ChiCTR2400088531 版本V1.0 版本创建时间2024/08/20 17:33:57 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2400088531 

最近更新日期：

Date of Last Refreshed on：

2024-08-20 17:33:50 

注册时间：

Date of Registration：

2024-08-20 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

肿瘤患者免疫相关不良事件护理教育课程构建及初步应用

Public title：

Construction and initial application of a nursing education curriculum for cancer immune-related adverse events

注册题目简写：

English Acronym：

研究课题的正式科学名称：

肿瘤患者免疫相关不良事件护理教育课程构建及初步应用

Scientific title：

Construction and initial application of a nursing education curriculum for cancer immune-related adverse events

研究课题代号(代码)：

Study subject ID：

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：

申请注册联系人：

苏珍珍 

研究负责人：

张丽燕 

Applicant：

Suzhenzhe 

Study leader：

Zhangliyan 

申请注册联系人电话：

Applicant telephone：

+86 188 2200 0458

研究负责人电话：

Study leader's telephone：

+86 182 1018 7087

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

2211210149@bjmu.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

zl54920@bjmu.edu.cn

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)：

申请注册联系人通讯地址：

北京海淀区学院路38号

研究负责人通讯地址：

北京海淀区阜成路52号

Applicant address：

38 Xueyuan Road, Haidian District, Beijing, China

Study leader's address：

52 Fucheng Road, Haidian District, Beijing, China

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：

申请人所在单位：

北京大学护理学院

Applicant's institution：

Peking University School of Nursing

研究负责人所在单位：

北京大学肿瘤医院暨北京市肿瘤防治研究所 消化肿瘤内科,恶性肿瘤发病机制及转化研究教育部重点实验室

Affiliation of the Leader：

Key laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Department of Gastrointestinal Oncology, Peking University Cancer Hospital & Institute

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2024YJZ87

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

北京肿瘤医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Beijing Cancer Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2024-07-29 00:00:00

伦理委员会联系人：

张雷

Contact Name of the ethic committee：

Zhanglei

伦理委员会联系地址：

北京海淀区阜成路81号

Contact Address of the ethic committee：

81 Fucheng Road, Haidian District, Beijing, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 137 0103 2906

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

北京大学肿瘤医院

Primary sponsor：

Beijing cancer hospital

研究实施负责（组长）单位地址：

北京海淀区阜成路52号

Primary sponsor's address：

52 Fucheng Road, Haidian District, Beijing, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

北京

市(区县)：

Country：

China

Province：

Beijing

City：

单位(医院)：

北京大学肿瘤医院

具体地址：

北京海淀区阜成路52号

Institution
hospital：

Beijing cancer hospital

Address：

52 Fucheng Road, Haidian District, Beijing, China

经费或物资来源：

无

Source(s) of funding：

None

Target disease：

immune-related adverse events

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

非随机对照试验 

Study design：

Non randomized control 

研究目的：

通过质性访谈和专家函询，构建适合我国肿瘤科护士的肿瘤患者免疫相关不良事件护理教育课程并初步应用  

Objectives of Study：

Construction of a nursing education curriculum on immune-related adverse events in oncology patients suitable for oncology nurses in China and preliminary application through qualitative interviews and expert correspondence

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

质性访谈：具有护士资质的在职护士；从事肿瘤护理临床免疫治疗的护理工作 ≥1 年；有良好的语言表达能力；知情同意参加本研究 专家会议：本科学历及以上；从事肿瘤患者 irAEs 治疗/护理工作年限 5 年以上；自愿参与研究。 专家函询：本科及以上学历；irAEs 治疗/护理/管理领域 5 年以上；具有中高级技术职称；自愿参加研究。 初步应用：①获得中华人民共和国护士执业证并按规定注册的护士；②免疫治疗肿瘤患者的责任护士；③在肿瘤免疫治疗领域工作 ＞1年；④本科学历及以上；⑤护师资历及以上；⑥自愿参加本研究。

Inclusion criteria

Qualitative interview: nurses with nursing qualifications; more than a year of nursing practice in oncology nursing clinical immunotherapy; good verbal skills; informed consent to participate in this study Expert meeting: bachelor's degree and above; more than 5 years of experience in the treatment/care of tumor patients with irAEs; voluntary participation in the study. Expert Correspondence: Bachelor's degree or higher; more than 5 years in irAEs treatment/nursing/management field; intermediate to advanced technical title; voluntary participation in the study. Preliminary Applications: (i)Nurses who have obtained the certificate of nursing practice of the People's Republic of China and registered according to the regulations; (ii)Responsible nurses for immunotherapy patients with tumors; (iii) Worked in the field of tumor immunotherapy >1 year; (iv) Bachelor's degree or above; (v) Nurse practitioner qualification or above; (vi) Volunteer to participate in this study.

排除标准：

质性访谈：研究期间未在岗的护士；中途退出研究的护士 专家会议：无 专家函询：无 初步应用：①研究期间因事假、病假、进修、出国不在岗；②进修/学习/轮转的护理人员。

Exclusion criteria：

Qualitative interviews: nurses who were not on duty during the study; nurses who withdrew from the study midway through the study Expert meetings: none Expert correspondence: none Preliminary application: (i) Absence during the study period due to casual leave, sick leave, further study, or overseas; (ii) Nursing staff on further training/study/rotation.

研究实施时间：

Study execute time：

从 From 2024-08-01 00:00:00至 To 2025-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-09-01 00:00:00 至 To 2025-03-31 00:00:00  

干预措施：

Interventions：

组别：

干预前/后

样本量：

23

Group：

pre-intervention/post-intervention

Sample size：

干预措施：

成立教育团队并进行课程培训，培训内容根据前期构建的“肿瘤患者免疫相关不良事件护理教育课程”制定

干预措施代码：

Intervention：

Establishment of an education team and training of the curriculum, which is based on the "Nursing Education Curriculum for Immunization-Related Adverse Events in Oncology Patients" constructed in the early stage.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 北京 

市(区县)：

  

Country：

China 

Province：

Beijing 

City：

 

单位(医院)：

北京大学肿瘤医院 

单位级别：

三甲 

Institution
hospital：

Beijing cancer hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

肿瘤科护士知识水平

指标类型：

主要指标

Outcome：

Knowledge level of oncology nurses

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

肿瘤科护士病例分析能力

指标类型：

主要指标

Outcome：

Case analysis skills for oncology nurses

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

肿瘤患者免疫相关不良事件护理教育课程满意度

指标类型：

主要指标

Outcome：

Satisfaction with a nursing education course on cancer immune-related adverse events

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

none

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 85 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

无

Randomization Procedure (please state who generates the random number sequence and by what method)：

None

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

盲法：

Blinding：

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

Yes

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）：

本研究的原始数据数据可于文章发表后向通讯作者寻求获取。

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

The raw data data of this study can be obtained from the corresponding author after the publication of the article.

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：

半结构化访谈由研究者实施，预期在取得护士同意之后，与护士进行一对一的面对面访谈。访谈场所安排在令护士感到舒适的场所，如护士休息室。访谈过程中对同意录音者进行录音和笔录，对不同意录音者进行笔录，访谈过程中记录护士的举止和态度。每次访谈20-40min。资料收集后，24小时内逐字转录。资料收集直至信息饱和。 《肿瘤科护士知识水平调查问卷》、《肿瘤科护士病例分析测试问卷》由研究小组在培训前后对纳入的护士进行资料收集，《肿瘤患者免疫相关不良事件护理教育课程满意度调查表》由研究小组在培训后对纳入的护士进行资料收集。参与研究的护士独立填写，填写后现场回收。为了保证护理人员测试的积极性和测试结果的真实性，采用匿名测试的方式进行。纳入结果剔除填写缺项、漏答、所勾选的选项为同一个、未按问卷指示填答的问卷。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Semi-structured interviews were conducted by the researcher, anticipating one-on-one face-to-face interviews with nurses after obtaining their consent. The interview venue was arranged in a place where the nurses felt comfortable, such as the nurses' lounge. The interviews were audio-recorded and transcribed for those who agreed to be recorded and for those who did not agree to be recorded, and the demeanor and attitude of the nurses were recorded during the interviews. Each interview was conducted for 20-40 min. information was collected and transcribed verbatim within 24 hours. Data were collected until information saturation. The Questionnaire on Knowledge Level of Oncology Nurses and the Questionnaire on Case Analysis Test for Oncology Nurses were administered by the research team to the included nurses before and after the training, and the Questionnaire on Satisfaction with Nursing Education Course on Immunization-Related Adverse Events in Oncology Patients was administered by the research team to the included nurses after the training. It was filled out independently by the nurses participating in the study and collected on site after completion. To ensure the motivation of the nursing staff to test and the authenticity of the test results, anonymous testing was used. The inclusion of the results excluded the questionnaires that were filled out with missing items, omitted answers, the options checked were the same, and the questionnaires were not filled out according to the instructions of the questionnaire.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2024-08-20 17:33:50