SWOG clinical trial number

Cluster Randomized Controlled Trial of Patient and Provider Decision Support to Increase Chemoprevention Informed Choice Among Women with Atypical Hyperplasia or Lobular Carcinoma In Situ - Making Informed Choices on Incorporating Chemoprevention into Care (MiCHOICE)

Abbreviated Title
Decision Support Tool
Status Notes
This study is approaching the overall accrual target, therefore, it will be permanently closed to new patient accrual, effective June 14, 2024, at 12:00 p.m. PT.

Research committees

Prevention & Epidemiology
Breast Cancer

Eligibility Criteria Expand/Collapse

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 not have a history of invasive breast cancer or ductal carcinoma in situ.
Patients must not have prior or current use of selective estrogen receptor modulators (SERMs) or aromatase inhibitors (AIs) and must not be currently taking hormone replacement therapy. Patients must be women at least 35 and no more than 74 years of age; must not have a history of bilateral mastectomies or breast implants since the risk calculator is not applicable to these women. Patients may be pre/perimenopausal or postmenopausal; Premenopausal patients must not have a history of thromboembolism, since it is a contraindication to tamoxifen. Patients must not be pregnant or lactating. Patients must be able to read and write in English or Spanish and baseline questionnaires and 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 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.

Publication Information Expand/Collapse


Lessons from Implementing Practice-Level Cluster Randomized Studies within the NCORP Setting

K Arnold;G Anderson;D Weatherbee Society for Clinical Trials (MAY 15-18, 2022 San Diego, CA), poster

SWOG 1904: Cluster-randomized controlled trial of patient and provider decision support to increase chemoprevention informed choice among women with atypical hyperplasia or lobular carcinoma in situ (MiCHOICE)

K Crew;G Anderson;K Arnold;A Stieb;J Amenta;C Law;A Sandoval-Leon;S Colonna;T King;D Mangino;S Pruthi;M Grosse-Perdekamp;C Braun-Inglis;S Krisher;L Lee;D Bertoni;S Seaward;T Ballinger;K Wisinski;J Floyd;C Zarwan;L VanderWalde;M Ross;P Steen;S Lo;A Conlin;K Yost;J Ellerton;E Lin;H Pederson;S Sardesai;S Sardesai;C Jernigan;D Hershman;M Neuhouser;B Arun;Rita Kukafka San Antonio Breast Cancer Symposium (December 6-10, 2022, San Antonio, TX), poster, trials in progress

Reports & Approvals

Trial Locations