Implementing the NYU Electronic Patient Visit Assessment (ePVA) for Head and Neck Cancer In Rural and Urban Populations

The PI and the research team developed the New York University (NYU) Electronic Patient Visit Assessment (ePVA) for head and neck cancer (HNC) as a patient-reported outcome measure (PRO) for the early detection of uncontrolled symptoms. The ePVA is digital patient-reported symptom monitoring system, providing actionable information at point-of-care that enables clinicians to provide real-time interventions. The study aims to advance the science of cancer care delivery by testing the effectiveness of the ePVA as a digital patient-reported monitoring system for patients with HNC in real-world settings and identify implementation strategies that optimize the effectiveness of the ePVA in diverse rural and urban settings. The study hypothesis is that participants assigned to the ePVA arm will have better swallowing, taste and smell, and social function than participants assigned to usual care arm at 4 weeks after completing radiation therapy.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer
• Intervention / Treatment: Behavioral: NYU Electronic Patient Visit Assessment (ePVA); Behavioral: Usual Care

• Study Type: Interventional
• Enrollment (Estimated): 270
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Janet H. Van Cleave, PhD, RN; Phone Number: (713) 500-2000; Email: Janet.H.VanCleave@uth.tmc.edu

Study Locations

• United States
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Recruiting
      • University of Kansas Cancer Center
      • Contact: Chris Lominska, MD; Email: clominska@kumc.edu
  • New York
    • New York, New York, United States, 10010
      • Not yet recruiting
      • NYU Meyers College of Nursing
      • Contact: Abraham A. Brody, PhD, RN; Email: ab.brody@nyu.edu
    • New York, New York, United States, 10016
      • Recruiting
      • NYU Langone Perlmutter Cancer Center
      • Contact: Kenneth Hu, MD; Email: Kenneth.Hu@nyulangone.org
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Not yet recruiting
      • Fox Chase Cancer Center
      • Contact: Jessica Bauman, MD; Email: Jessica.Bauman@fccc.edu
  • Texas
    • Houston, Texas, United States, 77030
      • Not yet recruiting
      • UTHealth Houston Cizik School of Nursing
      • Contact: Janet H. Van Cleave, PhD, RN; Email: Janet.H.VanCleave@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria (Patient Participants):

• Individuals with histologically diagnosed head and neck cancer (HNC) undergoing curative radiation therapy with or without chemotherapy
• English or Spanish speaking

Inclusion Criteria (Clinician Participants):

• Clinicians (i.e., physicians, nurses, dentists, physician assistants, social workers, nutritionists, speech swallow therapists) caring for patients with head and neck cancer at the participating institutions

Exclusion Criteria (Patient and Clinician Participants):

• Any medical condition that could limit the participant's ability to provide informed consent and complete the questionnaires.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Usual Care	Behavioral: Usual Care; Usual care encompasses pre-treatment, on treatment, and post-treatment care. Pre-treatment care includes education of patients on the treatment plan. On-treatment care includes daily monitoring by a nurse in the radiation therapy (RT) department, weekly on-treatment visits with the RT nurse practitioner and radiation oncologist, and weekly visits with medical oncology nurse practitioners and medical oncologists for patients receiving RT plus chemotherapy. Post-treatment care includes follow-up visits with HNC clinicians (i.e., surgeon, medical oncologist, oral maxillofacial surgeons, and radiation oncologist) to assess the patient's cancer status and identify the patient's acute and long-term symptoms. The clinician's decisions on radiologic exams and referrals to appropriate specialist services, including dental care, are based on the patient's cancer status and symptoms.
Experimental: NYU Electronic Patient Visit Assessment (ePVA) plus Usual Care	Behavioral: NYU Electronic Patient Visit Assessment (ePVA); The NYU Electronic Patient Visit Assessment (ePVA) for head and neck cancer is a digital patient-reported symptom monitoring system, providing actionable information at point-of-care that enables clinicians to provide real-time interventions. Patients access the ePVA through a web link and complete the survey questions within 10 minutes on digital devices (e.g., smart phones, laptops, or digital devices provided by the clinic).; Behavioral: Usual Care; Usual care encompasses pre-treatment, on treatment, and post-treatment care. Pre-treatment care includes education of patients on the treatment plan. On-treatment care includes daily monitoring by a nurse in the radiation therapy (RT) department, weekly on-treatment visits with the RT nurse practitioner and radiation oncologist, and weekly visits with medical oncology nurse practitioners and medical oncologists for patients receiving RT plus chemotherapy. Post-treatment care includes follow-up visits with HNC clinicians (i.e., surgeon, medical oncologist, oral maxillofacial surgeons, and radiation oncologist) to assess the patient's cancer status and identify the patient's acute and long-term symptoms. The clinician's decisions on radiologic exams and referrals to appropriate specialist services, including dental care, are based on the patient's cancer status and symptoms.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Head and neck cancer (HNC) symptoms as assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ)	The EORTC QLQ-C30 and QLQ-H&N35 will be used to measure head and neck cancer symptoms, such as social function, senses of taste and smell, and swallowing. The scores will be summed and then transformed to a single score ranging from 0=Best to 100=Worst.	4 weeks after completing radiation therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain as assessed by EORTC QLQ-H&N35 Quality of Life Questionnaire (QLQ)	The EORTC QLQ-H&N35 will be used to assess pain. The score will be summed and then transformed to a single score ranging from 0=Best to 100=Worst.	4 weeks after completing radiation therapy
Health-Related Quality of Life (HRQoL) as assessed by the EORTC QLQ-C30 Quality of Life Questionnaire (QLQ)	The EORTC QLQ-H&N35 will be used to assess Health-Related Quality of Life (HRQoL). The score will be summed and then transformed to a single score ranging from 0=Best to 100=Worst.	4 weeks after completing radiation therapy
Acute Care Services Use as assessed by number of acute care visits	Acute Care Services Use is the use of services delivered in acute care settings, such as feeding tube placements, emergency room visits, and hospitalizations.	4 weeks after completing radiation therapy
Acute Care Services Use as assessed by number of days of using acute care	Acute Care Services Use is the use of services delivered in acute care settings, such as feeding tube placements, emergency room visits, and hospitalizations.	4 weeks after completing radiation therapy

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: National Cancer Institute (NCI); Fox Chase Cancer Center; New York University; University of Kansas; Perlmutter New York University Cancer Center
• Investigators: Principal Investigator: Janet H. Van Cleave, PhD, RN, The University of Texas Health Science Center at Houston (UTHealth Houston)

Publications and helpful links

General Publications

• Van Cleave JH, Brody AA, Schulman-Green D, Hu KS, Li Z, Johnson SB, Major VJ, Lominska CE, Bauman JR, Hanania AN, Tatlonghari GV, Tsikis M, Egleston BL. Implementing the NYU Electronic Patient Visit Assessment (ePVA)(c) for head and neck cancer in rural and urban populations: a study protocol for a type 1 hybrid effectiveness-implementation clinical trial. Trials. 2025 Dec 9;26(1):563. doi: 10.1186/s13063-025-09268-w.

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2024
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): August 31, 2028

Study Registration Dates

• First Submitted: September 1, 2023
• First Submitted That Met QC Criteria: September 1, 2023
• First Posted (Actual): September 8, 2023

Study Record Updates

• Last Update Posted (Actual): July 6, 2026
• Last Update Submitted That Met QC Criteria: July 2, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms
• Other Study ID Numbers: HSC-SN-23-0784

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No