Empowering Patients' Lung Cancer Screening Uptake (Empower LCS/Call+) (Empower LCS+)
July 20, 2026 updated by: Gelareh Sadigh, University of California, Irvine
Empowering Patients' Lung Cancer Screening Uptake (Empower LCS/Call+): A Multi-Site Pilot Randomized Controlled Trial
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.
Study Overview
Status
Not yet recruiting
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Estimated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gelareh Sadigh, MD
- Phone Number: (714) 456-3610
- Email: gsadigh@hs.uci.edu
Study Locations
-
-
California
-
Anaheim, California, United States, 92801
- UCI Health Family Health Center - Anaheim
-
Contact:
- Gelareh Sadigh, MD
- Phone Number: (714) 456-3610
- Email: empowerlcs@hs.uci.edu
-
Costa Mesa, California, United States, 92627
- UCI Health - Costa Mesa
-
Contact:
- Gelareh Sadigh, MD
- Phone Number: (714) 456-3610
- Email: empowerlsc@hs.uci.edu
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Irvine, California, United States, 92697
- UCI Health Gottschalk Medical Plaza
-
Contact:
- Gelareh Sadigh, MD
- Phone Number: (714) 456-3610
- Email: empowerlcs@hs.uci.edu
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Irvine, California, United States, 92612
- CHAO Family Comprehensive Cancer Center- Irvine
-
Contact:
- Gelareh Sadigh, MD
- Phone Number: (714) 456-3610
- Email: empowerlcs@hs.uci.edu
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Laguna Hills, California, United States, 92653
- UCI Health - Laguna Hills
-
Contact:
- Gelareh Sadigh, MD
- Phone Number: (714) 456-3610
- Email: empowerlcs@hs.uci.edu
-
Newport Beach, California, United States, 92660
- UCI Health - Newport Beach MacArthur
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Contact:
- Gelareh Sadigh, MD
- Phone Number: (714) 456-3610
- Email: gsadigh@hs.uci.edu
-
Orange, California, United States, 92868
- UCI Chao Family Comprehensive Cancer Center
-
Contact:
- Gelareh Sadigh, MD
- Phone Number: (714) 456-3610
- Email: empowerlcs@hs.uci.edu
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Orange, California, United States, 92868
- UCI Health SeniorHealth Center -Pavillion 4
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Orange, California, United States, 92868
- UCI Medical Center, Pavilion 3
-
Contact:
- Gelareh Sadigh, MD
- Phone Number: (714) 456-3610
- Email: empowerlcs@hs.uci.edu
-
Orange, California, United States, 92868
- Primary Care & Internal Medicine Services
-
Contact:
- Gelareh Sadigh, MD
- Phone Number: (714) 456-3610
- Email: empowerlcs@hs.uci.edu
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Santa Ana, California, United States, 92701
- UCI Health Family Health Center - Santa Ana
-
Contact:
- Gelareh Sadigh, MD
- Phone Number: (714) 456-3610
- Email: empowerlcs@hs.uci.edu
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Tustin, California, United States, 92670
- UCI Health - Tustin
-
Contact:
- Gelareh Sadigh, MD
- Phone Number: (714) 456-3610
- Email: empowerlcs@hs.uci.edu
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Yorba Linda, California, United States, 92886
- UCI Health - Yorba Linda
-
Contact:
- Gelareh Sadigh, MD
- Phone Number: (714) 456-3610
- Email: empowerlcs@hs.uci.edu
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Georgia
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Alpharetta, Georgia, United States, 30009
- Emory at Avalon - Primary Care
-
Contact:
- Ilana Graetz, PhD
- Phone Number: 404-727-1483
- Email: empowerlcs@emory.edu
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Atlanta, Georgia, United States, 30047
- Emory Clinic at Old Fourth Ward
-
Contact:
- Ilana Graetz, PhD
- Phone Number: 404-727-1483
- Email: empowerlcs@emory.edu
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Atlanta, Georgia, United States, 30308
- Emory Clinic at Midtown
-
Contact:
- Ilana Graetz, PhD
- Phone Number: 404-727-1483
- Email: empowerlcs@emory.edu
