CHAMP Lung Cancer Screening Program (CHAMP)
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.
Tutkimuksen yleiskatsaus
Tila
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Laura Seegmiller
- Puhelinnumero: (319) 384-1494
- Sähköposti: champ-study@uiowa.edu
Opiskelupaikat
-
-
Iowa
-
Iowa City, Iowa, Yhdysvallat, 52242
- Rekrytointi
- University of Iowa
-
Ottaa yhteyttä:
- Laura Seegmiller
- Puhelinnumero: (319) 384-1494
- Sähköposti: champ-study@uiowa.edu
-
Päätutkija:
- Jill Kolesar, PharmD, MS, FCCP
-
Waterloo, Iowa, Yhdysvallat, 50701
- Rekrytointi
- Cedar Valley Primary Care & Walk-In Clinic
-
Ottaa yhteyttä:
- Sarah Larson, BSN, RN
- Puhelinnumero: 319-888-8270
- Sähköposti: slarson@cvmspc.com
-
Alatutkija:
- James Hoehns, PharmD, BCPS, FCCP
-
Waterloo, Iowa, Yhdysvallat, 50702
- Rekrytointi
- Greenwood Pharmacy and Compounding Center
-
Ottaa yhteyttä:
- Robert Nichols, PharmD, BCPS
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Seulonta
- Jako: Ei satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Ei mitään (avoin tarra)
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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. |
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.
|
|
Active Comparator: 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.
|
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.
|
|
Ei väliintuloa: 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.
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Proportion of pharmacy patrons receiving lung cancer screening
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Proportion of eligible participants that receive a DELFI Diagnostics FirstLook lung cancer screening blood test
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Rate of positive DELFI Diagnostics FirstLook lung cancer screening tests
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Jill Kolesar, PharmD, MS, FCCP, University of Iowa
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- 202512332
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .