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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03718546
• Other study ID #: 17-SIBS
• Status: Active, not recruiting
• Start date: April 3, 2019
• Est. completion date: August 31, 2024

Study information

• Verified date: December 2023
• Source: Center for International Blood and Marrow Transplant Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 754
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Quality of Life

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	Children's Healthcare of Atlanta	Atlanta	Georgia
United States	Children's Hospital Colorado	Aurora	Colorado
United States	NIH/NCI	Bethesda	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	University of North Carolina Hospitals	Chapel Hill	North Carolina
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Children's Health (formerly Children's Medical Center Dallas)	Dallas	Texas
United States	City of Hope	Duarte	California
United States	Duke University Medical Center	Durham	North Carolina
United States	Spectrum Health	Grand Rapids	Michigan
United States	The Children's Mercy Hospitals and Clinics	Kansas City	Missouri
United States	Loma Linda University	Loma Linda	California
United States	Children's Hospital of Los Angeles	Los Angeles	California
United States	University of Louisville Hospital - James Brown Cancer Center	Louisville	Kentucky
United States	Niklaus Children's Hospital	Miami	Florida
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Yale New Haven Hospital	New Haven	Connecticut
United States	Children's Hospital of New Orleans/LSUHSC	New Orleans	Louisiana
United States	Memorial Sloan-Kettering Cancer Center	New York	New York
United States	Westchester Medical Center	New York	New York
United States	Children's Hospital of Philadelphia	Philadelphia	Pennsylvania
United States	Phoenix Children's Hospital	Phoenix	Arizona
United States	St. Louis Children's Hospital	Saint Louis	Missouri
United States	University of Utah Blood and Marrow Transplant Program - Pediatrics	Salt Lake City	Utah
United States	Methodist Healthcare System of San Antonio/Texas Transplant Institute	San Antonio	Texas
United States	Rady Children's Hospital San Diego	San Diego	California
United States	University of California San Francisco Medical Center	San Francisco	California
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Center for International Blood and Marrow Transplant Research	University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 year post-donation	To identify and examine donor HRQoL trajectories from pre- through 1 year post-donation.	1 year
Secondary	Donor characteristics	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