Smoking Status and Body Image in Oral Cancer Patients

Completed

• Conditions: Oral Cavity Cancer
• Interventions: Behavioral: Questionnaire; Behavioral: Interview

• Registration Number: NCT00412490
• Lead Sponsor: M.D. Anderson Cancer Center

Brief Summary

Primary Objectives:

1. To characterize smoking behaviors and body image in patients with oral cavity cancer prior to and following surgical procedures.

2. To examine the relationship between smoking status and body image in this sample of head and neck cancer patients.

3. To examine the influence of smoking status and body image on quality of life outcomes.

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. About 75 people will take part in this research study. All will be enrolled at M. D. Anderson.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2006-12-15
• Study First Submitted QC: 2006-12-15
• Study First Posted: 2006-12-18
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-27
• Last Update Posted: 2016-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

Inclusion Criteria

1. 18 years of age or older
2. Able to provide written informed consent to participate
3. Diagnosis of head and neck malignancy involving an oral cavity site without previous treatment
4. Current treatment plan includes surgical intervention
5. English speaking

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Smoking Behavior Group	Interview	Individuals Having Surgery for Oral Cavity Cancer.
Smoking Behavior Group	Questionnaire	Individuals Having Surgery for Oral Cavity Cancer.

Primary Outcome Measures

Name	Time	Method
Primary analysis involve multiple linear regression of body image on gender, age and ethnicity while adjusting for disease and treatment related factors.	Baseline, 1 Month and 6 Months Post Surgery	Preliminary analyses involve two-sample t-tests of difference in body image between male and female, one-way ANOVA to compare body image across ethnicity groups, and calculation of Pearson product moment correlation coefficients between body image and age.

Trial Locations

Locations (1)

University of Texas MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States