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临床试验/NCT02758054
NCT02758054已完成不适用

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

University of Texas Southwestern Medical Center2 个研究点 分布在 1 个国家目标入组 447 人开始时间: 2017年6月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
447
试验地点
2
主要终点
Rate of Completion

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
Single (Investigator)

入排标准

年龄范围
55 Years 至 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Patients who do not speak English or Spanish
  • Patients who are or become ineligible as defined by USPSTF guidelines for lung cancer screening.

结局指标

主要结局

Rate of Completion

时间窗: 3 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David E Gerber

PROFESSOR

University of Texas Southwestern Medical Center

研究点 (2)

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