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RecruitingInterventional

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

NCT ID: NCT06030011Sponsor: The University of Texas Health Science Center, HoustonLast updated: 2024-07-15

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.

Arms & interventions

  • BehavioralNYU 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).

  • BehavioralUsual 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 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.

Outcome measures

Primary

  • 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.

    Time frame: 4 weeks after completing radiation therapy

Secondary

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

    Time frame: 4 weeks after completing radiation therapy

  • 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

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

    Time frame: 4 weeks after completing radiation therapy

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

    Time frame: 4 weeks after completing radiation therapy

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
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.

Study locations (5)

University of Kansas Cancer Center

Kansas City, Kansas, 66160

Recruiting
Chris Lominska, MD · Contact

NYU Meyers College of Nursing

New York, New York, 10010

Not Yet Recruiting
Abraham A. Brody, PhD, RN · Contact

NYU Langone Perlmutter Cancer Center

New York, New York, 10016

Recruiting
Kenneth Hu, MD · Contact

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111

Not Yet Recruiting
Jessica Bauman, MD · Contact

UTHealth Houston Cizik School of Nursing

Houston, Texas, 77030

Not Yet Recruiting
Janet H. Van Cleave, PhD, RN · Contact

References

  • 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.(PubMed)