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检索试验 按国家、省（市）统计 按疾病代码统计 按试验实施单位统计 按试验主办单位统计 按经费或物资来源统计 按征募研究对象情况统计 按注册状态统计 按干预措施统计 按伦理委员会统计 按研究类型统计
The Effects of Multi-modal Intervention in Managing Symptom Cluster of Cancer-Related Fatigue-Sleeping Problem-Depressed Mood in Breast Cancer Patients undergoing Chemotherapy: A Randomized Controlled Trial
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注册号：

Registration number：

 ChiCTR2100047819 

最近更新日期：

Date of Last Refreshed on：

 2021-06-27 05:04:54 

注册时间：

Date of Registration：

 2021-06-27 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

The Effects of Multi-modal Intervention in Managing Symptom Cluster of Cancer-Related Fatigue-Sleeping Problem-Depressed Mood in Breast Cancer Patients undergoing Chemotherapy: A Randomized Controlled Trial

Public title：

The Effects of Multi-modal Intervention in Managing Symptom Cluster of Cancer-Related Fatigue-Sleeping Problem-Depressed Mood in Breast 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：

The Effects of Multi-modal Intervention in Managing Symptom Cluster of Cancer-Related Fatigue-Sleeping Problem-Depressed Mood in Breast Cancer Patients undergoing Chemotherapy: A Randomized Controlled Trial

Scientific title：

The Effects of Multi-modal Intervention in Managing Symptom Cluster of Cancer-Related Fatigue-Sleeping Problem-Depressed Mood in Breast 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：

Wong Wai Man 

研究负责人：

Wong Wai Man 

Applicant：

Wong Wai Man 

Study leader：

Wong Wai Man 

申请注册联系人电话：

Applicant telephone：

 +852 65996594

研究负责人电话：

Study leader's
telephone：

+852 65996594

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：

 carmenw02m07@link.cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 carmenw02m07@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：

Flat 2, 11/F, Block A, Shui King Building, 172 Wo Yi Hop Road, Kwai Chung, New Territories, Hong Kong, China

研究负责人通讯地址：

Flat 2, 11/F, Block A, Shui King Building, 172 Wo Yi Hop Road, Kwai Chung, New Territories, Hong Kong, China

Applicant address：

Flat 2, 11/F, Block A, Shui King Building, 172 Wo Yi Hop Road, Kwai Chung, New Territories, Hong Kong, China

Study leader's address：

Flat 2, 11/F, Block A, Shui King Building, 172 Wo Yi Hop Road, Kwai Chung, New Territories, 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：

香港中文大學醫學院那打素護理學院

Applicant's institution：

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

研究负责人所在单位：

香港中文大學醫學院那打素護理學院

Affiliation of the Leader：

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

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：

 2

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：

香港中文大學-新界東醫院聯網臨床研究倫理聯席委員會

Name of the ethic committee：

CUHK-NTEC Clinical Ethics and Research Committee / Kowloon West Cluster Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2021-06-09 00:00:00

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銀城街威爾士親王醫院呂志和臨床醫學大樓八樓

Contact Address of the ethic committee：

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

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 35053935/29901017

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 crec@cuhk.edu.hk / kwcrec@ha.org.hk

研究实施负责（组长）单位：

香港中文大學醫學院那打素護理學院

Primary sponsor：

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

研究实施负责（组长）单位地址：

Flat 2, 11/F, Block A, Shui King Building, 172 Wo Yi Hop Road, Kwai Chung, New Territories, Hong Kong, China

Primary sponsor's address：

Flat 2, 11/F, Block A, Shui King Building, 172 Wo Yi Hop Road, Kwai Chung, New Territories, Hong Kong, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

No funding

Source(s) of funding：

No funding

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

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

The aim of this study is to examine the effect of multi-modal intervention in managing F-S-D cluster in BC patients undergoing chemotherapy in Hong Kong. The objectives are to investigate the effect of multimodal intervention on 1. CRF 2. sleeping quality 3. depressed mood 4. QOL in BC patients undergoing chemotherapy in Hong Kong  

Objectives of Study：

The aim of this study is to examine the effect of multi-modal intervention in managing F-S-D cluster in BC patients undergoing chemotherapy in Hong Kong. The objectives are to investigate the effect of multimodal intervention on 1. CRF 2. sleeping quality 3. depressed mood 4. QOL in BC patients undergoing chemotherapy in Hong Kong

药物成份或治疗方案详述：

The experimental group will receive a seven-weeks nurse-led multi-modal programme, which is developed based on Greens PRECEDE model, integrating psychological support, chemotherapy side effects education, chemotherapy side effects management, dietary advice, and exercise recommendation. Psychological Support In the nurse-led multi-modal programme, trained oncology nurses provide psychological support by exploring their concern, providing active listening, encouraging participants to express and addressing their feelings. Moreover, nurses monitor their symptoms and provide suggestions on side effects management skill, healthy diet modification and exercise. We also give encouragement, empathy and appreciation to their efforts in managing symptom cluster to strengthen their confidence. Education on Side Effects of Chemotherapy Education on seven common side effects of chemotherapy for BC patients are included. They are suppressed marrow function, nausea, vomiting and decreased appetite, hair loss, sore mouth, changes in menstrual period/menopause and fertility issue, darken skin and hypersensitivity. Others side effects specific to Docetaxel (muscle pain, fluid retention and hands and feet numbness) and Doxorubicin/Epirubicin (urine discoloration and heart problem) are also included. Chemotherapy Side Effects Management Besides the side effects of chemotherapy, their management on the corresponding side effects are included. For example, advise them to monitor any infection signs and bleeding tendency and checking body temperature if feeling sick in suppressed marrow function, wearing wig to protect the scalp when hair loss, and educate to make normal saline mouth wash in oral mucositis. Nutrition Advice Balanced diet is the daily intake of three to eight bowls of grain, three servings of vegetables, two servings of fruits, five to eight taels of meat, fish, egg and alternatives, one to two glasses of milk and alternative, which is suggested in this study. The portion and examples for balanced diet is listed in the booklet. During chemotherapy, there are various side effects which lead to poor nutritional status. Based on balanced diet, high protein and high calories food and strategies to increase protein and calories are suggested to poor appetite patients. Moreover, dietary advise on nausea and vomiting, oral mucositis and fatigue are suggested. Furthermore, suggestions on food handling, cooking and grocery shopping are provided in chemotherapy weaken immune system. Also, dietary topics related to Chineses culture, e.g., Lingzhi, chicken, soybean and traditional Chinese medicine are included. Exercise Recommendation In exercise advises, it suggested weekly exercise at least 150 minutes of moderate intensity or 75 minutes of vigorous intensity. Supervised or home-based exercise are both suggested in previous studies. In this progamme, home-based exercise is suggested to maximize the flexibility. Examples of moderate and vigorous intensity exercises, strategies on exercise planning, warm up and cool down exercise and safety tips are included in the programme. There are different examples of exercise types provided, such as, brisk walking, swimming, bicycling and jumping rope, which allow them to choose what they are interested in and maximize their motivation. It is also recommended to do exercise with family or friends to gain more social support which can reinforce the health behavior. Introduction of symptoms of F-S-D and its general management In order to address the participants about the symptoms of F-S-D, information on symptoms of F-S-D and their general management has also be included. For example, maintaining physical activities and avoid taking nap more than one hour per day for sleeping problem and encourage them to talk with family and friends for depressed mood. The validity of introduction of symptoms of F-S-D and their general management, chemotherapy side effects, management of chemotherapy side effects, dietary advice and exercise recommendation is reviewed by an oncology doctor, a nurse consultant in oncology, BC case manager, a dietitian and a physiotherapist. Two round of panel review were conducted. In second round of panel review, the Item-Content Validity Index reaches 1. The education booklet is also reviewed by five breast cancer patients to ensure the readability of the booklet. Routine Assessment of F-S-D Cluster In current practice, there is an absence of routine assessment of F-S-D symptoms, routine assessment of symptoms cluster of F-S-D are included in this programme to provide regular assessment and monitoring on this symptom cluster and hence maximizing the effectiveness of the multi-modal intervention. Brief Fatigue Inventory, Pittsburgh Sleep Quality Index and Center for Epidemiologic Studies Depression Scale will be used to assess F-S-D cluster respectively. The first education session, approximately 20 to 25 minutes, will be delivered in face-to-face before chemotherapy by breast cancer case manager or trained oncology nurses. Participants in the experimental group will receive an education booklet. This booklet consists of four chapters, they are introduction of F-S-D symptoms and their general management, side effects of chemotherapy and their management, dietary advice, and exercise recommendation. Subsequently, participants will receive weekly telephone follow-up (about 20 to 30 minutes) during daytime by trained oncology nurses. The assessment of F-S-D cluster will be conducted every three weeks. The trained oncology nurses, who have obtained masters degree in nursing and have at least five years of experience in oncology. Participants will receive a food diary to record and monitor their daily intake regarding balanced diet. Also, separate questions on the consumption of high protein and high calories food and strategies to increase intake of protein and calories food for poor appetite participants are included. The trained oncology nurses will assess the total number of days of meeting balanced diet. For poor appetite participants, nurses will assess the number of days of choosing high protein and high calories food and the ways to increase its intake. Nurses will provide clarification and suggestions about the dietary advice if needed. An exercise diary will also be delivered to participants in the first intervention session to record their exercise types, intensity and duration. This exercise diary allows self-monitoring and evaluation their exercise progress. The Godin-Shephard Leisure Time Physical Activity Questionnaire (GSLTPA) is used to assess weekly average frequency of light, moderate and vigorous exercise. GSLTPA is validated and the reliability is 0.74. The question is modified to the average duration of exercise and include a separate question in asking participants what exercise they do. The result is categorized into two groups. One is meeting the proposed exercise dose whereas another one is not meeting the goal. 

