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)
Trial Snapshot
- Phase
- Phase 1
- Sponsor
- New York University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Patient completion of 6 out of 7 assessments
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •To be eligible to participate in this study, an individual must meet all of the following criteria:
- •Histologically diagnosed HNC
- •Undergoing RT with or without chemotherapy,
- •English speaking,
- •aged 18 years or older.
Exclusion Criteria
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Unable to attend scheduled appointment due to geographical, social or mental reseaons,
- •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).
Arms & Interventions
Interventional: Electronic Patient Visit Assessment (ePVA)
Participants diagnosed with head and neck cancer randomized to Electronic Patient Visit Assessment intervention
Intervention: Electronic Patient Visit Assessment (ePVA) (Behavioral)
Usual care
Participants diagnosed with head and neck cancer randomized to usual care.
Outcomes
Primary Outcomes
Patient completion of 6 out of 7 assessments
Time Frame: 24 weeks
This is defined as a binary yes/no variable as to whether a participant completed 6 out of 7 assessments.
Secondary Outcomes
- Change in health-related quality of life(Baseline, week 4, week 12, week 24)
- Change in pain severity(Baseline, Day 7, Day 21, Day 35)