NCT06383026 · Medical College of Wisconsin
Individuals on Hormone Therapy Breast Cancer Screening Pilot
What this study is about
This investigation is a forward-looking breast cancer screening study open to all individuals on hormone therapy.
View original scientific description
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.
Interventions
DIAGNOSTIC_TEST
Breast Cancer Screening
Screening mammography as well as whole breast ultrasound interpreted by BI-RADS.
OTHER
Survey/Interview
A mixed-methods approach including electronic surveys and one on one interviews.
OTHER
Focus Group
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.
Primary outcome measures
Callback and Biopsy Rates after Breast Cancer Screening
Time frame: 3.5 years
Determine the callback and biopsy rates after screening imaging of the entire individuals on hormone therapy patient cohort who complete breast imaging exams.
Reflexive Thematic Analysis of the Physical, Cognitive, and Emotional Experience of Breast Cancer Screening in Individuals on Hormone Therapy
Time frame: 3.5 years
Qualitative data utilized to identify themes around health beliefs, anxiety, and the breast cancer screening experience by describing the physical, cognitive, and emotional experience (perceived seriousness, perceived susceptibility, and anxiety) of individuals on hormone therapy cohort participants who complete surveys or participate in one-on-one interviews.
Reflexive Thematic Analysis on the Individual & System-Level Barriers to Breast Cancer Screening
Time frame: 3.5 years
Qualitative date utilized to identify individual and healthcare systems-level barriers to breast cancer screening for individuals on hormone therapy who complete surveys and/or participate in one-on-one interviews and breast imaging faculty and staff who participate in focus groups.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 1\. Does not work with the breast radiology team.
Where
- Milwaukee, Wisconsin
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 23, 2025 · Source of record for eligibility and locations