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

15. Juni 2026 aktualisiert von: 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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

200

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Vereinigte Staaten
    • California
      • San Francisco, California, Vereinigte Staaten, 94143
        • University of California, San Francisco
        • Kontakt:
        • Hauptermittler:
          • Laura Huppert, MD
        • Hauptermittler:
          • Michelle Melisko, MD
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Adult participants at University of California, San Francisco who are actively receiving care for cancer that has spread to the brain and/or leptomeninges.

Beschreibung

Inclusion Criteria:

  1. Be male or female 18 years of age or older.
  2. Have stage 4 (metastatic) breast cancer with spread to the brain parenchyma and/or leptomeninges.
  3. Have the intention to start or continue anticancer therapy.
  4. Be able to provide informed consent.
  5. 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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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).
Sonstiges: Health-Related Quality of Life (QOL) questionnaires
Participants can complete questionnaires online, via tablet in clinic, or via paper and pencil in clinic
Andere Namen:
  • Health-Related Quality of Life (HrQOL) questionnaires
  • Symptom Questionnaire
Sonstiges: Medical Chart Review
Data will be collected from the participants electronic medical record
Andere Namen:
  • Überprüfung der Krankenakten

Was misst die Studie?

Primäre Ergebnismessungen

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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Changes in PROMIS - Cognitive function scores over time by non-investigational treatment regimen
Zeitfenster: Up to 5 years
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.
Up to 5 years
Changes in PROMIS - Physical function scores over time by non-investigational treatment regimen
Zeitfenster: Up to 5 years
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.
Up to 5 years
Changes in MDASI-BT scores over time by non-investigational treatment regimen
Zeitfenster: Up to 5 years
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.
Up to 5 years

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of California, San Francisco

Ermittler

  • Hauptermittler: Laura Huppert, MD, University of California, San Francisco
  • Hauptermittler: Michelle Melisko, MD, University of California, San Francisco

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

15. Juni 2026

Primärer Abschluss (Geschätzt)

31. Dezember 2030

Studienabschluss (Geschätzt)

31. Dezember 2035

Studienanmeldedaten

Zuerst eingereicht

9. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

15. Juni 2026

Zuerst gepostet (Tatsächlich)

22. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

22. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

15. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 26757
  • NCI-2026-04200 (Registrierungskennung: NCI Clinical Trials Reporting Program (CTRP))

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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