Implementing the NYU Electronic Patient Visit Assessment (ePVA) for Head and Neck Cancer In Rural and Urban Populations
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 270
- Locations
- 10
- Primary Endpoint
- Head and neck cancer (HNC) symptoms as assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ)
Study Overview
Brief Summary
The PI and the research team developed the New York University (NYU) Electronic Patient Visit Assessment (ePVA) for head and neck cancer (HNC) as a patient-reported outcome measure (PRO) for the early detection of uncontrolled symptoms. The ePVA is digital patient-reported symptom monitoring system, providing actionable information at point-of-care that enables clinicians to provide real-time interventions. The study aims to advance the science of cancer care delivery by testing the effectiveness of the ePVA as a digital patient-reported monitoring system for patients with HNC in real-world settings and identify implementation strategies that optimize the effectiveness of the ePVA in diverse rural and urban settings. The study hypothesis is that participants assigned to the ePVA arm will have better swallowing, taste and smell, and social function than participants assigned to usual care arm at 4 weeks after completing radiation therapy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •(Patient Participants):
- •Individuals with histologically diagnosed head and neck cancer (HNC) undergoing curative radiation therapy with or without chemotherapy
- •English or Spanish speaking
- •Inclusion Criteria (Clinician Participants):
- •Clinicians (i.e., physicians, nurses, dentists, physician assistants, social workers, nutritionists, speech swallow therapists) caring for patients with head and neck cancer at the participating institutions
Exclusion Criteria
- •(Patient and Clinician Participants):
- •Any medical condition that could limit the participant's ability to provide informed consent and complete the questionnaires.
Arms & Interventions
NYU Electronic Patient Visit Assessment (ePVA) plus Usual Care
Intervention: NYU Electronic Patient Visit Assessment (ePVA) (Behavioral)
NYU Electronic Patient Visit Assessment (ePVA) plus Usual Care
Intervention: Usual Care (Behavioral)
Usual Care
Intervention: Usual Care (Behavioral)
Outcomes
Primary Outcomes
Head and neck cancer (HNC) symptoms as assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ)
Time Frame: 4 weeks after completing radiation therapy
The EORTC QLQ-C30 and QLQ-H\&N35 will be used to measure head and neck cancer symptoms, such as social function, senses of taste and smell, and swallowing. The scores will be summed and then transformed to a single score ranging from 0=Best to 100=Worst.
Secondary Outcomes
- Pain as assessed by EORTC QLQ-H&N35 Quality of Life Questionnaire (QLQ)(4 weeks after completing radiation therapy)
- Health-Related Quality of Life (HRQoL) as assessed by the EORTC QLQ-C30 Quality of Life Questionnaire (QLQ)(4 weeks after completing radiation therapy)
- Acute Care Services Use as assessed by number of acute care visits(4 weeks after completing radiation therapy)
- Acute Care Services Use as assessed by number of days of using acute care(4 weeks after completing radiation therapy)
Investigators
Janet Van Cleave
Associate Professor
The University of Texas Health Science Center, Houston