COLORECTUM+ Digital System for Postoperative Quality Improvement in Colorectal Cancer

NCT ID: NCT06685497

Last Updated: 2024-11-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 236 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2026-05-31

Brief 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 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.

Conditions

Colorectal Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

experimental group

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.

Group Type: EXPERIMENTAL

Mobile application follow-up

Intervention Type: DEVICE

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.

Interventions

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 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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Shen Kang Hospital Development Center

OTHER

Sponsor Role: collaborator

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jun Qin

Role: PRINCIPAL_INVESTIGATOR

RenJi Hospital

Central Contacts

Xiaomiao Wang

Role: CONTACT

wangxm0109@163.com

+8617843321256

Other Identifiers

LY2024-208-B

Identifier Type: -

Identifier Source: org_study_id