Using Multimodal Prehabilitation to Improve Outcomes for Frail Patients Undergoing Resection of Colorectal Cancer
1 other identifier
interventional
120
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2015
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 15, 2015
CompletedFirst Posted
Study publicly available on registry
July 20, 2015
CompletedStudy Start
First participant enrolled
August 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 19, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 19, 2019
CompletedAugust 16, 2019
August 1, 2019
3.9 years
July 15, 2015
August 14, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Post operative complications
Comprehensive Complication Index (CCI)
30 days after surgery
Secondary Outcomes (5)
6 Minutes Walk Test Distance
4 weeks after discharge
Hospital Length of Stay
3-6 days
Readmission rates
30 days after discharge
Anxiety and Depression
30 days after discharge
Health Related Quality of Life
30 days after discharge
Other Outcomes (1)
Cost Effectiveness of treatment
30 days after hospital discharge
Study Arms (2)
Prehabilitation
EXPERIMENTALImmediately after randomization and until surgery, patients in this arm will: 1. \- Receive a personalized physical exercise program 2. \- Receive nutritional counselling with Whey protein isolate powder 3. \- Receive relaxation techniques
Rehabilitation
ACTIVE COMPARATORPatients 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.
Interventions
Physical exercises personalized by a kinesiologist consisting of walking or stationary bike and elastic band exercises.
Nutritional counselling is given to patients to ensure their daily proteins and energy requirements are met. Whey Protein Isolate Powder (Immunocal) is provided. Immunocal1.5g/kg PO (by mouth) per day separated in 2 daily doses
Relaxation techniques consisting of breathing exercises and using a relaxation CD.
Eligibility Criteria
You may qualify if:
- Colorectal cancer patient undergoing resection
- Frail or intermediately frail patients (Fried score 2 and above)
You may not qualify if:
- Unable to communicate in French or English
- Premorbid conditions contraindicating physical exercise (dementia, Parkinson Disease, previous stroke with paresis, taking carbidopa/levodopa, donepezil or antidepressants)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
McGill University Health Center; Montreal General Hospital
Montreal, Quebec, H3G 1A4, Canada
Sir Mortimer B. Davis - Jewish General Hospital
Montreal, Quebec, H3T1E2, Canada
Related Publications (3)
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: 37162250DERIVEDMolenaar 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: 35588252DERIVEDCarli 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.
PMID: 31968063DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Franco Carli, MD, MPhil
Professor, Department of Anesthesia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor, Montreal General Hospital Department of Anesthesia
Study Record Dates
First Submitted
July 15, 2015
First Posted
July 20, 2015
Study Start
August 1, 2015
Primary Completion
June 19, 2019
Study Completion
June 19, 2019
Last Updated
August 16, 2019
Record last verified: 2019-08