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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 : July 12, 2022
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 Show detailed description

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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)
Actual Study Start Date : October 2, 2019
Estimated Primary Completion Date : April 1, 2024
Estimated Study Completion Date : June 1, 2024


Group/Cohort
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=20 child/parent pairs
3/Project 1 Child/caregiver-proxy
Children age 13-17 with cGVHD and their caregiver, n=20 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



Primary Outcome Measures :
  1. Feasability [ 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

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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 caregiver, 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 12 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
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Contact: Lori Wiener, Ph.D. (240) 760-6419 lori.wiener@nih.gov

Locations
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United States, Colorado
Children's Hospital Colorado (CHCO) Recruiting
Aurora, Colorado, United States, 80045
Contact: Amy Keating, M.D.    720-777-0166    Amy.Keating@UCDenver.edu   
United States, District of Columbia
Children s National Medical Center (CNMC) Recruiting
Washington, District of Columbia, United States, 20010
Contact: Alexa Yarish    202-476-6250    ajyarish@childrensnational.org   
United States, Georgia
Children's Healthcare of Atlanta - Egleston Hospital Recruiting
Atlanta, Georgia, United States, 30322
Contact: Katherine K. Garrett, MPH, ELS    404-785-3644    Katherine.Garrett@choa.org   
United States, Illinois
Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact: Anne Lakes    312-227-1876    alakes@luriechildrens.org   
United States, Maryland
Johns Hopkins Hospital (JHH) Recruiting
Baltimore, Maryland, United States, 21287
Contact: Kenneth R. Cook, M.D.    410-955-8751    kcooke5@jhmi.edu   
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    macmi002@umn.edu   
United States, Ohio
Cincinnati Children's Hospital Medical Center (CCHMC) Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Pooja Khandelwal, M.D.    513-803-9063    pooja.khandelwal@cchmc.org   
United States, Tennessee
St. Jude Children s Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Marian Shaw    901-595-8149    Marian.Shaw@stjude.org   
United States, Texas
Texas Children's Hospital - Baylor College of Medicine Not yet recruiting
Houston, Texas, United States, 77030
Contact: Josalind Randall    832-824-6835    jxrandal@texaschildrens.org   
The University of Texas MD Anderson Cancer Institute Recruiting
Houston, Texas, United States, 77030
Contact: Alba Rubi Banegas    713-792-9857    aarubi@mdanderson.org   
United States, Washington
Fred Hutchinson Cancer Center (FHCC) Recruiting
Seattle, Washington, United States, 98104
Contact: Sheri Ballard    206-667-5160    sballard@fredhutch.org   
Canada
Children's & Women's Health Centre of British Columbia (CWHC of BC) Recruiting
Vancouver BC, Canada
Contact: Colleen Fitzgerald    (604) 875-2345    cfitzgerald@cw.bc.ca   
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Lori Wiener, Ph.D. National Cancer Institute (NCI)
Additional Information:
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Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT04044365    
Other Study ID Numbers: 190131
19-C-0131
First Posted: August 5, 2019    Key Record Dates
Last Update Posted: July 12, 2022
Last Verified: July 7, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: .All IPD recorded in the medical record will be shared with intramural investigators upon request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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
Natural History
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases