Making Informed Choices on Incorporating Chemoprevention Into Care (MiCHOICE)

  • STATUS
    Recruiting
  • End date
    Jun 1, 2024
  • participants needed
    415
  • sponsor
    Southwest Oncology Group
Updated on 28 January 2021

Summary

This trial studies the implementation of decision support tools integrated into the electronic health record and patient portal 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.

Details
Condition Lobular Breast Carcinoma in Situ, Lobular Carcinoma In Situ, LCIS, Atypical Hyperplasia of the Breast, Pleomorphic Lobular Breast Carcinoma In Situ
Treatment questionnaire administration, Interview, Decision Aid, Cancer Educational Materials
Clinical Study IdentifierNCT04496739
SponsorSouthwest Oncology Group
Last Modified on28 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Gender: Male or Female
Do you have any of these conditions: LCIS or Lobular Breast Carcinoma in Situ or Pleomorphic Lobular Breast Carcinoma In Situ or Lobular Carcinoma In Situ or Atypical Hyperplasia of the B...?
Do you have any of these conditions: Lobular Breast Carcinoma in Situ or LCIS or Lobular Carcinoma In Situ or Pleomorphic Lobular Breast Carcinoma In Situ or Atypical Hyperplasia of the B...?
Do you have any of these conditions: Atypical Hyperplasia of the Breast or Lobular Breast Carcinoma in Situ or Pleomorphic Lobular Breast Carcinoma In Situ or LCIS or Lobular Carcinoma In...?
Do you have any of these conditions: Lobular Breast Carcinoma in Situ or Lobular Carcinoma In Situ or Atypical Hyperplasia of the Breast or LCIS or Pleomorphic Lobular Breast Carcinoma In...?
Do you have any of these conditions: Atypical Hyperplasia of the Breast or Pleomorphic Lobular Breast Carcinoma In Situ or LCIS or Lobular Carcinoma In Situ or Lobular Breast Carcinoma in...?
Do you have any of these conditions: Atypical Hyperplasia of the Breast or LCIS or Pleomorphic Lobular Breast Carcinoma In Situ or Lobular Breast Carcinoma in Situ or Lobular Carcinoma In...?
Do you have any of these conditions: Atypical Hyperplasia of the Breast or LCIS or Lobular Carcinoma In Situ or Pleomorphic Lobular Breast Carcinoma In Situ or Lobular Breast Carcinoma in...?
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 8 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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