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Motivational interviewing intervention to enhance self-learning and practicing of Tai Chi in patients with advanced lung cancer: A feasibility randomized controlled trial
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注册号：

Registration number：

 ChiCTR2500105487 

最近更新日期：

Date of Last Refreshed on：

 2025-07-04 09:17:11 

注册时间：

Date of Registration：

 2025-07-04 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

Motivational interviewing intervention to enhance self-learning and practicing of Tai Chi in patients with advanced lung cancer: A feasibility randomized controlled trial

Public title：

Motivational interviewing intervention to enhance self-learning and practicing of Tai Chi in patients with advanced lung cancer: A feasibility randomized controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Motivational interviewing intervention to enhance self-learning and practicing of Tai Chi in patients with advanced lung cancer: A feasibility randomized controlled trial

Scientific title：

Motivational interviewing intervention to enhance self-learning and practicing of Tai Chi in patients with advanced lung cancer: A feasibility 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：

Lam Tsz Fung 

研究负责人：

Takemura Naomi 

Applicant：

Lam Tsz Fung 

Study leader：

Takemura Naomi 

申请注册联系人电话：

Applicant telephone：

 +852 3910 2732

研究负责人电话：

Study leader's
telephone：

+852 2766 4534

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：

 alexltf@hku.hk

研究负责人电子邮件：

Study leader's E-mail：

 naomi.takemura@polyu.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：

School of Nursing The University of Hong Kong 5/F, Academic Building 3 Sassoon Road, Pokfulam, Hong Kong

研究负责人通讯地址：

GH526, School of Nursing The Hong Kong Polytechnic University Hung Hom, Kowloon, HKSAR

Applicant address：

School of Nursing The University of Hong Kong 5/F, Academic Building 3 Sassoon Road, Pokfulam, Hong Kong

Study leader's address：

GH526, School of Nursing The Hong Kong Polytechnic University Hung Hom, Kowloon, HKSAR

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：

The University of Hong Kong

Applicant's institution：

The University of Hong Kong

研究负责人所在单位：

The Hong Kong Polytechnic University/The University of Hong Kong

Affiliation of the Leader：

The Hong Kong Polytechnic University/The 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：

 UW 23-572

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：

Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster (HKU/HA HKW IRB)

Name of the ethic committee：

Institutional Review Board of the University of Hong Kong/Hospital Authority Hong Kong West Cluster (HKU/HA HKW IRB)

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-12-05 00:00:00

伦理委员会联系人：

Mr. Chris Yip

Contact Name of the ethic committee：

Mr. Chris Yip

伦理委员会联系地址：

Room 901, 9/F, Administration Block, Queen Mary Hospital, 102 Pokfulam Road, Hong Kong, China

Contact Address of the ethic committee：

Room 901, 9/F, Administration Block, Queen Mary Hospital, 102 Pokfulam Road, Hong Kong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 2255 3923

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：

The University of Hong Kong

Primary sponsor：

The University of Hong Kong

研究实施负责（组长）单位地址：

Nursing School, 5th Floor, Teaching Building, Li Ka Shing Faculty of Medicine, The University of Hong Kong, No. 3 Sassoon Road, Pokfulam, Hung Hom, Kowloon, Hong Kong Special Administrative Region

Primary sponsor's address：

Nursing School, 5th Floor, Teaching Building, Li Ka Shing Faculty of Medicine, The University of Hong Kong, No. 3 Sassoon Road, Pokfulam, Hung Hom, Kowloon, Hong Kong Special Administrative Region

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

China

省(直辖市)：

Hong Kong Special Administrative Region

市(区县)：

Country：

China

Province：

Hong Kong Special Administrative Region

City：

单位(医院)：

The Hong Kong Polytechnic University

具体地址：

GH506, School of Nursing The Hong Kong Polytechnic University Hung Hom, Kowloon, HKSAR

Institution
hospital：

The Hong Kong Polytechnic University

Address：

GH506, School of Nursing The Hong Kong Polytechnic University Hung Hom, Kowloon, HKSAR

经费或物资来源：

Health and Medical Research Fund

Source(s) of funding：

Health and Medical Research Fund

研究疾病：

Advanced Lung Cancer  

Target disease：

Advanced Lung 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

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

To examine the feasibility and the potential effectiveness of MI interventions to enhance self-learning and practicing of Tai Chi among patients with advanced lung cancer at 3-month and 6-month follow-ups compared with the control group.  

