogenic variants. Here, we report the usefulness of PSA screening, prostate cancer incidence, and tumour characteristics after the first screening round in men with and without these germline pathogenic variants., Methods: The IMPACT study is an international, prospective study. Men aged 40-69 years without a previous prostate cancer diagnosis and with a known germline pathogenic variant in the MLH1, MSH2, or MSH6 gene, and age-matched male controls who tested negative for a familial pathogenic variant in these genes were recruited from 34 genetic and urology clinics in eight countries, and underwent a baseline PSA screening. Men who had a PSA level higher than 3·0 ng/mL were offered a transrectal, ultrasound-guided, prostate biopsy and a histopathological analysis was done. All participants are undergoing a minimum of 5 years' annual screening. The primary endpoint was to determine the incidence, stage, and pathology of screening-detected prostate cancer in carriers of pathogenic variants compared with non-carrier controls. We used Fisher's exact test to compare the number of cases, cancer incidence, and positive predictive values of the PSA cutoff and biopsy between carriers and non-carriers and the differences between disease types (ie, cancer vs no cancer, clinically significant cancer vs no cancer). We assessed screening outcomes and tumour characteristics by pathogenic variant status. Here we present results from the first round of PSA screening in the IMPACT study. This study is registered with ClinicalTrials.gov, NCT00261456, and is now closed to accrual., Findings: Between Sept 28, 2012, and March 1, 2020, 828 men were recruited (644 carriers of mismatch repair pathogenic variants [204 carriers of MLH1, 305 carriers of MSH2, and 135 carriers of MSH6] and 184 non-carrier controls [65 non-carriers of MLH1, 76 non-carriers of MSH2, and 43 non-carriers of MSH6]), and in order to boost the sample size for the non-carrier control groups, we randomly selected 134 non-carriers from the BRCA1 and BRCA2 cohort of the IMPACT study, who were included in all three non-carrier cohorts. Men were predominantly of European ancestry (899 [93%] of 953 with available data), with a mean age of 52·8 years (SD 8·3). Within the first screening round, 56 (6%) men had a PSA concentration of more than 3·0 ng/mL and 35 (4%) biopsies were done. The overall incidence of prostate cancer was 1·9% (18 of 962; 95% CI 1·1-2·9). The incidence among MSH2 carriers was 4·3% (13 of 305; 95% CI 2·3-7·2), MSH2 non-carrier controls was 0·5% (one of 210; 0·0-2·6), MSH6 carriers was 3·0% (four of 135; 0·8-7·4), and none were detected among the MLH1 carriers, MLH1 non-carrier controls, and MSH6 non-carrier controls. Prostate cancer incidence, using a PSA threshold of higher than 3·0 ng/mL, was higher in MSH2 carriers than in MSH2 non-carrier controls (4·3% vs 0·5%; p=0·011) and MSH6 carriers than MSH6 non-carrier controls (3·0% vs 0%; p=0·034). The overall positive predictive value of biopsy using a PSA threshold of 3·0 ng/mL was 51·4% (95% CI 34·0-68·6), and the overall positive predictive value of a PSA threshold of 3·0 ng/mL was 32·1% (20·3-46·0)., Interpretation: After the first screening round, carriers of MSH2 and MSH6 pathogenic variants had a higher incidence of prostate cancer compared with age-matched non-carrier controls. These findings support the use of targeted PSA screening in these men to identify those with clinically significant prostate cancer. Further annual screening rounds will need to confirm these findings., Funding: Cancer Research UK, The Ronald and Rita McAulay Foundation, the National Institute for Health Research support to Biomedical Research Centres (The Institute of Cancer Research and Royal Marsden NHS Foundation Trust; Oxford; Manchester and the Cambridge Clinical Research Centre), Mr and Mrs Jack Baker, the Cancer Council of Tasmania, Cancer Australia, Prostate Cancer Foundation of Australia, Cancer Council of Victoria, Cancer Council of South Australia, the Victorian Cancer Agency, Cancer Australia, Prostate Cancer Foundation of Australia, Asociación Española Contra el Cáncer (AECC), the Instituto de Salud Carlos III, Fondo Europeo de Desarrollo Regional (FEDER), the Institut Català de la Salut, Autonomous Government of Catalonia, Fundação para a Ciência e a Tecnologia, National Institutes of Health National Cancer Institute, Swedish Cancer Society, General Hospital in Malmö Foundation for Combating Cancer., Competing Interests: Declaration of interests HL holds patents on intact PSA assays and is named on a patent for a statistical method to detect prostate cancer licensed to Arctic Partners and commercialised by OPKO Health, and has stock in Arctic Partners and OPKO Health and receives royalties from sales of the 4Kscore test. RAE has received speaker honoraria from Genitourinary-American Society of Clinical Oncology, The University of Chicago, European Society for Medical Oncology (paid by Bayer and Ipsen), and The Royal Marsden NHS Foundation Trust (with support from Janssen), and is a member of the AstraZeneca UK Limited Prostate Dx Advisory Panel external expert committee. No organisation had any role in the decision to publish or in the writing of the manuscript. All other authors declare no competing interests., (Copyright © 2021 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Objective: Psychosocial interventions can reduce cancer-related fatigue effectively. However, it is still unclear if intervention effects differ across subgroups of patients. These meta-analyses aimed at evaluating moderator effects of (a) sociodemographic characteristics, (b) clinical characteristics, (c) baseline levels of fatigue and other symptoms, and (d) intervention-related characteristics on the effect of psychosocial interventions on cancer-related fatigue in patients with non-metastatic breast and prostate cancer., Methods: Data were retrieved from the Predicting OptimaL cAncer RehabIlitation and Supportive care (POLARIS) consortium. Potential moderators were studied with meta-analyses of pooled individual patient data from 14 randomized controlled trials through linear mixed-effects models with interaction tests. The analyses were conducted separately in patients with breast (n = 1091) and prostate cancer (n = 1008)., Results: Statistically significant, small overall effects of psychosocial interventions on fatigue were found (breast cancer: β = -0.19 [95% confidence interval (95%CI) = -0.30; -0.08]; prostate cancer: β = -0.11 [95%CI = -0.21; -0.00]). In both patient groups, intervention effects did not differ significantly by sociodemographic or clinical characteristics, nor by baseline levels of fatigue or pain. For intervention-related moderators (only tested among women with breast cancer), statistically significant larger effects were found for cognitive behavioral therapy as intervention strategy (β = -0.27 [95%CI = -0.40; -0.15]), fatigue-specific interventions (β = -0.48 [95%CI = -0.79; -0.18]), and interventions that only targeted patients with clinically relevant fatigue (β = -0.85 [95%CI = -1.40; -0.30])., Conclusions: Our findings did not provide evidence that any selected demographic or clinical characteristic, or baseline levels of fatigue or pain, moderated effects of psychosocial interventions on fatigue. A specific focus on decreasing fatigue seems beneficial for patients with breast cancer with clinically relevant fatigue., (© 2020 John Wiley & Sons Ltd.)

