ChiCTR2500103371 版本V1.0 版本创建时间2025/05/28 14:33:27 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：

 ChiCTR2500103371 

最近更新日期：

Date of Last Refreshed on：

 2025-05-28 14:33:22 

注册时间：

Date of Registration：

 2025-05-28 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

基于移动应用程序的网络正念干预：提升鼻咽癌患者创伤后成长的方案构建和实证研究

Public title：

Improving The Psychological Post-traumatic Growth Of Nasopharyngeal Carcinoma Patients Through Online Mindfullness Intervention:Mixed Methods Feasibility Study

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于移动应用程序的网络正念干预：提升鼻咽癌患者创伤后成长的方案构建和实证研究

Scientific title：

Improving the Psychological post-traumatic growth of Nasopharyngeal Carcinoma Patients through Online Mindfullness Intervention:Mixed Methods Feasibility Study

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：

李佳丝 

研究负责人：

高云 

Applicant：

LiJiasi 

Study leader：

GaoYun 

申请注册联系人电话：

Applicant telephone：

 +86 131 9370 6044

研究负责人电话：

Study leader's
telephone：

+86 186 2043 8940

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：

 2466839674@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 gaoyunlily@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：

广东省广州市越秀区广州医科大学

研究负责人通讯地址：

广东省广州市越秀区广州医科大学

Applicant address：

Guangzhou Medical University

Study leader's address：

Guangzhou Medical University

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：

广州医科大学

Applicant's institution：

Guangzhou Medical University

研究负责人所在单位：

广州医科大学

Affiliation of the Leader：

Guangzhou Medical University

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：

 202504015

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：

广州医科大学医学伦理委员会

Name of the ethic committee：

GuangZhou Medical University Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-04-02 00:00:00

伦理委员会联系人：

陈宣朗

Contact Name of the ethic committee：

Chen XuanLang

伦理委员会联系地址：

广州医科大学番禺校区行政楼321

Contact Address of the ethic committee：

Guanazhou Medical University Room 321. Administration Building, Panyy County Kung Campus

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 20 3710 3519

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：

广州医科大学

Primary sponsor：

Guangzhou Medical University

研究实施负责（组长）单位地址：

广州医科大学

Primary sponsor's address：

Guangzhou Medical University

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

广州

市(区县)：

GUANZG ZHOU

Country：

China

Province：

YUEXIU

City：

GUANZG ZHOU

单位(医院)：

广州医科大学

具体地址：

广东省广州市越秀区广州医科大学

Institution
hospital：

Guangzhou Medical University

Address：

GuangZhou Medical University

经费或物资来源：

广州医科大学

Source(s) of funding：

Guangzhou Medical University

研究疾病：

鼻咽癌  

Target disease：

Nasopharyngeal Carcinoma NPC

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：

遵循实施科学整合理论框架的指导，结合鼻咽癌患者的身心特点，构建基于网络的正念干预方案，并通过研究评估app的网络正念干预对鼻咽癌患者创伤后成长中进行使用的干预效果。  

Objectives of Study：

Following the guidance of implementing the scientific integration theoretical framework, combining the physical and psychological characteristics of nasopharyngeal cancer patients, constructing a web-based positive thinking intervention program, and evaluating the intervention effects of the app's web-based positive thinking intervention for use in the post-traumatic growth of nasopharyngeal cancer patients through the study.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

(1)年龄18～65岁； (2)经鼻咽镜、病理学、EB 病毒壳抗原、lgA 抗体、CT 等检查，均确诊为鼻咽癌。 (3)治疗方案为同步放、化疗。其中放疗方案为调强放疗，次数为31~33次，剂量（1.8～2.2) Gy／次; (4)简易智能精神状态检查量表（MMSE）得分≥27分； (5)能操作智能手机，手机日常可联网，每天使用手机≥1小时； (6)无语言障碍，沟通良好；具备汉语读、写、说能力。 (7)知情同意，自愿接受配合本研究的实施。

Inclusion criteria

(1)Age 18~65 years old; (2) Nasopharyngeal cancer was diagnosed by Nasopharyngeal Carcinoma , pathology, EB virus shell antigen, antibody and CT. (3) The treatment plan was simultaneous radiotherapy and chemotherapy. The radiotherapy program was intensity-modulated radiotherapy (IMRT), with a dose of (1.8-2.2) Gy/times for 31-33 times. (4) A score of >= 27 on the Brief Intelligent Mental State Examination (MMSE) scale; (5) Ability to operate a smartphone, with daily internet access on the phone, and use the phone for >= 1 hour per day; (6) No language barrier and good communication; ability to read, write and speak Chinese. (7) Informed consent and voluntary acceptance to cooperate with the implementation of this study.

排除标准：

(1)预计生存期 <6 个月； (2)正在参与或以往参与过正念干预试验研究； (3)合并心脑血管、肝肾功能严重障碍或其他类型恶性肿瘤者； (4)放疗前伴严重营养不良，即血清白蛋白< 30 g/L 或体重指数（BMI，kg/m2）<18. 5； (5)患有精神疾病或意识、交流障碍者； (6)在研究期间服用任何精神类药物，如抗抑郁药、抗精神病药、情绪稳定剂、麻醉药品和苯二氮卓类药物，以及任何治疗失眠或其他抗抑郁药物的处方；

Exclusion criteria：

(1) Expected survival <6 months; (2) Are participating or have previously participated in a pilot study of orthostatic intervention; (3) Combined cardiovascular, cerebrovascular, liver and renal dysfunction severe or other types of malignant tumors; (4) With severe malnutrition before radiotherapy, i.e., serum albumin < 30 g/L or body mass index (BMI, kg/m^2) < 18. 5; (5) Those suffering from mental illness or disorders of consciousness or communication; (6) Taking any psychotropic medications during the study period, such as antidepressants, antipsychotics, mood stabilizers, narcotics, and benzodiazepines, as well as any prescription for insomnia or other antidepressants;

研究实施时间：

Study execute time：

从 From 2025-06-05 00:00:00至 To 2025-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-06-05 00:00:00 至 To 2025-12-31 00:00:00

干预措施：

Interventions：

组别：

干预组

样本量：

 30

Group：

intervention group

Sample size：

干预措施：

干预组患者给予同步放化疗常规护理和心理护理，主要为介绍同步放、化疗相关知识，给予鼓励与安慰以及三次线下一对一指导。给予为期８周的线上正念减压疗法。提前为患者解释参与内容以及讲解app的使用，利用app进行线上的学习和互动。每周至少5天，每天至少10分钟进行干预内容的学习和正念的相关练习，并完成家庭作业的练习。研究团队还通过app在科普圈分享正念相关阅读材料，包括正念的相关知识，如正念的来源、发展、应用、与睡眠的关系等内容，增强对正念疗法的信心；研究人员将会在app科普圈上传疾病相关内容等，方便患者进行查看和学习，促进患者对疾病的认识和了解；研究团队通过线上app打卡群督促患者完成练习的时间和次数，鼓励参与者每天在微信群内进行正念练习的打卡，交流正念练习的体验和感受，说出内心的疑惑。

干预措施代码：

Intervention：

Patients in the intervention group were given routine care and psychological care for synchronized radiotherapy, which mainly consisted of introduction of knowledge related to synchronized radiotherapy and chemotherapy, encouragement and comfort as well as three offline one-on-one guidance. The patients were given 8 weeks of online positive thinking stress reduction therapy. Explain the content of the participation as well as explain the use of the app to the patients in advance, and utilize the app for online learning and interaction. Learning of the intervention content and positive thinking-related exercises were conducted for at least 10 minutes per day, at least 5 days per week, and homework exercises were completed. The research team also shared reading materials related to positive thinking in the science circle through the app, including knowledge related to positive thinking, such as the source, development, application, and relationship with sleep, to enhance confidence in positive thinking therapy; the researchers will upload disease-related content and other content in the app's science circle, which is convenient for patients to view and learn, and promotes patients' knowledge and understanding of the disease; the research team urged patients to complete the exercise through the online app Through the online app, the research team urges patients to complete the time and frequency of the exercises, and encourages participants to clock in and out of the WeChat group every day to share their experiences and feelings about the exercises, and to express their inner doubts.

