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

基本信息

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
项目类别：
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

项目摘要

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研究视频会议延迟认知行为疗法的功效（CBT），记忆和注意适应训练（MAAT），在大型多站点，随机对照试验中（RCT）用于化疗相关认知功能障碍（CRCD）的乳腺癌幸存者（RCT）。结果措施包括评估主观和客观认知功能。另一个目标研究是使用功能性MRI（fMRI）来评估大脑激活模式的潜在变化被认为与MAAT的积极作用有关。 MPI的最新分析已证明在MAAT治疗的个体中，与工作记忆相关的皮质激活增强了创伤性脑损伤（TBI）。目前的工作旨在确定是否发生相同的激活模式。在乳腺癌幸存者中使用MAAT与注意力控制条件（支持疗法； ST）治疗。如果成功，这项工作的结果将是：（1）产生一个基于证据的治疗，可以立即传播到癌症中心和其他医疗机构以治疗CRCD，（2）有助于进一步告知通过改善对促进CRCD恢复的机制的理解，治疗开发。马特利用非药物的CBT方法来增强自我管理，行为适应和应对化学疗法的认知作用。 MAAT已在以前的四个小试验中进行了评估：1）单组试点研究（NCI R03）; 2）一项随机候补控制审判（Lance Armstrong Foundation）； 3）和一个随机具有主动对照组条件（支持疗法； ST）的试验，其中MAAT和ST干预措施都通过视频会议（NCI R21）交付。乳腺癌幸存者的研究显示出令人鼓舞的结果具有改善的主观和客观认知功能。在第四次试验中，患有认知症状的人创伤性脑损伤后（TBI）在单独或在MAAT中治疗时表现出改善的认知功能相对于接受行为或药丸安慰剂的哌醋甲酯的结合。迄今为止的研究很有利，MAAT尚未在具有独立的，多个临床医生或多个的大型RCT中评估在乳腺癌人群中建立功效和普遍性的站点。只有一位临床医生交付先前乳腺癌生存研究和样本量的MAAT很小。因此，拟议的研究使用多站点中的样本量较大，进行了重要的方法学改进，具有ST控制状态的多智性RCT，并通过交付两者来减轻生存旅行负担 MAAT和ST上有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影响，将有助于提供有效的非药物治疗使用移动技术，特别是对农村幸存者进行传播，以减少旅行和时间负担，改善生存护理。