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: 10092983
• 负责人: Michael J Overman
• 金额: $ 64.36万
• 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/10092983
• 关键词: Accelerometer; Advanced Malignant Neoplasm; Assessment tool; Cancer Patient; Caring; Cellular Phone; Cessation of life; Clinical; Clinical Trials; Clinical trial protocol document; 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; Time; Toxic effect; Validity and Reliability; Work; Wrist; base; clinical decision-making; cyber infrastructure; digital; evidence base; fitness; improved; innovation; predict clinical outcome; prognostic; prognostic of survival; recruit; risk stratification; sensor; standard of care; survival outcome; survival prediction; tool

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.

项目摘要 尽管在肿瘤学实践中广泛使用和接受，以确定患者的合格性和身体耐受性 对于临床试验参与，性能状态-单一最强大的预后和关键临床 所有实体瘤类型的决策工具-有一个非常重要的局限性：它的主观性。因为 在与生存率的相关性中，临床医生通常将体能状态评分作为 生存预测（prediction of survival）。这些主观确定的分数也被用来评估健身 治疗能力，作为临床试验合格性的分层和选择因素，以评估 根据临床试验方案继续治疗，作为生活质量的全球指标，并评估合格性 以及为临终关怀和家庭护理服务分配医疗基金。我们建议审查该协会 持续客观测量的身体活动（PA）和临床医生评估的表现之间的关系 状态评分、总患者存活率和显著性的临床结果（即，症状负担，质量 生命测量、死亡、疾病进展、由于毒性导致的治疗终止、住院和 急诊室就诊和转诊支持/临终关怀）。该项目将利用技术 一个系统（CYCORE）的能力，该系统将基于家庭的监测传感器连接到网络基础设施， 将真实的数据发送给患者的医疗团队。为了确定客观评估的PA水平是否 与卫生保健提供者评估的表现状态评分和总生存率相关，我们将招募 4个体能状态组（0-3级）各75例患者。他们将提供PA相关数据， 戴上两个PA设备，一个是商用的，另一个是研究级的。我们将 将这些数据与医生评估的体能状态评分和生存结果相关联。评价 长期和连续PA监测的可行性以及与临床结局的相关性， 晚期癌症患者，我们将招募100名患者，他们将佩戴市售PA 6个月， 设备，并将提供PA-和自我报告的数据从他们的个人智能手机。我们会把这些数据 多种临床结果。我们的长期目标是消除绩效状态中的主观性 评估。