Head and Neck Cancer Clinical Trial
Official title:
Sexual Behavior in Oropharyngeal Patients Versus Head and Neck Cancer Patients, With or Without HPV Infection
Primary Objectives:
1. To determine whether high-risk sexual behaviors are more common in patients with
oropharyngeal cancer than in patients with head and neck cancers of other sub-sites.
2. To determine if high-risk sexual behaviors are more common in patients with HPV (human
papillomavirus) associated head and neck cancer than those without evidence of HPV-16
infection.
Squamous cell cancer of the head and neck (SCCHN) is believed to be caused by the long-term
exposure of the mucous membrane on the inside of the mouth to different types of
cancer-causing agents. This results in changes in the mouth, which can lead to the
development of cancer.
Infection with HPV-16 has been linked with SCCHN. Half of all cancers of the oropharynx (the
middle part of the throat including the soft palate, base of the tongue, and tonsils) are
caused by HPV-16. HPV-16 is normally sexually transmitted, and is the cause of cervical
cancer in women. By finding out if the virus is also sexually transmitted to the oropharynx,
doctors may be able to educate patients about risk factors for developing cancer in this
region. Eventually, doctors may be able to vaccinate people who are at risk for getting this
virus.
You have received this questionnaire because you gave researchers your verbal consent for
the mail-out. Along with the questionnaire, included are 2 self-addressed stamped envelopes
for you to return the questionnaire and consent separately.
If you agree to take part in this study, you will complete the questionnaire about your
sexual history such as specific sexual practices and number of partners, exposure to HPV and
other viruses, and any relevant medical history. This questionnaire should take about 10
minutes to complete. The questionnaire will be given a study code number so that your name
or M. D. Anderson patient ID number will not appear on the questionnaire.
Once you have finished the questionnaire, for added privacy and confidentiality, you should
place the signed consent form in 1 self-addressed stamped envelope (SASE) and the completed
questionnaire into the other self-addressed stamped envelope (SASE) that has been provided.
Please mail both envelopes back within 15 days of receiving the questionnaire.
Once you have completed the questionnaire, your participation in this study is over.
This is an investigational study. About 1,267 patients will be enrolled in this study. All
will be enrolled at M. D. Anderson.
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