A Collaborative Palliative and Oncology Care Model for Metastatic Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- End of life care preference documentation
研究概览
简要总结
The purpose of this research study is to test a new way to deliver oncology and palliative care for patients with metastatic breast cancer.
- The goal of this study is to test a model where oncology and palliative care work together to care for participants with metastatic breast cancer who were recently admitted to the hospital or have new or worsening cancer involving their brain or the fluid around the brain or spinal cord.
- The investigators are studying whether participants who receive care from both teams have better communication about their care and improved quality of life and mood compared to those receiving care from only their oncologists.
The purpose of this randomized clinical trial is to conduct a randomized trial testing the impact of the collaborative palliative and oncology care model or standard oncology care models among patients with poor prognosis metastatic breast cancer. Participants assigned to the intervention arm will participate in a series of structured palliative care visits, following tailored clinical practice guidelines previously developed for patients with metastatic breast cancer.
详细描述
This research study tests whether or not the earlier introduction of a team of clinicians that specialize in the lessening (palliation) of symptoms and addressing quality of life concerns may improve the end-of-life care, quality of life, and mood of women with poor prognosis metastatic breast cancer.
Palliative care is a specific type of medical care given to patients to improve their pain and other symptoms like fatigue, and to support patients and their families as they cope with their illness. Palliative care includes physicians and advanced practice nurses who have been specifically trained in how to help patients with serious illness.
Increasingly, the role of palliative care has been shown to benefit patients when introduced early in the disease trajectory. For example, in patients with metastatic (or spread) lung cancer, early involvement of palliative care improves patients' quality of life and mood. Patients with some metastatic cancers, like breast cancer, have an unpredictable disease trajectory, which makes it difficult to determine the best time to introduce palliative care services.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Already receiving palliative care in the outpatient setting.
- •Active, untreated, unstable, serious mental illness (e.g., active, untreated psychotic, bi-polar, or substance-dependence disorder) interfering with ability to participate.
- •Cognitive impairment (e.g., delirium, dementia) interfering with ability to participate.
- •Requires urgent palliative or hospice care.
结局指标
主要结局
End of life care preference documentation
时间窗: 1 year
Compare differences in rate of documentation of end of life care preferences (Yes documented vs. No)
次要结局
- Patient-reported end of life care conversation(6 months)
- Patient-reported quality of life (FACT-Breast)(Weeks 6, 12, 18, and 24)
- Patient-reported depression symptoms (Hospital Anxiety and Depression Scale)(Weeks 6, 12, 18, and 24)
- Patient-reported anxiety symptoms (Hospital Anxiety and Depression Scale)(Weeks 6, 12, 18, and 24)
- Chemotherapy at the end of life(14, 7 and 3 days before death)
- Rate of hospice utilization at the end of life(6 months)
- Length of stay on hospice(6 months)
研究者
Jennifer Temel, MD
Principal Investigator
Massachusetts General Hospital