UG3 Pilot Clinical Trial

NCT07073898 | Completed DMC

• 2 other identifiers: HCI177308UG3CA287109-02
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

LungSMART Utah utilizes a Population Health Management (PHM) approach that addresses key barriers to Lung Cancer Screening (LCS) implementation by deploying a centralized Hub infrastructure for eligibility assessment, individualized risk assessment and Shared Decision Making (SDM), LCS referral, and screening completion assistance, thereby increasing LCS reach at scale among Community Health Centers (CHCs) patients across the state of Utah.

Conditions

Lung Cancer

Outcome Measures

Primary Outcomes (2)

• Engagement - Lung Cancer Screening (LCS)

  This outcome measure will report the proportion of enrolled subjects who engaged with Lung Cancer Screening (LCS) text messages during the study period. LCS Engagement will be defined as any documented interaction with the text messaging system, as recorded by the study platform.

  up to 3 months from study enrollment

• Engagement - Shared Decision Making (SDM)

  This outcome measure will report the proportion of enrolled subjects who engaged with Shared Decision Making (SDM) conversations during the study period. SDM Engagement will be defined as any documented interaction with SDM conversations, as recorded in study documentation.

  up to 3 months from study enrollment

Secondary Outcomes (3)

• Trustworthiness

  up to 3 months from study enrollment

• Acceptability

  up to 3 months from study enrollment

• Usefulness

  up to 3 months from study enrollment

Study Arms (6)

Repeated Text Messages (TM+)

OTHER

Repeated text messages notifying patients that they may be eligible for Lung Cancer Screening (LCS).

Other: Repeated Text Messages (TM+)

Repeated Text Messages plus a Conversational Agent (TM+, CA)

OTHER

Repeated text messages notifying patients that they may be eligible for LCS. In addition to text messages, patients will receive an automated, scripted, and interactive CA.

Other: Repeated Text Messages (TM+); Other: Conversational Agent (CA)

Repeated Text Messages plus a Video (TM+, Video)

OTHER

Repeated text messages notifying patients that they may be eligible for LCS. In addition to text messages, patients will receive an educational video sent directly to their cell phone.

Other: Repeated Text Messages (TM+); Other: Educational Video

Repeated Text Messages plus a Conversational Agent and Video (TM+, CA, Video)

OTHER

Repeated text messages notifying patients that they may be eligible for LCS. In addition to text messages, patients will receive an educational video sent directly to the patient's cell phone, along with a conversational agent to answer frequently asked LCS questions. Additionally, patients will receive an educational video sent directly to the patient's cell phone and a chatbot to answer frequently asked LCS questions.

Other: Repeated Text Messages (TM+); Other: Conversational Agent (CA); Other: Educational Video

CA/PPN

OTHER

A conversational agent to answer frequently asked LCS questions. In addition to proactive patient navigation.

Other: Conversational Agent (CA); Other: Proactive Patient Navigation (PPN)

CA/RPN

OTHER

A conversational agent to answer frequently asked LCS questions. In addition to reactive patient navigation.

Other: Conversational Agent (CA); Other: Reactive Patient Navigation (RPN)

Interventions

Repeated Text Messages (TM+) OTHER

The text message notifies patients that they may be eligible for LCS and provides the patient with a connection to an registered nurse (RN) for LCS eligibility assessment and Shared Decision-Making (SDM) discussion. Response options include YES (to request that the HUB RN call the patient) or STOP (to opt out of any further messages).

Repeated Text Messages (TM+); Repeated Text Messages plus a Conversational Agent (TM+, CA); Repeated Text Messages plus a Conversational Agent and Video (TM+, CA, Video); Repeated Text Messages plus a Video (TM+, Video)

Conversational Agent (CA) OTHER

The CA is designed to address specific hesitancy factors and barriers to Lung Cancer Screening (LCS). The CA uses a rule-based approach. CAs use a predefined conversation script with a fixed set of possible questions and responses to educate patients regarding the importance of LCS and engage them to be connected with RN for eligibility assessment and SDM.

CA/PPN; CA/RPN; Repeated Text Messages plus a Conversational Agent (TM+, CA); Repeated Text Messages plus a Conversational Agent and Video (TM+, CA, Video)

Educational Video OTHER

The educational video provides patients with information and answers commonly asked questions about LCS.

Repeated Text Messages plus a Conversational Agent and Video (TM+, CA, Video); Repeated Text Messages plus a Video (TM+, Video)

Proactive Patient Navigation (PPN) OTHER

Proactive patient navigation enables trained navigators to actively identify and reach out to patients who may need assistance completing LCS, rather than waiting for patients to seek help on their own.

CA/PPN

Reactive Patient Navigation (RPN) OTHER

Reactive patient navigation makes trained navigators available to those who seek assistance in completing LCS.

CA/RPN

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is currently a patient at Mountainlands CHCs
• Speak English or Spanish
• Current or former male or female smokers
• Age 50-80
• Have a phone that can receive text messages
• Electronic health records indicate they have not opted out of receiving text contact from the clinic

You may not qualify if:

• Persons with lung cancer or previous SDM

Sponsors & Collaborators

• University of Utah: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Huntsman Cancer Institute/ University of Utah

Salt Lake City, Utah, 84112, United States

Location

Related Publications (202)

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MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• David Wetter, Ph.D.

  Huntsman Cancer Institute/ University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 18, 2025
• Study Start: September 26, 2025
• Primary Completion: January 27, 2026
• Study Completion: January 27, 2026
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

US (1)