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Environmental Exposure Assessment in High-Risk and Early-Onset Breast Cancer Care

6. Juli 2026 aktualisiert von: City of Hope Medical Center

Precision Prevention: Environmental Exposure Assessment in High-Risk and Early-Onset Breast Cancer Care

This study evaluates patient and provider attitudes about environmental exposure risk assessments into clinical care for female patients at average or high risk for breast cancer and/or diagnosed with early onset breast cancer.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

PRIMARY OBJECTIVES:

I. To assess patient interest and emotional responses toward EERA and return of results.

II. To assess provider attitudes toward EERA integration into clinical workflows.

OUTLINE: This is an observational study. Participants are assigned to 1 of 3 aims.

AIM I: Average and high risk breast cancer participants and early onset breast cancer patients complete a survey over 15-25 minutes and may attend an interview over 30-45 minutes. Participants' and patients' medical records are reviewed.

AIM II: COH providers complete a survey over 15-25 minutes and may attend an interview over 30-45 minutes.

AIM III: Average and high risk breast cancer participants complete a baseline survey over 15-25 minutes and wear Fresh Air Clip wristbands for 1 week. Participants then complete a follow up survey over 15-25 minutes and may attend an interview over 30-45 minutes. Participants' medical records are reviewed.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

423

Kontakte und Standorte

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

Studienorte

  • Vereinigte Staaten
    • California
      • Duarte, California, Vereinigte Staaten, 91010
        • City of Hope Medical Center
        • Hauptermittler:
          • Stacy W. Gray
        • 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

Ja

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Female patients aged 18 years or older who either are considered average risk for developing breast cancer or high-risk for developing breast cancer or have early-onset breast cancer as well as providers at City of Hope.

Beschreibung

Inclusion Criteria:

  • AIM 1 INCLUSION CRITERIA:

    • ONE of the following:

      • Either average risk of developing breast cancer (defined by woman with no Tyrer-Cuzick model ≥ 20%, no mention of Tyrer-Cuzick model, and no Pathogenic/Likely Pathogenic [P/LP] in breast cancer related genes) OR high risk of developing breast cancer (defined by ≥ 20% chance of developing breast cancer across lifetime measured by Tyrer-Cuzick model or gene mutation carrier, P/LP carrier in breast cancer related genes including BRCA1, BRCA2, BARD1, ATM, CHEK2, CDH1, NF1, PALB2, PTEN, RAD51C, RAD51D, STK11, TP53) OR early onset breast cancer (defined by a breast cancer diagnosis in a patient younger than 50 years of age)
    • Age: ≥ 18 years
    • Speak English or Spanish
    • Sex: female

    • Willingness to:

      • Participate in study activities
      • Permit medical record/ clinical laboratory result review

  • AIM 2 INCLUSION CRITERIA

    • Practice at COH (i.e., genetic counselors, geneticists, oncologists, nurse practitioners)

    • Willingness to:

      • Participate in study activities

  • AIM 3 INCLUSION CRITERIA:

    • Provide written consent

    • ONE of the following:

      • Either average risk of developing breast cancer (defined by woman with no Tyrer-Cuzick model ≥ 20%, no mention of Tyrer-Cuzick model, and no P/LP in breast cancer related genes) OR High risk: empirical risk of developing breast cancer (defined by ≥ 20% chance of developing breast cancer across lifetime measured by Tyrer-Cuzick model and no P/LP in breast cancer related genes) OR High Risk: gene carrier (defined by P/LP carrier in breast cancer related genes, including BRCA1, BRCA2, BARD1, ATM, CHEK2, CDH1, NF1, PALB2, PTEN, RAD51C, RAD51D, STK11, TP53)
    • Age: ≥ 18 years
    • Speak English or Spanish
    • Sex: female

    • Willingness to:

      • Wear the wristband for 1 week
      • Participate in study activities
      • Permit medical record/ clinical laboratory result review

