Ignite Creation Date:
2025-12-24 @ 2:30 PM
Ignite Modification Date:
2025-12-26 @ 1:25 AM
Study NCT ID:
NCT06559059
Status:
RECRUITING
Last Update Posted:
2025-09-25
First Post:
2024-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief 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
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D004194', 'term': 'Disease'}, {'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'ECOLOGIC_OR_COMMUNITY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1800}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-22', 'studyFirstSubmitDate': '2024-08-15', 'studyFirstSubmitQcDate': '2024-08-16', 'lastUpdatePostDateStruct': {'date': '2025-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-08-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of raw telehealth visits', 'timeFrame': 'Post-NTO implementation (up to 3 months)', 'description': 'Telehealth utilization among Veterans with cancer will be measured through raw telehealth visit counts.'}, {'measure': 'Fraction of patients engaging in at least one telehealth visit', 'timeFrame': 'Post-NTO implementation (up to 3 months)', 'description': 'Telehealth utilization among Veterans with cancer will be measured by fraction of patients engaging in at least one telehealth visit.'}], 'secondaryOutcomes': [{'measure': 'Change in provider level Quality Oncology Practice Initiative (QOPI) score', 'timeFrame': 'Pre-implementation, post-NTO implementation (up to 3 months)', 'description': '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.'}, {'measure': 'Time of consultation to time of first appointment', 'timeFrame': 'Pre-implementation, post-NTO implementation (up to 3 months)', 'description': 'Time to care will be measured through time of consultation to time of first appointment.'}, {'measure': 'Time of consultation to time of first treatment', 'timeFrame': 'Pre-implementation, post-NTO implementation (up to 3 months)', 'description': 'Time to care will be measured through time of consultation to time of first treatment.'}, {'measure': 'Average total cost for cancer diagnosis, treatment and downstream HealthCare utilization', 'timeFrame': 'Post-NTO implementation (up to 3 months)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Cancer Diagnosis', 'Colorectal Cancer (Diagnosis)', 'Prostate Cancer Diagnosis', 'Breast Cancer Diagnosis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Veterans aged 18 years or older newly diagnosed with lung, colorectal, prostate or breast cancer.\n\nVA health care providers and staff members participating in cancer care at NTO program medical centers, including physicians, nurse practitioners, physicians' assistants and nurses.", 'healthyVolunteers': False, 'eligibilityCriteria': "Patients Inclusion Criteria:\n\n1. A Veteran\n2. Aged 18 years or older\n3. Newly diagnosed with lung, prostate, breast, or colon cancer within 3 months of telemedicine visit\n4. Engaged in an oncology visit during the 36-month analysis period at a Veterans Affairs Medical Center (VAMC) location.\n\nVAMC Providers and Staff Inclusion Criteria:\n\n1. Provider or staff member at one of the VAMC locations including physicians, nurse practitioners, physicians' assistants, and nurses caring for Veterans\n2. Providers or staff members having helped provide care for at least 5 Veterans with cancer in the previous 6 months at a VAMC location\n\nPatients Exclusion Criteria:\n\n1. Veterans who have not seen any providers in the VA within the past year\n2. Patients previously diagnosed with lung, prostate, breast, or colon cancer\n3. Pregnant patients\n\nVAMC Providers and Staff Exclusion Criteria:\n\n1\\. Providers or staff members who do not help treat Veterans with specified cancers in oncology at the VA"}, 'identificationModule': {'nctId': 'NCT06559059', 'briefTitle': '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', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '22-01448'}, 'secondaryIdInfos': [{'id': '5P50CA271358', 'link': 'https://reporter.nih.gov/quickSearch/5P50CA271358', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Veterans', 'description': '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).'}, {'label': 'VA health care providers and staff members', 'description': "VA health care providers and staff members participating in cancer care at NTO program medical centers, including physicians, nurse practitioners, physicians' assistants and nurses."}]}, 'contactsLocationsModule': {'locations': [{'zip': '11209', 'city': 'Brooklyn', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'VA New York Harbor Healthcare System - Brooklyn', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '11425', 'city': 'Jamaica', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'VA New York Harbor Healthcare System - St. Albans Community Living Center', 'geoPoint': {'lat': 40.69149, 'lon': -73.80569}}, {'zip': '10010', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'VA New York Harbor Health Care System - Manhattan', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10027', 'city': 'New York', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'VA New York Harbor Healthcare System - Harlem Community Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10314', 'city': 'Staten Island', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'VA New York Harbor Healthcare System - Staten Island Community Clinic', 'geoPoint': {'lat': 40.56233, 'lon': -74.13986}}], 'centralContacts': [{'name': 'Janeth Juarez Padilla', 'role': 'CONTACT', 'email': 'Janeth.juarezpadilla@nyulangone.org', 'phone': '646-501-3588'}, {'name': 'Navid Dardashti', 'role': 'CONTACT', 'email': 'Navid.dardashti@nyulangone.org', 'phone': '201-906-7713'}], 'overallOfficials': [{'name': 'Danil Makarov, MD, MHS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.', 'ipdSharing': 'YES', '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.', 'accessCriteria': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}