Today is 2021-07-30

The effectiveness of training for communication skills in cancer patient
download

注册号:

Registration number:

ChiCTR1900027530 

最近更新日期:

Date of Last Refreshed on:

2020-07-31 

注册时间:

Date of Registration:

1990-01-01 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

肿瘤患者沟通培训的效果评价 

Public title:

The effectiveness of training for communication skills in cancer patient 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

肿瘤患者沟通培训的效果评价 

Scientific title:

The effectiveness of training for communication skills in cancer patient 

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:

杨如美 

研究负责人:

杨如美 

Applicant:

Yang Rumei 

Study leader:

Yang Rumei 

申请注册联系人电话:

Applicant telephone:

+86 18114517518 

研究负责人电话:

Study leader's telephone:

+86 18114517518 

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:

rumeiyang@njmu.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

rumeiyang@njmu.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:

江苏南京市江宁区龙眠大道101号 

研究负责人通讯地址:

江苏南京市江宁区龙眠大道101号 

Applicant address:

101 Longmian Avenue, Jiangning District, Nanjing, Jiangsu, China 

Study leader's address:

101 Longmian Avenue, Jiangning District, Nanjing, Jiangsu, 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:

南京医科大学护理学院 

Applicant's institution:

School of Nursing, Nanjing Medical 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:

ChiECRCT20190255 

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:

中国注册临床试验伦理审查委员会 

Name of the ethic committee:

Chinese Ethics Committee of Registering Clinical Trials 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-12-08 

伦理委员会联系人:

米娜瓦尔 

Contact Name of the ethic committee:

Mina DE 

伦理委员会联系地址:

成都国学巷37号,四川大学华西医院行政楼八角亭2楼2092室 

Contact Address of the ethic committee:

Room 2092, 2 / F, Bajiao Pavilion, Administration Building, West China Hospital, Sichuan University, No. 37 Guoxue Lane, Chengdu 

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:

南京医科大学护理学院 

Primary sponsor:

Nanjing Medical University, School of Nursing 

研究实施负责(组长)单位地址:

江苏南京南京医科大学 

Primary sponsor's address:

101 Longmian Avenue, Jiangning District, Nanjing, Jiangsu, 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):

江苏

市(区县):

Country:

China

Province:

Jiangsu

City:

单位(医院):

南京医科大学护理学院

具体地址:

江苏南京市江宁区龙眠大道101号

Institution
hospital:

Nanjing Medical University, School of Nursing

Address:

101 Longmian Avenue, Jiangning District, Nanjing

经费或物资来源:

NMUR2020006;JX10631803 

Source(s) of funding:

南京医科大学 

研究疾病:

肿瘤 

Target disease:

CANCER 

研究疾病代码:

 

Target disease code:

 

研究类型:

卫生服务研究 

Study type:

Health Services Research 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

本研究的目的旨在改善肿瘤患者沟通效能,促进其与护士、家属对其症状进行沟通,以改善其症状体验、促进共同决策、降低照顾负担。 

Objectives of Study:

The purpose of this study is to improve the communication efficiency of tumor patients, promote their communication with nurses and family members about their symptoms, so as to improve their symptom experience, promote common decision-making and reduce the burden of care. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

年龄大于18岁;预期剩余治疗次数至少1次者;可普通话沟通 

Inclusion criteria

Older than 18 years; Those who have completed the first chemotherapy and expected to have at least one remaining chemotherapy; Use the Anderson symptom assessment scale with at least one symptom score above 3; Pathological diagnosis of tumor; KPS score greater than or equal to 60; Can communicate in mandarin. 

排除标准:

排除有精神认知障碍者及不知晓病情者。 

Exclusion criteria:

Exclusion of mental cognitive impairment and do not know the disease. 

研究实施时间:

Study execute time:

From2019-12-01To 2022-12-01 

征募观察对象时间:

Recruiting time:

From2019-12-02To 2022-12-01 

干预措施:

Interventions:

组别:

干预组

样本量:

100

Group:

intervention group

Sample size:

干预措施:

沟通培训

干预措施代码:

Intervention:

communication training

Intervention code:

组别:

对照组

样本量:

100

Group:

Compared group

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:

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):

南方医科大学附属第三医院 

单位级别:

三甲医院 

Institution
hospital:

The 3rd affiliated hospital of Southern Medical University  

Level of the institution:

Tertiary A Hospital 

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):

珠江医院 

单位级别:

三甲医院 

Institution
hospital:

Zhujiang Hospital  

Level of the institution:

Tertiary A Hospital 

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):

南方医院 

单位级别:

三甲医院 

Institution
hospital:

Nanfang Fospital  

Level of the institution:

Tertiary A Hospital 

国家:

中国 

省(直辖市):

广东 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

南方医科大学附中西医结合医院 

单位级别:

三甲 

Institution
hospital:

Hospital of Integrated Chinese and Western Medicine, Southern Medical University  

Level of the institution:

Tertiary Hospital 

国家:

中国 

省(直辖市):

湖南 

市(区县):

长沙 

Country:

China 

Province:

Hunan 

City:

Changsha 

单位(医院):

湘雅医院 

单位级别:

三甲 

Institution
hospital:

Xiangya Hosipital  

Level of the institution:

Tertiary Hospital 

国家:

中国 

省(直辖市):

湖南 

市(区县):

长沙 

Country:

China 

Province:

Hunan 

City:

Changsha 

单位(医院):

湘雅二医院 

单位级别:

三甲 

Institution
hospital:

The 2nd xiangya Hospital of Central South University  

Level of the institution:

Tertiary Hospital 

国家:

中国 

省(直辖市):

江苏 

市(区县):

苏州 

Country:

