Postoperative Prognosis Management Service Based mHealth for Prostate Cancer Patients

NCT ID: NCT05021952

Last Updated: 2021-08-26

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

324 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-21

Study Completion Date

2024-05-30

Brief Summary

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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.

Detailed Description

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Conditions

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Prostate Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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mHealth App and wearable device

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.

Group Type EXPERIMENTAL

mHealth App and wearable device

Intervention Type DEVICE

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.

Education brochure

Control group is provided general education through the hospital brochure.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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mHealth App and wearable device

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Maximum Eligible Age

100 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National IT Industry Promotion Agency

UNKNOWN

Sponsor Role collaborator

Seoul St. Mary's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ji Youl Lee

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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JIYOUL LEE, Professor

Role: PRINCIPAL_INVESTIGATOR

Department of Urology Seoul St. Mary's Hospital

Locations

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Korea University Anam Hospital

Seoul, Seongbuk-gu, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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JIYOUL LEE, Professor

Role: CONTACT

82-10-8945-3843

Facility Contacts

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Seokho Kang, Professor

Role: primary

82-10-9928-8097

Other Identifiers

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NIPA AIoT_Cancer

Identifier Type: -

Identifier Source: org_study_id

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