Psychological Impact of Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation on Donors

NCT06089850 | Recruiting

• 1 other identifier: APHP211342
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Haplo-identical Transplantation; Transplantation

Keywords

HSC transplantation; anxiety; depression; donors; hematology; familly; psychic state

Outcome Measures

Primary Outcomes (1)

• Anxiety

  Assessed by the State-Trait anxiety Inventory (STAI-Y), self-questionnaire validated in French STAI-Y : Spielberger trait anxiety questionnaire minimum value : almost never maximum value : almost always Higher score = better outcome

  D0 ; D90, D180 and D360

Secondary Outcomes (9)

• Depression

  Day 360

• Quality of donor's life

  Day 360

• Family functioning

  Day 360

• Describe the donor management methods

  Day 0

• Describe the symptoms experienced during the administration of the growth factor and the collection of HSCs

  Day 90

Study Arms (1)

HSC donors

EXPERIMENTAL

Completion of questionnaires + socio-demographic data

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.

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. 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

HSC donors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- Insufficient understanding of the French language

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

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

Paris, France

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Eolia Brissot

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eolia Brissot

CONTACT

01 49 28 34 38; eolia.brissot@aphp.fr

Alice Polomeni

CONTACT

01 49 28 34 38; alice.polomeni@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: October 18, 2023
• Study Start: January 22, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2028
• Last Updated: April 2, 2025

Record last verified: 2025-04

Locations

FR (1)