Lung CancerVPCNCT06389981
Co-Design and Pilot Testing of Peer-led Community Outreach to Improve Equity, Veteran-Centeredness and Uptake of Lung Cancer Screening
A study testing Veterans peer connect Program in people with Lung Cancer, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Co-design will be implemented to develop an innovative, Veteran-centered intervention (Vet Peer Connects program) that meets the needs of Black Veterans. Next, a feasibility pilot test of the Vet Peer Connects program will be conducted. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Veterans peer connect Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2025to 15 Oct 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Self-identified Black Veterans
- Meet United States Preventive Services Task Force guidelines for lung cancer ( still smoking cigarettes or quit within past 15 years, greater than or equal to 20 pack-years total)
- Have not yet undergone lung cancer screening
Who cannot join
- Non-Black Veterans
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Boston Healthcare System
Boston, Massachusetts, 02130
About this study
Co-design will be implemented to develop an innovative, Veteran-centered intervention (Vet Peer Connects program) that meets the needs of Black Veterans.
Next, a feasibility pilot test of the Vet Peer Connects program will be conducted. The Peer will lead up to 5 group lung cancer screening orientations in community partner sites to reach up to 40 lung cancer screening eligible Black Veterans. The Peer will provide one-to-one tailored support to up to 15 Veterans (coaching, goal-setting, navigation to access Veterans Affairs lung cancer screening). Then, the study team will evaluate program delivery through ethnographic observation and field notes, Peer activity logs, and weekly check-ins between the study team and Peer. Investigators will interview Veteran participants, community partners, and lung cancer screening clinical staff to explore feasibility and acceptability of the Vet Peer Connects program and solicit suggestions for improvement. Preliminary data on the outcomes of the Vet Peer Connects program will be collected by study team through administering surveys to assess change in Social Cognitive Theory constructs, and extracting lung cancer screening uptake and tobacco treatment 3 months post enrollment from VA's Corporate Data Warehouse. This work will inform a subsequent multi-site stepped-wedge trial to assess effectiveness, implementation, and cost of the Vet Peer Connects program in VA lung cancer screening sites and neighboring branches of the National Association for Black Veterans.
- Conditions
- Lung Cancer
- Being tested
- Veterans peer connect Program
- Keywords
- Screening
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Veterans peer connect ProgramOther
To assess outcomes of the Peer-led program, the study team will collect information from Veteran pilot test participants via surveys and data abstraction on healthcare utilization (Lung cancer screening completion, tobacco treatment) from the Veterans Affairs Corporate Data Warehouse. Survey data will be collected at 3 timepoints: baseline, post-Peer-led orientation, and 3-months post-enrollment. Healthcare utilization data will be abstracted from the corporate data warehouse to reflect the 3-month post-enrollment timepoint. Finally, interviews will be conducted with a subset of participants.
| Study group | Role | What they receive |
|---|---|---|
| Peer led intervention | Experimental | The peer-led program will be pilot tested enrolling up to 40 self-identified lung cancer screening eligible Black Veterans. Receives: Other: Veterans peer connect Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lung Cancer Screening Uptake
Electronic health record review on all enrolled subjects to determine if low dose chest CT for lung cancer screening occurred between the time of study enrollment and 3 months post-enrollment.
Measured: 3 months
Secondary outcomes (11)
Tobacco Cessation Treatment
Electronic health record review on all enrolled subjects to determine if the participant was provided tobacco cessation treatment, including nicotine replacement therapy, other pharmacotherapy, or referral for smoking cessation counseling, between the time of study enrollment and 3 months post-enrollment.
Measured: 3 months
Stigma Related to Smoking
Assess via qualitative interviews
Measured: between 3-7 months post-enrollment, after completion of peer support intervention
Perceived Support From Peer
Assess via qualitative interviews
Measured: between 3-7 months post-enrollment, after completion of peer support intervention
Lung Cancer Screening Knowledge
Assessed via survey measure: Knowledge of risks and benefits of lung cancer screening. Scale 0-18, higher score means a better outcome
Measured: 3 months
Lung Cancer Screening Fatalism
Assessed via survey measure: Adapted Illness Perception Questionnaire. Scale 10-50, higher score means better outcome
Measured: 3 months
Trust in VA
Assessed via survey measure: Adapted Modified trust scale for Veterans Affairs health system. New Scale 4-20, higher score means a better outcome
Measured: 3 months
Lung Cancer Self-efficacy
Assessed via survey measure: Lung cancer screening health belief self-efficacy scale. Scale 9-36, higher score means a better outcome
Measured: 3 months
General Cancer Self-efficacy
Assessed via survey measure: New General Self-efficacy scale. Scale 8-40, higher score means a better outcome
Measured: 3 months
Intention to Engage in Shared Decision Making
Assessed via survey measure: Preparation for Decision Making, scale 10-40, lower score means better outcome
Measured: 3 months
Motivation to Quit Smoking
Assessed via survey measure: Readiness to change smoking behavior, contemplation ladder, scale 1-10, higher score means a better outcome
Measured: 3 months
Intention to Undergo Lung Cancer Screening
Assessed via survey measure: Low Literacy Decisional Conflict Scale. Scale 0-9, higher score means a better outcome
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start1 Feb 2025
- Primary completion28 Jun 2025
- Study completion15 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung CancerStudies 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
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Renda Wiener, MD, Principal investigator, VA Boston Healthcare System, Boston MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06389981
- Sponsor's protocol ID
- PPO 22-161
- Other IDs
- 1692052
- Acronym
- VPC
- Status last verified
- Jul 2026
- First submitted
- 1 Apr 2024
- Last updated
- 11 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Datasets meeting VA standards for disclosure to the public will be made available within 1 year of publication. Prior to distribution, a local privacy officer will certify that all datasets contains no protected health information. Final data sets will be maintained locally until enterprise-level resources become available for long-term storage and access. Guidance on request and distribution processes will be provided by office of research and development. Those requesting data will be asked to sign a Letter of Agreement.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-Design and Pilot Testing of Peer-led Community Outreach to Improve Equity, Veteran-Centeredness and Uptake of Lung Cancer Screening
- ClinicalTrials.gov ID
- NCT06389981
- Acronym / sponsor ID
- VPC / PPO 22-161
- Conditions
- Lung Cancer
- Keywords
- Screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 28 Jun 2025 (actual)
- Study completion
- 15 Oct 2025 (actual)
- First posted
- 29 Apr 2024 (actual)
- Results
- Posted 11 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Co-design will be implemented to develop an innovative, Veteran-centered intervention (Vet Peer Connects program) that meets the needs of Black Veterans.
