Lung Cancer
Conditions
Brief 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.
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.
Interventions
BEHAVIORALText 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.
BEHAVIORALChatbot (CA)
Access to a chatbot for frequently asked questions about LCS
BEHAVIORALVideo (VID)
An educational video about LCS
BEHAVIORALReactive Patient Navigation (RPN)
RPN to help complete the LCS appointment. RPN requires the participant to initiate the PN request
BEHAVIORALProactive 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.
Sponsors
University of Utah
National Cancer Institute (NCI)
Huntsman Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stage 1: Completion of eligibility assessment | 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Cost-effectiveness: Incremental Cost | 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. |
| Cost-effectiveness: Incremental Effectiveness | 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. |
| Proportion of patients who engage with interventions | 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. |
| Proportion of patients who reply opting out of receiving interventions | up to 30 weeks | The outcome measure will report the proportion of participants who reply to opt out of receiving interventions. |
| Proportion of patients who complete SDM | up to 18 weeks | The outcome measure will report the proportion of participants who complete SDM. This outcome measure is only applicable in Stage1. |
| Proportion of patients who request to speak with a patient navigator | 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. |
| Proportion of patients who speak with a patient navigator | 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. |
Countries
United States
Contacts
CONTACTIndy Li, MS
PRINCIPAL_INVESTIGATORDavid Wetter, PhD, MS
Huntsman Cancer Institute/ University of Utah
Outcome results
None listed