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Standard nursing program for patients with breast cancer
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注册号:

Registration number:

ChiCTR-IOR-16008253 

最近更新日期:

Date of Last Refreshed on:

2016-08-05 

注册时间:

Date of Registration:

2016-04-09 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

乳腺癌患者标准化护理方案 

Public title:

Standard nursing program for patients with breast cancer 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

多模式标准化护理方案对女性乳腺癌患者健康相关生活质量干预效果的单盲整群随机对照试验研究 

Scientific title:

Effectiveness of a multimodal standard nursing program on health-related quality of life in female patients with breast cancer: a single-blind cluster 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:

周凯娜 

研究负责人:

周凯娜 

Applicant:

Zhou Kaina 

Study leader:

Zhou Kaina 

申请注册联系人电话:

Applicant telephone:

+86 15829362648 

研究负责人电话:

Study leader's telephone:

+86 15829362648 

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:

zhoukaina@mail.xjtu.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

zhoukaina@mail.xjtu.edu.cn 

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:

陕西西安雁塔西路76号 

研究负责人通讯地址:

陕西西安雁塔西路76号 

Applicant address:

76 West Yanta Road, Xi'an, Shaanxi, China  

Study leader's address:

76 West Yanta Road, Xi'an, Shaanxi, China  

申请注册联系人邮政编码:

Applicant postcode:

710061 

研究负责人邮政编码:

Study leader's postcode:

710061 

申请人所在单位:

西安交通大学医学部 

Applicant's institution:

Xi'an Jiaotong University Health Science Center 

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:

2015-170 

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:

西安交通大学医学部生物医学伦理委员会 

Name of the ethic committee:

Biomedical Ethics Committee of Xi’an Jiaotong University Health Science Center 

伦理委员会批准日期:

Date of approved by ethic committee:

2015-03-04 

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:

西安交通大学医学部 

Primary sponsor:

Xi'an Jiaotong University Health Science Center 

研究实施负责(组长)单位地址:

陕西西安雁塔西路76号,710061 

Primary sponsor's address:

76 West Yanta Road, Xi'an, Shaanxi, 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):

陕西

市(区县):

西安

Country:

China

Province:

Shaanxi

City:

Xi'an

单位(医院):

西安交通大学医学部

具体地址:

陕西西安雁塔西路76号,710061

Institution
hospital:

Xi'an Jiaotong University Health Science Center

Address:

76 West Yanta Road, Xi'an, Shaanxi, China

经费或物资来源:

国家自然科学基金 

Source(s) of funding:

National Natural Science Foundation of China 

研究疾病:

乳腺癌 

Target disease:

breast 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 

研究目的:

探讨多模式标准化护理方案对女性乳腺癌患者健康相关生活质量的干预效果,为乳腺癌患者综合健康管理和干预提供科学依据。 

Objectives of Study:

The objective of the trial is to explore the effectiveness of a multimodal standard nursing program on health-related quality of life in female patients with breast cancer. Findings of the trial will provide evidence for comprehensive health management and intervention in breast cancer patient populations. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

纳入标准为新诊断乳腺癌患者,女性,年龄>=18岁,拟行根治术和其他辅助治疗(如化疗、放疗、内分泌疗法),并提供书面知情同意书。 

Inclusion criteria

Newly diagnosed with breast cancer, female, aged 18 years and older, preparing to receive radical mastectomy and other auxiliary treatments (e.g., chemotherapy, radiotherapy, endocrine therapy), and providing written informed consent. 

排除标准:

排除患有认知障碍、精神障碍、其他恶性肿瘤、活动性感染或其他严重潜在感染的患者。 

Exclusion criteria:

Patients with cognitive disorders, psychiatric disorders, other malignant tumors, active infection, or other severe potential infection will be excluded.  

