癌症患者养育忧虑现状及影响因素研究

注册号:

Registration number:

ChiCTR2500110897 

最近更新日期:

Date of Last Refreshed on:

2025-10-22 14:32:43 

注册时间:

Date of Registration:

2025-10-22 00:00:00 

注册号状态:

补注册

Registration Status:

Retrospective registration

注册题目:

癌症患者养育忧虑现状及影响因素研究

Public title:

Research on the current situation and influencing factors of cancer patients' parenting worries

注册题目简写:

English Acronym:

研究课题的正式科学名称:

癌症患者养育忧虑现状及影响因素研究

Scientific title:

Research on the current situation and influencing factors of cancer patients' parenting worries

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:

张富丽 

研究负责人:

张富丽 

Applicant:

Fuli Zhang 

Study leader:

Fuli Zhang 

申请注册联系人电话:

Applicant telephone:

+86 178 7609 3390

研究负责人电话:

Study leader's
telephone:

+86 178 7609 3390

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:

flzhang1@163.com

研究负责人电子邮件:

Study leader's E-mail:

flzhang1@163.com

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:

中国广东省广州市海珠区盈丰路33号

研究负责人通讯地址:

中国广东省广州市海珠区盈丰路33号

Applicant address:

No. 33, Yingfeng Road, Haizhu District, Guangzhou City, Guangdong Province, China

Study leader's address:

No. 33, Yingfeng Road, Haizhu District, Guangzhou City, Guangdong Province, 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:

中山大学孙逸仙纪念医院

Applicant's institution:

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

研究负责人所在单位:

中山大学孙逸仙纪念医院

Affiliation of the Leader:

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

SYSKY-2025-164-01

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:

中山大学孙逸仙纪念医院医学伦理委员会

Name of the ethic committee:

Medical Ethics Committee of Sun Yat-sen Memorial Hospital, Sun Yat-sen University

伦理委员会批准日期:

Date of approved by ethic committee:

2025-03-21 00:00:00

伦理委员会联系人:

区柳珊、彭珊小

Contact Name of the ethic committee:

Liushan Ou, Shanxiao Peng

伦理委员会联系地址:

广州市越秀区长堤大马路171-181号一方长堤7楼715

Contact Address of the ethic committee:

715, 7th Floor, Long Causeway, No. 171-181, Long Beach Road, Yuexiu District, Guangzhou

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 20 8133 2587

伦理委员会联系人邮箱:

Contact email of the ethic committee:

sysyxllwyh@163.com

研究实施负责(组长)单位:

中山大学孙逸仙纪念医院

Primary sponsor:

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

研究实施负责(组长)单位地址:

中国广东省广州市海珠区盈丰路33号

Primary sponsor's address:

No. 33, Yingfeng Road, Haizhu District, Guangzhou City, Guangdong Province, China

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

广东

市(区县):

广州

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

中山大学孙逸仙纪念医院

具体地址:

中国广东省广州市海珠区盈丰路33号

Institution
hospital:

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Address:

No. 33, Yingfeng Road, Haizhu District, Guangzhou City, Guangdong Province, China

经费或物资来源:

研究者

Source(s) of funding:

Investigator-Sponsored

研究疾病:

癌症  

Target disease:

Cancer

研究疾病代码:

Target disease code:

研究类型:

观察性研究

Study type:

Observational study

研究所处阶段:

其它 

Study phase:

N/A

研究设计:

横断面 

Study design:

Cross-sectional 

研究目的:

(1)应用中文版养育忧虑问卷对癌症患者的养育忧虑程度进行现况调查并分析其影响因素。 (2)运用中文版养育忧虑问卷可以对国内癌症患者的养育忧虑水平及程度进行评估,可以了解其影响因素,理清与其他变量的关系,有助于临床医务人员快速识别养育忧虑高危人群,为开展癌症患者养育忧虑的相关干预研究提供策略与依据。最终可以促进家庭全员身心健康、改善患者的生存现状。  

Objectives of Study:

(1) The Chinese version of the parenting anxiety questionnaire was used to investigate the current situation of parenting anxiety of cancer patients and analyze its influencing factors. (2) The Chinese version of the parenting anxiety questionnaire can be used to evaluate the level and degree of parenting anxiety of cancer patients in China, understand its influencing factors, clarify the relationship with other variables, help clinical medical staff quickly identify high-risk groups of parenting anxiety, and provide strategies and basis for carrying out related intervention research on parenting anxiety of cancer patients. In the end, it can promote the physical and mental health of all members of the family and improve the living conditions of patients.

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

排除标准:

(1)神志不清者、既往有精神疾病者; (2)患有其他严重疾病者。

Exclusion criteria:

(1) Those who are delirious or have mental illness in the past; (2) Those who have other serious diseases.

研究实施时间:

Study execute time:

From 2025-03-21 00:00:00 To 2025-10-31 00:00:00  

征募观察对象时间:

Recruiting time:

From 2025-03-21 00:00:00 To 2025-10-31 00:00:00

干预措施:

Interventions:

组别:

观察组

样本量:

200

Group:

Trial group

Sample size:

干预措施:

干预措施代码:

Intervention:

NA

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国

省(直辖市):

广东 

市(区县):

广州 

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

中山大学孙逸仙纪念医院 

单位级别:

三甲 

Institution
hospital:

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

养育忧虑得分

指标类型:

主要指标

Outcome:

Parenting Concerns Questionnaire Core

Type:

Primary indicator

测量时间点:

治疗当天

测量方法:

养育忧虑问卷

Measure time point of outcome:

On the day of treatment

Measure method:

Parenting Concerns Questionnaire

指标中文名:

家庭关怀度

指标类型:

次要指标

Outcome:

Family APGAR Index

Type:

Secondary indicator

测量时间点:

治疗当天

测量方法:

家庭关怀度指数问卷

Measure time point of outcome:

On the day of treatment

Measure method:

Family APGAR Index Questionnaire

指标中文名:

信息需求度

指标类型:

次要指标

Outcome:

Information demand

Type:

Secondary indicator

测量时间点:

治疗当天

测量方法:

信息需求度问卷

Measure time point of outcome:

On the day of treatment

Measure method:

Information Demand Questionnaire

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

none

Tissue:

none

人体标本去向

其它  

说明

Fate of sample:

0thers  

Note:

none

征募研究对象情况:

Recruiting status:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 0 years
最大 Max age 70 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):

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

none

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

是Yes

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):

五年内,http://www.medresman.org.cn/login.aspx

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

within five years, it will be published in the form of academic papers

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:

/

数据与安全监察委员会:

Data and Safety Monitoring Committee:

无/No

注册人:

Name of Registration:

 2025-10-22 14:32:26