ChiCTR2200055954 版本V1.2 版本创建时间2022/09/05 15:55:16 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：

 ChiCTR2200055954 

最近更新日期：

Date of Last Refreshed on：

 2022-09-05 15:52:06 

注册时间：

Date of Registration：

 2022-01-29 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

教育干预对促进中国大陆农村女性宫颈癌筛查有效性的研究：一项类实验研究

Public title：

Effectiveness of a theory-driven, cultural-tailored, community-based educational intervention on promoting cervical cancer screening among rural females in Chinese Mainland: A quasi-experimental study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

教育干预对促进中国大陆农村女性宫颈癌筛查有效性的研究：一项类实验研究

Scientific title：

Effectiveness of a theory-driven, cultural-tailored, community-based educational intervention on promoting cervical cancer screening among rural females in Chinese Mainland: A quasi-experimental study

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：

张蒙悦 

研究负责人：

张蒙悦 

Applicant：

ZHANG MENGYUE 

Study leader：

ZHANG MENGYUE 

申请注册联系人电话：

Applicant telephone：

 +86 18821730758

研究负责人电话：

Study leader's
telephone：

+86 18821730758

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：

 kassiezhang@link.cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 assiezhang@link.cuhk.edu.hk

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：

香港新界沙田香港中文大学利黄瑶璧楼6楼601室

研究负责人通讯地址：

香港新界沙田香港中文大学利黄瑶璧楼6楼601室

Applicant address：

Room 601, 6/F, Esther Lee Building, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong

Study leader's address：

Room 601, 6/F, Esther Lee Building, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong

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：

香港中文大学那打素护理学院

Applicant's institution：

The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong

研究负责人所在单位：

香港中文大学那打素护理学院

Affiliation of the Leader：

The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 2021.618

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：

香港中文大学-新界东医院联网临床研究伦理联席委员会

Name of the ethic committee：

Joint Chinese University of Hong Kong - New Territories East Cluster Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2021-12-22 00:00:00

伦理委员会联系人：

Envy Lee

Contact Name of the ethic committee：

Envy Lee

伦理委员会联系地址：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, HK

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, HK

伦理委员会联系人电话：

Contact phone of the ethic committee：

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：

香港中文大学那打素护理学院

Primary sponsor：

The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

香港新界沙田香港中文大学利黄瑶璧楼6楼601室

Primary sponsor's address：

601, 6/F, Esther Lee Building, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

香港

市(区县)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

香港中文大学那打素护理学院

具体地址：

新界沙田香港中文大学利黄瑶璧楼6楼601室

Institution
hospital：

The Nethersole School of Nursing, Faculty of Medicine, The Chinese University of Hong Kong

Address：

601, 6/F, Esther Lee Building, The Chinese University of Hong Kong, Shatin, N.T.

经费或物资来源：

无

Source(s) of funding：

N/A

研究疾病：

宫颈癌  

Target disease：

Cervical 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：

The study aims to evaluate the effectiveness of a theory-driven, cultural-tailored, community-based educational intervention on promoting cervical cancer screening in rural Chinese Mainland. The objectives of the study are as the followings. i. To evaluate the effectiveness of the intervention on increasing the uptake of cervical cancer screening among rural Chinese females. ii. To evaluate the effectiveness of the intervention on increasing the self-efficacy of cervical cancer screening among rural Chinese females. iii. To evaluate the effectiveness of the intervention on increasing the knowledge level of cervical cancer screening among rural Chinese females. iv. To evaluate the effectiveness of the intervention on increasing the intention of receiving cervical cancer screening among rural Chinese females.  

Objectives of Study：

The study aims to evaluate the effectiveness of a theory-driven, cultural-tailored, community-based educational intervention on promoting cervical cancer screening in rural Chinese Mainland. The objectives of the study are as the followings. i. To evaluate the effectiveness of the intervention on increasing the uptake of cervical cancer screening among rural Chinese females. ii. To evaluate the effectiveness of the intervention on increasing the self-efficacy of cervical cancer screening among rural Chinese females. iii. To evaluate the effectiveness of the intervention on increasing the knowledge level of cervical cancer screening among rural Chinese females. iv. To evaluate the effectiveness of the intervention on increasing the intention of receiving cervical cancer screening among rural Chinese females.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

(i) rural females aged 25-64 years; (ii) settled in rural areas with permanent registered rural residence; (iii) having sexual experience; (iv) without an existing or previous diagnosis of cervical cancer nor a prior hysterectomy; (v) never have any kind of cervical cancer screening or have not had any kind of cervical cancer screening within 3 years

Inclusion criteria

(i) rural females aged 25-64 years; (ii) settled in rural areas with permanent registered rural residence; (iii) having sexual experience; (iv) without an existing or previous diagnosis of cervical cancer nor a prior hysterectomy; (v) never have any kind of cervical cancer screening or have not had any kind of cervical cancer screening within 3 years

排除标准：

(i) being pregnant; (ii) having medical diagnosis of any serious physical illness or mental disorders or cognitive disorders; (iii) having difficulties with verbal expression or communication; (iv) participating in other cervical cancer screening-related research at the same time

Exclusion criteria：

(i) being pregnant; (ii) having medical diagnosis of any serious physical illness or mental disorders or cognitive disorders; (iii) having difficulties with verbal expression or communication; (iv) participating in other cervical cancer screening-related research at the same time

研究实施时间：

Study execute time：

从 From 2022-02-15 00:00:00至 To 2023-01-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2022-02-15 00:00:00 至 To 2022-03-31 00:00:00

干预措施：

Interventions：

组别：

干预组

样本量：

 177

Group：

Intervention group

Sample size：

干预措施：

教育干预

干预措施代码：

Intervention：

Educational intervention

Intervention code：

组别：

对照组

样本量：

 177

Group：

Control Group

Sample size：

干预措施：

常规护理

干预措施代码：

Intervention：

Usual care

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 山东 

市(区县)：

 枣庄 

Country：

China

Province：

Shandong

City：

Zaozhuang

单位(医院)：

 社区 

单位级别：

 无 

Institution
hospital：

Community

Level of the institution：

N/A

测量指标：

Outcomes：

指标中文名：

筛查率

指标类型：

主要指标

Outcome：

the uptake of cervical cancer screening

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

自我效能

指标类型：

次要指标

Outcome：

self-efficacy

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

知识

指标类型：

次要指标

Outcome：

knowledge

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

筛查意向

指标类型：

次要指标

Outcome：

intention

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

未来继续筛查意向

指标类型：

次要指标

Outcome：

intention of continuing receiving regular cervical cancer screening

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

医护人员未来实施该项目的意愿

指标类型：

次要指标

Outcome：

willingness of local health professionals to implement the intervention in the future

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：

无

组织：

Sample Name：

N/A

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

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 25 岁 years
最大 Max age 64 岁 years

性别：

女性

Gender：

Female

随机方法（请说明由何人用什么方法产生随机序列）：

非随机对照试验

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

N/A

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

否No

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）：

不共享

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

N/A

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：

数据使用纸质版问卷收集，使用电子管理系统（Epidata和SPSS）进行管理

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

Electronic Data Capture: Epidata

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2022-01-29 08:52:56