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

Istituto Clinico Humanitas

Status: Enrolling

Conditions: Surgery; Colorectal Cancer

Treatments: Device: Care 4 Today ® (Johnson and Johnson) mobile app

Study type: Interventional

Funder types: Other

Identifiers

NCT06302751

3647

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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• Patients with a planned elective intervention requiring urgent or emergent surgery will be withdrawn from the study.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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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600 participants in 2 patient groups

Care 4 Today ® (Johnson and Johnson) mobile app

Experimental group

Description:

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).

Treatment:

Device: Care 4 Today ® (Johnson and Johnson) mobile app

Standard perioperative management

No Intervention group

Description:

The historic cohort include patients who underwent standard perioperative management from March 2020 to April 2023.