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Atlanta, Georgia, United States, 30309
- Emory at Peachtree Hills - Primary Care
-
Contact:
- Ilana Graetz, PhD
- Phone Number: 404-727-1483
- Email: empowerlcs@emory.edu
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Atlanta, Georgia, United States, 30322
- Emory Clinic at 1365 Clifton Road - Primary Care
-
Contact:
- Ilana Graetz, PhD
- Phone Number: 404-7271483
- Email: empowerlcs@emory.edu
-
Atlanta, Georgia, United States, 30322
- Emory Clinic at 1525 Clifton Road - Primary Care
-
Contact:
- Ilana Graetz, PhD
- Phone Number: 404-727-1483
- Email: empowerlcs@emory.edu
-
Atlanta, Georgia, United States, 30329
- Emory at Toco Hills - Primary Care
-
Contact:
- Ilana Graetz, PhD
- Phone Number: 404-727-1483
- Email: empowerlcs@emory.edu
-
Atlanta, Georgia, United States, 30342
- Emory Gastroenterology
-
Contact:
- Ilana Graetz, PhD
- Phone Number: 404-727-1483
- Email: empowerlcs@emory.edu
-
Atlanta, Georgia, United States, 30345
- Emory at Northlake - Primary Care
-
Contact:
- Ilana Graetz, PhD
- Phone Number: 404-727-1483
- Email: empowerlcs@emory.edu
-
Buford, Georgia, United States, 30519
- Emory at Buford - Primary Care
-
Contact:
- Ilana Graetz, PhD
- Phone Number: 404-727-1483
- Email: empowerlcs@emory.edu
-
Decatur, Georgia, United States, 30030
- Emory at Decatur - Primary Care (Irvin Court)
-
Contact:
- Ilana Graetz, PhD
- Phone Number: 404-727-1483
- Email: empowerlcs@emory.edu
-
Decatur, Georgia, United States, 30030
- Emory at Decatur - Primary Care (Scott Boulevard)
-
Contact:
- Ilana Graetz, PhD
- Phone Number: 404-727-1483
- Email: empowerlcs@emory.edu
-
Decatur, Georgia, United States, 30030
- Emory Clinic Downtown Decatur
-
Contact:
- Ilana Graetz, PhD
- Phone Number: 404-727-1483
- Email: empowerlcs@emory.edu
-
Decatur, Georgia, United States, 30033
- Emory at Decatur - Primary Care
-
Contact:
- Ilana Graetz, PhD
- Phone Number: 404-727-1483
- Email: empowerlcs@emory.edu
-
Decatur, Georgia, United States, 30033
- Emory at Oak Grove - Primary Care
-
Contact:
- Ilana Graetz, PhD
- Phone Number: 404-727-1483
- Email: empowerlcs@emory.edu
-
Decatur, Georgia, United States, 30033
- Emory Clinic at Decatur - Primary Care
-
Contact:
- Ilana Graetz, PhD
- Phone Number: 404-727-1483
- Email: empowerlcs@emory.edu
-
Decatur, Georgia, United States, 30034
- Emory at Flat Shoals - Primary Care
-
Contact:
- Ilana Graetz, PhD
- Phone Number: 404-727-1483
- Email: empowerlcs@emory.edu
-
Duluth, Georgia, United States, 30096
- Emory at Duluth
-
Contact:
- Ilana Graetz, PhD
- Phone Number: 404-727-1483
- Email: empowerlcs@emory.edu
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Duluth, Georgia, United States, 30097
- Emory at Sugarloaf - Primary Care
-
Contact:
- Ilana Graetz, PhD
- Phone Number: 404-727-1483
- Email: empowerlcs@emory.edu
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Dunwoody, Georgia, United States, 30338
- Emory at Dunwoody
-
Contact:
- Ilana Graetz, PhD
- Phone Number: 404-727-1483
- Email: empowerlcs@emory.edu
-
Dunwoody, Georgia, United States, 30342
- Emory Clinic at Saint Joseph's
-
Contact:
- Ilana Graetz, PhD
- Phone Number: 404-727-1483
- Email: empowerlcs@emory.edu
-
Johns Creek, Georgia, United States, 30097
- Emory at Findley Road
-
Contact:
- Ilana Graetz, PhD
- Phone Number: 404-727-1483
- Email: empowerlcs@emory.edu
-
Jonesboro, Georgia, United States, 30236
- Emory at Spivey Station - Primary Care
-
Contact:
- Ilana Graetz, PhD
- Phone Number: 404-727-1483
- Email: empowerlcs@emory.edu
-
La Grange, Georgia, United States, 30240
- Emory at LaGrange - Smith Street - Primary Care
-
Contact:
- Ilana Graetz, PhD
- Phone Number: 404-727-1483
- Email: empowerlcs@emory.edu
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La Grange, Georgia, United States, 30241
- Emory at LaGrange - Davis Road
-
Contact:
- Ilana Graetz, PhD
- Phone Number: 404-727-1483
- Email: empowerlcs@emory.edu
