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| ID | Type | Description | Link |
|---|---|---|---|
| 1UG3CA287109-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Huntsman Cancer Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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). |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Indy Li, MS | Contact | 801-213-5697 | Indy.li@hci.utah.edu |
| Name | Affiliation | Role |
|---|---|---|
| David Wetter, PhD, MS | Huntsman Cancer Institute/ University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Huntsman Cancer Institute/University of Utah | Salt Lake City | Utah | 84112 | United States |
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| 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. |
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| 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. |
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| 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. |
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| Chatbot (CA) | Behavioral | Access to a chatbot for frequently asked questions about LCS |
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| Video (VID) | Behavioral | An educational video about LCS |
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| Reactive Patient Navigation (RPN) | Behavioral | RPN to help complete the LCS appointment. RPN requires the participant to initiate the PN request |
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| 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. |
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| 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 |
| 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 |
| up to 30 weeks |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D014743 | Videotape Recording |
| ID | Term |
|---|---|
| D013637 | Tape Recording |
| D001296 | Audiovisual Aids |
| D018961 | Educational Technology |
| D013672 | Technology |
| D013676 | Technology, Industry, and Agriculture |
| D013690 | Television |
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