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.
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. EXPLORATORY OBJECTIVES: I. To evaluate the interaction between QOL and demographics, social determinants of health, and control of systemic disease in patients with breast cancer brain metastases and/or leptomeningeal disease. OUTLINE: Participants will be given questionnaires and followed for at least 3 years but may withdraw at any time.
Study Type
OBSERVATIONAL
Enrollment
200
Participants can complete questionnaires online, via tablet in clinic, or via paper and pencil in clinic
Data will be collected from the participants electronic medical record
University of California, San Francisco
San Francisco, California, United States
Overall changes in reported symptom burden
Participants will complete the 22-item MD Anderson Symptom Inventory for Brain Tumor (MDASI-BT) questionnaire which is designed to capture the severity of various symptoms related to cancer (13 items) and symptoms specifically related to brain cancer (9 items) during the last 24 hours. Participants responses are given on a scale from 0 (not present) to 10 (worst possible). The higher the score the more severe the symptom. A subset of the most prevalent or severe symptoms reported will be used to represent symptom burden. Additional information on the questionnaire development scoring and copyright details can be found at https://www.mdanderson.org/research/departments-labs-institutes/departments-divisions/symptom-research/symptom-assessment-tools/md-anderson-symptom-inventory-brain-tumor.html
Time frame: Every 3 months for up to approximately 5 years.
Frequency of moderate to severe symptoms
Participants will complete the 22-item MD Anderson Symptom Inventory for Brain Tumor (MDASI-BT) questionnaire which is designed to capture the severity of various symptoms related to cancer (13 items) and symptoms specifically related to brain cancer (9 items) during the last 24 hours. Participants responses are given on a scale from 0 (not present) to 10 (worst possible). The higher the score the more severe the symptom. The frequency of responses to the MDASI-BT items with a score of 4 or higher will be reported as a percentage of the total number of participants.
Time frame: Every 3 months for up to approximately 5 years
Overall change in scores on reported symptom interference (MDASI-BT)
Participants will complete the 6-item section of the MD Anderson Symptom Inventory for Brain Tumor (MDASI-BT) questionnaire which is designed to capture the interference of cancer symptoms during the last 24 hours. Participants responses are given on a scale from 0 (no interference) to 10 (interfered complete) and address general activity, mood, work/housework, relationships, walking, and enjoyment of life. The higher the score the more the symptom interfered with daily life. Additional information on the questionnaire development scoring and copyright details can be found at https://www.mdanderson.org/research/departments-labs-institutes/departments-divisions/symptom-research/symptom-assessment-tools/md-anderson-symptom-inventory-brain-tumor.html
Time frame: Every 3 months for up to approximately 5 years
Change in the Mean Scores on the Patient-Reported Outcome Measurement Information System (PROMIS) - Cognitive Function Short Form 8a Questionnaire over time
This 8-item questionnaire to measure cognitive function based on responses to statements about how the participants feel regarding various cognitive tasks in the past 7 days with responses ranging from 5="Never" to 1="Very Often", and a total raw score ranging from 8 - 40, which are converted to a scaled T-score (range 22.41 to 63.48) with lower scores indicating a greater impairment of cognitive function.
Time frame: Up to 5 years.
Change in the Mean Scores on the Patient-Reported Outcome Measurement Information System (PROMIS) - Physical Function Questionnaire over time
This 6-item questionnaire to measures self-reported capability to physically function in the context of cancer and/or cancer treatment experiences, based on responses to statements about how the participants feel regarding various physical tasks in the past 7 days with responses ranging from 5="Without difficulty" to 1="Unable to do", or 5="Not at all" to 1="Cannot do" and a total raw score ranging from 6 - 30, which are converted to a scaled T-score with a range from 20.8 -59), with lower scores indicating a greater impairment of physical function.
Time frame: Every 3 months for approximately 5 years.
Changes in PROMIS - Cognitive function scores over time by non-investigational treatment regimen
The overall changes in scores on the Patient-Reported Outcomes Measurement Information System (PROMIS) cognitive function scores by non-investigational treatment regimen, including whole brain radiation or craniospinal radiation versus stereotactic radiosurgery only, participants who have undergone surgical resection versus not, and participants treated with CNS penetrant systemic therapies versus not will be analyzed using logistic regression models.
Time frame: Up to 5 years
Changes in PROMIS - Physical function scores over time by non-investigational treatment regimen
The overall changes in scores on both the PROMIS physical function scores by non-investigational treatment regimen, including whole brain radiation or craniospinal radiation versus stereotactic radiosurgery only, participants who have undergone surgical resection versus not, and participants treated with CNS penetrant systemic therapies versus not will be analyzed using logistic regression models.
Time frame: Up to 5 years
Changes in MDASI-BT scores over time by non-investigational treatment regimen
The overall changes in scores on the MD Anderson Symptom Inventory for Brain Tumor (MDASI-BT) by non-investigational treatment regimen, including whole brain radiation or craniospinal radiation versus stereotactic radiosurgery only, participants who have undergone surgical resection versus not, and participants treated with CNS penetrant systemic therapies versus not will be analyzed using logistic regression models.
Time frame: Up to 5 years
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