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NCT04172818 Clinical Trial

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

Hematopoietic/Lymphoid Cancer Clinical Trial

— JACintHE  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04172818
Other study ID # PI2019_843_0005
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2019
Est. completion date March 21, 2023

Study information
Verified date March 2023
Source Centre Hospitalier Universitaire, Amiens
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date March 21, 2023
Est. primary completion date May 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Behavioral:
• quality of life questionnaire
Since 10 years ago, diaries are used in intensive care unit to limit these symptoms after a coma.In analogy, the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences. The psychological impact of a diary on patients hospitalized for allogenic hematopoetic stem cell transplantation and on their relatives will be evaluated.

Locations
Country Name City State
France CHU Amiens Amiens

Sponsors (1)
Lead Sponsor Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Measure of diary impact on patient quality of life the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences. at day 0
Primary Measure of diary impact on patient quality of life the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences. through the end of hospitalisation, an average of 3 weeks
Primary Measure of diary impact on patient quality of life the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences. at 30 days after transplantation
Primary Measure of diary impact on patient quality of life the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences. at day 100 after transplantation
Primary Measure of diary impact on patient quality of life the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences. 6 months after transplantation
Primary Measure of diary impact on patient quality of life the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences. a year after transplantation
Secondary Measure of diary impact on health care team satisfaction the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences. at day 0
Secondary Measure of diary impact on health care team satisfaction the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences. through the end of hospitalisation, an average of 3 weeks
Secondary Measure of diary impact on health care team satisfaction the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences. at 30 days after transplantation
Secondary Measure of diary impact on health care team satisfaction the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences. at day 100 after transplantation
Secondary Measure of diary impact on health care team satisfaction the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences. 6 months after transplantation
Secondary Measure of diary impact on health care team satisfaction the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences. a year after transplantation
Secondary Measure of diary impact on patient relative quality of life the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences. at day 0
Secondary Measure of diary impact on patient relative quality of life the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences. through the end of hospitalisation, an average of 3 weeks
Secondary Measure of diary impact on patient relative quality of life the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences. at 30 days after transplantation
Secondary Measure of diary impact on patient relative quality of life the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences. at day 100 after transplantation
Secondary Measure of diary impact on patient relative quality of life the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences. 6 months after transplantation
Secondary Measure of diary impact on patient relative quality of life the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences. a year after transplantation
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