Mobile Device CBT for Chemotherapy-Related Cognitive Dysfunction: A Multi-Center Randomized Controlled Trial

摘要 这项拟议中的研究将检查视频会议提供的认知行为疗法的有效性 (CBT)，记忆和注意力适应训练（MAAT），在一项大型、多中心、随机对照试验中 (RCT)化疗相关认知功能障碍（CRCD）的乳腺癌幸存者。结果 测量包括主观和客观认知功能的评估。的另一个目标 研究是使用功能性磁共振成像（fMRI）来评估大脑激活模式的潜在变化， 据信与MAAT的积极作用有关。MPI最近的分析表明， MAAT治疗后工作记忆相关皮层激活增强 创伤性脑损伤（TBI）。目前的工作旨在确定是否发生相同的激活模式后， MAAT治疗与注意力控制条件（支持疗法; ST）在乳腺癌幸存者中的比较。如果 成功，这项工作的结果将：（1）产生一个循证治疗，可以立即 传播到癌症中心和其他医疗机构治疗CRCD和（2）帮助进一步了解 通过更好地理解促进CRCD康复的机制来开发治疗方法。MAAT 利用非药物的CBT方法来增强自我管理，行为适应和应对晚期 化疗对认知的影响MAAT已经在之前的四项小型试验中进行了评估：1）单组 试点研究（NCI R 03）; 2）随机候补对照试验（兰斯阿姆斯特朗基金会）; 3）和随机 一项活性对照组条件（支持性治疗; ST）试验，其中MAAT和ST干预 通过视频会议（NCI R21）进行。对乳腺癌幸存者的研究显示了有希望的结果 主观和客观认知功能得到改善。在第四项试验中，有认知症状的人 创伤性脑损伤（TBI）后的患者在单独使用MAAT或联合使用MAAT治疗时表现出认知功能改善。 与哌醋甲酯组合的那些相比，接受行为或药丸安慰剂的那些。虽然迄今为止的研究 是有利的，MAAT尚未在独立的多名临床医生或多名临床医生参与的大型RCT中进行评价。 在乳腺癌人群中建立疗效和普遍性的研究中心。只有一位临床医生 MAAT在以前的乳腺癌生存率研究中，样本量很小。因此 拟议的研究在多中心使用更大的样本量进行了重要的方法改进， ST控制条件下的多名临床医生RCT，并通过提供 MAAT和ST通过安全的视频会议链接。因此，拟议的研究具有巨大的潜力， 临床和科学的影响，并将有助于提供有效的非药物治疗，可以广泛 利用移动的技术传播，特别是向农村幸存者传播，以减少旅行和时间负担， 改善幸存者护理。

ABSTRACT The proposed research will examine the efficacy of a videoconference-delivered cognitive-behavioral therapy (CBT), Memory and Attention Adaptation Training (MAAT), in a large, multi-site, randomized controlled trial (RCT) for breast cancer survivors with chemotherapy-related cognitive dysfunction (CRCD). Outcome measures include assessment of both subjective and objective cognitive functioning. Another goal of the research is to use functional MRI (fMRI) to evaluate underlying changes in brain activation patterns that are believed to be associated with positive effects of MAAT. Recent analyses by the MPIs have demonstrated enhanced working memory-related cortical activation following MAAT treatment among individuals with traumatic brain injury (TBI). The present work seeks to determine if the same activation patterns occur post- treatment with MAAT vs. an attention control condition (supportive therapy; ST) in breast cancer survivors. If successful, the results of this work will: (1) produce an evidence-based treatment that can be immediately disseminated to cancer centers and other healthcare settings to treat CRCD and (2) help inform further treatment development through improved understanding of mechanisms that promote CRCD recovery. MAAT utilizes a non-drug, CBT approach to enhance self-management, behavioral adaptation, and coping with late cognitive effects of chemotherapy. MAAT has been evaluated in four previous small trials: 1) a single-group pilot study (NCI R03); 2) a randomized waitlist control trial (Lance Armstrong Foundation); 3) and a randomized trial with an active control group condition (supportive therapy; ST) in which both MAAT and ST interventions were delivered via videoconference (NCI R21). Research with breast cancer survivors shows promising results with improved subjective and objective cognitive function. In a fourth trial, individuals with cognitive symptoms after traumatic brain injury (TBI) showed improved cognitive function when treated with MAAT alone or in combination with methylphenidate relative to those receiving behavioral or pill placebo. While research to date is favorable, MAAT has not been evaluated in a large RCT with independent, multiple clinicians or at multiple sites to establish efficacy and generalizability in the breast cancer population. Only one clinician has delivered MAAT in previous breast cancer survivorship studies and the sample sizes were small. Therefore, the proposed study makes important methodological improvements using a larger sample size in a multi-site, multi-clinician RCT with an ST control condition, and reduces survivorship travel burden by delivering both MAAT and ST over secured videoconference link. The proposed study therefore has the potential for great clinical and scientific impact, and will help offer effective non-pharmacologic treatment that can be widely disseminated using mobile technology, especially to rural survivors, to reduce travel and time burden and improve survivorship care.