ChiCTR2500105926 版本V1.0 版本创建时间2025/07/15 08:20:03 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：

ChiCTR2500105926 

最近更新日期：

Date of Last Refreshed on：

2025-07-15 08:19:58 

注册时间：

Date of Registration：

2025-07-15 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Public title：

Effects of a linguistically appropriate decision aid for the mammography screening of South Asian women in Hong Kong: A pilot randomised controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Scientific title：

Effects of a linguistically appropriate decision aid for the mammography screening of South Asian women in Hong Kong: A pilot randomised 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：

申请注册联系人：

 

研究负责人：

 

Applicant：

Chan Ngo Sheung Dorothy 

Study leader：

Chan Ngo Sheung Dorothy 

申请注册联系人电话：

Applicant telephone：

+852 3943 8165

研究负责人电话：

Study leader's telephone：

+852 3943 8165

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：

dorothycns@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

dorothycns@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：

研究负责人通讯地址：

Applicant address：

Room 821, 8/F, Esther Lee Building, the Chinese University of Hong Kong, Shatin, the New Territories

Study leader's address：

Room 821, 8/F, Esther Lee Building, the Chinese University of Hong Kong, Shatin, the New Territories

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：

Applicant's institution：

the Chinese University of Hong Kong

研究负责人所在单位：

Affiliation of the Leader：

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：

NTEC-2024-385

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：

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：

2024-09-26 00:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

Amy Li

伦理委员会联系地址：

Contact Address of the ethic committee：

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

伦理委员会联系人电话：

Contact phone of the ethic committee：

+852 3505 3935

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：

Primary sponsor：

the Chinese University of Hong Kong

研究实施负责（组长）单位地址：

Primary sponsor's address：

6-8/F, Esther Lee Building, the Chinese University of Hong Kong

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

省(直辖市)：

市(区县)：

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

具体地址：

Institution
hospital：

the Chinese University of Hong Kong

Address：

6-8/F, Esther Lee Building, the Chinese University of Hong Kong , Shatin, the New Territories

经费或物资来源：

Source(s) of funding：

N/A

Target disease：

Breast Cancer

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：

随机平行对照 

Study design：

Parallel 

研究目的：

 

Objectives of Study：

1. to examine the feasibility and acceptability of a decision aid for the mammography screening of South Asian women aged 40 years or older 2. to preliminarily examine the changes in risk perception, decisional conflicts, clarity of values, screening decision and mammography screening uptake after they use the aid.

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

1. South Asian women (Indian, Pakistani or Nepalese) aged 40 years or older 2. No history of breast cancer 3. The inability to understand Chinese but the ability to read or communicate in English, Hindi, Urdu or Nepali 4. No mammography screening in their lifetime or due for a biennial mammography screening

排除标准：

Exclusion criteria：

N/A

研究实施时间：

Study execute time：

从 From 2025-07-20 00:00:00至 To 2026-07-19 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-07-20 00:00:00 至 To 2026-07-19 00:00:00  

干预措施：

Interventions：

组别：

样本量：

24

Group：

intervention group

Sample size：

干预措施：

干预措施代码：

Intervention：

A linguistically appropriate printed decision with information covering breast cancer screening (mammography) and value clarification exercise, delivered and supported by trained South Asian Community Health Workers

Intervention code：

组别：

样本量：

24

Group：

control group

Sample size：

干预措施：

干预措施代码：

Intervention：

a brief fact sheet about healthy living delivered by South Asian Community Health Workers

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

省(直辖市)：

  

市(区县)：

  

Country：

China 

Province：

Hong Kong SAR 

City：

 

单位(医院)：

 

单位级别：

 

Institution
hospital：

Community centres

Level of the institution：

N/A

测量指标：

Outcomes：

指标中文名：

指标类型：

主要指标

Outcome：

decisional conflict

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

T0, T1

Measure method：

questionnaire

指标中文名：

指标类型：

次要指标

Outcome：

risk perception

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

T0, T1

Measure method：

questionnaire

指标中文名：

指标类型：

次要指标

Outcome：

value clarification

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

T0, T1

Measure method：

questionnaire

指标中文名：

指标类型：

次要指标

Outcome：

screening decision

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

T0, T1

Measure method：

questionnaire

指标中文名：

指标类型：

主要指标

Outcome：

mammography screening uptake

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

T2

Measure method：

questionnaire with the support of screening receipt

指标中文名：

指标类型：

次要指标

Outcome：

acceptability of intervention

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

T2

Measure method：

semi-structure interview

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

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 40 岁 years
最大 Max age 100 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）：

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

Stratified permuted block randomisation (by the three ethnic minority groups) will be performed by a statistician who will not be otherwise involved in the study, using a computer-generated random schedule. A block size of eight will be used to allocate participants at a 1:1 ratio into either the intervention group or control group. The JRA will be responsible for participant recruitment and will be blinded to the participant group allocation. Sequentially numbered opaque sealed envelopes that contain information on the group assignments will be given to the participants in the sequence they enter the study after the participants are screened for eligibility, have signed the consent form and have completed the baseline questionnaire.

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：

the outcome assessor will be blinded

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）：

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：

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

The investigator will contact stakeholders, namely people in charge of centres and presidents of ethnic minority associations, to gain access to potential participants. The purpose of the study, eligibility criteria and data collection methods will be explained to the stakeholders in obtaining their support. The schedule for recruitment will then be agreed and established. The JRA will approach potential participants, and those eligible will be briefed on the study. An information sheet will be distributed. Written consent will be obtained when participation is agreed upon. Eligible participants will be asked to complete a baseline questionnaire after providing written consent. Two weeks after the intervention, the participants will complete the post questionnaire. Information on screening uptake will be collected six months after the intervention. To determine the acceptability of the decision aid, data will be collected at T1 through semi-structured telephone interviews. The interviews will last approximately 30 minutes and will be conducted by the JRA (blinded to group allocation) over the phone. The interviews will be audio-recorded. The feasibility and uptake of the intervention will be assessed by comparing the number of South Asian women who are approached, screened and deemed eligible for participation with the number who join and complete the intervention. All data will be anonymised and used for research only. The data will be kept confidential in a locked cabinet and password-protected computer for no more than 5 years after the study and will then be destroyed.

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：

  2025-07-15 08:19:58