Clinical trial · Interventional
Empowering Patients' Lung Cancer Screening Uptake (Empower LCS/Call+)
Empowering Patients' Lung Cancer Screening Uptake (Empower LCS/Call+): A Multi-Site Pilot Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early Detection of Cancer | — | UNRESOLVED | — |
| Lung Cancer Screening | — | UNRESOLVED | — |
| Lung Neoplasms | Lung Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Smoking ( Cigarette) | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Call+ Telephone Navigation | Behavioral | — | UNRESOLVED |
| Education | Other | — | UNRESOLVED |
| Empower LCS | Behavioral | — | UNRESOLVED |
| Usual Care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Enhanced Usual Care
- description
- Usual care + educational brochure
- interventionNames
- Other: Usual Care
- Other: Education
- type
- EXPERIMENTAL
- label
- Empower LCS/Call+
- description
- Empower LCS with Call+ offered to non-responders
- interventionNames
- Behavioral: Empower LCS
- Behavioral: Call+ Telephone Navigation
- Other: Usual Care
Primary outcomes (2)
- measure
- Completion of lung cancer screening with low-dose computed tomography (LDCT)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (6)
- BACKGROUNDO'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105. PMID 7898294
- BACKGROUNDCarter-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. PMID 27244666
- BACKGROUNDQuezada 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. PMID 39577140
- BACKGROUNDShojazadeh 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. PMID 41241060
- BACKGROUNDJung 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. PMID 40044305
- BACKGROUNDNational 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. PMID 21714641