Individuals on Hormone Therapy Breast Cancer Screening Pilot

Medical College of Wisconsin

Status: Enrolling

Conditions: Breast Cancer

Treatments: Other: Focus Group; Other: Survey/Interview; Diagnostic Test: Breast Cancer Screening

Study type: Observational

Funder types: Other

Identifiers

NCT06383026

PRO00047199

Details and patient eligibility

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.

Enrollment: 130 estimated patients

Sex: All

Ages: 30 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Individuals on Hormone Therapy:

1. Males 40-75 years of age with a history of ≥9 months of estrogen and/or progesterone hormone therapy.
2. Females 40-75 years of age with any history of testosterone hormone therapy, with or without cosmetic mastectomy, but have not undergone complete mastectomy.
3. Persons who have undergone breast cancer screening before can participate.
4. 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.
5. Ability to speak, read, and write in English.
6. Ability to understand a written informed consent document, and the willingness to sign it.

Inclusion Criteria for Breast Radiology Faculty:

1. 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).
2. Part of the breast radiology faculty who read both ABUS and MMG of the study participants.
3. Ability to speak, read, and write in English.
4. Ability to understand a written informed consent document, and the willingness to sign it.

Inclusion Criteria for Breast Radiology Staff:

1. 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).
2. Ability to understand a written informed consent document, and the willingness to sign it.
3. Ability to speak, read, and write in English.

Exclusion Criteria for Individuals on Hormone Therapy

1. Females who have undergone or planned to undergo a complete mastectomy.
2. Females who are post-menopausal on estrogen +/- progesterone hormone therapy since it is a well-established risk for breast cancer).
3. 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

1. Not a board-certified radiologist.
2. Does not specialize in breast imaging.
3. 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.

Trial design

130 participants in 2 patient groups

Individuals on Hormone Therapy

Description:

Breast imaging data in the form of standard screening mammography in addition to screening whole breast ultrasound will be gathered and interpretations will follow the standard Breast Imaging Reporting and Data Systems. Insight on the perceptions and experiences of being involved in a breast cancer screening program will be gathered.

Treatment:

Diagnostic Test: Breast Cancer Screening

Other: Survey/Interview

Breast Imaging Stakeholders

Description:

A semi-structure focus group to explore radiology faculty and staff experiences while capturing information on the perceived screening barriers, what support and/or training staff require to ensure patients are treated equitable in the screening process, and areas for providers and healthcare systems to improve breast cancer screening for individuals on hormone therapy.

Treatment:

Other: Focus Group