Defining Cognitive Patient Reported Outcomes of Breast Cancer Survivors in the Context of Everyday Functioning and Quality of Life

项目总结/摘要 癌症相关的认知障碍（CRCI）是癌症最令人痛苦和负担的影响之一。 乳腺癌及其治疗当使用患者报告结局（PRO）时，高达75%的幸存者 报告CRCI。认知PRO是可访问的，简短的，并代表日常认知功能和质量， 生活质量（QOL）。然而，认知PRO在CRCI研究中被忽视为主要结局， 没有衡量的最佳做法。为了推动科学的发展，我们必须确定哪些认知PRO 最能反映和预测日常功能和生活质量。我们还需要在以下背景下评估CRCI： 幸存者的真实的生活中，相互竞争的需求很高，功能很差。这将有助于更好地 了解CRCI的个体变异和表型， 可能无法捕获。这样做将提高我们检测和量化临床CRCI的能力， 旨在改善CRCI的干预效果。这项拟议的前瞻性研究将收集124例乳腺癌患者的数据。 完成化疗（基线）后1年内的癌症幸存者（BCS，21岁以上）和2个月内的癌症幸存者 后续（Follow up）在基线和后续数据收集之间，生态瞬时评估（EMA） 将每天施用56天（总共5天：当前的日常活动、焦虑的自我评定、 抑郁、疲劳、认知功能）和移动的认知测试（MCT），用于工作记忆、执行记忆、 功能、处理速度和记忆（共4项），每隔一天给药一次。我们的目标是1）比较 跨时间的日常功能（社会功能，QOL）的认知PRO预测因子和2）确定 通过EMA、MCT和认知PRO测量的真实的生活情境因素之间的纵向关系（在 跟进）。考虑到PRO在医疗保健研究中的重要性以及向精准健康的转变 在CRCI中使用认知PRO的护理方法、知识差距和研究弱点 迄今为止的研究是至关重要的。拟议的研究在几个方面是创新的：我们将直接比较， 根据他们预测日常功能和QOL的能力评估认知PRO， 我们将使用一种新的方法，密集的纵向评估，来定义CRCI， 捕捉认知过程中固有的人与人之间的日常变化。目标1的结果将提供 数据，为CRCI实践和研究中的仪器选择提供信息。目标2的结果将确定有效性 和可靠性的EMA和MCT在BCS与CRCI和促进准确和精确的测量， 生活经验。两者都将促进未来对CRCI进行严格的观察和干预研究。 我们的初步研究和以前的工作有力地支持了我们开展拟议研究的能力。这 研究解决了国家护理研究所的健康促进和预防优先事项， 具体来说，是三级预防，以减轻癌症等慢性疾病的症状、严重程度和进展。

PROJECT SUMMARY/ABSTRACT Cancer-related cognitive impairments (CRCI) are some of the most distressing and burdensome effects of breast cancer and its treatment. When patient reported outcomes (PROs) are used, up to 75% of survivors report CRCI. Cognitive PROs are accessible, brief, and represent everyday cognitive functioning and quality of life (QOL). Yet, cognitive PROs have been overlooked as primary outcomes in CRCI research, and there are no best practices for measurement. To move the science forward, we have to determine which cognitive PRO best reflects and predicts everyday functioning and QOL. We also need to assess CRCI within the context of survivors’ real life where competing demands are high and functioning poor. This will facilitate a better understanding of the individual variations and phenotypes of CRCI that traditional retrospective assessments may not capture. Doing so will enhance our ability to detect and quantify clinical CRCI, and better measure intervention effects aimed at improving CRCI. The proposed prospective study will collect data from 124 breast cancer survivors (BCS, ages 21+) within 1 year of completing chemotherapy (baseline) and again 2 months later (follow up). Between baseline and follow up data collection, ecological momentary assessments (EMAs) will be administered daily for 56 days (5 total: current daily activity, self-ratings of anxiety, feelings of depression, fatigue, cognitive functioning), and mobile cognitive tests (MCTs) for working memory, executive functioning, processing speed, and memory (4 total) administered every other day. We aim to 1) compare cognitive PRO predictors of everyday functioning (social function, QOL) across time and 2) determine longitudinal relationships among real life contextual factors measured by EMAs, MCTs, and cognitive PROs (at follow up). Considering the importance of PROs in healthcare research and the shift towards precision health approaches to care, the gaps in knowledge and weaknesses of research using cognitive PROs in CRCI research to date are critical. The proposed study is innovative in several ways: we will directly compare and evaluate cognitive PROs based on their ability to predict everyday functioning and QOL which has not been done before; and we will use a new methodology, intensive longitudinal assessments, to define CRCI and capture day-to-day within person variability inherent to cognitive processes. Findings from Aim 1 will provide data to inform instrument choices in CRCI practice and research. Findings from Aim 2 will establish the validity and reliability of EMAs and MCTs in BCS with CRCI and facilitate accurate and precise measurement of the lived experience. Both will facilitate rigorous observational and interventional research on CRCI in the future. Our preliminary studies and previous work strongly support our ability to carry out the proposed study. This study addresses the health promotion and prevention priority of the National Institute of Nursing Research— specifically, tertiary prevention to reduce symptoms, severity, and progression of chronic diseases like cancer.