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A Randomized Controlled Trial to Evaluate a Novel Treatment Strategy for Body Image-Related Distress Among Head and Neck Cancer Survivors

Award Number: R37CA269385
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 12/15/2022
PERIOD OF PERFORMANCE END DATE: 11/30/2027

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A Randomized Controlled Trial to Evaluate a Novel Treatment Strategy for Body Image-Related Distress Among Head and Neck Cancer Survivors - 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.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $631,942 )
2026	2026	THE MEDICAL UNIVERSITY OF SOUTH CAROLINA	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Cancer Cause and Prevention Research	000	4	12/8/2025	NON-COMPETING CONTINUATION	$568,748
2026	2026	THE MEDICAL UNIVERSITY OF SOUTH CAROLINA	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Cancer Cause and Prevention Research	001	4	4/16/2026	NON-COMPETING CONTINUATION	$63,194
														Subtotal = $631,942

Issue Date FY: 2025 ( Subtotal = $631,830 )
2025	2025	THE MEDICAL UNIVERSITY OF SOUTH CAROLINA	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Cancer Cause and Prevention Research	001	3	5/29/2025	NON-COMPETING CONTINUATION	$63,182
2025	2025	THE MEDICAL UNIVERSITY OF SOUTH CAROLINA	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Cancer Cause and Prevention Research	000	3	11/26/2024	NON-COMPETING CONTINUATION	$568,648
														Subtotal = $631,830

Issue Date FY: 2024 ( Subtotal = $600,063 )
2024	2024	THE MEDICAL UNIVERSITY OF SOUTH CAROLINA	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Cancer Cause and Prevention Research	000	2	11/14/2023	NON-COMPETING CONTINUATION	$568,482
2024	2024	THE MEDICAL UNIVERSITY OF SOUTH CAROLINA	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Cancer Cause and Prevention Research	001	2	4/16/2024	NON-COMPETING CONTINUATION	$31,581
														Subtotal = $600,063

Issue Date FY: 2023 ( Subtotal = $658,153 )
2023	2023	MEDICAL UNIVERSITY OF SOUTH CAROLINA THE	179 ASHLEY AVE	CHARLESTON	SC	29425	CHARLESTON	USA	Cancer Cause and Prevention Research	000	1	12/15/2022	NEW	$658,153
														Subtotal = $658,153

Grand Total All Awards = $2,521,988

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A Randomized Controlled Trial to Evaluate a Novel Treatment Strategy for Body Image-Related Distress Among Head and Neck Cancer Survivors

Award Number: R37CA269385

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 12/15/2022

PERIOD OF PERFORMANCE END DATE: 11/30/2027

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