1. Prospective Cohort Study of Body Image Disturbance in Surgically-Managed Head and Neck Cancer Patients
Evan Graboyes MD
Department of Otolaryngology-Head & Neck Surgery
Cancer Control Program, Hollings Cancer Center
Medical University of South Carolina

2. Study Question/Hypothesis
Knowledge Gap
Uncertain risk factors for Body Image Disturbance (BID) following treatment of head and neck cancer (HNC)
Hypothesis: Patients w/ baseline (pre-treatment) depression have an increased risk of developing BID following HNC treatment

3. Study Design Design: Prospective cohort study
Target Population: surgically-treated HNC
Source Population: single academic medical center
Inclusion Criteria
> 18 years of age
SCC of OC, OP, HP, Lx or cutaneous malignancy of HN
Surgery at MUSC+/- reconstruction +/- adjuvant therapy
Exposure: Depression
Outcome: Body Image Disturbance

4. Data Analysis: Exposure, Covariates, Outcome
Exposure (Depression)
Quick Inventory of Depressive Symptomatology-Self-Rated
1-5=none; 6-10=mild ; 11-15=mod; 16-20=severe; 21-27=very severe
Covariates
Sociodemographics and severity of comorbidity
Oncologic + treatment characteristics
PROMs: Satisfaction w/ roles, social isolation, Shame and Stigma
Performance Status Scale-HN
Primary Outcome Measure (Body Image Disturbance)
Body Image Scale (BIS)
10 items; scored 0-30; > 10 is clinically significant
Measure of Association: Rate ratio

5. Data Analysis: Data Collection
Data collection methods
Tablet-based collection in clinic by project coordinator
Data collection timeline
Clinical encounters timed with NCCN surveillance visits

6. Sample Size Estimate

7. Limitations Study Setting Patient population Exposure status Measures
Single institution study  limited external validity
Patient demographics, case complexity/mix, preop counseling, care processes, etc
Patient population
Heterogeneous inclusion criteria  limited internal validity
Exposure status
Treatment of patients w/ depression  bias towards null
Measures
BIS not designed nor specifically validated in HNC patients
MCID btw groups or changes over time not known
Data analysis
Unmeasured residual confounding
Continuous vs categorical variables for exposure and outcome