Empowering Patients' Lung Cancer Screening Uptake (Empower LCS/Call+)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorUniversity of California, Irvine
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Empower LCS
BehavioralEmpower 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
BehavioralParticipants 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 interventionUsual care
Education
Other interventionOne-page educational material about benefits and risks of lung cancer screening
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: Enhanced Usual CareActive comparator 2 interventions
Group B: Empower LCS/Call+Experimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Completion of lung cancer screening with low-dose computed tomography (LDCT)
Completion of LDCT lung cancer screening, determined by electronic health record review.
Time frame
4 months after randomization2
Completion of lung cancer screening with low-dose computed tomography (LDCT)
Completion of LDCT lung cancer screening, determined by electronic health record review.
Time frame
8 months after randomizationSecondary outcomes
1
Completion of any chest CT
Completion of any chest CT, determined by electronic health record review.
Time frame
4 months after randomization2
Completion of any chest CT
Completion of any chest CT
Time frame
8 months after randomization3
Ordering of low-dose computed tomography (LDCT)
Provider order for LDCT identified through electronic health record review.
Time frame
4 months after randomization4
Ordering of low-dose computed tomography (LDCT)
Provider order for LDCT identified through electronic health record review.
Time frame
8 months after randomizationSponsors and contacts
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Source ClinicalTrials.gov