Making Informed Choices on Incorporating Chemoprevention into Care (MiCHOICE)

Summary

Objectives

PRIMARY OBJECTIVE:
I. To compare the frequency of chemoprevention informed choice at 6 months after registration among women with atypical hyperplasia (AH) or lobular carcinoma in situ (LCIS) between the intervention (RealRisks decision aid/breast cancer risk navigation [BNAV] + standard educational materials) and control (standard educational materials alone) arms.

SECONDARY OBJECTIVES:
I. To assess patient chemoprevention knowledge, chemoprevention intention/decision, perceived breast cancer risk and worry, accuracy of breast cancer risk perception, decision conflict and decision regret at baseline, 6 months, and 12 months in the intervention and control arms.
II. To compare patient chemoprevention usage, adherence, and reasons for discontinuation of a selective estrogen receptor modulator (SERM) or aromatase inhibitor (AI) annually for up to 5 years between the intervention and control arms.
III. To assess shared decision-making about chemoprevention among patients and healthcare providers after their 6-month clinic visit in the intervention and control arms.

IMPLEMENTATION OBJECTIVE:
I. To assess the implementation of the decision support tools, RealRisks and BNAV, into clinic workflow, and to better understand barriers and facilitators to chemoprevention usage by conducting telephone/video-conference interviews of healthcare providers and high-risk women with AH or LCIS assigned to the active intervention.

OUTLINE: Recruitment centers are randomized to 1 of 2 groups.

GROUP I (CONTROL): Patients receive standard educational materials about breast cancer risk and chemoprevention in RealRisks via the patient portal or website.

GROUP II (INTERVENTION): Patients receive standard educational materials about breast cancer risk and chemoprevention in RealRisks via the patient portal or website. Patients receive patient-centered decision support within the patient portal via an action plan summarizing their breast cancer risk profile, their risks and benefits of SERMs and AIs, and personal preferences for chemoprevention. Health care providers receive decision support and action plans based on their patients' interactions with RealRisks via the BNAV provider-centered support tool within the electronic health record (EHR). A sample of patients participate in an audio-recorded interview via telephone or video conference over 45-60 minutes within 3 months after the 6-month follow-up visit. A sample of health care providers participate in 2 audio-recorded interviews via telephone or video conference over 45-60 minutes each at baseline and within 12-36 months after study activation.

After completion of study, patients are followed up at 6, 12, 24, 36, 48, and 60 months.