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临床试验/NCT04735991
NCT04735991暂停不适用

A Real-world Clinical Study Evaluating the Quality of Life in Family Members of Colorectal Cancer Patients Based on a Whole Course Chronic Disease Management System for Cancer Patients' Family

Chinese Academy of Medical Sciences2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年5月8日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
入组人数
100
试验地点
2
主要终点
To assess the difference in the quality of life of the family members of patients with colorectal cancer after application of follow-up disease management using mobile network terminals and routine clinical treatment follow-up management.

研究概览

简要总结

This study is a prospective and effective research study. The aim is to assess the difference in the quality of life of the family members of patients with colorectal cancer after application of follow-up disease management using mobile network terminals and routine clinical treatment follow-up management. The hypothesis is that the application of mobile-based disease management system significantly improves the quality of life of the patients' family members, thereby improving the quality of life of the patients' families.

Approximately 100 families of colorectal cancer patients who had been diagnosed as high-risk stage II or stage III and required adjuvant chemotherapy XELOX regimen within 6 months after initial diagnosis were randomly assigned to the control and study groups at a 1: 1 ratio, with approximately 50 cases in the control group and about 50 patients in the study group. The reason for choosing these tumors is because the patients with these tumors will present a series of clinical symptoms during the treatment, which requires family members to take care of them. All patient and their family demographics, questionnaires on quality of life of patient's family, adverse events and other information will be collected.

The study uses a network-centric randomization system. In the randomization process, stratified randomization will be carried out according to the education level of the patient's family members (junior college degree or above vs. below college degree). The family members of the patients participating in the study will be randomly assigned to the tumor patient management platform or clinical routine treatment follow-up group.

Family members of all patients will be followed up to 2 months after randomization, or withdrew from the study (with the preceding events as the end point). Unless the patient's family member withdraws from the study, lost to follow-up, or the study is terminated, the patient is considered to be in the study. Family members of patients who are randomly assigned to the full management platform need to participate in a 60 minutes concentrated training session for 27 days, taught by experts online. The content of the lectures includes medical treatment guidelines, pain relief, family rehabilitation, family communication, family roles, early screening prevention, Medical insurance and other aspects. The contents of the online courses are: 1) Doctors are also mortal; 2) New medicines and new therapies; 3) Alternative therapies; 4) Don't panic during the operation; 5) Pain relief; 6) Side effects of treatment; 8) About the truth; 9) New topics; 10) Anti-cancer cost-effectiveness; 11) Medical insurance; 12) Commercial medical insurance; 13) Exercise and rehabilitation; 14) Nutrition and Foods to increase leukocytes level ; 15) Long-term persistence; 16) Acceptance Change; 17) Two new roles; 18) Future expectation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • (1) Subject: The main family members caring for patients are ≥18 and ≤65 years old;
  • (2) Family members of patients who can understand the purpose of the study, voluntarily participate and sign an informed consent form, and are willing to complete follow-up as required by the protocol;
  • (3) Family members of colorectal cancer patients who need to receive adjuvant chemotherapy XELOX regimen within 6 months after initial diagnosis of high-risk stage II or stage III

排除标准

  • (1) Patient life expectancy is less than 3 months
  • (2) Family members of patients cannot use electronic mobile products
  • (3) The family of the patient has a history of malignant tumors or other serious diseases
  • (4) Family members of patients are considered unsuitable by the researcher

结局指标

主要结局

To assess the difference in the quality of life of the family members of patients with colorectal cancer after application of follow-up disease management using mobile network terminals and routine clinical treatment follow-up management.

时间窗: 1 Month

First of all, The Cronbach's α coefficient of the QOLLTI-F family quality of life questionnaire that is used in this study will be calculated; then the minimum, maximum, median (quartile) and mean (standard deviation) of the quality of life scores of the family members of the study group and the control group will be determined; finally we will use t test to compare the scores to investigate whether there is a difference in the quality of life score between two groups; in order to eliminate the influence of confounding factors (such as age, gender, education level, etc.) on the main research results, several common influencing factors will be selected to construct a covariance analysis regression model to assess whether the intervention strategy of this study has an impact on the quality of life of patients' family members.

次要结局

  • To assess the difference in quality of life of subjects (family of patients) with different educational levels(1 Month)
  • To assess the difference in the quality of life of the relationship between the subject (patient's family member) and the patient(1 Month)
  • To assess the difference in quality of life of the subjects (family of patients) with difference length of time spent taking care of the patients daily(1 Month)
  • To assess the differences in patients' quality of life(1 Month)
  • To assess the difference in the quality of life of the subjects (family of patients) 2 months after follow-up management.(2 Months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aiping Zhou

Chief physician

Chinese Academy of Medical Sciences

研究点 (2)

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