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Study Summary
No. 2005-0727:.......Blood And Marrow Transplantation......Loretta A. Williams......Symptom Research
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Study Summary Title
Study Summary
Number:		2005-0727
Study Title:The Experience of Having Chronic Graft-versus-Host Disease
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Physician New Patient Referral
Name:Loretta A. WilliamsPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Symptom ResearchReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-745-3470
Contact us about clinical trials
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General Information
Disease Group:Blood And Marrow TransplantationSupported By:N/A
Phase of Study:N/AReturn
Visit:		No return visits will be required.
Treatment
Agents:		NoneHome Care:No home care is required.
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:		No hospitalization is required.
Description/
Intervention:		The goal of this study is to learn 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.
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Study Objectives / Outcomes
The objective of this study is 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. The primary aim is 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. A secondary aim is to develop a detailed description of the experience of having cGHVD. A secondary aim is to develop a detailed description of the symptom experience of cGHVD to allow development of a symptoms instrument for cGVHD. A secondary aim is to assess the understanding of questions to measure the symptoms of cGVHD in patients with various levels of education. A secondary aim is to develop a detailed description of caring for a patient with cGVHD.
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Study Status Information
Study Activation / Registration Date:02/16/2006
IRB Review and Approval Date:02/16/2006
Study Type:Behavioral
Recruitment Status:Terminated
Projected Accrual:256, M. D. Anderson Cancer Center: 211 participants; Roswell Park Cancer Center: 45 participants.
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) 18 years of age or older

2) Ability to speak and read English

3) Clinical or histological diagnosis of active cGVHD or at least 3 months post allogeneic BMT without a diagnosis of active GVHD (PATIENT ONLY)

4) Identification as the single primary family caregiver by a patient with cGVHD (CAREGIVER ONLY)

5) Physician or nurse with at least 5 years experience caring for patients with cGHVD (PROFESSIONAL EXPERT ONLY)

6) At least one publication in the last 5 years dealing with cGVHD (PHYSICIAN PROFESSIONAL EXPERT ONLY)

7) Consent to participate
Exclusion Criteria:1) Inability to understand the intent of the study

2) Medical condition that would preclude participation in an interview lasting 30 minutes (PHASE 1 OF STUDY ONLY)

3) Diagnosis of active psychosis or severe cognitive impairment

4) Bone marrow or stem cell donor for patient (CAREGIVER ONLY)

5) Disease for which BMT was performed not in remission (PATIENT ONLY)
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Links
Registration Number: NCT00353106
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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