Impact of a Novel Cancer Communication Intervention on Caregiver Bereavement

描述(由申请人提供)：晚期癌症患者的家庭照顾者有患丧亲相关疾病的风险。在癌症护理方面更好的沟通可能会改善失去亲人的人的健康结果。目的：在一项嵌套在父母随机对照试验(R01CA140419)内的专注于患者结局的研究中，我们建议检查健康沟通干预是否可以导致更好的照顾者心理健康(目标1)和身体健康(目标2)。在目标3中，我们试图通过进行调解分析和定性分析来了解这些发现的背景。前者将探索干预效果是否通过患者报告的生活质量和患者的医疗保健利用来调节。将使用定性方法将丧亲结果与父母研究沟通结果联系起来。设计：多波照顾者评估将被添加到NIH资助的两站点集群RCT中。在这项研究中，肿瘤学家被随机分为常规护理组(n=15)或沟通干预组(n=15)，后者包括两次办公室会议，提供关于他们患者沟通技能的个性化反馈。肿瘤学家在常规护理组(n=128对)中看的晚期癌症患者和他们的照顾者将接受常规癌症护理。肿瘤学家在干预组中看到的两个人(n=128个人)将接受访问前的指导和问题提示列表，以提高他们的沟通技能。在这项应用中，我们建议在患者活着时以及患者死亡后2个月和7个月评估照顾者的经历和结果。为期2个月的尸检评估将包括录音访谈，以探索照顾者在决策关键要素方面的经历：信息交流(例如，量身定做)、审议(例如，参与)和社会情感问题(例如，尊重、遗弃)。主要结果：患者死亡7个月后持续的悲伤症状(PG-13)和身体功能(SF-36)。次要结果包括抑郁和焦虑症状、决策后悔、自杀念头和残疾。对于定性分析，将采用基于标准的有目的抽样，以干预臂、沟通质量和长期悲伤3个标准为基础，对父母研究和本研究进行有意的比较。意义：这是对正在进行的随机对照试验的有效补充，是第一次尝试检验可以整合到常规癌症护理中的干预措施对丧失亲人结果的影响。由于干预是系统性的，但简单且容易传播，研究结果将对癌症护理、公共卫生和政策产生影响。

DESCRIPTION (provided by applicant): Family caregivers of patients with advanced cancer are at risk for bereavement- related morbidity. Better communication in the context of cancer care may improve health outcomes of the bereaved. Aims: In a study nested within a parent RCT (R01CA140419) focused on patient outcomes, we propose to examine whether a health communication intervention can lead to better caregiver mental health (Aim 1) and physical health (Aim 2). In Aim 3, we seek to contextualize these findings by conducting mediational analyses and qualitative analyses. The former will explore whether intervention effects are mediated by patient-reported quality of life and patient health care utilization. Qualitative methods will be used to link bereavement outcomes with parent study communication outcomes. Design: Multiple waves of caregiver assessments will be added to a NIH-funded two-site cluster RCT. In that study, oncologists are randomized to usual-care (n=15) or the communication intervention (n=15), which involves two in-office sessions providing individually tailored feedback on their patient communication skills. Patients with advanced cancer and their caregivers seen by oncologists in the usual-care arm (n=128 dyads) will receive usual cancer care. Dyads seen by oncologists in the intervention arm (n=128 dyads) will receive pre-visit coaching and question- prompt lists to enhance their communication skills. In this application, we propose to assess caregiver experiences and outcomes while the patients are alive, as well as 2 and 7 months after the patients' deaths. The 2-month post-mortem assessment will include an audiotaped interview to explore caregivers' experiences with key elements of decision-making: information exchange (e.g., tailored), deliberation (e.g. participation), and socioemotional issues (e.g. respect, abandonment). Main outcomes: Prolonged grief symptoms (PG-13) and physical function (SF-36) 7 months following the patients' deaths. Secondary outcomes include symptoms of depression and anxiety, decisional regret, thoughts of suicide, and disability. For the qualitative analyses, criterion based purposeful sampling will be used to make deliberate comparisons linking the parent study and this one based on 3 criteria: intervention arm, communication quality, and prolonged grief. Significance: This efficient addition to an ongoing RCT is the first attempt to examine the effects on bereavement outcomes of an intervention that could be integrated into routine cancer care. As the intervention is systemic, yet simple and readily disseminated, findings will have implications for cancer care, public health, and policy.