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

Sponsor
University of Texas Southwestern Medical Center (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02758054
Collaborator
Cancer Prevention Research Institute of Texas (Other)
446
1
2
68.5
6.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Patient Navigation
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
446 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Screening
Official Title:
A Randomized Controlled Trial (RCT) of Patient Navigation for Lung Cancer Screening in an Urban Safety-Net System
Actual Study Start Date :
Jun 16, 2017
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Rate of Completion [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years to 74 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas Texas United States 75390

Sponsors and Collaborators

  • University of Texas Southwestern Medical Center
  • Cancer Prevention Research Institute of Texas

Investigators

  • Principal Investigator: David Gerber, University of Texas Southwestern Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
David E Gerber, PROFESSOR, University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT02758054
Other Study ID Numbers:
  • STU 122015-046
First Posted:
May 2, 2016
Last Update Posted:
Apr 1, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 1, 2022