Centralized Lung Cancer Screening Engagement in At-Risk Populations

N/AEnrolling By InvitationNCT07216144

Weill Medical College of Cornell University2,000 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

SINGLE

Enrollment

2,000

Conditions

Lung Cancer Screening

Interventions

Centralized patient outreach for lung cancer screeningBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 50 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Weill Cornell Medicine

New York, New York, United States

Outcomes

Primary Outcomes

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

Time frame: Within 15 months of randomization

Secondary Outcomes

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

Proportion of individuals with Lung-RADS 1, 2, 3, and 4

Time frame: Within 15 months of randomization

LDCT incident findings

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)

Time frame: Within 15 months of randomization

Follow-up care

Proportion of individuals receiving a biopsy or lung cancer treatment

Time frame: Within 6 months after screening

Average costs of implementing centralized outreach per individual

Time frame: Within 15 months of randomization

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.