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

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.

Study Overview

• Status: Completed
• Conditions: Hematopoietic/Lymphoid Cancer; Psychological Disorder
• Intervention / Treatment: Behavioral: quality of life questionnaire

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Amiens, France, 80054
    • CHU Amiens

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire, Amiens
• Investigators: Principal Investigator: Delphine Lebon, MD, CHU Amiens; Principal Investigator: Marie Beaumont, MD, CHU Amiens

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): May 1, 2021
• Study Completion (Actual): March 21, 2023

Study Registration Dates

• First Submitted: November 14, 2019
• First Submitted That Met QC Criteria: November 19, 2019
• First Posted (Actual): November 21, 2019

Study Record Updates

• Last Update Posted (Actual): March 22, 2023
• Last Update Submitted That Met QC Criteria: March 21, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: allogenic hematopoietic stem cell transplantation; diary; psychological disorders
• Additional Relevant MeSH Terms: Mental Disorders
• Other Study ID Numbers: PI2019_843_0005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No