Colorectal CancerRAISe-CareNCT06302751
A Mobile Application to Improve Postoperative Outcomes in Colorectal Cancer
A study testing Care 4 Today ® (Johnson and Johnson) mobile app in people with Colorectal Cancer and Surgery, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Surgery
- What is being tested?
- Care 4 Today ® (Johnson and Johnson) mobile app
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteItaly
- Study dates
- 26 Feb 2024to 31 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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- Patients with a planned elective intervention requiring urgent or emergent surgery will be withdrawn from the study.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 locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Humanitas Research Hospital
Rozzano, MI, 20089
Annalisa Maroli, PhD, 02 8224 7776 ext. 0039, colorapp@humanitas.it
Stefano De Zanet, MS, 02 8224 4623 ext. 0039, colorapp@humanitas.it
About this study
Official title: 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.
Read the 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.
- Conditions
- Colorectal Cancer, Surgery
- Being tested
- Care 4 Today ® (Johnson and Johnson) mobile app
- Keywords
- Colorectal cancer, Surgery, Mobile app, Unplanned readmissions
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unplanned hospital readmissions
Rate difference of unplanned hospital readmissions between the experimental group and historical cohort of comparison.
Measured: 30 days after surgery
Secondary outcomes (4)
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.
Measured: 30 days after surgery
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.
Measured: 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.
Measured: 30 days after surgery
Healthcare costs
Compare the healthcare resources utilization between the experimental group and the historical cohort of comparison.
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start26 Feb 2024
- Primary completion26 Feb 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, prospective, interventional case-series study with a historical cohort of comparison
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Caterina Foppa, MD, PhD, Principal investigator, Humanitas Research Hospital IRCCS, Rozzano-MilanSpinelli Antonino, MD, PhD, Principal investigator, Humanitas Research Hospital IRCCS, Rozzano-Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06302751
- Sponsor's protocol ID
- 3647
- Acronym
- RAISe-Care
- Status last verified
- Mar 2024
- First submitted
- 4 Mar 2024
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Electronic Remote Application to Improve the Postoperative Outcomes in Colorectal Cancer Patients: Single-center, Interventional Study
- ClinicalTrials.gov ID
- NCT06302751
- Acronym / sponsor ID
- RAISe-Care / 3647
- Conditions
- Colorectal Cancer, Surgery
- Keywords
- Colorectal cancer, Surgery, Mobile app, Unplanned readmissions
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 26 Feb 2024 (actual)
- Primary completion
- 26 Feb 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single-center, prospective, interventional case-series study with a historical cohort of comparison
| Arm | Type | Receives |
|---|---|---|
| Care 4 Today ® (Johnson and Johnson) mobile app | Experimental | Device: Care 4 Today ® (Johnson and Johnson) mobile appPatients 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). |
| Standard perioperative management | No intervention | –The historic cohort include patients who underwent standard perioperative management from March 2020 to April 2023. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Care 4 Today ® (Johnson and Johnson) mobile appCare 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. | Device | Care 4 Today ® (Johnson and Johnson) mobile app |
Primary outcome
Unplanned hospital readmissions
Time frame: 30 days after surgery
Rate difference of unplanned hospital readmissions between the experimental group and historical cohort of comparison.
4 secondary outcomes
Severity of postoperative complications
Time frame: 30 days after surgery
Length of hospital stay
Time frame: From the day of surgery to the day of discharge
Time from symptoms onset to diagnosis
Time frame: 30 days after surgery
Healthcare costs
Time frame: 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Caterina Foppa, MD, PhD principal investigator
Humanitas Research Hospital IRCCS, Rozzano-Milan
Spinelli Antonino, MD, PhD principal investigator
Humanitas Research Hospital IRCCS, Rozzano-Milan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care 4 Today ® (Johnson and Johnson) mobile app in people with Colorectal Cancer and Surgery, run by Istituto Clinico Humanitas at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annalisa Maroli, PhD (02 8224 7776 ext. 0039, colorapp@humanitas.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unplanned hospital readmissions (time frame: 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2024.