ChiCTR1800015671 版本V1.0 版本创建时间2018/04/14 00:14:24 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：

ChiCTR1800015671 

最近更新日期：

Date of Last Refreshed on：

2018-04-14 00:14:01 

注册时间：

Date of Registration：

2018-04-10 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

A community health worker-led multimedia intervention to increase cervical cancer screening uptake among South Asians women: A randomized controlled trial

Public title：

A community health worker-led multimedia intervention to increase cervical cancer screening uptake among South Asians women: A randomized controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

A community health worker-led multimedia intervention to increase cervical cancer screening uptake among South Asians women: A randomized controlled trial

Scientific title：

A community health worker-led multimedia intervention to increase cervical cancer screening uptake among South Asians women: A randomized controlled trial

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：

CUHK_CCRB00600

申请注册联系人：

Wong Cho Lee 

研究负责人：

Wong Cho Lee 

Applicant：

Wong Cho Lee 

Study leader：

Wong Cho Lee 

申请注册联系人电话：

Applicant telephone：

+852 39438166

研究负责人电话：

Study leader's telephone：

+852 39438166

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：

jojowong@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

jojowong@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：

Room 824, 8/F, Esther Lee Building, The Chinese University of Hong Kong

研究负责人通讯地址：

Room 824, 8/F, Esther Lee Building, The Chinese University of Hong Kong

Applicant address：

Room 824, 8/F, Esther Lee Building, The Chinese University of Hong Kong

Study leader's address：

Room 824, 8/F, Esther Lee Building, The Chinese University of 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：

The Chinese University of Hong Kong

Applicant's institution：

The Chinese University of Hong Kong

研究负责人所在单位：

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

Affiliation of the Leader：

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

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：

2018.002

伦理委员会批件附件：

Approved file of Ethical Committee：

批准本研究的伦理委员会名称：

Joint CUHK-NTEC Clinical Research Ethics Committee

Name of the ethic committee：

Joint CUHK-NTEC Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

2018-03-09 00:00:00

伦理委员会联系人：

Joint CUHK-NTEC Clinical Research Ethics Committee

Contact Name of the ethic committee：

Joint CUHK-NTEC Clinical Research Ethics Committee

伦理委员会联系地址：

Contact Address of the ethic committee：

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：

Food and Health Bureau

Primary sponsor：

Food and Health Bureau

研究实施负责（组长）单位地址：

Food and Health Bureau

Primary sponsor's address：

Food and Health Bureau

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

Health Care Promotion Scheme

Source(s) of funding：

Health Care Promotion Scheme

Target disease：

cervical cancer

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 I期临床试验 

Study phase：

1

研究设计：

横断面 

Study design：

Cross-sectional 

研究目的：

A community health worker-led multimedia intervention to increase cervical cancer screening uptake among South Asians women  

Objectives of Study：

A community health worker-led multimedia intervention to increase cervical cancer screening uptake among South Asians women

药物成份或治疗方案详述：

The intervention has two components: (1) a multimedia education tested by our team members in an earlier study and (2) monthly telephone follow-up and navigation assistance. (1)Multimedia education The trained CHW will deliver two half-hour health talk using a PowerPoint presentation, which covers the following topics: 1) definition of cervical cancer; risk factors, signs, and symptoms of cervical cancer, 3) myths and misconceptions about cervical cancer, 4) preventive measures for cervical cancer, and 5) available preventive measures and service providers in Hong Kong. Participants will then be asked to watch a four-minute video clip to reinforce the information they received. At the end of the health talk, participants will receive an information booklet about cervical cancer that details the health content covered in the health talk. The CHW will discuss the booklet with the participants and instruct them on its use. (2)Telephone follow-up and navigation assistance For the three months following the multimedia education, the CHWs will make a monthly telephone follow up to reinforce the knowledge of participants and motivate them to undergo cervical cancer screening. CHWs will also offer navigation assistance, including making a screening appointment, accompanying participants to undergo screening, and completing the paperwork related to the screening.  

Description for medicine or protocol of treatment in detail：

The intervention has two components: (1) a multimedia education tested by our team members in an earlier study and (2) monthly telephone follow-up and navigation assistance. (1)Multimedia education The trained CHW will deliver two half-hour health talk using a PowerPoint presentation, which covers the following topics: 1) definition of cervical cancer; risk factors, signs, and symptoms of cervical cancer, 3) myths and misconceptions about cervical cancer, 4) preventive measures for cervical cancer, and 5) available preventive measures and service providers in Hong Kong. Participants will then be asked to watch a four-minute video clip to reinforce the information they received. At the end of the health talk, participants will receive an information booklet about cervical cancer that details the health content covered in the health talk. The CHW will discuss the booklet with the participants and instruct them on its use. (2)Telephone follow-up and navigation assistance For the three months following the multimedia education, the CHWs will make a monthly telephone follow up to reinforce the knowledge of participants and motivate them to undergo cervical cancer screening. CHWs will also offer navigation assistance, including making a screening appointment, accompanying participants to undergo screening, and completing the paperwork related to the screening.  

纳入标准：

(1) Self-identifies as South Asian (from Pakistan, India, or Nepal);
(2) aged 25 or older who ever had sex;
(3) never had a Pap test or has not undertaken cancer screening in the last five years;
(4) have not reported being diagnosed with cancer;
(5) have not attended any intervention or education program related to cervical cancer screening in the previous year; and
(6) able to communicate with English, Urdu, Nepali, Punjabi or Hindi and read English, Urdu, Nepali, or Punjabi.

Inclusion criteria

(1) Self-identifies as South Asian (from Pakistan, India, or Nepal);
(2) aged 25 or older who ever had sex;
(3) never had a Pap test or has not undertaken cancer screening in the last five years;
(4) have not reported being diagnosed with cancer;
(5) have not attended any intervention or education program related to cervical cancer screening in the previous year; and
(6) able to communicate with English, Urdu, Nepali, Punjabi or Hindi and read English, Urdu, Nepali, or Punjabi.

排除标准：

Those who enrolled and participated in a project titled ‘Effect of a family-based multimedia intervention on the uptake of colorectal cancer screening among South Asian older adults in Hong Kong: a randomized control trial’ will be excluded.

Exclusion criteria：

Those who enrolled and participated in a project titled Effect of a family-based multimedia intervention on the uptake of colorectal cancer screening among South Asian older adults in Hong Kong: a randomized control trial will be excluded.

研究实施时间：

Study execute time：

从 From 1990-01-01 00:00:00至 To 1990-01-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2018-09-01 00:00:00 至 To 1990-01-01 00:00:00  

干预措施：

Interventions：

组别：

Two groups

样本量：

400

Group：

Two groups

Sample size：

干预措施：

Community health worker led multimedia intervention versus Nil

干预措施代码：

Intervention：

Community health worker led multimedia intervention versus Nil

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China 

Province：

Hong Kong SR 

City：

 

单位(医院)：

The Chinese University of Hong Kong 

单位级别：

The Chinese University of Hong Kong 

Institution
hospital：

The Chinese University of Hong Kong

Level of the institution：

The Chinese University of Hong Kong

测量指标：

Outcomes：

指标中文名：

Cervical screening uptake

指标类型：

主要指标

Outcome：

Cervical screening uptake

Type：

Primary indicator

测量时间点：

3 months post intervention

测量方法：

A receipt of the screening test

Measure time point of outcome：

3 months post intervention

Measure method：

A receipt of the screening test

指标中文名：

Readiness to undergo screening

指标类型：

次要指标

Outcome：

Readiness to undergo screening

Type：

Secondary indicator

测量时间点：

Immediate and three months post-intervention

测量方法：

Participants will be asked regarding their readiness to undergo a Pap test

Measure time point of outcome：

Immediate and three months post-intervention

Measure method：

Participants will be asked regarding their readiness to undergo a Pap test

指标中文名：

Cervical cancer screening belief

指标类型：

次要指标

Outcome：

Cervical cancer screening belief

Type：

Secondary indicator

测量时间点：

Immediate and three months post-intervention

测量方法：

The cervical cancer screening belief scale

Measure time point of outcome：

Immediate and three months post-intervention

Measure method：

The cervical cancer screening belief scale

采集人体标本：

Collecting sample(s)
from participants：

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 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）：

Cluster-randomized, wait-list controlled trial

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

Cluster-randomized, wait-list controlled trial

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：

Single-blind, Investigator/research team

Blinding：

Single-blind, Investigator/research team

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

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）：

Not stated

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

Not stated

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：

Not stated

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

Not stated

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2018-04-14 00:14:01