Actively Recruiting
Psychological Impact of Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation on Donors
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-04-02
50
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are exploring the psychological effects on adults who donate hematopoietic stem cells (HSC) to family members through haploidentical transplantation, a treatment option for blood cancers when fully matched donors are unavailable. This study aims to understand the mental health impact, including anxiety and depression, on donors who are parents or children of recipients, considering the growing use of intra-family donations and their unique emotional challenges. Participants will complete questionnaires at multiple time points: on the day of donation (D0), and then at 90, 180, and 360 days after donation. These questionnaires assess anxiety, depression, quality of life, and family functioning. In addition, a semi-structured phone interview will be offered at one year post-donation to gain deeper insight into their experiences. The study also collects socio-demographic data and documents symptoms and medical issues related to donation and growth factor administration. Donors will be monitored over a full year with evaluations of their psychological state, symptoms experienced during donation, and perceptions of care received. Researchers will also assess medical events in donors and transplant recipients to understand any impact on donors' mental health. This comprehensive follow-up involves questionnaires and interviews to gather quantitative and qualitative data about the donor experience.
CONDITIONS
Brief Title
Psychological Impact of Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation on Donors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult haploidentical hematopoietic stem cell donors who are parents or children (ascendants or descendants)
- Living in mainland France and receiving care at participating centers
- Covered by the Social Security System
- Able to read and write in French
- Have signed the consent form
You will not qualify if you...
- Insufficient understanding of the French language
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for pre-donation assessment and questionnaire completion
Duration - 1 day
Participants undergo hematopoietic stem cell donation and complete questionnaires about their psychosocial state.
1 visit (in-person) for stem cell collection and questionnaire completion
Duration - 12 months post donation
Participants complete questionnaires assessing anxiety, depression, quality of life, family functioning, and medical events after donation. A semi-structured interview by telephone may occur at 12 months post-donation.
4 follow-up assessments: at day 0, day 90, day 180, and day 360 post donation; day 360 includes an optional telephone interview
Trial Site Locations
Total: 1 location
1
Service D'hématologie Clinique et thérapie cellulaire - Hôpital St Antoine
Paris, France
Actively Recruiting
Research Team
E
Eolia Brissot
A
Alice Polomeni
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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