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Trials
Published in: Trials 1/2024

Open Access 01-12-2024 | Prostate Cancer | Study protocol

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

Authors: 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, on behalf of the STAMINA co-investigators

Published in: Trials | Issue 1/2024

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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.
Appendix
Available only for authorised users
Footnotes
1
Where a man is due to start Taxane based chemotherapy in conjunction with ADT, an initial health questionnaire will be conducted but inclusion in the trial will be deferred until after completion of the course of chemotherapy (typically 18–20 weeks). Baseline assessments will be repeated before randomisation where necessary.
 
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Metadata
Title
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
Authors
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
on behalf of the STAMINA co-investigators
Publication date
01-12-2024
Publisher
BioMed Central
Published in
Trials / Issue 1/2024
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-024-07989-y

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