Postoperative Prognosis Management Service Based mHealth for Colon Cancer Patients

Korea University

Status: Enrolling

Conditions: Colon Cancer

Treatments: Device: mHealth App and wearable device

Study type: Interventional

Funder types: Other

Identifiers

NCT05046756

2021AN0104

Details and patient eligibility

About

Recently, the use of mobile health is increasing for the purpose of managing prognosis such as recurrence, survival and quality of life by using a wearable smart band and a smartphone application. In the era of the 4th revolution, mobile health for the purpose of comprehensive prognosis for cancer patients is becoming a very good tool.

It is possible to confirm the clinical significance of short-term and temporary health care through a mobile application and a smart band during the treatment process for cancer patients, but the study is insufficient to generalize the number of subjects.

Therefore, for colon cancer patients who need prognosis management after surgery, we will investigate the effect of a mobile application using a smart band which has a modular structure reflecting the treatment method and treatment process after surgery.

This study targets patients who underwent prostate cancer surgery. An intervention group (App+IoT device) uses a smart care application for 12 months. This application was tailored for prostate cancer patients and created by reflecting the treatment process after surgery. And they also uses a wearable smart band for 12 months. Control group is provided general education through the hospital brochure. Evaluation will be conducted 2-3days after surgery (before discharge), and at 1, 3, 6, and 12 months after surgery.

Enrollment: 324 estimated patients

Sex: All

Ages: 19 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Those who have been diagnosed with colorectal cancer and have undergone surgery (not related to chemotherapy treatment)
• Patients aged 19 to 75 years old
• Those who can use prognosis management applications and can perform regular follow-up inspections outpatients
• Patients carrying Android or iOS smartphones
• Patients who voluntarily decide to participate and give written consent after hearing detailed explanations about this study

Exclusion criteria

• Those who are judged to be difficult to perform smartphone exercise and dietary management for colorectal cancer in general due to uncontrolled severe or underlying diseases, neuromuscular and musculoskeletal diseases
• Serious complications of Clavein dindo classification grade 3 or higher after surgery
• Patients who were not discharged within 2 weeks after surgery

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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324 participants in 2 patient groups

mHealth App and wearable device

Experimental group

Description:

An intervention group (App+IoT device) uses a smart care application for 12 months. This application was tailored for colon cancer patients and created by reflecting the treatment process after surgery. And they also uses a wearable smart band for 12 months.

Treatment:

Device: mHealth App and wearable device

Education brochure

No Intervention group

Description:

Control group is provided general education through the hospital brochure.