Empowering Patients' Lung Cancer Screening Uptake (Empower-LCS)

Empowering Patients' Lung Cancer Screening Uptake (Empower LCS)

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.

Study Overview

• Status: Completed
• Conditions: Lung Cancer
• Intervention / Treatment: Behavioral: Patient education; Behavioral: Referral to financial navigation resources; Behavioral: Patient Reminders; Behavioral: Provider Reminers

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Costa Mesa, California, United States, 92627
      • UCI Health - Costa Mesa
    • Irvine, California, United States, 92697
      • UCI Health Gottschalk Medical Plaza
    • Laguna Hills, California, United States, 92653
      • UCI Health - Laguna Hills
    • Newport Beach, California, United States, 92660
      • UCI Health - Newport Beach MacArthur
    • Orange, California, United States, 92868
      • UCI Medical Center
    • Tustin, California, United States, 92670
      • UCI Health - Tustin
    • Yorba Linda, California, United States, 92886
      • UCI Health-Yorba Linda

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Patients' Inclusion Criteria:

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

Patients' Exclusion Criteria:

1. Prior history of lung cancer
2. chest CT for any reason in the last 12 months based on self-report and UCI EMR
3. history of Alzheimer's disease or dementia

Providers' Inclusion Criteria:

1. Primary Care Providers whose patients were enrolled in the Empower LCS trial.
2. Received notifications about the eligibility of their patients for lung cancer screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Empower LCS; 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; 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.; Behavioral: Referral to financial navigation resources; 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.; Behavioral: Patient Reminders; 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.; Behavioral: Provider Reminers; Within 2 weeks prior to primary care appointment, providers will be notified of their patient's eligibility for LCS.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Receipt of LDCT	Number of participants who were completed 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
LCS Discussion	Number of participants who had a discussion about screening with Low Dose Computed Tomographyorder (LDCT) with their primary care provider measured within 6 months after enrollment, through self-reported surveys or EMR documentation of discussion in the primary care notes.	within 6 months after enrollment
Perceived Risk of Lung Cancer	3-item validated survey questions (from Carter Harris et al) assessing patients' perceived risk of lung cancer. Item responses use 5-point Likert scale. Total scores are calculated by summing item responses. Score is ranging between 3-15. Higher score= higher perceived risk of lung cancer.	At 6 months post-enrollment
Perceived Severity of Lung Cancer	5-item validated survey questions assessing patients' perceived severity of lung cancer. Item responses use 5-point Likert scale. Total scores are calculated by summing item responses. Score is ranging between 5-25. Higher score= higher perceived severity of lung cancer.	At 6 months post-enrollment
Perceived Benefit of Lung Cancer Screening	6-item validated survey questions (from Carter Harris et al) assessing patients' perceived benefits of lung cancer screening. Item responses use 5-point Likert scale. Total scores are calculated by summing item responses. Score is ranging between 6-30. Higher score= higher perceived benefits of lung cancer screening.	At 6 months post-enrollment
Perceived Barriers to Lung Cancer Screening	19-item validated survey questions (from Carter Harris et al) assessing patients' perceived barriers to lung cancer screening. Item responses use 5-point Likert scale. Total scores are calculated by summing item responses. Score is ranging between 19-95. Higher score= higher perceived barriers to lung cancer screening.	At 6 months post-enrollment
Perceived Self-efficacy for Lung Cancer Screening	10-item validated survey questions (from Carter Harris et al) assessing patients' perceived self-efficacy to undergo lung cancer screening. Item responses use 5-point Likert scale. Total scores are calculated by summing item responses. Score is ranging between 5-50. Higher score= higher perceived self-efficacy.	At 6 months post-enrollment
Knowledge About Lung Cancer and Screening	Knowledge of lung cancer and LCS was assessed using 8-items validated questions (from Volk et al), and scored by awarding one point per correct answer selected and one point per incorrect answer not selected. The total score was calculated as sum of all points. Total score ranged between 0 to 8. Higher score= higher knowledge.	At 6 months post-enrollment
Providers' Perceived Barriers to Lung Cancer Screening	9-item survey questions assessing providers' perceived barriers to lung cancer screening. Item responses use 5-point Likert scale. Total scores are calculated by summing item responses. Score is ranging between 9-45. Higher score= higher perceived barriers to lung cancer screening.	Baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient and Provider Experience With Intervention	Patient and Providers were asked questions about their experience with intervention components. Outcomes	At the end of all study enrollments a subgroup of patients and providers were interviewed

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Investigators: Principal Investigator: Gelareh Sadigh, MD, University of California, Irvine

Study record dates

Study Major Dates

• Study Start (Actual): October 13, 2023
• Primary Completion (Actual): March 21, 2025
• Study Completion (Actual): November 25, 2025

Study Registration Dates

• First Submitted: August 14, 2023
• First Submitted That Met QC Criteria: August 14, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): February 20, 2026
• Last Update Submitted That Met QC Criteria: February 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services; Health Education; Patient Education as Topic
• Other Study ID Numbers: 3432; UCI 23-107 (Other Identifier: University of California Irvine IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No