Идёт набор NCT07547007

Benefits of a 6-month, Individualized, Hybrid, "Real-life" Adapted Physical Activity Program on the Quality of Life of Patients Treated for Multiple Myeloma

Без фазы С лечением Multiple Myeloma (MM)

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Adapted physical activity.
Кому может быть актуально: Состояния в реестре: Multiple Myeloma (MM). Базовые параметры: от 61 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Франция
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Benefits of a 6-month, Individualized, Hybrid, "Real-life" Adapted Physical Activity Program on the Quality of Life of Patients Treated for Multiple Myeloma: a Multicenter Randomized Controlled Trial

Обзор

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).

Вмешательства

Процедура Adapted 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.

Первичные конечные точки

compare EORTC-QLQ-C30 summary score at 6 months between both groups [Срок оценки: 6 months post inclusion]

Вторичные конечные точки (11)

compare functional and symptomatic dimension of EORTC-QLQ-C30 at 3 and 6 months between both groups [Срок оценки: 3 and 6 months after inclusion]
study the effect of 6 months intervention on objective and subjective level of physical activity [Срок оценки: 3 months and 6 months after inclusion]
study effect of 6 months of intervention on bone pain (FACT-Bone) evolution [Срок оценки: 3 and 6 months post inclusion]
Study effect of 6 months intervention on muscular mass [Срок оценки: 6 months post inclusion]
study the effect of 6 months intervention on osteolytic lesion [Срок оценки: 6 months post inclusion]
faisability of the intervention in population of interest [Срок оценки: from frist intervention day to 6 months]
study the effect of 6 months intervention on patient tolerance to immunomodulators [Срок оценки: from inclusion to end of intervention]
study effect of 6 months intervention on immunomodulators treatment response [Срок оценки: 3 and 6 months after inclusion]
Identification of the factors mediating the improvement in quality of life following the intervention [Срок оценки: 0 and 6 months of intervention]
safety of the intervention [Срок оценки: from 0 to 6 months]
study effect of 6 months of intervention on disease-specific patient's reported outcomes (FACT-MM) [Срок оценки: 3 and 6 months post inclusion]

Критерии участия

Критерии включения

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