Smoking Status and Body Image in Oral Cancer Patients
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Purpose
Primary Objectives:
- To characterize smoking behaviors and body image in patients with oral cavity cancer prior to and following surgical procedures.
- To examine the relationship between smoking status and body image in this sample of head and neck cancer patients.
- 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 |
- 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 |
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:
- 18 years of age or older
- Able to provide written informed consent to participate
- Diagnosis of head and neck malignancy involving an oral cavity site without previous treatment
- Current treatment plan includes surgical intervention
- English speaking
Exclusion Criteria:
- Previous treatment for malignancy in the head and neck region
- Significant preexisting facial disfigurement from a previous trauma or congenital defect
- Diagnosis of a serious mental illness involving formal thought disorder (e.g., Schizophrenia) documented in medical record.
Contacts and Locations| United States, Texas | |
| UT MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| 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 10, 2012 |
| 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 Smoking Head and Neck Neoplasms Neoplasms by Site |
Neoplasms Mouth Diseases Stomatognathic Diseases Habits |
ClinicalTrials.gov processed this record on June 18, 2013