Empowering Hispanic Patients' Lung Cancer Screening Uptake (Empower Latinx)

NCT ID: NCT06225414

Last Updated: 2026-01-22

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-12
• Study Completion Date: 2026-02-28

Brief Summary

The Hispanic/Latinx community (hereafter Hispanic) is the country's second-largest racial/ethnic group, accounting for 19.1% of the total population. However, they remain one of the most underserved populations with suboptimal access to healthcare and screening services due to low income, lack of health insurance, perceived discrimination, language barriers, and limited health literacy. Lung cancer is the leading cause of cancer related mortality with 1.8 million annual deaths worldwide, with Hispanic patients known to have lower survival rates compared with non-Hispanic whites. Lung cancer screening (LCS) with low dose computed tomography (LDCT) decreases this mortality rate of lung cancer by 20%. Yet many Latinx 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 and compare the effect of a multi-level intervention on ordering LDCT within 4 months after patient enrollment to those in an Enhanced Usual Care. Our proposed intervention includes:

• Primary care provider notifications of patients' LCS eligibility;
• Patients' education;
• Patients' referral to financial navigation resources;
• Patients' reminder to discuss LCS during primary care provider (PCP) visit.

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Arm A: Enhanced Usual Care

Usual Care + Brief Educational Material

Group Type: EXPERIMENTAL

Usual Care

Intervention Type: OTHER

The usual care includes a provider flag in electronic medical record (EMR) on patients' eligibility for LCS if their smoking history is complete.

Brief Patient Education

Intervention Type: BEHAVIORAL

Brief one-page education material on lung cancer screening benefits and risk

Arm B: Empower Latinx

• PCP notifications of patients' LCS eligibility (addressing provider time constraints and barrier in identifying eligible patients);
• Patients' education (addressing knowledge barriers);
• Patients' referral to financial navigation resources (addressing health-related social risks)
• Patients' reminder to discuss LCS during PCP visit.

Group Type: EXPERIMENTAL

Usual Care

Intervention Type: OTHER

The usual care includes a provider flag in electronic medical record (EMR) on patients' eligibility for LCS if their smoking history is complete.

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 appointment, patients will receive a text message or a phone call (if not having a phone that receives text messaging) encouraging patients to discuss lung cancer screening with their provider.

Provider Reminders

Intervention Type: BEHAVIORAL

Within 2 weeks prior to primary care appointment, providers will be notified of their patient's eligibility for lung cancer screening and their reported barriers.

Interventions

Usual Care

The usual care includes a provider flag in electronic medical record (EMR) on patients' eligibility for LCS if their smoking history is complete.

Intervention Type: OTHER

Brief Patient Education

Brief one-page education material on lung cancer screening benefits and risk

Intervention Type: 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.

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 appointment, patients will receive a text message or a phone call (if not having a phone that receives text messaging) encouraging patients to discuss lung cancer screening with their provider.

Intervention Type: BEHAVIORAL

Provider Reminders

Within 2 weeks prior to primary care appointment, providers will be notified of their patient's eligibility for lung cancer screening and their reported barriers.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Aged 50- 80 years of age.
• Be able to speak English and Spanish
• Must have a Primary Care Provider.
• 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)
• Resident of California

Exclusion Criteria

• 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

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

Sponsors

Radiological Society of North America

OTHER

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: lead

Responsible Party

Gelareh Sadigh

Associate Professor In Residence

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gelareh Sadigh, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Irvine

Locations

UCI Health Family Health Center - Anaheim

Anaheim, California, United States

UCI Health-Costa Mesa

Costa Mesa, California, United States

UCI Health-Irvine

Irvine, California, United States

UCI Health-Laguna hilla

Laguna Hills, California, United States

UCI Health-Newport

Newport Beach, California, United States

UCI Health SeniorHealth Center -Pavillion 4

Orange, California, United States

UCI Medical Center, Pavilion 3

Orange, California, United States

UCI Health Family Health Center - Santa Ana

Santa Ana, California, United States

UCI-Health Tustin

Tustin, California, United States

UCI Health-Yorba Linda

Yorba Linda, California, United States

Countries

United States

Other Identifiers

UCI 23-219

Identifier Type: OTHER

Identifier Source: secondary_id

4471

Identifier Type: -

Identifier Source: org_study_id