A Real-world Clinical Study of Kapok Initiative

NCT ID: NCT04735991

Last Updated: 2021-02-03

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-08
• Study Completion Date: 2022-10-31

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.

Conditions

Quality of Life

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Control group

The patient's family members need to fill in the family member quality of life questionnaire during the screening and follow-up period. They are able to contact the doctor for questions in terms of medical treatment.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Study group

The family members of the patients need to fill in the family member quality of life questionnaire during the screening period and follow-up period, and are involved in an interactive management program on the mobile terminal, full participation required.

Group Type: EXPERIMENTAL

Kapok Initiative

Intervention Type: BEHAVIORAL

The detailed process is:

1. After randomization, the Kapok assistant will contact the patient's family

2. The family of the patient joins the "Kapok Initiative". They will participate in a 60-minute training program for 27 days, which is taught online by experts; The contents of the lectures are as follows: 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.

Interventions

Kapok Initiative

The detailed process is:

1. After randomization, the Kapok assistant will contact the patient's family

2. The family of the patient joins the "Kapok Initiative". They will participate in a 60-minute training program for 27 days, which is taught online by experts; The contents of the lectures are as follows: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

QTC care

UNKNOWN

Sponsor Role: collaborator

Chinese Academy of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Aiping Zhou

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cancer Hospital & Institute, Chinese Academy of Medical Sciences

Beijing, , China

Countries

China

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Other Identifiers

LZMMH-2020

Identifier Type: -

Identifier Source: org_study_id