Making Informed Choices on Incorporating Chemoprevention Into Care (MiCHOICE)

Inclusion Criteria:

• Patients must have histologically-confirmed atypical hyperplasia (AH) or lobularcarcinoma in situ (LCIS) documented by breast pathology report at any time in thepast. Patients with borderline breast lesions and pleomorphic LCIS are also eligible

• Patients must be women at least 35 and no more than 74 years of age at registration,since the Breast Cancer Surveillance Consortium (BCSC) risk calculator is valid onlyfor this age range

• Both pre/perimenopausal and postmenopausal women are eligible

• Patients must be able to read and write in English or Spanish since studyquestionnaires and educational materials are only available in English and Spanish

• Baseline questionnaires must be completed prior to patient registration

• The S1904 Patient Contact form must be completed prior to patient registration

• Patients must be able to access the internet and receive email or text messages.This is required to access study materials and receive email/text message remindersfrom the S1904 Study Team at Columbia University Irving Medical Center (CUIMC). Thepatient decision aid, RealRisks, is accessible via smartphones, tablets, or personalcomputers. If patients do not own these devices, local study personnel will provideresources for patients to access RealRisks via computer kiosks or tablets in clinicwaiting rooms or public locations, such as community centers or public libraries

• Patients and healthcare providers must be informed of the investigational nature ofthis study and must sign and give written informed consent in accordance withinstitutional and federal guidelines

• As a part of the Oncology Patient Enrollment Network (OPEN) registration process thetreating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study hasbeen entered in the system

• IMPLEMENTATION: Providers who enrolled in S1904 at Group 2 (intervention)recruitment center and consented to future contact are eligible to participate inthe interviews

• IMPLEMENTATION EVALUATION: Patients who registered to S1904 at a Group 2 (Intervention) Recruitment Center and consented to be contacted for future researchare eligible to participate in the interviews

• Recruitment Centers must be National Clinical Trials Network (NCTN), National CancerInstitute Community Oncology Research Program (NCORP) or Minority Underserved (MU)-NCORP institutions

• Recruitment Centers must have an active EHR and patient portal used in theoutpatient clinics which is common and accessible across all sites belonging to theRecruitment Center

• Recruitment Centers must be willing to allow the S1904 study team access to thesite's application program interface (API) for integration of the study materials (standard educational materials and decision support tools) into the EHR and patientportal. (NOTE: Both Group 1 (control) and Group 2 (intervention) recruitment centersmay access the standard educational materials via the patient portal or uniformresource locator (URL)/website)

• Recruitment centers must see at least 50 AH and/or LCIS patients per year

• Recruitment centers must identify a lead principal investigator (PI) to facilitaterecruitment and retention of patients and healthcare providers and to participate inquarterly stakeholder meetings/conference calls

• Recruitment centers must be willing to register at about 16 patients and 5healthcare providers to the study

• Recruitment Centers must be willing to submit monthly screening logs to CUIMC

• Providers must regularly see patients with AH or LCIS at an approved recruitmentcenter

• Providers must be willing to provide informed consent and complete an onlinebaseline questionnaire

• Providers who will register patients must be registered members of a CooperativeGroup

• Providers who register patients to S1904 must be willing to see those same patientsfor their 6-month study visits, as the provider intervention tools require that the "treating investigator" as designated in OPEN and the provider at the 6-month studyvisit be the same

Exclusion Criteria:

• Patients must not have a history of invasive breast cancer or ductal carcinoma insitu

• Patients must not have prior or current use of selective estrogen receptormodulators (SERMs) or aromatase inhibitors (AIs)

• NOTE: The following are approved SERMS and AIs, however, the study is notlimited to these.

• SERMs: tamoxifen, raloxifene

• AIs: anastrozole, exemestane, letrozole

• Patients must not be currently taking hormone replacement therapy

• Patients must not have a history of bilateral mastectomies or breast implants sincethe risk calculator is not applicable to these women

• Patients must not be pregnant or lactating

• Premenopausal patients must not have a history of thromboembolism, since it is acontraindication to tamoxifen. Tamoxifen is the only Food and Drug Administration (FDA)-approved drug for breast cancer chemoprevention among high-risk premenopausalwomen, whereas postmenopausal women are eligible for both SERMs and AIs