Ignite Creation Date:
2025-12-24 @ 11:54 PM
Ignite Modification Date:
2025-12-25 @ 9:50 PM
Study NCT ID:
NCT06302751
Status:
RECRUITING
Last Update Posted:
2024-03-15
First Post:
2024-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Mobile Application to Improve Postoperative Outcomes in Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single-center, prospective, interventional case-series study with a historical cohort of comparison'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2026-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-13', 'studyFirstSubmitDate': '2024-03-04', 'studyFirstSubmitQcDate': '2024-03-04', 'lastUpdatePostDateStruct': {'date': '2024-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Unplanned hospital readmissions', 'timeFrame': '30 days after surgery', 'description': 'Rate difference of unplanned hospital readmissions between the experimental group and historical cohort of comparison.'}], 'secondaryOutcomes': [{'measure': 'Severity of postoperative complications', 'timeFrame': '30 days after surgery', 'description': '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.'}, {'measure': 'Length of hospital stay', 'timeFrame': 'From the day of surgery to the day of discharge', 'description': '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.'}, {'measure': 'Time from symptoms onset to diagnosis', 'timeFrame': '30 days after surgery', 'description': 'Compare the time (in hours) from symptoms onset to diagnosis of postoperative complications occurring in the experimental group and historical cohort of comparison.'}, {'measure': 'Healthcare costs', 'timeFrame': '30 days after surgery', 'description': 'Compare the healthcare resources utilization between the experimental group and the historical cohort of comparison.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Colorectal cancer', 'Surgery', 'Mobile app', 'Unplanned readmissions'], 'conditions': ['Colorectal Cancer', 'Surgery']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged more than 18 years old.\n* 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.\n* Patients willing to comply with the study procedures.\n* Proficient understanding of the Italian language\n\nExclusion Criteria:\n\n* Any condition that, in the opinion of the investigator, may interfere with the study procedures.\n* Patients scheduled for palliative surgery.\n* Patients with a planned elective intervention requiring urgent or emergent surgery will be withdrawn from the study.\n* Pregnant or breastfeeding women.\n* Inability to comply with the study procedures.'}, 'identificationModule': {'nctId': 'NCT06302751', 'acronym': 'RAISe-Care', 'briefTitle': 'A Mobile Application to Improve Postoperative Outcomes in Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Clinico Humanitas'}, 'officialTitle': 'An Electronic Remote Application to Improve the Postoperative Outcomes in Colorectal Cancer Patients: Single-center, Interventional Study', 'orgStudyIdInfo': {'id': '3647'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Care 4 Today ® (Johnson and Johnson) mobile app', '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).', 'interventionNames': ['Device: Care 4 Today ® (Johnson and Johnson) mobile app']}, {'type': 'NO_INTERVENTION', 'label': 'Standard perioperative management', 'description': 'The historic cohort include patients who underwent standard perioperative management from March 2020 to April 2023.'}], 'interventions': [{'name': 'Care 4 Today ® (Johnson and Johnson) mobile app', 'type': 'DEVICE', '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.', 'armGroupLabels': ['Care 4 Today ® (Johnson and Johnson) mobile app']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20089', 'city': 'Rozzano', 'state': 'MI', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Annalisa Maroli, PhD', 'role': 'CONTACT', 'email': 'colorapp@humanitas.it', 'phone': '02 8224 7776', 'phoneExt': '0039'}, {'name': 'Stefano De Zanet, MS', 'role': 'CONTACT', 'email': 'colorapp@humanitas.it', 'phone': '02 8224 4623', 'phoneExt': '0039'}], 'facility': 'IRCCS Humanitas Research Hospital', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}], 'centralContacts': [{'name': 'Annalisa Maroli, PhD', 'role': 'CONTACT', 'email': 'colorapp@humanitas.it', 'phone': '02 8224 7776', 'phoneExt': '0039'}, {'name': 'Stefano De Zanet, MS', 'role': 'CONTACT', 'email': 'colorapp@humanitas.it', 'phone': '02 8224 4623', 'phoneExt': '0039'}], 'overallOfficials': [{'name': 'Caterina Foppa, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Humanitas Research Hospital IRCCS, Rozzano-Milan'}, {'name': 'Spinelli Antonino, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Humanitas Research Hospital IRCCS, Rozzano-Milan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Clinico Humanitas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}