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CompletedNCT00412490Updated Jan 29, 2016

Smoking Status and Body Image in Oral Cancer Patients

An observational study in Oral Cavity Cancer, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-01-29.

Sponsored by M.D. Anderson Cancer Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
75
Ages
18 Years and older
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Oral Cavity Cancer

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Keywords

  • Oral Cavity Cancer
  • Body Image
  • Smoking
  • Appearance
  • Questionnaire
  • Interview
03

In context

Mouth Neoplasms

377 studies on the registry are indexed under Mouth Neoplasms; 126 are open to participants now.

This study's enrollment of 75 is below the median of 90 across 103 observational studies indexed under Mouth Neoplasms.

Browse Mouth Neoplasms studies →

Lead sponsor

M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.

Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
75 participants (actual)

Groups and cohorts

  • Smoking Behavior Group

    Individuals Having Surgery for Oral Cavity Cancer.

    Behavioral: Questionnaire · Behavioral: Interview

Interventions

  • BehavioralQuestionnaire

    Written survey at 1 Month \& 6 Months post surgery.

  • BehavioralInterview

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, 1 Month and 6 Months Post Surgery

07

Study locations

1 site
  • University of Texas MD Anderson Cancer Center
    Houston, Texas 77030, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 29, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00412490
Lead sponsor
M.D. Anderson Cancer Center
Responsible party
Sponsor
First posted
Dec 18, 2006
Start date
Dec 2005
Primary completion
Dec 2014
Completion
Dec 2014
Last update
Jan 29, 2016

Study contacts

Ellen R. Gritz, PhD
principal investigator · M.D. Anderson Cancer Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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