Clinical trial NCT04735991: A Real-world Clinical Study of Kapok Initiative
Official title: 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
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Quality of Life
Lead sponsor: ChineseAMS
Sponsor class: UNKNOWN
Collaborators: name: QTC care
First posted: 2021-02-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* (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

Exclusion Criteria:

* (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

Primary outcomes:
measure: 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.
timeFrame: 1 Month
Secondary outcomes:
measure: To assess the difference in quality of life of subjects (family of patients) with different educational levels
timeFrame: 1 Month
measure: To assess the difference in the quality of life of the relationship between the subject (patient's family member) and the patient
timeFrame: 1 Month
measure: 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
timeFrame: 1 Month
measure: To assess the differences in patients' quality of life
timeFrame: 1 Month
measure: To assess the difference in the quality of life of the subjects (family of patients) 2 months after follow-up management.
timeFrame: 2 Months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital & Institute, Chinese Academy of Medical Sciences
Study officials:
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