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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.
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;
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HSC donors | Experimental | Completion of questionnaires + socio-demographic data |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Evaluate the evolution of the psychic state of the donors (ascendants and descendants), by means of questionnaires, within the framework of haplo-identical allograft. | Other | 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 |
| 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 |
| 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):
Coding questions 4/8/12/16:
Higher score = worse outcome |
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Inclusion criteria:
Exclusion Criteria:
- Insufficient understanding of the French language
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Eolia Brissot | Contact | 01 49 28 34 38 | +33 | eolia.brissot@aphp.fr |
| Alice Polomeni | Contact | 01 49 28 34 38 | +33 | alice.polomeni@aphp.fr |
| Name | Affiliation | Role |
|---|---|---|
| Eolia Brissot | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Service D'hématologie Clinique et thérapie cellulaire - Hôpital St Antoine | Recruiting | Paris | France |
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|
| 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.
| 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 |
| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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