Clinical trial NCT06089850: Psychological Impact of Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation on Donors
Official title: Psychological Impact of Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation on Donors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Haplo-identical Transplantation
Transplantation
Keywords: HSC transplantation
anxiety
depression
donors
hematology
familly
psychic state
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-10-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Allogeneic hematopoietic stem cell transplantation (allo-HSC) is currently one of the only curative treatments for haematological malignancies with a poor prognosis, the realization of which presupposes the identification and availability of a compatible donor. In recent years, haploidentical transplants have been developed, a reliable alternative for patients who do not have 100% compatible donors.

The development of haplo-identical transplants leads to an exponential increase in the use of intra-family donation. Intrafamilial donation of hematopoietic stem cells (HSC) has the advantages of lower financial cost and faster availability of the graft, thus avoiding the risk of relapse before the procedure. Nevertheless, intrafamilial donation raises clinical and ethical questions. Indeed, the psychological impact of intra-family donation on the donor cannot be overlooked. Thus, in the context of the development of haplo-identical transplants, measuring the impact of donation on donors (ascendants and descendants) will make it possible to assess the relevance of taking psychosocial aspects into consideration in the choice of donors, to assess the psychological impact of haplo-identical donation and to offer psychological support adapted to donors.

Detailed description: This is a prospective, exploratory and bicentric study with a quantitative and qualitative approach, with the aim of exploring the psychosocial aspects of the experience of haplo-identical transplantation in adult HSC donors for transplantation. haplo-identical for their children or for their parents.

For this, the evolution of the anxiety and depression) of the donors will be evaluated on D0, D90, D180 and D360 post donation, thanks to State-Trait anxiety Inventory questionnaire, Center for Epidemiologic Studies Depression Scale and by the 12-Item Short Form Health Survey;

Eligibility criteria: Inclusion criteria:

* Identical haplo CSH donors ascending (parents) or descending (children)
* Major identical haplo HSC donors
* Haplo-identical HSC donors living in mainland France and cared for in the centers participating in the study
* Haplo-identical HSC donors benefiting from Social Security System.
* Haplo-identical HSC donors who have signed the consent form
* - Ability to read and write in French

Exclusion Criteria:

- Insufficient understanding of the French language

Primary outcomes:
measure: Anxiety
timeFrame: D0 ; D90, D180 and D360
Secondary outcomes:
measure: Depression
timeFrame: Day 360
measure: Quality of donor's life
timeFrame: Day 360
measure: Family functioning
timeFrame: Day 360
measure: Describe the donor management methods
timeFrame: Day 0
measure: Describe the symptoms experienced during the administration of the growth factor and the collection of HSCs
timeFrame: Day 90
measure: Describe the medical problems encountered since the donation of HSCs
timeFrame: Day 360
measure: Evaluate the donors' perception of the care offered to them
timeFrame: Day 360
measure: Describe the medical events concerning the donation of CSH
timeFrame: Day 360
measure: Describe medical events in patients and assess the impact on the donor's mental state
timeFrame: Day 360
Other outcomes:
Locations:
city: Paris
country: France
facility: Service D'hématologie Clinique et thérapie cellulaire - Hôpital St Antoine
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Eolia Brissot
role: PRINCIPAL_INVESTIGATOR
References: