A Type I Hybrid Effectiveness-Implementation Trial to Evaluate a Navigation-Based Multilevel Intervention to Decrease Delays Starting Adjuvant Therapy Among Patients with Head and Neck Cancer

PROJECT SUMMARY/ABSTRACT This R01 proposal aims to test the effectiveness, mechanism, and implementation of a navigation-based multilevel intervention to improve the delivery of timely, equitable, guideline-adherent adjuvant therapy among patients with head and neck cancer (HNC). HNC is a disease with poor survival and profound racial disparities

in mortality. For locally advanced HNC, guidelines recommend initiating postoperative radiation therapy (PORT) within 6-weeks of surgery to optimize survival. However, delays starting guideline-adherent PORT (i.e., > 6 weeks after surgery) affect ~50% of patients with HNC and nearly 70% of Black patients with HNC and are thus

a key driver of poor survival and racial disparities in mortality. To date, interventions that improve the delivery of timely, equitable guideline-adherent PORT among patients with HNC are lacking. To address this gap, we developed ENDURE (Enhanced Navigation for Disparities and Untimely Radiation thErapy) as a navigation-

based multilevel intervention that modifies the structure, care delivery pathways, and behaviors of the cancer care multiteam system to address patient-, team-, and organization-level barriers and thus improve the delivery of timely, equitable PORT following surgery for HNC. Data from our single-arm and pilot randomized trial provide

evidence of NDURE’s feasibility, acceptability, and preliminary effectiveness at improving timely guideline- adherent PORT and decreasing racial disparities in delays. To build on these promising data and characterize ENDURE’s implementation across diverse settings, we propose a hybrid type 1 effectiveness-implementation

study. We will conduct a stepped wedge cluster randomized trial with n = 4 cancer centers (N = 484 patients) randomized to sequentially deliver treatment as usual (TAU) then ENDURE to patients with HNC undergoing surgery and PORT. Concurrently, we will conduct a mixed-methods study with quantitative assessments

supplemented by semi-structured interviews of patients, providers, and administrators to characterize the implementation of ENDURE. Specific Aim 1 will evaluate the effectiveness of ENDURE at decreasing delays starting guideline-adherent PORT relative to TAU. Specific Aim 2 will identify the mechanisms through which

ENDURE reduces treatment delays. Specific Aim 3 will characterize the implementation of ENDURE across diverse clinical settings. Findings from our proposal have potential to address three important gaps. First, results may support ENDURE as the first evidence-based strategy to decrease delays starting adjuvant therapy for

patients with HNC. Such a result may help change the current standard of care, improve survival, and decrease racial disparities in mortality for these patients. Second, findings address an understudied but critical aspect of cancer care delivery and could be translated to other types of cancer (e.g., breast, colon, lung) for which delays

initiating adjuvant therapy are common. Third, mechanism data may provide actionable knowledge to improve the delivery of effective interprofessional team-based cancer care.