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

March 13, 2025 updated by: Center for International Blood and Marrow Transplant Research
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
754

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Phoenix Children's Hospital
    • California
      • Duarte, California, United States, 91010
        • City of Hope
      • Loma Linda, California, United States, 92354
        • Loma Linda University
      • Los Angeles, California, United States, 90027
        • Children's Hospital of Los Angeles
      • San Diego, California, United States, 92123
        • Rady Children's Hospital San Diego
      • San Francisco, California, United States, 94143
        • University Of California San Francisco Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital Colorado
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Yale New Haven Hospital
    • District of Columbia
      • Washington, District of Columbia, United States, 20910
        • Children's National Medical Center
    • Florida
      • Miami, Florida, United States, 33155
        • Niklaus Children's Hospital
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Children's Healthcare of Atlanta
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville Hospital - James Brown Cancer Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70118
        • Children's Hospital of New Orleans/LSUHSC
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • NIH/NCI
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • The Children's Mercy Hospitals and Clinics
      • Saint Louis, Missouri, United States, 63110
        • St. Louis Children's Hospital
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan-Kettering Cancer Center
      • New York, New York, United States, 10595
        • Westchester Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina Hospitals
      • Durham, North Carolina, United States, 27705
        • Duke University Medical Center
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Children's Hospital of Philadelphia
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Vanderbilt University Medical Center
    • Texas
      • Dallas, Texas, United States, 75235
        • Children's Health (formerly Children's Medical Center Dallas)
      • San Antonio, Texas, United States, 78229
        • Methodist Healthcare System of San Antonio/Texas Transplant Institute
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • University of Utah Blood and Marrow Transplant Program - Pediatrics
    • Washington
      • Seattle, Washington, United States, 98109
        • Fred Hutchinson Cancer Research Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Children's Hospital of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

5 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
HRQoL (Health Related Quality of Life)
Time Frame: 1 year
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
1 year post-donation
Time Frame: 1 year
To identify and examine donor HRQoL trajectories from pre- through 1 year post-donation.
1 year
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Center for International Blood and Marrow Transplant Research

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Pittsburgh

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Galen Switzer, Ph.D, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 3, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 8, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 8, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 23, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 23, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 24, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17-SIBS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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