Evaluation of a PREHABilitation Protocol Using Adapted Physical Activity (APA) for Multiple Myeloma Patients Eligible for Intensive Autologous Stem Cell Transplantation Treatment (PREHAB-APA)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- 1. Evaluate the effect of the APA program on fatigue status.
研究概览
简要总结
Adapted physical activity for patients with haematological malignancies generally has positive effects on quality of life, fatigue and physical condition. However, some studies show little or no effect.
This may be explained by inefficient protocols, but also by low rates of patient acceptability regarding the proposed exercises.
The multiplicity of APA protocols and the fluctuation of their results mean that validity, methodology and effects on patients need to be verified before they can be considered for implementation in healthcare services. A program must prove its feasibility, but patients must also adhere to it.
Acceptability can be measured by adherence, which represents the number of validated sessions in relation to the number of planned sessions, and by attrition, which corresponds to the number of stops or drop-outs for any reason. The various APA programs offered in the context of intensive auto or allograft treatment are limited, notably by adherence, which can fall by as much as 24%, and attrition, which can be as high as 67%. Optimization of the proposed exercises and follow-up methods is therefore necessary in order to propose an APA program that will be feasible, effective and acceptable to a maximum number of patients.
To meet these objectives for patients with multiple myeloma eligible for autologous stem cell transplantation, the protocol for this study took into consideration the various recommendations of previous publications and the guidelines from HAS (French National Authority for Health).
The ultimate goal of this study is to validate, in terms of effectiveness and acceptability, the methodology and in particular the use of new specific tools for optimizing an APA program. It will subsequently be offered to all patients with multiple myeloma eligible for autologous stem cell transplantation, independently of their age or physical condition, while respecting their rhythm and physical condition.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old.
- •CML patient in chronic phase, eligible for oral therapy.
- •Diagnosis of multiple myeloma.
- •Patient eligible for autologous stem cell transplantation.
- •Patient capable to read, understand and complete a questionnaire in french.
- •WHO less than or equal to
- •Patient affiliated with french social security.
- •Patient with a medical prescription for APA.
排除标准
- •Patient with previous cancer within the previous 3 years (except basal cell and squamous cell skin cancers, carcinomas in situ of any type that have been previously resected, and stable prostate or breast cancers more than 3 years old and undergoing adjuvant hormone therapy).
- •Medical contraindications to APA (heart failure, angina, unbalanced hypertension, bone metastases, severe osteoporosis, etc.)
- •Sensory or motor neuropathy.
- •Patient deprived of liberty, under guardianship or curatorship.
- •Patient considered socially or psychologically unfit to be enrolled in a study.
研究组 & 干预措施
Control group
干预措施: Physical condition (Behavioral)
APA group
干预措施: Adapted exercises (Other)
APA group
干预措施: Physical activity questionnaire (Behavioral)
APA group
干预措施: Questionnaire of Fatigue (Behavioral)
APA group
干预措施: Physical condition (Behavioral)
Control group
干预措施: Quality of Life questionnaire (Behavioral)
Control group
干预措施: Questionnaire of Fatigue (Behavioral)
Control group
干预措施: Physical activity questionnaire (Behavioral)
APA group
干预措施: Quality of Life questionnaire (Behavioral)
Control group
干预措施: No intervention (Other)
结局指标
主要结局
1. Evaluate the effect of the APA program on fatigue status.
时间窗: Baseline, mid-term assessment (after 2 cycles of chemotherapy, each cycle has a duration of 21 days), assessment before transplant and assessment after transplant (on average about 30 weeks after inclusion)
Cancer Related Fatigue : EORTC QLQ-FA12 questionnaire (minimum = 0, maximum = 100, higher score means better outcome).
次要结局
- Evaluate the effect of the APA program on quality of life.(Baseline, mid-term assessment (after 2 cycles of chemotherapy, each cycle has a duration of 21 days), assessment before transplant and assessment after transplant (on average about 30 weeks after inclusion))
- Nutritional status.(Baseline, mid-term assessment (after 2 cycles of chemotherapy, each cycle has a duration of 21 days), assessment before transplant and assessment after transplant (on average about 30 weeks after inclusion))
- Grade III-IV adverse events rate.(From inclusion to assessment after transplant (on average about 30 weeks after inclusion))
- Comparison of hospitalization length.(Assessment after transplant (on average about 30 weeks after inclusion))
- 15. Attraction to sport assessment.(Assessment after transplant (on average about 30 weeks after inclusion))
- Adherence rate.(Assessment after transplant (on average about 30 weeks after inclusion))
- Attrition rate.(Assessment after transplant (on average about 30 weeks after inclusion))
- Rate of effective APA sessions.(Assessment after transplant (on average about 30 weeks after inclusion))
- Reasons for discontinuing the APA program.(Assessment after transplant (on average about 30 weeks after inclusion))
- Patient's comments and remarks.(100 days after transplant)
- Patient satisfaction.(100 days after transplant)
- Fitness assessment.(Baseline, mid-term assessment (after 2 cycles of chemotherapy, each cycle has a duration of 21 days), assessment before transplant and assessment after transplant (on average about 30 weeks after inclusion))