NCT06389981

Brief 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. 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable lung-cancer

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2024

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 29, 2024

Completed
9 months until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2025

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

July 18, 2025

Status Verified

March 1, 2025

Enrollment Period

5 months

First QC Date

April 1, 2024

Last Update Submit

July 15, 2025

Conditions

Keywords

Screening

Outcome Measures

Primary Outcomes (1)

  • Lung Cancer Screening Uptake

    Assessing electronic health record data to determine if screening has occurred

    3 months

Secondary Outcomes (11)

  • Tobacco cessation Treatment

    3 months

  • Stigma Related to Smoking

    7 months

  • Perceived support from peer

    7 months

  • Lung Cancer Screening Knowledge

    7 months

  • Lung Cancer Screening Fatalism

    7 months

  • +6 more secondary outcomes

Study Arms (1)

Peer led intervention

EXPERIMENTAL

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

Other: Veterans peer connect Program

Interventions

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.

Peer led intervention

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Non-Black Veterans

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Boston Healthcare System

Boston, Massachusetts, 02130, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 1, 2024

First Posted

April 29, 2024

Study Start

February 1, 2025

Primary Completion

June 28, 2025

Study Completion

June 30, 2025

Last Updated

July 18, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Within 1 year of publication
Access Criteria
Those requesting data will be asked to sign a Letter of Agreement.

Locations