PROJECT SUMMARY/ABSTRACT
This R01 proposal aims to test the efficacy of a tele-cognitive behavioral therapy (CBT) intervention as a novel
treatment paradigm for body image-related distress (BID) among head and neck cancer (HNC) survivors,
examine it’s underlying mechanism of change, and characterize factors affecting its future adoption into clinical
practice. Treatment of HNC results in substantial life-altering morbidity related to disfigurement, challenges
speaking, and difficulty swallowing. As a result, 75% of HNC survivors express body image concerns and 28%
meet criteria for BID. BID is a source of devastating psychosocial morbidity, as HNC survivors with BID have a
six-fold increase in depression, high rates of social isolation, decreased quality of life (QOL), and a 2-fold higher
rate of suicide mortality relative to other cancer survivors. To date, evidence-based strategies to manage HNC-
related BID are lacking. To address this gap, we developed BRIGHT (Building a Renewed ImaGe after Head &
neck cancer Treatment), a 5-session manualized tele-CBT intervention based on a transactional coping model
of HNC-related BID. Findings from our single-arm and pilot randomized controlled trial (RCT) showed that
BRIGHT was feasible, acceptable, and resulted in a statistically and clinically significant reduction in BID relative
to dose- and delivery-matched controls at 1- and 3-month follow-up. Our preliminary data suggest that BRIGHT
reduces HNC-related BID by enhancing adaptive body image coping skills (reducing avoidance, increasing
positive rational acceptance [i.e., rational appearance related self-talk]). Based on these promising preliminary
efficacy and mechanistic data, we propose a multi-site RCT in which HNC survivors with clinically significant BID
(N=180) will be randomized to BRIGHT or attention control (AC), a manualized tele-supportive care intervention
that controls for time, professional attention, and common factors. HNC survivors will complete measures of
HNC-related BID, psychological and social well-being, QOL, and measures of theory-derived mechanisms of
change underlying CBT. We will conduct semi-structured interviews and in-depth site visits to develop an
implementation toolkit to enhance the adoption of BRIGHT into clinical care. Specific Aim 1 will evaluate the
efficacy of BRIGHT relative to AC on (a) HNC-related BID and (b) psychological and social well-being and QOL.
Specific Aim 2 will examine the mechanism of change underlying BRIGHT for HNC-related BID. Specific Aim
3 will characterize key determinants that will affect the future adoption of BRIGHT into routine clinical practice.
Findings from our study may support BRIGHT as the first evidence-based strategy to manage BID among HNC
survivors, thereby developing new standards of care and improving psychosocial morbidity and QOL in this
population. Theory-driven mechanism of change data may help identify specific therapeutic elements to optimize
the effectiveness of CBT for BID as well as advance our understanding of the underlying theory of CBT. Finally,
findings may enhance the implementation of psychosocial interventions for cancer survivors in diverse settings.
