Clinical trial NCT04496739: Making Informed Choices on Incorporating Chemoprevention Into Care (MiCHOICE)
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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Atypical Hyperplasia of the Breast
Lobular Breast Carcinoma In Situ
Pleomorphic Lobular Breast Carcinoma In Situ
Lead sponsor: SWOG Cancer Research Network
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-08-03
Enrollment: 412
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Chemoprevention informed choice
timeFrame: At 6 months
Secondary outcomes:
measure: Perceived breast cancer risk
timeFrame: Up to 12 months
measure: Actual breast cancer risk score
timeFrame: Up to 12 months
measure: Accuracy of risk perception
timeFrame: Up to 12 months
measure: Breast cancer worry
timeFrame: Up to 12 months
measure: Decision conflict
timeFrame: Up to 12 months
measure: Decision regret
timeFrame: Up to 12 months
measure: Chemoprevention usage
timeFrame: Up to 5 years
measure: Chemoprevention adherence
timeFrame: Up to 5 years
measure: Reasons for chemoprevention discontinuation
timeFrame: Up to 5 years
measure: Shared decision-making
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Antioch
country: United States
facility: Kaiser Permanente-Deer Valley Medical Center
state: California
city: Costa Mesa
country: United States
facility: UC Irvine Health Cancer Center-Newport
state: California
city: Duarte
country: United States
facility: City of Hope Comprehensive Cancer Center
state: California
city: Oakland
country: United States
facility: Kaiser Permanente-Oakland
state: California
city: Orange
country: United States
facility: UC Irvine Health/Chao Family Comprehensive Cancer Center
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente Downtown Commons
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente-South Sacramento
state: California
city: San Rafael
country: United States
facility: Kaiser San Rafael-Gallinas
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente Medical Center - Santa Clara
state: California
city: South Pasadena
country: United States
facility: City of Hope South Pasadena
state: California
city: South San Francisco
country: United States
facility: Kaiser Permanente-South San Francisco
state: California
city: Vallejo
country: United States
facility: Kaiser Permanente-Vallejo
state: California
city: Walnut Creek
country: United States
facility: Kaiser Permanente-Walnut Creek
state: California
city: Aventura
country: United States
facility: Mount Sinai Comprehensive Cancer Center at Aventura
state: Florida
city: Miami Beach
country: United States
facility: Mount Sinai Medical Center
state: Florida
city: Miami
country: United States
facility: Miami Cancer Institute
state: Florida
city: Plantation
country: United States
facility: Miami Cancer Institute at Plantation
state: Florida
city: Atlanta
country: United States
facility: Grady Health System
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital Midtown
state: Georgia
city: Atlanta
country: United States
facility: Emory University Hospital/Winship Cancer Institute
state: Georgia
city: Atlanta
country: United States
facility: Emory Saint Joseph's Hospital
state: Georgia
city: 'Aiea
country: United States
facility: Hawaii Cancer Care - Westridge
state: Hawaii
city: 'Aiea
country: United States
facility: Pali Momi Medical Center
state: Hawaii
city: 'Aiea
country: United States
facility: Queen's Cancer Center - Pearlridge
state: Hawaii
city: 'Aiea
country: United States
facility: The Cancer Center of Hawaii-Pali Momi
state: Hawaii
city: 'Ewa Beach
country: United States
facility: The Queen's Medical Center - West Oahu
state: Hawaii
city: Honolulu
country: United States
facility: Hawaii Cancer Care Inc - Waterfront Plaza
state: Hawaii
city: Honolulu
country: United States
facility: Queen's Cancer Cenrer - POB I
state: Hawaii
city: Honolulu
country: United States
facility: Queen's Medical Center
state: Hawaii
city: Honolulu
country: United States
facility: Straub Clinic and Hospital
state: Hawaii
city: Honolulu
country: United States
facility: University of Hawaii Cancer Center
state: Hawaii
city: Honolulu
country: United States
facility: Hawaii Cancer Care Inc-Liliha
state: Hawaii
city: Honolulu
country: United States
facility: Hawaii Diagnostic Radiology Services LLC
state: Hawaii
city: Honolulu
country: United States
facility: Kuakini Medical Center
state: Hawaii
city: Honolulu
country: United States
facility: Queen's Cancer Center - Kuakini
state: Hawaii
city: Honolulu
country: United States
facility: The Cancer Center of Hawaii-Liliha
state: Hawaii
city: Honolulu
country: United States
facility: Kapiolani Medical Center for Women and Children
state: Hawaii
city: Kahului
country: United States
facility: Straub Medical Center - Kahului Clinic
state: Hawaii
city: Kailua
country: United States
facility: Castle Medical Center
state: Hawaii
city: Lihue
country: United States
facility: Wilcox Memorial Hospital and Kauai Medical Clinic
state: Hawaii
city: Burr Ridge
country: United States
facility: Loyola Center for Health at Burr Ridge
state: Illinois
city: Centralia
country: United States
facility: Centralia Oncology Clinic
state: Illinois
city: Chicago
country: United States
facility: Advocate Illinois Masonic Medical Center
state: Illinois
city: Danville
country: United States
facility: Carle at The Riverfront
state: Illinois
city: Decatur
country: United States
facility: Cancer Care Specialists of Illinois - Decatur
state: Illinois
city: Effingham
country: United States
facility: Carle Physician Group-Effingham
state: Illinois
city: Effingham
country: United States
facility: Crossroads Cancer Center
state: Illinois
city: Mattoon
country: United States
facility: Carle Physician Group-Mattoon/Charleston
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center
state: Illinois
city: O'Fallon
country: United States
facility: Cancer Care Center of O'Fallon
state: Illinois
city: Park Ridge
country: United States
facility: Advocate Lutheran General Hospital
state: Illinois
city: Urbana
country: United States
facility: Carle Cancer Center
state: Illinois
city: Urbana
country: United States
facility: The Carle Foundation Hospital
state: Illinois
city: Avon
country: United States
facility: IU Health West Hospital
state: Indiana
city: Carmel
country: United States
facility: IU Health North Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University/Melvin and Bren Simon Cancer Center
state: Indiana
city: Indianapolis
country: United States
facility: Sidney and Lois Eskenazi Hospital
state: Indiana
city: Beverly
country: United States
facility: Beverly Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Burlington
country: United States
facility: Lahey Hospital and Medical Center
state: Massachusetts
city: Gloucester
country: United States
facility: Addison Gilbert Hospital
state: Massachusetts
city: Winchester
country: United States
facility: Winchester Hospital
state: Massachusetts
city: Kalamazoo
country: United States
facility: West Michigan Cancer Center
state: Michigan
city: Kalamazoo
country: United States
facility: Borgess Medical Center
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Basking Ridge
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Monmouth
state: New Jersey
city: Montvale
country: United States
facility: Memorial Sloan Kettering Bergen
state: New Jersey
city: Commack
country: United States
facility: Memorial Sloan Kettering Commack
state: New York
city: Harrison
country: United States
facility: Memorial Sloan Kettering Westchester
state: New York
city: New York
country: United States
facility: NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Nassau
state: New York
city: Fargo
country: United States
facility: Sanford Roger Maris Cancer Center
state: North Dakota
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
city: Corvallis
country: United States
facility: Good Samaritan Hospital
state: Oregon
city: Portland
country: United States
facility: Providence Portland Medical Center
state: Oregon
city: Portland
country: United States
facility: Providence Saint Vincent Medical Center
state: Oregon
city: Meadowbrook
country: United States
facility: Holy Redeemer Hospital and Medical Center
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Sanford Cancer Center Oncology Clinic
state: South Dakota
city: Collierville
country: United States
facility: Baptist Memorial Hospital and Cancer Center-Collierville
state: Tennessee
city: Memphis
country: United States
facility: Baptist Memorial Hospital and Cancer Center-Memphis
state: Tennessee
city: Memphis
country: United States
facility: Baptist Memorial Hospital for Women
state: Tennessee
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute/University of Utah
state: Utah
city: Newport News
country: United States
facility: Peninsula Cancer Institute-Newport News
state: Virginia
city: Richmond
country: United States
facility: Virginia Cancer Institute
state: Virginia
city: Richmond
country: United States
facility: VCU Massey Cancer Center at Stony Point
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University/Massey Cancer Center
state: Virginia
city: South Hill
country: United States
facility: VCU Community Memorial Health Center
state: Virginia
city: Winchester
country: United States
facility: Shenandoah Oncology PC
state: Virginia
city: Eau Claire
country: United States
facility: Mayo Clinic Health System-Eau Claire Clinic
state: Wisconsin
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora Saint Luke's Medical Center
state: Wisconsin
city: Two Rivers
country: United States
facility: Vince Lombardi Cancer Clinic-Two Rivers
state: Wisconsin
city: West Allis
country: United States
facility: Aurora West Allis Medical Center
state: Wisconsin
city: Tamuning
country: Guam
facility: FHP Health Center-Guam
Study officials:
affiliation: SWOG Cancer Research Network
name: Katherine D Crew
role: PRINCIPAL_INVESTIGATOR
References:
citation: McGuinness JE, Bhatkhande G, Amenta J, Silverman T, Mata J, Guzman A, He T, Dimond J, Jones T, Kukafka R, Crew KD. Strategies to Identify and Recruit Women at High Risk for Breast Cancer to a Randomized Controlled Trial of Web-based Decision Support Tools. Cancer Prev Res (Phila). 2022 Jun 2;15(6):399-406. doi: 10.1158/1940-6207.CAPR-21-0593.