Can online tools help women decide on breast cancer prevention?

NCT ID NCT04496739

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

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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