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

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.

Study Overview

• Status: Completed
• Conditions: Prevention Harmful Effects; Compliance Behavior; Non-Small Cell Lung Carcinoma
• Intervention / Treatment: Behavioral: Patient Navigation

Detailed Description

Widespread implementation of CT-based lung cancer screening is underway, but its impact on cancer morbidity and mortality can only be achieved IF people are screened at appropriate intervals and abnormal findings are appropriately assessed. The degree to which individuals, especially those from medically underserved populations with highest lung cancer risks, will adhere to the complex, multi-step process of CT-based lung cancer screening has emerged as a key question with immediate need for solution. Specific aims of the study are as follows:

• Aim 1: Compare rates of completion for clinically recommended steps in the lung cancer screening process between patients referred for CT-based lung cancer screening who are randomized to the navigation intervention versus patients who receive usual care.
• Aim 2: Compare changes in patient-reported outcomes, including satisfaction with care, psychosocial distress, and tobacco use between patients in the navigation intervention versus those who receive usual care for the CT-based lung cancer screening process.
• Aim 3 (Exploratory): Explore whether differences seen in Aims 1 and 2 are moderated theory-based patient attitudes and beliefs (perceived susceptibility, severity of lung cancer, perceived benefits/barriers to screening, self-efficacy).

This study will offer unprecedented insight into implementation of lung cancer screening for high-risk individuals in underserved settings. Findings will show whether navigation interventions increase adherence to the screening process and affect patient-reported outcomes among underserved populations. The proposed program aims to address these issues for lung cancer screening at its inception, rather than after disparities in screening uptake have already emerged.

• Study Type: Interventional
• Enrollment (Actual): 447
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patients who do not speak English or Spanish
• Patients who are or become ineligible as defined by USPSTF guidelines for lung cancer screening.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care; Participants will experience standard practice for lung cancer early detection.
Experimental: Usual Care + Patient Navigation; Participants will experience standard practice for lung cancer early detection plus the intervention.	Behavioral: Patient Navigation; Patient navigated reminder calls containing information about screening appointments, reminders, hints to facilitate communication with physicians, and smoking cessation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Rate of Completion	3 years

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center
• Collaborators: Cancer Prevention Research Institute of Texas
• Investigators: Principal Investigator: David Gerber, University of Texas Southwestern Medical Center

Publications and helpful links

General Publications

• Gerber 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2017
• Primary Completion (Actual): February 28, 2020
• Study Completion (Actual): February 28, 2020

Study Registration Dates

• First Submitted: April 25, 2016
• First Submitted That Met QC Criteria: April 28, 2016
• First Posted (Estimate): May 2, 2016

Study Record Updates

• Last Update Posted (Actual): April 6, 2023
• Last Update Submitted That Met QC Criteria: April 5, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
• Other Study ID Numbers: STU 122015-046

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No