Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

Empowering Patients' Lung Cancer Screening Uptake (Empower LCS/Call+) (Empower LCS+)

20 juli 2026 bijgewerkt door: Gelareh Sadigh, University of California, Irvine

Empowering Patients' Lung Cancer Screening Uptake (Empower LCS/Call+): A Multi-Site Pilot Randomized Controlled Trial

Lung cancer screening (LCS) with low-dose computed tomography (LDCT) can reduce the risk of dying from lung cancer, but many people who are eligible for screening do not receive it. The purpose of the Empower LCS/Call+ study is to evaluate new strategies to improve lung cancer screening among adults who are eligible for screening based on current U.S. Preventive Services Task Force (USPSTF) guidelines.

This pilot randomized controlled trial will enroll approximately 80 participants from UC Irvine Health and Emory Healthcare. Participants will be randomly assigned to receive either enhanced usual care or the Empower LCS/Call+ intervention. The intervention includes educational materials, reminders for patients and primary care providers, and information about financial and community resources when appropriate. Participants who do not complete lung cancer screening after the initial intervention may receive additional telephone-based navigation through the Call+ program to help identify and address barriers to screening and help with scheduling.

Participants will complete a baseline survey and follow-up surveys at 4 and 8 months, and researchers will review electronic health record information to determine whether lung cancer screening was discussed, ordered, and completed. Some participants will also be invited to complete a one-time interview about their experiences with the study.

The results of this study will help determine the feasibility, acceptability, and preliminary effectiveness of the Empower LCS/Call+ intervention and will inform future efforts to improve equitable access to lung cancer screening.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Lung cancer is the leading cause of cancer-related death in the United States. Although annual lung cancer screening with LDCT is recommended for adults at high risk and has been shown to reduce lung cancer mortality, screening uptake remains low. Barriers to screening exist at the patient, provider, and health system levels, including limited awareness of screening eligibility, incomplete documentation of smoking history in the electronic health record, logistical challenges, financial concerns, and psychosocial barriers such as fear, stigma, and mistrust.

The Empower LCS is a multilevel intervention designed to improve lung cancer screening uptake by combining patient education, provider notification, patient reminders, and information on financial and community resources. The intervention demonstrated improvements in lung cancer screening discussions and low-dose computed tomography ordering and completion compared with enhanced usual care in prior pilot study.

The current study evaluates an enhanced version of the intervention, Empower LCS/Call+. Participants who have not completed lung cancer screening after the initial intervention will be eligible to receive the Call+ telephone navigation intervention. Call+ is delivered by lay navigators and is designed to identify participant-specific barriers to screening, provide education and motivational support, facilitate primary care or imaging scheduling when appropriate, connect participants with available financial or community resources, and encourage completion of recommended lung cancer screening.

This prospective, multi-site, pilot randomized controlled trial will enroll participants from UC Irvine Health and Emory Healthcare. Potentially eligible participants will be identified using a combination of structured data and natural language processing of free text notes to extract smoking history from electronic medical records. Eligibility will be confirmed via self-report.

Participants will be randomly assigned to receive either the Empower LCS/Call+ intervention or enhanced usual care. Data will be collected through participant surveys, electronic health record review, intervention process measures, and qualitative interviews with a subset of participants to evaluate implementation experiences.

The primary purpose of this pilot study is to evaluate the feasibility, acceptability, and preliminary effectiveness of the enhanced intervention while providing implementation data to inform future randomized trials.

Studietype

Ingrijpend

Inschrijving (Geschat)

80

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigde Staten
    • California
      • Anaheim, California, Verenigde Staten, 92801
        • UCI Health Family Health Center - Anaheim
        • Contact:
      • Costa Mesa, California, Verenigde Staten, 92627
        • UCI Health - Costa Mesa
        • Contact:
      • Irvine, California, Verenigde Staten, 92697
        • UCI Health Gottschalk Medical Plaza
        • Contact:
      • Irvine, California, Verenigde Staten, 92612
        • CHAO Family Comprehensive Cancer Center- Irvine
        • Contact:
      • Laguna Hills, California, Verenigde Staten, 92653
        • UCI Health - Laguna Hills
        • Contact:
      • Newport Beach, California, Verenigde Staten, 92660
        • UCI Health - Newport Beach MacArthur
        • Contact:
      • Orange, California, Verenigde Staten, 92868
        • UCI Chao Family Comprehensive Cancer Center
        • Contact:
      • Orange, California, Verenigde Staten, 92868
        • UCI Health SeniorHealth Center -Pavillion 4
      • Orange, California, Verenigde Staten, 92868
        • UCI Medical Center, Pavilion 3
        • Contact:
      • Orange, California, Verenigde Staten, 92868
        • Primary Care & Internal Medicine Services
        • Contact:
      • Santa Ana, California, Verenigde Staten, 92701
        • UCI Health Family Health Center - Santa Ana
        • Contact:
      • Tustin, California, Verenigde Staten, 92670
        • UCI Health - Tustin
        • Contact:
      • Yorba Linda, California, Verenigde Staten, 92886
        • UCI Health - Yorba Linda
        • Contact:
    • Georgia
      • Alpharetta, Georgia, Verenigde Staten, 30009
        • Emory at Avalon - Primary Care
        • Contact:
      • Atlanta, Georgia, Verenigde Staten, 30047
        • Emory Clinic at Old Fourth Ward
        • Contact:
      • Atlanta, Georgia, Verenigde Staten, 30308
        • Emory Clinic at Midtown
        • Contact:
      • Atlanta, Georgia, Verenigde Staten, 30309
        • Emory at Peachtree Hills - Primary Care
        • Contact:
      • Atlanta, Georgia, Verenigde Staten, 30322
        • Emory Clinic at 1365 Clifton Road - Primary Care
        • Contact:
      • Atlanta, Georgia, Verenigde Staten, 30322
        • Emory Clinic at 1525 Clifton Road - Primary Care
        • Contact:
      • Atlanta, Georgia, Verenigde Staten, 30329
        • Emory at Toco Hills - Primary Care
        • Contact:
      • Atlanta, Georgia, Verenigde Staten, 30342
        • Emory Gastroenterology
        • Contact:
      • Atlanta, Georgia, Verenigde Staten, 30345
        • Emory at Northlake - Primary Care
        • Contact:
      • Buford, Georgia, Verenigde Staten, 30519
        • Emory at Buford - Primary Care
        • Contact:
      • Decatur, Georgia, Verenigde Staten, 30030
        • Emory at Decatur - Primary Care (Irvin Court)
        • Contact:
      • Decatur, Georgia, Verenigde Staten, 30030
        • Emory at Decatur - Primary Care (Scott Boulevard)
        • Contact:
      • Decatur, Georgia, Verenigde Staten, 30030
        • Emory Clinic Downtown Decatur
        • Contact:
      • Decatur, Georgia, Verenigde Staten, 30033
        • Emory at Decatur - Primary Care
        • Contact:
      • Decatur, Georgia, Verenigde Staten, 30033
        • Emory at Oak Grove - Primary Care
        • Contact:
      • Decatur, Georgia, Verenigde Staten, 30033
        • Emory Clinic at Decatur - Primary Care
        • Contact:
      • Decatur, Georgia, Verenigde Staten, 30034
        • Emory at Flat Shoals - Primary Care
        • Contact:
      • Duluth, Georgia, Verenigde Staten, 30096
        • Emory at Duluth
        • Contact:
      • Duluth, Georgia, Verenigde Staten, 30097
        • Emory at Sugarloaf - Primary Care
        • Contact:
      • Dunwoody, Georgia, Verenigde Staten, 30338
        • Emory at Dunwoody
        • Contact:
      • Dunwoody, Georgia, Verenigde Staten, 30342
        • Emory Clinic at Saint Joseph's
        • Contact:
      • Johns Creek, Georgia, Verenigde Staten, 30097
        • Emory at Findley Road
        • Contact:
      • Jonesboro, Georgia, Verenigde Staten, 30236
        • Emory at Spivey Station - Primary Care
        • Contact:
      • La Grange, Georgia, Verenigde Staten, 30240
        • Emory at LaGrange - Smith Street - Primary Care
        • Contact:
      • La Grange, Georgia, Verenigde Staten, 30241
        • Emory at LaGrange - Davis Road
        • Contact:
      • Lilburn, Georgia, Verenigde Staten, 30047
        • Emory at Beaver Ruin - Primary Care
        • Contact:
      • Lilburn, Georgia, Verenigde Staten, 30047
        • Emory at Mountain Park - Primary Care
        • Contact:
      • Lithonia, Georgia, Verenigde Staten, 30058
        • Emory at Hillandale Family Medicine
        • Contact:
      • Lithonia, Georgia, Verenigde Staten, 30058
        • Emory at Miller Grove - Primary Care
        • Contact:
      • Lithonia, Georgia, Verenigde Staten, 30058
        • Emory Clinic at Lithonia - Primary Care
        • Contact:
      • Marietta, Georgia, Verenigde Staten, 30068
        • Emory at East Cobb - Primary Care
        • Contact:
      • Peachtree City, Georgia, Verenigde Staten, 30269
        • Emory at Peachtree City - Primary Care
        • Contact:
      • Sharpsburg, Georgia, Verenigde Staten, 30277
        • Emory at Sharpsburg
        • Contact:
      • Smyrna, Georgia, Verenigde Staten, 30080
        • Emory at Belmont - Primary Care
        • Contact:
      • Snellville, Georgia, Verenigde Staten, 30078
        • Emory at Snellville - Primary Care (Lenora Church Road)
        • Contact:
      • Snellville, Georgia, Verenigde Staten, 30078
        • Emory at Snellville - Primary Care (Oak Road)
        • Contact:
      • Snellville, Georgia, Verenigde Staten, 30078
        • Emory at Snellville Primary Care (Presidential Circle)
        • Contact:
      • Snellville, Georgia, Verenigde Staten, 30339
        • Emory at Centerville - Primary Care
        • Contact:
      • Stockbridge, Georgia, Verenigde Staten, 30281
        • Emory at Eagles Landing Primary Care
        • Contact:
      • Stone Mountain, Georgia, Verenigde Staten, 30083
        • Emory at Stone Mountain - Primary Care
        • Contact:
      • Stone Mountain, Georgia, Verenigde Staten, 30087
        • Emory at Rockbridge Primary Care & Nephrology
        • Contact:
      • Tucker, Georgia, Verenigde Staten, 30084
        • Emory at Tucker - Primary Care (1459 Montreal Road)
        • Contact:
      • Warner Robins, Georgia, Verenigde Staten, 31093
        • Pavilion Family Medicine Center
        • Contact:
      • West Point, Georgia, Verenigde Staten, 31833
        • Emory at West Point
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

Inclusion Criteria:

  1. Must meet current USPSTF eligibility criteria for lung cancer screening (Current criteria: age 50-80 years old with a 20 pack-year smoking history, who currently smoke or have quit within the last 15 years)
  2. Must have an electronic health record-assigned primary care provider within University of California Irvine Health or Emory Healthcare
  3. Must have recent engagement with respective health system (i.e., office or emergency department (ED) visit, hospitalization with discharged home in the last 12 months, or a scheduled office visit in the next 3 months).
  4. Must speak English or Spanish
  5. Able and willing to provide informed consent

Exclusion Criteria:

  1. Meet the eligibility upper age limit during initial 4-month participation.
  2. Have a prior history of lung cancer.
  3. Have a new diagnosis of other cancers in the 12 months
  4. Have a chest CT or LDCT in the last 12 months
  5. Have ICD-10 code of Alzheimer's disease in EHR

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Onderzoek naar gezondheidsdiensten
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Enhanced Usual Care
Usual care + educational brochure
Ander: Gebruikelijke zorg
Gebruikelijke zorg
Ander: Education
One-page educational material about benefits and risks of lung cancer screening
Experimenteel: Empower LCS/Call+
Empower LCS with Call+ offered to non-responders
Ander: Gebruikelijke zorg
Gebruikelijke zorg
Gedragsmatig: Empower LCS
Empower LCS consists of (1) a lung cancer screening decision aid, (2) primary care provider notification of patients' eligibility for lung cancer screening, (3) patient text reminders to discuss lung cancer screening with their primary care provider, and (4) tailored support materials including financial education and national/local resources for patients who screen positive for health-related social needs.
Gedragsmatig: Call+ Telephone Navigation
Participants who do not complete lung cancer screening by approximately 4 months after randomization will receive the Call+, a telephone-based navigation intervention delivered by a lay navigator to identify and address barriers to screening, facilitate scheduling, and connect participants with available resources.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Completion of lung cancer screening with low-dose computed tomography (LDCT)
Tijdsspanne: 4 months after randomization
Completion of LDCT lung cancer screening, determined by electronic health record review.
4 months after randomization
Completion of lung cancer screening with low-dose computed tomography (LDCT)
Tijdsspanne: 8 months after randomization
Completion of LDCT lung cancer screening, determined by electronic health record review.
8 months after randomization

