Implementing the NYU Electronic Patient Visit Assessment (ePVA) for Head and Neck Cancer In Rural and Urban Populations
1 other identifier
interventional
270
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable head-and-neck-cancer
Started Jun 2024
Typical duration for not_applicable head-and-neck-cancer
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 1, 2023
CompletedFirst Posted
Study publicly available on registry
September 8, 2023
CompletedStudy Start
First participant enrolled
June 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 31, 2028
July 15, 2024
July 1, 2024
4.2 years
September 1, 2023
July 12, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Head and neck cancer (HNC) symptoms as assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ)
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.
4 weeks after completing radiation therapy
Secondary Outcomes (4)
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
Study Arms (2)
NYU Electronic Patient Visit Assessment (ePVA) plus Usual Care
EXPERIMENTALUsual Care
ACTIVE COMPARATORInterventions
The NYU Electronic Patient Visit Assessment (ePVA) for head and neck cancer is a digital patient-reported symptom monitoring system, providing actionable information at point-of-care that enables clinicians to provide real-time interventions. Patients access the ePVA through a web link and complete the survey questions within 10 minutes on digital devices (e.g., smart phones, laptops, or digital devices provided by the clinic).
Usual care encompasses pre-treatment, on treatment, and post-treatment care. Pre-treatment care includes education of patients on the treatment plan. On-treatment care includes daily monitoring by a nurse in the radiation therapy (RT) department, weekly on-treatment visits with the RT nurse practitioner and radiation oncologist, and weekly visits with medical oncology nurse practitioners and medical oncologists for patients receiving RT plus chemotherapy. Post-treatment care includes follow-up visits with HNC clinicians (i.e., surgeon, medical oncologist, oral maxillofacial surgeons, and radiation oncologist) to assess the patient's cancer status and identify the patient's acute and long-term symptoms. The clinician's decisions on radiologic exams and referrals to appropriate specialist services, including dental care, are based on the patient's cancer status and symptoms.
Eligibility Criteria
You may qualify if:
- Individuals with histologically diagnosed head and neck cancer (HNC) undergoing curative radiation therapy with or without chemotherapy
- English or Spanish speaking
- 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
You may not qualify if:
- Any medical condition that could limit the participant's ability to provide informed consent and complete the questionnaires.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The University of Texas Health Science Center, Houstonlead
- National Cancer Institute (NCI)collaborator
- New York University Meyers College of Nursingcollaborator
- New York University Langone Perlmutter Cancer Centercollaborator
- University of Kansascollaborator
- Fox Chase Cancer Centercollaborator
Study Sites (5)
University of Kansas Cancer Center
Kansas City, Kansas, 66160, United States
NYU Meyers College of Nursing
New York, New York, 10010, United States
NYU Langone Perlmutter Cancer Center
New York, New York, 10016, United States
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111, United States
UTHealth Houston Cizik School of Nursing
Houston, Texas, 77030, United States
Related Publications (1)
Van 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: 41366462DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Janet H. Van Cleave, PhD, RN
The University of Texas Health Science Center at Houston (UTHealth Houston)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
September 1, 2023
First Posted
September 8, 2023
Study Start
June 25, 2024
Primary Completion (Estimated)
August 31, 2028
Study Completion (Estimated)
August 31, 2028
Last Updated
July 15, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share