China 

Province:

Jiangsu 

City:

Suzhou 

单位(医院):

苏州大学附属第二医院 

单位级别:

三甲 

Institution
hospital:

The Second Affiliated Hospital of Suzhou University  

Level of the institution:

Tertiary 

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):

广州医科大学肿瘤医院 

单位级别:

三甲 

Institution
hospital:

Cancer centre of Guangzhou Medical University  

Level of the institution:

Tertiary 

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):

中山大学附属第六医院 

单位级别:

三甲 

Institution
hospital:

The sixth Affiliated Hospital of Sun Yat-sen University  

Level of the institution:

Tertiary 

国家:

中国 

省(直辖市):

江苏 

市(区县):

南京 

Country:

China 

Province:

Jiangsu 

City:

Nanjing 

单位(医院):

江苏省人民医院 

单位级别:

三甲 

Institution
hospital:

Jiangsu Provincial People's Hospital  

Level of the institution:

Tertiary 

国家:

中国 

省(直辖市):

江苏 

市(区县):

南京 

Country:

China 

Province:

Jiangsu 

City:

 

单位(医院):

南京鼓楼医院 

单位级别:

三甲 

Institution
hospital:

Nanjing Gulou Hospital  

Level of the institution:

Tertiary 

国家:

中国 

省(直辖市):

江苏 

市(区县):

无锡 

Country:

China 

Province:

Jiangsu 

City:

Wuxi 

单位(医院):

无锡人民医院 

单位级别:

三甲 

Institution
hospital:

Wuxi People's Hospital  

Level of the institution:

Tertiary 

国家:

中国 

省(直辖市):

江苏 

市(区县):

常州 

Country:

China 

Province:

Jiangsu 

City:

Changzhou 

单位(医院):

常州第一人民医院 

单位级别:

三甲 

Institution
hospital:

Changzhou First People's Hospital  

Level of the institution:

Tertiary 

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):

广东省第二人民医院 

单位级别:

三甲 

Institution
hospital:

Second People's Hospital of Guangdong Province  

Level of the institution:

Tertiary 

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):

中山大学肿瘤防治中心 

单位级别:

三甲 

Institution
hospital:

Cancer Prevention and Treatment Center, Sun Yat-sen University  

Level of the institution:

Tertiary 

测量指标:

Outcomes:

指标中文名:

患者感知的症状严重程度

指标类型:

主要指标 

Outcome:

symptom severiy

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

患者感知的护患关系

指标类型:

次要指标 

Outcome:

patient-nurse relationship

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

患者感知的参与决策程度

指标类型:

主要指标 

Outcome:

decision involvement

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

患者积极参与度

指标类型:

次要指标 

Outcome:

postive involvement

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

患者沟通效能

指标类型:

主要指标 

Outcome:

communication efficacy

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

患者感知照顾负担

指标类型:

次要指标 

Outcome:

patient perceived care burden

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

患者社会人口学资料

指标类型:

附加指标 

Outcome:

patient demographic information

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

患者疾病相关病历资料

指标类型:

附加指标 

Outcome:

patient disease information based on medical records

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

照顾者社会人口学资料

指标类型:

附加指标 

Outcome:

caregiver's demographic information

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

照顾者沟通效能

指标类型:

主要指标 

Outcome:

caregiver's communication efficacy

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

照顾者照顾负担

指标类型:

次要指标 

Outcome:

care burden

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

照顾者积极体验

指标类型:

次要指标 

Outcome:

care positive experience

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

照顾者感知患者症状严重程度

指标类型:

主要指标 

Outcome:

patient symptom severity peceived by caregiver

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

护士人口学资料

指标类型:

附加指标 

Outcome:

nurse's demograhpic information

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

护士沟通效能

指标类型:

主要指标 

Outcome:

nurse-patient communication efficacy

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

护士感知护患关系

指标类型:

次要指标 

Outcome:

nurse-patient relationship

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

护士感知患者参与决策

指标类型:

次要指标 

Outcome:

patient decision involvement perceived by nurse

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

护士感知的患者症状严重程度

指标类型:

主要指标 

Outcome:

patient symptom severity peceived by nurse

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

症状管理需求

指标类型:

主要指标 

Outcome:

Symptom management needs

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

自我管理

指标类型:

主要指标 

Outcome:

self management

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

照顾质量

指标类型:

主要指标 

Outcome:

care quality

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生命质量

指标类型:

主要指标 

Outcome:

Qualtiy of life

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

患者经历

指标类型:

主要指标 

Outcome:

patient experience

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

照顾者经历

指标类型:

主要指标 

Outcome:

Experience of Caregiver

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

症状管理体验

指标类型:

主要指标 

Outcome:

Experience of symptom management

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

患者、照顾者、护士访谈

指标类型:

附加指标 

Outcome:

interview:experience and perceptions of communication

Type:

Additional indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

患者、照顾者、护士访谈

指标类型:

附加指标 

Outcome:

interview

Type:

Additional indicator 

测量时间点:

测量方法:

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:

none

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 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):

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

N/A

盲法:

随机数字表或随机程序

Blinding:

N/A

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):

http://www.chictr.org.cn/

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

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:

所有问卷收集员均接受统一培训,熟悉数据收集的注意事项及患者信息隐私保护方法,不泄漏患者任何信息。数据由课题组负责人保存,严格遵守与患者的保密协议;数据采用ResMan管理。

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

All questionnaire collectors received unified training to be familiar with matters needing attention in data collection and methods of patient information privacy protection and not to disclose any patient information. The data shall be kept by the head of the research group and the confidentiality agreement with the patient shall be strictly observed. The data was managed by ResMan.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 1990-01-01
return list