Identifying Predictors of Poor Health-Related Quality-of-Life Among Pediatric Hematopoietic Stem Cell Donors
- Conditions
- Quality of Life
- Registration Number
- NCT03718546
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 754
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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
-
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
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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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HRQoL (Health Related Quality of Life) 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.
- Secondary Outcome Measures
Name Time Method 1 year post-donation 1 year To identify and examine donor HRQoL trajectories from pre- through 1 year post-donation.
Donor characteristics 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.
Trial Locations
- Locations (31)
Children's Hospital of Philadelphia
๐บ๐ธPhiladelphia, Pennsylvania, United States
Vanderbilt University Medical Center
๐บ๐ธNashville, Tennessee, United States
Children's Health (formerly Children's Medical Center Dallas)
๐บ๐ธDallas, Texas, United States
University of Utah Blood and Marrow Transplant Program - Pediatrics
๐บ๐ธSalt Lake City, Utah, United States
University of Alabama at Birmingham
๐บ๐ธBirmingham, Alabama, United States
Loma Linda University
๐บ๐ธLoma Linda, California, United States
Phoenix Children's Hospital
๐บ๐ธPhoenix, Arizona, United States
City of Hope
๐บ๐ธDuarte, California, United States
University of California San Francisco Medical Center
๐บ๐ธSan Francisco, California, United States
Spectrum Health
๐บ๐ธGrand Rapids, Michigan, United States
Children's Hospital of Los Angeles
๐บ๐ธLos Angeles, California, United States
Methodist Healthcare System of San Antonio/Texas Transplant Institute
๐บ๐ธSan Antonio, Texas, United States
Children's Hospital of New Orleans/LSUHSC
๐บ๐ธNew Orleans, Louisiana, United States
NIH/NCI
๐บ๐ธBethesda, Maryland, United States
University of Louisville Hospital - James Brown Cancer Center
๐บ๐ธLouisville, Kentucky, United States
Medical University of South Carolina
๐บ๐ธCharleston, South Carolina, United States
University of North Carolina Hospitals
๐บ๐ธChapel Hill, North Carolina, United States
Westchester Medical Center
๐บ๐ธNew York, New York, United States
Fred Hutchinson Cancer Research Center
๐บ๐ธSeattle, Washington, United States
Niklaus Children's Hospital
๐บ๐ธMiami, Florida, United States
Rady Children's Hospital San Diego
๐บ๐ธSan Diego, California, United States
Duke University Medical Center
๐บ๐ธDurham, North Carolina, United States
University of Michigan
๐บ๐ธAnn Arbor, Michigan, United States
Children's Hospital Colorado
๐บ๐ธAurora, Colorado, United States
Yale New Haven Hospital
๐บ๐ธNew Haven, Connecticut, United States
St. Louis Children's Hospital
๐บ๐ธSaint Louis, Missouri, United States
Children's Hospital of Wisconsin
๐บ๐ธMilwaukee, Wisconsin, United States
Memorial Sloan-Kettering Cancer Center
๐บ๐ธNew York, New York, United States
Children's National Medical Center
๐บ๐ธWashington, District of Columbia, United States
Children's Healthcare of Atlanta
๐บ๐ธAtlanta, Georgia, United States
The Children's Mercy Hospitals and Clinics
๐บ๐ธKansas City, Missouri, United States