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

Part of paid clinical trials in Anaheim, California.

Sponsor
University of California, Irvine
Study ID
NCT07711691
Status
Not Yet Recruiting

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Conditions

  • Early Detection of Cancer
  • Lung Cancer Screening
  • Lung Neoplasms
  • Smoking ( Cigarette)

Eligibility Criteria

Sex
ALL
Age
50 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Empower LCS — BEHAVIORAL
    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.
  • Call+ Telephone Navigation — BEHAVIORAL
    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.
  • Usual Care — OTHER
    Usual care
  • Education — OTHER
    One-page educational material about benefits and risks of lung cancer screening

Study Details

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.

Key Dates

First listed
Jul 17, 2026
Start date
Sep 1, 2026
Status verified
Jul 2026
Primary completion
Aug 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Active Comparator: Enhanced Usual Care
    Usual care + educational brochure
  • Experimental: Empower LCS/Call+
    Empower LCS with Call+ offered to non-responders

Primary Outcome Measure

Completion of lung cancer screening with low-dose computed tomography (LDCT) [ Time Frame: 4 months after randomization ]

Central Contacts

Locations (14)

FacilityCityStateZIPSite coordinators
UCI Health Family Health Center - AnaheimAnaheimCalifornia92801
Gelareh Sadigh, MD
(714) 456-3610
UCI Health - Costa MesaCosta MesaCalifornia92627
Gelareh Sadigh, MD
(714) 456-3610
CHAO Family Comprehensive Cancer Center- IrvineIrvineCalifornia92612
Gelareh Sadigh, MD
(714) 456-3610
UCI Health Gottschalk Medical PlazaIrvineCalifornia92697
Gelareh Sadigh, MD
(714) 456-3610
UCI Health - Laguna HillsLaguna HillsCalifornia92653
Gelareh Sadigh, MD
(714) 456-3610
UCI Health - Newport Beach MacArthurNewport BeachCalifornia92660
Gelareh Sadigh, MD
(714) 456-3610
Primary Care & Internal Medicine ServicesOrangeCalifornia92868
Gelareh Sadigh, MD
(714) 456-3610
UCI Chao Family Comprehensive Cancer CenterOrangeCalifornia92868
Gelareh Sadigh, MD
(714) 456-3610
UCI Health SeniorHealth Center -Pavillion 4OrangeCalifornia92868-
UCI Medical Center, Pavilion 3OrangeCalifornia92868
Gelareh Sadigh, MD
(714) 456-3610
UCI Health Family Health Center - Santa AnaSanta AnaCalifornia92701
Gelareh Sadigh, MD
(714) 456-3610
UCI Health - TustinTustinCalifornia92670
Gelareh Sadigh, MD
(714) 456-3610
UCI Health - Yorba LindaYorba LindaCalifornia92886
Gelareh Sadigh, MD
(714) 456-3610
The Emory ClinicAtlantaGeorgia30322
Ilana Graetz, PhD
404-7271483

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