Lung CancerNCT06225414
Empowering Hispanic Patients' Lung Cancer Screening Uptake (Empower Latinx)
A study testing Brief Patient Education, Patient education and Referral to financial navigation resources in people with Lung Cancer, run by University of California, Irvine at 10 sites in United States.
Trial 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… 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?
- Brief Patient Education, Patient education and Referral to financial navigation resources
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 10 sitesUnited States
- Study dates
- 12 Feb 2024to 11 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
UCI Health Family Health Center - Anaheim
Anaheim, California, 92801
UCI Health-Costa Mesa
Costa Mesa, California, 92627
UCI Health-Irvine
Irvine, California, 92612
UCI Health-Laguna hilla
Laguna Hills, California, 92653
UCI Health-Newport
Newport Beach, California, 92660
UCI Health SeniorHealth Center -Pavillion 4
Orange, California, 92868
UCI Medical Center, Pavilion 3
Orange, California, 92868
UCI Health Family Health Center - Santa Ana
Santa Ana, California, 92701
UCI-Health Tustin
Tustin, California, 92780
UCI Health-Yorba Linda
Yorba Linda, California, 92886
About this study
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.
- Conditions
- Lung Cancer
- Being tested
- Usual Care, Brief Patient Education, Patient education, Referral to financial navigation resources, Patient Reminders
- Keywords
- Lung Cancer, Screening, Multi-level intervention
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual CareOther
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 EducationBehavioural
Brief one-page education material on lung cancer screening benefits and risk
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 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 RemindersBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm A: Enhanced Usual Care | Experimental | Usual Care + Brief Educational Material Receives: Other: Usual Care; Behavioral: Brief Patient Education |
| Arm B: Empower Latinx | Experimental | * PCP notifications of patients' LCS eligibility (addressing provider time constraints and barrier in identifying eligible patients);
* Patients' education (addressing knowledge barriers);
* Patients' referral to financial navigation resources (addressing health-related social risks)
* Patients' reminder to discuss LCS during PCP visit. Receives: Other: Usual Care; Behavioral: Patient education; Behavioral: Referral to financial navigation resources; Behavioral: Patient Reminders; Behavioral: Provider Reminders |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with order of Low-dose CT (LDCT) for lung cancer screening (LCS)
Measured: Within 4 months of randomization
Secondary outcomes (8)
Number of Participants who received LDCT for LCS
Measured: Within 4 months of randomization
Number of Participants with the documented discussion of lung cancer screening with their providers in the electronic medical record
Measured: Within 4 months of randomization
Patients' perceived risk of lung cancer
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.
Measured: Baseline and 4 months after randomization
Patients' perceived severity of lung cancer
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.
Measured: Baseline and 4 months after randomization
Patients' perceived benefits of lung cancer screening
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.
Measured: Baseline and 4 months after randomization
Patients' perceived barriers of lung cancer screening
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.
Measured: Baseline and 4 months after randomization
Patients' self-efficacy of lung cancer screening
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.
Measured: Baseline and 4 months after randomization
Patients' knowledge about lung cancer screening
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.
Measured: Baseline and 4 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start12 Feb 2024
- Primary completion11 Dec 2025
- Study completion11 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Radiological Society of North America
- Responsible party
- Principal investigator, Gelareh Sadigh, University of California, Irvine
- Investigators
- Gelareh Sadigh, MD, Principal investigator, University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06225414
- Sponsor's protocol ID
- 4471
- Other IDs
- UCI 23-219
- Status last verified
- Mar 2026
- First submitted
- 15 Jan 2024
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Empowering Hispanic Patients' Lung Cancer Screening Uptake (Empower Latinx)
- ClinicalTrials.gov ID
- NCT06225414
- Acronym / sponsor ID
- 4471
- Conditions
- Lung Cancer
- Keywords
- Lung Cancer, Screening, Multi-level intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Radiological Society of North America
- Study start
- 12 Feb 2024 (actual)
- Primary completion
- 11 Dec 2025 (actual)
- Study completion
- 11 Feb 2026 (actual)
- First posted
- 26 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A: Enhanced Usual Care | Experimental | Other: Usual Care, Behavioral: Brief Patient EducationUsual Care + Brief Educational Material |
| Arm B: Empower Latinx | Experimental | Other: Usual Care, Behavioral: Patient education, Behavioral: Referral to financial navigation resources, Behavioral: Patient Reminders, Behavioral: Provider Reminders* PCP notifications of patients' LCS eligibility (addressing provider time constraints and barrier in identifying eligible patients); * Patients' education (addressing knowledge barriers); * Patients' referral to financial navigation resources (addressing health-related social risks) * Patients' reminder to discuss LCS during PCP visit. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual CareThe usual care includes a provider flag in electronic medical record (EMR) on patients' eligibility for LCS if their smoking history is complete. | Other | Arm A: Enhanced Usual Care, Arm B: Empower Latinx |
| Brief Patient EducationBrief one-page education material on lung cancer screening benefits and risk | Behavioural | Arm A: Enhanced Usual Care |
| Patient educationPatients 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. | Behavioural | Arm B: Empower Latinx |
| Referral to financial navigation resourcesPatients 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. | Behavioural | Arm B: Empower Latinx |
| Patient Reminderswithin 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. | Behavioural | Arm B: Empower Latinx |
| Provider RemindersWithin 2 weeks prior to primary care appointment, providers will be notified of their patient's eligibility for lung cancer screening and their reported barriers. | Behavioural | Arm B: Empower Latinx |
Primary outcome
Number of participants with order of Low-dose CT (LDCT) for lung cancer screening (LCS)
Time frame: Within 4 months of randomization
8 secondary outcomes
Number of Participants who received LDCT for LCS
Time frame: Within 4 months of randomization
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
Patients' perceived risk of lung cancer
Time frame: Baseline and 4 months after randomization
Patients' perceived severity of lung cancer
Time frame: Baseline and 4 months after randomization
Patients' perceived benefits of lung cancer screening
Time frame: Baseline and 4 months after randomization
Patients' perceived barriers of lung cancer screening
Time frame: Baseline and 4 months after randomization
Patients' self-efficacy of lung cancer screening
Time frame: Baseline and 4 months after randomization
Patients' knowledge about lung cancer screening
Time frame: Baseline and 4 months after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gelareh Sadigh, MD principal investigator
University of California, Irvine
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brief Patient Education, Patient education and Referral to financial navigation resources in people with Lung Cancer, run by University of California, Irvine at 10 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?
The sponsor lists 6 inclusion and 3 exclusion criteria. 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 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of participants with order of Low-dose CT (LDCT) for lung cancer screening (LCS) (time frame: Within 4 months of randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Mar 2026.