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

基本信息

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
项目类别：
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

项目摘要

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）：拟议项目将开发一种创新的基于网络的决策辅助（DA），以改善因吸烟而患肺癌高风险个体的肺癌筛查（LCS）决策。最近的国家肺部筛查试验 (NLST) 数据表明，在肺癌高危人群中，与胸部 X 光检查相比，低剂量计算机断层扫描筛查的肺癌死亡率相对降低了 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 人死于肺癌，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、不良心理社会后果以及辐射暴露增加。此外，尚不清楚 LCS 是否会降低吸烟但不符合 NLST 资格标准的个体的肺癌死亡率。因此，对于特定个体是否应该进行筛查，目前还没有明确的最佳选择。关于参加 LCS 的决定应该充分了解并符合个人偏好。然而，我们之前的数据表明，接受 LCS 的个人很少对风险或收益有透彻的了解。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)，以促进肺癌高风险个体（即吸烟者）做出有关 LCS 的知情决策，以及 2) 评估DA管理的可行性并提出了未来进行 DA 有效性随机临床试验 (RCT) 的方法。发展议程的内容将基于我们之前探索濒海战斗舰决策的研究和其他近期研究。目前提出的研究的具体目标是：目标 1：制定 DA 来帮助个人就 LCS 做出符合其价值观和偏好的明智决策。我们将根据之前开发的 KEV 框架并以之前的研究（包括我们的濒海战斗舰决策研究计划）为指导来开发 DA。目标 2：开展在因大量吸烟而患肺癌的高风险人群中进行 DA 的可行性试验。我们将招募参与者来评估以下方面的可行性：1）在社区环境中进行 DA 干预，2）按照未来随机对照试验的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，因为濒海战斗舰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尚不确定，数百万美国人将面临有关筛查的决定。我们的工作也具有高度创新性，因为 LCS-DA 可以从根本上改进这些决策的制定方式。此外，将联合调查工具整合为濒海战斗舰发展议程的一部分是一种新方法，有助于在这一庞大的高风险人群中做出明智的决策。