Clinical trial NCT02758054: 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
Overall status: COMPLETED
Phase: NA
Conditions: Non-Small Cell Lung Carcinoma
Compliance Behavior
Prevention Harmful Effects
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
Collaborators: name: Cancer Prevention Research Institute of Texas
First posted: 2016-05-02
Enrollment: 447
Sex: ALL
Minimum age (years): 55
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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.

Primary outcomes:
measure: Rate of Completion
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
state: Texas
Study officials:
affiliation: University of Texas Southwestern Medical Center
name: David Gerber
role: PRINCIPAL_INVESTIGATOR
References:
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.