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Emergency Department Lung Cancer URMFG Pilot

Primary Purpose

Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Text Messaging
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Lung Cancer

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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:

  • 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

Sites / Locations

  • Strong Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Non-adherent control

Non-adherent intervention

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 16, 2021
Last Updated
August 13, 2023
Sponsor
University of Rochester
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1. Study Identification

Unique Protocol Identification Number
NCT04979169
Brief Title
Emergency Department Lung Cancer URMFG Pilot
Official Title
Increasing Lung Cancer Screening Uptake Among Emergency Department Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
December 8, 2021 (Actual)
Primary Completion Date
August 10, 2023 (Actual)
Study Completion Date
August 10, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The proposed study will utilize a randomized, prospectively collected, convenience sample and a longitudinal design.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
303 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Non-adherent control
Arm Type
No Intervention
Arm Description
Subjects who are determined to be non-adherent to screening guidelines and are assigned to usual treatment via randomization in REDCap.
Arm Title
Non-adherent intervention
Arm Type
Experimental
Arm Description
Subjects who are determined to be non-adherent to screening guidelines and are assigned to intervention treatment (text messaging) via randomization in REDCap.
Intervention Type
Behavioral
Intervention Name(s)
Text Messaging
Intervention Description
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.
Primary Outcome Measure Information:
Title
Screening Uptake
Description
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 Outcome Measure Information:
Title
Quality Indicators
Description
Preliminarily assess quality indicators driven by engagement of study participants with the LCS program.
Time Frame
150 days
Title
Barriers and Perceptions about Lung Cancer Screening
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Adler, MD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
Strong Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Emergency Department Lung Cancer URMFG Pilot

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