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

移动设备 CBT 治疗化疗相关认知功能障碍：一项多中心随机对照试验

• 批准号: 10652586
• 负责人: Robert J Ferguson
• 金额: $ 59.23万
• 依托单位: UNIVERSITY OF PITTSBURGH AT PITTSBURGH
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-06-01 至 2025-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10652586
• 关键词: Address; Aftercare; Attention; Behavioral; Brain; Brain Injuries; Brain region; Breast Cancer survivor; Breast Cancer survivorship; Cancer Center; Cancer Survivor; Caring; Clinical; Cognitive; Cognitive Therapy; Compensation; Data; Development; Evidence based treatment; Failure; Fostering; Foundations; Functional Magnetic Resonance Imaging; Goals; Health Services Accessibility; Impaired cognition; Individual; Intervention; Life; Link; Memory; Methodology; Modification; Neurobehavioral Manifestations; Neurocognitive; Outcome; Outcome Measure; Participant; Patient Self-Report; Patients; Pattern; Performance; Personal Satisfaction; Pharmaceutical Preparations; Physical activity; Pilot Projects; Placebos; Population; Process; Publishing; Quality of life; Randomized; Randomized, Controlled Trials; Recommendation; Recovery; Rehabilitation therapy; Research; Risk; Ritalin; Rural; Sample Size; Secure; Self Management; Self Perception; Short-Term Memory; Site; Supportive care; Survivors; Task Performances; Testing; Time; Training; Traumatic Brain Injury; Travel; Videoconferencing; Visit; Waiting Lists; Work; active control; active control group; attentional control; cancer care; chemotherapy; cognitive change; cognitive enhancement; cognitive function; cognitive performance; cognitive training; computerized; control trial; coping; density; design; disability; effective therapy; efficacy evaluation; emotion regulation; emotional adjustment; experience; follow up assessment; follow-up; frontal lobe; gray matter; handheld mobile device; health care settings; improved; malignant breast neoplasm; mindfulness; mobile computing; neuroimaging; non-drug; nondrug therapy; personalized intervention; pill; primary outcome; processing speed; public health priorities; randomized trial; rural area; survivorship; therapy development; translational potential; videoconference

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.

抽象的 拟议的研究将检验视频会议提供的认知行为疗法的功效 (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 （随机对照试验）针对患有化疗相关认知功能障碍（CRCD）的乳腺癌幸存者。结果 措施包括主观和客观认知功能的评估。的另一个目标是 研究目的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，这些变化是 据信与 MAAT 的积极作用有关。 MPI 最近的分析表明 MAAT 治疗后，工作记忆相关的皮层激活增强 创伤性脑损伤（TBI）。目前的工作旨在确定相同的激活模式是否发生后 MAAT 治疗与乳腺癌幸存者的注意力控制条件（支持疗法；ST）的比较。如果 如果成功的话，这项工作的结果将：（1）产生一种可以立即实施的循证治疗方法 传播到癌症中心和其他医疗机构以治疗 CRCD，并且 (2) 帮助进一步提供信息 通过更好地了解促进 CRCD 康复的机制来开发治疗方法。 MAAT 利用非药物、CBT 方法来增强自我管理、行为适应和应对晚期症状 化疗对认知的影响。 MAAT 已在之前的四项小型试验中进行了评估：1) 单组试验 试点研究（NCI R03）； 2) 随机候补对照试验（兰斯·阿姆斯特朗基金会）； 3）和随机 积极对照组条件（支持疗法；ST）的试验，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出有希望的结果 具有改善的主观和客观认知功能。在第四项试验中，有认知症状的个体 创伤性脑损伤 (TBI) 后，单独使用 MAAT 或联合使用 MAAT 治疗后，认知功能得到改善 与接受行为或药物安慰剂的患者相比，与哌醋甲酯联合使用。迄今为止的研究 是有利的，MAAT 尚未在独立、多名临床医生或多个机构的大型随机对照试验中进行评估 确定乳腺癌人群的有效性和普遍性的网站。只有一名临床医生已分娩 以往乳腺癌生存研究中的MAAT且样本量较小。因此， 拟议的研究在多地点使用更大的样本量进行了重要的方法改进， 具有 ST 控制条件的多临床医生随机对照试验，并通过提供两者来减少幸存者旅行负担 MAAT 和 ST 通过安全视频会议链接。因此，拟议的研究具有巨大的潜力 临床和科学影响，并将有助于提供可广泛应用的有效非药物治疗 使用移动技术进行传播，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。