Individuals on Hormone Therapy Breast Cancer Screening Pilot
Understanding Breast Cancer Risk and Screening in Individuals on Hormone Therapy Through a Pilot Breast Cancer Screening Program
Medical College of Wisconsin
130 participants
Apr 17, 2024
OBSERVATIONAL
Conditions
Summary
This investigation is a prospective breast cancer screening study open to all individuals on hormone therapy. Using a mixed methods approach, the study will 1) gather prospective quantitative breast imaging data in conjunction with hormone therapy and family cancer history and 2) investigate individuals on hormone therapy perceptions and experiences in the breast cancer screening program, and 3) identify individual and systems-level barriers to breast cancer screening.
Eligibility
Inclusion Criteria13
- Males 40-75 years of age with a history of ≥9 months of estrogen and/or progesterone hormone therapy.
- Females 40-75 years of age with any history of testosterone hormone therapy, with or without cosmetic mastectomy, but have not undergone complete mastectomy.
- Persons who have undergone breast cancer screening before can participate.
- Individuals who meet criteria for above eligibility and are ≥30-39 years of age with a 1st or 2nd degree family member with breast cancer.
- Ability to speak, read, and write in English.
- Ability to understand a written informed consent document, and the willingness to sign it.
- Board-certified radiologist that specializes in breast imaging and are an actively employed faculty member at Froedtert \& the Medical College of Wisconsin (main campus location).
- Part of the breast radiology faculty who read both ABUS and MMG of the study participants.
- Ability to speak, read, and write in English.
- Ability to understand a written informed consent document, and the willingness to sign it.
- Must be either a technician, nurse, or clerical staff that works with the breast radiology team at Froedtert \& the Medical College of Wisconsin (main campus location).
- Ability to understand a written informed consent document, and the willingness to sign it.
- Ability to speak, read, and write in English.
Exclusion Criteria8
- Females who have undergone or planned to undergo a complete mastectomy.
- Females who are post-menopausal on estrogen +/- progesterone hormone therapy since it is a well-established risk for breast cancer).
- A personal history of breast cancer or a known pathogenic gene mutation that increases the risk of breast cancer development (e.g., BRCA1/2, etc.) given that well-defined surveillance and screening recommendations exist for these persons.
- Not a board-certified radiologist.
- Does not specialize in breast imaging.
- Does not read ABUS and MMG and/or has not read imaging for study participants.
- Exclusion for Breast Radiology Staff
- \. Does not work with the breast radiology team.
Interventions
Screening mammography as well as whole breast ultrasound interpreted by BI-RADS.
A mixed-methods approach including electronic surveys and one on one interviews.
A semi-structured focus group with open-ended questions that explores faculty and staff experiences in a breast cancer screening program for individuals on hormone therapy.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06383026