Patient Navigation for Lung Cancer Screening in an Urban Safety-Net System

Not Applicable

Completed

• Conditions: Non-Small Cell Lung Carcinoma; Compliance Behavior; Prevention Harmful Effects
• Interventions: Behavioral: Patient Navigation

• Registration Number: NCT02758054
• Lead Sponsor: University of Texas Southwestern Medical Center

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-04-25
• Study First Submitted QC: 2016-04-28
• Study First Posted: 2016-05-02
• Study Start: 2017-06-16
• Primary Completion: 2020-02-28
• Study Completion: 2020-02-28
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-05
• Last Update Posted: 2023-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 447

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care + Patient Navigation	Patient Navigation	Participants will experience standard practice for lung cancer early detection plus the intervention.

Primary Outcome Measures

Name	Time	Method
Rate of Completion	3 years

Trial Locations

Locations (1)

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas; 🇺🇸 Dallas, Texas, United States