Recruiting

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

Sponsor:

UCLA

Code:

NCT07711691

Conditions

Lung Cancer Screening

Lung Neoplasms

Smoking ( Cigarette)

Early Detection of Cancer

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Empower LCS

Call+ Telephone Navigation

Usual Care

Education

Study Details

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.

Conditions

Lung Cancer Screening

Lung Neoplasms

Smoking ( Cigarette)

Early Detection of Cancer

Study ID

NCT07711691

Start date

Sep 16, 2026

Status verified date

Sep, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Aug, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

active comparator: Enhanced Usual Care

Usual care + educational brochure

experimental: Empower LCS/Call+

Empower LCS with Call+ offered to non-responders

Interventions

Empower LCS

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

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

Usual care

Education

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

Primary outcome measure

Completion of lung cancer screening with low-dose computed tomography (LDCT) [ Time Frame: 4 months after randomization ]
Completion of lung cancer screening with low-dose computed tomography (LDCT) [ Time Frame: 8 months after randomization ]

Central Contacts and Locations

Central contacts

Gelareh Sadigh, MD

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

Locations

UCI Health Family Health Center - Anaheim

Recruiting

Anaheim, California, United States, 92801

Contacts

Gelareh Sadigh, MD

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

UCI Health - Costa Mesa

Recruiting

Costa Mesa, California, United States, 92627

Contacts

Gelareh Sadigh, MD

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

CHAO Family Comprehensive Cancer Center- Irvine

Recruiting

Irvine, California, United States, 92612

Contacts

Gelareh Sadigh, MD

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

UCI Health Gottschalk Medical Plaza

Recruiting

Irvine, California, United States, 92697

Contacts

Gelareh Sadigh, MD

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

UCI Health - Laguna Hills

Recruiting

Laguna Hills, California, United States, 92653

Contacts

Gelareh Sadigh, MD

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

UCI Health - Newport Beach MacArthur

Recruiting

Newport Beach, California, United States, 92660

Contacts

Gelareh Sadigh, MD

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

Primary Care & Internal Medicine Services

Recruiting

Orange, California, United States, 92868

Contacts

Gelareh Sadigh, MD

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

UCI Chao Family Comprehensive Cancer Center

Recruiting

Orange, California, United States, 92868

Contacts

Gelareh Sadigh, MD

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

UCI Health SeniorHealth Center -Pavillion 4

Recruiting

Orange, California, United States, 92868

Contacts

Gelareh Sadigh, MD

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

UCI Medical Center, Pavilion 3

Recruiting

Orange, California, United States, 92868

Contacts

Gelareh Sadigh, MD

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

UCI Health Family Health Center - Santa Ana

Recruiting

Santa Ana, California, United States, 92701

Contacts

Gelareh Sadigh, MD

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

UCI Health - Tustin

Recruiting

Tustin, California, United States, 92670

Contacts

Gelareh Sadigh, MD

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

UCI Health - Yorba Linda

Recruiting

Yorba Linda, California, United States, 92886

Contacts

Gelareh Sadigh, MD

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

More Information

Sponsor

University of California, Irvine

Last update posted

Sep 21, 2026

Last verified

Sep, 2026

Keywords

Lung cancer screening
Low-dose computed tomography (LDCT)
Patient navigation
Natural language processing
Smoking
Health-related social needs
Multilevel intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by University of California, Irvine on 2026-09-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.