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

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

Sponsors

Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Source 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.

Overall Status Not yet recruiting
Start Date November 2019
Completion Date October 2021
Primary Completion Date May 2021
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Measure of diary impact on patient quality of life at day 0
Measure of diary impact on patient quality of life through the end of hospitalisation, an average of 3 weeks
Measure of diary impact on patient quality of life at 30 days after transplantation
Measure of diary impact on patient quality of life at day 100 after transplantation
Measure of diary impact on patient quality of life 6 months after transplantation
Measure of diary impact on patient quality of life a year after transplantation
Secondary Outcome
Measure Time Frame
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 health care team satisfaction a year 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
Measure of diary impact on patient relative quality of life a year after transplantation
Enrollment 20
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: quality of life questionnaire

Description: 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.

Arm Group Label: Patients with diary

Eligibility

Criteria:

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

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Overall Contact

Last Name: Delphine Lebon, MD

Phone: (33)322455914

Email: [email protected]

Location
Facility: Contact: Contact Backup: CHU Amiens Delphine Lebon, MD (33)322455914 [email protected]
Location Countries

France

Verification Date

November 2019

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 1
Arm Group

Label: Patients with diary

Type: Experimental

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

Acronym JACintHE
Patient Data No
Study Design Info

Allocation: N/A

Intervention Model: Single Group Assignment

Primary Purpose: Other

Masking: None (Open Label)

Source: ClinicalTrials.gov