Supported exercise training for men on ADT (WP 3)
Research type
Research Study
Full title
Supported exercise TrAining for Men wIth prostate caNcer on Androgen deprivation therapy - the STAMINA programme: work package 3
IRAS ID
253778
Contact name
Jemima Clarke
Contact email
Sponsor organisation
Sheffield Teaching Hospitals trust
ISRCTN Number
ISRCTN15691664
Duration of Study in the UK
1 years, 0 months, 30 days
Research summary
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 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) when compared with usual care.
*Please note*. This application only pertains to work package 3. All approvals for other work packages i.e. 1,2,4 and 5 will be sought elsewhere and/or later in the programme time line.
Work package 3 overview: Taking what we have learned from other previous work packages (i.e. work package 1 and 2) we will carry out a preliminary test in a non-randomised cohort study to determine whether it is feasible and acceptable to deliver our 'in development' STAMINA intervention. We call this preliminary testing phase a 'pre-pilot'. Qualitative evaluation only will be undertaken from participants including NHS staff, men with prostate cancer and exercise staff from our commercial partner, Nuffield Health.
The full scope of the 5 year programme is split into separate but iterative projects called 'work packages' and we have (for reference only) detailed all of these below:
Objectives
• WORK PACKAGE 1: To understand variations in NHS PCa care pathways and exercise provision available to men on ADT
• WORK PACKAGE 2: Develop our embedded STAMINA service-level intervention
• WORK PACKAGE 3: To determine whether it is feasible and acceptable to deliver our 'in development' version of STAMINA intervention in a 'pre-pilot' study
• WORK PACKAGE 4: To compare clinical-effectiveness and cost-effectiveness between the STAMINA intervention and usual care in a cluster-randomised trial
• WORK PACKAGE 5: To undertake a mixed-methods process-evaluationSummary of Results
The STAMINA intervention demonstrated good feasibility and acceptability. Men on hormone therapy reported positive impacts on lifestyle behaviours and measures of physical fitness and function. Furthermore, the intervention was deemed highly acceptable by health care professionals and exercise professionals. Some research processes will need to be improved before the larger clinical trial happens.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
19/NW/0025
Date of REC Opinion
4 Feb 2019
REC opinion
Favourable Opinion