Smoking Status and Body Image in Oral Cancer Patients

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00412490
First received: December 15, 2006
Last updated: September 11, 2013
Last verified: September 2013
  Purpose

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 Intervention
Oral Cavity Cancer
Behavioral: Questionnaire
Behavioral: Interview

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Individual Smoking Behaviors + Feelings about Appearance [ Time Frame: Baseline, 1 Month and 6 Months Post Surgery ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: December 2005
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00412490

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Ellen R. Gritz, PhD M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00412490     History of Changes
Other Study ID Numbers: 2005-0126
Study First Received: December 15, 2006
Last Updated: September 11, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Oral Cavity Cancer
Body Image
Smoking
Appearance
Questionnaire
Interview

Additional relevant MeSH terms:
Mouth Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on August 20, 2014