Individuals on Hormone Therapy Breast Cancer Screening Pilot
Recruiting · NCT06383026 · Observational (researchers observe without assigning treatment) · Lead sponsor: Medical College of Wisconsin
View the official record on ClinicalTrials.gov →Interventions studied
Breast Cancer ScreeningFocus GroupSurvey/Interview
What this trial is about
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.
Who can take part
Age range
30 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- for Individuals on Hormone Therapy:
- 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.
- Inclusion Criteria for Breast Radiology Faculty:
- 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.
- Inclusion Criteria for Breast Radiology Staff:
- 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 criteria
- for Individuals on Hormone Therapy
- 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.
- Exclusion Criteria for Breast Radiology Faculty
- 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.
Where it is running
1 location listed across 1 US state.
- Medical College of Wisconsin - Milwaukee, Wisconsin, United States