Sexual Behavior in Head and Neck Cancer Patients
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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 |
- 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 2017 (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 |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Approximately 600 oropharynx study participants and 900 non-oropharynx study participants.
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00662662
| United States, Texas | |
| University of Texas MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Principal Investigator: | Erich Sturgis, MD | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| 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 17, 2015 |
| 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, Squamous Cell Head and Neck Neoplasms Carcinoma Neoplasms |
Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell |
ClinicalTrials.gov processed this record on February 27, 2015