Impact on Quality of Life of an Early Management Supportive Care of Patients With Acute Leukemia in First Relapse.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- mesure of quality of life
研究概览
简要总结
Several studies have shown that patients with acute leukemia have many symptoms during disease These symptoms decrease the quality of life and may even appear or worsen other symptoms such as depression Several studies point to the involvement of supportive care and palliative care is delayed in these patients The aim of this study is to evaluate the impact on the quality of life of an early and standardized involvement of a support / palliative care team for patients with acute leukemia in first relapse compared to a control group .
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
- •> 18 years old
- •acute lymphoblastic or myeloblastic leukemia at first relapse and diagnosed within 8 weeks before inclusion.
- •Patients in whom a curative strategy (transplant) is not considered.
- •patients older that 75 years at the diagnosis
- •informed signed consent
排除标准
- •unable to answer the questionnaire
- •psychiatric disorders other than depression
- •persons under guardianship
研究组 & 干预措施
Supportive /palliative care intervention
patients will be supported by a multidisciplinary palliative specialist team
干预措施: Supportive /palliative care intervention (Other)
usual medical follow up
patients will be supported by the support care team if asked by the oncologist
结局指标
主要结局
mesure of quality of life
时间窗: 12 weeks
Quality of life measured by FACT Leu questionnaire. score of quality of life will be compared between the 2 groups
次要结局
- measure of symptoms intensity(12 weeks)
- measure of anxiety(12 weeks)
- measure of depression(12 weeks)
- measure of the quality of the end of life(up to 9 months)
- overall survival(9 months)