Purpose: Information about prostate cancer patients' experiences with their treatment is crucial to optimize shared decision-making. This study examined unmet expectations in prostate cancer patients and their association with decision regret., Methods: We conducted a prospective, observational, multi-center study of men diagnosed with localized prostate cancer between 2014 and 2016. Questionnaires were completed at baseline (pre-treatment), and up to 12 months after treatment. Unmet expectations were reported as the proportion of patients who experienced side effects as worse than expected. Linear regression analysis was used to identify factors associated significantly (p ≤ 0.05) with unmet expectations and its association with decision regret., Results: At 1-year follow-up, the majority of the patients (71%, 210/296) reported at least one unmet expectation. The proportion of patients who reported worse than expected erectile problems was 56%, recovery period = 29%, urinary problems = 28%, fatigue = 24%, and bowel problems = 17%. Unmet expectations were comparable between treatment groups, except for fatigue. A passive role in the decision-making process (eta squared (η 2 ) = 0.02) and higher scores on the decisional conflict scale (η 2  = 0.02) were associated with more unmet expectations, and unmet expectations were associated with decision regret (η 2  = 0.08)., Conclusions: Unmet expectations are common among men treated for localized prostate cancer. Involving patients in the treatment decision-making process and offering additional counseling to patients who indicate uncertainty about their decision, may help to avoid unmet expectations., Implications for Cancer Survivors: The current study emphasizes the need for involving prostate cancer patients in the decision-making process in order to mitigate unmet expectations.

