Respondent Burden and Retention in Cancer Clinical Trials

描述(由申请人提供)：参与临床试验(CT)需要癌症患者承担多种义务，这可能会增加癌症诊断和治疗的负担。负担，也称为应答者负担，是一种在参加临床研究的重病癌症患者中尚未得到充分研究的现象。受试者对研究情况有不同的理解，并且可能愿意接受与感知到的利益相关的相当程度的负担。了解受试者自愿同意所涉及的利益-负担平衡是研究的基本原则，对于确保受试者做出关于他们参与研究的知情决定很重要。这一应用直接响应了PA对危及生命的疾病的临床决策研究的目标，因为我们的研究将调查对益处和负担的感知如何影响癌症受试者继续参加CT的临床决策。几乎没有概念性和经验性的研究来更好地了解CT保留的重要因素，包括那些同意参与临床癌症研究试验的人所感受到的好处和负担。为了更好地了解CT中的利益和负担的维度及其对癌症受试者保留的潜在影响，本研究的具体目的是：1)确定成人癌症研究受试者认为CT中的身体、心理、经济、社会和教育方面的益处和负担；2)开发用于构建初步的利益负担测量的项目，以评估癌症受试者与CT保留相关的决策；以及3)确定影响成人癌症研究受试者对CT保留的益处、负担和保留的知觉的因素。这些目标将通过使用定性和定量方法的混合方法两阶段项目来实现。这项研究的第一阶段将使用面对面的半结构访谈，在30-35名参加癌症CT的癌症受试者中探索和产生关于应答者利益-负担的主题；并将利用调查结果根据这些主题制定与利益和负担相关的调查问卷项目。在第二阶段，将对109名癌症受试者进行有目的的样本调查，以便测试假设，这些假设将几个维度上的利益和负担知觉与CT中的保留有关。为这项研究组建的调查小组在哲学基础、方法论方法和对伦理问题的实证测试方面经验丰富，这些问题对于建立关于研究参与者的利益和负担以及留住的知识至关重要。研究结果将支持NINR和NCI的任务，因为探索受试者认为在临床研究中哪些是有益的和繁重的是识别早期受试者的第一步，这些受试者有“消耗的风险”。在癌症临床试验中遇到保留问题之前，及早识别和先发制人的干预可能会减轻应答者的负担，并导致重要的、资源密集型临床试验的完成。

DESCRIPTION (provided by applicant): Participation in clinical trials (CTs) requires multiple obligations by cancer patients that can add to the burden of a cancer diagnosis and treatment. Burden, also called respondent burden, is a phenomenon that has not been adequately studied in seriously ill cancer patients enrolled in clinically based research. Subjects interpret research situations differently and may be willing to accept considerable levels of burden in relationship to the perceived benefits. Understanding the benefit-burden balance involved in the voluntary consent of human subjects is a fundamental tenet of research and important to ensure subjects have made an informed decision regarding their research participation. This application directly responds to the objectives of the PA on Research on Clinical Decision Making in Life-Threatening Illness as our study will investigate how perceptions of benefit and burden influences cancer subjects' clinical decisions to remain enrolled in CTs. Little conceptual and empirical research exists to better understand factors important in CT retention, including the perceived benefit and burden to those who have consented to participate in clinical cancer research trials. To better understand the dimensions of benefit and burden in CTs and its potential influence on retention among cancer subjects, the specific aims intend to: 1) determine what adult cancer research subjects perceive as physical, psychological, economical, social, and educational benefits and burdens in CTs; 2) develop items for future use in constructing a preliminary benefit-burden measure to assess cancer subjects' decisions related to CT retention; and 3) identify the factors that influence adult cancer research subjects' perceptions of benefit and burden and retention in CTs. These aims will be met through a mixed methods two phase project using qualitative and quantitative methods. Phase I of this study will explore and generate themes about respondent benefit-burden in 30-35 cancer subjects enrolled in cancer CTs using face-to-face semi-structured interviews; and will use the findings to develop survey questionnaire items related to benefit and burden based on these themes. In Phase Two, a purposive sample of 109 cancer subjects will be surveyed so that hypotheses can be tested that relate perceptions of benefit and burden on several dimensions to retention in CTs. The investigative team assembled for this study is experienced in philosophical foundations, methodological approaches and empirical testing of ethical issues central to building knowledge about benefit and burden and retention of research participants. Study findings will support the missions of both NINR and NCI as exploring what subjects believe to be beneficial and burdensome in clinical research is a first step at identifying early subjects who are "at-risk for attrition." Early identification and pre-emptive interventions prior to encountering retention problems in cancer clinical trials may mitigate respondent burden and lead to completion of important, resource intensive clinical trials.