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Psychological Impact of Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation on Donors

NCT06089850 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-04-02

No results posted yet for this study

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.

Conditions

  • Haplo-identical Transplantation
  • Transplantation

Interventions

OTHER

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

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Eolia Brissot · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-01-22
Primary Completion
2026-01-31
Completion
2028-01-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06089850 on ClinicalTrials.gov