Supported exercise TrAining for Men with prostate caNcer on Androgen deprivation therapy - STAMINA

Aim To determine whether either a specific behaviour-change informed, supervised exercise intervention (STAMINA) with support embedded in existing standard NHS prostate cancer (PCa) care pathways over 12 months will confer long-term benefits in cancer-specific quality of life (QoL) and fatigue for men on androgen deprivation therapy (ADT) and be cost-effective, compared with usual care. Background and rationale ADT for advanced PCa has debilitating adverse effects that impair QoL. ADT increases the risk of diabetes and cardiovascular disease, which are expensive to treat. The NICE PCa guidelines (CG175) recommend 12-weeks supervised exercise-training for men on ADT to improve cancer-specific QoL and fatigue. There is no current understanding of how to integrate such interventions into NHS care, sustain benefits or of cost implications. Research plan The programme consists of five work-packages (WPs), each building on our programme development grant (PDG) work and on preceding WPs. WP 1: understanding variations in NHS PCa-care pathways and exercise provision for men on ADT. Building on information gained in our PDG, we shall interrogate the provision of prostate cancer (PCa) care and exercise facilities for men started on ADT at participating NHS sites to pinpoint optimal opportunities for patient-professional interactions to maximise exercise behaviour change. Methods Online survey of healthcare professionals (HCPs) to determine touch-points of care and training preferences, parallel mapping of exercise facilities and exercise professional (EP) expertise and extent of communication between HCPs and EPs. Schematics will inform intervention and process evaluation development for WP2, WP3 and WP5. Where sites are allocated to control, these schematics will be used to define usual care. WP2 and WP3: develop, optimise and test STAMINA service-level intervention. Methods Map PDG qualitative findings to behaviour change theory. Develop behaviour-change interventions in partnership with patients, HCPs and EPs via focus groups and workshops (WP2). Pre-pilot (WP3). The core STAMINA intervention will be delivered at affiliated Nuffield Health (NH) to 32 men from up to four NHS-sites followed by a mixed-methods process-evaluation (PE) of process data (e.g. training package use, recruitment, retention, adherence) for fidelity and acceptability. The health economics team will be involved throughout intervention design to identify resource implications and unit costs to minimise intervention costs, increasing the likelihood of financial viability. WP 4: Evaluate effectiveness and cost-effectiveness between STAMINA and usual care in a cluster-randomised trial (cRCT) and discrete choice experiment (DCE) exploring alternative funding arrangements. Methods Three-arm, cluster randomised controlled trial in 40 UK NHS sites randomised to STAMINA or usual care (1:1) in men with prostate cancer on ADT, incorporating an internal pilot phase to ensure acceptable recruitment, follow-up and intervention adherence rates. Sample size: 20 sites per arm (mean = 25 per site, Total = 1000), provide 90% power to detect an effect size of 0.33 for the primary outcome (8-point difference on FACT-P, assuming maximum SD of 24) at 5% significance level, an ICC of 0.05, coefficient of variation of 0.3 and assuming 25% loss to follow-up. Main trial analysis: Primary intention-to-treat analysis comparing QoL (FACT-P) between trial arms, using mixed effects linear regression, with participants nested within hospitals, and with hospitals treated as a random intercept, adjusting for participant and hospital-level covariates. Primary end-point in the economic evaluation will be cost per incremental quality-adjusted life year (QALY). A Discrete Choice Experiment will generate estimates of men s demand and willingness to pay for an extended exercise programme. WP5: process evaluation of the RCT Methods Mixed-methods likely to include rating according to validated scale