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

基本信息

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
项目类别：
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

项目摘要

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可用性和身体容忍度对于临床试验，表现状态 - 最强大的预后和关键临床所有实体瘤类型的决策工具都是非常重要的局限性：它的主观性。因为与生存的关联，临床通常将表现状态得分定为一个预测生存（预后）。这些客观确定的分数也用于评估健身治疗的能力，作为临床试验资格的分层和选择因子，以评估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的医疗保健资金分配。我们建议检查关联在连续和客观测量的体育活动（PA）和临床评估的表现之间状态评分，整体患者生存和显着性的临床结果（即症状伯恩，质量生命指标，死亡，疾病进展，由于毒性，住院和治疗终止急诊室就诊，并转介提供支持/临终关怀）。该项目将利用技术将基于家庭的监视传感器与网络基础结构联系起来的系统（cycore）的容量实时发送数据到患者的医疗团队。确定客观评估的PA水平是否为与由医疗保健提供者评估的绩效状况评分和整体生存有关的相关，我们将招募四个表现状态组中的每一个患者（0-3级）。他们将为7提供与PA相关的数据几天，戴着两台PA设备（一种商业上可用）和第二个研究级。我们将将这些数据与物理评估的性能状态得分和生存结果相关联。评估长期和连续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，他们将在6个月内穿上商业可用的PA 设备，将从其个人智能手机中提供PA和自我报告的数据。我们将关联这些数据多个临床结果。我们的长期目标是消除绩效状态的主观性评估。