Smoking Status and Body Image in Oral Cancer Patients

Oral Cavity Cancer Clinical Trial

Official title:

A Prospective Examination of Smoking Status and Body Image in Surgical Patients With Cancer of the Oral Cavity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00412490
• Other study ID #: 2005-0126
• Secondary ID: 5 R25 CA 57730 -
• Status: Completed
• Phase: N/A
• First received: December 15, 2006
• Last updated: January 27, 2016
• Start date: December 2005
• Est. completion date: December 2014

Study information

• Verified date: January 2016
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Mouth Neoplasms
• Oral Cavity Cancer

Intervention

Behavioral:
• Questionnaire
Written survey at 1 Month & 6 Months post surgery.
• Interview
One-on-One meeting lasting about one hour, at 1 Month & 6 Months post surgery.

Locations

Country	Name	City	State
United States	University of Texas MD Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Primary analysis involve multiple linear regression of body image on gender, age and ethnicity while adjusting for disease and treatment related factors.	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.	Baseline, 1 Month and 6 Months Post Surgery	No

External Links

•   University of Texas MD Anderson Cancer Center Website