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)

New York University (NYU)

Status and phase: Unknown; Early Phase 1

Conditions: Head and Neck Cancer

Treatments: Behavioral: Electronic Patient Visit Assessment (ePVA)

Study type: Interventional

Funder types: Other

Identifiers

NCT04502797

19-01914

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Interventional: Electronic Patient Visit Assessment (ePVA)

Experimental group

Description:

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

Treatment:

Behavioral: Electronic Patient Visit Assessment (ePVA)

Usual care

No Intervention group

Description:

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