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NCT07711691NARecruiting

Empowering Patients' Lung Cancer Screening Uptake (Empower LCS/Call+)

University of California, Irvine

Start Date

9/16/2026

Completion Date

12/1/2028

Summary

Lung cancer screening (LCS) with low-dose computed tomography (LDCT) can reduce the risk of dying from lung cancer, but many people who are eligible for screening do not receive it. The purpose of the Empower LCS/Call+ study is to evaluate new strategies to improve lung cancer screening among adults who are eligible for screening based on current U.S. Preventive Services Task Force (USPSTF) guidelines. This pilot randomized controlled trial will enroll approximately 80 participants from UC Irvine Health and Emory Healthcare. Participants will be randomly assigned to receive either enhanced usual care or the Empower LCS/Call+ intervention. The intervention includes educational materials, reminders for patients and primary care providers, and information about financial and community resources when appropriate. Participants who do not complete lung cancer screening after the initial intervention may receive additional telephone-based navigation through the Call+ program to help identify and address barriers to screening and help with scheduling. Participants will complete a baseline survey and follow-up surveys at 4 and 8 months, and researchers will review electronic health record information to determine whether lung cancer screening was discussed, ordered, and completed. Some participants will also be invited to complete a one-time interview about their experiences with the study. The results of this study will help determine the feasibility, acceptability, and preliminary effectiveness of the Empower LCS/Call+ intervention and will inform future efforts to improve equitable access to lung cancer screening.

Detailed Description

Lung cancer is the leading cause of cancer-related death in the United States. Although annual lung cancer screening with LDCT is recommended for adults at high risk and has been shown to reduce lung cancer mortality, screening uptake remains low. Barriers to screening exist at the patient, provider, and health system levels, including limited awareness of screening eligibility, incomplete documentation of smoking history in the electronic health record, logistical challenges, financial concerns, and psychosocial barriers such as fear, stigma, and mistrust. The Empower LCS is a multilevel intervention designed to improve lung cancer screening uptake by combining patient education, provider notification, patient reminders, and information on financial and community resources. The intervention demonstrated improvements in lung cancer screening discussions and low-dose computed tomography ordering and completion compared with enhanced usual care in prior pilot study. The current study evaluates an enhanced version of the intervention, Empower LCS/Call+. Participants who have not completed lung cancer screening after the initial intervention will be eligible to receive the Call+ telephone navigation intervention. Call+ is delivered by lay navigators and is designed to identify participant-specific barriers to screening, provide education and motivational support, facilitate primary care or imaging scheduling when appropriate, connect participants with available financial or community resources, and encourage completion of recommended lung cancer screening. This prospective, multi-site, pilot randomized controlled trial will enroll participants from UC Irvine Health and Emory Healthcare. Potentially eligible participants will be identified using a combination of structured data and natural language processing of free text notes to extract smoking history from electronic medical records. Eligibility will be confirmed via self-report. Participants will be randomly assigned to receive either the Empower LCS/Call+ intervention or enhanced usual care. Data will be collected through participant surveys, electronic health record review, intervention process measures, and qualitative interviews with a subset of participants to evaluate implementation experiences. The primary purpose of this pilot study is to evaluate the feasibility, acceptability, and preliminary effectiveness of the enhanced intervention while providing implementation data to inform future randomized trials.

Eligibility Criteria

Age Range: 50 years to 80 years

Inclusion Criteria: 1. Must meet current USPSTF eligibility criteria for lung cancer screening (Current criteria: age 50-80 years old with a 20 pack-year smoking history, who currently smoke or have quit within the last 15 years) 2. Must have an electronic health record-assigned primary care provider within University of California Irvine Health or Emory Healthcare 3. Must have recent engagement with respective health system (i.e., office or emergency department (ED) visit, hospitalization with discharged home in the last 12 months, or a scheduled office visit in the next 3 months). 4. Must speak English or Spanish 5. Able and willing to provide informed consent Exclusion Criteria: 1. Meet the eligibility upper age limit during initial 4-month participation. 2. Have a prior history of lung cancer. 3. Have a new diagnosis of other cancers in the 12 months 4. Have a chest CT or LDCT in the last 12 months 5. Have ICD-10 code of Alzheimer's disease in EHR

Interventions

BEHAVIORAL

Empower LCS

BEHAVIORAL

Call+ Telephone Navigation

OTHER

Usual Care

OTHER

Education

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Conditions

Lung Cancer ScreeningLung NeoplasmsSmoking ( Cigarette)Early Detection of Cancer

Locations

UCI Health Family Health Center - Anaheim

Anaheim, California 92801

United States

UCI Health - Costa Mesa

Costa Mesa, California 92627

United States

CHAO Family Comprehensive Cancer Center- Irvine

Irvine, California 92612

United States

UCI Health Gottschalk Medical Plaza

Irvine, California 92697

United States

UCI Health - Laguna Hills

Laguna Hills, California 92653

United States

UCI Health - Newport Beach MacArthur

Newport Beach, California 92660

United States

Primary Care & Internal Medicine Services

Orange, California 92868

United States

UCI Chao Family Comprehensive Cancer Center

Orange, California 92868

United States

UCI Health SeniorHealth Center -Pavillion 4

Orange, California 92868

United States

UCI Medical Center, Pavilion 3

Orange, California 92868

United States

UCI Health Family Health Center - Santa Ana

Santa Ana, California 92701

United States

UCI Health - Tustin

Tustin, California 92670

United States

UCI Health - Yorba Linda

Yorba Linda, California 92886

United States

Emory at Avalon - Primary Care

Alpharetta, Georgia 30009

United States

Emory Clinic at Old Fourth Ward

Atlanta, Georgia 30047

United States

Emory Clinic at Midtown

Atlanta, Georgia 30308

United States

Emory at Peachtree Hills - Primary Care

Atlanta, Georgia 30309

United States

Emory Clinic at 1365 Clifton Road - Primary Care

Atlanta, Georgia 30322

United States

Emory Clinic at 1525 Clifton Road - Primary Care

Atlanta, Georgia 30322

United States

Emory at Toco Hills - Primary Care

Atlanta, Georgia 30329

United States

Emory Gastroenterology

Atlanta, Georgia 30342

United States

Emory at Northlake - Primary Care

Atlanta, Georgia 30345

United States

Emory at Buford - Primary Care

Buford, Georgia 30519

United States

Emory at Decatur - Primary Care (Irvin Court)

Decatur, Georgia 30030

United States

Emory at Decatur - Primary Care (Scott Boulevard)

Decatur, Georgia 30030

United States

Emory Clinic Downtown Decatur

Decatur, Georgia 30030

United States

Emory at Decatur - Primary Care

Decatur, Georgia 30033

United States

Emory at Oak Grove - Primary Care

Decatur, Georgia 30033

United States

Emory Clinic at Decatur - Primary Care

Decatur, Georgia 30033

United States

Emory at Flat Shoals - Primary Care

Decatur, Georgia 30034

United States

Emory at Duluth

Duluth, Georgia 30096

United States

Emory at Sugarloaf - Primary Care

Duluth, Georgia 30097

United States

Emory at Dunwoody

Dunwoody, Georgia 30338

United States

Emory Clinic at Saint Joseph's

Dunwoody, Georgia 30342

United States

Emory at Findley Road

Johns Creek, Georgia 30097

United States

Emory at Spivey Station - Primary Care

Jonesboro, Georgia 30236

United States

Emory at LaGrange - Smith Street - Primary Care

La Grange, Georgia 30240

United States

Emory at LaGrange - Davis Road

La Grange, Georgia 30241

United States

Emory at Beaver Ruin - Primary Care

Lilburn, Georgia 30047

United States

Emory at Mountain Park - Primary Care

Lilburn, Georgia 30047

United States

Emory at Hillandale Family Medicine

Lithonia, Georgia 30058

United States

Emory at Miller Grove - Primary Care

Lithonia, Georgia 30058

United States

Emory Clinic at Lithonia - Primary Care

Lithonia, Georgia 30058

United States

Emory at East Cobb - Primary Care

Marietta, Georgia 30068

United States

Emory at Peachtree City - Primary Care

Peachtree City, Georgia 30269

United States

Emory at Sharpsburg

Sharpsburg, Georgia 30277

United States

Emory at Belmont - Primary Care

Smyrna, Georgia 30080

United States

Emory at Snellville - Primary Care (Lenora Church Road)

Snellville, Georgia 30078

United States

Emory at Snellville - Primary Care (Oak Road)

Snellville, Georgia 30078

United States

Emory at Snellville Primary Care (Presidential Circle)

Snellville, Georgia 30078

United States

Emory at Centerville - Primary Care

Snellville, Georgia 30339

United States

Emory at Eagles Landing Primary Care

Stockbridge, Georgia 30281

United States

Emory at Stone Mountain - Primary Care

Stone Mountain, Georgia 30083

United States

Emory at Rockbridge Primary Care & Nephrology

Stone Mountain, Georgia 30087

United States

Emory at Tucker - Primary Care (1459 Montreal Road)

Tucker, Georgia 30084

United States

Pavilion Family Medicine Center

Warner Robins, Georgia 31093

United States

Emory at West Point

West Point, Georgia 31833

United States