RecruitingRecruiting
Multilevel Intervention for Precision Oncology
NCT06825715 · VA Office of Research and Development
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
Multilevel Veteran-centric Intervention to Improve Precision Oncology
About this study
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
Study design
Enrollment target: 2653 participants
Allocation: na
Masking: none
Age groups: child, adult, older_adult
Timeline
Starts: 2025-07-02
Estimated completion: 2030-02-28
Last updated: 2026-07-07
Interventions
Other: Multilevel intervention
Primary outcomes
- • Use of molecular testing (3 years)
Sponsor
VA Office of Research and Development · fed
With: VA Madison Health Care, VA Pittsburgh Healthcare System, Martinsburg VA Medical Center, VA Eastern Oklahoma Health Care, New Orleans VA Medical Center, Northport VA Medical Center, Fargo VA Medical Center
Contacts & investigators
ContactAntoinette Vo, BA MA · contact · antoinette.vo@va.gov · (212) 686-7500
ContactDaniel J Becker, MD · contact · Daniel.Becker2@va.gov · (212) 686-7500
InvestigatorDaniel J Becker, MD · principal_investigator, VA NY Harbor Healthcare System, New York, NY
All locations (1)
VA NY Harbor Healthcare System, New York, NYRecruiting
New York, New York, United States