Smoking Status and Body Image in Oral Cancer Patients - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00412490

Purpose

Primary Objectives:

To characterize smoking behaviors and body image in patients with oral cavity cancer prior to and following surgical procedures.
To examine the relationship between smoking status and body image in this sample of head and neck cancer patients.
To examine the influence of smoking status and body image on quality of life outcomes.

Condition	Intervention
Oral Cavity Cancer	Behavioral: Questionnaire Behavioral: Interview

MedlinePlus related topics: Cancer Smoking

U.S. FDA Resources

Study Type:	Observational
Study Design:	Natural History, Longitudinal, Defined Population, Prospective Study
Official Title:	A Prospective Examination of Smoking Status and Body Image in Surgical Patients With Cancer of the Oral Cavity

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

Enrollment:	75
Study Start Date:	December 2005

Detailed Description:

If you agree to take part in this study, researchers will first perform a test to check the level of carbon monoxide (CO) in your blood. To do this test, you will be asked to blow into a cardboard tube attached to a machine. You will then be asked to fill out some questionnaires and complete a one-on-one interview. All of these things combined will take about an hour to complete. You will be asked basic questions such as your age, education level, and smoking history. You will also be asked questions about your mood, quality of life, and how you feel about your appearance.

If you do not have surgery, your participation in this study will end after this visit. If you have surgery, you will be asked to come back for 2 more study visits, 1 month and 6 months after your surgery. During these evaluations, you will be asked once again to blow into the cardboard tube, fill out questionnaires, and a complete a one-on-one interview. Each visit will last about an hour. You will again be asked questions about your smoking behaviors, mood, quality of life, and how you feel about your appearance. Your participation in this study will be finished after the 6-month evaluation.

This is an investigational study. There are no costs to you for taking part in this research study. About 75 people will take part in this research study. All will be enrolled at M. D. Anderson.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

18 years of age or older
Able to provide written informed consent to participate
Diagnosis of head and neck malignancy involving an oral cavity site without previous treatment
Current treatment plan includes surgical intervention
English speaking

Exclusion Criteria:

Previous treatment for malignancy in the head and neck region
Significant preexisting facial disfigurement from a previous trauma or congenital defect
Diagnosis of a serious mental illness involving formal thought disorder (e.g., Schizophrenia) documented in medical record.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00412490

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Ellen R. Gritz, PhD

U.T.M.D. Anderson Cancer Center

More Information

Study ID Numbers:	2005-0126
Study First Received:	December 15, 2006
Last Updated:	June 27, 2007
ClinicalTrials.gov Identifier:	NCT00412490
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Oral Cavity Cancer
Body Image
Smoking

Appearance
Questionnaire
Interview

Study placed in the following topic categories:

Tooth Diseases
Smoking
Oral cancer
Stomatognathic Diseases

Lip and oral cavity cancer
Mouth Neoplasms
Dental Caries

Additional relevant MeSH terms:

Tooth Demineralization

ClinicalTrials.gov processed this record on January 14, 2009