NCT07599943

Brief Summary

The long-term goal of LungSMART Utah is to increase the reach of Low-Dose Computed Tomography (LDCT) screening for lung cancer (hereafter referred to as Lung Cancer Screening or LCS) at scale in low-resource healthcare settings.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
18,894

participants targeted

Target at P75+ for not_applicable lung-cancer

Timeline
45mo left

Started Aug 2026

Typical duration for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
not yet 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

First Submitted

Initial submission to the registry

May 13, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 20, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2026

Expected
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2030

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2030

Last Updated

May 20, 2026

Status Verified

May 1, 2026

Enrollment Period

3.7 years

First QC Date

May 13, 2026

Last Update Submit

May 13, 2026

Conditions

Outcome Measures

Primary Outcomes (2)

  • Stage 1: Completion of eligibility assessment

    To evaluate patient-level interventions with respect to increasing completed assessments in Stage 1. The outcome measure will report the proportion of participants who complete the LCS eligibility assessment.

    up to 18 weeks

  • Stage 2: Completion of LCS

    To evaluate patient-level interventions with respect to increasing completed LCS in Stage 2. The outcome measure will report the proportion of participants who complete LCS.

    up to 30 weeks

Secondary Outcomes (7)

  • Cost-effectiveness: Incremental Cost

    up to 30 weeks

  • Cost-effectiveness: Incremental Effectiveness

    up to 30 weeks

  • Proportion of patients who engage with interventions

    up to 18 weeks

  • Proportion of patients who reply opting out of receiving interventions

    up to 30 weeks

  • Proportion of patients who complete SDM

    up to 18 weeks

  • +2 more secondary outcomes

Other Outcomes (1)

  • Baseline Characteristics that predict outcomes or moderate intervention effects

    up to 30 weeks

Study Arms (6)

Stage 1: Repeated Text Messages (TM+)

OTHER

Participants will receive up to nine text messages containing eligibility questions, along with up to nine reminder messages. If a participant successfully responds to the eligibility questions, no more messages will be sent. If a participant does not respond to the eligibility questions after receiving a text message, they will receive a reminder message three days later, prompting them to answer the questions.

Behavioral: Text Messages (TM+)

Stage 1: Repeated Text Messages and Chatbot (TM+/CA)

OTHER

Participants will receive up to nine text messages containing eligibility questions, along with up to nine reminder messages. If a participant successfully responds to the eligibility questions, no more messages will be sent. If a participant does not respond to the eligibility questions after receiving a text message, they will receive a reminder message three days later, prompting them to answer the questions. Participants will have access to a Lung Cancer Screening (LCS) Chatbot delivered via SMS.

Behavioral: Text Messages (TM+)Behavioral: Chatbot (CA)

Stage 1: Repeated Text Messages and Video (TM+/VID)

OTHER

Participants will receive up to nine text messages containing eligibility questions, along with up to nine reminder messages. If a participant successfully responds to the eligibility questions, no more messages will be sent. If a participant does not respond to the eligibility questions after receiving a text message, they will receive a reminder message three days later, prompting them to answer the questions. Participants can watch an educational video via SMS.

Behavioral: Text Messages (TM+)Behavioral: Video (VID)

Stage 1: Repeated Text Messages, Chatbot, and Video (TM+/CA/VID)

OTHER

Participants will receive up to nine text messages containing eligibility questions, along with up to nine reminder messages. If a participant successfully responds to the eligibility questions, no more messages will be sent. If a participant does not respond to the eligibility questions after receiving a text message, they will receive a reminder message three days later, prompting them to answer the questions. Participants will have access to a Lung Cancer Screening (LCS) Chatbot delivered via SMS. Participants can watch an educational video via SMS.

Behavioral: Text Messages (TM+)Behavioral: Chatbot (CA)Behavioral: Video (VID)

Stage 2: Chatbot and Reactive Patient Navigation (CA/RPN)

OTHER

RPN requires the participant to initiate the PN request. Participants receive up to three text messages scheduled four weeks apart.

Behavioral: Chatbot (CA)Behavioral: Reactive Patient Navigation (RPN)

Stage 2: Chatbot and Proactive Patient Navigation (CA/PPN)

OTHER

PPN does not require the participant to initiate the PN request and instead is a proactive call to the participant. Participants receive up to three text messages scheduled four weeks apart.

Behavioral: Chatbot (CA)Behavioral: Proactive Patient Navigation (PPN)

Interventions

A message informs the participants that an RN from the Hub will call them about SDM and LCS.

Stage 1: Repeated Text Messages (TM+)Stage 1: Repeated Text Messages and Chatbot (TM+/CA)Stage 1: Repeated Text Messages and Video (TM+/VID)Stage 1: Repeated Text Messages, Chatbot, and Video (TM+/CA/VID)
Chatbot (CA)BEHAVIORAL

Access to a chatbot for frequently asked questions about LCS

Also known as: Chatbot
Stage 1: Repeated Text Messages and Chatbot (TM+/CA)Stage 1: Repeated Text Messages, Chatbot, and Video (TM+/CA/VID)Stage 2: Chatbot and Proactive Patient Navigation (CA/PPN)Stage 2: Chatbot and Reactive Patient Navigation (CA/RPN)
Video (VID)BEHAVIORAL

An educational video about LCS

Stage 1: Repeated Text Messages and Video (TM+/VID)Stage 1: Repeated Text Messages, Chatbot, and Video (TM+/CA/VID)

RPN to help complete the LCS appointment. RPN requires the participant to initiate the PN request

Stage 2: Chatbot and Reactive Patient Navigation (CA/RPN)

Proactive patient navigation to help complete the LCS appointment. PPN does not require the participant to initiate the PN request and instead is a proactive call to the participant.

Stage 2: Chatbot and Proactive Patient Navigation (CA/PPN)

Eligibility Criteria

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

You may qualify if:

  • Is currently a patient at participating CHCs
  • Speak English or Spanish
  • Current or former tobacco smoker
  • Male or Female
  • Age 50-80
  • Electronic health records indicate they have not opted out of receiving text contact from the clinic
  • Has a phone that can receive text messages

You may not qualify if:

  • Persons with lung cancer or who have previously participated in a Shared Decision Making discussion with a health provider regarding lung cancer or have completed LCS.

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

Location

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

  • David Wetter, PhD, MS

    Huntsman Cancer Institute/ University of Utah

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

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

Study Record Dates

First Submitted

May 13, 2026

First Posted

May 20, 2026

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

April 1, 2030

Study Completion (Estimated)

April 1, 2030

Last Updated

May 20, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations