Diabetes Mellitus, Colo-rectal Cancer, Hypertension, Dyslipidemia
Conditions
Brief summary
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
Interventions
BEHAVIORALEducational Booklet
A printed booklet containing general information on chronic disease management provided to participants for reference without interactive or digital features
BEHAVIORALMobile Health Application
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.
Sponsors
National Cancer Center, Korea
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Individuals aged 19 years or older Colorectal cancer survivors (patients within 5 years of completion of curative treatments such as surgery, radiation therapy, or chemotherapy) who also have chronic conditions (hypertension, dyslipidemia, or diabetes) 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
* Individuals who are unable to speak, listen, or read in Korean Individuals determined by a physician to be physically or mentally unfit (e.g., shortness of breath, severe depression) to participate in the study Individuals who are deemed unable to use the ICT-based program
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Physical Activity Levels | From enrollment to the end of treatment at 3months | Check if the level has decreased |
| Systolic and Diastolic Blood Pressure | From enrollment to the end of treatment at 3months | Check if the level has decreased |
| Body Weight | From enrollment to the end of treatment at 3months | Check if the level has decreased |
| Body Mass Index | From enrollment to the end of treatment at 3months | Check if the level has decreased |
| Fasting Blood Sugar | From enrollment to the end of treatment at 3months | Check for decreased blood sugar levels |
| Hemoglobin A1c | From enrollment to the end of treatment at 3months | check if the level has decreased |
| Total Cholesterol | From enrollment to the end of treatment at 3months | Check if the level has decreased |
| LDL Cholesterol | From enrollment to the end of treatment at 3months | Check if the level has decreased |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Increase in Health Behavior Patterns | From enrollment to the end of treatment at 3months | Differences in Questionnaire of Health Behavior and Practice Index |
| Emotional and Subjective Health Status | From enrollment to the end of treatment at 3months | Differences in Questionnaire of Patient Health Questionnaire-9 |
| Improvement in Health Management Capability | From enrollment to the end of treatment at 3months | Differences in Questionnaire of Self-Assessment Tool |
Countries
South Korea
Outcome results
None listed