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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. 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. 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. 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. US National Institutes of Health; Swedish Cancer Society; Foundation in Memory of Johanna Hagstrand and Sigfrid Linnér.

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. 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. 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. 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. Cancer Research UK, Department of Health, and the National Institute for Health Research Cancer Research Network.

Physical activity (PA) can improve a range of outcomes following a cancer diagnosis. These include an improvement in experience of side effects of treatment (eg, fatigue) and management of comorbid conditions. PA might also increase survival and reduce recurrence. Digital interventions have shown potential for PA promotion among cancer survivors, but most in a previous review were Web-based, and few studies used mobile apps. There are many PA apps available for general public use, but it is unclear whether these are suitable as a PA intervention after a cancer diagnosis. This study sought posttreatment nonmetastatic breast, prostate, and colorectal cancer survivors' opinions of using smartphone apps to promote PA and gathered their views on existing publicly available PA apps to inform a future intervention. Each participant was randomly assigned to download 2 of 4 apps (Human, The Walk, The Johnson & Johnson Official 7 Minute Workout, and Gorilla Workout). Participants used each app for 1 week consecutively. In-depth semistructured telephone interviews were then conducted to understand participants' experiences of using the apps and how app-based PA interventions could be developed for cancer survivors. The interviews were analyzed using thematic analysis. Thirty-two participants took part: 50% (16/32) had prostate cancer, 25% (8/32) had breast cancer, and 25% (8/32) had colorectal cancer. Three core themes were identified. The first theme was that multiple factors affect engagement with PA apps and this is highly personalized. Factors affecting engagement included participants' perceptions of (1) the advantages and disadvantages of using apps to support PA, (2) the relevance of the app to the user (eg, in terms of cancer-related factors, their PA goals, the difficulty level of the app, the way in which they interact with their mobile phone, and the extent to which the app fits with their self-identity), (3) the quality of the app (eg, usability, accuracy, quality of production, and scientific evidence-base), and (4) the behavior change techniques used to promote PA. In the second theme, participants recommended that apps that promote walking are most appealing, as walking removes many barriers to PA. Finally, the participants suggested that PA apps should be integrated into cancer care, as they valued guidance and recommendations from health care professionals. This sample of breast, prostate, and colorectal cancer survivors was receptive to the use of apps to promote PA. Although no publicly available PA app was deemed wholly suitable, many suggestions for adaptation and intervention development were provided. The results can inform the development of an app-based PA intervention for cancer survivors. They also highlight the wide-ranging and dynamic influences on engagement with digital interventions, which can be applied to other evaluations of mobile health products in other health conditions and other health behaviors.

We aimed to investigate the safety and efficacy of dutasteride, a 5α-reductase inhibitor, on prostate cancer progression in men with low-risk disease who chose to be followed up with active surveillance. In our 3 year, randomised, double-blind, placebo-controlled study, undertaken at 65 academic medical centres or outpatient clinics in North America, we enrolled men aged 48–82 years who had low-volume, Gleason score 5–6 prostate cancer and had chosen to be followed up with active surveillance. We randomly allocated participants in a one-to-one ratio, stratified by site and in block sizes of four, to receive once-daily dutasteride 0·5 mg or matching placebo. Participants were followed up for 3 years, with 12-core prostate biopsy samples obtained after 18 months and 3 years. The primary endpoint was time to prostate cancer progression, defined as the number of days between the start of study treatment and the earlier of either pathological progression (in patients with ≥1 biopsy assessment after baseline) or therapeutic progression (start of medical therapy). This trial is registered with ClinicalTrials.gov, number NCT00363311. Between Aug 10, 2006, and March 26, 2007, we randomly allocated 302 participants, of whom 289 (96%) had at least one biopsy procedure after baseline and were included in the primary analysis. By 3 years, 54 (38%) of 144 men in the dutasteride group and 70 (48%) of 145 controls had prostate cancer progression (pathological or therapeutic; hazard ratio 0·62, 95% CI 0·43–0·89; p=0·009). Incidence of adverse events was much the same between treatment groups. 35 (24%) men in the dutasteride group and 23 (15%) controls had sexual adverse events or breast enlargement or tenderness. Eight (5%) men in the dutasteride group and seven (5%) controls had cardiovascular adverse events, but there were no prostate cancer-related deaths or instances of metastatic disease. Dutasteride could provide a beneficial adjunct to active surveillance for men with low-risk prostate cancer. GlaxoSmithKline.

