Evidence map›Paper›PMID 38610058›Full record

ArticleTrials2024

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.

Emma McNaught, Sophie Reale, Liam Bourke, Janet E Brown, Michelle Collinson, Florence Day, Jenny Hewison, Amanda J Farrin, Saïd Ibeggazene, Aidan Q Innes and 8 more

Open access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.3field-weighted citation impact, top 40% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 citations in OpenAlex.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

18 authors at 7 institutions in 1 country.

Emma McNaught *Clinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.
Sophie Reale *Department of Allied Health Professions, Sheffield Hallam University, Sheffield, S10 2BP, UK.
Liam BourkeDepartment of Allied Health Professions, Sheffield Hallam University, Sheffield, S10 2BP, UK.
Janet E BrownDivision of Clinical Medicine, University of Sheffield, Sheffield, S10 2RX, UK.
Michelle CollinsonClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.
Florence DayClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.
Jenny HewisonDivision of Health Services Research, Leeds Institute of Health Sciences, University of Leeds, Leeds, LS2 9JT, UK.
Amanda J FarrinClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.
Saïd IbeggazeneDepartment of Allied Health Professions, Sheffield Hallam University, Sheffield, S10 2BP, UK.
Aidan Q InnesNuffield Health, 2 Ashley Avenue, Epsom, Surrey, KT18 5AL, UK.
Ellen MasonClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.
David MeadsAcademic Unit of Health Economics, Leeds Institute of Health Sciences, University of Leeds, Leeds, LS2 9JT, UK.
Alison ScopeDepartment of Allied Health Professions, Sheffield Hallam University, Sheffield, S10 2BP, UK.
Chris TaylorClinical Trials Research Unit, Leeds Institute of Clinical Trials Research, University of Leeds, Leeds, LS2 9JT, UK.
Steph Jc TaylorWolfson Institute of Population Health, Queen Mary University of London, Yvonne Carter Building, 58 Turner Street, London, E1 2AB, UK.
Rebecca R TurnerDivision of Psychology and Mental Health in the School of Health Sciences, The University of Manchester, Manchester, M13 9PL, UK.
Derek J Rosario *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 http://orcid.org/0000-0002-9086-3592
STAMINA co-investigators
University of Leeds · GBSheffield Hallam University · GBNuffield Health · GBQueen Mary University of London · GBRoyal Hallamshire Hospital · GBUniversity of Manchester · GBUniversity of Sheffield · GB

Funding

Programme Grants for Applied Research RP-PG-1016-20007
6 · The paper itself

Abstract

backgroundUK 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.

methodsMen 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 registrationISRCTN 46385239, registered on 30/07/2020. Cancer Research UK 17002, retrospectively registered on 24/08/2022.

Indexed as

Prostatic NeoplasmsAndrogen AntagonistsAndrogensCost-Benefit AnalysisExerciseFatigueHumansLife StyleMaleMulticenter Studies as TopicQuality of LifeRandomized Controlled Trials as TopicAndrogen AntagonistsAndrogensBehaviour changeComplex interventionExercise professionalsHealthcare professionalsHealth economicsLifestyle interventionProcess evaluationProstate cancerRandomised controlled trialSupervised exercise

Identifiers

PMID38610058
PMCPMC11010375
OpenAlexW4394755931

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.