Background: In its 2006 report, From cancer patient to cancer survivor: lost in transition, the U.S. Institute of Medicine raised the need for a more coordinated and comprehensive care model for cancer survivors. Given the ever increasing number of cancer survivors, in general, and prostate cancer survivors, in particular, there is a need for a more sustainable model of follow-up care. Currently, patients who have completed primary treatment for localized prostate cancer are often included in a specialist-based follow-up care program. General practitioners already play a key role in providing continuous and comprehensive health care. Studies in breast and colorectal cancer suggest that general practitioners could also consider to provide survivorship care in prostate cancer. However, empirical data are needed to determine whether follow-up care of localized prostate cancer survivors by the general practitioner is a feasible alternative., Methods: This multicenter, randomized, non-inferiority study will compare specialist-based (usual care) versus general practitioner-based (intervention) follow-up care of prostate cancer survivors who have completed primary treatment (prostatectomy or radiotherapy) for localized prostate cancer. Patients are being recruited from hospitals in the Netherlands, and randomly (1:1) allocated to specialist-based (N = 195) or general practitioner-based (N = 195) follow-up care. This trial will evaluate the effectiveness of primary care-based follow-up, in comparison to usual care, in terms of adherence to the prostate cancer surveillance guideline for the timing and frequency of prostate-specific antigen assessments, the time from a biochemical recurrence to retreatment decision-making, the management of treatment-related side effects, health-related quality of life, prostate cancer-related anxiety, continuity of care, and cost-effectiveness. The outcome measures will be assessed at randomization (≤6 months after treatment), and 12, 18, and 24 months after treatment., Discussion: This multicenter, prospective, randomized study will provide empirical evidence regarding the (cost-) effectiveness of specialist-based follow-up care compared to general practitioner-based follow-up care for localized prostate cancer survivors., Trial Registration: Netherlands Trial Registry, Trial NL7068 (NTR7266). Prospectively registered on 11 June 2018.

Background: Well-documented reports of patients' experiences with different treatments are important for helping localised prostate cancer (LPC) patients choose among the available treatment options., Objective: To document differences in patient-reported outcomes (PROs) following radical prostatectomy (RP), external beam radiotherapy (EBRT), brachytherapy (BT), and active surveillance (AS), and to evaluate how these PROs and other factors are associated with treatment decision regret., Design, Setting, and Participants: A prospective, observational, multicentre study of men diagnosed with LPC (stage cT1-2) during 2014-2016., Outcome Measurements and Statistical Analysis: Patients completed validated PRO measures (Quality of Life Questionnaire Core 30 [QLQ-C30], Quality of Life Questionnaire prostate cancer-specific module [QLQ-PR25], Decision Regret Scale, and the Memorial Anxiety Scale for Prostate Cancer) before treatment and at 3, 6, and 12mo after treatment. Mixed-effect models were used to describe different PRO patterns., Results and Limitations: The analytic cohort included 434 men (AS=32%; RP=45%; EBRT=12%; BT=10%). Follow-up response rates were above 90%. At 1-yr follow-up, (1) men who had received RP reported significantly (p<0.01) more urinary incontinence, sexual dysfunction, hormonal/masculinity-related symptoms, and less emotional distress; (2) those having received EBRT reported more sexual dysfunction, hormonal/masculinity-related symptoms, and physical distress; and (3) those having received BT reported more urinary obstruction and irritation symptoms, compared with patients under AS. Irrespective of the treatment modality, 23% of the patients reported clinically relevant treatment regret (99% confidence interval, 17-28%). Multivariate correlates of decision regret were hormonal/masculinity-related symptoms, educational level, and positive surgical margins., Conclusions: Post-treatment physical and psychosocial functioning was significantly associated with specific treatment modalities and pretreatment functioning. Regret was relatively frequently reported by patients who experienced unwanted physical, psychosocial, and oncological outcomes. Greater efforts should be made to understand whether carefully educating patients about the possible consequences and effectiveness of treatments may help limit the feeling of treatment regret., Patient Summary: In men with localised prostate cancer, regret about the treatment choice was more common among those who experienced more treatment-related symptoms during the year after treatment., (Copyright © 2018 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Background: Mutations in BRCA2 cause a higher risk of early-onset aggressive prostate cancer (PrCa). The IMPACT study is evaluating targeted PrCa screening using prostate-specific-antigen (PSA) in men with germline BRCA1/2 mutations., Objective: To report the utility of PSA screening, PrCa incidence, positive predictive value of PSA, biopsy, and tumour characteristics after 3 yr of screening, by BRCA status., Design, Setting, and Participants: Men aged 40-69 yr with a germline pathogenic BRCA1/2 mutation and male controls testing negative for a familial BRCA1/2 mutation were recruited. Participants underwent PSA screening for 3 yr, and if PSA > 3.0 ng/ml, men were offered prostate biopsy., Outcome Measurements and Statistical Analysis: PSA levels, PrCa incidence, and tumour characteristics were evaluated. Statistical analyses included Poisson regression offset by person-year follow-up, chi-square tests for proportion t tests for means, and Kruskal-Wallis for medians., Results and Limitations: A total of 3027 patients (2932 unique individuals) were recruited (919 BRCA1 carriers, 709 BRCA1 noncarriers, 902 BRCA2 carriers, and 497 BRCA2 noncarriers). After 3 yr of screening, 527 men had PSA > 3.0 ng/ml, 357 biopsies were performed, and 112 PrCa cases were diagnosed (31 BRCA1 carriers, 19 BRCA1 noncarriers, 47 BRCA2 carriers, and 15 BRCA2 noncarriers). Higher compliance with biopsy was observed in BRCA2 carriers compared with noncarriers (73% vs 60%). Cancer incidence rate per 1000 person years was higher in BRCA2 carriers than in noncarriers (19.4 vs 12.0; p =  0.03); BRCA2 carriers were diagnosed at a younger age (61 vs 64 yr; p =  0.04) and were more likely to have clinically significant disease than BRCA2 noncarriers (77% vs 40%; p =  0.01). No differences in age or tumour characteristics were detected between BRCA1 carriers and BRCA1 noncarriers. The 4 kallikrein marker model discriminated better (area under the curve [AUC] = 0.73) for clinically significant cancer at biopsy than PSA alone (AUC = 0.65)., Conclusions: After 3 yr of screening, compared with noncarriers, BRCA2 mutation carriers were associated with a higher incidence of PrCa, younger age of diagnosis, and clinically significant tumours. Therefore, systematic PSA screening is indicated for men with a BRCA2 mutation. Further follow-up is required to assess the role of screening in BRCA1 mutation carriers., Patient Summary: We demonstrate that after 3 yr of prostate-specific antigen (PSA) testing, we detect more serious prostate cancers in men with BRCA2 mutations than in those without these mutations. We recommend that male BRCA2 carriers are offered systematic PSA screening., (Copyright © 2019 The Authors. Published by Elsevier B.V. All rights reserved.)

Objectives: To report the baseline results of a longitudinal psychosocial study that forms part of the IMPACT study, a multi-national investigation of targeted prostate cancer (PCa) screening among men with a known pathogenic germline mutation in the BRCA1 or BRCA2 genes., Particpants and Methods: Men enrolled in the IMPACT study were invited to complete a questionnaire at collaborating sites prior to each annual screening visit. The questionnaire included sociodemographic characteristics and the following measures: the Hospital Anxiety and Depression Scale (HADS), Impact of Event Scale (IES), 36-item short-form health survey (SF-36), Memorial Anxiety Scale for Prostate Cancer, Cancer Worry Scale-Revised, risk perception and knowledge. The results of the baseline questionnaire are presented., Results: A total of 432 men completed questionnaires: 98 and 160 had mutations in BRCA1 and BRCA2 genes, respectively, and 174 were controls (familial mutation negative). Participants' perception of PCa risk was influenced by genetic status. Knowledge levels were high and unrelated to genetic status. Mean scores for the HADS and SF-36 were within reported general population norms and mean IES scores were within normal range. IES mean intrusion and avoidance scores were significantly higher in BRCA1/BRCA2 carriers than in controls and were higher in men with increased PCa risk perception. At the multivariate level, risk perception contributed more significantly to variance in IES scores than genetic status., Conclusion: This is the first study to report the psychosocial profile of men with BRCA1/BRCA2 mutations undergoing PCa screening. No clinically concerning levels of general or cancer-specific distress or poor quality of life were detected in the cohort as a whole. A small subset of participants reported higher levels of distress, suggesting the need for healthcare professionals offering PCa screening to identify these risk factors and offer additional information and support to men seeking PCa screening., (© 2018 The Authors BJU International published by John Wiley & Sons Ltd on behalf of BJU International.)

