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。在癌症护理的背景下，更好的沟通可以改善失去亲人的健康结果。目的：在一项关注患者预后的父母随机对照试验（R01CA140419）中，我们建议检查健康沟通干预是否能改善照顾者的心理健康（目的1）和身体健康（目的2）。在目标3中，我们试图通过进行中介分析和定性分析来将这些发现置于背景中。前者将探讨干预效果是否由患者报告的生活质量和患者的医疗保健利用介导。将使用定性方法将丧亲结果与父母学习交流结果联系起来。设计：多波护理人员评估将被添加到美国国立卫生研究院资助的双点集群随机对照试验中。在那项研究中，肿瘤学家被随机分配到常规护理组（n=15）或沟通干预组（n=15），其中包括两次办公室会议，提供针对患者沟通技巧的个性化反馈。在常规护理组（n=128对），肿瘤学家看到的晚期癌症患者及其护理人员将接受常规癌症治疗。由肿瘤学家在干预组（n=128）治疗的夫妇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巧。在本应用中，我们建议评估患者在世时以及患者死亡后2个月和7个月的护理人员经验和结果。为期2个月的死后评估将包括一次录音访谈，以探讨护理人员在决策的关键要素方面的经验：信息交流（例如，量身定制）、审议（例如，参与）和社会情感问题（例如，尊重、遗弃）。主要结局：患者死亡后7个月的延长悲伤症状（PG-13）和身体功能（SF-36）。次要结局包括抑郁和焦虑症状、后悔决定、自杀念头和残疾。对于定性分析，基于标准的有目的的抽样将被用来进行有意识的比较，将父母研究与基于3个标准的研究联系起来：干预臂、沟通质量和长期悲伤。意义：这是对一项正在进行的随机对照试验的有效补充，是首次尝试检验一项干预措施对丧亲结局的影响，该干预措施可以整合到常规癌症治疗中。由于干预是系统性的，但简单且易于传播，研究结果将对癌症治疗、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.