Clinical trial NCT03718546: Identifying Predictors of Poor Health-Related Quality-of-Life Among Pediatric Hematopoietic Stem Cell Donors
Official title: Identifying Predictors of Poor Health-Related Quality-of-Life Among Pediatric Hematopoietic Stem Cell Donors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Quality of Life
Lead sponsor: Center for International Blood and Marrow Transplant Research
Sponsor class: NETWORK
Collaborators: name: University of Pittsburgh
First posted: 2018-10-24
Enrollment: 754
Sex: ALL
Minimum age (years): 5
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: HRQoL (Health Related Quality of Life)
timeFrame: 1 year
Secondary outcomes:
measure: 1 year post-donation
timeFrame: 1 year
measure: Donor characteristics
timeFrame: 1 year
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: Duarte
country: United States
facility: City of Hope
state: California
city: Loma Linda
country: United States
facility: Loma Linda University
state: California
city: Los Angeles
country: United States
facility: Children's Hospital of Los Angeles
state: California
city: San Diego
country: United States
facility: Rady Children's Hospital San Diego
state: California
city: San Francisco
country: United States
facility: University of California San Francisco Medical Center
state: California
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Miami
country: United States
facility: Niklaus Children's Hospital
state: Florida
city: Atlanta
country: United States
facility: Children's Healthcare of Atlanta
state: Georgia
city: Louisville
country: United States
facility: University of Louisville Hospital - James Brown Cancer Center
state: Kentucky
city: New Orleans
country: United States
facility: Children's Hospital of New Orleans/LSUHSC
state: Louisiana
city: Bethesda
country: United States
facility: NIH/NCI
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
city: Kansas City
country: United States
facility: The Children's Mercy Hospitals and Clinics
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis Children's Hospital
state: Missouri
city: New York
country: United States
facility: Memorial Sloan-Kettering Cancer Center
state: New York
city: New York
country: United States
facility: Westchester Medical Center
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina Hospitals
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: Children's Health (formerly Children's Medical Center Dallas)
state: Texas
city: San Antonio
country: United States
facility: Methodist Healthcare System of San Antonio/Texas Transplant Institute
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Blood and Marrow Transplant Program - Pediatrics
state: Utah
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Pittsburgh
name: Galen Switzer, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: