A Real-world Clinical Study of Kapok Initiative

NCT04735991 | Suspended

• 1 other identifier: LZMMH-2020
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  1 Month

Secondary Outcomes (5)

• 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

Study Arms (2)

Control group

NO INTERVENTION

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.

Study group

EXPERIMENTAL

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.

Behavioral: Kapok Initiative

Interventions

Kapok Initiative 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.

Study group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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

You may not qualify if:

• (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

Sponsors & Collaborators

• Chinese Academy of Medical Sciences: lead
• QTC care: collaborator

Study Sites (1)

Cancer Hospital & Institute, Chinese Academy of Medical Sciences

Beijing, 100021, China

Location

Related Publications (14)

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  BACKGROUND

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  BACKGROUND

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  PMID: 29545714 BACKGROUND

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  PMID: 17148530 BACKGROUND

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  BACKGROUND

• 肖惠敏, 郑建伟, 兰秀燕. 晚期癌症患者生存质量对家庭照顾者生存质量的影响The impact of advanced cancer patients' quality of life on family caregivers' quality of life[J]. 中华护理杂志, 2015, 050(004):415-419

  BACKGROUND

• 杨理, 刘伟, 邓映, et al. 血液肿瘤患儿家庭照顾者生活质量与家庭环境的相关性分析[J]. 国际护理学杂志, 2018, 37(18):2520-2524

  BACKGROUND

• Bergman B, Aaronson NK, Ahmedzai S, Kaasa S, Sullivan M. The EORTC QLQ-LC13: a modular supplement to the EORTC Core Quality of Life Questionnaire (QLQ-C30) for use in lung cancer clinical trials. EORTC Study Group on Quality of Life. Eur J Cancer. 1994;30A(5):635-42. doi: 10.1016/0959-8049(94)90535-5.

  PMID: 8080679 BACKGROUND

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  PMID: 8433390 BACKGROUND

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  PMID: 11858978 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: January 29, 2021
• First Posted: February 3, 2021
• Study Start: May 8, 2020
• Primary Completion: September 1, 2021
• Study Completion: October 1, 2022
• Last Updated: February 3, 2021

Record last verified: 2021-01

Locations

CN (1)