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.

PROJECT NARRATIVE 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. We propose to examine the association between continuously and objectively measured 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). Our long-term goal is to increase objectivity in performance status assessments.