Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
340

Summary

Conditions
  • Compliance Behavior
  • Non Small Cell Lung Carcinoma
  • Prevention Harmful Effects
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Investigator)Primary Purpose: Screening

Participation Requirements

Age
Between 55 years and 74 years
Gender
Both males and females

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 medi...

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.

Tracking Information

NCT #
NCT02758054
Collaborators
Cancer Prevention Research Institute of Texas
Investigators
Principal Investigator: David Gerber University of Texas Southwestern Medical Center