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Active, Not Recruiting

NCT Number: NCT06759844

Effectiveness of a Mobile Health Management Program for Colorectal Cancer Survivors With Chronic Conditions

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Diabetes Mellitus Cardiovascular Diseases Colo-rectal Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Dyslipidemia Dyslipidemias Endocrine System Diseases Gastrointestinal Diseases Gastrointestinal Neoplasms Glucose Metabolism Disorders Hypertension Intestinal Diseases Intestinal Neoplasms Lipid Metabolism Disorders Metabolic Diseases Neoplasms Neoplasms by Site Nutritional and Metabolic Diseases Vascular Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

SNU-SMG Boramae Medical Center

Seoul, 07061, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Educational booklet

Behavioral

A printed booklet containing general information on chronic disease management provided to participants for reference without interactive or digital features

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.

Primary outcomes

  1. Fasting Blood Sugar

    Time frame: From enrollment to the end of treatment at 3months

    Check for decreased blood sugar levels

  2. Hemoglobin A1c

    Time frame: From enrollment to the end of treatment at 3months

    check if the level has decreased

  3. Total Cholesterol

    Time frame: From enrollment to the end of treatment at 3months

    Check if the level has decreased

  4. LDL Cholesterol

    Time frame: From enrollment to the end of treatment at 3months

    Check if the level has decreased

  5. Systolic and Diastolic Blood Pressure

    Time frame: From enrollment to the end of treatment at 3months

    Check if the level has decreased

  6. Body Weight

    Time frame: From enrollment to the end of treatment at 3months

    Check if the level has decreased

  7. Body Mass Index

    Time frame: From enrollment to the end of treatment at 3months

    Check if the level has decreased

  8. Physical Activity Levels

    Time frame: From enrollment to the end of treatment at 3months

    Check if the level has decreased

Secondary outcomes

  1. Improvement in Health Management Capability

    Time frame: From enrollment to the end of treatment at 3months

    Differences in Questionnaire of Self-Assessment Tool

  2. Increase in Health Behavior Patterns

    Time frame: From enrollment to the end of treatment at 3months

    Differences in Questionnaire of Health Behavior and Practice Index

  3. Emotional and Subjective Health Status

    Time frame: From enrollment to the end of treatment at 3months

    Differences in Questionnaire of Patient Health Questionnaire-9

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Collaborators

  • National Cancer Center, Korea

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 6, 2025
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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