Transgender and Gender-Diverse Breast Cancer Screening Pilot

Active, not recruiting

• Conditions: Breast Cancer
• Interventions: Other: Focus Group; Diagnostic Test: Breast Cancer Screening; Other: Survey/Interview

• Registration Number: NCT06383026
• Lead Sponsor: Medical College of Wisconsin

Brief Summary

This investigation is a prospective breast cancer screening study open to all transgender and gender-diverse persons (regardless of sex assigned at birth). Using a mixed methods approach, the study will 1) gather prospective quantitative breast imaging data in conjunction with gender-affirming therapy and family cancer history and 2) investigate TGD persons perceptions and experiences in the breast cancer screening program, and 3) identify individual and systems-level barriers to breast cancer screening.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-17
• Study First Submitted: 2024-04-17
• Study First Submitted QC: 2024-04-22
• Study First Posted: 2024-04-25
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-15
• Last Update Posted: 2025-04-18
• Primary Completion: 2027-12
• Study Completion: 2028-02

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Transgender and Gender-Diverse Persons	Survey/Interview	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	Focus Group	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 transgendered and nonbinary persons.
Transgender and Gender-Diverse Persons	Breast Cancer Screening	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.

Primary Outcome Measures

Name	Time	Method
Reflexive Thematic Analysis of the Physical, Cognitive, and Emotional Experience of Breast Cancer Screening in Transgender and Gender Diverse Persons	3.5 years	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 TGD cohort participants who complete surveys or participate in one-on-one interviews.
Reflexive Thematic Analysis on the Individual & System-Level Barriers to Breast Cancer Screening	3.5 years	Qualitative date utilized to identify individual and healthcare systems-level barriers to breast cancer screening for transgender persons who complete surveys and/or participate in one-on-one interviews and breast imaging faculty and staff who participate in focus groups.
Callback and Biopsy Rates after Breast Cancer Screening	3.5 years	Determine the callback and biopsy rates after screening imaging of the entire TGD patient cohort who complete breast imaging exams.

Trial Locations

Locations (1)

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States