Sexual Behavior in Head and Neck Cancer Patients - Full Text View

Purpose

The goal of this behavioral research study is to learn if certain sexual behaviors increase the risk for developing head and neck cancers associated with a virus called human papillomavirus (HPV-16). Knowing this information could help doctors better teach patients about avoiding certain risk factors, which may help to prevent the disease.

Condition	Intervention
Oropharyngeal Cancer Head and Neck Cancer Squamous Cell Carcinoma	Behavioral: Questionnaire


Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Sexual Behavior in Head and Neck Cancer Patients

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer

U.S. FDA Resources

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To find out if certain sexual behaviors increase the risk for developing head and neck cancers associated with a virus called human papillomavirus (HPV-16). [ Time Frame: 6 Years ] [ Designated as safety issue: No ]


Estimated Enrollment:	1500
Study Start Date:	April 2008
Estimated Primary Completion Date:	April 2018 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Oropharyngeal Cancer	Behavioral: Questionnaire The questionnaire contains 18 questions and is estimated to take approximately 10-15 minutes to complete.
Non-Oropharyngeal Cancer	Behavioral: Questionnaire The questionnaire contains 18 questions and is estimated to take approximately 10-15 minutes to complete.

Detailed Description:

SCCHN is believed to be caused by different types of viruses being exposed to the mucous membrane on the inside of the mouth, throat, and voice box, over a long period of time. This exposure results in changes in the cells of the mouth, throat, and voice box, which can lead to the development of cancer.

HPV-16 has been linked to SCCHN. Half of all cancers of the oropharynx (the middle part of the throat, the base of the tongue, and tonsils) may be caused by HPV-16. HPV-16 is normally spread sexually, and is one of the main causes of cervical cancer in women. By finding out if the virus is also spread sexually to the throat, doctors may be able to teach patients about risk factors for developing cancer in this area.

Study Procedures:

If you agree to take part in this study, you will be asked to complete a questionnaire about your sexual history, such as specific sexual practices, number of partners, exposure to HPV and other viruses, and any medical history related to HPV-16. The questionnaire will take 10-15 minutes to complete.

None of your personal identifying information will be attached to your questionnaire, and the questionnaire will be assigned a one-of-a-kind study code number.

To check your cancer diagnosis, your medical records will be reviewed.

Length of Study:

Once you have completed the questionnaire, your participation in this study is over.

This is an investigational study.

Up to 1,500 patients will be enrolled in this study. All will be enrolled at MD Anderson.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Approximately 600 oropharynx study participants and 900 non-oropharynx study participants.

Criteria

Inclusion Criteria:

Patients with newly diagnosed, previously untreated squamous cell carcinoma of the head and neck (SCCHN) who are candidates for the molecular epidemiology study LAB00-062 of head and neck cancer.
Must have the ability to understand and provide informed consent.
Patients must be 18 years and older.
Ability to read, write, and speak English.
Resident of the United States.
Agrees to have tumor tissue, if available, tested for HPV. No additional biopsy will be requested.

Exclusion Criteria:

Previous cancer diagnosis excluding non-melanoma skin cancer.
Blood transfusion within the previous 6 months.
Immune suppression, such as HIV disease or immune-suppressing therapy (i.e., steroids).

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662662

Locations


United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators


Principal Investigator:	Erich Sturgis, MD	M.D. Anderson Cancer Center

More Information

Additional Information:

University of Texas MD Anderson Cancer Center Website This link exits the ClinicalTrials.gov site


Responsible Party:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00662662 History of Changes
Other Study ID Numbers:	2007-0485
Study First Received:	April 17, 2008
Last Updated:	February 18, 2016
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:


Oropharyngeal Cancer Non-Oropharyngeal Cancer Head and Neck Cancer Squamous Cell Carcinoma Squamous cell carcinoma of the head and neck	SCCHN HPV-16 Questionnaire Sexual Behavior Survey

Additional relevant MeSH terms:


Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Oropharyngeal Neoplasms Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms	Neoplasms, Squamous Cell Neoplasms by Site Pharyngeal Neoplasms Otorhinolaryngologic Neoplasms Pharyngeal Diseases Stomatognathic Diseases Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on September 30, 2016