Through the work of a well-established research partnership among the Chinese American Service League (CASL), Mercy Hospital & Medical Center (Mercy), and Northwestern University (NU), our team completed a trial evaluating a one-on-one patient navigation (PN) intervention for breast and cervical cancer tailored to Chicago’s Chinatown. Our completed trial and others have demonstrated that PN is effective in improving consistency of cancer care and addressing Social Determinants of Health (SDoH) among underserved populations. Unfortunately, current standard one-on-one PN is difficult to scale and sustain without intensive financial resources, which limits one-on-one cancer PN to a temporary “Band-Aid” for fragmented healthcare systems. We have an opportunity to apply our team’s lessons learned from our completed PN trial in order to create a paradigm shift in PN to produce systems change in cancer care delivery to meet the needs of underserved populations. To do so, we propose a learning health system PN 2.0 Checklist implementation strategy that scales implementation of PN across cancers and builds a sustainable team-based checklist that will support coordination and integration of SDoH-related efforts across community oncology and community social service settings. In Aim 1, we will employ a design-thinking framework of co-creation and iterative prototyping to develop the PN 2.0 Checklist, transforming one-on-one PN into a learning health system PN approach centered around a team-based checklist that leverages the PN evidence base and active participation of community oncology and community social service stakeholders. In Aim 2, through a Hybrid Type 2 randomized effectiveness- implementation pragmatic trial, we will compare the effectiveness (non-inferiority) of the PN 2.0 Checklist relative to one-on-one PN in resolving SDoH barriers and increasing patient receipt of clinical cancer preventive services. N=600 Chinese adults recruited from Chicago’s Chinatown will be randomized to standard one-on-one cancer PN (control) or cancer PN 2.0 Checklist (intervention). The primary outcome is an adjusted, composite proportion of SDoH barriers resolved and completion of U.S. Preventive Services Task Force recommended cancer-related screenings, behavioral counseling, and immunizations, collected via chart review and patient surveys. We will explore the effect of the PN 2.0 Checklist on organizational change and patient assessment of care team quality using pre/post surveys. Secondary outcomes include time to diagnostic resolution and time to treatment initiation. In Aim 3, we will use the Consolidated Framework for Implementation Research (CFIR) and mixed-methods (process evaluation, qualitative interviews, cost analysis) to evaluate the implementation of the learning health system PN 2.0 Checklist strategy. Results will have important implications for implementation, sustainability, and scaling of PN in community oncology settings where medically underserved U.S. immigrant populations, such as linguistically isolated Chinese, receive the bulk of their cancer care.

PROJECT NARRATIVE Cancer patient navigation (PN) is an effective strategy for resolving patient barriers to care and improving completion and consistency of cancer screening, follow-up of abnormal findings, and treatment initiation. However, as the current standard one-on-one PN model is challenging to scale across cancers and economically difficult to sustain, we propose to convert one-on-one PN into a learning health system “PN 2.0 Checklist” that will help coordinate navigation workflow and integrate clinical team members with community/local resources. We will conduct a pragmatic, randomized trial to test whether this checklist strategy is as effective as one-on- one PN in addressing patients’ social determinants of health and recommended cancer-related screenings, behavioral counseling, and immunizations.