Prospective Data Collection of Patients Treated With Proton Therapy for Head and Neck Malignancies
If you agree to take part in this study, information will be collected from your medical
records that is related to your personal medical history, diagnosis, and the treatment you
received or are scheduled to receive for head and neck cancer. The information from your
medical record will be collected at least 1 time, however, the study doctor may collect
additional information from your medical records at any time in the future for the purposes
of this study.
You will complete 5 questionnaires before your treatment begins, at each visit during your
treatment, and again at all follow-up visits related to your treatment. It should take about
30 minutes to complete the questionnaires each time.
All information that is collected for this study will be stored in a password-protected
computer and database at MD Anderson for use in future research related to cancer.
Your medical record information will be given a code number. No identifying information
will be directly linked to your medical record information. Only the researcher in charge
of the password-protected computer and database will have access to the code numbers and be
able to link your medical record information back to you. This is to allow medical data
related to your medical record information to be updated as needed. Other researchers using
your medical record information from the password-protected computer and database will not
be able to link any information back to you.
Length of Study After you sign this consent form, your active participation in this study
will be over. Your medical record information may be collected indefinitely.
This is an investigational study.
Up to 250 participants will take part in this study. All will be enrolled at MD Anderson.
Observational Model: Cohort
Overall Survival Analysis of Proton Therapy for Head and Neck Malignancies
Chart analysis performed on all patients documented to have head and neck cancer treated with proton therapy from January 1, 2008 through December 31, 2014. Overall survival estimated using Kaplan-Meier method. Cox proportional hazards regression used to explore predictors of time-to-event outcomes. Mann-Whitney test used to compare continuous parameters between temporal cohorts.
Steven J. Frank, MD
UT MD Anderson Cancer Center
United States: Institutional Review Board
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