Individuals on Hormone Therapy Breast Cancer Screening Pilot
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Breast Cancer Screening, Survey/Interview, Focus Group.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: 30 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Understanding Breast Cancer Risk and Screening in Individuals on Hormone Therapy Through a Pilot Breast Cancer Screening Program
Overview
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.
Interventions
- Diagnostic test Breast Cancer Screening
Screening mammography as well as whole breast ultrasound interpreted by BI-RADS. - Other Survey/Interview
A mixed-methods approach including electronic surveys and one on one interviews. - Other Focus Group
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.
Primary outcome measures
- Callback and Biopsy Rates after Breast Cancer Screening [Time frame: 3.5 years]
- Reflexive Thematic Analysis of the Physical, Cognitive, and Emotional Experience of Breast Cancer Screening in Individuals on Hormone Therapy [Time frame: 3.5 years]
- Reflexive Thematic Analysis on the Individual & System-Level Barriers to Breast Cancer Screening [Time frame: 3.5 years]
Eligibility criteria
Inclusion Criteria for Individuals on Hormone Therapy:
- 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.
Inclusion Criteria for Breast Radiology Faculty:
- 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.
Inclusion Criteria for Breast Radiology Staff:
- 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.
Exclusion Criteria for Individuals on Hormone Therapy
- 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.
Exclusion Criteria for Breast Radiology Faculty
- 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.
Exclusion for Breast Radiology Staff
1\. Does not work with the breast radiology team.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Medical College of Wisconsin — Milwaukee
Identifiers
NCT: NCT06383026 · PRO00047199