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 4 group lung cancer screening orientations in community partner sites to reach around 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: Not yet recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Other: Veterans peer connect Program

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Renda Wiener, MD; Phone Number: 857-364-5685; Email: renda.wiener@va.gov
• Study Contact Backup: Name: Jacquelyn Pendergast, MS; Phone Number: 857-364-2760; Email: jacquelyn.pendergast@va.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

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)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Peer led intervention; The peer-led program will be pilot tested enrolling 40 self-identified lung cancer screening eligible Black Veterans.

Other: Veterans peer connect Program; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lung Cancer Screening Uptake	Assessing electronic health record data to determine if screening has occurred	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tobacco cessation Treatment	Assessing electronic health record data to determine if tobacco treatment has been utilized	3 months
Stigma Related to Smoking	Assess via qualitative interviews	7 months
Perceived support from peer	Assess via qualitative interviews	7 months
Lung Cancer Screening Knowledge	a brief measure of smokers' knowledge of lung cancer screening with low-dose computed tomography. Scale 0-12, higher score means better outcome	7 months
Lung Cancer Screening Fatalism	Adapted Illness Perception Questionnaire. Scale 10-50, higher score means better outcome	7 months
Trust in VA	Modified trust scale for VA health system. Scale 10-90, higher score means better outcome	7 months
Lung Cancer Self-efficacy	Lung cancer screening health belief self-efficacy scale Scale 9-36, higher score means a better outcome	7 months
General Cancer Self-efficacy	New General Self-efficacy scale Scale 8-40, higher score means a better outcome	7 months
Intention to engage in shared decision making	Preparation for Decision Making, scale 10-40, lower score means better outcome	7 months
Motivation to quit smoking	Readiness to change smoking behavior, contemplation ladder, scale 1-10, higher score means a better outcome	7 months
Intention to undergo lung cancer screening	decisional conflict scale, scale 16-80, higher score means a better outcome	7 months

Collaborators and Investigators

• Sponsor: VA Boston Healthcare System

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): February 28, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: April 1, 2024
• First Submitted That Met QC Criteria: April 25, 2024
• First Posted (Actual): April 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Screening
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 1692052

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Within 1 year of publication
• IPD Sharing Access Criteria: Those requesting data will be asked to sign a Letter of Agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No