Decision Making in Patients with Advanced Prostate Cancer

描述（由申请人提供）：许多晚期前列腺癌患者及其护理人员在治疗决策方面遇到困难，例如何时终止癌症导向治疗。在大多数临床实践中，患者对后续决定（包括终止癌症导向治疗）的准备并没有得到很好的处理。这项研究的具体目标是：1）确定实施短期，临床为基础的，决策援助的可行性（认知行为技能干预）治疗激素难治性前列腺癌患者（和他们的照顾者）预期癌症导向治疗;和2）收集初步数据以检验晚期前列腺癌患者接受决策辅助以提高关于癌症治疗的决策技能的患者（及其护理者）将表现出（a）提高的决策质量，（B）减少的决策冲突，和（c）提高的决策满意度。这项试验性研究为前瞻性随机临床试验做准备，将收集初步数据，以测试45对患者/护理人员的决策帮助。它将在两个地点进行：一个在弗吉尼亚州的弗吉尼亚大学，另一个在纽约的纪念斯隆-凯特琳癌症中心。将使用混合方法：1）单盲、前测/后测设计将测量一个时间段，包括在治疗过程中的两个单事件决定，直到终止癌症定向治疗; 2）定性回顾性设计将允许在研究完成时的1小时访谈中分别探索患者和护理人员的经验。人种（非裔美国人和高加索人/其他）将采用分层区组随机化设计。将有两组：30对在加强护理/干预组（EC）; 15对在常规护理/对照组（UC）。欧盟委员会将收到由七个组成部分组成的决策援助：1）社会支持，2）预期指导，3）坚持患者参与治疗决策的偏好，4）高质量的决策过程指导，5）规范化（使用CD家庭套件），6）与肿瘤学专业人员讨论困难决定的结构化时间，和7）在整个治疗过程中对2个决定的价值澄清（使用资产负债表）。自我报告的措施将用于所有参与者除了探头的录音采访EC。主要的结果指标是决策质量、决策冲突和决策满意度。两个小组（决策和前列腺癌）将对方案进行两次审查。该计划将包括对任命名册进行连续筛选。决策辅助将在两次诊所访视期间进行。定量部分的数据分析将采用广义线性模型;定性部分的数据分析将采用专题饱和度。 前列腺癌是美国男性中最常见的诊断癌症和癌症死亡的第二大原因。患有晚期前列腺癌的男性亚组，特别是耐药前列腺癌（HRPC），由于其疾病的性质和有限的选择，特别容易受到难以选择的治疗。探索使用一种决策辅助工具，专注于HRPC，并帮助患者参与有关其健康的治疗决策是非常重要的。这项研究将测试晚期前列腺癌患者的决策辅助工具，以帮助促进有关影响患者生活质量的治疗的知情共享决策。

DESCRIPTION (provided by applicant): Many patients with advanced prostate cancer and their caregivers struggle with treatment decisions, such as when to terminate cancer-directed treatment. Patient preparation for consequential decisions, including termination of cancer-directed treatment, is not well handled in most clinical practices. Specific aims for this study will be to: 1) determine the feasibility of implementing a short, clinic-based, decision-making aid (cognitive-behavioral skills intervention) for patients with hormone refractory prostate cancer (and their caregivers) anticipating cancer-directed treatment; and 2) To gather preliminary data for testing the hypothesis that patients with advanced prostate cancer (and their caregivers), who receive a decision aid to enhance decision-making skills about cancer treatment, will demonstrate (a) increased quality decision making, (b) decreased decisional conflict, and (c) increased decisional satisfaction. This pilot study, in preparation for a prospective, randomized clinical trial, will gather preliminary data to test decision-making aid for 45 patient/caregiver pairs. It will be conducted at two sites: one at the University of Virginia in Virginia and the other at Memorial Sloan-Kettering Cancer Center in New York. A mixed-method approach will be used: 1) a single blind, pretest/posttest design will measure a time period that includes two single- event decisions over the course of their treatment until cancer-directed treatment is terminated; and 2) a qualitative retrospective design will allow exploring the experiences of both patients and caregivers separately in a 1-hour interview at the completion of the study. A stratified block randomization design will be used for race (African- American and Caucasian/Other). There will be two groups: 30 pairs in the enhanced care/intervention group (EC); 15 pairs in the usual care/control group (UC). EC will receive a decision aid with seven components: 1) social support, 2) anticipatory guidance, 3) adherence to the patient's preference for participation in treatment decision making, 4) a quality decision-making process tutorial, 5) normalization (using a CD home kit), 6) structured time with oncology professionals to discuss difficult decisions, and 7) values clarification of 2 decisions throughout treatment (using balance sheets). Self-report measures will be used for all participants in addition to probes for the taped interviews with EC. The primary outcome measures are quality decision making, decisional conflict, and decisional satisfaction. Two panels (decision making and prostate cancer) will review the protocol twice. The plan will include serially screening the appointment roster. The decision aid will be administered during two clinic visits. Generalized linear models will be used for data analysis for the quantitative component; saturation of themes will be used for the qualitative component. Prostate cancer is the most commonly diagnosed cancer and the second leading cause of cancer deaths among men in the U.S. The subgroup of men with advanced prostate cancer, specifically hormone-resistant prostate cancer (HRPC), is particularly vulnerable to difficult choices for treatment because of the nature of their disease and having limited options. Exploring the use of a decision aid that focuses on HRPC and helps patients participate in their treatment decisions about their health is very important. This study will test a decision aid for patients with advanced prostate cancer to help facilitate informed shared decisions about treatment that affects patients' quality of life.