Psychological Impact of Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation on Donors

Study Overview
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Brief Summary
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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
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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;

Official Title
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Psychological Impact of Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation on Donors

Conditions
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Haplo-identical Transplantation, Transplantation

Intervention / Treatment
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* 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.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HSC donors<br>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.<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HSC transplantation, anxiety, depression, donors, hematology, familly, psychic state