Purpose The aim was to compare quality of life (QoL) of patients with testosterone recovery (TR) to patients without TR after the completion of either 18- or 36-month androgen deprivation therapy (ADT) for prostate cancer. Methods From a Phase III trial, we selected all 630 randomised patients with testosterone measured at baseline (during screening, before randomisation) and follow-up and who completed baseline, 6-month and, at least, one further QoL questionnaire in follow-up (EORTC 30 - PR25). We estimated means and standard deviation of items and scales for each group at each time point. We analyzed items and scales scores with general linear model with repeated measures to evaluate changes between patients with or without TR to a normal level. p-values were adjusted for multiple comparisons with Benjamini-Hochberg’s false discovery rate procedure (p adj ). A p adj < 0.05 was considered significant and mean differences of 10 points or more considered clinically relevant. Results 494 patients retained for analysis (median follow-up 16.2 years). A significantly higher number of patients (177/314 vs 79/180, p = 0.008) recovered a normal testosterone level in a significantly shorter time [median (IQR): 3.06 (2.55–3.65) vs 5.00 years (4.5–5.96), p < 0.001] in the 18- vs the 36-month cohort. Patients with TR had a significantly better QoL: 37/55 items and 14/21 scales (p adj <0.05) in the 18-month and 25/55 items and 13/21 scales in the 36-month cohort. Moreover, 9 items and one scale reached clinical relevance in the 18-month cohort and 7 items and one scale in the 36-month cohort. Conclusions TR is associated with significant regaining in QoL. A faster and significantly higher TR is seen in the shorter ADT schedule.

IntroductionThe period directly after primary treatment for breast or prostate cancer is a time when patients feel unprepared about how to manage life and address unexpected health challenges. Supportive care should focus on identifying symptoms and concerns and involving survivors in their self‐care. Interventions using a blended model encompassing remote and in-person components may inform how supportive care can be organised. This protocol describes two pilot randomised controlled trials with the aim to investigate the acceptability, feasibility and potential effects of a 6 month digital and nurse-led support intervention in primary care for patients with breast or prostate cancer during the first year after primary treatment.Methods and analysisTwo cluster randomised pilot trials including patients with breast or prostate cancer during the first year after ending primary treatment will run from 2023 in primary care centres in Region Stockholm. The trials will have an estimated sample size of 20 patients in each arm. The intervention groups receive a digital and nurse-led support intervention in combination with standard care, and the control groups receive standard care alone. To assess acceptability and feasibility, the participants in the intervention groups and the study nurses will be interviewed. Furthermore, digitally logged data and field notes by study-specific nurses will be analysed. Data collection for the potential effects of the intervention is conducted through self-reported standardised and validated questionnaires at baseline, and at 3, 6, 12, 18 and 24 months. Data entry and analyses will be blinded to the researchers. Qualitative data will be analysed with content analysis, quantitative data will be evaluated by comparing changes within and between groups.Ethics and disseminationThis project was reviewed and approved by the Swedish Ethical Review Authority. Study results will be published in peer-reviewed journals and presented at scientific and professional meetings.Trial registration numbersClinicalTrials.gov, NCT06471452 and NCT05100121.

Physical exercise has been shown to be effective in relation to fatigue, aerobic fitness, and lower body strength in men with prostate cancer. However, research into the clinically relevant effects of interventions conducted in heterogeneous patient populations and in real-life clinical practice settings is warranted. We conducted a pragmatic, multicentre, parallel randomised controlled trial in 5 Danish urological departments. Recruitment began in May 2015, the first participant was randomised in June 2015, and the last participant was included in February 2017. In total, 214 men with prostate cancer were randomly assigned to either 6 months of free-of-charge football training twice weekly at a local club (football group [FG]) (n = 109) or usual care (usual care group [UG]) (n = 105), including brief information on physical activity recommendations at randomisation. Participants were on average 68.4 (SD 6.2) years old, 157 (73%) were retired, 87 (41%) were on castration-based treatment, 19 (9%) had received chemotherapy, and 41 (19%) had skeletal metastases at baseline. In this 1-year follow-up study, we evaluated the effects of community-based football training on the following outcomes: primary outcome, quality of life; secondary outcomes: continuation of football after 6 months, hip and lumbar spine bone mineral density (BMD), mental health score, fat and lean body mass, and safety outcomes, i.e., fractures, falls, and hospital admissions. Intention to treat (ITT) and per protocol (PP) analyses were conducted. No statistically significant between-group difference was observed in change in prostate-cancer-specific quality of life (ITT: 1.9 points [95% CI -1.9 to 5.8], p = 0.325; PP: 3.6 points [95% CI -0.9 to 8.2], p = 0.119). A statistically significant between-group difference was observed in change in total hip BMD, in favour of FG (0.007 g/cm2 [95% CI 0.004 to 0.013], p = 0.037). No differences were observed in change in lumbar spine BMD or lean body mass. Among patients allocated to football, 59% chose to continue playing football after the end of the 6-month intervention period. At 1-year follow-up in the PP population, FG participants had more improvement on the Mental Component Summary (2.9 [95% CI 0.0 to 5.7], p = 0.048 points higher) than UG participants, as well as a greater loss of fat mass (-0.9 kg [95% CI -1.7 to -0.1], p = 0.029). There were no differences between groups in relation to fractures or falls. Hospital admissions were more frequent in UG compared to FG (33 versus 20; the odds ratio based on PP analysis was 0.34 for FG compared to UG). There were 3 deaths in FG and 4 in UG. Main limitations of the study were the physically active control group and assessment of physical activity by means of self-report. In this trial, participants allocated to football appeared to have improved hip BMD and fewer hospital admissions. Men who played football more than once a week for 1 year lost fat mass and reported improved mental health. Community-based football proved to be acceptable, even when club membership was not subsidised. ClinicalTrials.gov NCT02430792.

