Development and Validation of a Symptom Scale for Children With Chronic Graft-Versus-Host Disease (cGVHD)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by Ann & Robert H Lurie Children's Hospital of Chicago.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
University of Minnesota - Clinical and Translational Science Institute
Dana-Farber Cancer Institute
Fred Hutchinson Cancer Research Center
Information provided by:
Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier:
NCT00632658
First received: March 4, 2008
Last updated: January 27, 2009
Last verified: January 2009
  Purpose

Chronic Graft-versus-Host Disease (cGVHD) is an important cause of morbidity and mortality in patients undergoing allogeneic bone marrow transplantation. cGVHD usually occurs after 100 days following transplantation and develops in 20-60% of transplant recipients. The incidence of cGVHD varies depending on the age of the marrow recipient, the use of sibling or unrealted donor bone marrow, teh use of unmanipulated T cell-depleted bone marrow, and perhaps other factors. Clinically, cGVHD is characterized by multi-system disease, which frequently mimics the clinical features of autoimmune diseases. The manifestations include skin changes (lichenoid and sclerodermatous changes, changes in pigmentation, loss of accessory structures such as hair, dystrophic nails, and rash), joint contractures, severe cramping, hepatic dysfunctions, sicca syndrome, obstructive lung disease, esophageal dysmotility, weight loss, polyserositis, immunodeficiency, and autoantibodies including anti-nuclear antibody, anti-erythrocyte antibodies, and anti-platelet antibodies.


Condition
Graft vs Host Disease

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Development and Validation of a Symptoms Scale for Children With Chronic Graft-Versus-Host Disease

Resource links provided by NLM:


Further study details as provided by Ann & Robert H Lurie Children's Hospital of Chicago:

Primary Outcome Measures:
  • To develop a Pediatric Chronic GVHD Symptoms Scale (PCSS) that reliably measures the disease specific burden of chronic GVHD in children [ Time Frame: One Day Interview will be performed ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: January 2008
Estimated Study Completion Date: July 2010
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
Patients with cGVHD
Pediatric Patients with cGVHD will be asked to participate in an interview with their Physician. The interview will ask the pediatric patients questions about their cGVHD. The interview will be audio-recorded.

Detailed Description:

A large number of children with cGVHD have to deal with many years of a disfiguring and painful chronic illness with the side effects of long term steroid use. The number of stem cell transplants done in children is only growing given that we are now transplanting patients with a variety of nonmalignant disorders and given the use of alternative donor sources. The broad categories of limited and extensive cGVHD are recognized by clinicans, but are not particularly useful in clinical practice. Since cGVHD may involve almost every organ system adn since cGVHD constitutes a waxing and waning nature, cGVHD makes clinical management very difficult and complicated. Currently, there is a symptoms scale used in the adult population for measuring symptom burden for adults with cGVHD. This scale is called the "Lee Symptoms Scale". The purpose of this project is to develop a scale that is similar in design to the Lee Scale, but it is specifically designed to measure the burden of cGVHD in the pediatric population

  Eligibility

Ages Eligible for Study:   5 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with cGVHD will be identified by their local physican and asked to participate in this research study. A total of 24 children will be asked to participate in this study. The parents of all of the 24 children will also be asked to participate and give us their feed-back on what it is like to cope with a child with cGVHD.

Criteria

Inclusion Criteria:

  • 5-18 years of age
  • Prior allogeneic Stem Cell Transplant, with any graft source, donor type, and GVHD prophylaxis allowed
  • Clinical diagnosis of cGVHD
  • Need for systemic treatment, defined as any medication or intervention delivered
  • No evidence of primary disease relapse
  • Signed, informed consent, and if applicable, adolescent assent

Exclusion Criteria:

  • Inability to give signed informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00632658

Contacts
Contact: David A Jacobsohn, MD 773-880-3694 djacobsohn@childrensmemorial.org
Contact: Colleen E Schaefer, BS 773-880-3459 cschaefer@childrensmemorial.org

Locations
United States, Illinois
Childrens Memorial Hospital Recruiting
Chicago, Illinois, United States, 60614
Sponsors and Collaborators
Ann & Robert H Lurie Children's Hospital of Chicago
University of Minnesota - Clinical and Translational Science Institute
Dana-Farber Cancer Institute
Fred Hutchinson Cancer Research Center
Investigators
Principal Investigator: David A Jacobsohn, MD Ann & Robert H Lurie Children's Hospital of Chicago
  More Information

No publications provided

Responsible Party: David Jacobsohn, MD, Children's Memorial Hospital
ClinicalTrials.gov Identifier: NCT00632658     History of Changes
Other Study ID Numbers: SCT 0208B
Study First Received: March 4, 2008
Last Updated: January 27, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Ann & Robert H Lurie Children's Hospital of Chicago:
cGVHD

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

ClinicalTrials.gov processed this record on April 16, 2014