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

头颈癌幸存者身体形象障碍的新治疗策略

• 批准号: 10057080
• 负责人: Evan Michael Graboyes
• 金额: $ 38.7万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-01 至 2022-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10057080
• 关键词: Address; Appearance; Area; Behavioral; Behavioral Mechanisms; Body Image; Body measure procedure; Cancer Survivor; Cancer Survivorship; Clinical; Cognitive Therapy; Coping Behavior; Cosmetics; Data; Deglutition; Dose; Enrollment; Equipment and supply inventories; Future; Goals; Head Cancer; Head and Neck Cancer; Image; Intervention; Life; Measures; Mediating; Mediator of activation protein; Methodology; Morbidity - disease rate; Neck Cancer; Participant; Patients; Pilot Projects; Population; Preparation; Quality of life; Randomized; Randomized Controlled Trials; Research; Scientific Advances and Accomplishments; Site; Social isolation; Source; Stigmatization; Tablets; Telemedicine; Testing; Therapeutic; Therapeutic Intervention; Well in self; active control; arm; base; cancer therapy; clinical care; clinical effect; clinical efficacy; clinical practice; coping; effective therapy; implementation research; improved; improved outcome; innovation; novel; patient oriented; post intervention; primary endpoint; psychologic; psychosocial; secondary endpoint; social; treatment strategy

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.

项目总结/摘要 这个R21项目将测试一种新的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）干预治疗头颈部癌症的体像障碍（BID） (HNC)通过平板电脑远程医疗平台为幸存者提供服务。HNC在宇宙中产生， 功能关键区域，导致与毁容、困难相关的改变生活的发病率 吞咽和挑战说话。因此，HNC幸存者的BID率很高，这是一个多方面的问题。 以外观和/或功能上令人不安的自我感知变化为特征的构造。虽然BID是 一个重要的发病率来源，并与耻辱，社会孤立和生活质量下降有关 (QOL)因此，对于BID的HNC幸存者缺乏有效的治疗。至关重要的是， 新的干预措施，以尽量减少心理社会发病率和改善生活质量在这一人群。我们开发并 BRIGHT（Building a Renewed ImaGe after Head & Neck Cancer Treatment），5个疗程，手动 基于平板电脑的远程CBT干预，针对HNC相关BID的行为和态度组成部分。 我们的单组初步研究表明，BRIGHT是可行的，是可接受的，有可能降低BID， 并可能通过改善身体形象应对行为来介导BID的降低。这一总体目标 我们的建议是评估BRIGHT作为一种新型药物的初步临床影响和行为机制， 在HNC幸存者中治疗BID的范例，估计效应量，并优化我们的方法学， 大规模、多中心、随机对照试验（RCT）。在本试验性RCT中，BID的HNC幸存者将 随机分配至BRIGHT或活性对照组（AC）。该提案的核心前提是，HNC幸存者的BID可以 通过远程CBT干预治疗，针对BID的行为介质。具体目标1将评估 BRIGHT对HNC幸存者BID的初步影响。我们假设BRIGHT会有一个更大的 对BID的影响大于AC。具体目标2将探索BRIGHT的行为作用机制。 我们假设，改善身体形象的应对行为将部分介导减少BID。研究 研究结果有望提供评估BRIGHT临床效果的有价值数据，从而解决 重大未满足的需求，并帮助制定新的标准，临床护理HNC幸存者与BID。的 研究的行为焦点有望通过阐明机制来推进科学理解 对BID的HNC幸存者进行CBT干预的潜在结局改善。最后，通过帮助推进 为具有高转化潜力的癌症幸存者提供心理行为干预的创新平台， 本研究可能具有比BID更广泛的意义和治疗意义。结果将提供必要的 进一步完善BRIGHT的初步数据，并为未来的多中心RCT提供动力，以全面评估临床疗效 BRIGHT作为治疗HNC幸存者BID的新范例的行为机制。

项目成果

Factors Associated With Risk of Body Image-Related Distress in Patients With Head and Neck Cancer.

• DOI: 10.1001/jamaoto.2021.1378
• 发表时间: 2021-12-01
• 期刊: JAMA otolaryngology-- head & neck surgery
• 作者: Macias D;Hand BN;Maurer S;Balliet W;Ellis MA;Pipkorn P;Huang AT;Nilsen ML;Ruggiero KJ;Williams AM;Marsh CH;Li H;Rhoten BA;Sterba KR;Graboyes EM
• 通讯作者: Graboyes EM

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.

• DOI: 10.1001/jamaoto.2022.3700
• 发表时间: 2023-01-01
• 期刊: JAMA OTOLARYNGOLOGY-HEAD & NECK SURGERY
• 影响因子: 7.8
• 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.
• 通讯作者: Sterba, Katherine R.

Efficacy of a Brief Cognitive Behavioral Therapy for Head and Neck Cancer Survivors with Body Image Distress: Secondary Outcomes from the BRIGHT Pilot Randomized Clinical Trial.

简短的认知行为疗法对患有身体形象困扰的头颈癌幸存者的疗效：来自 BRIGHT 试点随机临床试验的次要结果。

• DOI: 10.21203/rs.3.rs-3222601/v1
• 发表时间: 2023
• 期刊: Research square
• 作者: Graboyes,EvanM;Kistner-Griffin,Emily;Hill,ElizabethG;Maurer,Stacey;Balliet,Wendy;Williams,AmyM;Padgett,Lynne;Yan,Flora;Rush,Angie;Johnson,Brad;McLeod,Taylor;Dahne,Jennifer;Ruggiero,KennethJ;Sterba,KatherineR
• 通讯作者: Sterba,KatherineR

Association Between Observer-Rated Disfigurement and Body Image-Related Distress Among Head and Neck Cancer Survivors.

头颈癌幸存者中观察者评定的毁容与身体形象相关的困扰之间的关联。

• DOI: 10.1001/jamaoto.2022.0822
• 发表时间: 2022
• 期刊: JAMA otolaryngology-- head & neck surgery
• 作者: Macias,David;Hand,BrittanyN;Zenga,Joseph;Pipkorn,Patrik;Nilsen,MarciL;Williams,AmyM;Graboyes,EvanM
• 通讯作者: Graboyes,EvanM

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

对患有身体形象困扰的头颈癌幸存者进行简短认知行为治疗的机制。

• DOI: 10.21203/rs.3.rs-3303379/v1
• 发表时间: 2023
• 期刊: Research square
• 作者: Graboyes,EvanM;Kistner-Griffin,Emily;Hill,ElizabethG;Maurer,Stacey;Balliet,Wendy;Williams,AmyM;Padgett,Lynne;Yan,Flora;Rush,Angie;Johnson,Brad;McLeod,Taylor;Dahne,Jennifer;Ruggiero,KennethJ;Sterba,KatherineR
• 通讯作者: Sterba,KatherineR