Clinical trial NCT06759844: Effectiveness of a Mobile Health Management Program for Colorectal Cancer Survivors with Chronic Conditions
Official title: A Randomized Controlled Clinical Study for Validating the Effectiveness of a Mobile Health Management Program Aimed At Colorectal Cancer Survivors with Comorbid Chronic Conditions
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus
Colo-rectal Cancer
Hypertension
Dyslipidemia
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: National Cancer Center, Korea
First posted: 2025-01-06
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: SUPPORTIVE_CARE

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


Eligibility criteria: 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

Primary outcomes:
measure: Fasting Blood Sugar
timeFrame: From enrollment to the end of treatment at 3months
measure: Hemoglobin A1c
timeFrame: From enrollment to the end of treatment at 3months
measure: Total Cholesterol
timeFrame: From enrollment to the end of treatment at 3months
measure: LDL Cholesterol
timeFrame: From enrollment to the end of treatment at 3months
measure: Systolic and Diastolic Blood Pressure
timeFrame: From enrollment to the end of treatment at 3months
measure: Body Weight
timeFrame: From enrollment to the end of treatment at 3months
measure: Body Mass Index
timeFrame: From enrollment to the end of treatment at 3months
measure: Physical Activity Levels
timeFrame: From enrollment to the end of treatment at 3months
Secondary outcomes:
measure: Improvement in Health Management Capability
timeFrame: From enrollment to the end of treatment at 3months
measure: Increase in Health Behavior Patterns
timeFrame: From enrollment to the end of treatment at 3months
measure: Emotional and Subjective Health Status
timeFrame: From enrollment to the end of treatment at 3months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SNU-SMG Boramae Medical Center
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.