研究实施时间:

Study execute time:

From2016-01-01To 2018-12-31 

征募观察对象时间:

Recruiting time:

From2016-07-01To 2017-12-31 

干预措施:

Interventions:

组别:

干预组

样本量:

180

Group:

intervention arm

Sample size:

干预措施:

多模式标准化护理方案+常规护理

干预措施代码:

Intervention:

multimodal standard nursing program + routine nursing care

Intervention code:

组别:

对照组

样本量:

180

Group:

control arm

Sample size:

干预措施:

常规护理

干预措施代码:

Intervention:

routine nursing care

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

测量指标:

Outcomes:

指标中文名:

健康相关生活质量

指标类型:

主要指标 

Outcome:

health-related quality of life

Type:

Primary indicator 

测量时间点:

12个月

测量方法:

问卷调查

Measure time point of outcome:

at 12 months

Measure method:

questionnaire survey

指标中文名:

健康相关生活质量

指标类型:

次要指标 

Outcome:

health-related quality of life

Type:

Secondary indicator 

测量时间点:

1、3、6个月

测量方法:

问卷调查

Measure time point of outcome:

at 1, 3, and 6 months

Measure method:

questionnaire survey

指标中文名:

疼痛

指标类型:

次要指标 

Outcome:

pain

Type:

Secondary indicator 

测量时间点:

1、3、6、12个月

测量方法:

问卷调查

Measure time point of outcome:

at 1, 3, 6, and 12 months

Measure method:

questionnaire survey

指标中文名:

疲劳

指标类型:

次要指标 

Outcome:

fatigue

Type:

Secondary indicator 

测量时间点:

1、3、6、12个月

测量方法:

问卷调查

Measure time point of outcome:

at 1, 3, 6, and 12 months

Measure method:

questionnaire survey

指标中文名:

睡眠

指标类型:

次要指标 

Outcome:

sleep

Type:

Secondary indicator 

测量时间点:

1、3、6、12个月

测量方法:

问卷调查

Measure time point of outcome:

at 1, 3, 6, and 12 months

Measure method:

questionnaire survey

指标中文名:

乳腺癌相关淋巴水肿

指标类型:

次要指标 

Outcome:

breast cancer-related lymphedema

Type:

Secondary indicator 

测量时间点:

1、3、6、12个月

测量方法:

问卷调查

Measure time point of outcome:

at 1, 3, 6, and 12 months

Measure method:

questionnaire survey

指标中文名:

患肢功能

指标类型:

次要指标 

Outcome:

upper limb function

Type:

Secondary indicator 

测量时间点:

1、3、6、12个月

测量方法:

问卷调查

Measure time point of outcome:

at 1, 3, 6, and 12 months

Measure method:

questionnaire survey

采集人体标本:

Collecting sample(s)
from participants:

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 years
最大 Max age 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):

在西安市24所三级医院中,随机抽取12所医院并按计算机产生的随机数字表分配到干预组和对照组(每组6所医院,每所医院30例患者)。该过程将由本课题组的一名组员独立实施。

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

A total of 12 tertiary hospitals will be randomly selected from the 24 tertiary hospitals in Xi’an district and allocated to the intervention and control arms (6 hospitals in each arm, 30 patients in each hospital). This will be carried out independently by a member of the research team.

盲法:

12所医院所有纳入的女性乳腺癌患者,参与干预的临床工作人员以及经过培训的资料收集人员对分组信息不知情。对照组患者在试验期间对多模式标准化护理方案信息不知情。

Blinding:

All recruited female patients with breast cancer, participating clinical staff, and trained data collectors of the 12 hospitals will be blinded to the allocation information. Patients in the control arm will not be offered any information on the multimodal standard nursing program during the study period in case of bias.

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

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):

本研究数据将通过ResMan (www.medresman.org) 公共临床试验管理平台进行共享。

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

Data of this trial will be shared through ResMan (www.medresman.org) public clinical trial management platform.

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:

所有资料采用纸质问卷收集,每一位纳入的患者具有唯一的ID号码。资料由课题组专人负责保管,每日核查。采用Epidata3.1软件建立数据库;数据由专人双录入,不同之处由第三位数据管理员核实。电子数据库建立完成后,所有资料均做加密,由数据管理员采用密码控制对数据库的访问并做每日备份。

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

All quantitative data will be collected using paper questionnaires with unique ID numbers for each recruited patient. Data will be stored at the research team office at the end of each day. Daily checking of data will be carried out by the research coordinator, with queries identified and resolved promptly. A database will be built using Epidata3.1; double entry and checking will be performed by an assigned data entry team. Discrepancies will be resolved by a third data manager. Once in an electronic file, all data will be password protected, with data managers controlling access to passwords and ensuring the database is backed up daily.

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:

 2016-04-09
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