Head and Neck Cancer
Conditions
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.
Interventions
BEHAVIORALElectronic 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.
Sponsors
New York University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Contacts
Primary ContactJanet VanCleave, PhD, RN
Outcome results
None listed