NCT07716280

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
800

participants targeted

Target at P75+ for not_applicable lung-cancer

Timeline
5mo left

Started Jan 2026

Shorter than P25 for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress58%
Jan 2026Jan 2027

Study Start

First participant enrolled

January 1, 2026

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 21, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

July 21, 2026

Status Verified

July 1, 2026

Enrollment Period

1 year

First QC Date

July 2, 2026

Last Update Submit

July 15, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Impact of Implementation Strategies on LCS Shared Decision Making (SDM) completion

    up to 7 weeks after completion of LCS eligibility screen

  • Impact of Implementation Strategies on LCS Completion

    up to 6 months after placement of LCS referral

Study Arms (6)

Stage 1: TM+

OTHER

Basic text messages sent directly to the patient's cell phone.

Behavioral: Text Messages (TM+)

Stage 1: TM+, CA

OTHER

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+)Behavioral: Chat bot (CA)

Stage 1: TM+, Video

OTHER

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+)Behavioral: Video

Stage 1: TM+, CA, Video

OTHER

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+)Behavioral: Chat bot (CA)Behavioral: Video

Stage 2: TM+, RPN

OTHER

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+)Behavioral: Reactive Patient Navigation (RPN)

Stage 2:TM+, PPN

OTHER

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+)Behavioral: Proactive Patient Navigation (PPN)

Interventions

Basic text messages sent directly to the patient's cell phone.

Stage 1: TM+Stage 1: TM+, CAStage 1: TM+, CA, VideoStage 1: TM+, VideoStage 2: TM+, RPNStage 2:TM+, PPN
Chat bot (CA)BEHAVIORAL

Chat bot to answer frequently asked LCS questions.

Stage 1: TM+, CAStage 1: TM+, CA, Video
VideoBEHAVIORAL

Educational video about LCS.

Stage 1: TM+, CA, VideoStage 1: TM+, Video

Proactive patient navigation to help get to the LCS appointment.

Stage 2:TM+, PPN

Reactive patient navigation to help get to the LCS appointment.

Stage 2: TM+, RPN

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huntsman Cancer Institute/ University of Utah

Salt Lake City, Utah, 84112, United States

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Study Officials

  • Chelsey Schlechter, MPH, PhD

    Huntsman Cancer Institute/ University of Utah

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2026

First Posted

July 21, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

July 21, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations