Breast Carcinoma
Conditions
Brief summary
This study assesses breast cancer screening adherence for women at moderately increased risk for developing breast cancer based on gene mutation status or empiric risk model estimates. It also seeks to determine facilitators and barriers to screening.
Detailed description
PRIMARY OBJECTIVE: I. Among women without a history of breast cancer: to compare women with moderate risk breast cancer gene mutations (Mutation Carrier Group) to women with a 20-40% empiric lifetime risk of breast cancer (Empiric Risk Group) in terms of how likely they are to undergo recommended breast MRI screening. OUTLINE: This is an observational study. Patients complete a questionnaire and have their medical records reviewed on study.
Interventions
OTHERNon-Interventional Study
Non-interventional study
Sponsors
University of Southern California
National Cancer Institute (NCI)
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* \* \>= 30 years * =\< 75 years * Women with either: * Genetic test results showing moderately increased breast cancer risk due to a pathogenic/likely pathogenic variant in ATM, CHEK2, BARD1, RAD51C, or RAD51D (Mutation carrier group) OR * Calculated lifetime breast cancer risk estimates between 20% and 40% according to the Tyrer-Cuzick V8.0B empiric risk model (Empiric risk group) * Patients provided breast cancer risk assessments by genetic counselors at USC Norris or LA General Hospital beginning in 2021 and at least 12 months ago * Women recommended to undergo annual breast MRI and/or annual mammogram beginning at the time of their genetic counseling risk assessment * English or Spanish speaking patients
Exclusion criteria
* \* History of breast cancer before genetic counseling at University of Southern California (USC) * Any metastatic cancer diagnosis at time of genetic counseling risk assessment * Deceased * Patient underwent a risk reducing mastectomy before their genetic counseling risk assessment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of women who undergo a screening breast MRI within 12 months of genetic test counseling | Up to 2 years | Will be calculated for each of the 4 Hospital-by-Age subgroups for the 2 risk groups; then a one-sided, α=0.05 Mantel Haenszel test, stratifying by hospital and age, will be used to compare the Mutation Carrier Risk and the Empiric Risk groups in terms of adherence to screening MRI. Homogeneity of odds ratios will be tested to ensure that difference (odds ratio) between the two risk groups is fairly consistent across the 4 strata. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJacob Comeaux
University of Southern California
Outcome results
None listed