RECRUITING
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Making Informed Choices on Incorporating Chemoprevention Into Care (MiCHOICE)
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.
Conditions:
🦠 Atypical Hyperplasia of the Breast 🦠 Lobular Breast Carcinoma In Situ 🦠 Pleomorphic Lobular Breast Carcinoma In Situ
🗓️ Study Start (Actual) 23 October 2020
🗓️ Primary Completion (Estimated) 1 May 2025
✅ Study Completion (Estimated) 1 June 2028
👥 Enrollment (Estimated) 415
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Antioch, California, United States
📍 Costa Mesa, California, United States
📍 Duarte, California, United States
📍 Oakland, California, United States
📍 Orange, California, United States
📍 Sacramento, California, United States
📍 Sacramento, California, United States
📍 San Rafael, California, United States
📍 Santa Clara, California, United States
📍 South Pasadena, California, United States
📍 South San Francisco, California, United States
📍 Vallejo, California, United States
📍 Walnut Creek, California, United States
📍 Aventura, Florida, United States
📍 Miami Beach, Florida, United States
📍 Miami, Florida, United States
📍 Plantation, Florida, United States
📍 Atlanta, Georgia, United States
📍 Atlanta, Georgia, United States
📍 Atlanta, Georgia, United States
📍 Atlanta, Georgia, United States
📍 'Aiea, Hawaii, United States
📍 'Aiea, Hawaii, United States
📍 'Aiea, Hawaii, United States
📍 'Aiea, Hawaii, United States
📍 'Ewa Beach, Hawaii, United States
📍 Honolulu, Hawaii, United States
📍 Honolulu, Hawaii, United States
📍 Honolulu, Hawaii, United States
📍 Honolulu, Hawaii, United States
📍 Honolulu, Hawaii, United States
📍 Honolulu, Hawaii, United States
📍 Honolulu, Hawaii, United States
📍 Honolulu, Hawaii, United States
📍 Honolulu, Hawaii, United States
📍 Honolulu, Hawaii, United States
📍 Honolulu, Hawaii, United States
📍 Kahului, Hawaii, United States
📍 Kailua, Hawaii, United States
📍 Lihue, Hawaii, United States
📍 Burr Ridge, Illinois, United States
📍 Centralia, Illinois, United States
📍 Chicago, Illinois, United States
📍 Danville, Illinois, United States
📍 Decatur, Illinois, United States
📍 Effingham, Illinois, United States
📍 Effingham, Illinois, United States
📍 Mattoon, Illinois, United States
📍 Maywood, Illinois, United States
📍 O'Fallon, Illinois, United States
📍 Park Ridge, Illinois, United States
📍 Urbana, Illinois, United States
📍 Urbana, Illinois, United States
📍 Avon, Indiana, United States
📍 Carmel, Indiana, United States
📍 Indianapolis, Indiana, United States
📍 Indianapolis, Indiana, United States
📍 Beverly, Massachusetts, United States
📍 Boston, Massachusetts, United States
📍 Burlington, Massachusetts, United States
📍 Gloucester, Massachusetts, United States
📍 Winchester, Massachusetts, United States
📍 Kalamazoo, Michigan, United States
📍 Kalamazoo, Michigan, United States
📍 Rochester, Minnesota, United States
📍 Basking Ridge, New Jersey, United States
📍 Middletown, New Jersey, United States
📍 Montvale, New Jersey, United States
📍 Commack, New York, United States
📍 Harrison, New York, United States
📍 New York, New York, United States
📍 New York, New York, United States
📍 Uniondale, New York, United States
📍 Fargo, North Dakota, United States
📍 Cleveland, Ohio, United States
📍 Columbus, Ohio, United States
📍 Corvallis, Oregon, United States
📍 Portland, Oregon, United States
📍 Portland, Oregon, United States
📍 Meadowbrook, Pennsylvania, United States
📍 Sioux Falls, South Dakota, United States
📍 Collierville, Tennessee, United States
📍 Memphis, Tennessee, United States
📍 Memphis, Tennessee, United States
📍 Salt Lake City, Utah, United States
📍 Newport News, Virginia, United States
📍 Richmond, Virginia, United States
📍 Richmond, Virginia, United States
📍 Richmond, Virginia, United States
📍 South Hill, Virginia, United States
📍 Winchester, Virginia, United States
📍 Eau Claire, Wisconsin, United States
📍 Madison, Wisconsin, United States
📍 Milwaukee, Wisconsin, United States
📍 Two Rivers, Wisconsin, United States
📍 West Allis, Wisconsin, United States
📍 Tamuning, Guam
More locations available...

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * 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

    Exclusion Criteria:

    • * 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
Ages Eligible for Study: N/A to N/A (CHILD, ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 29 July 2020
  • First Submitted that Met QC Criteria 29 July 2020
  • First Posted 3 August 2020

Study Record Updates

  • Last Update Submitted that Met QC Criteria 20 March 2024
  • Last Update Posted 22 March 2024
  • Last Verified March 2024
I'm interested ...!!