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临床试验/NCT04172818
NCT04172818已完成不适用

Feasibility Study of a Diary for Allogenic Hematopoietic Stem Cell Transplantation Patients and Families

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
1
主要终点
Measure of diary impact on patient quality of life

研究概览

简要总结

Allogenic hematopoietic stem cell transplantation is a specific time during hematological disease management for the patients, theirs relatives and the healthcare team. This heavy treatment is most of the time the last possible curative therapy and could cause many side effects such as infectious diseases and graft versus host reaction. The protective isolation is also a source of physical and psychological isolation. Published studies reported depressive syndrome, anxiety symptoms and post-traumatic stress disorders for patients and their families. Since 10 years ago, diaries are used in intensive care unit to limit these symptoms after a coma. In analogy, the diary for the patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long terms consequences. The investigators want to evaluate the psychological impact of a diary on the patients hospitalized for allogenic hematopoetic stem cell transplantation and on their relatives.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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

  • •patient age > 18 years
  • •patient hospitalized for an hematopoietic allogenic stem cell transplantation
  • •patient agreeing to participate

排除标准

  • •patient not hospitalized for an hematopoietic allogenic stem cell transplantation

研究组 & 干预措施

Patients with diary

Experimental

Evaluation the psychological impact of a diary on the patients hospitalized for allogenic hematopoetic stem cell transplantation and on their relatives.

干预措施: quality of life questionnaire (Behavioral)

结局指标

主要结局

Measure of diary impact on patient quality of life

时间窗: a year after transplantation

the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.

Measure of diary impact on patient quality of life

时间窗: at day 0

the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.

Measure of diary impact on patient quality of life

时间窗: through the end of hospitalisation, an average of 3 weeks

the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.

Measure of diary impact on patient quality of life

时间窗: at 30 days after transplantation

the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.

Measure of diary impact on patient quality of life

时间窗: at day 100 after transplantation

the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.

Measure of diary impact on patient quality of life

时间窗: 6 months after transplantation

the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.

次要结局

  • Measure of diary impact on patient relative quality of life(a year after transplantation)
  • Measure of diary impact on health care team satisfaction(a year after transplantation)
  • Measure of diary impact on health care team satisfaction(at day 0)
  • Measure of diary impact on health care team satisfaction(through the end of hospitalisation, an average of 3 weeks)
  • Measure of diary impact on health care team satisfaction(at 30 days after transplantation)
  • Measure of diary impact on health care team satisfaction(at day 100 after transplantation)
  • Measure of diary impact on health care team satisfaction(6 months after transplantation)
  • Measure of diary impact on patient relative quality of life(at day 0)
  • Measure of diary impact on patient relative quality of life(through the end of hospitalisation, an average of 3 weeks)
  • Measure of diary impact on patient relative quality of life(at 30 days after transplantation)
  • Measure of diary impact on patient relative quality of life(at day 100 after transplantation)
  • Measure of diary impact on patient relative quality of life(6 months after transplantation)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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