Prospective Evaluation of Quality of Life in Patients With Breast Cancer Brain Metastases and Leptomeningeal Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 1
研究概览
简要总结
Central nervous system (CNS) metastases including breast cancer brain metastases (BCBMs) and leptomeningeal disease (LMD) are common affecting up to 30% of patients with metastatic breast cancer (MBC). The goal of this research is to understand symptom burden and quality of life trajectories in this population and how treatments guide care management decisions.
详细描述
PRIMARY OBJECTIVE:
I. To describe overall symptom experience and quality of life (QOL) over time in breast cancer patients with brain metastases and/or leptomeningeal disease.
SECONDARY OBJECTIVES:
I. To evaluate the impact of cancer-directed treatments over time on quality of life, physical function, and cognitive function in patients with breast cancer brain metastases and/or leptomeningeal disease including:
- The impact of whole brain radiation versus stereotactic radiosurgery on QOL.
- The impact of brain metastasis surgical resection on QOL.
- The impact of CNS-penetrant systemic therapies on QOL.
- The impact of craniospinal irradiation and other treatment modalities for LMD on QOL.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Be male or female 18 years of age or older.
- •Have stage 4 (metastatic) breast cancer with spread to the brain parenchyma and/or leptomeninges.
- •Have the intention to start or continue anticancer therapy.
- •Be able to provide informed consent.
- •Be able to speak and read English.
排除标准
- •Participants who are not on any anticancer therapy and are not planning to start any anticancer therapy will be excluded from the study.
结局指标
主要结局
未指定
次要结局
- Changes in PROMIS - Cognitive function scores over time by non-investigational treatment regimen(Up to 5 years)
- Changes in MDASI-BT scores over time by non-investigational treatment regimen(Up to 5 years)