Identifying Predictors of Poor Health-Related Quality-of-Life Among Pediatric Hematopoietic Stem Cell Donors

Center for International Blood and Marrow Transplant Research (CIBMTR)

Status

Completed

Conditions

Quality of Life

Study type

Observational

Funder types

Other

NETWORK

Identifiers

NCT03718546

17-SIBS

Details and patient eligibility

About

To compare donors to their non-donor counterparts and healthy controls as well as to generate trajectory classes based on longitudinal patterns of donor HRQoL and identify predictors of poor donor HRQoL.

Full description

There is limited data to show the effects that donation has on pediatric donors to their siblings. There is widespread agreement that it is critical to investigate the medical and psychosocial aspects of sibling pediatric HSC donation for multiple reasons including (a) the vulnerability of the pediatric population undergoing donation, (b) increasing use of pediatric HSC donation as a therapeutic option, (c) evidence that ~20% of pediatric HSC donors experience clinically important HRQoL deficits, and (d) the impact that improved understanding of factors predicting poor HRQoL will have on our ability to develop guidelines and/or interventions for assisting at-risk donors/families. The proposed study will help to compare donors to their non-donor counterparts and healthy controls as well as to generate trajectory classes based on longitudinal patterns of donor HRQoL and identify predictors of poor donor HRQoL.

Enrollment

754 patients

Sex

All

Ages

5+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Participants must fall into one of the following categories:
- Donor between the age of 5 and 17 who is donating to a sibling
- Parent/caregiver of study participating donor
- Recipient sibling aged 5 to 17 of study participating donor
- Any of the donor's non-donor/non-recipient siblings between 5 and 17
- Any child between 5 and 17 with a brother or sister (also between 5 and 17) receiving a transplant from an unrelated source
Be willing and able to provide signed informed consent:
- Adults must give consent for their children's and, if applicable, their own participation
- Assent will be obtained in accordance with guidelines at the participant's transplant institution
Be willing and able to respond to psychological assessment questions
Must be the donor's first donation
Recipient must consent to the CIBMTR research database

Exclusion criteria

For families with pediatric donors aged 5 to 17, at minimum, the donor child and/or one parent must consent/assent to participation. If that minimum is not met, the family will be excluded
Donor or non-donor siblings who do not live in the same household as the recipient at lease half of the time
Unable to consent/assent or complete a phone interview in English
- Parents may consent/assent in Spanish
No access to a telephone