Clinical trial NCT05021952: Postoperative Prognosis Management Service Based mHealth for Prostate Cancer Patients
Official title: Effects of Postoperative Prognosis Management Service Using Mobile Applications and Smart Bands for Prostate Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
Collaborators: name: National IT Industry Promotion Agency
First posted: 2021-08-26
Enrollment: 324
Sex: MALE
Minimum age (years): 19
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change of body composition (weight, kg)
timeFrame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Secondary outcomes:
measure: Change of Quality of life (EORTC-QLQ-C30)
timeFrame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
measure: Pain (Numeric rating scale, NRS)
timeFrame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
measure: Self-reported symptom and Quality of life (EORTC-QLQ-PR25)
timeFrame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
measure: Physical activity (IPAQ-SF)
timeFrame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
measure: Urination Symptom (ICIQ-SF)
timeFrame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
measure: Overactive Bladder Symptom (OABSS)
timeFrame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
measure: Prostatic Hyperplasia (IPSS)
timeFrame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
measure: Erectile Dysfunction Symptom (IIEF-5)
timeFrame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
measure: Grip strength
timeFrame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
measure: Lower extremity muscle endurance (30seconds chair stands test)
timeFrame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
measure: 2 Minute walk test (2MWT, evaluation of cardiopulmonary endurance)
timeFrame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
measure: Nutrition assessment (Mini-nutrition assessment, MNA)
timeFrame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
state: Seongbuk-gu
Study officials:
affiliation: Department of Urology Seoul St. Mary's Hospital
name: JIYOUL LEE, Professor
role: PRINCIPAL_INVESTIGATOR
References: