Centralized Lung Cancer Screening Engagement in At-Risk Populations

Not Applicable

Not yet recruiting

• Conditions: Lung Cancer Screening

• Registration Number: NCT07216144
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

This study will assess the impact of centralized outreach on lung cancer screening completion among individuals served by Federally Qualified Health Centers.

Detailed Description

This will be a two-arm, parallel, pragmatic randomized controlled trial (RCT) to evaluate the effectiveness of a centralized patient outreach strategy in increasing lung cancer screening (LCS) completion among populations served by Federally Qualified Health Centers (FQHCs). This study will randomize individuals potentially eligible for LCS (50-80 years, current or past smokers) to receive centralized patient outreach in addition to usual care (outreach arm) and usual care alone (usual care arm). Individuals assigned to the outreach arm will receive centralized patient outreach from the Lung screening team through a letter followed by up to three attempts of telephone contact. Individuals assigned to the usual care arm will not receive any contact during the study period and the referral for LCS will be made at the treating physician's discretion.

Study Timeline

• Status Verified: 2025-10
• Study Start: 2025-10-01
• Study First Submitted: 2025-10-08
• Study First Submitted QC: 2025-10-08
• Last Update Submitted: 2025-10-08
• Study First Posted: 2025-10-14
• Last Update Posted: 2025-10-14
• Primary Completion: 2027-02
• Study Completion: 2027-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

• Adults aged 50 to 80 years
• Current or past smokers
• Individuals without a recorded LDCT scan within the past year
• Individuals without a prior lung cancer diagnosis
• Active patients of Ryan Health
• Individuals with a mailing address in the New York City area and a phone number on file

Exclusion Criteria

• Individuals aged less than 50 or above 80 years
• Individuals without smoking history
• Individuals with a recorded LDCT scan within the past year
• Individuals with a prior lung cancer diagnosis
• Individuals without a mailing address in the New York City area or a phone number on file
• Individuals served by one of Ryan Health clinics where the centralized patient outreach was developed

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Proportion of individuals completing low-dose CT (LDCT) within 15 months of randomization.	Within 15 months of randomization

Secondary Outcome Measures

Name	Time	Method
Average costs of implementing centralized outreach per individual	Within 15 months of randomization
LDCT scan findings: Lung Imaging Reporting and Data System (Lung-RADS)	Within 15 months of randomization	Proportion of individuals with Lung-RADS 1, 2, 3, and 4
LDCT incident findings	Within 15 months of randomization	Proportion of individuals with incident findings on LDCT (including moderate to severe coronary artery calcification, lung-mediastinal findings, moderate to severe emphysema, and abdominal findings)
Follow-up care	Within 6 months after screening	Proportion of individuals receiving a biopsy or lung cancer treatment

Trial Locations

Locations (1)

Weill Cornell Medicine; 🇺🇸 New York, New York, United States