رادار التجارب AI | ||
|---|---|---|
حالة التجربة السريرية NCT07497256 (DA-BC) لـ سرطان الثدي، أداة اتخاذ القرار، اتخاذ القرار المشترك، فعالية التكلفة، جودة الحياة هي لم يبدأ القبول بعد. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
تجربة واحدة تطابق معايير الفلتر
عرض البطاقة
العودة إلى البحث
جامعة شيامنShared Decision-Making Decision Aid for Newly Diagnosed Breast Cancer : A Multi-Center Randomized Controlled Trial (DA-BC) ١٦٠ عشوائية متعددة المراكز
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ رادار التجارب AI مساعدتك؛ ما عليك سوى النقر على «وصف الدراسة» لعرض ومناقشة معلومات التجربة باللغة التي اخترتها.
التجربة السريرية NCT07497256 (DA-BC) هي دراسة تدخُّلية لـسرطان الثدي، أداة اتخاذ القرار، اتخاذ القرار المشترك، فعالية التكلفة، جودة الحياة وهي لم يبدأ القبول بعد. من المقرر أن يبدأ التسجيل في ١٣ شوال ١٤٤٧ هـ لتجنيد ١٦٠ مشاركًا. يقودها جامعة شيامن، ومن المتوقع اكتمالها بحلول ١ جمادى الأولى ١٤٤٩ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ٨ شوال ١٤٤٧ هـ.
الملخص
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...
عرض المزيدوصف مفصل
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...عرض المزيد
العنوان الرسمي
Development, Implementation, and Evaluation of a Multimodal Shared Decision-Making Decision Aid for Newly Diagnosed Breast Cancer Patients: A Multi-Center Randomized Controlled Trial
الحالات الطبية
سرطان الثديأداة اتخاذ القراراتخاذ القرار المشتركفعالية التكلفةجودة الحياةمعرّفات دراسة أخرى
- DA-BC
- KY-2024-049-H01
- 7231101009 (رقم منحة/تمويل آخر) (National Natural Science Foundation of China)
NCT معرّف
تاريخ البدء (فعلي)
2026-04
آخر تحديث مُنشور
2026-03-27
تاريخ الاكتمال (المقدر)
2027-10
عدد المشاركين المخطط لهم
١٦٠
نوع الدراسة
تدخُّلية
المرحلة
غ/م
الحالة
لم يبدأ القبول بعد
الكلمات الرئيسية
breast cancer
decision aid
decision conflict
shared decision making
cost effectiveness
decision aid
decision conflict
shared decision making
cost effectiveness
الغرض الأساسي
بحوث خدمات صحية
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
التصميم المتوازي
التعمية
أحادي
مجموعات/التدخلات
| مجموعة المشاركين/الذراع | التدخل/العلاج |
|---|---|
تجريبيةBCT 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...عرض المزيد |
مقارن نشطUsual Care Group Participants in this arm receive usual care, which consists of standard clinical consultation and routine information provision as per hospital practice. | الرعاية المعتادة 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. |
النتيجة الرئيسية
النتيجة الثانوية
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
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) |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
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) |
مساعد المشاركة
معايير الأهلية
الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
18 Years
الجنس المؤهل
أنثى
- 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.
جامعة شيامن153 تجارب سريرية نشطة للاستكشافالجهة المسؤولة عن الدراسة
Jiemin Zhu, المحقق الرئيسي, Professor, Xiamen University
جهة اتصال مركزية للدراسة
جهة اتصال: Jiemin Zhu, +86 15960212649, [email protected]
3 مواقع الدراسة في 1 بلدان
Fujian
The First Affiliated Hospital of Xiamen University, Xiamen, Fujian, 361003, China
Anqi Qiu, جهة اتصال, +86 15319783286, [email protected]
Anqi Qiu, المحقق الرئيسي
Women and Children's Hospital Affiliated to Xiamen University, Xiamen, Fujian, 361003, China
Ying Hua, جهة اتصال, +86 15027022676, [email protected]
Ying Hua, المحقق الرئيسي
Xiang'an Hospital Affiliated to Xiamen University, Xiamen, Fujian, 361102, China
Xiaojing Su, جهة اتصال, +86 13023925784, [email protected]
Xiaojing Su, المحقق الرئيسي