ChiCTR2000038923 版本V1.3 版本创建时间2021/01/03 23:43:02 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2000038923 

最近更新日期：

Date of Last Refreshed on：

2021-01-03 23:42:42 

注册时间：

Date of Registration：

2020-10-10 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

表达性写作对肿瘤患者及家属心理状态及生活质量影响的临床研究

Public title：

A clinical study on the influence of expressive writing on the mental state and quality of life of cancer patients and their families

注册题目简写：

English Acronym：

研究课题的正式科学名称：

表达性写作对肿瘤患者及家属心理状态及生活质量影响的临床研究

Scientific title：

A clinical study on the influence of expressive writing on the mental state and quality of life of cancer patients and their families

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：

林楠 

研究负责人：

邓窈窕 

Applicant：

Lin Nan 

Study leader：

Deng Yaotiao 

申请注册联系人电话：

Applicant telephone：

+86 18708305692

研究负责人电话：

Study leader's telephone：

+86 13547879325

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：

linnan@stu.scu.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

dengyaotiao@163.com

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：

四川省成都市武侯区国学巷37号

研究负责人通讯地址：

四川省成都市武侯区国学巷37号

Applicant address：

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China

Study leader's address：

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, 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：

四川大学华西医院

Applicant's institution：

West China Hospital of Sichuan University

研究负责人所在单位：

四川大学华西医院

Affiliation of the Leader：

West China Hospital of Sichuan University

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

2020审（557）号

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：

四川大学华西医院生物医学伦理委员会

Name of the ethic committee：

Ethics Committee of West China Hospital of Sichuan University

伦理委员会批准日期：

Date of approved by ethic committee：

2020-09-04 00:00:00

伦理委员会联系人：

邓绍林

Contact Name of the ethic committee：

Deng Shaolin

伦理委员会联系地址：

四川省成都市武侯区国学巷37号四川大学华西医院老八教四楼412室

Contact Address of the ethic committee：

Room 412, Old 8th Teaching Building, West China Hospital of Sichuan University, 37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, China

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：

四川大学华西医院

Primary sponsor：

West China Hospital of Sichuan University

研究实施负责（组长）单位地址：

四川省成都市武侯区国学巷37号

Primary sponsor's address：

37 Guoxue Lane, Wuhou District, Chengdu, Sichuan, 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)：

四川

市(区县)：

成都

Country：

China

Province：

Sichuan

City：

Chengdu

单位(医院)：

四川大学华西医院

具体地址：

武侯区国学巷37号

Institution
hospital：

West China Hospital of Sichuan University

Address：

37 Guoxue Lane, Wuhou District

经费或物资来源：

无

Source(s) of funding：

None

Target disease：

Soft tissue sarcoma, malignant melanoma, nasopharyngeal carcinoma

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. 主要目的： 1）评估表达性写作能否改善鼻咽癌、恶性软组织肉瘤及恶性黑色素瘤患者的焦虑、抑郁等情绪问题，改善患者的症状负担、社会支持和生活质量以及治疗后患者的复发恐惧。 2）评估表达性写作能否改善肿瘤患者家属的焦虑、抑郁、孤独等心理状况与照护负担。 2. 次要目的： 1）对比受试者在写作后的治疗依从性和医疗满意度有无区别。通过继续随访各组患者，对比健康结局有无差异。 2）收集患者及家属对表达性写作的评价。检验表达性写作对于鼻咽癌、软组织肉瘤和黑色素瘤患者和肿瘤患者家属心理治疗的可行性。 3）对受试者的写作进行文本分析，比较患者在写作过程中对各主题的接受程度与思考程度。  

Objectives of Study：

1. Main purpose: (1) Assess whether expressive writing can improve the anxiety, depression and other emotional problems of patients with nasopharyngeal carcinoma, malignant soft tissue sarcoma and malignant melanoma, and improve the patient's symptom burden, social support and quality of life, and the patient's fear of recurrence after treatment. (2) Assess whether expressive writing can improve the anxiety, depression, and loneliness of the family members of cancer patients and the burden of care. 2. Secondary purpose: 1) Compare the subjects' treatment compliance and medical satisfaction after writing. By continuing to follow up each group of patients, compare the health outcomes for differences. 2) Collect the evaluation of expressive writing from patients and their families. To test the feasibility of expressive writing for the psychological treatment of patients with nasopharyngeal carcinoma, soft tissue sarcoma and melanoma and their families. 3) Conduct a text analysis of the subjects writing, and compare the patients acceptance and thinking on each topic during the writing process.

药物成份或治疗方案详述：

1. 研究设计： 研究对象分组： 根据肿瘤患者与家属的实际情况，本研究进行如下分组： 1）治疗中患者：随机分为表达性写作组、肿瘤事实写作组和中性写作组，人数比为2：2：1。 2）治疗后患者：只进行表达性写作，进行自身前后对照 3）肿瘤患者家属：随机分为表达性写作组与中性写作组，人数比为1：1。 研究样本量评估： 1）治疗中患者：采用多个样本均数比较差异性检验的方法估计样本，根据Oh, P. J. and S. H. Kim的meta 分析中关于表达性写作的研究数据计算样本，最终计算得到需要患者大于或等于100个，假设脱组率为10%，预计需110例患者。 2）治疗后患者：采用单组均值与固定值比较的方法计算样本，根据Carmark, C针对治疗后结直肠癌患者的既往研究，预计需治疗后患者50例。 3）患者家属：采用两组均数比较差异性检验计算样本，根据Harvey, J的既往研究，计算得到每组需要样本40个，假设脱组率10%，我们预计需要88例家属。 2.研究方法： 1) 问卷调查评估： 针对治疗中的患者，除搜集患者基本信息外，采用标准心理痛苦量表（DT）、广泛焦虑量表（GAD-7）、9条目患者健康问卷（PHQ-9）、单条目疲乏量表、医疗社会支持量表（MOS-SSS）、欧洲癌症研究与治疗组织开发的生活质量测定量表（EORTC QLQ-C30），匹兹堡睡眠质量指数量表（PSQI），安德森症状调查量表 （MD Anderson）分别针对患者心理痛苦，焦虑，抑郁，疲乏，社会支持，生存质量，睡眠与症状负担进行评估。 6对于治疗后的患者，我们还额外补充癌症患者恐惧疾病进展简化量表（FCRI）对患者的复发恐惧进行评估。 针对患者家属，除搜集家属基本信息外，采用Zarit护理者负担量表（ZBI）和照护能量蓄电池（Burnout Battery）评估护理压力，DT，PHQ-9，GAD-7评估心理痛苦，抑郁和焦虑，UCLA孤独感量表（ULS-6）评估家属孤独感。 2) 制作研究手册，确定治疗中患者表达性写作组、肿瘤相关事实组、中性写作组；治疗后患者表达性写作组；家属表达性写作组、中性写作组的写作结构和每次写作的主题，所有入组患者和家属采取标准指导用语。对于部分理解有疑问的患者和家属，可进行相应解释，但不予暗示性指导。所有研究者进行统一培训。 3) 研究者写作指导：考虑到患者与家属对于各种主题的接受程度，在简短地问候之后，分别对不同分组的患者和家属进行规范化的不同主题的写作指导。对于患者，进行写作的频率为每周一次，总共干预次数为6次。对于家属，频率为每周一次，总共干预次数为4次。发布任务后三天内，受试者需要将写作内容提交给研究者。