ChiCTR2400089956 版本V1.0 版本创建时间2024/09/20 11:00:06 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：

ChiCTR2400089956 

最近更新日期：

Date of Last Refreshed on：

2024-09-20 11:00:03 

注册时间：

Date of Registration：

2024-09-20 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

基于IKAP模式的出院准备度护理干预在乳腺癌病人配偶或子女的应用研究

Public title：

Application of IKAP model based on discharge readiness nursing intervention in spouses or children of breast cancer patients

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于IKAP模 式的出院准备度护理干预在乳腺癌病人配偶或子女的应用研究

Scientific title：

Application of IKAP model based on discharge readiness nursing intervention in spouses or children of breast cancer 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：

王丽 

研究负责人：

王丽 

Applicant：

Li Wang 

Study leader：

Li Wang 

申请注册联系人电话：

Applicant telephone：

+86 138 2353 5516

研究负责人电话：

Study leader's telephone：

+86 138 2353 5516

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：

1176265298@qq.com

研究负责人电子邮件：

Study leader's E-mail：

1176265298@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：

广东省深圳市福田区莲花街道1120号北京大学深圳医院外科楼5楼肿瘤科

研究负责人通讯地址：

广东省深圳市福田区莲花街道1120号北京大学深圳医院外科楼5楼肿瘤科

Applicant address：

Department of Oncology, 5th Floor, Surgical Building, Shenzhen Hospital, Peking University, No.1120 Lianhua Street, Futian District, Shenzhen City, Guangdong Province

Study leader's address：

Department of Oncology, 5th Floor, Surgical Building, Shenzhen Hospital, Peking University, No.1120 Lianhua Street, Futian District, Shenzhen City, Guangdong Province

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：

北京大学深圳医院

Applicant's institution：

Peking University Shenzhen Hospital

研究负责人所在单位：

北京大学深圳医院

Affiliation of the Leader：

Peking University Shenzhen Hospital

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：

北大深医伦审(研)[2024]第(101)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：

北京大学深圳医院科研伦理委员会

Name of the ethic committee：

Research Ethics Committee of Peking University Shenzhen Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2024-06-27 00:00:00

伦理委员会联系人：

陈嘉仪

Contact Name of the ethic committee：

Jiayi Chen

伦理委员会联系地址：

广东省深圳市福田区莲花街道1120号北京大学深圳医院综合楼科研伦理办公室

Contact Address of the ethic committee：

Office of Research Ethics, Comprehensive Building, Shenzhen Hospital, Peking University, No.1120 Lianhua Street, Futian District, Shenzhen City, Guangdong Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 755 8392 3333

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：

北京大学深圳医院

Primary sponsor：

Peking University Shenzhen Hospital

研究实施负责（组长）单位地址：

广东省深圳市福田区莲花街道1120号北京大学深圳医院外科楼5楼肿瘤科

Primary sponsor's address：

Department of Oncology, 5th Floor, Surgical Building, Shenzhen Hospital, Peking University, No.1120 Lianhua Street, Futian District, Shenzhen City, Guangdong 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)：

广东

市(区县)：

深圳

Country：

China

Province：

Guangdong

City：

Shenzhen

单位(医院)：

北京大学深圳医院

具体地址：

广东省深圳市福田区莲花街道1120号北京大学深圳医院外科楼5楼肿瘤科

Institution
hospital：

Peking University Shenzhen Hospital

Address：

Department of Oncology, 5th Floor, Surgical Building, Shenzhen Hospital, Peking University, No.1120 Lianhua Street, Futian District, Shenzhen City, Guangdong Province

经费或物资来源：

深圳市科技创新委员会

Source(s) of funding：

Shenzhen Science and Technology Innovation Commission

Target disease：

Breast 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：

乳腺癌病人治疗过程漫长复杂，病人在医院经过短暂治疗后，出院时仍需继续康复和照护，在常规护理的出院准备中，我们通常聚焦于提高病人的自我照顾能力，而忽略了提高家属照顾病人的能力，但实际上配偶或子女确是乳腺癌病人最重要的照护者和家庭支持来源。但研究发现，乳腺癌病人配偶或子女在照顾病人的过程中，在面临处理病人术后康复锻炼、放化疗治疗后不良反应应对、情感支持、家庭结构重新调整如性适应、家务管理、子女照顾等问题时，却无法给予更好地照顾，严重阻碍病人居家康复，影响病人的心理健康和生活质量。在出院准备度的理念提出后，国内外研究已证明，发挥有效的出院准备度，病人能更顺利地实现医院向家庭的过渡，出院后有效应对能力较强，病人居家康复效果更理想，非计划再入院率较低，可节约医疗资源，减轻病人及配偶与子女的负担。此外，多项研究表明，IKAP模式的护理干预同样可有效的提高病人及照护者照护能力，提高病人生活质量，尽快地回归家庭和适应社会角色。但两者结合二者联合应用于乳腺癌病人配偶或子女出院准备度能否满足乳腺癌病人的信息需求，减少其并发症，提高其生活质量，促进其更好的回归家庭角色及适应社会角色，则需进一步探讨。本课题拟开展基于IKAP模式的出院准备度护理干预在乳腺癌病人配偶或子女的研究项目，对提高乳腺癌病人生活质量作出以下可期的贡献： 1.明确IKAP模式应用于乳腺癌病人配偶或子女的出院准备度的有效性; 2.阐明基于IKAP模式的出院准备度护理干预在乳腺癌病人配偶或子女的应用是否为促进病人居家康复、提高生活质量的重要科学手段。  

Objectives of Study：

The treatment process of breast cancer patients is long and complex, and patients still need to continue rehabilitation and care when discharged from the hospital after a short treatment. In the preparation for discharge of conventional care, we usually focus on improving the self-care ability of patients, while ignoring the ability of family members to take care of patients. In fact, spouses or children are the most important caregivers and family support sources for breast cancer patients. However, studies have found that spouses or children of breast cancer patients cannot provide better care in the process of taking care of patients, when faced with problems such as postoperative rehabilitation exercise, adverse reactions after radiotherapy and chemotherapy treatment, emotional support, family structure readjust such as sexual adaptation, household management, and child care, which seriously hinder patients' home rehabilitation. Affecting patients' mental health and quality of life. After the concept of discharge readiness was put forward, domestic and foreign studies have proved that patients with effective discharge readiness can realize the transition from hospital to family more smoothly, have stronger effective coping ability after discharge, have better home rehabilitation effect of patients, and have lower unplanned readmission rate, which can save medical resources and reduce the burden of patients, spouses and children. In addition, a number of studies have shown that IKAP mode of nursing intervention can also effectively improve the caring ability of patients and caregivers, improve the quality of life of patients, and return to the family and adapt to the social role as soon as possible. However, whether the combined application of the two methods in the discharge readiness of spouses or children of breast cancer patients can meet the information needs of breast cancer patients, reduce their complications, improve their quality of life, and promote their better return to family roles and adapt to social roles needs further discussion. This project intends to carry out a research project on discharge readiness nursing intervention based on IKAP model in spouses or children of breast cancer patients, and make the following predictable contributions to improving the quality of life of breast cancer patients: 1. To determine the effectiveness of the IKAP model for the discharge readiness of spouses or children of breast cancer patients; 2. Clarify whether the application of IKAP model based discharge readiness nursing intervention in spouses or children of breast cancer patients is an important scientific means to promote home rehabilitation of patients and improve 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照顾对象限定为首次或第二次入院（住院次数＞2次的乳腺癌病人的照护者已经基本了解和掌握疾病治疗和照护的相关内容,会干扰临床数据分析）行肿瘤治疗的乳腺癌病人、预计生存期≥6个月；②配偶、子女年龄（18-65）周岁；③自愿参加本研究并能全程配合,签署知情同意书；④能正常沟通；⑤承担病人的主要照顾责任，照顾时长＞40小时/每周，预计照顾时间≥6个月。⑥配偶、子女健康状况良好。

Inclusion criteria

① The object of care is limited to the first or second admission of breast cancer patients (the caregiver of breast cancer patients with more than 2 inpatient times has a basic understanding and mastery of the relevant contents of disease treatment and care, which will interfere with clinical data analysis), and the expected survival time is ≥6 months; ② Spouse and children (18-65 years old); ③ Volunteer to participate in the study and be able to cooperate throughout the study, sign the informed consent; ④ can communicate normally; ⑤ Take the main responsibility for the care of patients, care time > 40 hours/week, expected care time ≥6 months. ⑥ Spouses and children are in good health.

排除标准：

①病人或照护者既往有精神类疾病或精神类家族史；②病人合并有其他严重疾病；③照顾对象多于1人；④照顾者有严重基础疾病。

Exclusion criteria：

① The patient or caregiver has a previous psychiatric illness or family history of psychiatric illness; ② The patient has other serious diseases; ③ More than one person to take care of; ④ The caregiver has a serious underlying disease.

研究实施时间：

Study execute time：

从 From 2024-07-01 00:00:00至 To 2025-11-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-07-01 00:00:00 至 To 2025-06-30 00:00:00  

干预措施：

Interventions：

组别：

干预组

样本量：

50

Group：

Intervention group

Sample size：

干预措施：

1.病人、配偶或子女住院期间接受同样的常规管理模式，出院当天对病人、配偶或子女进行常规出院宣教。 2.采取基于IKAP模式的出院准备度护理干预： （1）成立IKAP模式的出院准备度服务团队：包括主管医生、责任护士、心理咨询师、教育护士、乳腺癌相关的康复指导师等。 （2）实施干预（基于IKAP模式的出院准备度）： ①信息收集：入院当天随机入组，讲解项目研究的目的、内容及注意事项，签署知情同意书；评估研究对象的健康教育需求，制定个性化出院准备度干预计划，建立档案；入院第二天初次放发相关量表：向乳腺癌病人配偶或子女发放《疾病不确定感家属量表（MUIS—FM）》、《照顾者出院准备度量表（CPS）》;向乳腺癌病人发放中文版《乳腺癌患者生命质量测定量表(FACT-B)》; ②认知教育：根据干预计划采用一对一、成组学习、乳腺癌专科医生开展乳腺癌专题知识讲座并针对性的解答疑惑的方式的进行相关知识教育；并用讲解、示范、引导阅读等形式对病人配偶或子女进行乳腺癌抗肿瘤治疗相关知识、护理技能培训，包括：肿瘤治疗不良反应知识指导、营养饮食指导、功能康复运动、活动协助、用药指导、皮肤与伤口护理、管道护理、心理支持、家庭结构重整、规划出院后居家生活和照顾者角色适应生活等。 ③信念支持：依托我科“自我效能加油站”项目开展个体教育、成组教育、专家座谈会、榜样案例现身说法的形式进行信念支持。由肿瘤护士、乳腺癌专科医生、心理治疗师组成的团队对乳腺癌病人配偶或子女进行心理疏导，消除负性情绪，树立坚强信念，增强未来信心；邀请熟练掌握乳腺癌照顾知识及技能的家属现身说法，讲述他们的故事，分享体会和经验；鼓励研究对象积极交流心声，述说其在照顾乳腺癌病人过程中存在的困扰，宣泄不良情绪，缓解压力。 ④行为干预：采用代角色、同理心、他人视觉多样化的形式对研究对象实施行为干预，内容包括肿瘤治疗不良反应的识别与应对、常用照顾技能培训与考核、角色转化、获取乳腺癌照护知识途径培训、自我心理疏导、自我健康生活方式等。对病人、配偶或子女必须掌握的技能责任护士进行反复演示，指导熟练掌握为止，并将相关学习内容制作成远程学习教育包（视频、PPT、文字材料、流程指引等），方便其居家重新查阅、学习。 ⑤延续性护理：运用电话、微信、云随访数据平台在乳腺癌病人出院后第3天、第7天及以后每周对其配偶或子女进行随访一次，实施针对性指导并纠正偏差；安排专员值班，在微信交流群中及时回答研究对象提出的问题。随访内容包括病人情况（肿瘤治疗后疾病变化情况、饮食及活动情况、心理状况等）和照顾者情况（照顾技能掌握及实施情况、应变能力、角色转化情况、心理状况、生理状况、获取信息途径的运用等）。并于出院当天、3周、6周、9周、12周再次向乳腺癌病人配偶或子女发放《疾病不确定感家属量表（MUIS—FM）》、《照顾者出院准备度量表（CPS）》，向乳腺癌病人发放中文版《乳腺癌患者生命质量测定量表(FACT-B)》。

干预措施代码：

Intervention：

1. The patient, spouse or child shall receive the same routine management mode during hospitalization, and routine discharge education shall be conducted on the day of discharge. 2. Nursing intervention for discharge readiness based on IKAP model: (1) Establish a discharge readiness service team based on IKAP model: including a doctor in charge, a nurse in charge, a psychological consultant, an educational nurse, and a rehabilitation instructor related to breast cancer. (2) Implementation of the intervention (discharge readiness based on IKAP model) : ① Information collection: Randomly enrolled on the day of admission, explained the purpose, content and precautions of the project research, and signed the informed consent; Assess the health education needs of study subjects, develop individualized discharge readiness intervention plans, and establish archives; On the second day of admission, relevant scales were distributed for the first time: spouses or children of breast cancer patients were given the "Family Uncertainty Scale (MUIS-FM)" and "Caregiver Readiness Scale for Discharge (CPS)"; The Chinese version of the Breast Cancer Quality of Life Scale (FACT-B) was distributed to breast cancer patients; ② Cognitive education: According to the intervention plan, one-to-one, group learning, breast cancer specialist lectures on breast cancer and targeted answers to doubts are used to carry out relevant knowledge education; Conduct training on knowledge and nursing skills related to breast cancer anti-tumor treatment for patients' spouses or children in the form of explanation, demonstration and guided reading, including: Adverse reaction knowledge guidance, nutritional diet guidance, functional rehabilitation exercise, activity assistance, medication guidance, skin and wound care, pipeline care, psychological support, family structure restructuring, planning home life after discharge and caregiver role adaptation, etc. ③ Belief support: Relying on the "self-efficacy gas station" project of our department to carry out individual education, group education, expert symposia, and belief support in the form of example cases. A team composed of cancer nurses, breast cancer specialists and psychotherapists provides psychological counseling to spouses or children of breast cancer patients to eliminate negative emotions, establish strong faith and enhance confidence in the future; Invite family members who are proficient in the knowledge and skills of breast cancer care to share their stories and experiences; The subjects were encouraged to actively communicate their inner feelings, describe their troubles in the process of taking care of breast cancer patients, vent bad emotions, and relieve pressure. (4) Behavioral intervention: Behavioral intervention was carried out on the study subjects in the form of role-playing, empathy, and the diversification of other people's vision, including the identification and response to adverse reactions of tumor treatment, training and assessment of common care skills, role transformation, training on ways to acquire knowledge of breast cancer care, self-psychological counseling, self-healthy lifestyle, etc. The responsible nurse will repeatedly demonstrate the skills that patients, spouses or children must master, guide them to master them, and make the relevant learning content into a distance learning education package (video, PPT, text materials, process guides, etc.) for their convenience to review and learn at home. ⑤ Continuous care: Use telephone, wechat and cloud follow-up data platform to follow up breast cancer patients on the 3rd and 7th day after discharge and once a week thereafter, implement targeted guidance and correct deviations; Arrange specialists on duty to answer questions raised by the research subjects in a timely manner in the wechat communication group. The follow-up included the patient's condition (disease changes after tumor treatment, diet and activity, psychological condition, etc.) and the caregiver's condition (mastery and implementation of caring skills, resilience, role transformation, psychological condition, physiological condition, use of access to information, etc.). On the day of discharge, at 3 weeks, 6 weeks, 9 weeks, and 12 weeks, the spouses or children of breast cancer patients were given the "Family Uncertainty Scale (MUIS-FM)" and the "Caregiver Readiness Scale for Discharge (CPS)", and the Chinese version of the "Breast Cancer Patients Quality of Life Scale (FACT-B)" were given to breast cancer patients.

Intervention code：

组别：

对照组

样本量：

50

Group：

Control group

Sample size：

干预措施：

病人、配偶或子女住院期间接受同样的常规管理模式，出院当天对病人、配偶或子女进行常规出院宣教：①住院期间对病人实施常规乳腺癌肿瘤护理②根据病人的情况发放肿瘤治疗相关健康处方（出入院处方、骨髓抑制处方、疼痛处方、导管处方、恶心呕吐处方等）；③回答乳腺癌病人、配偶或子女的提问；④对乳腺癌病人进行出院后饮食指导及潜在风险的预防与处理相关知识指导。⑤协助办理出院。⑥对病人出院后行常规随访。

干预措施代码：

Intervention：

Patients, spouses or children receive the same routine management mode during hospitalization, and routine discharge education is carried out on the day of discharge: (1) Routine breast cancer tumor care is carried out during hospitalization; (2) health prescriptions related to tumor treatment are issued according to the patient's situation (exit and admission prescriptions, myelosuppression prescriptions, pain prescriptions, catheter prescriptions, nausea and vomiting prescriptions, etc.); Answer questions from breast cancer patients, spouses or children; (4) Dietary guidance for breast cancer patients after discharge and relevant knowledge guidance on the prevention and treatment of potential risks. ⑤ Assist in discharge. ⑥ Routine follow-up was performed after discharge.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东 

市(区县)：

 深圳 

Country：

China 

Province：

Guangdong  

City：

Shenzhen 

单位(医院)：

北京大学深圳医院 

单位级别：

三甲 

Institution
hospital：

Peking University Shenzhen Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

照顾者准备度

指标类型：

主要指标

Outcome：

Caregiver readiness

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

家属疾病不确定感

指标类型：

次要指标

Outcome：

The uncertainty of family illness

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

乳腺癌病人生命质量评定

指标类型：

次要指标

Outcome：

Quality of life assessment of breast cancer patients

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

非计划入院率指标

指标类型：

次要指标

Outcome：

Indicators of unplanned admission rates

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

负性事件指标

指标类型：

次要指标

Outcome：

Negative event indicator

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：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 65 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）：

由项目实施者按照随机数字表法随机分组，把入组研究对象分成对照组和干预组；将两组研究对象分别安置在病区两端的病房中，确保同一病房的研究对象均在同一研究组，避免串组现象。

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

According to the random number table method, the subjects were randomly divided into control group and intervention group. The two groups of subjects were placed in the wards at both ends of the ward to ensure that the subjects in the same ward were in the same study group to avoid the phenomenon of tandem groups.

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）：

研究完成六个月后可联系主要研究者邮箱获得

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

Available six months after completion of the study by contacting the principal investigator's email address.

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：

EDC

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

EDC

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：

  2024-09-20 11:00:03