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Trial Title:
EXTRA-Meso (EXercise TheRApy in Mesothelioma) Feasibility
NCT ID:
NCT06491784
Condition:
Mesothelioma
Conditions: Official terms:
Mesothelioma
Mesothelioma, Malignant
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
1:1 randomisation, feasibility study
Primary purpose:
Other
Masking:
None (Open Label)
Masking description:
Open label, no masking
Intervention:
Intervention type:
Other
Intervention name:
Exercise Therapy
Description:
12 week personalised exercise, nutrition and wellbeing programme
Arm group label:
Exercise Therapy (Intervention)
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Diagnosis of mesothelioma, ratified by a mesothelioma multi-disciplinary team (MDT)
meeting
2. Performance status 0 - 2
3. Clinical frailty score ≤5
4. Informed written consent
Exclusion Criteria:
1. Performance status ≥3
2. Clinical frailty score ≥6
3. Unlikely to be able to participate in an exercise programme
(clinician/physiotherapist judgement)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Queen Elizabeth University Hospital
Address:
City:
Glasgow
Zip:
G51 4TF
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Selina Tsim, PhD
Phone:
0141 451 6163
Email:
Selina.Tsim@ggc.scot.nhs.uk
Investigator:
Last name:
Selina Tsim, PhD
Email:
Principal Investigator
Facility:
Name:
Wythenshawe Hospital
Address:
City:
Manchester
Zip:
M23 9LT
Country:
United Kingdom
Status:
Recruiting
Contact:
Last name:
Matthew Evison, MD
Phone:
0161 915 320
Email:
Matthew.Evison@mft.nhs.uk
Investigator:
Last name:
Matthew Evison, MD
Email:
Principal Investigator
Start date:
January 25, 2024
Completion date:
July 31, 2025
Lead sponsor:
Agency:
NHS Greater Glasgow and Clyde
Agency class:
Other
Collaborator:
Agency:
University of Surrey
Agency class:
Other
Collaborator:
Agency:
Manchester University NHS Foundation Trust
Agency class:
Other
Collaborator:
Agency:
Mesothelioma UK
Agency class:
Other
Source:
NHS Greater Glasgow and Clyde
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06491784
