Multiple myeloma lifestyle study
| ISRCTN | ISRCTN38480455 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN38480455 |
| Secondary identifying numbers | 16255 |
- Submission date
- 29/07/2015
- Registration date
- 29/07/2015
- Last edited
- 22/05/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Contact information
Dr Maggie Heinrich
Public
Public
University College London
Gower Street
London
WC1E 6BT
United Kingdom
Study information
| Study design | Randomised; Interventional and Observational; Design type: Treatment, Cohort study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Lifestyle study of patients with multiple myeloma |
| Study objectives | The aim of this study is to evaluate the practicality and feasibility of carrying out an exercise training programme in patients with myeloma (a cancer of the bone marrow), and to determine the benefits of such a programme. The programme will improve fatigue by clinically significant levels after 3 months of the exercise programme, when compared with usual care. |
| Ethics approval(s) | NRES Committee London - Queen Square, 10/01/2014, ref: 13/LO/1105 |
| Health condition(s) or problem(s) studied | Topic: Cancer; Subtopic: Haematological Oncology; Disease: Myeloma |
| Intervention | Patients are randomised to either a control group or to receive a physical activity intervention. Patients in the control group receive usual care which includes their regular check-ups in the UCLH myeloma clinic and/or their local hospitals and receiving maintenance or consolidation treatment, if applicable. Patients in the treatment arm are offered a physical activity programme, led by a physiotherapist, which requires them to attend a hospital gym once a week as well as carry out a home-based programme of exercises two days a week. After the 3 months patients attend the gym once a month and follow a home-based exercise programme three days a week for 3 additional months. Patients in both control and intervention groups are assessed in terms of outcome measures at 3, 6 and 12 months follow up. Follow Up Length: 12 month(s) |
| Intervention type | Behavioural |
| Primary outcome measure | Fatigue; Timepoint(s): baseline, 3, 6 and 12 months |
| Secondary outcome measures | 1. Anxiety and depression; Timepoint(s): baseline, 3, 6 and 12 months 2. Body mass and body composition; Timepoint(s): baseline, 3, 6 and 12 months 3. Diet; Timepoint(s): baseline, 3, 6 and 12 months 4. Exercise capacity and cardiorespiratory fitness; Timepoint(s): baseline, 3, 6 and 12 months 5. Haematology, biochemistry, bone health markers (basic ALP, osteocalcin); Timepoint(s): baseline, 3, 6 and 12 months 6. Muscle strength and endurance; Timepoint(s): baseline, 3, 6, 12 months 7. Physical activity; Timepoint(s): baseline, 3, 6 and 12 months 8. Resting blood pressure; Timepoint(s): baseline, 3, 6 and 12 months 9. Self-efficacy; Timepoint(s): baseline, 3, 6 and 12 months 10. Sleep quality; Timepoint(s): baseline, 3, 6 and 12 months 11. Well-being; Timepoint(s): baseline, 3, 6 and 12 months |
| Overall study start date | 05/06/2014 |
| Completion date | 31/12/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 138; UK Sample Size: 138; Description: Patients with Multiple Myeloma; 34 in control group and 104 in the intervention group (3:1 randomisation) |
| Total final enrolment | 131 |
| Key inclusion criteria | 1. Myeloma survivors, who are assigned to UCLH myeloma clinics 2. Stable disease for at least 6 weeks, off treatment or on maintenance or consolidation treatment 3. Ability to give informed consent 4. A good performance status (ECOG 02) 5. Clinically able to carry out an exercise training programme on a regular basis (assessed by initial screening) 6. Aged at least 18 |
| Key exclusion criteria | 1. Spinal instability (as assessed on radiology in multidisciplinary team (MDT)) meetings 2. Those who have recently (within 4 weeks) had spinal or other surgery for pathological fractures 3. An abnormal resting ECG, where clinically indicated unexplained by further cardiological workup 4. At risk of pathological fracture (Mirel’s score, see Appendix 1 of Protocol) 5. Already participating in an exercise programme as part of a research study 6. Unstable angina 7. Musculoskeletal disease limiting mobility 8. Cognitive impairment that impedes ability to complete questionnaires |
| Date of first enrolment | 19/06/2014 |
| Date of final enrolment | 30/04/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University College London Hospital,
Haematology
Cancer Division
250 Euston Road
London
NW1 2PJ
United Kingdom
Cancer Division
250 Euston Road
London
NW1 2PJ
United Kingdom
Sponsor information
University College London
University/education
University/education
UCL Cancer Institute
Paul O'Gorman Building
72 Huntley Street
London
WC1E 6DD
England
United Kingdom
"ROR" |
https://ror.org/02jx3x895 |
|---|
Funders
Funder type
Charity
Cancer Research UK
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Celgene Europe Ltd
No information available
Results and Publications
| Intention to publish date | 31/12/2016 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | The results of the trial will be disseminated in relevant scientific conferences and meetings. The results will also be written up as paper publications and submitted to scientific, peer-reviewed journals. This is planned for the end of 2016. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/07/2020 | 22/05/2020 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
22/05/2020: Publication reference and total final enrolment number added.
26/06/2018: The overall trial end date was changed from 30/04/2016 to 31/12/2017.
01/06/2018: No publications found, verifying study status with principal investigator.
The registration was initiated on 20/03/2014 and finalised on 29/07/2015. Following the prospective submission on 20/03 /2014, there were no changes to the protocol prior to registration being finalised. The recruitment started on 19/06/2014, after initiation of public registration.
