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CHAMP Lung Cancer Screening Program (CHAMP)

12 czerwca 2026 zaktualizowane przez: Jill Kolesar

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

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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

300

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

  • Stany Zjednoczone
    • Iowa
      • Iowa City, Iowa, Stany Zjednoczone, 52242
        • Rekrutacyjny
        • University of Iowa
        • Kontakt:
        • Główny śledczy:
          • Jill Kolesar, PharmD, MS, FCCP
      • Waterloo, Iowa, Stany Zjednoczone, 50701
        • Rekrutacyjny
        • Cedar Valley Primary Care & Walk-In Clinic
        • Kontakt:
        • Pod-śledczy:
          • James Hoehns, PharmD, BCPS, FCCP
      • Waterloo, Iowa, Stany Zjednoczone, 50702
        • Rekrutacyjny
        • Greenwood Pharmacy and Compounding Center
        • Kontakt:
          • Robert Nichols, PharmD, BCPS

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Ekranizacja
  • Przydział: Nielosowe
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: DELFI FirstLook Lung Cancer Screening Blood Test

Participants may choose to receive the DELFI Diagnostics FirstLook Lung test, a blood-based screening test designed to support early detection of lung cancer. The test analyzes patterns in cell-free DNA fragments using whole-genome sequencing and machine-learning techniques. Designed to augment traditional low-dose CT screening, it offers a minimally invasive and accessible option for early lung cancer detection.

If a participant elects to receive this test, a blood sample will be collected at a study clinic and sent to a DELFI Diagnostics lab without any personal identifying health information attached. After processing, results are returned to the study team. Participants will be notified if results are not elevated, in which case repeating the test in one year is recommended. If results are elevated, study staff will recommend follow-up screening with a low-dose CT scan from local clinic for further evaluation.

Both the blood test and CT will be provided by the study at no cost.
Test diagnostyczny: 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.
Aktywny komparator: Low-Dose CT
Participants can choose to follow current US Preventive Services Task Force recommendations of a low-dose CT scan ordered through their primary care physician.
Test diagnostyczny: 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.
Brak interwencji: No lung cancer screening
Participants chose to not participate in lung cancer screening. Annually, participants will be informed about lung cancer screening options and given the opportunity to participate in one of the screening options. Participants will have the ability to change their mind and choose one of the lung cancer screening options in between their annual screening discussion.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Proportion of pharmacy patrons receiving lung cancer screening
Ramy czasowe: 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.
From enrollment through six months after enrollment

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Proportion of eligible participants that receive a DELFI Diagnostics FirstLook lung cancer screening blood test
Ramy czasowe: 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.
From enrollment through six months after enrollment
Determine the proportion of eligible participants that receive a low-dose CT scan
Ramy czasowe: 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.
From enrollment through six months after enrollment
Correlations between demographic data and declining of initial screening
Ramy czasowe: 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.
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
Ramy czasowe: 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.
From 12 through 18 months after initial enrollment

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Rate of positive DELFI Diagnostics FirstLook lung cancer screening tests
Ramy czasowe: From enrollment through 12 months after enrollment
Determine the rate of positive DELFI tests.
From enrollment through 12 months after enrollment
Diagnostic CT completion rate among participants with a positive DELFI Diagnostics FirstLook lung cancer screening test
Ramy czasowe: From time of positive DELFI test through 12 months after test results
Determine what percentage of participants with a positive DELFI Diagnostics FirstLook lung cancer screening test complete the recommended low-dose CT scan.
From time of positive DELFI test through 12 months after test results
Percentage of participants diagnosed with lung cancer
Ramy czasowe: From time of CT scan until completion of study, up to three years
Determine percentage of participants diagnosed with lung cancer among those ultimately completing diagnostic CT scans.
From time of CT scan until completion of study, up to three years
Positive DELFI Diagnostics Firstlook lung cancer screening test correlation to clinical demographics and lung cancer detection
Ramy czasowe: After completing data collection upon study completion, three years
Rates of positive DELFI tests, CT completion, and diagnosed lung cancers will be estimated with binomial proportion and exact Clopper-Pearson 95% confidence intervals. Associations between DELFI test positivity and demographic factors will be assessed univariably with non-parametric Wilcoxon rank-sum tests for quantitative factors and Fisher's exact tests for qualitative factors.
After completing data collection upon study completion, three years
Participant decisional conflict as measured by the Traditional Decisional Conflict Scale (DCS)
Ramy czasowe: From enrollment through 30 days after enrollment
The DCS consists of 16 items with 5 response categories ranging from strongly agree to strongly disagree
From enrollment through 30 days after enrollment

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Jill Kolesar

Współpracownicy

Eli Lilly and Company

Śledczy

  • Główny śledczy: Jill Kolesar, PharmD, MS, FCCP, University of Iowa

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

12 czerwca 2026

Zakończenie podstawowe (Szacowany)

1 czerwca 2028

Ukończenie studiów (Szacowany)

1 czerwca 2028

Daty rejestracji na studia

Pierwszy przesłany

23 kwietnia 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

30 kwietnia 2026

Pierwszy wysłany (Rzeczywisty)

7 maja 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

16 czerwca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

12 czerwca 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 202512332

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Tak

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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