Understanding Breast Cancer Risk and Screening in Individuals on Hormone Therapy Through a Pilot Breast Cancer Screening Program

Status: Recruiting
Location: See location...
Intervention Type: Other, Diagnostic test
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 30
Maximum Age: 75
Healthy Volunteers: t
View:

• 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.

Locations
United States
Wisconsin
Medical College of Wisconsin
RECRUITING
Milwaukee
Contact Information
Primary
Chandler S Cortina, MD, MS
ccortina@mcw.edu
4149551453
Time Frame
Start Date: 2024-04-17
Estimated Completion Date: 2028-02
Participants
Target number of participants: 130
Treatments
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 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.
Related Therapeutic Areas
Sponsors
Leads: Medical College of Wisconsin

This content was sourced from clinicaltrials.gov