Using community-engaged methods to develop a study protocol for a cost analysis of a multi-site patient navigation intervention for breast cancer care.

BACKGROUND: Patient navigation is an evidence-based intervention for reducing delays in oncology care among underserved populations. In order to address the financial sustainability of this intervention, information is needed on the cost of implementing patient navigation in diverse healthcare settings. Because patient navigation programs and care settings are highly variable, this paucity of cost data creates difficulties in identifying best practices and decisions about the feasibility of implementing navigation programs within a health care system. One barrier to collecting these cost data is the lack of assessment tools available to support patient navigation programs. These tools must be relevant to the wide variety of navigation activities that exist in health care settings, and be flexible enough to collect cost data important to stakeholders in fee-for-service and value-based care environments. METHODS AND RESULTS: We present a novel approach and methods for assessing the cost of a patient navigation program implemented across six hospital systems to enhance timely entry and uptake of breast cancer care and treatment. These methods and tools were developed in partnership with breast oncology patient navigators and supervisors using principles of stakeholder engagement, with the goal of increasing usability and feasibility in the field. CONCLUSIONS: This methodology can be used to strengthen cost analysis and assessment tools for other navigation programs for improving care and treatment for patients with chronic conditions. TRIAL REGISTRATION: NCT03514433.

Development of a workflow process mapping protocol to inform the implementation of regional patient navigation programs in breast oncology.

BACKGROUND: Implementing city-wide patient navigation processes that support patients across the continuum of cancer care is impeded by a lack of standardized tools to integrate workflows and reduce gaps in care. The authors present an actionable workflow process mapping protocol for navigation process planning and improvement based on methods developed for the Translating Research Into Practice study. METHODS: Key stakeholders at each study site were identified through existing community partnerships, and data on each site's navigation processes were collected using mixed methods through a series of team meetings. The authors used Health Quality Ontario's Quality Improvement Guide, service design principles, and key stakeholder input to map the collected data onto a template structured according to the case-management model. RESULTS: Data collection and process mapping exercises resulted in a 10-step protocol that includes: 1) workflow mapping procedures to guide data collection on the series of activities performed by health care personnel that comprise a patient's navigation experience, 2) a site survey to assess program characteristics, 3) a semistructured interview guide to assess care coordination workflows, 4) a site-level swim lane workflow process mapping template, and 5) a regional high-level process mapping template to aggregate data from multiple site-level process maps. CONCLUSIONS: This iterative, participatory approach to data collection and process mapping can be used by improvement teams to streamline care coordination, ultimately improving the design and delivery of an evidence-based navigation model that spans multiple treatment modalities and multiple health systems in a metropolitan area. This protocol is presented as an actionable toolkit so the work may be replicated to support other quality-improvement initiatives and efforts to design truly patient-centered breast cancer treatment experiences. LAY SUMMARY: Evidence-based patient navigation in breast cancer care requires the integration of services through each phase of cancer treatment. The Translating Research Into Practice study aims to implement patient navigation for patients with breast cancer who are at risk for delays and are seeking care across 6 health systems in Boston, Massachusetts. The authors designed a 10-step protocol outlining procedures and tools that support a systematic assessment for health systems that want to implement breast cancer patient navigation services for patients who are at risk for treatment delays.

Patient navigator team perceptions on the implementation of a citywide breast cancer patient navigation protocol: a qualitative study.

BACKGROUND: In 2018 Translating Research Into Practice (TRIP), an evidence-based patient navigation intervention aimed at addressing breast cancer care disparities, was implemented across six Boston hospitals. This study assesses patient navigator team member perspectives regarding implementation barriers and facilitators one year post-study implementation. METHODS: We conducted in-depth qualitative interviews at the six sites participating in the pragmatic TRIP trial from December 2019 to March 2021. Navigation team members involved with breast cancer care navigation processes at each site were interviewed at least 12 months after intervention implementation. Interview questions were designed to address domains of the Consolidated Framework for Implementation Research (CFIR), focusing on barriers and facilitators to implementing the intervention that included 1) rigorous 11-step guidelines for navigation, 2) a shared patient registry and 3) a social risk screening and referral program. Analysis was structured using deductive codes representing domains and constructs within CFIR. RESULTS: Seventeen interviews were conducted with patient navigators, their supervisors, and designated clinical champions. Participants identified the following benefits provided by the TRIP intervention: 1) increased networking and connections for navigators across clinical sites (Cosmopolitanism), 2) formalization of the patient navigation process (Goals and Purpose, Access to Knowledge and Information, and Relative Advantage), and 3) flexibility within the TRIP intervention that allowed for diversity in implementation and use of TRIP components across sites (Adaptability). Barriers included those related to documentation requirements (Complexity) and the structured patient follow up guidelines that did not always align with the timeline of existing site navigation processes (Relative Priority). CONCLUSIONS: Our analysis provides data using real-world experience from an intervention trial in progress, identifying barriers and facilitators to implementing an evidence-based patient navigation intervention for breast cancer care. We identified core processes that facilitated the navigators' patient-focused tasks and role on the clinical team. Barriers encountered reflect limitations of navigator funding models and high caseload. TRIAL REGISTRATION: Clinical Trial Registration Number NCT03514433 , 5/2/2018.

Solid stress impairs lymphocyte infiltration into lymph-node metastases.

Strong and durable anticancer immune responses are associated with the generation of activated cancer-specific T cells in the draining lymph nodes. However, cancer cells can colonize lymph nodes and drive tumour progression. Here, we show that lymphocytes fail to penetrate metastatic lesions in lymph nodes. In tissue from patients with breast, colon, and head and neck cancers, as well as in mice with spontaneously developing breast-cancer lymph-node metastases, we found that lymphocyte exclusion from nodal lesions is associated with the presence of solid stress caused by lesion growth, that solid stress induces reductions in the number of functional high endothelial venules in the nodes, and that relieving solid stress in the mice increased the presence of lymphocytes in lymph-node lesions by about 15-fold. Solid-stress-mediated impairment of lymphocyte infiltration into lymph-node metastases suggests a therapeutic route for overcoming T-cell exclusion during immunotherapy.