Lung Cancer DiagnosisNCT06559059
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
A study testing National TeleOncology in people with Lung Cancer Diagnosis and Colorectal Cancer (Diagnosis), run by NYU Langone Health at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer Diagnosis, Colorectal Cancer (Diagnosis), Prostate Cancer Diagnosis
- What is being tested?
- National TeleOncology
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,800 participants
- Where
- 5 sitesUnited States
- Study dates
- 18 Jun 2024to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Patients Inclusion Criteria:
- 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.
VAMC Providers and Staff Inclusion Criteria:
- 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
Patients Exclusion Criteria:
- 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
VAMC Providers and Staff Exclusion Criteria:
- Providers or staff members who do not help treat Veterans with specified cancers in oncology at the VA
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites, 5 recruiting
- Recruiting
VA New York Harbor Healthcare System - Brooklyn
Brooklyn, New York, 11209
- Recruiting
VA New York Harbor Healthcare System - St. Albans Community Living Center
Jamaica, New York, 11425
- Recruiting
VA New York Harbor Health Care System - Manhattan
New York, New York, 10010
- Recruiting
VA New York Harbor Healthcare System - Harlem Community Center
New York, New York, 10027
- Recruiting
VA New York Harbor Healthcare System - Staten Island Community Clinic
Staten Island, New York, 10314
About this study
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.
Read the 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).
- Conditions
- Lung Cancer Diagnosis, Colorectal Cancer (Diagnosis), Prostate Cancer Diagnosis, Breast Cancer Diagnosis
- Being tested
- National TeleOncology
- Medical subject headings
- Colorectal Neoplasms, Disease, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
National TeleOncologyBehavioural
Medical and/or subspecialty oncology care offered via facility-to-facility telehealth as an alternative to usual in-person care at the nearest VA or community oncology care setting offering similar services.
| Study group | Role | What they receive |
|---|---|---|
| VA National TeleOncology Service (NTO) | Experimental | This arm will include
1. Veterans with a new cancer diagnosis of the lung, prostate, breast, or colon and a telehealth visit utilizing the VA National TeleOncology Service (NTO), and
2. VA health care providers and staff members participating in cancer care at NTO program medical centers. Receives: Behavioral: National TeleOncology |
| Usual Care | No intervention | This arm will include 1. Veterans with a new cancer diagnosis of the lung, prostate, breast, or colon and a visit at a VA medical center location that has not implemented NTO, and 2. VA health care providers and staff members participating in cancer care at a medical center where the NTO program has not been implemented. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of raw telehealth visits
Telehealth utilization among Veterans with cancer will be measured through raw telehealth visit counts.
Measured: 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.
Measured: Post-NTO implementation (up to 3 months)
Secondary outcomes (4)
Change in provider level Quality Oncology Practice Initiative (QOPI) score
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.
Measured: Pre-implementation, post-NTO implementation (up to 3 months)
Time of consultation to time of first appointment
Time to care will be measured through time of consultation to time of first appointment.
Measured: Pre-implementation, post-NTO implementation (up to 3 months)
Time of consultation to time of first treatment
Time to care will be measured through time of consultation to time of first treatment.
Measured: Pre-implementation, post-NTO implementation (up to 3 months)
Average total cost for cancer diagnosis, treatment and downstream HealthCare utilization
Measured: Post-NTO implementation (up to 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start18 Jun 2024
- Primary completion31 May 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung Cancer DiagnosisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Danil Makarov, MD, MHS, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06559059
- Sponsor's protocol ID
- 22-01448
- Other IDs
- 5P50CA271358
- Status last verified
- Jun 2026
- First submitted
- 15 Aug 2024
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06559059
- Acronym / sponsor ID
- 22-01448
- Conditions
- Lung Cancer Diagnosis, Colorectal Cancer (Diagnosis), Prostate Cancer Diagnosis, Breast Cancer Diagnosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,800 participants (estimated)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 18 Jun 2024 (actual)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 19 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VA National TeleOncology Service (NTO) | Experimental | Behavioral: National TeleOncologyThis arm will include 1. Veterans with a new cancer diagnosis of the lung, prostate, breast, or colon and a telehealth visit utilizing the VA National TeleOncology Service (NTO), and 2. VA health care providers and staff members participating in cancer care at NTO program medical centers. |
| Usual Care | No intervention | –This arm will include 1. Veterans with a new cancer diagnosis of the lung, prostate, breast, or colon and a visit at a VA medical center location that has not implemented NTO, and 2. VA health care providers and staff members participating in cancer care at a medical center where the NTO program has not been implemented. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| National TeleOncologyMedical and/or subspecialty oncology care offered via facility-to-facility telehealth as an alternative to usual in-person care at the nearest VA or community oncology care setting offering similar services. | Behavioural | VA National TeleOncology Service (NTO) |
Primary outcome
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.
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.
4 secondary outcomes
Change in provider level Quality Oncology Practice Initiative (QOPI) score
Time frame: 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 of consultation to time of first treatment
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Danil Makarov, MD, MHS principal investigator
NYU Langone Health
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing National TeleOncology in people with Lung Cancer Diagnosis and Colorectal Cancer (Diagnosis), run by NYU Langone Health at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Janeth Juarez Padilla (646-501-3588, Janeth.juarezpadilla@nyulangone.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of raw telehealth visits (time frame: Post-NTO implementation (up to 3 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.