A Randomized trial of early palliative care for newly diagnosed cancer patients

描述(申请人提供)：尽管癌症治疗有所改进，但转移性肺癌和非结直肠癌的预后仍然很差，中位存活率不到一年。在疾病过程中，这些患者往往在生命末期经历明显的身体痛苦、心理痛苦和资源密集型护理。虽然癌症治疗可以延长生存期，但对这些患者来说，它对生活质量和痛苦的影响微乎其微。此外，在生命末期增加抗癌治疗的趋势对死亡质量、家庭照顾者丧亲和医疗保健提供成本产生了负面影响。全面的癌症护理最好包括减少痛苦的干预措施，以及提高对预期寿命有限和症状负担高的患者的护理质量和提供服务。我们假设，高度整合的早期姑息治疗模式将改善患者及其家庭照顾者的生活质量和情绪，并有助于提供高质量的临终关怀。姑息治疗临床医生专注于多个方面的护理，包括支持和教育，以协助治疗决策，身体和心理症状，以及精神和生存关切。我们之前在新诊断的转移性非小细胞肺癌患者中进行的早期综合姑息和肿瘤治疗与单独使用标准肿瘤治疗的随机研究显示，患者报告的结果、临终治疗的质量和资源使用都有显著改善。尽管在生命末期接受的化疗较少，并利用了更多的临终关怀服务，但与接受标准护理的患者相比，被分配到早期姑息治疗的患者的生存时间更长。我们现在提出了一项更大规模的随机对照试验，使用定量和定性的混合方法来扩大我们在新诊断的转移性肺和非结直肠胃肠道恶性肿瘤患者中的发现。本研究的目标是：1)展示早期姑息治疗模式在改善预后不良、转移性癌症患者的生活质量、情绪、临终关怀质量、资源利用和生存方面的有效性和普适性；2)检查接受早期姑息治疗与患者预后(包括延长生存时间)之间关系的潜在中介因素；以及3)将国家高质量门诊姑息治疗指南转化为可广泛传播用于临床和研究目的的首选做法的循证手册。这项单一机构的研究将作为多点试验的基础，利用我们的首选姑息治疗做法循证手册，确保可测量和可重复的干预。这项研究的长期目标是通过提高临终关怀的质量并通过及时整合转移性疾病患者的姑息和癌症护理来优化资源利用，从而改善患者的结局并改变肿瘤学实践。不可否认，在不对患者生存产生负面影响的情况下实现这些关键目标将对现有的癌症护理模式构成挑战。

DESCRIPTION (provided by applicant): Despite improvements in cancer therapy, the prognosis of metastatic lung and non-colorectal gastrointestinal cancers remains poor, with median survival rates of less than one year. During the course of illness, these patients often experience marked physical suffering, psychological distress and resource-intensive care at the end of life. While cancer treatment can extend survival, its impact on quality of life and distress is minimal for these patients. Moreover, the trend toward increased administration of anti-cancer therapy near the end of life negatively impacts quality of death, family caregiver bereavement, and the cost of health care delivery. Comprehensive cancer care ideally would include interventions to diminish suffering as well as enhance the quality and delivery of care for patients with limited life expectancy and high symptom burden. We hypothesize that a highly integrated model of early palliative care will improve quality of life and mood in both patients and their family caregivers as well as facilitate the delivery of quality end-of-life care. Palliative care clinicians focus on multiple aspects of care including support and education to assist with treatment decision-making, physical and psychological symptoms, as well as spiritual and existential concerns. Our previous randomized study of early, integrated palliative and oncology care versus standard oncology care alone in patients with newly diagnosed metastatic non-small cell lung cancer demonstrated marked improvements in patient-reported outcomes, quality of end-of-life care and resource use. Despite receiving less chemotherapy at the end of life and utilizing more hospice services, patients assigned to early palliative care had prolonged survival compared with patients receiving standard care. We now propose a larger, randomized controlled trial using mixed quantitative and qualitative methods to expand our findings in patients with newly diagnosed metastatic lung and non-colorectal gastrointestinal malignancies. The goals of this study are to: 1) demonstrate the efficacy and generalization of the early palliative care model to improve quality of life, mood, quality of end of life care, resource utilization and survival in a more diverse sample of patients with poor prognosis, metastatic cancers; 2) examine potential mediators of the relationship between receiving early palliative care and patient outcomes, including prolonged survival; and 3) operationalize national guidelines for quality ambulatory palliative care into an evidence-based manual of preferred practices that can be disseminated broadly for clinical and research purposes. This single-institution study will serve as the foundation for a multisite trial utilizing our evidence-based manual of preferred palliative care practices to ensure a measurable and reproducible intervention. The long-term goals of this research are to improve patient outcomes and transform oncology practice by enhancing the quality of end-of-life care and optimizing resource utilization through timely integration of palliative and cancer care in patients with metastatic disease. Achieving these critical goals without negatively impacting patient survival would undeniably challenge existing paradigms in cancer care.