NCT06360822

Brief Summary

The overall objective of this mixed methods study is to: 1) Refine the Emergency Department Lung Cancer Screening (ED-LCS) intervention using qualitative interviews among key stakeholders; 2) pilot test the ED-LCS intervention evaluating the intervention efficacy, acceptability, and feasibility; and 3) provide an in-depth description of stakeholders' experiences with the ED-LCS intervention for future refinement.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
144

participants targeted

Target at P50-P75 for not_applicable lung-cancer

Timeline
9mo left

Started Dec 2023

Typical duration for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress77%
Dec 2023Feb 2027

Study Start

First participant enrolled

December 1, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2024

Completed
17 days until next milestone

First Posted

Study publicly available on registry

April 11, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

August 6, 2025

Status Verified

August 1, 2025

Enrollment Period

3.2 years

First QC Date

March 25, 2024

Last Update Submit

August 1, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Rate of patients receive Lung Cancer Screening

    6-12 months

Secondary Outcomes (1)

  • Patients ratings of intervention

    At delivery

Study Arms (2)

Intervention

EXPERIMENTAL

Patients will be shown a modified version of LungTalk.

Behavioral: ED-LCS

Usual Care

NO INTERVENTION

Patients will receive usual care.

Interventions

ED-LCSBEHAVIORAL

This is a lung cancer educational intervention for patients in the emergency department.

Intervention

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eligible for LCS (50-80 years old, smoked in past 15 years, and smoked at least 20 pack years)

You may not qualify if:

  • Non-English/Spanish speaking
  • Decompensated psychiatric illness (suicidal, homicidal, psychosis). Will confirm with attending physicians at time of enrollment
  • Intoxicated with alcohol or drugs
  • Cannot provide reliable follow up contact information (cell phone)
  • Presenting to the ED with a life-threatening condition
  • Have received chest CT scan in past 12 months
  • Already enrolled in LCS
  • Hospice enrolled

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eskenazi Health

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 25, 2024

First Posted

April 11, 2024

Study Start

December 1, 2023

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

August 6, 2025

Record last verified: 2025-08

Locations