Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06302751

An Electronic Remote Application to Improve Postoperative Outcomes in Colorectal Cancer Patients: Single-center Interventional Study

Led by Istituto Clinico Humanitas · Updated on 2024-03-15

600

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of a mobile app called Care 4 Today 4 (Johnson & Johnson) to improve outcomes after colorectal cancer surgery. Despite enhanced recovery programs, many patients still face unplanned hospital readmissions after surgery, which may be preventable with better postoperative management. This study focuses on whether using this mobile app for perioperative remote monitoring can reduce these readmissions and improve overall postoperative results. Participants will receive standard care for their colorectal cancer surgery. In addition, they will use the Care 4 Today 4 mobile app starting from the preoperative assessment day until 30 days after surgery. The app provides daily reminders for preoperative preparation like water intake, medication adherence, mobilization, and smoking cessation, as well as monitoring postoperative symptoms such as fever, pain, and mood changes. The study compares this group to a historic group who received only standard care without the app. During the study, participants will be monitored for 30 days after surgery. Researchers will track unplanned hospital readmissions, severity of complications, length of hospital stay, time from symptom onset to diagnosis, and healthcare costs. The study involves daily symptom tracking through the app and assessments based on medical records. This approach aims to enhance postoperative monitoring and support recovery after colorectal cancer surgery.

CONDITIONS

Brief Title

A Mobile Application to Improve Postoperative Outcomes in Colorectal Cancer

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged more than 18 years old
  • Scheduled for elective curative colorectal resection such as right or left colectomy, rectal resection, total colectomy, recanalization, or multiple colon resections
  • Willing to comply with study procedures
  • Proficient in the Italian language
Not Eligible

You will not qualify if you...

  • Conditions that may interfere with study procedures as judged by the investigator
  • Scheduled for palliative surgery
  • Planned urgent or emergent surgery
  • Pregnant or breastfeeding women
  • Inability to comply with study procedures

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person) for preoperative assessment

Implementation

Duration - Approximately 5 weeks (from preoperative assessment day to 30 days after surgery)

Participants use the Care 4 Today ® mobile app for remote monitoring starting from the preoperative assessment day to 30 days after surgery, including daily reminders and symptom monitoring.

Daily remote monitoring through the mobile app

Post-operative Follow-up

Duration - 30 days after surgery

Participants are monitored for unplanned hospital readmissions and postoperative complications for 30 days following surgery.

Regular monitoring via mobile app and possible follow-up visits as needed

Trial Site Locations

Total: 1 location

1

IRCCS Humanitas Research Hospital

Rozzano, MI, Italy, 20089

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Research Team

A

Annalisa Maroli, PhD

S

Stefano De Zanet, MS

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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