Colorectal CarcinomaNCT06685497
COLORECTUM+ Digital System for Postoperative Quality Improvement in Colorectal Cancer
A study testing Mobile application follow-up in people with Colorectal Carcinoma, run by RenJi Hospital at 1 site in China.
Trial summary
This is a single-center, prospective, interventional study. A total of 236 colorectal cancer patients who underwent surgery will be enrolled and followed for 52 weeks. The digital healthcare quality management system, based on the COLORECTUM+ model, will be used for post-treatment quality evaluation and continuous… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Carcinoma
- What is being tested?
- Mobile application follow-up
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 236 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 1 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years old.
- Pathologically confirmed colorectal cancer patients.
- Underwent surgery at the Colorectal Cancer Diagnosis and Treatment Center, Gastrointestinal Surgery, Renji Hospital, Shanghai Jiao Tong University School of Medicine.
- Signed informed consent form.
Who cannot join
- Unable to access electronic devices that can connect to the internet or mobile communications.
- Uncontrolled psychiatric illness.
- The ECOG score is greater than or equal to 3.
- Deemed unsuitable for participation by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Shanghai Jiao Tong University School of Medicine, Renji Hospital
Shanghai, 200135
yunyue guo, 021-68383312, guoyunyue@renji.com
About this study
Official title: Construction and Application of a Digital Postoperative Medical Quality Evaluation and Promotion System for Colorectal Cancer Based on the COLORECTUM+ Model
This is a single-center, prospective, interventional study. A total of 236 colorectal cancer patients who underwent surgery will be enrolled and followed for 52 weeks. The digital healthcare quality management system, based on the COLORECTUM+ model, will be used for post-treatment quality evaluation and continuous improvement.
Patients will be managed using an Internet+ post-treatment healthcare management platform. The platform integrates AI technology for real-time symptom analysis and alerts. Patients will report symptoms and health data through the platform, which will generate alerts based on symptom severity to guide appropriate interventions. Follow-up assessments will include patient adherence, satisfaction, quality of life, and healthcare utilization.
The study expects to demonstrate that the digital healthcare quality management system improves follow-up rates, enhances patient adherence, reduces unplanned hospital visits, and increases overall patient satisfaction. The findings aim to provide evidence for the implementation of digital management systems in colorectal cancer post-treatment care, potentially leading to improved long-term outcomes for patients.
Read the detailed description
The aim of this study is to evaluate the adherence of postoperative colorectal cancer patients using a digital follow-up platform. The primary endpoint is follow-up rate at 3 months after surgery. The secondary endpoints are: follow-up rate at 6, 9, and 12 months, adherence during 12 months, medication adherence (MMS-4), the number and reasons for alerts triggered by patients, the frequency and reasons for patient-initiated report, quality of life (FACT-C), patient satisfaction (FACIT-TS-PS), the system's usability (SUS), the monitoring rates of imaging exams, colonoscopies, and CEA markers at 3, 6, 9, and 12 months will be analyzed. Differences in clinical outcomes: progression-free survival, overall survival, adverse events, the incidence of complications, hospital admissions (unplanned hospital visit rates, average unplanned hospital stay duration, and potentially preventable emergency visits) are additional outcomes.
- Conditions
- Colorectal Carcinoma
- Being tested
- Mobile application follow-up
- Keywords
- colorectal carcinoma, follow-up, Ehealth, adherence
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile application follow-upDevice
Colorectal cancer patients enrolled in the 'Internet Plus' post-treatment management platform use the digital medical quality management system based on the 'COLORECTUM+' model for quality evaluation and continuous improvement. The platform integrates AI, using natural language processing and machine learning to analyze patient-reported symptoms, automatically assess severity, and generate alerts. Alerts are classified as yellow, orange, or red. Yellow indicates mild issues with self-care recommendations; consecutive yellow alerts prompt doctor contact within 24 hours. Orange indicates moderate severity, requiring doctor intervention within 24 hours. Red alerts signify serious symptoms or high-risk medication errors, prompting immediate notification of the doctor and emergency team. The system monitors symptom changes and updates alerts to support treatment optimization.
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Colorectal cancer patients enrolled in the 'Internet Plus' post-treatment management platform use the digital medical quality management system based on the 'COLORECTUM+' model for quality evaluation and continuous improvement. The platform integrates AI, using natural language processing and machine learning to analyze patient-reported symptoms, automatically assess severity, and generate alerts. Alerts are classified as yellow, orange, or red. Yellow indicates mild issues with self-care recommendations; consecutive yellow alerts prompt doctor contact within 24 hours. Orange indicates moderate severity, requiring doctor intervention within 24 hours. Red alerts signify serious symptoms or high-risk medication errors, prompting immediate notification of the doctor and emergency team. The system monitors symptom changes and updates alerts to support treatment optimization. Receives: Device: Mobile application follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
three-month follow-up rate
Our mobile application aims to monitor the three-month follow-up rate for patients, assessing whether they adhere to the follow-up schedule as outlined，providing a streamlined approach to track post-discharge appointments. By utilizing real-time notifications and easy scheduling features, the app encourages patients to attend their follow-up visits, ensuring continuity of care. The application records and analyzes data on scheduled and completed appointments within three months post-discharge, offering insights into adherence rates and identifying factors impacting follow-up compliance. This data-driven approach helps healthcare providers improve patient outcomes and optimize follow-up strategies.
Measured: At 12 weeks after enrollment.
Secondary outcomes (9)
adherance
User adherence with the mHealth intervention will be measured by following approaches
- User log-in data retrieved from app or website：
- Number of log-ins to app
- Length of time spent in app
- Manual user data entry in app - The frequency at which users manually enter data in the app, such as blood glucose level, weight, date and time when medicine was taken, or blood pressure values.
Measured: From enrollment to the end of treatment at 52 weeks, patient adherence will be assessed at each visit.
Quality of life
Quality of life (QoL) was captured by survey with the 27-Item Functional Assessment of Cancer Therapy-Colorectal (FACT-C), which consists of 27 items with physical component summary and mental component summary scores. The score range is 0 to 136, with higher scores indicating better quality of life.
Measured: From enrollment to the end of treatment at 52 weeks
Average unplanned hospitalization days
Unplanned Hospitalization Days" refers to the duration of hospital stays that occur outside of a patient's scheduled follow-up plan. These unplanned admissions indicate instances where a patient's condition requires urgent or unexpected inpatient care, reflecting potential health complications or acute needs beyond the regular follow-up schedule. Monitoring unplanned hospitalization days can provide valuable insights into patient health outcomes, care management, and the effectiveness of follow-up programs.
Measured: The 3rd, 6th, 9th, and 12th months after enrollment
Potentially preventable emergency department visits
"Potentially Preventable Emergency Visits" are defined as emergency visits where the primary diagnoses include conditions such as anemia, nausea, fever, dehydration, neutropenia, diarrhea, pain, pneumonia, sepsis, or vomiting. These visits represent cases where timely outpatient care, effective management, or preventive measures might have reduced the need for emergency intervention. Tracking potentially preventable emergency visits helps healthcare providers identify areas for improvement in outpatient management and preventive care, ultimately aiming to reduce avoidable strain on emergency services.
Measured: The 3rd, 6th, 9th, and 12th months after enrollment
Number and distribution of alerts
"Number and Distribution of Alerts" involves collecting patient-reported symptoms, medication information, and health data such as tumor markers and imaging results through symptom questionnaires and patient self-reports. When risks or abnormalities are detected, alerts are automatically triggered. Alerts are categorized by urgency and severity into yellow, orange, and red levels. Descriptive statistical methods are used to analyze alert occurrences, with frequencies and percentages summarizing the number and reasons for each alert type. The average number of alerts triggered per patient, along with the standard deviation, is calculated. Correlation or regression analyses are applied to explore relationships between the number of alerts and other variables.
