NCT06559059

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,800

participants targeted

Target at P75+ for all trials

Timeline
15mo left

Started Jun 2024

Typical duration for all trials

Geographic Reach
1 country

5 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress61%
Jun 2024Jul 2027

Study Start

First participant enrolled

June 18, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 19, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2027

Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

August 15, 2024

Last Update Submit

March 25, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Number of raw telehealth visits

    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

    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 Outcomes (4)

  • Change in provider level Quality Oncology Practice Initiative (QOPI) score

    Pre-implementation, post-NTO implementation (up to 3 months)

  • 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

    Pre-implementation, post-NTO implementation (up to 3 months)

  • Average total cost for cancer diagnosis, treatment and downstream HealthCare utilization

    Post-NTO implementation (up to 3 months)

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • A Veteran
  • Aged 18 years or older
  • Newly diagnosed with lung, prostate, breast, or colon cancer within 3 months of telemedicine visit
  • Engaged in an oncology visit during the 36-month analysis period at a Veterans Affairs Medical Center (VAMC) location.
  • Provider or staff member at one of the VAMC locations including physicians, nurse practitioners, physicians' assistants, and nurses caring for Veterans
  • Providers or staff members having helped provide care for at least 5 Veterans with cancer in the previous 6 months at a VAMC location

You may not qualify if:

  • Veterans who have not seen any providers in the VA within the past year
  • Patients previously diagnosed with lung, prostate, breast, or colon cancer
  • Pregnant patients
  • \. Providers or staff members who do not help treat Veterans with specified cancers in oncology at the VA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

VA New York Harbor Healthcare System - Brooklyn

Brooklyn, New York, 11209, United States

RECRUITING

VA New York Harbor Healthcare System - St. Albans Community Living Center

Jamaica, New York, 11425, United States

RECRUITING

VA New York Harbor Health Care System - Manhattan

New York, New York, 10010, United States

RECRUITING

VA New York Harbor Healthcare System - Harlem Community Center

New York, New York, 10027, United States

RECRUITING

VA New York Harbor Healthcare System - Staten Island Community Clinic

Staten Island, New York, 10314, United States

RECRUITING

MeSH Terms

Conditions

Colorectal NeoplasmsDiseaseBreast Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Danil Makarov, MD, MHS

    NYU Langone Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 15, 2024

First Posted

August 19, 2024

Study Start

June 18, 2024

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

July 31, 2027

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
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.
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.

Locations