Preparatory Aid to Improve Decision Making about Cancer Clinical Trials

描述(由申请人提供)：临床试验对于改进的癌症系统疗法的发展是必要的。然而，只有不到10%的癌症患者参加了这些研究。参与临床试验代表着一种决定。对于癌症患者来说，这一决定可能尤其困难，因为他们面临死亡，治疗往往与发病率的巨大潜力相关，而且风险和收益可能存在很大的不确定性。这项研究应用的主要目标是通过评估和解决参与的心理社会障碍，改善患者为考虑将临床试验作为一种治疗选择的准备。在认知-社会健康信息处理和渥太华决策支持框架的指导下，一个基于互联网的交互式临床试验准备援助(Pre-ACT)将提供量身定制的信息，以解决与知识、目标和价值观以及信念和期望有关的障碍，然后再去看医生。具体目标是：1)开发和试行ACT前的三个组成部分：通过基于互联网的调查评估个别患者参与临床试验的心理社会障碍，障碍和偏好澄清的自动反馈，以及提供个性化定制的信息视频剪辑以解决障碍；2)在大约1500名癌症患者中进行随机临床试验，以比较ACT前和对照的情况，以改进临床试验的准备；3)调查与准备、障碍和治疗决策结果相关的相关背景和心理社会变量；4)探讨ACT治疗前对决策冲突、对临床试验信息和讨论的满意度、对治疗选择的满意度和临床试验参与度的影响。潜在的假设是，通过让患者为临床试验的讨论做好准备，他们将能够更好地权衡这种治疗方案的风险和好处，处理结果的不确定性，并得出最符合他们偏好的治疗决定。预计在这一背景下改善决策将转化为患者更多地参与临床试验。

DESCRIPTION (provided by applicant): Clinical trials are necessary for the development of improved systemic therapies for cancer. However, less than ten percent of cancer patients enroll in these studies. Taking part in a clinical trial represents a decision. This decision may be particularly difficult for cancer patients, as they are facing mortality, treatments are often associated with significant potential for morbidity, and there may be substantial uncertainty regarding risks and benefits. The primary objective of this research application is to improve patient preparation for consideration of clinical trials as a treatment option, by assessing and addressing psychosocial barriers to participation. Guided by the Cognitive-Social Health Information Processing and Ottawa Decision Support frameworks, an interactive Internet-based Preparatory Aid for Clinical Trials (PRE-ACT) will deliver tailored information to address barriers related to knowledge, goals and values, and beliefs and expectancies before the initial physician visit. The specific aims are 1) to develop and pilot test three PRE-ACT components: assessment of individual patient psychosocial barriers to clinical trial participation by Internet-based survey, automated feedback of barriers and preference clarification, and provision of individually-tailored informational video clips to address barriers; 2) to conduct a randomized clinical trial in approximately 1500 cancer patients to compare PRE-ACT vs. control condition in improving preparation to consider clinical trials; 3) to investigate relevant background and psychosocial variables associated with preparation, barriers, and treatment decision outcomes; 4) to investigate the impact of PRE-ACT on decisional conflict, satisfaction with information and discussion about clinical trials, satisfaction with treatment choice, and clinical trial participation. The underlying hypothesis is that by preparing patients for a discussion about clinical trials, they will be better able to weigh risks and benefits of this treatment option, deal with uncertainty regarding outcomes, and arrive at a treatment decision most consonant with their preferences. It is anticipated that improving decision making in this context will translate into increased patient participation in clinical trials.