Co-Design and Pilot Testing of Peer-led Community Outreach to Improve Equity, Veteran-Centeredness and Uptake of Lung Cancer Screening

Lung Cancer Clinical Trial

— VPC  

Official title:

Co-Design and Pilot Testing of Peer-led Community Outreach to Improve Equity, Veteran-Centeredness and Uptake of Lung Cancer Screening

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06389981
• Other study ID #: 1692052
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2024
• Est. completion date: June 30, 2025

Study information

• Verified date: April 2024
• Source: VA Boston Healthcare System
• Contact: Renda Wiener, MD
• Phone: 857-364-5685
• Email: renda.wiener[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: June 30, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
VA Boston Healthcare System

Outcome

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