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Can online tools help women decide on breast cancer prevention?

NCT ID NCT04496739

Knowledge-focused Sponsor: SWOG Cancer Research Network Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looks at whether web-based decision support tools can help women with atypical hyperplasia or lobular carcinoma in situ (conditions that raise breast cancer risk) make informed choices about chemoprevention. About 412 women and their healthcare providers will use educational materials and action plans. The goal is to see if these tools improve understanding and decision-making, not to test a new drug.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Decision support tools (educational materials, action plans, and interviews)
What this could lead to
If successful, this could show that decision support tools help women at high risk for breast cancer make more informed choices about preventive medication.
What could go wrong
This is a behavioral study, not a treatment trial, so it won't directly prevent or cure cancer. Results may vary across clinics and may not change actual health outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

412 people

The number who actually took part.

Started

Oct 2020

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

atypical lobular breast hyperplasia breast carcinoma in situ lobular breast carcinoma in situ

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atypical hyperplasia of the breast Lobular breast carcinoma in situ Pleomorphic lobular breast carcinoma in situ

Contacts and locations

Locations

  • Addison Gilbert Hospital

    Gloucester, Massachusetts, 01930, United States

  • Advocate Illinois Masonic Medical Center

    Chicago, Illinois, 60657, United States

  • Advocate Lutheran General Hospital

    Park Ridge, Illinois, 60068, United States

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215, United States

  • Aurora West Allis Medical Center

    West Allis, Wisconsin, 53227, United States

  • Baptist Memorial Hospital and Cancer Center-Collierville

    Collierville, Tennessee, 38017, United States

  • Baptist Memorial Hospital and Cancer Center-Memphis

    Memphis, Tennessee, 38120, United States

  • Baptist Memorial Hospital for Women

    Memphis, Tennessee, 38120, United States

  • Beverly Hospital

    Beverly, Massachusetts, 01915, United States

  • Borgess Medical Center

    Kalamazoo, Michigan, 49048, United States

  • Cancer Care Center of O'Fallon

    O'Fallon, Illinois, 62269, United States

  • Cancer Care Specialists of Illinois - Decatur

    Decatur, Illinois, 62526, United States

  • Carle Cancer Center

    Urbana, Illinois, 61801, United States

  • Carle Physician Group-Effingham

    Effingham, Illinois, 62401, United States

  • Carle Physician Group-Mattoon/Charleston

    Mattoon, Illinois, 61938, United States

  • Carle at The Riverfront

    Danville, Illinois, 61832, United States

  • Castle Medical Center

    Kailua, Hawaii, 96734, United States

  • Centralia Oncology Clinic

    Centralia, Illinois, 62801, United States

  • City of Hope Comprehensive Cancer Center

    Duarte, California, 91010, United States

  • City of Hope South Pasadena

    South Pasadena, California, 91030, United States

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Crossroads Cancer Center

    Effingham, Illinois, 62401, United States

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342, United States

  • Emory University Hospital Midtown

    Atlanta, Georgia, 30308, United States

  • Emory University Hospital/Winship Cancer Institute

    Atlanta, Georgia, 30322, United States

  • FHP Health Center-Guam

    Tamuning, 96913, Guam

  • Good Samaritan Hospital

    Corvallis, Oregon, 97330, United States

  • Grady Health System

    Atlanta, Georgia, 30303, United States

  • Hawaii Cancer Care - Westridge

    ‘Aiea, Hawaii, 96701, United States

  • Hawaii Cancer Care Inc - Waterfront Plaza

    Honolulu, Hawaii, 96813, United States

  • Hawaii Cancer Care Inc-Liliha

    Honolulu, Hawaii, 96817, United States

  • Hawaii Diagnostic Radiology Services LLC

    Honolulu, Hawaii, 96817, United States

  • Holy Redeemer Hospital and Medical Center

    Meadowbrook, Pennsylvania, 19046, United States

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112, United States

  • IU Health North Hospital

    Carmel, Indiana, 46032, United States

  • IU Health West Hospital

    Avon, Indiana, 46123, United States

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202, United States

  • Kaiser Permanente Downtown Commons

    Sacramento, California, 95814, United States

  • Kaiser Permanente Medical Center - Santa Clara

    Santa Clara, California, 95051, United States

  • Kaiser Permanente-Deer Valley Medical Center

    Antioch, California, 94531, United States

  • Kaiser Permanente-Oakland

    Oakland, California, 94611, United States

  • Kaiser Permanente-South Sacramento

    Sacramento, California, 95823, United States

  • Kaiser Permanente-South San Francisco

    South San Francisco, California, 94080, United States

  • Kaiser Permanente-Vallejo

    Vallejo, California, 94589, United States

  • Kaiser Permanente-Walnut Creek

    Walnut Creek, California, 94596, United States

  • Kaiser San Rafael-Gallinas

    San Rafael, California, 94903, United States

  • Kapiolani Medical Center for Women and Children

    Honolulu, Hawaii, 96826, United States

  • Kuakini Medical Center

    Honolulu, Hawaii, 96817, United States

  • Lahey Hospital and Medical Center

    Burlington, Massachusetts, 01805, United States

  • Loyola Center for Health at Burr Ridge

    Burr Ridge, Illinois, 60527, United States

  • Loyola University Medical Center

    Maywood, Illinois, 60153, United States

  • Mayo Clinic Health System-Eau Claire Clinic

    Eau Claire, Wisconsin, 54701, United States

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905, United States

  • Memorial Sloan Kettering Basking Ridge

    Basking Ridge, New Jersey, 07920, United States

  • Memorial Sloan Kettering Bergen

    Montvale, New Jersey, 07645, United States

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065, United States

  • Memorial Sloan Kettering Commack

    Commack, New York, 11725, United States

  • Memorial Sloan Kettering Monmouth

    Middletown, New Jersey, 07748, United States

  • Memorial Sloan Kettering Nassau

    Uniondale, New York, 11553, United States

  • Memorial Sloan Kettering Westchester

    East White Plains, New York, 10604, United States

  • Miami Cancer Institute

    Miami, Florida, 33176, United States

  • Miami Cancer Institute at Plantation

    Plantation, Florida, 33324, United States

  • Mount Sinai Comprehensive Cancer Center at Aventura

    Aventura, Florida, 33180, United States

  • Mount Sinai Medical Center

    Miami Beach, Florida, 33140, United States

  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center

    New York, New York, 10032, United States

  • Ohio State University Comprehensive Cancer Center

    Columbus, Ohio, 43210, United States

  • Pali Momi Medical Center

    ‘Aiea, Hawaii, 96701, United States

  • Peninsula Cancer Institute-Newport News

    Newport News, Virginia, 23601, United States

  • Providence Portland Medical Center

    Portland, Oregon, 97213, United States

  • Providence Saint Vincent Medical Center

    Portland, Oregon, 97225, United States

  • Queen's Cancer Cenrer - POB I

    Honolulu, Hawaii, 96813, United States

  • Queen's Cancer Center - Kuakini

    Honolulu, Hawaii, 96817, United States

  • Queen's Cancer Center - Pearlridge

    ‘Aiea, Hawaii, 96701, United States

  • Queen's Medical Center

    Honolulu, Hawaii, 96813, United States

  • Sanford Cancer Center Oncology Clinic

    Sioux Falls, South Dakota, 57104, United States

  • Sanford Roger Maris Cancer Center

    Fargo, North Dakota, 58122, United States

  • Shenandoah Oncology PC

    Winchester, Virginia, 22601, United States

  • Sidney and Lois Eskenazi Hospital

    Indianapolis, Indiana, 46202, United States

  • Straub Clinic and Hospital

    Honolulu, Hawaii, 96813, United States

  • Straub Medical Center - Kahului Clinic

    Kahului, Hawaii, 96732, United States

  • The Cancer Center of Hawaii-Liliha

    Honolulu, Hawaii, 96817, United States

  • The Cancer Center of Hawaii-Pali Momi

    ‘Aiea, Hawaii, 96701, United States

  • The Carle Foundation Hospital

    Urbana, Illinois, 61801, United States

  • The Queen's Medical Center - West Oahu

    ‘Ewa Beach, Hawaii, 96706, United States

  • UC Irvine Health Cancer Center-Newport

    Costa Mesa, California, 92627, United States

  • UC Irvine Health/Chao Family Comprehensive Cancer Center

    Orange, California, 92868, United States

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813, United States

  • University of Wisconsin Carbone Cancer Center

    Madison, Wisconsin, 53792, United States

  • VCU Community Memorial Health Center

    South Hill, Virginia, 23970, United States

  • VCU Massey Cancer Center at Stony Point

    Richmond, Virginia, 23235, United States

  • Vince Lombardi Cancer Clinic-Two Rivers

    Two Rivers, Wisconsin, 54241, United States

  • Virginia Cancer Institute

    Richmond, Virginia, 23229, United States

  • Virginia Commonwealth University/Massey Cancer Center

    Richmond, Virginia, 23298, United States

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007, United States

  • Wilcox Memorial Hospital and Kauai Medical Clinic

    Lihue, Hawaii, 96766, United States

  • Winchester Hospital

    Winchester, Massachusetts, 01890, United States

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