Clinical trial NCT06491784: EXTRA-Meso (EXercise TheRApy in Mesothelioma) Feasibility
Official title: EXercise TheRApy in Mesothelioma - A Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mesothelioma
Lead sponsor: NHS Greater Glasgow and Clyde
Sponsor class: OTHER
Collaborators: name: University of Surrey
name: Manchester University NHS Foundation Trust
name: Mesothelioma UK
First posted: 2024-07-09
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 1:1 randomisation, feasibility study
Primary purpose: OTHER

Brief 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.

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)

Primary outcomes:
measure: Number of patients recruited
timeFrame: 12 months
Secondary outcomes:
measure: Proportion of screened patients who are ineligible
timeFrame: 12 months
measure: Study drop-out rate
timeFrame: 12 months
measure: Intervention adherence rate
timeFrame: 12 months
measure: Health-related Quality of Life questionnaire completion rate
timeFrame: 18 months
measure: Framework analysis from qualitative interviews
timeFrame: 12 months
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
city: Manchester
country: United Kingdom
facility: Wythenshawe Hospital
Study officials:
affiliation: NHS Greater Glasgow & Clyde
name: Selina Tsim, PhD
role: PRINCIPAL_INVESTIGATOR
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