Postoperative Prognosis Management Service Based mHealth for Prostate Cancer Patients

NCT05021952 | Unknown

• 1 other identifier: NIPA AIoT_Cancer
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Change of body composition (weight, kg)

  According to time frame with between-group and within group, trends will be found.

  Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month

Secondary Outcomes (12)

• Change of Quality of life (EORTC-QLQ-C30)

  Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month

• Pain (Numeric rating scale, NRS)

  Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month

• Self-reported symptom and Quality of life (EORTC-QLQ-PR25)

  Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month

• Physical activity (IPAQ-SF)

  Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month

• Urination Symptom (ICIQ-SF)

  Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month

Study Arms (2)

mHealth App and wearable device

EXPERIMENTAL

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.

Device: mHealth App and wearable device

Education brochure

NO INTERVENTION

Control group is provided general education through the hospital brochure.

Interventions

mHealth App and wearable device 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.

mHealth App and wearable device

Eligibility Criteria

• Age: 19 Years - 100 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul St. Mary's Hospital: lead
• National IT Industry Promotion Agency: collaborator

Study Sites (1)

Korea University Anam Hospital

Seoul, Seongbuk-gu, 02841, South Korea

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Wearable Electronic Devices

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Study Officials

• JIYOUL LEE, Professor

  Department of Urology Seoul St. Mary's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

JIYOUL LEE, Professor

CONTACT

82-10-8945-3843; uroljy@catholic.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 19, 2021
• First Posted: August 26, 2021
• Study Start: May 21, 2021
• Primary Completion: May 30, 2023
• Study Completion: May 30, 2024
• Last Updated: August 26, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)