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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：
8658026
负责人：
Daniel P. Dohan
金额：
$ 43.18万
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 2016-04-30
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8658026
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）：由一位新研究者提出的这一提案审查了晚期癌症患者关于早期临床试验的决定。基础和转化研究的进展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，然后才能使公众受益。招募更多的患者参加EP试验可能会加速新癌症疗法的开发，有些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--已经用尽标准治疗选择的晚期癌症患者--是一个非常脆弱的人群，目前确保知情同意的程序并不健全。即使生物伦理学家和社会及行为科学家寻求改善EP癌症试验中的知情同意过程，但在知情同意过程开始前的一段时间内，对患者决策的关注较少。本研究提供了一个丰富的描述性和纵向的“同意前”期间通过三个具体的目标。对于目标1，焦点小组被用来描述提供者在早期招募中的作用。在目标2中，使用经验证的定量工具、定性访谈和临床参与者观察来组装晚期癌症队列（ACC，n=150），以收集关于ACC患者的EP经历和决定以及家庭照顾者和提供者的观点的数据。目的3分析ACC患者对早期试验的认识和了解（目的3a），哪些患者决定参加试验以及他们如何做出这一决定（目的3b），以及知情同意过程的性质和结果（目的3c）。通过对知情同意前早期决策的丰富理解，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。该研究可以确定可以增加EP试验入组同时还提高患者提供EP参与的有意义的知情同意的能力的方法。

项目成果

期刊论文数量（7）

专著数量（0）

科研奖励数量（0）

会议论文数量（0）

专利数量（0）

BEYOND TEXT: USING ARRAYS TO REPRESENT AND ANALYZE ETHNOGRAPHIC DATA.

DOI：
10.1177/0081175015578740
发表时间：
2015-08-01
期刊：
Sociological methodology
影响因子：
3
作者：
Abramson CM;Dohan D
通讯作者：
Dohan D

Qualitative Coding in the Computational Era: A Hybrid Approach to Improve Reliability and Reduce Effort for Coding Ethnographic Interviews.

DOI：
10.1177/23780231211062345
发表时间：
2021-01
期刊：
SOCIUS
影响因子：
4.5
作者：
Li, Zhuofan;Dohan, Daniel;Abramson, Corey M.
通讯作者：
Abramson, Corey M.

An exploratory typology of provider responses that encourage and discourage conversation about complementary and integrative medicine during routine oncology visits.

提供者响应的探索性类型，鼓励和阻止在常规肿瘤就诊期间谈论补充和综合医学。

DOI：
10.1016/j.pec.2015.02.018
发表时间：
2015
期刊：
Patient education and counseling
影响因子：
3.5
作者：
Koenig,ChristopherJ;Ho,EvelynY;Trupin,Laura;Dohan,Daniel
通讯作者：
Dohan,Daniel

What advanced cancer patients with limited treatment options know about clinical research: a qualitative study.

DOI：
10.1007/s00520-017-3734-4
发表时间：
2017-10
期刊：
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer
影响因子：
0
作者：
Garrett SB;Koenig CJ;Trupin L;Hlubocky FJ;Daugherty CK;Reinert A;Munster P;Dohan D
通讯作者：
Dohan D

Approaches to decision-making among late-stage melanoma patients: a multifactorial investigation.

DOI：
10.1007/s00520-018-4395-7
发表时间：
2019-03
期刊：
Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer
影响因子：
0
作者：
Garrett SB;Abramson CM;Rendle KA;Dohan D
通讯作者：
Dohan D