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Active, not recruiting No phase listed Observational

Pediatric cGVHD Symptom Scale

ClinicalTrials.gov ID: NCT04044365

Public ClinicalTrials.gov record NCT04044365. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 9, 2026, 2:01 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

Development and Psychometric Testing of a Pediatric Chronic Graft- Versus-Host Disease (GVHD) Symptom Scale (PCSS)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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. ...

Study identification

NCT ID
NCT04044365
Recruitment status
Active, not recruiting
Study type
Observational
Phase
Not listed
Enrollment
139 participants

Conditions and interventions

Interventions

Not listed

Eligibility (public fields only)

Age range
5 Years to 99 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 1, 2019
Primary completion
Dec 30, 2026
Completion
Dec 30, 2026
Last update posted
Aug 9, 2026

2019 – 2026

United States locations

U.S. sites
15
U.S. states
13
U.S. cities
14
Facility City State ZIP Site status
Phoenix Children's Hospital Phoenix Arizona 85016
City of Hope Duarte California 91010
Children's Hospital Colorado (CHCO) Aurora Colorado 80045
Children s National Medical Center (CNMC) Washington D.C. District of Columbia 20010
Children's Healthcare of Atlanta - Egleston Hospital Atlanta Georgia 30322
Lurie Children's Hospital of Chicago Chicago Illinois 60611
Johns Hopkins Hospital (JHH) Baltimore Maryland 21287
National Institutes of Health Clinical Center Bethesda Maryland 20892
University of Minnesota Minneapolis Minnesota 55455
University of Pittsburgh - Children's Hospital of Pittsburgh Pittsburgh Pennsylvania 15224
St. Jude Children s Research Hospital Memphis Tennessee 38105
Texas Children's Hospital (TCH)-Baylor Houston Texas 77030
The University of Texas MD Anderson Cancer Institute Houston Texas 77030
Fred Hutchinson Cancer Center (FHCC) Seattle Washington 98109
Children's Wisconsin Milwaukee Wisconsin 53226

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04044365, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 9, 2026 · Synced Sep 9, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT04044365 live on ClinicalTrials.gov.

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