Making Informed Choices on Incorporating Chemoprevention Into Care (MiCHOICE)

March 20, 2024 updated by: SWOG Cancer Research Network

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To compare the frequency of chemoprevention informed choice at 6 months after registration among women with atypical hyperplasia (AH) or lobular carcinoma in situ (LCIS) between the intervention (RealRisks decision aid/breast cancer risk navigation [BNAV] + standard educational 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 conflict and decision regret at baseline, 6 months, and 12 months in the intervention and control arms.

II. To compare patient chemoprevention usage, adherence, and reasons for discontinuation of a selective 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 healthcare providers 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, into clinic workflow, 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 risk and chemoprevention in RealRisks via the patient portal or website.

GROUP II (INTERVENTION): Patients receive standard educational materials about breast cancer risk and chemoprevention in RealRisks via the patient portal or website. Patients receive patient-centered decision support within the patient portal via an action plan summarizing their breast cancer risk profile, their risks and benefits of SERMs and AIs, and personal preferences for chemoprevention. Health care providers receive decision support and action plans based on their patients' interactions with RealRisks via the BNAV provider-centered support tool within the electronic health record (EHR). A sample of patients participate in an audio-recorded interview via telephone or video conference over 45-60 minutes at 12 months after registration. A sample of health care providers participate in 3 audio-recorded interviews 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.

Study Type

Interventional

Enrollment (Estimated)

