Study Results
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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COMPLETED
75 participants
OBSERVATIONAL
2005-12-31
2014-12-31
Brief Summary
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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.
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Detailed Description
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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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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Smoking Behavior Group
Individuals Having Surgery for Oral Cavity Cancer.
Questionnaire
Written survey at 1 Month \& 6 Months post surgery.
Interview
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.
Interview
One-on-One meeting lasting about one hour, at 1 Month \& 6 Months post surgery.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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M.D. Anderson Cancer Center
OTHER
Responsible Party
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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
Countries
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Related Links
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University of Texas MD Anderson Cancer Center Website
Other Identifiers
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2005-0126
Identifier Type: -
Identifier Source: org_study_id
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