Empowering Patients' Lung Cancer Screening Uptake

NCT06000683 | Completed Results

• 2 other identifiers: 3432UCI 23-107
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 7

Brief Summary

Lung cancer is the leading cause of cancer related mortality. Lung cancer screening (LCS) with low dose computed tomography (LDCT) decreases mortality rate of lung cancer by 20%. Yet many patients who are eligible for lung cancer screening are still falling through the cracks which prevents patients the ability to detect lung cancer early. This study will test the effect of a a multi-level intervention on ordering LDCT within 6 months after patient enrollment. Our proposed intervention includes (1) Primary care provider notifications of patients' LCS eligibility; (2) patients' education ; (3) patients' referral to financial navigation resources; and (4) patients' reminder to discuss LCS during PCP visit.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (1)

• Order of LDCT

  Number of participants who were ordered screening with Low Dose Computed Tomographyorder (LDCT) within 6 months after enrollment, assessed with self-reported surveys or EMR data extraction.

  within 6 months of enrollment

Secondary Outcomes (9)

• Receipt of LDCT

  Within 6 months of enrollment

• LCS Discussion

  within 6 months after enrollment

• Perceived Risk of Lung Cancer

  At 6 months post-enrollment

• Perceived Severity of Lung Cancer

  At 6 months post-enrollment

• Perceived Benefit of Lung Cancer Screening

  At 6 months post-enrollment

Other Outcomes (1)

• Patient and Provider Experience With Intervention

  At the end of all study enrollments a subgroup of patients and providers were interviewed

Study Arms (1)

Empower LCS

EXPERIMENTAL

Patient will be given education material(addressing knowledge barriers); patients' referral to financial navigation resources (addressing health-related social risks); and patients' reminder to discuss LCS during PCP visit. Providers will also be notified of eligibility of their patients to receive LCS.

Behavioral: Patient education; Behavioral: Referral to financial navigation resources; Behavioral: Patient Reminders; Behavioral: Provider Reminers

Interventions

Referral to financial navigation resources BEHAVIORAL

Patients who self-report needing help with health-related social risks at baseline will be sent a brochure (in preferred language) from patient advocate foundation (PAF), a national non-profit financial navigation organization, where patients can self-refer.

Empower LCS

Patient education BEHAVIORAL

Patients will be sent information (in preferred language) on lung cancer risk, lung cancer screening (LCS) benefits, harms, false positive rates, recommendations of follow-up for positive results, and exam insurance coverage.

Empower LCS

Patient Reminders BEHAVIORAL

Within 2 weeks prior to primary care appointment, patients will receive a text message or a phone call (if not having a phone that receives text messaging) encouraging patients to discuss the LCS with their provider.

Empower LCS

Provider Reminers BEHAVIORAL

Within 2 weeks prior to primary care appointment, providers will be notified of their patient's eligibility for LCS.

Empower LCS

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 50- 80 years of age.
• Be able to Speak English, Spanish, or Vietnamese
• Must have a scheduled appointment with their Primary Care Providers within next one to three months.
• The Scheduled PCP appointment is at any of the UCI Health primary care clinics in Orange County including two UCI federally qualified health centers
• History of 20 pack year smoking history ( based on survey self report)
• Current smoker or a former smoker who has quit smoking within the last 15 years (based on survey self report)

You may not qualify if:

• Prior history of lung cancer
• chest CT for any reason in the last 12 months based on self-report and UCI EMR
• history of Alzheimer's disease or dementia
• Primary Care Providers whose patients were enrolled in the Empower LCS trial.
• Received notifications about the eligibility of their patients for lung cancer screening.

Sponsors & Collaborators

• University of California, Irvine: lead

Study Sites (7)

UCI Health - Costa Mesa

Costa Mesa, California, 92627, United States

Location

UCI Health Gottschalk Medical Plaza

Irvine, California, 92697, United States

Location

UCI Health - Laguna Hills

Laguna Hills, California, 92653, United States

Location

UCI Health - Newport Beach MacArthur

Newport Beach, California, 92660, United States

Location

UCI Medical Center

Orange, California, 92868, United States

Location

UCI Health - Tustin

Tustin, California, 92670, United States

Location

UCI Health-Yorba Linda

Yorba Linda, California, 92886, United States

Location

Related Publications (1)

• Sharifian M, Hoyt MA, Madan A, Lee S, Nguyen TQ, Sadigh G. Patients' and Providers' Perspective of a Multi-level Approach to Improve Participation in Low-dose CT for Lung Cancer Screening (Empower LCS): A Mixed-Methods Analysis. Acad Radiol. 2026 Mar 28:S1076-6332(26)00182-0. doi: 10.1016/j.acra.2026.03.014. Online ahead of print.

  PMID: 41904093 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Patient Education as Topic

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Gelareh Sadigh, MD
• Organization: University of California Irvine

gsadigh@hs.uci.edu

(714) 456-3610

Study Officials

• Gelareh Sadigh, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Patient participants (n=70) will receive the study intervention, complete surveys and a subset of them (n=11) will participate in a one-time qualitative interview. Provider participants (n=9) will not receive any intervention. Provider participants will participate in a one-time survey, and a subset of them (n=5) will participate in a one-time qualitative interview.

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 21, 2023
• Study Start: October 13, 2023
• Primary Completion: March 21, 2025
• Study Completion: November 25, 2025
• Last Updated: February 20, 2026
• Results First Posted: February 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)