NCT06030011

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

Recruiting now NA Last updated 15 July 2024

What this trial tests

NA trial testing NYU Electronic Patient Visit Assessment (ePVA) in Head and Neck Cancer in 270 participants. Currently enrolling.

Timeline

25 June 2024

Primary endpoint
31 August 2028

31 August 2028

Quick facts

Lead sponsor	The University of Texas Health Science Center, Houston
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	270
Start date	25 June 2024
Primary completion	31 August 2028
Estimated completion	31 August 2028
Sites	5 locations across United States

Drugs / interventions tested

• NYU Electronic Patient Visit Assessment (ePVA)
• Usual Care

Conditions studied

• Head and Neck Cancer — all drugs for Head and Neck Cancer →

Sponsor

The University of Texas Health Science Center, Houston

Who can join

18 and older, any sex, with Head and Neck Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Implementing the NYU Electronic Patient Visit Assessment (ePVA)<sup>©</sup> for head and neck cancer in rural and urban populations: a study protocol for a type 1 hybrid effectiveness-implementation clinical trial.
   Van Cleave JH, Brody AA, Schulman-Green D, Hu KS, et al · · 2025 · PMID 41366462 · DOI 10.1186/s13063-025-09268-w