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

The University of Texas System (UT)

Status: Enrolling

Conditions: Head and Neck Cancer

Treatments: Behavioral: NYU Electronic Patient Visit Assessment (ePVA); Behavioral: Usual Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06030011

HSC-SN-23-0784

Details and patient eligibility

About

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.

Enrollment: 270 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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270 participants in 2 patient groups

NYU Electronic Patient Visit Assessment (ePVA) plus Usual Care

Experimental group

Treatment:

Behavioral: Usual Care

Behavioral: NYU Electronic Patient Visit Assessment (ePVA)

Usual Care

Active Comparator group

Treatment:

Behavioral: Usual Care