ChiCTR2500112401 版本V1.0 版本创建时间2025/12/31 09:32:52 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：

 ChiCTR2500112401 

最近更新日期：

Date of Last Refreshed on：

 2025-11-13 15:51:26 

注册时间：

Date of Registration：

 2025-11-13 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

基于即时适配干预的肺癌术后化疗患者前哨症状管理模式构建及实证研究

Public title：

Development and empirical study of sentinel symptom management model for postoperative lung cancer patients undergoing chemotherapy with real-time adaptive intervention

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于即时适配干预的肺癌术后化疗患者前哨症状管理模式构建及实证研究

Scientific title：

Development and empirical study of sentinel symptom management model for postoperative lung cancer patients undergoing chemotherapy with real-time adaptive intervention

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：

马景双 

研究负责人：

马景双 

Applicant：

Ma Jingshuang 

Study leader：

Ma Jingshuang 

申请注册联系人电话：

Applicant telephone：

 +86 188 4242 8125

研究负责人电话：

Study leader's
telephone：

+86 188 4242 8125

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：

 723494553@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 723494553@qq.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：

中国辽宁省沈阳市皇姑区崇山东路77号

研究负责人通讯地址：

中国辽宁省沈阳市皇姑区崇山东路77号

Applicant address：

Chongshandong Road 77, Huanggu District, Shenyang, Liaoning, China

Study leader's address：

Chongshandong Road 77, Huanggu District, Shenyang, Liaoning, 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：

辽宁中医药大学

Applicant's institution：

Liaoning University of Traditional Chinese Medicine

研究负责人所在单位：

辽宁中医药大学

Affiliation of the Leader：

Liaoning University of Traditional Chinese Medicine

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：

 Y2025297CS(KT)-297-01

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：

辽宁中医药大学附属医院伦理委员会

Name of the ethic committee：

IRB of The Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-10-30 00:00:00

伦理委员会联系人：

于萍

Contact Name of the ethic committee：

Yu Ping

伦理委员会联系地址：

中国辽宁省沈阳市皇姑区崇山东路72号

Contact Address of the ethic committee：

Chongshandong Road 72, Huanggu District, Shenyang, Liaoning, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 24 8296 1989

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：

辽宁中医药大学

Primary sponsor：

Liaoning University of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

中国辽宁省沈阳市皇姑区崇山东路77号

Primary sponsor's address：

Chongshandong Road 77, Huanggu District, Shenyang, Liaoning, 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)：

辽宁

市(区县)：

Country：

China

Province：

Liaoning

City：

单位(医院)：

辽宁中医药大学

具体地址：

中国辽宁省沈阳市皇姑区崇山东路77号

Institution
hospital：

Liaoning University of Traditional Chinese Medicine

Address：

Chongshandong Road 77, Huanggu District, Shenyang, Liaoning, China

经费或物资来源：

博士课题经费

Source(s) of funding：

Doctor project funds

研究疾病：

肺癌  

Target disease：

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：

综合前期纵向调查和质性研究结果，结合文献分析，以症状管理理论为理论框架，构建肺癌术后化疗患者症状群干预方案并评价其受否可以改善患者症状严重度和提高生活质量。  

Objectives of Study：

Based on the results of a comprehensive previous longitudinal investigation and qualitative research, combined with literature analysis, the symptom management theory was used as the theoretical framework to construct the symptom group intervention program for patients with postoperative chemotherapy for lung cancer and evaluate whether it could improve the severity of patients' symptoms and improve their quality of life.

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. 病理诊断为肺癌； 2. 术后拟接受至少4个周期的化疗； 3. 年龄>=18岁。

Inclusion criteria

1. Pathological diagnosis of lung cancer; 2. Planned to receive at least 4 cycles of chemotherapy post-surgery; 3. Age >= 18 years.

排除标准：

1. 肺癌复发或转移； 2. 合并较严重的认知及精神障碍； 3. 合并心、脑、肾等重要脏器严重疾病。

Exclusion criteria：

1. Recurrence or metastasis of lung cancer; 2. Coexisting moderate to severe cognitive or psychiatric disorders; 3. Coexisting severe diseases of vital organs such as heart, brain, or kidney.

研究实施时间：

Study execute time：

从 From 2026-01-01 00:00:00至 To 2026-07-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2026-01-01 00:00:00 至 To 2026-04-01 00:00:00

干预措施：

Interventions：

组别：

干预组

样本量：

 45

Group：

Intervention group

Sample size：

干预措施：

干预组在常规护理的基础上，接受4个化疗周期的消化道症状群护理干预方案。随着化疗的深入，每个化疗周期干预内容侧重点不同。第1个化疗周期主要进行疾病相关知识的科普及常用化疗药物不良反应介绍，化疗前心理准备、饮食准备等，目的是帮助患者正确认识疾病，树立乐观心态，积极配合治疗。随着化疗药物在体内蓄积，患者消化道症状较为明显，故第2~3个周期主要以症状管理为主，目的是降低症状发生率和严重程度，帮助患者适应化疗状态，提高治疗依从性。第4个化疗周期重点关注患者的心理状态，肯定患者的努力坚持，鼓励家属继续支持及陪伴，提高患者抗癌信念。在患者住院化疗之前，为患者及家属详细介绍恶心症状相关内容，同时向患者发放“肺癌术后化疗患者恶心自我管理手册”。在患者化疗间歇期居家期间，对患者进行微信、电话或线上会议随访2次，25~30min/次，时间分别在出院第7、14天，共8次，使用视频、图片和文字等形式，询问患者的恶心体验，督促患者进行症状管理行为，强化患者症状管理的信念，制订个体化的自我管理方案。

干预措施代码：

Intervention：

The Intervention group received four chemotherapy cycles of gastrointestinal symptom management interventions in addition to standard care. As chemotherapy progressed, the intervention focus shifted with each cycle. The first cycle emphasized disease education, introduction of common chemotherapy drug side effects, and pre-treatment psychological preparation and dietary guidance to help patients understand their condition, maintain optimism, and actively participate in treatment. During the second and third cycles, symptom management became primary, aiming to reduce symptom frequency and severity while helping patients adapt to chemotherapy and improve treatment compliance. The fourth cycle prioritized psychological support, acknowledging patients' efforts, encouraging family support, and strengthening their cancer-fighting resolve. Before hospitalization, patients and families received detailed nausea symptom education, along with distribution of the "Self-Management Handbook for Nausea in Lung Cancer Chemotherapy Patients". During home recovery periods between treatments, patients underwent two follow-ups (25-30 minutes each) via WeChat, phone, or video calls on the 7th and 14th post-discharge days, using multimedia formats to assess nausea experiences, guide symptom management behaviors, reinforce treatment adherence, and develop personalized self-care plans.

Intervention code：

组别：

对照组

样本量：

 45

Group：

Control group

Sample size：

干预措施：

对照组患者实施常规护理。在化疗前为患者一对一简单介绍化疗的基本知识、化疗前、化疗中及化疗后注意事项、常见化疗不良反应的应对方法等，告知患者做好心理准备，给予饮食指导，每周期1次，共4次，时间为10~15min；居家期间对患者进行电话或微信随访1次，随访内容包括评估患者恶心程度，告知其恶心呕吐导致的并发症居家处理措施、居家饮食注意事项、居家运动注意事项、穴位按摩方法、渐进性肌肉放松疗法及冥想疗法练习方法、用药注意事项等，时间在出院第7天，每周期1次，共4次，时间为15~20min。

干预措施代码：

Intervention：

Control group patients receive standard care. Before chemotherapy, they receive one-on-one briefings covering basic chemotherapy knowledge, precautions before, during, and after treatment, and management of common adverse reactions. Patients are advised to prepare mentally and receive dietary guidance. These sessions are conducted once per cycle (total 4 sessions), lasting 10-15 minutes. During home care, patients undergo telephone or WeChat follow-ups once per cycle (total 4 sessions), assessing nausea severity and providing guidance on home management of nausea/vomiting complications, dietary precautions, exercise guidelines, acupoint massage techniques, progressive muscle relaxation therapy, meditation practice methods, and medication precautions. These follow-ups occur on the 7th day after discharge, lasting 15-20 minutes per session.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 辽宁 

市(区县)：

  

Country：

China

Province：

Liaoning

City：

单位(医院)：

 辽宁中医药大学附属医院 

单位级别：

 三甲 

Institution
hospital：

Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

消化道症状群

指标类型：

主要指标

Outcome：

Gastrointestinal symptoms

Type：

Primary indicator

测量时间点：

在患者第1、3、5次化疗前

测量方法：

安德森症状评估量表

Measure time point of outcome：

Before the first, third, and fifth chemotherapy

Measure method：

M.D.Anderson symptom inventory

指标中文名：

生活质量

指标类型：

次要指标

Outcome：

Quality of life

Type：

Secondary indicator

测量时间点：

在患者第1、3、5次化疗前

测量方法：

健康状况调查简表，SF-36

Measure time point of outcome：

Before the first, third, and fifth chemotherapy

Measure method：

MOS 36-item short-form health survey

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

None

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 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）：

本研究按照病区进行分组，肿瘤内科一病区和二病区。按照抛硬币法，将其中一个病区分为干预组，另一病区为对照组。

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

The study subjects were grouped according to the ward, the first ward and the second ward of the medical oncology. According to the coin toss method, one ward was divided into intervention group and the other ward into control 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：

无

Blinding：

None

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)：

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：

收集资料前，研究者征得医院护理部主任和科室护士长同意。依据标准招募患者，向患者详细解释研究目的，对自愿参加研究的患者给与一定物质报酬，与患者或家属建立微信、电话联系，居家期间积极主动与患者或家属沟通交流，利用所学专科知识随时解决患者提出的问题，如提醒下次入院时间、告知静脉管路居家维护知识等，充分取得患者信任和配合，以提高依从性，降低失访率。在患者第1次化疗前收集两组研究对象的一般资料调查表、消化道症状群和生活质量量表的数据，在患者第3次化疗前和第5次化疗前再次收集消化道症状群和生活质量量表的数据。为每个患者建立一个excel文档用于数据管理。患者化疗出院后居家期间症状管理行为主要由家属或者其主要照顾者负责督促并向研究者进行反馈，对于文字表述困难但能语言表达的患者，采取电话、微信语音或视频形式与患者沟通，获得患者信息。

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

Before data collection, the researchers obtained the consent of the director of the nursing department and the head nurse of the department. According to the standard to recruit patients, explain the purpose, in patients volunteered to study give certain material remuneration, establish WeChat, telephone contact with patients or families, home during active communication with patients or family members, using specialized knowledge at any time to solve the problems of the patients, such as remind next admission time, inform venous line home maintenance knowledge, fully obtain patient trust and cooperation, in order to improve compliance, reduce the loss rate. Data from the general data questionnaire, gastrointestinal symptom group and quality of life scale were collected before the first chemotherapy, and data from the gastrointestinal symptom group and quality of life scale were collected again before the third and the fifth chemotherapy. Establish an excel document for each patient for data management. During the symptom management at home after chemotherapy, the patients are mainly supervised and supervised by the family members or their main caregivers and give feedback to the researchers. For patients who are difficulty in writing but can express language, they can communicate with the patients in the form of telephone, wechat voice or video to obtain patient information.

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：

  2025-11-13 15:51:26