Today is 2019-12-14

Risk-based Care and Education for Survivors of Childhood Cancer in Hong Kong
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注册号:

Registration number:

ChiCTR1800019015 

最近更新日期:

Date of Last Refreshed on:

2018-10-21 

注册时间:

Date of Registration:

2018-10-19 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

為香港兒童癌症康復者提供風險護理教育和相關知識 

Public title:

Risk-based Care and Education for Survivors of Childhood Cancer in Hong Kong 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

為香港兒童癌症康復者提供風險護理教育和相關知識 

Scientific title:

Personalized Risk-based Care and Education for Early Survivors of Childhood Cancer in Hong Kong 

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_CCRB00629 

申请注册联系人:

Cheung Yin Ting 

研究负责人:

Cheung Yin Ting 

Applicant:

Cheung Yin Ting 

Study leader:

Cheung Yin Ting 

申请注册联系人电话:

Applicant telephone:

+852 39436833 

研究负责人电话:

Study leader's telephone:

+852 39436833 

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:

yinting.cheung@cuhk.edu.hk 

研究负责人电子邮件:

Study leader's E-mail:

yinting.cheung@cuhk.edu.hk 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

https://www2.ccrb.cuhk.edu.hk/registry/public/613 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

https://www2.ccrb.cuhk.edu.hk/registry/public/613 

申请注册联系人通讯地址:

Rm 801, 8/F., Lo Kwee-Seong Integrated Biomedical Sciences Building, Area 39, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong SAR, China 

研究负责人通讯地址:

Rm 801, 8/F., Lo Kwee-Seong Integrated Biomedical Sciences Building, Area 39, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong SAR, China 

Applicant address:

Rm 801, 8/F., Lo Kwee-Seong Integrated Biomedical Sciences Building, Area 39, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong SAR, China 

Study leader's address:

Rm 801, 8/F., Lo Kwee-Seong Integrated Biomedical Sciences Building, Area 39, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong SAR, China 

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 

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:

2018.338 

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:

2018-09-10 

伦理委员会联系人:

 

Contact Name of the ethic 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:

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:

The Chinese University of Hong Kong 

Primary sponsor's address:

The Chinese University of Hong Kong 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中國

省(直辖市):

香港特別行政區

市(区县):

Country:

China

Province:

Hong Kong SAR

City:

单位(医院):

食物及衞生局

具体地址:

香港添馬添美道2號政府總部東翼18樓

Institution
hospital:

Food and Health Bureau

Address:

18/F, East Wing, Central Government Offices, 2 Tim Mei Avenue, Tamar, Hong Kong

经费或物资来源:

Health and Medical Research Fund (HMRF) Research Fellowship 

Source(s) of funding:

Health and Medical Research Fund (HMRF) Research Fellowship 

研究疾病:

兒童癌症 

Target disease:

Childhood cancer 

研究疾病代码:

 

Target disease code:

 

研究类型:

卫生服务研究 

Study type:

Health services reaserch 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

為香港兒童癌症康復者提供風險護理教育和相關知識 

Objectives of Study:

Risk-based Care and Education for Survivors of Childhood Cancer in Hong Kong 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

1. Diagnosed with cancer before the age of 18 years; 2. At early phase of cancer survivorship, defined as 2 to 10 years post-therapy; 3. Previously treated at a local medical institution in Hong Kong; 4. Able to understand Cantonese and read Chinese; 5. Currently residing in Hong Kong; *Patients under 18 years of age must be accompanied by a parent/guardian who (a) understands Cantonese and reads Chinese, and currently residing with and actively providing care for the patient. 

Inclusion criteria

1. Diagnosed with cancer before the age of 18 years; 2. At early phase of cancer survivorship, defined as 2 to 10 years post-therapy; 3. Previously treated at a local medical institution in Hong Kong; 4. Able to understand Cantonese and read Chinese; 5. Currently residing in Hong Kong; *Patients under 18 years of age must be accompanied by a parent/guardian who (a) understands Cantonese and reads Chinese, and currently residing with and actively providing care for the patient. 

排除标准:

Cognitively incapable of providing informed consent 

Exclusion criteria:

Cognitively incapable of providing informed consent 

研究实施时间:

Study execute time:

FromTo  

干预措施:

Interventions:

组别:

Case series

样本量:

250

Group:

Case series

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

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 SAR 

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:

Health literacy and awareness of health risk

指标类型:

主要指标 

Outcome:

Health literacy and awareness of health risk

Type:

Primary indicator 

测量时间点:

测量方法:

Structured questionniares

Measure time point of outcome:

Measure method:

Structured questionniares

指标中文名:

Health behaviours and psychological distress

指标类型:

次要指标 

Outcome:

Health behaviours and psychological distress

Type:

Secondary indicator 

测量时间点:

测量方法:

measurement used Structured questionniares

Measure time point of outcome:

Measure method:

measurement used Structured questionniares

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 years
最大 Max age 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):

N/A

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

N/A

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Real time access

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

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2018-10-19
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