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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.
 
ClinicalTrials.gov Identifier: NCT00412490
Recruitment Status : Completed
First Posted : December 18, 2006
Last Update Posted : January 29, 2016
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date December 15, 2006
First Posted Date December 18, 2006
Last Update Posted Date January 29, 2016
Study Start Date December 2005
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 27, 2016)
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.
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00412490 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Smoking Status and Body Image in Oral Cancer Patients
Official Title A Prospective Examination of Smoking Status and Body Image in Surgical Patients With Cancer of the Oral Cavity
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.
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Oral Cavity Cancer
Intervention
  • 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.
Study Groups/Cohorts Smoking Behavior Group
Individuals Having Surgery for Oral Cavity Cancer.
Interventions:
  • Behavioral: Questionnaire
  • Behavioral: Interview
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 15, 2006)
75
Original Enrollment Same as current
Actual Study Completion Date December 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00412490
Other Study ID Numbers 2005-0126
5R25CA057730-11 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor M.D. Anderson Cancer Center
Collaborators Not Provided
Investigators
Principal Investigator: Ellen R. Gritz, PhD M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date January 2016