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

描述：此应用程序响应PA-11-180：生物医学、社会和行为研究中的伦理问题研究，重点关注参加癌症临床试验(CCT)的重症癌症患者和科学伦理。风险-效益评估是知情同意的一个重要组成部分，它为患者参与者在临床试验中做出与研究相关的决定提供了核心信息。事实上，机构审查委员会的职责是辨别“与受试者的预期收益相关的风险是否合理”。然而，患者参与者的风险-收益评估可能在很大程度上不同，特别是当他们面临癌症等限制生命的疾病时，没有其他接受癌症护理的方法，或者只是信任医生研究员和其他研究团队成员。知情同意的理论理想(即处理的所有信息和彻底评估的风险和收益)与人们，特别是那些患有严重疾病的人如何做出研究参与决定之间存在着严重的差距。当患者-参与者没有权衡参与试验的风险和收益时，可能会导致研究结果受损、参与者退出以及患者和研究人员体验不佳。在最近完成的R21研究工作的基础上，这项R01应用程序将创新性地检查患者参与者、研究人员、临床特征和其他外部因素(来自他人的压力)如何影响风险-收益评估和随后在CCT中的保留。为了完全捕捉患者参与者的体验，我们独特地测量了参与者风险-收益评估的流行率(评估与未评估)和程度/程度(评估的程度和感知的强度)。我们的具体目标是：1)检查患者-参与者、临床和研究人员特征之间的关系，以及其他外部影响对患者-参与者的风险-收益评估的影响；2)在先验地调整重要的预后因素后，检查CCT中风险-收益评估和保留率之间的关系；以及3)定义、命名和描述(通过聚类分析技术)类型 根据患者的CCT风险-收益评估对患者参与者进行评估。此外，我们将通过感知映射(多维缩放)对每个患者类型如何概念化CCT所涉及的风险和好处进行建模/映射。我们还将探索在我们第一次登记的参与者队列中(基线：自同意后30-59天；第二次评估：自登记有条件现金转移以来的90天)在有条件现金转移登记的过程中，风险-收益认知是否发生变化，以帮助评估潜在的差异信息或回忆偏差。这些目标将通过混合方法实现，将有432名参与者参加有条件现金转移支付。互补性的定性半结构访谈将加深对风险-收益评估的理解，并考察影响参与者退出的因素。因此，该项目将从根本上促进我们对重症患者CCT风险-收益评估的理论、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.