Efficacy of a Brief Tele–Cognitive Behavioral Treatment vs Attention Control for Head and Neck Cancer Survivors With Body Image Distress

Abstract

ImportanceAlthough 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.ObjectiveTo 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 ParticipantsThis 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.InterventionsBRIGHT 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 MeasuresChange 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.ResultsOf 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 RelevanceIn 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 RegistrationClinicalTrials.gov Identifier: NCT03831100

Clinical Practice Strategies to Address Sexual Health in Female Cancer Survivors

“…The intervention consisted of five weekly CBT sessions with a psychologist via a telemedicine video platform (tele-CBT), workbook, and educational materials that included psychoeducation, self-monitoring, cognitive restructuring, coping strategies, and relapse prevention topics related to body image. 66 Compared with an attention control group, those participants in the tele-CBT group reported significantly less body image distress with a large effect size. 66 While these studies offer support for psychosexual counseling, none of the new psychosexual counseling studies reported adverse events.…”

“…66 Compared with an attention control group, those participants in the tele-CBT group reported significantly less body image distress with a large effect size. 66 While these studies offer support for psychosexual counseling, none of the new psychosexual counseling studies reported adverse events. Access because of a lack of insurance coverage or knowledgeable professionals continues to be a challenge for counseling-based interventions.…”

“…62,63,65 Recent data provide evidence for the effectiveness of psychosexual counseling for female cancer survivors. Six studies evaluating CBT, 33,64,66 couples-based sexual education and counseling, 67 self-healing training, 68 and group therapy with guided imagery found benefit. 69 Two of the psychosexual counseling interventions used remote delivery for their CBT intervention.…”

Mechanism Underlying a Brief Cognitive Behavioral Treatment for Head and Neck Cancer Survivors with Body Image Distress

“…The CONSORT diagram (eFigure 1 in Supplement 1), methods, and primary and secondary analyses for the RCT have been described in detail. 13,14 Results are reported according to the Consolidated Standards of Reporting Trials Extension (CONSORT Extension) reporting guidelines for randomized pilot and psychological intervention trials. 19,20…”

“…[7][8][9] Cognitive behavioral therapy (CBT)-based approaches have emerged as potential treatment paradigms for HNC survivors with BID. 10,11 BRIGHT (Building a Renewed ImaGe after Head & neck cancer Treatment) is a brief tailored CBT that has demonstrated feasibility, acceptability, telehealth compatibility, and preliminary e cacy in both single-arm 12 and pilot randomized clinical trial (RCT) 13,14 settings. BRIGHT was developed to target maladaptive body image coping among HNC survivors.…”