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Using Multimodal Prehabilitation to Improve Outcomes for Frail Patients Undergoing Resection of Colorectal Cancer

Primary Purpose

Colorectal Neoplasms

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Physical Exercise Program
Whey Protein Isolate Powder
Relaxation Techniques
Sponsored by
McGill University Health Centre/Research Institute of the McGill University Health Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colorectal Neoplasms focused on measuring Postoperative Complications, Perioperative Care, Colorectal Surgery, Frail Elderly

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Colorectal cancer patient undergoing resection
  • Frail or intermediately frail patients (Fried score 2 and above)

Exclusion Criteria:

  • 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)

Sites / Locations

  • McGill University Health Center; Montreal General Hospital
  • Sir Mortimer B. Davis - Jewish General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Prehabilitation

Rehabilitation

Arm Description

Immediately after randomization and until surgery, patients in this arm will: - Receive a personalized physical exercise program - Receive nutritional counselling with Whey protein isolate powder - Receive relaxation techniques

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.

Outcomes

Primary Outcome Measures

Post operative complications
Comprehensive Complication Index (CCI)

Secondary Outcome Measures

6 Minutes Walk Test Distance
Hospital Length of Stay
Readmission rates
Anxiety and Depression
Using the Hospital Anxiety Depression Scale (HADS)
Health Related Quality of Life
Using the Short Form Health Survey (SF-36)

Full Information

First Posted
July 15, 2015
Last Updated
August 14, 2019
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Sir Mortimer B. Davis - Jewish General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02502760
Brief Title
Using Multimodal Prehabilitation to Improve Outcomes for Frail Patients Undergoing Resection of Colorectal Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
June 19, 2019 (Actual)
Study Completion Date
June 19, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Sir Mortimer B. Davis - Jewish General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Neoplasms
Keywords
Postoperative Complications, Perioperative Care, Colorectal Surgery, Frail Elderly

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prehabilitation
Arm Type
Experimental
Arm Description
Immediately after randomization and until surgery, patients in this arm will: - Receive a personalized physical exercise program - Receive nutritional counselling with Whey protein isolate powder - Receive relaxation techniques
Arm Title
Rehabilitation
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Physical Exercise Program
Intervention Description
Physical exercises personalized by a kinesiologist consisting of walking or stationary bike and elastic band exercises.
Intervention Type
Dietary Supplement
Intervention Name(s)
Whey Protein Isolate Powder
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Relaxation Techniques
Intervention Description
Relaxation techniques consisting of breathing exercises and using a relaxation CD.
Primary Outcome Measure Information:
Title
Post operative complications
Description
Comprehensive Complication Index (CCI)
Time Frame
30 days after surgery
Secondary Outcome Measure Information:
Title
6 Minutes Walk Test Distance
Time Frame
4 weeks after discharge
Title
Hospital Length of Stay
Time Frame
3-6 days
Title
Readmission rates
Time Frame
30 days after discharge
Title
Anxiety and Depression
Description
Using the Hospital Anxiety Depression Scale (HADS)
Time Frame
30 days after discharge
Title
Health Related Quality of Life
Description
Using the Short Form Health Survey (SF-36)
Time Frame
30 days after discharge
Other Pre-specified Outcome Measures:
Title
Cost Effectiveness of treatment
Description
Factoring the cost of the program versus possible savings related to other primary and secondary outcomes
Time Frame
30 days after hospital discharge

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Colorectal cancer patient undergoing resection Frail or intermediately frail patients (Fried score 2 and above) Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franco Carli, MD, MPhil
Organizational Affiliation
Professor, Department of Anesthesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
McGill University Health Center; Montreal General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
Sir Mortimer B. Davis - Jewish General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T1E2
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35588252
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.
Results Reference
derived
PubMed Identifier
31968063
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. Erratum In: JAMA Surg. 2020 Mar 1;155(3):269.
Results Reference
derived

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Using Multimodal Prehabilitation to Improve Outcomes for Frail Patients Undergoing Resection of Colorectal Cancer

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