Feasibility Study of Collecting Multicenter Chronic GVHD Data
2 Years
N/A
Both
Graft-Versus-Host Disease
Trial Information
Feasibility Study of Collecting Multicenter Chronic GVHD Data
If you agree to take part in this study, you will be asked to fill-out some questionnaires,
and your medical records will be reviewed. Your doctor or healthcare provider will also be
asked to complete a questionnaire.
You will be asked to fill-out questionnaires at 3 different times (when you join this study,
3 months later, and 6 months later). The questionnaires will include questions about how
your chronic GvHD impacts your body, your day-to-day activities, your emotions and
perceptions, and your social and sexual life. Each questionnaire has 195 questions. Each
should take about 20-30 minutes to complete, but you will also be asked how long it takes
you to complete each questionnaire. For most participants, these visits will be part of
your routine schedule for follow-up for the disease.
You have several options for where you may choose to complete the questionnaires. They may
be completed when you visit the doctor for your appointments, at home (you will have to mail
them back in self-addressed stamped envelopes that will be provided to you), or over the
internet. If you are interested in the internet option, please ask study staff for more
details. If at any time, your healthcare provider does not think it would be in your best
interest to receive a survey at one of your scheduled time points, you will not be given a
survey at that time, and you will be taken off this study.
Your healthcare provider will be asked to fill-out a questionnaire that asks about what was
found on your physical exam and routine laboratory tests, what medications you are taking,
and how severe your chronic GvHD is at that clinic visit.
Your medical records will be reviewed for about 1 year after your enrollment in this study
to collect information about your stem cell transplant procedure, your medications, your
medical condition, and the results of tests and procedures. The reviewing of your medical
records does not require your active participation.
You will be on this study until you have completed the 6-month questionnaire.
This is an investigational study. There is no cost involved for participation in this
study. Up to 40 participants will take part in this multicenter study. Up to 15 will be
enrolled M. D. Anderson.
Inclusion Criteria:
1. Age greater than or equal to 2 years
2. Prior allogeneic stem cell transplant, with any graft source, donor type, and GVHD
prophylaxis allowed
3. If a prevalent case (defined as enrollment three or more months after chronic GVHD
diagnosis), then subject must be within 2 years of stem cell infusion
4. Diagnosis of chronic GVHD meeting the diagnostic criteria of the diagnosis and
staging group of the NIH consensus conference
5. Need for systemic treatment, defined as any medication or intervention delivered
systemically, including extracorporeal photopheresis. If a patient only received
topical or local therapy at diagnosis, but subsequently requires systemic treatment,
they may be enrolled upon initiation of systemic therapy. (Note, these patients will
be classified as incident or prevalent cases depending on time from chronic GVHD
diagnosis, not start of systemic therapy)
6. Progression-free for their malignancy at enrollment (no evidence of primary disease
progression since transplant, although residual disease may still be present)
7. Evaluation at the transplant center at the time of study enrollment, and agreement to
be re-evaluated at the transplant center at 3 and 6 months
8. Signed, informed consent and if applicable, child assent
Exclusion Criteria:
1. Inability to verbally communicate in English
2. Inability to comply with study procedures
3. Anticipated survival less than 6 months due to co-morbid disease or persistent
malignancy
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Principal Investigator
Amin Alousi, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
2006-0541
NCT ID:
NCT00506233
Start Date:
August 2006
Completion Date:
Related Keywords:
- Graft-Versus-Host Disease
- Graft-Versus-Host Disease
- GVHD
- Questionnaire
- Graft vs Host Disease
Name | Location |
|---|---|
| Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
| U.T.M.D. Anderson Cancer Center | Houston, Texas 77030 |