415

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Guam
      • Tamuning, Guam, 96913
        • Suspended
        • FHP Health Center-Guam
  • United States
    • California
      • Antioch, California, United States, 94531
        • Recruiting
        • Kaiser Permanente-Deer Valley Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • Costa Mesa, California, United States, 92627
        • Active, not recruiting
        • UC Irvine Health Cancer Center-Newport
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope Comprehensive Cancer Center
        • Principal Investigator:
          • Lisa D. Yee
        • Contact:
      • Oakland, California, United States, 94611
        • Suspended
        • Kaiser Permanente-Oakland
      • Orange, California, United States, 92868
        • Active, not recruiting
        • UC Irvine Health/Chao Family Comprehensive Cancer Center
      • Sacramento, California, United States, 95814
        • Recruiting
        • Kaiser Permanente Downtown Commons
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • Sacramento, California, United States, 95823
        • Recruiting
        • Kaiser Permanente-South Sacramento
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • San Rafael, California, United States, 94903
        • Recruiting
        • Kaiser San Rafael-Gallinas
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • Santa Clara, California, United States, 95051
        • Recruiting
        • Kaiser Permanente Medical Center - Santa Clara
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • South Pasadena, California, United States, 91030
        • Recruiting
        • City of Hope South Pasadena
        • Principal Investigator:
          • Lisa D. Yee
        • Contact:
      • South San Francisco, California, United States, 94080
        • Recruiting
        • Kaiser Permanente-South San Francisco
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • Vallejo, California, United States, 94589
        • Recruiting
        • Kaiser Permanente-Vallejo
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
      • Walnut Creek, California, United States, 94596
        • Recruiting
        • Kaiser Permanente-Walnut Creek
        • Contact:
          • Site Public Contact
          • Phone Number: 877-642-4691
          • Email: Kpoct@kp.org
        • Principal Investigator:
          • Samantha A. Seaward
    • Florida
      • Aventura, Florida, United States, 33180
        • Recruiting
        • Mount Sinai Comprehensive Cancer Center at Aventura
        • Contact:
        • Principal Investigator:
          • Ragisha Gopalakrishnan
      • Miami, Florida, United States, 33176
        • Recruiting
        • Miami Cancer Institute
        • Principal Investigator:
          • Ana C. Sandoval Leon
        • Contact:
          • Site Public Contact
          • Phone Number: 786-596-2000
      • Miami Beach, Florida, United States, 33140
        • Recruiting
        • Mount Sinai Medical Center
        • Contact:
        • Principal Investigator:
          • Ragisha Gopalakrishnan
      • Plantation, Florida, United States, 33324
        • Recruiting
        • Miami Cancer Institute at Plantation
        • Principal Investigator:
          • Ana C. Sandoval Leon
        • Contact:
          • Site Public Contact
          • Phone Number: 954-837-1490
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital/Winship Cancer Institute
        • Contact:
          • Site Public Contact
          • Phone Number: 404-778-1868
        • Principal Investigator:
          • Cathy L. Graham
      • Atlanta, Georgia, United States, 30303
        • Recruiting
        • Grady Health System
        • Contact:
          • Site Public Contact
          • Phone Number: 404-489-9164
        • Principal Investigator:
          • Cathy L. Graham
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Emory University Hospital Midtown
        • Contact:
          • Site Public Contact
          • Phone Number: 888-946-7447
        • Principal Investigator:
          • Cathy L. Graham
      • Atlanta, Georgia, United States, 30342
        • Recruiting
        • Emory Saint Joseph's Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 404-851-7115
        • Principal Investigator:
          • Cathy L. Graham
    • Hawaii
      • 'Aiea, Hawaii, United States, 96701
        • Recruiting
        • Pali Momi Medical Center
        • Principal Investigator:
          • Christa Braun-Inglis
        • Contact:
          • Site Public Contact
          • Phone Number: 808-486-6000
      • 'Aiea, Hawaii, United States, 96701
        • Recruiting
        • Queen's Cancer Center - Pearlridge
        • Principal Investigator:
          • Christa Braun-Inglis
        • Contact:
