Cognitive Training for Cancer-related Cognitive Impairment: A Multi-Center Randomized Controlled Trial

项目摘要/摘要 该项目的目标是确定计算机认知训练对乳腺癌的疗效。 患有癌症相关认知障碍(CRCI)的幸存者(BC)。对于数百万癌症幸存者来说， CRCI是一种普遍、严重和持续的问题，对工作成果(工作能力和 生产力)、健康认知和与健康相关的生活质量。有证据表明，多达75%的更多 美国超过380万BCS将在接受治疗后经历可能持续数年的认知变化 结束了。不幸的是，管理癌症幸存者这些认知变化的科学基础是极其重要的 有限的。来自试点研究的现有证据，包括我们自己的工作，表明计算机化的认知 训练，基于神经可塑性原理(大脑神经元重组和形成的能力 新的神经网络)，可能是一种可行的治疗选择。然而，到目前为止，之前的试验受到以下因素的限制 缺乏注意力控制的设计，样本少，随访有限。因此，要克服 在过去研究和我们试验结果的基础上，这2组的目的是双掩蔽，随机对照 试验是进行第一次全面的疗效试验，将计算机化认知训练(BrainHQ)与 计算机化的主动注意控制(数独、填字游戏、单词查找等)在BCS。具体目标是：(1) 电脑认知训练对改善认知功能的效果 干预和随时间推移，比较主动注意控制；(2)测试计算机化认知的效果 与注意力控制相比，随着时间的推移，训练对认知表现的影响；以及(3)探索迁移对 真实世界的日常结果，包括与工作相关的结果和与健康相关的生活质量 与主动注意力控制相比。这项建议已经过同行审查，并得到了NRG的认可 NCI社区肿瘤研究计划肿瘤学研究基地(NCI NCORP)和 NCI癌症预防部门已批准NRG肿瘤学在其附属公司进行试验 网站。将通过NCI NCORP和NCI National确定和同意总共386个符合条件的BCS 临床试验网络(NCTN)站点，由2000多个参与站点组成，包括社区和 少数人临床肿瘤学网站。结果将在四个时间点收集：干预前的基线 (T1)、干预后即刻(T2)、干预后3个月(T3)、干预后6个月(T4)。数据将是 使用线性混合模型对重复测量进行分析。目前的提案直接回应了NCI 特别关注测试旨在解决癌症不良衰老相关影响的干预措施的通知 和癌症治疗，建立在我们之前的初步研究的基础上，同时也对方法进行了改进， 并利用对所有NCORP站点的访问。因此，这将是第一次全面测试计算机化的研究 癌症存活者CRCI的认知训练为临床医生提供经验证据 治疗认知障碍的建议和幸存者的治疗选择。

PROJECT SUMMARY/ABSTRACT The goal of this project is to determine the efficacy of computerized cognitive training for breast cancer survivors (BCS) suffering from cancer-related cognitive impairment (CRCI). For millions of cancer survivors, CRCI is a prevalent, severe, and persistent problem that negatively impacts work outcomes (work ability and productivity), health perception, and health-related quality of life. Evidence suggests that up to 75% of the more than 3.8 million BCS in the U.S. will experience cognitive changes that may persist for years after treatment ends. Unfortunately, the scientific basis for managing these cognitive changes in cancer survivors is extremely limited. Available evidence from pilot studies, including our own work, suggests that computerized cognitive training, which is based on the principles of neuroplasticity (ability of brain neurons to re-organize and form new neural networks), may be a viable treatment option. However, previous trials to date have been limited by lack of attention-controlled designs, small samples, and limited follow-up. Therefore, to overcome limitations of past studies and build on our pilot results, the purpose of this 2-group, double-masked, randomized controlled trial is to conduct the first full-scale efficacy trial to compare computerized cognitive training (BrainHQ) to computerized active attention control (Sudoku, crossword, word find, etc.) in BCS. Specific aims are to: (1) test the efficacy of computerized cognitive training on improving perceived cognitive function immediately post- intervention and over time, compared to active attention control; (2) test the efficacy of computerized cognitive training on cognitive performance over time compared to attention control; and (3) explore transfer effects on real-world, everyday outcomes including work-related outcomes and health-related quality of life over time compared to active attention control. This proposal has been peer-reviewed and endorsed by the NRG Oncology Research Base of the NCI Community Oncology Research Program (NCI NCORP) and the NCI Division of Cancer Prevention has approved NRG Oncology to conduct the trial at their affiliated sites. A total of 386 eligible BCS will be identified and consented through the NCI NCORP and NCI National Clinical Trials Network (NCTN) sites, composed of over 2,000 participating locations including community and minority clinical oncology sites. Outcomes will be collected at four time points: baseline, prior to intervention (T1), immediately post-intervention (T2), 3 months (T3), and 6 months (T4) post-intervention. Data will be analyzed using linear mixed models for repeated measures. The current proposal responds directly to the NCI Notice of Special Interest to test interventions designed to address the adverse aging-related effects of cancer and cancer treatments, builds on our previous pilot studies while also making methodological improvements, and leverages access to all NCORP sites. Therefore, this will be the first full-scale study to test computerized cognitive training in cancer survivors with CRCI and provide empirical evidence for clinicians’ recommendations and survivors’ treatment selections for managing cognitive impairment.