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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Quality of Life

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 5 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sibling pediatric donors<br>Donors who are donating to a sibling | |
| Sibling recipients and caregivers<br>Recipients who are receiving a transplant from a sibling | |
| Non-donor sibling<br>From the donor-recipient families | |
| Non-donor siblings<br>Of patients receiving unrelated transplants | |
| Healthy comparison<br>A matched sample | |
| Parents<br>Parent/caregiver of study participating donor. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1 year post-donation | To identify and examine donor HRQoL trajectories from pre- through 1 year post-donation. | 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. | 1 year |