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Breast CarcinomaNCT07690852

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

An observational study of Breast Carcinoma, run by City of Hope Medical Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Breast Carcinoma
What is being tested?
Non-Interventional Study
How many people
423 participants
Where
1 siteUnited States
Study dates
6 Oct 2026to 26 Feb 2029
Phase
Observational

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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
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  • 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

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting
  • City of Hope Medical Center

    Duarte, California, 91010

    Stacy W. Gray, 626-218-4768, stagray@coh.org

    Stacy W. Gray

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. 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.

Being tested
Non-Interventional Study
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Non-Interventional StudyOther

    Also called Non-Interventional Observational Study, Noninterventional (Observational) Study

    Non-interventional study

Study groups in NCT07690852
Study groupRoleWhat they receive
Observational Aim IAverage 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.
Receives: Other: Non-Interventional Study
Observational Aim IICOH providers complete a survey over 15-25 minutes and may attend an interview over 30-45 minutes.
Receives: Other: Non-Interventional Study
Observational Aim IIIAverage 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.
Receives: Other: Non-Interventional Study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient survey responses on perceived utility

    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.

    Measured: Up to one year

  2. Patient survey responses on willingness to engage

    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.

    Measured: Up to one year

  3. Patient survey responses on preferences for receiving EERA results

    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.

    Measured: Up to one year

  4. Provider survey responses on perceived utility

    Descriptive analysis will be used to examine all quantitative variables.

    Measured: Up to one year

  5. Provider survey responses on feasibility

    Descriptive analysis will be used to examine all quantitative variables.

    Measured: Up to one year

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

    Descriptive analysis will be used to examine all quantitative variables.

    Measured: Up to one year

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

    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.

    Measured: Up to one year

  8. Chemical exposure measured by Fresh Air Clip wristband

    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.

    Measured: Up to one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2026
  2. Study start6 Oct 2026
  3. Primary completion26 Jan 2029 (estimated)
  4. Study completion26 Feb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
423 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07690852
Sponsor's protocol ID
260159
Other IDs
NCI-2026-04271, 260159, P30CA033572
Status last verified
Oct 2026
First submitted
26 Jun 2026
Last updated
20 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

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