写作前除公布写作指导外，研究者不能对患者或家属进行情绪的引导 4) 写作后随访：在受试者完成24小时后，以及完成后的2周、1个月、3个月、6个月，对受试者采用相同的量表进行评估，以评价写作的效果。在写作完成时，研究者通过与受试者现场交流或电话随访，以及通过填写问卷形式，对受试者写作的满意度及相关建议进行采集。 3. 统计分析： 我们的实验将得到以下数据：患者与家属的基本信息，患者与家属填写的基线与随访量表，患者与家属的写作资料，患者与家属的写作反馈。 1)患者与家属写作资料采用现象学的研究方法。详细的研究过程如下： i. 研究者将受试者的写作资料转录为WORD文档ii. 研究者阅读所有的文章并理解文章的整体含义iii. 研究者回顾转录后的文档，识别其中有意义的主题与语句iv. 用日常用语来归纳写作中的主题与语句v. 逐行分析转录后的文档，总结表达了相关主题的段落。 vi. 重新阅读并讨论，添加新的主题和子主题，删除预先确定的主题，重复之前的操作直到所有人员均同意。 7vii. 归纳受试者写作主题以及在写作中表达的主要情感2)写作反馈在分析干预效果之前，针对写作后的受试者回答的关于写作独立的隐私，揭露情感的情况，写作的收获，对疾病理解的程度等进行比较，初步得出受试者对写作的评价。 3）患者与家属的基本信息使用ANOVA以及方差检验针对患者年龄，性别，疾病分期等检查受试者是否存在人口统计学偏差。 4）基线与随访量表使用Excel收集信息后，我们将采用SPSS24. 0 进行统计汇总与分析，会把最初数据与新加入的数据，遗漏数据重复分析，以保证处理效率。 本研究的目的是检验表达性写作是否能否改善鼻咽癌、恶性软组织肉瘤及恶性黑色素瘤患者的焦虑、抑郁等情绪问题，改善患者的症状负担、社会支持和生活质量，治疗后患者的复发恐惧以及家属的焦虑、抑郁、孤独等心理状况与照护负担。针对治疗中的患者，首先进行三组受试者的基线测量差异性检验，如果没有显著差异，则采用重复测量的方差分析，以不同写作主题分类作为时间变量，以不同测量时间点作为被试变量，对不同量表得分进行检验。根据不同的分组以及入组人数确定具体分析方法。 4. 研究步骤 1）基线评估采用相关量表收集受试者基本信息以及干预前的心理状况等资料。 2）写作干预受试者在研究者的指导下进行每周一次，患者总共6次，家属总共4次的具体主题的写作，并及时将写作提交给研究者。 3）写作后随访在受试者完成24小时后，以及完成后的2周、1个月、3个月、6个月，对受试者进行随访与评估。每一个阶段的问卷设计与基线问卷除受试者基本信息外采用的量表相同。写作完成时受试者会另外收到一个单独调查对于写作的效果与看法的问卷。  

Description for medicine or protocol of treatment in detail：

1. Research design The subjects were divided into two groups According to the actual situation of tumor patients and their families, this study was divided into the following groups (1) Patients in treatment: they were randomly divided into expression writing group, tumor fact writing group and neutral writing group, with the ratio of 2:2:1. (2) Patients after treatment: only expressive writing, before and after their own control (3) Family members of cancer patients: they were randomly divided into expressive writing group and neutral writing group, with the ratio of 1:1. Evaluation of sample size: (1) Patients in treatment: the samples were estimated by the method of multiple sample mean comparison difference test, and the samples were calculated according to the research data of expressive writing in Oh, P. J. and S. h. Kim's meta-analysis. Finally, the number of patients needed was more than or equal to 100, assuming that the out group rate was 10%, and 110 patients were expected. (2) Patients after treatment: the sample was calculated by comparing the mean value of a single group with the fixed value. According to carmark, C's previous research on patients with colorectal cancer after treatment, it is estimated that 50 patients need to be treated. (3) Family members of patients: according to Harvey, J's previous research, we calculated that each group needs 40 samples. Assuming that the out group rate is 10%, we expect to need 88 family members. 2. Research methods: (1) Questionnaire evaluation: In addition to collecting basic information of patients, standard psychological distress scale (DT), generalized anxiety scale (GAD-7), nine item patient health questionnaire (PHQ-9), single item fatigue scale, medical social support scale (MOS-SSS) and European Organization for research and treatment of cancer quality of life scale (EORTC) were used QLQ-C30), Pittsburgh sleep quality index (PSQI) and Anderson symptom scale (MD Anderson) were used to evaluate the psychological distress, anxiety, depression, fatigue, social support, quality of life, sleep and symptom burden of the patients. For the patients after treatment, we also added the simplified fear of disease progression scale (fcri) to evaluate the fear of recurrence. In addition to collecting the basic information of family members, Zarit Caregiver Burden Scale (ZBI) and burnout battery were used to assess the nursing pressure, DT, PHQ-9 and GAD-7 were used to assess the psychological pain, depression and anxiety, and UCLA Loneliness Scale (uls-6) was used to assess the loneliness of family members. (2) The research manual was made to determine the writing structure and theme of each writing in the patients' expressive writing group, tumor related facts group and neutral writing group during the treatment; the patients' expressive writing group after the treatment; the family members' expressive writing group and neutral writing group. For some patients and their families who have doubts about their understanding, corresponding explanations can be given, but no suggestive guidance is given. All researchers received unified training. (3) Researchers' writing guidance: considering the acceptance of patients and their families for various topics, after a brief greeting, standardized writing guidance on different topics was given to patients and their families in different groups. For patients, the frequency of writing was once a week, and the total number of interventions was 6. For family members, the frequency was once a week, and the total number of interventions was 4. Within three days after the release of the task, the subjects were required to submit the writing content to the researchers. In addition to publishing the writing guidance before writing, researchers can not provide emotional guidance to patients or their families (4) Follow up after writing: 24 hours after the completion of writing, and 2 weeks, 1 month, 3 months, 6 months after the completion, the subjects were evaluated with the same scale to evaluate the effect of writing. The subjects were asked to fill in the questionnaire and make suggestions by telephone. 3. Statistical analysis Our experiment will get the following data: basic information of patients and their families, baseline and follow-up scales filled by patients and their families, writing materials of patients and their families, and writing feedback of patients and their families. (1) The data of patients and their families were written by phenomenological method. The detailed research process is as follows The researchers transcribed the subjects' writing materials into word documents Researchers read all the articles and understand the whole meaning of the articles Researchers review the transcribed documents and identify meaningful topics and sentences To sum up the theme of daily writing Analyze the transcribed document line by line, and summarize the paragraphs expressing related topics. Reread and discuss, add new topics and sub topics, delete pre-determined topics, and repeat the previous operation until all personnel agree. Before analyzing the effect of the intervention, the paper compares the independent privacy of writing, the situation of exposing emotions, the harvest of writing, and the degree of understanding of diseases, etc. answered by the subjects after writing, so as to get the preliminary evaluation of writing. (2) The basic information of patients and their families was analyzed by ANOVA and variance test, and the demographic bias was examined according to the patient's age, gender, disease stage and so on. (3) After the baseline and follow-up scales use Excel to collect information, we will use spss24.0 for statistical summary and analysis. We will repeat the analysis of the initial data with the newly added data and the missing data to ensure the processing efficiency. The purpose of this study is to test whether expressive writing can improve the anxiety, depression and other emotional problems of patients with nasopharyngeal carcinoma, malignant soft tissue sarcoma and malignant melanoma, improve the symptom burden, social support and quality of life of patients, the fear of recurrence of patients after treatment, and the psychological status and care burden of family members such as anxiety, depression and loneliness. For the patients in treatment, the baseline measurement differences of the three groups were tested firstly. If there was no significant difference, the repeated measurement analysis of variance was used to test the scores of different scales with different writing topic classification as time variables and different measurement time points as subjects variables. According to the different groups and the number of participants to determine the specific analysis method. 4. Research steps (1) The basic information and psychological status of the subjects before the intervention were collected by relevant scales. (2) Writing intervention: under the guidance of the researcher, the subjects wrote about specific topics once a week, six times for the patients and four times for the family members, and submitted the writing to the researcher in time. (3) The subjects were followed up 24 hours after writing and 2 weeks, 1 month, 3 months and 6 months after writing. The questionnaire design of each stage is the same as that of the baseline questionnaire except for the basic information of the subjects. At the completion of writing, the subjects will receive a separate questionnaire to investigate their opinions and effects on writing. 

纳入标准：

患者：
1. 病理学诊断为鼻咽癌、恶性软组织肉瘤或恶性黑色素瘤；
2. ≥18岁的患者；
3. 写作无障碍；
4. 自愿参与；
5. 能够理解并独立完成量表；
6. 愿意进行每周一次的写作。
家属：
1. 肿瘤患者的主要照护者；
2. ≥18岁；
3. 写作无障碍；
4. 自愿参与；
5. 能够理解并独立完成量表；
6. 愿意进行每周一次的写作

Inclusion criteria

Patients:
1. Pathological diagnosis was nasopharyngeal carcinoma, malignant soft tissue sarcoma or malignant melanoma;
2. Patients aged over 18 years;
3. Barrier free writing;
4. Voluntary participation;
5. Be able to understand and complete the scale independently;
6. Willing to write once a week
Family members:
1. The main caregivers of cancer patients;
2. Over 18 years old;
3. Barrier free writing;
4. Voluntary participation;
5. Be able to understand and complete the scale independently;
6. Willing to write once a week.

排除标准：

患者：
1. 病情严重，不能耐受长时间写作；
2. 有精神疾病史的受试者；
3. 正在进行其他心理治疗或精神类药物治疗(苯二氮卓类药物除外，因临床多数患者使用该类药物进行化疗止吐治疗)。
家属：
1. 不能耐受长时间写作；
2. 有精神疾病史的受试者；
3. 正在进行其他心理治疗或精神类药物治疗。

Exclusion criteria：

Patients:
1. Serious illness, unable to tolerate writing for a long time;
2. Subjects with a history of mental illness.
3. Other psychotherapy or psychotherapy is in progress (except benzodiazepines, which are used for chemotherapy and antiemetic treatment in most patients).
Family members:
1. Can't stand writing for a long time;
2. Subjects with a history of mental illness.
3. Other psychotherapy or psychotherapy is in progress.

研究实施时间：

Study execute time：

从 From 2020-11-11 00:00:00至 To 2022-11-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2020-11-01 00:00:00 至 To 2020-11-01 00:00:00  

干预措施：

Interventions：

组别：

治疗中患者：表达性写作组

样本量：

44

Group：

Patients under treatment: Expressive writing group

Sample size：

干预措施：

表达性写作

干预措施代码：

 1

Intervention：

Expressive writing

Intervention code：

组别：

治疗中患者：肿瘤事实组

样本量：

44

Group：

Patients under treatment: tumor facts group

Sample size：

干预措施：

肿瘤事实写作

干预措施代码：

 2

Intervention：

Tumor fact writing

Intervention code：

组别：

治疗中患者：中性写作组

样本量：

22

Group：

Patients under treatment: Neutral writing group

Sample size：

干预措施：

中性写作

干预措施代码：

 3

Intervention：

Neutral writing

Intervention code：

组别：

治疗后患者：表达性写作组

样本量：

50

Group：

Post-treatment patients: Expressive writing group

Sample size：

干预措施：

表达性写作

干预措施代码：

 4

Intervention：

Expressive writing

Intervention code：

组别：

患者家属：表达性写作组

样本量：

44

Group：

Family members of patients: Expressive writing grou

Sample size：

干预措施：

表达性写作

干预措施代码：

 5

Intervention：

Expressive writing

Intervention code：

组别：

患者家属：中性写作组

样本量：

44

Group：

Family members of patients: Neutral Writing Group

Sample size：

干预措施：

中性写作

干预措施代码：

 6

Intervention：

Neutral writing

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 四川 

市(区县)：

 成都 

Country：

China 

Province：

Sichuan 

City：

Chengdu 

单位(医院)：

四川大学华西医院 

单位级别：

三甲 

Institution
hospital：

West China Hospital of Sichuan University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

心理痛苦

指标类型：

次要指标

Outcome：

Psychological pain

Type：

Secondary indicator

测量时间点：

基线，随访

测量方法：

心理痛苦温度计（DT ）

Measure time point of outcome：

Baseline, follow-up

Measure method：

Psychological pain thermometer (DT)

指标中文名：

生存质量

指标类型：

主要指标

Outcome：

Quality of Life

Type：

Primary indicator

测量时间点：

基线，随访

测量方法：

EORTC QLQ-30 生存质量量表

Measure time point of outcome：

Baseline, follow-up

Measure method：

EORTC QLQ-30

指标中文名：

护理负担

指标类型：

主要指标

Outcome：

Nursing burden

Type：

Primary indicator

测量时间点：

基线，随访

测量方法：

ZBI护理负担量表

Measure time point of outcome：

Baseline, follow-up

Measure method：

ZBI Nursing Burden Scale

指标中文名：

复发恐惧

指标类型：

主要指标

Outcome：

Fear of recurrence

Type：

Primary indicator

测量时间点：

基线，随访

测量方法：

ZBI护理负担量表

Measure time point of outcome：

Baseline, follow-up

Measure method：

ZBI Nursing Burden Scale

指标中文名：

自我感觉症状

指标类型：

主要指标

Outcome：

Self-feeling symptoms

Type：

Primary indicator

测量时间点：

基线，随访

测量方法：

安德森症状评估量表（MDASI）

Measure time point of outcome：

Baseline, follow-up

Measure method：

Anderson Symptom Assessment Scale (MDASI)

指标中文名：

焦虑

指标类型：

次要指标

Outcome：

anxiety

Type：

Secondary indicator

测量时间点：

基线，随访

测量方法：

广泛性焦虑量表（GAD-7）

Measure time point of outcome：

Baseline, follow-up

Measure method：

Generalized Anxiety Scale (GAD-7)

指标中文名：

抑郁

指标类型：

次要指标

Outcome：

Depression

Type：

Secondary indicator

测量时间点：

基线，随访

测量方法：

患者健康问卷（PHQ-9）

Measure time point of outcome：

Baseline, follow-up

Measure method：

Patient Health Questionnaire (PHQ-9)

指标中文名：

睡眠质量

指标类型：

次要指标

Outcome：

Sleep quality

Type：

Secondary indicator

测量时间点：

基线，随访

测量方法：

匹兹堡睡眠质量指数问卷（PSQI）

Measure time point of outcome：

Baseline, follow-up

Measure method：

Pittsburgh Sleep Quality Index Questionnaire (PSQI)

指标中文名：

社会支持

指标类型：

次要指标

Outcome：

social support

Type：

Secondary indicator

测量时间点：

基线，随访

测量方法：

社会支持量表（MOS-SSS）

Measure time point of outcome：

Baseline, follow-up

Measure method：

Social Support Scale (MOS-SSS)

指标中文名：

照护能量

指标类型：

次要指标

Outcome：

Caring energy

Type：

Secondary indicator

测量时间点：

基线，随访

测量方法：

照护能量蓄电池（Burnout Battery）

Measure time point of outcome：

Baseline, follow-up

Measure method：

Burnout Battery

指标中文名：

孤独

指标类型：

次要指标

Outcome：

lonelyness

Type：

Secondary indicator

测量时间点：

基线，随访

测量方法：

孤独量表（ULS-6）

Measure time point of outcome：

Baseline, follow-up

Measure method：

Loneliness Scale (ULS-6)

采集人体标本：

Collecting sample(s)
from participants：

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 80 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）：

研究负责人采用SPSS生成随机数进行随机化，并根据其大小排序进行分组。

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

The research leader uses SPSS to generate random numbers for randomization and sorts them into groups according to their size.

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：

未说明

Blinding：

Not stated

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

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）：

ResMan临床试验公共管理平台, http://www.medresman.org.cn.

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

ResMan, http://www.medresman.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：

研究人员通过CRF表收集数据，EXCEL整理，SPSS统计分析病例报告表

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

The data were collected by the experimenter through CRF, sorted out by excel, and statistically analyzed by spss.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2020-10-10 18:51:09