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

Primary Purpose

Hematopoietic/Lymphoid Cancer, Psychological Disorder

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
quality of life questionnaire
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Hematopoietic/Lymphoid Cancer focused on measuring allogenic hematopoietic stem cell transplantation, diary, psychological disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU Amiens

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with diary

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
November 14, 2019
Last Updated
March 21, 2023
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT04172818
Brief Title
Feasibility Study of a Diary for Allogenic Hematopoietic Stem Cell Transplantation Patients and Families
Acronym
JACintHE
Official Title
Feasibility Study of a Diary for Allogenic Hematopoietic Stem Cell Transplantation Patients and Families
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
May 1, 2021 (Actual)
Study Completion Date
March 21, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematopoietic/Lymphoid Cancer, Psychological Disorder
Keywords
allogenic hematopoietic stem cell transplantation, diary, psychological disorders

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with diary
Arm Type
Experimental
Arm Description
Evaluation the psychological impact of a diary on the patients hospitalized for allogenic hematopoetic stem cell transplantation and on their relatives.
Intervention Type
Behavioral
Intervention Name(s)
quality of life questionnaire
Intervention 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.
Primary Outcome Measure Information:
Title
Measure of diary impact on patient quality of life
Description
the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.
Time Frame
at day 0
Title
Measure of diary impact on patient quality of life
Description
the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.
Time Frame
through the end of hospitalisation, an average of 3 weeks
Title
Measure of diary impact on patient quality of life
Description
the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.
Time Frame
at 30 days after transplantation
Title
Measure of diary impact on patient quality of life
Description
the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.
Time Frame
at day 100 after transplantation
Title
Measure of diary impact on patient quality of life
Description
the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.
Time Frame
6 months after transplantation
Title
Measure of diary impact on patient quality of life
Description
the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.
Time Frame
a year after transplantation
Secondary Outcome Measure Information:
Title
Measure of diary impact on health care team satisfaction
Description
the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.
Time Frame
at day 0
Title
Measure of diary impact on health care team satisfaction
Description
the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.
Time Frame
through the end of hospitalisation, an average of 3 weeks
Title
Measure of diary impact on health care team satisfaction
Description
the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.
Time Frame
at 30 days after transplantation
Title
Measure of diary impact on health care team satisfaction
Description
the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.
Time Frame
at day 100 after transplantation
Title
Measure of diary impact on health care team satisfaction
Description
the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.
Time Frame
6 months after transplantation
Title
Measure of diary impact on health care team satisfaction
Description
the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.
Time Frame
a year after transplantation
Title
Measure of diary impact on patient relative quality of life
Description
the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.
Time Frame
at day 0
Title
Measure of diary impact on patient relative quality of life
Description
the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.
Time Frame
through the end of hospitalisation, an average of 3 weeks
Title
Measure of diary impact on patient relative quality of life
Description
the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.
Time Frame
at 30 days after transplantation
Title
Measure of diary impact on patient relative quality of life
Description
the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.
Time Frame
at day 100 after transplantation
Title
Measure of diary impact on patient relative quality of life
Description
the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.
Time Frame
6 months after transplantation
Title
Measure of diary impact on patient relative quality of life
Description
the diary for patients with allogenic hematopoietic stem cell transplantation could be a mean to reduce the psychological adverse impact and long term consequences.
Time Frame
a year after transplantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Delphine Lebon, MD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marie Beaumont, MD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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