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)
Closed
      
  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
Other Clinical Trials
SWOG Clinical Trial Number
              CTSU-A012301
          LoTam: A Randomized, Phase III Clinical Trial of Low-Dose Tamoxifen for Selected Patients with Molecular Low-Risk Early-Stage Breast Cancer
Research Committee(s)
      
            Breast Cancer
Activated
              02/05/2025
          Open
      
  Phase
              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
  
                          
      21%
      
  
    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
  
                          
      31%
      
  
    Open
      
  Phase