Actively Recruiting

Age: 5Years - 99Years
All Genders
Healthy Volunteers
NCT04044365

Pediatric cGVHD Symptom Scale

Led by National Cancer Institute (NCI) · Updated on 2026-04-22

420

Participants Needed

17

Research Sites

378 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Background: Some children/adolescents who have had a stem cell transplant live with chronic graft-versus-host-disease (cGVHD). cGVHD is a side effect of the transplant that can cause multiple bothersome symptoms and negatively affect a child/adolescent squality of daily life. The questionnaires that measure thesymptoms caused by cGVHD are designed for adults. Children/adolescents may not describe their symptoms in the same way. The goal of this research is to improve the way we measure how bothersome these symptoms are for children/adolescents living with cGVHD. Objective: To develop a questionnaire (The Pediatric cGHVD Symptom Scale) for children/adolescents living with cGVHD to identify the symptoms they are experiencing and describe how bothersome those symptoms are to them. An additional goal is to design a parent/guardian companion questionnaire that can be used to capture the symptom experiences of very young children who may not be able to complete a questionnaire. Eligibility: Children/adolescents ages 5-17 who are receiving treatment for cGVHD after a stem cell transplant, and their parent/guardian.. Design: This study consists of 2 projects. Children/adolescents with cGVHD and their parent/guardianparticipants will be grouped by the child/adolescent s age: 5-7, 8-12, and 13-17. In project 1, participants will complete an age-appropriate questionnaire about cGVHD symptoms. The questionnaire will ask about the child/adolescent s physical functioning and emotional well-being. The parent/guardian will out fill out a companion questionnaire online. The child/adolescent will then review their completed questionnaire during an interview with a researcher and will be asked whether the questions about their symptoms were difficult to understand. The parent/guardian and child/adolescent will then be interviewed together to further explore their responses to the questionnaires. Interviews will be done in person, by phone, and online. . Based on what is learned through these interviews, the wording of the questionnaire will be improved for better comprehension and ease of response. In project 2, participants will complete this revised questionnairefor their age group along with some other questionnaires that ask about quality of life. Both the child/adolescent and parent/guardian will fill out the questionnaires online at three separate time points. In both projects, children/adolescents with cGVHD and their parent/guardian participants will be grouped by the child/adolescent s age: 5-7, 8-12, and 13-17. ...

CONDITIONS

Official Title

Pediatric cGVHD Symptom Scale

Who Can Participate

Age: 5Years - 99Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Children aged 5 to 17 years old (Project 1) or 8 to 17 years old (Project 2)
  • Clinical diagnosis of chronic graft-versus-host disease (cGVHD) after allogeneic stem cell transplant
  • Currently receiving systemic treatment for cGVHD or had systemic therapy tapered off within the past 12 months
  • No evidence of malignant disease relapse, including molecular relapse and minimal residual disease
  • Eligible caregiver proxy willing to participate in the study
  • Parent or guardian able and willing to sign informed consent
  • Ability to comprehend and speak English
  • Adult caregivers (18 years or older) of eligible children who can provide informed consent and speak English
Not Eligible

You will not qualify if you...

  • Children judged by investigators to be too ill to participate
  • Children whose cognitive ability would interfere with study procedures

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 17 locations

1

Phoenix Children's Hospital

Phoenix, Arizona, United States, 85016

Actively Recruiting

2

City of Hope

Duarte, California, United States, 91010

Not Yet Recruiting

3

Children's Hospital Colorado (CHCO)

Aurora, Colorado, United States, 80045

Active, Not Recruiting

4

Children s National Medical Center (CNMC)

Washington D.C., District of Columbia, United States, 20010

Active, Not Recruiting

5

Children's Healthcare of Atlanta - Egleston Hospital

Atlanta, Georgia, United States, 30322

Active, Not Recruiting

6

Lurie Children's Hospital of Chicago

Chicago, Illinois, United States, 60611

Active, Not Recruiting

7

Johns Hopkins Hospital (JHH)

Baltimore, Maryland, United States, 21287

Active, Not Recruiting

8

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Active, Not Recruiting

9

University of Minnesota

Minneapolis, Minnesota, United States, 55455

Active, Not Recruiting

10

University of Pittsburgh - Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, United States, 15224

Actively Recruiting

11

St. Jude Children s Research Hospital

Memphis, Tennessee, United States, 38105

Active, Not Recruiting

12

Texas Children's Hospital (TCH)-Baylor

Houston, Texas, United States, 77030

Active, Not Recruiting

13

The University of Texas MD Anderson Cancer Institute

Houston, Texas, United States, 77030

Active, Not Recruiting

14

Fred Hutchinson Cancer Center (FHCC)

Seattle, Washington, United States, 98109

Active, Not Recruiting

15

Children's Wisconsin

Milwaukee, Wisconsin, United States, 53226

Actively Recruiting

16

Hospital for Sick Children (SickKids)

Toronto, Canada

Active, Not Recruiting

17

Children's & Women's Health Centre of British Columbia (CWHC of BC)

Vancouver BC, Canada

Active, Not Recruiting

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Research Team

L

Lori S Wiener, Ph.D.

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

6

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