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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Behavioral: Chatbot (CA); Behavioral: Video (VID); Behavioral: Reactive Patient Navigation (RPN); Behavioral: Proactive Patient Navigation (PPN); Behavioral: Text Messages (TM+)

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 18894
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Indy Li, MS; Phone Number: 801-213-5697; Email: Indy.li@hci.utah.edu

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84112
      • Huntsman Cancer Institute/University of Utah
      • Contact: David Wetter, PhD, MS; Phone Number: 801-213-6178; Email: David.Wetter@hci.utah.edu
      • Principal Investigator: David Wetter, PhD, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Stage 1: Repeated Text Messages (TM+); 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+); A message informs the participants that a Registered Nurse (RN) from the Hub will call them about shared decision making (SDM) and LCS.
Other: Stage 1: Repeated Text Messages and Video (TM+/VID); 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: Video (VID); An educational video about LCS; Behavioral: Text Messages (TM+); A message informs the participants that a Registered Nurse (RN) from the Hub will call them about shared decision making (SDM) and LCS.
Other: Stage 1: Repeated Text Messages, Chatbot, and Video (TM+/CA/VID); 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: Chatbot (CA); Access to a chatbot for frequently asked questions about LCS; Other Names: Chatbot; Behavioral: Video (VID); An educational video about LCS; Behavioral: Text Messages (TM+); A message informs the participants that a Registered Nurse (RN) from the Hub will call them about shared decision making (SDM) and LCS.
Other: Stage 1: Repeated Text Messages and Chatbot (TM+/CA); 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 Short Message Service (SMS).	Behavioral: Chatbot (CA); Access to a chatbot for frequently asked questions about LCS; Other Names: Chatbot; Behavioral: Text Messages (TM+); A message informs the participants that a Registered Nurse (RN) from the Hub will call them about shared decision making (SDM) and LCS.
Other: Stage 2: Chatbot and Reactive Patient Navigation (CA/RPN); Reactive Patient Navigation (RPN) requires the participant to initiate the patient navigation (PN) request. Participants receive up to three text messages scheduled four weeks apart.	Behavioral: Chatbot (CA); Access to a chatbot for frequently asked questions about LCS; Other Names: Chatbot; Behavioral: Reactive Patient Navigation (RPN); RPN to help complete the LCS appointment. RPN requires the participant to initiate the PN request
Other: Stage 2: Chatbot and Proactive Patient Navigation (CA/PPN); Proactive Patient Navigation (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); Access to a chatbot for frequently asked questions about LCS; Other Names: Chatbot; Behavioral: Proactive Patient Navigation (PPN); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients who engage with interventions	The outcome measure will report the proportion of participants who engage with interventions. This outcome measure is only applicable in Stage 1.	up to 18 weeks
Proportion of patients who reply opting out of receiving interventions	The outcome measure will report the proportion of participants who reply to opt out of receiving interventions.	up to 30 weeks
Proportion of patients who complete SDM	The outcome measure will report the proportion of participants who complete SDM. This outcome measure is only applicable in Stage1.	up to 18 weeks
Proportion of patients who request to speak with a patient navigator	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.	up to 30 weeks
Proportion of patients who speak with a patient navigator	The outcome measure will report the proportion of participants who speak with a patient navigator. This outcome measure is only applicable in Stage 2.	up to 30 weeks
Cost-effectiveness: Incremental Cost	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.	up to 30 weeks
Cost-effectiveness: Incremental Effectiveness	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.	up to 30 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline Characteristics that predict outcomes or moderate intervention effects	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.	up to 30 weeks

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: National Cancer Institute (NCI); Huntsman Cancer Institute
• Investigators: Principal Investigator: David Wetter, PhD, MS, Huntsman Cancer Institute/ University of Utah

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): April 1, 2030
• Study Completion (Estimated): April 1, 2030

Study Registration Dates

• First Submitted: May 13, 2026
• First Submitted That Met QC Criteria: May 13, 2026
• First Posted (Actual): May 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Respiratory Tract Diseases; Lung Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Technology, Industry, and Agriculture; Technology; Tape Recording; Audiovisual Aids; Educational Technology; Television; Videotape Recording
• Other Study ID Numbers: HCI190012; 1UG3CA287109-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No