高级实践护士视角下胃癌患者全程管理模式构建与实证研究

注册号:

Registration number:

ChiCTR2500113716 

最近更新日期:

Date of Last Refreshed on:

2025-12-02 11:41:29 

注册时间:

Date of Registration:

2025-12-02 00:00:00 

注册号状态:

补注册

Registration Status:

Retrospective registration

注册题目:

高级实践护士视角下胃癌患者全程管理模式构建与实证研究

Public title:

Construction and Empirical Study of Whole Process Management Model for Gastric Cancer Patients from the Perspective of Advanced Practical Nurses

注册题目简写:

English Acronym:

研究课题的正式科学名称:

高级实践护士视角下胃癌患者全程管理模式构建与实证研究

Scientific title:

Construction and Empirical Study of Whole Process Management Model for Gastric Cancer Patients from the Perspective of Advanced Practical Nurses

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:

费超男 

研究负责人:

费超男 

Applicant:

Fei Chaonan 

Study leader:

Fei Chaonan 

申请注册联系人电话:

Applicant telephone:

+86 158 5070 8638

研究负责人电话:

Study leader's
telephone:

+86 158 5070 8638

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:

631993889@qq.com

研究负责人电子邮件:

Study leader's E-mail:

631993889@qq.com

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:

江苏省南京市秦淮区汉中路155号

研究负责人通讯地址:

江苏省南京市秦淮区汉中路155号

Applicant address:

No. 155 Hanzhong Road, Qinhuai District, Nanjing City, Jiangsu Province

Study leader's address:

No. 155 Hanzhong Road, Qinhuai District, Nanjing City, Jiangsu Province

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:

江苏省中医院

Applicant's institution:

Jiangsu Province Hospital of Chinese Medicine

研究负责人所在单位:

江苏省中医院

Affiliation of the Leader:

Jiangsu Province Hospital of Chinese Medicine

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

2025-NL-078-01

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:

江苏省中医院伦理委员会

Name of the ethic committee:

Ethics Committee of Jiangsu Provincial Hospital of Chinese Medicine

伦理委员会批准日期:

Date of approved by ethic committee:

2025-03-26 00:00:00

伦理委员会联系人:

王卯

Contact Name of the ethic committee:

WANG Mao

伦理委员会联系地址:

江苏省南京市秦淮区汉中路155号

Contact Address of the ethic committee:

No. 155 Hanzhong Road, Qinhuai District, Nanjing City, Jiangsu Province

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 25 8656 0515

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:

江苏省中医院

Primary sponsor:

Jiangsu Province Hospital of Chinese Medicine

研究实施负责(组长)单位地址:

江苏省南京市秦淮区汉中路155号

Primary sponsor's address:

No. 155 Hanzhong Road, Qinhuai District, Nanjing City, Jiangsu Province

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

江苏

市(区县):

南京

Country:

China

Province:

Jiangsu

City:

单位(医院):

江苏省中医院

具体地址:

江苏省南京市秦淮区汉中路155号

Institution
hospital:

Jiangsu Province Hospital of Chinese Medicine

Address:

No. 155 Hanzhong Road, Qinhuai District, Nanjing City, Jiangsu Province

经费或物资来源:

院级课题基金

Source(s) of funding:

Institute level project fund

研究疾病:

胃癌  

Target disease:

Gastric Cancer

研究疾病代码:

Target disease code:

研究类型:

干预性研究

Study type:

Interventional study

研究所处阶段:

其它 

Study phase:

N/A

研究设计:

非随机对照试验 

Study design:

Non randomized control 

研究目的:

构建以高级实践护士为主导的胃癌全程管理模式并进行初步实施,探索胃癌专科护理实践的新模式,为胃癌患者提供持续的、专业的、个体化的管理。  

Objectives of Study:

Construct a comprehensive management model for gastric cancer led by senior practice nurses and carry out preliminary implementation, explore new models of specialized nursing practice for gastric cancer, and provide continuous, professional, and personalized management for gastric cancer patients.

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

Inclusion criteria

排除标准:

1.存在严重认知功能障碍或精神疾病;2.患有严重心、脑、肾等功能障碍;3.预计生存时间小于6个月;4.对病情不知晓。

Exclusion criteria:

1.Having severe cognitive impairment or mental illness; 2. Suffering from severe heart, brain, kidney and other functional disorders; 3. Expected survival time is less than 6 months;4.Not aware of the condition.

研究实施时间:

Study execute time:

From 2025-04-22 00:00:00 To 2026-04-22 00:00:00  

征募观察对象时间:

Recruiting time:

From 2025-04-22 00:00:00 To 2026-04-22 00:00:00

干预措施:

Interventions:

组别:

干预组

样本量:

50

Group:

intervention group

Sample size:

干预措施:

高级实践护士主导的管理模式

干预措施代码:

Intervention:

Advanced practice nurse led management model

Intervention code:

组别:

对照组

样本量:

50

Group:

control group

Sample size:

干预措施:

常规护理模式

干预措施代码:

Intervention:

usual care model

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

江苏 

市(区县):

 

Country:

China

Province:

Jiangsu

City:

单位(医院):

江苏省中医院 

单位级别:

三甲 

Institution
hospital:

Jiangsu Province Hospital of Chinese Medicine

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

症状严重程度

指标类型:

主要指标

Outcome:

severity of symptoms

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生活质量

指标类型:

主要指标

Outcome:

quality of life

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

抑郁

指标类型:

主要指标

Outcome:

depression

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

焦虑

指标类型:

主要指标

Outcome:

anxious

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

满意度

指标类型:

次要指标

Outcome:

satisfaction

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院天数

指标类型:

次要指标

Outcome:

hospitalization days

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院费用

指标类型:

次要指标

Outcome:

hospitalization expenses

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

及时就诊率

指标类型:

次要指标

Outcome:

timely medical consultation rate

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

非计划入院率

指标类型:

次要指标

Outcome:

unplanned admission rate

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

治疗计划完成率

指标类型:

次要指标

Outcome:

completion rate of treatment plan

Type:

Secondary 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:

组织:

Sample Name:

Non

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 80 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):

非随机对照研究

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

Non randomized control

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:

None

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

是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):

2025,国家生物信息中心 https://ngdc.cncb.ac.cn/gsub/

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

2025, China National center for Bioinformation (https://ngdc.cncb.ac.cn/gsub/)

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:

病例记录表

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

Case Record Form

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2025-12-02 11:41:25