NCT04496739|Active Not RecruitingDMC

Making Informed Choices on Incorporating Chemoprevention Into Care (MiCHOICE)

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)

SWOG Cancer Research Network ClinicalTrials.gov

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5 other identifiers

S1904NCI-2019-08755SWOG-S1904R01CA226060UG1CA189974

Study Type

interventional

Target

412

Locations

2 countries

Sites

Timeline

RegisteredAug 2020

StartedOct 2020

CompletionJun 2028

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

412

participants targeted

Target at P75+ for not_applicable

Timeline

26mo left

Started Oct 2020

Longer than P75 for not_applicable

Geographic Reach

2 countries

97 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7.6 years study duration

Study Progress73%

Oct 2020Jun 2028

First Submitted

Initial submission to the registry

July 29, 2020

Completed

5 days until next milestone

First Posted

Study publicly available on registry

August 3, 2020

Completed

3 months until next milestone

Study Start

First participant enrolled

October 23, 2020

Completed

4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed

2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2028

Expected

Last Updated

September 17, 2025

Status Verified

September 1, 2025

Enrollment Period

4.9 years

First QC Date

July 29, 2020

Last Update Submit

September 15, 2025

Conditions

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

Outcome Measures

Primary Outcomes (1)

Chemoprevention informed choice
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 Outcomes (10)

Perceived breast cancer risk
Up to 12 months
Actual breast cancer risk score
Up to 12 months
Accuracy of risk perception
Up to 12 months
Breast cancer worry
Up to 12 months
Decision conflict
Up to 12 months
+5 more secondary outcomes

Study Arms (2)

Group I (educational materials)

ACTIVE COMPARATOR

Patients receive standard educational materials about breast cancer risk and chemoprevention in RealRisks via the patient portal or website.

Behavioral: Cancer Educational MaterialsOther: Questionnaire Administration

Group II (educational materials, decision support, interview)

EXPERIMENTAL

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.

Behavioral: Cancer Educational MaterialsOther: Decision AidOther: InterviewOther: Questionnaire Administration

Interventions

Cancer Educational MaterialsBEHAVIORAL

Receive educational materials about breast cancer risk and chemoprevention via RealRisk

Group I (educational materials)Group II (educational materials, decision support, interview)

Decision AidOTHER

Given patient-centered decision support via an action plan

Group II (educational materials, decision support, interview)

InterviewOTHER

Participate in audio-recorded interview via telephone or video conference

Group II (educational materials, decision support, interview)

Questionnaire AdministrationOTHER

Ancillary studies

Group I (educational materials)Group II (educational materials, decision support, interview)

Eligibility Criteria

Sexall

Healthy VolunteersYes

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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
+7 more criteria

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

SWOG Cancer Research Networklead
National Cancer Institute (NCI)collaborator

Study Sites (97)

Kaiser Permanente-Deer Valley Medical Center

Antioch, California, 94531, United States

Location

UC Irvine Health Cancer Center-Newport

Costa Mesa, California, 92627, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010, United States

Location

Kaiser Permanente-Oakland

Oakland, California, 94611, United States

Location

UC Irvine Health/Chao Family Comprehensive Cancer Center

Orange, California, 92868, United States

Location

Kaiser Permanente Downtown Commons

Sacramento, California, 95814, United States

Location

Kaiser Permanente-South Sacramento

Sacramento, California, 95823, United States

Location

Kaiser San Rafael-Gallinas

San Rafael, California, 94903, United States

Location

Kaiser Permanente Medical Center - Santa Clara

Santa Clara, California, 95051, United States

Location

City of Hope South Pasadena

South Pasadena, California, 91030, United States

Location

Kaiser Permanente-South San Francisco

South San Francisco, California, 94080, United States

Location

Kaiser Permanente-Vallejo

Vallejo, California, 94589, United States

Location

Kaiser Permanente-Walnut Creek

Walnut Creek, California, 94596, United States

Location

Mount Sinai Comprehensive Cancer Center at Aventura

Aventura, Florida, 33180, United States

Location

Miami Cancer Institute

Miami, Florida, 33176, United States

Location

Mount Sinai Medical Center

Miami Beach, Florida, 33140, United States

Location

Miami Cancer Institute at Plantation

Plantation, Florida, 33324, United States

Location

Grady Health System

Atlanta, Georgia, 30303, United States

Location

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Emory University Hospital/Winship Cancer Institute

Atlanta, Georgia, 30322, United States

Location

Emory Saint Joseph's Hospital

Atlanta, Georgia, 30342, United States

Location

Hawaii Cancer Care Inc - Waterfront Plaza

Honolulu, Hawaii, 96813, United States

Location

Queen's Cancer Cenrer - POB I

Honolulu, Hawaii, 96813, United States

Location

Queen's Medical Center

Honolulu, Hawaii, 96813, United States

Location

Straub Clinic and Hospital

Honolulu, Hawaii, 96813, United States

Location

University of Hawaii Cancer Center

Honolulu, Hawaii, 96813, United States

Location

Hawaii Cancer Care Inc-Liliha