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Development and Validation of a Symptom Scale for Children With Chronic Graft-versus-Host Disease

NCT01036958 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3

Last updated 2018-09-26

No results posted yet for this study

Summary

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.

Conditions

  • Chronic Graft-Versus-Host-Disease

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Lori Wiener, Ph.D. · National Cancer Institute (NCI)

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-11-25
Completion
2018-02-06

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01036958 on ClinicalTrials.gov