Colon CancerNCT05046756
Postoperative Prognosis Management Service Based mHealth for Colon Cancer Patients
A study testing mHealth App and wearable device in people with Colon Cancer, run by Korea University Anam Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 75 years
- Conditions the study is for
- Colon Cancer
- What is being tested?
- mHealth App and wearable device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 1 siteSouth Korea
- Study dates
- 11 May 2021to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Korea University Anam Hospital
Seoul, Seongbuk-gu, 02841
Korea University Anam Hospital, 1577-0083
About this study
Official title: Treatment and Prognosis Management Service for Cancer Patients Using AIoT(AI+IoT):Stomach Cancer,Colon Cancer, Prostate Cancer
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.
Read more
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.
- Conditions
- Colon Cancer
- Being tested
- mHealth App and wearable device
- Medical subject headings
- Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth App and wearable deviceDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| mHealth App and wearable device | Experimental | 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. Receives: Device: mHealth App and wearable device |
| Education brochure | No intervention | Control group is provided general education through the hospital brochure. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of body composition (weight, kg)
According to time frame with between-group and within group, trends will be found.
Measured: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Secondary outcomes (10)
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.
Measured: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
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.
Measured: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
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.
Measured: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
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.
Measured: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
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.
Measured: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
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.
Measured: postoperative 1month, 3month, 6month, 12month
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.
Measured: postoperative 1month, 3month, 6month, 12month
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.
Measured: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
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.
Measured: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
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.
Measured: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2021
- Study start11 May 2021
- Primary completion30 May 2023 (estimated)
- Study completion30 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 324 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National IT Industry Promotion Agency, South Korea
- Responsible party
- Sponsor
- Investigators
- Yoon-suk Lee, Principal investigator, Seoul St. Mary's HospitalJi-Hye Hwang, Professor, Principal investigator, Seoul, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05046756
- Sponsor's protocol ID
- 2021AN0104
- Status last verified
- Sep 2021
- First submitted
- 7 Sep 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 37013485
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment and Prognosis Management Service for Cancer Patients Using AIoT(AI+IoT):Stomach Cancer,Colon Cancer, Prostate Cancer
- ClinicalTrials.gov ID
- NCT05046756
- Acronym / sponsor ID
- 2021AN0104
- Conditions
- Colon Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 324 participants (estimated)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Collaborators
- National IT Industry Promotion Agency, South Korea
- Study start
- 11 May 2021 (actual)
- Primary completion
- 30 May 2023 (estimated)
- Study completion
- 30 May 2024 (estimated)
- First posted
- 16 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mHealth App and wearable device | Experimental | Device: mHealth App and wearable deviceAn 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 intervention | –Control group is provided general education through the hospital brochure. |
Who may qualify
- Ages
- 19 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mHealth App and wearable deviceAn 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. | Device | mHealth App and wearable device |
Primary outcome
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.
10 secondary outcomes
Change of Quality of life (EORTC-QLQ-C30)
Time frame: 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
Change of Quality of life (EORTC-QLQ-C29)
Time frame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Physical activity (IPAQ-SF)
Time frame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Grip strength
Time frame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Lower extremity muscle endurance (30seconds chair stands test)
Time frame: postoperative 1month, 3month, 6month, 12month
2 Minute walk test (2MWT, evaluation of cardiopulmonary endurance)
Time frame: postoperative 1month, 3month, 6month, 12month
Nutrition assessment (Mini-nutrition assessment, MNA)
Time frame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
LARS(Low Anterior Rectal Resection Syndrome) score questionnaire
Time frame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
The Wexner score
Time frame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
- Derived from this study: PubMed 37013485Kim 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoon-suk Lee principal investigator
Seoul St. Mary's Hospital
Ji-Hye Hwang, Professor principal investigator
Seoul, Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth App and wearable device in people with Colon Cancer, run by Korea University Anam Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seok-Ho Kang, Medical Doctor degree, College (+81-9928-8097, mdksh@korea.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of body composition (weight, kg) (time frame: Enrollment (postoperative 2-3days), postoperative 1month, 3month, 6month, 12month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05046756, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2021.