Background: Higher levels of physical activity (PA) after treatment are associated with beneficial effects on physical and psychosocial functioning of cancer survivors. However, survivors often do not meet the recommended levels of PA. In order to promote PA, we developed a closed internet-based program. The aim of the study is to evaluate the (cost-)effectiveness of an internet-based PA-promotion program, alone or combined with physiotherapy counselling, compared to usual care, on PA-levels of breast or prostate cancer survivors. In this multicenter randomised controlled trial (RCT), breast or prostate cancer survivors who completed their primary treatment 3-12 months earlier, will be randomised to either 6-months access to a fully-automated internet-based intervention alone, an internet-based intervention plus remote support by a physiotherapist, or a control group. The intervention is based on the Transtheoretical Model and includes personalized feedback, information, video's and assignments. Additionally, in a second arm, physiotherapy counselling is provided through monthly scheduled and on-demand telephone calls. The control group will receive usual care and a leaflet with PA guidelines., Methods: At baseline, 6 and 12 months, the primary outcome (PA) will be measured during 7 consecutive days by accelerometers. Secondary outcomes are self-reported PA, fatigue, mood, health-related quality of life, and costs. The group differences for primary and secondary outcomes will be analyzed using linear mixed models., Discussion: If proven to be (cost)effective, this internet-based intervention, either alone or in combination with telephone support, will be a welcome addition to previous RCT's., Trial Registration: Netherlands trial register (NTR6911), Date of trial registration: December 21, 2017.

Purpose: The aims of this study were to 1) describe preferred and experienced roles in treatment decision making among patients with localized prostate cancer, 2) identify how often the roles experienced by patients matched their preferred roles and 3) determine whether active involvement in decision making regardless of role preferences or concordance between preferred and experienced roles would be the strongest predictor of more favorable patient reported outcomes., Materials and Methods: In this prospective, multicenter, observational study we obtained serial questionnaire data from 454 patients with newly diagnosed, localized prostate cancer (cT1-cT2, or Gleason 7 or less and prostate specific antigen 20 ng/ml or less). Questionnaires were completed prior to treatment and at the 3, 6 and 12-month posttreatment followups. Clinical data were obtained from the patient medical records. Active involvement and role concordance were operationalized using the CPS (Control Preferences Scale). ANOVA and effect sizes (small and medium Cohen d = 0.2 and 0.5, respectively) were used to compare patient knowledge of prostate cancer, decision conflict, decision regret and overall health related quality of life., Results: Of the patients 393 (87%) reported having been actively involved in treatment decision making. However, 78 patients (17%) indicated having had less or more involvement than preferred. Active involvement was significantly associated with more prostate cancer knowledge (d = 0.30), less decision conflict (d = 0.52) and less decision regret (d = 0.34). Role concordance was also but less strongly associated with less decision conflict (d = 0.41)., Conclusions: Our findings support a policy of encouraging all patients with localized prostate cancer regardless of their stated role preferences to be actively involved in the treatment decision., (Copyright © 2018 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.)

Objective: To assess the accuracy of patients' perceptions of the risks associated with localised prostate cancer treatments (radical prostatectomy [RP], radiotherapy [RT], and active surveillance [AS]), and to identify correlates of misperceptions., Patients and Methods: We used baseline data (questionnaires completed after treatment information was provided but before treatment) of 426 patients with newly diagnosed localised prostate cancer who participated (87% response rate) in a prospective, longitudinal, multicentre study. Patients' pretreatment perceptions of differences in adverse outcomes of treatments were compared to those based on the literature. We used univariate and multivariate linear regression to identify correlates of misperceptions., Results: About two-thirds (68%, n = 211) of the patients did not understand that the risk of disease recurrence is comparable between RP and RT. More than half of the patients did not comprehend that RP patients are at greater risk of urinary incontinence (65%, n = 202) and erectile dysfunction (61%, n = 190), and less at risk of bowel problems (53%, n = 211) compared to RT patients. Many patients overestimated the risk of requiring definitive treatment following AS (45%, n = 157) and did not understand that mortality rates following AS, RP, and RT are comparable (80%, n = 333). Consulting a radiotherapist or a clinical nurse specialist was positively associated with, and emotional distress was negatively associated with, better understanding of the risks (P < 0.05), although effect sizes were small., Conclusion: Prior to choosing treatment, most patients with prostate cancer poorly understood the differences in treatment risks. Greater efforts should be made to better understand why these misperceptions occur and, most importantly, how they can be corrected.

Objectives: To assess the accuracy of patients' perceptions of the risks associated with localised prostate cancer treatments (radical prostatectomy [RP], radiotherapy [RT], and active surveillance [AS]), and to identify correlates of misperceptions., Patients and Methods: We used baseline data (questionnaires completed after treatment information was provided but before treatment) of 426 patients with newly diagnosed localised prostate cancer who participated (87% response rate) in a prospective, longitudinal, multicentre study. Patients' pretreatment perceptions of differences in adverse outcomes of treatments were compared to those based on the literature. We used univariate and multivariate linear regression to identify correlates of misperceptions., Results: About two-thirds (68%, n = 211) of the patients did not understand that the risk of disease recurrence is comparable between RP and RT. More than half of the patients did not comprehend that RP patients are at greater risk of urinary incontinence (65%, n = 202) and erectile dysfunction (61%, n = 190), and less at risk of bowel problems (53%, n = 211) compared to RT patients. Many patients overestimated the risk of requiring definitive treatment following AS (45%, n = 157) and did not understand that mortality rates following AS, RP, and RT are comparable (80%, n = 333). Consulting a radiotherapist or a clinical nurse specialist was positively associated with, and emotional distress was negatively associated with, better understanding of the risks (P < 0.05), although effect sizes were small., Conclusion: Prior to choosing treatment, most patients with prostate cancer poorly understood the differences in treatment risks. Greater efforts should be made to better understand why these misperceptions occur and, most importantly, how they can be corrected., (© 2017 The Authors BJU International © 2017 BJU International Published by John Wiley & Sons Ltd.)

Objective: The purpose of this study was to identify factors associated with mental health (MH) problems in prostate cancer (PC) survivors. Toward this end, we evaluated (1) differences in the prevalence of MH problems between PC survivors and age-matched men from the general population (GenPop) and (2) correlates of MH in PC survivors and the GenPop., Methods and Materials: In this observational case-control study, we age-matched PC survivors (n = 644, alive≥5y after diagnosis of a stage I-IV carcinoma) recruited from Dutch community hospitals (Patient Reported Outcomes Following Initial treatment and Long-term Evaluation of Survivorship registry) with GenPop peers (n = 644) selected from a population-based sample recruited in general practices (NIVEL). MH was operationalized using the 5-item Mental Health Inventory of the Short Form Health Survey (SF-36). Potential correlates of MH included sociodemographic characteristics, health-related quality of life scores, and clinical characteristics (PC survivors only). We used analysis of (co)variance and chi-square tests to address the 2 research questions., Results: We observed clinically relevant MH symptoms in 14% of the PC survivors and 6% of the GenPop controls (P<0.01, odds ratio = 2.45 [1.66-3.62]). The most important correlates of lower MH scores in the PC survivors were being widowed, a lower educational level, lower general health perceptions, more bodily pain and urinary bother, and less sexual satisfaction. The most important correlates of lower MH scores in the GenPop were as follows: lower general health perceptions, more role limitations because of physical problems, and more bodily pain., Conclusions: Our results indicate that long-term PC survivors have poorer MH, as assessed by the 5-item Mental Health Inventory questionnaire, than men of a comparable age from the GenPop without a history of PC. Attention to potentially modifiable factors associated with MH problems in PC survivors, such as urinary function and its related bother, bodily pain, and sexual satisfaction, may help to prevent or limit MH problems in this survivor population., (Copyright © 2017 Elsevier Inc. All rights reserved.)

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.

Background: Cancer-related fatigue is a common problem in persons with cancer, influencing health-related quality of life and causing a considerable challenge to society. Current evidence supports the beneficial effects of physical exercise in reducing fatigue, but the results across studies are not consistent, especially in terms of exercise intensity. It is also unclear whether use of behaviour change techniques can further increase exercise adherence and maintain physical activity behaviour. This study will investigate whether exercise intensity affects fatigue and health related quality of life in persons undergoing adjuvant cancer treatment. In addition, to examine effects of exercise intensity on mood disturbance, adherence to oncological treatment, adverse effects from treatment, activities of daily living after treatment completion and return to work, and behaviour change techniques effect on exercise adherence. We will also investigate whether exercise intensity influences inflammatory markers and cytokines, and whether gene expressions following training serve as mediators for the effects of exercise on fatigue and health related quality of life., Methods/design: Six hundred newly diagnosed persons with breast, colorectal or prostate cancer undergoing adjuvant therapy will be randomized in a 2 × 2 factorial design to following conditions; A) individually tailored low-to-moderate intensity exercise with or without behaviour change techniques or B) individually tailored high intensity exercise with or without behaviour change techniques. The training consists of both resistance and endurance exercise sessions under the guidance of trained coaches. The primary outcomes, fatigue and health related quality of life, are measured by self-reports. Secondary outcomes include fitness, mood disturbance, adherence to the cancer treatment, adverse effects, return to activities of daily living after completed treatment, return to work as well as inflammatory markers, cytokines and gene expression., Discussion: The study will contribute to our understanding of the value of exercise and exercise intensity in reducing fatigue and improving health related quality of life and, potentially, clinical outcomes. The value of behaviour change techniques in terms of adherence to and maintenance of physical exercise behaviour in persons with cancer will be evaluated., Trial Registration: NCT02473003 , October, 2014.

Background: The impact of salvage radiotherapy (SRT) and its timing on health-related quality of life (HRQoL) in prostate cancer patients is still unclear., Objective: To compare the HRQoL of patients who underwent SRT with that of patients who underwent radical prostatectomy (RP) only and to investigate whether SRT timing is associated with HRQoL., Design, Setting, and Participants: All SRT patients (n=241) and all RP-only patients (n=1005) were selected from a prospective database (2004-2015). The database contained HRQoL and prostate problem assessments up to 2 yr after last treatment., Outcome Measurement and Statistical Analysis: Mixed effects growth modelling adjusting for significant differences in patient characteristics and baseline HRQoL was used to analyze the association between: (1) "treatment" (RP-only vs SRT) and (2) "timing of SRT" with changes in HRQoL., Results and Limitations: SRT patients showed significantly (p<0.05) poorer recovery from urinary, bowel, and erectile function after their last treatment (clinically meaningful difference for urinary and erectile function). Patients with a longer interval (≥ 7 mo) between RP and SRT reported significantly better sexual satisfaction after SRT (p=0.02), and a better urinary function recovery (p=0.03). Limitations of the study include the nonrandom design and the variability in timing of HRQoL measurements., Conclusions: Up to 2 yr after treatment, SRT patients reported poorer HRQoL in several HRQoL domains compared with RP-only patients, but not in overall HRQoL. Delaying the start of SRT after RP may limit the incidence and duration of urinary and sexual problems. Nevertheless, decisions regarding SRT timing should also be based on the potential benefits in disease recurrence., Patient Summary: Patients who receive radiotherapy after surgery may experience poorer urinary, bowel, and erectile function compared with patients who undergo surgery only. Although more research is needed, delaying radiotherapy seems to limit its impact on urinary and sexual functioning., (Copyright © 2016 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

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., (Copyright © 2014 Elsevier Ltd. All rights reserved.)

Objectives: To examine the concordance between clinicians and men diagnosed with prostate cancer on a clinician-derived pathophysiological classification of the following self-reported urinary complications: storage (irritative), voiding (obstructive), and leakage/incontinence., Materials and Methods: Fourteen urology experts classified 37 urinary function questionnaire items into 3 primary conceptual dimensions (e.g., storage [irritative], voiding [obstructive] and urinary leakage/incontinence) that would best reflect each item's content. In addition, 218 patient participants provided responses to the 37 items. Using classifications by experts to develop the conceptual framework, the structure was tested using confirmatory factor analyses with patient data., Results: Expert consensus was achieved in the classification of 31 out of 37 items. Using the 3-factor conceptual framework and patient data, the fit indices for the overall correlated factor model suggested an acceptable overall model fit. The analyses of the separate domains showed acceptable fit for the storage/irritative domain and the leaking/incontinence domain. The dimensionality of the voiding/obstructive domain was too difficult to estimate., Conclusions: Our analysis found items that conceptually and psychometrically support 2 constructs (leaking/incontinence and storage/irritative). The consistency of this support between the groups suggests a clinical relevance that is useful in treating patients. We have conceptual support for a third hypothesis (voiding/obstructive), although there were too few items to assess this psychometrically. Relative motivating factors of bother and urinary complaints were not addressed and remain an unmet need in this field., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Objective: To assess the health-related quality of life (HRQoL) of long-term, disease-free prostate cancer survivors and compare it with that of prostate cancer survivors with diabetes mellitus (DM), and a Dutch normative population, as comorbidity can have a major impact on HRQoL in cancer survivors., Patients and Methods: The Eindhoven Cancer Registry was used to select all men diagnosed with prostate cancer from 1994 to 1998. Questionnaires on HRQoL (Short Form 36) and prostate specific problems (University of California, Los Angeles Expanded Prostate Cancer Index) were sent to 964 patients, and 780 (81%) responded. Excluding patients with disease progression, the sample comprised 525 with prostate cancer and 65 with both prostate cancer and DM. Survivors with DM were more likely to have other comorbid conditions at the time of survey besides DM than were those without DM (74% vs 60%, P = 0.05). At 5-10 years after diagnosis, patients with DM reported worse General Health Perceptions than patients without DM or the normative population (means 52, 61 and 63; P < 0.001). Patients with DM also reported worse Vitality scores (59 vs 63; P < 0.001) than the normative population. Regression analysis indicated that DM was negatively associated with General Health Perceptions (beta = -0.13; P < 0.01) and Vitality (beta = -0.12; P < 0.01). Survivors with DM did not report worse urinary and bowel function or bother, nor more sexual problems than those without DM., Conclusions: Except for general health perceptions and vitality, the HRQoL of prostate cancer survivors with or without DM was comparable to a normative population. Survivorship selection can possibly explain, in part, why patients with DM did not report worse generic or disease-specific HRQoL than those without DM, as had been expected.

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.

Background: In this report, the authors describe the health-related quality of life (HRQL) of long-term prostate cancer survivors 5 to 10 years after diagnosis and compare it with the HRQL of an age-matched, normative sample of the general Dutch population., Methods: The population-based Eindhoven Cancer Registry was used to select all men who were diagnosed with prostate cancer from 1994 to 1998. Nine hundred sixty-four patients received questionnaires (the 36-item Short Form Health Survey [SF-36] and the Quality of Life-Cancer Survivors questionnaire), and 780 of 964 patients responded (81%)., Results: Unselected, long-term prostate cancer survivors reported comparable HRQL scores but worse General Health Perceptions and better Mental Health scores than an age-matched, normative population. Patients who underwent radical prostatectomy had the highest physical HRQL, followed by patients who received 'watchful waiting,' and patients who received radiotherapy. Patients who received hormone treatment, in general, had the lowest physical HRQL., Conclusions: The results of this study suggested that the long-term HRQL of prostate cancer survivors may vary significantly as a function of the type of primary treatment. Because baseline differences between treatment groups cannot be excluded as part of the explanation for these differences, the current findings need to be verified in longitudinal studies., ((c) 2006 American Cancer Society.)

Purpose: Quality of life is of great concern to patients considering treatment options for prostate cancer. In the absence of clinical trial data clearly demonstrating that a particular treatment is superior to another for localized prostate cancer, in terms of cause specific survival, patients may value quality of life as much as quantity of life. The goal of this review is to familiarize the reader with the methodology of quality of life research and to review the recent literature on quality of life outcomes in prostate cancer., Materials and Methods: A structured MEDLINE review of literature on health related quality of life in prostate cancer for the years 1995 to 2001 was performed, and was augmented with highly relevant articles from additional selected journals., Results: In the case of advanced or metastatic disease, where the goal of treatment is palliation and symptom-free survival, quality of life often becomes the primary desired outcome. In localized disease all treatments affect health related quality of life, although the impact of each therapy on sexual, urinary and bowel function is unique., Conclusions: Although a highly personal and subjective entity, health related quality of life can be assessed using rigorous and scientifically stringent methods from the field of psychometric test theory. A substantial amount of literature exists regarding the use of established and validated instruments for assessing the impact of prostate cancer and its treatment on health related quality of life. This information is of critical importance when counseling men with newly diagnosed prostate cancer regarding treatment choices and is also helpful in setting appropriate expectations for men with metastatic disease.

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.

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.

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.

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.

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.

This paper reviews a range of issues related to the assessment of subjective response and quality of life in prostate cancer clinical research. With regard to subjective response criteria, the Karnofsky performance status scale and the subjective components of the World Health Organization acute and subacute toxicity scales appear to hold certain advantages over competing measurement systems. Nevertheless, the available evidence suggests that further developmental work is needed to improve the precision of these instruments. In the area of quality of life assessment, there does not appear to be a clear choice among the array of available measures. Although there are several promising instruments, none has undergone sufficient field testing to justify widespread adoption in clinical research settings. A number of suggestions are offered to facilitate further development in quality of life instrumentation and research implementation.