Experience of Having Chronic Graft-Versus-Host Disease - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00353106

Purpose

Primary Objectives:

To explore the experience of chronic graft-versus-host disease (cGVHD) following allogeneic blood or marrow transplantation from the perspective of the patient and the patient's primary family caregiver.
To develop and validate an instrument to measure the severity of multiple symptoms and the impact of these symptoms on daily functioning in patients who have cGVHD.

Secondary Objectives:

To develop a detailed description of the experience of having cGVHD.
To develop a detailed description of the symptom experience of cGVHD to allow for development of a symptoms instrument for cGVHD.
To assess the understanding of questions to measure the symptoms of cGVHD in patients with various levels of education.
To develop a detailed description of caring for a patient with cGVHD.

Condition	Intervention
Graft-Versus-Host Disease	Behavioral: Interview Behavioral: Questionnaire

MedlinePlus related topics: Caregivers

U.S. FDA Resources

Study Type:	Observational
Study Design:	Prospective
Official Title:	The Experience of Having Chronic Graft-Versus-Host Disease

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To better understand what it is like for a patient to have chronic GVHD and what it is like for a family member to help care for a patient with chronic GVHD [ Time Frame: 4 Years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	256
Study Start Date:	February 2006
Estimated Primary Completion Date:	February 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Patients with chronic GVHD	Behavioral: Interview 30-minute interviews of participating patients and their caregiver(s). Behavioral: Questionnaire Questionnaires that will take approximately 5 minutes to complete.
2 Content expert panel with 5 years experience caring for patients with cGVHD.	Behavioral: Questionnaire Questionnaires that will take approximately 5 minutes to complete.
3 Caregivers of patients with cGVHD.	Behavioral: Interview 30-minute interviews of participating patients and their caregiver(s). Behavioral: Questionnaire Questionnaires that will take approximately 5 minutes to complete.

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

Study participants with chronic graft-versus-host disease (cGVHD) following allogeneic blood or marrow transplantation, the patient's primary family caregiver, and content expert panel.

Criteria

Inclusion Criteria:

18 years of age or older
Ability to speak and read English
Clinical or histological diagnosis of active cGVHD or at least 3 months post allogeneic BMT without a diagnosis of active GVHD (PATIENT ONLY)
Identification as the single primary family caregiver by a patient with cGVHD (CAREGIVER ONLY)
Physician or nurse with at least 5 years experience caring for patients with cGVHD (PROFESSIONAL EXPERT ONLY)
At least one publication in the last 5 years dealing with cGVHD (PHYSICIAN PROFESSIONAL EXPERT ONLY)
Consent to participate

Exclusion Criteria:

Inability to understand the intent of the study
Medical condition that would preclude participation in an interview lasting 30 minutes (PHASE 1 OF STUDY ONLY)
Diagnosis of active psychosis or severe cognitive impairment
Bone marrow or stem cell donor for patient (CAREGIVER ONLY)
Disease for which BMT was performed not in remission (PATIENT ONLY)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00353106

Contacts

Contact: Loretta A. Williams, DSN

713-745-3470

Locations

United States, New York
Roswell Park Cancer Institute	Recruiting
Buffalo, New York, United States, 14263
United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Loretta A. Williams, DSN

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Loretta A. Williams, DSN

M.D. Anderson Cancer Center

More Information

UT MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Loretta A. Williams, DSN )
Study ID Numbers:	2005-0727
Study First Received:	July 13, 2006
Last Updated:	December 15, 2008
ClinicalTrials.gov Identifier:	NCT00353106
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Graft-Versus-Host Disease
GVHD
Chronic Graft-Versus-Host Disease
cGVHD

Interview
Questionnaire
Survey
Caregiver

Study placed in the following topic categories:

Graft versus host disease
Graft vs Host Disease
Homologous wasting disease

Additional relevant MeSH terms:

Immune System Diseases

ClinicalTrials.gov processed this record on January 14, 2009