Body Image Functioning Among Surgically Treated Patients With Head and Neck Cancer - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00824174

Purpose

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 cancer to those with cutaneous cancer.

Condition	Intervention
Head and Neck Cancer Skin Cancer	Behavioral: Questionnaire

MedlinePlus related topics: Cancer Head and Neck Cancer Skin Cancer Surgery

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Retrospective
Official Title:	Body Image Functioning Among Surgically Treated Patients With Head and Neck Cancer

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To study how patients with head and neck cancer feel about bodily changes caused by cancer. [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	250
Study Start Date:	December 2008
Estimated Primary Completion Date:	November 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 The study participant will be asked to fill out 1 questionnaire. This questionnaire will take about 15-20 minutes to complete.	Behavioral: Questionnaire The study participant will be asked to fill out 1 questionnaire. This questionnaire will take about 15-20 minutes to complete.

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 250 people will take part in this study. All will be enrolled at M. D. Anderson.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Study Participants with oral cavity or cutaneous cancer receiving surgical treatment will be selected for inclusion with a study population of 250 participants.

Criteria

Inclusion Criteria:

18 years of age or older
able to provide written informed consent to participate
diagnosis of oral cavity cancer or a cutaneous 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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00824174

Contacts

Contact: Michelle C Fingeret, PHD

713-563-8032

Locations

United States, Texas
The University of Texas M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030q

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Michelle C Fingeret, PHD

M.D. Anderson Cancer Center

More Information

Additional Information:

The University of Texas M.D.Anderson Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Michelle C. Fingeret, PHD/Assistant Professor )
Study ID Numbers:	2008-0080
Study First Received:	January 15, 2009
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00824174 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Questionnaire
Head and Neck Cancer
Skin Cancer
Body Image

Surgical Treatment
Oral Cavity Cancer
Cutaneous Cancer

Study placed in the following topic categories:

Skin Diseases
Head and Neck Neoplasms
Skin Neoplasms

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Head and Neck Neoplasms
Skin Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009