Smoking Status and Body Image in Oral Cancer Patients
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|ClinicalTrials.gov Identifier: NCT00412490|
Recruitment Status : Completed
First Posted : December 18, 2006
Last Update Posted : January 29, 2016
- 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 or disease||Intervention/treatment|
|Oral Cavity Cancer||Behavioral: Questionnaire Behavioral: Interview|
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.
|Study Type :||Observational|
|Actual Enrollment :||75 participants|
|Official Title:||A Prospective Examination of Smoking Status and Body Image in Surgical Patients With Cancer of the Oral Cavity|
|Study Start Date :||December 2005|
|Primary Completion Date :||December 2014|
|Study Completion Date :||December 2014|
Smoking Behavior Group
Individuals Having Surgery for Oral Cavity Cancer.
Written survey at 1 Month & 6 Months post surgery.Behavioral: Interview
One-on-One meeting lasting about one hour, at 1 Month & 6 Months post surgery.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00412490
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Ellen R. Gritz, PhD||M.D. Anderson Cancer Center|