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.
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.
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DOI：
10.1001/jamaoto.2022.3700
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发表时间：
2023-01-01
影响因子：
7.8
通讯作者：
Sterba, Katherine R.
中科院分区：
文献类型：
--
作者：
Graboyes, Evan M.;Maurer, Stacey;Balliet, Wendy;Li, Hong;Williams, Amy M.;Osazuwa-Peters, Nosayaba;Yan, Flora;Padgett, Lynne;Rush, Angie;Ruggiero, Kenneth J.;Sterba, Katherine R.
虽然1/4的头颈癌（HNC）幸存者经历临床显著的身体形象困扰（BID），心理社会发病率，对生活质量产生不利影响，但缺乏对这些患者的有效干预。评估BRIGHT（在头颈癌治疗后建立更新的ImaGe）的可接受性和初步疗效，这是一种简短的远程认知行为疗法，可减少HNC幸存者的BID。这项平行组初探性随机临床试验在2020年8月13日至2021年12月9日期间从南卡罗来纳州医科大学HNC诊所招募了BID的成人HNC幸存者。数据分析时间为2022年5月3日至6月16日。BRIGHT由5个每周一次的心理学家领导的视频远程认知行为治疗会议组成。注意力控制（AC）包括剂量和分娩匹配的生存教育。使用IMAGE-HN（测量和评估头颈部影像障碍的清单）评估HNC相关BID的变化，这是一种经验证的患者报告结局（评分范围为0-84，评分越高表示HNC相关BID越大）。临床应答率测量为IMAGE-HN评分发生有临床意义变化的患者比例。在44例BID分配至BRIGHT组（n = 20）或AC组（n = 24）的HNC幸存者中，中位（范围）年龄为63（41-80）岁，27例患者（61%）为女性。患者对BRIGHT的可接受性评价很高（所有指标的平均评分≥4.5/5），20例接受BRIGHT治疗的患者中有19例（95%）可能或非常可能将其推荐给BID的其他HNC幸存者。BRIGHT降低了HNC相关BID从基线至干预后1个月相对于AC（IMAGE-HN评分变化的平均模型差异，−7.9分; 90% CI，−15.9至0.0分）和从基线至干预后3个月相对于AC（IMAGE-HN评分变化的平均模型差异，−17.1分; 90% CI，−25.6至−8.6分）。在干预后3个月，BRIGHT的临床反应率是AC的6.6倍（基于模型的比值比，6.6; 90%CI，2.0-21.8）。3个月时，BRIGHT与AC相比，HNC相关BID的改善具有临床意义，效应量较大（Cohen d，−0.9; 90% CI，−1.4至−0.4）。在这项初步随机临床试验中，BRIGHT是可接受的，可能导致HNC相关BID出现具有临床意义的改善，并显示出较高的临床应答率。这些有希望的初步数据支持进行一项大型疗效试验，以确定BRIGHT是BID HNC幸存者的第一个循证治疗。ClinicalTrials.gov标识符：NCT 03831100
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. 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. 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. BRIGHT consisted of 5 weekly psychologist-led video tele–cognitive behavioral therapy sessions. Attention control (AC) consisted of dose- and delivery-matched survivorship education. 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. 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). 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. ClinicalTrials.gov Identifier: NCT03831100
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