          • Site Public Contact
          • Phone Number: 808-487-7447
      • 'Aiea, Hawaii, United States, 96701
        • Recruiting
        • The Cancer Center of Hawaii-Pali Momi
        • Principal Investigator:
          • Christa Braun-Inglis
        • Contact:
          • Site Public Contact
          • Phone Number: 808-678-9000
      • 'Aiea, Hawaii, United States, 96701
        • Recruiting
        • Hawaii Cancer Care - Westridge
        • Principal Investigator:
          • Christa Braun-Inglis
        • Contact:
      • 'Ewa Beach, Hawaii, United States, 96706
        • Recruiting
        • The Queen's Medical Center - West Oahu
        • Principal Investigator:
          • Christa Braun-Inglis
        • Contact:
      • Honolulu, Hawaii, United States, 96826
        • Recruiting
        • Kapiolani Medical Center for Women and Children
        • Principal Investigator:
          • Christa Braun-Inglis
        • Contact:
          • Site Public Contact
          • Phone Number: 808-983-6090
      • Honolulu, Hawaii, United States, 96813
        • Recruiting
        • Hawaii Cancer Care Inc - Waterfront Plaza
        • Principal Investigator:
          • Christa Braun-Inglis
        • Contact:
      • Honolulu, Hawaii, United States, 96813
        • Recruiting
        • Queen's Cancer Cenrer - POB I
        • Principal Investigator:
          • Christa Braun-Inglis
        • Contact:
          • Site Public Contact
          • Phone Number: 808-532-0315
      • Honolulu, Hawaii, United States, 96813
        • Recruiting
        • Queen's Medical Center
        • Principal Investigator:
          • Christa Braun-Inglis
        • Contact:
          • Site Public Contact
          • Phone Number: 808-545-8548
      • Honolulu, Hawaii, United States, 96813
        • Recruiting
        • Straub Clinic and Hospital
        • Principal Investigator:
          • Christa Braun-Inglis
        • Contact:
          • Site Public Contact
          • Phone Number: 808-522-4333
      • Honolulu, Hawaii, United States, 96813
        • Recruiting
        • University of Hawaii Cancer Center
        • Principal Investigator:
          • Christa Braun-Inglis
        • Contact:
          • Site Public Contact
          • Phone Number: 808-586-2979
      • Honolulu, Hawaii, United States, 96817
        • Recruiting
        • Hawaii Diagnostic Radiology Services LLC
        • Principal Investigator:
          • Christa Braun-Inglis
        • Contact:
      • Honolulu, Hawaii, United States, 96817
        • Recruiting
        • Kuakini Medical Center
        • Principal Investigator:
          • Christa Braun-Inglis
        • Contact:
          • Site Public Contact
          • Phone Number: 808-547-9816
      • Honolulu, Hawaii, United States, 96817
        • Recruiting
        • Queen's Cancer Center - Kuakini
        • Principal Investigator:
          • Christa Braun-Inglis
        • Contact:
          • Site Public Contact
          • Phone Number: 808-531-8521
      • Honolulu, Hawaii, United States, 96817
        • Recruiting
        • The Cancer Center of Hawaii-Liliha
        • Principal Investigator:
          • Christa Braun-Inglis
        • Contact:
          • Site Public Contact
          • Phone Number: 808-547-6881
      • Honolulu, Hawaii, United States, 96817
        • Suspended
        • Hawaii Cancer Care Inc-Liliha
      • Kahului, Hawaii, United States, 96732
        • Recruiting
        • Straub Medical Center - Kahului Clinic
        • Principal Investigator:
          • Christa Braun-Inglis
        • Contact:
      • Kailua, Hawaii, United States, 96734
        • Recruiting
        • Castle Medical Center
        • Principal Investigator:
          • Christa Braun-Inglis
        • Contact:
      • Lihue, Hawaii, United States, 96766
        • Recruiting
        • Wilcox Memorial Hospital and Kauai Medical Clinic
        • Principal Investigator:
          • Christa Braun-Inglis
        • Contact:
          • Site Public Contact
          • Phone Number: 808-535-7960
    • Illinois
      • Burr Ridge, Illinois, United States, 60527
        • Recruiting
        • Loyola Center for Health at Burr Ridge
        • Principal Investigator:
          • Shelly S. Lo
        • Contact:
          • Site Public Contact
          • Phone Number: 708-216-9000
      • Centralia, Illinois, United States, 62801
        • Recruiting
        • Centralia Oncology Clinic
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Chicago, Illinois, United States, 60657
        • Recruiting
        • Advocate Illinois Masonic Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 773-296-5360
        • Principal Investigator:
          • Thomas J. Saphner
      • Danville, Illinois, United States, 61832
