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

July 15, 2026 updated by: University of Utah

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
800

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute/ University of Utah
        • Contact:
        • Principal Investigator:
          • Chelsey Schlechter, MPH, PhD

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Impact of Implementation Strategies on Lung Cancer Screening (LCS) eligibility screening
Time Frame: up to 15 weeks after study enrollment
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Impact of Implementation Strategies on LCS Shared Decision Making (SDM) completion
Time Frame: up to 7 weeks after completion of LCS eligibility screen
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
Time Frame: up to 6 months after placement of LCS referral
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

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Utah

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Centers for Disease Control and Prevention

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chelsey Schlechter, MPH, PhD, Huntsman Cancer Institute/ University of Utah

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 21, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

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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