This R21 project will test the preliminary clinical impact and underlying behavioral mechanism of action of a novel
cognitive behavioral therapy (CBT) intervention to treat body image disturbance (BID) in head and neck cancer
(HNC) survivors that is delivered via a tablet-based telemedicine platform. HNC arises in cosmetically and
functionally critical areas, resulting in substantial life-altering morbidity related to disfigurement, difficulty
swallowing, and challenges speaking. As a result, HNC survivors suffer high rates of BID, a multidimensional
construct characterized by a displeasing self-perceived change in appearance and/or function. Although BID is
a source of significant morbidity and associated with stigmatization, social isolation, and decreased quality of life
(QOL), effective therapies for HNC survivors with BID are lacking. It is critically important to develop and test
novel interventions to minimize psychosocial morbidity and improve QOL in this population. We developed and
pilot-tested BRIGHT (Building a Renewed ImaGe after Head & neck cancer Treatment), a 5-session, manualized
tablet-based tele-CBT intervention that targets the behavioral and attitudinal components of HNC-related BID.
Our single-arm pilot study showed that BRIGHT is feasible, is acceptable, has the potential to decrease BID,
and may mediate a reduction in BID by improving body image coping behavior. The overall objectives of this
proposal are to evaluate the preliminary clinical impact and behavioral mechanism of BRIGHT as a novel
paradigm for treating BID in HNC survivors, estimate effect sizes, and optimize our methodology in preparation
for a large-scale, multi-site, randomized controlled trial (RCT). In this pilot RCT, HNC survivors with BID will be
randomized to BRIGHT or active control (AC). The proposal’s central premise is that BID in HNC survivors can
be treated by a tele-CBT intervention that targets the behavioral mediators of BID. Specific Aim 1 will evaluate
the preliminary impact of BRIGHT on BID in HNC survivors. We hypothesize that BRIGHT will have a larger
effect on BID than AC will. Specific Aim 2 will explore the behavioral mechanism of action underlying BRIGHT.
We hypothesize that improvements in body image coping behavior will partially mediate a decrease in BID. Study
findings are expected to provide valuable data evaluating the clinical effect of BRIGHT, thereby addressing a
significant unmet need and helping develop new standards of clinical care for HNC survivors with BID. The
behavioral focus of the research is expected to advance scientific understanding by elucidating mechanisms
underlying improved outcomes for CBT interventions for HNC survivors with BID. Finally, by helping advance an
innovative platform to deliver psychobehavioral interventions to cancer survivors with high translational potential,
this study may have broad significance and therapeutic implications beyond BID. Results will provide essential
preliminary data to further refine BRIGHT and power a future multi-site RCT to evaluate fully the clinical efficacy
and behavioral mechanisms of BRIGHT as a novel paradigm for treating BID in HNC survivors.
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