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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06225414
• Other study ID #: 4471.
• Secondary ID: UCI 23-219
• Status: Recruiting
• Phase: N/A
• Start date: February 12, 2024
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: University of California, Irvine
• Contact: Gelareh Sadigh, MD
• Phone: 949-745-5066
• Email: GSADIGH[@]UCI.EDU
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Other:
• Usual Care
The usual care includes a provider flag in electronic medical record (EMR) on patients' eligibility for LCS if their smoking history is complete.

Behavioral:
• Brief Patient Education
Brief one-page education material on lung cancer screening benefits and risk
• Patient education
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
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
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
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.

Locations

Country	Name	City	State
United States	UCI Health Family Health Center - Anaheim	Anaheim	California
United States	UCI Health SeniorHealth Center -Pavillion 4	Orange	California
United States	UCI Medical Center, Pavilion 3	Orange	California
United States	UCI Health Family Health Center - Santa Ana	Santa Ana	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Irvine	Radiological Society of North America

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patients' experience with intervention	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
Other	Providers experience with intervention	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
Primary	Number of participants with order of Low-dose CT (LDCT) for lung cancer screening (LCS)		Within 4 months of randomization
Secondary	Number of Participants who received LDCT for LCS		Within 4 months of randomization
Secondary	Number of Participants with the documented discussion of lung cancer screening with their providers in the electronic medical record		Within 4 months of randomization
Secondary	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.	Baseline and 4 months after randomization
Secondary	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.	Baseline and 4 months after randomization
Secondary	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.	Baseline and 4 months after randomization
Secondary	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.	Baseline and 4 months after randomization
Secondary	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.	Baseline and 4 months after randomization
Secondary	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.	Baseline and 4 months after randomization