Retention in Cancer Clinical Trials: Modeling Patients' Risk Benefit Assessments

产品描述： 本申请响应PA-11-180：生物医学，社会和行为研究中的伦理问题研究，重点是参加癌症临床试验（CCT）的重病癌症患者和科学伦理。风险-获益评估是知情同意的重要组成部分，并为患者参与者在CCT中做出研究相关决策提供了重要信息。事实上，机构审查委员会负责辨别“与受试者的预期利益（如果有的话）相比，风险是否合理。“然而，患者参与者的风险效益评估可能会有很大的不同，特别是如果他们面临着癌症等限制生命的疾病，没有其他方法接受癌症治疗，或者只是信任医生研究者和其他研究团队成员。知情同意的理论理想（即，所有信息经过处理，风险和益处经过彻底评估），以及人们，特别是那些患有严重疾病的人如何做出参与研究的决定。当患者参与者没有权衡参与试验的风险和获益时，可能会导致研究结局受损、受试者退出以及患者和研究者体验欠佳。在最近完成的R21研究工作的基础上，该R 01申请将创新性地研究患者-参与者、研究者、临床特征和其他外部因素（来自他人的压力）如何影响风险-受益评估和随后在CCT中的保留。为了充分获取患者参与者的经验，我们唯一地测量了参与者风险受益评估的患病率（评估与未评估）和范围/程度（评估范围和感知强度）。我们的具体目标是：1）检查患者-参与者、临床和研究者特征与患者-参与者风险-获益评估的其他外部影响之间的关系; 2）在先验调整重要预后因素后，检查风险-获益评估与CCT保留率之间的关系; 3）定义、命名和描述（通过聚类分析技术）一种类型学 患者-参与者基于他们的CCT风险-受益评估。此外，我们将通过感知映射（多维缩放）建模/映射每种患者类型如何概念化CCT涉及的风险和益处。我们还将探讨在我们招募的第一次参与者队列中，风险-获益认知在CCT招募过程中是否发生变化（基线：自同意后30-59天;第二次评估：自CCT招募后90天），以帮助评估潜在的差异信息或回忆偏倚。这些目标将通过混合方法实现，432名参与者参加了CCT。补充的定性半结构化访谈将导致对风险-收益评估的更深入理解，并检查影响参与者退出的因素。因此，该项目将从根本上推进我们对重症患者CCT风险-获益评估的理论，经验和临床理解。

Description: This application responds to PA-11-180: Research on Ethical Issues in Biomedical, Social and Behavioral Research with a focus on seriously ill cancer patients enrolled in cancer clinical trials (CCTs) and the ethics of science. Risk-benefit assessment is an essential component of informed consent and provides information central to patient-participants' research-related decisions in CCTs. Indeed, institutional review boards are charged with discerning whether the "risks are reasonable in relation to anticipated benefits, if any, to subjects." However, patient-participants' risk-benefit assessments may differ in significant ways, especially if they are confronted with a life-limiting illness such as cancer, have no other means to receive cancer care, or simply place their trust in the physician investigator and other study team members. A critical gap exists between the theoretical ideal of informed consent (i.e., all information processed and risks and benefits thoroughly evaluated) and how people, particularly those with serious illnesses, make research participation decisions. When patient-participants do not weigh the risks and benefits of trial participation, it may lead to compromised study outcomes, participant withdrawal, and sub-optimal patient and investigator experiences. Building on the work of a recently completed R21 study, this R01 application will innovatively examine how patient-participant, investigator, clinical characteristics and other external factors (pressure from others) influence risk-benefit assessment and subsequent retention in CCTs. To fully capture the experiences of patient-participants, we uniquely measure both the prevalence (assessed versus not assessed) and the extent/degree (extent of assessment and intensity of perceptions) of participants' risk-benefit assessment. Our specific aims intend to: 1) examine the relationship between patient-participant, clinical, and investigator characteristics and other external influences on patient-participants' risk-benefit assessment; 2) examine the relationship between risk-benefit assessment and retention in CCTs after adjusting for important prognostic factors a priori; and 3) define, name, and profile (through cluster analysis techniques) a typology of patient- participants based on their CCT risk-benefit assessment. Moreover, we will model/map via perceptual mapping (multidimensional scaling) how each patient type conceptualizes the risks and benefits involved in CCTs. We will also explore whether risk-benefit perceptions change during the course of CCT enrollment among the first time cohort of participants we enroll (baseline: 30-59 days since consent; second assessment: 90 days since CCT enrollment) in order to help assess potential differential informational or recall bias. These aims will be met through a mixed methods approach with 432 participants enrolled in CCTs. The complementary qualitative semi-structured interviews will lead to a deeper understanding of risk-benefit assessment as well as examine the factors that influence participant withdrawal. Thus, this project will fundamentally advance our theoretical, empirical, and clinical understanding of risk-benefit assessment in CCTs for those who are seriously ill.