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NCT Number: NCT06030011

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

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Cancer Center, Kansas City, Kansas, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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)

    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

  1. Pain as assessed by EORTC QLQ-H&N35 Quality of Life Questionnaire (QLQ)

    Time frame: 4 weeks after completing radiation therapy

    The EORTC QLQ-H&N35 will be used to assess pain. The score will be summed and then transformed to a single score ranging from 0=Best to 100=Worst.

  2. Health-Related Quality of Life (HRQoL) as assessed by the EORTC QLQ-C30 Quality of Life Questionnaire (QLQ)

    Time frame: 4 weeks after completing radiation therapy

    The EORTC QLQ-H&N35 will be used to assess Health-Related Quality of Life (HRQoL). The score will be summed and then transformed to a single score ranging from 0=Best to 100=Worst.

  3. Acute Care Services Use as assessed by number of acute care visits

    Time frame: 4 weeks after completing radiation therapy

    Acute Care Services Use is the use of services delivered in acute care settings, such as feeding tube placements, emergency room visits, and hospitalizations.

  4. Acute Care Services Use as assessed by number of days of using acute care

    Time frame: 4 weeks after completing radiation therapy

    Acute Care Services Use is the use of services delivered in acute care settings, such as feeding tube placements, emergency room visits, and hospitalizations.

Study contacts

Contact information is provided by the study sponsor or research team.

Janet H. Van Cleave, PhD, RN

CONTACT

[email protected]

(713) 500-2000

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Fox Chase Cancer Center
  • National Cancer Institute (NCI)
  • New York University
  • Perlmutter New York University Cancer Center
  • University of Kansas

Registry information

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Sep 8, 2023
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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