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Pilot Study of a New Decision Aid for Women With Early-Stage Breast Cancer Choosing Between Lumpectomy and Mastectomy
Led by University of Colorado, Denver · Updated on 2025-08-12
60
Participants Needed
3
Research Sites
12 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying a new decision aid designed to help women recently diagnosed with early-stage breast cancer choose between lumpectomy and mastectomy. The study aims to assess how feasible and acceptable this tool is by gathering feedback from patients and observing the implementation process. This pilot study is a step toward planning a larger trial to compare the decision aid with the standard educational materials currently used. Participants will be randomly assigned to one of two groups. Patients in the treatment group will receive an electronic copy of the novel decision aid via email, which is designed to support shared decision-making by helping patients weigh risks and benefits based on their values. The control group will receive an electronic educational pamphlet that discusses surgical options for breast cancer, representing the standard of care. During the one-year study period, participants will complete various assessments including patient-reported outcomes using the BREAST-Q, decision aid evaluations, health literacy tests, distress screenings, web-based surveys, and semi-structured interviews. Researchers will measure how well patients receive and engage with the decision aid and use the results to guide future larger studies. The total participation involves completing these evaluations and providing feedback to improve the decision-making support process.
CONDITIONS
Brief Title
A Novel Patient Decision Aid for Surgical Treatment Options in Early-Stage Breast Cancer
Research Team
J
Jakob Durden, MD
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