Clinical trial NCT04172818: Feasibility Study of a Diary for Allogenic Hematopoietic Stem Cell Transplantation Patients and Families
Official title: Feasibility Study of a Diary for Allogenic Hematopoietic Stem Cell Transplantation Patients and Families
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hematopoietic/Lymphoid Cancer
Psychological Disorder
Keywords: allogenic hematopoietic stem cell transplantation
diary
psychological disorders
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2019-11-21
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Measure of diary impact on patient quality of life
timeFrame: at day 0
measure: Measure of diary impact on patient quality of life
timeFrame: through the end of hospitalisation, an average of 3 weeks
measure: Measure of diary impact on patient quality of life
timeFrame: at 30 days after transplantation
measure: Measure of diary impact on patient quality of life
timeFrame: at day 100 after transplantation
measure: Measure of diary impact on patient quality of life
timeFrame: 6 months after transplantation
measure: Measure of diary impact on patient quality of life
timeFrame: a year after transplantation
Secondary outcomes:
measure: Measure of diary impact on health care team satisfaction
timeFrame: at day 0
measure: Measure of diary impact on health care team satisfaction
timeFrame: through the end of hospitalisation, an average of 3 weeks
measure: Measure of diary impact on health care team satisfaction
timeFrame: at 30 days after transplantation
measure: Measure of diary impact on health care team satisfaction
timeFrame: at day 100 after transplantation
measure: Measure of diary impact on health care team satisfaction
timeFrame: 6 months after transplantation
measure: Measure of diary impact on health care team satisfaction
timeFrame: a year after transplantation
measure: Measure of diary impact on patient relative quality of life
timeFrame: at day 0
measure: Measure of diary impact on patient relative quality of life
timeFrame: through the end of hospitalisation, an average of 3 weeks
measure: Measure of diary impact on patient relative quality of life
timeFrame: at 30 days after transplantation
measure: Measure of diary impact on patient relative quality of life
timeFrame: at day 100 after transplantation
measure: Measure of diary impact on patient relative quality of life
timeFrame: 6 months after transplantation
measure: Measure of diary impact on patient relative quality of life
timeFrame: a year after transplantation
Other outcomes:
Locations:
city: Amiens
country: France
facility: CHU Amiens
Study officials:
affiliation: CHU Amiens
name: Delphine Lebon, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: CHU Amiens
name: Marie Beaumont, MD
role: PRINCIPAL_INVESTIGATOR
References: