Individuals on Hormone Therapy Breast Cancer Screening Pilot

NCT06383026 | Recruiting

• 1 other identifier: PRO00047199
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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

Keywords

Mammogram; Mammography; Breast Cancer Screening; Breast Ultrasound; Breast Ultrasonography; Individuals on Hormone Therapy

Outcome Measures

Primary Outcomes (3)

• Callback and Biopsy Rates after Breast Cancer Screening

  Determine the callback and biopsy rates after screening imaging of the entire individuals on hormone therapy patient cohort who complete breast imaging exams.

  3.5 years

• Reflexive Thematic Analysis of the Physical, Cognitive, and Emotional Experience of Breast Cancer Screening in Individuals on Hormone Therapy

  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.

  3.5 years

• Reflexive Thematic Analysis on the Individual & System-Level Barriers to Breast Cancer Screening

  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.

  3.5 years

Study Arms (2)

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.

Diagnostic Test: Breast Cancer Screening; Other: Survey/Interview

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.

Other: Focus Group

Interventions

Breast Cancer Screening DIAGNOSTIC_TEST

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

Individuals on Hormone Therapy

Survey/Interview OTHER

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

Individuals on Hormone Therapy

Focus Group 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.

Breast Imaging Stakeholders

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals on hormone therapy and breast cancer radiology stakeholders.

You may qualify if:

• 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.

You may not qualify if:

• 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.
• \. Does not work with the breast radiology team.

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Surveys and Questionnaires; Interviews as Topic; Focus Groups

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Chandler S Cortina, MD, MS

  The Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chandler S Cortina, MD, MS

CONTACT

4149551453; ccortina@mcw.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Surgery

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 25, 2024
• Study Start: April 17, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): February 1, 2028
• Last Updated: September 23, 2025

Record last verified: 2025-09

Locations

US (1)