Pediatric cGVHD Symptom Scale
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04044365|
Recruitment Status : Recruiting
First Posted : August 5, 2019
Last Update Posted : June 5, 2020
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|
|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)|
|Actual Study Start Date :||October 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|
|Pediatric BMTC Program at the University of Colorado Sch of Medicine||Recruiting|
|Denver, Colorado, United States, 80045|
|United States, District of Columbia|
|Children s National Medical Center||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||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||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: Kenneth Cook, M.D. 410-955-8751 email@example.com|
|National Institutes of Health Clinical Center||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||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||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||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||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)|