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

20 luglio 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

80

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: Enhanced Usual Care
Usual care + educational brochure
Altro: Solita cura
Solita cura
Altro: Education
One-page educational material about benefits and risks of lung cancer screening
Sperimentale: Empower LCS/Call+
Empower LCS with Call+ offered to non-responders
Altro: Solita cura
Solita cura
Comportamentale: 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.
Comportamentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Completion of lung cancer screening with low-dose computed tomography (LDCT)
Lasso di tempo: 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)
Lasso di tempo: 8 months after randomization
Completion of LDCT lung cancer screening, determined by electronic health record review.
8 months after randomization

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Completion of any chest CT
Lasso di tempo: 4 months after randomization
Completion of any chest CT, determined by electronic health record review.
4 months after randomization
Completion of any chest CT
Lasso di tempo: 8 months after randomization
Completion of any chest CT
8 months after randomization
Ordering of low-dose computed tomography (LDCT)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 4 months post-randomization
scheduling of lung cancer screening as self-reported by patient
4 months post-randomization
Patient knowledge of lung cancer screening
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

University of California, Irvine

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 settembre 2026

Completamento primario (Stimato)

1 agosto 2028

Completamento dello studio (Stimato)

1 dicembre 2028

Date di iscrizione allo studio

Primo inviato

13 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

13 luglio 2026

Primo Inserito (Effettivo)

17 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

22 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

20 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • STUDY00001802

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

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

Periodo di condivisione IPD

Upon publication of primary outcome manuscript

Criteri di accesso alla condivisione IPD

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

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • ICF

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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