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

NCT06225414 | Completed

• 2 other identifiers: 4471UCI 23-219
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 10

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

Keywords

Lung Cancer; Screening; Multi-level intervention

Outcome Measures

Primary Outcomes (1)

• Number of participants with order of Low-dose CT (LDCT) for lung cancer screening (LCS)

  Within 4 months of randomization

Secondary Outcomes (8)

• Number of Participants who received LDCT for LCS

  Within 4 months of randomization

• Number of Participants with the documented discussion of lung cancer screening with their providers in the electronic medical record

  Within 4 months of randomization

• Patients' perceived risk of lung cancer

  Baseline and 4 months after randomization

• Patients' perceived severity of lung cancer

  Baseline and 4 months after randomization

• Patients' perceived benefits of lung cancer screening

  Baseline and 4 months after randomization

Study Arms (2)

Arm A: Enhanced Usual Care

EXPERIMENTAL

Usual Care + Brief Educational Material

Other: Usual Care; Behavioral: Brief Patient Education

Arm B: Empower Latinx

EXPERIMENTAL

* 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.

Other: Usual Care; Behavioral: Patient education; Behavioral: Referral to financial navigation resources; Behavioral: Patient Reminders; Behavioral: Provider Reminders

Interventions

Usual Care OTHER

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

Arm A: Enhanced Usual Care; Arm B: Empower Latinx

Brief Patient Education BEHAVIORAL

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

Arm A: Enhanced Usual Care

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.

Arm B: Empower Latinx

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.

Arm B: Empower Latinx

Patient Reminders 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.

Arm B: Empower Latinx

Provider Reminders 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.

Arm B: Empower Latinx

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 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

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

Sponsors & Collaborators

• University of California, Irvine: lead
• Radiological Society of North America: collaborator

Study Sites (10)

UCI Health Family Health Center - Anaheim

Anaheim, California, 92801, United States

Location

UCI Health-Costa Mesa

Costa Mesa, California, 92627, United States

Location

UCI Health-Irvine

Irvine, California, 92612, United States

Location

UCI Health-Laguna hilla

Laguna Hills, California, 92653, United States

Location

UCI Health-Newport

Newport Beach, California, 92660, United States

Location

UCI Health SeniorHealth Center -Pavillion 4

Orange, California, 92868, United States

Location

UCI Medical Center, Pavilion 3

Orange, California, 92868, United States

Location

UCI Health Family Health Center - Santa Ana

Santa Ana, California, 92701, United States

Location

UCI-Health Tustin

Tustin, California, 92780, United States

Location

UCI Health-Yorba Linda

Yorba Linda, California, 92886, United States

Location

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

Study Officials

• Gelareh Sadigh, MD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor In Residence

Study Record Dates

• First Submitted: January 15, 2024
• First Posted: January 26, 2024
• Study Start: February 12, 2024
• Primary Completion: December 11, 2025
• Study Completion: February 11, 2026
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)