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) (ePVA)

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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Janet VanCleave, PhD, RN; Phone Number: 212 - 992 - 7340; Email: Janet.vancleave@nyu.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10010
      • Recruiting
      • NYU Rory Meyers College of Nursing
      • Contact: Janet VanCleave, PhD, RN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

To be eligible to participate in this study, an individual must meet all of the following criteria:

1. Histologically diagnosed HNC
2. Undergoing RT with or without chemotherapy,
3. English speaking,
4. aged 18 years or older.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

1. Unable to attend scheduled appointment due to geographical, social or mental reseaons,
2. In the opinion of the investigator, is unable or unlikely to comply fully with the study requirements or procedures for any reason (e.g. cognitve or physical impairment).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Interventional: Electronic Patient Visit Assessment (ePVA); Participants diagnosed with head and neck cancer randomized to Electronic Patient Visit Assessment intervention	Behavioral: Electronic Patient Visit Assessment (ePVA); The ePVA is an mHealth clinical support tool. The ePVA consists of a patient-reported measure that focuses on symptoms common to HNC (i.e. pain, eye, ear, nasal, mouth, voice, fibrosis, edema, skin, gastrointestinal, fatigue, limitation in movement, sleep, breathing, difficulty eating or drinking, swallowing, communication, social activities, anxiety, depression, and daily activities). PROMIS® questionnaires (pain intensity 3a, fatigue 6a, sleep disturbance 6a, anxiety 6a, depression 6a) are embedded within the ePVA.
NO_INTERVENTION: Usual care; Participants diagnosed with head and neck cancer randomized to usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient completion of 6 out of 7 assessments	This is defined as a binary yes/no variable as to whether a participant completed 6 out of 7 assessments.	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in health-related quality of life	Measured by EORTC QLQ-C30 global QoL/health scale, which consists of 30 questions, building five functional scales (physical, role, emotional, cognitive, social), a global QoL/health scale, symptom scales (fatigue, pain, nausea and vomiting, dyspnea, sleep disturbance, appetite loss, constipation and diarrhea) and perceived financial difficulties. The scale will be transformed to scores 0 to 100 (100 indicates best quality of life and 0 indicates least).	Baseline, week 4, week 12, week 24
Change in pain severity	Measured by European Organization for Research and Treatment of Cancer (EORTC) QLQ-H&N-35 pain scale. The scale will be transformed to scores 0 to 100 (0 indicates least and 100 indicates most symptoms).	Baseline, Day 7, Day 21, Day 35

Collaborators and Investigators

• Sponsor: New York University
• Investigators: Principal Investigator: Janet VanCleave, PhD, RN, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 8, 2020
• Primary Completion (ANTICIPATED): March 15, 2022
• Study Completion (ANTICIPATED): March 15, 2022

Study Registration Dates

• First Submitted: July 28, 2020
• First Submitted That Met QC Criteria: August 4, 2020
• First Posted (ACTUAL): August 6, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 3, 2021
• Last Update Submitted That Met QC Criteria: March 1, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: 19-01914

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to janet.vancleave@nyu.edu. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health.
• IPD Sharing Access Criteria: Requests may be directed to janet.vancleave@nyu.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

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