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)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-08

Study Completion Date

2022-03-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Head and Neck Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Interventional: Electronic Patient Visit Assessment (ePVA)

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

Group Type EXPERIMENTAL

Electronic Patient Visit Assessment (ePVA)

Intervention Type BEHAVIORAL

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.

Usual care

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No