Individuals on Hormone Therapy Breast Cancer Screening Pilot
Part of paid clinical trials in Milwaukee, Wisconsin.
- Sponsor
- Medical College of Wisconsin
- Study ID
- NCT06383026
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 30 Years - 75 Years
- Healthy Volunteers
- Accepted
Interventions
- Breast Cancer Screening — DIAGNOSTIC_TESTScreening mammography as well as whole breast ultrasound interpreted by BI-RADS.
- Survey/Interview — OTHERA mixed-methods approach including electronic surveys and one on one interviews.
- Focus Group — OTHERA 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.
Study Details
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.
Key Dates
- Start date
- Apr 17, 2024
- Status verified
- Sep 2025
- Primary completion
- Dec 31, 2027
- Completion
- Feb 29, 2028
Study Design
- Enrollment
- 130 participants (estimated)
Arms
- Arm: Individuals on Hormone TherapyBreast 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.
- Arm: Breast Imaging StakeholdersA 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.
Primary Outcome Measure
Callback and Biopsy Rates after Breast Cancer Screening [ Time Frame: 3.5 years ]
Central Contacts
- Chandler S Cortina, MD, MS4149551453
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | Chandler S Cortina, MD, MS |
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