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

NCT ID: NCT06759844

Last Updated: 2025-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-01-01

Study Completion Date

2025-12-31

Brief Summary

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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

Detailed Description

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Conditions

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Diabetes Mellitus Colo-rectal Cancer Hypertension Dyslipidemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Educational Booklet

Intervention Type BEHAVIORAL

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

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.

Group Type EXPERIMENTAL

Mobile Health Application

Intervention Type 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.

Interventions

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Educational Booklet

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

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Center, Korea

OTHER_GOV

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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SNU-SMG Boramae Medical Center

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 32012053 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34298552 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30123367 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24105007 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24032114 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24278855 (View on PubMed)

Other Identifiers

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20-2024-4

Identifier Type: -

Identifier Source: org_study_id

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