- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Gelareh Sadigh, MD
- Phone Number: 949-745-5066
- Email: GSADIGH@UCI.EDU
Study Contact Backup
- Name: Richard Echeverria
- Phone Number: 949-745-5066
- Email: rjecheve@uci.edu
Study Locations
-
-
California
-
Anaheim, California, United States, 92801
- Recruiting
- UCI Health Family Health Center - Anaheim
-
Contact:
- Mahnur Bharucha
- Email: empowerlcs@hs.uci.edu
-
Orange, California, United States, 92868
- Recruiting
- UCI Health SeniorHealth Center -Pavillion 4
-
Contact:
- Mahnur Bharucha
- Email: empowerlcs@hs.uci.edu
-
Orange, California, United States, 92868
- Recruiting
- UCI Medical Center, Pavilion 3
-
Contact:
- Mahnur Bharucha
- Email: empowerlcs@hs.uci.edu
-
Santa Ana, California, United States, 92701
- Recruiting
- UCI Health Family Health Center - Santa Ana
-
Contact:
- Mahnur Bharucha
- Email: empowerlcs@hs.uci.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Aged 50- 80 years of age.
- Be able to speak English and Spanish
- 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 4 University of California Irvine Health (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)
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Arm A: Enhanced Usual Care
Usual Care + Brief Educational Material
|
The usual care includes a provider flag in electronic medical record (EMR) on patients' eligibility for LCS if their smoking history is complete.
Brief one-page education material on lung cancer screening benefits and risk
|
Experimental: Arm B: Empower Latinx
|
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.
The usual care includes a provider flag in electronic medical record (EMR) on patients' eligibility for LCS if their smoking history is complete.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of participants with order of Low-dose CT (LDCT) for lung cancer screening (LCS)
Time Frame: Within 4 months of randomization
|
Within 4 months of randomization
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants who received LDCT for LCS
Time Frame: Within 4 months of randomization
|
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
|
Within 4 months of randomization
|
|
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.
|
Baseline and 4 months after randomization
|
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.
|
Baseline and 4 months after randomization
|
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.
|
Baseline and 4 months after randomization
|
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.
|
Baseline and 4 months after randomization
|
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.
|
Baseline and 4 months after randomization
|
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.
|
Baseline and 4 months after randomization
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patients' experience with intervention
Time Frame: Within 6 months after completion of the follow-ups
|
Patient experience with intervention components will be assessed through qualitative interview of a subset of patients in Arm B (Empower Latinx).
The results will be qualitatively described.
|
Within 6 months after completion of the follow-ups
|
Providers experience with intervention
Time Frame: Within 3 months after last patient completion of follow-up
|
Provider experience with intervention components will be assessed through qualitative interview of a subset of providers taking care of patients in Arm B (Empower Latinx).
The results will be qualitatively described.
|
Within 3 months after last patient completion of follow-up
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Gelareh Sadigh, MD, University of California, Irvine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 4471.
- UCI 23-219 (Other Identifier: CFCCC)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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