ChiCTR2500108726 版本V1.0 版本创建时间2025/09/04 09:02:39 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：

 ChiCTR2500108726 

最近更新日期：

Date of Last Refreshed on：

 2025-09-04 09:02:22 

注册时间：

Date of Registration：

 2025-09-04 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

The effects of theory-guided multimodal educational (TIME) programme on the faecal occult blood test uptake rates among adults at average-risk of colorectal cancer: A randomized controlled trial

Public title：

The effects of theory-guided multimodal educational (TIME) programme on the faecal occult blood test uptake rates among adults at average-risk of colorectal cancer: A randomized controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

The effects of theory-guided multimodal educational (TIME) programme on the faecal occult blood test uptake rates among adults at average-risk of colorectal cancer: A randomized controlled trial

Scientific title：

The effects of theory-guided multimodal educational (TIME) programme on the faecal occult blood test uptake rates among adults at average-risk of colorectal cancer: 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：

申请注册联系人：

Kwan Siu Kuen 

研究负责人：

Chan Ngao Sheung, Dorothy 

Applicant：

Kwan Siu Kuen 

Study leader：

Chan Ngao Sheung, Dorothy 

申请注册联系人电话：

Applicant telephone：

 +852 3943 9922

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：

 winniekwan@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：

Room 630, 6/F, Esther Lee Building, CUHK

研究负责人通讯地址：

Room 804A, 8/F, Esther Lee Building, CUHK

Applicant address：

Room 630, 6/F, Esther Lee Building, CUHK

Study leader's address：

Room 804A, 8/F, Esther Lee Building, CUHK

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 Chinese University of Hong Kong

Affiliation of the Leader：

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：

 2025.329-T

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：

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

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：

 2025-07-04 00:00:00

伦理委员会联系人：

Ms Amy Li

Contact Name of the ethic committee：

Ms Amy Li

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：

 +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：

The Chinese University of Hong Kong

Primary sponsor：

The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

Rm 630, 6/F, Esther Lee Building, CUHK

Primary sponsor's address：

Rm 630, 6/F, Esther Lee Building, CUHK

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

China

省(直辖市)：

Hong Kong SAR

市(区县)：

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

The Chinese University of Hong Kong

具体地址：

Rm 630, 6/F, Esther Lee Building, CUHK

Institution
hospital：

The Chinese University of Hong Kong

Address：

Rm 630, 6/F, Esther Lee Building, CUHK

经费或物资来源：

N/A

Source(s) of funding：

N/A

研究疾病：

Colorectal cancer  

Target disease：

Colorectal 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：

随机平行对照 

Study design：

Parallel 

研究目的：

i) To develop and implement the TIME programme among adults at average-risk of colorectal cancer (CRC). ii) To examine the effects of TIME programme on CRC uptake rates, perceived susceptibility to CRC, perceived severity of CRC, perceived barriers to CRC screening, perceived benefits of CRC screening, and self-efficacy. iii) To evaluate the participants’ satisfaction with the TIME programme.  

Objectives of Study：

i) To develop and implement the TIME programme among adults at average-risk of colorectal cancer (CRC). ii) To examine the effects of TIME programme on CRC uptake rates, perceived susceptibility to CRC, perceived severity of CRC, perceived barriers to CRC screening, perceived benefits of CRC screening, and self-efficacy. iii) To evaluate the participants’ satisfaction with the TIME programme.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1. aged between 50 and 75; 2. Hong Kong residents; 3. no symptoms of CRC; 4. no history of CRC, polyps or inflammatory bowel disease; 5. no family history of CRC; 6. able to access WhatsApp Messenger or WeChat; 7. able to read Chinese and communicate in Cantonese; 8. willing to be followed up by telephone.

Inclusion criteria

1. aged between 50 and 75; 2. Hong Kong residents; 3. no symptoms of CRC; 4. no history of CRC, polyps or inflammatory bowel disease; 5. no family history of CRC; 6. able to access WhatsApp Messenger or WeChat; 7. able to read Chinese and communicate in Cantonese; 8. willing to be followed up by telephone.

排除标准：

Individuals who have undergone a faecal occult blood test (FOBT) in the past 2 years, a sigmoidoscopy in the past 5 years, or a colonoscopy in the past 10 years, as well as those who do not have a smartphone, are mentally incapable, have hearing or visual impairments, or are unable to provide informed consent will be excluded.

Exclusion criteria：

Individuals who have undergone a faecal occult blood test (FOBT) in the past 2 years, a sigmoidoscopy in the past 5 years, or a colonoscopy in the past 10 years, as well as those who do not have a smartphone, are mentally incapable, have hearing or visual impairments, or are unable to provide informed consent will be excluded.