Next, a feasibility pilot test of the Vet Peer Connects program will be conducted. The Peer will lead up to 5 group lung cancer screening orientations in community partner sites to reach up to 40 lung cancer screening eligible Black Veterans. The Peer will provide one-to-one tailored support to up to 15 Veterans (coaching, goal-setting, navigation to access Veterans Affairs lung cancer screening). Then, the study team will evaluate program delivery through ethnographic observation and field notes, Peer activity logs, and weekly check-ins between the study team and Peer. Investigators will interview Veteran participants, community partners, and lung cancer screening clinical staff to explore feasibility and acceptability of the Vet Peer Connects program and solicit suggestions for improvement. Preliminary data on the outcomes of the Vet Peer Connects program will be collected by study team through administering surveys to assess change in Social Cognitive Theory constructs, and extracting lung cancer screening uptake and tobacco treatment 3 months post enrollment from VA's Corporate Data Warehouse. This work will inform a subsequent multi-site stepped-wedge trial to assess effectiveness, implementation, and cost of the Vet Peer Connects program in VA lung cancer screening sites and neighboring branches of the National Association for Black Veterans.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peer led intervention | Experimental | Other: Veterans peer connect ProgramThe peer-led program will be pilot tested enrolling up to 40 self-identified lung cancer screening eligible Black Veterans. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Self-identified Black Veterans
- Meet United States Preventive Services Task Force guidelines for lung cancer ( still smoking cigarettes or quit within past 15 years, greater than or equal to 20 pack-years total)
- Have not yet undergone lung cancer screening
Key exclusion criteria (1 listed)
- Non-Black Veterans
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 |
|---|---|---|
| Veterans peer connect ProgramTo assess outcomes of the Peer-led program, the study team will collect information from Veteran pilot test participants via surveys and data abstraction on healthcare utilization (Lung cancer screening completion, tobacco treatment) from the Veterans Affairs Corporate Data Warehouse. Survey data will be collected at 3 timepoints: baseline, post-Peer-led orientation, and 3-months post-enrollment. Healthcare utilization data will be abstracted from the corporate data warehouse to reflect the 3-month post-enrollment timepoint. Finally, interviews will be conducted with a subset of participants. | Other | Peer led intervention |
Primary outcome
Lung Cancer Screening Uptake
Time frame: 3 months
Electronic health record review on all enrolled subjects to determine if low dose chest CT for lung cancer screening occurred between the time of study enrollment and 3 months post-enrollment.
11 secondary outcomes
Tobacco Cessation Treatment
Time frame: 3 months
Stigma Related to Smoking
Time frame: between 3-7 months post-enrollment, after completion of peer support intervention
Perceived Support From Peer
Time frame: between 3-7 months post-enrollment, after completion of peer support intervention
Lung Cancer Screening Knowledge
Time frame: 3 months
Lung Cancer Screening Fatalism
Time frame: 3 months
Trust in VA
Time frame: 3 months
Lung Cancer Self-efficacy
Time frame: 3 months
General Cancer Self-efficacy
Time frame: 3 months
Intention to Engage in Shared Decision Making
Time frame: 3 months
Motivation to Quit Smoking
Time frame: 3 months
Intention to Undergo Lung Cancer Screening
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Datasets meeting VA standards for disclosure to the public will be made available within 1 year of publication. Prior to distribution, a local privacy officer will certify that all datasets contains no protected health information. Final data sets will be maintained locally until enterprise-level resources become available for long-term storage and access. Guidance on request and distribution processes will be provided by office of research and development. Those requesting data will be asked to sign a Letter of Agreement.
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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. This study is not recruiting at the moment.
Renda Wiener, MD principal investigator
VA Boston Healthcare System, Boston MA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Veterans peer connect Program in people with Lung Cancer, 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 3 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: finished, as of the sponsor's last update on 11 Aug 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?
Yes. Results are posted in the registry (first posted 11 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung Cancer Screening Uptake (time frame: 3 months). 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 11 Aug 2026.