SWOG clinical trial number
S1904
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)
Open
Phase
Accrual
99%
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.
Activated
09/01/2020
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.
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
2024
PMid: PMID38704119 | PMC number: PMC11180561
2022
Lessons from Implementing Practice-Level Cluster Randomized Studies within the NCORP Setting
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SWOG Clinical Trial Number
S2206
A Randomized trial of neoadjuvant durvalumab plus chemotherapy versus chemotherapy alone for Adults with MammaPrint Ultrahigh (MP2) hormone receptor (HR) positive /Human Epidermal Growth Factor receptor (HER2) negative stage II-III breast cancer
Research Committee(s)
Breast Cancer
Symptom Control and Quality of Life
Activated
10/30/2023
Accrual
9%
Open
Phase
SWOG Clinical Trial Number
S2212
TIL Adapted Neo adjuvant Chemotherapy Optimization in Triple negative breast cancer (SCARLET)
Research Committee(s)
Breast Cancer
Activated
07/21/2023
Accrual
16%
Open
Phase
SWOG Clinical Trial Number
CTSU/NRG-BR007
A Phase III Clinical Trial Evaluating De-escalation of Breast Radiation for Conservative Treatment of Stage I, Hormone Sensitive, HER2-Negative, Treatment of Stage I, Hormone Sensitive, HER2-Negative, Oncotype Recurrence Score </= 18 Breast Cancer
Research Committee(s)
Breast Cancer
Activated
06/07/2021
Open
Phase