Increasing Lung Cancer Screening Uptake Among Emergency Department Patients

NCT ID: NCT07287085

Last Updated: 2025-12-17

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 349 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-31
• Study Completion Date: 2028-11-30

Brief Summary

The objective of the proposed clinical trial is to determine if we can increase LCS among ED patients using a combination of facilitated referral to an LCS program plus text message reminders to get screened. Step 1 of the approach is to identify participants that are eligible for LCS. Step 2 is to randomize eligible study participants between two study arms: (1) basic referral for LCS (i.e.

verbal referral with written materials), and (2) facilitated referral for LCS (i.e. submission of a requisition to LCS program by staff) plus a subsequent series of text messages aimed at generating intention and motivation to get screened. The investigators' preliminary work showed this approach was feasible in the ED setting. The proposed study will build on this preliminary work with the goal of having a significant positive impact on LCS uptake.

A total of 300 individuals eligible for LCS will be recruited from a high-volume urban ED, randomized between study arms, and followed-up at 120 days to assess interval LCS uptake. The Specific Aims of the proposed project are, (1) Compare LCS uptake between the two study arms, (2) Identify predictors of individuals that are not up-to-date with LCS at the time of enrollment, and (3) Evaluate study participant feedback on (a) barriers and facilitators to getting screened and (b) acceptability and appropriateness of ED-based promotion of LCS. The study team is at the forefront of developing ED-based interventions to promote cancer screening. This project leverages the universal access setting of the ED to identify individuals at greatest risk for lung cancer and get them screened. A scalable ED-based intervention that increases LCS uptake would save lives.

Conditions

Screening Compliance; Lung Cancer (Diagnosis); Lung Cancer Diagnosis; Lung Cancer

Keywords

screening; lung cancer; screening compliance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Basic Referral (enhanced control arm)

Participants assigned to Arm 1 will be referred to the UR Medicine LCS Program and their primary care provider (if they have one) to discuss LCS. They will also be provided with written materials that include telephone contact information for the LCS Program Navigator.

Group Type: ACTIVE_COMPARATOR

Basic Referral (enhanced control arm)

Intervention Type: BEHAVIORAL

They will also be provided with written materials that include telephone contact information for the LCS Program Navigator. If contacted, the LCS Program Navigator will conduct a shared decision-making (SDM) discussion, schedule the screening CT scan at one of the 8 regional American College of Radiology-designated LCS centers and arrange follow-up as needed. Since determination of LCS needs is not routine during an ED visit, this "control arm" reflects an enhancement over usual care. It would not be ethical to identify a patient with screening needs without providing a referral.

Facilitated Referral + Text Messaging

For participants assigned to Arm 2, an LCS requisition form will be submitted to the UR Medicine LCS Program on behalf of the participant during their ED visit. The participant's primary care provider (if they have one) will be CC'd on the requisition. Participants will be instructed that the LCS program will reach out to them to discuss LCS and, if decided upon, schedule screening. An LCS Program Navigator will call the participant by phone, conduct a shared decision-making discussion, and schedule the screening CT scan (assuming eligibility is confirmed and the discussion results in the participant's decision to schedule screening). In addition, participants in Arm 2 will receive a series of text messages, grounded in the TPB, SDT, and HBM aimed at generating intention and motivation to get LCS.

Group Type: EXPERIMENTAL

Facilitated referral and text messaging

Intervention Type: BEHAVIORAL

Participants randomized to the experimental arm will be instructed that the LCS program will reach out to them to discuss LCS and, if decided upon, schedule screening. An LCS Program Navigator will call the participant by phone, conduct a shared decision-making discussion, and schedule the screening CT scan (assuming eligibility is confirmed and the discussion results in the participant's decision to schedule screening). In addition, participants in Arm 2 will receive a series of text messages, grounded in the TPB, SDT, and HBM aimed at generating intention and motivation to get LCS.

Interventions

Facilitated referral and text messaging

Participants randomized to the experimental arm will be instructed that the LCS program will reach out to them to discuss LCS and, if decided upon, schedule screening. An LCS Program Navigator will call the participant by phone, conduct a shared decision-making discussion, and schedule the screening CT scan (assuming eligibility is confirmed and the discussion results in the participant's decision to schedule screening). In addition, participants in Arm 2 will receive a series of text messages, grounded in the TPB, SDT, and HBM aimed at generating intention and motivation to get LCS.

Intervention Type: BEHAVIORAL

Basic Referral (enhanced control arm)

They will also be provided with written materials that include telephone contact information for the LCS Program Navigator. If contacted, the LCS Program Navigator will conduct a shared decision-making (SDM) discussion, schedule the screening CT scan at one of the 8 regional American College of Radiology-designated LCS centers and arrange follow-up as needed. Since determination of LCS needs is not routine during an ED visit, this "control arm" reflects an enhancement over usual care. It would not be ethical to identify a patient with screening needs without providing a referral.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Age 50 - 80
• ≥ 20 pack-year smoking history
• current smoker or quit within 15 years
• English speaking
• Current patient in URMC involved Emergency Department

Exclusion Criteria

• Non-English
• Inability to provide consent (e.g. high clinical acuity, cognitive deficit)
• Lack of text-capable mobile phone and/or inability to use text function
• Not being a patient in URMC involved Emergency Department There are no restrictions for gender, racial and ethnic origins.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Lung Cancer Research Foundation

OTHER

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Rochester

Rochester, New York, United States

Countries

United States

Central Contacts

Peter MacDowell

Role: CONTACT

Phone: 585-274-1509

Email: peter_macdowell@urmc.rochester.edu

Facility Contacts

Peter MacDowell

Role: primary

Nancy Wood

Role: backup

Other Identifiers

FP 9214

Identifier Type: -

Identifier Source: org_study_id