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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：
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
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/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

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.

项目总结