About this 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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Is currently a patient at participating CHCs
Speak English or Spanish
Current or former tobacco smoker
Male or Female
Disqualifiers
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 design
Sequential
Treatments tested in this trial
Text Messages (TM+)
BehavioralA message informs the participants that a Registered Nurse (RN) from the Hub will call them about shared decision making (SDM) and LCS.
Chatbot (CA)
BehavioralAccess to a chatbot for frequently asked questions about LCS
Video (VID)
BehavioralAn educational video about LCS
Reactive Patient Navigation (RPN)
BehavioralRPN to help complete the LCS appointment. RPN requires the participant to initiate the PN request
Proactive Patient Navigation (PPN)
BehavioralProactive 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.
Treatment groups
6
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
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.
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.
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.
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.
Other outcomes
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.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Utah
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Huntsman Cancer Institute
Collaborator
This trial is not recruiting at the moment. You can still explore other options: