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Xiamen UniversityShared Decision-Making Decision Aid for Newly Diagnosed Breast Cancer : A Multi-Center Randomized Controlled Trial (DA-BC) 160 Randomized Multi-Center
Clinical Trial NCT07497256 (DA-BC) is an interventional study for Breast Cancer, Decision Aid, Shared Decision Making, Cost Effectiveness, Quality of Life and is currently not yet recruiting. Enrollment is planned to begin on 1 April 2026 and continue until the study accrues 160 participants. Led by Xiamen University, this study is expected to complete by 1 October 2027. The latest data from ClinicalTrials.gov was last updated on 27 March 2026.
Brief Summary
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...
Show MoreDetailed 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...Show More
Official Title
Development, Implementation, and Evaluation of a Multimodal Shared Decision-Making Decision Aid for Newly Diagnosed Breast Cancer Patients: A Multi-Center Randomized Controlled Trial
Conditions
Breast CancerDecision AidShared Decision MakingCost EffectivenessQuality of LifeOther Study IDs
- DA-BC
- KY-2024-049-H01
- 7231101009 (Other Grant/Funding Number) (National Natural Science Foundation of China)
NCT ID Number
Start Date (Actual)
2026-04
Last Update Posted
2026-03-27
Completion Date (Estimated)
2027-10
Enrollment (Estimated)
160
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
breast cancer
decision aid
decision conflict
shared decision making
cost effectiveness
decision aid
decision conflict
shared decision making
cost effectiveness
Primary Purpose
Health Services Research
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalBCT 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. | 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 indiv...Show More |
Active ComparatorUsual Care Group Participants in this arm receive usual care, which consists of standard clinical consultation and routine information provision as per hospital practice. | 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. |
Primary Outcome Measures
Secondary 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 (at diagnosis, pre-surgery), 6 months (post-intervention), and 12 months (6 months post-intervention) |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 baseline (at diagnosis, pre-surgery), 6 months (post-intervention), and 12 months (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 baseline (at diagnosis, pre-surgery), 6 months (post-intervention), and 12 months (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 (at diagnosis, pre-surgery), 6 months (post-intervention), and 12 months (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. | Baseline (pre-surgery), 3 months (during intervention period), 6 months (post-intervention), 9 months (3 months post-intervention), 12 months (6 months post-intervention), 15 months (9 months post-intervention), 18 months (12 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. | At 6 months (post-intervention) |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
Female
- Age ≥ 18 years.
- Newly diagnosed with breast cancer, with clinical stage 0-II, or stage III patients who have achieved eligibility 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.
- Male breast cancer patients.
- Patients who are clinically eligible for only one surgical option or who are not candidates for surgery.
- History of other malignancies (except adequately treated cervical carcinoma in situ and treated basal cell carcinoma of the skin).
- Presence of psychiatric disorders, visual or hearing impairments, or cognitive impairment.
Xiamen University153 active studies to exploreStudy Responsible Party
Jiemin Zhu, Principal Investigator, Professor, Xiamen University
Study Central Contact
Contact: Jiemin Zhu, +86 15960212649, [email protected]
3 Study Locations in 1 Countries
Fujian
The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, 361003, China
Anqi Qiu, Contact, +86 15319783286, [email protected]
Anqi Qiu, Principal Investigator
Women and Children's Hospital Affiliated to Xiamen University, Xiamen, Fujian, 361003, China
Ying Hua, Contact, +86 15027022676, [email protected]
Ying Hua, Principal Investigator
Xiang'an Hospital Affiliated to Xiamen University, Xiamen, Fujian, 361102, China
Xiaojing Su, Contact, +86 13023925784, [email protected]
Xiaojing Su, Principal Investigator