ChiCTR2400087838 版本V1.0 版本创建时间2024/08/05 17:48:02 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：

ChiCTR2400087838 

最近更新日期：

Date of Last Refreshed on：

2024-08-05 17:47:44 

注册时间：

Date of Registration：

2024-08-05 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

线上线下融合式病友互助对肺癌晚期患者心理痛苦影响的研究

Public title：

Research on the influence of Online and Offline Patient Peer Support on the Psychological Distress of Patients with Advanced Lung Cancer

注册题目简写：

English Acronym：

研究课题的正式科学名称：

线上线下融合式病友互助对肺癌晚期患者心理痛苦影响的研究

Scientific title：

Research on the influence of Online and Offline Patient Peer Support on the Psychological Distress of Patients with Advanced Lung Cancer

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：

练素英 

研究负责人：

练素英 

Applicant：

Lian Suying  

Study leader：

Lian Suying  

申请注册联系人电话：

Applicant telephone：

+86 181 5063 9183

研究负责人电话：

Study leader's telephone：

+86 181 5063 9183

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：

85027650@qq.com

研究负责人电子邮件：

Study leader's E-mail：

85027650@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：

福建省福州肺科医院

研究负责人通讯地址：

福建省福州肺科医院内四区

Applicant address：

Fuzhou Pulmonary Hospital, Fujian Province

Study leader's address：

Fuzhou Pulmonary Hospital in Fujian province fouth deparment

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：

福建省福州肺科医院

Applicant's institution：

Fuzhou Pulmonary Hospital, Fujian Province

研究负责人所在单位：

福建省福州肺科医院

Affiliation of the Leader：

Fuzhou Pulmonary Hospital, Fujian Province

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：

2022-008(科研)-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：

福建省福州结核病防治院伦理委员会

Name of the ethic committee：

Fuzhou Tuberculosis Control Hospital of Fujian Province

伦理委员会批准日期：

Date of approved by ethic committee：

2022-08-11 00:00:00

伦理委员会联系人：

苏林玲

Contact Name of the ethic committee：

Su Linling

伦理委员会联系地址：

福建省福州市仓山区湖边2号

Contact Address of the ethic committee：

2 Lakeside, Cangshan District, Fuzhou City, Fujian Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 591 6262 7341

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：

福建省福州肺科医院

Primary sponsor：

Fuzhou Pulmonary Hospital, Fujian Province

研究实施负责（组长）单位地址：

福建省福州市仓山区湖边2号

Primary sponsor's address：

2 Lakeside, Cangshan District, Fuzhou City, Fujian Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

福建省

市(区县)：

福州市

Country：

China

Province：

Fujian Province

City：

Fuzhou

单位(医院)：

福建省福州肺科医院

具体地址：

福建省福州市仓山区湖边2号

Institution
hospital：

Fuzhou Pulmonary Hospital, Fujian Province

Address：

2 Lakeside, Cangshan District, Fuzhou City, Fujian Province

经费或物资来源：

福州市科技局

Source(s) of funding：

Fuzhou Science and Technology Bureau

Target disease：

The Psychological Distress of Patients with Advanced 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：

明确线下病房探访服务融合线上微信病友互助模式对减轻肺癌晚期患者心理痛苦、减少焦虑抑郁情绪等方面的干预效果  

Objectives of Study：

To clarify the intervention effect of offline ward visit service combined with online wechat patient mutual assistance mode on reducing psychological pain, anxiety and depression in advanced lung cancer patients

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

志愿者纳入标准：（1）诊断肺癌半年以上，肺癌患者已完成放化疗等主要治疗，一般情况较好；（2）年龄：≤70岁；（3）能进行日常沟通交流；（4）生活自理，行走功能正常，能完成一般体力活动；（5）会使用微信者。 患者纳入标准：（1）肺癌晚期患者，首次住院治疗；（2）自行或在研究者的帮助下能完成问卷填写；（3）与研究者沟通无障碍；（4）愿意接受本研究的病友互助服务。

Inclusion criteria

Inclusion criteria for volunteers: (1) Diagnosed with lung cancer for more than half a year, and completed the main treatments such as radiotherapy and chemotherapy, and in a good general condition; (2) Age: ≤70 years old; (3) Able to communicate with others in daily life; (4) Self-care and normal walking function, able to complete general physical activities; (5) Able to use WeChat. Inclusion criteria for patients: (1) Patients with advanced lung cancer, undergoing hospitalization for the first time; (2) Able to complete the questionnaire independently or with the help of researchers; (3) Able to communicate with researchers without barriers; (4) Willing to accept the peer support service provided in this study.

排除标准：

志愿者排除标准：（1）不愿参加规范化志愿者培训的肺癌患者；（2）无法按时进行志愿服务者。 患者排除标准：（1）严重躯体疾病，不能配合的患者；（2）患有精神疾病、认知障碍的患者。

Exclusion criteria：

Exclusion criteria for volunteers: (1) Lung cancer patients who are unwilling to participate in standardized volunteer training; (2) Those who are unable to perform volunteer services on time. Exclusion criteria for patients: (1) Patients with severe physical illnesses who are unable to cooperate; (2) Patients with mental illnesses or cognitive impairments.

研究实施时间：

Study execute time：

从 From 2022-10-01 00:00:00至 To 2024-04-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2023-03-03 00:00:00 至 To 2023-08-17 00:00:00  

干预措施：

Interventions：

组别：

A组

样本量：

50

Group：

Group A

Sample size：

干预措施：

研究前期信息工程师根据研究的需求建立“与癌共舞，向阳而生”的微信小程序平台，患者入组后指导患者搜索小程序并完善个人信息、填写服务需求及阅读病友互助相关注意事项。干预开始前研究者先向志愿者介绍研究对象的一般情况及相关注意事项，研究开始之际研究者向患者介绍病友志愿者的一般资料和治疗经历，确认无误后，患者使用微信小程序中的个人中心连线志愿者进行为期1小时的线上病友互助。病友志愿者互助服务内容包括自我介绍，分享自己的治疗经历和经验分享，自我康复和功能锻炼指导及治疗相关问题解答，倾听研究对象诉说心理困扰并给予指导性的方案等，服务结束后志愿者将无法解答或遗留问题在反馈研究者。志愿服务时间点为入组后第二天、第八天、第十五天，共3次。患者住院期间研究者与患者在干预实施前的沟通采用面对面的沟通，患者出院后采用电话形式沟通。除一对一线上沟通外，研究对象仍可以在微信小程序中咨询留言，研究者每日定期解答。

干预措施代码：

 A

Intervention：

Intervention method for Group A In the early stage of the study, information engineers established a WeChat Mini Program platform titled "Dancing with Cancer, Growing Towards the Sun" based on the research requirements. After patients were enrolled, they were guided to search for the Mini Program, complete their personal information, fill in their service needs, and read the relevant precautions for peer support. Before the intervention began, the researchers first introduced the general situation of the research subjects and relevant precautions to the volunteers. At the start of the study, the researchers introduced the general information and treatment experiences of the peer volunteers to the patients. After confirmation, the patients used the personal center in the WeChat Mini Program to connect with the volunteers for a one-hour online peer support session. The content of the peer volunteer support service included self-introduction, sharing their own treatment experiences and tips, guidance on self-recovery and functional exercises, answering questions related to treatment, listening to the psychological troubles of the research subjects, and providing guidance. After the service, volunteers would report any unanswered or remaining questions to the researchers. The volunteer service time points were set on the second day, eighth day, and fifteenth day after enrollment, with a total of three sessions. During the hospitalization period, the researchers communicated with the patients face-to-face before the intervention, and after discharge, the communication was conducted via telephone. In addition to the one-on-one online communication, research subjects could still leave consultation messages in the WeChat Mini Program, and the researchers would answer them regularly every day.

