Clinical trial NCT05046756: Postoperative Prognosis Management Service Based mHealth for Colon Cancer Patients
Official title: Treatment and Prognosis Management Service for Cancer Patients Using AIoT(AI+IoT):Stomach Cancer,Colon Cancer, Prostate Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colon Cancer
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
Collaborators: name: National IT Industry Promotion Agency
First posted: 2021-09-16
Enrollment: 324
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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 colon 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:

* Those who have been diagnosed with colorectal cancer and have undergone surgery (not related to chemotherapy treatment)
* Patients aged 19 to 75 years old
* Those who can use prognosis management applications and can perform regular follow-up inspections outpatients
* Patients carrying Android or iOS smartphones
* Patients who voluntarily decide to participate and give written consent after hearing detailed explanations about this study

Exclusion Criteria:

* Those who are judged to be difficult to perform smartphone exercise and dietary management for colorectal cancer in general due to uncontrolled severe or underlying diseases, neuromuscular and musculoskeletal diseases
* Serious complications of Clavein dindo classification grade 3 or higher after surgery
* Patients who were not discharged within 2 weeks after surgery

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: Change of Quality of life (EORTC-QLQ-C29)
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: Grip strength
timeFrame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
measure: Lower extremity muscle endurance (30seconds chair stands test)
timeFrame: postoperative 1month, 3month, 6month, 12month
measure: 2 Minute walk test (2MWT, evaluation of cardiopulmonary endurance)
timeFrame: postoperative 1month, 3month, 6month, 12month
measure: Nutrition assessment (Mini-nutrition assessment, MNA)
timeFrame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
measure: LARS(Low Anterior Rectal Resection Syndrome) score questionnaire
timeFrame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
measure: The Wexner score
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: Seoul St. Mary's Hospital
name: Yoon-suk Lee
role: PRINCIPAL_INVESTIGATOR
affiliation: Seoul, Samsung Medical Center
name: Ji-Hye Hwang, Professor
role: PRINCIPAL_INVESTIGATOR
References: