About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial population
Adult participants at University of California, San Francisco who are actively receiving care for cancer that has spread to the brain and/or leptomeninges.
Trial design
Cohort
Prospective
Treatments tested in this trial
Health-Related Quality of Life (QOL) questionnaires
Other interventionParticipants can complete questionnaires online, via tablet in clinic, or via paper and pencil in clinic
Medical Chart Review
Other interventionData will be collected from the participants electronic medical record
Treatment groups
Trial outcomes
Primary outcomes
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
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.
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
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.
Secondary outcomes
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.
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.
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.
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