Evaluating the Implementation of a Comprehensive Multilevel Virtual Oncology Program Among Veterans Diagnosed With Lung, Colorectal, Prostate, and Breast Cancers in the US Department of Veterans Affairs

March 25, 2026 updated by: NYU Langone Health
The objective of the pragmatic trial to test the effectiveness of an existing, ongoing clinical service, the VA National TeleOncology program (NTO), a multilevel telehealth population health management program. The primary aims are to study the intervention and determine its effectiveness on telehealth engagement, clinical quality, and healthcare cost outcomes across personal characteristics.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Study staff will use the Veterans Health Information Systems and Technology Architecture (VistA), the VA health information technology system, to identify eligible patients at VA sites based on listed inclusion and exclusion criteria. Patient records will be observed of Veterans with a new cancer diagnosis of the lung, prostate, breast, or colon and a telehealth visit utilizing the VA National TeleOncology Service (NTO).

Study Type

Observational

Enrollment (Estimated)

1800

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • Brooklyn, New York, United States, 11209
        • Recruiting
        • VA New York Harbor Healthcare System - Brooklyn
      • Jamaica, New York, United States, 11425
        • Recruiting
        • VA New York Harbor Healthcare System - St. Albans Community Living Center
      • New York, New York, United States, 10010
        • Recruiting
        • VA New York Harbor Health Care System - Manhattan
      • New York, New York, United States, 10027
        • Recruiting
        • VA New York Harbor Healthcare System - Harlem Community Center
      • Staten Island, New York, United States, 10314
        • Recruiting
        • VA New York Harbor Healthcare System - Staten Island Community Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Veterans aged 18 years or older newly diagnosed with lung, colorectal, prostate or breast cancer.

VA health care providers and staff members participating in cancer care at NTO program medical centers, including physicians, nurse practitioners, physicians' assistants and nurses.

Description

Patients Inclusion Criteria:

  1. A Veteran
  2. Aged 18 years or older
  3. Newly diagnosed with lung, prostate, breast, or colon cancer within 3 months of telemedicine visit
  4. Engaged in an oncology visit during the 36-month analysis period at a Veterans Affairs Medical Center (VAMC) location.

VAMC Providers and Staff Inclusion Criteria:

  1. Provider or staff member at one of the VAMC locations including physicians, nurse practitioners, physicians' assistants, and nurses caring for Veterans
  2. Providers or staff members having helped provide care for at least 5 Veterans with cancer in the previous 6 months at a VAMC location

Patients Exclusion Criteria:

  1. Veterans who have not seen any providers in the VA within the past year
  2. Patients previously diagnosed with lung, prostate, breast, or colon cancer
  3. Pregnant patients

VAMC Providers and Staff Exclusion Criteria:

1. Providers or staff members who do not help treat Veterans with specified cancers in oncology at the VA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Veterans
Veterans aged 18 years or older newly diagnosed with lung, colorectal, prostate or breast cancer. Patient records will be observed of Veterans with a new cancer diagnosis of the lung, prostate, breast, or colon and a telehealth visit utilizing the VA National TeleOncology Service (NTO).
VA health care providers and staff members
VA health care providers and staff members participating in cancer care at NTO program medical centers, including physicians, nurse practitioners, physicians' assistants and nurses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of raw telehealth visits
Time Frame: Post-NTO implementation (up to 3 months)
Telehealth utilization among Veterans with cancer will be measured through raw telehealth visit counts.
Post-NTO implementation (up to 3 months)
Fraction of patients engaging in at least one telehealth visit
Time Frame: Post-NTO implementation (up to 3 months)
Telehealth utilization among Veterans with cancer will be measured by fraction of patients engaging in at least one telehealth visit.
Post-NTO implementation (up to 3 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in provider level Quality Oncology Practice Initiative (QOPI) score
Time Frame: Pre-implementation, post-NTO implementation (up to 3 months)
The quality of care of the intervention will be evaluating utilizing the American Society of Clinical Oncology Practice Initiative (QOPI) performance measures. The scale consists of 26 performance measures assessed at the patient, provider, and facility levels. Each cancer care provider will have his or her patient QOPI measures aggregated together for a provider level QOPI score. Our primary interest is the difference in QOPI score by intervention condition, as estimated by the fixed-effect coefficient for the intervention indicator variable. Scores of 75% or more indicate the standard is met, scores less than 75% indicate the standards have not been met. An increase in the QOPI score indicates improvement.
Pre-implementation, post-NTO implementation (up to 3 months)
Time of consultation to time of first appointment
Time Frame: Pre-implementation, post-NTO implementation (up to 3 months)
Time to care will be measured through time of consultation to time of first appointment.
Pre-implementation, post-NTO implementation (up to 3 months)
Time of consultation to time of first treatment
Time Frame: Pre-implementation, post-NTO implementation (up to 3 months)
Time to care will be measured through time of consultation to time of first treatment.
Pre-implementation, post-NTO implementation (up to 3 months)
Average total cost for cancer diagnosis, treatment and downstream HealthCare utilization
Time Frame: Post-NTO implementation (up to 3 months)
Post-NTO implementation (up to 3 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Danil Makarov, MD, MHS, NYU Langone Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2024

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

July 31, 2027

Study Registration Dates

First Submitted

August 15, 2024

First Submitted That Met QC Criteria

August 16, 2024

First Posted (Actual)

August 19, 2024

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 25, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-01448
  • 5P50CA271358 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The de-identified participant data for survey and interview participants who have been consented and signed Health Insurance Portability and Accountability Act (HIPAA) waivers will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Per Veterans Health Administration (VHA) policy, the deidentified national data is unable to be shared. Requests may be directed to: janeth.juarezpadilla@nyulangone.org. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

IPD Sharing Time Frame

Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.

IPD Sharing Access Criteria

The investigator who proposed to use the data will be provided access upon reasonable request. Requests should be directed to janeth.juarezpadilla@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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