Intervention code：

组别：

B组

样本量：

50

Group：

Group B

Sample size：

干预措施：

患者入组后由研究者收集患者的服务需求及告知病友互助相关注意事项。第一次干预前预约志愿者，待志愿抵达病房后，研究者向志愿者介绍患者的一般资料、互助服务需求及相关注意事项，后由研究者将志愿者带入患者病室开始进行为期1小时的互助服务。第二次及第三次干预如患者在住院，则按第一次干预模式。若患者已出院则在门诊随访诊室开展干预，干预程序同第一次。服务内容和服务时间点同A组。

干预措施代码：

 B

Intervention：

After patients were enrolled, the researchers collected their service needs and informed them of the relevant precautions for peer support. Before the first intervention, volunteers were scheduled, and upon their arrival at the ward, the researchers introduced the patient's general information, mutual assistance service needs, and relevant precautions to the volunteers. After that, the researchers escorted the volunteers to the patient's room to start a one-hour mutual assistance service. For the second and third interventions, if the patient was still hospitalized, the intervention mode would follow the same pattern as the first intervention. If the patient had been discharged, the intervention would be conducted in the outpatient follow-up clinic, with the same procedure as the first intervention. The service content and service time points were the same as Group A.

Intervention code：

组别：

C组

样本量：

50

Group：

Group C

Sample size：

干预措施：

第一次干预内容和形式同B组，第二次干预前指导其搜索小程序并完善个人信息、填写服务需求及阅读病友互助相关注意事项。第二次及第三次互助服务形式和内容同A组。

干预措施代码：

 C

Intervention：

The content and format of the first intervention are the same as Group B. Before the second intervention, patients were instructed to search for the Mini Program, complete their personal information, fill in their service needs, and read the relevant precautions for peer support. The format and content of the second and third mutual assistance services are the same as Group A.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 福建 

市(区县)：

 福州 

Country：

China 

Province：

fujian 

City：

fuzhou 

单位(医院)：

福建省福州肺科医院 

单位级别：

三甲 

Institution
hospital：

Fuzhou Pulmonary Hospital, Fujian Province

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

心理痛苦

指标类型：

主要指标

Outcome：

Distress Thermometer

Type：

Primary indicator

测量时间点：

干预前，干预后一周，干预后两周，干预后一个月

测量方法：

问卷调查

Measure time point of outcome：

Before intervention, one week after intervention, two weeks after intervention, and one month after intervention

Measure method：

questionnaire survey

指标中文名：

医院焦虑抑郁量表

指标类型：

次要指标

Outcome：

Hospital Anxiety and Depression Scale

Type：

Secondary indicator

测量时间点：

干预前，干预后一周，干预后两周，干预后一个月

测量方法：

问卷调查

Measure time point of outcome：

Before intervention, one week after intervention, two weeks after intervention, and one month after intervention

Measure method：

questionnaire survey

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

without

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 70 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 SPSS 21.0软件完成随机分组，研究者先对150 名研究对象从 1～ 150 编号，在软件中生成150个随机数字，对随机数字进行排序，按排序的序号由小到大均分成A组和B组和C组各50例。将序号码装入信封内，研究对象入组后随机抽取一个信封，内的号码作为入组依据。

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

SPSS 21.0 software was used to complete the random grouping. The researchers first numbered 150 subjects from 1 to 150, generated 150 random numbers in the software, sorted the random numbers, and divided them into group A, Group B and Group C with 50 cases each according to the sequence number from small to large. The sequence number was put into the envelope, and an envelope was randomly selected after the study subjects were enrolled, and the number inside was used as the basis for inclusion.

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

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）：

2024.12.30前在ResMan(www.medreman.org.cn)公开原始数据

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

Publish the raw data on ResMan (www.medreman.org.cn) by December 30, 2024.

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：

CRF

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

CRF

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：

  2024-08-05 17:47:44