Development and feasibility testing of a lung cancer screening decision aid

肺癌筛查决策辅助工具的开发和可行性测试

• 批准号: 8791650
• 负责人: Margaret M Byrne
• 金额: $ 16.24万
• 依托单位: UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
• 依托单位国家: 美国
• 财政年份: 2014
• 资助国家: 美国
• 起止时间: 2014-01-15 至 2016-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8791650
• 关键词: Address; American; American Cancer Society; American Lung Association; Area; Benefits and Risks; Cancer Etiology; Cessation of life; Cigarette Smoker; Communication; Complex; County; Data; Decision Aid; Decision Making; Development; Diagnosis; Dose; Effectiveness; Eligibility Determination; Ensure; Feedback; Funding; Future; Guidelines; Health; Health Personnel; Healthcare Systems; Individual; Internet; Intervention; Kentucky; Knowledge; Lung; Malignant neoplasm of lung; Methodology; Methods; Modification; National Comprehensive Cancer Network; Online Systems; Outcome; Participant; Population; Procedures; Process; Public Health; Qualifying; Radiation; Randomized Clinical Trials; Recommendation; Recruitment Activity; Relative (related person); Reporting; Research; Risk; Smoke; Surveys; Technology; Testing; Thoracic Radiography; Uncertainty; United States; Work; X-Ray Computed Tomography; base; cancer risk; cigarette smoking; community setting; decision research; design; empowerment; follow-up; high risk; improved; innovation; instrument; interest; lung cancer screening; meetings; mortality; novel strategies; preference; programs; psychosocial; screening; tool; usability

DESCRIPTION (provided by applicant): 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 given individual should be screened or not. Decisions about participating in LCS should be well informed and consistent with individual preferences. However, our 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 will 1) develop 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 2) 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 our previous studies exploring LCS decision making and other recent research. The specific aims of the currently proposed research are: Aim 1: Develop a DA to help individuals make informed decisions about LCS that are consistent with their values and preferences. We will develop the DA based on our previously developed KEV framework and guided by previous research, including our program of LCS decision research. Aim 2: Conduct a feasibility trial of the DA among individuals at high risk of lung cancer due to heavy cigarette smoking. We will recruit participants to assess feasibility of: 1) delivering the DA intervention i a community setting, and 2) conducting research procedures and assessment tools as planned for a future RCT. Our proposed work is highly significant, as the potential risks and limitations of LCS are substantial, the benefits of screening for populations outside the NLST criteria are uncertain, and millions of Americans will be facing decisions about screening. Our work is also highly innovative, as a LCS-DA can fundamentally improve the way these decisions are made. In addition, integrating a conjoint survey instrument as part of a DA for LCS is a novel approach to facilitate informed decision making among this large, high-risk population.

描述（由申请人提供）：拟议的项目将开发一种创新的基于Web的决策援助（DA），以改善由于吸烟而患有肺癌高风险的个体中肺癌筛查（LCS）的决策。最近的国家肺筛查试验（NLST）数据表明，与高肺癌风险的个体中的胸部X射线相比，低剂量计算机断层扫描筛查的肺癌死亡率相对降低了20％。鉴于肺癌是美国癌症死亡的主要原因，估计预计2012年的160,340例死亡，因此新数据已重振了对LCS的兴趣。但是，LCS具有重大风险，包括高误报率，过度诊断，不良的社会心理后果和增加的辐射暴露。此外，尚不清楚LCS是否会降低吸烟但不符合NLST资格标准的人的肺癌死亡率。因此，目前没有明确的最佳选择对于是否应该筛选给定个人。有关参加LCS的决定应得到充分了解，并且与个人偏好一致。但是，我们以前的数据表明，经历LCS的个人很少对风险或福利有透彻的了解。为了应对这一迅速新兴的公共卫生挑战，这项研究将1）开发基于网络的决策援助（DA），以促进有关肺癌高风险（即吸烟者）的个人LC的明智决策做出，并2）评估DA管理的可行性 并提出了进行DA有效性的未来随机临床试验（RCT）的拟议方法。 DA的内容将基于我们以前的研究，探讨了LCS决策和其他最近的研究。当前提出的研究的具体目的是：目标1：开发DA，以帮助个人对与其价值观和偏好一致的LC做出明智的决定。我们将根据先前开发的KEV框架开发DA，并在先前的研究中进行指导，包括我们的LCS决策研究计划。目标2：进行 由于大量吸烟而导致的肺癌高风险的个体对DA的可行性试验。我们将招募参与者评估：1）提供DA干预I社区环境，以及2）为未来RCT计划进行研究程序和评估工具。我们的 拟议的工作非常重要，因为LC的潜在风险和局限性很大， 在NLST标准以外的人群筛查的好处是不确定的，数以百万计的美国人将面临有关筛查的决定。我们的工作也具有很高的创新性，因为LCS-DA可以从根本上改善这些决定的做出方式。此外，将联合调查工具整合为LCS的DA的一部分是一种新型的方法，可以促进这个大型高风险人群中明智的决策。