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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06225414
Enrollment
60
Registered
2024-01-26
Start date
2024-02-12
Completion date
2026-02-11
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

Lung Cancer, Screening, Multi-level intervention

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.

Interventions

OTHERUsual Care

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

BEHAVIORALBrief Patient Education

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

BEHAVIORALPatient 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.

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.

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.

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.

Sponsors

University of California, Irvine
Lead SponsorOTHER
Radiological Society of North America
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Number of participants with order of Low-dose CT (LDCT) for lung cancer screening (LCS)Within 4 months of randomization

Secondary

MeasureTime frameDescription
Number of Participants who received LDCT for LCSWithin 4 months of randomization
Number of Participants with the documented discussion of lung cancer screening with their providers in the electronic medical recordWithin 4 months of randomization
Patients' perceived risk of lung cancerBaseline and 4 months after randomization3-item perceived risk of lung cancer questionnaire developed by Carter Harris et al (Cancer Nurs, 2018) will be used. The responses for each item will be based on a 5-point likert scale. A sum score will be calculated based on responses to all 3 item. Score will range between 3 and 15. Higher score= higher perceived risk.
Patients' perceived severity of lung cancerBaseline and 4 months after randomization5-items about the health consequences and severity of lung cancer will be used. The responses for each item will be based on a 5-point likert scale. A sum score will be calculated based on responses to all items. Score will range between 5-25. Higher score= higher perceived benefits.
Patients' perceived benefits of lung cancer screeningBaseline and 4 months after randomization6-item perceived benefit of lung cancer questionnaire developed by Carter Harris et al (Cancer Nurs, 2018) will be used. The responses for each item will be based on a 5-point likert scale. A sum score will be calculated based on responses to all items. Score will range between 6-30. Higher score= higher perceived benefits.
Patients' perceived barriers of lung cancer screeningBaseline and 4 months after randomization19-item perceived barriers of lung cancer questionnaire will be used. 17 of these items were developed by Carter Harris et al (Cancer Nurs, 2018). The responses for each item will be based on a 5-point likert scale. A sum score will be calculated based on responses to all 17 validated items. Score will range between 17 and 85. Higher score= higher perceived barriers. An additional score including all 19 items will also be calculated.
Patients' self-efficacy of lung cancer screeningBaseline and 4 months after randomization10-item self-efficacy for lung cancer screening questionnaire will be used. 9 of these items were developed by Carter Harris et al (Cancer Nurs, 2018). The responses for each item will be based on a 5-point likert scale. A sum score will be calculated based on responses to all 9 validated item. Score will range between 9 and 45. Higher score= higher self-efficacy. An additional score including all 10 items will also be calculated.
Patients' knowledge about lung cancer screeningBaseline and 4 months after randomization9 questions adopted and modified from Volk R et al (PMID: 24518006) will be used. Responses will be based on true, false, unsure. Sum of correctly responded questions will be calculated. Higher score= higher knowledge.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORGelareh Sadigh, MD

University of California, Irvine

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 31, 2026