ChiCTR2600122254 版本V1.1 版本创建时间2026/04/13 16:17:53 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：

ChiCTR2600122254 

最近更新日期：

Date of Last Refreshed on：

2026-04-10 15:14:41 

注册时间：

Date of Registration：

2026-04-10 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

生命末期患者治疗决策转变研究

Public title：

Study on the Changes in Treatment Decision-Making of Terminally Ill Patients.

注册题目简写：

English Acronym：

研究课题的正式科学名称：

生命末期患者治疗决策转变研究

Scientific title：

Study on the Changes in Treatment Decision-Making of Terminally Ill 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：

曾冬艳 

研究负责人：

曾冬艳 

Applicant：

Zeng Dongyan 

Study leader：

Zeng Dongyan 

申请注册联系人电话：

Applicant telephone：

+86 15992603485

研究负责人电话：

Study leader's telephone：

+86 756 2528888

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：

zengdy7@mail.sysu.cn

研究负责人电子邮件：

Study leader's E-mail：

zengdy7@mail.sysu.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：

中国广东省珠海市香洲区梅华东路52号

研究负责人通讯地址：

中国广东省珠海市香洲区梅华东路52号

Applicant address：

52 Meihua East Road, Xiangzhou District, Zhuhai, Guangdong, China

Study leader's address：

52 Meihua East Road, Xiangzhou District, Zhuhai, Guangdong, 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：

中山大学附属第五医院

Applicant's institution：

The Fifth Affiliated Hospital of Sun Yat-sen University

研究负责人所在单位：

中山大学附属第五医院

Affiliation of the Leader：

The Fifth Affiliated Hospital of Sun Yat-sen 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：

中大五院【2025】伦字第（K311-1）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：

中山大学附属第五医院医学伦理委员会

Name of the ethic committee：

The Fifth Affiliated Hospital Sun Yat sen University Committee on medical ethics

伦理委员会批准日期：

Date of approved by ethic committee：

2025-12-05 00:00:00

伦理委员会联系人：

傅雪婷

Contact Name of the ethic committee：

Fu Xueting

伦理委员会联系地址：

中国广东省珠海市香洲区梅华东路52号

Contact Address of the ethic committee：

52 Meihua East Road, Xiangzhou District, Zhuhai, Guangdong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 756 2528895

伦理委员会联系人邮箱：

Contact email of the ethic committee：

813510375@qq.com

研究实施负责（组长）单位：

中山大学附属第五医院

Primary sponsor：

The Fifth Affiliated Hospital of Sun Yat-sen University

研究实施负责（组长）单位地址：

中国广东省珠海市香洲区梅华东路52号

Primary sponsor's address：

52 Meihua East Road, Xiangzhou District, Zhuhai, Guangdong, 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)：

广东

市(区县)：

Country：

China

Province：

Guangdong

City：

单位(医院)：

中山大学附属第五医院

具体地址：

中国广东省珠海市香洲区梅华东路52号

Institution
hospital：

The Fifth Affiliated Hospital of Sun Yat-sen University

Address：

52 Meihua East Road, Xiangzhou District, Zhuhai, Guangdong, China

经费或物资来源：

自筹

Source(s) of funding：

Self-funded

Target disease：

end-stage cancer patients

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

横断面 

Study design：

Cross-sectional 

研究目的：

系统探讨终末期肿瘤患者ICU治疗撤除后转入普通病房的决策演变过程、关键节点与支持需求，并结合回顾性病例资料和医生访谈，分析该人群的治疗特征及医患互动中影响决策的关键机制。  

Objectives of Study：

This study aims to systematically explore the evolutionary process, critical nodes, and support needs of decision-making regarding the transfer of end?stage cancer patients from the ICU to general wards after the withdrawal of life?sustaining treatments.
Combined with retrospective case data and physician interviews, it further analyzes the treatment characteristics of this population and the key mechanisms influencing decision-making in doctor?patient interactions.

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. 家属质性访谈：(1) 家属年龄>=18岁，系患者主要决策者（如配偶、子女等），并亲自参与本次住院相关医疗决策；(2) 患者年龄>=18岁，临床诊断为晚期/转移性恶性肿瘤，且被主治团队评估为预计生存期＜6个月；(3) 患者本次住院进入ICU>=24小时且接受至少一项生命维持治疗（如气管插管/有创或无创通气、血管活性药、CRRT/透析、ECMO、CPR等）；(4) 病历/医嘱中有明确治疗目标转变记录（如“仅舒缓治疗/放弃进一步抢救/DNR/DNI/不再升级治疗”），且随后出现相应处置改变（如拔管、停用或不再升级LST、转回普通病房/安宁病房）；(5) 家属具备良好沟通与认知能力，能完成汉语访谈；(6) 自愿参加并签署知情同意书。 2. 医生质性访谈：纳入标准：(1) 具有执业医师资格，现为在岗临床医生；(2) 临床工作年限>=1年；(3) 来自肿瘤科、ICU、呼吸内科、心内科、老年科等相关科室；(4) 过去6个月接诊终末期患者并参与治疗决策；(5) 自愿参加并签署知情同意书。 3. 病例分析：(1) 年龄>=18岁；(2) 晚期/转移性恶性肿瘤；(3) 本次住院进入ICU并接受>=1项LST（插管/机械通气、血管活性药、CRRT/透析、ECMO、CPR等）；(4) 病历/医嘱明确治疗目标转变（如“仅舒缓治疗/放弃进一步抢救/DNR/DNI/不再升级治疗”等）；(5) 目标转变后有对应处置（如拔管、停用/不再升级LST、转回普通病房/安宁病房或出院居家舒缓）。

Inclusion criteria

1. Family member qualitative interview:(1) Family members aged >=18 years, who are the primary decision-makers for the patient (e.g., spouse, children, etc.) and have personally participated in medical decision-making related to the current hospitalization;
(2) Patients aged >=18 years with a clinical diagnosis of advanced or metastatic malignant tumor, and with an estimated survival of <6 months as assessed by the attending medical team;
(3) Patients admitted to the ICU for >=24 hours during the current hospitalization and receiving at least one life-sustaining treatment (LST), such as endotracheal intubation/invasive or non-invasive ventilation, vasoactive drugs, CRRT/dialysis, ECMO, CPR, etc.;
(4) Clear documentation of a shift in treatment goals in medical records/physician orders (e.g., "palliative care only," "no further resuscitation," DNR, DNI, "no escalation of treatment"), followed by corresponding changes in management (e.g., extubation, discontinuation or no escalation of LST, transfer to general ward or hospice ward);
(5) Family members with good communication and cognitive ability who can complete interviews in Chinese;
(6) Voluntary participation and signed informed consent. 2. Qualitative Interviews with Physicians: Inclusion Criteria: (1) Possess a medical practitioner qualification and currently working as an active clinician; (2) >=1 year of clinical work experience; (3) From relevant departments such as Oncology, ICU, Respiratory Medicine, Cardiology, and Geriatrics; (4) Have consulted end-of-life patients and participated in treatment decision-making within the past 6 months; (5) Voluntarily participate and sign the informed consent form; 3. Case Analysis: Inclusion Criteria: (1) Age >=18 years; (2) Advanced or metastatic malignancy; (3) Admitted to the ICU during the current hospitalization and received >=1 form of life-sustaining treatment (LST) (e.g., intubation/mechanical ventilation, vasoactive medications, CRRT/dialysis, ECMO, CPR); (4) Medical records/orders clearly document a shift in treatment goals (e.g., "palliative-only care," "do not resuscitate (DNR)," "do not intubate (DNI)," "no further escalation of treatment"); (5) Appropriate management actions followed the goal shift (e.g., extubation, discontinuation of LST, no further escalation of care, transfer to general ward/hospice, or discharge for home-based palliation).

排除标准：

1. 家属质性访谈：（任一即排）：(1) 访谈时处于急性悲伤/明显心理危机，经研究团队或临床评估不适宜接受访谈；(2) 非主要决策者或对关键决策过程知情度不足；(3) 存在严重认知障碍/精神障碍/语言沟通障碍，无法完成访谈；(4) 涉及进行中的医疗纠纷/法律诉讼不宜受访（如有）； 2. 医生质性访谈：(1) 未直接参与终末期决策或不在临床一线工作者；(2) 拒绝录音或无法完成访谈者；(3) 近期参与过同主题研究者。 3. 病例分析：(1) 无明确晚期癌症诊断；(2) 关键病历资料缺失，无法确认是否发生治疗目标转变或相关处置；(3) 仅短暂停留急诊/未住院者（如与研究范围不符）；

Exclusion criteria：

1. Family Member Qualitative Interviews: (Exclusion if any one criterion applies): (1) Experiencing acute grief or obvious psychological crisis at the time of interview, deemed unsuitable for participation by the research team or clinical assessment; (2) Not the primary decision-maker or insufficiently informed about the key decision-making process; (3) Presence of severe cognitive impairment, mental disorder, or language communication barrier preventing completion of the interview; (4) Involved in ongoing medical disputes or legal litigation that makes participation inadvisable. 2. Physician Qualitative Interviews: (1) Did not directly participate in end-of-life decision-making or are not frontline clinicians; (2) Refused audio recording or was unable to complete the interview; (3) Recently participated in a study on the same topic. 3. Case Analysis: (1) No definitive diagnosis of advanced cancer; (2) Critical medical records missing, making it impossible to confirm whether a shift in treatment goals or corresponding management occurred; (3) Emergency department visits only with no hospital admission (e.g., not aligned with the study scope).

研究实施时间：

Study execute time：

从 From 2026-04-12 00:00:00至 To 2026-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-04-12 00:00:00 至 To 2026-12-31 00:00:00  

干预措施：

Interventions：

组别：

观察组

样本量：

20

Group：

Observational group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

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)：

  

Country：

China 

Province：

Guangdong 

City：

 

单位(医院)：

中山大学附属第五医院 

单位级别：

三级甲等 

Institution
hospital：

The Fifth Affiliated Hospital of Sun Yat-sen University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

生命末期肿瘤患者ICU治疗撤退后转入普通病房的决策关键影响因素

指标类型：

主要指标

Outcome：

Key influencing factors for the decision to transfer end-of-life cancer patients from ICU to general ward after withdrawal of ICU treatment

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

生命末期肿瘤患者ICU治疗撤退后转入普通病房各影响因素及支持需求

指标类型：

次要指标

Outcome：

Influencing factors and support needs for the decision to transfer end-of-life cancer patients from ICU to general ward after withdrawal of ICU treatment

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：

NA

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 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）：

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：

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）：

受研究数据保密协议、伦理规范或相关管理规定限制，本研究涉及的原始数据暂不对外公开。若读者对数据有合理研究需求，可在征得相关方同意后，通过通讯作者申请

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

Due to the restrictions of the research data confidentiality agreement, ethical norms or relevant management regulations, the original data involved in this study is temporarily not made public. If readers have reasonable research needs for the data, they may apply through the corresponding author after obtaining the consent of the relevant parties

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：

数据采集由病例记录表（回顾性查阅）、半结构化访谈、结构化调查问卷三部分组成： 1. 病例记录表：回顾性查阅受试者既往病历，提取研究相关临床数据，确保与原始病历一致。 2. 访谈与问卷：由经培训研究者开展面对面访谈，同步完成标准化问卷填写，记录受试者主观信息。 3. 数据管理：所有数据采用匿名化处理，去除个人标识；纸质资料锁存归档，电子数据加密存储，严格限制访问权限，充分保护受试者隐私。

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

Data collection consists of three parts: case record forms (retrospective review), semi-structured interviews, and structured questionnaires.1. Case Record Form: Retrospectively review the subjects' past medical records, extract relevant clinical data for the study, and ensure consistency with the original medical records.2. Interviews and Questionnaires: Trained researchers conducted face-to-face interviews, completed standardized questionnaires simultaneously, and recorded the subjective information of the subjects.3. Data Management: All data is anonymized to remove personal identifiers. Paper materials are locked and archived, electronic data is encrypted and stored, access rights are strictly restricted, and the privacy of the subjects is fully protected.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-04-10 15:14:32