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Completion of any chest CT
Tijdsspanne: 4 months after randomization
Completion of any chest CT, determined by electronic health record review.
4 months after randomization
Completion of any chest CT
Tijdsspanne: 8 months after randomization
Completion of any chest CT
8 months after randomization
Ordering of low-dose computed tomography (LDCT)
Tijdsspanne: 4 months after randomization
Provider order for LDCT identified through electronic health record review.
4 months after randomization
Ordering of low-dose computed tomography (LDCT)
Tijdsspanne: 8 months after randomization
Provider order for LDCT identified through electronic health record review.
8 months after randomization
Discussion of lung cancer screening with a primary care provider
Tijdsspanne: 4 months after enrollment
Electronic health record documentation of discussion regarding lung cancer screening with primary care provider.
4 months after enrollment
Discussion of lung cancer screening with a primary care provider
Tijdsspanne: 8 months after enrollment
Electronic health record documentation of discussion regarding lung cancer screening with primary care provider.
8 months after enrollment
Lung cancer screening scheduling
Tijdsspanne: 4 months post-randomization
scheduling of lung cancer screening as self-reported by patient
4 months post-randomization
Patient knowledge of lung cancer screening
Tijdsspanne: 4 months after randomization
Participant knowledge regarding lung cancer screening assessed via 9-item survey previously used (Shojazadeh et al. JACR; 2025)
4 months after randomization
Decisional conflict regarding lung cancer screening
Tijdsspanne: 4 months after randomization
Participant decisional conflict measured using 10-item decisional conflict scale (O'Connor AM)
4 months after randomization
Perceived lung cancer risk
Tijdsspanne: 4 months after randomization
Perceived lung cancer risk will be measured using 3-item validated survey (Carter-Harris et al. Cancer Nurs; 2017)
4 months after randomization
Perceived lung cancer severity
Tijdsspanne: 4 months after randomization
Perceived lung cancer severity will be measured using 5-item survey (Shojazadeh et al. JACR; 2015)
4 months after randomization
Perceived lung cancer screening benefits
Tijdsspanne: 4 months after randomization
Perceived lung cancer screening benefits will be measured using 6-item validated survey (Carter-Harris et al. Cancer Nurs; 2017)
4 months after randomization
Perceived lung cancer screening barriers
Tijdsspanne: 4 months after randomization
Perceived lung cancer screening barriers will be measured using 18-item validated survey (Carter-Harris et al. Cancer Nurs; 2017)
4 months after randomization
Perceived lung cancer screening self-efficacy
Tijdsspanne: 4 months after randomization
Perceived lung cancer screening self-efficacy will be measured using 9-item validated survey (Carter-Harris et al. Cancer Nurs; 2017)
4 months after randomization

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of California, Irvine

Onderzoekers

  • Hoofdonderzoeker: Ilana Graetz, PhD, Emory University
  • Hoofdonderzoeker: Gelareh Sadigh, University of California, Irvine

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

1 september 2026

Primaire voltooiing (Geschat)

1 augustus 2028

Studie voltooiing (Geschat)

1 december 2028

Studieregistratiedata

Eerst ingediend

13 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

13 juli 2026

Eerst geplaatst (Werkelijk)

17 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

22 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

20 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • STUDY00001802

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

De-identified data will be share upon request from study chair and establishing data use agreements.

IPD-tijdsbestek voor delen

Upon publication of primary outcome manuscript

IPD-toegangscriteria voor delen

Researchers upon sending a request to study chair (Dr. Gelareh Sadigh; gsadigh@hs.uci.edu)

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • ICF

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren