[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100631175":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":35,"locations":41,"responsibleParty":85,"collaborators":34,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":23,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":34,"enrollmentInfo":96,"targetDuration":34,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":109,"overallStatus":114,"whyStopped":34,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Xiamen University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"BCT Aid Intervention Group","EXPERIMENTAL","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.",[13],"Behavioral: BCT Aid",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual Care Group","ACTIVE_COMPARATOR","Participants in this arm receive usual care, which consists of standard clinical consultation and routine information provision as per hospital practice.",[19],"Behavioral: Usual Care",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"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.",[9],[27],"decision aid",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"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.",[15],[33],"Standard Care",null,[36],{"name":37,"role":38,"phone":39,"phoneExt":34,"email":40},"Jiemin Zhu","CONTACT","+86 15960212649","jieminzhu@xmu.edu.cn",[42,62,73],{"facility":43,"status":34,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"The First Affiliated Hospital of Xiamen University","Xiamen","Fujian","361003","China","CN",{"type":50,"coordinates":51},"Point",[52,53],118.08187,24.47979,{"lat":53,"lon":52},[56,60],{"name":57,"role":38,"phone":58,"phoneExt":34,"email":59},"Anqi Qiu","+86 15319783286","qiuanqi66@163.com",{"name":57,"role":61,"phone":34,"phoneExt":34,"email":34},"PRINCIPAL_INVESTIGATOR",{"facility":63,"status":34,"city":44,"state":45,"zip":46,"country":47,"countryCode":48,"cosmosGeoPoint":64,"geoPoint":66,"contacts":67},"Women and Children's Hospital Affiliated to Xiamen University",{"type":50,"coordinates":65},[52,53],{"lat":53,"lon":52},[68,72],{"name":69,"role":38,"phone":70,"phoneExt":34,"email":71},"Ying Hua","+86 15027022676","huaying@stu.xmu.edu.cn",{"name":69,"role":61,"phone":34,"phoneExt":34,"email":34},{"facility":74,"status":34,"city":44,"state":45,"zip":75,"country":47,"countryCode":48,"cosmosGeoPoint":76,"geoPoint":78,"contacts":79},"Xiang'an Hospital Affiliated to Xiamen University","361102",{"type":50,"coordinates":77},[52,53],{"lat":53,"lon":52},[80,84],{"name":81,"role":38,"phone":82,"phoneExt":34,"email":83},"Xiaojing Su","+86 13023925784","suxiaojing@stu.xmu.edu.cn",{"name":81,"role":61,"phone":34,"phoneExt":34,"email":34},{"type":61,"investigatorFullName":37,"investigatorTitle":86,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"Professor","100631175","decision-aid-for-women-newly-diagnosed-with-breast-cancer-100631175",false,"NCT07497256","Decision Aid for Women Newly Diagnosed With Breast Cancer","Effectiveness and Cost-effectiveness of a Multimodal Shared Decision-Making Decision Aid ( BCT Aid) for Women Newly Diagnosed With Breast Cancer","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Newly diagnosed with breast cancer, with clinical stage 0-II, or stage III eligible for breast-conserving surgery after neoadjuvant chemotherapy.\n3. Clinically eligible for breast-conserving surgery and considering one of the following surgical options: breast-conserving surgery, mastectomy, or mastectomy with reconstruction.\n4. Clinically eligible for adjuvant therapy after surgery.\n5. Able to access the internet via smartphone.\n6. Able to read, speak, and understand Mandarin.\n\nExclusion Criteria:\n\n1. Male breast cancer patients.\n2. Clinically eligible for only one surgical option or not candidates for surgery.\n3. Have a history of other malignancies, except adequately treated cervical carcinoma in situ and basal cell carcinoma of the skin.\n4. Presence of psychiatric disorders, visual or hearing impairments, or cognitive impairment.","FEMALE","18 Years",{"count":97,"type":98},160,"ESTIMATED","INTERVENTIONAL",[101],"NA","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:\n\nDoes 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.\n\nParticipants will:\n\nBe randomly assigned to either the intervention group (receiving the BCT Aid intervention for 6 months) or the control group (usual care).\n\nComplete 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.\n\nHave clinical outcomes (breast-conserving surgery rate) and health resource utilization data collected from medical records.",[104,105,106,107,108],"Breast Cancer","Decision Aid","Shared Decision Making","Cost Effectiveness","Quality of Life",[110,27,111,112,113],"breast cancer","decision conflict","shared decision making","cost effectiveness","NOT_YET_RECRUITING","2026-04-26",{"date":117,"type":118},"2026-04-30","ACTUAL",{"date":120,"type":98},"2026-04-01",{"date":122,"type":98},"2027-10",{"name":5,"class":6},3]