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.

项目概要/摘要 该 R21 项目将测试一种新型药物的初步临床影响和潜在行为机制。 认知行为疗法 (CBT) 干预治疗头颈癌的身体意象障碍 (BID) 通过基于平板电脑的远程医疗平台提供的 HNC 幸存者出现在美容和护理领域。 功能关键区域，导致与毁容、困难相关的严重改变生活的发病率 因此，HNC 幸存者患有 BID（一种多维疾病）的比例很高。 尽管 BID 是一种以外观和/或功能上令人不快的自我感知变化为特征的构造。 是严重发病的根源，并与耻辱、社会孤立和生活质量下降有关 (QOL)，缺乏针对 BID 的 HNC 幸存者的有效疗法，开发和测试至关重要。 我们开发并实施了新颖的干预措施，以最大限度地减少心理社会发病率并改善该人群的生活质量。 经过试点测试的 BRIGHT（在头颈癌治疗后建立更新的形象），一个为期 5 次的手动操作 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。 我们的单臂试点研究表明 BRIGHT 是可行的，是可以接受的，有可能降低 BID， 并可能通过改善身体形象应对行为来减少 BID 的总体目标。 建议评估 BRIGHT 作为一种新型药物的初步临床影响和行为机制 HNC 幸存者中治疗 BID 的范例，估计效应大小，并优化我们的准备方法 一项大规模、多中心、随机对照试验 (RCT) 在这项试点 RCT 中，患有 BID 的 HNC 幸存者将被纳入研究范围。 该提案的核心前提是 HNC 幸存者可以进行 BID。 通过针对 BID 行为中介的远程 CBT 干预进行治疗，具体目标 1 将进行评估。 BRIGHT 对 HNC 幸存者 BID 的初步影响我们认为 BRIGHT 会有更大的影响。 具体目标 2 将探讨 BRIGHT 的行为机制。 我们探索身体形象应对行为的改善将部分介导 BID 研究的减少。 研究结果预计将提供评估 BRIGHT 临床效果的宝贵数据，从而解决 重大未满足的需求，并帮助为患有 BID 的 HNC 幸存者制定新的临床护理标准。 研究的行为焦点预计将通过阐明机制来促进科学理解 最后，通过帮助推进一项针对 BID 的 HNC 幸存者的 CBT 干预的潜在改善结果。 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， 这项研究可能具有广泛的意义和超越 BID 的治疗意义。结果将提供重要的信息。 初步数据进一步完善 BRIGHT 并为未来的多部位随机对照试验提供动力，以全面评估临床疗效 BRIGHT 的行为机制和行为机制作为治疗 HNC 幸存者 BID 的新范例。

项目成果

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。

• 发表时间: 2023-08-07
• 作者: Graboyes, Evan M;Kistner;Hill, Elizabeth G;Maurer, Stacey;Balliet, Wendy;Williams, Amy M;Padgett, Lynne;Yan, Flora;Rush, Angie;Johnson, Brad;McLeod, Taylor;Dahne, Jennifer;Ruggiero, Kenneth J;Sterba, Katherine R
• 通讯作者: Sterba, Katherine R

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短暂认知行为治疗的机制。

• 发表时间: 2023-12-16
• 作者: Graboyes, Evan M;Kistner;Hill, Elizabeth G;Maurer, Stacey;Balliet, Wendy;Williams, Amy M;Padgett, Lynne;Yan, Flora;Rush, Angie;Johnson, Brad;McLeod, Taylor;Dahne, Jennifer;Ruggiero, Kenneth J;Sterba, Katherine R
• 通讯作者: Sterba, Katherine R

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

与头颈癌患者身体形象相关痛苦风险相关的因素。

• 发表时间: 2021
• 作者: Macias, David;Hand, Brittany N;Maurer, Stacey;Balliet, Wendy;Ellis, Mark A;Pipkorn, Patrik;Huang, Andrew T;Nilsen, Marci L;Ruggiero, Kenneth J;Williams, Amy M;Marsh, Courtney H;Li, Hong;Rhoten, Bethany A;Sterba, Katherine R;Graboyes, Evan M
• 通讯作者: Graboyes, Evan M

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。

• 发表时间: 2023-08-29
• 作者: Graboyes, Evan M;Kistner;Hill, Elizabeth G;Maurer, Stacey;Balliet, Wendy;Williams, Amy M;Padgett, Lynne;Yan, Flora;Rush, Angie;Johnson, Brad;McLeod, Taylor;Dahne, Jennifer;Ruggiero, Kenneth J;Sterba, Katherine R
• 通讯作者: Sterba, Katherine R

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.

简短的远程认知行为治疗与注意力控制对患有身体形象困扰的头颈癌幸存者的疗效：一项试点随机临床试验。

• 发表时间: 2023-01-01
• 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.