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

February 11, 2025 updated by: Seoul National University Hospital

A Randomized Controlled Clinical Study for Validating the Effectiveness of a Mobile Health Management Program Aimed At Colorectal Cancer Survivors with Comorbid 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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Educational Booklet
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.
Behavioral: Educational Booklet
A printed booklet containing general information on chronic disease management provided to participants for reference without interactive or digital features
Experimental: Mobile Health Application
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.
Behavioral: Mobile 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fasting Blood Sugar
Time Frame: From enrollment to the end of treatment at 3months
Check for decreased blood sugar levels
From enrollment to the end of treatment at 3months
Hemoglobin A1c
Time Frame: From enrollment to the end of treatment at 3months
check if the level has decreased
From enrollment to the end of treatment at 3months
Total Cholesterol
Time Frame: From enrollment to the end of treatment at 3months
Check if the level has decreased
From enrollment to the end of treatment at 3months
LDL Cholesterol
Time Frame: From enrollment to the end of treatment at 3months
Check if the level has decreased
From enrollment to the end of treatment at 3months
Systolic and Diastolic Blood Pressure
Time Frame: From enrollment to the end of treatment at 3months
Check if the level has decreased
From enrollment to the end of treatment at 3months
Body Weight
Time Frame: From enrollment to the end of treatment at 3months
Check if the level has decreased
From enrollment to the end of treatment at 3months
Body Mass Index
Time Frame: From enrollment to the end of treatment at 3months
Check if the level has decreased
From enrollment to the end of treatment at 3months
Physical Activity Levels
Time Frame: From enrollment to the end of treatment at 3months
Check if the level has decreased
From enrollment to the end of treatment at 3months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in Health Management Capability
Time Frame: From enrollment to the end of treatment at 3months
Differences in Questionnaire of Self-Assessment Tool
From enrollment to the end of treatment at 3months
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
From enrollment to the end of treatment at 3months
Emotional and Subjective Health Status
Time Frame: From enrollment to the end of treatment at 3months
Differences in Questionnaire of Patient Health Questionnaire-9
From enrollment to the end of treatment at 3months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

National Cancer Center, Korea

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Estimated)

September 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

November 13, 2024

First Submitted That Met QC Criteria

December 29, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 11, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-2024-4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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