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卵巢癌化疗患者主要照顾者体验的质性研究
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注册号:

Registration number:

ChiCTR2000039930 

最近更新日期:

Date of Last Refreshed on:

2020-11-14 

注册时间:

Date of Registration:

2020-11-14 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

卵巢癌化疗患者主要照顾者体验的质性研究 

Public title:

Qualitative Research on Experience of Main Caregivers of Ovarian Cancer Patients during chemotherapy 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

卵巢癌化疗患者主要照顾者体验的质性研究 

Scientific title:

Qualitative Research on Experience of Main Caregivers of Ovarian Cancer Patients during chemotherapy 

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:

于秀丽 

研究负责人:

张琪 

Applicant:

Yu Xiuli 

Study leader:

Zhang Qi 

申请注册联系人电话:

Applicant telephone:

13654362510 

研究负责人电话:

Study leader's telephone:

13936595667 

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:

yuxl20079@163.com 

研究负责人电子邮件:

Study leader's E-mail:

zhangqiphd@gmail.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:

吉林省长春市朝阳区新民大街1号 

研究负责人通讯地址:

广州市中山大学护理学院 

Applicant address:

No. 1, Xinmin Street, Chaoyang District, Changchun City, Jilin Province 

Study leader's address:

School of Nursing, Sun Yat-sen University, Guangzhou 

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:

吉林大学第一医院 

Applicant's institution:

The First Bethune Hospital of Jinlin University 

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:

20K051-001 

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:

吉林大学第一医院伦理委员会 

Name of the ethic committee:

Ethics Committee of the First Bethune Hospital of Jinlin University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-09-24 

伦理委员会联系人:

牛俊奇 

Contact Name of the ethic committee:

Niu Junqi 

伦理委员会联系地址:

吉林省长春市朝阳区新民大街1号 

Contact Address of the ethic committee:

No. 1, Xinmin Street, Chaoyang District, Changchun City, Jilin Province 

伦理委员会联系人电话:

Contact phone of the ethic committee:

0431-88782013 

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:

吉林大学第一医院 

Primary sponsor:

Yu Xiuli, Zhang Qi, 

研究实施负责(组长)单位地址:

吉林省长春市朝阳区新民大街1号 吉大一院3号楼17层妇科 

Primary sponsor's address:

No. 1, Xinmin Street, Chaoyang District, Changchun City, Jilin Province 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

吉林省

市(区县):

长春市

Country:

China

Province:

Jilin Province

City:

Changchun City

单位(医院):

吉林大学第一医院

具体地址:

吉林省长春市朝阳区新民大街1号

Institution
hospital:

The First Bethune Hospital of Jinlin University

Address:

No. 1, Xinmin Street, Chaoyang District, Changchun City, Jilin Province

经费或物资来源:

研究者自发课题 

Source(s) of funding:

Researcher-initiated project 

研究疾病:

卵巢癌 

Target disease:

Ovarian 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:

探索性研究/预试验 

Study phase:

研究目的:

1. 了解卵巢癌化疗患者主要照顾者照顾负担和生存质量现状。 2. 分析影响卵巢癌化疗患者主要照顾者生存质量的因素。 3. 深入探索卵巢癌化疗患者主要照顾者的真实感受。 4. 提出相应的措施和解决方案,降低卵巢癌化疗患者主要照顾者的照顾负担,提高其生存质量,以期为今后多种不同干预模式的发展奠定基础。 

Objectives of Study:

1. Understand the current status of the care burden and quality of life of the main caregivers of patients with ovarian cancer chemotherapy. 2. Analyze the factors affecting the quality of life of the main caregivers of ovarian cancer chemotherapy patients. 3. In-depth exploration of the true feelings of the main caregivers of ovarian cancer chemotherapy patients. 4. Propose corresponding measures and solutions to reduce the burden of care for the main caregivers of ovarian cancer chemotherapy patients and improve their quality of life, in order to lay the foundation for the development of multiple different intervention models in the future. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

