Clinical trial · Interventional
Implementing the NYU Electronic Patient Visit Assessment (ePVA) for Head and Neck Cancer In Rural and Urban Populations
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| NYU Electronic Patient Visit Assessment (ePVA) | Behavioral | — | UNRESOLVED |
| Usual Care | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- NYU Electronic Patient Visit Assessment (ePVA) plus Usual Care
- interventionNames
- Behavioral: NYU Electronic Patient Visit Assessment (ePVA)
- Behavioral: Usual Care
- type
- ACTIVE_COMPARATOR
- label
- Usual Care
- interventionNames
- Behavioral: Usual Care
Primary outcomes (1)
- measure
- Head and neck cancer (HNC) symptoms as assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ)
- timeFrame
- 4 weeks after completing radiation therapy
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (1)
- DERIVEDVan Cleave JH, Brody AA, Schulman-Green D, Hu KS, Li Z, Johnson SB, Major VJ, Lominska CE, Bauman JR, Hanania AN, Tatlonghari GV, Tsikis M, Egleston BL. Implementing the NYU Electronic Patient Visit Assessment (ePVA)(c) for head and neck cancer in rural and urban populations: a study protocol for a type 1 hybrid effectiveness-implementation clinical trial. Trials. 2025 Dec 9;26(1):563. doi: 10.1186/s13063-025-09268-w. PMID 41366462