Before Consent: Cancer Patients' Deliberations about Early Phase Clinical Trials

同意之前：癌症患者对早期临床试验的考虑

• 批准号: 8256596
• 负责人: Daniel P. Dohan
• 金额: $ 57.79万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-06-01 至 2015-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8256596
• 关键词: Address; Administrator; Advanced Malignant Neoplasm; Affect; Attention; Awareness; Basic Science; Behavioral; Bioethics Consultants; Cancer Patient; Caregivers; Cessation of life; Clinic; Clinical; Clinical Nursing Research; Clinical Research; Clinical Trials; Communication; Communications Media; Consent; Consent Forms; Data; Databases; Decision Making; Demographic Factors; Development; Disease; Emotions; Employee Strikes; Enrollment; Ensure; Equipoise; Ethics; Face; Family; Family Caregiver; Family health status; Focus Groups; Funding Agency; Goals; Health Personnel; Health Professional; Human; Individual; Informed Consent; Institution; Intervention; Interview; Investments; Judgment; Knowledge; Lead; Literature; Malignant Neoplasms; Methods; Mission; Motivation; Nature; Outcome; Participant; Patient Recruitments; Patients; Pattern; Phase; Physicians; Procedures; Process; Provider; Qualitative Research; Quality of life; Randomized; Recruitment Activity; Research; Research Methodology; Research Personnel; Risk; Role; Running; Sampling; Scientist; Shapes; Social Characteristics; Speed; Surveys; Symptoms; System; Testing; Therapeutic; Time; Translational Research; Trust; United States; Vulnerable Populations; advanced disease; cancer care; cancer therapy; cohort; exhaust; expectation; experience; high reward; high risk; improved; information gathering; instrument; longitudinal database; mortality; novel strategies; programs; public health relevance; safety testing; social; social science research; standard care

DESCRIPTION (provided by applicant): This proposal by a new investigator examines decisions made by advanced cancer patients regarding early phase clinical trials. Advances in basic and translational research may herald the arrival of new, targeted therapies that will improve cancer treatment and reduce mortality, but all of these therapies must be tested for safety in early phase (EP) clinical trials before they can benefit the public. Recruiting more patients to EP trials may speed the development of new cancer therapies, and some have argued that trials< participation is a societal obligation. But, those who participate in early phase trials - advanced cancer patients who have run out of standard therapeutic options - are a highly vulnerable population, and current procedures to ensure informed consent are not robust. Even as bioethicists and social and behavioral scientists seek to improve the informed consent process in EP cancer trials, less attention has focused on patients< decision-making in the period before the consent process begins. This study provides a rich descriptive and longitudinal perspective of the "pre-consent" period via three specific aims. For aim 1, focus groups are used to describe providers< role in early phase recruitment. In aim 2, an Advanced Cancer Cohort (ACC, n=150) is assembled using validated quantitative instruments, qualitative interviews, and clinic participant- observation to gather data on ACC patients' EP experiences and decisions as well as the perspectives of family caregivers and providers. Aim 3 analyzes ACC patients< awareness and knowledge of early phase trials (aim 3a), which patients decide to participate in trials and how they make this decision (aim 3b), and the nature and outcome of the informed consent process (aim 3c). Through the development of rich understandings of early phase decision-making before consent, the study findings may have relevance for clinician-investigators and early phase trial programs throughout the United States. The study may identify approaches that can increase EP trial enrollment while also improving patients< ability to provide meaningful informed consent for EP participation. PUBLIC HEALTH RELEVANCE: Developing new cancer therapies is a national priority, but the advanced cancer patients in whom these therapies are first tested are highly vulnerable. This study examines how advanced cancer patients make decisions about participating in a trial of a new therapy. The study aims to gather information that can improve the system for developing cancer therapies without putting vulnerable cancer patients at undue risk.

描述（由申请人提供）：新研究者的这项提案审查了晚期癌症患者关于早期临床试验的决定。基础研究和转化研究的进步可能预示着新的靶向疗法的到来，这些疗法将改善癌症治疗并降低死亡率，但所有这些疗法都必须在早期（EP）临床试验中进行安全性测试，然后才能造福公众。招募更多患者参加 EP 试验可能会加速新癌症疗法的开发，一些人认为参与试验是一项社会义务。但是，那些参与早期试验的人​​——已经用尽标准治疗方案的晚期癌症患者——是一个高度脆弱的人群，而目前确保知情同意的程序并不健全。 尽管生物伦理学家以及社会和行为科学家寻求改善 EP 癌症试验中的知情同意程序，但在同意程序开始之前，对患者决策的关注较少。本研究通过三个具体目标，对“同意前”时期提供了丰富的描述性和纵向视角。对于目标 1，焦点小组用于描述提供者在早期招聘中的作用。在目标 2 中，使用经过验证的定量工具、定性访谈和临床参与者观察来组建晚期癌症队列（ACC，n=150），以收集有关 ACC 患者的 EP 经验和决策以及家庭护理人员和患者的观点的数据。提供商。目标 3 分析 ACC 患者对早期试验的认识和知识（目标 3a）、哪些患者决定参加试验以及他们如何做出这一决定（目标 3b），以及知情同意过程的性质和结果（目标 3c） 。 通过对同意前的早期决策形成丰富的理解，研究结果可能与美国各地的临床研究人员和早期试验项目相关。该研究可能会确定可以增加 EP 试验注册人数的方法，同时还可以提高患者为 EP 参与提供有意义的知情同意的能力。 公共健康相关性：开发新的癌症疗法是国家优先事项，但首先测试这些疗法的晚期癌症患者非常脆弱。这项研究探讨了晚期癌症患者如何做出参与新疗法试验的决定。该研究旨在收集可以改进癌症疗法开发系统的信息，而不会让脆弱的癌症患者面临过度的风险。