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

项目总结/摘要 这个项目的目标是确定计算机化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（BCS）。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），健康感知和健康相关的生活质量。有证据表明，75%以上的 在美国，超过380万名BCS患者将经历认知变化，这些变化可能在治疗后持续数年 形接头.不幸的是，管理癌症幸存者这些认知变化的科学基础是非常困难的。 有限公司包括我们自己的工作在内的试点研究的现有证据表明，计算机化的认知 训练，这是基于神经可塑性的原则（大脑神经元的能力，重新组织和形成 新的神经网络），可能是一个可行的治疗选择。然而，迄今为止，以前的审判受到以下限制： 缺乏注意力控制的设计，小样本和有限的后续行动。因此，为了克服 过去的研究，并建立在我们的试点结果，这个2组，双盲，随机对照的目的 试验是进行第一个全面的疗效试验，比较计算机认知训练（BrainHQ）， 电脑主动注意力控制（数独，填字游戏，单词查找等）在BCS。具体目标是：（1） 测试计算机化认知训练对改善术后即刻认知功能的有效性， 干预和随着时间的推移，与主动注意控制相比;（2）测试计算机认知的功效 随着时间的推移，与注意力控制相比，培训对认知表现的影响;（3）探索迁移对 真实世界的日常结果，包括随时间推移的工作相关结果和健康相关生活质量 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社区肿瘤学研究计划（NCI NCORP）的肿瘤学研究基地 NCI癌症预防部门已批准NRG肿瘤学在其附属机构进行试验 网站.将通过NCI NCORP和NCI National确定并同意共计386例合格BCS 临床试验网络（NCTN）网站，由2,000多个参与地点组成，包括社区和 少数临床肿瘤学站点。将在四个时间点收集结局：基线、干预前 (T1)干预后即刻（T2）、干预后3个月（T3）和干预后6个月（T4）。数据将 使用重复测量的线性混合模型进行分析。目前的提案直接响应NCI 特别关注的通知，以测试旨在解决癌症的不良衰老相关影响的干预措施 和癌症治疗，建立在我们以前的试点研究的基础上，同时也进行了方法上的改进， 并利用对所有NCORP站点的访问。因此，这将是第一个全面的研究，以测试计算机化的 CRCI癌症幸存者的认知训练，并为临床医生提供经验证据， 建议和幸存者的治疗选择管理认知障碍。

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.