Measured: The 3rd, 6th, 9th, and 12th months after enrollment
Number and distribution of proactive reports
Measured: The 3rd, 6th, 9th, and 12th months after enrollment
Patient satisfaction
The FACIT-TS-PS Questionnaire (Functional Assessment of Chronic Illness Therapy - Treatment Satisfaction - Patient Satisfaction) is a tool designed to evaluate patients' satisfaction with their overall treatment and the use of specific applications. It assesses various aspects of treatment satisfaction, including the effectiveness, convenience, and overall experience of therapy, as well as the patient's satisfaction with digital applications used as part of their care. The insights gained from this questionnaire help healthcare providers improve treatment approaches and enhance the patient-centered design of healthcare applications.
Measured: At the end of patient follow-up
System usability of the digital health quality management system
The System Usability Scale (SUS) is a standardized questionnaire used to assess the usability of a system. It consists of 10 items with a five-point Likert scale, allowing users to express their level of agreement or disagreement with statements about the system's functionality and ease of use. The SUS provides a quick and reliable measure of overall usability, enabling evaluators to identify potential improvements and gain insights into users' experiences.
Measured: The 3rd and 12th months after enrollment
Nutritional status
The nutritional status of the selected patients was evaluated using the Patient-Generated Subjective Global Assessment (PG-SGA) questionnaire. The PG-SGA questionnaire consists of two parts: the PG section, which is completed by the patient through self-assessment and includes information on recent weight changes, recent dietary intake, symptoms and signs related to diet, activity, and function; and the SGA section, which is filled out by the investigator after assessment, including the patient's age at onset of disease, metabolic stress status, and physical examination findings. The total score from both sections constitutes the PG-SGA score, with higher scores indicating worse nutritional status. A PG-SGA score of 4 or above is indicative of malnutrition
Measured: From enrollment to the end of treatment at 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start1 Dec 2024
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CarcinomaStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 236 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Shen Kang Hospital Development Center
- Responsible party
- Sponsor
- Investigators
- Jun Qin, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06685497
- Sponsor's protocol ID
- LY2024-208-B
- Status last verified
- Jul 2026
- First submitted
- 11 Oct 2024
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Application of a Digital Postoperative Medical Quality Evaluation and Promotion System for Colorectal Cancer Based on the COLORECTUM+ Model
- ClinicalTrials.gov ID
- NCT06685497
- Acronym / sponsor ID
- LY2024-208-B
- Conditions
- Colorectal Carcinoma
- Keywords
- colorectal carcinoma, follow-up, Ehealth, adherence
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 236 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Shanghai Shen Kang Hospital Development Center
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 12 Nov 2024 (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.
This is a single-center, prospective, interventional study. A total of 236 colorectal cancer patients who underwent surgery will be enrolled and followed for 52 weeks. The digital healthcare quality management system, based on the COLORECTUM+ model, will be used for post-treatment quality evaluation and continuous improvement.
Patients will be managed using an Internet+ post-treatment healthcare management platform. The platform integrates AI technology for real-time symptom analysis and alerts. Patients will report symptoms and health data through the platform, which will generate alerts based on symptom severity to guide appropriate interventions. Follow-up assessments will include patient adherence, satisfaction, quality of life, and healthcare utilization.
The study expects to demonstrate that the digital healthcare quality management system improves follow-up rates, enhances patient adherence, reduces unplanned hospital visits, and increases overall patient satisfaction. The findings aim to provide evidence for the implementation of digital management systems in colorectal cancer post-treatment care, potentially leading to improved long-term outcomes for patients.
