Know Your Risk: Assessment at Screening for Breast Cancer - Pilot Study
KYRAS
Study of Web-based Decision Aids for Breast Cancer Risk Assessment and Increasing Breast Cancer Chemoprevention in the Primary Care Setting: Pilot
2 other identifiers
interventional
40
1 country
1
Brief Summary
The purpose of this pilot study is to evaluate a decision support website (RealRisks) designed to inform patients about breast cancer chemoprevention. It is coupled with a physician-centered (BNAV) decision support website as part of clinical workflow in the primary care setting. The investigator hypothesizes that improving accuracy of breast cancer risk perception and understanding of the risks/benefits of chemoprevention will enhance informed decision-making and uptake of breast cancer prevention strategies in the primary care setting.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 15, 2016
CompletedFirst Submitted
Initial submission to the registry
July 12, 2016
CompletedFirst Posted
Study publicly available on registry
November 4, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2018
CompletedJanuary 8, 2021
January 1, 2021
2.5 years
July 12, 2016
January 7, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in the accuracy of risk perception (Likert Scale Score)
To measure the patient's accuracy of perceived breast cancer risk before and after exposure to the RealRisks decision aid. Perception will be assessed by comparing the difference between a patient's perceived risk and their actual risk based on the Gail breast cancer model. Patients are asked to make a comparative risk assessment about themselves on a 3-point Likert scale.
Baseline, 2 weeks
Secondary Outcomes (3)
Change in a patient's breast cancer knowledge (Survey Score)
Baseline, 2 weeks
Chemoprevention uptake rate among high-risk women
6 months
Referral rates to the breast clinic
12 months
Study Arms (1)
Decision aid
OTHER50 women at high-risk for developing breast cancer will use a decision support tool, RealRisks, when discussing breast cancer risk with their providers who will have access to the BNAV provider clinical decision support tool.
Interventions
RealRisks is a web-based patient decision aid with modules that present information about risk assessment and chemoprevention.
Breast Cancer Risk Navigation (BNAV) tool is a web-based decision support tool with modules that present pertinent information for primary care providers regarding breast cancer risk assessment and preventative measures for their patients.
Eligibility Criteria
You may qualify if:
- year breast risk of 1.67% or lifetime risk of 20% according to the Gail model
- The participant understands and is willing to provide informed consent in English or Spanish
- Has a primary care provider at Columbia University Medical Center (CUMC) / New York-Presbyterian Hospital
You may not qualify if:
- Prior use of a selective estrogen receptor modulator (SERM) or aromatase inhibitor (AI) for chemoprevention
- Prior history of breast cancer
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Columbia Universitylead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Columbia University Medical Center
New York, New York, 10032, United States
Related Publications (3)
Kukafka R, Yi H, Xiao T, Thomas P, Aguirre A, Smalletz C, David R, Crew K. Why Breast Cancer Risk by the Numbers Is Not Enough: Evaluation of a Decision Aid in Multi-Ethnic, Low-Numerate Women. J Med Internet Res. 2015 Jul 14;17(7):e165. doi: 10.2196/jmir.4028.
PMID: 26175193BACKGROUNDYi H, Xiao T, Thomas PS, Aguirre AN, Smalletz C, Dimond J, Finkelstein J, Infante K, Trivedi M, David R, Vargas J, Crew KD, Kukafka R. Barriers and Facilitators to Patient-Provider Communication When Discussing Breast Cancer Risk to Aid in the Development of Decision Support Tools. AMIA Annu Symp Proc. 2015 Nov 5;2015:1352-60. eCollection 2015.
PMID: 26958276BACKGROUNDKukafka R, Fang J, Vanegas A, Silverman T, Crew KD. Pilot study of decision support tools on breast cancer chemoprevention for high-risk women and healthcare providers in the primary care setting. BMC Med Inform Decis Mak. 2018 Dec 17;18(1):134. doi: 10.1186/s12911-018-0716-5.
PMID: 30558581DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Katherine D Crew, M.D., M.S.
Columbia University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Medicine and Epidemiology
Study Record Dates
First Submitted
July 12, 2016
First Posted
November 4, 2016
Study Start
March 15, 2016
Primary Completion
October 1, 2018
Study Completion
October 1, 2018
Last Updated
January 8, 2021
Record last verified: 2021-01