Psychological Impact of Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation on Donors

Transplantation Clinical Trial

— HAPLOGREF  

Official title:

Psychological Impact of Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation on Donors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06089850
• Other study ID #: APHP211342
• Status: Recruiting
• Phase: N/A
• Start date: January 22, 2024
• Est. completion date: January 2028

Study information

• Verified date: January 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Eolia Brissot
• Phone: 01 49 28 34 38
• Email: eolia.brissot[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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;

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2028
• Est. primary completion date: January 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Transplantation

Intervention

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

Locations

Country	Name	City	State
France	Service D'hématologie Clinique et thérapie cellulaire - Hôpital St Antoine	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Family functioning	Explored by semi-structured telephone interview	Day 360
Secondary	Describe the donor management methods	Sheet to be completed by the participating centers	Day 0
Secondary	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
Secondary	Describe the medical problems encountered since the donation of HSCs	Questionnaire to be completed by donors	Day 360
Secondary	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
Secondary	Describe the medical events concerning the donation of CSH	Questionnaire to be completed by donors	Day 360
Secondary	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