Ta strona została przetłumaczona automatycznie i dokładność tłumaczenia nie jest gwarantowana. Proszę odnieść się do angielska wersja za tekst źródłowy.

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

20 lipca 2026 zaktualizowane przez: 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.

Przegląd badań

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

80

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Lokalizacje studiów

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

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Badania usług zdrowotnych
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Pojedynczy

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Aktywny komparator: Enhanced Usual Care
Usual care + educational brochure
Zwykła opieka
One-page educational material about benefits and risks of lung cancer screening
Eksperymentalny: Empower LCS/Call+
Empower LCS with Call+ offered to non-responders
Zwykła opieka
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.

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Completion of lung cancer screening with low-dose computed tomography (LDCT)
Ramy czasowe: 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)
Ramy czasowe: 8 months after randomization
Completion of LDCT lung cancer screening, determined by electronic health record review.
8 months after randomization

Miary wyników drugorzędnych

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

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Śledczy

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

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Publikacje ogólne

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

1 września 2026

Zakończenie podstawowe (Szacowany)

1 sierpnia 2028

Ukończenie studiów (Szacowany)

1 grudnia 2028

Daty rejestracji na studia

Pierwszy przesłany

13 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

13 lipca 2026

Pierwszy wysłany (Rzeczywisty)

17 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

22 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

20 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

TAK

Opis planu IPD

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

Ramy czasowe udostępniania IPD

Upon publication of primary outcome manuscript

Kryteria dostępu do udostępniania IPD

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

Typ informacji pomocniczych dotyczących udostępniania IPD

  • PROTOKÓŁ BADANIA
  • ICF

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

Subskrybuj