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.

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

Journal

Trials
ISSN: 1745-6215
Titre abrégé: Trials
Pays: England
ID NLM: 101263253

Informations de publication

Date de publication:
12 Apr 2024
Historique:
received: 01 12 2023
accepted: 05 02 2024
medline: 13 4 2024
pubmed: 13 4 2024
entrez: 12 4 2024
Statut: epublish

Résumé

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.

Sections du résumé

BACKGROUND 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 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 CONCLUSIONS
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 BACKGROUND
ISRCTN 46385239, registered on 30/07/2020. Cancer Research UK 17002, retrospectively registered on 24/08/2022.

Identifiants

DOI: 10.1186/s13063-024-07989-y PMID: 38610058
pubmed: 38610058
doi: 10.1186/s13063-024-07989-y
pii: 10.1186/s13063-024-07989-y
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

257

Subventions

Organisme : Programme Grants for Applied Research
ID : RP-PG-1016-20007

Informations de copyright

© 2024. The Author(s).

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Auteurs

Emma McNaught (E)

Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.

Sophie Reale (S)

Department of Allied Health Professions, Sheffield Hallam University, Sheffield, S10 2BP, UK.

Liam Bourke (L)

Department of Allied Health Professions, Sheffield Hallam University, Sheffield, S10 2BP, UK.

Janet E Brown (JE)

Division of Clinical Medicine, University of Sheffield, Sheffield, S10 2RX, UK.

Michelle Collinson (M)

Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.

Florence Day (F)

Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.

Jenny Hewison (J)

Division of Health Services Research, Leeds Institute of Health Sciences, University of Leeds, Leeds, LS2 9JT, UK.

Amanda J Farrin (AJ)

Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.

Saïd Ibeggazene (S)

Department of Allied Health Professions, Sheffield Hallam University, Sheffield, S10 2BP, UK.

Aidan Q Innes (AQ)

Nuffield Health, 2 Ashley Avenue, Epsom, Surrey, KT18 5AL, UK.

Ellen Mason (E)

Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.

David Meads (D)

Academic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, LS2 9JT, UK.

Alison Scope (A)

Department of Allied Health Professions, Sheffield Hallam University, Sheffield, S10 2BP, UK.

Chris Taylor (C)

Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.

Steph Jc Taylor (SJ)

Wolfson Institute of Population Health, Queen Mary University of London, Yvonne Carter Building, 58 Turner Street, London, E1 2AB, UK.

Rebecca R Turner (RR)

Division of Psychology and Mental Health in the School of Health Sciences, The University of Manchester, Manchester, M13 9PL, UK.

Derek J Rosario (DJ)

Department of Urology, Sheffield Teaching Hospitals NHS Foundation Trust, Royal Hallamshire Hospital, Glossop Road, Sheffield, S10 2JF, UK. d.j.rosario@sheffield.ac.uk.
ORCID: 0000-0002-9086-3592

Classifications MeSH