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

Not Applicable

Completed

• Conditions: Psychological Disorder; Hematopoietic/Lymphoid Cancer
• Interventions: Behavioral: quality of life questionnaire

• Registration Number: NCT04172818
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-01
• Study First Submitted: 2019-11-14
• Study First Submitted QC: 2019-11-19
• Study First Posted: 2019-11-21
• Primary Completion: 2021-05-01
• Status Verified: 2023-03
• Study Completion: 2023-03-21
• Last Update Submitted: 2023-03-21
• Last Update Posted: 2023-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

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

Exclusion Criteria

• patient not hospitalized for an hematopoietic allogenic stem cell transplantation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with diary	quality of life questionnaire	Evaluation the psychological impact of a diary on the patients hospitalized for allogenic hematopoetic stem cell transplantation and on their relatives.

Primary Outcome Measures

Name	Time	Method
Measure of diary impact on patient quality of life	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.

Secondary Outcome Measures

Name	Time	Method
Measure of diary impact on health care team satisfaction	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 relative quality of life	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.

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France