Objectives of Study：

To examine the feasibility and the potential effectiveness of MI interventions to enhance self-learning and practicing of Tai Chi among patients with advanced lung cancer at 3-month and 6-month follow-ups compared with the control group.

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. Suffering from a condition that hinders exercise performance (e.g., active neurological disorder, recent heart attack, or chronic obstructive pulmonary disease); 2. Engaging in regular exercise, defined as at least 150 minutes of moderate-intensity exercise per week; 3. Scored 7 or higher on the contemplation ladder (preparation, action or maintenance stage).

Exclusion criteria：

1. Suffering from a condition that hinders exercise performance (e.g., active neurological disorder, recent heart attack, or chronic obstructive pulmonary disease); 2. Engaging in regular exercise, defined as at least 150 minutes of moderate-intensity exercise per week; 3. Scored 7 or higher on the contemplation ladder (preparation, action or maintenance stage).

研究实施时间：

Study execute time：

从 From 2024-12-30 00:00:00至 To 2026-01-15 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-12-30 00:00:00 至 To 2025-07-15 00:00:00

干预措施：

Interventions：

组别：

Intervention group

样本量：

 28

Group：

Intervention group

Sample size：

干预措施：

Face-to-face individualized MI sessions Online videos of Tai Chi

干预措施代码：

Intervention：

Face-to-face individualized MI sessions Online videos of Tai Chi

Intervention code：

组别：

Control group

样本量：

 28

Group：

Control group

Sample size：

干预措施：

Online videos of Tai Chi

干预措施代码：

Intervention：

Online videos of Tai Chi

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong Special Administrative Region 

市(区县)：

  

Country：

China

Province：

Hong Kong Special Administrative Region

City：

单位(医院)：

 The Hong Kong Polytechnic University 

单位级别：

 University 

Institution
hospital：

The Hong Kong Polytechnic University

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

Adherence to home practise

指标类型：

主要指标

Outcome：

Adherence to home practise

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Feasibility of recruitment

指标类型：

次要指标

Outcome：

Feasibility of recruitment

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Programme acceptability

指标类型：

次要指标

Outcome：

Programme acceptability

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Credibility and expectancy

指标类型：

次要指标

Outcome：

Credibility and expectancy

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Interventionist adherence to MI manual

指标类型：

次要指标

Outcome：

Interventionist adherence to MI manual

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Programme satisfaction

指标类型：

次要指标

Outcome：

Programme satisfaction

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Programme safety

指标类型：

次要指标

Outcome：

Programme safety

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Physical activity

指标类型：

次要指标

Outcome：

Physical activity

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Motivation

指标类型：

次要指标

Outcome：

Motivation

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Tai Chi exercise self efficacy

指标类型：

次要指标

Outcome：

Tai Chi exercise self efficacy

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Self-perceived health status

指标类型：

次要指标

Outcome：

Self-perceived health status

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Exercise adherence

指标类型：

次要指标

Outcome：

Exercise adherence

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Physical function

指标类型：

次要指标

Outcome：

Physical function

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Baseline characteristics

指标类型：

次要指标

Outcome：

Baseline characteristics

Type：

Secondary 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：

N/A

组织：

Sample Name：

N/A

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

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 岁 years
最大 Max age 岁 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）：

An independent statistician will generate the randomization list using computer and keep a secure copy of the randomization code assignments.

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

An independent statistician will generate the randomization list using computer and keep a secure copy of the randomization code assignments.

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：

The RAs responsible for assessing the outcome measures and entering the data will be blinded as to group allocation.

Blinding：

The RAs responsible for assessing the outcome measures and entering the data will be blinded as to group allocation.

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）：

The data will be available upon request after the study period.

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

The data will be available upon request after the study period.

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：

The study leader will be responsible for using a data management plan (DMP) to describe the use of data, and depositing a dataset in the University of Hong Kong Polytechnic University Scholars Hub.

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

The study leader will be responsible for using a data management plan (DMP) to describe the use of data, and depositing a dataset in the University of Hong Kong Polytechnic University Scholars Hub.

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：

  2025-07-04 09:15:49
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