이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

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

2026년 7월 20일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

80

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

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

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 건강 서비스 연구
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Enhanced Usual Care
Usual care + educational brochure
다른: 평상시 관리
평소 케어
다른: Education
One-page educational material about benefits and risks of lung cancer screening
실험적: Empower LCS/Call+
Empower LCS with Call+ offered to non-responders
다른: 평상시 관리
평소 케어
행동: 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.
행동: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Completion of lung cancer screening with low-dose computed tomography (LDCT)
기간: 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)
기간: 8 months after randomization
Completion of LDCT lung cancer screening, determined by electronic health record review.
8 months after randomization

2차 결과 측정

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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of California, Irvine

수사관

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

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 9월 1일

기본 완료 (추정된)

2028년 8월 1일

연구 완료 (추정된)

2028년 12월 1일

연구 등록 날짜

최초 제출

2026년 7월 13일

QC 기준을 충족하는 최초 제출

2026년 7월 13일

처음 게시됨 (실제)

2026년 7월 17일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 22일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 20일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • STUDY00001802

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

예

IPD 계획 설명

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

IPD 공유 기간

Upon publication of primary outcome manuscript

IPD 공유 액세스 기준

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

IPD 공유 지원 정보 유형

  • 연구_프로토콜
  • ICF

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

구독하다