ChiCTR2400091076 版本V1.0 版本创建时间2024/10/21 09:03:11 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：

ChiCTR2400091076 

最近更新日期：

Date of Last Refreshed on：

2024-10-21 09:03:03 

注册时间：

Date of Registration：

2024-10-21 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

肺癌术后老年患者居家自我管理方案的构建与应用研究

Public title：

The Development and Application Study of a Home-Based Self-Management Program for Elderly Patients Post-Lung Cancer Surgery

注册题目简写：

English Acronym：

研究课题的正式科学名称：

肺癌术后老年患者居家自我管理方案的构建与应用研究

Scientific title：

The Development and Application Study of a Home-Based Self-Management Program for Elderly Patients Post-Lung Cancer Surgery

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：

王淑雅 

研究负责人：

吴燕 

Applicant：

Wang Shuya 

Study leader：

WuYan 

申请注册联系人电话：

Applicant telephone：

+86 181 3443 3969

研究负责人电话：

Study leader's telephone：

+86 137 6190 1925

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：

wangshuya202103@163.com

研究负责人电子邮件：

Study leader's E-mail：

rachelwu@sina.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：

上海市徐汇区枫林路180号复旦大学附属中山医院西院区1号门

研究负责人通讯地址：

上海市徐汇区枫林路180号复旦大学附属中山医院西院区1号门

Applicant address：

No. 1 Gate, West Campus of Zhongshan Hospital Affiliated with Fudan University, 180 Fenglin Road, Xuhui District, Shanghai

Study leader's address：

No. 1 Gate, West Campus of Zhongshan Hospital Affiliated with Fudan University, 180 Fenglin Road, Xuhui District, Shanghai

申请注册联系人邮政编码：

Applicant postcode：

200030

研究负责人邮政编码：

Study leader's postcode：

200030

申请人所在单位：

复旦大学附属中山医院

Applicant's institution：

Zhongshan Hospital Affiliated to Fudan University

研究负责人所在单位：

复旦大学附属中山医院

Affiliation of the Leader：

Zhongshan Hospital Affiliated to Fudan 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：

B2024-404R

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：

复旦大学附属中山医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Zhongshan Hospital Affiliated to Fudan University

伦理委员会批准日期：

Date of approved by ethic committee：

2024-09-26 00:00:00

伦理委员会联系人：

复旦大学附属中山医院医学伦理委员会

Contact Name of the ethic committee：

Medical Ethics Committee of Zhongshan Hospital Affiliated to Fudan University

伦理委员会联系地址：

上海市徐汇区枫林路180号

Contact Address of the ethic committee：

180 Fenglin Road, Xuhui District, Shanghai

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 21 3158 7871

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：

复旦大学附属中山医院

Primary sponsor：

Zhongshan Hospital Affiliated to Fudan University

研究实施负责（组长）单位地址：

上海市徐汇区枫林路180号

Primary sponsor's address：

180 Fenglin Road, Xuhui District, Shanghai

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

上海

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

复旦大学附属中山医院

具体地址：

上海市徐汇区枫林路180号

Institution
hospital：

Zhongshan Hospital Affiliated to Fudan University

Address：

180 Fenglin Road, Xuhui District, Shanghai

经费或物资来源：

2022年度厦门市自然科学基金（3502Z20227281）

Source(s) of funding：

Xiamen Natural Science Foundation (3502Z20227281) for the Year 2022

Target disease：

lung cancer

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：

主要目的：探讨肺癌术后老年患者居家自我管理方案对老年患者自我管理水平的影响效果。 次要目的：探讨肺癌术后老年患者居家自我管理方案对老年患者自我管理效能感、症状发生的严重程度、出院准备度、再入院率、生活质量的影响效果。  

Objectives of Study：

Primary Objective: To investigate the impact of a home-based self-management program on the self-management level of elderly patients after lung cancer surgery. Secondary Objectives: To explore the effects of a home-based self-management program on the self-efficacy, severity of symptom occurrence, discharge readiness, readmission rate, and quality of life of elderly patients after lung cancer surgery.

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）组织学或细胞学病理确诊为肺癌； （2）接受肺癌相关手术； （3）年龄不低于60岁； （4）自愿参加本次调查，并签署知情同意书； （5）具备阅读理解能力。

Inclusion criteria

Histologically or cytologically confirmed diagnosis of lung cancer. Undergone surgery related to lung cancer. Age 60 years or older. Voluntarily agreed to participate in this study and signed the informed consent form. Possess the ability to read and understand.

排除标准：

（1）因精神或智力因素无法正确理解及回答问题； （2）同时患有身体其它部位恶性肿瘤； （3）不知晓自己真实病情者； （4）合并各种重要脏器严重疾病。

Exclusion criteria：

Unable to correctly understand and answer questions due to mental or intellectual factors. Concurrently diagnosed with malignant tumors in other parts of the body. Unaware of their true medical condition. Presence of severe diseases in vital organs.

研究实施时间：

Study execute time：

从 From 2024-10-01 00:00:00至 To 2025-06-30 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-10-31 00:00:00 至 To 2025-01-31 00:00:00  

干预措施：

Interventions：

组别：

干预组

样本量：

18

Group：

intervention group

Sample size：

干预措施：

干预组患者在常规护理的基础上接受肺癌术后老年患者居家自我管理方案的干预。 ①术前：研究者本人向患者及家属发放《肺癌术后老年患者居家自我管理方案》初稿，讲解出院后可能会遇见的大部分问题，解释该方案的作用和意义，采用一对一床旁指导的方式讲解方案具体内容、使用方法，及时为患者解答疑问，时间30~45分钟。 ②出院前1天：再次为患者讲解方案具体内容，根据方案指导让患者进行呼吸功能锻炼示范等，检查有无问题并解决，便于患者居家进行自我管理。另外向患者发放居家自我管理行为记录表，方便患者自我监督和记录自我管理行为，时间30~45分钟。 ③出院后1周：电话随访，向患者巩固自我管理方案内容，督促患者进行自我管理行为并完成记录，还要询问患者在这一周有没有遇见问题，怎么解决的，对患者的疑问予以解答，时间30~45分钟。 ④出院后3周：电话随访，巩固自我管理方案内容，督促患者进行自我管理行为并完成记录，询问患者遇见的问题和处理方式，对患者的疑问予以解答，时间30~45分钟。 ⑤出院后7周：电话随访，巩固自我管理方案内容，督促患者进行自我管理行为并完成记录，询问患者遇见的问题和处理方式，对患者的疑问予以解答，时间30~45分钟。 ⑥出院后11周：电话随访，巩固自我管理方案内容，督促患者进行自我管理行为并完成记录，询问患者遇见的问题和处理方式，对患者的疑问予以解答，时间30~45分钟。

干预措施代码：

Intervention：

Intervention Group: Patients in the intervention group will receive the home-based self-management program for elderly patients after lung cancer surgery, in addition to routine care. Pre-surgery: The researcher will provide the initial draft of the "Home-Based Self-Management Program for Elderly Patients After Lung Cancer Surgery" to the patient and their family. The researcher will explain the common issues that may arise after discharge, the purpose and significance of the program, and the specific content and usage methods through one-on-one bedside guidance. The researcher will answer any questions the patient may have. This session will last 30-45 minutes. One day before discharge: The researcher will again explain the specific content of the program. The researcher will demonstrate respiratory function exercises and other self-management activities as per the program guidelines. The researcher will check for any issues and resolve them, ensuring the patient is prepared for home-based self-management. The patient will be provided with a self-management behavior record form to facilitate self-monitoring and recording of self-management activities. This session will last 30-45 minutes. One week after discharge: A follow-up phone call will be made to reinforce the content of the self-management program. The researcher will encourage the patient to continue with the self-management activities and complete the record form. The researcher will ask about any issues encountered during the week and how they were resolved, and will address any questions the patient may have. This call will last 30-45 minutes. Three weeks after discharge: A follow-up phone call will be made to reinforce the content of the self-management program. The researcher will encourage the patient to continue with the self-management activities and complete the record form. The researcher will ask about any issues encountered and how they were resolved, and will address any questions the patient may have. This call will last 30-45 minutes. Seven weeks after discharge: A follow-up phone call will be made to reinforce the content of the self-management program. The researcher will encourage the patient to continue with the self-management activities and complete the record form. The researcher will ask about any issues encountered and how they were resolved, and will address any questions the patient may have. This call will last 30-45 minutes. Eleven weeks after discharge: A follow-up phone call will be made to reinforce the content of the self-management program. The researcher will encourage the patient to continue with the self-management activities and complete the record form. The researcher will ask about any issues encountered and how they were resolved, and will address any questions the patient may have. This call will last 30-45 minutes.

