Background: Delays initiating guideline-adherent postoperative radiation therapy (PORT) in head and neck squamous cell carcinoma (HNSCC) occur in more than 50% of patients and are key drivers of excess mortality and racial disparities in survival. Theory-based multilevel interventions to address delays and racial disparities in timely PORT have not been described and effective interventions to improve timely, equitable PORT are lacking. Purpose: This study aims to describe the development of NDURE (Navigation for Disparities and Untimely Radiation Therapy), a novel theory- based, multilevel intervention to decrease delays starting PORT and evaluate its feasibility, acceptability, and preliminary clinical efficacy. Methods: An intervention mapping approach was used to develop NDURE. Consecutive patients with locally- advanced HNSCC undergoing surgery and PORT were enrolled into a single-arm clinical trial. Results: NDURE targets the determinants of timely, guideline-adherent PORT through the following core functions: 1) patient education, 2) standardization of the process for initiating the discussion of PORT, 3) PORT care plans, 4) provider role definition, 5) referral tracking and follow-up, and 6) transportation assistance.

NDURE was feasible, as judged by trial accrual (88% overall; 100% for African Americans) and dropout (n=0). 100% of patients reported moderate/strong agreement that NDURE helped solve challenges starting PORT; 86% were highly likely to recommend NDURE. The rate of timely, guideline-adherent PORT was 86% overall and 100% for African Americans. Conclusions: NDURE is a novel, theory-based, multilevel intervention targeting determinants of timely PORT among HNSCC patients. NDURE is feasible, acceptable, and has potential to improve the timely, equitable, guideline-adherent PORT. These results support conducting a randomized controlled trial to test NDURE’s clinical efficacy. clinicaltrials.gov number NCT04030130

Citation Format: Evan M. Graboyes, Katherine R. Sterba, Hong Li, Graham Warren, Anthony J. Alberg, Elizabeth A. Calhoun, Brian Nussenbaum, Jessica McCay, Courtney H. Marsh, David M. Neskey, John Kaczmar, Anand K. Sharma, Jennifer Harper, Terry A. Day, Chanita Hughes Halbert. Development and evaluation of a theory-based, multilevel intervention to improve the delivery of timely, guideline-adherent adjuvant therapy for patients with head and neck cancer [abstract]. In: Proceedings of the AACR Virtual Conference: Thirteenth AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2020 Oct 2-4. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2020;29(12 Suppl):Abstract nr PO-231.