Decision-Making Under Uncertainty in Prostate Cancer

描述：(由申请人提供)这项拟议的研究测试了决策干预的有效性，以帮助新诊断为前列腺癌的男性成为医生决策过程中知情的参与者。由于前列腺癌没有首选的治疗方法，从医生的角度来看，这种情况是一种治疗的不确定性，而对于新诊断的癌症患者来说，这是一种信息的不确定性。将测试两种实施干预措施的方法：仅向患者提供干预措施(直接治疗)或向患者及其主要支助人员提供干预措施(补充治疗)。干预的重点将是通过护士提供的电话协议向患者提供有关治疗方案的信息。这些信息将得到决策辅助工具的补充，包括一个研究设计的门户网站，可以访问选定的前列腺癌决策网站。干预还将侧重于沟通技能培训，以提高患者的沟通者行为。决策干预将在收到癌症诊断和与医生会面讨论治疗方案之间的2-3周内在高加索和非裔美国人中进行测试。设计为2×3随机区组，重复测量设计，3个水平的干预(治疗直接、治疗补充和对照条件)与2个种族水平交叉。将在基线以及基线后4周和4个月采取措施。与对照组相比，接受决策干预的男性预计会有更少的决策遗憾、更少的决策不确定性、更多的治疗知识、更好的患者与提供者的沟通、更有效的决策、更积极的沟通行为和更好的报告生活质量。将使用多变量模型进行分析。将为传播干预方案估算提供干预的成本。

DESCRIPTION: (provided by applicant) The proposed study tests the efficacy of a decision-making intervention to help men newly diagnosed with prostate cancer become informed participants in the decision-making process with the physician. Since there is no preferred treatment for prostate cancer, the situation is one of therapeutic uncertainty from the perspective of the physician and one of informational uncertainty experienced by newly diagnosed cancer patients. Two approaches for the delivery of the intervention will be tested: intervention delivered to the patient only (treatment direct) or intervention to the patient and his primary support person (treatment supplemented). The intervention will focus on providing the patient with information about treatment options via a nurse-delivered telephone protocol. The information will be supplemented with decision aids including a study-designed portal to selected Internet sites on decision-making in prostate cancer. The intervention will also focus on communication skills training to enhance patient communicator behaviors. The decision-making intervention will be tested with Caucasian and African-American men within the 2-3 week period between receiving a cancer diagnosis and meeting with the physician to discuss treatment options. The design is a 2 X 3 randomized block, repeated measures design with 3 levels of intervention (treatment direct, treatment supplemented, and control condition) crossed with 2 levels of ethnicity. Measures will be taken at baseline and at 4 weeks and 4 months post baseline. Men who receive the decision-making intervention are expected to have less decisional regret, less decisional uncertainty, more treatment knowledge, better patient-provider communication, more perceived effective decision-making, more active communication behaviors, and better reported quality of life than the control group. Multivariate models will be used for analysis. Costs of delivering the intervention will be estimated for dissemination of intervention protocol.