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

20. Juli 2026 aktualisiert von: 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.

Studienübersicht

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

80

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Versorgungsforschung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Enhanced Usual Care
Usual care + educational brochure
Übliche Pflege
One-page educational material about benefits and risks of lung cancer screening
Experimental: Empower LCS/Call+
Empower LCS with Call+ offered to non-responders
Übliche Pflege
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.
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Completion of lung cancer screening with low-dose computed tomography (LDCT)
Zeitfenster: 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)
Zeitfenster: 8 months after randomization
Completion of LDCT lung cancer screening, determined by electronic health record review.
8 months after randomization

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

1. September 2026

Primärer Abschluss (Geschätzt)

1. August 2028

Studienabschluss (Geschätzt)

1. Dezember 2028

Studienanmeldedaten

Zuerst eingereicht

13. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

13. Juli 2026

Zuerst gepostet (Tatsächlich)

17. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

22. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

20. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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

IPD-Sharing-Zeitrahmen

Upon publication of primary outcome manuscript

IPD-Sharing-Zugriffskriterien

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

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • ICF

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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