Empowering Patients' Lung Cancer Screening Uptake

NCT ID: NCT06000683

Last Updated: 2026-02-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 79 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-13
• Study Completion Date: 2025-11-25

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Patient education

Intervention Type: 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.

Referral to financial navigation resources

Intervention Type: 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.

Patient Reminders

Intervention Type: 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.

Provider Reminers

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Provider Reminers

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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)

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.

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Gelareh Sadigh

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gelareh Sadigh, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

UCI Health - Costa Mesa

Costa Mesa, California, United States

UCI Health Gottschalk Medical Plaza

Irvine, California, United States

UCI Health - Laguna Hills

Laguna Hills, California, United States

UCI Health - Newport Beach MacArthur

Newport Beach, California, United States

UCI Medical Center

Orange, California, United States

UCI Health - Tustin

Tustin, California, United States

UCI Health-Yorba Linda

Yorba Linda, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

UCI 23-107

Identifier Type: OTHER

Identifier Source: secondary_id

3432

Identifier Type: -

Identifier Source: org_study_id