Environmental Exposure Assessment in High-Risk and Early-Onset Breast Cancer Care
Purpose
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.
Condition
- Breast Carcinoma
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- Female
- Accepts Healthy Volunteers
- Yes
Criteria
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
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Case-Control
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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. |
|
| Observational Aim II | COH providers complete a survey over 15-25 minutes and may attend an interview over 30-45 minutes. |
|
| 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. |
|
Recruiting Locations
Duarte, California 91010
More Details
- Status
- Recruiting
- Sponsor
- City of Hope Medical Center
Study Contact
Detailed Description
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.