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

ConditionLung Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-80
SponsorUniversity of Utah

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 volunteers

Qualifiers

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

Design model

Sequential

Treatments tested in this trial

  • 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.

  • Chatbot (CA)

    Behavioral

    Access to a chatbot for frequently asked questions about LCS

  • Video (VID)

    Behavioral

    An educational video about LCS

  • Reactive Patient Navigation (RPN)

    Behavioral

    RPN to help complete the LCS appointment. RPN requires the participant to initiate the PN request

  • 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.

Treatment groups

18,894 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Stage 1: Repeated Text Messages (TM+)Other 1 intervention
Group B: Stage 1: Repeated Text Messages and Chatbot (TM+/CA)Other 2 interventions
Group C: Stage 1: Repeated Text Messages and Video (TM+/VID)Other 2 interventions
Group D: Stage 1: Repeated Text Messages, Chatbot, and Video (TM+/CA/VID)Other 3 interventions
Group E: Stage 2: Chatbot and Reactive Patient Navigation (CA/RPN)Other 2 interventions
Group F: Stage 2: Chatbot and Proactive Patient Navigation (CA/PPN)Other 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
up to 18 weeks
2

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.

Time frame
up to 30 weeks

Secondary outcomes

1

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.

Time frame
up to 30 weeks
2

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.

Time frame
up to 30 weeks
3

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.

Time frame
up to 18 weeks
4

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.

Time frame
up to 30 weeks

Other outcomes

1

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.

Time frame
up to 30 weeks

Sponsors and contacts

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University of Utah

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Huntsman Cancer Institute

Collaborator

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