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

Официальное название

Empowering Patients' Lung Cancer Screening Uptake (Empower LCS/Call+): A Multi-Site Pilot Randomized Controlled Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.
• Другое Usual Care
  Usual care
• Другое Education
  One-page educational material about benefits and risks of lung cancer screening

Первичные конечные точки

• Completion of lung cancer screening with low-dose computed tomography (LDCT) [Срок оценки: 4 months after randomization]
• Completion of lung cancer screening with low-dose computed tomography (LDCT) [Срок оценки: 8 months after randomization]

Вторичные конечные точки (12)

• Completion of any chest CT [Срок оценки: 4 months after randomization]
• Completion of any chest CT [Срок оценки: 8 months after randomization]
• Ordering of low-dose computed tomography (LDCT) [Срок оценки: 4 months after randomization]
• Ordering of low-dose computed tomography (LDCT) [Срок оценки: 8 months after randomization]
• Discussion of lung cancer screening with a primary care provider [Срок оценки: 4 months after enrollment]
• Discussion of lung cancer screening with a primary care provider [Срок оценки: 8 months after enrollment]
• Lung cancer screening scheduling [Срок оценки: 4 months post-randomization]
• Patient knowledge of lung cancer screening [Срок оценки: 4 months after randomization]
• Decisional conflict regarding lung cancer screening [Срок оценки: 4 months after randomization]
• Perceived lung cancer risk [Срок оценки: 4 months after randomization]
• Perceived lung cancer severity [Срок оценки: 4 months after randomization]
• Perceived lung cancer screening benefits [Срок оценки: 4 months after randomization]

Критерии участия

Критерии включения

• 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)
• Must have an electronic health record-assigned primary care provider within University of California Irvine Health or Emory Healthcare
• 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).
• Must speak English or Spanish
• Able and willing to provide informed consent

Критерии исключения

• Meet the eligibility upper age limit during initial 4-month participation.
• Have a prior history of lung cancer.
• Have a new diagnosis of other cancers in the 12 months
• Have a chest CT or LDCT in the last 12 months
• Have ICD-10 code of Alzheimer's disease in EHR

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Организация здравоохранения

Центры проведения

США · 57 центров

• UCI Health Family Health Center - Anaheim — Anaheim
• UCI Health - Costa Mesa — Costa Mesa
• CHAO Family Comprehensive Cancer Center- Irvine — Irvine
• UCI Health Gottschalk Medical Plaza — Irvine
• UCI Health - Laguna Hills — Laguna Hills
• UCI Health - Newport Beach MacArthur — Newport Beach
• Primary Care & Internal Medicine Services — Orange
• UCI Chao Family Comprehensive Cancer Center — Orange
• … и ещё 49 центров

Публикации

• O'Connor AM. Validation of a decisional conflict scale. Med Decis Making. 1995 Jan-Mar;15(1):25-30. doi: 10.1177/0272989X9501500105. PMID 7898294
• Carter-Harris L, Slaven JE 2nd, Monohan P, Rawl SM. Development and Psychometric Evaluation of the Lung Cancer Screening Health Belief Scales. Cancer Nurs. 2017 May/Jun;40(3):237-244. doi: 10.1097/NCC.0000000000000386. PMID 27244666
• Quezada JJ, Avenido AR, Jia S, Bernaba A, Nguyen S, Gharagozlou SS, Nguyen TQ, Keshava H, Sadigh G. Assessing Providers' knowledge about and barriers to lung cancer screening. Cancer Treat Res Commun. 2024;41:100850. doi: 10.1016/j.ctarc.2024.100850. Epub 2024 Nov 15. PMID 39577140
• Shojazadeh A, Kao R, Pham T, Madan A, Echeverria R, Chen WP, Nguyen V, Gutierrez O, Lee S, Hoyt MA, Ziogas A, Nguyen TQ, Keshava H, Sadigh G. A Multilevel Approach to Improve Participation in Low-Dose CT for Lung Cancer Screening (Empower LCS): A Single-Arm Pilot Feasibility Clinical Trial. J Am Coll Radiol. 2026 Apr;23(4):556-564. doi: 10.1016/j.jacr.2025.11.005. Epub 2025 Nov 13. PMID 41241060
• Jung J, Razzak E, Avenido AR, Rashidi A, Jia S, Tran NQ, Yao R, Nguyen EL, Bernaba A, Echeverria R, Nguyen TQ, Imanzadeh A, Sadigh G. Patient-Reported Barriers and Preferred Interventions to Improve Lung Cancer Screening Uptake. J Am Coll Radiol. 2025 Mar;22(3):269-279. doi: 10.1016/j.jacr.2024.10.010. PMID 40044305
• National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29. PMID 21714641

Идентификаторы

NCT: NCT07711691 · STUDY00001802

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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