Smoking Status and Body Image in Oral Cancer Patients

NCT ID: NCT00412490

Last Updated: 2016-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

75 participants

Study Classification

OBSERVATIONAL

Study Start Date

2005-12-31

Study Completion Date

2014-12-31

Brief Summary

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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

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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.

Conditions

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Oral Cavity Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Smoking Behavior Group

Individuals Having Surgery for Oral Cavity Cancer.

Questionnaire

Intervention Type BEHAVIORAL

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

Interview

Intervention Type BEHAVIORAL

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

Interventions

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Questionnaire

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

Intervention Type BEHAVIORAL

Interview

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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M.D. Anderson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ellen R. Gritz, PhD

Role: PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Locations

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University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status

Countries

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United States

Related Links

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http://www.mdanderson.org

University of Texas MD Anderson Cancer Center Website

Other Identifiers

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5R25CA057730-11

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2005-0126

Identifier Type: -

Identifier Source: org_study_id

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