Making Informed Choices on Incorporating Chemoprevention Into Care (MiCHOICE)

Running, not enrolling · Not applicable

Conditions studied: Atypical Hyperplasia of the Breast, Lobular Breast Carcinoma In Situ, Pleomorphic Lobular Breast Carcinoma In Situ

In brief

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.

Key facts

Study ID: NCT04496739
Run by: SWOG Cancer Research Network
People needed: 412
Starts: 2020-10-23
Expected to finish: 2028-06-01
Last updated by the study team: 2026-04-07

Who can join

Age: any. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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 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

You may not qualify if…

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)
NOTE: The following are approved SERMS and AIs, however, the study is not limited to these.
SERMs: tamoxifen, raloxifene
AIs: anastrozole, exemestane, letrozole
Patients must not be currently taking hormone replacement therapy
Patients must not have a history of bilateral mastectomies or breast implants since the risk calculator is not applicable to these women
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

Where it is running

UC Irvine Health Cancer Center-Newport — Costa Mesa, California, United States
City of Hope Comprehensive Cancer Center — Duarte, California, United States
Kaiser Permanente-Oakland — Oakland, California, United States
UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California, United States
Kaiser Permanente Downtown Commons — Sacramento, California, United States
Kaiser Permanente-South Sacramento — Sacramento, California, United States
Kaiser San Rafael-Gallinas — San Rafael, California, United States
Kaiser Permanente Medical Center - Santa Clara — Santa Clara, California, United States
City of Hope South Pasadena — South Pasadena, California, United States
Kaiser Permanente-South San Francisco — South San Francisco, California, United States
Kaiser Permanente-Vallejo — Vallejo, California, United States
Kaiser Permanente-Walnut Creek — Walnut Creek, California, United States
Mount Sinai Comprehensive Cancer Center at Aventura — Aventura, Florida, United States
Miami Cancer Institute — Miami, Florida, United States
Mount Sinai Medical Center — Miami Beach, Florida, United States
Miami Cancer Institute at Plantation — Plantation, Florida, United States
Grady Health System — Atlanta, Georgia, United States
Emory University Hospital Midtown — Atlanta, Georgia, United States
Emory University Hospital/Winship Cancer Institute — Atlanta, Georgia, United States
Emory Saint Joseph's Hospital — Atlanta, Georgia, United States
Hawaii Cancer Care Inc - Waterfront Plaza — Honolulu, Hawaii, United States
Queen's Cancer Cenrer - POB I — Honolulu, Hawaii, United States
Queen's Medical Center — Honolulu, Hawaii, United States
Straub Clinic and Hospital — Honolulu, Hawaii, United States
Kaiser Permanente-Deer Valley Medical Center — Antioch, California, United States

Full record on ClinicalTrials.gov

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