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

ClinicalTrials.gov ID

NCT07711691

Lead Sponsor

University of California, IrvineOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

80Estimated

Last Update Posted

Jul 22, 2026Actual

Start Date

Sep 1, 2026Estimated

Primary Completion Date

Aug 2028Estimated

Completion Date

Dec 2028Estimated

Official Title

Empowering Patients' Lung Cancer Screening Uptake (Empower LCS/Call+): A Multi-Site Pilot Randomized Controlled Trial

Brief 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.

• Lung Cancer Screening
• Lung Neoplasms
• Smoking ( Cigarette)
• Early Detection of Cancer

• Empower LCS
• Call+ Telephone Navigation
• Usual Care
• Education

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Health Services Research

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

University of California, IrvineOTHER

empowerlsc@hs.uci.edu(714) 456-3610

empowerlcs@hs.uci.edu(714) 456-3610

empowerlcs@hs.uci.edu(714) 456-3610

empowerlcs@hs.uci.edu(714) 456-3610

gsadigh@hs.uci.edu(714) 456-3610

empowerlcs@hs.uci.edu(714) 456-3610

empowerlcs@hs.uci.edu(714) 456-3610

empowerlcs@hs.uci.edu(714) 456-3610

empowerlcs@hs.uci.edu(714) 456-3610

empowerlcs@hs.uci.edu(714) 456-3610

empowerlcs@hs.uci.edu(714) 456-3610

empowerlcs@emory.edu404-727-1483

empowerlcs@emory.edu404-727-1483

empowerlcs@emory.edu404-727-1483

empowerlcs@emory.edu404-727-1483

empowerlcs@emory.edu404-7271483

empowerlcs@emory.edu404-727-1483

empowerlcs@emory.edu404-727-1483

empowerlcs@emory.edu404-727-1483

empowerlcs@emory.edu404-727-1483

empowerlcs@emory.edu404-727-1483

empowerlcs@emory.edu404-727-1483

empowerlcs@emory.edu404-727-1483

empowerlcs@emory.edu404-727-1483

empowerlcs@emory.edu404-727-1483

empowerlcs@emory.edu404-727-1483

empowerlcs@emory.edu404-727-1483

empowerlcs@emory.edu404-727-1483

empowerlcs@emory.edu404-727-1483

empowerlcs@emory.edu404-727-1483

empowerlcs@emory.edu404-727-1483

empowerlcs@emory.edu404-727-1483

empowerlcs@emory.edu404-727-1483

empowerlcs@emory.edu404-727-1483

empowerlcs@emory.edu404-727-1483

empowerlcs@emory.edu404-727-1483

empowerlcs@emory.edu404-727-1483

empowerlcs@emory.edu404-727-1483

empowerlcs@emory.edu404-727-1483

empowerlcs@emory.edu404-727-1483

empowerlcs@emory.edu404-727-1483

empowerlcs@emory.edu404-727-1483

empowerlcs@emory.edu404-727-1483

empowerlcs@emory.edu404-727-1483

empowerlcs@emory.edu404-727-1483

empowerlcs@emory.edu404-727-1483

empowerlcs@emory.edu404-727-1483

empowerlcs@emory.edu404-727-1483

empowerlcs@emory.edu404-727-1483

empowerlcs@emory.edu404-727-1483

empowerlcs@emory.edu404-727-1483

empowerlcs@emory.edu404-727-1483

empowerlcs@emory.edu404-727-1483

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