Analysis of ECOG-ACRIN adverse event data to optimize strategies for the longitudinal assessment of tolerability in the context of evolving cancer treatment paradigms (EVOLV)

分析 ECOG-ACRIN 不良事件数据，以优化在不断发展的癌症治疗范式 (EVOLV) 背景下纵向耐受性评估的策略

• 批准号: 10472654
• 负责人: ROBERT J GRAY
• 金额: $ 61.42万
• 依托单位: DANA-FARBER CANCER INST
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-18 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10472654
• 关键词: Adverse effects; Adverse event; Advocate; American College of Radiology Imaging Network; Aromatase Inhibitors; Cancer Survivor; Chronic; Classification; Clinical; Clinical Trials; Collaborations; Common Terminology Criteria for Adverse Events; Complex; Data; Decision Making; Demographic Factors; Development; Disease; Dose; Drug Side Effects; Early treatment; Eastern Cooperative Oncology Group; Equilibrium; Frequencies; Immunotherapy; Individual; Insurance Coverage; Lead; Measurement; Methodology; Methods; Modeling; Modification; Monitor; Nature; Oral; Patient Outcomes Assessments; Patients; Pharmaceutical Preparations; Phenotype; Positioning Attribute; Predictive Value; Provider; Race; Reporting; Research; Risk; Sampling; Severities; Standardization; Supportive care; Symptoms; Therapeutic; Therapeutic Trials; Time; Treatment Protocols; Treatment outcome; Woman; anticancer research; base; cancer therapy; comorbidity; expectation; experience; improved; indexing; individual patient; innovation; longitudinal analysis; malignant breast neoplasm; novel; patient oriented; public health relevance; recruit; side effect; targeted agent; targeted treatment; treatment adherence; treatment risk; treatment strategy; willingness

Project Summary EVOLV proposes to deliver sophisticated and standardized methods for assessing, monitoring, analyzing, and reporting adverse events (AEs) experienced by individuals undergoing cancer treatment. These methods will harness the potential of the patient-reported outcomes version of the NCI Common Terminology Criteria for Adverse Events (PRO-CTCAETM) to provide previously unavailable patient perspectives on the tolerability of treatments (including targeted agents, immunotherapies, and other evolving treatments for which the type, severity, timing, and trajectory of adverse events is less known). Such information will help providers better identify and support patients at risk for treatment discontinuation, dose reductions, and treatment delays. Specifically, this study aims to: 1) perform longitudinal analyses of CTCAE and PRO-CTCAE data from trials conducted within the ECOG-ACRIN Cancer Research Group, using traditional and innovative strategies to examine AE trajectories and to produce a new reporting standard that reflects severity and fluctuations over time; 2) examine PRO-CTCAE and CTCAE predictors of treatment adherence and discontinuation; and 3) validate the broader predictive value of GP5, a single item from the Functional Assessment of Cancer Therapy- General (FACT-G) shown to predict early treatment discontinuation among women with breast cancer taking aromatase inhibitors. The study will also explore two novel measurement models for PRO-CTCAE scores and CTCAE grades: a phenotypic model including co-occurrence of symptoms and a cumulative burden index (CBI) for characterizing the quantity of burden accumulated by patients over time. Analyses will include demographic factors and insurance status to identify potential disparities.

项目摘要 Evolv提议提供评估，监视，分析和的复杂和标准化方法 报告接受癌症治疗的个人经历的不良事件（AES）。这些方法将 利用NCI公共术语标准的患者报告结果版本的潜力 不良事件（Pro-CTCAETM）提供以前无法获得的患者观点 治疗（包括靶向药物，免疫疗法和其他不断发展的治疗方法 不良事件的严重性，时机和轨迹鲜为人知）。这些信息将帮助提供者更好 确定并支持有治疗中断，减少剂量和治疗延迟风险的患者。 具体而言，本研究的目的是：1）从试验中对CTCAE和Pro-CTCAE数据进行纵向分析 使用传统和创新策略在ECOG-ACRIN癌症研究小组中进行 检查AE轨迹并产生反映严重性和波动的新报告标准 时间; 2）检查治疗依从性和中断的前CTCAE和CTCAE预测指标； 3） 验证GP5的更广泛的预测值，这是癌症治疗功能评估的单个项目 - 一般（FACT-G）证明可以预测患有乳腺癌女性的早期治疗中停用 芳香酶抑制剂。该研究还将探索两个新的针对核CTCAE评分的新型测量模型和 CTCAE等级：一种表型模型，包括症状的同时出现和累积负担指数 （CBI）表征患者随时间累积的负担数量。分析将包括 人口因素和保险状况，以识别潜在的差异。