Intervention code：

组别：

对照组

样本量：

 30

Group：

control group

Sample size：

干预措施：

患者给予同步放化疗常规护理和心理护理，主要为介绍同步放、化疗相关知识，给予鼓励与安慰以及三次线下一对一指导。

干预措施代码：

Intervention：

Patients were given synchronized radiotherapy routine care and psychological care, which mainly consisted of introduction of knowledge related to synchronized radiotherapy and chemotherapy, encouragement and comfort as well as three offline one-on-one guidance.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广州 

市(区县)：

  

Country：

China

Province：

GuangZhou

City：

单位(医院)：

 广州医科大学 

单位级别：

 大学 

Institution
hospital：

Guangzhou Medical University

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

创伤后成长

指标类型：

主要指标

Outcome：

post-traumatic growth

Type：

Primary indicator

测量时间点：

干预前 干预四周 干预八周

测量方法：

问卷

Measure time point of outcome：

Pre-intervention, four weeks of intervention, eight weeks of intervention

Measure method：

poll

指标中文名：

病耻感

指标类型：

次要指标

Outcome：

sense of shame

Type：

Secondary indicator

测量时间点：

干预前 干预四周 干预八周

测量方法：

问卷

Measure time point of outcome：

Pre-intervention, four weeks of intervention, eight weeks of intervention

Measure method：

poll

指标中文名：

正念水平

指标类型：

次要指标

Outcome：

mindfulness level

Type：

Secondary indicator

测量时间点：

干预前 干预四周 干预八周

测量方法：

问卷

Measure time point of outcome：

Pre-intervention, four weeks of intervention, eight weeks of intervention

Measure method：

poll

指标中文名：

生存质量

指标类型：

次要指标

Outcome：

Quality of life

Type：

Secondary indicator

测量时间点：

干预前 干预四周 干预八周

测量方法：

问卷

Measure time point of outcome：

Pre-intervention, four weeks of intervention, eight weeks of intervention

Measure method：

poll

指标中文名：

心理痛苦

指标类型：

次要指标

Outcome：

psychological distress

Type：

Secondary indicator

测量时间点：

干预前 干预四周 干预八周

测量方法：

问卷

Measure time point of outcome：

Pre-intervention, four weeks of intervention, eight weeks of intervention

Measure method：

poll

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

无

Sample Name：

None

Tissue：

no

人体标本去向

 使用后销毁  

说明

无

Fate of sample：

Destruction after use  

Note：

no

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 65 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）：

采用简单随机化法，在研究对象招募结束后，委托一名不参与本课题的研究人员采用随机数字表法生成60个随机数字，指定单数为对照组，双数为干预组。

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

A simple randomization method was used, whereby a researcher who was not involved in the subject was commissioned to generate 60 random numbers using the random number table method after the recruitment of the study subjects was completed, designating odd numbers as the control group and even numbers as the intervention group.

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：

在干预中遵循单盲的原则，各阶段的资料收集者均不知晓参与者的分组情况，只有干预人员知晓分组情况。

Blinding：

Single blinded. None of the data collectors at each stage are aware of the participants' groupings. Only the interventionists are aware of the groupings.

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

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）：

无

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

no

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：

1. 确保受试者秘密和匿名的措施 数据匿名化：在数据收集阶段，所有受试者的个人信息（如姓名、身份证号、联系方式）将被替换为唯一的编码（如ID号）；访谈录音和转录文件将删除任何可能识别受试者身份的内容（如具体地点、人名等）。 2.销毁时间：纸质文件（如知情同意书）将在研究结束后保存至少1年，之后通过碎纸机销毁；电子数据将在研究结束后保存至少1年，之后通过安全删除软件彻底销毁。 销毁记录：所有销毁操作将记录在案，包括销毁时间、方式和负责人。 3.未来使用保存的资料：保存的资料可能用于后续研究（如长期干预效果评估或Meta分析）；也可能用于学术交流或发表（仅限匿名数据）。

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

1. Measures to ensure subject confidentiality and anonymity Data anonymization: During the data collection phase, all subjects' personal information (e.g., name, ID number, contact information) will be replaced with a unique code (e.g., ID number); audio recordings of interviews and transcribed documents will be deleted of any content that may identify subjects (e.g., specific locations, names of people, etc.). 2. Destruction time: Paper documents (e.g., informed consent forms) will be kept for at least 1 year after the end of the study, after which they will be destroyed through a shredder; electronic data will be kept for at least 1 year after the end of the study, after which they will be completely destroyed through secure deletion software. Destruction records: all destruction operations will be recorded, including the time, manner and person in charge of destruction. 3. Future use of preserved data: Preserved data may be used for follow-up studies (e.g., long-term evaluation of intervention effects or Meta-analysis); they may also be used for academic communication or publication (anonymized data only).

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：

  2025-05-28 14:33:22