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.
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