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Not yet recruiting NCT07599943

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

No phase Interventional Lung Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Text Messages (TM+), Chatbot (CA), Video (VID), Reactive Patient Navigation (RPN).
Who it may be relevant to
Registry conditions: Lung Cancer. Basic parameters: 50 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Population Health Management Approaches to Increase Lung Cancer Screening in Community Health Centers - LungSMART UH3 Clinical Trial

Overview

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

  • Behavioral 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.
  • Behavioral Chatbot (CA)
    Access to a chatbot for frequently asked questions about LCS
  • Behavioral Video (VID)
    An educational video about LCS
  • Behavioral Reactive Patient Navigation (RPN)
    RPN to help complete the LCS appointment. RPN requires the participant to initiate the PN request
  • Behavioral 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.

Primary outcome measures

  • Stage 1: Completion of eligibility assessment [Time frame: up to 18 weeks]
  • Stage 2: Completion of LCS [Time frame: up to 30 weeks]
Secondary outcome measures (7)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 1 center
  • Huntsman Cancer Institute/University of Utah — Salt Lake City

Identifiers

NCT: NCT07599943 · HCI190012 · 1UG3CA287109-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