Postoperative Prognosis Management Service Based mHealth for Colon Cancer Patients
Primary Purpose
Colon Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
mHealth App and wearable device
Sponsored by
About this trial
This is an interventional health services research trial for Colon Cancer
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
Sites / Locations
- Korea University Anam HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
mHealth App and wearable device
Education brochure
Arm Description
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.
Control group is provided general education through the hospital brochure.
Outcomes
Primary Outcome Measures
Change of body composition (weight, kg)
According to time frame with between-group and within group, trends will be found.
Secondary Outcome Measures
Change of Quality of life (EORTC-QLQ-C30)
comparison between groups in change of quality of life between baseline (postoperative 2-3days) and postoperative day 6 months
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). Each scale includes a different set of items, which are calculated using specific coding procedures. Higher scores for the general health status and the functional scales imply positive results, whereas the symptom and the single-item scales are interpreted inversely.
Pain (Numeric rating scale, NRS)
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). Higher score indicates higher pain.
Change of Quality of life (EORTC-QLQ-C29)
The Multi-Attribute Scale Analysis module evaluates four scales to evaluate urine frequency, stool leakage, stool consistency, and body image, as well as other common problems after treatment for colorectal cancer.
Physical activity (IPAQ-SF)
According to time frame with between-group and within group, trends will be found. There are two forms of output from scoring the IPAQ. Results can be reported in categories (low activity levels, moderate activity levels or high activity levels) or as a continuous variable (MET minutes a week). MET minutes represent the amount of energy expended carrying out physical activity. Higher METs or category level indicates higher physical activity.
Grip strength
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.
Since this test is judged to have a mild effect of abdominal pain after surgery, it is evaluated from enrollment.
Lower extremity muscle endurance (30seconds chair stands test)
According to time frame with between-group and within group, trends will be found. It measures the number of times you sit and stand up in a chair for 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.
2 Minute walk test (2MWT, evaluation of cardiopulmonary endurance)
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.
Nutrition assessment (Mini-nutrition assessment, MNA)
According to time frame with between-group and within group, trends will be found. The short form of the MNA (MNA-SF) 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.
LARS(Low Anterior Rectal Resection Syndrome) score questionnaire
Developed under the leadership of S. Laurberg to initially assess the severity of symptoms after anterior resection of the rectum for cancer, it can be used to assess the disability caused in multiple situations (isolated anorectal irradiation, rectosigmoid resection, prolapse surgery…). It is correlated with the quality of life.
The Wexner score
This score, very easy to use, is most frequently used when a summary assessment of the severity of anal incontinence is necessary.
Full Information
NCT ID
NCT05046756
First Posted
September 7, 2021
Last Updated
September 7, 2021
Sponsor
Korea University Anam Hospital
Collaborators
National IT Industry Promotion Agency
1. Study Identification
Unique Protocol Identification Number
NCT05046756
Brief Title
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
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Recruiting
Study Start Date
May 11, 2021 (Actual)
Primary Completion Date
May 30, 2023 (Anticipated)
Study Completion Date
May 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Korea University Anam Hospital
Collaborators
National IT Industry Promotion Agency
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
324 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
mHealth App and wearable device
Arm Type
Experimental
Arm Description
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.
Arm Title
Education brochure
Arm Type
No Intervention
Arm Description
Control group is provided general education through the hospital brochure.
Intervention Type
Device
Intervention Name(s)
mHealth App and wearable device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of body composition (weight, kg)
Description
According to time frame with between-group and within group, trends will be found.
Time Frame
Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Secondary Outcome Measure Information:
Title
Change of Quality of life (EORTC-QLQ-C30)
Description
comparison between groups in change of quality of life between baseline (postoperative 2-3days) and postoperative day 6 months
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). Each scale includes a different set of items, which are calculated using specific coding procedures. Higher scores for the general health status and the functional scales imply positive results, whereas the symptom and the single-item scales are interpreted inversely.
Time Frame
Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Title
Pain (Numeric rating scale, NRS)
Description
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). Higher score indicates higher pain.
Time Frame
Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Title
Change of Quality of life (EORTC-QLQ-C29)
Description
The Multi-Attribute Scale Analysis module evaluates four scales to evaluate urine frequency, stool leakage, stool consistency, and body image, as well as other common problems after treatment for colorectal cancer.
Time Frame
Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Title
Physical activity (IPAQ-SF)
Description
According to time frame with between-group and within group, trends will be found. There are two forms of output from scoring the IPAQ. Results can be reported in categories (low activity levels, moderate activity levels or high activity levels) or as a continuous variable (MET minutes a week). MET minutes represent the amount of energy expended carrying out physical activity. Higher METs or category level indicates higher physical activity.
Time Frame
Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Title
Grip strength
Description
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.
Since this test is judged to have a mild effect of abdominal pain after surgery, it is evaluated from enrollment.
Time Frame
Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Title
Lower extremity muscle endurance (30seconds chair stands test)
Description
According to time frame with between-group and within group, trends will be found. It measures the number of times you sit and stand up in a chair for 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.
Time Frame
postoperative 1month, 3month, 6month, 12month
Title
2 Minute walk test (2MWT, evaluation of cardiopulmonary endurance)
Description
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.
Time Frame
postoperative 1month, 3month, 6month, 12month
Title
Nutrition assessment (Mini-nutrition assessment, MNA)
Description
According to time frame with between-group and within group, trends will be found. The short form of the MNA (MNA-SF) 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.
Time Frame
Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Title
LARS(Low Anterior Rectal Resection Syndrome) score questionnaire
Description
Developed under the leadership of S. Laurberg to initially assess the severity of symptoms after anterior resection of the rectum for cancer, it can be used to assess the disability caused in multiple situations (isolated anorectal irradiation, rectosigmoid resection, prolapse surgery…). It is correlated with the quality of life.
Time Frame
Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Title
The Wexner score
Description
This score, very easy to use, is most frequently used when a summary assessment of the severity of anal incontinence is necessary.
Time Frame
Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seok-Ho Kang, Medical Doctor degree, College
Phone
+81-9928-8097
Email
mdksh@korea.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Jeong-Myeon kwak
Phone
+82-4627-5961
Email
jmkwak@korea.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yoon-suk Lee
Organizational Affiliation
Seoul St. Mary's Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ji-Hye Hwang, Professor
Organizational Affiliation
Seoul, Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Korea University Anam Hospital
City
Seoul
State/Province
Seongbuk-gu
ZIP/Postal Code
02841
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Korea University Anam Hospital
Phone
1577-0083
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Postoperative Prognosis Management Service Based mHealth for Colon Cancer Patients
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