Psychological Impact of Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation on Donors (HAPLOGREF)

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.

Study Overview

• Status: Recruiting
• Conditions: Transplantation; Haplo-identical Transplantation
• Intervention / Treatment: 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.

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;

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eolia Brissot; Phone Number: +33 01 49 28 34 38; Email: eolia.brissot@aphp.fr
• Study Contact Backup: Name: Alice Polomeni; Phone Number: +33 01 49 28 34 38; Email: alice.polomeni@aphp.fr

Study Locations

• France
  • Paris, France
    • Recruiting
    • Service D'hématologie Clinique et thérapie cellulaire - Hôpital St Antoine
    • Contact: Eolia Brissot; Email: eolia.brissot@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: HSC donors; 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.; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depression	Assessed by the Center for Epidemiologic Studies Depression Scale (CES-D self-questionnaire) validated in French CES-D : Center for Epidemiologic Studies -Despression Minimum value : never (0) Maximum value : all the time (3) Coding (except questions 4/8/12/16): Never = 0 pts; Very rarely (less than 1 day) = 0 pts; Occasionally (1 to 2 days) = 1 pts; Quite often (3 to 4 days) = 2 pts; Frequently (5 to 7 days) = 3 pts; All the time = 3 pts Coding questions 4/8/12/16: Never = 3 pts; Very rarely (less than 1 day) = 3 pts; Occasionally (1 to 2 days) = 2 pts; Quite often (3 to 4 days) = 1 pts; Frequently (5 to 7 days) = 0 pts; Constantly = 0 pts Higher score = worse outcome	Day 360
Quality of donor's life	Assessed by the 12-Item Short Form Health Survey (SF-12), validated for the French population SF-12 : quality of life It is a quality of life questionnaire and no score is reported on a scale	Day 360
Family functioning	Explored by semi-structured telephone interview	Day 360
Describe the donor management methods	Sheet to be completed by the participating centers	Day 0
Describe the symptoms experienced during the administration of the growth factor and the collection of HSCs	Questionnaire to be completed by the donors	Day 90
Describe the medical problems encountered since the donation of HSCs	Questionnaire to be completed by donors	Day 360
Evaluate the donors' perception of the care offered to them	Questionnaire to be completed by donors FRI : French adaptation of the Family Relationship Index Scale : true (1)/False (0) A high score indicates respectively: high family cohesion, high expression/verbalization of feelings, high conflict and good family relationships.; Describe the donor management methods : no scale; Describe the symptoms experienced during the administration of the growth factor and the collection of HSCs (questionnaire B at D90) : no scale. It is a questionnaire where the donor describes his feelings during the administration of the growth factor; Describe the medical problems encountered since the donation of HSC (questionnaire C at D180 and 360) : no scale, It is a questionnaire in which the donor describes any medical problems encountered since the donation; Evaluate the donors' perception of the care offered to them (questionnaire D at D360) : no scale, This is a questionnaire that the patient answers in order to improve donor management.	Day 360
Describe the medical events concerning the donation of CSH	Questionnaire to be completed by donors	Day 360
Describe medical events in patients and assess the impact on the donor's mental state	Collect information on the patient journey (GVH, relapse, death) The experiences of the donors will be explored through semi-structured interviews, the interest of the qualitative approach having been demonstrated for an in-depth understanding of the psychological problems.	Day 360

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Eolia Brissot, Assistance Publique - Hopitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): January 22, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): January 1, 2028

Study Registration Dates

• First Submitted: December 7, 2022
• First Submitted That Met QC Criteria: October 17, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Actual): April 2, 2025
• Last Update Submitted That Met QC Criteria: April 1, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: depression; anxiety; donors; hematology; HSC transplantation; familly; psychic state
• Other Study ID Numbers: APHP211342

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No