Making Informed Choices on Incorporating Chemoprevention Into Care (MiCHOICE)

T
Tarah Ballinger, MD

Primary Investigator

Overview

This trial studies the implementation of web-based decision support tools for patients withypical hyperplasia or lobular carcinoma in situ and healthcare providers. Decision supportdesigned to improve informed choice about breast cancer chemoprevention. Recognizing barriers and facilitators that can influence the adoption of decision supportuitment centers may help researchers learn how to best implement them into.

Description

PRIMARY OBJECTIVE:
I. To compare the frequency of chemoprevention informed choice at 6 months after registrationg women with atypical hyperplasia (AH) or lobular carcinoma in situ (LCIS) between thevention (RealRisks decision aid/breast cancer risk navigation [BNAV] + standardducational materials) and control (standard educational materials alone) arms.
SECONDARY OBJECTIVES:
I. To assess patient chemoprevention knowledge, chemoprevention intention/decision, perceived breast cancer risk and worry, accuracy of breast cancer risk perception, decision conflictd decision regret at baseline, 6 months, and 12 months in the intervention and control.
II. To compare patient chemoprevention usage, adherence, and reasons for discontinuation of ave estrogen receptor modulator (SERM) or aromatase inhibitor (AI) annually for up to 5 years between the intervention and control arms.
III. To assess shared decision-making about chemoprevention among patients and healthcareviders after their 6-month clinic visit in the intervention and control arms.
IMPLEMENTATION OBJECTIVE:
I. To assess the implementation of the decision support tools, RealRisks and BNAV, intoworkflow, and to better understand barriers and facilitators to chemoprevention usage by conducting telephone/video-conference interviews of healthcare providers and high-risk women with AH or LCIS assigned to the active intervention.
OUTLINE: Recruitment centers are randomized to 1 of 2 groups.
GROUP I (CONTROL): Patients receive standard educational materials about breast cancer riskd chemoprevention in RealRisks via the patient portal or website.
GROUP II (INTERVENTION): Patients receive standard educational materials about breast cancerk and chemoprevention in RealRisks via the patient portal or website. Patients received decision support within the patient portal via an action plan summarizingheir breast cancer risk profile, their risks and benefits of SERMs and AIs, and personalhemoprevention. Health care providers receive decision support and actionbased on their patients' interactions with RealRisks via the BNAV provider-centeredupport tool within the electronic health record (EHR). A sample of patients participate inudio-recorded interview via telephone or video conference over 45-60 minutes at 12 monthsgistration. A sample of health care providers participate in 3 audio-recordedviews via telephone or video conference over 45-60 minutes each at baseline, within 12-36 months after study activation, and within 12 months after study closure to accrual.
After completion of study, patients are followed up at 6, 12, 24, 36, 48, and 60 months.

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Atypical Hyperplasia of the Breast, Lobular Breast Carcinoma In Situ, Pleomorphic Lobular Breast Carcinoma In Situ
  • Gender: All

Inclusion Criteria:
  • Patients must have histologically-confirmed atypical hyperplasia (AH) or lobularu (LCIS) documented by breast pathology report at any time in the. 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,he Breast Cancer Surveillance Consortium (BCSC) risk calculator is valid onlyhis age range
  • Both pre/perimenopausal and postmenopausal women are eligible
  • Patients must be able to read and write in English or Spanish since studyquestionnaires 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. Thisquired to access study materials and receive email/text message reminders fromhe S1904 Study Team at Columbia University Irving Medical Center (CUIMC). The patientdecision aid, RealRisks, is accessible via smartphones, tablets, or personaluters. If patients do not own these devices, local study personnel will provideurces for patients to access RealRisks via computer kiosks or tablets in clinicwaiting rooms or public locations, such as community centers or public libraries
  • Patients and healthcare providers must be informed of the investigational nature ofhis study and must sign and give written informed consent in accordance withutional and federal guidelines
  • As a part of the Oncology Patient Enrollment Network (OPEN) registration process theg 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 beend in the system
  • IMPLEMENTATION: Providers who enrolled in S1904 at Group 2 (intervention) recruitmentd 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 researchgible to participate in the interviews
  • Recruitment Centers must be National Clinical Trials Network (NCTN), National Cancerute Community Oncology Research Program (NCORP) or Minority Underserved(MU)-NCORP institutions
  • Recruitment Centers must have an active EHR and patient portal used in the outpatientwhich is common and accessible across all sites belonging to the RecruitmentCenter
  • Recruitment Centers must be willing to allow the S1904 study team access to the site'sgram interface (API) for integration of the study materials (standardducational materials and decision support tools) into the EHR and patient portal.(NOTE: Both Group 1 (control) and Group 2 (intervention) recruitment centers mayhe standard educational materials via the patient portal or uniform resource(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 facilitateuitment and retention of patients and healthcare providers and to participate inquarterly stakeholder meetings/conference calls
  • Recruitment centers must be willing to register at about 16 patients and 5 healthcareviders 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
  • Providers must be willing to provide informed consent and complete an online baselinequestionnaire
  • 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 patientsheir 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 studyvisit 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 limitedhese.
      • 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 sincehe 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 adication to tamoxifen. Tamoxifen is the only Food and Drug Administration(FDA)-approved drug for breast cancer chemoprevention among high-risk premenopausalwomen, whereas postmenopausal women are eligible for both SERMs and AIs

Updated on 29 Apr 2024. Study ID: S1904
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