Intervention code：

组别：

对照组

样本量：

18

Group：

control group

Sample size：

干预措施：

常规护理方法，在院时医护人员对老年肺癌手术患者进行正常的护理、治疗和健康宣教，告知其手术前后主要注意事项、并发症防治指导；出院时发放“肺癌术后出院指导”（包括积极态度、休息与活动、饮食、用药、伤口、呼吸道的保养、随访等内容），嘱咐其按时复诊；出院后跟干预组一样的频次进行电话随访有关“肺癌术后出院指导”的内容。

干预措施代码：

Intervention：

During Hospitalization: Healthcare providers will provide normal nursing care, treatment, and health education to elderly patients who have undergone lung cancer surgery. Patients will be informed about the main precautions before and after surgery, as well as guidance on preventing and managing complications. At Discharge: Patients will be provided with a "Post-Lung Cancer Surgery Discharge Instructions" pamphlet, which includes information on maintaining a positive attitude, rest and activity, diet, medication, wound care, respiratory maintenance, and follow-up appointments. Patients will be instructed to attend their follow-up appointments as scheduled. After Discharge: Follow-up phone calls will be conducted at the same frequency as the intervention group to review the content of the "Post-Lung Cancer Surgery Discharge Instructions." These calls will cover topics such as the patient's adherence to the discharge instructions, any issues or questions they may have, and general support. Each call will last 30-45 minutes.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 上海 

市(区县)：

  

Country：

China 

Province：

Shanghai 

City：

 

单位(医院)：

复旦大学附属中山医院 

单位级别：

三甲 

Institution
hospital：

Zhongshan Hospital Affiliated to Fudan University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

癌症患者自我管理测评量表

指标类型：

主要指标

Outcome：

Cancer Patient Self-Management Assessment Scale

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

安德森症状评估量表

指标类型：

次要指标

Outcome：

M.D. Anderson Symptom Inventory, MDASI

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

出院准备度量表

指标类型：

次要指标

Outcome：

Readiness for Hospital Discharge Scale,RHDS

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

肺癌患者生活质量评估量表

指标类型：

次要指标

Outcome：

Functional Assessment of Cancer Therapy-Lung,FACT-L

Type：

Secondary indicator

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 60 岁 years
最大 Max age 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）：

研究者本人采用随机数表法按照患者入院的顺序匹配一个随机数，然后对随机数进行排序，前50%进入对照组，后50%进入干预组。

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

The researcher will use a random number table to assign a random number to each patient according to their order of admission. The patients will then be sorted based on these random numbers, with the first 50% being assigned to the control group and the second 50% being assigned to 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:

不公开/Private

盲法：

无

Blinding：

None

是否共享原始数据：

IPD sharing

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）：

不共享原始数据

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

The raw data will not be shared.

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：

本研究为干预性研究，采用EDC系统进行数据录入、清理、锁定、移交等。

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

This study is an interventional study and will use an Electronic Data Capture (EDC) system for data entry, cleaning, locking, and transfer.

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：

  2024-10-21 09:03:03