Decision Aid for Patients with Advanced Lung Cancer

描述（由申请人提供）：许多晚期肺癌患者及其护理人员在治疗决策中挣扎，例如何时说“够了”。“在大多数临床实践中，患者对后续决定的准备，包括终止癌症定向治疗，都没有得到很好的处理。这项研究的具体目标是：1）确定实施决策援助的可行性（认知行为技能干预）对晚期肺癌患者的影响（以及他们的照顾者）面临癌症导向治疗;以及2）收集初步数据以检验晚期肺癌患者接受决策辅助以提高癌症治疗决策技能的患者（及其护理人员）将报告（a）决策质量提高，和（B）与常规护理/对照组相比，在决定3（终止癌症定向治疗）结束时减少的决定冲突。这项先导性研究为一项前瞻性随机临床试验做准备，将测试40名IIIB或IV期肺癌患者及其40名护理人员的决策辅助。它将在弗吉尼亚州的一家诊所进行。将使用混合方法：1）回顾性现象学设计将允许在1小时的访谈中分别探索患者和护理人员的经验; 2）前测/后测设计将测量一个时间段，包括化疗过程中的三个决定（早期、中期和晚期），直到癌症定向治疗终止。将使用分层区组随机化设计，其中分层由两个变量（决策和人种）确定。将有两组：加强护理（EC）和常规护理（UC）。EC将获得由七个组成部分组成的决策辅助：社会支持，预期指导，坚持患者参与治疗决策的偏好，高质量的决策过程指南，规范化（使用CD程序），与肿瘤学专业人员讨论困难决策的结构化时间，以及在整个治疗过程中澄清3个决策的价值。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。结果测量是质量决策和决策冲突。两个小组（决策和肺癌）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。将在三次临床访视期间给予决策辅助。广义线性模型将用于数据分析。定性部分将采用主题饱和度。

DESCRIPTION (provided by applicant): Many patients with advanced lung cancer and their caregivers struggle with treatment decisions, such as when to say "enough." 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 decision-making aid (cognitive-behavioral skills intervention) for patients with advanced lung cancer (and their caregivers) facing cancer-directed treatment; and 2) gather preliminary data for testing the hypothesis that patients with advanced lung cancer (and their caregivers), who receive a decision aid to enhance decision-making skills about cancer treatment, will report (a) increased quality decision making, and (b) decreased decisional conflict at the end of Decision 3 (termination of cancer directed therapy), compared to the usual care/control group. This pilot study, in preparation for a prospective, randomized clinical trial, will test a decision-making aid for 40 patients with stage IIIB or IV lung cancer and their 40 caregivers. It will be conducted at one clinic in Virginia. A mixed-method approach will be used: 1) a retrospective phenomenological design will allow exploring the experiences of both patients and caregivers separately in a 1-hour interview; and 2) a pretest/posttest design will measure a time period including three decisions (early, midway, and late) over the course of chemotherapy until cancer-directed treatment is terminated. A stratified block randomization design will be used in which strata are determined by two variables, decision making and race. There will be two groups: enhanced care (EC) and usual care (UC). EC will receive a decision aid with seven components: social support, anticipatory guidance, adhering to the patient's preference for participation in treatment decision making, a quality decision-making process tutorial, normalization (using a CD program), structured time with oncology professionals to discuss difficult decisions, and values clarification of 3 decisions throughout treatment. Self-report measures will be used for all participants in addition to probes for the taped interviews with EC. The outcome measures are quality decision making and decisional conflict. Two panels (decision making and lung cancer) will review the protocol twice. The plan will include serially screening the appointment roster. The decision aid will be administered during three clinic visits. Generalized linear models will be used for data analysis. Saturation of themes will be used for the qualitative component.