Value of gym-based group exercise versus usual care for young adults receiving antipsychotic medication: study protocol for the multicenter randomized controlled Vega trial.

BACKGROUND: Exercise is recommended to protect physical health among people with severe mental illness and holds the potential to facilitate long-term recovery. An inclusive exercise community provides an opportunity for life skill training and social connectedness and may reduce the experience of loneliness and internalized stigmatization which together may improve personal recovery. Using a pragmatic randomized design, we aim to examine the effectiveness of a gym-based exercise intervention tailored to young adults in antipsychotic treatment (i.e., Vega Exercise Community) compared to usual care. It is hypothesized that the Vega Exercise Community will be superior to usual care for personal recovery at four months. METHODS: The trial will be conducted at four sites in Denmark from which 400 participants, aged 18 to 35 years, who are in current treatment with antipsychotic medications for the management of schizophrenia spectrum or affective disorders, will be recruited. Participants will be randomized (2:1) to Vega Exercise Community or usual care. Vega Exercise Community includes three weekly group-based exercise sessions hosted in commercial functional training centers delivered by certified Vega instructors. After four months, participants in Vega Exercise Community will be randomized (1:1) to minimal versus extended support with regards to sustained physical activity. Data will be collected at baseline, four, six and 12 months. The primary outcome is personal recovery assessed by Questionnaire about the Process of Recovery at four months. Behavioral symptoms, health-related quality of life, metabolic health, and program costs will be evaluated to further determine the effectiveness and cost-effectiveness of the Vega Exercise Community. Finally, the quality of life and physical and mental health of the participants' primary relative will be evaluated. DISCUSSION: The results of this trial may have important implications for health, sustained physical activity, and recovery for individuals in treatment with antipsychotics. Given the pragmatic design, positive results may readily be implemented by mental health care professionals to promote exercise as an integrated part of treatment of severe mental illness. TRIAL REGISTRATION: Clinical Trials.gov (NCT05461885, initial registration June 29th, 2022). WHO Universal Trial Number (UTN): U1111-1271-9928.

Easier in Practice Than in Theory: Experiences of Coaches in Charge of Community-Based Soccer Training for Men with Prostate cancer-A Descriptive Qualitative Study.

BACKGROUND: Evidence suggests that community-based exercise programs and sports participation benefit long-term physical activity adherence and promote health in clinical populations. Recent research shows that community-based soccer can improve mental health and bone health and result in fewer hospital admissions in men with prostate cancer. However, little knowledge exists on what coaches experience, leading to a scarcity of knowledge on how to assist them in promoting and supporting the sustainability of programs. The purpose of this study was to explore the experiences of non-professional soccer coaches in providing community-based soccer training for men with prostate cancer. RESULTS: We interviewed 13 out of 21 eligible non-professional soccer coaches in charge of delivering the Football Club Prostate Community program, which is community-based soccer training for men with prostate cancer at 12 local soccer clubs across Denmark. Qualitative content analysis, as described by Graneheim and Lundman, was applied to analyze the data using NVivo 12 software. We identified the five following overall categories with 10 subcategories on what the coaches experienced: (1) enabling training of a clinical population in a community setting, (2) dedication based on commitment, (3) coaching on the players' terms, (4) navigating the illness, and (5) ensuring sustainability. Collectively, the findings suggest that, while the coaches felt adequately prepared to coach, their coaching role developed and was refined only through interaction with the players, indicating that coaching clinical populations may be easier in practice than in theory and a potentially transformative learning experience. CONCLUSIONS: Non-professional soccer coaches in charge of delivering soccer training for men with prostate cancer value being educated about specific illness-related issues. Initial concerns about how to coach a clinical population disappeared once the coaches engaged with the players and developed their own team norms and illness management strategies. They also gained a broader perspective on their own lives, which they valued and would not otherwise have achieved by coaching a healthy population. Our study indicates that sustainable implementation and the program's sustainability can be promoted and supported through additional formal, easily accessible communication with trained health professionals and by networking with peer coaches.

Do Patients with Prostate Cancer Benefit from Exercise Interventions? A Systematic Review and Meta-Analysis.

