EXTRA-Meso (EXercise TheRApy in Mesothelioma) Feasibility

July 3, 2024 updated by: NHS Greater Glasgow and Clyde

EXercise TheRApy in Mesothelioma - A Feasibility Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • Glasgow, United Kingdom, G51 4TF
        • Recruiting
        • Queen Elizabeth University Hospital
        • Contact:
        • Principal Investigator:
          • Selina Tsim, PhD
      • Manchester, United Kingdom, M23 9LT
        • Recruiting
        • Wythenshawe Hospital
        • Contact:
        • Principal Investigator:
          • Matthew Evison, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard Care
Routine clinical follow-up
Active Comparator: Exercise Therapy (Intervention)
12 week multi-modal exercise and wellbeing programme
Other: Exercise Therapy
12 week personalised exercise, nutrition and wellbeing programme

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients recruited
Time Frame: 12 months
Number of patients recruited to the study
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of screened patients who are ineligible
Time Frame: 12 months
Proportion of screened patients who are ineligible for the study
12 months
Study drop-out rate
Time Frame: 12 months
Proportion of patients who enter the study who withdraw prior to study completion
12 months
Intervention adherence rate
Time Frame: 12 months
Proportion of patients randomised to the intervention arm who complete the exercise programme
12 months
Health-related Quality of Life questionnaire completion rate
Time Frame: 18 months
Number of Health-related Quality of Life questionnaires completed by participants in the study (higher numbers of completed questionnaires equates to better outcome)
18 months
Framework analysis from qualitative interviews
Time Frame: 12 months
Framework analysis from qualitative interviews with study participants
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NHS Greater Glasgow and Clyde

Collaborators

Manchester University NHS Foundation Trust
University of Surrey
Mesothelioma UK

Investigators

  • Principal Investigator: Selina Tsim, PhD, NHS Greater Glasgow & Clyde

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2024

Primary Completion (Estimated)

January 31, 2025

Study Completion (Estimated)

July 31, 2025

Study Registration Dates

First Submitted

March 27, 2024

First Submitted That Met QC Criteria

July 3, 2024

First Posted (Actual)

July 9, 2024

Study Record Updates

Last Update Posted (Actual)

July 9, 2024

Last Update Submitted That Met QC Criteria

July 3, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GN22ON168

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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