研究实施时间：

Study execute time：

从 From 2025-08-15 00:00:00至 To 2026-08-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-09-08 00:00:00 至 To 2026-05-31 00:00:00

干预措施：

Interventions：

组别：

Intervention group

样本量：

 104

Group：

Intervention group

Sample size：

干预措施：

The TIME programme includes two parts: Part I) a 1-hour educational talk with the aid of PowerPoint presentations, along with an educational booklet and narrative videos; and Part II) reminders consisting of two text messages and one follow-up telephone call.

干预措施代码：

Intervention：

The TIME programme includes two parts: Part I) a 1-hour educational talk with the aid of PowerPoint presentations, along with an educational booklet and narrative videos; and Part II) reminders consisting of two text messages and one follow-up telephone call.

Intervention code：

组别：

Wait-list control group

样本量：

 104

Group：

Wait-list control group

Sample size：

干预措施：

provide the same intervention after all datacollection has been completed.

干预措施代码：

Intervention：

provide the same intervention after all datacollection has been completed.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 HONG KONG SAR 

市(区县)：

  

Country：

China

Province：

HONG KONG SAR

City：

单位(医院)：

 Community Centres 

单位级别：

 NA 

Institution
hospital：

Community Centres

Level of the institution：

NA

测量指标：

Outcomes：

指标中文名：

FOBT uptake rates (T2)

指标类型：

主要指标

Outcome：

FOBT uptake rates (T2)

Type：

Primary indicator

测量时间点：

3 months after the educational talk

测量方法：

Self-report and verify by records from the eHRSS, medical reports or letters from the primary care doctors.

Measure time point of outcome：

3 months after the educational talk

Measure method：

Self-report and verify by records from the eHRSS, medical reports or letters from the primary care doctors.

指标中文名：

Colorectal cancer perceptions (T0)

指标类型：

次要指标

Outcome：

Colorectal cancer perceptions (T0)

Type：

Secondary indicator

测量时间点：

Before randomizatoin

测量方法：

Self-reported questionnaire

Measure time point of outcome：

Before randomizatoin

Measure method：

Self-reported questionnaire

指标中文名：

Self-efficacy on FOBT (T0)

指标类型：

次要指标

Outcome：

Self-efficacy on FOBT (T0)

Type：

Secondary indicator

测量时间点：

Before randomization

测量方法：

Self-reported questionnaire

Measure time point of outcome：

Before randomization

Measure method：

Self-reported questionnaire

指标中文名：

Colorectal cancer perceptions (T1)

指标类型：

次要指标

Outcome：

Colorectal cancer perceptions (T1)

Type：

Secondary indicator

测量时间点：

1 month after education session

测量方法：

Self-reported questionnaire

Measure time point of outcome：

1 month after education session

Measure method：

Self-reported questionnaire

指标中文名：

Self-efficacy on FOBT (T1)

指标类型：

次要指标

Outcome：

Self-efficacy on FOBT (T1)

Type：

Secondary indicator

测量时间点：

1 month after education session

测量方法：

Self-reported questionnaire

Measure time point of outcome：

1 month after education session

Measure method：

self-reported questionnaire

指标中文名：

Process evaluation

指标类型：

次要指标

Outcome：

Process evaluation

Type：

Secondary indicator

测量时间点：

After the data collection is completed at T2

测量方法：

A semi-structure interview by telephone

Measure time point of outcome：

After the data collection is completed at T2

Measure method：

A semi-structure interview by telephone

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

N/A

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 50 岁 years
最大 Max age 75 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）：

Block randomization will be used to assign the participants to the intervention group or wait-list control group in a 1:1 ratio with a block size of 8. An independent statistician will use a computer to generate a random assignment sequence of group identifiers. The sequence of group identifiers will be printed on identical cards and inserted into sequentially numbered, sealed opaque envelopes.

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

Block randomization will be used to assign the participants to the intervention group or wait-list control group in a 1:1 ratio with a block size of 8. An independent statistician will use a computer to generate a random assignment sequence of group identifiers. The sequence of group identifiers will be printed on identical cards and inserted into sequentially numbered, sealed opaque envelopes.

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：

Due to the nature of the educational intervention and the use of a wait-list control group in this study, it is not possible for the study participants to be blinded to their group allocation.

Blinding：

Due to the nature of the educational intervention and the use of a wait-list control group in this study, it is not possible for the study participants to be blinded to their group allocation.

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）：

N/A

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：

All the electronic data files will be encrypted, and paper documents will be stored in a locked cabinet. Only the project team members will have access to the data file and paper documents. The principal investigator will be responsible for safekeeping of the data. Paper documents will be destroyed five years after the completion of the study or publication, while electronic data will be destroyed ten years after the completion of the study or publication.

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

All the electronic data files will be encrypted, and paper documents will be stored in a locked cabinet. Only the project team members will have access to the data file and paper documents. The principal investigator will be responsible for safekeeping of the data. Paper documents will be destroyed five years after the completion of the study or publication, while electronic data will be destroyed ten years after the completion of the study or publication.

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：

  2025-09-04 09:02:22