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: 8253697
• 负责人: Jennifer Sue Temel
• 金额: $ 39.82万
• 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/8253697
• 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. PUBLIC HEALTH RELEVANCE: The goal of this project is to enhance the care of patients with poor prognosis, metastatic cancers by involving palliative care soon after diagnosis. Although palliative care teams have traditionally seen patients late in the course of disease, this study seeks to demonstrate that their early involvement aids with treatment decision- making and leads to improved quality of life and mood in patients with advanced cancer. We hope that combining palliative care with traditional cancer treatment will not only prove beneficial for patients and their families but also transform comprehensive 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的预后仍然很差，中位生存率不到一年。在患病期间，这些病人往往经历明显的身体痛苦，心理痛苦和资源密集型护理在生命的尽头。虽然癌症治疗可以延长生存期，但对这些患者的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、家庭照顾者的丧亲以及医疗保健提供的成本产生了负面影响。理想情况下，全面的癌症护理将包括干预措施，以减少痛苦，并提高预期寿命有限和症状负担高的患者的护理质量和服务。我们假设，一个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，以及促进提供高质量的临终关怀。姑息治疗临床医生专注于护理的多个方面，包括支持和教育，以协助治疗决策，身体和心理症状，以及精神和存在的问题。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治疗和肿瘤治疗与单独标准肿瘤治疗的随机研究表明，患者报告的结局、临终护理质量和资源使用均显著改善。尽管在生命结束时接受较少的化疗，并利用更多的临终关怀服务，与接受标准治疗的患者相比，分配到早期姑息治疗的患者生存期延长。我们现在提出一个更大的，随机对照试验，使用混合定量和定性方法，以扩大我们的研究结果，在新诊断的转移性肺和非结直肠胃肠道恶性肿瘤患者。本研究的目的是：1）证明早期姑息治疗模式的有效性和推广性，以改善预后不良、转移性癌症患者的生活质量、情绪、临终关怀质量、资源利用和生存率; 2）检查接受早期姑息治疗与患者结局（包括延长生存期）之间关系的潜在介质;以及3）将国家高质量流动姑息治疗指南转化为可广泛传播用于临床和研究目的的基于证据的首选做法手册。这项单机构研究将作为多中心试验的基础，利用我们的首选姑息治疗实践的循证手册，以确保可测量和可重现的干预。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并优化资源利用，从而改善患者预后并改变肿瘤学实践。在不对患者生存率产生负面影响的情况下实现这些关键目标无疑将挑战癌症护理中的现有范式。 公共卫生相关性：该项目的目标是通过在诊断后不久提供姑息治疗来加强对预后不良、转移性癌症患者的护理。虽然姑息治疗团队传统上在疾病过程的后期看到患者，但这项研究旨在证明他们的早期参与有助于治疗决策，并导致晚期癌症患者的生活质量和情绪改善。我们希望将姑息治疗与传统癌症治疗相结合，不仅对患者及其家人有益，而且还能改变全面的癌症护理。