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NCT Number: NCT07599943

Population Health Management -Increase Lung Cancer Screening in Community Health Centers (LungSMART)

The long-term goal of Lung Sequential Multiple Assignment Randomized Trial (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.

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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–80 year

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

Location contact

David Wetter, PhD, MS

CONTACT

[email protected]

801-213-6178

David Wetter, PhD, MS

PRINCIPAL_INVESTIGATOR

About this study

LungSMART is a Sequential Multiple Assignment Randomized Trial (SMART) conducted in Utah Community Health Centers (CHCs). The SMART design is structured in two sequential stages: Stage 1 aims to increase uptake of Lung Cancer Screening (LCS) eligibility assessment, while Stage 2 aims to increase LCS completion.

In Stage 1, the Eligibility Assessment Stage, LungSMART Utah uses Azara, a population health management software, to identify potentially eligible patients from participating CHCs. Patients who are enrolled in the study will be randomized to digital health interventions and connected with a centralized hub (Hub) for eligibility assessment and shared decision making (SDM) with a qualified registered nurse (RN).

In Stage 2, the LCS Completion Stage, participants referred for LCS receive access to a Chatbot and are randomized to receive reactive (patient needs to request navigation) vs proactive (navigator proactively calls the patient) patient navigation (PN) delivered via telehealth by a community health worker (CHW) at the Hub to address logistical barriers and hesitancy in completing LCS.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Text Messages (TM+)

Behavioral

A message informs the participants that a Registered Nurse (RN) from the Hub will call them about shared decision making (SDM) and LCS.

Chatbot (CA)

Behavioral

Access to a chatbot for frequently asked questions about LCS

Other names: Chatbot

Video (VID)

Behavioral

An educational video about LCS

Reactive Patient Navigation (RPN)

Behavioral

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

Proactive Patient Navigation (PPN)

Behavioral

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.

Primary outcomes

  1. Stage 1: Completion of eligibility assessment

    Time frame: up to 18 weeks

    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.

  2. Stage 2: Completion of LCS

    Time frame: up to 30 weeks

    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.

Secondary outcomes

  1. Cost-effectiveness: Incremental Cost

    Time frame: up to 30 weeks

    To evaluate the cost-effectiveness of the interventions in Stage 1 and Stage 2.

    Incremental cost-effectiveness ratios (ICER) will be constructed for Stage 1 and 2 among participants. The ICER estimates the additional resource consumption needed to successfully attain an additional unit of an outcome (e.g., completed assessment in Stage 1, completed LCS in Stage 2) using one intervention relative to another. Cost-Effectiveness Analysis (CEA) will determine the most cost-effective combination of strategies to increase reach across Stages.

  2. Cost-effectiveness: Incremental Effectiveness

    Time frame: up to 30 weeks

    To evaluate the cost-effectiveness of the interventions in Stage 1 and Stage 2.

    Incremental cost-effectiveness ratios (ICER) will be constructed for Stage 1 and 2 among participants. The ICER estimates the additional resource consumption needed to successfully attain an additional unit of an outcome (e.g., completed assessment in Stage 1, completed LCS in Stage 2) using one intervention relative to another. CEA will determine the most cost-effective combination of strategies to increase reach across Stages.

  3. Proportion of patients who engage with interventions

    Time frame: up to 18 weeks

    The outcome measure will report the proportion of participants who engage with interventions. This outcome measure is only applicable in Stage 1.

  4. Proportion of patients who reply opting out of receiving interventions

    Time frame: up to 30 weeks

    The outcome measure will report the proportion of participants who reply to opt out of receiving interventions.

  5. Proportion of patients who complete SDM

    Time frame: up to 18 weeks

    The outcome measure will report the proportion of participants who complete SDM. This outcome measure is only applicable in Stage1.

  6. Proportion of patients who request to speak with a patient navigator

    Time frame: up to 30 weeks

    The outcome measure will report the proportion of participants who request to speak with a patient navigator. This outcome measure is only applicable in Stage 2.

  7. Proportion of patients who speak with a patient navigator

    Time frame: up to 30 weeks

    The outcome measure will report the proportion of participants who speak with a patient navigator. This outcome measure is only applicable in Stage 2.

Other outcomes

  1. Baseline Characteristics that predict outcomes or moderate intervention effects

    Time frame: up to 30 weeks

    This outcome measure will assess characteristics of participants that predict outcomes and/or moderate intervention effects.

    To evaluate effect modification in Stages 1 and 2 with respect to smoking status, gender, sex as a biological variable, age, race/ethnicity, partner status, social vulnerability index, and insurance status.

Study contacts

Contact information is provided by the study sponsor or research team.

Indy Li, MS

CONTACT

[email protected]

801-213-5697

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • Huntsman Cancer Institute
  • National Cancer Institute (NCI)

Registry information

Official study title

Population Health Management Approaches to Increase Lung Cancer Screening in Community Health Centers - LungSMART UH3 Clinical Trial

Acronym: LungSMART

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
May 20, 2026
Registry last updated
May 27, 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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