横断面 

Study design:

Cross-sectional 

纳入标准:

(1)临床病理检查确诊为卵巢癌术后需要进行化疗的患者主要照顾者; (2)主要照顾者包括配偶、子女、父母等,照顾期间与患者同住; (3)年龄在18周岁以上;70周岁以下,执行大多数照顾患者活动; (4)认知正常,有正常沟通能力,言语表达清楚; (5)患者及家属知情同意,自愿参与,能够合作并签署知情同意书。 

Inclusion criteria

(1) Clinical pathological examination is confirmed as the main caregiver of patients who need chemotherapy after ovarian cancer; (2) The main caregivers include spouses, children, parents, etc., who live with the patient during the care; (3) Aged over 18; under 70 years old, perform most of the patient care activities; (4) Normal cognition, normal communication skills, and clear speech; (5) Patients and their families informed consent, participated voluntarily, and were able to cooperate and sign informed consent. 

排除标准:

(1)领取薪酬的护工; (2)家属无手机或者其他联系工具,无法取得联系者; (3)患者家属存在严重精神或者心理障碍; (4)照顾者本人或患者拒绝照顾者参加本研究。 

Exclusion criteria:

(1) Nursing workers receiving salaries; (2) Family members who do not have mobile phones or other contact tools and cannot get in touch; (3) The patient's family members have severe mental or psychological disorders; (4) The caregiver himself or the patient refused the caregiver to participate in this study. 

研究实施时间:

Study execute time:

From2020-11-02To 2020-12-18 

征募观察对象时间:

Recruiting time:

From2020-11-02To 2020-12-18 

干预措施:

Interventions:

组别:

无分组

样本量:

30

Group:

no group

Sample size:

干预措施:

无干预

干预措施代码:

Intervention:

not have intervention

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

吉林省 

市(区县):

长春市 

Country:

China 

Province:

Jilin Province 

City:

Changchun City 

单位(医院):

吉林大学第一医院 

单位级别:

三级甲等 

Institution
hospital:

The First Bethune Hospital of Jinlin University  

Level of the institution:

Third-class hospital 

测量指标:

Outcomes:

指标中文名:

照顾者的心理、症状感受

指标类型:

主要指标 

Outcome:

The caregiver’s feeling of psychology and symptoms

Type:

Primary indicator 

测量时间点:

卵巢癌患者化疗期间

测量方法:

电话或面对面访谈

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

noting

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

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 18 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):

无分组

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

No group

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):

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

完成后6个月内公开,采用网络平台的方式,名称为《中国临床试验注册中心》平台,网址:http://www.chictr.org.cn

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

完成后6个月内公开,采用网络平台的方式,名称为《中国临床试验注册中心》平台,网址:http://www.chictr.org.cn

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:

研究将由主要研究员以面对面或者电话访谈的形式进行。每个访谈持续大约30–60分钟,平均约45分钟。在访谈之前,患者主要照顾者的基本资料将被收集,例如:年龄,性别,婚姻状况,照顾时长等。 为了保证访谈的自由,访谈提纲将采用半结构式,鼓励患者照顾者自由表达内心真实体验。访谈将会被录音,用作后续分析,所有资料仅供科研用途,将编号保存。 回收的问卷统一编号,应用数据管理软件Epidata建立数据库,基线调查采用双录入核查和一致性核查。

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

The research will be conducted by the main researcher in the form of face-to-face or telephone interviews. Each interview lasts approximately 30-60 minutes, with an average of approximately 45 minutes. Before the interview, basic data of the patient's main caregiver will be collected, such as age, gender, marital status, length of care, etc. In order to ensure the freedom of the interview, the interview outline will adopt a semi-structured format to encourage patient caregivers to express their true inner experience freely. The interview will be recorded for subsequent analysis. All information is for scientific research purposes only and the serial number will be kept. The recovered questionnaires are numbered uniformly, and the data management software Epidata is used to establish a database. The baseline survey adopts double entry verification and consistency verification.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-11-14
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