        • Recruiting
        • Carle at The Riverfront
        • Contact:
        • Principal Investigator:
          • Maria T. Grosse-Perdekamp
      • Decatur, Illinois, United States, 62526
        • Recruiting
        • Cancer Care Specialists of Illinois - Decatur
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Carle Physician Group-Effingham
        • Contact:
        • Principal Investigator:
          • Maria T. Grosse-Perdekamp
      • Effingham, Illinois, United States, 62401
        • Recruiting
        • Crossroads Cancer Center
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Mattoon, Illinois, United States, 61938
        • Recruiting
        • Carle Physician Group-Mattoon/Charleston
        • Contact:
        • Principal Investigator:
          • Maria T. Grosse-Perdekamp
      • Maywood, Illinois, United States, 60153
        • Recruiting
        • Loyola University Medical Center
        • Principal Investigator:
          • Shelly S. Lo
        • Contact:
          • Site Public Contact
          • Phone Number: 708-226-4357
      • O'Fallon, Illinois, United States, 62269
        • Recruiting
        • Cancer Care Center of O'Fallon
        • Principal Investigator:
          • Bryan A. Faller
        • Contact:
      • Park Ridge, Illinois, United States, 60068
        • Recruiting
        • Advocate Lutheran General Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 847-384-3621
        • Principal Investigator:
          • Thomas J. Saphner
      • Urbana, Illinois, United States, 61801
        • Recruiting
        • Carle Cancer Center
        • Contact:
        • Principal Investigator:
          • Maria T. Grosse-Perdekamp
      • Urbana, Illinois, United States, 61801
        • Suspended
        • The Carle Foundation Hospital
    • Indiana
      • Avon, Indiana, United States, 46123
        • Recruiting
        • IU Health West Hospital
        • Contact:
        • Principal Investigator:
          • Tarah J. Ballinger
      • Carmel, Indiana, United States, 46032
        • Recruiting
        • IU Health North Hospital
        • Contact:
        • Principal Investigator:
          • Tarah J. Ballinger
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University/Melvin and Bren Simon Cancer Center
        • Contact:
        • Principal Investigator:
          • Tarah J. Ballinger
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Sidney and Lois Eskenazi Hospital
        • Contact:
        • Principal Investigator:
          • Tarah J. Ballinger
    • Massachusetts
      • Beverly, Massachusetts, United States, 01915
        • Recruiting
        • Beverly Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 2405 978-922-3000
        • Principal Investigator:
          • Corrine L. Zarwan
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Dana-Farber Cancer Institute
        • Principal Investigator:
          • Tari A. King
        • Contact:
          • Site Public Contact
          • Phone Number: 877-442-3324
      • Burlington, Massachusetts, United States, 01805
        • Recruiting
        • Lahey Hospital and Medical Center
        • Contact:
        • Principal Investigator:
          • Corrine L. Zarwan
      • Gloucester, Massachusetts, United States, 01930
        • Recruiting
        • Addison Gilbert Hospital
        • Contact:
          • Site Public Contact
          • Phone Number: 559 978-283-4000
        • Principal Investigator:
          • Corrine L. Zarwan
      • Winchester, Massachusetts, United States, 01890
        • Recruiting
        • Winchester Hospital
        • Contact:
        • Principal Investigator:
          • Corrine L. Zarwan
    • Michigan
      • Kalamazoo, Michigan, United States, 49007
        • Recruiting
        • West Michigan Cancer Center
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
      • Kalamazoo, Michigan, United States, 49048
        • Recruiting
        • Borgess Medical Center
        • Contact:
        • Principal Investigator:
          • Kathleen J. Yost
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic in Rochester
        • Principal Investigator:
          • Sandhya Pruthi
        • Contact:
          • Site Public Contact
          • Phone Number: 855-776-0015
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering Basking Ridge
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Giacomo Montagna
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Giacomo Montagna
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering Bergen
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Giacomo Montagna
    • New York
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Commack
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Giacomo Montagna
