- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04735991
A Real-world Clinical Study of Kapok Initiative
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
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.
Study Overview
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Beijing, China, 100021
- Cancer Hospital & Institute, Chinese Academy of Medical Sciences
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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No Intervention: 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.
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Experimental: 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.
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The detailed process is:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: 1 Month
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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.
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1 Month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To assess the difference in quality of life of subjects (family of patients) with different educational levels
Time Frame: 1 Month
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Patients' families are grouped based on their educational level, and the minimum, maximum, median (quartile), and mean (standard deviation) of the scores of quality of life questionnaire of each group will be calculated; Analysis of variance will be used to compare whether there are differences in the quality of life scores of patients' families among different education levels.
If a general difference occurs, the Bonferroni method will be used to further perform multiple comparisons.
At the same time, the Kruskal-Wallis rank-sum test will be used to compare the overall differences between the groups and the Steel-Dwass-Critchlow-Fligner test will be used for further multiple comparisons.
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1 Month
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To assess the difference in the quality of life of the relationship between the subject (patient's family member) and the patient
Time Frame: 1 Month
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The subjects will be grouped according to the relationship between the subjects (families of patients) and patients.
The minimum, maximum, median (quartile), and mean (standard deviation) of the scores of quality of life questionnaire of each group will be calculated; Analysis of variance will be used to compare whether there are differences in the quality of life scores of patients' families among different education levels.
If a general difference occurs, the Bonferroni method will be used to further perform multiple comparisons.
At the same time, the Kruskal-Wallis rank-sum test will be used to compare the overall differences between the groups and the Steel-Dwass-Critchlow-Fligner test will be used for further multiple comparisons.
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1 Month
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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
Time Frame: 1 Month
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The minimum, maximum, median (quartile), and mean (standard deviation) of the scores of quality of life questionnaire based on difference length of time spent on daily care will be calculated; Analysis of variance will be used to compare whether there are differences in the quality of life scores of patients' families among different education levels.
If a general difference occurs, the Bonferroni method will be used to further perform multiple comparisons.
At the same time, the Kruskal-Wallis rank-sum test will be used to compare the overall differences between the groups and the Steel-Dwass-Critchlow-Fligner test will be used for further multiple comparisons.
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1 Month
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To assess the differences in patients' quality of life
Time Frame: 1 Month
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First of all, The Cronbach's α coefficient of the EORTC QLQ-C30 patient 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 patients of the study group and the control group will be determined; we will use t test to compare the scores to investigate whether two groups are statistically different in each field.
Finally, several common influencing factors will be selected to construct a covariance analysis regression model to assess whether the scores of the quality of life of the two groups are statistically different in various fields.
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1 Month
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To assess the difference in the quality of life of the subjects (family of patients) 2 months after follow-up management.
Time Frame: 2 Months
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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 patients after 2 months of follow-up are calculated; T test will be used to compare whether there is a difference in the quality of life score between two groups; then several common influencing factors will be selected to construct a covariance analysis regression model to assess whether the quality of life scores of the two groups of patients are statistically different after 2 months of follow-up.
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2 Months
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Collaborators and Investigators
Collaborators
Publications and helpful links
General Publications
- He Jie, Zhao Ping, Chen Wanqing. China tumor registration report in 2012[M]. Beijing: Military Medical Science Press, 2012:1-302.
- Borji 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.
- Wander K, Brindle E, O'Connor KA. C-reactive protein across the menstrual cycle. Am J Phys Anthropol. 2008 Jun;136(2):138-46. doi: 10.1002/ajpa.20785.
- 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
- Greer 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.
- Kim 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.
- Chen 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.
- Cohen 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.
- 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
- 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
- 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
- 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.
- Aaronson NK, Ahmedzai S, Bergman B, Bullinger M, Cull A, Duez NJ, Filiberti A, Flechtner H, Fleishman SB, de Haes JC, et al. The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology. J Natl Cancer Inst. 1993 Mar 3;85(5):365-76. doi: 10.1093/jnci/85.5.365.
- Fayers P, Bottomley A; EORTC Quality of Life Group; Quality of Life Unit. Quality of life research within the EORTC-the EORTC QLQ-C30. European Organisation for Research and Treatment of Cancer. Eur J Cancer. 2002 Mar;38 Suppl 4:S125-33. doi: 10.1016/s0959-8049(01)00448-8.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- LZMMH-2020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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