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

The purpose of this study is to further understand the factors involved in increasing lung cancer screening.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Behavioral: Pre-Visit Planner; Behavioral: Pre-Visit Planner + MyChart

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 (Estimated): 2869
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lucy Rios, M.P.H.; Phone Number: 916-734-7722; Email: lucrios@ucdavis.edu
• Study Contact Backup: Name: Neha Singh, B.S; Email: nehsingh@ucdavis.edu

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • Recruiting
      • University of California, Davis
      • Contact: Moon Chen, M.P.H, Ph.D; Phone Number: 916-548-3928; Email: mschenjr@ucdavis.edu
      • Principal Investigator: Moon Chen, M.P.H, Ph.D

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

3

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	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	Key informant interviews with UC Davis staff and patients to determine approach to intervention.	156 Weeks

Collaborators and Investigators

• Sponsor: University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2022
• Primary Completion (Estimated): April 14, 2025
• Study Completion (Estimated): April 14, 2025

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): April 8, 2024
• Last Update Submitted That Met QC Criteria: April 1, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Lung Cancer Screening
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 1937769-1

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