Clinical trial NCT06030011: Implementing the NYU Electronic Patient Visit Assessment (ePVA) for Head and Neck Cancer In Rural and Urban Populations
Official title: Implementing the NYU Electronic Patient Visit Assessment (ePVA) for Head and Neck Cancer In Rural and Urban Populations
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Head and Neck Cancer
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: New York University Meyers College of Nursing
name: New York University Langone Perlmutter Cancer Center
name: University of Kansas
name: Fox Chase Cancer Center
First posted: 2023-09-08
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
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)
timeFrame: 4 weeks after completing radiation therapy
Secondary outcomes:
measure: Pain as assessed by EORTC QLQ-H&N35 Quality of Life Questionnaire (QLQ)
timeFrame: 4 weeks after completing radiation therapy
measure: Health-Related Quality of Life (HRQoL) as assessed by the EORTC QLQ-C30 Quality of Life Questionnaire (QLQ)
timeFrame: 4 weeks after completing radiation therapy
measure: Acute Care Services Use as assessed by number of acute care visits
timeFrame: 4 weeks after completing radiation therapy
measure: Acute Care Services Use as assessed by number of days of using acute care
timeFrame: 4 weeks after completing radiation therapy
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Kansas Cancer Center
state: Kansas
city: New York
country: United States
facility: NYU Meyers College of Nursing
state: New York
city: New York
country: United States
facility: NYU Langone Perlmutter Cancer Center
state: New York
city: Philadelphia
country: United States
facility: Fox Chase Cancer Center
state: Pennsylvania
city: Houston
country: United States
facility: UTHealth Houston Cizik School of Nursing
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center at Houston (UTHealth Houston)
name: Janet H. Van Cleave, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References: