Making Informed Choices on Incorporating Chemoprevention Into Care (MiCHOICE) (NCT04496739) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Making Informed Choices on Incorporating Chemoprevention Into Care (MiCHOICE)
United States412 participantsStarted 2020-10-23
Plain-language summary
This trial studies the implementation of web-based decision support tools for patients with atypical hyperplasia or lobular carcinoma in situ and healthcare providers. Decision support tools are designed to improve informed choice about breast cancer chemoprevention. Recognizing barriers and facilitators that can influence the adoption of decision support tools at recruitment centers may help researchers learn how to best implement them into clinical practice.
Who can participate
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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
* 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
* Both pre/perimenopausal and postmenopausal women are eligible
* 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 email 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). 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…