An interventional study of Empower LCS and Call+ Telephone Navigation in Lung Cancer Screening, Lung Neoplasms and Smoking ( Cigarette), sponsored by University of California, Irvine. Recruiting at 57 sites in United States. Open to participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-21.
Sponsored by University of California, Irvine · Not applicable, Interventional, and Health services research
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.
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.
5,422 studies on the registry are indexed under Lung Neoplasms; 1,346 are open to participants now.
This study's planned enrollment of 80 is above the median of 60 across 3,656 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →University of California, Irvine is the lead sponsor of 476 studies on the registry; 98 are open to participants now.
Of its 41 completed or terminated interventional studies of FDA-regulated products, 30 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Usual care + educational brochure
Other: Usual Care · Other: Education
Empower LCS with Call+ offered to non-responders
Behavioral: Empower LCS · Behavioral: Call+ Telephone Navigation · Other: Usual Care
Empower LCS consists of (1) a lung cancer screening decision aid, (2) primary care provider notification of patients' eligibility for lung cancer screening, (3) patient text reminders to discuss lung cancer screening with their primary care provider, and (4) tailored support materials including financial education and national/local resources for patients who screen positive for health-related social needs.
Participants who do not complete lung cancer screening by approximately 4 months after randomization will receive the Call+, a telephone-based navigation intervention delivered by a lay navigator to identify and address barriers to screening, facilitate scheduling, and connect participants with available resources.
Usual care
One-page educational material about benefits and risks of lung cancer screening
Completion of lung cancer screening with low-dose computed tomography (LDCT)
Completion of LDCT lung cancer screening, determined by electronic health record review.
Time frame: 4 months after randomization
Completion of lung cancer screening with low-dose computed tomography (LDCT)
Completion of LDCT lung cancer screening, determined by electronic health record review.
Time frame: 8 months after randomization
Completion of any chest CT
Completion of any chest CT, determined by electronic health record review.
Time frame: 4 months after randomization
Completion of any chest CT
Completion of any chest CT
Time frame: 8 months after randomization
Ordering of low-dose computed tomography (LDCT)
Provider order for LDCT identified through electronic health record review.
Time frame: 4 months after randomization
Ordering of low-dose computed tomography (LDCT)
Provider order for LDCT identified through electronic health record review.
Time frame: 8 months after randomization
Discussion of lung cancer screening with a primary care provider
Electronic health record documentation of discussion regarding lung cancer screening with primary care provider.
Time frame: 4 months after enrollment
Discussion of lung cancer screening with a primary care provider
Electronic health record documentation of discussion regarding lung cancer screening with primary care provider.
Time frame: 8 months after enrollment
Lung cancer screening scheduling
scheduling of lung cancer screening as self-reported by patient
Time frame: 4 months post-randomization
Patient knowledge of lung cancer screening
Participant knowledge regarding lung cancer screening assessed via 9-item survey previously used (Shojazadeh et al. JACR; 2025)
Time frame: 4 months after randomization
Decisional conflict regarding lung cancer screening
Participant decisional conflict measured using 10-item decisional conflict scale (O'Connor AM)
Time frame: 4 months after randomization
Perceived lung cancer risk
Perceived lung cancer risk will be measured using 3-item validated survey (Carter-Harris et al. Cancer Nurs; 2017)
Time frame: 4 months after randomization
Perceived lung cancer severity
Perceived lung cancer severity will be measured using 5-item survey (Shojazadeh et al. JACR; 2015)
Time frame: 4 months after randomization
Perceived lung cancer screening benefits
Perceived lung cancer screening benefits will be measured using 6-item validated survey (Carter-Harris et al. Cancer Nurs; 2017)
Time frame: 4 months after randomization
Perceived lung cancer screening barriers
Perceived lung cancer screening barriers will be measured using 18-item validated survey (Carter-Harris et al. Cancer Nurs; 2017)
Time frame: 4 months after randomization
Perceived lung cancer screening self-efficacy
Perceived lung cancer screening self-efficacy will be measured using 9-item validated survey (Carter-Harris et al. Cancer Nurs; 2017)
Time frame: 4 months after randomization
Plan to share: Yes — De-identified data will be share upon request from study chair and establishing data use agreements.
Supporting information: Study protocol, Informed consent form
Time frame: Upon publication of primary outcome manuscript
Access criteria: Researchers upon sending a request to study chair (Dr. Gelareh Sadigh; gsadigh@hs.uci.edu)
Started Sep 2026 (actual). Primary completion is estimated for Aug 2028, 23 months after the start.
Of 864 non-industry interventional studies with no phase under Lung Neoplasms, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 68. This study's planned 23 months is below that.
Counting every sponsor, half of 915 studies reached it within 34 months; a quarter within 15 and three quarters within 67.
How these figures are worked out, and which studies are left out of them.
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