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: 8638579
• 负责人: Margaret M Byrne
• 金额: $ 20.95万
• 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 2015-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8638579
• 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 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; public health relevance; screening; tool; usability

Abstract 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, 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 in 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.

摘要 拟议的项目将开发一个创新的基于网络的决策辅助（DA），以改善决策， 肺癌筛查（LCS）是在吸烟导致肺癌高风险人群中进行的。最近 国家肺筛查试验（NLST）数据显示， 低剂量计算机断层扫描筛查与胸部X线检查在肺癌高发人群中的比较 风险鉴于肺癌是美国癌症死亡的主要原因， 预计2012年将有160，340例死亡，新数据重新激发了人们对LCS的兴趣。然而，LCS携带 重大风险，包括高假阳性率、过度诊断、不良心理社会后果，以及 增加辐射暴露。此外，尚不清楚LCS是否会降低肺癌死亡率， 吸烟但不符合NLST资格标准的个人。因此，目前还没有明确的最佳 选择一个特定的人是否应该被筛选。参与LCS的决定应 充分了解并符合个人偏好。然而，我们之前的数据表明， 进行LCS的个体很少对风险或益处有透彻的了解。 为了应对这一迅速出现的公共卫生挑战，这项研究将1）开发一个基于网络的 决策辅助（DA），以促进高风险个体对LCS的知情决策， 肺癌（即，吸烟者），和2）评估DA管理的可行性，并建议 进行未来DA有效性随机临床试验（RCT）的方法。的内容 DA将基于我们以前的研究探索LCS决策和其他最近的研究。 目前拟议的研究的具体目标是：目标1：开发一个DA，以帮助个人 做出与他们的价值观和偏好一致的关于LCS的明智决策。我们将 基于我们以前开发的KEV框架并在以前研究的指导下开发DA， 包括我们的LCS决策研究项目目标2：对发展议程进行可行性试验， 肺癌的危险性高的人，由于大量吸烟。我们将招募参与者， 评估可行性：1）在社区环境中提供DA干预，2）进行研究 未来随机对照试验计划的程序和评估工具。 我们提出的工作是非常重要的，因为LCS的潜在风险和局限性是巨大的， 筛查NLST标准之外的人群的好处是不确定的，数百万美国人将 面临筛选的决定我们的工作也是高度创新的，因为LCS-DA可以从根本上 改善这些决策的方式。此外，将联合调查工具整合为DA的一部分 LCS是一种新的方法，以促进这一庞大的高风险人群中的知情决策。