Individuals on Hormone Therapy Breast Cancer Screening Pilot

NCT ID: NCT06383026

Last Updated: 2025-09-23

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 130 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-17
• Study Completion Date: 2028-02-29

Brief 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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Individuals on Hormone Therapy

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.

Breast Cancer Screening

Intervention Type: DIAGNOSTIC_TEST

Screening mammography as well as whole breast ultrasound interpreted by BI-RADS.

Survey/Interview

Intervention Type: OTHER

A mixed-methods approach including electronic surveys and one on one interviews.

Breast Imaging Stakeholders

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.

Focus Group

Intervention Type: OTHER

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.

Interventions

Breast Cancer Screening

Screening mammography as well as whole breast ultrasound interpreted by BI-RADS.

Intervention Type: DIAGNOSTIC_TEST

Survey/Interview

A mixed-methods approach including electronic surveys and one on one interviews.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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.

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.

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

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.

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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medical College of Wisconsin

OTHER

Sponsor Role: lead

Responsible Party

Chandler S Cortina

Associate Professor of Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Chandler S Cortina, MD, MS

Role: PRINCIPAL_INVESTIGATOR

The Medical College of Wisconsin

Locations

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Chandler S Cortina, MD, MS

Role: CONTACT

ccortina@mcw.edu

4149551453

Facility Contacts

Chandler S Cortina, MD, MS

Role: primary

ccortina@mcw..edu

Other Identifiers

PRO00047199

Identifier Type: -

Identifier Source: org_study_id