Efficacy of a Brief Tele-Cognitive Behavioral Treatment vs Attention Control for Head and Neck Cancer Survivors With Body Image Distress: A Pilot Randomized Clinical Trial.

Importance: Although 1 in 4 head and neck cancer (HNC) survivors experience clinically significant body image distress (BID), a psychosocial morbidity that adversely affects quality of life, effective interventions for these patients are lacking. Objective: To evaluate the acceptability and preliminary efficacy of BRIGHT (Building a Renewed ImaGe after Head and neck cancer Treatment), a brief tele-cognitive behavioral therapy, at reducing BID among HNC survivors. Design, Setting, and Participants: This parallel-group pilot randomized clinical trial recruited adult HNC survivors with BID between August 13, 2020, and December 9, 2021, from the Medical University of South Carolina HNC clinic during a routine survivorship encounter. Data were analyzed from May 3 to June 16, 2022. Interventions: BRIGHT consisted of 5 weekly psychologist-led video tele-cognitive behavioral therapy sessions. Attention control (AC) consisted of dose- and delivery-matched survivorship education. Main Outcomes and Measures: Change in HNC-related BID was assessed using IMAGE-HN (Inventory to Measure and Assess imaGe disturbancE-Head and Neck), a validated patient-reported outcome (score range, 0-84, with higher scores indicating greater HNC-related BID). Clinical response rate was measured as the proportion of patients with a clinically meaningful change in IMAGE-HN scores. Results: Of the 44 HNC survivors with BID allocated to BRIGHT (n = 20) or AC (n = 24), the median (range) age was 63 (41-80) years, and 27 patients (61%) were female. Patients rated BRIGHT's acceptability highly (all metrics had a mean rating of ≥4.5/5), and 19 of 20 patients (95%) receiving BRIGHT were likely or highly likely to recommend it to other HNC survivors with BID. BRIGHT decreased HNC-related BID from baseline to 1 month postintervention relative to AC (mean model-based difference in change in IMAGE-HN score, -7.9 points; 90% CI, -15.9 to 0.0 points) and from baseline to 3 months postintervention relative to AC (mean model-based difference in change in IMAGE-HN score, -17.1 points; 90% CI, -25.6 to -8.6 points). At 3 months postintervention, the clinical response rate of BRIGHT was 6.6-fold higher than AC (model-based odds ratio, 6.6; 90% CI, 2.0-21.8). The improvement in HNC-related BID for BRIGHT vs AC at 3 months was clinically significant, and the effect size was large (Cohen d, -0.9; 90% CI, -1.4 to -0.4). Conclusions and Relevance: In this pilot randomized clinical trial, BRIGHT was acceptable, may result in a clinically meaningful improvement in HNC-related BID, and showed a high clinical response rate. These promising preliminary data support conducting a large efficacy trial to establish BRIGHT as the first evidence-based treatment for HNC survivors with BID. Trial Registration: ClinicalTrials.gov Identifier: NCT03831100.