Early vs. Later Palliative Cancer Care: Clinical and Biobehavioral Effects

描述（申请人提供）：2008年，癌症夺去了超过565，000名美国人的生命-每天1，500人。姑息治疗致力于提高生活质量（QOL），并通过提供专家，跨学科的护理来管理疾病和治疗的影响，以防止“死亡”。有效的临终关怀（EOL）取决于积极主动的，以患者为中心的干预措施，为患者和家属准备应对绝症的挑战。我们能够证明并行肿瘤姑息治疗（COPC）干预的可行性和有效性;然而，我们的知识仍然存在一些差距。拟议的研究是这项工作的逻辑延伸。这项随机对照临床试验将确定COPC干预（在诊断后立即或12周引入）是否可以改善晚期癌症患者及其护理人员的临床结局和临终（EOL）护理。我们还将研究潜在的机制，调解人和主持人，使干预有其影响。探索性目的将调查招募不太常见的实体瘤和血液恶性肿瘤患者的可行性，应激和免疫生物标志物的模式，以及生物标志物与QOL，情绪，症状和生存的关系。患者将被随机分配至晚期或复发性癌症的新诊断后立即或12周后开始干预。这种基于电话的干预包括：1）高级实践姑息护理护士干预师，建立1a）6节手动患者课程-绘制您的课程，1b）4节手动护理人员课程-科普计划，以及1c）持续的患者和护理人员随访;以及2）姑息护理团队综合评估和管理。患者将完成关于QOL、抑郁和症状的基线问卷。照顾者将完成关于照顾者负担和悲伤的问卷。将在第6、12和18周使用基于网络的门户网站完成问卷调查，此后每12周一次，直至患者死亡或研究完成。在参与者死亡后三个月，护理人员将被要求完成一份关于患者死亡时接受的护理质量的死后调查问卷。将在基线和第12周和第24周从选择参与研究的患者中采集唾液和血液样本，以检查应激和免疫功能的生物标志物。将进行定量和定性分析，以确定早期与晚期进入姑息治疗的EOL结局。 公共卫生相关性：2008年，癌症夺去了56.5万多美国人的生命，每天1,500人。这项研究将确定姑息性癌症护理的并行模式（在诊断时或诊断后12周引入）是否可以改善晚期癌症患者的临终（EOL）护理。我们将要求患者完成关于生活质量、抑郁和症状的调查，我们将要求他们的护理人员完成关于患者临终时所接受的负担和护理质量的调查。此外，我们会要求一些患者提供血液和唾液样本，以确定这种护理是否会影响他们的生物免疫力和应激反应。这项研究的结果可以帮助确定指导方针，并改善服务不足，脆弱的癌症患者的EOL护理。

DESCRIPTION (provided by applicant): In 2008, cancer claimed more than 565,000 American lives -1,500 people a day. Palliative care strives to improve quality of life (QOL) and to prevent "bad deaths" by providing expert, interdisciplinary care to manage the effects of disease and treatment. Effective end-of-life (EOL) care depends upon proactive, patient-centered interventions to prepare patients and families for the challenges of terminal illness. We were able to demonstrate feasibility and efficacy of a concurrent oncology palliative care (COPC) intervention; however, a number of gaps in our knowledge remain. The proposed study is a logical extension of that work. This randomized controlled clinical trial will determine whether a COPC intervention (introduced immediately or 12 weeks after diagnosis) can improve clinical outcomes and end-of-life (EOL) care for patients with advanced cancer and their caregivers. We will also examine potential mechanisms, mediators, and moderators whereby the intervention has its effects. Exploratory aims will investigate the feasibility of recruiting patients with less common solid tumors and hematological malignancies, the patterns of stress and immune biomarkers, and the biomarkers' relationship to QOL, mood, symptoms, and survival. Patients will be randomized to begin the intervention either immediately or 12 weeks after a new diagnosis of advanced or recurrent cancer. This phone-based intervention consists of: 1) an Advanced Practice Palliative Care Nurse Interventionist instituting 1a) a 6-session manualized patient curriculum- Charting Your Course, 1b) a 4-session manualized, caregiver curriculum- the COPE program, and 1c) on-going patient and caregiver follow up; and 2) Palliative Care Team Comprehensive Assessment & Management. Patients will complete baseline questionnaires about QOL, depression, and symptoms. Caregivers will complete questionnaires on caregiver burden, and grief. Questionnaires will be completed using a web-based portal at 6, 12, and 18 weeks, and every 12 weeks thereafter until the patients' death or study completion. Three months after a participant's death, caregivers will be asked to complete an after death questionnaire about the quality of care the patient received while dying. Saliva and blood samples will be collected at baseline and 12 and 24 weeks from patients who choose to participate in the study to examine biomarkers of stress and immune function. Quantitative and qualitative analyses will be performed to determine EOL outcomes of early vs. later entry into palliative care. PUBLIC HEALTH RELEVANCE: In 2008, cancer claimed more than 565,000 American lives -1,500 people a day. This study will determine whether a concurrent model of palliative cancer care (introduced at diagnosis or 12 weeks after diagnosis) can improve end-of-life (EOL) care for patients with advanced cancer. We will ask patients to complete surveys on quality of life, depression, and symptoms and we will ask their caregivers to complete surveys on burden and the quality of care the patient received while dying. In addition, we will ask some patients to provide blood and saliva samples to determine if this care affects their biological immunity and stress responses. Findings from this study could help to determine guidelines and improve EOL care for underserved, vulnerable cancer patients.