Grant Number:	1UG3CA315308-01 Interpret this number
Primary Investigator:	Haddad, Tufia
Organization:	Mayo Clinic Rochester
Project Title:	Evaluation of a Novel Remote Patient Monitoring Program for Cancer Patients Initiating Cancer-Directed Therapy: the Shield (Smart Health Integration for Early Life-Saving Detection)
Fiscal Year:	2026

Project Summary Infectious complications of malignancy and cancer-directed therapy remain the leading cause of cancer- related mortality and a major driver of preventable healthcare utilization, accounting for more than $16 billion annually in emergency and hospital care costs. Despite evidence that remote patient monitoring (RPM) and electronic patient-reported outcomes (ePROs) programs can improve clinical outcomes and symptom management among cancer patients receiving systemic therapy, these approaches remain underutilized in real-world oncology practice. The absence of scalable, reimbursable, and sustainable monitoring models has limited broad implementation. Current programs are hindered by high upfront technology and infrastructure costs, complex logistics, challenging clinical workflow integrations, and limited to non-reimbursable billing structures under the Centers for Medicare and Medicaid Services. Consequently, a critical gap persists in translating the advances made by ePRO and RPM programs in cancer care delivery research to their sustainable implementation in routine clinical practice. This proposal introduces SHIELD (Smart Health Integration for Early Life-saving Detection)—an innovative, scalable, and sustainable RPM care delivery model for patients initiating cancer-directed systemic therapy. The model integrates ePRO symptom monitoring via an EHR-integrated web and mobile application with a FDA-approved continuous temperature monitoring (CTM) technology. The CTM device is small, wearable, low-cost, and disposable. As the device enables passive, automated collection and transmission of physiological (core body temperature) data that is EHR-integrated and utilized for care management, it qualifies the SHIELD program as a reimbursable RPM service. The overarching goal of this proposal is to establish a scalable, sustainable, ePRO- and CTM-integrated RPM program – the SHIELD – for adult and pediatric cancer patients initiating systemic therapy. Our objective is to evaluate the multi-level impact of the SHIELD program, implemented through a pre-post parallel cluster randomized pragmatic trial design across an academic and multi-state community oncology practice network that serves a highly rural region. The proposed study will evaluate patient safety and healthcare resource utilization outcomes, patient-reported experiences and technology engagement, as well as healthcare system and patient-reported economic impact. By combining scalable technology, integrated workflows, and sustainable reimbursement models, the SHIELD program addresses a critical gap in cancer care innovation— proactively identifying infection-related complications before hospitalization while improving access for underserved populations, including a focus on rural and pediatric patients. This project represents a transformative step toward establishing a novel, scalable, and sustainable standard for modern oncology care.





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