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.
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.
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.
ISRCTN 46385239, registered on 30/07/2020. Cancer Research UK 17002, retrospectively registered on 24/08/2022.
Trials. 2024 Apr 12*** epublish ***
Emma McNaught, Sophie Reale, Liam Bourke, Janet E Brown, Michelle Collinson, Florence Day, Jenny Hewison, Amanda J Farrin, Saïd Ibeggazene, Aidan Q Innes, Ellen Mason, David Meads, Alison Scope, Chris Taylor, Steph Jc Taylor, Rebecca R Turner, Derek J Rosario, STAMINA co-investigators
Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK., Department of Allied Health Professions, Sheffield Hallam University, Sheffield, S10 2BP, UK., Division of Clinical Medicine, University of Sheffield, Sheffield, S10 2RX, UK., Division of Health Services Research, Leeds Institute of Health Sciences, University of Leeds, Leeds, LS2 9JT, UK., Nuffield Health, 2 Ashley Avenue, Epsom, Surrey, KT18 5AL, UK., Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, LS2 9JT, UK., Wolfson Institute of Population Health, Queen Mary University of London, Yvonne Carter Building, 58 Turner Street, London, E1 2AB, UK., Division of Psychology and Mental Health in the School of Health Sciences, The University of Manchester, Manchester, M13 9PL, UK., Department of Urology, Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital, Glossop Road, Sheffield, S10 2JF, UK. .