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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seoul National University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 29, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 11, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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