Body Image Functioning Among Surgically Treated Patients With Head and Neck Cancer

October 1, 2012 updated by: M.D. Anderson Cancer Center

Objectives:

The purpose of this study is to obtain descriptive information about the nature and extent of body image concerns among surgical patients with head and neck cancer, satisfaction with care received regarding body image issues, and interest in psychosocial services targeting body image disturbance. Findings from this study provide important preliminary data to guide future large scale research on the critical, yet understudied, psychosocial issue of body image functioning for head and neck cancer patients. Information obtained from this study can specifically be used to facilitate the development of appropriate disease-specific body image instruments and to determine the need for body image focused psychosocial interventions to enhance quality of life and the survivorship experience for these patients.

Primary Aims

  1. To characterize the nature and extent of body image concerns in surgically treated patients with head and neck cancer and determine preferences for psychosocial intervention.
  2. To compare body image and quality of life outcomes for patients at different time points relative to initiation of treatment. Specific time points of interest are pre-treatment, within one year of initial surgical treatment, and greater than 1 year following initial surgical treatment.

Secondary Aim

1. To compare body image and quality of life outcomes for patients with oral cavity, cutaneous, and midface cancers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

If you agree to take part in this study, you will be asked to fill out 1 questionnaire. This questionnaire can be filled out while you are waiting to be seen by your head and neck doctor and will take about 15-20 minutes to complete.

In this questionnaire, you will be asked questions such as your age, gender, education level, and smoking history. You will also be asked about your treatment for cancer and how it has affected your appearance and body. There will also be questions about your mood, physical health, alcohol use, and social well-being.

Length of Study:

You will be off study after you complete the questionnaire.

This is an investigational study. Up to 350 people will take part in this study. All will be enrolled at M. D. Anderson.

Study Type

Observational

Enrollment (Actual)

289

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • UT MD Anderson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients, 18 years or older, with oral cavity or cutaneous cancer receiving surgical treatment.

Description

Inclusion Criteria:

  1. 18 years of age or older
  2. Able to provide written informed consent to participate
  3. Diagnosis of oral cavity, cutaneous or other midface cancer involving the head and neck region
  4. Treatment plan includes surgical intervention
  5. English speaking

Exclusion Criteria:

  1. Significant preexisting facial disfigurement from a previous trauma or congenital defect
  2. Diagnosis of a serious mental illness involving formal thought disorder (e.g., schizophrenia) documented in medical record
  3. Cognitive impairment (e.g., dementia, delirium)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Questionnaire
1 questionnaire, about 15-20 minutes.
Behavioral: Questionnaire
1 questionnaire, about 15-20 minutes.
Other Names:
  • Survey

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Body image outcomes (i.e., Body Image Scale) for patients at different time points relative to initiation of treatment
Time Frame: Specific time points of interest are pre-treatment, within one year of initial surgical treatment, and greater than 1 year following initial surgical treatment
Specific time points of interest are pre-treatment, within one year of initial surgical treatment, and greater than 1 year following initial surgical treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Investigators

  • Principal Investigator: Michelle C Fingeret, PHD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

January 15, 2009

First Submitted That Met QC Criteria

January 15, 2009

First Posted (Estimate)

January 16, 2009

Study Record Updates

Last Update Posted (Estimate)

October 2, 2012

Last Update Submitted That Met QC Criteria

October 1, 2012

Last Verified

October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-0080

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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