Recruiting
Early Phase 1

ePVA

Sponsor:

New York University

Code:

NCT04502797

Conditions

Head and Neck Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Electronic Patient Visit Assessment (ePVA)

Study Details

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.

Conditions

Head and Neck Cancer

Study ID

NCT04502797

Start date

Oct 8, 2020

Status verified date

Mar, 2021

Completion date

Mar 15, 2022

Anticipated

Primary completion date

Mar 15, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Interventional: Electronic Patient Visit Assessment (ePVA)

Participants diagnosed with head and neck cancer randomized to Electronic Patient Visit Assessment intervention

no intervention: Usual care

Participants diagnosed with head and neck cancer randomized to usual care.

Interventions

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.

Primary outcome measure

  • Patient completion of 6 out of 7 assessments [ Time Frame: 24 weeks ]

Central Contacts and Locations

Central contacts

Janet VanCleave, PhD, RN

212 - 992 - 7340Janet.vancleave@nyu.edu

Locations

NYU Rory Meyers College of Nursing

Recruiting

New York, New York, United States, 10010

More Information

Sponsor

New York University

Last update posted

Mar 3, 2021

Last verified

Mar, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by New York University on 2021-03-03.