Anguera Joaquin A, Snowberg Karin, Paul Steven M, Cooper Bruce A, Oppegaard Kate, Harris Carolyn, Miaskowski Christine
School of Medicine, University of California, San Francisco, CA, USA.
School of Nursing, University of California, San Francisco, CA, USA.
Support Care Cancer. 2025 Mar 7;33(4):255. doi: 10.1007/s00520-025-09321-z.
The primary aims of this four week pilot randomized clinical trial (RCT) involving a targeted cognitive intervention (TCI, n = 25) compared to an expectancy matched active control intervention (EMACI, n = 24), in a sample of cancer survivors were to: determine recruitment and retention rates; evaluate preliminary efficacy to improve three objective measures of cognitive function (i.e., attention, working memory, multi-tasking); evaluate adherence rates for and satisfaction with the interventions, and evaluate for treatment-related adverse events (e.g., nausea, motion sickness).
Cancer survivors were recruited from previous studies through email. Following a screening call, survivors who consented to participate were oriented to the study measures and procedures via Zoom. Survivors were randomized to the TCI or EMACI and mailed an iPad with the software for their specific intervention and the Adaptive Cognitive Evaluation Explorer (ACE-X, the objective measure of cognitive function). Survivors used the intervention for 25 min per day at least 5 days per week. Differences in objective measures of attention, working memory, and multi-tasking were evaluated using multilevel regression analyses.
For the sustained attention measure, a significant cross-level interaction was found in favor of the TCI group. While improvements in multi-tasking occurred in both groups, while not statistically significant, the trend was larger for the TCI group. Equally important, in both groups, adherence with the intervention was high and adverse effects were minimal.
These preliminary findings provide promising evidence of feasibility, acceptability, and efficacy that warrant evaluation in a RCT with a larger sample of cancer survivors.
这项为期四周的试点随机临床试验(RCT),在癌症幸存者样本中,将靶向认知干预(TCI,n = 25)与预期匹配的积极对照干预(EMACI,n = 24)进行比较,其主要目的是:确定招募和保留率;评估改善认知功能三项客观指标(即注意力、工作记忆、多任务处理)的初步疗效;评估干预措施的依从率和满意度,并评估与治疗相关的不良事件(如恶心、晕动病)。
通过电子邮件从先前的研究中招募癌症幸存者。在进行筛选电话后,同意参与的幸存者通过Zoom了解研究措施和程序。幸存者被随机分配到TCI或EMACI组,并通过邮件收到一台配备其特定干预软件和自适应认知评估浏览器(ACE-X,认知功能的客观指标)的iPad。幸存者每周至少5天,每天使用该干预措施25分钟。使用多层次回归分析评估注意力、工作记忆和多任务处理客观指标的差异。
在持续注意力测量方面,发现了有利于TCI组的显著跨层次交互作用。虽然两组在多任务处理方面均有改善,虽无统计学意义,但TCI组的改善趋势更大。同样重要的是,两组对干预措施的依从性都很高,且不良反应最小。
这些初步研究结果为可行性、可接受性和疗效提供了有前景的证据,值得在更大样本的癌症幸存者RCT中进行评估。