Ignite Creation Date:
2024-07-17 @ 11:06 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06491784
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-03-27
Brief Title:
EXTRA-Meso EXercise TheRApy in Mesothelioma Feasibility
Sponsor:
NHS Greater Glasgow and Clyde
Organization:
NHS Greater Glasgow and Clyde
Study Overview
Official Title:
EXercise TheRApy in Mesothelioma - A Feasibility Study
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn whether running an exercise study in patients with mesothelioma is feasible The main questions 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
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 eg 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 11 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
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 11 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None