Development and feasibility testing of a lung cancer screening decision aid

描述（由申请人提供）：拟议的项目将开发一个创新的基于网络的决策辅助（DA），以改善由于吸烟而导致肺癌高风险个体的肺癌筛查（LCS）决策。最近的国家肺筛查试验（NLST）数据表明，在肺癌高风险人群中，与胸部X线检查相比，低剂量计算机断层扫描筛查的肺癌死亡率相对降低20%。鉴于肺癌是美国癌症死亡的主要原因，预计2012年将有160，340人死亡，新数据重新激发了人们对LCS的兴趣。然而，LCS具有很大的风险，包括高假阳性率，过度诊断，不良的心理社会后果和增加的辐射暴露。此外，还不清楚LCS是否会降低吸烟但不符合NLST资格标准的个人的肺癌死亡率。因此，目前还没有明确的最佳选择，以确定是否应筛选特定的个人。关于参加LCS的决定应该是充分知情的，并与个人偏好一致。然而，我们以前的数据表明，接受LCS的人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，本研究将1）开发基于网络的决策辅助（DA），以促进肺癌高危人群（即，吸烟者），以及2）评估DA给药的可行性 并提出了进行未来DA有效性随机临床试验（RCT）的方法。DA的内容将基于我们以前的研究探索LCS决策和其他最近的研究。目前提出的研究的具体目标是：目标1：发展DA，以帮助个人作出明智的决定，LCS是符合他们的价值观和偏好。我们将开发DA的基础上，我们以前开发的KEV框架和指导以前的研究，包括我们的LCS决策研究计划。目标2：开展 在因大量吸烟而患肺癌的高危人群中进行DA的可行性试验。我们将招募参与者，以评估以下可行性：1）在社区环境中提供DA干预，以及2）按照未来RCT的计划开展研究程序和评估工具。我们 拟议的工作非常重要，因为LCS的潜在风险和局限性很大， 对NLST标准之外的人群进行筛查的好处是不确定的，数百万美国人将面临是否进行筛查的决定。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，将联合调查工具作为LCS DA的一部分，是一种新的方法，可以促进这一庞大的高风险人群做出明智的决策。

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.