Emergency Department Lung Cancer URMFG Pilot

NCT04979169 | Completed

• 1 other identifier: 00006395
• Study Type: interventional
• Target: 303
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Cancer

Outcome Measures

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

  150 days

Secondary Outcomes (2)

• Quality Indicators

  150 days

• Barriers and Perceptions about Lung Cancer Screening

  150 days

Study Arms (2)

Non-adherent control

NO INTERVENTION

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

Non-adherent intervention

EXPERIMENTAL

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

Text Messaging BEHAVIORAL

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.

Non-adherent intervention

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 50 - 80
• + 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

Strong Hospital

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• David Adler, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The proposed study will utilize a randomized, prospectively collected, convenience sample and a longitudinal design.

Study Record Dates

• First Submitted: July 16, 2021
• First Posted: July 28, 2021
• Study Start: December 8, 2021
• Primary Completion: August 10, 2023
• Study Completion: August 10, 2023
• Last Updated: August 15, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)