Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-27 @ 11:12 PM
Study NCT ID:
NCT02965794
Status:
COMPLETED
Last Update Posted:
2020-01-28
First Post:
2014-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Care Pathways for Colorectal Cancer Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019091', 'term': 'Critical Pathways'}], 'ancestors': [{'id': 'D010347', 'term': 'Patient Care Planning'}, {'id': 'D003191', 'term': 'Comprehensive Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 480}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2019-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-27', 'studyFirstSubmitDate': '2014-08-04', 'studyFirstSubmitQcDate': '2016-11-16', 'lastUpdatePostDateStruct': {'date': '2020-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Length of stay', 'timeFrame': 'through study completion, an average of 4 months', 'description': 'Number of days in hospital'}], 'secondaryOutcomes': [{'measure': 'Time to return to normal diet', 'timeFrame': 'through study completion, an average of 4 months', 'description': 'number of days in between surgery and day of normal diet'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['surgery', 'bowel', 'rectum', 'cancer', 'nutrition'], 'conditions': ['Cancer']}, 'referencesModule': {'references': [{'pmid': '33397382', 'type': 'DERIVED', 'citation': 'van Zelm R, Coeckelberghs E, Sermeus W, Wolthuis A, Bruyneel L, Panella M, Vanhaecht K. A mixed methods multiple case study to evaluate the implementation of a care pathway for colorectal cancer surgery using extended normalization process theory. BMC Health Serv Res. 2021 Jan 4;21(1):11. doi: 10.1186/s12913-020-06011-w.'}]}, 'descriptionModule': {'briefSummary': 'EVALUATE THE CARE PROCESS AND THE QUALITY OF CARE FOR ADULT CANCER PATIENTS WHO ARE ADMITTED FOR COLORECTAL SURGERY', 'detailedDescription': 'This descriptive study uses an interrupted time series approach combining a retrospective with a prospective multicenter design to evaluate the current state of the care process for adult colorectal cancer patients who are admitted for surgery. This study will give attention to evidence based key interventions, follow-up and interprofessional teamwork necessary to provide appropriate care. In 4 countries (Belgium, Germany, France and The Netherlands) 3 hospitals will participate (total number of hospitals is 12). They will perform a clinical audit of the actual organization of the care process, and a team audit on the level of interprofessional teamwork. Each team will develop and implement a quality improvement initiative based on the concept of care pathways, the findings from the audit and the available evidence, and will measure the effect of their improvement strategy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adults undergoing surgery for colorectal cancer', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. All consecutive scheduled admissions starting September 2, 2013;\n2. Minimum age of 18 years;\n3. Elective admission for colorectal cancer surgery\n\nExclusion Criteria:\n\n1. Emergency (not planned) admission for colorectal cancer surgery;\n2. Patients with severe dementia (DSM IV) or severe concomitant disease that may affect very short-term outcome (life expectancy less than 3 months) and hence influence deviations from standard acute care.'}, 'identificationModule': {'nctId': 'NCT02965794', 'acronym': 'CP4GICAN', 'briefTitle': 'Care Pathways for Colorectal Cancer Surgery', 'organization': {'class': 'OTHER', 'fullName': 'European Pathway Association'}, 'officialTitle': 'Descriptive Study to Evaluate the Care Process and the Quality of Care for Adult Cancer Patients Who Are Admitted for Colorectal Cancer Surgery.', 'orgStudyIdInfo': {'id': 'CP4NutriGICAN2014'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Usual care', 'description': 'quality of care will be measured in the participating hospitals, using a retrospective patient record analysis'}, {'label': 'Care Pathway', 'description': 'Care pathways for colorectal cancer', 'interventionNames': ['Other: Care pathways for colorectal cancer']}], 'interventions': [{'name': 'Care pathways for colorectal cancer', 'type': 'OTHER', 'otherNames': ['care pathway', 'clinical pathway', 'critical pathway'], 'description': 'development of a care pathway for this patient group', 'armGroupLabels': ['Care Pathway']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'KULeuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'overallOfficials': [{'name': 'Kris Vanhaecht, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KU Leuven'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Pathway Association', 'class': 'OTHER'}, 'collaborators': [{'name': 'KU Leuven', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor in Healthcare Quality Management', 'investigatorFullName': 'Dr. Kris Vanhaecht', 'investigatorAffiliation': 'European Pathway Association'}}}}