An interventional study of BCT Aid and Usual Care in Breast Cancer, Decision Aid and Shared Decision Making, sponsored by Xiamen University. Not yet recruiting at 3 sites in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-30.
Sponsored by Xiamen University · Not applicable, Interventional, and Health services research
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.
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's planned enrollment of 160 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Xiamen University is the lead sponsor of 26 studies on the registry; 7 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Participants in this arm receive usual care, which consists of standard clinical consultation and routine information provision as per hospital practice.
Behavioral: Usual Care
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.
Also known as: decision aid
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.
Also known as: Standard Care
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.
Time frame: At baseline (T0), post-consultation with the surgeon (T1), 6 months (T2, post-intervention), and 12 months (T3, 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.
Time frame: At 6 months (T2, post-intervention), 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.
Time frame: At post-consultation with the surgeon (T1), 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.
Time frame: 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.
Time frame: At baseline (T0), 3 months, 6 months (T2, post-intervention), 9 months, and 12 months (T3, 6 months post-intervention).
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.
Time frame: At 6 months (post-intervention)
Plan to share: No — Sharing of individual participant data is not planned due to patient confidentiality concerns and institutional data protection policies.
No publications or documents are linked to this record.
Start is estimated for Apr 2026; primary completion for Apr 2027, 12 months later.
Of 2,661 non-industry interventional studies with no phase under Breast Neoplasms, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 66. This study's planned 12 months is below that.
Counting every sponsor, half of 2,771 studies reached it within 33 months; a quarter within 15 and three quarters within 66.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Xiamen University