Psychological Impact of Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation on Donors

Not Applicable

Recruiting

• 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.

• Registration Number: NCT06089850
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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;

Study Timeline

• Study First Submitted: 2022-12-07
• Study First Submitted QC: 2023-10-17
• Study First Posted: 2023-10-18
• Status Verified: 2024-01
• Study Start: 2024-01-22
• Last Update Submitted: 2024-01-30
• Last Update Posted: 2024-01-31
• Primary Completion: 2026-01
• Study Completion: 2028-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

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Exclusion Criteria

• Insufficient understanding of the French language

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HSC donors	Evaluate the evolution of the psychic state of the donors (ascendants and descendants), by means of questionnaires, within the framework of haplo-identical allograft.	Completion of questionnaires + socio-demographic data

Primary Outcome Measures

Name	Time	Method
Anxiety	D0 ; D90, D180 and D360	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

Secondary Outcome Measures

Name	Time	Method
Describe the donor management methods	Day 0	Sheet to be completed by the participating centers
Describe medical events in patients and assess the impact on the donor's mental state	Day 360	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.
Quality of donor's life	Day 360	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
Family functioning	Day 360	Explored by semi-structured telephone interview
Describe the medical problems encountered since the donation of HSCs	Day 360	Questionnaire to be completed by donors
Describe the symptoms experienced during the administration of the growth factor and the collection of HSCs	Day 90	Questionnaire to be completed by the donors
Describe the medical events concerning the donation of CSH	Day 360	Questionnaire to be completed by donors
Depression	Day 360	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
Evaluate the donors' perception of the care offered to them	Day 360	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.

Trial Locations

Locations (1)

Service D'hématologie Clinique et thérapie cellulaire - Hôpital St Antoine; 🇫🇷 Paris, France