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

基本信息

批准号：
8450179
负责人：
Daniel P. Dohan
金额：
$ 51.98万
依托单位：
UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
依托单位国家：
美国
项目类别：
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/8450179
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

项目摘要

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.

描述（由申请人提供）：新研究人员的这一提案检查了晚期癌症患者对早期临床试验做出的决定。基础和转化研究的进步可能会预示着新的有针对性疗法的到来，这些疗法将改善癌症治疗并降低死亡率，但是所有这些疗法必须在早期（EP）临床试验中进行安全测试，然后才能使公众受益。招募更多患者参加EP试验可能会加快新的癌症疗法的发展，并且有人认为试验<参与是一种社会义务。但是，那些参加早期试验的人 - 已经用完标准治疗选择的晚期癌症患者 - 是一个高度脆弱的人群，并且当前的程序以确保知情同意并不强大。即使生物伦理学家以及社会和行为科学家试图改善EP癌症试验中知情同意过程，在同意过程开始之前的期间，人们对患者的关注较少。这项研究通过三个特定目标提供了“预先陈述”时期的丰富描述性和纵向观点。对于AIM 1，焦点小组用于描述提供者<在早期招聘中的角色。在AIM 2中，使用经过验证的定量工具，定性访谈和诊所参与者观察，以收集有关ACC患者的EP经验和决策的数据以及家庭护理人员和家庭护理人员的观点，使用验证的定量工具，定性访谈和诊所参与者组装高级癌症队列（ACC，n = 150）。提供者。 AIM 3分析ACC患者<意识和对早期试验的知识（AIM 3A），该患者决定参加试验以及他们如何做出决定（AIM 3B），以及知情同意过程的性质和结果（AIM 3C）。通过在同意之前对早期决策的丰富理解的发展，研究结果可能与美国各地的临床医生评估者和早期试验计划有关。该研究可能会确定可以增加EP试验入学率的方法，同时也改善患者<提供有意义的知情同意以进行EP参与的能力。