Sexual Behavior in Oropharyngeal Patients Versus Head and Neck Cancer Patients, With or Without HPV Infection
18 Years
N/A
Both
Head and Neck Cancer, Oropharyngeal Cancer, Human Papillomavirus Infection
Trial Information
Sexual Behavior in Oropharyngeal Patients Versus Head and Neck Cancer Patients, With or Without HPV 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.
Inclusion Criteria:
1. Patients with diagnosed squamous cell carcinoma of the head and neck that
participated in the molecular epidemiology study LAB00-062 of head and neck cancer
between 1995 and 2005.
2. Head and Neck cancer participants of LAB00-062 that are still alive.
3. Head and Neck cancer participants of LAB00-062 that have known mailing addresses in
the U.S.A.
4. Patients must be 18 years and older.
5. Patients will have completed their primary treatment but may be undergoing treatment
for a second primary or recurrent disease.
6. Ability to read, write, and speak Spanish or English.
Exclusion Criteria:
n/a
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Outcome Measure:
Number of Responders with High-risk Sexual Behaviors
Outcome Description:
Written self-administered questionnaire responses analyzed to determine whether patients with oropharyngeal cancer have history of high-risk sexual behavior (defined as 15 or more lifetime sexual partners) greater than that of patients with tumors of other sites of head and neck
Outcome Time Frame:
1 month for mailing and return of questionnaires
Safety Issue:
No
Principal Investigator
Erich Sturgis, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
UT MD Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
2005-0519
NCT ID:
NCT00508170
Start Date:
March 2006
Completion Date:
January 2010
Related Keywords:
- Head and Neck Cancer
- Oropharyngeal Cancer
- Human Papillomavirus Infection
- Head and Neck Cancer
- Human Papillomavirus Infection
- Oropharyngeal Patients
- Sexual Behavior
- Questionnaire
- Head and Neck Neoplasms
- Oropharyngeal Neoplasms
- Warts
- Papillomavirus Infections
Name | Location |
|---|---|
| UT MD Anderson Cancer Center | Houston, Texas 77030 |
