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WhatsApp-assisted prehabilitation programme for adult patient undergoing elective colorectal cancer surgery
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注册号：

Registration number：

 ChiCTR2500110717 

最近更新日期：

Date of Last Refreshed on：

 2025-10-20 09:41:54 

注册时间：

Date of Registration：

 2025-10-20 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

WhatsApp-assisted prehabilitation programme for adult patient undergoing elective colorectal cancer surgery

Public title：

WhatsApp-assisted prehabilitation programme for adult patient undergoing elective colorectal cancer surgery

注册题目简写：

English Acronym：

研究课题的正式科学名称：

WhatsApp-assisted prehabilitation programme for adult patient undergoing elective colorectal cancer surgery

Scientific title：

WhatsApp-assisted prehabilitation programme for adult patient undergoing elective colorectal cancer surgery

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：

Sung Hoi Ling Shering 

研究负责人：

Sung Hoi Ling Shering 

Applicant：

Sung Hoi Ling Shering 

Study leader：

Sung Hoi Ling Shering 

申请注册联系人电话：

Applicant telephone：

 +852 6291 7101

研究负责人电话：

Study leader's
telephone：

+852 6291 7101

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：

 sheringsung@link.cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 sheringsung@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：

The Nethersole School of Nursing, The Chinese University of Hong Kong, Shatin, HKSAR

研究负责人通讯地址：

The Nethersole School of Nursing, The Chinese University of Hong Kong, Shatin, HKSAR

Applicant address：

The Nethersole School of Nursing, The Chinese University of Hong Kong, Shatin, HKSAR

Study leader's address：

The Nethersole School of Nursing, The Chinese University of Hong Kong, Shatin, 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 Chinese University of Hong Kong

Applicant's institution：

The Chinese University of Hong Kong

研究负责人所在单位：

The Chinese University of Hong Kong

Affiliation of the Leader：

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：

 CREC:2025.185

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：

 2025-09-25 00:00:00

伦理委员会联系人：

Ms Amy Li

Contact Name of the ethic committee：

Ms Amy Li

伦理委员会联系地址：

8/F, Lui Che Woo Clinical Science Building, Prince of Wales Hospital, Shatin, Hong Kong

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Science Building, Prince of Wales Hospital, Shatin, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 3505 3935

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 Chinese University of Hong Kong

Primary sponsor：

The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

The Nethersole School of Nursing, The Chinese University of Hong Kong, Shatin, HKSAR

Primary sponsor's address：

The Nethersole School of Nursing, The Chinese University of Hong Kong, Shatin, HKSAR

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 SAR

市(区县)：

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

Tseung Kwan O Hospital

具体地址：

2 Po Ning Lane, Tseung Kwan O, HKSAR

Institution
hospital：

Tseung Kwan O Hospital

Address：

2 Po Ning Lane, Tseung Kwan O, HKSAR

经费或物资来源：

None

Source(s) of funding：

None

研究疾病：

Colorectal Cancer  

Target disease：

Colorectal 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：

1.To develop and implement a technology-assisted prehabilitation for CRC patient undergoing elective surgery. 2.To examine the effects of the technology-assisted prehabilitation on postoperative complications, length of stay (LOS), physical activity (PA), nutritional status, gastrointestinal (GI) recovery and psychological well-being. 3.To evaluate the feasibility and patients' perception towards the technology-assisted prehabilitation.  

Objectives of Study：

1.To develop and implement a technology-assisted prehabilitation for CRC patient undergoing elective surgery. 2.To examine the effects of the technology-assisted prehabilitation on postoperative complications, length of stay (LOS), physical activity (PA), nutritional status, gastrointestinal (GI) recovery and psychological well-being. 3.To evaluate the feasibility and patients' perception towards the technology-assisted prehabilitation.

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：

Patients with (1) expected surgery date less than 21 days, (2) identified cognitive disorder, (3) respiratory disease or (4) musculoskeletal problems, that is, showed difficulties in understanding the study procedures, providing informed consent or following instructions, in their medical records, (5) requiring neoadjuvant therapy. Participants will be also excluded if their surgery is cancelled (as judged by surgeon or patient refused operation) after randomization.

Exclusion criteria：

Patients with (1) expected surgery date less than 21 days, (2) identified cognitive disorder, (3) respiratory disease or (4) musculoskeletal problems, that is, showed difficulties in understanding the study procedures, providing informed consent or following instructions, in their medical records, (5) requiring neoadjuvant therapy. Participants will be also excluded if their surgery is cancelled (as judged by surgeon or patient refused operation) after randomization.

研究实施时间：

Study execute time：

从 From 2025-09-10 00:00:00至 To 2026-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-10-20 00:00:00 至 To 2026-11-30 00:00:00

干预措施：

Interventions：

组别：

Intervention group

样本量：

 50

Group：

Intervention group

Sample size：

干预措施：

In addition to standard care, participants will receive digital approach of WhatsApp-assisted prehabilitation programme and then start the home-based training for about 3-4 weeks prior to the surgery. The WhatsApp-assisted prehabilitation includes exercises training, dietary advice and psychological support. Contents will contain elements of physical training and psychological therapy will be delivered through WhatsApp at three sessions (day 1, 3 & 5) per week for 30 minutes and 15 minutes respectively, educational information associated with colorectal cancer surgery and prehabilitation(e.g. high risks factors towards surgical complications) and dietary advices (e.g. recipes) will be delivered on weekly basis (day 1)

干预措施代码：

Intervention：

In addition to standard care, participants will receive digital approach of WhatsApp-assisted prehabilitation programme and then start the home-based training for about 3-4 weeks prior to the surgery. The WhatsApp-assisted prehabilitation includes exercises training, dietary advice and psychological support. Contents will contain elements of physical training and psychological therapy will be delivered through WhatsApp at three sessions (day 1, 3 & 5) per week for 30 minutes and 15 minutes respectively, educational information associated with colorectal cancer surgery and prehabilitation(e.g. high risks factors towards surgical complications) and dietary advices (e.g. recipes) will be delivered on weekly basis (day 1)

Intervention code：

组别：

Control group

样本量：

 50

Group：

Control group

Sample size：

干预措施：

Participants in the control group will receive the standard care without digital intervention prior to surgery. Standard care involves physical training, dietary and psychological advice as per the protocol in the study hospital

干预措施代码：

Intervention：

Participants in the control group will receive the standard care without digital intervention prior to surgery. Standard care involves physical training, dietary and psychological advice as per the protocol in the study hospital

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong SAR 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 Tseung Kwan O Hospital 

单位级别：

 Tertiary 

Institution
hospital：

Tseung Kwan O Hospital

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

Postoperative complications

指标类型：

主要指标

Outcome：

Postoperative complications

Type：

Primary indicator

测量时间点：

测量方法：

Comprehensive complication index

Measure time point of outcome：

Measure method：

Comprehensive complication index

指标中文名：

Length of stay

指标类型：

次要指标

Outcome：

Length of stay

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Gastrointestinal recovery

指标类型：

次要指标

Outcome：

Gastrointestinal recovery

Type：

Secondary indicator

测量时间点：

测量方法：

Time to first flatus (in hours), time to first bowel (in hours), occurrence of associated events

Measure time point of outcome：

Measure method：

Time to first flatus (in hours), time to first bowel (in hours), occurrence of associated events

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：

Day of recruitment (baseline), weekly before operation and upon discharge.

测量方法：

International Physical Activity Questionnaire Short Form (Chinese version) (IPAQ-SF)

Measure time point of outcome：

Day of recruitment (baseline), weekly before operation and upon discharge.

Measure method：

International Physical Activity Questionnaire Short Form (Chinese version) (IPAQ-SF)

指标中文名：

Anxiety and depression

指标类型：

次要指标

Outcome：

Anxiety and depression

Type：

Secondary indicator

测量时间点：

Day of recruitment (baseline) and on day of discharge

测量方法：

The Chinese version of Hospital Anxiety and Depression Scale (C-HADS)

Measure time point of outcome：

Day of recruitment (baseline) and on day of discharge

Measure method：

The Chinese version of Hospital Anxiety and Depression Scale (C-HADS)

指标中文名：

Quality of life

指标类型：

次要指标

Outcome：

Quality of life

Type：

Secondary indicator

测量时间点：

Day of recruitment (baseline) and on day of discharge

测量方法：

Short Form 12 Health Survey (SF-12 version 2 (Hong Kong)

Measure time point of outcome：

Day of recruitment (baseline) and on day of discharge

Measure method：

Short Form 12 Health Survey (SF-12 version 2 (Hong Kong)

指标中文名：

Perception towards prehabilitation

指标类型：

附加指标

Outcome：

Perception towards prehabilitation

Type：

Additional indicator

测量时间点：

After discharge

测量方法：

Self-reported survey

Measure time point of outcome：

After discharge

Measure method：

Self-reported survey

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

None

组织：

Sample Name：

None

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：

尚未开始

Not yet 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）：

A computer-based randomization will be utilized to allocate patients into either one group. Eligible participants will be randomly assigned in a 1:1 ratio to either control group or intervention group. Block randomization was performed through a computer-generated sequence, and serial and opaque with sealed envelopes will be prepared in by independent staff not involved in clinical care or screening or assessment, in which will be used to conceal the sequence until the intervention as assigned at the outpatient preoperative clinic

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

A computer-based randomization will be utilized to allocate patients into either one group. Eligible participants will be randomly assigned in a 1:1 ratio to either control group or intervention group. Block randomization was performed through a computer-generated sequence, and serial and opaque with sealed envelopes will be prepared in by independent staff not involved in clinical care or screening or assessment, in which will be used to conceal the sequence until the intervention as assigned at the outpatient preoperative clinic

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

Assessor will be blinded for the allocation of the participants and intervention.

Blinding：

Assessor will be blinded for the allocation of the participants and intervention.

是否共享原始数据：

IPD sharing

否No

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）：

None

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

None

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 data would be handled in line with HA/Hospital’s policy in handling/storage/destruction of patients’ medical records. All collected data will be kept strictly confidential and for research purposes and only the investigator and responsible research staff have exclusive access to the datasets. The storage period will be 6 years including the period of study. A new electronic device (Smartphone) and a new SIM card will be purchased for this study. This SIM card will be verified and completed with the real name registration under study investigator according to the Telecommunication (Registration of SIM Cards) Regulation in Hong Kong and the phone number of this SIM card will be used to register for the WhatsApp Business Account. During these periods, the electronic device (mobile) used for digital intervention and the informed consent will be kept in a specific locked cabinet. The electronic device is also encrypted with a password and the password will be changed regularly in every 3 months. Trusted and encrypted network is used to deliver the WhatsApp intervention. After completion of aforesaid storage period, the mobile SIM card and the WhatsApp account will be destroyed and reset. All hard copy of data will also be discarded as confidential waste 6 years after the completion of study. The Principal Investigator, and the coordinating investigator will be responsible for safekeeping of the personal data and study data during and after the study.

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

All research data would be handled in line with HA/Hospital’s policy in handling/storage/destruction of patients’ medical records. All collected data will be kept strictly confidential and for research purposes and only the investigator and responsible research staff have exclusive access to the datasets. The storage period will be 6 years including the period of study. A new electronic device (Smartphone) and a new SIM card will be purchased for this study. This SIM card will be verified and completed with the real name registration under study investigator according to the Telecommunication (Registration of SIM Cards) Regulation in Hong Kong and the phone number of this SIM card will be used to register for the WhatsApp Business Account. During these periods, the electronic device (mobile) used for digital intervention and the informed consent will be kept in a specific locked cabinet. The electronic device is also encrypted with a password and the password will be changed regularly in every 3 months. Trusted and encrypted network is used to deliver the WhatsApp intervention. After completion of aforesaid storage period, the mobile SIM card and the WhatsApp account will be destroyed and reset. All hard copy of data will also be discarded as confidential waste 6 years after the completion of study. The Principal Investigator, and the coordinating investigator will be responsible for safekeeping of the personal data and study data during and after the study.

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：

  2025-10-20 09:41:41
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