Decision Aid for Women Newly Diagnosed With Breast Cancer (BCT Aid)

Effectiveness and Cost-effectiveness of a Multimodal Shared Decision-Making Decision Aid ( BCT 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Quality of Life; Breast Cancer; Decision Aid; Shared Decision Making; Cost Effectiveness
• Intervention / Treatment: Behavioral: BCT Aid; Behavioral: Usual Care

Detailed Description

Breast cancer is one of the most common cancers among women in China. More than 90% of breast cancer patients undergo either modified radical mastectomy (mastectomy with or without reconstruction) or breast-conserving surgery (lumpectomy with radiation therapy), with no significant difference in survival outcomes between the two approaches for patients with early-stage breast cancer. The National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Breast Cancer recommend breast-conserving surgery as the preferred surgical option for early-stage breast cancer in the absence of clinical contraindications. However, while the breast-conserving surgery rate ranges from 56.4% to 64.5% in Western countries, it remains only 22% in China. Common reasons for the low rate of breast-conserving surgery in China include fear of cancer recurrence, limited healthcare resources, information asymmetry between patients and healthcare providers, and distrust toward breast-conserving surgery.

A preliminary study conducted by the research team found that patients undergoing breast-conserving surgery had significantly lower levels of decision conflict, decision regret, and stigma compared with those undergoing modified radical mastectomy, and these three factors together explained 32.6% of the variance in quality of life. In a further study by the same team, data from 1,592 breast cancer patients were collected from two hospitals affiliated with Xiamen University between 2009 and 2017, and these data were linked with mortality records from the Xiamen Center for Disease Control and Prevention. The results showed that patients who underwent modified radical mastectomy and breast-conserving surgery had similar survival rates, and endocrine therapy was associated with improved survival. Based on these findings, the research team developed a survival predict model for breast cancer.

The World Health Organization has proposed that breast cancer patients should be fully informed about their diagnosis and the risks and benefits of available treatment options, and should be involved in making clinical treatment decisions together with healthcare providers, taking into account their personal values and preferences. In recent years, awareness of shared decision-making has increased among breast cancer patients in China, but the actual level of patient participation remains lower than their desired level of involvement.

Decision Aids (DAs) are tools designed to facilitate shared decision-making between patients and healthcare providers, particularly in situations where multiple treatment options are available. Currently, there is a lack of accessible, continuous, and cost-effective DAs to support shared decision-making for breast cancer patients in China. Globally, few randomized controlled trials of web-based DAs have been conducted. Due to limitations such as small sample sizes, single-center designs, and inconsistent outcome measures, the effectiveness of breast cancer DAs remains inconclusive, with no reported cost-effectiveness analyses to date.

In this study, a decision aid (BCT Aid) for newly diagnosed breast cancer patients was developed based on the shared decision-making model, integrating a patient values module, , a survival predict module, and a information module. A multi-center, assessor-blind, randomized controlled trial will then be conducted at three hospitals (Women and Children's Hospital Affiliated to Xiamen University, the First Affiliated Hospital of Xiamen University, and Xiang'an Hospital Affiliated to Xiamen University) to evaluate the effectiveness of the BCT Aid and perform a cost-effectiveness analysis. If the trial demonstrates its effectiveness, the BCT Aid can be directly implemented in clinical practice. Patients can use the BCT Aid to access survival predictions for different treatment options, weigh the benefits and harms, and make better-informed clinical decisions. When physicians discuss surgical options with patients, they can input patient demographic information (e.g., age), clinical information (e.g., breast cancer stage and subtype), and different treatment options into the BCT Aid, which will present survival prediction for each option in a simple and intuitive graphical format. In the values module, patients' values and preferences will be clarified through human-computer interaction to help guide treatment recommendations. The BCT Aid is designed to support patient participation in and facilitate high-quality clinical decision-making.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiemin Zhu; Phone Number: +86 15960212649; Email: jieminzhu@xmu.edu.cn

Study Locations

• China
  • Fujian
    • Xiamen, Fujian, China, 361003
      • The first affiliated hospital of xiamen university
      • Contact: Anqi Qiu; Phone Number: +86 15319783286; Email: qiuanqi66@163.com
      • Principal Investigator: Anqi Qiu
    • Xiamen, Fujian, China, 361003
      • Women and Children's Hospital Affiliated to Xiamen University
      • Contact: Ying Hua; Phone Number: +86 15027022676; Email: huaying@stu.xmu.edu.cn
      • Principal Investigator: Ying Hua
    • Xiamen, Fujian, China, 361102
      • Xiang'an Hospital Affiliated to Xiamen University
      • Contact: Xiaojing Su; Phone Number: +86 13023925784; Email: suxiaojing@stu.xmu.edu.cn
      • Principal Investigator: Xiaojing Su

