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

NCT ID: NCT03718546

Last Updated: 2025-03-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

754 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-03

Study Completion Date

2024-10-08

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Quality of Life

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Sibling pediatric donors

Donors who are donating to a sibling

No interventions assigned to this group

Sibling recipients and caregivers

Recipients who are receiving a transplant from a sibling

No interventions assigned to this group

Non-donor sibling

From the donor-recipient families

No interventions assigned to this group

Non-donor siblings

Of patients receiving unrelated transplants

No interventions assigned to this group

Healthy comparison

A matched sample

No interventions assigned to this group

Parents

Parent/caregiver of study participating donor.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pittsburgh

OTHER

Sponsor Role collaborator

Center for International Blood and Marrow Transplant Research

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Galen Switzer, Ph.D

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Phoenix Children's Hospital

Phoenix, Arizona, United States

Site Status

City of Hope

Duarte, California, United States

Site Status

Loma Linda University

Loma Linda, California, United States

Site Status

Children's Hospital of Los Angeles

Los Angeles, California, United States

Site Status

Rady Children's Hospital San Diego

San Diego, California, United States

Site Status

University of California San Francisco Medical Center

San Francisco, California, United States

Site Status

Children's Hospital Colorado

Aurora, Colorado, United States

Site Status

Yale New Haven Hospital

New Haven, Connecticut, United States

Site Status

Children's National Medical Center

Washington D.C., District of Columbia, United States

Site Status

Niklaus Children's Hospital

Miami, Florida, United States

Site Status

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Site Status

University of Louisville Hospital - James Brown Cancer Center

Louisville, Kentucky, United States

Site Status

Children's Hospital of New Orleans/LSUHSC

New Orleans, Louisiana, United States

Site Status

NIH/NCI

Bethesda, Maryland, United States

Site Status

University of Michigan

Ann Arbor, Michigan, United States

Site Status

Spectrum Health

Grand Rapids, Michigan, United States

Site Status

The Children's Mercy Hospitals and Clinics

Kansas City, Missouri, United States

Site Status

St. Louis Children's Hospital

St Louis, Missouri, United States

Site Status

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Site Status

Westchester Medical Center

New York, New York, United States

Site Status

University of North Carolina Hospitals

Chapel Hill, North Carolina, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

Children's Health (formerly Children's Medical Center Dallas)

Dallas, Texas, United States

Site Status

Methodist Healthcare System of San Antonio/Texas Transplant Institute

San Antonio, Texas, United States

Site Status

University of Utah Blood and Marrow Transplant Program - Pediatrics

Salt Lake City, Utah, United States

Site Status

Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Site Status

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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17-SIBS

Identifier Type: -

Identifier Source: org_study_id

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