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Giacomo Montagna
      • New York, New York, United States, 10032
        • Recruiting
        • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
        • Principal Investigator:
          • Katherine D. Crew
        • Contact:
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Giacomo Montagna
      • Uniondale, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Nassau
        • Contact:
          • Site Public Contact
          • Phone Number: 212-639-7592
        • Principal Investigator:
          • Giacomo Montagna
    • North Dakota
      • Fargo, North Dakota, United States, 58122
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Suspended
        • Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University Comprehensive Cancer Center
        • Contact:
        • Principal Investigator:
          • Doreen M. Agnese
    • Oregon
      • Corvallis, Oregon, United States, 97330
        • Recruiting
        • Good Samaritan Hospital
        • Contact:
        • Principal Investigator:
          • Rachel Shirley
      • Portland, Oregon, United States, 97213
        • Recruiting
        • Providence Portland Medical Center
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
      • Portland, Oregon, United States, 97225
        • Recruiting
        • Providence Saint Vincent Medical Center
        • Contact:
        • Principal Investigator:
          • Charles W. Drescher
    • Pennsylvania
      • Meadowbrook, Pennsylvania, United States, 19046
        • Recruiting
        • Holy Redeemer Hospital and Medical Center
        • Contact:
          • Site Public Contact
          • Phone Number: 215-938-3551
        • Principal Investigator:
          • Stacy L. Krisher
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
    • Tennessee
      • Collierville, Tennessee, United States, 38017
        • Recruiting
        • Baptist Memorial Hospital and Cancer Center-Collierville
        • Principal Investigator:
          • Lindi H. VanderWalde
        • Contact:
      • Memphis, Tennessee, United States, 38120
        • Recruiting
        • Baptist Memorial Hospital for Women
        • Principal Investigator:
          • Lindi H. VanderWalde
        • Contact:
      • Memphis, Tennessee, United States, 38120
        • Recruiting
        • Baptist Memorial Hospital and Cancer Center-Memphis
        • Principal Investigator:
          • Lindi H. VanderWalde
        • Contact:
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • Huntsman Cancer Institute/University of Utah
        • Principal Investigator:
          • Sarah V. Colonna
        • Contact:
    • Virginia
      • Newport News, Virginia, United States, 23601
        • Recruiting
        • Peninsula Cancer Institute-Newport News
        • Principal Investigator:
          • Masey M. Ross
        • Contact:
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University/Massey Cancer Center
        • Principal Investigator:
          • Masey M. Ross
        • Contact:
      • Richmond, Virginia, United States, 23235
        • Recruiting
        • VCU Massey Cancer Center at Stony Point
        • Principal Investigator:
          • Masey M. Ross
        • Contact:
      • Richmond, Virginia, United States, 23229
        • Active, not recruiting
        • Virginia Cancer Institute
      • South Hill, Virginia, United States, 23970
        • Recruiting
        • VCU Community Memorial Health Center
        • Principal Investigator:
          • Masey M. Ross
        • Contact:
      • Winchester, Virginia, United States, 22601
        • Active, not recruiting
        • Shenandoah Oncology PC
    • Wisconsin
      • Eau Claire, Wisconsin, United States, 54701
        • Recruiting
        • Mayo Clinic Health System-Eau Claire Clinic
        • Principal Investigator:
          • Sandhya Pruthi
        • Contact:
          • Site Public Contact
          • Phone Number: 855-776-0015
      • Madison, Wisconsin, United States, 53792
        • Recruiting
        • University of Wisconsin Carbone Cancer Center
        • Principal Investigator:
          • Kari B. Wisinski
        • Contact:
          • Site Public Contact
          • Phone Number: 800-622-8922
      • Milwaukee, Wisconsin, United States, 53215
        • Recruiting
        • Aurora Saint Luke's Medical Center
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • Two Rivers, Wisconsin, United States, 54241
        • Recruiting
        • Vince Lombardi Cancer Clinic-Two Rivers
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner
      • West Allis, Wisconsin, United States, 53227
        • Recruiting
        • Aurora West Allis Medical Center
        • Contact:
        • Principal Investigator:
          • Thomas J. Saphner

