Patient Navigation for Lung Cancer Screening in an Urban Safety-Net System
A Randomized Controlled Trial (RCT) of Patient Navigation for Lung Cancer Screening in an Urban Safety-Net System
1 other identifier
interventional
447
1 country
1
Brief Summary
The study proposes to evaluate a patient navigation intervention among a sample of 446 individuals referred for CT-based lung cancer screening in an urban safety-net setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 25, 2016
CompletedFirst Posted
Study publicly available on registry
May 2, 2016
CompletedStudy Start
First participant enrolled
June 16, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2020
CompletedApril 6, 2023
April 1, 2023
2.7 years
April 25, 2016
April 5, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of Completion
3 years
Study Arms (2)
Usual Care
NO INTERVENTIONParticipants will experience standard practice for lung cancer early detection.
Usual Care + Patient Navigation
EXPERIMENTALParticipants will experience standard practice for lung cancer early detection plus the intervention.
Interventions
Patient navigated reminder calls containing information about screening appointments, reminders, hints to facilitate communication with physicians, and smoking cessation.
Eligibility Criteria
You may qualify if:
- Patients referred for lung cancer screening using a low-dose CT scan modality who are considered high risk by USPSTF guidelines.
- Patients who speak English or Spanish
You may not qualify if:
- Patients who do not speak English or Spanish
- Patients who are or become ineligible as defined by USPSTF guidelines for lung cancer screening.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, 75390, United States
Related Publications (2)
Lee SJC, Lee J, Zhu H, Chen PM, Wahid U, Hamann HA, Bhalla S, Cardenas RC, Natchimuthu VS, Johnson DH, Santini NO, Patel HR, Gerber DE. Assessing Barriers and Facilitators to Lung Cancer Screening: Initial Findings from a Patient Navigation Intervention. Popul Health Manag. 2023 Jun;26(3):177-184. doi: 10.1089/pop.2023.0053. Epub 2023 May 19.
PMID: 37219548DERIVEDGerber DE, Hamann HA, Santini NO, Abbara S, Chiu H, McGuire M, Quirk L, Zhu H, Lee SJC. Patient navigation for lung cancer screening in an urban safety-net system: Protocol for a pragmatic randomized clinical trial. Contemp Clin Trials. 2017 Sep;60:78-85. doi: 10.1016/j.cct.2017.07.003. Epub 2017 Jul 5.
PMID: 28689056DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Gerber
University of Texas Southwestern Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PROFESSOR
Study Record Dates
First Submitted
April 25, 2016
First Posted
May 2, 2016
Study Start
June 16, 2017
Primary Completion
February 28, 2020
Study Completion
February 28, 2020
Last Updated
April 6, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will share