Men diagnosed and treated for prostate cancer experience severe adverse effects on quality of life (QoL) and metabolic health, some of which may be preventable or reversible with exercise, the benefits of which healthcare providers and patients increasingly acknowledge, though existing evidence on its effects varies in significance and magnitude. We aimed to review the effect of exercise on QoL and metabolic health in a broad prostate cancer population. A systematic search was conducted in nine databases and eligible trials were included in the meta-analytic procedure. All outcomes were stratified into aerobic exercise, resistance exercise, and a combination of both. The review identified 33 randomised controlled trials (2567 participants) eligible for inclusion. Exercise had a borderline small positive effect on cancer-specific QoL (standardised mean difference (SMD) = 0.10, 95% confidence interval (CI) -0.01-0.22), and a moderate to large effect on cardiovascular fitness (SMD = 0.46, 95% CI 0.34-0.59) with aerobic exercise being the superior modality (SMD = 0.60, 95% CI 0.29-0.90). A positive significant effect was seen in lower body strength, whole-body fat mass, general mental health, and blood pressure. No significant effect was seen in fatigue, lean body mass, and general physical health. We thereby conclude that exercise is effective in improving metabolic health in men diagnosed with prostate cancer, with aerobic exercise as the superior modality. The effect of exercise on QoL was small and not mediated by choice of exercise modality.

Exercise training complementary to specialised early intervention in patients with first-episode psychosis: a feasibility randomised trial.

BACKGROUND: The aim of this study was to examine feasibility of trial processes and group-based, structured exercise training in patients with first-episode psychosis. METHODS: Twenty-five patients with first-episode psychosis took part in a two-arm randomised feasibility trial. They were individually randomised (1:1) via a computer-generated randomisation sequence and allocated to either an exercise intervention group (INT) or a control group (CON). Patients allocated to INT completed a physical exercise training programme at moderate-to-vigorous intensity, 1 h three times weekly for 8 weeks. CON patients were encouraged to continue their usual level of activity and were offered the training programme after 8 weeks. Primary outcomes included screening rate, recruitment rate, retention rate, attendance and adverse events. Secondary outcomes included heart rate response during training, cardiovascular health (VO2max, resting heart rate, blood pressure), body composition (muscle mass, fat percentage), muscle strength (sit-to-stand, grip strength, jump height) and balance. RESULTS: Recruitment lasted 6 weeks and 86 out of 324 patients (27%) were screened, 71 of whom (83%) were deemed eligible. Twenty-five (35%) accepted inclusion (mean age 25.5; mean body mass index 25.1) and were subsequently randomised (INT = 13, CON = 12). Retention of patients was 76% and 52% at the 8-week and 16-week follow-up, respectively. Attendance was 43% (min. 9%, max. 96%). No significant changes were observed between groups in secondary physiological outcome measures. CONCLUSIONS: Feasibility was challenged by limited recruitment and retention rates, suggesting that modifications are required if a large-scale randomised controlled trial is to be conducted. Recommendations for modifications are presented and discussed. TRIAL REGISTRATION: Clinicaltrials.gov, NCT03409393 . Retrospectively registered.

Female partner experiences of prostate cancer patients' engagement with a community-based football intervention: a qualitative study.

BACKGROUND: Prostate cancer is often labelled a couple's disease wherein the partner plays an important role in the man's illness management and related health promotion activities. The aim of this study was to explore partner experiences of prostate cancer patients' engagement with a community-based football program. METHODS: Eight audio-visual recorded semi-structured focus group interviews were conducted with a total of 39 female partners of men with prostate cancer who participated in a community-based football program as part of the nationwide FC Prostate Community Trial (NCT02430792). Data was managed with the software program Nvivo 11 and analysed inductively to derive thematic findings. RESULTS: The four thematic findings were: 1) 'Hope of a new beginning' which included stories of hope that football would mitigate the negative effects of men's prostate cancer treatment [s]; 2) 'My new partner' was characterized by attributing connections between physical activity and elevated mood as a by-product of men's involvement in the program; 3) 'Football first' included assertions of the couples mutual commitment to the football program; and 4) 'Invisible needs' contrasted insecurity, and unforeseen challenges for partners feeling somewhat neglected. Overall, the results confirm the need for cohesion and flexibility amongst couple-dyads to ensure partners and men with prostate cancer benefit from their involvement in football programs. CONCLUSIONS: This study indicates that partners of prostate cancer survivors' engaging with community-based football align to idealized gender relations, roles and identities. In many instances, these gendered dimensions aided positive dyadic coping and long-term exercise adherence.

Safety and Effects of Football in Skeletal Metastatic Prostate Cancer: a Subgroup Analysis of the FC Prostate Community Randomised Controlled Trial.

