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.
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
- Are there results?
- Not yet: the study is under way
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
Show all 24Show fewer
- 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
- Recruiting
City of Hope Medical Center
Duarte, California, 91010
Stacy W. Gray, 626-218-4768, stagray@coh.org
Stacy W. Gray
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:
- 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.
- Conditions
- Breast Carcinoma
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Non-Interventional Study | |
| Observational Aim II | COH providers complete a survey over 15-25 minutes and may attend an interview over 30-45 minutes. Receives: Other: Non-Interventional Study | |
| 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. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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
Provider survey responses on perceived utility
Descriptive analysis will be used to examine all quantitative variables.
Measured: Up to one year
Provider survey responses on feasibility
Descriptive analysis will be used to examine all quantitative variables.
Measured: Up to one year
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
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
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.
- First posted8 Jul 2026
- Study start6 Oct 2026
- Primary completion26 Feb 2029 (estimated)
- Study completion26 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CarcinomaStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Stacy W Gray, Principal investigator, City of Hope Medical Center
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
- 30 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Prevention: Environmental Exposure Assessment in High-Risk and Early-Onset Breast Cancer Care
- ClinicalTrials.gov ID
- NCT07690852
- Acronym / sponsor ID
- 260159
- Conditions
- Breast Carcinoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 423 participants (estimated)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 6 Oct 2026 (actual)
- Primary completion
- 26 Feb 2029 (estimated)
- Study completion
- 26 Feb 2029 (estimated)
- First posted
- 8 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Observational Aim I | – | Other: Non-Interventional StudyAverage 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. |
| Observational Aim II | – | Other: Non-Interventional StudyCOH providers complete a survey over 15-25 minutes and may attend an interview over 30-45 minutes. |
| Observational Aim III | – | Other: Non-Interventional StudyAverage 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 may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (24 listed)
- AIM 1 INCLUSION CRITERIA:
- AIM 2 INCLUSION CRITERIA
- AIM 3 INCLUSION CRITERIA:
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Interventional StudyAlso: Non-Interventional Observational Study, Noninterventional (Observational) StudyNon-interventional study | Other | Observational Aim I, Observational Aim II, Observational Aim III |
Primary outcome
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.
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.
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.
Provider survey responses on perceived utility
Time frame: Up to one year
Descriptive analysis will be used to examine all quantitative variables.
Provider survey responses on feasibility
Time frame: Up to one year
Descriptive analysis will be used to examine all quantitative variables.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stacy W Gray principal investigator
City of Hope Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Carcinoma, run by City of Hope Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient survey responses on perceived utility (time frame: Up to one year). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Oct 2026.