Multiple Myeloma (MM)
Conditions
Keywords
physical activity, multiple myeloma, control group
Brief summary
The goal of this clinical trial is to evaluate the effect of a long-term, individualized, hybrid adapted physical activity program on the quality of life of patients with multiple myeloma. The main question it aims to answer are : Does this logn term, individualized and hybrid adapted physical activity program improve quality of life in multiple myeloma patient ? What are the effects of this program on effort tolerance, pain, muscular mass, osteolytic lesions, tolerance to treatment, response to treatment? If there is a comparison group: Researchers will compare \[arm information\] to see if \[insert effects\]. Participants will be randomised in 2 groups. * control group: patients will receive only advices about physical activities benefit * interventional group: This group will be offered a program of adapted physical activities mixing sessions at home (remote) and sessions at the hospital (in person).
Interventions
PROCEDUREAdapted physical activity
the intervention is a "real life"6 months adapted physical activity program which is individualised and hybrid (presential and distancial) . It includes a session in presential (at hospital) every 2 weeks for the first 3 months then once a month and 3 sessions par week for 6 months at home.
Sponsors
Centre Hospitalier Metropole Savoie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
61 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* newly diagnosed or relapse multiple myeloma, \> 60 yo, not eligible to transplant * 1st to 4th line of treatment initiated during the last 3 months * receiving a systemic treatment that involved visit to the hospital at least twice a month durig the first 3 months and at least once a month the next 3 months
Exclusion criteria
* severe cardiac amyloidosis * absolute contraindication to physical activity * inability to comply with the protocol requirements * not french speaker * patient under guardianship or curatorship * pregnant or lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| compare EORTC-QLQ-C30 summary score at 6 months between both groups | 6 months post inclusion | EORTC-QLQ-C30 questionnaire will be given to participant at inclusion and at 6 months, score will be calculated |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| compare functional and symptomatic dimension of EORTC-QLQ-C30 at 3 and 6 months between both groups | 3 and 6 months after inclusion | score of functional and symptomatic dimension of EORTC-QLQ-C30 will be calculated and compared between both groups |
| study the effect of 6 months intervention on objective and subjective level of physical activity | 3 months and 6 months after inclusion | mean daily time in moderate to elevate intensity during intervention and IPAQ score at 3 and 6 months |
| study effect of 6 months of intervention on bone pain (FACT-Bone) evolution | 3 and 6 months post inclusion | compare FACT-Bone pain score at 3 and 6 months betaween both groups |
| Study effect of 6 months intervention on muscular mass | 6 months post inclusion | compare between both groups muscular surface on CT scan at L3 level at 6 months |
| study the effect of 6 months intervention on osteolytic lesion | 6 months post inclusion | compare evolution of osteolytic lesionnel volume at 6 months between both group |
| faisability of the intervention in population of interest | from frist intervention day to 6 months | number realised session in experimental group |
| study the effect of 6 months intervention on patient tolerance to immunomodulators | from inclusion to end of intervention | dose adaptation number during 6 months and incidence of gastrointestinal symptoms thanks to NCI-PRO-CTCAE custom survey |
| study effect of 6 months intervention on immunomodulators treatment response | 3 and 6 months after inclusion | objective response rate at 3 and 6 months accroding to IMWG |
| Identification of the factors mediating the improvement in quality of life following the intervention | 0 and 6 months of intervention | Multivariate analysis including the changes of quality of life (before/after intervention) as dependant variable and changes in exercise tolerance (6-minutes walking distance), Bone pain (FACT-Bone Pain), muscle mass (L3 section on CT-scan), osteolytic lesion on CT-scan and tolerance to immunomodulators as independant variables. The variables selection will be based on stepwise regression. |
| safety of the intervention | from 0 to 6 months | incidence, type, severity, relationship of adverse event and intervention |
| study effect of 6 months of intervention on disease-specific patient's reported outcomes (FACT-MM) | 3 and 6 months post inclusion | compare FACT-MM score at 3 and 6 months betaween both groups |
Countries
France
Contacts
CONTACTCharlene DUPRE
Outcome results
None listed