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审核状态: Project audit state: |
通过审核 Successful |
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注册号: Registration number: |
ChiCTR2500104459 |
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最近更新日期: Date of Last Refreshed on: |
2025-06-17 18:00:48 |
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注册时间: Date of Registration: |
2025-06-17 00:00:00 |
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注册号状态: |
预注册 |
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Registration Status: |
Prospective registration |
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注册题目: |
多中心乳腺癌术后上肢康复指导医护认知的调查研究 |
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Public title: |
Investigation of cognitive between doctors and nurses in upper limb rehabilitation guidance after multicenter breast cancer surgery |
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注册题目简写: |
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English Acronym: |
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研究课题的正式科学名称: |
多中心乳腺癌术后上肢康复指导医护认知的调查研究 |
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Scientific title: |
Investigation of cognitive between doctors and nurses in upper limb rehabilitation guidance after multicenter breast cancer surgery |
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研究课题代号(代码): Study subject ID: |
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在二级注册机构或其它机构的注册号: The registration number of the Partner Registry or other register: |
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申请注册联系人: |
侯啟雯 |
研究负责人: |
韩宝三 |
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Applicant: |
Qiwen Hou |
Study leader: |
Baosan Han |
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申请注册联系人电话: Applicant telephone: |
+86 178 0214 1027 |
研究负责人电话: Study leader's telephone: |
+86 139 1733 0933 |
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申请注册联系人传真 : Applicant Fax: |
研究负责人传真: Study leader's fax: |
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申请注册联系人电子邮件: Applicant E-mail: |
hqw01234@163.com |
研究负责人电子邮件: Study leader's E-mail: |
hanbaosan@126.com |
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申请单位网址(自愿提供): Applicant website(voluntary supply): |
研究负责人网址(自愿提供): Study leader's website(voluntary supply): |
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申请注册联系人通讯地址: |
上海市杨浦区军工路334号 |
研究负责人通讯地址: |
上海市杨浦区控江路1665号 |
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Applicant address: |
No. 334 Jungong Road, Yangpu District, Shanghai |
Study leader's address: |
1665 Kongjiang Road, Yangpu, Shanghai, China |
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申请注册联系人邮政编码: Applicant postcode: |
研究负责人邮政编码: Study leader's postcode: |
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申请人所在单位: |
上海理工大学健康科学与工程学院 |
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Applicant's institution: |
School of Health Science and Engineering, Shanghai University of Technology |
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研究负责人所在单位: |
上海交通大学医学院附属新华医院 |
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Affiliation of the Leader: |
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine |
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是否获伦理委员会批准: |
是/Yes |
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Approved by ethic committee: |
Yes |
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伦理委员会批件文号: Approved No. of ethic committee: |
XHEC-C-2025-067-1 |
伦理委员会批件附件: Approved file of Ethical Committee: |
查看附件View |
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批准本研究的伦理委员会名称: |
上海交通大学医学院附属新华医院医学伦理委员会 |
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Name of the ethic committee: |
Ethics Committee of Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine |
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伦理委员会批准日期: Date of approved by ethic committee: |
2025-04-01 00:00:00 |
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伦理委员会联系人: |
施敏 |
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Contact Name of the ethic committee: |
Min Shi |
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伦理委员会联系地址: |
上海市杨浦区控江路1665号 |
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Contact Address of the ethic committee: |
1665 Kongjiang Road, Yangpu District, Shanghai, China |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 138 1680 2752 |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
xinhuahospitalec@163.com |
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研究实施负责(组长)单位: |
上海交通大学医学院附属新华医院 |
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Primary sponsor: |
Xinhua Hospital Affiliated to Shanghai Jiaotong University School of Medicine |
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研究实施负责(组长)单位地址: |
上海市杨浦区控江路1665号 |
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Primary sponsor's address: |
1665 Kongjiang Road, Yangpu District, Shanghai, China |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
新疆生产建设兵团 2024 年度兵团科技计划项目(编号:2024AB065) |
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Source(s) of funding: |
Xinjiang Production and Construction Corps 2024 Science and Technology Plan Project (No. 2024AB065) |
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Target disease: |
Breast Cancer |
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Target disease code: |
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研究类型: |
观察性研究 |
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Study type: |
Observational study |
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研究所处阶段: |
其它 | ||||||||||||||||||||||
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Study phase: |
N/A |
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研究设计: |
横断面 |
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Study design: |
Cross-sectional |
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研究目的: |
1. 评估医护人员对术后康复的认知水平。 2. 比较不同地区医护人员的康复指导差异。 3. 探索康复指导差异的影响因素。 |
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Objectives of Study: |
1. To assess the level of awareness of medical staff on postoperative rehabilitation. 2. Compare the differences in rehabilitation guidance of medical staff in different regions. 3. Explore the influencing factors of differences in rehabilitation guidance. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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纳入标准: |
医护人员: 1.符合2023年国家卫生健康委规定的医疗事业合法从业者,具有从业资格证; 2.有乳腺外科任职经历,对乳腺癌术后康复有一定了解; 3.能够熟练填写线上问卷,自愿加入本次研究; 4.愿意参与研究,接受伦理委员会审查。 患者数据: 1.乳腺恶性肿瘤手术术后患者; 2.患者术后接受过上肢功能锻炼培训; 3.思维清晰,能够熟练填写线上问卷,自愿加入本次研究; 4.患者在研究期间有完整的康复数据记录,可以用于后续分析; 5.愿意参与研究,接受伦理委员会审查。 |
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Inclusion criteria |
Medical staff: 1. Legal practitioners in the medical industry who meet the regulations of the National Health Commission in 2023 and have a professional qualification certificate; 2. Have experience in breast surgery, and have a certain understanding of postoperative rehabilitation of breast cancer; 3. Able to proficiently fill out online questionnaires and voluntarily participate in this study; 4. Willing to participate in research and accept ethical committee review. Patient data: 1. Postoperative patients with breast malignant tumors; 2. The patient has received upper limb functional exercise training after surgery; 3. Clear thinking, proficient in filling out online questionnaires, and willing to participate in this study; 4. Patients have complete rehabilitation data records during the study period, which can be used for subsequent analysis; 5. Willing to participate in research and accept ethical committee review. |
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排除标准: |
医护人员: 1.不具备乳腺外科工作经验,或不涉及乳腺癌术后康复指导的医护人员; 2.已经离职超过2年,或在研究期间不再从事相关工作的医护人员; 3.培训或教育人员:专职从事培训、教育等非临床工作的医护人员; 4.未获得知情同意或不同意参与研究的医护人员。 患者数据: 1.合并其他严重系统性疾病(如严重心脏病、肾功能衰竭、严重的肝病等); 2.术前已存在明显的上肢功能障碍(如肢体运动受限或其他严重疾病导致的上肢功能损害); 3.术后出现严重并发症,如严重感染、伤口不愈合、术后出血等,可能影响康复过程的患者; 4.由于认知障碍(如阿尔茨海默病、精神病等)导致无法理解或执行康复指导的患者; 5.怀孕或哺乳期的患者,因激素变化可能对康复过程产生影响; 6.明确拒绝参与研究的患者; 7.缺少必要的康复数据记录或康复过程中途停止的患者。 |
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Exclusion criteria: |
Medical staff: 1. Medical staff who do not have experience in breast surgery or do not involve in rehabilitation guidance after breast cancer surgery; 2. Medical staff who have resigned for more than 2 years or no longer engaged in related work during the research period; 3. Training or education personnel: medical staff who are dedicated to non clinical work such as training and education; 4. Medical staff who did not obtain informed consent or did not agree to participate in the study. Patient data: 1. Merge other serious systemic diseases (such as severe heart disease, renal failure, severe liver disease, etc.); 2. There is already obvious upper limb dysfunction before surgery (such as upper limb function impairment caused by restricted limb movement or other serious diseases); 3. Patients who experience serious complications after surgery, such as severe infection, non healing wounds, postoperative bleeding, etc., which may affect the recovery process; 4. Patients who are unable to understand or implement rehabilitation guidance due to cognitive impairments (such as Alzheimer's disease, mental illness, etc.); 5. Pregnant or lactating patients may have an impact on their recovery process due to hormonal changes; 6. Patients who explicitly refuse to participate in the study; 7. Patients who lack necessary rehabilitation data records or have their rehabilitation process stopped midway. |
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研究实施时间: Study execute time: |
从 From 2024-12-01 00:00:00至 To 2025-12-31 00:00:00 |
征募观察对象时间: Recruiting time: |
从From 2025-06-17 00:00:00 至 To 2025-07-31 00:00:00 |
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干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
尚未开始 Not yet recruiting |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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随机方法(请说明由何人用什么方法产生随机序列): |
简单随机抽样 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
Simple random sampling |
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是否公开试验完成后的统计结果: Calculated Results after the Study Completed public access: |
公开/Public |
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盲法: |
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Blinding: |
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试验完成后的统计结果(上传文件): |
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Calculated Results after
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是否共享原始数据: IPD sharing |
Yes |
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共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址): |
无 |
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The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
None |
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数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC: |
1.参与者基础信息将被记录在EXCEL登记表;问卷数据将使用线上电子版采集。 2.数据将由研究者进行保管,原始数据不传递给无关人员。 |
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Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
1. The basic information of the participant will be recorded in the EXCEL registration form; The questionnaire data will be collected using an online electronic version. 2. The data will be kept by the researcher, and the original data will not be passed on to irrelevant personnel. |
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数据与安全监察委员会: Data and Safety Monitoring Committee: |
暂未确定/Not yet |