Making Informed Choices on Incorporating Chemoprevention into Care (MiCHOICE)

Inclusion Criteria

• Patients must have histologically-confirmed atypical hyperplasia (AH) or lobular carcinoma in situ (LCIS) documented by breast pathology report at any time in the past. Patients with borderline breast lesions and pleomorphic LCIS are also eligible as long as the pathology is considered benign
• Patients must not have a history of invasive breast cancer or ductal carcinoma in situ
• No other prior malignancy is allowed except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease free for at least five years
• Patients must not have prior or current use of selective estrogen receptor modulators (SERMs) or aromatase inhibitors (AIs). Examples of such therapy include but are not limited to: tamoxifen, raloxifene, anastrozole, exemestane. NOTE: Patients who have had prior topical tamoxifen are eligible. Patients who have had prior oral SERM or AI are NOT eligible
• Patients must not be currently taking systemic hormone replacement therapy. NOTE: Patients who are currently using topical/vaginal estrogen are eligible. Examples of such therapy include but are not limited to: Premarin®, Estrace registered trademark, Vagifem registered trademark, Estradiol, and Divigel registered trademark
• Patients who are co-enrolled in other chemoprevention trials must not have started on an oral SERM or AI at the time of registration to S1904
• 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 only for this age range
• Patients must not have a history of bilateral mastectomies or breast implants since the risk calculator is not applicable to these women
• Both pre/perimenopausal and postmenopausal women are eligible
• Patients must not be pregnant or lactating
• Premenopausal patients must not have a history of thromboembolism, since it is a contraindication to tamoxifen. Tamoxifen is the only Food and Drug Administration (FDA)-approved drug for breast cancer chemoprevention among high-risk premenopausal women, whereas postmenopausal women are eligible for both SERMs and AIs
• Patients must be able to read and write in English or Spanish since study questionnaires 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 phone calls, emails or text messages. This is required to access study materials and receive email/text message reminders from the S1904 study team at Columbia University Irving Medical Center (CUIMC), and to complete a tutorial of the RealRisks tool via phone or video-conference with the S1904 study team at CUIMC. The patient decision aid, RealRisks, is accessible via smartphones, tablets, or personal computers. If patients do not own these devices, local study personnel will provide resources for patients to access RealRisks via computer kiosks or tablets in clinic waiting rooms or public locations, such as community centers or public libraries
• Patients and healthcare providers must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines
• As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been 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 in the interviews
• IMPLEMENTATION EVALUATION: Patients who registered to S1904 at a Group 2 (Intervention) Recruitment Center and consented to be contacted for future research are eligible to participate in the interviews
• Recruitment Centers must be National Clinical Trials Network (NCTN), National Cancer Institute Community Oncology Research Program (NCORP) or Minority Underserved (MU)-NCORP institutions
• Recruitment Centers must have an active EHR and patient portal used in the outpatient clinics which is common and accessible across all sites belonging to the Recruitment Center
• Recruitment Centers must be willing to allow the S1904 study team access to the site’s application program interface (API) for integration of the study materials (standard educational materials and decision support tools) into the EHR and patient portal. (NOTE: Both Group 1 (control) and Group 2 (intervention) recruitment centers may access the standard educational materials via the patient portal or uniform resource 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 facilitate recruitment and retention of patients and healthcare providers and to participate in quarterly stakeholder meetings/conference calls
• Recruitment centers must be willing to register at about 16 patients and 5 healthcare 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 recruitment center
• Providers must be willing to provide informed consent and complete an online baseline questionnaire
• Providers who will register patients must be registered members of a Cooperative Group
• Providers who register patients to S1904 must be willing to see those same patients for 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 study visit be the same