AzTrials
AzTrials

Lung CancerEmpower-LCSNCT06000683

Empowering Patients' Lung Cancer Screening Uptake

A study testing Patient education, Referral to financial navigation resources and Patient Reminders in people with Lung Cancer, run by University of California, Irvine at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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%. Read more about this study

Who is it for?
Ages 50 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Lung Cancer
What is being tested?
Patient education, Referral to financial navigation resources and Patient Reminders
Could I receive a placebo?
No, everyone receives an active treatment
How many people
79 participants
Where
7 sitesUnited States
Study dates
13 Oct 2023to 25 Nov 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Patients' Inclusion Criteria:

  1. Aged 50- 80 years of age.
  2. Be able to Speak English, Spanish, or Vietnamese
  3. Must have a scheduled appointment with their Primary Care Providers within next one to three months.
  4. The Scheduled PCP appointment is at any of the UCI Health primary care clinics in Orange County including two UCI federally qualified health centers
  5. History of 20 pack year smoking history ( based on survey self report)
  6. Current smoker or a former smoker who has quit smoking within the last 15 years (based on survey self report)

Patients' Exclusion Criteria:

  1. Prior history of lung cancer
  2. chest CT for any reason in the last 12 months based on self-report and UCI EMR
  3. history of Alzheimer's disease or dementia

Providers' Inclusion Criteria:

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

Trial locations and contacts

7 sites in 1 country.

7 sites in 1 country

United States7 sites

  • UCI Health - Costa Mesa

    Costa Mesa, California, 92627

  • UCI Health Gottschalk Medical Plaza

    Irvine, California, 92697

  • UCI Health - Laguna Hills

    Laguna Hills, California, 92653

  • UCI Health - Newport Beach MacArthur

    Newport Beach, California, 92660

  • UCI Medical Center

    Orange, California, 92868

  • UCI Health - Tustin

    Tustin, California, 92670

  • UCI Health-Yorba Linda

    Yorba Linda, California, 92886

Other trials in United States

About this study

Official title: Empowering Patients' Lung Cancer Screening Uptake (Empower LCS)

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.

Conditions
Lung Cancer
Being tested
Patient education, Referral to financial navigation resources, Patient Reminders, Provider Reminers
Medical subject headings
Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Patient educationBehavioural

    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 resourcesBehavioural

    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 RemindersBehavioural

    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 ReminersBehavioural

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

Study groups in NCT06000683
Study groupRoleWhat they receive
Empower LCSExperimentalPatient will be given education material(addressing knowledge barriers); patients' referral to financial navigation resources (addressing health-related social risks); and patients' reminder to discuss LCS during PCP visit. Providers will also be notified of eligibility of their patients to receive LCS.
Receives: Behavioral: Patient education; Behavioral: Referral to financial navigation resources; Behavioral: Patient Reminders; Behavioral: Provider Reminers

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Order of LDCT

    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.

    Measured: within 6 months of enrollment

Secondary outcomes (9)

  1. Receipt of LDCT

    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.

    Measured: Within 6 months of enrollment

  2. LCS Discussion

    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.

    Measured: within 6 months after enrollment

  3. Perceived Risk of Lung Cancer

    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.

    Measured: At 6 months post-enrollment

  4. Perceived Severity of Lung Cancer

    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.

    Measured: At 6 months post-enrollment

  5. Perceived Benefit of Lung Cancer Screening

    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.

    Measured: At 6 months post-enrollment

  6. Perceived Barriers to Lung Cancer Screening

    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.

    Measured: At 6 months post-enrollment

  7. Perceived Self-efficacy for Lung Cancer Screening

    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.

    Measured: At 6 months post-enrollment

  8. Knowledge About Lung Cancer and Screening

    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.

    Measured: At 6 months post-enrollment

  9. Providers' Perceived Barriers to Lung Cancer Screening

    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.

    Measured: Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2023
  2. Study start13 Oct 2023
  3. Primary completion21 Mar 2025
  4. Study completion25 Nov 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Model description
Patient participants (n=70) will receive the study intervention, complete surveys and a subset of them (n=11) will participate in a one-time qualitative interview. Provider participants (n=9) will not receive any intervention. Provider participants will participate in a one-time survey, and a subset of them (n=5) will participate in a one-time qualitative interview.
Masking
None (open label)
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06000683
Sponsor's protocol ID
3432
Other IDs
UCI 23-107
Acronym
Empower-LCS
Status last verified
Feb 2026
First submitted
14 Aug 2023
Last updated
20 Feb 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Sharifian M, Hoyt MA, Madan A, Lee S, Nguyen TQ, Sadigh G. Patients' and Providers' Perspective of a Multi-level Approach to Improve Participation in Low-dose CT for Lung Cancer Screening (Empower LCS): A Mixed-Methods Analysis. Acad Radiol. 2026 Jun;33(6):2352-2360. doi: 10.1016/j.acra.2026.03.014. Epub 2026 Mar 28.

    PubMed 41904093

  • Shojazadeh A, Kao R, Pham T, Madan A, Echeverria R, Chen WP, Nguyen V, Gutierrez O, Lee S, Hoyt MA, Ziogas A, Nguyen TQ, Keshava H, Sadigh G. A Multilevel Approach to Improve Participation in Low-Dose CT for Lung Cancer Screening (Empower LCS): A Single-Arm Pilot Feasibility Clinical Trial. J Am Coll Radiol. 2026 Apr;23(4):556-564. doi: 10.1016/j.jacr.2025.11.005. Epub 2025 Nov 13.

    PubMed 41241060

Questions about this trial

What is this clinical trial studying?

A study testing Patient education, Referral to financial navigation resources and Patient Reminders in people with Lung Cancer, run by University of California, Irvine at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Order of LDCT (time frame: within 6 months of enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06000683, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2026.

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