Quality of LifeNCT03718546
Identifying Predictors of Poor Health-Related Quality-of-Life Among Pediatric Hematopoietic Stem Cell Donors
An observational study of Quality of Life, run by Center for International Blood and Marrow Transplant Research at 31 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 5 years and olderHealthy volunteers can take part
- Conditions the study is for
- Quality of Life
- How many people
- 754 participants
- Where
- 31 sitesUnited States
- Study dates
- 3 Apr 2019to 8 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
University of Michigan
Ann Arbor, Michigan, 48109
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
Children's Hospital Colorado
Aurora, Colorado, 80045
NIH/NCI
Bethesda, Maryland, 20892
University of Alabama at Birmingham
Birmingham, Alabama, 35233
University of North Carolina Hospitals
Chapel Hill, North Carolina, 27599
Medical University of South Carolina
Charleston, South Carolina, 29425
Children's Health (formerly Children's Medical Center Dallas)
Dallas, Texas, 75235
City of Hope
Duarte, California, 91010
Duke University Medical Center
Durham, North Carolina, 27705
Spectrum Health
Grand Rapids, Michigan, 49503
The Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 64108
Loma Linda University
Loma Linda, California, 92354
Children's Hospital of Los Angeles
Los Angeles, California, 90027
University of Louisville Hospital - James Brown Cancer Center
Louisville, Kentucky, 40202
Niklaus Children's Hospital
Miami, Florida, 33155
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
Yale New Haven Hospital
New Haven, Connecticut, 06510
Children's Hospital of New Orleans/LSUHSC
New Orleans, Louisiana, 70118
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
Westchester Medical Center
New York, New York, 10595
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Phoenix Children's Hospital
Phoenix, Arizona, 85016
University of Utah Blood and Marrow Transplant Program - Pediatrics
Salt Lake City, Utah, 84112
Methodist Healthcare System of San Antonio/Texas Transplant Institute
San Antonio, Texas, 78229
Rady Children's Hospital San Diego
San Diego, California, 92123
University of California San Francisco Medical Center
San Francisco, California, 94143
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109
St. Louis Children's Hospital
St Louis, Missouri, 63110
Children's National Medical Center
Washington D.C., District of Columbia, 20910
About this study
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.
Read the 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.
- Conditions
- Quality of Life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (2)
1 year post-donation
To identify and examine donor HRQoL trajectories from pre- through 1 year post-donation.
Measured: 1 year
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2018
- Study start3 Apr 2019
- Primary completion8 Oct 2024
- Study completion8 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 754 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center for International Blood and Marrow Transplant Research
- Sponsor type
- Research network
- Collaborators
- University of Pittsburgh
- Responsible party
- Sponsor
- Investigators
- Galen Switzer, Ph.D, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03718546
- Sponsor's protocol ID
- 17-SIBS
- Status last verified
- Mar 2025
- First submitted
- 23 Oct 2018
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Predictors of Poor Health-Related Quality-of-Life Among Pediatric Hematopoietic Stem Cell Donors
- ClinicalTrials.gov ID
- NCT03718546
- Acronym / sponsor ID
- 17-SIBS
- Conditions
- Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 754 participants (actual)
- Lead sponsor
- Center for International Blood and Marrow Transplant ResearchResearch network
- Collaborators
- University of Pittsburgh
- Study start
- 3 Apr 2019 (actual)
- Primary completion
- 8 Oct 2024 (actual)
- Study completion
- 8 Oct 2024 (actual)
- First posted
- 24 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- Participants must fall into one of the following categories:
- Be willing and able to provide signed informed consent:
- 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
Key exclusion criteria (5 listed)
- 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
- No access to a telephone
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
1 year post-donation
Time frame: 1 year
Donor characteristics
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Galen Switzer, Ph.D principal investigator
University of Pittsburgh
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life, run by Center for International Blood and Marrow Transplant Research at 31 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HRQoL (Health Related Quality of Life) (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2025.