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Smoking Status and Body Image in Oral Cancer Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00412490
Recruitment Status : Completed
First Posted : December 18, 2006
Last Update Posted : January 29, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Oral Cavity Cancer Behavioral: Questionnaire Behavioral: Interview

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.

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Study Type : Observational
Actual Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Oral Cancer Smoking

Group/Cohort Intervention/treatment
Smoking Behavior Group
Individuals Having Surgery for Oral Cavity Cancer.
Behavioral: Questionnaire
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 Outcome Measures :
  1. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Individuals, age 18 years or older, diagnosed with head and neck malignancy involving an oral cavity site without previous treatment, and current treatment plan includes surgical intervention.

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00412490

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United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
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Principal Investigator: Ellen R. Gritz, PhD M.D. Anderson Cancer Center
Additional Information:
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Responsible Party: M.D. Anderson Cancer Center Identifier: NCT00412490    
Other Study ID Numbers: 2005-0126
5R25CA057730-11 ( U.S. NIH Grant/Contract )
First Posted: December 18, 2006    Key Record Dates
Last Update Posted: January 29, 2016
Last Verified: January 2016
Keywords provided by M.D. Anderson Cancer Center:
Oral Cavity Cancer
Body Image
Additional relevant MeSH terms:
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Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Mouth Diseases
Stomatognathic Diseases