Psychological Impact of Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation on Donors

NCT ID: NCT06089850

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-22
• Study Completion Date: 2028-01-31

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;

Conditions

Haplo-identical Transplantation; Transplantation

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

HSC donors

Completion of questionnaires + socio-demographic data

Group Type: EXPERIMENTAL

Evaluate the evolution of the psychic state of the donors (ascendants and descendants), by means of questionnaires, within the framework of haplo-identical allograft.

Intervention Type: OTHER

Donors are included in the study during the pre-donation assessment. Completion of questionnaires + socio-demographic data

CSH collection visit (V1): Visit at which donors are collected for CSH donation. Completion by the donor of the questionnaires

Follow-up of donors at D90 (+/-7) post V1, D180 (+/-15D) post V1 and D360 (+/-15D) post V1. The donors participating in the study will complete the scales/questionnaires

D360: Completion by the donor of the questionnaires + semi-structured interview by telephone if accepted by the participant

Interventions

Evaluate the evolution of the psychic state of the donors (ascendants and descendants), by means of questionnaires, within the framework of haplo-identical allograft.

Donors are included in the study during the pre-donation assessment. Completion of questionnaires + socio-demographic data

CSH collection visit (V1): Visit at which donors are collected for CSH donation. Completion by the donor of the questionnaires

Follow-up of donors at D90 (+/-7) post V1, D180 (+/-15D) post V1 and D360 (+/-15D) post V1. The donors participating in the study will complete the scales/questionnaires

D360: Completion by the donor of the questionnaires + semi-structured interview by telephone if accepted by the participant

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Eolia Brissot

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

Service D'hématologie Clinique et thérapie cellulaire - Hôpital St Antoine

Paris, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Eolia Brissot

Role: CONTACT

eolia.brissot@aphp.fr

01 49 28 34 38 ext. +33

Alice Polomeni

Role: CONTACT

alice.polomeni@aphp.fr

01 49 28 34 38 ext. +33

Facility Contacts

Eolia Brissot

Role: primary

eolia.brissot@aphp.fr

Other Identifiers

APHP211342

Identifier Type: -

Identifier Source: org_study_id