Smoking Status and Body Image in Oral Cancer Patients

NCT00412490 | Completed

• 2 other identifiers: 2005-01265R25CA057730-11
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Primary Objectives:

1. 1.To characterize smoking behaviors and body image in patients with oral cavity cancer prior to and following surgical procedures.
2. 2.To examine the relationship between smoking status and body image in this sample of head and neck cancer patients.
3. 3.To examine the influence of smoking status and body image on quality of life outcomes.

Conditions

Oral Cavity Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Primary analysis involve multiple linear regression of body image on gender, age and ethnicity while adjusting for disease and treatment related factors.

  Preliminary 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.

  Baseline, 1 Month and 6 Months Post Surgery

Study Arms (1)

Smoking Behavior Group

Individuals Having Surgery for Oral Cavity Cancer.

Behavioral: Questionnaire; Behavioral: Interview

Interventions

Questionnaire BEHAVIORAL

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

Smoking Behavior Group

Interview BEHAVIORAL

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

Smoking Behavior Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Mouth Neoplasms; Smoking

Interventions

Surveys and Questionnaires; Interviews as Topic

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Ellen R. Gritz, PhD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2006
• First Posted: December 18, 2006
• Study Start: December 1, 2005
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 29, 2016

Record last verified: 2016-01

Locations

US (1)