结直肠癌营养不良患者中医辨证施食管理方案的构建与应用

注册号:

Registration number:

ITMCTR2024000395

最近更新日期:

Date of Last Refreshed on:

2024-09-06

注册时间:

Date of Registration:

2024-09-06

注册号状态:

Registration Status:

补注册

Retrospective registration

注册题目:

结直肠癌营养不良患者中医辨证施食管理方案的构建与应用

Public title:

Construction and application of a Chinese medicine evidence-based dietary management programme for malnourished patients with colorectal cancer

注册题目简写:

English Acronym:

研究课题的正式科学名称:

结直肠癌营养不良患者中医辨证施食管理方案的构建与应用

Scientific title:

Construction and application of a Chinese medicine evidence-based dietary management programme for malnourished patients with colorectal cancer

研究课题的正式科学名称简写:

Scientific title acronym:

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:

林桂娇

研究负责人:

邓燕萍

Applicant:

Guijiao Lin

Study leader:

Yanping Deng

申请注册联系人电话:

Applicant telephone:

+86 178 5039 1702

研究负责人电话:

Study leader's telephone:

+86 13509363736

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:

2581103560@qq.com

研究负责人电子邮件:

Study leader's E-mail:

1160464404@qq.com

申请单位网址(自愿提供):

Study leader's 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:

福建省福州市闽侯县上街镇邱阳西路1号福建中医药大学旗山校区

研究负责人通讯地址:

福建省福州市晋安区福马路456号

Applicant address:

Fujian University of Traditional Chinese Medicine Qishan Campus No.1 Qiuyang West Road Shangjie Town Minhou County Fuzhou City Fujian Province China

Study leader's address:

No.456 Fuma Road Jin'an District Fuzhou City Fujian Province 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:

福建中医药大学护理学院

Applicant's institution:

School of Nursing Fujian University of Traditional Chinese Medicine

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

K2024-058-01

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件

批准本研究的伦理委员会名称:

福建省肿瘤医院伦理委员会

Name of the ethic committee:

Ethics Committee of Fujian Cancer Hospital

伦理委员会批准日期:

Date of approved by ethic committee:

2024/2/23 0:00:00

伦理委员会联系人:

连至炜

Contact Name of the ethic committee:

Zhiwei Lian

伦理委员会联系地址:

福建省福州市晋安区福马路456号

Contact Address of the ethic committee:

No.456 Fuma Road Jin'an District Fuzhou City Fujian Province China

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 178 5080 5371

伦理委员会联系人邮箱:

Contact email of the ethic committee:

fjszlyyjgb@163.com

研究实施负责(组长)单位:

福建中医药大学

Primary sponsor:

Fujian University of Chinese Medicine

研究实施负责(组长)单位地址:

福建省福州市闽侯县上街镇邱阳西路1号福建中医药大学旗山校区

Primary sponsor's address:

Fujian University of Traditional Chinese Medicine Qishan Campus No.1 Qiuyang West Road Shangjie Town Minhou County Fuzhou City Fujian Province 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):

福建

市(区县):

福州

Country:

China

Province:

Fujian

City:

Fuzhou

单位(医院):

福建省肿瘤医院

具体地址:

福建省福州市晋安区福马路456号

Institution
hospital:

Fujian Cancer Hospital

Address:

No.456 Fuma Road Jin'an District Fuzhou City Fujian Province China

经费或物资来源:

自筹

Source(s) of funding:

self-finance

研究疾病:

结直肠癌

研究疾病代码:

Target disease:

colorectal cancer

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

非随机对照试验

Non randomized control

研究所处阶段:

Study phase:

其它

Others

研究目的:

第一部分通过证据总结和质性研究,分析结直肠癌围手术期化疗患者中西医结合营养管理现状,掌握其最佳证据和临床难点。 第二部分结合目标达成理论,通过文献研究和德尔菲专家函询法,设计、构建基于目标达成理论的结直肠癌营养不良患者中医辨证施食管理方案。 第三部分采用非随机对照研究方法,探讨结直肠癌营养不良患者中医辨证施食管理方案对患者营养状况、依从性和食疗知信行的影响,并调查患者与医护人员对方案的满意度,以验证中医辨证施食管理方案在结直肠癌营养不良患者中的可用性和有效性。

Objectives of Study:

The first part analyses the current status of combined Chinese and Western medicine nutritional management for perioperative chemotherapy patients with colorectal cancer and grasps the best evidence and clinical difficulties through evidence summary and qualitative research. The second part combines the theory of goal attainment and designs and constructs a Chinese medicine evidence-based dietary management program for malnourished patients with colorectal cancer based on the theory of goal attainment by means of literature research and the Delphi expert correspondence method. In the third part a non-randomized controlled study was conducted to investigate the effects of the TCM dietary management program on patients' nutritional status adherence and knowledge and beliefs of therapeutic feeding in patients with malnutrition of colorectal cancer and to investigate the satisfaction of the program between patients and healthcare professionals in order to validate the usability and effectiveness of the TCM dietary management program in patients with malnutrition of colorectal cancer.

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)年龄≥18 岁且≤80 岁;(2)符合 CRC 的诊断标准;(3)中医辨证属脾虚气滞证或气血两虚证;(4)既往无根治或姑息手术、放化疗病史等的初治患者;(5)以铂类化疗药物为化疗方案的静脉化疗至少 6 个疗程;(6)接受术后化疗第 1 个疗程结束后;(7)经 NRS 2002 评分≥3 分;(8)经 PG-SGA 评分≥2 分;(9)患者无精神疾病、无沟通障碍,能独立完成问卷调查;(10)签署知情同意书并参加本研究,依从性好,可随访患者;(11)预计生存期大于 3 个月,Karnofsky 功能状态评分>60 分

Inclusion criteria

(1) aged ≥18 years and ≤80 years; (2) fulfilled the diagnostic criteria of CRC; (3) identified by Chinese medicine as having spleen deficiency and qi stagnation or qi and blood deficiency; (4) primary patients with no previous radical or palliative surgery radiotherapy or chemotherapy; (5) received at least 6 courses of intravenous chemotherapy with platinum-based chemotherapy; (6) received postoperative chemotherapy after the completion of the 1st course; (7) scored ≥3 points in the NRS 2002 score ≥3 points; (8) PG-SGA score ≥2 points; (9) patients without mental illness no communication disorders and able to complete questionnaires independently; (10) signing the informed consent form and participating in the study with good adherence and available for follow-up; (11) with an expected survival of more than 3 months and a Karnofsky Functional Status Score of >60 points. Translated with www.DeepL.com/Translator (free version)

排除标准:

(1)合并严重的并发症;(2)已参与除本研究外任何其他临床试验者。

Exclusion criteria:

(1) comorbid serious complications; and (2) those who have participated in any other clinical trial other than this study.

研究实施时间:

Study execute time:

From 2024-04-01

To      2024-11-30

征募观察对象时间:

Recruiting time:

From 2024-04-01

To      2024-10-20

干预措施:

Interventions:

组别:

对照组

样本量:

43

Group:

control group

Sample size:

干预措施:

对照组采取常规治疗和常规护理,具体措施如下: (1)常规治疗:根据常规化疗方案进行化疗,依据“营养不良五阶梯疗法”(饮食+营养教育、饮食+口服营养补充、全肠内营养、部分肠内营养+部分肠外营养、全肠外营养)给予常规营养支持,根据症状予对应的抗贫血、消炎、止吐、保护胃黏膜、护肝等治疗; (2)常规护理: ①疾病相关知识指导:包括疾病的病因和发病机制、高危因素、临床症状及健康指导等;②睡眠指导:指导患者睡眠有规律,养成早睡早起的好习惯,尽量保证每天睡眠时间8h;③心理护理:为患者提供心理护理,耐心回答患者提出的问题,加强对患者的关心和关爱,鼓励其保持正能量心境,树立及强化其对疾病治疗和预后的信心,同时为患者提供放松方法,如听音乐、伸展运动、呼气运动等;④给予常规饮食指导,发放营养手册并向患者口头宣教,阐述手术、化疗与营养的关系,告知患者要少食多餐,进食高热量、高蛋白、高维生素的清淡易消化食物,保持大便通畅,保持心情愉悦,规律进行户外活动,积极锻炼身体。

干预措施代码:

Intervention:

The control group adopts conventional treatment and routine care the specific measures are as follows: (1) Conventional treatment: chemotherapy is carried out according to the conventional chemotherapy plan and conventional nutritional support is given according to the five-step therapy for malnutrition (diet + nutritional education diet + oral nutritional supplementation total enteral nutrition partially enteral nutrition + partially pare

Intervention code:

组别:

干预组

样本量:

43

Group:

intervention group

Sample size:

干预措施:

干预组在对照组的基础上,给予基于目标达成理论食疗管理方案中“诊断、计划、实施”的内容。

干预措施代码:

Intervention:

The intervention group was given the ‘Diagnose, Plan, Do’ component of the therapeutic dietary management program based on goal-attainment theory on top of the control group.

Intervention code:

样本总量 Total sample size : 86

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):

福建省肿瘤医院

单位级别:

三甲

Institution/hospital:

Fujian Cancer Hospital

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

肌肉质量

指标类型:

主要指标

Outcome:

muscle mass

Type:

Primary indicator

测量时间点:

测量方法:

通过握力/体重比值(hand grip strength/weight ratio, HGS/W)评价肌肉质量。使用香山CAMRY EH101电子握力计(弹簧式)测量非惯用臂的HGS,测量3次得到平均值,将HGS除以W得到HGS/W。测量方法:患者身体站立挺直,双腿自然分开,双臂自然下垂,肘部向外伸展15-45°。患者以直角(90°)握住电子握力计并使出自身最大力量,重复测量三次,每次间隔30s。

Measure time point of outcome:

Measure method:

Muscle mass was evaluated by grip strength/weight ratio (HGS/W). The HGS of the non-dominant arm was measured with a CAMRY EH101 electronic grip strength meter (spring-loaded), and the average value was obtained by taking three measurements and dividing the HGS by W to obtain the HGS/W. Measurement method: The patient's body stood up straight, with legs naturally apart, arms naturally hanging down, and elbows extended outward by 15-45°. The patie

指标中文名:

食疗知信行水平

指标类型:

次要指标

Outcome:

Food Therapy Knowledge, Trust and Practice Level

Type:

Secondary indicator

测量时间点:

测量方法:

采用李芳编制的《居民药膳食疗行为影响因素问卷》进行调查。包含药膳食疗知识、信念、主观规范、知觉行为控制、行为五个维度,共 45 个条目。

Measure time point of outcome:

Measure method:

The Questionnaire on Influencing Factors of Residents' Medicinal Food Therapy Behaviour prepared by Li Fang was used for the survey. It contains five dimensions of medicinal dietary food therapy knowledge, beliefs, subjective norms, perceived behavioural control, and behaviours, with a total of 45 entries.

指标中文名:

安全性

指标类型:

副作用指标

Outcome:

safety

Type:

Adverse events

测量时间点:

测量方法:

试验组患者或家属通过微信小程序“班小二”或纸质版“摄入食疗相关不适症状记录表”记录摄入食疗相关不适症状,如腹泻。计算摄食食疗相关不适症状(如腹泻)的发生次数评价食疗安全性。安全性在2个化疗周期结束后(42天,即6周)收集

Measure time point of outcome:

Measure method:

Patients or their family members in the test group recorded the symptoms of discomfort associated with ingestion of therapeutic feeding, such as diarrhoea, through the WeChat app ‘Banxiao Er’ or the paper version of the ‘Record of Symptoms Associated with Ingested Therapeutic Feeding’ form. The safety of therapeutic feeding will be evaluated by counting the number of episodes of therapeutic feeding-related symptoms (e.g., diarrhoea). Safety was c

指标中文名:

生活质量

指标类型:

次要指标

Outcome:

quality of life

Type:

Secondary indicator

测量时间点:

测量方法:

采用欧洲癌症研究与治疗组织的生命质量核心量表(EORTC QLQ-C30量表),欧洲癌症研究与治疗组织于1986年开始研制面向癌症病人的核心量表(普适性量表),在此基础上增加不同的特异性条目(模块),即构成不同病种的特异量表。

Measure time point of outcome:

Measure method:

The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Core Scale (EORTC QLQ-C30 scale) was used. The EORTC started to develop a core scale (universal scale) for cancer patients in 1986, to which different specific entries (modules) were added, i.e., constituting disease-specific scales.

指标中文名:

PG-SGA

指标类型:

主要指标

Outcome:

PG-SGA

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医证候

指标类型:

次要指标

Outcome:

Chinese medicine evidence and symptoms

Type:

Secondary indicator

测量时间点:

测量方法:

采用中医症状及体征评分量表进行评估,包括失眠多梦、消瘦、腹泻、神疲乏力、气短、心悸、少气懒言、面色萎黄或苍白、头晕目眩9个条目,根据症状轻重分为无、轻、中、重,分别为0、1、2、3分。

Measure time point of outcome:

Measure method:

The assessment was performed using the Chinese Medicine Symptoms and Signs Rating Scale, which included 9 entries of insomnia and dreaminess, emaciation, diarrhoea, fatigue, shortness of breath, palpitation, less breath and lazy speech, yellowish or pale complexion, and dizziness, which were classified as none, light, moderate, and severe according to the severity of the symptoms, with scores of 0, 1, 2, and 3, respectively. Translated with www.

指标中文名:

NRS 2002

指标类型:

主要指标

Outcome:

NRS 2002

Type:

Primary 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:

血清白蛋白、外周血总淋巴计数、血红蛋白

组织:

Sample Name:

Serum albumin total peripheral blood lymph count haemoglobin

Tissue:

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note:

征募研究对象情况:

正在进行

Recruiting

年龄范围:

最小 18
Min age years
最大 80
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

通过目的抽样法,选2024年4月—2024年11月在福州市某三级甲等医院的结直肠癌营养不良气血两虚证患者作为研究对象。将2024年4月-7月的研究对象纳入对照组,进行常规治疗护理;将2024年8-11月的研究对象纳入试验组,进行基于目标达成理论的食疗管理+常规治疗护理。

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

Through the purposive sampling method patients with colorectal cancer malnutrition with Qi and blood deficiency were selected from April 2024 to November 2024 in Fuzhou City as the study subjects. The study subjects from April to July 2024 were included in the control group for conventional treatment and care; the study subjects from August to November 2024 were included in the experimental group for therapeutic dietary management + conventional treatment and care based on goal-achievement theory.

盲法:

结果评价者盲

Blinding:

Outcome evaluator blind

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

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

unshared

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:

由两名经过培训的未参与该研究的临床护士进行数据的收集,收集完成后两名研究人员分别进行数据的录入、统计,并对结果进行双人核对。将数据统一存储在U盘,由专人保管,放在有锁的柜子,仅允许研究者用于数据分析。

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

Data collection was conducted by two trained clinical nurses who did not participate in the study. After the collection, two researchers entered and statistically analyzed the data respectively and double-checked the results. The data were uniformly saved on a USB stick which was kept by a staff member in a locked cabinet and only allowed to be used by the researcher for data analysis.

数据管理委员会:

Data Managemen Committee:

暂未确定

Not yet

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

国际传统医学临床试验注册平台 京ICP备07032215号-5 提示:推荐使用IE8.0以上版本 宽屏显示分辨率下使用系统