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Effectiveness of a Modified Dignity Therapy Program on dignity, depression and spiritual well-being among cancer patients undergoing chemotherapy: A randomized controlled trial
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注册号:

Registration number:

ChiCTR1900020806 

最近更新日期:

Date of Last Refreshed on:

2019-01-20 

注册时间:

Date of Registration:

2019-01-20 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

Effectiveness of a Modified Dignity Therapy Program on dignity, depression and spiritual well-being among cancer patients undergoing chemotherapy: A randomized controlled trial 

Public title:

Effectiveness of a Modified Dignity Therapy Program on dignity, depression and spiritual well-being among cancer patients undergoing chemotherapy: A randomized controlled trial 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

Effectiveness of a Modified Dignity Therapy Program on dignity, depression and spiritual well-being among cancer patients undergoing chemotherapy: A randomized controlled trial 

Scientific title:

Effectiveness of a Modified Dignity Therapy Program on dignity, depression and spiritual well-being among cancer patients undergoing chemotherapy: A 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:

Xiao Jinnan 

研究负责人:

Xiao Jinnan 

Applicant:

Xiao Jinnan 

Study leader:

Xiao Jinnan 

申请注册联系人电话:

Applicant telephone:

+86 13278851623 

研究负责人电话:

Study leader's telephone:

+86 13278851623 

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:

Eleven@link.cuhk.edu.hk 

研究负责人电子邮件:

Study leader's E-mail:

Eleven@link.cuhk.edu.hk 

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:

中國香港特別行政區新界沙田香港中文大學利黃瑤璧樓601 

研究负责人通讯地址:

中國香港特別行政區新界沙田香港中文大學利黃瑤璧樓601 

Applicant address:

601 Esther Lee Building, The Chinese University of Hong Kong Shatin, N.T., Hong Kong 

Study leader's address:

601 Esther Lee Building, The Chinese University of Hong Kong Shatin, N.T., Hong Kong 

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:

香港中文大學 

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:

2018.400 

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:

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee 

Name of the ethic committee:

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-10-24 

伦理委员会联系人:

Envy Lee 

Contact Name of the ethic committee:

Envy Lee 

伦理委员会联系地址:

中國香港特別行政區新界沙田威爾斯親王醫院呂志和臨床科學大樓8/F 

Contact Address of the ethic committee:

8/F, Lui Cho Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, HK 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+852 35053935 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

crec@cuhk.edu.hk 

研究实施负责(组长)单位:

香港中文大學 

Primary sponsor:

The Chinese University of Hong Kong 

研究实施负责(组长)单位地址:

中國香港特別行政區新界沙田香港中文大學利黃瑤璧樓601 

Primary sponsor's address:

601 Esther Lee Building, The Chinese University of Hong Kong, Shatin, N.T., 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 Special Administrative Region

City:

Hong Kong

单位(医院):

香港中文大學

具体地址:

新界沙田香港中文大學利黃瑤璧樓601

Institution
hospital:

The Chinese University of Hong Kong

Address:

601 Esther Lee Building, The Chinese University of Hong Kong

国家:

中国

省(直辖市):

湖南

市(区县):

长沙

Country:

China

Province:

Hu'nan

City:

Changsha

单位(医院):

湖南肿瘤医院

具体地址:

长沙岳麓区咸嘉湖路582号

Institution
hospital:

Hu’nan Cancer Hospital

Address:

582 Xianjiahu Road, Yuelu District, Changsha, China

经费或物资来源:

No 

Source(s) of funding:

No funding 

研究疾病:

肿瘤 

Target disease:

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:

This is a randomized controlled trial (RCT) to evaluate the effects of a Modified Dignity Therapy Program (MDTP) on dignity, depression and spiritual well-being among cancer patients undergoing chemotherapy, as well as to investigate patients satisfaction, perceived benefits and feedback about MDTP. Our hypotheses are that MDTP significantly improve dignity, spiritual well-being and decrease depression among cancer patients undergoing chemotherapy compared with a placebo control group. 

Objectives of Study:

This is a randomized controlled trial (RCT) to evaluate the effects of a Modified Dignity Therapy Program (MDTP) on dignity, depression and spiritual well-being among cancer patients undergoing chemotherapy, as well as to investigate patients satisfaction, perceived benefits and feedback about MDTP. Our hypotheses are that MDTP significantly improve dignity, spiritual well-being and decrease depression among cancer patients undergoing chemotherapy compared with a placebo control group. 

药物成份或治疗方案详述:

Patients and family member will be interviewed together, in which way promotes both patients and family member to supplement the reminiscence, as well as promote their communication. The interview will be audio-recorded, quickly verbatim, then shaped into a life memoir document using a formatted editing process. Both patient and family members will be invited to read and share the life memoir. They will be encouraged to express their feelings and thoughts to each other after reading the documents. 

