Набор скоро начнётся NCT07659652

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

— Наблюдательное Breast Cancer, Quality of Life Breast Cancer, Metastatic Breast Cancer, Metastatic Breast Cancer Leptomeningeal Metastasis of Breast Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Health-Related Quality of Life (QOL) questionnaires, Medical Chart Review.
Кому может быть актуально: Состояния в реестре: Breast Cancer, Quality of Life, Breast Cancer, Metastatic, Breast Cancer, Metastatic Breast Cancer, Leptomeningeal Metastasis of Breast Cancer. Базовые параметры: от 18 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Prospective Evaluation of Quality of Life in Patients With Breast Cancer Brain Metastases and Leptomeningeal Disease

Обзор

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.

Подробное описание

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.

Вмешательства

Другое Health-Related Quality of Life (QOL) questionnaires
Participants can complete questionnaires online, via tablet in clinic, or via paper and pencil in clinic
Другое Medical Chart Review
Data will be collected from the participants electronic medical record

Первичные конечные точки

Overall changes in reported symptom burden [Срок оценки: Every 3 months for up to approximately 5 years.]
Frequency of moderate to severe symptoms [Срок оценки: Every 3 months for up to approximately 5 years]
Overall change in scores on reported symptom interference (MDASI-BT) [Срок оценки: 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 [Срок оценки: Up to 5 years.]
Change in the Mean Scores on the Patient-Reported Outcome Measurement Information System (PROMIS) - Physical Function Questionnaire over time [Срок оценки: Every 3 months for approximately 5 years.]

Вторичные конечные точки (3)

Changes in PROMIS - Cognitive function scores over time by non-investigational treatment regimen [Срок оценки: Up to 5 years]
Changes in PROMIS - Physical function scores over time by non-investigational treatment regimen [Срок оценки: Up to 5 years]
Changes in MDASI-BT scores over time by non-investigational treatment regimen [Срок оценки: Up to 5 years]

Критерии участия

Критерии включения

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.