Emergency Department Lung Cancer URMFG Pilot
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Emergencies
Study type: Interventional

Summary: 
      This is a randomized controlled pilot trial of a text-based behavioral intervention aimed at
      increasing uptake of lung cancer screening among emergency department patients. We will
      conduct a 2-year randomized controlled clinical trial with a prospectively collected
      convenience sample of 366 adults who are eligible for LCS but non-adherent with LCS screening
      guidelines. Adults aged 50-80 will be recruited from a high-volume urban ED and a low-volume
      rural ED, assigned to study conditions, and followed-up at 150 days to assess interval
      engagement with the University of Rochester Medical Center's LCS screening program (primary
      outcome). Electronic Health Record (EHR) review will be conducted to assess screening results
      and subsequent clinical endpoints.
    

Detailed description: 
      Lung cancer is the number one cancer cause of death in the US1 accounting for a quarter of
      all cancer deaths. Five-year survival for lung cancer is just 19%. However, early detection
      of lung cancer increases 5-year survival three-fold and lung cancer screening (LCS) among
      high-risk patients using low-dose CT scan is cost-effective and has been proven to reduce
      lung cancer mortality by approximately 20%. Despite this potential, uptake of LCS has been
      poor with only 14.4% of eligible patients found to have been screened in a recent 10 state
      study. Indeed, the US Department of Health & Human Services and the USPSTF have both
      explicitly prioritized increasing the uptake of LCS among their goals. In 2021, the USPSTF
      revised the eligibility criteria for LCS, expanding the age range to 50-80 and lowering the
      pack-year threshold to 20.

      The Emergency Department (ED) is an ideal setting to target an intervention aimed at
      increasing LCS uptake because the patient populations most in need are available for
      intervention. Our team has been at the forefront of ED-based cancer prevention efforts,
      serving as investigators on preventive work on cervical cancer and smoking cessation. EDs
      care for a disproportionate number of patients with the socio-economic factors that are
      associated with vulnerability to non-adherence with LCS including non-White race, lower
      income, and lack of health insurance. Moreover, smoking accounts for 90% of all lung cancer
      and ED patients have a higher smoking prevalence than the general population. In addition, ED
      visits generally involve periods of waiting during which preventive health needs can be
      assessed and intervened upon. LCS is a complex process - it is more than just an imaging
      study. However, the first critical step is to engage high-risk patients with this process.
      USPSTF has emphasized the importance of "pathways besides referral from primary care" to the
      success of this effort.

      The vast majority of Americans - 95% - own a cell phone and an estimated 98% of all cell
      phones have SMS capabilities. Importantly, while there still exists a "digital divide" with
      regards to home computing among Americans of different backgrounds, phone ownership is nearly
      identical among white, black, and Hispanic Americans. SMS health interventions have been
      studied for over a decade and have been proven effective for a wide range of applications
      including smoking cessation, diabetes self care, and breast cancer screening. SMS
      interventions are low-cost, not staff-intensive, simple, familiar, scalable, tailorable to
      individuals, instantaneous in delivery, asynchronous in receipt, reproducible, and accessible
      regardless of geographical or socioeconomic factors. Our project adapts and targets this
      effective technology to improve LCS uptake among ED patients.

      An empirically supported theoretical framework is central to developing an effective
      behavioral intervention, particularly in a setting like the ED where a long-term therapeutic
      relationship cannot be leveraged. The proposed trial makes use of two complementary theories:
      the Theory of Planned Behavior (TPB) and Self-Determination Theory (SDT). The TPB posits that
      the strongest predictor of a behavior is the intention to engage in the behavior. These
      intentions are predicted by an individual's attitudes toward the behavior, subjective
      normative beliefs about the behavior, and perceived control over whether they can perform the
      behavior. SDT states that individuals are motivated to engage in behaviors that satisfy the
      needs for (a) autonomy, (b) competence, and (c) relatedness. Individuals are autonomously
      motivated when these needs are met, which leads to engagement in a behavior.

      The proposed study will utilize a randomized, prospectively collected, convenience sample and
      a longitudinal design with a sample size of 366 recruited from urban and rural UR Medicine
      EDs. Research enrollers will determine adherence of patients to USPSTF LCS recommendations
      using an adaptive REDCap survey. Non-adherent patients will be randomized to intervention or
      control conditions, with patients in the intervention condition receiving a series of
      theory-informed text messages encouraging them to contact their primary care provider and the
      UR LCS Program's Patient Navigator to coordinate screening, along with contact information to
      do so. Follow-up to determine LCS program uptake (primary outcome) will occur at 150 days, at
      which time feedback will also be solicited.
    

Intervention name(s): Text Messaging
Intervention type(s): Behavioral
Intervention description(s): A series of theory-informed text messages encouraging them to contact their primary care provider and the UR LCS Program's Patient Navigator to coordinate screening, along with contact information to do so.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The proposed study will utilize a randomized, prospectively collected, convenience sample and a longitudinal design.
Masking: None (Open Label)
Primary purpose: Prevention