Implementing the NYU Electronic Patient Visit Assessment (ePVA)© for head and neck cancer in rural and urban populations: a study protocol for a type 1 hybrid effectiveness-implementation clinical trial.

BACKGROUND: Aggressive treatment with multimodal therapies such as surgery, chemotherapy, and radiation therapy has improved survival in head and neck cancer (HNC) but at a human cost of a substantial symptom burden and impact on quality of life. We developed the NYU Electronic Patient Visit Assessment (ePVA)© for HNC as a digital patient-reported symptom monitoring system that enables early symptom detection and real-time interventions at the point of care. With this study protocol, we aim to test the effectiveness of the ePVA in improving HNC outcomes in real-world settings and to identify implementation strategies optimizing its effectiveness. METHODS: We will conduct a longitudinal mixed-methods hybrid type I study at four National Cancer Institute-designated Comprehensive Cancer Centers serving diverse populations in rural and urban settings (New York University, the University of Kansas Cancer Center, Fox Chase Cancer Center, and Baylor College of Medicine) guided by the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Patient eligibility criteria include having histologically diagnosed HNC and undergoing radiation therapy with or without chemotherapy for curative intent. We will also interview clinicians caring for patients with HNC at the participating institutions regarding facilitators and barriers to implementing the ePVA. The accrual goal is 270 patients. Aim 1 is to determine the effect of the ePVA on HNC symptoms in a two-arm (usual care vs. ePVA + usual care) trial. The study's primary outcomes are patients' self-reported social function, senses of taste and smell, and swallowing, measured by the European Organization for Research and Treatment of Cancer QLQ-C30 and QLQ-H&N35. For Aim 2, we will interview patients (n = 40) as well as clinicians (n = 30) caring for patients with HNC at the participating institutions regarding facilitators and barriers to implementing the ePVA. In Aim 3, we will integrate Aims 1 and 2 data to identify strategies that optimize the use of the ePVA. DISCUSSION: The overarching goal of this research is to advance cancer care by identifying implementation standards for effective, widespread use of the ePVA that apply to all patient-reported outcomes in cancer care. TRIAL REGISTRATION: ClinicalTrials.gov NCT06030011. Registered on 8 September 2023.