Implementing the NYU Electronic Patient Visit Assessment (ePVA) for Head and Neck Cancer In Rural and Urban Populations

Part of paid clinical trials in Kansas City, Kansas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT06030011
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • NYU Electronic Patient Visit Assessment (ePVA) — BEHAVIORAL
    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 — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Jun 25, 2024
Status verified
Jul 2024
Primary completion
Aug 31, 2028
Completion
Aug 31, 2028

Study Design

Enrollment
270 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: NYU Electronic Patient Visit Assessment (ePVA) plus Usual Care
  • Active Comparator: Usual Care

Primary Outcome 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) [ Time Frame: 4 weeks after completing radiation therapy ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
University of Kansas Cancer CenterKansas CityKansas66160
Chris Lominska, MD
NYU Langone Perlmutter Cancer CenterNew YorkNew York10016
Kenneth Hu, MD
NYU Meyers College of NursingNew YorkNew York10010
Abraham A. Brody, PhD, RN
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111
Jessica Bauman, MD
UTHealth Houston Cizik School of NursingHoustonTexas77030
Janet H. Van Cleave, PhD, RN

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