A Novel Treatment Strategy for Body Image Disturbance in Head and Neck Cancer Survivors

项目摘要/摘要 这个R21项目将测试一种新型药物的初步临床影响和潜在的行为作用机制 认知行为疗法(CBT)干预治疗头颈癌患者的体像障碍 (HNC)幸存者，通过基于平板电脑的远程医疗平台提供。HNC出现在化妆品和 功能关键区，导致与毁容、困难有关的严重改变生活的发病率 吞咽，挑战说话。结果，HNC幸存者遭受了高出价率，一个多维的 以令人不快的自我感知的外观和/或功能变化为特征的结构。尽管出价是 严重发病率的来源，与污名化、社会孤立和生活质量下降有关 对于患有BID的HNC幸存者，缺乏有效的治疗方法。开发和测试是至关重要的 新的干预措施，以最大限度地减少心理社会发病率和改善该人群的生活质量。我们开发了和 试点测试BREAT(在头颈部癌症治疗后重建形象)，5个疗程，手册 基于平板电脑的远程CBT干预，针对HNC相关BID的行为和态度组件。 我们的单臂试点研究表明，光明是可行的，可以接受的，有可能降低报价， 并且可以通过改善身体形象应对行为来调节出价的减少。这个项目的总体目标是 建议评估BLANT作为一种新的药物的初步临床影响和行为机制 治疗HNC幸存者BID的范例，估计效应大小，并在准备过程中优化我们的方法 用于大规模、多地点、随机对照试验(RCT)。在这个试点RCT中，HNC幸存者将出价 随机分为亮光对照或主动对照(AC)。该提案的核心前提是，竞标HNC幸存者可以 接受远程CBT干预，目标是BID的行为调解人。特定目标1将评估 BLANT对HNC幸存者竞标的初步影响。我们假设布莱特会有一个更大的 对投标的影响比AC更大。具体目标2将探索BREAT背后的行为机制。 我们假设，身体形象应对行为的改善将在一定程度上调节出价的下降。学习 这些发现有望提供有价值的数据，评估BREAT的临床效果，从而解决 重大未得到满足的需求，并通过BID帮助为HNC幸存者制定新的临床护理标准。这个 这项研究的行为焦点有望通过阐明机制来促进科学理解 通过BID对HNC幸存者进行CBT干预的潜在改善结果。最后，通过帮助推进 为癌症幸存者提供心理行为干预的创新平台，具有高翻译潜力， 本研究可能在BID之外具有广泛的意义和治疗意义。结果将提供必要的 初步数据将进一步提炼BIGH，并为未来的多部位RCT提供动力，以全面评估临床疗效 BREAT可作为治疗HNC存活者BID的新范例。

PROJECT SUMMARY/ABSTRACT This R21 project will test the preliminary clinical impact and underlying behavioral mechanism of action of a novel cognitive behavioral therapy (CBT) intervention to treat body image disturbance (BID) in head and neck cancer (HNC) survivors that is delivered via a tablet-based telemedicine platform. HNC arises in cosmetically and functionally critical areas, resulting in substantial life-altering morbidity related to disfigurement, difficulty swallowing, and challenges speaking. As a result, HNC survivors suffer high rates of BID, a multidimensional construct characterized by a displeasing self-perceived change in appearance and/or function. Although BID is a source of significant morbidity and associated with stigmatization, social isolation, and decreased quality of life (QOL), effective therapies for HNC survivors with BID are lacking. It is critically important to develop and test novel interventions to minimize psychosocial morbidity and improve QOL in this population. We developed and pilot-tested BRIGHT (Building a Renewed ImaGe after Head & neck cancer Treatment), a 5-session, manualized tablet-based tele-CBT intervention that targets the behavioral and attitudinal components of HNC-related BID. Our single-arm pilot study showed that BRIGHT is feasible, is acceptable, has the potential to decrease BID, and may mediate a reduction in BID by improving body image coping behavior. The overall objectives of this proposal are to evaluate the preliminary clinical impact and behavioral mechanism of BRIGHT as a novel paradigm for treating BID in HNC survivors, estimate effect sizes, and optimize our methodology in preparation for a large-scale, multi-site, randomized controlled trial (RCT). In this pilot RCT, HNC survivors with BID will be randomized to BRIGHT or active control (AC). The proposal’s central premise is that BID in HNC survivors can be treated by a tele-CBT intervention that targets the behavioral mediators of BID. Specific Aim 1 will evaluate the preliminary impact of BRIGHT on BID in HNC survivors. We hypothesize that BRIGHT will have a larger effect on BID than AC will. Specific Aim 2 will explore the behavioral mechanism of action underlying BRIGHT. We hypothesize that improvements in body image coping behavior will partially mediate a decrease in BID. Study findings are expected to provide valuable data evaluating the clinical effect of BRIGHT, thereby addressing a significant unmet need and helping develop new standards of clinical care for HNC survivors with BID. The behavioral focus of the research is expected to advance scientific understanding by elucidating mechanisms underlying improved outcomes for CBT interventions for HNC survivors with BID. Finally, by helping advance an innovative platform to deliver psychobehavioral interventions to cancer survivors with high translational potential, this study may have broad significance and therapeutic implications beyond BID. Results will provide essential preliminary data to further refine BRIGHT and power a future multi-site RCT to evaluate fully the clinical efficacy and behavioral mechanisms of BRIGHT as a novel paradigm for treating BID in HNC survivors.