ChiCTR2600121440 版本V1.0 版本创建时间2026/03/31 08:59:12 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：

 ChiCTR2600121440 

最近更新日期：

Date of Last Refreshed on：

 2026-03-31 08:59:07 

注册时间：

Date of Registration：

 2026-03-31 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

基于BCW理论对肺癌化疗患者运动依从性干预方案的构建研究

Public title：

A Study on Developing an Exercise Adherence Intervention Program for Lung Cancer Chemotherapy Patients Based on the BCW

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于BCW理论对肺癌化疗患者运动依从性干预方案的构建研究

Scientific title：

A Study on Developing an Exercise Adherence Intervention Program for Lung Cancer Chemotherapy Patients Based on the BCW Theory

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：

杨然然 

研究负责人：

马莉 

Applicant：

Yang Ranran 

Study leader：

Ma Li 

申请注册联系人电话：

Applicant telephone：

 +86 135 4778 6107

研究负责人电话：

Study leader's
telephone：

+86 177 6776 1372

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：

 2394566095@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 ma_L@jlu.edu.cn

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：

中国吉林省长春市朝阳区新疆街888号

研究负责人通讯地址：

中国吉林省长春市南关区自强街218号

Applicant address：

888 Xinjiang Street, Chaoyang District, Changchun, Jilin, China

Study leader's address：

218 Ziqiang Street, Nanguan District, Changchun, Jilin, 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：

吉林大学护理学院

Applicant's institution：

School of Nursing, Jilin University Changchun City, Jilin Province

研究负责人所在单位：

吉林大学第二医院自强院区

Affiliation of the Leader：

Second Hospital of Jilin University, Changchun City, Jilin Province, Ziqiang Campus

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：

 (2025)年院审第(008)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：

吉林大学第二医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of the Second Hospital of Jilin University

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-01-08 00:00:00

伦理委员会联系人：

杨薇

Contact Name of the ethic committee：

Yang Wei

伦理委员会联系地址：

中国吉林省长春市南关区亚泰大街4026号

Contact Address of the ethic committee：

4026 Yatai Street, Nanguan District, Changchun, Jilin, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 431 8113 6555

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：

吉林大学第二医院

Primary sponsor：

The Second Hospital of Jilin University

研究实施负责（组长）单位地址：

中国吉林省长春市南关区自强街218号

Primary sponsor's address：

218 Ziqiang Street, Nanguan District, Changchun, Jilin, 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)：

吉林

市(区县)：

长春

Country：

China

Province：

Jilin

City：

Changchun

单位(医院)：

吉林大学第二医院

具体地址：

中国吉林省长春市南关区自强街218号

Institution
hospital：

The Second Hospital of Jilin University

Address：

218 Ziqiang Street, Nanguan District, Changchun, Jilin, China

经费或物资来源：

自筹

Source(s) of funding：

Self-funded

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：

 探索性研究/预试验 

Study phase：

0

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

总结影响肺癌化疗患者运动依从性的因素，探究患者的运动依从性及医护人员在运动管理经验；整合研究成果，并基于BCW理论为肺癌化疗患者制定运动依从性方案。  

Objectives of Study：

Summarize the factors influencing exercise adherence among lung cancer chemotherapy patients, investigate patients' exercise adherence and healthcare providers' experiences with exercise management; integrate research findings and develop an exercise adherence program for lung cancer chemotherapy patients based on the BCW theory.

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. 经病理检查确诊为肺癌，且根据第八版国际肺癌 TNM 分期：III期-IV 期无法接受手术治疗但有化疗指征的患者 2. 简易体能状况（Short Physical Performance Battery，SPPB）得分>=7分 3. 年龄>=18岁； 4. 无精神疾病及认知障碍，语言表达能力正常，有正常沟通、书写能力； 5. 对此次研究知情，自愿签署知情同意书。

Inclusion criteria

1. Patients diagnosed with lung cancer following pathological examination, and classified as Stage III–IV according to the 8th edition of the International Union Against Cancer (UICC) TNM staging system, who are ineligible for surgical treatment but meet the criteria for chemotherapy 2. Short Physical Performance Battery (SPPB) score of >=7 3. Age >= 18 years; 4. No history of psychiatric disorders or cognitive impairment; normal verbal expression; normal communication and writing abilities; 5. Informed about this study and voluntarily signed the informed consent form.

排除标准：

1. 有阻力训练禁忌症的患者，如中度至重度衰竭； 2. 合并严重的心肺疾病、高血压、糖尿病者； 3. 合并其他部位癌症或癌症远处转移者以及患有躯体疾病者； 4. 有精神疾病史或存在运动禁忌症如骨质疏松症、椎间盘突出、神经肌肉骨骼病、凝血障碍、癫痫等； 5. 合并有明显的胸腹水，经医生诊断后需要限制活动量者。 6. 研究期间病情加重，经与医生讨论后不适宜进行康复锻炼的患者； 7. 研究期间因不可抗力去世者

Exclusion criteria：

1. Patients with contraindications to resistance training, such as moderate to severe heart failure; 2. Patients with severe concomitant cardiopulmonary disease, hypertension or diabetes; 3. Patients with cancer in other parts of the body or distant metastases, as well as those with systemic diseases; 4. Patients with a history of mental illness or with contraindications to exercise, such as osteoporosis, herniated discs, neuromusculoskeletal disorders, coagulation disorders or epilepsy; 5. Patients with significant pleural or abdominal effusion who, following medical assessment, require restricted activity levels; 6. Patients whose condition worsens during the study and who, following consultation with a doctor, are deemed unsuitable for rehabilitation exercises; 7. Patients who die during the study due to circumstances beyond human control;

研究实施时间：

Study execute time：

从 From 2025-06-01 00:00:00至 To 2026-02-28 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-06-03 00:00:00 至 To 2025-10-31 00:00:00

