Postoperative Prognosis Management Service Based mHealth for Prostate Cancer Patients

August 19, 2021 updated by: Ji Youl Lee, Seoul St. Mary's Hospital

Effects of Postoperative Prognosis Management Service Using Mobile Applications and Smart Bands for Prostate Cancer Patients

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

324

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Seongbuk-gu
      • Seoul, Seongbuk-gu, Korea, Republic of, 02841
        • Recruiting
        • Korea University Anam Hospital
        • Contact:
        • Principal Investigator:
          • Seokho Kang, Professor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Education brochure
Control group is provided general education through the hospital brochure.
Experimental: 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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of body composition (weight, kg)
Time Frame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
According to time frame with between-group and within group, trends will be found.
Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Quality of life (EORTC-QLQ-C30)
Time Frame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month

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

This questionnaire contains 30 items regarding general health status, five functional scales (ie, physical, role, cognitive, emotional, and social functioning), three symptom scales (ie, fatigue, pain, and nausea or vomiting), and six single-item scales (ie, dyspnea, appetite loss, constipation, diarrhea, financial difficulties, and insomnia).
Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Pain (Numeric rating scale, NRS)
Time Frame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
According to time frame with between-group and within group, trends will be found. NRS score (11 point scales) ranges from 0 (no pain) to 10 (possible to image maximum pain). A higher score means more pain.
Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Self-reported symptom and Quality of life (EORTC-QLQ-PR25)
Time Frame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
According to time frame with between-group and within group, trends will be found. EORTC-QLQ-PR25 consists of 25 questions and identifies various symptoms or problems that patients may experience.
Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Physical activity (IPAQ-SF)
Time Frame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
According to time frame with between-group and within group, trends will be found. IPAQ-SF finds out about the physical activities that patients do on a daily basis. This includes activities that patients do at work or at home, activities they do while using transportation, activities they do in their spare time, and exercise. This questionnaire consists of 7 questions.
Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Urination Symptom (ICIQ-SF)
Time Frame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
According to time frame with between-group and within group, trends will be found. ICIQ-SF is about the urine symptom that patients are experiencing, and consists of a total of 4 questions.
Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Overactive Bladder Symptom (OABSS)
Time Frame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
According to time frame with between-group and within group, trends will be found. OABSS is a questionnaire about overactive bladder symptom and consists of a total of 4 items.
Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Prostatic Hyperplasia (IPSS)
Time Frame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
According to time frame with between-group and within group, trends will be found. IPSS is a questionnaire about prostatic hyperplasia to find out uncomfortable symptoms that may appear when urinating. This questionnaire consists of 8 questions.
Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Erectile Dysfunction Symptom (IIEF-5)
Time Frame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
According to time frame with between-group and within group, trends will be found. IIEF-5 is a questionnaire about the symptoms of erectile dysfunction that may appear after surgery, and consists of 5 questions.
Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Grip strength
Time Frame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
According to time frame with between-group and within group, trends will be found. Using a grip dynamometer, take three measurements on both hands. Higher value (kg) indicates higher grip strength.
Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Lower extremity muscle endurance (30seconds chair stands test)
Time Frame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month

According to time frame with between-group and within group, trends will be found. It measures the number of times you sit down and stand up from a chair in 30 seconds. Higher value (number) indicates higher lower extremity muscle endurance.

It is judged that the 30seconds chair stands test will be difficult due to abdominal pain after surgery, so the evaluation is performed only at the other F/U points excluding the enrollment date.
Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
2 Minute walk test (2MWT, evaluation of cardiopulmonary endurance)
Time Frame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month

According to time frame with between-group and within group, trends will be found. The 2MWT is a measurement of endurance that assesses walking distance over two minutes.

It is judged that the 2MWT will be difficult due to abdominal pain after surgery, so the evaluation is performed only at the other F/U points excluding the enrollment date.
Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Nutrition assessment (Mini-nutrition assessment, MNA)
Time Frame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
According to time frame with between-group and within group, trends will be found. The short form of the MNA (MNASF) is a screening tool consisting of six questions on food intake, weight loss, mobility, psychological stress, or acute disease, the presence of dementia or depression, and body mass index (BMI). The maximum score for this part is equal to 14. A score equal to or higher than 12 indicates that the subject under study has an acceptable nutritional status thus excluding malnutrition and/or malnutrition risk, meanwhile, a score ≤ 11 implicates to proceed with the complete version of the MNA (MNA-LF). This version consists of 12 additional items and provides a maximum possible overall assessment of 30 scores: a score of fewer than 17 indicates malnutrition, a score of 17-23.5 indicates a risk for malnutrition and a score higher 23.5 indicates well-nourishment.
Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul St. Mary's Hospital

Collaborators

National IT Industry Promotion Agency

Investigators

  • Principal Investigator: JIYOUL LEE, Professor, Department of Urology Seoul St. Mary's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2021

Primary Completion (Anticipated)

May 30, 2023

Study Completion (Anticipated)

May 30, 2024

Study Registration Dates

First Submitted

August 19, 2021

First Submitted That Met QC Criteria

August 19, 2021

First Posted (Actual)

August 26, 2021

Study Record Updates

Last Update Posted (Actual)

August 26, 2021

Last Update Submitted That Met QC Criteria

August 19, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NIPA AIoT_Cancer

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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