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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Randomized Controlled Trial (RCT) of Patient Navigation for Lung Cancer Screening in an Urban Safety-Net System

Conditions
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Non-Small Cell Lung Carcinoma, Compliance Behavior, Prevention Harmful Effects

Intervention / Treatment
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* Behavioral: Patient Navigation


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Completion |  | 3 years |