Supported exercise TrAining for Men wIth prostate caNcer on Androgen deprivation therapy (STAMINA): study protocol for a randomised controlled trial of the clinical and cost-effectiveness of the STAMINA lifestyle intervention compared with optimised usual care, including internal pilot and parallel process evaluation

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MCNAUGHT, Emma, REALE, Sophie, BOURKE, Liam, BROWN, Janet E., COLLINSON, Michelle, DAY, Florence, HEWISON, Jenny, FARRIN, Amanda J., IBEGGAZENE, Said, INNES, Aidan Q., MASON, Ellen, MEADS, David, SCOPE, Alison, TAYLOR, Chris, TAYLOR, Steph JC., TURNER, Rebecca R. and ROSARIO, Derek J. (2024). Supported exercise TrAining for Men wIth prostate caNcer on Androgen deprivation therapy (STAMINA): study protocol for a randomised controlled trial of the clinical and cost-effectiveness of the STAMINA lifestyle intervention compared with optimised usual care, including internal pilot and parallel process evaluation. Trials, 25 (1): 257. [Article]

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Abstract

Background: UK national clinical guidance recommends that men with prostate cancer on androgen deprivation therapy are offered twice weekly supervised aerobic and resistance exercise to address iatrogenic harm caused by treatment. Very few NHS trusts have established adequate provision of such services. Furthermore, interventions fail to demonstrate sustained behaviour change. The STAMINA lifestyle intervention offers a system-level change to clinical care delivery addressing barriers to long-term behaviour change and implementation of new prostate cancer care pathways. This trial aims to establish whether STAMINA is clinically and cost-effective in improving cancer-specific quality of life and/or reducing fatigue compared to optimised usual care. The process evaluation aims to inform the interpretation of results and, if the intervention is shown to benefit patients, to inform the implementation of the intervention into the NHS. Methods: Men with prostate cancer on androgen deprivation therapy (n = 697) will be identified from a minimum of 12 UK NHS trusts to participate in a multi-centre, two-arm, individually randomised controlled trial. Consenting men will have a ‘safety to exercise’ check and be randomly allocated (5:4) to the STAMINA lifestyle intervention (n = 384) or optimised usual care (n = 313). Outcomes will be collected at baseline, 3-, 6- and 12-month post-randomisation. The two primary outcomes are cancer-specific quality of life and fatigue. The parallel process evaluation will follow a mixed-methods approach to explore recruitment and aspects of the intervention including, reach, fidelity, acceptability, and implementation. An economic evaluation will estimate the cost-effectiveness of the STAMINA lifestyle intervention versus optimised usual care and a discrete choice experiment will explore patient preferences. Discussion: The STAMINA lifestyle intervention has the potential to improve quality of life and reduce fatigue in men on androgen deprivation therapy for prostate cancer. Embedding supervised exercise into prostate cancer care may also support long-term positive behaviour change and reduce adverse events caused by treatment. Findings will inform future clinical care and could provide a blueprint for the integration of supervised exercise and behavioural support into other cancer and/or clinical services. Trial registration: ISRCTN 46385239, registered on 30/07/2020. Cancer Research UK 17002, retrospectively registered on 24/08/2022.

