Haplo-identical TransplantationHAPLOGREFNCT06089850
Psychological Impact of Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation on Donors
A study testing Evaluate the evolution of the psychic state of the donors (ascendants and descendants), by means of questionnaires, within the framework of haplo-identical allograft. in people with Haplo-identical Transplantation and Transplantation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Haplo-identical Transplantation, Transplantation
- What is being tested?
- Evaluate the evolution of the psychic state of the donors (ascendants and descendants), by means of questionnaires, within the framework of haplo-identical allograft.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 22 Jan 2024to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Insufficient understanding of the French language
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Service D'hématologie Clinique et thérapie cellulaire - Hôpital St Antoine
Paris
Eolia Brissot, eolia.brissot@aphp.fr
About this study
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.
Read the 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;
- Conditions
- Haplo-identical Transplantation, Transplantation
- Being tested
- Evaluate the evolution of the psychic state of the donors (ascendants and descendants), by means of questionnaires, within the framework of haplo-identical allograft.
- Keywords
- HSC transplantation, anxiety, depression, donors, hematology, familly, psychic state
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| HSC donors | Experimental | Completion of questionnaires + socio-demographic data Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: D0 ; D90, D180 and D360
Secondary outcomes (9)
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
Measured: Day 360
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
Measured: Day 360
Family functioning
Explored by semi-structured telephone interview
Measured: Day 360
Describe the donor management methods
Sheet to be completed by the participating centers
Measured: Day 0
Describe the symptoms experienced during the administration of the growth factor and the collection of HSCs
Questionnaire to be completed by the donors
Measured: Day 90
Describe the medical problems encountered since the donation of HSCs
Questionnaire to be completed by donors
Measured: Day 360
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.
Measured: Day 360
Describe the medical events concerning the donation of CSH
Questionnaire to be completed by donors
Measured: Day 360
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.
Measured: Day 360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start22 Jan 2024
- Primary completionJan 2026 (estimated)
- Study completionJan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haplo-identical TransplantationStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eolia Brissot, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089850
- Sponsor's protocol ID
- APHP211342
- Acronym
- HAPLOGREF
- Status last verified
- Apr 2025
- First submitted
- 7 Dec 2022
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological Impact of Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation on Donors
- ClinicalTrials.gov ID
- NCT06089850
- Acronym / sponsor ID
- HAPLOGREF / APHP211342
- Conditions
- Haplo-identical Transplantation, Transplantation
- Keywords
- HSC transplantation, anxiety, depression, donors, hematology, familly, psychic state
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 22 Jan 2024 (actual)
- Primary completion
- Jan 2026 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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;
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HSC donors | Experimental | 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.Completion of questionnaires + socio-demographic data |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (1 listed)
- Insufficient understanding of the French language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Other | HSC donors |
Primary outcome
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
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eolia Brissot principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluate the evolution of the psychic state of the donors (ascendants and descendants), by means of questionnaires, within the framework of haplo-identical allograft. in people with Haplo-identical Transplantation and Transplantation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eolia Brissot (01 49 28 34 38 ext. +33, eolia.brissot@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: D0 ; D90, D180 and D360). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2025.