Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

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

15. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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.

Studietype

Observasjonsmessig

Registrering (Antatt)

200

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Forente stater
    • California
      • San Francisco, California, Forente stater, 94143
        • University of California, San Francisco
        • Ta kontakt med:
        • Hovedetterforsker:
          • Laura Huppert, MD
        • Hovedetterforsker:
          • Michelle Melisko, MD
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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).
Annen: Health-Related Quality of Life (QOL) questionnaires
Participants can complete questionnaires online, via tablet in clinic, or via paper and pencil in clinic
Andre navn:
  • Health-Related Quality of Life (HrQOL) questionnaires
  • Symptom Questionnaire
Annen: Medical Chart Review
Data will be collected from the participants electronic medical record
Andre navn:
  • Medisinsk journalgjennomgang

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Overall changes in reported symptom burden
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Changes in PROMIS - Cognitive function scores over time by non-investigational treatment regimen
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University of California, San Francisco

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

15. juni 2026

Primær fullføring (Antatt)

31. desember 2030

Studiet fullført (Antatt)

31. desember 2035

Datoer for studieregistrering

Først innsendt

9. juni 2026

Først innsendt som oppfylte QC-kriteriene

15. juni 2026

Først lagt ut (Faktiske)

22. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

22. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

15. juni 2026

Sist bekreftet

1. juni 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

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

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Hjernemetastaser fra brystkreft

Kliniske studier på Health-Related Quality of Life (QOL) questionnaires

Søk i lignende forsøk

Sponsorer og samarbeidspartnere

Medisinsk tilstand

Legemiddelintervensjoner

CROs by country

CROs in Papua New Guinea

Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

Kosttilskudd

Sponsor / samarbeidspartnere

Steder

Abonnere