Identifying Predictors of Poor Health-Related Quality-of-Life Among Pediatric Hematopoietic Stem Cell Donors
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|ClinicalTrials.gov Identifier: NCT03718546|
Recruitment Status : Not yet recruiting
First Posted : October 24, 2018
Last Update Posted : January 30, 2019
|Condition or disease|
|Quality of Life|
|Study Type :||Observational|
|Estimated Enrollment :||1876 participants|
|Official Title:||Identifying Predictors of Poor Health-Related Quality-of-Life Among Pediatric Hematopoietic Stem Cell Donors|
|Estimated Study Start Date :||February 2019|
|Estimated Primary Completion Date :||December 2021|
|Estimated Study Completion Date :||December 2022|
|Sibling pediatric donors|
|Sibling recipients and caregivers|
From the donor-recipient families
Of patients receiving unrelated transplants
A matched sample
- HRQoL [ Time Frame: 1 year ]To longitudinally and quantitatively describe the HRQoL of a diverse nation-wide cohort of sibling pediatric HSC donors and to compare their HRQoL to that of (1) healthy non-donor sibling from the same family, (2) siblings of children with similar diseases who receive alternate treatments (e.g., unrelated cord blood transplants), and (3) healthy age, gender, and race/ethnicity-matched controls.
- 1 year post-donation [ Time Frame: 1 year ]To identify and examine donor HRQoL trajectories from pre- through 1 year post-donation.
- Donor characteristics [ Time Frame: 1 year ]To determine which donor characteristics (e.g., demographic, psychosocial, and donation-related), recipient characteristics (e.g., recipient disease, transplant complications and outcomes), family characteristics (e.g., composition, cohesiveness, stress), and transplant center characteristics (e.g., presence of a donor advocate) most strongly predict membership in trajectory classes with poor HRQoL among donors.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03718546
|Contact: Alisha Mussetter, B.Semail@example.com|
|Contact: Briana Personfirstname.lastname@example.org|