Health TrialsbyHealthPanel

EXTRA-Meso (EXercise TheRApy in Mesothelioma) Feasibility

ConditionMesothelioma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorNHS Greater Glasgow and Clyde

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of mesothelioma, ratified by a mesothelioma multi-disciplinary team (MDT) meeting

Performance status 0 - 2

Clinical frailty score ≤5

Informed written consent

Disqualifiers

Performance status ≥3

Clinical frailty score ≥6

Unlikely to be able to participate in an exercise programme (clinician/physiotherapist judgement)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Exercise Therapy

    Other intervention

    12 week personalised exercise, nutrition and wellbeing programme

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Standard CareNo intervention 0 interventions
Group B: Exercise Therapy (Intervention)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of patients recruited

Number of patients recruited to the study

Time frame
12 months

Secondary outcomes

1

Proportion of screened patients who are ineligible

Proportion of screened patients who are ineligible for the study

Time frame
12 months
2

Study drop-out rate

Proportion of patients who enter the study who withdraw prior to study completion

Time frame
12 months
3

Intervention adherence rate

Proportion of patients randomised to the intervention arm who complete the exercise programme

Time frame
12 months
4

Health-related Quality of Life questionnaire completion rate

Number of Health-related Quality of Life questionnaires completed by participants in the study (higher numbers of completed questionnaires equates to better outcome)

Time frame
18 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NHS Greater Glasgow and Clyde

Lead sponsor

University of Surrey

Collaborator

Manchester University NHS Foundation Trust

Collaborator

Mesothelioma UK

Collaborator

Source ClinicalTrials.gov
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