NCT06745258

Brief Summary

Lung cancer is the leading cause of cancer-related death among Veterans with 90% of cases attributable to smoking. Lung cancer screening (LCS) combined with smoking cessation saves the most lives. ICARE-LCS seeks to decrease health inequality and improve Veteran health by reducing smoking rates among Veterans receiving LCS. ICARE-LCS will use implementation methods to inform national cancer prevention efforts and build infrastructure necessary to support broad implementation of high-impact tobacco dependence treatment (TDT) processes in LCS programs.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
14mo left

Started May 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

Study Progress2%
May 2026Jun 2027

First Submitted

Initial submission to the registry

December 16, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 20, 2024

Completed
1.4 years until next milestone

Study Start

First participant enrolled

May 1, 2026

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2027

Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

1.2 years

First QC Date

December 16, 2024

Last Update Submit

February 19, 2026

Conditions

Keywords

Lung CancerLung NoduleTobaccoLung Cancer Screening

Outcome Measures

Primary Outcomes (1)

  • Receipt of Combined Tobacco Dependence Treatment

    Participation in counseling and pharmacotherapy within 90 days of lung cancer screening referral

    Approximately 3 years

Secondary Outcomes (5)

  • Number of Veterans Receiving ANY Tobacco Dependence Treatment Therapy

    Approximately 3 years

  • Number of Veterans Receiving of Pharmacotherapy or Counseling Alone

    Approximately 3 years

  • Cost Associated with Tobacco Dependence Treatment Among Lung Cancer Screening Participants who Smoke

    Approximately 3 years

  • Rate of Short-term Cessation Among Veterans In Lung Cancer Screening who Smoke

    Approximately 3 years

  • Implementation Outcomes Assessed at Participating Sites

    Approximately 3 years

Study Arms (2)

Veterans Participating in Lung Cancer Screening who Smoke

Veterans participating in lung cancer screening who smoke and are receiving care at participating VA medical centers

Participating VA Medical Centers

Seven sites that have agreed to participate in implementation intervention

Other: External Facilitation

Interventions

Multi-component facilitation strategy to address identified implementation needs

Participating VA Medical Centers

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participating VA Medical Centers

You may qualify if:

  • This is a VAMC based Quality Improvement Partnered Evaluation Initiative. VA sites from around the country that agreed to participate are included.

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417-2309, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Anne C. Melzer, MD MS

    Minneapolis VA Health Care System, Minneapolis, MN

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Anne C Melzer, MD MS

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 16, 2024

First Posted

December 20, 2024

Study Start

May 1, 2026

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

June 30, 2027

Last Updated

February 20, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations