Enhancing Lung Cancer Screening Through Human-Centered Intervention (ELFE)

May 4, 2026 updated by: University of California, Davis
The purpose of this study is to further understand the factors involved in increasing lung cancer screening.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The study aims to identify patient, primary care team and health system factors that facilitate participation in lung cancer screening. Additionally, conduct a two-arm randomized comparative effectiveness intervention study to increase lung cancer screening compared with a usual care control arm and further evaluate the differential impact of the intervention conditions compared to usual care.

Study Type

Interventional

Enrollment (Actual)

2869

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • University of California, Davis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Interviews:

  • UC Davis Health Systems (UCDHS) primary care providers and clinic staff who provide services to patients ages 50-80.
  • Patients who are eligible for lung cancer screening.

Screening Intervention:

- Patients ages 50-80 who have a history of smoking per review of their electronic medical record and who receive care at the following UCDH ambulatory care clinics: Ellison Ambulatory Care Clinic; Elk Grove; Midtown.

Exclusion Criteria:

Interviews:

  • Non-consenting patients and patients who do not speak English or Spanish
  • Patients aged 49 and younger
  • Non UCDHS primary care providers and clinic staff

Screening Intervention:

  • UCDHS patients who have already received Lung Cancer Screening
  • Patients with existing Cancer diagnosis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
Patients will receive usual care.
Other: Pre-Visit Planner (PVP)
A Licensed Vocational Nurse (LVN) will verify patient smoking history and calculate pack years with the patient over the phone.
Behavioral: Pre-Visit Planner
The study is comparing the implementation of a Pre-Visit Planner to go through the shared decision making process.
Other: Pre-Visit Planner (PVP) + MyChart
A Licensed Vocational Nurse (LVN) will verify patient smoking history and calculate pack years with the patient over the phone. In addition, the patient will receive educational video through MyChart prior to an LVN calling.
Behavioral: Pre-Visit Planner + MyChart
The study is comparing the implementation of a Pre-Visit Planner to go through the shared decision making process as well as testing if watching educational videos about the Lung Cancer Screening (LCS) process prior to talking to an LVN will help with LCS uptake.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lung Cancer Screening
Time Frame: 156 Weeks
The primary outcome is the proportion of patients aged 50-80 with a history of smoking who receive Lung Cancer Screening during the study period; this outcome will be measured in both intervention groups and the control group.
156 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completion of Interviews with Staff and Patients
Time Frame: 156 Weeks
Key informant interviews with UC Davis staff and patients to determine approach to intervention.
156 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2022

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

March 26, 2024

First Submitted That Met QC Criteria

April 1, 2024

First Posted (Actual)

April 8, 2024

Study Record Updates

Last Update Posted (Actual)

May 8, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1937769

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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