Respondent Burden and Retention in Cancer Clinical Trials

癌症临床试验中的受访者负担和保留

• 批准号: 7385525
• 负责人: CONNIE Marie ULRICH
• 金额: $ 19.69万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 2008
• 资助国家: 美国
• 起止时间: 2008-01-15 至 2009-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7385525
• 关键词: Address; Adult; Affect; Age; Area; Cancer Patient; Clinical; Clinical Research; Clinical Trials; Communication; Complex; Consent; Decision Making; Development; Dimensions; Early identification; Economics; Effectiveness; Empirical Research; Enrollment; Ensure; Equilibrium; Ethical Issues; Foundations; Future; Gender; Health; Human; Intervention; Interview; Knowledge; Lead; Life; Malignant Neoplasms; Measures; Methods; Minority; Mission; Participant; Patients; Perception; Phase; Phase I Clinical Trials; Process; Questionnaires; Randomized; Rate; Research; Research Personnel; Research Subjects; Resources; Respondent; Risk; Sampling; Scientist; Severity of illness; Social support; Structure; Surveys; Testing; Time; Translating; Translations; anticancer research; base; cancer diagnosis; design; experience; human subject; innovation; instrument; novel; psychologic; psychological distress; research to practice; social

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.

描述（由申请人提供）：参与临床试验（CTS）需要癌症患者的多种义务，以增加癌症诊断和治疗的负担。负担，也称为受访者负担，是一种现象，在临床研究的严重癌症患者中尚未得到充分研究。受试者以不同的方式解释研究情况，并可能愿意接受与感知的收益关系的相当多的负担。了解人类受试者自愿同意涉及的福利 - 负责人的平衡是研究的基本宗旨，对于确保受试者就其研究参与做出明智的决定很重要。该申请直接响应PA对威胁生命疾病临床决策的研究的目标，因为我们的研究将调查对福利和负担的看法如何影响癌症受试者的临床决策，以便继续参加CTS。几乎没有概念性和实证研究就可以更好地理解在CT保留中重要的因素，包括对同意参加临床癌症研究试验的人的感知利益和负担。为了更好地了解CTS的利益和负担的维度及其对癌症受试者保留的潜在影响，具体目的是：1）确定哪些成人癌症研究受试者认为哪些成人，心理，心理，经济，社会，社会和教育福利，以及负担在CTS中； 2）开发用于未来使用的项目，以构建初步的福利 - 负担措施，以评估与CT保留有关的癌症受试者的决定； 3）确定影响成人癌症研究对象对CTS的收益，负担和保留的看法的因素。这些目标将通过使用定性和定量方法的混合方法两相项目实现。这项研究的第一阶段将使用面对面的半结构化访谈探索并产生有关受访者福利 - 责任的主题；并将利用这些发现来开发与这些主题相关的调查问卷项目。在第二阶段中，将对109名癌症受试者进行目的样本，以便可以测试假设，以将对福利和负担的看法与CTS保留有关。为这项研究组装的调查团队在哲学基础，方法论方法和对伦理问题的经验测试中经验丰富，这是建立有关研究参与者的利益，负担和保留的知识的核心。研究结果将支持尼尔和NCI的任务，因为探索临床研究中认为是有益和繁重的受试者是识别“处于损失危险的早期受试者”的第一步。在遇到癌症临床试验中遇到保留问题之前的早期识别和先发制人的干预措施可能会减轻受访者负担，并导致完成重要的资源密集临床试验。