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


N/A
18 Years
N/A
Open (Enrolling)
Both
Oral Cavity Cancer

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Trial Information

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


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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Individual Smoking Behaviors + Feelings about Appearance

Outcome Time Frame:

Baseline, 1 Month and 6 Months Post Surgery

Safety Issue:

No

Principal Investigator

Ellen R. Gritz, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2005-0126

NCT ID:

NCT00412490

Start Date:

December 2005

Completion Date:

Related Keywords:

  • Oral Cavity Cancer
  • Oral Cavity Cancer
  • Body Image
  • Smoking
  • Appearance
  • Questionnaire
  • Interview
  • Mouth Neoplasms
  • Smoking

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030