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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06089850
Other study ID # APHP211342
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 22, 2024
Est. completion date January 2028

Study information

Verified date January 2024
Source Assistance Publique - Hôpitaux de Paris
Contact Eolia Brissot
Phone 01 49 28 34 38
Email eolia.brissot@aphp.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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;


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date January 2028
Est. primary completion date January 2026
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France Service D'hématologie Clinique et thérapie cellulaire - Hôpital St Antoine Paris

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Secondary 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
Day 360
Secondary 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
Secondary Family functioning Explored by semi-structured telephone interview Day 360
Secondary Describe the donor management methods Sheet to be completed by the participating centers Day 0
Secondary 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
Secondary Describe the medical problems encountered since the donation of HSCs Questionnaire to be completed by donors Day 360
Secondary 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.
Day 360
Secondary Describe the medical events concerning the donation of CSH Questionnaire to be completed by donors Day 360
Secondary 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
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