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重义务，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，是一种尚未在临床研究中对严重癌症患者进行充分研究的现象。受试者对研究情况的解释不同，可能愿意接受相当程度的负担与感知到的好处的关系。了解人类受试者自愿同意所涉及的获益-负担平衡是研究的基本原则，对于确保受试者就其参与研究做出知情决定非常重要。该申请直接响应了PA关于危及生命疾病临床决策研究的目标，因为我们的研究将研究获益和负担的感知如何影响癌症受试者继续入组CT的临床决策。几乎没有概念和实证研究可以更好地了解CT保留的重要因素，包括对那些同意参加临床癌症研究试验的人的感知益处和负担。为了更好地理解CT的益处和负担的维度及其对癌症受试者保留的潜在影响，具体目标旨在：1）确定成人癌症研究受试者对CT的生理，心理，经济，社会和教育益处和负担的看法; 2）开发项目以供将来用于构建初步获益-负担测量，以评估癌症受试者与CT保留相关的决定;确定影响成人癌症研究受试者对CT获益和负担以及保留的看法的因素。这些目标将通过采用定性和定量方法的混合方法两阶段项目来实现。本研究的第一阶段将采用面对面半结构化访谈，在30-35名癌症CT受试者中探索并生成关于应答者获益-负担的主题;并将使用调查结果开发基于这些主题的与获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抽样调查，以便可以检验将几个维度上的获益和负担与CT保留相关的假设。为这项研究组建的调查小组在哲学基础、方法论方法和伦理问题的实证检验方面经验丰富，这些问题对于建立有关研究参与者的利益和负担以及保留的知识至关重要。研究结果将支持NINR和NCI的使命，因为探索受试者认为在临床研究中哪些是有益的，哪些是负担，是识别早期受试者“有损耗风险”的第一步。“在癌症临床试验中遇到保留问题之前进行早期识别和先发制人的干预可能会减轻应答者的负担，并导致完成重要的资源密集型临床试验。

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.