Early Lung Cancer Detection, Lung Cancer
Conditions
Keywords
lung cancer, early lung cancer detection, lung cancer screening, community pharmacy intervention, pharmacy cancer screening
Brief summary
The U.S. Preventive Services Task Force recommends annual lung cancer screening (LCS) with low-dose CT for adults aged 50-80 with a ≥20 pack-year smoking history who currently smoke or quit within the past 15 years. Despite insurance coverage, only 17% of eligible Iowans were screened in 2024. Barriers include the complexity of screening and competing demands in primary care. To address these challenges, investigators propose a two-part intervention: a blood-based screening test to simplify LCS and a community pharmacist-led referral program integrated into routine pharmacy care. Eligible patients will be identified at Greenwood Pharmacy in Waterloo, Iowa. Interested individuals will be consented by a pharmacist and engaged in shared decision-making about LCS. Participants may decline screening, complete the DELFI Diagnostics FirstLook lung cancer screening blood test, or pursue CT screening through their primary care physician. Those choosing the blood test will be referred to Cedar Valley Family Medicine. Patients with a positive result will complete a standard shared decision-making visit with their PCP and, if appropriate, undergo confirmatory CT imaging. Patients with a negative result will enter a screening cohort and be re-screened annually for an additional year.
Detailed description
The US Preventive Services Task Force recommends annual lung cancer screening (LCS) with low dose Computerized Tomography (CT) scans for adults aged 50-80 with a 20-pack year smoking history who are current smokers or who have quit within the last 15 years. Despite these recommendations and Medicaid/Medicare coverage, only about 17% of eligible patients were screened in Iowa in 2024. Barriers to implementing LCS are multifactorial and include patient and clinician barriers, specifically complexity of screening and primary care physician competing demands. To overcome these barriers, investigators propose a two-part intervention: first, a blood test, that reduces the complexity of lung cancer screening and second, a community pharmacist referral program that can be performed as part of routine care received in the pharmacy. LCS eligible participants will be identified in Greenwood Pharmacy in Waterloo, Iowa and invited to participate in a lung cancer screening study. If they are interested, the pharmacist will review the consent form with them, explaining the study and answering any questions they have. After the consent is signed, the participant will engage in a shared decision-making conversation about LCS with the pharmacist. As part of this conversation, patients will be told they are eligible for LCS and given three options: Decline to participate; agree to participate and get DELFI blood test; or agree to participate but decline blood test and pursue a CT scan with their PCP. Patients agreeable to the blood test will be referred to Cedar Valley Family Medicine, where they can receive the DELFI FirstLook Lung Cancer Screening Test. Those with a positive (elevated) blood test will have a standard of care clinic appointment with the primary care physician at Cedar Valley Family Medicine for a shared decision-making visit about LCS and if warranted, order confirmatory CT scanning which is standard of care and billed to the study. Patients with a negative blood test will be added to the "Screening Cohort" and approached annually for a total of 2 years to participate in screening.
Interventions
DIAGNOSTIC_TESTDELFI Diagnostics FirstLook Lung Cancer Screening Blood Test
A participant can choose to receive this test. This is done by receiving a blood draw. The blood sample is sent to the DELFI Diagnositics lab without any personal health information attached. Results will be relayed to the participant as either "elevated" or "not elevated". IF the result is "elevated" the participant will be recommended to receive a low-dose CT scan.
DIAGNOSTIC_TESTLow-Does CT Scan
If a participant chooses this arm, the participant will request their primary care physician to order them a low-dose CT scan as part of the USPSTF standards for lung cancer screening. Participants will be asked to fax the results of those scans to the study.
Sponsors
Jill Kolesar
Eli Lilly and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 77 Years
Healthy volunteers
No
Inclusion criteria
* aged 50-77 * smoking pack-year history of ≥ 20 years * current smoker or quit smoking 15 or less years ago * ability to understand and willingness to sign a written informed consent document
Exclusion criteria
* self-report of lung cancer screening in the last 12 months * psychiatric illness/social situations that would limit compliance with study requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of pharmacy patrons receiving lung cancer screening | From enrollment through six months after enrollment | To determine the proportion of pharmacy patrons eligible for lung cancer screening who accept a pharmacist's recommendation for screening and subsequently undergo lung cancer screening. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of eligible participants that receive a DELFI Diagnostics FirstLook lung cancer screening blood test | From enrollment through six months after enrollment | What proportion of enrolled participants choose to receive a DELFI Diagnostics FirstLook lung cancer screening blood test as their lung cancer screening option. |
| Determine the proportion of eligible participants that receive a low-dose CT scan | From enrollment through six months after enrollment | What proportion of eligible participants offered lung cancer screening by a pharmacist accept the recommendation and undergo lung cancer screening by low-dose CT scan. |
| Correlations between demographic data and declining of initial screening | From time of enrollment through 30 days after enrollment | Correlations between demographic factors and declining of initial screening will be assessed univariably using two-sample t-tests for quantitative factors and Pearson's chi-squared tests for qualitative factors. The sample size is expected to be large enough to justify the distributional assumptions of these tests, but if that is not the case, then non-parametric Wilcoxon rank-sum and Fisher's exact tests will be used instead. Multivariable effects of demographic factors will be modeled with logistic regression. Frequency of year 2 and 3 completion of screening will be estimated with binomial proportions. |
| Frequency of individuals who complete screening in year 1 that return for screening in year 2 | From 12 through 18 months after initial enrollment | Determine the frequency of individuals who complete screening in year 1 that return for screening in year 2. |
Countries
United States
Contacts
CONTACTLaura Seegmiller
PRINCIPAL_INVESTIGATORJill Kolesar, PharmD, MS, FCCP
University of Iowa
Outcome results
None listed