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| Name | Class |
|---|---|
| National Cancer Center, Korea | OTHER_GOV |
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The goal of this clinical trial is to evaluate if a mobile health management program can improve chronic disease management among colorectal cancer survivors with comorbid conditions such as hypertension, diabetes, and dyslipidemia. The main questions it aims to answer are:
Does the mobile health application improve clinical outcomes such as blood pressure, blood glucose levels, and lipid profiles? Does the application enhance participants' health behaviors and self-management capabilities? Researchers will compare the mobile health application group to the educational booklet group to see if the digital intervention leads to better health outcomes and adherence to lifestyle changes
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Educational Booklet | Active Comparator | Basic content on chronic disease management is provided. The content includes a basic booklet on managing chronic diseases without specific strategies. It covers topics like maintaining a positive mindset, managing stress, and exercising. |
|
| Mobile Health Application | Experimental | Participants in this arm will use a mobile health application designed for colorectal cancer survivors with comorbid chronic conditions. The application provides daily educational content, goal-setting features, and self-monitoring tools to promote healthy behaviors. It includes modules on exercise, dietary management, and adherence to a personalized health plan. Participants will use the app daily for 3 months, with weekly progress evaluations and feedback provided through the application interface. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Booklet | Behavioral | A printed booklet containing general information on chronic disease management provided to participants for reference without interactive or digital features |
| Measure | Description | Time Frame |
|---|---|---|
| Fasting Blood Sugar | Check for decreased blood sugar levels | From enrollment to the end of treatment at 3months |
| Hemoglobin A1c | check if the level has decreased | From enrollment to the end of treatment at 3months |
| Total Cholesterol | Check if the level has decreased | From enrollment to the end of treatment at 3months |
| LDL Cholesterol | Check if the level has decreased | From enrollment to the end of treatment at 3months |
| Systolic and Diastolic Blood Pressure | Check if the level has decreased | From enrollment to the end of treatment at 3months |
| Body Weight | Check if the level has decreased | From enrollment to the end of treatment at 3months |
| Body Mass Index | Check if the level has decreased | From enrollment to the end of treatment at 3months |
| Physical Activity Levels | Check if the level has decreased | From enrollment to the end of treatment at 3months |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Health Management Capability | Differences in Questionnaire of Self-Assessment Tool | From enrollment to the end of treatment at 3months |
| Increase in Health Behavior Patterns | Differences in Questionnaire of Health Behavior and Practice Index |
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Inclusion Criteria:
Specific registration criteria:
Diabetes: Fasting blood sugar (FBS) ≥ 126 mg/dL or HbA1c ≥ 6.5% Dyslipidemia: Low-density lipoprotein cholesterol (LDL) ≥ 130 mg/dL Hypertension: Systolic blood pressure (SBP) ≥ 140 mmHg or Diastolic blood pressure (DBP) ≥ 90 mmHg Individuals who understand the purpose of this study and provide informed consent to participate Individuals who own and use a smartphone (able to use an ICT-based health management program)
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SNU-SMG Boramae Medical Center | Seoul | 07061 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32012053 | Result | Yun YH, Kang E, Cho YM, Park SM, Kim YJ, Lee HY, Kim KH, Lee K, Koo HY, Kim S, Rhee Y, Lee J, Min JH, Sim JA. Efficacy of an Electronic Health Management Program for Patients With Cardiovascular Risk: Randomized Controlled Trial. J Med Internet Res. 2020 Jan 22;22(1):e15057. doi: 10.2196/15057. | |
| 34298552 | Result |
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This study is a randomized controlled trial evaluating the effectiveness of a mobile health application in colorectal cancer survivors with chronic conditions. The study does not involve any drug, biological product, or combination product.
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| Mobile Health Application | Behavioral | A mobile health application that facilitates self-management of chronic conditions through daily education, personalized goal setting, and lifestyle monitoring. The intervention aims to improve participants' health behaviors and clinical outcomes by promoting active engagement with their health. |
|
| From enrollment to the end of treatment at 3months |
| Emotional and Subjective Health Status | Differences in Questionnaire of Patient Health Questionnaire-9 | From enrollment to the end of treatment at 3months |
| Shin S, Wook Shin D, Young Cho I, Jeong SM, Jung H. Status of dyslipidemia management and statin undertreatment in Korean cancer survivors: A Korean National Health and Nutrition Examination Survey study. Eur J Prev Cardiol. 2021 Jul 23;28(8):864-872. doi: 10.1177/2047487320905722. Epub 2020 Feb 23. |
| 30123367 | Result | Shen Y, Wang C, Ren Y, Ye J. A comprehensive look at the role of hyperlipidemia in promoting colorectal cancer liver metastasis. J Cancer. 2018 Jul 30;9(16):2981-2986. doi: 10.7150/jca.25640. eCollection 2018. |
| 24105007 | Result | Mills KT, Bellows CF, Hoffman AE, Kelly TN, Gagliardi G. Diabetes mellitus and colorectal cancer prognosis: a meta-analysis. Dis Colon Rectum. 2013 Nov;56(11):1304-19. doi: 10.1097/DCR.0b013e3182a479f9. |
| 24032114 | Result | Park HC, Shin A, Kim BW, Jung KW, Won YJ, Oh JH, Jeong SY, Yu CS, Lee BH. Data on the characteristics and the survival of korean patients with colorectal cancer from the Korea central cancer registry. Ann Coloproctol. 2013 Aug;29(4):144-9. doi: 10.3393/ac.2013.29.4.144. Epub 2013 Aug 29. |
| 24278855 | Result | Park HC, Jung KW, Kim BW, Shin A, Won YJ, Oh JH, Jeong SY, Yu CS, Lee BH. Characteristics and survival of korean anal cancer from the Korea central cancer registry data. Ann Coloproctol. 2013 Oct;29(5):182-5. doi: 10.3393/ac.2013.29.5.182. Epub 2013 Oct 31. |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D003110 | Colonic Neoplasms |
| D006973 | Hypertension |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D052439 | Lipid Metabolism Disorders |
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