Decision Aid for Women Newly Diagnosed With Breast Cancer

The goal of this multi-center randomized controlled trial is to determine if the clinical decision aid (BCT Aid) works to help breast cancer patients participate in decision-making and make high-quality decisions, thereby improving the rate of breast-conserving surgery and quality of life. The main questions it aims to answer are: Does the BCT Aid significantly increase the rate of breast-conserving surgery compared to usual care? Does the BCT Aid reduce decision conflict and decision regret, while improving shared decision-making and quality of life? Does the BCT Aid demonstrate better cost-effectiveness in terms of health resource utilization? Researchers will compare the BCT Aid to usual care (standard clinical consultation) to evaluate the effectiveness and cost-effectiveness of BCT Aid. Participants will: Be randomly assigned to either the intervention group (receiving the BCT Aid intervention for 6 months) or the control group (usual care). Complete assessments including decision conflict and shared decision-making at baseline (T0), post-consultation with the surgeon (T1), 6 months (T2, post-intervention), and 12 months (T3, 6 months post-intervention), decision regret at T2 and T3, and quality of life at T0, T2, and T3, with additional EQ-5D-5L measurements at baseline, 3, 6, 9, and 12 months for cost-effectiveness analysis. Have clinical outcomes (breast-conserving surgery rate) and health resource utilization data collected from medical records.

NCT Number	NCT07497256
Lead Sponsor	Xiamen University
Conditions	Breast Cancer, Decision Aid, Shared Decision Making, Cost Effectiveness, Quality of Life
Enrollment	160 participants
Start Date	2026-04-01
Primary Completion	2027-04 (estimated)
Study Completion	2027-10 (estimated)
Updated on ClinicalTrials.gov	2026-04-30