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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient Navigation
Sponsored by
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Non-Small Cell Lung Carcinoma

Eligibility Criteria

55 Years - 74 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care

Usual Care + Patient Navigation

Arm Description

Participants will experience standard practice for lung cancer early detection.

Participants will experience standard practice for lung cancer early detection plus the intervention.

Outcomes

Primary Outcome Measures

Rate of Completion

Secondary Outcome Measures

Full Information

First Posted
April 25, 2016
Last Updated
April 5, 2023
Sponsor
University of Texas Southwestern Medical Center
Collaborators
Cancer Prevention Research Institute of Texas
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1. Study Identification

Unique Protocol Identification Number
NCT02758054
Brief Title
Patient Navigation for Lung Cancer Screening in an Urban Safety-Net System
Official Title
A Randomized Controlled Trial (RCT) of Patient Navigation for Lung Cancer Screening in an Urban Safety-Net System
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 16, 2017 (Actual)
Primary Completion Date
February 28, 2020 (Actual)
Study Completion Date
February 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Texas Southwestern Medical Center
Collaborators
Cancer Prevention Research Institute of Texas

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Carcinoma, Compliance Behavior, Prevention Harmful Effects

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
447 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Participants will experience standard practice for lung cancer early detection.
Arm Title
Usual Care + Patient Navigation
Arm Type
Experimental
Arm Description
Participants will experience standard practice for lung cancer early detection plus the intervention.
Intervention Type
Behavioral
Intervention Name(s)
Patient Navigation
Intervention Description
Patient navigated reminder calls containing information about screening appointments, reminders, hints to facilitate communication with physicians, and smoking cessation.
Primary Outcome Measure Information:
Title
Rate of Completion
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Gerber
Organizational Affiliation
University of Texas Southwestern Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
28689056
Citation
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.
Results Reference
derived

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

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