BACKGROUND: Skeletal metastatic disease excludes many cancer patients from participating in exercise and physical activity due to safety concerns. Empirical evidence from high-quality trials is warranted to guide clinicians and patients. OBJECTIVE: To evaluate the safety and potential benefits of high-impact aerobic exercise in patients with prostate cancer with skeletal metastases. DESIGN: Exploratory subgroup analysis of a pragmatic, multicentre, parallel randomised controlled trial. SETTING: The trial recruited 214 patients from five hospital urological departments in Denmark. PARTICIPANTS: Patients with prostate cancer with skeletal metastases (n = 41). INTERVENTION: Six months of football training twice weekly at a local club or usual care. Both groups received brief information on physical activity recommendations at the time of randomisation. MAIN OUTCOME(S) AND MEASURE(S): Safety, defined as falls, fractures and hospital admissions. Effects were evaluated on the primary outcome (prostate cancer-specific quality of life) and secondary outcomes (lean body mass, fat mass, hip and spine bone mineral density, and general physical and mental health). RESULTS: The original trial comprised 214 participants, 41 of whom had skeletal metastases at enrolment. Of these, 22 were allocated to football and 19 to usual care. The trial retention rate was 95% at 12 weeks and 88% at 6 months. Football participants attended 13 sessions on average at 12 weeks and 23 at 6 months. There were two falls, one in each group after 6 months, and no fractures. There were four unplanned hospital admissions in the study period, all four in the usual care group. Statistically significant between-group difference was observed in the primary outcome change in prostate cancer-specific quality of life at 12 weeks (7.6 points [95% CI 0.5 to 15.0]; P = 0.038). No statistical changes were found in the secondary outcomes. CONCLUSION: The analysis showed that football training was safe in patients with skeletal metastatic prostate cancer and significantly improved quality of life. Larger analyses and/or trials are warranted to confirm the safety of exercise more broadly in cancer patients with skeletal metastatic disease. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02430792 . Date of registration 30 April 2015.

Community-based football in men with prostate cancer: 1-year follow-up on a pragmatic, multicentre randomised controlled trial.

BACKGROUND: 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. METHODS AND FINDINGS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: ClinicalTrials.gov NCT02430792.

Football Compared with Usual Care in Men with Prostate Cancer (FC Prostate Community Trial): A Pragmatic Multicentre Randomized Controlled Trial.

BACKGROUND: Physical activity has been shown to mitigate the unwanted psychological and physiological side effects of prostate cancer treatments, but sustainable exercise possibilities are limited. OBJECTIVE: Our objective was to examine whether football in a real-world setting (i.e., local football clubs) was safe and feasible in practice and could improve quality of life, mitigate decline in muscle mass and bone density, and increase fat mass in patients with prostate cancer. METHODS: In this pragmatic, multicentre, parallel randomized controlled trial, men diagnosed with prostate cancer were recruited from five Danish urological departments. Men (N = 214) diagnosed with prostate cancer were randomly allocated, using random generated lists (block size 4-8) stratified for center and androgen-deprivation therapy status, to either 1 h of football twice weekly in a local football club or to usual care, which was a 15- to 30-min telephone session covering their options for physical activity or free-of-charge rehabilitation delivered as standard in Denmark. Allocation was concealed from the trial investigator performing the randomization, but-given the nature of the intervention-this was not possible for personnel and participants. Assessments were performed at baseline, 12 weeks, and 6 months. The primary outcome was mean change difference in prostate cancer-specific quality of life at 12 weeks. Secondary outcomes were body composition, 12-Item Short Form Health Survey (SF-12) physical and mental health, and safety-reported as fractures, falls, and serious adverse events. RESULTS: Attrition was 1 and 3% at 12 weeks, and 5% and 5% at 6 months for the usual care and football groups, respectively. Prostate cancer-specific quality of life was equal between groups at 12 weeks (mean difference + 1.9 points, 95% confidence interval [CI] -1.0-4.8; P = 0.20) and at 6 months (+ 0.5 points, 95% CI -2.8-3.8; P = 0.76). Fractures were equally distributed, with two fractures in the usual care group and one in the football group. Likewise, body composition outcomes were equal. Mental health improved after 6 months of football (mean difference + 2.7 points, 95% CI 0.8-4.6; P = 0.006). CONCLUSIONS: In this trial, community-based football was a feasible exercise strategy for men with prostate cancer. Football did not improve prostate cancer-specific quality of life but did improve mental health; the clinical significance of this is unclear. TRIAL REGISTRATION: ClinicalTrials.gov: NCT02430792.

