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NCT Number: NCT07690852

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.

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Key information

Conditions

Breast Carcinoma Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

City of Hope Medical Center

Duarte, California, 91010, United States

Location contact

Stacy W. Gray

CONTACT

[email protected]

626-218-4768

Stacy W. Gray

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Non-Interventional Study

Other

Non-interventional study

Other names: Non-Interventional Observational Study, Noninterventional (Observational) Study

Primary outcomes

  1. Patient survey responses on perceived utility

    Time frame: 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.

  2. Patient survey responses on willingness to engage

    Time frame: 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.

  3. Patient survey responses on preferences for receiving EERA results

    Time frame: 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.

  4. Provider survey responses on perceived utility

    Time frame: Up to one year

    Descriptive analysis will be used to examine all quantitative variables.

  5. Provider survey responses on feasibility

    Time frame: Up to one year

    Descriptive analysis will be used to examine all quantitative variables.

  6. Provider survey responses on preferences for EERA disclosures into workflows

    Time frame: Up to one year

    Descriptive analysis will be used to examine all quantitative variables.

  7. Proportion of participants who wear the work wristband for a total of 1 week

    Time frame: 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.

  8. Chemical exposure measured by Fresh Air Clip wristband

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

City of Hope Medical Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jul 8, 2026
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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