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

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

Recruiting
18 years and older
Female
Phase N/A

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Overview

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.

Description

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.

Eligibility

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

Study details
    Breast Carcinoma

NCT07690852

City of Hope Medical Center

20 October 2026

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