HAPLOGREF: Psychological Impact of Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation on Donors
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: HSC donors 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.
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
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Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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 donor management methods [Day 0]
Sheet to be completed by the participating centers
- 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 problems encountered since the donation of HSCs [Day 360]
Questionnaire to be completed by donors
- 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.
- Describe the medical events concerning the donation of CSH [Day 360]
Questionnaire to be completed by donors
- 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.
Eligibility Criteria
Criteria
Inclusion criteria:
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Identical haplo CSH donors ascending (parents) or descending (children)
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Major identical haplo HSC donors
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Haplo-identical HSC donors living in mainland France and cared for in the centers participating in the study
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Haplo-identical HSC donors benefiting from Social Security System.
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Haplo-identical HSC donors who have signed the consent form
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- Ability to read and write in French
Exclusion Criteria:
- Insufficient understanding of the French language
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Service D'hématologie Clinique et thérapie cellulaire - Hôpital St Antoine | Paris | France |
Sponsors and Collaborators
- Assistance Publique - Hôpitaux de Paris
Investigators
- Principal Investigator: Eolia Brissot, Assistance Publique - Hôpitaux de Paris
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- APHP211342