Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07711691

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCI Health Family Health Center - Anaheim, Anaheim, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • Must have an electronic health record-assigned primary care provider within University of California Irvine Health or Emory Healthcare
  • 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).
  • Must speak English or Spanish
  • Able and willing to provide informed consent

Exclusion criteria

  • Meet the eligibility upper age limit during initial 4-month participation.
  • Have a prior history of lung cancer.
  • Have a new diagnosis of other cancers in the 12 months
  • Have a chest CT or LDCT in the last 12 months
  • Have ICD-10 code of Alzheimer's disease in EHR

Treatment and study plan

Empower LCS

Behavioral

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.

Call+ Telephone Navigation

Behavioral

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

Other

Usual care

Education

Other

One-page educational material about benefits and risks of lung cancer screening

Primary outcomes

  1. Completion of lung cancer screening with low-dose computed tomography (LDCT)

    Time frame: 4 months after randomization

    Completion of LDCT lung cancer screening, determined by electronic health record review.

  2. Completion of lung cancer screening with low-dose computed tomography (LDCT)

    Time frame: 8 months after randomization

    Completion of LDCT lung cancer screening, determined by electronic health record review.

Secondary outcomes

  1. Completion of any chest CT

    Time frame: 4 months after randomization

    Completion of any chest CT, determined by electronic health record review.

  2. Completion of any chest CT

    Time frame: 8 months after randomization

    Completion of any chest CT

  3. Ordering of low-dose computed tomography (LDCT)

    Time frame: 4 months after randomization

    Provider order for LDCT identified through electronic health record review.

  4. Ordering of low-dose computed tomography (LDCT)

    Time frame: 8 months after randomization

    Provider order for LDCT identified through electronic health record review.

  5. Discussion of lung cancer screening with a primary care provider

    Time frame: 4 months after enrollment

    Electronic health record documentation of discussion regarding lung cancer screening with primary care provider.

  6. Discussion of lung cancer screening with a primary care provider

    Time frame: 8 months after enrollment

    Electronic health record documentation of discussion regarding lung cancer screening with primary care provider.

  7. Lung cancer screening scheduling

    Time frame: 4 months post-randomization

    scheduling of lung cancer screening as self-reported by patient

  8. Patient knowledge of lung cancer screening

    Time frame: 4 months after randomization

    Participant knowledge regarding lung cancer screening assessed via 9-item survey previously used (Shojazadeh et al. JACR; 2025)

  9. Decisional conflict regarding lung cancer screening

    Time frame: 4 months after randomization

    Participant decisional conflict measured using 10-item decisional conflict scale (O'Connor AM)

  10. Perceived lung cancer risk

    Time frame: 4 months after randomization

    Perceived lung cancer risk will be measured using 3-item validated survey (Carter-Harris et al. Cancer Nurs; 2017)

  11. Perceived lung cancer severity

    Time frame: 4 months after randomization

    Perceived lung cancer severity will be measured using 5-item survey (Shojazadeh et al. JACR; 2015)

  12. Perceived lung cancer screening benefits

    Time frame: 4 months after randomization

    Perceived lung cancer screening benefits will be measured using 6-item validated survey (Carter-Harris et al. Cancer Nurs; 2017)

  13. Perceived lung cancer screening barriers

    Time frame: 4 months after randomization

    Perceived lung cancer screening barriers will be measured using 18-item validated survey (Carter-Harris et al. Cancer Nurs; 2017)

  14. Perceived lung cancer screening self-efficacy

    Time frame: 4 months after randomization

    Perceived lung cancer screening self-efficacy will be measured using 9-item validated survey (Carter-Harris et al. Cancer Nurs; 2017)

Study contacts

Contact information is provided by the study sponsor or research team.

Gelareh Sadigh, MD

CONTACT

[email protected]

(714) 456-3610

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Official study title

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

Acronym: Empower LCS+

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 17, 2026
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.