A Mobile Application to Improve Postoperative Outcomes in Colorectal Cancer (RAISe-Care)

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

The unplanned readmission rate after colorectal cancer surgery is still high, despite the implementation of enhanced recovery programs. The use of a mobile-based application for perioperative remote monitoring may improve the postoperative outcomes and reduce the unplanned postoperative readmissions.

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Surgery
• Intervention / Treatment: Device: Care 4 Today ® (Johnson and Johnson) mobile app

Detailed Description

Despite the implementation of enhanced recovery programs, the rate of unplanned readmissions remains high after colorectal cancer surgery. These readmissions are often preventable with a better postoperative management. Increasing studies have demonstrated the feasibility and efficacy of perioperative remote monitoring mobile applications in improving the postoperative outcomes but are often limited to one restricted outcome. This project aims to evaluate the effect of the Care 4 Today® (Johnson & Johnson) perioperative mobile app on the postoperative outcomes of colorectal cancer patients, with a focus on unplanned readmissions.

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Annalisa Maroli, PhD; Phone Number: 0039 02 8224 7776; Email: colorapp@humanitas.it
• Study Contact Backup: Name: Stefano De Zanet, MS; Phone Number: 0039 02 8224 4623; Email: colorapp@humanitas.it

Study Locations

• Italy
  • MI
    • Rozzano, MI, Italy, 20089
      • Recruiting
      • IRCCS Humanitas Research Hospital
      • Contact: Annalisa Maroli, PhD; Phone Number: 0039 02 8224 7776; Email: colorapp@humanitas.it
      • Contact: Stefano De Zanet, MS; Phone Number: 0039 02 8224 4623; Email: colorapp@humanitas.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients aged more than 18 years old.
• Patients scheduled for elective curative colorectal resection, including right (or extended) colectomy, left colectomy, rectal resection (with or without ileostomy), total colectomy, recanalization, or multiple colon resection.
• Patients willing to comply with the study procedures.
• Proficient understanding of the Italian language

Exclusion Criteria:

• Any condition that, in the opinion of the investigator, may interfere with the study procedures.
• Patients scheduled for palliative surgery.
• Patients with a planned elective intervention requiring urgent or emergent surgery will be withdrawn from the study.
• Pregnant or breastfeeding women.
• Inability to comply with the study procedures.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Care 4 Today ® (Johnson and Johnson) mobile app; Patients will undergo standard perioperative management. Additionally, patients will use the Care 4 Today ® (Johnson and Johnson) mobile app for remote monitoring from the preoperative assessment day to 30 days after surgery. The Care 4 Today Care ® (Johnson and Johnson) mobile app will include daily reminds for preoperative recommendations adherence (water intake, medications adherence, mobilization, smoking quit...) and postoperative monitoring of symptoms (fever, pain, and mood deflections).	Device: Care 4 Today ® (Johnson and Johnson) mobile app; Care 4 Today ® (Johnson and Johnson) mobile app will cover the perioperative period spanning through the preoperative assessment day (approximately -seven to -one from surgery) to 30 days after surgery and will monitor the adherence to preoperative and postoperative recommendations.
No Intervention: Standard perioperative management; The historic cohort include patients who underwent standard perioperative management from March 2020 to April 2023.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unplanned hospital readmissions	Rate difference of unplanned hospital readmissions between the experimental group and historical cohort of comparison.	30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	Compare the median length of hospital stay (calculated in days from the day of surgery to the day of discharge) between the experimental group and the historical cohort of comparison.	From the day of surgery to the day of discharge
Time from symptoms onset to diagnosis	Compare the time (in hours) from symptoms onset to diagnosis of postoperative complications occurring in the experimental group and historical cohort of comparison.	30 days after surgery
Healthcare costs	Compare the healthcare resources utilization between the experimental group and the historical cohort of comparison.	30 days after surgery
Severity of postoperative complications	Compare the severity of postoperative complications- classified according to the Clavien-Dindo scale (ranging from 0 [no postoperative complications] to 5 [postoperative complications leading to death]- between the experimental group and historical cohort of comparison.	30 days after surgery

Collaborators and Investigators

• Sponsor: Istituto Clinico Humanitas
• Investigators: Principal Investigator: Caterina Foppa, MD, PhD, IRCCS Humanitas Research Hospital; Principal Investigator: Spinelli Antonino, MD, PhD, IRCCS Humanitas Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2024
• Primary Completion (Estimated): February 26, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Surgery; Colorectal cancer; Mobile app; Unplanned readmissions
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 3647

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No