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Smoking Status and Body Image in Oral Cancer Patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00412490
Enrollment
75
Registered
2006-12-18
Start date
2005-12-31
Completion date
2014-12-31
Last updated
2016-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Cavity Cancer

Keywords

Oral Cavity Cancer, Body Image, Smoking, Appearance, Questionnaire, Interview

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.

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.

Sponsors

M.D. Anderson Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Primary analysis involve multiple linear regression of body image on gender, age and ethnicity while adjusting for disease and treatment related factors.Baseline, 1 Month and 6 Months Post SurgeryPreliminary 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026