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

City of Hope Medical Center423 enrolled

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.

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.

Study Type

OBSERVATIONAL

Enrollment

423

Conditions

Breast Carcinoma

Interventions

Non-Interventional StudyOTHER

Non-interventional study

Eligibility

Sex: FEMALEMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

City of Hope Medical Center

Duarte, California, United States

RECRUITING

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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