Health TrialsbyHealthPanel

Psychological Impact of Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation on Donors

ConditionsHaplo-identical TransplantationTransplantation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • 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 intervention

    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

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: HSC donorsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
D0 ; D90, D180 and D360

Secondary outcomes

1

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
2

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
3

Family functioning

Explored by semi-structured telephone interview

Time frame
Day 360
4

Describe the donor management methods

Sheet to be completed by the participating centers

Time frame
Day 0

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Source ClinicalTrials.gov
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