Postoperative Prognosis Management Service Based mHealth for Prostate Cancer Patients

Seoul St. Mary's Hospital

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Device: mHealth App and wearable device

Study type: Interventional

Funder types: Other

Identifiers

NCT05021952

NIPA AIoT_Cancer

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 prostate 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: Male

Ages: 19 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients 19 years of age or older who have been diagnosed with prostate cancer
• Patients who have completed surgical treatment for cancer within 3 months of screening and have no additional treatment planned
• Patients who can use a prognosis management application and can perform regular follow-up examinations in outpatient settings
• Patients carrying an Android or iOS smartphone
• Patients who voluntarily decide to participate and give written consent after hearing detailed explanations about this study

Exclusion criteria

• Patients who have been treated within the last 3 months for other serious diseases (hematologic cancer, malignancy, etc.)
• Patients for whom additional treatment was planned due to cancer recurrence or metastasis
• Patients with severe cardiopulmonary disease who are unable to proceed with rehabilitation exercise programs
• Patients who find it difficult to proceed with the rehabilitation exercise program due to pain caused by bone metastasis and concerns about pathological fractures
• Patients who underwent lower extremity artificial joint TKRA and THRA
• Patients who are not eligible for rehabilitation exercise as judged by medical personnel

Trial design

Primary purpose: Supportive Care

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 prostate 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.