An observational study in Breast Cancer, sponsored by Medical College of Wisconsin. Recruiting at 1 site in United States. Open to participants aged 30 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-09-23.
Sponsored by Medical College of Wisconsin · Observational
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 130 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Medical College of Wisconsin is the lead sponsor of 540 studies on the registry; 120 are open to participants now.
Of its 71 completed or terminated interventional studies of FDA-regulated products, 56 (79%) have results posted.
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Individuals on hormone therapy and breast cancer radiology stakeholders.
Inclusion Criteria for Individuals on Hormone Therapy:
Inclusion Criteria for Breast Radiology Faculty:
Inclusion Criteria for Breast Radiology Staff:
Exclusion Criteria for Individuals on Hormone Therapy
Exclusion Criteria for Breast Radiology Faculty
Exclusion for Breast Radiology Staff
1. Does not work with the breast radiology team.
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
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
Screening mammography as well as whole breast ultrasound interpreted by BI-RADS.
A mixed-methods approach including electronic surveys and one on one interviews.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 3.5 years
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Medical College of Wisconsin