Experience of Having Chronic Graft-Versus-Host Disease

NCT00353106 | Completed

• 1 other identifier: 2005-0727
• Study Type: observational
• Target: 187
• Locations: 1 country
• Sites: 2

Brief Summary

Primary Objectives:

1. 1.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.
2. 2.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.
3. 3.To develop a detailed description of the experience of having cGVHD.
4. 4.To develop a detailed description of the symptom experience of cGVHD to allow for development of a symptoms instrument for cGVHD.
5. 5.To assess the understanding of questions to measure the symptoms of cGVHD in patients with various levels of education.
6. 6.To develop a detailed description of caring for a patient with cGVHD.

Conditions

Graft-Versus-Host Disease

Keywords

Graft-Versus-Host Disease; GVHD; Chronic Graft-Versus-Host Disease; cGVHD; Interview; Questionnaire; Survey; Caregiver

Outcome Measures

Primary Outcomes (1)

• Phase 1: Open-Ended Interview/Questions designed to elicit specific descriptions of experience of having cGVHD or caring for a patient with cGVHD

  At time of treatment, duration approximately 30 minutes

Study Arms (3)

Patients

Patients with chronic GVHD

Behavioral: Interview; Behavioral: Questionnaire

Content Expert Panel

Content expert panel with 5 years experience caring for patients with cGVHD.

Behavioral: Questionnaire

Caregivers

Caregivers of patients with cGVHD

Behavioral: Interview; Behavioral: Questionnaire

Interventions

Interview BEHAVIORAL

30-minute interviews of participating patients and their caregiver(s).

Caregivers; Patients

Questionnaire BEHAVIORAL

Questionnaires that will take approximately 5 minutes to complete.

Also known as: Survey

Caregivers; Content Expert Panel; Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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 cGHVD (PROFESSIONAL EXPERT ONLY)
• At least one publication in the last 5 years dealing with cGVHD (PHYSICIAN PROFESSIONAL EXPERT ONLY)
• Consent to participate

You may not qualify if:

• 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)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (2)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• UT MD Anderson Cancer Center

MeSH Terms

Conditions

Graft vs Host Disease; Bronchiolitis Obliterans Syndrome

Interventions

Interviews as Topic; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Immune System Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Loretta A. Williams, DSN

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2006
• First Posted: July 17, 2006
• Study Start: February 1, 2006
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: July 30, 2012

Record last verified: 2012-07

Locations

US (2)