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

NCT ID: NCT02758054

Last Updated: 2023-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 447 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-16
• Study Completion Date: 2020-02-28

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: SINGLE

Study Groups

Usual Care

Participants will experience standard practice for lung cancer early detection.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Usual Care + Patient Navigation

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

Group Type: EXPERIMENTAL

Patient Navigation

Intervention Type: BEHAVIORAL

Patient navigated reminder calls containing information about screening appointments, reminders, hints to facilitate communication with physicians, and smoking cessation.

Interventions

Patient Navigation

Patient navigated reminder calls containing information about screening appointments, reminders, hints to facilitate communication with physicians, and smoking cessation.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Cancer Prevention Research Institute of Texas

OTHER

Sponsor Role: collaborator

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Responsible Party

David E Gerber

PROFESSOR

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Gerber

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

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

Dallas, Texas, United States

Countries

United States

References

Lee SJC, Lee J, Zhu H, Chen PM, Wahid U, Hamann HA, Bhalla S, Cardenas RC, Natchimuthu VS, Johnson DH, Santini NO, Patel HR, Gerber DE. Assessing Barriers and Facilitators to Lung Cancer Screening: Initial Findings from a Patient Navigation Intervention. Popul Health Manag. 2023 Jun;26(3):177-184. doi: 10.1089/pop.2023.0053. Epub 2023 May 19.

Reference Type: DERIVED

PMID: 37219548 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28689056 (View on PubMed)

Other Identifiers

STU 122015-046

Identifier Type: -

Identifier Source: org_study_id