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

NCT04172818 | Completed

• 1 other identifier: PI2019_843_0005
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic/Lymphoid Cancer; Psychological Disorder

Keywords

allogenic hematopoietic stem cell transplantation; diary; psychological disorders

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (12)

• 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

Study Arms (1)

Patients with diary

EXPERIMENTAL

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

Interventions

quality of life questionnaire BEHAVIORAL

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.

Patients with diary

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• patient not hospitalized for an hematopoietic allogenic stem cell transplantation

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

CHU Amiens

Amiens, 80054, France

Location

MeSH Terms

Conditions

Hematologic Neoplasms; Mental Disorders

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Delphine Lebon, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

• Marie Beaumont, MD

  CHU Amiens

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: November 21, 2019
• Study Start: November 1, 2019
• Primary Completion: May 1, 2021
• Study Completion: March 21, 2023
• Last Updated: March 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)