Psychological Impact of Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation on Donors

Overview

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

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;

Interventions

• 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 intervi

Primary outcome measures

• Anxiety [Time frame: D0 ; D90, D180 and D360]

Secondary outcome measures (9)

• Depression [Time frame: Day 360]
• Quality of donor's life [Time frame: Day 360]
• Family functioning [Time frame: Day 360]
• Describe the donor management methods [Time frame: Day 0]
• Describe the symptoms experienced during the administration of the growth factor and the collection of HSCs [Time frame: Day 90]
• Describe the medical problems encountered since the donation of HSCs [Time frame: Day 360]
• Evaluate the donors' perception of the care offered to them [Time frame: Day 360]
• Describe the medical events concerning the donation of CSH [Time frame: Day 360]
• Describe medical events in patients and assess the impact on the donor's mental state [Time frame: Day 360]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Other

Study locations

France · 1 center

• Service D'hématologie Clinique et thérapie cellulaire - Hôpital St Antoine — Paris

Identifiers

NCT: NCT06089850 · APHP211342

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