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Completed

NCT Number: NCT06225414

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

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.

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Key information

Conditions

Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCI Health Family Health Center - Anaheim, Anaheim, California, United States

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Brief Patient Education

Behavioral

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

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.

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.

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.

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.

Primary outcomes

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

    Time frame: Within 4 months of randomization

Secondary outcomes

  1. Number of Participants who received LDCT for LCS

    Time frame: Within 4 months of randomization

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

    Time frame: Within 4 months of randomization

  3. Patients' perceived risk of lung cancer

    Time frame: Baseline and 4 months after randomization

    3-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.

  4. Patients' perceived severity of lung cancer

    Time frame: Baseline and 4 months after randomization

    5-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.

  5. Patients' perceived benefits of lung cancer screening

    Time frame: Baseline and 4 months after randomization

    6-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.

  6. Patients' perceived barriers of lung cancer screening

    Time frame: Baseline and 4 months after randomization

    19-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.

  7. Patients' self-efficacy of lung cancer screening

    Time frame: Baseline and 4 months after randomization

    10-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.

  8. Patients' knowledge about lung cancer screening

    Time frame: Baseline and 4 months after randomization

    9 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.

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Collaborators

  • Radiological Society of North America

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jan 26, 2024
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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