Development of an Educational Program for Non-Professional Soccer Coaches in Charge of Community-Based Soccer in Men with Prostate Cancer: a Qualitative Study.

BACKGROUND: While clinical trials have demonstrated the benefits of structured exercise for prostate cancer survivors, few attempts have been made to investigate and implement sustainable community-based exercise programs supporting adoption of long-term physical activity behavior. Against this background, the aims of this study was to explore the perspectives of experts and stakeholders on the development of a training course and intervention manual used to support the delivery of community-based soccer training in men with prostate cancer (the FC Prostate Community [FCPC] trial). METHODS: A two-step qualitative design including triangulation of methods, data sources, and researchers. Step 1 comprised key informant interviews with clinical and scientific experts (n = 4). Step 2 included stakeholder focus group interviews with nurses (n = 5), non-professional soccer coaches and club representatives (n = 5), and prostate cancer survivors (n = 7). RESULTS: Four themes emerged from the analysis of the key informant interviews: The Coach's Qualifications, Structure of the Training, Prevention of Injuries, and A Non-Patient Environment, which informed development of the training course and intervention manual. The stakeholders added the importance of clarifying the Responsibility of the Coach, the value of Positive Competition, and Social Inclusion of the prostate cancer survivors in the club. Based on these results, we present the final templates for the training course and intervention manual. CONCLUSIONS: No general set of rules or safety measures to promote or optimize the delivery of community-based exercise in cancer survivors is recommended. However, the general principles related to the necessary clarification of the coach's responsibility in relation to the prevention and management of injuries and participant adherence through a non-patient environment may be transferable to the training and education of other groups of lay persons in charge of delivering exercise interventions to other clinical subpopulations in a non-hospital setting.

Minimum clinically important differences in chronic pain vary considerably by baseline pain and methodological factors: systematic review of empirical studies.

BACKGROUND: The minimum clinically important difference (MCID) is used to interpret the relevance of treatment effects, e.g., when developing clinical guidelines, evaluating trial results or planning sample sizes. There is currently no agreement on an appropriate MCID in chronic pain and little is known about which contextual factors cause variation. METHODS: This is a systematic review. We searched PubMed, EMBASE, and Cochrane Library. Eligible studies determined MCID for chronic pain based on a one-dimensional pain scale, a patient-reported transition scale of perceived improvement, and either a mean change analysis (mean difference in pain among minimally improved patients) or a threshold analysis (pain reduction associated with best sensitivity and specificity for identifying minimally improved patients). Main results were descriptively summarized due to considerable heterogeneity, which were quantified using meta-analyses and explored using subgroup analyses and metaregression. RESULTS: We included 66 studies (31.254 patients). Median absolute MCID was 23 mm on a 0-100 mm scale (interquartile range [IQR] 12-39) and median relative MCID was 34% (IQR 22-45) among studies using the mean change approach. In both cases, heterogeneity was very high: absolute MCID I2 = 99% and relative MCID I2 = 96%. High variation was also seen among studies using the threshold approach: median absolute MCID was 20 mm (IQR 15-30) and relative MCID was 32% (IQR 15-41). Absolute MCID was strongly associated with baseline pain, explaining approximately two-thirds of the variation, and to a lesser degree with the operational definition of minimum pain relief and clinical condition. A total of 15 clinical and methodological factors were assessed as possible causes for variation in MCID. CONCLUSIONS: MCID for chronic pain relief vary considerably. Baseline pain is strongly associated with absolute, but not relative, measures. To a much lesser degree, MCID is also influenced by the operational definition of relevant pain relief and possibly by clinical condition. Explicit and conscientious reflections on the choice of an MCID are required when classifying effect sizes as clinically important or trivial.

Sarcopenia and Postoperative Complication Risk in Gastrointestinal Surgical Oncology: A Meta-analysis.

OBJECTIVE: The aim of the study was to evaluate sarcopenia as a predictor of postoperative risk of major and total complications after surgery for gastrointestinal cancer. BACKGROUND: Sarcopenia is associated with poor survival in gastrointestinal cancer patients, but the role of sarcopenia as prognostic tool in surgical oncology has not been established, and no consensus exists regarding assessment and management of sarcopenic patients. METHODS: We performed a systematic search for citations in EMBASE, Web of Science, and PubMed from 2004 to January 31, 2017. Random effects meta-analyses were used to estimate the pooled risk ratio for postoperative complications by Clavien-Dindo grade (total complications: grade ≥2; major complications: grade ≥3) in patients with sarcopenia versus patients without sarcopenia. Stratified analyses were performed by sarcopenia criteria, cutoff level, assessment methods, study quality, cancer diagnosis, and "Enhanced Recovery After Surgery" care. RESULTS: Twenty-nine studies (n = 7176) were included with sarcopenia prevalence ranging between 12% and 78%. Preoperative incidence of sarcopenia was associated with increased risk of major complications (risk ratio 1.40; 95% confidence interval, 1.20-1.64; P < 0.001; I = 52%) and total complications (risk ratio 1.35; 95% confidence interval, 1.12-1.61; P = 0.001; I = 60%). Moderate heterogeneity was found for both meta-analyses. Subgroup analyses showed that sarcopenia remained a consistent risk factor across stratification by sarcopenia criteria, assessment methods, study quality, and diagnoses. CONCLUSIONS: Sarcopenia was associated with an increased risk of complications after gastrointestinal tumor resection, but lack of methodological consensus hampers the interpretation and clinical utilization of these findings. Combining assessment of muscle mass with measures of physical function may increase the prognostic value and accuracy in preoperative risk stratification.

Pain relief that matters to patients: systematic review of empirical studies assessing the minimum clinically important difference in acute pain.

BACKGROUND: The minimum clinically important difference (MCID) is used to interpret the clinical relevance of results reported by trials and meta-analyses as well as to plan sample sizes in new studies. However, there is a lack of consensus about the size of MCID in acute pain, which is a core symptom affecting patients across many clinical conditions. METHODS: We identified and systematically reviewed empirical studies of MCID in acute pain. We searched PubMed, EMBASE and Cochrane Library, and included prospective studies determining MCID using a patient-reported anchor and a one-dimensional pain scale (e.g. 100 mm visual analogue scale). We summarised results and explored reasons for heterogeneity applying meta-regression, subgroup analyses and individual patient data meta-analyses. RESULTS: We included 37 studies (8479 patients). Thirty-five studies used a mean change approach, i.e. MCID was assessed as the mean difference in pain score among patients who reported a minimum degree of improvement, while seven studies used a threshold approach, i.e. MCID was assessed as the threshold in pain reduction associated with the best accuracy (sensitivity and specificity) for identifying improved patients. Meta-analyses found considerable heterogeneity between studies (absolute MCID: I2 = 93%, relative MCID: I2 = 75%) and results were therefore presented qualitatively, while analyses focused on exploring reasons for heterogeneity. The reported absolute MCID values ranged widely from 8 to 40 mm (standardised to a 100 mm scale) and the relative MCID values from 13% to 85%. From analyses of individual patient data (seven studies, 918 patients), we found baseline pain strongly associated with absolute, but not relative, MCID as patients with higher baseline pain needed larger pain reduction to perceive relief. Subgroup analyses showed that the definition of improved patients (one or several categories improvement or meaningful change) and the design of studies (single or multiple measurements) also influenced MCID values. CONCLUSIONS: The MCID in acute pain varied greatly between studies and was influenced by baseline pain, definitions of improved patients and study design. MCID is context-specific and potentially misguiding if determined, applied or interpreted inappropriately. Explicit and conscientious reflections on the choice of a reference value are required when using MCID to classify research results as clinically important or trivial.

Feasibility and acceptability of active book clubs in cancer survivors - an explorative investigation.