-
Lilburn, Georgia, United States, 30047
- Emory at Beaver Ruin - Primary Care
-
Contact:
- Ilana Graetz, PhD
- Phone Number: 404-727-1483
- Email: empowerlcs@emory.edu
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Lilburn, Georgia, United States, 30047
- Emory at Mountain Park - Primary Care
-
Contact:
- Ilana Graetz, PhD
- Phone Number: 404-727-1483
- Email: empowerlcs@emory.edu
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Lithonia, Georgia, United States, 30058
- Emory at Hillandale Family Medicine
-
Contact:
- Ilana Graetz, PhD
- Phone Number: 404-727-1483
- Email: empowerlcs@emory.edu
-
Lithonia, Georgia, United States, 30058
- Emory at Miller Grove - Primary Care
-
Contact:
- Ilana Graetz, PhD
- Phone Number: 404-727-1483
- Email: empowerlcs@emory.edu
-
Lithonia, Georgia, United States, 30058
- Emory Clinic at Lithonia - Primary Care
-
Contact:
- Ilana Graetz, PhD
- Phone Number: 404-727-1483
- Email: empowerlcs@emory.edu
-
Marietta, Georgia, United States, 30068
- Emory at East Cobb - Primary Care
-
Contact:
- Ilana Graetz, PhD
- Phone Number: 404-727-1483
- Email: empowerlcs@emory.edu
-
Peachtree City, Georgia, United States, 30269
- Emory at Peachtree City - Primary Care
-
Contact:
- Ilana Graetz, PhD
- Phone Number: 404-727-1483
- Email: empowerlcs@emory.edu
-
Sharpsburg, Georgia, United States, 30277
- Emory at Sharpsburg
-
Contact:
- Ilana Graetz, PhD
- Phone Number: 404-727-1483
- Email: empowerlcs@emory.edu
-
Smyrna, Georgia, United States, 30080
- Emory at Belmont - Primary Care
-
Contact:
- Ilana Graetz, PhD
- Phone Number: 404-727-1483
- Email: empowerlcs@emory.edu
-
Snellville, Georgia, United States, 30078
- Emory at Snellville - Primary Care (Lenora Church Road)
-
Contact:
- il Graetz, PhD
- Phone Number: 404-727-1483
- Email: empowerlcs@emory.edu
-
Snellville, Georgia, United States, 30078
- Emory at Snellville - Primary Care (Oak Road)
-
Contact:
- Ilana Graetz, PhD
- Phone Number: 404-727-1483
- Email: empowerlcs@emory.edu
-
Snellville, Georgia, United States, 30078
- Emory at Snellville Primary Care (Presidential Circle)
-
Contact:
- Ilana Graetz, PhD
- Phone Number: 404-727-1483
- Email: empowerlcs@emory.edu
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Snellville, Georgia, United States, 30339
- Emory at Centerville - Primary Care
-
Contact:
- Ilana Graetz, PhD
- Phone Number: 404-727-1483
- Email: empowerlcs@emory.edu
-
Stockbridge, Georgia, United States, 30281
- Emory at Eagles Landing Primary Care
-
Contact:
- Ilana Graetz, PhD
- Phone Number: 404-727-1483
- Email: empowerlcs@emory.edu
-
Stone Mountain, Georgia, United States, 30083
- Emory at Stone Mountain - Primary Care
-
Contact:
- Ilana Graetz, PhD
- Phone Number: 404-727-1483
- Email: empowerlcs@emory.edu
-
Stone Mountain, Georgia, United States, 30087
- Emory at Rockbridge Primary Care & Nephrology
-
Contact:
- Ilana Graetz, PhD
- Phone Number: 404-727-1483
- Email: empowerlcs@emory.edu
-
Tucker, Georgia, United States, 30084
- Emory at Tucker - Primary Care (1459 Montreal Road)
-
Contact:
- Ilana Graetz, PhD
- Phone Number: 404-727-1483
- Email: empowerlcs@emory.edu
-
Warner Robins, Georgia, United States, 31093
- Pavilion Family Medicine Center
-
Contact:
- Ilana Graetz, PhD
- Phone Number: 404-727-1483
- Email: empowerlcs@emory.edu
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West Point, Georgia, United States, 31833
- Emory at West Point
-
Contact:
- Ilana Graetz, PhD
- Phone Number: 404-727-1483
- Email: empowerlcs@emory.edu
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Enhanced Usual Care
Usual care + educational brochure
|
Usual care
One-page educational material about benefits and risks of lung cancer screening
|
|
Experimental: Empower LCS/Call+
Empower LCS with Call+ offered to non-responders
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
4 months after randomization
|
|
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.
