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NCT00824174 Clinical Trial

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

Head and Neck Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00824174
Other study ID # 2008-0080
Secondary ID
Status Completed
Phase N/A
First received January 15, 2009
Last updated October 1, 2012
Start date December 2008

Study information
Verified date October 2012
Source M.D. Anderson Cancer Center
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 289
Est. completion date
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Behavioral:
• Questionnaire
1 questionnaire, about 15-20 minutes.

Locations
Country Name City State
United States UT MD Anderson Cancer Center Houston Texas

Sponsors (1)
Lead Sponsor Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Body image outcomes (i.e., Body Image Scale) 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 No
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