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.

Objectives

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 within 3 months after the 6-month follow-up visit. A sample of health care providers participate in 2 audio-recorded interviews via telephone or video conference over 45-60 minutes each at baseline and within 12-36 months after study activation.

After completion of study, patients are followed up at 6, 12, 24, 36, 48, and 60 months.

Eligibility

1. 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 as long as the pathology is considered benign
2. Patients must not have a history of invasive breast cancer or ductal carcinoma in situ
3. No other prior malignancy is allowed except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease free for at least five years
4. Patients must not have prior or current use of selective estrogen receptor modulators (SERMs) or aromatase inhibitors (AIs). Examples of such therapy include but are not limited to: tamoxifen, raloxifene, anastrozole, exemestane. NOTE: Patients who have had prior topical tamoxifen are eligible. Patients who have had prior oral SERM or AI are NOT eligible
5. Patients must not be currently taking systemic hormone replacement therapy. NOTE: Patients who are currently using topical/vaginal estrogen are eligible. Examples of such therapy include but are not limited to: Premarin®, Estrace registered trademark, Vagifem registered trademark, Estradiol, and Divigel registered trademark
6. Patients who are co-enrolled in other chemoprevention trials must not have started on an oral SERM or AI at the time of registration to S1904
7. 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
8. Patients must not have a history of bilateral mastectomies or breast implants since the risk calculator is not applicable to these women
9. Both pre/perimenopausal and postmenopausal women are eligible
10. Patients must not be pregnant or lactating
11. 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
12. 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
13. Baseline questionnaires must be completed prior to patient registration
14. The S1904 Patient Contact form must be completed prior to patient registration
15. Patients must be able to access the internet and receive phone calls, emails 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), and to complete a tutorial of the RealRisks tool via phone or video-conference with the S1904 study team at 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
16. 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
17. 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
18. IMPLEMENTATION: Providers who enrolled in S1904 at Group 2 (intervention) recruitment center and consented to future contact are eligible to participate in the interviews
19. 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
20. Recruitment Centers must be National Clinical Trials Network (NCTN), National Cancer Institute Community Oncology Research Program (NCORP) or Minority Underserved (MU)-NCORP institutions
21. 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
22. 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)
23. Recruitment centers must see at least 50 AH and/or LCIS patients per year
24. 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
25. Recruitment centers must be willing to register at about 16 patients and 5 healthcare providers to the study
26. Recruitment Centers must be willing to submit monthly screening logs to CUIMC
27. Providers must regularly see patients with AH or LCIS at an approved recruitment center
28. Providers must be willing to provide informed consent and complete an online baseline questionnaire
29. Providers who will register patients must be registered members of a Cooperative Group
30. 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

Treatment Sites in Georgia