Centralized Lung Cancer Screening Engagement in At-Risk Populations (CLEAR)

Weill Cornell Medicine (WCM)

Status: Invitation-only

Conditions: Lung Cancer Screening

Treatments: Behavioral: Centralized patient outreach for lung cancer screening

Study type: Interventional

Funder types: Other

Identifiers

NCT07216144

25-04028716

Details and patient eligibility

About

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

Full 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.

Enrollment: 2,000 estimated patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2,000 participants in 2 patient groups

Outreach arm

Experimental group

Description:

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

Treatment:

Behavioral: Centralized patient outreach for lung cancer screening

Usual care arm

No Intervention group

Description:

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.