Compliance With Lung Cancer Screening

遵守肺癌筛查

• 批准号: 7663432
• 负责人: Ilana F Gareen
• 金额: $ 8.07万
• 依托单位: BROWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2009
• 资助国家: 美国
• 起止时间: 2009-06-01 至 2011-05-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7663432
• 关键词: Adherence; Age; American College of Radiology; American College of Radiology Imaging Network; Area; Benign; Characteristics; Clinical Trials; Communities; Country; Data; Demographic Factors; Diagnosis; Diagnostic; Disease; Dose; Educational Background; Effectiveness; Family history of; Future; Health; Health Status; Income; Intervention; Lead; Lung; Malignant Neoplasms; Malignant neoplasm of lung; Measures; Modeling; Outcome; Participant; Phase; Population Research; Probability; Race; Randomized; Randomized Clinical Trials; Recording of previous events; Reporting; Risk; Schedule; Screening Result; Screening for cancer; Screening procedure; Site; Smoking Behavior; Smoking History; Smoking Status; Spiral Computed Tomography; Staging; Target Populations; Techniques; Technology; Testing; Thoracic Radiography; Time; United States; Upper arm; Woman; Work; X-Ray Computed Tomography; base; clinical practice; efficacy testing; follow-up; health related quality of life; improved; indexing; interest; lung cancer screening; mortality; non-compliance; sex; therapy design

DESCRIPTION (provided by applicant): Randomized cancer screening trials are considered the best approach for evaluating new cancer screening technologies. Unfortunately, these trials may underestimate the efficacy of a new screening technique if study participants fail to comply with screening, diagnostic confirmation, or treatment. In this study, we propose to examine the factors associated with cancer screening nonadherence in a large, multi-center lung cancer screening trial. This study will be conducted using existing data collected as part of the American College of Radiology (ACRIN) arm of the National Lung Screening Trial (NLST). ACRIN is responsible for screening 18,843 participants at 23 sites across the United States. These participants are currently being followed to determine whether screening with low-dose spiral computed tomography (CT) or chest X-ray (CXR) reduces lung cancer mortality. We will focus on participants who receive a diagnosis at the baseline screening exam that is negative or false positive for lung cancer (meaning that the screening exam is positive, but further testing indicates that the screening abnormality is benign). Our first aim in this trial is to determine whether participants who receive a diagnosis that is false positive for lung cancer at the baseline screening exam are less likely to return for screening at their next scheduled screening exam than are participants who receive a screening result negative for lung cancer. Our second aim in this trial is to identify those participant characteristics, measured before the baseline screening exam, that are associated with nonadherence at the next scheduled screening exam. In this phase of the study, we plan to examine the influence of demographic factors, including sex, age, race, education level, income, area of the country, as well as health history, family history of lung cancer, smoking status and history, health related quality of life indices, and perceived risk of lung cancer. Obtaining information on characteristics associated with noncompliance is useful for two reasons: 1) Information on characteristics associated with noncompliance can be used to better target interventions and reduce nonadherence in future clinical trials and clinical practice, and 2) The standard approach to analyzing clinical trials is the intent to treat (ITT) analysis, in which the outcome of interest is compared between the two randomization groups regardless of participant noncompliance. Using an ITT analysis, however, assumes that the noncompliance rate observed in the trial will be equal to that in the communities in which the intervention will be implemented. This is often not the case. In screening trials, with many participants and few anticipated cancer cases, noncompliance by even a small proportion of participants with screening, follow-up, or treatment, may lead to inaccurate estimates of the efficacy of the screening exam. This study focuses on noncompliance at the screening stage. Future work will examine noncompliance with diagnostic follow-up and treatment and use the information on noncompliance to developed models that estimate the potential effectiveness of lung cancer screening under different conditions and in different target populations. This study proposes to examine factors that are associated with cancer screening nonadherence. Information on the reasons for nonadherence may be used to develop tailored interventions designed to improve adherence in future clinical trials and in clinical practice. This information may also be used to develop models that estimate the potential effectiveness of lung cancer screening under different conditions and in different target populations.

描述（由申请人提供）：随机癌症筛查试验被认为是评估新的癌症筛查技术的最佳方法。不幸的是，如果研究参与者无法遵守筛查，诊断确认或治疗，这些试验可能会低估新筛查技术的功效。在这项研究中，我们建议在一项大型多中心肺癌筛查试验中检查与癌症筛查不依从性相关的因素。这项研究将使用现有数据作为美国国家肺部筛查试验（NLST）的美国放射学学院（ACRIN）部门的一部分进行。 Acrin负责在美国23个地点筛选1843名参与者。目前正在遵循这些参与者，以确定使用低剂量螺旋计算机断层扫描（CT）或胸部X射线（CXR）筛查是否会降低肺癌的死亡率。我们将专注于在基线筛查考试中接受诊断的参与者，该检查对肺癌的阳性或假阳性（这意味着筛查检查是​​阳性的，但进一步的检查表明筛查异常是良性的）。我们在这项试验中的第一个目的是确定在基线筛查检查中接受肺癌呈假阳性的诊断的参与者在下一次预定的筛查检查中返回筛查的可能性较小，而对肺癌的筛查结果为阴性的参与者。我们在这项试验中的第二个目标是确定在基线筛查考试之前测量的那些参与者特征，这些特征与下一次预定的筛选考试有关。在研究的这一阶段，我们计划研究人口因素的影响，包括性别，年龄，种族，教育水平，收入，国家领域以及健康史，肺癌家族史，吸烟状况和历史，与健康相关的生活质量指数以及感知的肺癌风险。获取与不符合性相关的特征的信息有两个原因：1）有关与非遵从性相关的特征的信息，可以用来更好地靶向干预措施，并在未来的临床试验和临床实践中降低不依赖性，而2）分析临床试验的标准方法是对（ITT）分析的意图（ITT）分析，而不是进行两次不合格群体之间的结果。但是，使用ITT分析，假设试验中观察到的不符合率的率将等于将实施干预措施的社区。通常情况并非如此。在筛查试验中，由于许多参与者和预期的癌症病例很少，即使是少数参与者进行筛查，随访或治疗的不合规性，可能会导致筛查检查功效的估计不准确。这项研究的重点是在筛查阶段的违规行为。未来的工作将检查与诊断随访和治疗的不合规，并使用违规的信息与开发的模型，以估计在不同条件和不同目标人群中肺癌筛查的潜在有效性。这项研究建议检查与癌症筛查不遵守相关的因素。有关不遵守原因的信息可用于制定量身定制的干预措施，旨在提高未来的临床试验和临床实践中的依从性。该信息还可以用于开发模型，以估计在不同条件和不同目标种群中肺癌筛查的潜在有效性。