Decision Aid for Women Newly Diagnosed With Breast Cancer

Starting soon · Not applicable

Conditions studied: Breast Cancer, Decision Aid, Shared Decision Making, Cost Effectiveness, Quality of Life

In brief

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.

Key facts

Study ID

NCT07497256

Run by

Xiamen University

People needed

160

Starts

2026-04-01

Expected to finish

2027-10-01

Last updated by the study team

2026-04-30

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 18 years.
• Newly diagnosed with breast cancer, with clinical stage 0-II, or stage III eligible for breast-conserving surgery after neoadjuvant chemotherapy.
• Clinically eligible for breast-conserving surgery and considering one of the following surgical options: breast-conserving surgery, mastectomy, or mastectomy with reconstruction.
• Clinically eligible for adjuvant therapy after surgery.
• Able to access the internet via smartphone.
• Able to read, speak, and understand Mandarin.

You may not qualify if…

• Male breast cancer patients.
• Clinically eligible for only one surgical option or not candidates for surgery.
• Have a history of other malignancies, except adequately treated cervical carcinoma in situ and basal cell carcinoma of the skin.
• Presence of psychiatric disorders, visual or hearing impairments, or cognitive impairment.

Where it is running

• The First Affiliated Hospital of Xiamen University — Xiamen, Fujian, China
• Women and Children's Hospital Affiliated to Xiamen University — Xiamen, Fujian, China
• Xiang'an Hospital Affiliated to Xiamen University — Xiamen, Fujian, China

Full record on ClinicalTrials.gov

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