Quality of Life for Patients With Breast Cancer Brain Metastases and Leptomeningeal Disease
2026년 6월 15일 업데이트: University of California, San Francisco
Prospective Evaluation of Quality of Life in Patients With Breast Cancer Brain Metastases and Leptomeningeal Disease
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.
연구 개요
상태
아직 모집하지 않음
상세 설명
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.
연구 유형
관찰
등록 (추정된)
200
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Amy Langdon
- 전화번호: 877-827-3222
- 이메일: Amy.DeLuca@ucsf.edu
연구 장소
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California
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San Francisco, California, 미국, 94143
- University of California, San Francisco
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연락하다:
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수석 연구원:
- Laura Huppert, MD
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수석 연구원:
- Michelle Melisko, MD
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연락하다:
- Amy Langdon
- 전화번호: 877-827-3222
- 이메일: Amy.DeLuca@ucsf.edu
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
샘플링 방법
비확률 샘플
연구 인구
Adult participants at University of California, San Francisco who are actively receiving care for cancer that has spread to the brain and/or leptomeninges.
설명
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.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Participants with Metastatic Breast Cancer
This is a prospective cohort study of patients with Stage 4 (metastatic) breast cancer with brain metastases and/or leptomeningeal disease who are receiving treatment for cancer or cancer-related disease.
Through a series of surveys, participants will be asked about race/menopausal status, social determinants, symptom experience, and cognitive and physical functioning.
Participants will be asked to update surveys every 3 months.
Additional demographic and on-investigational / routine care treatment information will be obtained from the Electronic Medical Record (EMR).
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Participants can complete questionnaires online, via tablet in clinic, or via paper and pencil in clinic
다른 이름들:
Data will be collected from the participants electronic medical record
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Overall changes in reported symptom burden
기간: Every 3 months for up to approximately 5 years.
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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
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Every 3 months for up to approximately 5 years.
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Frequency of moderate to severe symptoms
기간: Every 3 months for up to approximately 5 years
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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.
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Every 3 months for up to approximately 5 years
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Overall change in scores on reported symptom interference (MDASI-BT)
기간: Every 3 months for up to approximately 5 years
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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
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Every 3 months for up to approximately 5 years
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Change in the Mean Scores on the Patient-Reported Outcome Measurement Information System (PROMIS) - Cognitive Function Short Form 8a Questionnaire over time
기간: Up to 5 years.
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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.
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Up to 5 years.
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Change in the Mean Scores on the Patient-Reported Outcome Measurement Information System (PROMIS) - Physical Function Questionnaire over time
기간: Every 3 months for approximately 5 years.
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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.
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Every 3 months for approximately 5 years.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Changes in PROMIS - Cognitive function scores over time by non-investigational treatment regimen
기간: Up to 5 years
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The overall changes in scores on the 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.
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Up to 5 years
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Changes in PROMIS - Physical function scores over time by non-investigational treatment regimen
기간: Up to 5 years
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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.
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Up to 5 years
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Changes in MDASI-BT scores over time by non-investigational treatment regimen
기간: Up to 5 years
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The overall changes in scores on the 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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Up to 5 years
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Laura Huppert, MD, University of California, San Francisco
- 수석 연구원: Michelle Melisko, MD, University of California, San Francisco
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 6월 15일
기본 완료 (추정된)
2030년 12월 31일
연구 완료 (추정된)
2035년 12월 31일
연구 등록 날짜
최초 제출
2026년 6월 9일
QC 기준을 충족하는 최초 제출
2026년 6월 15일
처음 게시됨 (실제)
2026년 6월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 22일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 15일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- 26757
- NCI-2026-04200 (레지스트리 식별자: NCI Clinical Trials Reporting Program (CTRP))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .