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
Source
Centre Hospitalier Universitaire, Amiens
Oversight Info
Has Dmc
No
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
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
2019-11-01
Completion Date
2021-10-01
Primary Completion Date
2021-05-01
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
Conditions
Intervention
Intervention Type
Behavioral
Intervention Name
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
Last Name |
Role |
Affiliation |
|
Delphine Lebon, MD |
Principal Investigator |
CHU Amiens |
|
Marie Beaumont, MD |
Principal Investigator |
CHU Amiens |
Overall Contact
Location
Facility |
Contact |
|
CHU Amiens Amiens 80054 France |
Location Countries
Country
France
Verification Date
2019-11-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keywords
Has Expanded Access
No
Condition Browse
Number Of Arms
1
Arm Group
Arm Group Label
Patients with diary
Arm Group Type
Experimental
Description
Evaluation the psychological impact of a diary on the patients hospitalized for allogenic hematopoetic stem cell transplantation and on their relatives.
Firstreceived Results Date
N/A
Overall Contact Backup
Last Name
Marie Beaumont, MD
Phone
(33)322455914
Acronym
JACintHE
Patient Data
Sharing Ipd
No
Firstreceived Results Disposition Date
N/A
Study Design Info
Intervention Model
Single Group Assignment
Primary Purpose
Other
Masking
None (Open Label)
Study First Submitted
November 14, 2019
Study First Submitted Qc
November 19, 2019
Study First Posted
November 21, 2019
Last Update Submitted
November 19, 2019
Last Update Submitted Qc
November 19, 2019
Last Update Posted
November 21, 2019
ClinicalTrials.gov processed this data on January 23, 2020
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.