A technological approach for performance status assessment in advanced cancer patients

晚期癌症患者体能状态评估的技术方法

• 批准号: 10573160
• 负责人: Michael J Overman
• 金额: $ 55.91万
• 依托单位: UNIVERSITY OF TX MD ANDERSON CAN CTR
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-02-01 至 2025-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10573160
• 关键词: Accelerometer; Advanced Malignant Neoplasm; Assessment tool; Cancer Patient; Caring; Cellular Phone; Cessation of life; Clinical; Clinical Trials; Data; Data Reporting; Devices; Disease Progression; Eastern Cooperative Oncology Group; Eligibility Determination; Emergency department visit; Funding; Goals; Guidelines; Health Personnel; Healthcare; Home; Home Care Services; Hospice Care; Hospitalization; Hour; Karnofsky Performance Status; Link; Measurement; Measures; Medical Care Team; Methods; Monitor; Oncologist; Oncology; Outcome; Palliative Care; Patient Self-Report; Patients; Performance; Performance Status; Physical activity; Physical assessment; Physicians; Quality Indicator; Quality of life; Research; Solid Neoplasm; Standardization; Stratification; Symptoms; System; Systemic Therapy; Technology; Time; Toxic effect; Validity and Reliability; Work; clinical decision-making; clinical trial protocol; cyber infrastructure; digital; evidence base; fitness; improved; innovation; predict clinical outcome; prognostic; prognostication; recruit; risk stratification; sensor; standard of care; survival outcome; survival prediction; tool; wrist worn device

PROJECT SUMMARY Although widely used and accepted in oncology practice to determine patient eligibility and physical tolerance for clinical trial participation, performance status—the single most powerful prognostic and key clinical decision-making tool across all solid tumor types—has one very significant limitation: its subjectivity. Because of the association with survival, performance status scores are routinely assigned by the clinician as a prediction of survival (prognostication). These subjectively determined scores are also used to evaluate fitness capability for treatment, as a stratification and selection factor for clinical trial eligibility, to assess ability to continue treatment on a clinical trial protocol, as a global indicator of quality of life, and to evaluate eligibility and allocation of healthcare funds for hospice and home care services. We propose to examine the association between continuously and objectively measured physical activity (PA) and clinician-assessed performance status scores, overall patient survival, and clinical outcomes of significance (i.e., symptom burden, quality of life measures, death, disease progression, treatment termination due to toxicity, hospitalizations and emergency room visits, and referral for supportive/hospice care). This project will harness the technological capacity of a system (CYCORE) that links home-based monitoring sensors to a cyber-infrastructure and can send data in real time to the patient's healthcare team. To determine if objectively assessed PA levels are associated with health care provider-assessed performance status scores and overall survival, we will recruit 75 patients for each of four performance status groups (levels 0-3). They will provide PA-related data for 7 days by wearing two PA devices—one commercially available and the second research-grade. We will correlate those data with physician-assessed performance status scores and survival outcomes. To evaluate the feasibility of long-term and continuous PA monitoring and the associations with clinical outcomes in advanced cancer patients, we will recruit 100 patients who, for 6 months, will wear a commercially available PA device and will provide PA- and self-reported data from their personal smartphone. We will correlate those data to multiple clinical outcomes. Our long-term goal is to eliminate the subjectivity in performance status assessments.

项目概要 尽管在肿瘤学实践中广泛使用和接受，以确定患者的资格和身体耐受性 对于临床试验参与、表现状态——最有力的预后和关键临床指标 涵盖所有实体瘤类型的决策工具有一个非常重要的局限性：其主观性。因为 为了与生存相关，临床医生通常将表现状态评分作为 生存预测（预测）。这些主观确定的分数也用于评估健康状况 治疗能力，作为临床试验资格的分层和选择因素，以评估治疗能力 继续按照临床试验方案进行治疗，作为生活质量的全球指标，并评估资格 以及为临终关怀和家庭护理服务分配医疗保健资金。我们建议对协会进行审查 连续客观测量的体力活动 (PA) 与临床医生评估的表现之间的关系 状态评分、患者总体生存率和重要的临床结果（即症状负担、治疗质量） 生命指标、死亡、疾病进展、因毒性而终止治疗、住院和 急诊室就诊，以及转诊支持性/临终关怀）。该项目将利用技术 系统（CYCORE）的能力，该系统将家庭监控传感器连接到网络基础设施，并且可以 将数据实时发送给患者的医疗团队。确定客观评估的 PA 水平是否符合 与医疗保健提供者评估的表现状态分数和总体生存率相关，我们将招募 四个体能状态组（0-3 级）各有 75 名患者。他们将提供 7 的 PA 相关数据 佩戴两个 PA 设备需要几天的时间——一个是市售的，另一个是研究级的。我们将 将这些数据与医生评估的表现状态评分和生存结果相关联。评估 长期持续 PA 监测的可行性以及与临床结果的关联 晚期癌症患者，我们将招募 100 名患者，他们将佩戴商用 PA 为期 6 个月 设备，并将通过其个人智能手机提供 PA 和自我报告的数据。我们将关联这些数据 多种临床结果。我们的长期目标是消除绩效状态的主观性 评估。