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

This R01 proposal aims to test the effectiveness, mechanism, and implementation of a navigation-based multilevel intervention to improve the delivery of timely, guideline-adherent adjuvant therapy among patients with head and neck cancer (HNC). HNC is a disease with poor survival. 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 are thus a key driver of poor survival. To date, interventions that improve the delivery of timely, guideline-adherent PORT among patients with HNC are lacking. To address this gap, we developed ENDURE 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 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. To build on these promising data and characterize ENDURE’s implementation across different clinical 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 on starting timely, guideline-adherent PORT relative to TAU. Specific Aim 2 will identify the mechanisms through which ENDURE improves the delivery of timely PORT. Specific Aim 3 will characterize the implementation of ENDURE across different clinical settings. Findings from our proposal have potential to address three important gaps. First, effectiveness results may provide support for ENDURE as the first evidence-based strategy to improve the initiation of timely adjuvant therapy for patients with HNC. Such a result may help change the current standard of care and improve survival 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.