Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2025-12-25 @ 10:08 PM
Study NCT ID:
NCT01321658
Status:
COMPLETED
Last Update Posted:
2015-10-21
First Post:
2011-03-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Geriatric Intervention in Frail Elderly Patients With 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': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 122}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-20', 'studyFirstSubmitDate': '2011-03-18', 'studyFirstSubmitQcDate': '2011-03-22', 'lastUpdatePostDateStruct': {'date': '2015-10-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-03-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative complications', 'timeFrame': '30 days after surgery'}], 'secondaryOutcomes': [{'measure': 'Reoperation', 'timeFrame': '30 days after surgery', 'description': 'Number of patients in need of any operation within thirty days after the operation for colorectal cancer.'}, {'measure': 'Readmission', 'timeFrame': '30 days after surgery', 'description': 'Number of patients being readmitted to hospital within 30 days after operation for colorectal surgery.'}, {'measure': 'Length of hospital stay', 'timeFrame': '30 days after surgery'}, {'measure': 'Survival', 'timeFrame': '3 months after surgery'}, {'measure': 'Quality of life', 'timeFrame': '3 months after surgery'}, {'measure': 'Living at home or in institution', 'timeFrame': '3 months after surgery', 'description': 'Number of patients living at home, with or without formal help, and number of patients living in nursing homes 3 months after surgery.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Geriatric Assessment', 'Perioperative Care', 'Colorectal Neoplasms', 'Frail Elderly'], 'conditions': ['Colorectal Neoplasms']}, 'descriptionModule': {'briefSummary': 'This is a randomized, controlled trial on frail elderly patients (aged 65+) with colorectal cancer. The patients will be randomized into two groups. The control group will receive standard surgical treatment. The intervention group will in addition go through a preoperative comprehensive geriatric assessment. The assessment will include evaluation of co-morbidity and medication, social status, nutritional status, cognition, depression and physical performance. This assessment will form basis of an individualized perioperative intervention.\n\nThe main aim of the study is to see if the number of postoperative complications in this group can be reduced by a perioperative geriatric intervention. A study of inflammation markers in serum will also be performed, with focus on identifying potential biological frailty markers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 65+\n* Elective surgery for colorectal cancer\n* Frail\n\nExclusion Criteria:\n\n* Acute surgery\n* Not able to consent\n* Does not consent with registration'}, 'identificationModule': {'nctId': 'NCT01321658', 'briefTitle': 'Geriatric Intervention in Frail Elderly Patients With Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Oslo University Hospital'}, 'officialTitle': 'Geriatric Intervention in Elderly Surgical Patients With Colorectal Cancer - a Randomized, Controlled Trial.', 'orgStudyIdInfo': {'id': '2010/1634'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Geriatric intervention', 'interventionNames': ['Other: Geriatric intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Geriatric intervention', 'type': 'OTHER', 'description': 'A comprehensive geriatric assessment (CGA), focusing on co-morbidity, medication, cognitive status, depression, nutritional status and physical status is performed. The intervention is individualized according to the results of the CGA.', 'armGroupLabels': ['Geriatric intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0424', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Dept of gastrointestinal surgery, Oslo University Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Torgeir B Wyller, Dr.med', 'role': 'STUDY_CHAIR', 'affiliation': 'Geriatric dept., Oslo University hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oslo University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Norwegian Cancer Society', 'class': 'OTHER'}, {'name': 'University Hospital, Akershus', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Torgeir Bruun Wyller', 'investigatorAffiliation': 'Oslo University Hospital'}}}}