Feasibility Study of the ETOILE Program, a Therapeutic Education Program in Pediatric Hematology About Acute Lymphoblastic Leukemia and Allogenic Hematopoietic Steam Cells Transplantation, for Patient and Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Feasibility of the ETOILE program
研究概览
简要总结
Feasibility study of a therapeutic education program for the patient and his carers, intended for children suffering from acute lymphoblastic leukemia or having received an allograft of hematopoietic stem cells in the pediatric hematology department of Robert Debré hospital ( Paris, APHP). In addition to feasibility, the intermediate effectiveness of the program will be assessed.
详细描述
This is a pilot feasibility study, of the quasi-experimental before-after, non-randomized, mono-centric type. Feasibility is assessed on process criteria (adoption, reach implementation, satisfaction). Intermediate effectiveness is assessed on the skill level of patients and their caregivers, before, after and at a distance from education. Patients' anxiety levels will also be assessed before, after and at a distance from the program. The level of health literacy will be assessed at the start of the study.
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
- 1 Day 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Criteria relating to the population studied: child between 0 and 18 years old, followed at Robert Debré hospital (Paris), by a doctor from the hematology and immunology department
- •Of which the 2 holders of parental authority have been informed and have signed the consent
- •Having 1 or 2 caregivers available to accompany him during FTE sessions
- •1 to 2 of their adult caregivers will be eligible for the ETOILE program and will be included in the study after their consent.
- •Child with acute lymphoblastic leukemia, treated at Robert Debré Hospital (Paris), in the induction or consolidation phase
- •Child going to receive or having received an allograft of hematopoietic stem cells at the Robert Debré hospital (Paris)
- •Beneficiaries of a social security scheme or entitled to it,
排除标准
- •Child not mastering the French language,
- •Child with physical or cognitive disability to participate in the program,
结局指标
主要结局
Feasibility of the ETOILE program
时间窗: 6 months
number of patients which joined the programme compared to number of patients referred
次要结局
未报告次要终点