Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00824174
Recruitment Status : Completed
First Posted : January 16, 2009
Last Update Posted : October 2, 2012
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center

Tracking Information
First Submitted Date January 15, 2009
First Posted Date January 16, 2009
Last Update Posted Date October 2, 2012
Study Start Date December 2008
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 29, 2009)
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 ]
Original Primary Outcome Measures
 (submitted: January 15, 2009)
To study how patients with head and neck cancer feel about bodily changes caused by cancer. [ Time Frame: 2 Years ]
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Body Image Functioning Among Surgically Treated Patients With Head and Neck Cancer
Official Title Body Image Functioning Among Surgically Treated Patients With Head and Neck Cancer
Brief 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.

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
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients, 18 years or older, with oral cavity or cutaneous cancer receiving surgical treatment.
Condition
  • Head and Neck Cancer
  • Skin Cancer
Intervention Behavioral: Questionnaire
1 questionnaire, about 15-20 minutes.
Other Name: Survey
Study Groups/Cohorts Questionnaire
1 questionnaire, about 15-20 minutes.
Intervention: Behavioral: Questionnaire
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 1, 2012)
289
Original Estimated Enrollment
 (submitted: January 15, 2009)
250
Study Completion Date Not Provided
Actual Primary Completion Date September 2012   (Final data collection date for primary outcome measure)
Eligibility 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00824174
Other Study ID Numbers 2008-0080
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party M.D. Anderson Cancer Center
Study Sponsor M.D. Anderson Cancer Center
Collaborators Not Provided
Investigators
Principal Investigator: Michelle C Fingeret, PHD M.D. Anderson Cancer Center
PRS Account M.D. Anderson Cancer Center
Verification Date October 2012