Centralized Lung Cancer Screening Engagement in At-Risk Populations

NCT ID: NCT07216144

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 2000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-15
• Study Completion Date: 2027-08-31

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.

Conditions

Lung Cancer Screening

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: SINGLE

Study Groups

Outreach arm

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

Group Type: EXPERIMENTAL

Centralized patient outreach for lung cancer screening

Intervention Type: 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.

Usual care arm

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Centralized patient outreach for lung cancer screening

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jialin Mao, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Bradley B Pua, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

Weill Cornell Medicine

New York, New York, United States

Countries

United States

Other Identifiers

25-04028716

Identifier Type: -

Identifier Source: org_study_id