CHAMP Lung Cancer Screening Program

Официальное название

CHAMP: Community Health Assessment and Monitoring in the Pharmacy. Assessing the Impact of a Community Pharmacist Lung Cancer Screening (LCS) Program

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест DELFI 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.
• Диагностический тест Low-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.

Первичные конечные точки

• Proportion of pharmacy patrons receiving lung cancer screening [Срок оценки: From enrollment through six months after enrollment]

Вторичные конечные точки (4)

• Proportion of eligible participants that receive a DELFI Diagnostics FirstLook lung cancer screening blood test [Срок оценки: From enrollment through six months after enrollment]
• Determine the proportion of eligible participants that receive a low-dose CT scan [Срок оценки: From enrollment through six months after enrollment]
• Correlations between demographic data and declining of initial screening [Срок оценки: From time of enrollment through 30 days after enrollment]
• Frequency of individuals who complete screening in year 1 that return for screening in year 2 [Срок оценки: From 12 through 18 months after initial enrollment]

Критерии участия

Критерии включения

• 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

Критерии исключения

• self-report of lung cancer screening in the last 12 months
• psychiatric illness/social situations that would limit compliance with study requirements

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

США · 3 центра

• University of Iowa — Iowa City
• Cedar Valley Primary Care & Walk-In Clinic — Waterloo
• Greenwood Pharmacy and Compounding Center — Waterloo

Публикации

• Arredondo K, Touchett HN, Khan S, Vincenti M, Watts BV. Current Programs and Incentives to Overcome Rural Physician Shortages in the United States: A Narrative Review. J Gen Intern Med. 2023 Jul;38(Suppl 3):916-922. doi: 10.1007/s11606-023-08122-6. Epub 2023 Jun 20. PMID 37340266
• Ali N, Lifford KJ, Carter B, McRonald F, Yadegarfar G, Baldwin DR, Weller D, Hansell DM, Duffy SW, Field JK, Brain K. Barriers to uptake among high-risk individuals declining participation in lung cancer screening: a mixed methods analysis of the UK Lung Cancer Screening (UKLS) trial. BMJ Open. 2015 Jul 14;5(7):e008254. doi: 10.1136/bmjopen-2015-008254. PMID 26173719
• Kurzrock R, Chaudhuri AA, Feller-Kopman D, Florez N, Gorden J, Wistuba II. Healthcare disparities, screening, and molecular testing in the changing landscape of non-small cell lung cancer in the United States: a review. Cancer Metastasis Rev. 2024 Dec;43(4):1217-1231. doi: 10.1007/s10555-024-10187-6. Epub 2024 May 16. PMID 38750337
• Silvestri GA, Goldman L, Burleson J, Gould M, Kazerooni EA, Mazzone PJ, Rivera MP, Doria-Rose VP, Rosenthal LS, Simanowith M, Smith RA, Tanner NT, Fedewa S. Characteristics of Persons Screened for Lung Cancer in the United States : A Cohort Study. Ann Intern Med. 2022 Nov;175(11):1501-1505. doi: 10.7326/M22-1325. Epub 2022 Oct 11. PMID 36215712
• Lin Y, Tabatabaei SMH, Ding R, Sanders TA, Aberle DR, Hsu W, Prosper AE. Analyzing Patient Characteristics and Lung Cancer Outcomes Pre and Post the 2021 USPSTF Lung Cancer Screening Guidelines: Experience From a Large Academic Institution. J Thorac Imaging. 2025 Nov 1;40(6):e0838. doi: 10.1097/RTI.0000000000000838. PMID 40685891
• US Preventive Services Task Force; Krist AH, Davidson KW, Mangione CM, Barry MJ, Cabana M, Caughey AB, Davis EM, Donahue KE, Doubeni CA, Kubik M, Landefeld CS, Li L, Ogedegbe G, Owens DK, Pbert L, Silverstein M, Stevermer J, Tseng CW, Wong JB. Screening for Lung Cancer: US Preventive Services Task Force Recommendation Statement. JAMA. 2021 Mar 9;325(10):962-970. doi: 10.1001/jama.2021.1117. PMID 33687470

Идентификаторы

NCT: NCT07572773 · 202512332

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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