Description for medicine or protocol of treatment in detail：

The experimental group will receive a seven-weeks nurse-led multi-modal programme, which is developed based on Greens PRECEDE model, integrating psychological support, chemotherapy side effects education, chemotherapy side effects management, dietary advice, and exercise recommendation. Psychological Support In the nurse-led multi-modal programme, trained oncology nurses provide psychological support by exploring their concern, providing active listening, encouraging participants to express and addressing their feelings. Moreover, nurses monitor their symptoms and provide suggestions on side effects management skill, healthy diet modification and exercise. We also give encouragement, empathy and appreciation to their efforts in managing symptom cluster to strengthen their confidence. Education on Side Effects of Chemotherapy Education on seven common side effects of chemotherapy for BC patients are included. They are suppressed marrow function, nausea, vomiting and decreased appetite, hair loss, sore mouth, changes in menstrual period/menopause and fertility issue, darken skin and hypersensitivity. Others side effects specific to Docetaxel (muscle pain, fluid retention and hands and feet numbness) and Doxorubicin/Epirubicin (urine discoloration and heart problem) are also included. Chemotherapy Side Effects Management Besides the side effects of chemotherapy, their management on the corresponding side effects are included. For example, advise them to monitor any infection signs and bleeding tendency and checking body temperature if feeling sick in suppressed marrow function, wearing wig to protect the scalp when hair loss, and educate to make normal saline mouth wash in oral mucositis. Nutrition Advice Balanced diet is the daily intake of three to eight bowls of grain, three servings of vegetables, two servings of fruits, five to eight taels of meat, fish, egg and alternatives, one to two glasses of milk and alternative, which is suggested in this study. The portion and examples for balanced diet is listed in the booklet. During chemotherapy, there are various side effects which lead to poor nutritional status. Based on balanced diet, high protein and high calories food and strategies to increase protein and calories are suggested to poor appetite patients. Moreover, dietary advise on nausea and vomiting, oral mucositis and fatigue are suggested. Furthermore, suggestions on food handling, cooking and grocery shopping are provided in chemotherapy weaken immune system. Also, dietary topics related to Chineses culture, e.g., Lingzhi, chicken, soybean and traditional Chinese medicine are included. Exercise Recommendation In exercise advises, it suggested weekly exercise at least 150 minutes of moderate intensity or 75 minutes of vigorous intensity. Supervised or home-based exercise are both suggested in previous studies. In this progamme, home-based exercise is suggested to maximize the flexibility. Examples of moderate and vigorous intensity exercises, strategies on exercise planning, warm up and cool down exercise and safety tips are included in the programme. There are different examples of exercise types provided, such as, brisk walking, swimming, bicycling and jumping rope, which allow them to choose what they are interested in and maximize their motivation. It is also recommended to do exercise with family or friends to gain more social support which can reinforce the health behavior. Introduction of symptoms of F-S-D and its general management In order to address the participants about the symptoms of F-S-D, information on symptoms of F-S-D and their general management has also be included. For example, maintaining physical activities and avoid taking nap more than one hour per day for sleeping problem and encourage them to talk with family and friends for depressed mood. The validity of introduction of symptoms of F-S-D and their general management, chemotherapy side effects, management of chemotherapy side effects, dietary advice and exercise recommendation is reviewed by an oncology doctor, a nurse consultant in oncology, BC case manager, a dietitian and a physiotherapist. Two round of panel review were conducted. In second round of panel review, the Item-Content Validity Index reaches 1. The education booklet is also reviewed by five breast cancer patients to ensure the readability of the booklet. Routine Assessment of F-S-D Cluster In current practice, there is an absence of routine assessment of F-S-D symptoms, routine assessment of symptoms cluster of F-S-D are included in this programme to provide regular assessment and monitoring on this symptom cluster and hence maximizing the effectiveness of the multi-modal intervention. Brief Fatigue Inventory, Pittsburgh Sleep Quality Index and Center for Epidemiologic Studies Depression Scale will be used to assess F-S-D cluster respectively. The first education session, approximately 20 to 25 minutes, will be delivered in face-to-face before chemotherapy by breast cancer case manager or trained oncology nurses. Participants in the experimental group will receive an education booklet. This booklet consists of four chapters, they are introduction of F-S-D symptoms and their general management, side effects of chemotherapy and their management, dietary advice, and exercise recommendation. Subsequently, participants will receive weekly telephone follow-up (about 20 to 30 minutes) during daytime by trained oncology nurses. The assessment of F-S-D cluster will be conducted every three weeks. The trained oncology nurses, who have obtained masters degree in nursing and have at least five years of experience in oncology. Participants will receive a food diary to record and monitor their daily intake regarding balanced diet. Also, separate questions on the consumption of high protein and high calories food and strategies to increase intake of protein and calories food for poor appetite participants are included. The trained oncology nurses will assess the total number of days of meeting balanced diet. For poor appetite participants, nurses will assess the number of days of choosing high protein and high calories food and the ways to increase its intake. Nurses will provide clarification and suggestions about the dietary advice if needed. An exercise diary will also be delivered to participants in the first intervention session to record their exercise types, intensity and duration. This exercise diary allows self-monitoring and evaluation their exercise progress. The Godin-Shephard Leisure Time Physical Activity Questionnaire (GSLTPA) is used to assess weekly average frequency of light, moderate and vigorous exercise. GSLTPA is validated and the reliability is 0.74. The question is modified to the average duration of exercise and include a separate question in asking participants what exercise they do. The result is categorized into two groups. One is meeting the proposed exercise dose whereas another one is not meeting the goal.  

纳入标准：

Inclusion criteria

排除标准：

The exclusion criteria are patients who are receiving treatment for mental disorders; diagnosis of cognitive impairment e.g., dementia; pregnancy; refused to participate; unable to communicate in Cantonese or read Chinese; illiterates; mentally incapacitated person.

Exclusion criteria：

The exclusion criteria are patients who are receiving treatment for mental disorders; diagnosis of cognitive impairment e.g., dementia; pregnancy; refused to participate; unable to communicate in Cantonese or read Chinese; illiterates; mentally incapacitated person.

研究实施时间：

Study execute time：

从 From 2021-07-01 00:00:00至 To 2022-10-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2021-07-01 00:00:00 至 To 2022-10-31 00:00:00

干预措施：

Interventions：

组别：

1

样本量：

 59

Group：

1

Sample size：

干预措施：

Multi-modal intervention

干预措施代码：

Intervention：

Multi-modal intervention

Intervention code：

组别：

2

样本量：

 59

Group：

2

Sample size：

干预措施：

chemotherapy side effect education

干预措施代码：

Intervention：

chemotherapy side effect education

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 Princess Margaret Hospital 

单位级别：

 三级医院 

Institution
hospital：

Princess Margaret Hospital

Level of the institution：

Tertiary

测量指标：

Outcomes：

指标中文名：

Cancer-related fatigue

指标类型：

主要指标

Outcome：

Cancer-related fatigue

Type：

Primary indicator

测量时间点：

At baseline, week 7 and week 18

测量方法：

Questionnaire

Measure time point of outcome：

At baseline, week 7 and week 18

Measure method：

Questionnaire

指标中文名：

Sleeping Quality

指标类型：

主要指标

Outcome：

Sleeping Quality

Type：

Primary indicator

测量时间点：

At baseline, week 7 and week 18

测量方法：

Questionnaire

Measure time point of outcome：

At baseline, week 7 and week 18

Measure method：

Questionnaire

指标中文名：

Depressed mood

指标类型：

主要指标

Outcome：

Depressed mood

Type：

Primary indicator

测量时间点：

At baseline, week 7 and week 18

测量方法：

Questionnaire

Measure time point of outcome：

At baseline, week 7 and week 18

Measure method：

Questionnaire

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：

At baseline, week 7 and week 18

测量方法：

Questionnaire

Measure time point of outcome：

At baseline, week 7 and week 18

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

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 岁 years
最大 Max age 99 岁 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）：

All eligible participants are randomized into experimental or controls group through permuted block randomization with a block size of 4 and 6. The randomization sequence will be performed by a research assistant.

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

All eligible participants are randomized into experimental or controls group through permuted block randomization with a block size of 4 and 6. The randomization sequence will be performed by a research assistant.

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：

Control group will receive one education session (around 10 minutes) on the side effect of chemotherapy and their management. A paper material will be given to them. Two phones follow-up sessions (approximately 15-20 minutes in each session) will be provided to them to reinforce their knowledge on the side effects of chemotherapy and their management at week four and week seven. After completion of follow-up timepoint measurement, participants will receive the education booklet used in intervention group. All participants in control and experimental group are advised not to disclose the intervention to others.

Blinding：

Control group will receive one education session (around 10 minutes) on the side effect of chemotherapy and their management. A paper material will be given to them. Two phones follow-up sessions (approximately 15-20 minutes in each session) will be provided to them to reinforce their knowledge on the side effects of chemotherapy and their management at week four and week seven. After completion of follow-up timepoint measurement, participants will receive the education booklet used in intervention group. All participants in control and experimental group are advised not to disclose the intervention to others.

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）：

Email to principal investigator

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

Email to principal investigator

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 principal investigator or research assistant will screen the eligibility of potential participants. All eligible participants will be informed about the study. An information sheet of the study will be provided and written informed consent will be sought. After consenting to the study, a demographic and health information will be collected. All primary and secondary outcomes will be measured at baseline (T0), completion of intervention (T1), and 3 months following the completion of the intervention (T2). Most of the BC patients received four or six cycles chemotherapy and completed it at week 12 or 18 whereas others complete chemotherapy at week 24. Having considered that the numbers of BC patients completed chemotherapy and progressive reduction in symptoms after chemotherapy, week 18 is chosen to be T2 follow up timepoint to evaluate the outcomes. All patients will be completed a set of self-administrating questionnaires which measuring primary and secondary outcomes at T0. At T1, primary and secondary outcomes will be measured by independent research assistants by phone. Because routine assessment of primary outcomes is part of the intervention in experimental group, hence only assessment of QOL and programme evaluation will be performed by research assistants. At T2, all outcomes will be assessed by research assistants by phone. The data collected will be saved in a USB flash drive encrypted with password. A hard copy of the collected data and the thumb drive will be kept in a locker which can only be accessed by the research staff. Those data would only be used in this study. The nurses in charge, the principal investigator, CUHK-NTEC Clinical Ethics and Research Committee and Kowloon West Cluster Research Ethics Committee and other regulatory authorities will have access to the personal data during and after the study.All personal data and documents kept will be condemned after three years of the study as confidential waste. Electronic data will also be damaged and made unrecoverable.

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

The principal investigator or research assistant will screen the eligibility of potential participants. All eligible participants will be informed about the study. An information sheet of the study will be provided and written informed consent will be sought. After consenting to the study, a demographic and health information will be collected. All primary and secondary outcomes will be measured at baseline (T0), completion of intervention (T1), and 3 months following the completion of the intervention (T2). Most of the BC patients received four or six cycles chemotherapy and completed it at week 12 or 18 whereas others complete chemotherapy at week 24. Having considered that the numbers of BC patients completed chemotherapy and progressive reduction in symptoms after chemotherapy, week 18 is chosen to be T2 follow up timepoint to evaluate the outcomes. All patients will be completed a set of self-administrating questionnaires which measuring primary and secondary outcomes at T0. At T1, primary and secondary outcomes will be measured by independent research assistants by phone. Because routine assessment of primary outcomes is part of the intervention in experimental group, hence only assessment of QOL and programme evaluation will be performed by research assistants. At T2, all outcomes will be assessed by research assistants by phone. The data collected will be saved in a USB flash drive encrypted with password. A hard copy of the collected data and the thumb drive will be kept in a locker which can only be accessed by the research staff. Those data would only be used in this study. The nurses in charge, the principal investigator, CUHK-NTEC Clinical Ethics and Research Committee and Kowloon West Cluster Research Ethics Committee and other regulatory authorities will have access to the personal data during and after the study.All personal data and documents kept will be condemned after three years of the study as confidential waste. Electronic data will also be damaged and made unrecoverable.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2021-06-27 05:04:54
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