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临床试验/NCT02790866
NCT02790866已完成不适用

Development and Feasibility Testing of a Lung Cancer Screening Decision Aid

Jamie Studts4 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
4
主要终点
Satisfaction Rate POST

研究概览

简要总结

This study evaluates the feasibility and acceptability of LuCaS Choices, a web-based decision aid designed to facilitate informed decision making about participation in lung cancer screening among individuals at high risk of lung cancer due to heavy cigarette smoking.

详细描述

The proposed project will develop an innovative web-based decision aid (DA) to improve decision making for lung cancer screening (LCS) among individuals at high risk for lung cancer due to cigarette smoking. Recent National Lung Screening Trial (NLST) data demonstrated a 20% relative reduction in lung cancer mortality for low dose computed tomography screening as compared to chest X-ray among individuals at high lung cancer risk. Given that lung cancer is the leading cause of cancer death in the United States with an estimated 160,340 deaths predicted for 2012, the new data have reinvigorated interest in LCS. However, LCS carries substantial risks including a high false positive rate, over-diagnosis, adverse psychosocial consequences, and increased radiation exposure. Further, it is unknown whether LCS would reduce lung cancer mortality among individuals who smoke but do not meet NLST eligibility criteria. Therefore, there is currently no clear best choice for whether a given individual should be screened or not. Decisions about participating in LCS should be well informed and consistent with individual preferences. However, previous data indicate that individuals who do undergo LCS rarely have a thorough understanding of the risks or benefits.

To address this rapidly emerging public health challenge, this research has developed a web-based decision aid (DA) to facilitate informed decision making regarding LCS in individuals at high risk for lung cancer (i.e., cigarette smokers), and will assess feasibility of DA administration and proposed methods for conducting a future randomized clinical trial (RCT) of DA effectiveness. The content of the DA will be based on the investigators previous studies exploring LCS decision making and other recent research.

The specific aim of the currently proposed research are to conduct a feasibility trial of the DA among individuals at high risk of lung cancer due to heavy cigarette smoking. Investigators will recruit participants to assess feasibility of: 1) delivering the DA intervention in a community setting, and 2) conducting research procedures and assessment tools as planned for a future RCT.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • be at least 40 years of age
  • history of 20 or more pack years of smoking
  • ability to read and understand English
  • must have a personal phone
  • must have Internet access

排除标准

  • reporting or demonstrating significant psychological distress

研究组 & 干预措施

LuCaS Decision Aid

Experimental

Access to LuCaS, a web-based lung cancer screening decision aid

干预措施: LuCaS Decision Aid (Behavioral)

NCI Website

Active Comparator

Access to NCI website on lung cancer screening

干预措施: NCI Website (Behavioral)

结局指标

主要结局

Satisfaction Rate POST

时间窗: Two Weeks (POST)

Percentage of participants who indicated they were satisfied with LuCaS Choices or National Cancer Institute (NCI) website

Access Rate POST

时间窗: Two Weeks (POST)

Percentage of participants who access LuCaS Choices or National Cancer Institute (NCI) website

Recommendation Rate POST

时间窗: Two Weeks (POST)

Percentage of participants who would recommend LuCaS Choices or National Cancer Institute (NCI) website to others who want to learn more about lung cancer screening

Continued Access Rate POST

时间窗: Two Weeks (POST)

Percentage of participants who wish to have continued access to LuCaS Choices or National Cancer Institute (NCI) website

Retention Rate POST

时间窗: Two Weeks (POST)

Percentage of participants who complete the POST survey

Retention Rate FOL

时间窗: Four Months (FOL)

Percentage of participants who complete the FOL survey

次要结局

  • Continued Access Rate FOL(Four Months (FOL))
  • Satisfaction Rate FOL(Four Months (FOL))
  • Access Rate FOL(Four Months (FOL))
  • Recommendation Rate FOL(Four Months (FOL))

研究者

发起方
Jamie Studts
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jamie Studts

Associate Professor

University of Kentucky

研究点 (4)

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