A Real-world Clinical Study of Kapok Initiative

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.

Sex

All

Minimum age

18 Years

Maximum age

65 Years

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

• BACKGROUNDHe Jie, Zhao Ping, Chen Wanqing. China tumor registration report in 2012[M]. Beijing: Military Medical Science Press, 2012:1-302.
• BACKGROUNDBorji M, Nourmohammadi H, Otaghi M, Salimi AH, Tarjoman A. Positive Effects of Cognitive Behavioral Therapy on Depression, Anxiety and Stress of Family Caregivers of Patients with Prostate Cancer: A Randomized Clinical Trial. Asian Pac J Cancer Prev. 2017 Dec 28;18(12):3207-3212. doi: 10.22034/APJCP.2017.18.12.3207. PMID 29281868
• BACKGROUND梁文珍，谭文娟，舒放, 癌症患者家属心理健康状态的调查［J］, 临床 心身疾病杂志，2008，14（2）：136 _ 138
• BACKGROUND陈冰芳, 实施家属健康教育对鼻咽癌放疗病人生活质量的影响［J］, 护理研究，2010，24，（10c）：2220 _ 2221
• BACKGROUNDGreer JA, Jacobs J, Pensak N, MacDonald JJ, Fuh CX, Perez GK, Ward A, Tallen C, Muzikansky A, Traeger L, Penedo FJ, El-Jawahri A, Safren SA, Pirl WF, Temel JS. Randomized Trial of a Tailored Cognitive-Behavioral Therapy Mobile Application for Anxiety in Patients with Incurable Cancer. Oncologist. 2019 Aug;24(8):1111-1120. doi: 10.1634/theoncologist.2018-0536. Epub 2019 Jan 25. PMID 30683710
• BACKGROUNDKim Y, Schulz R. Family caregivers' strains: comparative analysis of cancer caregiving with dementia, diabetes, and frail elderly caregiving. J Aging Health. 2008 Aug;20(5):483-503. doi: 10.1177/0898264308317533. Epub 2008 Apr 17. PMID 18420838
• BACKGROUNDChen W, Sun K, Zheng R, Zeng H, Zhang S, Xia C, Yang Z, Li H, Zou X, He J. Cancer incidence and mortality in China, 2014. Chin J Cancer Res. 2018 Feb;30(1):1-12. doi: 10.21147/j.issn.1000-9604.2018.01.01. PMID 29545714
• BACKGROUNDCohen R, Leis AM, Kuhl D, Charbonneau C, Ritvo P, Ashbury FD. QOLLTI-F: measuring family carer quality of life. Palliat Med. 2006 Dec;20(8):755-67. doi: 10.1177/0269216306072764. PMID 17148530
• Alnjadat, R. M., Wan Adnan, W. A., & Ismail, Z. (2014). Psychometric properties of the QOLLTI-F questionnaire to assess quality of life in caregivers of cancer patients. Education in Medicine Journal, 6(2).doi:10.5959/eimj.v6i2.217