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)

Early Phase 1

• Conditions: Head and Neck Cancer
• Interventions: Behavioral: Electronic Patient Visit Assessment (ePVA)

• Registration Number: NCT04502797
• Lead Sponsor: New York University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-28
• Study First Submitted QC: 2020-08-04
• Study First Posted: 2020-08-06
• Study Start: 2020-10-08
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-01
• Last Update Posted: 2021-03-03
• Primary Completion: 2022-03-15
• Study Completion: 2022-03-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Interventional: Electronic Patient Visit Assessment (ePVA)	Electronic Patient Visit Assessment (ePVA)	Participants diagnosed with head and neck cancer randomized to Electronic Patient Visit Assessment intervention

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in health-related quality of life	Baseline, week 4, week 12, week 24	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).
Change in pain severity	Baseline, Day 7, Day 21, Day 35	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).

Trial Locations

Locations (1)

NYU Rory Meyers College of Nursing; 🇺🇸 New York, New York, United States