Feasibility Study of Collecting Multicenter Chronic GVHD Data
1. To determine the feasibility of conducting a multi-site longitudinal observational study of patients with chronic graft-versus-host disease (GVHD).
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Feasibility Study of Collecting Multicenter Chronic GVHD Data|
|Study Start Date:||August 2006|
|Primary Completion Date:||September 2007 (Final data collection date for primary outcome measure)|
Chronic Graft-Versus Host Disease (GvHD)
Participants with chronic graft-versus host disease (GvHD)
Completion of questionnaires at 3 different times (when joining this study, 3 months later, and 6 months later). Each should take about 20-30 minutes to complete.
Other Name: surveys
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00506233
|United States, Texas|
|U.T.M.D. Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|United States, Washington|
|Fred Hutchinson Cancer Research Center|
|Seattle, Washington, United States, 98109|
|Principal Investigator:||Amin Alousi, MD||M.D. Anderson Cancer Center|