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ACTIVE NOT RECRUITING

NCT04496739

Making Informed Choices on Incorporating Chemoprevention Into Care (MiCHOICE)

Sponsor: SWOG Cancer Research Network

View on ClinicalTrials.gov

Summary

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.

Official title: 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)

Key Details

Gender

All

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

412

Start Date

2020-10-23

Completion Date

2028-06-01

Last Updated

2026-04-07

Healthy Volunteers

Yes

Conditions

Atypical Hyperplasia of the Breast Lobular Breast Carcinoma In Situ Pleomorphic Lobular Breast Carcinoma In Situ

Interventions

BEHAVIORAL

Cancer Educational Materials

Receive educational materials about breast cancer risk and chemoprevention via RealRisk

OTHER

Decision Aid

Given patient-centered decision support via an action plan

OTHER

Decision Aid

Given decision support and action plans based on patient's interactions with RealRisks via the BNAV support tool

OTHER

Interview

Participate in audio-recorded interview via telephone or video conference

OTHER

Questionnaire Administration

Ancillary studies

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

Locations (97)

Kaiser Permanente-Deer Valley Medical Center

Antioch, California, United States

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