Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : Not yet recruiting
First Posted : August 5, 2019
Last Update Posted : August 13, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

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.


Condition or disease
Graft vs Host Disease

  Show Detailed Description

Layout table for study information
Study Type : Observational
Estimated Enrollment : 360 participants
Observational Model: Cohort
Time Perspective: Prospective
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


Group/Cohort
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



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   5 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children of 5 to 17 years of age and their parent/guardian, who have undergone prior allogeneic stem cell transplant
Criteria
  • INCLUSION CRITERIA:

Pediatric Subject Inclusion Criteria:

  • Children aged 5 to 17 years old, who have undergone prior allogeneic stem cell transplant
  • Clinical diagnosis of cGVHD
  • Currently receiving systemic treatment for cGVHD (including phototherapies), or has had systemic therapy for cGVHD tapered to discontinuation within the past 3 months
  • No evidence of malignant disease relapse including molecular relapse and minimal residual disease. Patients with mixed chimerism are eligible to participate
  • Parent or guardian ability and willingness to sign a written informed consent document
  • Subjects must be able to comprehend and speak the English language
  • Subjects may participate 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.

  • Parent or Guardian Proxy Inclusion Criteria
  • Parent or guardian of participating subject
  • Must be willing and able to provide informed consent. Parent or guardian (proxy) must be able to comprehend and speak the English language

EXCLUSOIN CRITERIA:

  • Patients who completed systemic treatment more than 3 months prior to enrollment or are receiving topical therapy only.
  • Patients may be excluded from this study if in the judgment of the Principal or Associate Investigator, the subject is too ill, or subject s cognitive ability would compromise their ability to participate in study related procedures.

Information from the National Library of Medicine

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


Contacts
Layout table for location contacts
Contact: Lori Wiener, Ph.D. (240) 760-6419 lori.wiener@nih.gov

Locations
Layout table for location information
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    dajacobs@childrensnational.org   
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    kpowers@luriechildrens.org   
United States, Maryland
Johns Hopkins Medical Center Not yet recruiting
Baltimore, Maryland, United States, 21287
Contact: Kenneth Cook, M.D.    410-955-8751    kcooke5@jhmi.edu   
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    macmi002@umn.edu   
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    nemeceke@ohsu.edu   
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    pcarpent@fredhutch.org   
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Lori Wiener, Ph.D. National Cancer Institute (NCI)

Additional Information:
Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT04044365     History of Changes
Other Study ID Numbers: 190131
19-C-0131
First Posted: August 5, 2019    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: July 31, 2019

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Hematopoietic Stem Cell Transplantation (HSCT)
Allogeneic Stem Cell Transplant
Phototherapies
Graft Vs Host Disease

Additional relevant MeSH terms:
Layout table for MeSH terms
Graft vs Host Disease
Immune System Diseases