Smoking Status and Body Image in Oral Cancer Patients

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.

Completed

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Key information

Conditions

Oral Cavity Cancer Behavior Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Smoking Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Questionnaire

Behavioral

Written survey at 1 Month & 6 Months post surgery.

Interview

Behavioral

One-on-One meeting lasting about one hour, at 1 Month & 6 Months post surgery.

Primary outcomes

Primary analysis involve multiple linear regression of body image on gender, age and ethnicity while adjusting for disease and treatment related factors.

Time frame: 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.

Sponsors and collaborators

Lead sponsor

M.D. Anderson Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start: 2005
Primary completion: 2014
Study completion: 2014
First posted: Dec 18, 2006
Registry last updated: Jan 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed