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CompletedNCT04979169Updated Aug 15, 2023

Emergency Department Lung Cancer URMFG Pilot

An interventional study of Text Messaging in Lung Cancer, sponsored by University of Rochester. Completed at 1 site in United States. Open to participants aged 50 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-08-15.

Sponsored by University of Rochester · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
303
Allocation
Randomized
Ages
50 Years to 80 Years
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Lung Cancer

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03

In context

Lung Neoplasms

7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.

This study's enrollment of 303 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.

Browse Lung Neoplasms studies →

Lead sponsor

University of Rochester is the lead sponsor of 715 studies on the registry; 116 are open to participants now.

Of its 56 completed or terminated interventional studies of FDA-regulated products, 44 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Age 50 - 80
  • 20+ pack-year smoking history
  • current smoker or quit within 15 years
  • English, ASL, or Spanish speaking
  • Presenting as a patient at the Strong Memorial or Noyes Community Hospital EDs

Exclusion criteria

Exclusion Criteria:

  • Non-English, Non-Spanish, and Non-ASL speaking
  • Inability to consent (e.g. high clinical acuity)
  • Lack of text-capable mobile phone and/or inability to use text function
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
303 participants (actual)

Study arms

  • No intervention
    Non-adherent control

    Subjects who are determined to be non-adherent to screening guidelines and are assigned to usual treatment via randomization in REDCap.

  • Experimental
    Non-adherent intervention

    Subjects who are determined to be non-adherent to screening guidelines and are assigned to intervention treatment (text messaging) via randomization in REDCap.

    Behavioral: Text Messaging

Interventions

  • BehavioralText Messaging

    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.

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What researchers measure

Primary outcomes

  1. Screening Uptake

    Comparison of non-adherent intervention and control subjects for who are compliant with screening guidelines by the 150 day assessment

    Time frame: 150 days

Secondary outcomes

  1. Quality Indicators

    Preliminarily assess quality indicators driven by engagement of study participants with the LCS program.

    Time frame: 150 days

  2. Barriers and Perceptions about Lung Cancer Screening

    Qualitative analysis of subject feedback on barriers to obtaining screening and perceptions of the intervention in order to inform refinement and implementation of the intervention.

    Time frame: 150 days

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Study locations

1 site
  • Strong Hospital
    Rochester, New York 14642, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 15, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04979169
Lead sponsor
University of Rochester
Responsible party
David Adler (Professor, University of Rochester) — Principal investigator
First posted
Jul 28, 2021
Start date
Dec 8, 2021
Primary completion
Aug 10, 2023
Completion
Aug 10, 2023
Last update
Aug 15, 2023

Study contacts

David Adler, MD
principal investigator · University of Rochester

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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