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

20. juli 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Antatt)

80

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

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

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Aktiv komparator: Enhanced Usual Care
Usual care + educational brochure
Annen: Vanlig omsorg
Vanlig omsorg
Annen: Education
One-page educational material about benefits and risks of lung cancer screening
Eksperimentell: Empower LCS/Call+
Empower LCS with Call+ offered to non-responders
Annen: Vanlig omsorg
Vanlig omsorg
Atferdsmessig: 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.
Atferdsmessig: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of California, Irvine

Etterforskere

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

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. september 2026

Primær fullføring (Antatt)

1. august 2028

Studiet fullført (Antatt)

1. desember 2028

Datoer for studieregistrering

Først innsendt

13. juli 2026

Først innsendt som oppfylte QC-kriteriene

13. juli 2026

Først lagt ut (Faktiske)

17. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

20. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • STUDY00001802

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (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

Tilgangskriterier for IPD-deling

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

IPD-deling Støtteinformasjonstype

  • STUDY_PROTOCOL
  • ICF

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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