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基于互联网平台的终末期肿瘤患者主要照顾者支持方案的构建与实证
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注册号：

Registration number：

 ChiCTR2400083056 

最近更新日期：

Date of Last Refreshed on：

 2024-04-15 14:55:51 

注册时间：

Date of Registration：

 2024-04-15 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

基于互联网平台的终末期肿瘤患者主要照顾者支持方案的构建与实证

Public title：

Construction and Empirical Evidence of an Internet Platform-Based Primary Caregiver Support Program for End-Stage Oncology Patients

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于互联网平台的终末期肿瘤患者主要照顾者支持方案的构建与实证

Scientific title：

Construction and Empirical Evidence of an Internet Platform-Based Primary Caregiver Support Program for End-Stage Oncology Patients

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：

许亚文 

研究负责人：

谌永毅 

Applicant：

Yawen Xu 

Study leader：

Yongyi Chen 

申请注册联系人电话：

Applicant telephone：

 +86 199 6700 3167

研究负责人电话：

Study leader's
telephone：

+86 189 7518 5580

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：

 1239332258@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 414700595@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：

湖南省长沙市岳麓区咸嘉湖街道湖南省肿瘤医院

研究负责人通讯地址：

湖南省长沙市岳麓区咸嘉湖街道湖南省肿瘤医院

Applicant address：

Hunan Cancer Hospital, Xianjiahu Street, Yuelu District, Changsha, Hunan Province, China

Study leader's address：

Hunan Cancer Hospital, Xianjiahu Street, Yuelu District, Changsha, Hunan Province, China

申请注册联系人邮政编码：

Applicant postcode：

 410013

研究负责人邮政编码：

Study leader's postcode：

 410013

申请人所在单位：

湖南中医药大学;湖南省肿瘤医院

Applicant's institution：

Hunan University of Chinese Medicine; Hunan Cancer Hospital

研究负责人所在单位：

湖南省肿瘤医院

Affiliation of the Leader：

Hunan Cancer Hospital

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：

 2024年科研简易程序审查[13]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：

湖南省肿瘤医院医学伦理审查委员会

Name of the ethic committee：

Medical Ethics Review Committee of Hunan Cancer Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-02-08 00:00:00

伦理委员会联系人：

刘超毅

Contact Name of the ethic committee：

Liu Chaoyi

伦理委员会联系地址：

湖南省肿瘤医院

Contact Address of the ethic committee：

Hunan Cancer Hospital

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 138 7584 9527

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：

湖南省肿瘤医院

Primary sponsor：

Hunan Cancer Hospital

研究实施负责（组长）单位地址：

湖南省长沙市岳麓区桐梓坡路283号

Primary sponsor's address：

283 Tongzipo Road, Yuelu District, Changsha City, Hunan 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)：

湖南省

市(区县)：

长沙市

Country：

China

Province：

Hunan Province

City：

Changsha

单位(医院)：

湖南省肿瘤医院

具体地址：

湖南省长沙市岳麓区桐梓坡路283号

Institution
hospital：

Hunan Cancer Hospital

Address：

283 Tongzipo Road, Yuelu District, Changsha City, Hunan Province

经费或物资来源：

来源于湖南省卫健委2024年科研项目一般项目20233408

Source(s) of funding：

Sourced from Hunan Provincial Health Commission 2024 Research Project General Project 20233408

研究疾病：

无  

Target disease：

no

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：

非随机对照试验 

Study design：

Non randomized control 

研究目的：

(1)在文献回顾、半结构式访谈的基础上，以社会支持理论为指导初步构建基于互联网平台的终末期肿瘤患者主要照顾者支持方案，再通过专家会议完成基于互联网平台的终末期肿瘤患者主要照顾者支持方案的最终构建；最后通过预实验对方案进行修订与完善。 (2)应用基于互联网平台的终末期肿瘤患者主要照顾者支持方案，将终末期肿瘤患者主要照顾者分为两组，比较两组各项指标得分差异，验证并评价干预方案的科学性、有效性及适当性。  

Objectives of Study：

(1) On the basis of literature review and semi-structured interviews, we initially constructed an Internet-based primary caregiver support program for patients with terminal tumors using social support theory as a guide, and then completed the final construction of the Internet-based primary caregiver support program for patients with terminal tumors through an expert meeting; and finally revised and improved the program through a pre-experiment. (2) Applying the Internet platform-based primary caregiver support program for patients with terminal tumors, the primary caregivers of patients with terminal tumors were divided into two groups, comparing the differences in the scores of various indexes between the two groups, and verifying and evaluating the scientificity, effectiveness and appropriateness of the intervention program.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

排除标准：

①既往有精神病或严重认知功能障碍者；②伴有严重的心、脑、肾、肺等功能障碍者；③近期内遭遇其他重大应激事件。

Exclusion criteria：

(i) those with previous mental illness or severe cognitive dysfunction; (ii) those with severe cardiac, cerebral, renal, and pulmonary dysfunction; and (iii) those who have suffered other major stressful events in the recent past.

研究实施时间：

Study execute time：

从 From 2024-04-15 00:00:00至 To 2024-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-04-15 00:00:00 至 To 2024-10-31 00:00:00

干预措施：

Interventions：

组别：

对照组

样本量：

 43

Group：

Control group

Sample size：

干预措施：

入选对照组的主要照顾者接受科室内的常规住院支持照护和出院随访指导。入院时由责任护士向照顾者介绍患者疾病知识等信息、病区环境、医护简介等，其余信息通过病室走廊宣传手册、宣传栏等进行展示。住院期间由医师和责任护士对照顾者定期开展照护技能指导、心理疏导等支持措施，频次一周一次，每次20~30min。出院时由责任护士对照顾者进行出院随访指导，主要内容包括居家照护患者技巧以及自身情绪、心理调节方法等，引导照顾者正视患者的病情变化，与患者共同探讨人生的意义，寻找人生价值。出院后病房医护人员采用标准化的随访流程，患者出院后7d由科室随访小组对主要照顾者进行电话随访，询问照护情况、自身需求情况，及时做好记录，每周1次。当有特殊情况时，根据具体情况增加随访次数，开展相应干预措施。

干预措施代码：

Intervention：

Primary caregivers enrolled in the control group received routine inpatient supportive care and discharge follow-up instructions within the unit. At the time of admission, the nurse-in-charge introduced the caregiver to the patient's knowledge of the disease, the environment of the ward, and a brief introduction to medical care, and the rest of the information was displayed through brochures in the corridors of the ward and on the bulletin boards. During the period of hospitalization, physicians and responsible nurses provide caregivers with regular guidance on caregiving skills, psychological counseling and other supportive measures once a week, each time for 20~30 min. When discharged from the hospital, responsible nurses provide caregivers with follow-up guidance, which mainly includes skills of taking care of the patient at home as well as methods of regulating one's own emotions and psychology, etc., and guides the caregivers to look at the changes of the patient's condition squarely and discuss the meaning and value of life with the patient together. We guide the caregivers to face the changes in the patient's condition, discuss the meaning of life with the patient, and find the value of life. After discharge, the medical staff of the ward adopted a standardized follow-up process, and the main caregiver was followed up by the follow-up team of the department by phone 7d after the patient was discharged, inquiring about the situation of the caregiver and his/her own needs, and making records in a timely manner, once a week. When there are special circumstances, the number of follow-up visits will be increased according to the specific situation, and appropriate interventions will be carried out.

Intervention code：

组别：

试验组

样本量：

 43

Group：

Experimental group

Sample size：

干预措施：

根据基于互联网平台的终末期肿瘤患者FCs支持方案进行实施，具体方案见附录二。在完成基线调查之后由责任护士向FCs介绍干预的目的、方法，由研究者向FCs介绍平台的使用方法，并开展第一次主题干预，干预主题为信息支持，之后每周进行一次干预直至出院后两周。此外，当FCs需要时，可随时通过平台获取信息支持。患者住院期间，研究者按干预方案向FCs实施第二次主题干预，干预主题为实际支持，主要内容包括对患者症状管理的支持、志愿服务支持等；干预频率为住院期间每周一次。此外，检查FCs使用平台的熟练程度，对不能熟练使用的FCs进行再教育。患者出院时进行第三次主题干预，干预主题为尊重支持，干预时间为30-60min。出院后一周进行第四次主题干预，干预主题为情感支持，干预时间为每周一次，每次30-60min，共两周。出院后两周进行第五次干预，干预主题为陪伴支持，干预时间为30-60min。干预期间通过平台的自动智能化识别功能、预警提醒、智能随访以及远程视频会诊等功能等保证干预的可及性。

干预措施代码：

Intervention：

The program was implemented according to the Internet-based platform for supporting FCs of patients with end-stage tumors, which is described in Appendix II. After completing the baseline survey the purpose and method of the intervention were introduced to the FCs by the nurse in charge, and the use of the platform was introduced to the FCs by the researcher, and the first thematic intervention was carried out, which was on the topic of information support, followed by weekly interventions until two weeks after discharge. In addition, FCs could access information support through the platform at any time when they needed it. During the patient's hospitalization, the researcher implemented the second thematic intervention to the FCs according to the intervention program, and the intervention theme was practical support, which mainly included support for the patient's symptom management, volunteering support, and so on; the frequency of the intervention was once a week during the hospitalization. In addition, FCs' proficiency in using the platform was checked, and FCs who could not use it proficiently were re-educated. Patients were discharged from the hospital with the third thematic intervention, the intervention topic was respect support, and the intervention time was 30-60 min. the fourth thematic intervention was conducted one week after discharge, the intervention topic was emotional support, and the intervention frequency was once a week for two weeks, each time for 30-60 min. The fifth intervention was conducted two weeks after discharge, with the theme of accompaniment support, and the intervention time was 30-60 min. the accessibility of the intervention was ensured by the automatic intelligent identification function, early warning reminder, intelligent follow-up, and remote video consultation functions of the platform during the intervention period.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 湖南省 

市(区县)：

 长沙市 

Country：

China

Province：

Hunan

City：

Changsha

单位(医院)：

 湖南省肿瘤医院 

单位级别：

 三甲 

Institution
hospital：

Hunan Cancer Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

癌症患者主要照顾者需求量表

指标类型：

主要指标

Outcome：

the needs assessment of family caregivers-cancer

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

生命威胁性疾病家庭照顾者生存质量量表

指标类型：

次要指标

Outcome：

Quality of Life in Life-threatening Illness-Family Carer Questionaire

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

远程照护满意度问卷

指标类型：

次要指标

Outcome：

Telemedicine Satisfaction Questionnaire

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 18 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）：

无

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

None

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：

Blinding：

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）：

Resman

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

Resman

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：

无

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

(Electronic Data Capture, EDC),ResManEDC:

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：

  2024-04-15 14:55:44
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