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

NCT06759844 | Active Not Recruiting

• 1 other identifier: 20-2024-4
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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

Conditions

Diabetes Mellitus; Colo-rectal Cancer; Hypertension; Dyslipidemia

Outcome Measures

Primary Outcomes (8)

• Fasting Blood Sugar

  Check for decreased blood sugar levels

  From enrollment to the end of treatment at 3months

• Hemoglobin A1c

  check if the level has decreased

  From enrollment to the end of treatment at 3months

• Total Cholesterol

  Check if the level has decreased

  From enrollment to the end of treatment at 3months

• LDL Cholesterol

  Check if the level has decreased

  From enrollment to the end of treatment at 3months

• Systolic and Diastolic Blood Pressure

  Check if the level has decreased

  From enrollment to the end of treatment at 3months

• Body Weight

  Check if the level has decreased

  From enrollment to the end of treatment at 3months

• Body Mass Index

  Check if the level has decreased

  From enrollment to the end of treatment at 3months

• Physical Activity Levels

  Check if the level has decreased

  From enrollment to the end of treatment at 3months

Secondary Outcomes (3)

• Improvement in Health Management Capability

  From enrollment to the end of treatment at 3months

• Increase in Health Behavior Patterns

  From enrollment to the end of treatment at 3months

• Emotional and Subjective Health Status

  From enrollment to the end of treatment at 3months

Study Arms (2)

Educational Booklet

ACTIVE COMPARATOR

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

Mobile Health Application

EXPERIMENTAL

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

Interventions

Educational Booklet BEHAVIORAL

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

Educational Booklet

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.

Mobile Health Application

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• National Cancer Center, Korea: collaborator

Study Sites (1)

SNU-SMG Boramae Medical Center

Seoul, 07061, South Korea

Location

Related Publications (6)

• 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.

  PMID: 32012053 BACKGROUND

• 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.

  PMID: 34298552 BACKGROUND

• 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.

  PMID: 30123367 BACKGROUND

• 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.

  PMID: 24105007 BACKGROUND

• 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.

  PMID: 24032114 BACKGROUND

• 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.

  PMID: 24278855 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus; Colonic Neoplasms; Hypertension; Dyslipidemias

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: January 6, 2025
• Study Start: January 1, 2025
• Primary Completion: September 30, 2025
• Study Completion: December 31, 2025
• Last Updated: February 13, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)