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
Observational Aim I
Average and high risk breast cancer participants and early onset breast cancer patients complete a survey over 15-25 minutes and may attend an interview over 30-45 minutes. Participants' and patients' medical records are reviewed.
Sonstiges: Nicht-interventionelle Studie
Nicht-interventionelle Studie
Andere Namen:
  • Nicht interventionelle Beobachtungsstudie
  • Nichtinterventionelle (Beobachtungs-) Studie
Observational Aim II
COH providers complete a survey over 15-25 minutes and may attend an interview over 30-45 minutes.
Sonstiges: Nicht-interventionelle Studie
Nicht-interventionelle Studie
Andere Namen:
  • Nicht interventionelle Beobachtungsstudie
  • Nichtinterventionelle (Beobachtungs-) Studie
Observational Aim III
Average and high risk breast cancer participants complete a baseline survey over 15-25 minutes and wear Fresh Air Clip wristbands for 1 week. Participants then complete a follow up survey over 15-25 minutes and may attend an interview over 30-45 minutes. Participants' medical records are reviewed.
Sonstiges: Nicht-interventionelle Studie
Nicht-interventionelle Studie
Andere Namen:
  • Nicht interventionelle Beobachtungsstudie
  • Nichtinterventionelle (Beobachtungs-) Studie

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Patient survey responses on perceived utility
Zeitfenster: Up to one year
Will compare emotional responses, environmental health literacy, compensatory health behaviors, and cancer fatalism across the three participant groups (average risk, high risk, and early onset) using analysis of covariance (ANCOVA). Emotional response scores will be constructed by summing items within the positive and negative subscales separately, while the environmental health literacy, compensatory health behaviors and cancer fatalism will be calculated as summed total scores. ANCOVA will be used to estimate adjusted mean differences across groups and to evaluate whether post intervention responses differ after accounting for demographic factors. Interview sessions will be audio-recorded and transcribed verbatim.
Up to one year
Patient survey responses on willingness to engage
Zeitfenster: Up to one year
Will compare emotional responses, environmental health literacy, compensatory health behaviors, and cancer fatalism across the three participant groups (average risk, high risk, and early onset) using ANCOVA. Emotional response scores will be constructed by summing items within the positive and negative subscales separately, while the environmental health literacy, compensatory health behaviors and cancer fatalism will be calculated as summed total scores. ANCOVA will be used to estimate adjusted mean differences across groups and to evaluate whether post intervention responses differ after accounting for demographic factors. Interview sessions will be audio-recorded and transcribed verbatim.
Up to one year
Patient survey responses on preferences for receiving EERA results
Zeitfenster: Up to one year
Will compare emotional responses, environmental health literacy, compensatory health behaviors, and cancer fatalism across the three participant groups (average risk, high risk, and early onset) using ANCOVA. Emotional response scores will be constructed by summing items within the positive and negative subscales separately, while the environmental health literacy, compensatory health behaviors and cancer fatalism will be calculated as summed total scores. ANCOVA will be used to estimate adjusted mean differences across groups and to evaluate whether post intervention responses differ after accounting for demographic factors. Interview sessions will be audio-recorded and transcribed verbatim.
Up to one year
Provider survey responses on perceived utility
Zeitfenster: Up to one year
Descriptive analysis will be used to examine all quantitative variables.
Up to one year
Provider survey responses on feasibility
Zeitfenster: Up to one year
Descriptive analysis will be used to examine all quantitative variables.
Up to one year
Provider survey responses on preferences for EERA disclosures into workflows
Zeitfenster: Up to one year
Descriptive analysis will be used to examine all quantitative variables.
Up to one year
Proportion of participants who wear the work wristband for a total of 1 week
Zeitfenster: Up to one year
Feasibility will be defined as the proportion of participants who wear the work wristband for a total of 1 week. The feasibility rate will be summarized descriptively using point estimates and 95% confidence intervals.
Up to one year
Chemical exposure measured by Fresh Air Clip wristband
Zeitfenster: Up to one year
Acceptability will be measured in the follow-up survey using the question: "Overall, how acceptable did you find wearing the 'Fresh Air clip' wristband to measure chemical exposures in your daily life?" Participants who respond "No opinion," "Acceptable," or "Completely acceptable" will be categorized as finding the wristband acceptable. The acceptability rate will be summarized descriptively using point estimates and 95% confidence intervals.
Up to one year

Mitarbeiter und Ermittler

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

Sponsor

City of Hope Medical Center

Mitarbeiter

National Cancer Institute (NCI)

Ermittler

  • Hauptermittler: Stacy W Gray, City of Hope Medical Center

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)

28. Dezember 2026

Primärer Abschluss (Geschätzt)

1. Januar 2028

Studienabschluss (Geschätzt)

1. Januar 2028

Studienanmeldedaten

Zuerst eingereicht

26. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

6. Juli 2026

Zuerst gepostet (Tatsächlich)

8. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

8. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

6. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 260159 (Andere Kennung: City of Hope Medical Center)
  • P30CA033572 (US NIH Stipendium/Vertrag)
  • NCI-2026-04271 (Registrierungskennung: CTRP (Clinical Trial Reporting Program))

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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