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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03718546
Recruitment Status : Not yet recruiting
First Posted : October 24, 2018
Last Update Posted : January 30, 2019
Sponsor:
Collaborator:
University of Pittsburgh
Information provided by (Responsible Party):
Center for International Blood and Marrow Transplant Research

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.

Condition or disease
Quality of Life

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,1,7,8,9 (c) evidence that ~20% of pediatric HSC donors experience clinically important HRQoL deficits,7 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.

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Study Type : Observational
Estimated Enrollment : 1876 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identifying Predictors of Poor Health-Related Quality-of-Life Among Pediatric Hematopoietic Stem Cell Donors
Estimated Study Start Date : February 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2022

Group/Cohort
Sibling pediatric donors
Sibling recipients and caregivers
Non-donor sibling
From the donor-recipient families
Non-donor siblings
Of patients receiving unrelated transplants
Healthy comparison
A matched sample



Primary Outcome Measures :
  1. HRQoL [ Time Frame: 1 year ]
    To longitudinally and quantitatively describe the HRQoL of a diverse nation-wide cohort of sibling pediatric HSC donors 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 :
  1. 1 year post-donation [ Time Frame: 1 year ]
    To identify and examine donor HRQoL trajectories from pre- through 1 year post-donation.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
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.
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
  • No access to a telephone

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03718546


Contacts
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Contact: Alisha Mussetter, B.S 7634064863 amussett@nmdp.org
Contact: Briana Person 7634064412 bperson@nmdp.org

Sponsors and Collaborators
Center for International Blood and Marrow Transplant Research
University of Pittsburgh
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Responsible Party: Center for International Blood and Marrow Transplant Research
ClinicalTrials.gov Identifier: NCT03718546    
Other Study ID Numbers: 17-SIBS
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: January 30, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No