Pediatric cGVHD Symptom Scale
Development and Psychometric Testing of a Pediatric Chronic Graft- Versus-Host Disease (GVHD) Symptom Scale (PCSS)
2 other identifiers
observational
139
2 countries
16
Brief Summary
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. ...
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Oct 2019
Longer than P75 for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 1, 2019
CompletedFirst Posted
Study publicly available on registry
August 5, 2019
CompletedStudy Start
First participant enrolled
October 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
June 11, 2026
June 9, 2026
7.3 years
August 1, 2019
June 10, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Feasability
To develop a psychometrically valid Pediatric cGVHD Symptom Scale (PCSS) and a companion parent-proxy measure as counterparts to the Lee cGVHD Symptom Scale.
3 years
Study Arms (6)
1/Project 1 Child/caregiver-proxy
Children age 5-7 with cGVHD and their caregiver, n=20 child/parent dyads
2/Project 1 Child/caregiver-proxy
Children age 8-12 with cGVHD and their caregiver, n=35 child/parent pairs
3/Project 1 Child/caregiver-proxy
Children age 13-17 with cGVHD and their caregiver, n=35 child/parent pairs
4/Project 2 Child/caregiver-proxy
Children age 5-7 with cGVHD and their caregiver, n=40 child/parent pairs
5/Project 2 Child/caregiver-proxy
Children age 8-12 with cGVHD and their caregiver, n=40 child/parent pairs
6/Project 2 Child/caregiver-proxy
Children age 13-17 with cGVHD and their caregiver, n=40 child/parent pairs
Eligibility Criteria
Children of 5 to 17 years of age and their caregiver, who have undergone prior allogeneic stem cell transplant
You may qualify if:
- Children aged 5 to 17 years old (Project 1) or children aged 8 to 17 years old (Project 2)
- Clinical diagnosis of cGVHD following allogeneic stem cell transplant
- Currently receiving systemic treatment for GVHD (including phototherapies), or has had systemic therapy for GVHD tapered to discontinuation within the past 12 months
- No evidence of malignant disease relapse including molecular relapse and minimal residual disease. Patients with mixed chimerism are eligible to participate
- Must have an eligible caregiver proxy who is willing to participate in the study.
- Parent or guardian ability and willingness to sign a written informed consent document
- Must be able to comprehend and speak the English language
- Participants may enroll in both Project 1 and Project 2 of the study. Participation in Project 1 is not required in order to be eligible to participate in Project 2.
- Must be willing and able to provide informed consent
- Must be able to comprehend and speak the English language
- EXCLUSOIN CRITERIA:
- Children may be excluded from this study if in the judgment of the Principal or Associate Investigator, the child is too ill, or the child s cognitive ability would compromise their ability to participate in study related procedures.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
Children's Hospital Colorado (CHCO)
Aurora, Colorado, 80045, United States
Children s National Medical Center (CNMC)
Washington D.C., District of Columbia, 20010, United States
Children's Healthcare of Atlanta - Egleston Hospital
Atlanta, Georgia, 30322, United States
Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Johns Hopkins Hospital (JHH)
Baltimore, Maryland, 21287, United States
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
University of Pittsburgh - Children's Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15224, United States
St. Jude Children s Research Hospital
Memphis, Tennessee, 38105, United States
Texas Children's Hospital (TCH)-Baylor
Houston, Texas, 77030, United States
The University of Texas MD Anderson Cancer Institute
Houston, Texas, 77030, United States
Fred Hutchinson Cancer Center (FHCC)
Seattle, Washington, 98109, United States
Children's Wisconsin
Milwaukee, Wisconsin, 53226, United States
Hospital for Sick Children (SickKids)
Toronto, Canada
Children's & Women's Health Centre of British Columbia (CWHC of BC)
Vancouver BC, Canada
Related Publications (1)
Mitchell SA, Hunter R, Fry A, Pavletic SZ, Widemann BC, Wiener L. Development and psychometric testing of a pediatric chronic graft-versus-host disease symptom scale: protocol for a two-phase, mixed methods study. Front Psychol. 2024 Jan 8;14:1243005. doi: 10.3389/fpsyg.2023.1243005. eCollection 2023.
PMID: 38259542DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lori S Wiener, Ph.D.
National Cancer Institute (NCI)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2019
First Posted
August 5, 2019
Study Start
October 2, 2019
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
June 11, 2026
Record last verified: 2026-06-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Clinical data available during the study and indefinitely.
- Access Criteria
- Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.
All IPD recorded in the medical record will be shared with intramural investigators upon request.