Digital Health Implementation Strategies to Improve Lung Cancer Screening Among Safety-Net Clinics (LUNG-IS)

Digital Health Implementation Strategies to Improve Lung Cancer Screening Among Safety-Net Clinics (LUNG-IS) - PATIENT

The long-term goal of this program of research is to increase the reach of Lung Cancer Screening (LCS) among low-resource healthcare settings and populations. The proposed project, LUNG-IS, is a mixed-methods, pre-post quasi-experimental design conducted in three Utah safety-net healthcare system clinics.

LUNG-IS employs a comprehensive conceptual model with theories, models, and frameworks of implementation and behavioral science, uses rigorous mixed-methods to evaluate factors that influence implementation of LCS, and uses patient navigation to facilitate clinic-community linkages.

LUNG-IS leverages existing pathways to care and Centralized Hub infrastructure that enables eligibility assessment, LCS Shared Decision Making (SDM) with clinical decision support, screening referral, and screening logistics assistance to help overcome barriers to LCS completion. The Centralized Hub model uses ubiquitous technologies (i.e., text messaging/telehealth) to enable patients to be assessed for LCS eligibility, engage in SDM if eligible, and be referred for LCS. For patients who decide to complete LCS, they will be provided patient navigation via Community Health Workers designed to address logistical barriers, hesitancy, and financial constraints around completing LCS.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Behavioral: Text Messages (TM+); Behavioral: Chat bot (CA); Behavioral: Video; Behavioral: Reactive Patient Navigation (RPN); Behavioral: Proactive Patient Navigation (PPN)

• Study Type: Interventional
• Enrollment (Estimated): 800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Indy Li, MS; Phone Number: 801-213-5697; Email: indy.li@hci.utah.edu

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Recruiting
      • Huntsman Cancer Institute/ University of Utah
      • Contact: Indy Li, MS; Phone Number: 801-213-5697; Email: indy.li@hci.utah.edu
      • Principal Investigator: Chelsey Schlechter, MPH, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Current or former, male and female, smokers.
• Age 50-80.
• Primary language English or Spanish.
• Have a phone that can send/receive text messages.

Exclusion Criteria:

• Patients who have never smoked.
• Patients who are under the age of 50 or above the age of 80.
• Primary language other than English or Spanish.
• Do not have access to a phone that can send/receive text messages.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Stage 1: TM+; Basic text messages sent directly to the patient's cell phone.	Behavioral: Text Messages (TM+); Basic text messages sent directly to the patient's cell phone.
Other: Stage 1: TM+, CA; Basic text messages sent directly to the patient's cell phone. Also includes the option for chat bot to answer frequently asked LCS questions.	Behavioral: Text Messages (TM+); Basic text messages sent directly to the patient's cell phone.; Behavioral: Chat bot (CA); Chat bot to answer frequently asked LCS questions.
Other: Stage 1: TM+, Video; Basic text messages sent directly to the patient's cell phone. Also includes the option for an educational video about LCS.	Behavioral: Text Messages (TM+); Basic text messages sent directly to the patient's cell phone.; Behavioral: Video; Educational video about LCS.
Other: Stage 1: TM+, CA, Video; Basic text messages sent directly to the patient's cell phone. Also includes the option for chat bot to answer frequently asked LCS questions and option for educational video about LCS. Patients who complete SDM and are referred to LCS will also be assigned to one of the following conditions. Descriptions of these conditions are as follows:	Behavioral: Text Messages (TM+); Basic text messages sent directly to the patient's cell phone.; Behavioral: Chat bot (CA); Chat bot to answer frequently asked LCS questions.; Behavioral: Video; Educational video about LCS.
Other: Stage 2: TM+, RPN; Patients who complete SDM and are referred to LCS may be assigned to this condition Patients will receive basic text messages and reactive patient navigation to help get to the LCS appointment.	Behavioral: Text Messages (TM+); Basic text messages sent directly to the patient's cell phone.; Behavioral: Reactive Patient Navigation (RPN); Reactive patient navigation to help get to the LCS appointment.
Other: Stage 2:TM+, PPN; Patients who complete SDM and are referred to LCS may be assigned to this condition Patients will receive basic text messages and proactive patient navigation to help get to the LCS appointment. Patients who need transportation financial assistance will receive transportation vouchers to help get them to and from their LCS appointment.	Behavioral: Text Messages (TM+); Basic text messages sent directly to the patient's cell phone.; Behavioral: Proactive Patient Navigation (PPN); Proactive patient navigation to help get to the LCS appointment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of Implementation Strategies on Lung Cancer Screening (LCS) eligibility screening	Evaluate the impact of implementation strategies on Lung Cancer Screening (LCS) eligibility screening. This outcome measure will report the proportion of participants who complete LCS eligibility screening.	up to 15 weeks after study enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of Implementation Strategies on LCS Shared Decision Making (SDM) completion	Evaluate the impact of implementation strategies on Shared Decision Making (SDM) completion. This outcome measure will report the proportion of patients who complete SDM.	up to 7 weeks after completion of LCS eligibility screen
Impact of Implementation Strategies on LCS Completion	Evaluate the impact of implementation strategies on LCS completion. This outcome measure will report the proportion of participants who complete LCS.	up to 6 months after placement of LCS referral

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: Centers for Disease Control and Prevention
• Investigators: Principal Investigator: Chelsey Schlechter, MPH, PhD, Huntsman Cancer Institute/ University of Utah

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: July 2, 2026
• First Submitted That Met QC Criteria: July 15, 2026
• First Posted (Actual): July 21, 2026

Study Record Updates

• Last Update Posted (Actual): July 21, 2026
• Last Update Submitted That Met QC Criteria: July 15, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Technology, Industry, and Agriculture; Technology; Tape Recording; Audiovisual Aids; Educational Technology; Television; Videotape Recording
• Other Study ID Numbers: 187448; 1U48DP006855-01 (U.S. NIH Grant/Contract)

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