Mesothelioma
Conditions
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.
Interventions
OTHERExercise Therapy
12 week personalised exercise, nutrition and wellbeing programme
Sponsors
University of Surrey
Manchester University NHS Foundation Trust
Mesothelioma UK
NHS Greater Glasgow and Clyde
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Masking description
Open label, no masking
Intervention model description
1:1 randomisation, feasibility study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients recruited | 12 months | Number of patients recruited to the study |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Intervention adherence rate | 12 months | Proportion of patients randomised to the intervention arm who complete the exercise programme |
| Proportion of screened patients who are ineligible | 12 months | Proportion of screened patients who are ineligible for the study |
| Study drop-out rate | 12 months | Proportion of patients who enter the study who withdraw prior to study completion |
| Health-related Quality of Life questionnaire completion rate | 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) |
| Framework analysis from qualitative interviews | 12 months | Framework analysis from qualitative interviews with study participants |
Countries
United Kingdom
Contacts
Primary ContactSelina Tsim, PhD
Outcome results
None listed