Myeloma Cancer
Conditions
Interventions
This pilot randomised, single site trial will involve participants with myeloma undergoing autologous stem cell transplantation (ASCT). This trial has two arms
an exercise intervention arm and a usual care control arm. Eligible participants will be randomised to an exercise intervention group or usual care control group.
Participants randomised to the exer
Sponsors
University College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult patients referred to the UCLH transplant multidisciplinary team (MDT) and awaiting autologous stem cell transplant as treatment for myeloma 2. Clinically able to carry out an exercise training programme on a regular basis 3. Patients must have a good command of written and spoken English 4. Willing and able to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with known spinal instability, spinal cord compression or neurological deficits 2. Those who have had recent (within six weeks) spinal surgery or other surgery for pathological fractures 3. Abnormal resting ECG and/or unstable angina 4. Those deemed unsuitable to partake by the MDT 5. Unable or unwilling to undertake an exercise programme on a regular basis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The feasibility of the intervention including: 1. Percentage uptake (recruitment rate) 2. Adherence to the intervention and acceptability of receiving the intervention (including any deviation from exercise protocol) 3. Attrition due to the intervention, loss to follow-up and adverse event rate These will be assessed by extracting data from screening and recruitment logs, attendance at supervised exercise training sessions and review of independent exercise log book records and review of adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| The following measures will be taken at four timepoints (at baseline 6-8 weeks before transplant, around day of their transplant, on discharge from transplant hospital admission and 3 months following date of transplant): 1. Fatigue, measured using the Functional Assessment of Chronic Illness Therapy (FACIT-F) 2. Quality of life, measured using the European Organisation for Research and Treatment of Cancer QOL Questionnaire (EORTC QLQ-C30 and myeloma specific module QLQ- MY20), Functional Assessment of Cancer Therapy Bone Marrow Transplantation scale (FACT- BMT) and EuroQol-5D 3. Frailty, measured using the International Myeloma Working Group Frailty Assessment outcome measure 4. Physical activity and sedentary time, measured using ActivPAL accelerometers 5. Functional capacity, measured using the six minute walk test, hand held dynamometry and a timed 30 second sit to stand test 6. Self-reported physical activity behaviour and self-efficacy, measured using the short form International Physical Activity Questionnaire (IPAQ-SF) and Exercise Self-Efficacy Scale (ESES) 7. Resting blood pressure and heart rate 8. Height and weight 9. Blood count and markers of immune system function, measured using blood samples The following measures will be taken at the final timepoint only (3 months following date of transplant): 1. Health and social care service use in the acute post-transplant period, including transplant hospital admission, using a questionnaire and medical record review 2. Qualitative interviews with a purposeful sample of up to 20 study participants | — |
Countries
England, United Kingdom
Outcome results
None listed