Description for medicine or protocol of treatment in detail:

Patients and family member will be interviewed together, in which way promotes both patients and family member to supplement the reminiscence, as well as promote their communication. The interview will be audio-recorded, quickly verbatim, then shaped into a life memoir document using a formatted editing process. Both patient and family members will be invited to read and share the life memoir. They will be encouraged to express their feelings and thoughts to each other after reading the documents. 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1. be diagnosed with lung cancer and are undergoing chemotherapy currently; 2. be aware of his/her diagnosis of cancer; 3. aged older than 18 years and able to read and communicate in Chinese (Mandarin); 4. can identify one family member who is considered as the significant caregiver to receive the intervention together. 

Inclusion criteria

1. be diagnosed with lung cancer and are undergoing chemotherapy currently; 2. be aware of his/her diagnosis of cancer; 3. aged older than 18 years and able to read and communicate in Chinese (Mandarin); 4. can identify one family member who is considered as the significant caregiver to receive the intervention together. 

排除标准:

1. currently participating in other psychosocial intervention studies; 2. patients and family caregivers who are deemed too ill to participate in the research as determined by the physician. 

Exclusion criteria:

1. currently participating in other psychosocial intervention studies; 2. patients and family caregivers who are deemed too ill to participate in the research as determined by the physician. 

研究实施时间:

Study execute time:

From2019-03-04To 2019-09-01 

征募观察对象时间:

Recruiting time:

From2019-03-04To 2019-05-13 

干预措施:

Interventions:

组别:

Intervention group

样本量:

60

Group:

Intervention group

Sample size:

干预措施:

interview patients about their significant memories, then a life memoir generated based on their reminiscence. the life memoir will be returned to the patient

干预措施代码:

Intervention:

interview patients about their significant memories, then a life memoir generated based on their reminiscence. the life memoir will be returned to the patient

Intervention code:

组别:

control group

样本量:

60

Group:

control group

Sample size:

干预措施:

health education

干预措施代码:

Intervention:

health education

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

湖南 

市(区县):

 

Country:

China 

Province:

Hu'nan 

City:

Changsha 

单位(医院):

湖南省肿瘤医院 

单位级别:

三甲医院 

Institution
hospital:

Hu'nan Cancer Hospital  

Level of the institution:

Tertiary A Hospitals 

测量指标:

Outcomes:

指标中文名:

dignity

指标类型:

主要指标 

Outcome:

dignity

Type:

Primary indicator 

测量时间点:

baseline, one week, four weeks

测量方法:

questionnaire

Measure time point of outcome:

baseline, one week, four weeks

Measure method:

questionnaire

指标中文名:

depression

指标类型:

次要指标 

Outcome:

depression

Type:

Secondary indicator 

测量时间点:

baseline, one week, four weeks

测量方法:

questionnaire

Measure time point of outcome:

baseline, one week, four weeks

Measure method:

questionnaire

指标中文名:

spiritual well-being

指标类型:

次要指标 

Outcome:

spiritual well-being

Type:

Secondary indicator 

测量时间点:

baseline, one week, four weeks

测量方法:

questionnaire

Measure time point of outcome:

baseline, one week, four weeks

Measure method:

questionnaire

指标中文名:

satisfaction with life

指标类型:

次要指标 

Outcome:

satisfaction with life

Type:

Secondary indicator 

测量时间点:

baseline, one week, four weeks

测量方法:

questionnaire

Measure time point of outcome:

baseline, one week, four weeks

Measure method:

questionnaire

指标中文名:

satisfaction with the program

指标类型:

次要指标 

Outcome:

satisfaction with the program

Type:

Secondary indicator 

测量时间点:

baseline, one week

测量方法:

questionnaire

Measure time point of outcome:

baseline, one week

Measure method:

questionnaire

指标中文名:

qualitative data

指标类型:

次要指标 

Outcome:

qualitative data

Type:

Secondary indicator 

测量时间点:

one week

测量方法:

qualitative interview

Measure time point of outcome:

one week

Measure method:

qualitative interview

指标中文名:

closeness

指标类型:

次要指标 

Outcome:

closeness

Type:

Secondary indicator 

测量时间点:

baseline

测量方法:

questionnaire

Measure time point of outcome:

baseline

Measure method:

questionnaire

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

No

组织:

Sample Name:

no sample

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 99 years

性别:

男性

Gender:

Male

随机方法(请说明由何人用什么方法产生随机序列):

Randomization will be conducted by using computer generated random numbers after collecting baseline measures. Treatment allocation will be performed by a sequence of block randomized number which would be put into opaque envelopes. Random block size among four or six instead of a fixed block size

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

Randomization will be conducted by using computer generated random numbers after collecting baseline measures. Treatment allocation will be performed by a sequence of block randomized number which would be put into opaque envelopes. Random block size among four or six instead of a fixed block size

盲法:

All participants, outcome assessors and medical staffs will be unaware of the allocation condition.

Blinding:

All participants, outcome assessors and medical staffs will be unaware of the allocation condition.

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:

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):

publication

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

publication

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:

All research-related documents and data will be carefully kept and locked in a secured cabinet and password protected computer, and only accessed by the PI. All documents would be completely destroyed five years after completion of the research project.

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

All research-related documents and data will be carefully kept and locked in a secured cabinet and password protected computer, and only accessed by the PI. All documents would be completely destroyed five years after completion of the research project.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-01-20
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