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

在日常功能和生活质量的背景下定义乳腺癌幸存者的认知患者报告结果

• 批准号: 10658037
• 负责人: Ashley M. Henneghan
• 金额: $ 25.35万
• 依托单位: UNIVERSITY OF TEXAS AT AUSTIN
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-03-13 至 2025-02-28
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10658037
• 关键词: Activities of Daily Living; Address; Aftercare; Age; Anxiety; Attention; Breast Cancer survivor; Cancer Survivor; Caring; Chronic Disease; Clinical; Cognition; Cognition Disorders; Cognitive; Consensus; Coupling; Data; Data Collection; Diagnosis; Distress; Ecological momentary assessment; Enrollment; European Organization for Research and Treatment of Cancer; Fatigue; Feeling; Foundations; Future; Goals; Health Care Research; Health Promotion; Information Systems; Intervention Studies; Knowledge; Life; Literature; Malignant Neoplasms; Measurement; Measures; Memory; Mental Depression; Methodology; Methods; Monitor; National Institute of Nursing Research; Nature; Observational Study; Occupational; Outcome; Outcome Measure; Patient Outcomes Assessments; Persons; Phenotype; Precision Health; Prevention; Prospective Studies; Psychometrics; Quality of life; Recommendation; Reporting; Research; Research Personnel; Sampling; Science; Self Assessment; Severities; Short-Term Memory; Social Functioning; Survivors; Symptoms; Time; Validity and Reliability; Work; cancer-related cognitive impairment; chemotherapy; clinical practice; clinically significant; cognitive function; cognitive process; cognitive testing; contextual factors; depressive symptoms; executive function; experience; follow-up; health management; improved; individual variation; innovation; insight; instrument; interest; intervention effect; malignant breast neoplasm; outcome prediction; performance tests; primary outcome; processing speed; prospective; reduce symptoms; social; tertiary prevention; therapy development; treatment planning

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.

项目概要/摘要 癌症相关认知障碍（CRCI）是癌症带来的最令人痛苦和负担最重的影响之一。 当使用患者报告结果 (PRO) 时，高达 75% 的乳腺癌幸存者。 报告 CRCI 认知 PRO 易于理解、简短且代表日常认知功能和质量。 然而，认知 PRO 作为 CRCI 研究的主要结果却被忽视了。 没有测量的最佳实践 为了推动科学前进，我们必须确定哪种认知 PRO。 最好地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。 幸存者的现实生活中竞争性要求高而功能性差，这将有助于更好的生活。 了解传统回顾性评估中 CRCI 的个体差异和表型 这样做将增强我们检测和量化临床 CRCI 的能力，并更好地测量。 旨在改善 CRCI 的干预效果 拟议的前瞻性研究将收集 124 个乳房的数据。 癌症幸存者（BCS，年龄 21 岁以上）在完成化疗后 1 年内（基线）并再次 2 个月 稍后（后续）。在基线和后续数据收集之间，生态瞬时评估（EMA）。 将每天进行一次，持续 56 天（总共 5 次：当前日常活动、焦虑自评、 抑郁症、疲劳、认知功能）以及针对工作记忆、执行力的移动认知测试 (MCT) 每隔一天进行一次功能、处理速度和记忆力（总共 4 项）我们的目标是 1) 进行比较。 随时间变化的日常功能（社交功能、QOL）的认知 PRO 预测因子，2) 确定 通过 EMA、MCT 和认知 PRO 测量的现实生活情境因素之间的纵向关系（在 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。 CRCI 中使用认知 PRO 的护理方法、知识差距和研究弱点 迄今为止的研究至关重要。拟议的研究在几个方面具有创新性：我们将直接进行比较和研究。 根据预测日常功能和生活质量的能力来评估认知 PRO，但这一点尚未得到证实。 我们将使用一种新的方法，即深入的纵向评估来定义 CRCI 和 目标 1 的研究结果将提供捕捉个体日常认知过程固有的变化。 为 CRCI 实践和研究中的工具选择提供信息的数据 目标 2 的结果将确定有效性。 和 BCS 中 EMA 和 MCT 的可靠性以及 CRCI，并有助于准确和精确地测量 两者都将促进未来对 CRCI 的严格观察和干预研究。 我们的初步研究和之前的工作有力地支持了我们开展这项研究的能力。 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，三级预防可减少癌症等慢性疾病的症状、严重程度和进展。