Detailed description
The aim of this study is to evaluate the adherence of postoperative colorectal cancer patients using a digital follow-up platform. The primary endpoint is follow-up rate at 3 months after surgery. The secondary endpoints are: follow-up rate at 6, 9, and 12 months, adherence during 12 months, medication adherence (MMS-4), the number and reasons for alerts triggered by patients, the frequency and reasons for patient-initiated report, quality of life (FACT-C), patient satisfaction (FACIT-TS-PS), the system's usability (SUS), the monitoring rates of imaging exams, colonoscopies, and CEA markers at 3, 6, 9, and 12 months will be analyzed. Differences in clinical outcomes: progression-free survival, overall survival, adverse events, the incidence of complications, hospital admissions (unplanned hospital visit rates, average unplanned hospital stay duration, and potentially preventable emergency visits) are additional outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Device: Mobile application follow-upColorectal cancer patients enrolled in the 'Internet Plus' post-treatment management platform use the digital medical quality management system based on the 'COLORECTUM+' model for quality evaluation and continuous improvement. The platform integrates AI, using natural language processing and machine learning to analyze patient-reported symptoms, automatically assess severity, and generate alerts. Alerts are classified as yellow, orange, or red. Yellow indicates mild issues with self-care recommendations; consecutive yellow alerts prompt doctor contact within 24 hours. Orange indicates moderate severity, requiring doctor intervention within 24 hours. Red alerts signify serious symptoms or high-risk medication errors, prompting immediate notification of the doctor and emergency team. The system monitors symptom changes and updates alerts to support treatment optimization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over 18 years old.
- Pathologically confirmed colorectal cancer patients.
- Underwent surgery at the Colorectal Cancer Diagnosis and Treatment Center, Gastrointestinal Surgery, Renji Hospital, Shanghai Jiao Tong University School of Medicine.
- Signed informed consent form.
Key exclusion criteria (4 listed)
- Unable to access electronic devices that can connect to the internet or mobile communications.
- Uncontrolled psychiatric illness.
- The ECOG score is greater than or equal to 3.
- Deemed unsuitable for participation by the investigator.
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 |
|---|---|---|
| Mobile application follow-upColorectal cancer patients enrolled in the 'Internet Plus' post-treatment management platform use the digital medical quality management system based on the 'COLORECTUM+' model for quality evaluation and continuous improvement. The platform integrates AI, using natural language processing and machine learning to analyze patient-reported symptoms, automatically assess severity, and generate alerts. Alerts are classified as yellow, orange, or red. Yellow indicates mild issues with self-care recommendations; consecutive yellow alerts prompt doctor contact within 24 hours. Orange indicates moderate severity, requiring doctor intervention within 24 hours. Red alerts signify serious symptoms or high-risk medication errors, prompting immediate notification of the doctor and emergency team. The system monitors symptom changes and updates alerts to support treatment optimization. | Device | experimental group |
Primary outcome
three-month follow-up rate
Time frame: At 12 weeks after enrollment.
Our mobile application aims to monitor the three-month follow-up rate for patients, assessing whether they adhere to the follow-up schedule as outlined，providing a streamlined approach to track post-discharge appointments. By utilizing real-time notifications and easy scheduling features, the app encourages patients to attend their follow-up visits, ensuring continuity of care. The application records and analyzes data on scheduled and completed appointments within three months post-discharge, offering insights into adherence rates and identifying factors impacting follow-up compliance. This data-driven approach helps healthcare providers improve patient outcomes and optimize follow-up strategies.
9 secondary outcomes
adherance
Time frame: From enrollment to the end of treatment at 52 weeks, patient adherence will be assessed at each visit.
Quality of life
Time frame: From enrollment to the end of treatment at 52 weeks
Average unplanned hospitalization days
Time frame: The 3rd, 6th, 9th, and 12th months after enrollment
Potentially preventable emergency department visits
Time frame: The 3rd, 6th, 9th, and 12th months after enrollment
Number and distribution of alerts
Time frame: The 3rd, 6th, 9th, and 12th months after enrollment
Number and distribution of proactive reports
Time frame: The 3rd, 6th, 9th, and 12th months after enrollment
Patient satisfaction
Time frame: At the end of patient follow-up
System usability of the digital health quality management system
Time frame: The 3rd and 12th months after enrollment
Nutritional status
Time frame: From enrollment to the end of treatment at 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
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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.
Jun Qin principal investigator
RenJi Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile application follow-up in people with Colorectal Carcinoma, run by RenJi Hospital at 1 site in China.
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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 28 Jul 2026. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaomiao Wang (+8617843321256, wangxm0109@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
three-month follow-up rate (time frame: At 12 weeks after enrollment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2026.