Clinical trial NCT06225414: Empowering Hispanic Patients' Lung Cancer Screening Uptake (Empower Latinx)
Official title: Empowering Hispanic Patients' Lung Cancer Screening Uptake (Empower Latinx)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Keywords: Lung Cancer
Screening
Multi-level intervention
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
Collaborators: name: Radiological Society of North America
First posted: 2024-01-26
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


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

Primary outcomes:
measure: Number of participants with order of Low-dose CT (LDCT) for lung cancer screening (LCS)
timeFrame: Within 4 months of randomization
Secondary outcomes:
measure: Number of Participants who received LDCT for LCS
timeFrame: Within 4 months of randomization
measure: Number of Participants with the documented discussion of lung cancer screening with their providers in the electronic medical record
timeFrame: Within 4 months of randomization
measure: Patients' perceived risk of lung cancer
timeFrame: Baseline and 4 months after randomization
measure: Patients' perceived severity of lung cancer
timeFrame: Baseline and 4 months after randomization
measure: Patients' perceived benefits of lung cancer screening
timeFrame: Baseline and 4 months after randomization
measure: Patients' perceived barriers of lung cancer screening
timeFrame: Baseline and 4 months after randomization
measure: Patients' self-efficacy of lung cancer screening
timeFrame: Baseline and 4 months after randomization
measure: Patients' knowledge about lung cancer screening
timeFrame: Baseline and 4 months after randomization
Other outcomes:
measure: Patients' experience with intervention
timeFrame: Within 6 months after completion of the follow-ups
measure: Providers experience with intervention
timeFrame: Within 3 months after last patient completion of follow-up
Locations:
city: Anaheim
country: United States
facility: UCI Health Family Health Center - Anaheim
state: California
city: Costa Mesa
country: United States
facility: UCI Health-Costa Mesa
state: California
city: Irvine
country: United States
facility: UCI Health-Irvine
state: California
city: Laguna Hills
country: United States
facility: UCI Health-Laguna hilla
state: California
city: Newport Beach
country: United States
facility: UCI Health-Newport
state: California
city: Orange
country: United States
facility: UCI Health SeniorHealth Center -Pavillion 4
state: California
city: Orange
country: United States
facility: UCI Medical Center, Pavilion 3
state: California
city: Santa Ana
country: United States
facility: UCI Health Family Health Center - Santa Ana
state: California
city: Tustin
country: United States
facility: UCI-Health Tustin
state: California
city: Yorba Linda
country: United States
facility: UCI Health-Yorba Linda
state: California
Study officials:
affiliation: University of California, Irvine
name: Gelareh Sadigh, MD
role: PRINCIPAL_INVESTIGATOR
References: