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

癌症相关认知障碍的认知训练：多中心随机对照试验

基本信息

批准号：
10562299
负责人：
PATRICIA A. GANZ
金额：
$ 63.91万
依托单位：
OHIO STATE UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2023
资助国家：
美国
起止时间：
2023-02-15 至 2028-01-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10562299
关键词：
Address Aftercare Age Aging Attention Brain Breast Cancer survivor Cancer Survivor Clinical Clinical Oncology Cognitive deficits Communities Community Clinical Oncology Program Consent Control Groups Data Division of Cancer Prevention Eligibility Determination Goals Health High Prevalence Home Impaired cognition Intervention Letters Life Location Malignant Neoplasms Masks Measures Memory Methodology Minority Modeling National Clinical Trials Network Negative Finding Neurocognitive Neuronal Plasticity Neurons Neuropsychological Tests Neuropsychology Oncology Outcome Patient Self-Report Peer Review Perception Performance Pilot Projects Productivity Randomized Randomized, Controlled Trials Recommendation Reporting Research Research Priority Sampling Science Site Survivors Testing Therapeutic Time Training Programs Translations Treatment-Related Cancer Waiting Lists Work attentional control base cancer therapy cancer-related cognitive impairment chemotherapy cognitive change cognitive function cognitive performance cognitive training computerized design efficacy evaluation efficacy testing efficacy trial evidence base experience follow-up health related quality of life hormone therapy improved interest neural network post intervention primary outcome processing speed programs remote assessment remote delivery secondary outcome therapy design

项目摘要

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.

项目概要/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 (BCS) 对于数百万癌症幸存者来说， CRCI 是一个普遍、严重且持续存在的问题，会对工作成果（工作能力和工作成果）产生负面影响。有证据表明，高达 75% 的人对健康认知以及与健康相关的生活质量有更高的要求。美国超过 380 万 BCS 将经历认知变化，这种变化可能在治疗后持续数年不幸的是，管理癌症幸存者这些认知变化的科学依据非常有限。来自试点研究（包括我们自己的工作）的现有证据表明，计算机化的认知能力是有限的。训练，基于神经可塑性原理（大脑神经元重新组织和形成的能力）新的神经网络）可能是一种可行的治疗选择，但是迄今为止的试验受到了限制。缺乏注意力控制设计、小样本和有限的后续研究因此需要克服局限性。过去的研究并以我们的试点结果为基础，这两组、双盲、随机对照的目的试验的目的是进行第一个全面的功效试验，以比较计算机化认知训练（BrainHQ）与 BCS 中的计算机化主动注意力控制（数独、填字游戏、单词查找等）具体目标是：(1) 测试计算机认知训练对术后立即改善感知认知功能的功效干预和随着时间的推移，与主动注意力控制相比；（2）测试计算机认知的功效；与注意力控制相比，认知表现随时间的训练；以及（3）探索转移对注意力控制的影响；现实世界的日常结果，包括随着时间的推移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，该提案已得到 NRG 的同行评审和认可。 NCI 社区肿瘤学研究计划 (NCI NCORP) 肿瘤学研究基地和 NCI 癌症预防部门已批准 NRG Oncology 在其附属机构进行试验将通过 NCI NCORP 和 NCI National 确定并同意总共 386 个符合条件的 BCS。临床试验网络 (NCTN) 站点由 2,000 多个参与地点组成，包括社区和少数临床肿瘤中心将在四个时间点收集结果：基线、干预前。 (T1)、干预后立即 (T2)、干预后 3 个月 (T3) 和 6 个月 (T4) 数据将是。使用线性混合模型进行重复测量分析当前的提案直接响应 NCI。特别关注测试旨在解决癌症与衰老相关的不利影响的干预措施的通知和癌症治疗，建立在我们之前的试点研究的基础上，同时还进行了方法改进，并利用对所有 NCORP 站点的访问因此，这将是第一个测试计算机化的全面研究。通过 CRCI 对癌症幸存者进行认知训练，并为信徒的认知训练提供经验证据管理认知障碍的建议和幸存者的治疗选择。