Prospective Evaluation of Quality of Life in Patients With Breast Cancer Brain Metastases and Leptomeningeal Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 200
- Locations
- 1
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •Participants who are not on any anticancer therapy and are not planning to start any anticancer therapy will be excluded from the study.
Outcomes
Primary Outcomes
Not specified
Secondary Outcomes
- 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)