Trial comparing treatments for adults with locally advanced head and neck cancer (NDURE)

A stepped wedge cluster randomized trial comparing a navigation based multilevel intervention with treatment as usual to improve initiation of timely postoperative radiation therapy in adults with locally advanced head and neck cancer (NDURE)

Although timely, guideline-adherent post-operative radiation therapy (PORT) is critical to prevent excess mortality and racial disparities in survival for patients with head and neck squamous cell carcinoma (HNSCC), effective interventions to improve the delivery of timely, equitable PORT among this population are lacking. Patient navigation (PN), a patient-centered intervention that aims to eliminate barriers to healthcare in a culturally-sensitive manner, is a potential strategy. PN has an extensive evidence base supporting its efficacy at decreasing delays and racial disparities in timely care for cancer screening, diagnostic resolution, and treatment initiation. However, the efficacy of PN at decreasing delays starting adjuvant therapy in sequential multimodal therapeutic paradigms is unclear.

To address the limitations of prior interventions that failed to improve the delivery of timely, equitable PORT, we developed ENDURE (Enhanced Navigation for Disparities and Untimely Radiation Therapy) based on the Theoretical Domains Framework and included intervention components that comprehensively target the multilevel barriers to timely PORT. The study evaluates the effectiveness of ENDURE compared with treatment as usual (TAU) on the initiation of timely, guideline-adherent PORT among patients with HNSCC undergoing surgical therapy with a pathologic indication for PORT as measured by the proportion of patients who initiate PORT within six weeks of surgery.