Practical Geriatric Assessment (PGA) Implementation Strategies and Correlative Evaluations (PACE-70): Protocol for a hybrid implementation-effectiveness study in three community oncology practices in the United States

INTRODUCTION: Developed and endorsed by the American Society for Clinical Oncology (ASCO) in 2023, the Practical Geriatric Assessment (PGA) is a pragmatic tool that identifies vulnerabilities in older adults with cancer. Although strong evidence supports PGA to guide clinical care for older adults with cancer, PGA remains underutilized in routine practice. The Practical Geriatric Assessment (PGA) Implementation Strategies and Correlative Evaluations (PACE-70) study evaluates an electronic health record (EHR)-based implementation strategy for the PGA in community oncology settings and investigates how PGA findings, combined with body composition and step count monitoring, can predict chemotherapy-related toxicity. MATERIALS AND METHODS: PACE-70 is a Type III hybrid implementation-effectiveness study conducted across three community oncology sites within a large academic health system in Pennsylvania and New Jersey. It will enroll approximately 140 patients in the implementation cohort and up to 100 patients in the correlative cohort. Eligible participants are adults aged ≥70 years with advanced or metastatic solid tumors initiating a new line of palliative-intent systemic therapy. In the implementation cohort, patients complete the PGA via the EHR before or during their oncology visit. Identified impairments trigger an automated alert with guideline-based recommendations for clinicians. The primary outcome is the PGA completion rate; the secondary outcome is the frequency of PGA-guided clinical actions, such as chemotherapy dose modifications or supportive care referrals. A subset of patients will consent to enroll in a prospective correlative cohort to assess the associations between PGA-identified impairments, CTbased body composition, and Fitbit-derived step counts with clinical outcomes, including toxicity, hospitalizations, falls, and quality of life. Multivariable logistic regression and model selection techniques will identify predictors of these outcomes. DISCUSSION: Despite ASCO recommendations, PGA are rarely used in routine oncology practice, largely due to barriers such as time constraints and perceived lack of clinical utility. The PACE-70 study seeks to address this gap by evaluating a scalable, EHR-based implementation strategy for the PGA, and by linking PGA results with recommendations for guideline-concordant clinical actions. By embedding PGA directly into clinical workflows, PACE-70 tests a practical model for delivering efficient, evidence-based, and age-sensitive care that can be adopted across diverse oncology settings. Moreover, PACE-70 explores adjunct strategies for monitoring objective markers of frailty, including body composition analysis and step count data - which will inform future strategies to personalize cancer care for older adults with cancer.