COLORECTUM+ Digital System for Postoperative Quality Improvement in Colorectal Cancer
ConditionColorectal Carcinoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRenJi Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
Mobile application follow-up
DeviceColorectal 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.
Treatment groups
236 Participants
are divided into 1 treatment groupGroup A: experimental groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
At 12 weeks after enrollment.Secondary outcomes
1
adherance
User adherence with the mHealth intervention will be measured by following approaches 1. User log-in data retrieved from app or website： * Number of log-ins to app * Length of time spent in app 2. 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.
Time frame
From enrollment to the end of treatment at 52 weeks, patient adherence will be assessed at each visit.2
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.
Time frame
From enrollment to the end of treatment at 52 weeks3
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.
Time frame
The 3rd, 6th, 9th, and 12th months after enrollment4
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.
Time frame
The 3rd, 6th, 9th, and 12th months after enrollmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
RenJi Hospital
Lead sponsor
Shanghai Shen Kang Hospital Development Center
Collaborator
Source ClinicalTrials.gov