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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06030011
• Other study ID #: HSC-SN-23-0784
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: January 2025

Study information

• Verified date: August 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: Janet H. Van Cleave, PhD, RN
• Phone: (713) 500-2000
• Email: Janet.H.VanCleave[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 270
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Behavioral:
• 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).
• 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 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.

Locations

Country	Name	City	State
United States	UTHealth Houston Cizik School of Nursing	Houston	Texas
United States	University of Kansas Cancer Center	Kansas City	Kansas
United States	NYU Langone Perlmutter Cancer Center	New York	New York
United States	NYU Meyers College of Nursing	New York	New York
United States	Fox Chase Cancer Center	Philadelphia	Pennsylvania

Sponsors (6)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Fox Chase Cancer Center, National Cancer Institute (NCI), New York University Langone Perlmutter Cancer Center, New York University Meyers College of Nursing, University of Kansas

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	4 weeks after completing radiation therapy
Secondary	Pain as assessed by EORTC QLQ-H&N35 Quality of Life Questionnaire (QLQ)	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.	4 weeks after completing radiation therapy
Secondary	Health-Related Quality of Life (HRQoL) as assessed by the EORTC QLQ-C30 Quality of Life Questionnaire (QLQ)	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.	4 weeks after completing radiation therapy
Secondary	Acute Care Services Use as assessed by number of acute care visits	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 weeks after completing radiation therapy
Secondary	Acute Care Services Use as assessed by number of days of using acute care	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 weeks after completing radiation therapy