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

Document Type

Article

Publication Date

1-1-2023

Publication Title

JAMA Otolaryngol Head Neck Surg

Keywords

Adult, Humans, Female, Middle Aged, Aged, Aged, 80 and over, Male, Quality of Life, Body Image, Pilot Projects, Head and Neck Neoplasms, Survivors, Cognitive Behavioral Therapy, Cognition

Abstract

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.

Medical Subject Headings

Adult; Humans; Female; Middle Aged; Aged; Aged, 80 and over; Male; Quality of Life; Body Image; Pilot Projects; Head and Neck Neoplasms; Survivors; Cognitive Behavioral Therapy; Cognition

PubMed ID

36454561

Volume

149

Issue

1

First Page

54

Last Page

62

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