COLORECTUM+ Digital System for Postoperative Quality Improvement in Colorectal Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mobile application follow-up.
- Who it may be relevant to
- Registry conditions: Colorectal Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Construction and Application of a Digital Postoperative Medical Quality Evaluation and Promotion System for Colorectal Cancer Based on the COLORECTUM+ Model
Overview
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.
Interventions
- Device Mobile application follow-up
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 recomm
Primary outcome measures
- three-month follow-up rate [Time frame: At 12 weeks after enrollment.]
Secondary outcome measures (9)
- 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]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
China · 1 center
- Shanghai Jiao Tong University School of Medicine, Renji Hospital — Shanghai
Identifiers
NCT: NCT06685497 · LY2024-208-B