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Development and Validation of a Symptoms Scale for Children With Chronic Graft-Versus-Host Disease


N/A
5 Years
18 Years
Open (Enrolling)
Both
Graft vs Host Disease

Thank you

Trial Information

Development and Validation of a Symptoms Scale for Children With Chronic Graft-Versus-Host Disease


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


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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

To develop a Pediatric Chronic GVHD Symptoms Scale (PCSS) that reliably measures the disease specific burden of chronic GVHD in children

Outcome Time Frame:

One Day Interview will be performed

Safety Issue:

No

Principal Investigator

David A Jacobsohn, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ann & Robert H Lurie Children's Hospital of Chicago

Authority:

United States: Institutional Review Board

Study ID:

SCT 0208B

NCT ID:

NCT00632658

Start Date:

January 2008

Completion Date:

July 2010

Related Keywords:

  • Graft Vs Host Disease
  • cGVHD
  • Graft vs Host Disease

Name

Location
Childrens Memorial Hospital Chicago, Illinois  60614