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BCT Aid Intervention Group; Participants in this arm will receive a multimodal shared decision-making decision aid (BCT Aid) for 6 months. The BCT Aid includes three module: value model, personalized survival prediction module, and information module.	Behavioral: BCT Aid; The BCT Aid is a multimodal shared decision-making decision aid for newly diagnosed breast cancer patients, designed to support patient participation in clinical decision-making and to improve the quality of decisions regarding surgical treatment. It consists of three core components: (1) a values module to elicit patient preferences for surgical options; (2) a personalized survival prediction module to provide individualized prognostic information; and (3) an information module offering evidence-based knowledge on breast cancer treatment, recovery, and rehabilitation. The intervention will be delivered to the BCT Aid intervention group for 6 months, with breast cancer patients receiving the tool at diagnosis and having access to it throughout the decision-making process.; Other Names: decision aid
Active Comparator: Usual Care Group; Participants in this arm receive usual care, which consists of standard clinical consultation and routine information provision as per hospital practice.	Behavioral: Usual Care; Usual care consists of standard clinical consultation and routine information provision as per hospital practice. Patients receive standard care from their healthcare providers, including routine discussions regarding diagnosis, treatment options, and follow-up plans. No additional decision aid or structured shared decision-making intervention will be provided.; Other Names: Standard Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Decision conflict	Decision conflict is measured using the Decisional Conflict Scale (DCS), a 16-item instrument that assesses uncertainty in decision-making, factors contributing to uncertainty, and perceived effectiveness of decision-making. Higher scores indicate greater decisional conflict.	At baseline (T0), post-consultation with the surgeon (T1), 6 months (T2, post-intervention), and 12 months (T3, 6 months post-intervention).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breast-conserving surgery rate	Breast-conserving surgery rate is defined as the proportion of participants who undergo breast-conserving surgery. Data on the type of surgery will be collected from medical records.	At 6 months (post-intervention)
Decision regret	Decision regret is measured using the Decision Regret Scale (DRS), a 5-item instrument that assesses distress or remorse associated with a healthcare decision. Higher scores indicate greater regret.	At 6 months (T2, post-intervention), and 12 months (T3, 6 months post-intervention).
Quality of life measured by the Functional Assessment of Cancer Therapy-Breast (FACT-B)	Quality of life is measured using the Functional Assessment of Cancer Therapy-Breast (FACT-B), a 37-item instrument that assesses physical, social, emotional, and functional well-being, as well as breast cancer-specific concerns. Higher scores indicate better quality of life.	At baseline (T0), 6 months (T2, post-intervention), and 12 months (T3, 6 months post-intervention).
Health-related quality of life	Health-related quality of life is measured using the EQ-5D-5L, a standardized instrument that assesses five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, each rated on five levels. The EQ-5D-5L also includes a visual analog scale (EQ-VAS) for self-rated health. Scores are converted into utility values for cost-effectiveness analysis.	At baseline (T0), 3 months, 6 months (T2, post-intervention), 9 months, and 12 months (T3, 6 months post-intervention).
Shared Decision-Making	Shared decision-making is measured using the 9-item Shared Decision-Making Questionnaire (SDM-Q-9), which assesses the patient's perceived involvement in the decision-making process. Higher scores indicate a higher level of shared decision-making.	At post-consultation with the surgeon (T1), 6 months (T2, post-intervention), and 12 months (T3, 6 months post-intervention).

Collaborators and Investigators

• Sponsor: Xiamen University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: March 22, 2026
• First Submitted That Met QC Criteria: March 22, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 30, 2026
• Last Update Submitted That Met QC Criteria: April 26, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: breast cancer; shared decision making; cost effectiveness; decision aid; decision conflict
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Health Services Administration; Health Care Quality, Access, and Evaluation; Investigative Techniques; Quality of Health Care; Quality Indicators, Health Care; Standard of Care; Decision Support Techniques
• Other Study ID Numbers: KY-2024-049-H01; 7231101009 (Other Grant/Funding Number: National Natural Science Foundation of China)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Sharing of individual participant data is not planned due to patient confidentiality concerns and institutional data protection policies.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No