Clinical trial NCT06825715: Multilevel Intervention for Precision Oncology
Official title: Multilevel Veteran-centric Intervention to Improve Precision Oncology
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Advanced Cancers of the Prostate
Cancers of the Lung
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: VA Madison Health Care
name: VA Pittsburgh Healthcare System
name: Martinsburg VA Medical Center
name: VA Eastern Oklahoma Health Care
name: New Orleans VA Medical Center
name: Northport VA Medical Center
name: Fargo VA Medical Center
name: VA Iron Mountain Health Care
First posted: 2025-02-13
Enrollment: 2653
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Multilevel intervention with components of patient education, provider audit/feedback, and change in electronic medical record test order and results return.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The investigators are rolling out a 3 level intervention designed to improve the use of Precision Oncology at 8 VA medical centers. The 3 components of the intervention are 1: a short educational video for patients, 2: audit and feedback to providers on their Precision Oncology practice patterns, and 3: a change in the electronic medical record to make it easier to order and review results of Precision Oncology tests.

Detailed description: Background: Precision oncology (PO), the use of molecular testing to identify tumor specific abnormalities which facilitate targeted therapy, is proven to extend lives and improve quality of life for patients with cancer. Extensive study, however, documents that up to 50% of patients in the VA, especially those with adverse social determinants of health (older age, rural), do not receive guideline recommended PO.

Methodology: Building on the investigators' previous analyses, and the Theoretical Domains Framework, the investigators designed a mixed-methods type I hybrid effectiveness-implementation study of a multilevel intervention (MLI) to improve the use of PO. The MLI will be instituted for veterans with advanced cancers of the colon, lung, and prostate, as well as providers at 8 sites, chosen to represent diversity at the level of rurality, geographic region, cancer volume, and mode of delivery (virtual/in-person). The patient intervention is a 5-minute educational module accessible by QR code. The provider intervention is a 45-minute academic detailing session, as well as individualized audit and feedback on practice patterns. The facility level intervention is a previously piloted integration of PO ordering, interdepartmental communication, and results return into the primary electronic medical record via a consult function. The primary efficacy outcome is the rate of molecular testing/eligible veterans. Validated survey measures will be used for stakeholder engagement. The process evaluation employs a mixed methods approach based in the RE-AIM framework, which includes quantitative analyses of collected data, and interviews of patients and providers. The statistical design is a randomized stepped-wedge trial over 3 years which retains control data from across all sites.

Eligibility criteria: Inclusion Criteria:

* Patients in the VA with cancer of the lung or prostate who are seen in the oncology clinic

Exclusion Criteria:

* Cancer that did not originate in the prostate or the lung

Primary outcomes:
measure: Use of molecular testing
timeFrame: 3 years
Secondary outcomes:
measure: Use of targeted therapy
timeFrame: 3 years
Other outcomes:
Locations:
city: New York
country: United States
facility: VA NY Harbor Healthcare System, New York, NY
state: New York
Study officials:
affiliation: VA NY Harbor Healthcare System, New York, NY
name: Daniel J Becker, MD
role: PRINCIPAL_INVESTIGATOR
References: