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Completed

NCT Number: NCT07073898

UG3 Pilot Clinical Trial

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.

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Key information

Conditions

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

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Huntsman Cancer Institute/ University of Utah

Salt Lake City, Utah, 84112, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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.

Educational Video

Other

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

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.

Reactive Patient Navigation (RPN)

Other

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

Primary outcomes

  1. Engagement - Lung Cancer Screening (LCS)

    Time frame: up to 3 months from study enrollment

    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.

  2. Engagement - Shared Decision Making (SDM)

    Time frame: up to 3 months from study enrollment

    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.

Secondary outcomes

  1. Trustworthiness

    Time frame: 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.

  2. Acceptability

    Time frame: 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.

  3. Usefulness

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Population Health Management Approaches to Increase Lung Cancer Screening in Community Health Centers - UG3 Pilot Clinical Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 18, 2025
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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