A muti-centre cohort study of TCM constitution、resilience、handgrip and sleep: based on latent variable growth mixed model

注册号:

Registration number:

ITMCTR2200005487

最近更新日期:

Date of Last Refreshed on:

2022-01-03

注册时间:

Date of Registration:

2022-01-03

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

乳腺癌患者中医体质、心理韧性、握力及睡眠的多中心队列研究:基于潜变量增长混合模型

Public title:

A muti-centre cohort study of TCM constitution、resilience、handgrip and sleep: based on latent variable growth mixed model

注册题目简写:

English Acronym:

研究课题的正式科学名称:

乳腺癌患者中医体质、心理韧性、握力及睡眠的多中心队列研究:基于潜变量增长混合模型

Scientific title:

A muti-centre cohort study of TCM constitution、resilience、handgrip and sleep: based on latent variable growth mixed model

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:

ChiCTR2200055206 ; ChiMCTR2200005487

申请注册联系人:

李姝含

研究负责人:

李姝含

Applicant:

Shuhan Li

Study leader:

Shuhan LI

申请注册联系人电话:

Applicant telephone:

13550896623

研究负责人电话:

Study leader's telephone:

13550896623

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:

473117611@qq.com

研究负责人电子邮件:

Study leader's E-mail:

473117611@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:

广东省广州市番禺区广州中医药大学

研究负责人通讯地址:

广东省广州市番禺区广州中医药大学

Applicant address:

Guangzhou University of Chinese Medicine, panyu District, Guangzhou City, Guangdong Province

Study leader's address:

Guangzhou University of Chinese Medicine, panyu District, Guangzhou 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:

广州中医药大学

Applicant's institution:

Guangzhou University of 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:

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

Name of the ethic committee:

伦理委员会批准日期:

Date of approved by ethic committee:

2013/8/26 0:00:00

伦理委员会联系人:

Contact Name of the ethic committee:

伦理委员会联系地址:

Contact Address of the ethic committee:

伦理委员会联系人电话:

Contact phone of the ethic committee:

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:

广州中医药大学

Primary sponsor:

Guangzhou University of Chinese Medicine

研究实施负责(组长)单位地址:

广东省广州市番禺区广州中医药大学

Primary sponsor's address:

Guangzhou University of Chinese Medicine, panyu District, Guangzhou 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):

广东省

市(区县):

Country:

China

Province:

Guangdong Province

City:

单位(医院):

广州中医药大学

具体地址:

广东省广州市番禺区广州中医药大学

Institution
hospital:

Guangzhou University of Chinese Medicine

Address:

Guangzhou University of Chinese Medicine,panyu District,Guangzhou City,Guangdong Province

经费或物资来源:

科研经费

Source(s) of funding:

research fund

研究疾病:

乳腺癌

研究疾病代码:

Target disease:

breast cancer

Target disease code:

研究类型:

Study type:

观察性研究

Observational study

研究设计:

Study design:

析因分组(即根据危险因素或暴露因素分组)

Factorial

研究所处阶段:

Study phase:

探索性研究/预试验

Pilot clinical trial

研究目的:

随着改革开放带来的经济发展以及观念解放,中国女性的劳动参与率达到了70%(世界第一),而同时期的印度、法国、美国分别是28%、50%和58%[1]。与此同时,数据显示[2],乳腺癌位于中国女性癌症发病首位,随着中国老龄化的加剧,新发病人数呈逐年上升的趋势,中国女性乳腺癌每年新增病例约21万。随着医学技术不断发展,早期发现及治疗,不断开拓出治疗乳腺癌的靶向药物、放疗化疗药物的更新迭代,使得乳腺癌患者的存活率以提升至88.5%[3]。然而由于术后疼痛、焦虑、恐惧、担心疾病预后、担心复发、术后自我形象紊乱等因素的,乳腺癌患者的睡眠质量受到影响[4-5]。研究表明,乳腺癌患者睡眠障碍发生率约为30%-75%不等,而术后睡眠障碍发生率攀至90%以上[6]。而睡眠不足会导致患者疲劳、生活质量下降等不良后果,甚至增加癌症复发和死亡的风险[7]。所以,了解乳腺癌患者睡眠质量低下的影响因素,早期识别睡眠质量低下的患者并给予针对性的干预以提高乳患者的睡眠质量,成为了医护人员及患者家庭亟需解决的现实问题。 目前乳腺癌患者睡眠质量主要受治疗方式、人格特质、情绪状态等诸多因素的影响。而有一部分乳腺癌患者能较好的面对患病结果并采取积极的应对方式去应对不良环境和刺激,这取决于心理韧性的调控[8]。心理韧性作为一种内在保护性因素,能调节乳腺癌患者的焦虑、抑郁情绪,提高身体意象、生活质量及睡眠质量[9-12]。此外,体质现象是人类生命活动中一种重要表现形式,是指人体生命过程中,在先天禀赋和后天获得的基础上形成的形态结构、生理功能和心理状态方面综合的、相对稳定的固有特质。研究表明,乳腺癌患者以气郁质、阴虚质为多见,其影响机制为长期肝郁不畅导致胸胁脉络气机不利以增加乳腺癌的患病风险[13]。值得注意的是,睡眠障碍在不同中医体质的人群中有显著差异,气虚、阴虚质患者睡眠质量较低[14],但缺乏其对于乳腺癌患者睡眠质量影响的研究。握力作为一项生理指标,能够直接的反应肌肉力量,而肌肉能够通过分泌肌红蛋白并作为器官的主要成分维持身体活动而影响癌症患者的负面情绪[15],有研究指出握力与睡眠质量存在一定的相关性,睡眠质量差的人群往往存在较低的握力值以及肌肉含量[16]。但由于混杂变量过多以及潜在因素的影响,对于乳腺癌患者中握力对于患者睡眠质量的相关性分析仍需进一步研究。因此,本研究将以王琦[17]的中医体质分类法(平和质、气虚质、阴虚质、阳虚质、痰湿质、湿热质、血瘀质、气郁质和特禀质)、乳腺癌患者的心理韧性、握力为预测指标。以乳腺癌患者的睡眠质量发展轨迹为焦点,探究乳腺癌患者在疾病进展各个阶段中,其心理韧性以及握力的变化情况,并对睡眠质量的不同发展轨迹与体质、握力、韧性进行相关、因果关系检验。目前对于乳腺癌患者的中医体质、心理韧性、握力、睡眠质量之间的关联机制暂无统一定论,缺乏针对影响乳腺癌患者睡眠质量的预测模型。在这种情况下,开展针对于乳腺癌患者的睡眠质量保障服务以及睡眠质量的评估就存在很大的差异性,而针对于乳腺癌患者的各种干预性试验也难以横向及纵向比较,这使得开发针对乳腺癌患者在疾病进展过程中的中医体质-心理韧性-握力-睡眠质量的模型和评估指标成为了亟待补充的现实需求。

Objectives of Study:

With the economic development and emancipation of ideas brought about by reform and opening up, The labor participation rate of Chinese women reached 70% (the first in the world), while that of India, France and the United States were 28%, 50% and 58% respectively in the same period [1]. At the same time, the data show that [2] Breast cancer is the leading cause of cancer in China. With the aging of China, the number of new cases is increasing year by year. The number of new cases of breast cancer in China is about 210 thousand. With the continuous development of medical technology, early detection and treatment, and constantly open up the treatment of breast cancer targeted drugs, radiotherapy and chemotherapy drugs update iteration, so that the survival rate of breast cancer patients to 88.5%[3]. However, due to postoperative pain, anxiety, fear, fear of disease prognosis, worry about recurrence, postoperative self image disorder and other factors, the quality of sleep of breast cancer patients is affected by [4-5]. Studies have shown that the incidence of sleep disorders in breast cancer patients is about 30%-75%, and the incidence of postoperative sleep disorders has climbed to more than 90% of [6]. Lack of sleep will lead to adverse consequences such as fatigue and decline in quality of life, and even increase the risk of cancer recurrence and death [7]. Therefore, understanding the influencing factors of low quality of sleep in breast cancer patients, identifying patients with low sleep quality and giving targeted interventions to improve the sleep quality of breast milk patients have become a realistic problem for medical staff and patients' families. At present, the sleep quality of breast cancer patients is mainly influenced by many factors, such as treatment style, personality traits, emotional state and so on. However, some breast cancer patients can better face the results of illness and adopt positive coping strategies to cope with adverse environment and stimulation, which depends on the regulation of resilience [8]. As an intrinsic protective factor, resilience can regulate anxiety and depression in breast cancer patients, improve body image, quality of life and sleep quality [9-12]. In addition, physical phenomenon is an important form of expression in human life activities. It refers to the comprehensive and relatively stable inherent characteristics of morphological structure, physiological function and psychological state formed on the basis of congenital endowment and acquired in the process of human life. Studies have shown that breast cancer patients are characterized by qi stagnation and yin deficiency. The mechanism is that chronic stagnation of the liver leads to the deficiency of the chest and collateral channels, which increases the risk of breast cancer by [13]. It is worth noting that sleep disorders in people with different TCM Constitution are significantly different. The sleep quality of patients with Qi deficiency and yin deficiency is lower than that of [14], but there is a lack of research on the influence of sleep disorders on the quality of sleep in patients with breast cancer. As a physiological index, grip strength can directly reflect muscle strength, and muscle can affect the negative mood of cancer patients by secreting myoglobin and maintaining physical activity as the main component of organs [15]. Some studies have pointed out that grip strength is related to sleep quality, and people with poor sleep quality often have lower grip strength value and muscle content [16]. However, due to the fact that there are too many confounding variables and potential factors, it is still necessary to further study the correlation between grip strength and sleep quality in breast cancer patients. So, This study will take Wang Qi [17]'s TCM constitution classification (mild temperament, Qi deficiency, yin deficiency, Yang deficiency, phlegm dampness, dampness heat, blood stasis, qi stagnation and special temperament), psychological resilience and grip strength of breast cancer patients were used as predictors. Based on the development trajectory of sleep quality of breast cancer patients, the psychological resilience and grip strength of breast cancer patients in various stages of disease progression were explored, and the quality of sleep was also investigated. The correlation and causality between different development trajectories and physique, grip strength and toughness were tested. At present, there is no unified theory on the relationship between TCM Constitution, resilience, grip strength and sleep quality of breast cancer patients. There is no prediction model for affecting the sleep quality of breast cancer patients. In this case, there are great differences in the quality of sleep service and sleep quality assessment for breast cancer patients, and the intervention tests for breast cancer patients are difficult to compare horizontally and vertically. This makes the development of the model of TCM Constitution, mental toughness, grip strength and sleep quality and evaluation index for breast cancer patients in the course of disease progression has become a realistic need to be supplemented. Based on kumpfer's psychological resilience theory, The Resilience Model to Breast Cancer (RM-BC, Figure 1) was constructed and validated by qualitative research. In addition, the team developed the trait Resilience Scale for cancer patients based on RM-BC and Shift-Persist theory. Currently, there are Chinese, English, Portuguese, Malaysia and Farsi. Several versions of language, such as (translation), German (Preparatory) and French (Preparatory), have been widely applied worldwide. Based on this project, based on the Stimulus-Organism-Response mode ("S-O-R"), this project constructs a TCM Constitution, mental toughness, handgrip and sleep quality model of breast cancer patients. (TCM Constitution resilience handgrip sleep quality model for breast cancer, crhsm-bc). In addition, the traditional linear statistical model does not consider the complex nonlinear relationship between longitudinal data and trajectory analysis, so it is difficult to further improve the prediction accuracy. Latent growth mixture modeling (lgmm) is a method to deal with population heterogeneity, Combining the traditional growth model with latent category analysis can not only describe the growth trend, but also consider the group heterogeneity. At present, this model has been widely applied in the prediction of disease risk. It also provides a scientific, objective and efficient analytical method for the prediction and analysis of grip strength, TCM Constitution, resilience and sleep quality of breast cancer patients. Therefore, this project will use LGMM, SEM and other modern statistical technology new ideas, according to the preliminary research basis to build breast cancer patients' TCM Constitution mental toughness grip strength sleep quality model, predict the development path of psychological stress and final sleep quality outcomes of breast cancer patients, and explore the predictive effect of grip strength, TCM Constitution and resilience on the trajectory of sleep quality. In order to provide reference for early recognition and screening of low sleep quality among medical staff, and promote the quality of sleep, mental health and quality of life of breast 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:

经影像学、细胞病理学检查确诊为乳腺癌的门诊或住院的中国癌症患者(Stage I-IV) (1)≥18岁;(2)初次诊断,且抗癌治疗小于3个月;(3)无认知功能障碍;(4)能阅读、理解量表文字;(5)知情同意。

Inclusion criteria

(1) ≥ 18 years old; (2) initial diagnosis and less than 3 months of anti-cancer treatment; (3) no cognitive impairment; (4) able to read and understand the scale text; (5) informed consent.

排除标准:

(1)既往或目前有精神疾病者;(2)拒绝参与者;(3)终末期慢性肾脏疾病或正在进行血液透析治疗者;(4)肌肉骨骼方面疾病者;(5)患者正处于疾病的急性状态或慢性疾病急性发作者;(6)安有起搏器装置者。

Exclusion criteria:

(1) Previous or current mental illness; (2) rejection of participants; (3) end-stage chronic kidney disease or hemodialysis treatment; (4) musculoskeletal disease; (5) the patient is in an acute state of disease or acute developer of chronic disease; (6) pacemaker device is installed.

研究实施时间:

Study execute time:

From 2021-12-30

To      2022-12-30

征募观察对象时间:

Recruiting time:

From 2022-03-01

To      2022-04-01

干预措施:

Interventions:

组别:

低睡眠质量组

样本量:

94

Group:

low quality of sleep

Sample size:

干预措施:

干预措施代码:

Intervention:

not applicable

Intervention code:

组别:

高睡眠质量组

样本量:

94

Group:

high quality of sleep

Sample size:

干预措施:

干预措施代码:

Intervention:

not applicable

Intervention code:

样本总量 Total sample size : 188

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

广东省

市(区县):

Country:

China

Province:

Guangdong province

City:

单位(医院):

广东省中医院

单位级别:

三级甲等

Institution/hospital:

Guangdong Hospital of traditional Chinese Medicine

Level of the institution:

third-class hospital

测量指标:

Outcomes:

指标中文名:

匹兹堡睡眠质量指数量表

指标类型:

主要指标

Outcome:

PSQI

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

握力值

指标类型:

次要指标

Outcome:

handgrip

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

恶性肿瘤患者特质心理韧性量表

指标类型:

次要指标

Outcome:

resilience scale specific for cancer

Type:

Secondary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

中医体质量表-30条目简版

指标类型:

次要指标

Outcome:

Chinese Medical Constitution Questionnaire with 30 Items

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:

征募研究对象情况:

尚未开始

Not yet recruiting

年龄范围:

最小 18
Min age years
最大 60
Max age years

Recruiting status:

Participant age:

性别:

Gender:

女性

Female

随机方法(请说明由何人用什么方法产生随机序列):

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

not applicable

盲法:

Blinding:

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):

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

not applicable

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:

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

not applicable

数据管理委员会:

Data Managemen Committee:

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):

ITMCTR BJ-ICP:07032215-5 Tip: IE8 is recommended Use the system with widescreen display resolution above