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

20. juli 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

80

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Enhanced Usual Care
Usual care + educational brochure
Andet: Sædvanlig pleje
Sædvanlig pleje
Andet: Education
One-page educational material about benefits and risks of lung cancer screening
Eksperimentel: Empower LCS/Call+
Empower LCS with Call+ offered to non-responders
Andet: Sædvanlig pleje
Sædvanlig pleje
Adfærdsmæssigt: 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.
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Completion of lung cancer screening with low-dose computed tomography (LDCT)
Tidsramme: 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)
Tidsramme: 8 months after randomization
Completion of LDCT lung cancer screening, determined by electronic health record review.
8 months after randomization

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Completion of any chest CT
Tidsramme: 4 months after randomization
Completion of any chest CT, determined by electronic health record review.
4 months after randomization
Completion of any chest CT
Tidsramme: 8 months after randomization
Completion of any chest CT
8 months after randomization
Ordering of low-dose computed tomography (LDCT)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 4 months post-randomization
scheduling of lung cancer screening as self-reported by patient
4 months post-randomization
Patient knowledge of lung cancer screening
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of California, Irvine

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

1. august 2028

Studieafslutning (Anslået)

1. december 2028

Datoer for studieregistrering

Først indsendt

13. juli 2026

Først indsendt, der opfyldte QC-kriterier

13. juli 2026

Først opslået (Faktiske)

17. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

20. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • STUDY00001802

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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

IPD-delingstidsramme

Upon publication of primary outcome manuscript

IPD-delingsadgangskriterier

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

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • ICF

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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