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

一项评估头颈癌幸存者身体形象相关困扰的新治疗策略的随机对照试验

• 批准号: 10586292
• 负责人: Evan Michael Graboyes
• 金额: $ 65.82万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-12-15 至 2027-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10586292
• 关键词: Address; Adoption; Affect; Appearance; Attention; Body Image; Cancer Intervention; Cancer Survivor; Cancer Survivorship; Caring; Chronic; Cognitive Therapy; Compassion; Consensus; Coping Skills; Data; Deglutition; Disease Management; Distress; Dose; Effectiveness; Elements; Empathy; Evaluation; Future; General Population; Head Cancer; Head and Neck Cancer; Image; Impairment; Intervention; Interview; Life; Manuals; Measures; Mediating; Mediator; Mental Depression; Methods; Modeling; Morbidity - disease rate; Neck Cancer; Oncology; Population; Psychosocial Assessment and Care; Psychotherapy; Quality of life; Randomized; Randomized, Controlled Trials; Site; Site Visit; Smiling; Social Well-Being; Social isolation; Source; Structure; Supportive care; Surveys; Therapeutic; Therapeutic Intervention; Time; Transact; Treatment Efficacy; arm; attentional control; cancer therapy; clinical care; clinical practice; clinically significant; coping; effective therapy; efficacy evaluation; efficacy testing; evidence base; expectation; follow-up; functional disability; improved; novel; post intervention; primary endpoint; psychologic; psychosocial; routine care; suicide mortality; theories; treatment strategy

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.

项目总结/摘要 这个R 01提案旨在测试远程认知行为疗法（CBT）干预作为一种新的 头颈癌（HNC）幸存者中身体意象相关痛苦（BID）的治疗范例， 检查其潜在的变化机制，并描述影响其未来应用于临床的因素 实践HNC的治疗导致与毁容、挑战相关的改变生活的发病率 说话和吞咽困难结果，75%的HNC幸存者表达了身体形象问题，28%的HNC幸存者表达了身体形象问题。 符合BID标准。BID是毁灭性的心理社会疾病的来源，因为患有BID的HNC幸存者有 抑郁症增加6倍，社会孤立率高，生活质量下降（QOL）， 相对于其他癌症幸存者的自杀死亡率。迄今为止，管理高营养不良的循证战略- 缺乏相关的BID。为了解决这一差距，我们开发了BRIGHT（在Head & 颈部癌症治疗），一个5会话手动远程CBT干预的基础上，交易应对模型 与HNC有关的BID。我们的单组和先导性随机对照试验（RCT）的结果显示， BRIGHT是可行的、可接受的，并导致BID相对于 在1个月和3个月随访时与剂量和给药匹配的对照组相比。我们的初步数据表明， 通过增强适应性身体形象应对技能（减少回避，增加 积极的理性接受[即，理性外表相关的自我对话]）。基于这些有希望的初步 疗效和机制数据，我们提出了一个多中心随机对照试验，其中HNC幸存者具有临床意义的BID （N=180）将被随机分配至BRIGHT或注意力控制（AC）组，这是一种手动远程支持护理干预 控制时间、专业注意力和共同因素。HNC幸存者将完成 HNC相关BID、心理和社会幸福感、QOL以及HNC理论衍生机制的测量 改变潜在的CBT。我们将进行半结构式访谈和深入实地考察， 实施工具包，以加强采用光明到临床护理。具体目标1将评估 BRIGHT相对于AC对（a）HNC相关BID和（B）心理和社会福祉及QOL的疗效。 具体目标2将检查HNC相关BID的BRIGHT潜在变化机制。具体目标 3将描述影响BRIGHT未来在常规临床实践中采用的关键决定因素。 我们的研究结果可能支持BRIGHT作为第一个管理HNC BID的循证策略 幸存者，从而制定新的护理标准，改善心理社会发病率和生活质量， 人口理论驱动的变化数据机制可能有助于识别特定的治疗元素进行优化 CBT对BID的有效性以及推进我们对CBT基本理论的理解。最后， 研究结果可能会加强对不同环境中癌症幸存者的心理社会干预的实施。