A Mobile Application to Improve Postoperative Outcomes in Colorectal Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-26

Study Completion Date

2026-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Colorectal Cancer Surgery

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Single-center, prospective, interventional case-series study with a historical cohort of comparison

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Care 4 Today ® (Johnson and Johnson) mobile app

Intervention Type DEVICE

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.

Standard perioperative management

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No