Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2026-02-25 @ 5:39 PM
Study NCT ID:
NCT02502760
Status:
COMPLETED
Last Update Posted:
2019-08-16
First Post:
2015-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Multimodal Prehabilitation to Improve Outcomes for Frail Patients Undergoing Resection of Colorectal Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}], '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'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012064', 'term': 'Relaxation Therapy'}], 'ancestors': [{'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-06-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-14', 'studyFirstSubmitDate': '2015-07-15', 'studyFirstSubmitQcDate': '2015-07-17', 'lastUpdatePostDateStruct': {'date': '2019-08-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-06-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Cost Effectiveness of treatment', 'timeFrame': '30 days after hospital discharge', 'description': 'Factoring the cost of the program versus possible savings related to other primary and secondary outcomes'}], 'primaryOutcomes': [{'measure': 'Post operative complications', 'timeFrame': '30 days after surgery', 'description': 'Comprehensive Complication Index (CCI)'}], 'secondaryOutcomes': [{'measure': '6 Minutes Walk Test Distance', 'timeFrame': '4 weeks after discharge'}, {'measure': 'Hospital Length of Stay', 'timeFrame': '3-6 days'}, {'measure': 'Readmission rates', 'timeFrame': '30 days after discharge'}, {'measure': 'Anxiety and Depression', 'timeFrame': '30 days after discharge', 'description': 'Using the Hospital Anxiety Depression Scale (HADS)'}, {'measure': 'Health Related Quality of Life', 'timeFrame': '30 days after discharge', 'description': 'Using the Short Form Health Survey (SF-36)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Postoperative Complications', 'Perioperative Care', 'Colorectal Surgery', 'Frail Elderly'], 'conditions': ['Colorectal Neoplasms']}, 'referencesModule': {'references': [{'pmid': '37162250', 'type': 'DERIVED', 'citation': 'Molenaar CJ, van Rooijen SJ, Fokkenrood HJ, Roumen RM, Janssen L, Slooter GD. Prehabilitation versus no prehabilitation to improve functional capacity, reduce postoperative complications and improve quality of life in colorectal cancer surgery. Cochrane Database Syst Rev. 2023 May 10;5(5):CD013259. doi: 10.1002/14651858.CD013259.pub3.'}, {'pmid': '35588252', 'type': 'DERIVED', 'citation': 'Molenaar CJ, van Rooijen SJ, Fokkenrood HJ, Roumen RM, Janssen L, Slooter GD. Prehabilitation versus no prehabilitation to improve functional capacity, reduce postoperative complications and improve quality of life in colorectal cancer surgery. Cochrane Database Syst Rev. 2022 May 19;5(5):CD013259. doi: 10.1002/14651858.CD013259.pub2.'}, {'pmid': '31968063', 'type': 'DERIVED', 'citation': 'Carli F, Bousquet-Dion G, Awasthi R, Elsherbini N, Liberman S, Boutros M, Stein B, Charlebois P, Ghitulescu G, Morin N, Jagoe T, Scheede-Bergdahl C, Minnella EM, Fiore JF Jr. Effect of Multimodal Prehabilitation vs Postoperative Rehabilitation on 30-Day Postoperative Complications for Frail Patients Undergoing Resection of Colorectal Cancer: A Randomized Clinical Trial. JAMA Surg. 2020 Mar 1;155(3):233-242. doi: 10.1001/jamasurg.2019.5474.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if a program of physical activity, nutritional supplements and relaxation techniques is effective at decreasing post operative complications in frail colorectal cancer patients undergoing resection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Colorectal cancer patient undergoing resection\n* Frail or intermediately frail patients (Fried score 2 and above)\n\nExclusion Criteria:\n\n* Unable to communicate in French or English\n* Premorbid conditions contraindicating physical exercise (dementia, Parkinson Disease, previous stroke with paresis, taking carbidopa/levodopa, donepezil or antidepressants)'}, 'identificationModule': {'nctId': 'NCT02502760', 'briefTitle': 'Using Multimodal Prehabilitation to Improve Outcomes for Frail Patients Undergoing Resection of Colorectal Cancer', 'organization': {'class': 'OTHER', 'fullName': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}, 'orgStudyIdInfo': {'id': '15-131-MUHC'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prehabilitation', 'description': 'Immediately after randomization and until surgery, patients in this arm will:\n\n1. \\- Receive a personalized physical exercise program\n2. \\- Receive nutritional counselling with Whey protein isolate powder\n3. \\- Receive relaxation techniques', 'interventionNames': ['Behavioral: Physical Exercise Program', 'Dietary Supplement: Whey Protein Isolate Powder', 'Behavioral: Relaxation Techniques']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rehabilitation', 'description': 'Patients in this arm will receive the same personalized physical exercise program, nutritional intervention and relaxation techniques as patients in the other arm but to be started after surgery.', 'interventionNames': ['Behavioral: Physical Exercise Program', 'Dietary Supplement: Whey Protein Isolate Powder', 'Behavioral: Relaxation Techniques']}], 'interventions': [{'name': 'Physical Exercise Program', 'type': 'BEHAVIORAL', 'description': 'Physical exercises personalized by a kinesiologist consisting of walking or stationary bike and elastic band exercises.', 'armGroupLabels': ['Prehabilitation', 'Rehabilitation']}, {'name': 'Whey Protein Isolate Powder', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Nutritional counselling is given to patients to ensure their daily proteins and energy requirements are met. Whey Protein Isolate Powder (Immunocal) is provided.\n\nImmunocal1.5g/kg PO (by mouth) per day separated in 2 daily doses', 'armGroupLabels': ['Prehabilitation', 'Rehabilitation']}, {'name': 'Relaxation Techniques', 'type': 'BEHAVIORAL', 'description': 'Relaxation techniques consisting of breathing exercises and using a relaxation CD.', 'armGroupLabels': ['Prehabilitation', 'Rehabilitation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3G 1A4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'McGill University Health Center; Montreal General Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'H3T1E2', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Sir Mortimer B. Davis - Jewish General Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Franco Carli, MD, MPhil', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor, Department of Anesthesia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McGill University Health Centre/Research Institute of the McGill University Health Centre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sir Mortimer B. Davis - Jewish General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Montreal General Hospital Department of Anesthesia', 'investigatorFullName': 'Franco Carli', 'investigatorAffiliation': 'McGill University Health Centre/Research Institute of the McGill University Health Centre'}}}}