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Diabetes MellitusNCT06759844

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

A study testing Educational Booklet and Mobile Health Application in people with Diabetes Mellitus and Colo-rectal Cancer, run by Seoul National University Hospital at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 years and older
What is being tested?
Educational Booklet and Mobile Health Application
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteSouth Korea
Study dates
1 Jan 2025to 31 Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

South Korea1 site

  • SNU-SMG Boramae Medical Center

    Seoul, 07061

Other trials in South Korea

About this study

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

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

Being tested
Educational Booklet, Mobile Health Application
Medical subject headings
Diabetes Mellitus, Colonic Neoplasms, Hypertension, Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Educational BookletBehavioural

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

  • Mobile Health ApplicationBehavioural

    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.

Study groups in NCT06759844
Study groupRoleWhat they receive
Educational BookletActive comparatorBasic 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.
Receives: Behavioral: Educational Booklet
Mobile Health ApplicationExperimentalParticipants 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.
Receives: Behavioral: Mobile Health Application

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fasting Blood Sugar

    Check for decreased blood sugar levels

    Measured: From enrollment to the end of treatment at 3months

  2. Hemoglobin A1c

    check if the level has decreased

    Measured: From enrollment to the end of treatment at 3months

  3. Total Cholesterol

    Check if the level has decreased

    Measured: From enrollment to the end of treatment at 3months

  4. LDL Cholesterol

    Check if the level has decreased

    Measured: From enrollment to the end of treatment at 3months

  5. Systolic and Diastolic Blood Pressure

    Check if the level has decreased

    Measured: From enrollment to the end of treatment at 3months

  6. Body Weight

    Check if the level has decreased

    Measured: From enrollment to the end of treatment at 3months

  7. Body Mass Index

    Check if the level has decreased

    Measured: From enrollment to the end of treatment at 3months

  8. Physical Activity Levels

    Check if the level has decreased

    Measured: From enrollment to the end of treatment at 3months

Secondary outcomes (3)

  1. Improvement in Health Management Capability

    Differences in Questionnaire of Self-Assessment Tool

    Measured: From enrollment to the end of treatment at 3months

  2. Increase in Health Behavior Patterns

    Differences in Questionnaire of Health Behavior and Practice Index

    Measured: From enrollment to the end of treatment at 3months

  3. Emotional and Subjective Health Status

    Differences in Questionnaire of Patient Health Questionnaire-9

    Measured: From enrollment to the end of treatment at 3months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jan 2025
  2. Study start1 Jan 2025
  3. Primary completion30 Sep 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06759844
Sponsor's protocol ID
20-2024-4
Status last verified
Sep 2024
First submitted
13 Nov 2024
Last updated
13 Feb 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 32012053

  • 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.

    PubMed 34298552

  • 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.

    PubMed 30123367

  • 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.

    PubMed 24105007

  • 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.

    PubMed 24032114

  • 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.

    PubMed 24278855

Questions about this trial

What is this clinical trial studying?

A study testing Educational Booklet and Mobile Health Application in people with Diabetes Mellitus and Colo-rectal Cancer, run by Seoul National University Hospital at 1 site in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fasting Blood Sugar (time frame: From enrollment to the end of treatment at 3months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06759844, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025.

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