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

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

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

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

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

Sample Size Estimate http://www.openepi.com/SampleSize/SSCohort.htm

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