COLORECTUM+ Digital System for Postoperative Quality Improvement in Colorectal Cancer

Официальное название

Construction and Application of a Digital Postoperative Medical Quality Evaluation and Promotion System for Colorectal Cancer Based on the COLORECTUM+ Model

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство 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

Первичные конечные точки

• three-month follow-up rate [Срок оценки: At 12 weeks after enrollment.]

Вторичные конечные точки (9)

• adherance [Срок оценки: From enrollment to the end of treatment at 52 weeks, patient adherence will be assessed at each visit.]
• Quality of life [Срок оценки: From enrollment to the end of treatment at 52 weeks]
• Average unplanned hospitalization days [Срок оценки: The 3rd, 6th, 9th, and 12th months after enrollment]
• Potentially preventable emergency department visits [Срок оценки: The 3rd, 6th, 9th, and 12th months after enrollment]
• Number and distribution of alerts [Срок оценки: The 3rd, 6th, 9th, and 12th months after enrollment]
• Number and distribution of proactive reports [Срок оценки: The 3rd, 6th, 9th, and 12th months after enrollment]
• Patient satisfaction [Срок оценки: At the end of patient follow-up]
• System usability of the digital health quality management system [Срок оценки: The 3rd and 12th months after enrollment]
• Nutritional status [Срок оценки: From enrollment to the end of treatment at 52 weeks]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Китай · 1 центр

• Shanghai Jiao Tong University School of Medicine, Renji Hospital — Шанхай

Идентификаторы

NCT: NCT06685497 · LY2024-208-B

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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