Preparatory Aid to Improve Decision Making about Cancer Clinical Trials

描述（由申请人提供）：临床试验是开发改进的癌症全身疗法的必要条件。然而，只有不到10%的癌症患者参加了这些研究。参加临床试验代表着一个决定。对于癌症患者来说，这一决定可能特别困难，因为他们面临着死亡，治疗往往与显著的潜在发病率相关，并且在风险和益处方面可能存在很大的不确定性。本研究申请的主要目的是通过评估和解决参与的心理障碍，提高患者对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，一个交互式的基于互联网的临床试验预备援助（PRE-ACT）将在初次医生访问之前提供量身定制的信息，以解决与知识、目标和价值观、信念和期望相关的障碍。具体目标是1)开发和试点测试PRE-ACT的三个组成部分：通过基于互联网的调查评估个体患者参与临床试验的心理障碍，障碍和偏好澄清的自动反馈，以及提供个性化的信息视频剪辑来解决障碍；2)在大约1500名癌症患者中进行随机临床试验，比较PRE-ACT与对照条件在改善临床试验准备方面的差异；3)调查与准备、障碍和治疗决策结果相关的相关背景和社会心理变量；4)探讨PRE-ACT对决策冲突、临床试验信息和讨论满意度、治疗选择满意度和临床试验参与的影响。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益处，处理有关结果的不确定性，并得出最符合他们偏好的治疗决定。预计在这种情况下，改进决策将转化为增加患者参与临床试验。

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.