Advanced Cancers of the ProstateMIPONCT06825715
Multilevel Intervention for Precision Oncology
A study testing Multilevel intervention in people with Advanced Cancers of the Prostate and Cancers of the Lung, run by VA Office of Research and Development at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Advanced Cancers of the Prostate, Cancers of the Lung
- What is being tested?
- Multilevel intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,653 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2025to 28 Feb 2030
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients in the VA with cancer of the lung or prostate who are seen in the oncology clinic
Who cannot join
- Cancer that did not originate in the prostate or the lung
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA NY Harbor Healthcare System, New York, NY
New York, New York, 10010-5011
Antoinette Vo, BA MA, 212-686-7500 ext. 3922, antoinette.vo@va.gov
Daniel J Becker, MD, (212) 686-7500 ext. 3303, Daniel.Becker2@va.gov
About this study
Official title: Multilevel Veteran-centric Intervention to Improve Precision Oncology
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.
- Being tested
- Multilevel intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multilevel interventionOther
3 components: patient education video, provider audit/feedback, and EMR ordering change
| Study group | Role | What they receive |
|---|---|---|
| During intervention period | Experimental | All sites will receive the 3 level intervention of patient education, provider audit/feedback, and EMR order change. Receives: Other: Multilevel intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of molecular testing
Proportion of eligible patients with lung and prostate cancer who have next generation sequencing molecular testing
Measured: 3 years
Secondary outcomes (1)
Use of targeted therapy
Proportion of patients with actionable molecular alterations who have targeted therapy.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2025
- Study start2 Jul 2025
- Primary completion28 Feb 2029 (estimated)
- Study completion28 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Cancers of the ProstateStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- Multilevel intervention with components of patient education, provider audit/feedback, and change in electronic medical record test order and results return.
- Masking
- None (open label)
- Enrolment
- 2,653 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- 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
- Investigators
- Daniel J Becker, MD, Principal investigator, VA NY Harbor Healthcare System, New York, NY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06825715
- Sponsor's protocol ID
- IIR 22-169
- Acronym
- MIPO
- Status last verified
- Jul 2026
- First submitted
- 7 Feb 2025
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multilevel Veteran-centric Intervention to Improve Precision Oncology
- ClinicalTrials.gov ID
- NCT06825715
- Acronym / sponsor ID
- MIPO / IIR 22-169
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,653 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- 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
- Study start
- 2 Jul 2025 (actual)
- Primary completion
- 28 Feb 2029 (estimated)
- Study completion
- 28 Feb 2030 (estimated)
- First posted
- 13 Feb 2025 (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 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multilevel intervention with components of patient education, provider audit/feedback, and change in electronic medical record test order and results return.
| Arm | Type | Receives |
|---|---|---|
| During intervention period | Experimental | Other: Multilevel interventionAll sites will receive the 3 level intervention of patient education, provider audit/feedback, and EMR order change. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients in the VA with cancer of the lung or prostate who are seen in the oncology clinic
Key exclusion criteria (1 listed)
- Cancer that did not originate in the prostate or the lung
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 |
|---|---|---|
| Multilevel intervention3 components: patient education video, provider audit/feedback, and EMR ordering change | Other | During intervention period |
Primary outcome
Use of molecular testing
Time frame: 3 years
Proportion of eligible patients with lung and prostate cancer who have next generation sequencing molecular testing
1 secondary outcome
Use of targeted therapy
Time frame: 3 years
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 7 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Daniel J Becker, MD principal investigator
VA NY Harbor Healthcare System, New York, NY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multilevel intervention in people with Advanced Cancers of the Prostate and Cancers of the Lung, run by VA Office of Research and Development at 1 site 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?
The sponsor lists 1 inclusion and 1 exclusion criteria. 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 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Antoinette Vo, BA MA ((212) 686-7500 ext. 3922, antoinette.vo@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of molecular testing (time frame: 3 years). 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 7 Jul 2026.