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The Experience of Having Chronic Graft-Versus-Host Disease


N/A
18 Years
N/A
Not Enrolling
Both
Graft-Versus-Host Disease

Thank you

Trial Information

The Experience of Having Chronic Graft-Versus-Host Disease


For Patient:

If you agree to take part in this study, you will be asked to take part in 1 interview.
During the interview, you will be asked to describe what it has been like for you to have
chronic GVHD. In addition, if you agree to take part in this study, your family caregiver,
if you have one, will be approached to take part in the study.

For Caregiver:

If you agree to take part in this study, you will be asked to take part in 1 interview.
During the interview, you will be asked to describe what it has been like for you to help
care for a family member with chronic GVHD.

Both Parties:

The interview face-to-face will take place while you are at M. D. Anderson receiving care.
You will be interviewed alone and the information gathered during the interview will be
strictly confidential. The interview will take about 30 minutes and will be tape recorded.
The audiotape of the interview will be kept in a locked cabinet in the office of the study
chairperson Dr. Loretta Williams. If other study personnel need the tape for analysis, they
must obtain the tape directly from Dr. Williams. They may keep the tape only while they are
listening to it and must return it immediately to Dr. Williams. Identification labels on the
tape will only contain your study number and will not contain your name, medical record
number, or other identifying information. When all analysis for the study has been completed
and reported, the audiotape will be destroyed.

After the interview, you will be asked to answer a face-to-face questionnaire. This
questionnaire will ask descriptive personal information (age, marital status, etc.).
Answering these questions should take about 5 minutes.

Your participation on this study ends after you complete the interview and questionnaire.

This is an investigational study. About 20 patients and 20 caregivers will take part in
this study. All will be enrolled at M. D. Anderson.

For Patient - Phase III:

If you agree to take part in this study, you will be asked to complete 1 questionnaire. The
questionnaire will have questions asking you to rate how severe your current symptoms are
and how much these symptoms disrupt your daily activities. You will be asked to complete
this questionnaire during your clinic visit. The questionnaire will take no more than 10
minutes to complete.

If you have chronic graft-versus-host disease, you will be asked to complete a second
questionnaire about your opinion of the symptom questionnaire (the first questionnaire). For
example, you will be asked if the symptom questionnaire was easy to understand and to
complete. Learning your opinion about this questionnaire will help researchers learn what
important questions may be missing from the questionnaire. The questionnaire will take no
more than 10 minutes to complete.

If you have chronic graft-versus-host disease, you will also be given questions asking you
to rate the overall quality of your life and your ability to function. These ratings should
take no more than 2 minutes to complete.

Finally, you will be asked to answer a questionnaire. This questionnaire will ask
descriptive personal information (such as age and marital status). Answering these
questions should take about 5 minutes.

If you have chronic GVHD, you may be asked to fill out the questionnaire rating your
symptoms 1 more time, about 3 days after you completed it the first time. You will return
this second questionnaire to the research staff in a pre-addressed, stamped envelope given
to you by the research staff. If you are asked to complete the questionnaire this second
time, the research staff will also ask for your telephone number so that they may contact
you and remind you to complete the questionnaire.

Identification labels on all study questionnaires and forms will only contain your study
number and will not contain your name, medical record number, or other identifying
information. All study materials will be kept in a locked cabinet at all times. When all
analysis for the study has been completed and reported, the questionnaires will be
destroyed.

The study ends when you have completed the questionnaires, rating scales, and interview in
the clinic, or when you have completed and returned the second questionnaire 3 days after
your clinic visit.

This is an investigational study. Up to 192 patients will take part in this study. 147
will be enrolled at M. D. Anderson and 45 will be enrolled at Roswell Park Cancer Institute.


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)

Type of Study:

Observational

Study Design:

Time Perspective: Prospective

Outcome Measure:

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

Outcome Time Frame:

At time of treatment, duration approximately 30 minutes

Safety Issue:

No

Principal Investigator

Loretta A. Williams, DSN

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2005-0727

NCT ID:

NCT00353106

Start Date:

February 2006

Completion Date:

January 2010

Related Keywords:

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

Name

Location

Roswell Park Cancer InstituteBuffalo, New York  14263
UT MD Anderson Cancer CenterHouston, Texas  77030