Quality of Life for Patients With Breast Cancer Brain Metastases and Leptomeningeal Disease

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Health-Related Quality of Life (QOL) questionnaires

    Other intervention

    Participants can complete questionnaires online, via tablet in clinic, or via paper and pencil in clinic

  • Medical Chart Review

    Other intervention

    Data will be collected from the participants electronic medical record

Treatment groups

200 Participants
are divided into 1 treatment group
Group A: Participants with Metastatic Breast Cancer2 interventions

Trial outcomes

Primary outcomes

1

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.
2

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
3

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
4

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.

Secondary outcomes

1

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
2

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
3

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

Other outcomes

Sponsors and contacts

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