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

NCT03718546 | Completed

• 1 other identifier: 17-SIBS
• Study Type: observational
• Target: 754
• Locations: 1 country
• Sites: 31

Brief Summary

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

Quality of Life

Outcome Measures

Primary Outcomes (1)

• HRQoL (Health Related Quality of Life)

  To longitudinally and quantitatively describe the HRQoL of a diverse nation-wide cohort of sibling pediatric Hematopoietic Stem Cell (HSC) donors (Peripheral Blood Stem Cell or Bone Marrow) 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

Secondary Outcomes (2)

• 1 year post-donation

  1 year

• Donor characteristics

  1 year

Study Arms (6)

Sibling pediatric donors

Donors who are donating to a sibling

Sibling recipients and caregivers

Recipients who are receiving a transplant from a sibling

Non-donor sibling

From the donor-recipient families

Non-donor siblings

Of patients receiving unrelated transplants

Healthy comparison

A matched sample

Parents

Parent/caregiver of study participating donor.

Eligibility Criteria

• Age: 5 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric donors, their recipients and caregivers, non-donor siblings from the donor-recipient families, and non-donor siblings of patients receiving unrelated transplants.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Center for International Blood and Marrow Transplant Research: lead
• University of Pittsburgh: collaborator

Study Sites (31)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

City of Hope

Duarte, California, 91010, United States

Location

Loma Linda University

Loma Linda, California, 92354, United States

Location

Children's Hospital of Los Angeles

Los Angeles, California, 90027, United States

Location

Rady Children's Hospital San Diego

San Diego, California, 92123, United States

Location

University of California San Francisco Medical Center

San Francisco, California, 94143, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20910, United States

Location

Niklaus Children's Hospital

Miami, Florida, 33155, United States

Location

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

University of Louisville Hospital - James Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

Children's Hospital of New Orleans/LSUHSC

New Orleans, Louisiana, 70118, United States

Location

NIH/NCI

Bethesda, Maryland, 20892, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Spectrum Health

Grand Rapids, Michigan, 49503, United States

Location

The Children's Mercy Hospitals and Clinics

Kansas City, Missouri, 64108, United States

Location

St. Louis Children's Hospital

St Louis, Missouri, 63110, United States

Location

Memorial Sloan-Kettering Cancer Center

New York, New York, 10065, United States

Location

Westchester Medical Center

New York, New York, 10595, United States

Location

University of North Carolina Hospitals

Chapel Hill, North Carolina, 27599, United States

Location

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

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

Dallas, Texas, 75235, United States

Location

Methodist Healthcare System of San Antonio/Texas Transplant Institute

San Antonio, Texas, 78229, United States

Location

University of Utah Blood and Marrow Transplant Program - Pediatrics

Salt Lake City, Utah, 84112, United States

Location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Study Officials

• Galen Switzer, Ph.D

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2018
• First Posted: October 24, 2018
• Study Start: April 3, 2019
• Primary Completion: October 8, 2024
• Study Completion: October 8, 2024
• Last Updated: March 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (31)