Randomized Trial of Enhanced Versus Standard Navigation to Promote Timely Initiation of Adjuvant Radiotherapy for Head and Neck Cancer

Abstract

Purpose: National Comprehensive Cancer Network Guidelines recommend initiating postoperative radiation therapy (PORT) within 6 weeks of surgery for patients with head and neck squamous cell carcinoma (HNSCC), but delays affect 50% of patients, disproportionately burden minoritized groups, and contribute to worse oncologic outcomes. This trial evaluates the efficacy of Navigation for Disparities and Untimely Radiation thErapy (NDURE), an enhanced navigation-based intervention, relative to usual care (UC) patient navigation for starting timely PORT.

Methods: Adults with locally advanced HNSCC planning to undergo surgery and PORT were randomly assigned 1:1 to standard multidisciplinary head and neck oncology care and either NDURE, a multilevel navigation-based intervention to enhance key processes of care and overcome barriers to timely PORT, or UC, which consisted of standard patient navigation. The primary end point, initiation of timely PORT, defined as ≤6 weeks after surgery, was evaluated using a generalized linear model binary regression with identity link, adjusting for random assignment stratification variables (race, predicted PORT location). Secondary end points were time to PORT (TTP) and treatment package time (TPT; the time from surgery to PORT completion).

Results: Among 176 eligible patients randomly assigned to NDURE (n = 88) or UC (n = 88), 145 (NDURE, n = 67; UC, n = 78) underwent surgery, had a pathologic indication for PORT, and were evaluable for the primary end point. NDURE improved initiation of timely PORT relative to UC (model-based initiation of timely PORT, 74% v 39%; risk difference, 35% [90% CI, 23 to 48]). NDURE increased the rate of PORT initiation (TTP hazard ratio [HR], 1.82 [90% CI, 1.32 to 2.50]) and treatment package completion (TPT HR, 1.67 [90% CI, 1.22 to 2.29]) relative to UC.

Conclusion: In this randomized clinical trial of patients with HNSCC undergoing surgery and PORT, NDURE improved initiation of timely PORT, TTP, and TPT.

Trial registration: ClinicalTrials.gov NCT04030130.