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

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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.