Making informed choices on incorporating chemoprevention into carE (MiCHOICE, SWOG 1904): Design and methods of a cluster randomized controlled trial


K D. Crew, Columbia University Irving Medical Center, New York, NY, USA. Electronic address:
G L. Anderson, SWOG Statistics and Data Management Center, Seattle, WA, USA.
K B. Arnold, SWOG Statistics and Data Management Center, Seattle, WA, USA.
A P. Stieb, Columbia University Irving Medical Center, New York, NY, USA.
J N. Amenta, Columbia University Irving Medical Center, New York, NY, USA.
N Collins, Columbia University Irving Medical Center, New York, NY, USA.
C W. Law, Columbia University Irving Medical Center, New York, NY, USA.
S Pruthi, Mayo Clinic, Rochester, MN, United States of America.
A Sandoval-Leon, Miami Cancer Institute at Baptist Health South Florida, Miami, FL, USA.
D Bertoni, Good Samaritan Hospital Corvallis, Corvallis, OR (, USA.
M T. Grosse Perdekamp, Carle Cancer Center, Urbana, IL, USA.
S Colonna, Huntsman Cancer Institute / University of Utah Medical Center, Salt Lake City, UT, USA.
S Krisher, Holy Redeemer Hospital and Medical Center, Meadowbrook, PA, USA.
T King, Dana-Farber Brigham Cancer Center, Brigham and Women's Hospital, Boston, MA, USA.
L D. Yee, City of Hope Comprehensive Cancer Center, Duarte, CA, USA.
T J. Ballinger, Indiana University Simon Comprehensive Cancer Center, Indianapolis, IN, USA.
C Braun-Inglis, University of Hawaii Cancer Center, Honolulu, HI, USA.
D Mangino, Memorial Sloan Kettering Cancer Center, New York, NY, USA.
K B. Wisinski, University of Wisconsin Carbone Cancer Center, Madison, WI, USA.
C A. DeYoung, Kaiser Permanente NCORP, Vallejo, CA, USA.
M Ross, Virginia Commonwealth University, Richmond, VA, USA.
J Floyd, Cancer Care Specialists of Illinois, Heartland NCORP, Decatur, IL, USA.
A Kaster, Sanford Roger Maris Cancer Center, Fargo, ND, United States of America.
L Vander Walde, Baptist Memorial Health Care, Memphis, TN, United States of America.
Thomas Saphner, Advocate Health - MidwestFollow
C Zarwan, Lahey Hospital & Medical Center, Burlington, MA, USA.
S Lo, Loyola University Stritch School of Medicine, Maywood, IL, USA.
C Graham, Emory University Hospital/Winship Cancer Institute, Atlanta, GA, USA.
A Conlin, Providence Cancer Institute, Portland, OR, USA.


Introduction:Women with atypical hyperplasia (AH) or lobular carcinoma in situ (LCIS) have a significantly increased risk of breast cancer, which can be substantially reduced with antiestrogen therapy for chemoprevention. However, antiestrogen therapy for breast cancer risk reduction remains underutilized. Improving knowledge about breast cancer risk and chemoprevention among high-risk patients and their healthcare providers may enhance informed decision-making about this critical breast cancer risk reduction strategy.

Methods/design:We are conducting a cluster randomized controlled trial to evaluate the effectiveness and implementation of patient and provider decision support tools to improve informed choice about chemoprevention among women with AH or LCIS. We have cluster randomized 26 sites across the U.S. through the SWOG Cancer Research Network. A total of 415 patients and 200 healthcare providers are being recruited. They are assigned to standard educational materials alone or combined with the web-based decision support tools. Patient-reported and clinical outcomes are assessed at baseline, after a follow-up visit at 6 months, and yearly for 5 years. The primary outcome is chemoprevention informed choice after the follow-up visit. Secondary endpoints include other patient-reported outcomes, such as chemoprevention knowledge, decision conflict and regret, and self-reported chemoprevention usage. Barriers and facilitators to implementing decision support into clinic workflow are assessed through patient and provider interviews at baseline and mid-implementation.

Results/discussion:With this hybrid effectiveness/implementation study, we seek to evaluate if a multi-level intervention effectively promotes informed decision-making about chemoprevention and provide valuable insights on how the intervention is implemented in U.S.

Trial registration:NCT04496739.

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