BackgroundFamilism, the cultural value that emphasizes feelings of loyalty and dedication to one’s family, has been related to both positive and negative outcomes in Hispanic cancer survivors. One potential source of observed inconsistencies may be limited attention to the family environment, as familism may be protective in a cohesive family whereas it can exacerbate distress in a conflictive family.PurposeThe current study explored the associations of familism with general and disease-specific health-related quality of life (HRQoL) in Hispanic men who completed prostate cancer (PC) treatment, and whether family cohesion may help explain these relationships.MethodsHispanic men treated for localized PC (e.g., radiation, surgery) were enrolled in a randomized controlled stress management trial and assessed prior to randomization. Familism (familial obligation) was assessed using Sabogal’s Familism Scale and family cohesion was measured using the Family Environment Scale (ranging from high to low). The sexual, urinary incontinence, and urinary obstructive/irritative domains of the Expanded Prostate Cancer Index Composite – Short Form measured disease-specific HRQoL. The physical, emotional, and functional well-being subscales of the Functional Assessment of Cancer Therapy – General captured general HRQoL. Hierarchical linear regression and the SPSS PROCESS macro were used to conduct moderation analyses, while controlling for relevant covariates.ResultsParticipants were 202 older men on average 65.7 years of age (SD = 8.0) who had been diagnosed with PC an average of 22 months prior to enrollment. Familism was not directly associated with general and disease-specific HRQoL. Moderation analyses revealed that greater familism was related to poorer urinary functioning in the incontinence (p = .03) and irritative/obstructive domains (p = .01), and lower emotional well-being (p = .02), particularly when family cohesion was low.ConclusionsThese findings underscore the importance of considering contextual factors, such as family cohesion, in understanding the influence of familism on general and disease-specific HRQoL among Hispanic PC patients. The combined influence of familism and family cohesion predicts clinically meaningful differences in urinary functioning and emotional well-being during the posttreatment phase. Culturally sensitive psychosocial interventions to boost family cohesion and leverage the positive impact of familistic attitudes are needed to enhance HRQoL outcomes in this population.

PurposePatients with metastatic cancer can experience debilitating symptoms, which may influence attitudes towards and engagement in physical activity. This study aimed to examine the attitudes of patients living with metastatic prostate cancer towards physical activity.Materials and methodsSemi-structured interviews were completed with male patients living with metastatic prostate cancer. Interviews included eight questions related to patients’ attitudes towards physical activity. Content analysis was conducted on the transcribed interview data. Twenty men with metastatic prostate cancer (mean age 71 ± 8.5 years; body mass index 30.19 ± 5.37 kg/cm2) and associated bone metastases (55% with > 2 regions affected) participated in the study.ResultsMen’s views towards physical activity were coded into the following major themes: (1) barriers to physical activity, (2) benefits of physical activity, (3) a reduction in physical activity levels post diagnosis and (4) social support for physical activity. Symptoms of metastatic prostate cancer and treatment side effects including pain and fatigue negatively influenced activity participation. In addition, many generic barriers to physical activity were described such as bad weather and a lack of suitable facilities for exercising in rural areas.ConclusionMen living with metastatic prostate cancer have unique needs regarding physical activity related to symptoms of both their cancer and cancer treatment. There is a need to increase prompts that encourage those with metastatic prostate cancer to maintain/increase physical activity levels post diagnosis. Given the individualised needs of this patient group, referral to a cancer exercise specialist should be considered for prescription of tailored physical activity programmes.Trial registrationClinicaltrials.gov NLM Identifier: NCT02453139