Clinical trial NCT06000683: Empowering Patients' Lung Cancer Screening Uptake
Official title: Empowering Patients' Lung Cancer Screening Uptake (Empower LCS)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Lung Cancer
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 70
Sex: ALL
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Order of LDCT
timeFrame: within 6 months of enrollment
Secondary outcomes:
measure: Perceived Risk of lung cancer
timeFrame: at baseline and 6 month post enrollment
measure: Perceived Severity of lung cancer
timeFrame: at baseline and 6 month post enrollment
measure: Perceived Benefit of lung cancer screening
timeFrame: at baseline and 6 month post enrollment
measure: Perceived barriers lung cancer screening
timeFrame: at baseline and 6 month post enrollment
measure: Self-efficacy for lung cancer screening
timeFrame: at baseline and 6 month post enrollment
measure: Knowledge about lung cancer and screening
timeFrame: at baseline and 6 month post enrollment
measure: LCS discussion
timeFrame: within 6 months after enrollment
measure: Receipt of LDCT
timeFrame: Within 6 months of enrollment
measure: Providers' Perceived barriers
timeFrame: within 3 month after last patient enrolled
Other outcomes:
measure: Patient and provider experience with intervention
timeFrame: At the end of all study enrollments a subgroup of patients and providers will be interviewed
Locations:
city: Costa Mesa
country: United States
facility: UCI Health - Costa Mesa
state: California
city: Irvine
country: United States
facility: UCI Health Gottschalk Medical Plaza
state: California
city: Laguna Hills
country: United States
facility: UCI Health - Laguna Hills
state: California
city: Newport Beach
country: United States
facility: UCI Health - Newport Beach MacArthur
state: California
city: Orange
country: United States
facility: UCI Medical Center
state: California
city: Tustin
country: United States
facility: UCI Health - Tustin
state: California
city: Yorba Linda
country: United States
facility: UCI Health-Yorba Linda
state: California
Study officials:
affiliation: University of California, Irvine
name: Gelareh Sadigh, MD
role: PRINCIPAL_INVESTIGATOR
References: