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临床试验/NCT02631811
NCT02631811已完成不适用

Impact on Quality of Life of an Early Management Supportive Care of Patients With Acute Leukemia in First Relapse.

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2016年2月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
49
试验地点
2
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

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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