Pediatric cGVHD Symptom Scale
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|ClinicalTrials.gov Identifier: NCT04044365|
Recruitment Status : Not yet recruiting
First Posted : August 5, 2019
Last Update Posted : August 13, 2019
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.
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.
Children/adolescents ages 5-17 who are receiving treatment for cGVHD after a stem cell transplant, and their parent/guardian..
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.
|Condition or disease|
|Graft vs Host Disease|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||360 participants|
|Official Title:||Development and Psychometric Testing of a Pediatric Chronic Graft-Versus-Host Disease (GVHD) Symptom Scale (PCSS)|
|Estimated Study Start Date :||September 2, 2019|
|Estimated Primary Completion Date :||June 1, 2022|
|Estimated Study Completion Date :||June 1, 2022|
1/Project 1 Child/parent-proxy
Children age 5-7 with cGVHD and their parent/guardian, n=20 child/parent dyads
2/Project 1 Child/parent-proxy
Children age 8-12 with cGVHD and their parent/guardian, n=20 child/parent pairs
3/Project 1 Child/parent-proxy
Children age 13-17 with cGVHD and their parent/guardian, n=20 child/parent pairs
4/Project 2 Child/parent-proxy
Children age 5-7 with cGVHD and their parent/guardian, n=40 child/parent pairs
5/Project 2 Child/parent-proxy
Children age 8-12 with cGVHD and their parent/guardian, n=40 child/parent pairs
6/Project 2 Child/parent-proxy
Children age 13-17 with cGVHD and their parent/guardian, n=40 child/parent pairs
- Feasibility [ Time Frame: 3 years ]To develop a psychometrically valid Pediatric cGVHD Symptom Scale (PCSS) and a companion parent-proxy measure as counterparts to the Lee cGVHD Symptom Scale.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04044365
|Contact: Lori Wiener, Ph.D.||(240) firstname.lastname@example.org|
|United States, Colorado|
|University of Colorado School of Medicine||Not yet recruiting|
|Denver, Colorado, United States, 80045|
|Contact: Amy Keating, MD 720-777-0166 Amy.Keating@UCDenver.edu|
|United States, District of Columbia|
|Children s National Medical Center||Not yet recruiting|
|Washington, District of Columbia, United States, 20010|
|Contact: David Jacobsohn, M.D. 202-476-6258 email@example.com|
|United States, Illinois|
|Lurie Children's Hospital of Chicago||Not yet recruiting|
|Chicago, Illinois, United States, 60611|
|Contact: Kimberly Powers, N.P. 312-227-1876 firstname.lastname@example.org|
|United States, Maryland|
|Johns Hopkins Medical Center||Not yet recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Kenneth Cook, M.D. 410-955-8751 email@example.com|
|National Institutes of Health Clinical Center||Not yet recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact National Cancer Institute Referral Office 888-624-1937|
|United States, Minnesota|
|University of Minnesota||Not yet recruiting|
|Minneapolis, Minnesota, United States, 55455|
|Contact: Margaret MacMillan, M.D. 612-626-2961 firstname.lastname@example.org|
|United States, Oregon|
|Doernbecher Children s Hospital, Oregon Health & Science University||Not yet recruiting|
|Portland, Oregon, United States, 97239|
|Contact: Eneida Nemecek, M.D. 503-494-0829 email@example.com|
|United States, Tennessee|
|St. Jude Children s Research Hospital||Not yet recruiting|
|Memphis, Tennessee, United States, 38105|
|Contact: Deena Levine, M.D. 901-595-8149 Deena.Levine@STJUDE.org|
|United States, Washington|
|Fred Hutchinson Cancer Research, Seattle Children s Hospital||Not yet recruiting|
|Seattle, Washington, United States, 98109|
|Contact: Paul Carpenter, M.D. 206-667-5160 firstname.lastname@example.org|
|Principal Investigator:||Lori Wiener, Ph.D.||National Cancer Institute (NCI)|