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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00824174
First received: January 15, 2009
Last updated: October 1, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention
Head and Neck Cancer
Skin Cancer
 Behavioral: Questionnaire

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

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 289
Study Start Date: December 2008
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Questionnaire
1 questionnaire, about 15-20 minutes.
 Behavioral: Questionnaire
1 questionnaire, about 15-20 minutes.
Other Name: Survey

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.

  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

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

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00824174

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Michelle C Fingeret, PHD M.D. Anderson Cancer Center
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: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00824174     History of Changes
Other Study ID Numbers: 2008-0080
Study First Received: January 15, 2009
Last Updated: October 1, 2012
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

Additional relevant MeSH terms:
Skin Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2013