Empowering Patients' Lung Cancer Screening Uptake

Lung Cancer Clinical Trial

— Empower-LCS  

Official title:

Empowering Patients' Lung Cancer Screening Uptake (Empower LCS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06000683
• Other study ID #: UCI 23-107
• Secondary ID: 3439
• Status: Recruiting
• Phase: N/A
• Start date: October 13, 2023
• Est. completion date: December 2024

Study information

• Verified date: January 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

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.

Recruitment information / eligibility

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

Eligibility

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)

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	UCI Health - Costa Mesa	Costa Mesa	California
United States	UCI Health Gottschalk Medical Plaza	Irvine	California
United States	UCI Health - Laguna Hills	Laguna Hills	California
United States	UCI Health - Newport Beach MacArthur	Newport Beach	California
United States	UCI Medical Center	Orange	California
United States	UCI Health - Tustin	Tustin	California
United States	UCI Health-Yorba Linda	Yorba Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Irvine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient and provider experience with intervention	Patient and Providers will be asked questions about their experience with intervention components interview	At the end of all study enrollments a subgroup of patients and providers will be interviewed
Primary	Order of LDCT	Primary end point is order of LDCT within 6 months after enrollment assessed with self-reported surveys and EMR data extraction.	within 6 months of enrollment
Secondary	Perceived Risk of lung cancer	self reported in survey	at baseline and 6 month post enrollment
Secondary	Perceived Severity of lung cancer	self reported in survey	at baseline and 6 month post enrollment
Secondary	Perceived Benefit of lung cancer screening	self reported in survey	at baseline and 6 month post enrollment
Secondary	Perceived barriers lung cancer screening	self reported in survey	at baseline and 6 month post enrollment
Secondary	Self-efficacy for lung cancer screening	self reported in survey	at baseline and 6 month post enrollment
Secondary	Knowledge about lung cancer and screening	self reported in survey	at baseline and 6 month post enrollment
Secondary	LCS discussion	Patient and Primary Care Provider discussing lung cancer screening	within 6 months after enrollment
Secondary	Receipt of LDCT	A receipt of LDCT for LCS will be checked either through self reported or EMR	Within 6 months of enrollment
Secondary	Providers' Perceived barriers	Provider will be asked about perceived barriers and knowledge of Lung cancer screening though a survey	within 3 month after last patient enrolled