NCT04502797: ePVA

A Feasibility Study to Evaluate The Effect of the Electronic Patient Visit Assessment On Pain and Quality of Life for Patients With Head and Neck Cancer (HNC)

Status unknown EARLY_PHASE1 Last updated 3 March 2021

What this trial tests

EARLY_PHASE1 trial testing Electronic Patient Visit Assessment (ePVA) in Head and Neck Cancer in 30 participants. Status unknown.

Timeline

8 October 2020

Primary endpoint
15 March 2022

15 March 2022

Quick facts

Lead sponsor	New York University
Phase	EARLY_PHASE1
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	30
Start date	8 October 2020
Primary completion	15 March 2022
Estimated completion	15 March 2022
Sites	1 location across United States

Drugs / interventions tested

• Electronic Patient Visit Assessment (ePVA)

Conditions studied

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

Sponsor

New York University

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

This randomized, non-blinded, phase 0/I study will assess the feasibility of conducting a large randomized clinical trial to evaluate the efficacy of the ePVA to improve pain management and HRQoL in HNC. Thirty participants undergoing radiation therapy (RT) (with or without chemotherapy) will be randomized to: 1) ePVA intervention or 2) usual care. The intervention consists of participants completing the ePVA every other week during radiation therapy (RT), then weeks 4, 12, and 24 after end of RT. Automated reports of ePVA data, including pain reports and patient-reports of pain medications, will be sent to providers to inform their clinical decisions.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.