CClinicalTrials.gg
RecruitingNCT06825715MIPOUpdated Jul 7, 2026

Multilevel Intervention for Precision Oncology

An interventional study of Multilevel intervention in Advanced Cancers of the Prostate and Cancers of the Lung, sponsored by VA Office of Research and Development. Recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-07-07.

Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Health services research

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
2,653
Allocation
Not applicable
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Advanced Cancers of the Prostate
  • Cancers of the Lung
03

In context

Lead sponsor

VA Office of Research and Development is the lead sponsor of 1,733 studies on the registry; 396 are open to participants now.

Of its 206 completed or terminated interventional studies of FDA-regulated products, 180 (87%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Cancer that did not originate in the prostate or the lung
05

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
2,653 participants (estimated)

Study arms

  • Experimental
    During intervention period

    All sites will receive the 3 level intervention of patient education, provider audit/feedback, and EMR order change.

    Other: Multilevel intervention

Interventions

  • OtherMultilevel intervention

    3 components: patient education video, provider audit/feedback, and EMR ordering change

06

What researchers measure

Primary outcomes

  1. Use of molecular testing

    Proportion of eligible patients with lung and prostate cancer who have next generation sequencing molecular testing

    Time frame: 3 years

Secondary outcomes

  1. Use of targeted therapy

    Proportion of patients with actionable molecular alterations who have targeted therapy.

    Time frame: 3 years

07

Study locations

1 of 1 sites recruiting
  • VA NY Harbor Healthcare System, New York, NY
    New York, New York 10010-5011, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06825715
Lead sponsor
VA Office of Research and Development
Collaborators
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
Responsible party
Sponsor
First posted
Feb 13, 2025
Start date
Jul 2, 2025
Primary completion
Feb 28, 2029 (estimated)
Completion
Feb 28, 2030 (estimated)
Last update
Jul 7, 2026

Study contacts

Antoinette Vo, BA MA
Contact
antoinette.vo@va.gov
(212) 686-7500 ext. 3922
Daniel J Becker, MD
Contact
Daniel.Becker2@va.gov
(212) 686-7500 ext. 3303
Daniel J Becker, MD
principal investigator · VA NY Harbor Healthcare System, New York, NY

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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