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Decision Aid for Women Newly Diagnosed With Breast Cancer

Study acronym: BCT Aid
StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

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  1. Secondary endpoints: details revised at 1 of 5 entriesv3
  2. Start date: Apr 2026 to Apr 1, 2026v2 Show 4 more changesShow less
    • Eligibility criteria shortened, about 8 words
    • Secondary endpoints: details revised at 4 of 5 entries
    • Study description expanded, about 11 words
    • Study title shortened, about 6 words
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07497256
Lead Sponsor Xiamen University
Conditions
(from sponsor)		 Breast Cancer, Decision Aid, Shared Decision Making, Cost Effectiveness, Quality of Life
Related terms Breast Neoplasms
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov