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Proton Therapy for Head and Neck Malignancies
Conditions
Head and Neck Cancer
Conditions: official terms
Head and Neck Neoplasms
Conditions: Keywords
Head and Neck Cancer, Head and Neck Malignancies, Chart Review, Proton Radiation Therapy
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort
Intervention
Name: Chart Review
Type: Other
Name: Questionnaires
Type: Behavioral
Overall Status
Recruiting
Summary
The goal of this data review research study is to collect medical record information from patients with head and neck cancer that have received or are scheduled to receive proton therapy at MD Anderson. Researchers will study the medical record information to try and improve therapy for future patients with head and neck cancer.
Detailed Description
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. The questionnaires may be performed in person by mail, by phone or by secure electronic methods. The research coordinator will notify you via telephone, mail or via electronic notification approximately 2-3 weeks after the questionnaire is sent to remind you and also give you the option of performing the survey by other means.
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.
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. The questionnaires may be performed in person by mail, by phone or by secure electronic methods. The research coordinator will notify you via telephone, mail or via electronic notification approximately 2-3 weeks after the questionnaire is sent to remind you and also give you the option of performing the survey by other means.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:
1) Retrospective chart analysis will be performed on all patients documented to have head and neck cancer treated with Proton Therapy at MDACC from January 1, 2008 through April 30, 2012. We will prospectively consent patients who receive treatment from May 1, 2012 through December 31, 2016. Patient charts will be reviewed to determine pretreatment characteristics, time to progression and overall survival of patients.
Exclusion Criteria:
N/A
1) Retrospective chart analysis will be performed on all patients documented to have head and neck cancer treated with Proton Therapy at MDACC from January 1, 2008 through April 30, 2012. We will prospectively consent patients who receive treatment from May 1, 2012 through December 31, 2016. Patient charts will be reviewed to determine pretreatment characteristics, time to progression and overall survival of patients.
Exclusion Criteria:
N/A
Location
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Status: Recruiting
Start Date
January 2012
Sponsors
M.D. Anderson Cancer Center
Source
M.D. Anderson Cancer Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page