NCT06491784

EXTRA-Meso (EXercise TheRApy in Mesothelioma) Feasibility

EXercise TheRApy in Mesothelioma - A Feasibility Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: NHS Greater Glasgow and Clyde · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn whether running an exercise study in patients with mesothelioma is feasible. The main question(s) it aims to answer are: 1. Is it feasible to recruit patients to a randomised clinical trial of exercise therapy 2. What are the barriers to study recruitment 3. What are the barriers to study retention Participants who decide to take part in the study will be randomly allocated one of two study arms: 1. Standard of care, where the participant will undergo their usual clinical follow-up 2. Exercise therapy, where the participant will receive a personalised 12 week exercise, nutrition and wellbeing programme Participants in both study arms will be asked to complete quality of life questionnaires and a basic fitness assessment at the start and end of the study follow-up period. Participants will be asked if they would be happy to conduct a short interview with a member of the research team, to assess their views on the study. This interview will be audio recorded and the audio recording will be transcribed anonymously to allow researchers to improve future study design.

Detailed description

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 Health Related Quality of Life (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 centres in the United Kingdom (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. The investigators will assess functional fitness and health-related quality of life scores as study outcome measures. The investigators 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.

Conditions

• Mesothelioma

Interventions

Type	Name	Description
OTHER	Exercise Therapy	12 week personalised exercise, nutrition and wellbeing programme

Timeline

• Start date: 2024-01-25
• Primary completion: 2025-01-31
• Completion: 2025-07-31
• First posted: 2024-07-09
• Last updated: 2024-07-09

Locations

2 sites across 1 country: United Kingdom