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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hematopoietic/Lymphoid Cancer, Psychological Disorder

Intervention / Treatment
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* Behavioral: quality of life questionnaire


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with diary<br>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<br>* 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.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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allogenic hematopoietic stem cell transplantation, diary, psychological disorders