干预措施：

Interventions：

组别：

干预组

样本量：

 12

Group：

Intervention Group

Sample size：

干预措施：

基于 BCW 理论的运动依从性方案：住院期间进行面对面团体/个体干预（含教育、说服、动机激发、实现、培训、激励、环境重建），居家期间进行微信随访（每日记录、拍照上传、反馈）、电话随访（评估实施情况、心理疏导），化疗第二三次住院期间进行收获分享、目标回顾、动作纠正及教育。具体包括健步走、弹力带抗阻运动等。

干预措施代码：

Intervention：

BCW-based physical activity adherence program: face-to-face group or individual interventions (including education, persuasion, motivation enhancement, implementation, training, incentives, and environmental restructuring) during hospitalization; WeChat follow-up (daily recording, photo upload, feedback) and telephone follow-up (assessment of implementation, psychological counseling) at home; sharing sessions, goal review, movement correction, and education during the second and third chemotherapy hospitalizations. Includes activities such as brisk walking and resistance band exercises.

Intervention code：

组别：

对照组

样本量：

 12

Group：

Control Group

Sample size：

干预措施：

常规护理指导：低中强度有氧联合抗阻训练（健步走 + 弹力带）。初始频率 3 次/周，抗阻运动 1-2 次/周，10 次/组。进阶速率每 1-2 周增加 5-10min，2-3 周后频次增至 5 次/周。最后达到每周累计至少 150min 中等有氧运动，每周至少 2 次抗阻运动。

干预措施代码：

Intervention：

Routine nursing guidance: low-to-moderate intensity aerobic combined with resistance training (brisk walking + resistance bands). Initial frequency: 3 times per week, resistance training 1–2 times per week, 10 repetitions per set. Progression rate: increase by 5–10 minutes every 1–2 weeks; increase frequency to 5 times per week after 2–3 weeks. Ultimately achieve at least 150 minutes of moderate-intensity aerobic exercise per week and at least 2 resistance training sessions per week.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 吉林 

市(区县)：

  

Country：

China

Province：

Jilin

City：

单位(医院)：

 吉林大学第二医院 

单位级别：

 三甲 

Institution
hospital：

The Second Hospital of Jilin University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

简易体能状况（Short Physical Performance Battery，SPPB）得分

指标类型：

主要指标

Outcome：

Short Physical Performance Battery (SPPB) Score

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

运动依从性

指标类型：

主要指标

Outcome：

Exercise Adherence

Type：

Primary indicator

测量时间点：

干预前、干预1个月、3个月

测量方法：

Measure time point of outcome：

Pre-intervention, 1 month post-intervention, 3 months post-intervention

Measure method：

指标中文名：

运动方案实施情况

指标类型：

主要指标

Outcome：

Implementation of Exercise Program

Type：

Primary indicator

测量时间点：

干预前、干预1个月、3个月

测量方法：

Measure time point of outcome：

Pre-intervention, 1 month post-intervention, 3 months post-intervention

Measure method：

指标中文名：

对微信群内推送内容的掌握情况

指标类型：

主要指标

Outcome：

Comprehension of Content Pushed in WeChat Group

Type：

Primary indicator

测量时间点：

每周五

测量方法：

Measure time point of outcome：

Every Friday

Measure method：

指标中文名：

不良事件

指标类型：

副作用指标

Outcome：

Adverse Events

Type：

Adverse events

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

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

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age NA 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）：

采用随机数表法实现分：由未参与研究、对干预方案及研究目的设盲的外部人员，生成1至24之间的24个随机数并按降序排列。前12个数字分配给干预组，后12个数字分配给对照组。随机化方案由一名未直接参与本研究、且不知晓研究目的或干预方案的外部研究人员制定。入组时按患者招募顺序依次编号。

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

Participants were randomly allocated to the intervention group or the control group in a 1:1 ratio using a random number table. Patients were sequentially numbered upon enrolment. A total of 24 random numbers between 1 and 24 were generated using the Group allocation was performed using a random number table: an external individual, who was not involved in the study and was blinded to the intervention and the study objectives, generated 24 random numbers between 1 and 24 and arranged them in descending order. The first 12 numbers were allocated to the intervention group, and the remaining 12 to the control group. The randomisation scheme was devised by an external researcher who was not directly involved in this study and was unaware of the study objectives or the intervention. Upon enrolment, patients were sequentially numbered according to the order of recruitment.

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：

本研究因干预措施为运动指导，无法对干预实施者及研究对象设盲，仅对数据收集者和统计分析者实施单盲，以减少测量偏倚。

Blinding：

As the intervention in this study involved exercise guidance, it was not possible to blind the intervention providers or the study participants; instead, a single-blind design was implemented for the data collectors and those conducting the statistical analysis, in order to minimise measurement bias.

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

是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）：

预计研究结束半年；Resman（http://www.medresman.org.cn/）

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

It is expected that the research will be completed within half a year. 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：

本研究，采用纸质病例记录表收集研究对象的一般资料及运动依从性相关问卷数据。选用EpiData3.1软件数据录入采用双人双录法，由2名经过培训的研究人员独立录入，录入完成后进行交叉核对，以确保数据准确无误。所有原始数据及电子数据库均存储于加密的专用电脑中，严格保护受试者隐私，符合伦理审查要求。

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

This study utilised paper-based medical record forms to collect general information on the study participants and data from questionnaires relating to exercise adherence. Data entry was carried out using a double-entry method, with two trained researchers entering the data independently; the entries were subsequently cross-checked to ensure accuracy. All raw data and electronic databases were stored on encrypted dedicated computers, strictly safeguarding participants’ privacy and complying with ethical review requirements.

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：

  2026-03-31 08:59:07