Postoperative Prognosis Management Service Based mHealth for Colon Cancer Patients
Treatment and Prognosis Management Service for Cancer Patients Using AIoT(AI+IoT):Stomach Cancer,Colon Cancer, Prostate Cancer
1 other identifier
interventional
324
1 country
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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 11, 2021
CompletedFirst Submitted
Initial submission to the registry
September 7, 2021
CompletedFirst Posted
Study publicly available on registry
September 16, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2024
CompletedSeptember 16, 2021
September 1, 2021
2.1 years
September 7, 2021
September 7, 2021
Conditions
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 (10)
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
Change of Quality of life (EORTC-QLQ-C29)
Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Physical activity (IPAQ-SF)
Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Grip strength
Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
- +5 more secondary outcomes
Study Arms (2)
mHealth App and wearable device
EXPERIMENTALAn intervention group (App+IoT device) uses a smart care application for 12 months. This application was tailored for colon cancer patients and created by reflecting the treatment process after surgery. And they also uses a wearable smart band for 12 months.
Education brochure
NO INTERVENTIONControl group is provided general education through the hospital brochure.
Interventions
An intervention group (App+IoT device) uses a smart care application for 12 months. This application was tailored for colon cancer patients and created by reflecting the treatment process after surgery. And they also uses a wearable smart band for 12 months.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Korea University Anam Hospital
Seoul, Seongbuk-gu, 02841, South Korea
Related Publications (1)
Kim I, Lim JY, Kim SW, Shin DW, Kim HC, Park YA, Lee YS, Kwak JM, Kang SH, Lee JY, Hwang JH. Effectiveness of personalized treatment stage-adjusted digital therapeutics in colorectal cancer: a randomized controlled trial. BMC Cancer. 2023 Apr 3;23(1):304. doi: 10.1186/s12885-023-10728-2.
PMID: 37013485DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yoon-suk Lee
Seoul St. Mary's Hospital
- PRINCIPAL INVESTIGATOR
Ji-Hye Hwang, Professor
Seoul, Samsung Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 7, 2021
First Posted
September 16, 2021
Study Start
May 11, 2021
Primary Completion
May 30, 2023
Study Completion
May 30, 2024
Last Updated
September 16, 2021
Record last verified: 2021-09