BACKGROUND: While the increasing number of people surviving cancer is promising, the long-term health effects warrant broad, innovative interventions. We investigated the feasibility and acceptability of a 24-week intervention called 'Active Book Club' comprising audio book listening, pedometer walking and supervised book club meetings. MATERIAL AND METHODS: An exploratory and descriptive design was applied. Qualitative data included baseline and post-intervention focus group interviews as well as post-intervention individual interviews. The study also included data on retention, attendance, and adherence. Seventeen self-referred cancer survivors with various oncological and sociodemographic backgrounds were included. RESULTS: Eight (47%) participants completed the entire intervention. Their median attendance at the book club meetings was eight [interquartile range (IQR) 6-9] of nine possible, and they reached the walking step goal in a median of 11 (IQR 7-12) of the first 12 weeks, and seven (IQR 1-10) of the last 12 weeks. The qualitative analysis revealed five themes including: Motivation and expectations (i.e. reasons for enrollment), Attentive listening (i.e. experiences of the audio book format), Affected by the story (i.e. experiences of the content of the books), Group involvement (i.e. experiences of the book club meetings) and Walking regularly (i.e. experiences of the walking program). Overall, findings revealed that while audio books may bring new meaning to physical activity and serve as a relief from own concerns, certain stories may affect some individuals negatively. The substantial dropout rate, however, suggested that modification is necessary and that patient involvement in choice of literature may be critical to enhance acceptability. CONCLUSION: The 'Active Book Club' represents a novel psychosocial intervention potentially supporting physical activity adoption and mental health in cancer survivors. However, several issues related to feasibility and acceptability including choice of literature genre, format and supervision of book club meetings need to be considered before larger scale clinical trials are initiated.

Effectiveness of community-based football compared to usual care in men with prostate cancer: Protocol for a randomised, controlled, parallel group, multicenter superiority trial (The FC Prostate Community Trial).

BACKGROUND: Prostate cancer is the most common non-cutaneous malignancy in men. Today most patients may expect to live years following the diagnosis and may thus experience significant morbidity due to disease progression and treatment toxicity. In order to address some of these problems exercise has been suggested and previously studies have shown improvements of disease specific quality of life and a reduction in treatment-related toxicity. Cohort studies with long term follow up have suggested that physical activity is associated with improved survival in prostate cancer patients. Previously one randomised controlled trial has examined the efficacy of football in prostate cancer patients undergoing androgen deprivation therapy to usual care and reported positive effects on lean body mass and bone markers. Against this background, we wish to examine the effectiveness of community-based football for men diagnosed with prostate cancer. METHODS: Using a randomised controlled parallel group, multicenter, superiority trial design, two hundred prostate cancer patients will be recruited and randomised (1:1) to either community-based football one hour twice weekly or to a control group. The intervention period will be six months. The primary outcome is quality of life assessed after 12 weeks based on the change from baseline in the Functional Assessment of Cancer Therapy-Prostate questionnaire. Secondary outcomes are change from baseline to six months in quality of life, lean body mass, fat mass, whole body and regional bone markers, as well as physical activity and functional capacity at 12 weeks and six months. Safety outcome variables will be falls resulting in seeking medical assessment and fractures during the six-month period. DISCUSSION: Football is viewed as a case for non-professional, supervised community-based team sport for promoting long-term physical activity in men diagnosed with prostate cancer. This randomised trial will provide data on effectiveness and safety for men with prostate cancer when football training is delivered in local football clubs. TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT02430792.

[Pragmatic trials are important to medical research]. / Pragmatiske studier er vigtige for medicinsk forskning.

High-quality scientific evidence may be inadequate to support real world decision-making. Assessment of applicability and generalizability of medical scientific evidence is needed for the practitioner. Often, large differences between trial participants and actual end-users of interventions exist. We present the difference between efficacy and effectiveness in connection with trial design and encourage critical evaluation of external validity. Pragmatic design of trials can be considered a preferred choice to limit the prevailing gap between current evidence and practice.

Community-based recreational football: a novel approach to promote physical activity and quality of life in prostate cancer survivors.

As the number of cancer survivors continues to increase, there is an increasing focus on management of the long-term consequences of cancer including health promotion and prevention of co-morbidity. Prostate cancer is the most frequent type of cancer type in men and causes increased risk of heart disease, diabetes and osteoporosis. Epidemiological evidence points to a positive effect of regular physical activity on all-cause and prostate cancer mortality and current clinical evidence supports the use of exercise in cancer rehabilitation. However, the external validity of existing exercise studies is limited and the majority of prostate cancer survivors remain sedentary. Hence, novel approaches to evaluate and promote physical activity are warranted. This paper presents the rationale behind the delivery and evaluation of community-based recreational football offered in existing football clubs under the Danish Football Association to promote quality of life and physical activity adherence in prostate cancer survivors. The RE-AIM framework will be applied to evaluate the impact of the intervention including outcomes both at the individual and organizational level. By introducing community-based sport environments, the study offers a novel approach in the strive towards sustained physical activity adherence and accessibility in prostate cancer survivors.