NCT06302751

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable colorectal-cancer

Timeline
4mo left

Started Feb 2024

Typical duration for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Feb 2024Aug 2026

Study Start

First participant enrolled

February 26, 2024

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 12, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 26, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Expected
Last Updated

March 15, 2024

Status Verified

March 1, 2024

Enrollment Period

2 years

First QC Date

March 4, 2024

Last Update Submit

March 13, 2024

Conditions

Colorectal CancerSurgery

Keywords

Colorectal cancerSurgeryMobile appUnplanned readmissions

Outcome Measures

Primary Outcomes (1)

  • Unplanned hospital readmissions

    Rate difference of unplanned hospital readmissions between the experimental group and historical cohort of comparison.

    30 days after surgery

Secondary Outcomes (4)

  • Severity of postoperative complications

    30 days after surgery

  • Length of hospital stay

    From the day of surgery to the day of discharge

  • Time from symptoms onset to diagnosis

    30 days after surgery

  • Healthcare costs

    30 days after surgery

Study Arms (2)

Care 4 Today ® (Johnson and Johnson) mobile app

EXPERIMENTAL

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

Standard perioperative management

NO INTERVENTION

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

Interventions

Care 4 Today ® (Johnson and Johnson) mobile appDEVICE

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.

Care 4 Today ® (Johnson and Johnson) mobile app

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IRCCS Humanitas Research Hospital

Rozzano, MI, 20089, Italy

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Caterina Foppa, MD, PhD

    Humanitas Research Hospital IRCCS, Rozzano-Milan

    PRINCIPAL INVESTIGATOR

  • Spinelli Antonino, MD, PhD

    Humanitas Research Hospital IRCCS, Rozzano-Milan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Annalisa Maroli, PhD

CONTACT

02 8224 7776colorapp@humanitas.it

Stefano De Zanet, MS

CONTACT

02 8224 4623colorapp@humanitas.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Single-center, prospective, interventional case-series study with a historical cohort of comparison
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2024

First Posted

March 12, 2024

Study Start

February 26, 2024

Primary Completion

February 26, 2026

Study Completion (Estimated)

August 31, 2026

Last Updated

March 15, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)