Breast Cancer
Conditions
Keywords
Mammogram, Mammography, Breast Cancer Screening, Breast Ultrasound, Breast Ultrasonography, Individuals on Hormone Therapy
Brief 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.
Interventions
DIAGNOSTIC_TESTBreast Cancer Screening
Screening mammography as well as whole breast ultrasound interpreted by BI-RADS.
OTHERSurvey/Interview
A mixed-methods approach including electronic surveys and one on one interviews.
OTHERFocus 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.
Sponsors
Medical College of Wisconsin
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
for Individuals on Hormone Therapy: 1. Males 40-75 years of age with a history of ≥9 months of estrogen and/or progesterone hormone therapy. 2. Females 40-75 years of age with any history of testosterone hormone therapy, with or without cosmetic mastectomy, but have not undergone complete mastectomy. 3. Persons who have undergone breast cancer screening before can participate. 4. 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. 5. Ability to speak, read, and write in English. 6. Ability to understand a written informed consent document, and the willingness to sign it. Inclusion Criteria for Breast Radiology Faculty: 1. 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). 2. Part of the breast radiology faculty who read both ABUS and MMG of the study participants. 3. Ability to speak, read, and write in English. 4. Ability to understand a written informed consent document, and the willingness to sign it. Inclusion Criteria for Breast Radiology Staff: 1. 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). 2. Ability to understand a written informed consent document, and the willingness to sign it. 3. Ability to speak, read, and write in English.
Exclusion criteria
for Individuals on Hormone Therapy 1. Females who have undergone or planned to undergo a complete mastectomy. 2. Females who are post-menopausal on estrogen +/- progesterone hormone therapy since it is a well-established risk for breast cancer). 3. 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Callback and Biopsy Rates after Breast Cancer Screening | 3.5 years | Determine the callback and biopsy rates after screening imaging of the entire individuals on hormone therapy patient cohort who complete breast imaging exams. |
| Reflexive Thematic Analysis of the Physical, Cognitive, and Emotional Experience of Breast Cancer Screening in Individuals on Hormone Therapy | 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 individuals on hormone therapy 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 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. |
Countries
United States
Contacts
Primary ContactChandler S Cortina, MD, MS
Outcome results
None listed