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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
86
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.
CH Annecy Genevois
Annecy, France
RECRUITINGCH Métropole Savoie
Chambéry, France
RECRUITINGcompare EORTC-QLQ-C30 summary score at 6 months between both groups
EORTC-QLQ-C30 questionnaire will be given to participant at inclusion and at 6 months, score will be calculated
Time frame: 6 months post inclusion
compare functional and symptomatic dimension of EORTC-QLQ-C30 at 3 and 6 months between both groups
score of functional and symptomatic dimension of EORTC-QLQ-C30 will be calculated and compared between both groups
Time frame: 3 and 6 months after inclusion
study the effect of 6 months intervention on objective and subjective level of physical activity
mean daily time in moderate to elevate intensity during intervention and IPAQ score at 3 and 6 months
Time frame: 3 months and 6 months after inclusion
study effect of 6 months of intervention on bone pain (FACT-Bone) evolution
compare FACT-Bone pain score at 3 and 6 months betaween both groups
Time frame: 3 and 6 months post inclusion
Study effect of 6 months intervention on muscular mass
compare between both groups muscular surface on CT scan at L3 level at 6 months
Time frame: 6 months post inclusion
study the effect of 6 months intervention on osteolytic lesion
compare evolution of osteolytic lesionnel volume at 6 months between both group
Time frame: 6 months post inclusion
faisability of the intervention in population of interest
number realised session in experimental group
Time frame: from frist intervention day to 6 months
study the effect of 6 months intervention on patient tolerance to immunomodulators
dose adaptation number during 6 months and incidence of gastrointestinal symptoms thanks to NCI-PRO-CTCAE custom survey
Time frame: from inclusion to end of intervention
study effect of 6 months intervention on immunomodulators treatment response
objective response rate at 3 and 6 months accroding to IMWG
Time frame: 3 and 6 months after inclusion
Identification of the factors mediating the improvement in quality of life following the 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.
Time frame: 0 and 6 months of intervention
safety of the intervention
incidence, type, severity, relationship of adverse event and intervention
Time frame: from 0 to 6 months
study effect of 6 months of intervention on disease-specific patient's reported outcomes (FACT-MM)
compare FACT-MM score at 3 and 6 months betaween both groups
Time frame: 3 and 6 months post inclusion
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