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

新诊断癌症患者早期姑息治疗的随机试验

• 批准号: 8443352
• 负责人: Jennifer Sue Temel
• 金额: $ 38.58万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-04-06 至 2016-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8443352
• 关键词: Accounting; Advanced Malignant Neoplasm; Bereavement; Cancer Patient; Caregivers; Caring; Cessation of life; Clinical; Clinical Research; Counseling; Decision Making; Diagnosis; Disease; Disseminated Malignant Neoplasm; Distress; Documentation; Education; Ensure; Family; Family Caregiver; Feedback; Focus Groups; Foundations; Goals; Guidelines; Institution; Intensive Care; Intervention; Length of Stay; Life; Life Expectancy; Literature; Lung; Malignant Neoplasms; Malignant neoplasm of gastrointestinal tract; Manuals; Measurable; Measures; Mediating; Mediator of activation protein; Medical Records; Modeling; Moods; Newly Diagnosed; Non-Small-Cell Lung Carcinoma; Outcome; Palliative Care; Patient Care; Patient Outcomes Assessments; Patients; Phase; Physical Sufferings; Qualitative Methods; Quality of Care; Quality of life; Randomized; Randomized Controlled Trials; Reporting; Research; Resources; Sampling; Services; Survival Rate; Symptoms; Terminal Disease; arm; base; cancer care; cancer palliative treatment; cancer therapy; care preference; chemotherapy; clinical care; coping; cost; depressive symptoms; end of life; evidence base; experience; gastrointestinal; health care delivery; hospice environment; improved; informant; oncology; outcome forecast; palliative; patient population; programs; psychologic; psychological distress; public health relevance; quality of death; randomized trial; standard care; trend

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.

描述（由申请人提供）：尽管癌症治疗有所改善，但转移性肺癌和非结直肠胃肠道癌症的预后仍然很差，中位生存率不到一年。在疾病过程中，这些患者经常经历明显的身体痛苦、心理困扰和生命末期的资源密集型护理。虽然癌症治疗可以延长生存期，但它对这些患者的生活质量和痛苦的影响是最小的。此外，在生命末期增加抗癌治疗的趋势对死亡质量、家庭照顾者丧亲之痛和医疗保健服务的成本产生了负面影响。理想情况下，全面的癌症护理应包括减少痛苦的干预措施，并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护理人员的生活质量和情绪，并促进提供高质量的临终关怀。姑息治疗临床医生关注护理的多个方面，包括支持和教育，以协助治疗决策，身体和心理症状，以及精神和存在问题。我们之前的随机研究表明，在新诊断的转移性非小细胞肺癌患者中，早期、综合姑息治疗和肿瘤治疗与单独的标准肿瘤治疗相比，在患者报告的结果、临终护理质量和资源利用方面有显著改善。尽管在生命末期接受较少的化疗和使用更多的临终关怀服务，与接受标准治疗的患者相比，被分配到早期姑息治疗的患者存活时间更长。我们现在建议进行一项更大规模的随机对照试验，使用混合定量和定性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。本研究的目的是：1)在更多样化的预后不良、转移性癌症患者样本中，证明早期姑息治疗模式在改善生活质量、情绪、临终关怀质量、资源利用和生存方面的疗效和推广；2)研究早期姑息治疗与患者预后（包括延长生存期）之间关系的潜在中介；3)将优质门诊姑息治疗的国家指导方针转化为基于证据的首选实践手册，可以广泛传播用于临床和研究目的。这项单机构研究将作为多地点试验的基础，利用我们的基于证据的首选姑息治疗实践手册，以确保可测量和可重复的干预。本研究的长期目标是通过及时整合转移性疾病患者的姑息治疗和癌症治疗，提高临终关怀的质量，优化资源利用，从而改善患者的预后并改变肿瘤学实践。在不影响患者生存的情况下实现这些关键目标，无疑将挑战现有的癌症治疗模式。