Decision Support for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether electronic tools can assist women at high risk for breast cancer and their doctors in using medications like tamoxifen to reduce that risk. The study tests if these tools can integrate into regular medical care. Women aged 40 to 79 at high risk for breast cancer, such as those with specific genetic markers or past medical conditions, might be suitable candidates. Participants will either receive standard educational materials or access a web-based decision aid, called RealRisks Decision Aid, which provides personalized risk assessments and action plans. As an unphased trial, this study allows participants to contribute to innovative approaches in preventive care.
What prior data suggests that the RealRisks Decision Aid is safe for use in breast cancer prevention?
A previous study found that women at high risk for breast cancer found the RealRisks decision-aid tool helpful. Participants received the tool well, indicating its ease and safety of use. No reports of harmful side effects have emerged from using the RealRisks tool. This online tool helps individuals understand their breast cancer risk and make informed prevention choices. By providing information and reminders through the web, it is unlikely to cause physical harm. Instead, it supports decision-making about taking preventive medications like tamoxifen, which have established safety records. Overall, the RealRisks tool is considered safe for assisting with these decisions.12345
Why are researchers excited about this trial?
Researchers are excited about the RealRisks decision aid because it offers a personalized approach to breast cancer prevention that current standard options don't provide. Unlike traditional educational materials, RealRisks combines standard information with a web-based tool that assesses individual breast cancer and cardiovascular risks. It includes educational modules tailored to the user's specific risk factors and helps create a personalized action plan. This means individuals get more relevant and actionable insights, potentially leading to better prevention strategies.
What evidence suggests that the RealRisks Decision Aid is effective for increasing the use of breast cancer risk-reducing medications?
Research has shown that tools like RealRisks, which participants in this trial may use, can increase the use of medications such as tamoxifen, reducing breast cancer risk by up to 50%. One study found that tamoxifen reduced breast cancer risk by 80% in women with atypical hyperplasia (a condition where cells grow abnormally) and by 50% in those with a high risk according to the Gail model. The RealRisks decision aid, which provides personalized risk assessments and action plans, effectively increases the use of preventive medications among women at high risk for breast cancer. Additionally, almost all users found the decision aid easy to use, making it a practical tool for supporting informed decisions.13678
Who Is on the Research Team?
Rita Kukafka, DrPH, MA
Principal Investigator
Columbia University
Are You a Good Fit for This Trial?
This trial is for people who are at high risk of developing breast cancer. Specific eligibility details aren't provided, but generally includes those identified as higher risk by their healthcare provider.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Intervention
Participants receive standard educational materials plus access to the RealRisks web-based decision aid for chemoprevention decision-making
Follow-up
Participants are monitored for chemoprevention uptake and secondary outcomes such as medication beliefs and risk perceptions
What Are the Treatments Tested in This Trial?
Interventions
- RealRisks Decision Aid
Trial Overview
The study tests if an electronic decision aid called RealRisks can help patients and doctors decide about using medications like tamoxifen to lower breast cancer risk. It looks at how well this tool works in regular medical care.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Standard educational materials plus access to the RealRisks web-based decision aid. RealRisks provides personalized breast cancer and ASCVD risk assessment, educational modules, and individualized action planning.
Standard educational materials regarding breast cancer chemoprevention.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Columbia University
Lead Sponsor
National Cancer Institute (NCI)
Collaborator
Citations
Decision Making in the Context of Breast Cancer ...
The risk reduction among women with a diagnosed atypia such as lobular carcinoma in situ (LCIS) or atypical hyperplasia (AH) was even greater: 56% and 86% ...
Women at high risk of breast cancer find novel decision-aid ...
A decision-making aid to help women at high risk of breast cancer decide whether to add MRIs to their screening regimen has proved popular ...
Decision-making in Breast Cancer Risk Reduction - PMC - NIH
Of 1023 participants, 726 made a decision: selective estrogen receptor modulators (SERMs) that have been shown to reduce breast cancer risk by up to 50% in ...
4.
digitalcommons.dartmouth.edu
digitalcommons.dartmouth.edu/cgi/viewcontent.cgi?article=3645&context=facoaDevelopment of a Personalized Decision Aid for Breast ...
Results: Overall, the evaluations were favorable. 94% found it easy to use. 91% of the providers (N = 23) indicated that they would use the ...
5.
deepblue.lib.umich.edu
deepblue.lib.umich.edu/bitstreams/2efc733c-5d39-4893-acd7-2c60608b4080/downloadInformed choice about breast cancer prevention
Tamoxifen and raloxifene are chemopreventive drugs that can reduce women's relative risk of primary breast cancer by 50% [1,2].
Patient Decisions About Breast Cancer Chemoprevention
Nine studies provided information about hypothetical breast cancer chemoprevention decisions (mean uptake rate, 24.7%) and five provided ...
Decision Support for Chemoprevention · Oncology | trialticker
The primary endpoint is chemoprevention uptake at 12 months. Secondary outcomes include medication beliefs, breast cancer risk perceptions, informed choice, and ...
What Factors Influence Decision-Making about Breast Cancer ...
Estrogen exposure is one of the strongest risk factors for breast cancer development. Chemoprevention with selective estrogen receptor modulators (SERM), ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.