Clinical trial NCT00824174: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Skin Cancer
Keywords: Questionnaire
Head and Neck Cancer
Skin Cancer
Body Image
Surgical Treatment
Oral Cavity Cancer
Cutaneous Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2009-01-16
Enrollment: 289
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients, 18 years or older, with oral cavity or cutaneous cancer receiving surgical treatment.

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.

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)

Primary outcomes:
measure: Body image outcomes (i.e., Body Image Scale) for patients at different time points relative to initiation of treatment
timeFrame: 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 outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: UT MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Michelle C Fingeret, PHD
role: PRINCIPAL_INVESTIGATOR
References: