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
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Hematopoietic/Lymphoid Cancer
• Mental Disorders
• Psychological Disorder

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