Clinical trial NCT06685497: COLORECTUM+ Digital System for Postoperative Quality Improvement in Colorectal Cancer
Official title: Construction and Application of a Digital Postoperative Medical Quality Evaluation and Promotion System for Colorectal Cancer Based on the COLORECTUM+ Model
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Colorectal Carcinoma
Keywords: colorectal carcinoma
follow-up
Ehealth
adherence
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Shanghai Shen Kang Hospital Development Center
First posted: 2024-11-12
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: three-month follow-up rate
timeFrame: At 12 weeks after enrollment.
Secondary outcomes:
measure: adherance
timeFrame: From enrollment to the end of treatment at 52 weeks, patient adherence will be assessed at each visit.
measure: Quality of life
timeFrame: From enrollment to the end of treatment at 52 weeks
measure: Average unplanned hospitalization days
timeFrame: The 3rd, 6th, 9th, and 12th months after enrollment
measure: Potentially preventable emergency department visits
timeFrame: The 3rd, 6th, 9th, and 12th months after enrollment
measure: Number and distribution of alerts
timeFrame: The 3rd, 6th, 9th, and 12th months after enrollment
measure: Number and distribution of proactive reports
timeFrame: The 3rd, 6th, 9th, and 12th months after enrollment
measure: Patient satisfaction
timeFrame: At the end of patient follow-up
measure: System usability of the digital health quality management system
timeFrame: The 3rd and 12th months after enrollment
measure: Nutritional status
timeFrame: From enrollment to the end of treatment at 52 weeks
Other outcomes:
Locations:
Study officials:
affiliation: RenJi Hospital
name: Jun Qin
role: PRINCIPAL_INVESTIGATOR
References: