STAMINA - Work Package 4 & 5
Research type
Research Study
Full title
Supported exercise TrAining for Men wIth prostate caNcer on Androgen deprivation therapy - the STAMINA programme Work Package 4: A cluster randomised controlled trial of the clinical and cost effectiveness of the STAMINA lifestyle intervention. Work Package 5: A process evaluation exploring implementation of the STAMINA lifestyle intervention
IRAS ID
259674
Contact name
Derek Rosario
Contact email
Sponsor organisation
Sheffield Teaching Hospitals Trust
ISRCTN Number
ISRCTN46385239
Duration of Study in the UK
3 years, 5 months, 31 days
Research summary
The STAMINA programme is a 5 year programme grant for applied research funded by the NIHR. The aim is to determine whether an exercise intervention, embedded in routine NHS cancer care and supported by behaviour change, will confer long-term benefits in cancer-specific quality of life (QoL) and fatigue for men with prostate cancer (PCa) on Androgen Deprivation Therapy (ADT), and be cost effective when compared with optimised usual care. The STAMINA programme has a number of work packages.
*Please note*. This application only pertains to work packages 4/5. All approvals for other work packages i.e. 1-3 have been sought elsewhere.
Work package 4 overview: Building on outputs from preceding work packages as part of the programme grant, and drawing on the MRC framework for complex interventions, Work Package 4 (WP4) will conduct a definitive, pragmatic cluster randomised controlled trial, evaluating the clinical and cost-effectiveness of the STAMINA intervention compared to optimised usual cancer care, in men with prostate cancer, incorporating an internal pilot phase to ensure acceptable recruitment, follow-up and intervention adherence rates.
Work Package 5 overview: A parallel, mixed methods process evaluation will be conducted based on the framework of Linnan and Steckler and informed by the Medical Research Council (MRC) guidance for process evaluation of complex interventions. The acceptability of the intervention is a key aspect for the process evaluation to explore but it is not an explicit element of the Linnan and Steckler framework. We will therefore include an assessment of acceptability following Sekhons framework.
REC name
West of Scotland REC 1
REC reference
20/WS/0069
Date of REC Opinion
9 Jul 2020
REC opinion
Further Information Favourable Opinion