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.
Observational Model: Cohort, Time Perspective: Prospective
Amin Alousi, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|Fred Hutchinson Cancer Research Center||Seattle, Washington 98109|
|U.T.M.D. Anderson Cancer Center||Houston, Texas 77030|