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.
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
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
50
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
Service D'hématologie Clinique et thérapie cellulaire - Hôpital St Antoine
Paris, France
RECRUITINGAnxiety
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
Time frame: D0 ; D90, D180 and D360
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
Time frame: 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
Time frame: Day 360
Family functioning
Explored by semi-structured telephone interview
Time frame: Day 360
Describe the donor management methods
Sheet to be completed by the participating centers
Time frame: 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
Time frame: Day 90
Describe the medical problems encountered since the donation of HSCs
Questionnaire to be completed by donors
Time frame: 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.
Time frame: Day 360
Describe the medical events concerning the donation of CSH
Questionnaire to be completed by donors
Time frame: 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.
Time frame: Day 360
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