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OpenTrials
Completed

NCT Number: NCT06000683

Empowering Patients' Lung Cancer Screening Uptake

Lung cancer is the leading cause of cancer related mortality. Lung cancer screening (LCS) with low dose computed tomography (LDCT) decreases mortality rate of lung cancer by 20%. Yet many 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 the effect of a a multi-level intervention on ordering LDCT within 6 months after patient enrollment. Our proposed intervention includes (1) Primary care provider notifications of patients' LCS eligibility; (2) patients' education ; (3) patients' referral to financial navigation resources; and (4) patients' reminder to discuss LCS during 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 - Costa Mesa, Costa Mesa, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Patients' Inclusion Criteria:

  • Aged 50- 80 years of age.
  • Be able to Speak English, Spanish, or Vietnamese
  • Must have a scheduled appointment with their Primary Care Providers within next one to three months.
  • The Scheduled PCP appointment is at any of the UCI Health primary care clinics in Orange County including two UCI federally qualified health centers
  • 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)

Patients' 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

Providers' Inclusion Criteria:

  • Primary Care Providers whose patients were enrolled in the Empower LCS trial.
  • Received notifications about the eligibility of their patients for lung cancer screening.

Treatment and study plan

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 primary care appointment, patients will receive a text message or a phone call (if not having a phone that receives text messaging) encouraging patients to discuss the LCS with their provider.

Provider Reminers

Behavioral

Within 2 weeks prior to primary care appointment, providers will be notified of their patient's eligibility for LCS.

Primary outcomes

  1. Order of LDCT

    Time frame: within 6 months of enrollment

    Number of participants who were ordered screening with Low Dose Computed Tomographyorder (LDCT) within 6 months after enrollment, assessed with self-reported surveys or EMR data extraction.

Secondary outcomes

  1. Receipt of LDCT

    Time frame: Within 6 months of enrollment

    Number of participants who were completed screening with Low Dose Computed Tomographyorder (LDCT) within 6 months after enrollment, assessed with self-reported surveys or EMR data extraction.

  2. LCS Discussion

    Time frame: within 6 months after enrollment

    Number of participants who had a discussion about screening with Low Dose Computed Tomographyorder (LDCT) with their primary care provider measured within 6 months after enrollment, through self-reported surveys or EMR documentation of discussion in the primary care notes.

  3. Perceived Risk of Lung Cancer

    Time frame: At 6 months post-enrollment

    3-item validated survey questions (from Carter Harris et al) assessing patients' perceived risk of lung cancer. Item responses use 5-point Likert scale. Total scores are calculated by summing item responses. Score is ranging between 3-15. Higher score= higher perceived risk of lung cancer.

  4. Perceived Severity of Lung Cancer

    Time frame: At 6 months post-enrollment

    5-item validated survey questions assessing patients' perceived severity of lung cancer. Item responses use 5-point Likert scale. Total scores are calculated by summing item responses. Score is ranging between 5-25. Higher score= higher perceived severity of lung cancer.

  5. Perceived Benefit of Lung Cancer Screening

    Time frame: At 6 months post-enrollment

    6-item validated survey questions (from Carter Harris et al) assessing patients' perceived benefits of lung cancer screening. Item responses use 5-point Likert scale. Total scores are calculated by summing item responses. Score is ranging between 6-30. Higher score= higher perceived benefits of lung cancer screening.

  6. Perceived Barriers to Lung Cancer Screening

    Time frame: At 6 months post-enrollment

    19-item validated survey questions (from Carter Harris et al) assessing patients' perceived barriers to lung cancer screening. Item responses use 5-point Likert scale. Total scores are calculated by summing item responses. Score is ranging between 19-95. Higher score= higher perceived barriers to lung cancer screening.

  7. Perceived Self-efficacy for Lung Cancer Screening

    Time frame: At 6 months post-enrollment

    10-item validated survey questions (from Carter Harris et al) assessing patients' perceived self-efficacy to undergo lung cancer screening. Item responses use 5-point Likert scale. Total scores are calculated by summing item responses. Score is ranging between 5-50. Higher score= higher perceived self-efficacy.

  8. Knowledge About Lung Cancer and Screening

    Time frame: At 6 months post-enrollment

    Knowledge of lung cancer and LCS was assessed using 8-items validated questions (from Volk et al), and scored by awarding one point per correct answer selected and one point per incorrect answer not selected. The total score was calculated as sum of all points. Total score ranged between 0 to 8. Higher score= higher knowledge.

  9. Providers' Perceived Barriers to Lung Cancer Screening

    Time frame: Baseline

    9-item survey questions assessing providers' perceived barriers to lung cancer screening. Item responses use 5-point Likert scale. Total scores are calculated by summing item responses. Score is ranging between 9-45. Higher score= higher perceived barriers to lung cancer screening.

Other outcomes

  1. Patient and Provider Experience With Intervention

    Time frame: At the end of all study enrollments a subgroup of patients and providers were interviewed

    Patient and Providers were asked questions about their experience with intervention components. Outcomes

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Registry information

Official study title

Empowering Patients' Lung Cancer Screening Uptake (Empower LCS)

Acronym: Empower-LCS

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 21, 2023
Registry last updated
Feb 20, 2026

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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