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Trial Title:
A Mobile Application to Improve Postoperative Outcomes in Colorectal Cancer
NCT ID:
NCT06302751
Condition:
Colorectal Cancer
Surgery
Conditions: Official terms:
Colorectal Neoplasms
Conditions: Keywords:
Colorectal cancer
Surgery
Mobile app
Unplanned readmissions
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Intervention model description:
Single-center, prospective, interventional case-series study with a historical cohort of
comparison
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Device
Intervention name:
Care 4 Today ® (Johnson and Johnson) mobile app
Description:
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.
Arm group label:
Care 4 Today ® (Johnson and Johnson) mobile app
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.
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
IRCCS Humanitas Research Hospital
Address:
City:
Rozzano
Zip:
20089
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Annalisa Maroli, PhD
Phone:
02 8224 7776
Phone ext:
0039
Email:
colorapp@humanitas.it
Contact backup:
Last name:
Stefano De Zanet, MS
Phone:
02 8224 4623
Phone ext:
0039
Email:
colorapp@humanitas.it
Start date:
February 26, 2024
Completion date:
August 31, 2026
Lead sponsor:
Agency:
Istituto Clinico Humanitas
Agency class:
Other
Source:
Istituto Clinico Humanitas
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06302751
