UG3 Pilot Clinical Trial

Not Applicable

Not yet recruiting

• Conditions: Lung Cancer

• Registration Number: NCT07073898
• Lead Sponsor: University of Utah

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.

Detailed Description

LungSMART Utah is a Sequential Multiple Assignment Randomized Trial (SMART) that promotes the reach of lung cancer screening (LCS) among patients who receive medical services at Utah Community Health Centers (CHCs). The study design consists of two sequential stages: an Eligibility Assessment phase to identify and engage individuals at risk to participate in a shared decision-making (SDM) session to assess LCS eligibility, recommendation, and preference, followed by an LCS Completion phase to promote follow-through with recommended screening.

In this pilot trial, 50 current or former tobacco users aged 50-80 who receive medical services at the Mountainlands CHC and have no recorded history of lung cancer and have not participated in a SDM about LCS will be identified for the study. In the Eligibility Assessment Phase, patients will be assessed for LCS eligibility through digital health interventions and, if eligible, will engage with a qualified registered nurse (RN) at a centralized "Hub" for a SDM session, with and be offered a referral for LCS if screening is recommended and preferred. Phase 1 interventions include repeated text messaging (TM+), conversational agent (CA), and educational video (VID) to engage patients in a SDM session. The LCS Completion phase evaluates telehealth interventions designed to address logistical barriers and hesitancy among referred patients in completing LCS. Interventions include CA and either proactive- or reactive-patient navigation (PN) to increase LCS completion among CHC patients. Clinic staff will also be queried to examine if further refinement of research workflow and procedures is needed. Mountainlands CHC has agreed to partner with us to recruit patient participants for this pilot study.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-09
• Study First Submitted QC: 2025-07-09
• Last Update Submitted: 2025-07-09
• Study First Posted: 2025-07-18
• Last Update Posted: 2025-07-18
• Study Start: 2025-09-01
• Primary Completion: 2028-09
• Study Completion: 2028-09-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

• 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

Exclusion Criteria

• Persons with lung cancer or previous SDM

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
Engagement - Lung Cancer Screening (LCS)	up to 3 months from study enrollment	Survey questions will measure engagement, trustworthiness, acceptability, and usefulness related to all interventions and content.; LCS text message engagement is measured as a single-item Yes/No question. This outcome measure will report the proportion of subjects who answered Yes to LCS engagement.
Engagement - Shared Decision Making (SDM)	up to 3 months from study enrollment	Survey questions will measure engagement, trustworthiness, acceptability, and usefulness related to all interventions and content.; SDM text message engagement is measured as a single-item Yes/No question. This outcome measure will report the proportion of subjects who answered Yes to SDM engagement.

Secondary Outcome Measures

Name	Time	Method
Trustworthiness	up to 3 months from study enrollment	Survey questions will measure engagement, trustworthiness, acceptability, and usefulness related to all interventions and content.; Text message trustworthiness is measured by two items that directly ask what made participants trust or not trust the initial text message. This outcome measure will report the proportion of subjects who reported text message trustworthiness.
Acceptability	up to 3 months from study enrollment	Survey questions will measure engagement, trustworthiness, acceptability, and usefulness related to all interventions and content.; Acceptability is measured as a composite of 4 dimensions: * Frequency: 3 items about text message frequency and call attempt frequency; * Pace: 2 items about information delivery pace; * Process: 1 item about technical issues, 2 items regarding improvement suggestions, and 3 open-ended questions about the overall experience; * Content: 4 Yes/No items about the educational video in the branching logic section.; This outcome measure will report the proportion of subjects who reported text message acceptability.
Usefulness	up to 3 months from study enrollment	Survey questions will measure engagement, trustworthiness, acceptability, and usefulness related to all interventions and content.; Usefulness is measured as a composite of 4 dimensions: * Perceived helpfulness: 1 question about the helpfulness of reminder texts, and 1 branching logic question about the helpfulness of additional information provided by the educational video that arrives via text.; * Confidence outcomes: 1 question measuring confidence in the next steps after shared decision-making; * Functional utility: 2 questions about opportunities to ask questions/express concerns and suggestions for additional valuable resources; * Overall utility: 2 closing questions about what worked well and the experience with the program.; This outcome measure will report the proportion of subjects who reported text message usefulness.

Trial Locations

Locations (1)

Huntsman Cancer Institute/ University of Utah; 🇺🇸 Salt Lake City, Utah, United States