EXTRA-Meso feasibility
Research type
Research Study
Full title
EXercise TheRApy in Mesothelioma - The EXTRA-Meso Feasibility Study
IRAS ID
315059
Contact name
Selina Tsim
Contact email
Sponsor organisation
NHS Greater Glasgow and Clyde
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
The aim of this study is to examine the feasibility of a randomised trial of exercise therapy in Mesothelioma. It will define likely rate of recruitment based on performance in two mesothelioma centres and identify barriers to recruitment and retention. Outcomes from the study will help refine the design of a future definitive phase 3 trial. That future phase 3 trial will have a patient-centred primary endpoint, e.g. a meaningful improvement in HRQOL or an increase in treatment uptake or tolerance. Additional outcome measures are likely to include functional fitness, hospital admissions and overall survival.
A randomised prospective feasibility study will be performed over 12 months in two UK centres (Glasgow and Manchester). If eligible for the study, patients will be randomised 1:1 to receive a personalised exercise programme or standard care. Patients randomised to the intervention (exercise) arm will undergo an individualised assessment by either a physiotherapist or a qualified exercise specialist with specialised exercise and health condition qualifications. Following this initial assessment, patients will receive a tailored exercise, wellbeing and nutritional support package. We will assess functional fitness and health-related quality of life scores as study outcome measures. We also aim to conduct semi-structured interviews in patients who decline to participate or drop out of the study in order to examine barriers to study recruitment and retention.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
23/WM/0186
Date of REC Opinion
2 Oct 2023
REC opinion
Further Information Favourable Opinion