- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00824174
Body Image Functioning Among Surgically Treated Patients With Head and Neck Cancer
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
- 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.
- 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
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Texas
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Houston, Texas, United States, 77030
- UT MD Anderson Cancer Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 18 years of age or older
- Able to provide written informed consent to participate
- Diagnosis of oral cavity, cutaneous or other midface cancer involving the head and neck region
- Treatment plan includes surgical intervention
- English speaking
Exclusion Criteria:
- 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
- Cognitive impairment (e.g., dementia, delirium)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Questionnaire
1 questionnaire, about 15-20 minutes.
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1 questionnaire, about 15-20 minutes.
Other Names:
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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
Sponsor
Investigators
- Principal Investigator: Michelle C Fingeret, PHD, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
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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