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NCT Number: NCT06089850

Psychological Impact of Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation on Donors

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.

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Key information

Conditions

Haplo-identical Transplantation Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Transplantation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Paris, France

Location status: Recruiting

Location contact

Eolia Brissot

CONTACT

[email protected]

About this study

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;

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. Anxiety

    Time frame: 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 outcomes

  1. Depression

    Time frame: 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

  2. Quality of donor's life

    Time frame: 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

  3. Family functioning

    Time frame: Day 360

    Explored by semi-structured telephone interview

  4. Describe the donor management methods

    Time frame: Day 0

    Sheet to be completed by the participating centers

  5. Describe the symptoms experienced during the administration of the growth factor and the collection of HSCs

    Time frame: Day 90

    Questionnaire to be completed by the donors

  6. Describe the medical problems encountered since the donation of HSCs

    Time frame: Day 360

    Questionnaire to be completed by donors

  7. Evaluate the donors' perception of the care offered to them

    Time frame: 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.

  8. Describe the medical events concerning the donation of CSH

    Time frame: Day 360

    Questionnaire to be completed by donors

  9. Describe medical events in patients and assess the impact on the donor's mental state

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alice Polomeni

CONTACT

[email protected]

01 49 28 34 38 ext. +33

Eolia Brissot

CONTACT

[email protected]

01 49 28 34 38 ext. +33

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Acronym: HAPLOGREF

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Oct 18, 2023
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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