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

Primary Purpose

Head and Neck Cancer

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NYU Electronic Patient Visit Assessment (ePVA)
Usual Care
Sponsored by
The University of Texas Health Science Center, Houston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Kansas Cancer Center
  • NYU Meyers College of Nursing
  • NYU Langone Perlmutter Cancer Center
  • Fox Chase Cancer Center
  • UTHealth Houston Cizik School of Nursing

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

NYU Electronic Patient Visit Assessment (ePVA) plus Usual Care

Usual Care

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
September 1, 2023
Last Updated
September 1, 2023
Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Cancer Institute (NCI), New York University Meyers College of Nursing, New York University Langone Perlmutter Cancer Center, University of Kansas, Fox Chase Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT06030011
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
January 2024 (Anticipated)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Texas Health Science Center, Houston
Collaborators
National Cancer Institute (NCI), New York University Meyers College of Nursing, New York University Langone Perlmutter Cancer Center, University of Kansas, Fox Chase Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
270 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NYU Electronic Patient Visit Assessment (ePVA) plus Usual Care
Arm Type
Experimental
Arm Title
Usual Care
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
NYU Electronic Patient Visit Assessment (ePVA)
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
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 Outcome Measure Information:
Title
Head and neck cancer (HNC) symptoms as assessed by the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ)
Description
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 Outcome Measure Information:
Title
Pain as assessed by EORTC QLQ-H&N35 Quality of Life Questionnaire (QLQ)
Description
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.
Time Frame
4 weeks after completing radiation therapy
Title
Health-Related Quality of Life (HRQoL) as assessed by the EORTC QLQ-C30 Quality of Life Questionnaire (QLQ)
Description
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.
Time Frame
4 weeks after completing radiation therapy
Title
Acute Care Services Use as assessed by number of acute care visits
Description
Acute Care Services Use is the use of services delivered in acute care settings, such as feeding tube placements, emergency room visits, and hospitalizations.
Time Frame
4 weeks after completing radiation therapy
Title
Acute Care Services Use as assessed by number of days of using acute care
Description
Acute Care Services Use is the use of services delivered in acute care settings, such as feeding tube placements, emergency room visits, and hospitalizations.
Time Frame
4 weeks after completing radiation therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Janet H. Van Cleave, PhD, RN
Phone
(713) 500-2000
Email
Janet.H.VanCleave@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janet H. Van Cleave, PhD, RN
Organizational Affiliation
The University of Texas Health Science Center at Houston (UTHealth Houston)
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kansas Cancer Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chris Lominska, MD
Email
clominska@kumc.edu
Facility Name
NYU Meyers College of Nursing
City
New York
State/Province
New York
ZIP/Postal Code
10010
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abraham A. Brody, PhD, RN
Email
ab.brody@nyu.edu
Facility Name
NYU Langone Perlmutter Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kenneth Hu, MD
Email
Kenneth.Hu@nyulangone.org
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Bauman, MD
Email
Jessica.Bauman@fccc.edu
Facility Name
UTHealth Houston Cizik School of Nursing
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Janet H. Van Cleave, PhD, RN
Email
Janet.H.VanCleave@uth.tmc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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