This randomized pilot clinical trial studies how well web-based decision aids work in increasing chemoprevention in patients with breast cancer. Web-based decision aids, such as RealRisks tool, may provide knowledge about breast cancer, actual/perceived risk, and risks/benefits of chemoprevention to women in a better way and promote breast cancer prevention strategies.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03069742.
PRIMARY OBJECTIVES:
I. To apply a user-centered design to evaluate and refine RealRisks for breast cancer chemoprevention.
II. To evaluate the effects of RealRisks on accuracy of breast cancer risk perception among 50 high-risk women identified at our breast clinic and high-risk registries.
III. To design and evaluate breast cancer navigation tool (BNAV) for primary care providers to facilitate the identification of high-risk women eligible for chemoprevention.
IV. To compare referral rates to the breast clinic among 50 high-risk women screened in primary care clinics randomized to BNAV versus (vs.) no BNAV.
V. To conduct a randomized controlled trial of standard educational materials alone or in combination with RealRisks and BNAV in 300 high-risk women identified in the primary care setting.
OUTLINE: Patients are randomized into 1 of 2 groups.
GROUP I: Patients use RealRisks tool supported by BNAV to interact with primary care provider prior to the next appointment.
GROUP II: Patients receive standard of care.
After completion of study, patients are followed up every 6 months.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationNYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
Principal InvestigatorKatherine D. Crew
