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

Обзор

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.

Вмешательства

• Поведенческое NYU Electronic Patient Visit Assessment (ePVA)
  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).
• Поведенческое Usual Care
  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 v

Первичные конечные точки

• Head and neck cancer (HNC) symptoms as assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ) [Срок оценки: 4 weeks after completing radiation therapy]

Вторичные конечные точки (4)

• Pain as assessed by EORTC QLQ-H&N35 Quality of Life Questionnaire (QLQ) [Срок оценки: 4 weeks after completing radiation therapy]
• Health-Related Quality of Life (HRQoL) as assessed by the EORTC QLQ-C30 Quality of Life Questionnaire (QLQ) [Срок оценки: 4 weeks after completing radiation therapy]
• Acute Care Services Use as assessed by number of acute care visits [Срок оценки: 4 weeks after completing radiation therapy]
• Acute Care Services Use as assessed by number of days of using acute care [Срок оценки: 4 weeks after completing radiation therapy]

Критерии участия

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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 5 центров

• University of Kansas Cancer Center — Kansas City
• NYU Meyers College of Nursing — New York
• NYU Langone Perlmutter Cancer Center — New York
• Fox Chase Cancer Center — Philadelphia
• UTHealth Houston Cizik School of Nursing — Houston

Публикации

• 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: 10.118 PMID 41366462

Идентификаторы

NCT: NCT06030011 · HSC-SN-23-0784

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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