Making Informed Choices on Incorporating Chemoprevention Into Care (MiCHOICE)

Lobular Breast Carcinoma In Situ Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04496739
• Other study ID #: S1904
• Secondary ID: NCI-2019-08755S1
• Status: Recruiting
• Phase: N/A
• Start date: October 23, 2020
• Est. completion date: June 1, 2028

Study information

• Verified date: March 2024
• Source: SWOG Cancer Research Network
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 415
• Est. completion date: June 1, 2028
• Est. primary completion date: May 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Atypical Hyperplasia of the Breast
• Breast Carcinoma In Situ
• Breast Neoplasms
• Carcinoma
• Carcinoma in Situ
• Carcinoma, Lobular
• Hyperplasia
• Lobular Breast Carcinoma In Situ
• Pleomorphic Lobular Breast Carcinoma In Situ

Intervention

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
• Decision Aid
Given decision support and action plans based on patient's interactions with RealRisks via the BNAV support tool
• Interview
Participate in audio-recorded interview via telephone or video conference
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
Guam	FHP Health Center-Guam	Tamuning
United States	Hawaii Cancer Care - Westridge	'Aiea	Hawaii
United States	Pali Momi Medical Center	'Aiea	Hawaii
United States	Queen's Cancer Center - Pearlridge	'Aiea	Hawaii
United States	The Cancer Center of Hawaii-Pali Momi	'Aiea	Hawaii
United States	The Queen's Medical Center - West Oahu	'Ewa Beach	Hawaii
United States	Kaiser Permanente-Deer Valley Medical Center	Antioch	California
United States	Emory Saint Joseph's Hospital	Atlanta	Georgia
United States	Emory University Hospital Midtown	Atlanta	Georgia
United States	Emory University Hospital/Winship Cancer Institute	Atlanta	Georgia
United States	Grady Health System	Atlanta	Georgia
United States	Mount Sinai Comprehensive Cancer Center at Aventura	Aventura	Florida
United States	IU Health West Hospital	Avon	Indiana
United States	Memorial Sloan Kettering Basking Ridge	Basking Ridge	New Jersey
United States	Beverly Hospital	Beverly	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Lahey Hospital and Medical Center	Burlington	Massachusetts
United States	Loyola Center for Health at Burr Ridge	Burr Ridge	Illinois
United States	IU Health North Hospital	Carmel	Indiana
United States	Centralia Oncology Clinic	Centralia	Illinois
United States	Advocate Illinois Masonic Medical Center	Chicago	Illinois
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Baptist Memorial Hospital and Cancer Center-Collierville	Collierville	Tennessee
United States	Ohio State University Comprehensive Cancer Center	Columbus	Ohio
United States	Memorial Sloan Kettering Commack	Commack	New York
United States	Good Samaritan Hospital	Corvallis	Oregon
United States	UC Irvine Health Cancer Center-Newport	Costa Mesa	California
United States	Carle at The Riverfront	Danville	Illinois
United States	Cancer Care Specialists of Illinois - Decatur	Decatur	Illinois
United States	City of Hope Comprehensive Cancer Center	Duarte	California
United States	Mayo Clinic Health System-Eau Claire Clinic	Eau Claire	Wisconsin
United States	Carle Physician Group-Effingham	Effingham	Illinois
United States	Crossroads Cancer Center	Effingham	Illinois
United States	Sanford Roger Maris Cancer Center	Fargo	North Dakota
United States	Addison Gilbert Hospital	Gloucester	Massachusetts
United States	Memorial Sloan Kettering Westchester	Harrison	New York
United States	Hawaii Cancer Care Inc - Waterfront Plaza	Honolulu	Hawaii
United States	Hawaii Cancer Care Inc-Liliha	Honolulu	Hawaii
United States	Hawaii Diagnostic Radiology Services LLC	Honolulu	Hawaii
United States	Kapiolani Medical Center for Women and Children	Honolulu	Hawaii
United States	Kuakini Medical Center	Honolulu	Hawaii
United States	Queen's Cancer Cenrer - POB I	Honolulu	Hawaii
United States	Queen's Cancer Center - Kuakini	Honolulu	Hawaii
United States	Queen's Medical Center	Honolulu	Hawaii
United States	Straub Clinic and Hospital	Honolulu	Hawaii
United States	The Cancer Center of Hawaii-Liliha	Honolulu	Hawaii
United States	University of Hawaii Cancer Center	Honolulu	Hawaii
United States	Indiana University/Melvin and Bren Simon Cancer Center	Indianapolis	Indiana
United States	Sidney and Lois Eskenazi Hospital	Indianapolis	Indiana
United States	Straub Medical Center - Kahului Clinic	Kahului	Hawaii
United States	Castle Medical Center	Kailua	Hawaii
United States	Borgess Medical Center	Kalamazoo	Michigan
United States	West Michigan Cancer Center	Kalamazoo	Michigan
United States	Wilcox Memorial Hospital and Kauai Medical Clinic	Lihue	Hawaii
United States	University of Wisconsin Carbone Cancer Center	Madison	Wisconsin
United States	Carle Physician Group-Mattoon/Charleston	Mattoon	Illinois
United States	Loyola University Medical Center	Maywood	Illinois
United States	Holy Redeemer Hospital and Medical Center	Meadowbrook	Pennsylvania
United States	Baptist Memorial Hospital and Cancer Center-Memphis	Memphis	Tennessee
United States	Baptist Memorial Hospital for Women	Memphis	Tennessee
United States	Miami Cancer Institute	Miami	Florida
United States	Mount Sinai Medical Center	Miami Beach	Florida
United States	Memorial Sloan Kettering Monmouth	Middletown	New Jersey
United States	Aurora Saint Luke's Medical Center	Milwaukee	Wisconsin
United States	Memorial Sloan Kettering Bergen	Montvale	New Jersey
United States	Memorial Sloan Kettering Cancer Center	New York	New York
United States	NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center	New York	New York
United States	Peninsula Cancer Institute-Newport News	Newport News	Virginia
United States	Cancer Care Center of O'Fallon	O'Fallon	Illinois
United States	Kaiser Permanente-Oakland	Oakland	California
United States	UC Irvine Health/Chao Family Comprehensive Cancer Center	Orange	California
United States	Advocate Lutheran General Hospital	Park Ridge	Illinois
United States	Miami Cancer Institute at Plantation	Plantation	Florida
United States	Providence Portland Medical Center	Portland	Oregon
United States	Providence Saint Vincent Medical Center	Portland	Oregon
United States	VCU Massey Cancer Center at Stony Point	Richmond	Virginia
United States	Virginia Cancer Institute	Richmond	Virginia
United States	Virginia Commonwealth University/Massey Cancer Center	Richmond	Virginia
United States	Mayo Clinic in Rochester	Rochester	Minnesota
United States	Kaiser Permanente Downtown Commons	Sacramento	California
United States	Kaiser Permanente-South Sacramento	Sacramento	California
United States	Huntsman Cancer Institute/University of Utah	Salt Lake City	Utah
United States	Kaiser San Rafael-Gallinas	San Rafael	California
United States	Kaiser Permanente Medical Center - Santa Clara	Santa Clara	California
United States	Sanford Cancer Center Oncology Clinic	Sioux Falls	South Dakota
United States	VCU Community Memorial Health Center	South Hill	Virginia
United States	City of Hope South Pasadena	South Pasadena	California
United States	Kaiser Permanente-South San Francisco	South San Francisco	California
United States	Vince Lombardi Cancer Clinic-Two Rivers	Two Rivers	Wisconsin
United States	Memorial Sloan Kettering Nassau	Uniondale	New York
United States	Carle Cancer Center	Urbana	Illinois
United States	The Carle Foundation Hospital	Urbana	Illinois
United States	Kaiser Permanente-Vallejo	Vallejo	California
United States	Kaiser Permanente-Walnut Creek	Walnut Creek	California
United States	Aurora West Allis Medical Center	West Allis	Wisconsin
United States	Shenandoah Oncology PC	Winchester	Virginia
United States	Winchester Hospital	Winchester	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
SWOG Cancer Research Network	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Guam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Perceived breast cancer risk	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
Secondary	Actual breast cancer risk score	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
Secondary	Accuracy of risk perception	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
Secondary	Breast cancer worry	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
Secondary	Decision conflict	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
Secondary	Decision regret	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
Secondary	Chemoprevention usage	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
Secondary	Chemoprevention adherence	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
Secondary	Reasons for chemoprevention discontinuation	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
Secondary	Shared decision-making	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