Esta página se tradujo automáticamente y no se garantiza la precisión de la traducción. por favor refiérase a versión inglesa para un texto fuente.

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

20 de julio de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Aún no reclutando

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

80

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Gelareh Sadigh, MD
  • Número de teléfono: (714) 456-3610
  • Correo electrónico: gsadigh@hs.uci.edu

Ubicaciones de estudio

  • Estados Unidos
    • California
      • Anaheim, California, Estados Unidos, 92801
        • UCI Health Family Health Center - Anaheim
        • Contacto:
      • Costa Mesa, California, Estados Unidos, 92627
        • UCI Health - Costa Mesa
        • Contacto:
      • Irvine, California, Estados Unidos, 92697
        • UCI Health Gottschalk Medical Plaza
        • Contacto:
      • Irvine, California, Estados Unidos, 92612
        • CHAO Family Comprehensive Cancer Center- Irvine
        • Contacto:
      • Laguna Hills, California, Estados Unidos, 92653
        • UCI Health - Laguna Hills
        • Contacto:
      • Newport Beach, California, Estados Unidos, 92660
        • UCI Health - Newport Beach MacArthur
        • Contacto:
          • Gelareh Sadigh, MD
          • Número de teléfono: (714) 456-3610
          • Correo electrónico: gsadigh@hs.uci.edu
      • Orange, California, Estados Unidos, 92868
        • UCI Chao Family Comprehensive Cancer Center
        • Contacto:
      • Orange, California, Estados Unidos, 92868
        • UCI Health SeniorHealth Center -Pavillion 4
      • Orange, California, Estados Unidos, 92868
        • UCI Medical Center, Pavilion 3
        • Contacto:
      • Orange, California, Estados Unidos, 92868
        • Primary Care & Internal Medicine Services
        • Contacto:
      • Santa Ana, California, Estados Unidos, 92701
        • UCI Health Family Health Center - Santa Ana
        • Contacto:
      • Tustin, California, Estados Unidos, 92670
        • UCI Health - Tustin
        • Contacto:
      • Yorba Linda, California, Estados Unidos, 92886
        • UCI Health - Yorba Linda
        • Contacto:
    • Georgia
      • Alpharetta, Georgia, Estados Unidos, 30009
        • Emory at Avalon - Primary Care
        • Contacto:
      • Atlanta, Georgia, Estados Unidos, 30047
        • Emory Clinic at Old Fourth Ward
        • Contacto:
      • Atlanta, Georgia, Estados Unidos, 30308
        • Emory Clinic at Midtown
        • Contacto:
      • Atlanta, Georgia, Estados Unidos, 30309
        • Emory at Peachtree Hills - Primary Care
        • Contacto:
      • Atlanta, Georgia, Estados Unidos, 30322
        • Emory Clinic at 1365 Clifton Road - Primary Care
        • Contacto:
      • Atlanta, Georgia, Estados Unidos, 30322
        • Emory Clinic at 1525 Clifton Road - Primary Care
        • Contacto:
      • Atlanta, Georgia, Estados Unidos, 30329
        • Emory at Toco Hills - Primary Care
        • Contacto:
      • Atlanta, Georgia, Estados Unidos, 30342
        • Emory Gastroenterology
        • Contacto:
      • Atlanta, Georgia, Estados Unidos, 30345
        • Emory at Northlake - Primary Care
        • Contacto:
      • Buford, Georgia, Estados Unidos, 30519
        • Emory at Buford - Primary Care
        • Contacto:
      • Decatur, Georgia, Estados Unidos, 30030
        • Emory at Decatur - Primary Care (Irvin Court)
        • Contacto:
      • Decatur, Georgia, Estados Unidos, 30030
        • Emory at Decatur - Primary Care (Scott Boulevard)
        • Contacto:
      • Decatur, Georgia, Estados Unidos, 30030
        • Emory Clinic Downtown Decatur
        • Contacto:
      • Decatur, Georgia, Estados Unidos, 30033
        • Emory at Decatur - Primary Care
        • Contacto:
      • Decatur, Georgia, Estados Unidos, 30033
        • Emory at Oak Grove - Primary Care
        • Contacto:
      • Decatur, Georgia, Estados Unidos, 30033
        • Emory Clinic at Decatur - Primary Care
        • Contacto:
      • Decatur, Georgia, Estados Unidos, 30034
        • Emory at Flat Shoals - Primary Care
        • Contacto:
      • Duluth, Georgia, Estados Unidos, 30096
        • Emory at Duluth
        • Contacto:
      • Duluth, Georgia, Estados Unidos, 30097
        • Emory at Sugarloaf - Primary Care
        • Contacto:
      • Dunwoody, Georgia, Estados Unidos, 30338
        • Emory at Dunwoody
        • Contacto:
      • Dunwoody, Georgia, Estados Unidos, 30342
        • Emory Clinic at Saint Joseph's
        • Contacto:
      • Johns Creek, Georgia, Estados Unidos, 30097
        • Emory at Findley Road
        • Contacto:
      • Jonesboro, Georgia, Estados Unidos, 30236
        • Emory at Spivey Station - Primary Care
        • Contacto:
      • La Grange, Georgia, Estados Unidos, 30240
        • Emory at LaGrange - Smith Street - Primary Care
        • Contacto:
      • La Grange, Georgia, Estados Unidos, 30241
        • Emory at LaGrange - Davis Road
        • Contacto:
      • Lilburn, Georgia, Estados Unidos, 30047
        • Emory at Beaver Ruin - Primary Care
        • Contacto:
      • Lilburn, Georgia, Estados Unidos, 30047
        • Emory at Mountain Park - Primary Care
        • Contacto:
      • Lithonia, Georgia, Estados Unidos, 30058
        • Emory at Hillandale Family Medicine
        • Contacto:
      • Lithonia, Georgia, Estados Unidos, 30058
        • Emory at Miller Grove - Primary Care
        • Contacto:
      • Lithonia, Georgia, Estados Unidos, 30058
        • Emory Clinic at Lithonia - Primary Care
        • Contacto:
      • Marietta, Georgia, Estados Unidos, 30068
        • Emory at East Cobb - Primary Care
        • Contacto:
      • Peachtree City, Georgia, Estados Unidos, 30269
        • Emory at Peachtree City - Primary Care
        • Contacto:
      • Sharpsburg, Georgia, Estados Unidos, 30277
        • Emory at Sharpsburg
        • Contacto:
      • Smyrna, Georgia, Estados Unidos, 30080
        • Emory at Belmont - Primary Care
        • Contacto:
      • Snellville, Georgia, Estados Unidos, 30078
        • Emory at Snellville - Primary Care (Lenora Church Road)
        • Contacto:
      • Snellville, Georgia, Estados Unidos, 30078
        • Emory at Snellville - Primary Care (Oak Road)
        • Contacto:
      • Snellville, Georgia, Estados Unidos, 30078
        • Emory at Snellville Primary Care (Presidential Circle)
        • Contacto:
      • Snellville, Georgia, Estados Unidos, 30339
        • Emory at Centerville - Primary Care
        • Contacto:
      • Stockbridge, Georgia, Estados Unidos, 30281
        • Emory at Eagles Landing Primary Care
        • Contacto:
      • Stone Mountain, Georgia, Estados Unidos, 30083
        • Emory at Stone Mountain - Primary Care
        • Contacto:
      • Stone Mountain, Georgia, Estados Unidos, 30087
        • Emory at Rockbridge Primary Care & Nephrology
        • Contacto:
      • Tucker, Georgia, Estados Unidos, 30084
        • Emory at Tucker - Primary Care (1459 Montreal Road)
        • Contacto:
      • Warner Robins, Georgia, Estados Unidos, 31093
        • Pavilion Family Medicine Center
        • Contacto:
      • West Point, Georgia, Estados Unidos, 31833
        • Emory at West Point
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Investigación de servicios de salud
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador activo: Enhanced Usual Care
Usual care + educational brochure
Otro: Cuidado usual
Cuidado usual
Otro: Education
One-page educational material about benefits and risks of lung cancer screening
Experimental: Empower LCS/Call+
Empower LCS with Call+ offered to non-responders
Otro: Cuidado usual
Cuidado usual
Conductual: 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.
Conductual: 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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Completion of lung cancer screening with low-dose computed tomography (LDCT)
Periodo de tiempo: 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)
Periodo de tiempo: 8 months after randomization
Completion of LDCT lung cancer screening, determined by electronic health record review.
8 months after randomization

Medidas de resultado secundarias

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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

University of California, Irvine

Investigadores

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

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de septiembre de 2026

Finalización primaria (Estimado)

1 de agosto de 2028

Finalización del estudio (Estimado)

1 de diciembre de 2028

Fechas de registro del estudio

Enviado por primera vez

13 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

13 de julio de 2026

Publicado por primera vez (Actual)

17 de julio de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

22 de julio de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

20 de julio de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • STUDY00001802

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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

Marco de tiempo para compartir IPD

Upon publication of primary outcome manuscript

Criterios de acceso compartido de IPD

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

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • CIF

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Suscribir