Empowering Patients' Lung Cancer Screening Uptake (Empower LCS/Call+)
Part of paid clinical trials in Anaheim, California.
- Sponsor
- University of California, Irvine
- Study ID
- NCT07711691
- Status
- Not Yet Recruiting
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Conditions
- Early Detection of Cancer
- Lung Cancer Screening
- Lung Neoplasms
- Smoking ( Cigarette)
Eligibility Criteria
- Sex
- ALL
- Age
- 50 Years - 80 Years
- Healthy Volunteers
- Not accepted
Interventions
- Empower LCS — BEHAVIORALEmpower 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 — BEHAVIORALParticipants 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 — OTHERUsual care
- Education — OTHEROne-page educational material about benefits and risks of lung cancer screening
Study Details
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.
Key Dates
- First listed
- Jul 17, 2026
- Start date
- Sep 1, 2026
- Status verified
- Jul 2026
- Primary completion
- Aug 31, 2028
- Completion
- Dec 31, 2028
Study Design
- Enrollment
- 80 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- Active Comparator: Enhanced Usual CareUsual care + educational brochure
- Experimental: Empower LCS/Call+Empower LCS with Call+ offered to non-responders
Primary Outcome Measure
Completion of lung cancer screening with low-dose computed tomography (LDCT) [ Time Frame: 4 months after randomization ]
Central Contacts
- Gelareh Sadigh, MD(714) 456-3610
Locations (14)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| UCI Health Family Health Center - Anaheim | Anaheim | California | 92801 | |
| UCI Health - Costa Mesa | Costa Mesa | California | 92627 | |
| CHAO Family Comprehensive Cancer Center- Irvine | Irvine | California | 92612 | |
| UCI Health Gottschalk Medical Plaza | Irvine | California | 92697 | |
| UCI Health - Laguna Hills | Laguna Hills | California | 92653 | |
| UCI Health - Newport Beach MacArthur | Newport Beach | California | 92660 | |
| Primary Care & Internal Medicine Services | Orange | California | 92868 | |
| UCI Chao Family Comprehensive Cancer Center | Orange | California | 92868 | |
| UCI Health SeniorHealth Center -Pavillion 4 | Orange | California | 92868 | - |
| UCI Medical Center, Pavilion 3 | Orange | California | 92868 | |
| UCI Health Family Health Center - Santa Ana | Santa Ana | California | 92701 | |
| UCI Health - Tustin | Tustin | California | 92670 | |
| UCI Health - Yorba Linda | Yorba Linda | California | 92886 | |
| The Emory Clinic | Atlanta | Georgia | 30322 |
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