Title: Is it feasible to conduct a randomised controlled trial of pre-transplant exercise (prehabilitation) for multiple myeloma patients awaiting autologous stem cell transplantation? (PREeMPT study)
Funder: Department of Health and Social Care

Abstract: BACKGROUND: Myeloma is an incurable long term condition. The cumulative consequences of disease effects and toxic lines of treatment for patients with multiple myeloma receiving an autologous stem cell transplantation are well documented. Survivorship issues for this patient group are therefore extensive. The cost to the NHS of both treatment for patients with the disease but also management of these consequences is costly. These costs are set to increase in future years as therapies for treatment of the disease continue to become more effective and instigated earlier. Extensive evidence to support the use of physical activity in the management of these consequences exists. Prehabilitation; targeted interventions aimed at reducing the severity of known consequences arising from disease/treatment following diagnosis is used with great effect in surgical cancer patients but evidence is scarce to support its use in non surgical cancer patients and non existent in those with multiple myeloma. AIM: To determine the feasibility of conducting a multi centre randomised controlled trial of a pre-transplant mixed exercise programme for patients with multiple myeloma awaiting autologous stem cell transplantation. METHOD: All patients with multiple myeloma who are awaiting autologous stem cell transplantation (approximately 70-80 patients and including first and second transplantation) will be eligible to be invited to participate in this study. All patients consenting to participate will receive a baseline assessment of exercise capacity followed by a personally tailored exercise prescription utilising heart rate reserve and will complete one set of four outcome measures to record baseline quality of life, mental health/wellbeing and self efficacy. An exercise booklet and exercise information will be provided at baseline and a gym induction through completion of an initial gym circuit will occur. On completion, participants will be offered subsequent appointments to attend a gym session once/twice a week for a minimum of six further weeks. Follow up will occur at six weeks, again on admission to the ward for transplantation and at discharge from hospital. At all time points, completion of all 5 outcome measures will reoccur. DATA COLLECTION: Data will be collected on the following: Demographics of sample population, reasons for non consent to participation and exercise perception, time from decision to transplant to actual transplantation, tracking information from first gym attendance to hospital admission, length of admission to hospital and outcome measurement data. Qualitative data will be collected following the completion of semi structured interviews on admission to hospital. DATA ANALYSIS: A range of feasibility outcomes will be determined for the quantitative data collected. Thematic analysis will be used for qualitative data collected. RESULTS: The results will intend to demonstrate whether delivery of a mixed exercise programme for multiple myeloma patients is feasible between the time a decision is taken to transplant and the actual autologous transplantation procedure. They will provide min and max data for an exercise programme length and will offer information on field utilisation of outcome measures. Patient satisfaction information will determine whether/how progression to a randomised controlled trial will occur. CONCLUSION: Demonstration of feasibility in offering pre autologous stem cell transplant mixed exercise for multiple myeloma patients will support a step forward to contributing to the initial three steps of the survivorship framework developed by the National Cancer Survivorship Initiative: Support and information from the point of diagnosis Promotion of recovery Sustaining recovery. A successful grant application for a subsequent RCT will allow us to demonstrate whether the well documented benefits of exercise and management of treatment consequences can be realised through a prehabilitation intervention as opposed to standard care (exercise booklet and advice during transplantation only with access to a post transplant mixed exercise prgramme)

Lay abstract: We propose to determine whether it is acceptable to patients with a diagnosis of multiple myeloma (a type of blood cancer that can cause bone weakness, pain and fatigue) to be offered and attend an exercise group before receiving an autologous stem cell transplantation (being given back one's own stem cells, following receipt of intensive chemotherapy, to enable your bone marrow to start producing blood cells again). Exercise has been shown to be effective in reducing many of the side effects of myeloma and the treatment patients receive to manage the disease. Prehabilitation i.e. providing an intervention after diagnosis but before treatment begins has been effective in reducing the severity of side effects of treatment in cancer patients receiving surgery. No evidence exists for its use in patients with myeloma. Patients awaiting transplantation will be provided with information regarding the study and invited to join. Patients who agree to take part will attend the hospital for an assessment of their exercise capability and to complete one set of four questionnaires. They will receive an exercise booklet, advice and complete one attempt at their exercise programme under supervision of a physiotherapist. Patients will be requested to attend the gym for a minimum of six further weeks to complete their exercise programme. Patients will complete a repeat set of questionnaires and a repeat walking test six weeks after the first, on admission to hospital for their transplant and on the day they leave hospital. Some patients will be invited to discuss their opinions of the exercise programme and how useful they felt it was to them in preparing for their transplant. If the study shows that the exercise programme is acceptable to patients and we can recruit enough patients to test it in a larger trial, we will apply for further funding.

Research activity codes: 6.7 PHYSICAL
Health categories: CANCER AND NEOPLASMS