Development and Validation of a Symptom Scale for Children With Chronic Graft-versus-Host Disease
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Official title
Development and Validation of a Symptom Scale for Children With Chronic Graft-Versus-Host Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Background: * Chronic graft-vs-host disease (GVHD) is an important cause of morbidity and mortality in patients undergoing allogeneic bone marrow transplantation. The symptoms of chronic GVHD are similar to those of other autoimmune diseases, and treatment for the pain often involves steroid use that can cause severe side effects over the long term. * At present, there is no research instrument that measures symptoms in children with chronic GVHD. Treatment practitioners may use one of several pediatric quality of life questionnaires, but because none of these is specific for chronic GVHD each instrument has potential gaps in its ability to assess the full spectrum of problems experienced by children with chronic GVHD. Researchers are interested in developing a better understanding of the disease burden experienced by children and adolescents with chronic GVHD. Objectives: \- To develop a Pediatric Chronic GVHD Symptom Scale (PCSS) that reliably measures the disease-specific burden of chronic GVHD in children. Eligibility: \- Children and adolescents 5 to 18 years of age who have undergone prior allogeneic stem cell transplant and have been diagnosed with chronic GVHD that requires treatment. Design: * There are two phases to the study; participants will enroll in phase I (question generation) at this time. * Researchers will interview participants and ask open-ended questions (requiring more than a one- or two-word response) about symptoms that adults with chronic GVHD have found problematic. * Both parents and children will participate in the interviews, which will be audio-recorded. Depending on the child or adolescent s age, the interviews may be conducted together with the parents or separately. * No treatment will be given as part of this study.
Study identification
- NCT ID
- NCT01036958
- Recruitment status
- Completed
- Study type
- Observational
- Phase
- Not listed
- Enrollment
- 3 participants
Conditions and interventions
Conditions
Interventions
Not listed
Eligibility (public fields only)
- Age range
- 5 Years to 18 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 25, 2009 (Type not available)
- Primary completion
- Not listed
- Completion
- Feb 6, 2018 (Type not available)
- Last update posted
- Sep 26, 2018
2009 – 2018
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland | 20892 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01036958, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 26, 2018 · Synced Nov 15, 2026
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