Pediatric cGVHD Symptom Scale (NCT04044365)
Development and Psychometric Testing of a Pediatric Chronic Graft- Versus-Host Disease (GVHD) Symptom Scale (PCSS)
🩺 Plain-English Summary (8th-Grade Level)
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. ...
Who can join: Review the eligibility criteria below.
Location: Phoenix Children's Hospital — Phoenix, Arizona
Age range: 5 Years to 99 Years
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (17 Sites)
- Phoenix Children's Hospital — Phoenix, Arizona
- City of Hope — Duarte, California
- Children's Hospital Colorado (CHCO) — Aurora, Colorado
- Children s National Medical Center (CNMC) — Washington D.C., District of Columbia
- Children's Healthcare of Atlanta - Egleston Hospital — Atlanta, Georgia
- Lurie Children's Hospital of Chicago — Chicago, Illinois
- Johns Hopkins Hospital (JHH) — Baltimore, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland
- University of Minnesota — Minneapolis, Minnesota
- University of Pittsburgh - Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania
- St. Jude Children s Research Hospital — Memphis, Tennessee
- Texas Children's Hospital (TCH)-Baylor — Houston, Texas
- The University of Texas MD Anderson Cancer Institute — Houston, Texas
- Fred Hutchinson Cancer Center (FHCC) — Seattle, Washington
- Children's Wisconsin — Milwaukee, Wisconsin
- Hospital for Sick Children (SickKids) — Toronto,
- Children's & Women's Health Centre of British Columbia (CWHC of BC) — Vancouver BC,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Graft vs Host Disease
- Cyclophosphamide, Abatacept, and Tacrolimus for the Prevention of GvHD — New York, New York
- A Randomized Phase II Study to Compare the Potential Long-Lasting Positive Effect of Decidual Stromal Cells to the Best Available Treatment in Graft Versus Host Disease — Toronto, Ontario
- Horizons Chronic Graft-Versus-Host-Disease Study — Miami, Florida
- Chronic GVHD Response Measures Validation — Seattle, Washington
- A Feasibility Study Using CLINIMACS® for Alpha/Beta T-Cell Depletion in Stem Cell Transplant — San Francisco, California
Explore by condition: All Graft vs Host Disease clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.