- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06389981
Co-Design and Pilot Testing of Peer-led Community Outreach to Improve Equity, Veteran-Centeredness and Uptake of Lung Cancer Screening (VPC)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Massachusetts
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Boston, Massachusetts, United States, 02130
- VA Boston Healthcare System
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Non-Black Veterans
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Peer led intervention
The peer-led program will be pilot tested enrolling up to 40 self-identified lung cancer screening eligible Black Veterans.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tobacco Cessation Treatment
Time Frame: 3 months
|
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.
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3 months
|
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Stigma Related to Smoking
Time Frame: between 3-7 months post-enrollment, after completion of peer support intervention
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Assess via qualitative interviews
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between 3-7 months post-enrollment, after completion of peer support intervention
|
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Perceived Support From Peer
Time Frame: between 3-7 months post-enrollment, after completion of peer support intervention
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Assess via qualitative interviews
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between 3-7 months post-enrollment, after completion of peer support intervention
|
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Lung Cancer Screening Knowledge
Time Frame: 3 months
|
Assessed via survey measure: Knowledge of risks and benefits of lung cancer screening.
Scale 0-18, higher score means a better outcome
|
3 months
|
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Lung Cancer Screening Fatalism
Time Frame: 3 months
|
Assessed via survey measure: Adapted Illness Perception Questionnaire.
Scale 10-50, higher score means better outcome
|
3 months
|
|
Trust in VA
Time Frame: 3 months
|
Assessed via survey measure: Adapted Modified trust scale for Veterans Affairs health system.
New Scale 4-20, higher score means a better outcome
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3 months
|
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Lung Cancer Self-efficacy
Time Frame: 3 months
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Assessed via survey measure: Lung cancer screening health belief self-efficacy scale.
Scale 9-36, higher score means a better outcome
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3 months
|
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General Cancer Self-efficacy
Time Frame: 3 months
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Assessed via survey measure: New General Self-efficacy scale.
Scale 8-40, higher score means a better outcome
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3 months
|
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Intention to Engage in Shared Decision Making
Time Frame: 3 months
|
Assessed via survey measure: Preparation for Decision Making, scale 10-40, lower score means better outcome
|
3 months
|
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Motivation to Quit Smoking
Time Frame: 3 months
|
Assessed via survey measure: Readiness to change smoking behavior, contemplation ladder, scale 1-10, higher score means a better outcome
|
3 months
|
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Intention to Undergo Lung Cancer Screening
Time Frame: 3 months
|
Assessed via survey measure: Low Literacy Decisional Conflict Scale.
Scale 0-9, higher score means a better outcome
|
3 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Renda Wiener, MD, VA Boston Healthcare System, Boston MA
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PPO 22-161
- 1692052 (Other Identifier: VA Boston Healthcare System)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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