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group I (educational materials)
Patients receive standard educational materials about breast cancer risk and chemoprevention in RealRisks via the patient portal or website.
Other: Questionnaire Administration
Ancillary studies
Behavioral: Cancer Educational Materials
Receive educational materials about breast cancer risk and chemoprevention via RealRisk
Experimental: Group II (educational materials, decision support, interview)
Patients receive standard educational materials about breast cancer risk and chemoprevention in RealRisks via the patient portal or website. Patients receive patient-centered decision support within the patient portal via an action plan summarizing their breast cancer risk profile, their risks and benefits of SERMs and AIs, and personal preferences for chemoprevention. Health care providers receive decision support and action plans based on their patients' interactions with RealRisks via the BNAV provider-centered support tool within the EHR. A sample of patients participate in an audio-recorded interview via telephone or video conference over 45-60 minutes at 12 months after registration. A sample of health care providers participate in 3 audio-recorded interviews 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.
Other: Questionnaire Administration
Ancillary studies
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chemoprevention informed choice
Time Frame: At 6 months
Will be provided by chemoprevention knowledge scale, a 1-item attitudes scale, and chemoprevention decision and measure at 6 and 12 months on the S1904 Follow-Up Choice form. All enrolled patients who provide outcomes data at the 6-month timepoint will be included in the primary analysis under the intention-to-treat principle. The primary analysis of the intervention effect on informed choice at 6 months will be based on a logistic regression model using a generalized estimating equation approach to account for clustering. Additional supportive analyses will adjust for both patient and clinic level factors. If there are substantial missing data for the components of the primary endpoint, a sensitivity analysis will be conducted imputing a response of no informed decision making for those women with missing information.
At 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived breast cancer risk
Time Frame: Up to 12 months
Will be assessed by absolute estimate ("How do you rate your chance of developing breast cancer?"), comparative risk ("Overall, how do you think your chance of developing breast cancer compares to the average woman your age?"), and numeric risk ("Please place an X on the line below at the point showing what you think your chance is of developing breast cancer in the next five years"). All are assessed on a scale of 0% to 100%, with 0% as "no chance of breast cancer" and 100% as "definitely will get breast cancer."
Up to 12 months
Actual breast cancer risk score
Time Frame: Up to 12 months
A numeric score between the values of 0% and 100%, as determined by the Breast Cancer Surveillance Consortium (BCSC) risk models. The 5-year and 10-year risk estimates are used. The items needed for the BCSC risk models are obtained at baseline from the S1904 Onstudy.
Up to 12 months
Accuracy of risk perception
Time Frame: Up to 12 months
Will be defined as the difference between numeric perceived breast cancer 10-year risk estimate (subjective) and actual 10-year breast cancer risk score, according to the BCSC risk model (objective). Categorized as: accurate if the difference between subjective and objective risk estimates are =< 10% in either direction; underestimate if > 10% below objective risk; and overestimate if > 10% above objective risk.
Up to 12 months
Breast cancer worry
Time Frame: Up to 12 months
Will be measured by two Likert-style items, with responses ranging from "Not at all" (1) to "All of the time" (7). Items are reported and scored separately. Breast cancer worry is assessed on the S1904 Breast Cancer Risk Questionnaire.
Up to 12 months
Decision conflict
Time Frame: Up to 12 months
Will be assessed on the S1904 Breast Cancer Risk Questionnaire. Will be measured by a validated 10-item scale with 3 response categories (Yes/Unsure/No) to assess the level of conflict women feel about their decisions regarding chemoprevention. Scores range from 0 (no decisional conflict) to 100 (extremely high decisional conflict) and will be scored according to the User Manual - Decisional Conflict Scale.
Up to 12 months
Decision regret
Time Frame: Up to 12 months
Will be assessed on the S1904 Decision Questionnaire. Will be measured by a validated 5-item scale composed of 5-point Likert-style items. Scores that range from 0 (no regret) to 100 (high regret). It is scored according to the User Manual - Decision Regret Scale.
Up to 12 months
Chemoprevention usage
Time Frame: Up to 5 years
Will be assessed on the S1904 Follow-Up form and the S1904 Breast Cancer Risk-Reducing Pill Usage form. Among patients who do not have a diagnosis of invasive breast cancer or ductal carcinoma in situ, it will be defined as reporting having started taking or currently taking a selective estrogen receptor modulators (SERM) or aromatase inhibitor (AI) for primary prevention, as assessed by self-report, and taking at least one dose of a SERM or AI for primary prevention, as assessed by the site based on the electronic health record log. Both measures will be reported. Reasons for never starting chemoprevention will be recorded.
Up to 5 years
Chemoprevention adherence
Time Frame: Up to 5 years
Will be assessed using a 3-item scale for patients currently taking a SERM or AI. Responses are given values 1 through 5, with the response corresponding to perfect adherence assigned 1. The three scores are averaged if at least 2 of the 3 items have responses. Non-adherence is defined as an average score of greater than 1. Will be assessed on the S1904 Breast Cancer Risk-Reducing Pill Usage form.
Up to 5 years
Reasons for chemoprevention discontinuation
Time Frame: Up to 5 years
For patients who report discontinuing a SERM or AI, reasons for discontinuing chemoprevention are reported on the S1904 Breast Cancer Risk-Reducing Pill Usage form.
Up to 5 years
Shared decision-making
Time Frame: Up to 6 months
Will be assessed by a validated 9-item scale with Likert-style responses to assess shared decision-making about chemoprevention. Scores range from 0 to 100. Provider and patient measures are evaluated separately and scored according to their respective validation papers. Will be assessed on the S1904 Patient Shared Decision-Making Questionnaire and on the S1904 Provider Shared Decision-Making Questionnaire.
Up to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

SWOG Cancer Research Network

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Katherine D Crew, SWOG Cancer Research Network

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

October 23, 2020

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

June 1, 2028

Study Registration Dates

First Submitted

July 29, 2020

First Submitted That Met QC Criteria

July 29, 2020

First Posted (Actual)

August 3, 2020

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

March 20, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • S1904 (Other Identifier: CTEP)
  • NCI-2019-08755 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • SWOG-S1904 (Other Identifier: DCP)
  • R01CA226060 (U.S. NIH Grant/Contract)
  • UG1CA189974 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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