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

Study ID
STU 122015-046

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

  • Parkland Health & Hospital System
  • UT Southwestern-Other

Contact
Molly McGuire
214/648-7976
Molly2.McGuire@UTSouthwestern.edu

Principal Investigator
David Gerber, M.D.

Summary

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.

Within Parkland Health and Hospital Systems, the safety-net provider for Dallas County, this study proposes a randomized controlled trial (RCT) comparing patients who do vs. do not receive patient navigation. 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 1a: included in our analysis of usual care, we will analyze a group of patients supplemental to those enrolled in the trial of patient navigation. in order to provide Parkland with a full understanding of the operationalization of clinical guidelines across various primary care settings, this includes any patient whose physicians refer them for lung cancer screening. using eMR extraction, we will review the prospective records for all referred patients of all ages and languages spoken. These patients will not be contacted.

* aim 2: Compare changes in patient-reported outcomes, including satisfaction with care, quality of life, 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.

Participant Eligibility

Study participants include Parkland patients who have received a physician's order for a low-dose CT for lung cancer screening purposes. In order to be referred initially within Parkland standard of care procedures, the patient must be deemed
* high-risk
* according to the U.S. Preventive Services Task Force (USPSTF).
* High risk
* patients are defined as:

* Patients who are between 55-74 years

* with a least a 30 pack-year smoking history

* and who are currently smoking or have quit within the past 15 years

To participate in our study, patients must speak English or Spanish.