Lung CancerLungSMARTNCT07599943
Population Health Management -Increase Lung Cancer Screening in Community Health Centers (LungSMART)
A study testing Text Messages (TM+), Chatbot (CA) and Video (VID) in people with Lung Cancer, run by University of Utah at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Text Messages (TM+), Chatbot (CA) and Video (VID)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18,894 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2026to Apr 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Huntsman Cancer Institute/University of Utah
Salt Lake City, Utah, 84112
David Wetter, PhD, MS, 801-213-6178, David.Wetter@hci.utah.edu
David Wetter, PhD, MS
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- Text Messages (TM+), Chatbot (CA), Video (VID), Reactive Patient Navigation (RPN), Proactive Patient Navigation (PPN)
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text Messages (TM+)Behavioural
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)Behavioural
Also called Chatbot
Access to a chatbot for frequently asked questions about LCS
Video (VID)Behavioural
An educational video about LCS
Reactive Patient Navigation (RPN)Behavioural
RPN to help complete the LCS appointment. RPN requires the participant to initiate the PN request
Proactive Patient Navigation (PPN)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Stage 1: Repeated Text Messages (TM+) | Other | 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. Receives: Behavioral: Text Messages (TM+) |
| Stage 1: Repeated Text Messages and Chatbot (TM+/CA) | Other | 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). Receives: Behavioral: Text Messages (TM+); Behavioral: Chatbot (CA) |
| Stage 1: Repeated Text Messages and Video (TM+/VID) | Other | 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. Receives: Behavioral: Text Messages (TM+); Behavioral: Video (VID) |
| Stage 1: Repeated Text Messages, Chatbot, and Video (TM+/CA/VID) | Other | 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. Receives: Behavioral: Text Messages (TM+); Behavioral: Chatbot (CA); Behavioral: Video (VID) |
| Stage 2: Chatbot and Reactive Patient Navigation (CA/RPN) | Other | 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. Receives: Behavioral: Chatbot (CA); Behavioral: Reactive Patient Navigation (RPN) |
| Stage 2: Chatbot and Proactive Patient Navigation (CA/PPN) | Other | 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. Receives: Behavioral: Chatbot (CA); Behavioral: Proactive Patient Navigation (PPN) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: up to 30 weeks
Secondary outcomes (7)
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.
Measured: 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.
Measured: up to 30 weeks
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: up to 30 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study startOct 2026 (estimated)
- Primary completionApr 2030 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18,894 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), Huntsman Cancer Institute
- Responsible party
- Sponsor
- Investigators
- David Wetter, PhD, MS, Principal investigator, Huntsman Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07599943
- Sponsor's protocol ID
- 190012
- Other IDs
- 1UG3CA287109-01
- Acronym
- LungSMART
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Population Health Management Approaches to Increase Lung Cancer Screening in Community Health Centers - LungSMART UH3 Clinical Trial
- ClinicalTrials.gov ID
- NCT07599943
- Acronym / sponsor ID
- LungSMART / 190012
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18,894 participants (estimated)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), Huntsman Cancer Institute
- Study start
- Oct 2026 (estimated)
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Stage 1: Repeated Text Messages (TM+) | Other | Behavioral: 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. |
| Stage 1: Repeated Text Messages and Chatbot (TM+/CA) | Other | Behavioral: Text Messages (TM+), Behavioral: Chatbot (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). |
| Stage 1: Repeated Text Messages and Video (TM+/VID) | Other | Behavioral: Text Messages (TM+), Behavioral: Video (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. |
| Stage 1: Repeated Text Messages, Chatbot, and Video (TM+/CA/VID) | Other | Behavioral: Text Messages (TM+), Behavioral: Chatbot (CA), Behavioral: Video (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. |
| Stage 2: Chatbot and Reactive Patient Navigation (CA/RPN) | Other | Behavioral: Chatbot (CA), Behavioral: Reactive Patient Navigation (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. |
| Stage 2: Chatbot and Proactive Patient Navigation (CA/PPN) | Other | Behavioral: Chatbot (CA), Behavioral: Proactive Patient Navigation (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. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Is currently a patient at participating CHCs
- Speak English or Spanish
- Current or former tobacco smoker
- Male or Female
- Age 50-80
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Stage 1: Repeated Text Messages (TM+), Stage 1: Repeated Text Messages and Chatbot (TM+/CA), Stage 1: Repeated Text Messages and Video (TM+/VID), Stage 1: Repeated Text Messages, Chatbot, and Video (TM+/CA/VID) |
| Chatbot (CA)Also: ChatbotAccess to a chatbot for frequently asked questions about LCS | Behavioural | Stage 1: Repeated Text Messages and Chatbot (TM+/CA), Stage 1: Repeated Text Messages, Chatbot, and Video (TM+/CA/VID), Stage 2: Chatbot and Proactive Patient Navigation (CA/PPN), Stage 2: Chatbot and Reactive Patient Navigation (CA/RPN) |
| Video (VID)An educational video about LCS | Behavioural | Stage 1: Repeated Text Messages and Video (TM+/VID), Stage 1: Repeated Text Messages, Chatbot, and Video (TM+/CA/VID) |
| Reactive Patient Navigation (RPN)RPN to help complete the LCS appointment. RPN requires the participant to initiate the PN request | Behavioural | Stage 2: Chatbot and Reactive Patient Navigation (CA/RPN) |
| 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. | Behavioural | Stage 2: Chatbot and Proactive Patient Navigation (CA/PPN) |
Primary outcome
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.
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.
7 secondary outcomes
Cost-effectiveness: Incremental Cost
Time frame: up to 30 weeks
Cost-effectiveness: Incremental Effectiveness
Time frame: up to 30 weeks
Proportion of patients who engage with interventions
Time frame: up to 18 weeks
Proportion of patients who reply opting out of receiving interventions
Time frame: up to 30 weeks
Proportion of patients who complete SDM
Time frame: up to 18 weeks
Proportion of patients who request to speak with a patient navigator
Time frame: up to 30 weeks
Proportion of patients who speak with a patient navigator
Time frame: up to 30 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Wetter, PhD, MS principal investigator
Huntsman Cancer Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text Messages (TM+), Chatbot (CA) and Video (VID) in people with Lung Cancer, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Indy Li, MS (801-213-5697, Indy.li@hci.utah.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Stage 1: Completion of eligibility assessment (time frame: up to 18 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.