NCT03595787进行中（未招募）不适用
Feasibility Study of Tripartite Prehabilitation of Patients With Acute Myeloid Leukaemia and High-risk Myelodysplastic Syndromes During Intensive Chemotherapy Before Allogenic Haematopoietic Stem Cell Transplantation: the COHABILIT Protocol
Institut Paoli-Calmettes2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年4月4日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- feasibility to the adapted multidisciplinary program
研究概览
简要总结
This faisability study aims to evaluate the adhesion of the patient to a multidisciplinary program (adapted physical activity, coaching and nutrition)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of acute myeloid leukemia or high-risk myelodysplastic syndrome
- •Age between 18 and 70 years
- •Eligible for an intensive chemotherapy
- •Eligible for allograft
- •Able to answer a questionnaire
排除标准
- •Diagnosis of acute promyelocytic Leukemia
- •Palliative treatment
- •Contraindication to moderate physical activity
- •Performans status 4, unless it is related to the disease
- •Patient who does not understand French
- •Patient unable to use a smartphone
- •Patient deprived of liberty or placed under the authority of a tutor,
- •Patient considered socially or psychologically unable to comply with the treatment and the required medical follow-up.
研究组 & 干预措施
Prehabilitation program
Experimental
Program based on nutritional support, physical activity program and coaching. Home-based monitoring will be done thanks to connected watches (step counter pedometer) and a connected body fat weight scale
干预措施: Coaching and Habilitation (Procedure)
结局指标
主要结局
feasibility to the adapted multidisciplinary program
时间窗: 6 months
proportion of patients who will complete more than 50% of the APA/coaching sessions prescribed
次要结局
- Evaluate correlation between APA coaching sessions undertaken and fatigue(6 months)
- evaluate number of days of hospitalisation(6 months)
- evaluate cause of overall mortality(6 months)
- Evaluation of the severity of digestive GVH disease(6 monts)
- Evaluate changes in upper limb strengt(6 months)
- evalaute number of patients disqualified for allotransplant(6 monts)
- Evaluate physical activity sessions modalities(6 months)
- Evaluate positive and negative affect(6 months)
- Evaluate body mass index(6 months)
- Evaluate muscle mass(6 months)
- - Evaluate number of infections documented(6 months)
- Evaluate the quality of the trainer-trainee relationship(6 months)
- Evaluate QoL(6 months)
- Evaluate correlation between APA coaching sessions undertaken and QoL(6 months)
- Evaluate change in functional capacity(6 months)
- Evaluate physical activity sessions feasability(6 months)
- Evaluate changes in weight(6 months)
- evaluate rate of overall mortality(30 days)
- Evaluate rate of non relapse Mortality (RNM)(6 months)
- evaluate survival without events(6 monts)
- Evaluate changes in lower limb strength(6 months)
- Evaluate self-efficacy(6 months)
- Evaluate correlation between APA coaching sessions undertaken and NRM(6 months)
- Evaluate correlation between APA coaching sessions undertaken and survival(6 months)
- Evaluate life satisfaction(6 months)
- Evaluate the level of depression(6 months)
- Evaluate relationship dynamics(6 months)
- Evaluate the cancer related fatigue(6 months)
- changes in impedancemetry data(6 months)
- Evaluate fat mass(6 months)
- Evaluate adherence to nutrition programme(6 months)
- evaluate rate of early mortality(30 days)
- degree of digestive GVH disease(6 monts)
- Evaluate skeletal muscle mass index (SMI) change in the course of the treatment(6 months)
- Complete remision(6 months)
- evaluate overall survival(6 months)
- Study correlation between variation in weight, BMI, muscle mass, fat mass and SMI on physical capacities, QoL, number of infections, number of days of hospitalisation, patients' outcomes (NRM, survival) and GvHD in allotransplant patients.(6 months)
- evaluate survival without relapse(6 monts)
- evaluate number of allotransplant patients(6 monts)
研究者
研究点 (2)
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