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** From Springer Nature via Jisc Publications Router ** Licence for this article: http://creativecommons.org/licenses/by/4.0/ ** Acknowledgements: We are especially grateful to Nuffield Health for their tremendous support in the setting up and delivery of this trial. We would in particular like to thank Aidan Innes and Ben Kelly for their support, and all local Clinical Exercise Specialists and fitness managers. Nuffield Health sites include: • Nuffield Health Plymouth Fitness & Wellbeing Gym • Nuffield Health The Devonshire Health & Racquets Club • Nuffield Health Nuneaton Fitness & Wellbeing Gym • Nuffield Health Rugby Fitness & Wellbeing Gym • Nuffield Health Warwick Fitness & Wellbeing Gym • Nuffield Health Chesterfield Fitness & Wellbeing Gym • Nuffield Health Nottingham Fitness & Wellbeing Gym • Nuffield Health Sheffield Fitness & Wellbeing Gym • Nuffield Health Crawley Fitness & Wellbeing Gym • Nuffield Health Crawley Central Fitness & Wellbeing Gym • Nuffield Health Liverpool Fitness & Wellbeing Gym • Nuffield Health Derby Fitness & Wellbeing Gym • Nuffield Health Cambridge Fitness & Wellbeing Gym • Nuffield Health Yeovil Fitness & Wellbeing Gym • Nuffield Health Didsbury Fitness & Wellbeing Gym • Nuffield Health Cottingley Fitness & Wellbeing Gym • Nuffield Health Gloucester Fitness & Wellbeing Gym • Nuffield Health Hull Fitness & Wellbeing Gym We are very grateful for the substantial contributions made by many to the setting up of this trial: our Sponsor team at Sheffield Teaching Hospitals NHS Foundation Trust; our PSC chaired by Peter Sasieni, and other members Alison Birtle, Richard Bryant and Rachel Elliott; our PMG and STAMINA co-applicants (Patrick Doherty, Liz Steed, Eileen Sutton, Diana Greenfield*, Dylan Morrissey, Suzanne Hartley and Malcolm Mason); PPIE lay member of our PSC (Geoff Ogden), and PMG/TMG (Tom Baker) who reports on behalf of the PPI Group, co-chaired with John Kidder and Chris Allen; colleagues at the University of Leeds CTRU and Sheffield Hallam University who supported development and implementation of the trial protocol. *Diana Greenfield is a National Institute for Health Research (NIHR) Senior Nurse Research Leader. We would also like to offer our gratitude to the sites participating in the trial for their huge support in its delivery. Site personnel include principal investigators, research staff, clinical staff and Clinical Research Networks. Our trial sites are: • University Hospitals Plymouth NHS Trust • University Hospitals Coventry & Warwickshire NHS Trust • Chesterfield Royal Hospital NHS Foundation Trust • Nottingham University Hospitals NHS Trust • Sheffield Teaching Hospitals NHS Trust • Surrey and Sussex Healthcare NHS Trust • Liverpool University Hospitals NHS Foundation Trust • University Hospitals of Derby and Burton NHS Foundation Trust • Cambridge University Hospital NHS Foundation Trust • Somerset NHS Foundation Trust • Stockport NHS Foundation Trust • Bradford Teaching Hospitals NHS Foundation Trust • Gloucestershire Hospitals NHS Foundation Trust • Hull University Teaching Hospitals NHS Trust • Clatterbridge Cancer Centre NHS Foundation Trust • University Hospitals Bristol and Weston NHS Foundation Trust Authors’ contributions {31b} All authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship and contributed to the work. DR is the chief investigator and conceived the trial. DR, LB, JB, AJF, ST, SR, SI, RT, AI, DM, JH and MC contributed to the trial design and to the development of the protocol. ST and AJF lead the process evaluation. DM leads the health economic evaluation. AJF, MC and EM developed the statistical analysis plan. SR, SI, AS, EMc, FD and CT perform trial and data management. EMc and SR produced a first draft of the manuscript. All authors read and approved the final manuscript. **Journal IDs: eissn 1745-6215 **Article IDs: publisher-id: s13063-024-07989-y; manuscript: 7989 **History: collection 12-2024; online 12-04-2024; published_online 12-04-2024; registration 15-02-2024; accepted 05-02-2024; submitted 01-12-2023

Uncontrolled Keywords:

Randomised controlled trial, Health economics, Healthcare professionals, Lifestyle intervention, Supervised exercise, Exercise professionals, Complex intervention, Behaviour change, Prostate cancer, Process evaluation

Identifiers

Identification Number:

10.1186/s13063-024-07989-y

ORCID for Sophie Reale: