Lung Cancer ScreeningEmpower LCS+NCT07711691
Empowering Patients' Lung Cancer Screening Uptake (Empower LCS/Call+)
A study testing Empower LCS, Call+ Telephone Navigation and Education in people with Lung Cancer Screening and Lung Neoplasms, run by University of California, Irvine at 57 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Lung Cancer Screening, Lung Neoplasms, Smoking ( Cigarette)
- What is being tested?
- Empower LCS, Call+ Telephone Navigation and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 57 sitesUnited States
- Study dates
- 16 Sep 2026to Dec 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
57 sites in 1 country. Contact the study team or a site near you to ask about taking part.
57 sites in 1 country
United States57 sites, 57 recruiting
- Not yet recruiting
Emory at Avalon - Primary Care
Alpharetta, Georgia, 30009
Ilana Graetz, PhD, 404-727-1483, empowerlcs@emory.edu
- Recruiting
UCI Health Family Health Center - Anaheim
Anaheim, California, 92801
Gelareh Sadigh, MD, (714) 456-3610, empowerlcs@hs.uci.edu
- Not yet recruiting
Emory Clinic at Old Fourth Ward
Atlanta, Georgia, 30047
Ilana Graetz, PhD, 404-727-1483, empowerlcs@emory.edu
- Not yet recruiting
Emory Clinic at Midtown
Atlanta, Georgia, 30308
Ilana Graetz, PhD, 404-727-1483, empowerlcs@emory.edu
- Not yet recruiting
Emory at Peachtree Hills - Primary Care
Atlanta, Georgia, 30309
Ilana Graetz, PhD, 404-727-1483, empowerlcs@emory.edu
- Not yet recruiting
Emory Clinic at 1365 Clifton Road - Primary Care
Atlanta, Georgia, 30322
Ilana Graetz, PhD, 404-7271483, empowerlcs@emory.edu
- Not yet recruiting
Emory Clinic at 1525 Clifton Road - Primary Care
Atlanta, Georgia, 30322
Ilana Graetz, PhD, 404-727-1483, empowerlcs@emory.edu
- Not yet recruiting
Emory at Toco Hills - Primary Care
Atlanta, Georgia, 30329
Ilana Graetz, PhD, 404-727-1483, empowerlcs@emory.edu
- Not yet recruiting
Emory Gastroenterology
Atlanta, Georgia, 30342
Ilana Graetz, PhD, 404-727-1483, empowerlcs@emory.edu
- Not yet recruiting
Emory at Northlake - Primary Care
Atlanta, Georgia, 30345
Ilana Graetz, PhD, 404-727-1483, empowerlcs@emory.edu
- Not yet recruiting
Emory at Buford - Primary Care
Buford, Georgia, 30519
Ilana Graetz, PhD, 404-727-1483, empowerlcs@emory.edu
- Recruiting
UCI Health - Costa Mesa
Costa Mesa, California, 92627
Gelareh Sadigh, MD, (714) 456-3610, empowerlsc@hs.uci.edu
- Not yet recruiting
Emory at Decatur - Primary Care (Irvin Court)
Decatur, Georgia, 30030
Ilana Graetz, PhD, 404-727-1483, empowerlcs@emory.edu
- Not yet recruiting
Emory at Decatur - Primary Care (Scott Boulevard)
Decatur, Georgia, 30030
Ilana Graetz, PhD, 404-727-1483, empowerlcs@emory.edu
- Not yet recruiting
Emory Clinic Downtown Decatur
Decatur, Georgia, 30030
Ilana Graetz, PhD, 404-727-1483, empowerlcs@emory.edu
- Not yet recruiting
Emory at Decatur - Primary Care
Decatur, Georgia, 30033
Ilana Graetz, PhD, 404-727-1483, empowerlcs@emory.edu
- Not yet recruiting
Emory at Oak Grove - Primary Care
Decatur, Georgia, 30033
Ilana Graetz, PhD, 404-727-1483, empowerlcs@emory.edu
- Not yet recruiting
Emory Clinic at Decatur - Primary Care
Decatur, Georgia, 30033
Ilana Graetz, PhD, 404-727-1483, empowerlcs@emory.edu
- Not yet recruiting
Emory at Flat Shoals - Primary Care
Decatur, Georgia, 30034
Ilana Graetz, PhD, 404-727-1483, empowerlcs@emory.edu
- Not yet recruiting
Emory at Duluth
Duluth, Georgia, 30096
Ilana Graetz, PhD, 404-727-1483, empowerlcs@emory.edu
- Not yet recruiting
Emory at Sugarloaf - Primary Care
Duluth, Georgia, 30097
Ilana Graetz, PhD, 404-727-1483, empowerlcs@emory.edu
- Not yet recruiting
Emory at Dunwoody
Dunwoody, Georgia, 30338
Ilana Graetz, PhD, 404-727-1483, empowerlcs@emory.edu
- Not yet recruiting
Emory Clinic at Saint Joseph's
Dunwoody, Georgia, 30342
Ilana Graetz, PhD, 404-727-1483, empowerlcs@emory.edu
- Recruiting
CHAO Family Comprehensive Cancer Center- Irvine
Irvine, California, 92612
Gelareh Sadigh, MD, (714) 456-3610, empowerlcs@hs.uci.edu
- Recruiting
UCI Health Gottschalk Medical Plaza
Irvine, California, 92697
Gelareh Sadigh, MD, (714) 456-3610, empowerlcs@hs.uci.edu
- Not yet recruiting
Emory at Findley Road
Johns Creek, Georgia, 30097
Ilana Graetz, PhD, 404-727-1483, empowerlcs@emory.edu
- Not yet recruiting
Emory at Spivey Station - Primary Care
Jonesboro, Georgia, 30236
Ilana Graetz, PhD, 404-727-1483, empowerlcs@emory.edu
- Not yet recruiting
Emory at LaGrange - Smith Street - Primary Care
La Grange, Georgia, 30240
Ilana Graetz, PhD, 404-727-1483, empowerlcs@emory.edu
- Not yet recruiting
Emory at LaGrange - Davis Road
La Grange, Georgia, 30241
Ilana Graetz, PhD, 404-727-1483, empowerlcs@emory.edu
- Recruiting
UCI Health - Laguna Hills
Laguna Hills, California, 92653
Gelareh Sadigh, MD, (714) 456-3610, empowerlcs@hs.uci.edu
- Not yet recruiting
Emory at Beaver Ruin - Primary Care
Lilburn, Georgia, 30047
Ilana Graetz, PhD, 404-727-1483, empowerlcs@emory.edu
- Not yet recruiting
Emory at Mountain Park - Primary Care
Lilburn, Georgia, 30047
Ilana Graetz, PhD, 404-727-1483, empowerlcs@emory.edu
- Not yet recruiting
Emory at Hillandale Family Medicine
Lithonia, Georgia, 30058
Ilana Graetz, PhD, 404-727-1483, empowerlcs@emory.edu
- Not yet recruiting
Emory at Miller Grove - Primary Care
Lithonia, Georgia, 30058
Ilana Graetz, PhD, 404-727-1483, empowerlcs@emory.edu
- Not yet recruiting
Emory Clinic at Lithonia - Primary Care
Lithonia, Georgia, 30058
Ilana Graetz, PhD, 404-727-1483, empowerlcs@emory.edu
- Not yet recruiting
Emory at East Cobb - Primary Care
Marietta, Georgia, 30068
Ilana Graetz, PhD, 404-727-1483, empowerlcs@emory.edu
- Recruiting
UCI Health - Newport Beach MacArthur
Newport Beach, California, 92660
Gelareh Sadigh, MD, (714) 456-3610, gsadigh@hs.uci.edu
- Recruiting
Primary Care & Internal Medicine Services
Orange, California, 92868
Gelareh Sadigh, MD, (714) 456-3610, empowerlcs@hs.uci.edu
- Recruiting
UCI Chao Family Comprehensive Cancer Center
Orange, California, 92868
Gelareh Sadigh, MD, (714) 456-3610, empowerlcs@hs.uci.edu
- Recruiting
UCI Health SeniorHealth Center -Pavillion 4
Orange, California, 92868
Gelareh Sadigh, MD, (714) 456-3610, empowerlcs@hs.uci.edu
- Recruiting
UCI Medical Center, Pavilion 3
Orange, California, 92868
Gelareh Sadigh, MD, (714) 456-3610, empowerlcs@hs.uci.edu
- Not yet recruiting
Emory at Peachtree City - Primary Care
Peachtree City, Georgia, 30269
Ilana Graetz, PhD, 404-727-1483, empowerlcs@emory.edu
- Recruiting
UCI Health Family Health Center - Santa Ana
Santa Ana, California, 92701
Gelareh Sadigh, MD, (714) 456-3610, empowerlcs@hs.uci.edu
- Not yet recruiting
Emory at Sharpsburg
Sharpsburg, Georgia, 30277
Ilana Graetz, PhD, 404-727-1483, empowerlcs@emory.edu
- Not yet recruiting
Emory at Belmont - Primary Care
Smyrna, Georgia, 30080
Ilana Graetz, PhD, 404-727-1483, empowerlcs@emory.edu
- Not yet recruiting
Emory at Snellville - Primary Care (Lenora Church Road)
Snellville, Georgia, 30078
il Graetz, PhD, 404-727-1483, empowerlcs@emory.edu
- Not yet recruiting
Emory at Snellville - Primary Care (Oak Road)
Snellville, Georgia, 30078
Ilana Graetz, PhD, 404-727-1483, empowerlcs@emory.edu
- Not yet recruiting
Emory at Snellville Primary Care (Presidential Circle)
Snellville, Georgia, 30078
Ilana Graetz, PhD, 404-727-1483, empowerlcs@emory.edu
- Not yet recruiting
Emory at Centerville - Primary Care
Snellville, Georgia, 30339
Ilana Graetz, PhD, 404-727-1483, empowerlcs@emory.edu
- Not yet recruiting
Emory at Eagles Landing Primary Care
Stockbridge, Georgia, 30281
Ilana Graetz, PhD, 404-727-1483, empowerlcs@emory.edu
- Not yet recruiting
Emory at Stone Mountain - Primary Care
Stone Mountain, Georgia, 30083
Ilana Graetz, PhD, 404-727-1483, empowerlcs@emory.edu
- Not yet recruiting
Emory at Rockbridge Primary Care & Nephrology
Stone Mountain, Georgia, 30087
Ilana Graetz, PhD, 404-727-1483, empowerlcs@emory.edu
- Not yet recruiting
Emory at Tucker - Primary Care (1459 Montreal Road)
Tucker, Georgia, 30084
Ilana Graetz, PhD, 404-727-1483, empowerlcs@emory.edu
- Recruiting
UCI Health - Tustin
Tustin, California, 92670
Gelareh Sadigh, MD, (714) 456-3610, empowerlcs@hs.uci.edu
- Not yet recruiting
Pavilion Family Medicine Center
Warner Robins, Georgia, 31093
Ilana Graetz, PhD, 404-727-1483, empowerlcs@emory.edu
- Not yet recruiting
Emory at West Point
West Point, Georgia, 31833
Ilana Graetz, PhD, 404-727-1483, empowerlcs@emory.edu
- Recruiting
UCI Health - Yorba Linda
Yorba Linda, California, 92886
Gelareh Sadigh, MD, (714) 456-3610, empowerlcs@hs.uci.edu
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Empower LCS, Call+ Telephone Navigation, Usual Care, Education
- Keywords
- Lung cancer screening, Low-dose computed tomography (LDCT), Patient navigation, Natural language processing, Smoking, Health-related social needs, Multilevel intervention
- Medical subject headings
- Lung Neoplasms, Cigarette Smoking, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empower LCSBehavioural
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 NavigationBehavioural
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 CareOther
Usual care
EducationOther
One-page educational material about benefits and risks of lung cancer screening
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Usual Care | Active comparator | Usual care + educational brochure Receives: Other: Usual Care; Other: Education |
| Empower LCS/Call+ | Experimental | Empower LCS with Call+ offered to non-responders Receives: Behavioral: Empower LCS; Behavioral: Call+ Telephone Navigation; Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of lung cancer screening with low-dose computed tomography (LDCT)
Completion of LDCT lung cancer screening, determined by electronic health record review.
Measured: 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.
Measured: 8 months after randomization
Secondary outcomes (14)
Completion of any chest CT
Completion of any chest CT, determined by electronic health record review.
Measured: 4 months after randomization
Completion of any chest CT
Completion of any chest CT
Measured: 8 months after randomization
Ordering of low-dose computed tomography (LDCT)
Provider order for LDCT identified through electronic health record review.
Measured: 4 months after randomization
Ordering of low-dose computed tomography (LDCT)
Provider order for LDCT identified through electronic health record review.
Measured: 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.
Measured: 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.
Measured: 8 months after enrollment
Lung cancer screening scheduling
scheduling of lung cancer screening as self-reported by patient
Measured: 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)
Measured: 4 months after randomization
Decisional conflict regarding lung cancer screening
Participant decisional conflict measured using 10-item decisional conflict scale (O'Connor AM)
Measured: 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)
Measured: 4 months after randomization
Perceived lung cancer severity
Perceived lung cancer severity will be measured using 5-item survey (Shojazadeh et al. JACR; 2015)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 4 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start16 Sep 2026
- Primary completionAug 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Lung Cancer ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized in a 1:1 ratio to either the Empower LCS/Call+ intervention or enhanced usual care. Participants assigned to the intervention arm who do not complete lung cancer screening by the 4-month follow-up will receive the Call+ telephone navigation intervention as part of the predefined intervention strategy. Participants will remain in their originally assigned study arm for the duration of the study, and outcomes will be compared between the two parallel groups.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gelareh Sadigh, University of California, Irvine
- Investigators
- Gelareh Sadigh, Principal investigator, University of California, IrvineIlana Graetz, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07711691
- Sponsor's protocol ID
- STUDY00001802
- Acronym
- Empower LCS+
- Status last verified
- Sep 2026
- First submitted
- 13 Jul 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data will be share upon request from study chair and establishing data use agreements.
Publications
O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105.
PubMed 7898294Carter-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.
PubMed 27244666Quezada 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.
PubMed 39577140Shojazadeh 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.
PubMed 41241060Jung 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.
PubMed 40044305National 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.
PubMed 21714641