|
8 months after randomization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Completion of any chest CT
Time Frame: 4 months after randomization
|
Completion of any chest CT, determined by electronic health record review.
|
4 months after randomization
|
|
Completion of any chest CT
Time Frame: 8 months after randomization
|
Completion of any chest CT
|
8 months after randomization
|
|
Ordering of low-dose computed tomography (LDCT)
Time Frame: 4 months after randomization
|
Provider order for LDCT identified through electronic health record review.
|
4 months after randomization
|
|
Ordering of low-dose computed tomography (LDCT)
Time Frame: 8 months after randomization
|
Provider order for LDCT identified through electronic health record review.
|
8 months after randomization
|
|
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.
|
4 months after enrollment
|
|
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.
|
8 months after enrollment
|
|
Lung cancer screening scheduling
Time Frame: 4 months post-randomization
|
scheduling of lung cancer screening as self-reported by patient
|
4 months post-randomization
|
|
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)
|
4 months after randomization
|
|
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)
|
4 months after randomization
|
|
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)
|
4 months after randomization
|
|
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)
|
4 months after randomization
|
|
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)
|
4 months after randomization
|
|
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)
|
4 months after randomization
|
|
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)
|
4 months after randomization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ilana Graetz, PhD, Emory University
- Principal Investigator: Gelareh Sadigh, University of California, Irvine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105.
- National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29.
- Carter-Harris L, Slaven JE 2nd, Monohan P, Rawl SM. Development and Psychometric Evaluation of the Lung Cancer Screening Health Belief Scales. Cancer Nurs. 2017 May/Jun;40(3):237-244. doi: 10.1097/NCC.0000000000000386.
- Quezada JJ, Avenido AR, Jia S, Bernaba A, Nguyen S, Gharagozlou SS, Nguyen TQ, Keshava H, Sadigh G. Assessing Providers' knowledge about and barriers to lung cancer screening. Cancer Treat Res Commun. 2024;41:100850. doi: 10.1016/j.ctarc.2024.100850. Epub 2024 Nov 15.
- Shojazadeh A, Kao R, Pham T, Madan A, Echeverria R, Chen WP, Nguyen V, Gutierrez O, Lee S, Hoyt MA, Ziogas A, Nguyen TQ, Keshava H, Sadigh G. A Multilevel Approach to Improve Participation in Low-Dose CT for Lung Cancer Screening (Empower LCS): A Single-Arm Pilot Feasibility Clinical Trial. J Am Coll Radiol. 2026 Apr;23(4):556-564. doi: 10.1016/j.jacr.2025.11.005. Epub 2025 Nov 13.
- Jung J, Razzak E, Avenido AR, Rashidi A, Jia S, Tran NQ, Yao R, Nguyen EL, Bernaba A, Echeverria R, Nguyen TQ, Imanzadeh A, Sadigh G. Patient-Reported Barriers and Preferred Interventions to Improve Lung Cancer Screening Uptake. J Am Coll Radiol. 2025 Mar;22(3):269-279. doi: 10.1016/j.jacr.2024.10.010.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
September 1, 2026
Primary Completion (Estimated)
August 1, 2028
Study Completion (Estimated)
December 1, 2028
Study Registration Dates
First Submitted
July 13, 2026
First Submitted That Met QC Criteria
July 13, 2026
First Posted (Actual)
July 17, 2026
Study Record Updates
Last Update Posted (Actual)
July 22, 2026
Last Update Submitted That Met QC Criteria
July 20, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00001802
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
De-identified data will be share upon request from study chair and establishing data use agreements.
IPD Sharing Time Frame
Upon publication of primary outcome manuscript
IPD Sharing Access Criteria
Researchers upon sending a request to study chair (Dr.
Gelareh Sadigh; gsadigh@hs.uci.edu)
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.