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

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.

• Non-Interventional Study (Other), also known as Non-Interventional Observational Study, Noninterventional (Observational) Study: Non-interventional study

Primary outcomes

• Patient survey responses on perceived utility [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 [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 [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 [Up to one year]: Descriptive analysis will be used to examine all quantitative variables.
• Provider survey responses on feasibility [Up to one year]: Descriptive analysis will be used to examine all quantitative variables.
• Provider survey responses on preferences for EERA disclosures into workflows [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 [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 [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.

Sex: Female, ages: 18 Years to any, accepts healthy volunteers

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

• Stacy W Gray, Principal investigator, City of Hope Medical Center

NIH grants: P30CA033572