Centralized Lung Cancer Screening Engagement in At-Risk Populations

NCT07216144 | Enrolling By Invitation

• 1 other identifier: 25-04028716
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lung Cancer Screening

Outcome Measures

Primary Outcomes (1)

• Proportion of individuals completing low-dose CT (LDCT) within 15 months of randomization.

  Within 15 months of randomization

Secondary Outcomes (4)

• LDCT scan findings: Lung Imaging Reporting and Data System (Lung-RADS)

  Within 15 months of randomization

• LDCT incident findings

  Within 15 months of randomization

• Follow-up care

  Within 6 months after screening

• Average costs of implementing centralized outreach per individual

  Within 15 months of randomization

Study Arms (2)

Outreach arm

EXPERIMENTAL

Individuals in the outreach arm will receive centralized patient outreach for lung cancer screening in addition to usual care.

Behavioral: Centralized patient outreach for lung cancer screening

Usual care arm

NO INTERVENTION

Individuals in the usual care arm will receive usual care and will not receive any outreach contacts (mail or telephone) within 15 months after randomization.

Interventions

Centralized patient outreach for lung cancer screening BEHAVIORAL

Centralized patient outreach for lung cancer screening will be conducted by the lung screening team and will consist of a letter followed by telephone contact. One week following the mail invitation, a senior patient coordinator (SPC) will make telephone contact with individuals to pre-screen eligibility determination based on pack-year smoking history. Up to three telephone contact attempts will be made within two weeks.

Outreach arm

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

Study Officials

• Jialin Mao, MD, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

• Bradley B Pua, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 8, 2025
• First Posted: October 14, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: December 10, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: 1 year after publication until 6 years after publication
• Access Criteria: Researchers who propose a methodologically sound proposal and receive IRB approval

Locations

US (1)