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Multimodal Prehabilitation for Colorectal Surgery

Primary Purpose

Colorectal Cancer, Colorectal Cancer Stage III

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
multimodal prehabilitation
multimodal prehabilitation
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 treatment trial for Colorectal Cancer focused on measuring colorectal cancer, colorectal surgery, prehabilitation, surgical recovery, exercise, referred for scheduled resection

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • referred for scheduled surgery for nonmetastasized colorectal cancer
  • age > 18 years old

Exclusion Criteria:

  • asa 4-5
  • Poor English or French comprehension
  • severe co-morbid disease interfering with ability to perform exercise at home or complete testing

Sites / Locations

  • McGill University Health Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

multimodal prehabilitation begun preop

Multimodal prehabilitation begun postop

Arm Description

The prehabilitation program will begin several weeks preop and continue in the postoperative period

The prehabilitation program will begin after the surgery.

Outcomes

Primary Outcome Measures

six minute walk test
6 MWT is a patient-relevant measure of functional walking capacity, reflective of the activities of daily living. Subjects are instructed to walk back and forth, in a 20 m stretch of hallway, for six minutes, at a pace that would make them tired by the end of the walk. The distance in meters is recorded. Reference equations are available for calculating percent of age- and gender-specific norms.

Secondary Outcome Measures

Health-related quality of life
The SF-36 is the most widely used HRQL measure and has been validated for surgical population; Canadian norms are also available. It incorporates behavioural functioning, subjective well-being and perceptions of health by assessing, on a 0 to 100 scale, eight health concepts.
physical activity level
Physical activity level will be measured through the Community Health Activities Model Program for Seniors (CHAMPS) questionnaire. CHAMPS is a self-reported measure of physical activity, comprising 41 activities evaluated according to the total number of hours done during an average week. Each physical activity is assigned a MET (metabolic equivalent) value yielding average weekly caloric expenditure for the listed physical activities
Depression and anxiety
Depression and anxiety will be assessed by The Hospital Anxiety and Depression Scale (HADS), a 14-question measure with seven items each for depression and anxiety. HADS generates separate scores for anxiety and depression as well as a combined score of psychological distress.
nutritional status
Nutritional status will be assessed at baseline by measuring body mass index (BMI), body weight loss over the preceding three months (> 10% ), and/or serum albumin < 35 g -1 will define poor nutritional status.
postoperative complications
Classified by Clavien Scale
Fatigue
Fatugue Index

Full Information

First Posted
May 17, 2011
Last Updated
September 26, 2015
Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Collaborators
Society of American Gastrointestinal and Endoscopic Surgeons, Immunotec Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01356264
Brief Title
Multimodal Prehabilitation for Colorectal Surgery
Official Title
Multimodal Prehabilitation to Enhance Functional Recovery After Colorectal Surgery: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
July 2011 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
December 2013 (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
Society of American Gastrointestinal and Endoscopic Surgeons, Immunotec Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Despite advances in surgical care, the incidence of postoperative complications and prolonged recovery following colorectal surgery remains high. Efforts to improve the recovery process have primarily focused on the intraoperative (eg, minimally invasive surgery, afferent neural blockade) and post-operative periods (eg, "fast track" early nutrition and mobilization. The pre-operative period may in fact be a better time to intervene in the factors that contribute to recovery. The process of enhancing functional capacity of the individual in anticipation of an upcoming stressor has been termed "prehabilitation". Based on the notion that preoperative exercise would have an impact on recovery of functional capacity after colorectal surgery, our group recently conducted a randomized controlled trial. Subgroup analysis identified that patients whose functional exercise capacity improved preoperatively, regardless of exercise technique, recovered well in the postoperative period. However, one-third of patients deteriorated preoperatively despite the exercise regimen, and these patients were also at greater risk for prolonged recovery after surgery. These results suggested that exercise alone is not sufficient to attenuate the stress response in all patients. In the present trial, the impact of a multimodal prehabilitation intervention composed of exercise, nutritional supplement and psychological well-being begun in the preoperative period will be compared to one begun in the postoperative period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer, Colorectal Cancer Stage III
Keywords
colorectal cancer, colorectal surgery, prehabilitation, surgical recovery, exercise, referred for scheduled resection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
89 (Actual)

8. Arms, Groups, and Interventions

Arm Title
multimodal prehabilitation begun preop
Arm Type
Experimental
Arm Description
The prehabilitation program will begin several weeks preop and continue in the postoperative period
Arm Title
Multimodal prehabilitation begun postop
Arm Type
Active Comparator
Arm Description
The prehabilitation program will begin after the surgery.
Intervention Type
Behavioral
Intervention Name(s)
multimodal prehabilitation
Intervention Description
multimodal prehabilitation program based on exercise, supplemental nutrition and psychological support starting 3-5 weeks before surgery and continuing postoperative for up to 8 weeks
Intervention Type
Behavioral
Intervention Name(s)
multimodal prehabilitation
Intervention Description
multimodal prehabilitation program based on exercise, supplemental nutrition and psychological support beginning postoperative and continuing for up to 8 weeks
Primary Outcome Measure Information:
Title
six minute walk test
Description
6 MWT is a patient-relevant measure of functional walking capacity, reflective of the activities of daily living. Subjects are instructed to walk back and forth, in a 20 m stretch of hallway, for six minutes, at a pace that would make them tired by the end of the walk. The distance in meters is recorded. Reference equations are available for calculating percent of age- and gender-specific norms.
Time Frame
baseline, preop, 4 weeks, 8weeks postop
Secondary Outcome Measure Information:
Title
Health-related quality of life
Description
The SF-36 is the most widely used HRQL measure and has been validated for surgical population; Canadian norms are also available. It incorporates behavioural functioning, subjective well-being and perceptions of health by assessing, on a 0 to 100 scale, eight health concepts.
Time Frame
baseline, preop, 4 weeks, 8 weeks
Title
physical activity level
Description
Physical activity level will be measured through the Community Health Activities Model Program for Seniors (CHAMPS) questionnaire. CHAMPS is a self-reported measure of physical activity, comprising 41 activities evaluated according to the total number of hours done during an average week. Each physical activity is assigned a MET (metabolic equivalent) value yielding average weekly caloric expenditure for the listed physical activities
Time Frame
baseline, preop, 4 weeks, 8 weeks
Title
Depression and anxiety
Description
Depression and anxiety will be assessed by The Hospital Anxiety and Depression Scale (HADS), a 14-question measure with seven items each for depression and anxiety. HADS generates separate scores for anxiety and depression as well as a combined score of psychological distress.
Time Frame
baseline, preop, 4 weeks, 8 weeks
Title
nutritional status
Description
Nutritional status will be assessed at baseline by measuring body mass index (BMI), body weight loss over the preceding three months (> 10% ), and/or serum albumin < 35 g -1 will define poor nutritional status.
Time Frame
baseline, preop, 4 weeks, 8 weeks
Title
postoperative complications
Description
Classified by Clavien Scale
Time Frame
4 weeks
Title
Fatigue
Description
Fatugue Index
Time Frame
baseline, preop, 4 wks, 8 wks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: referred for scheduled surgery for nonmetastasized colorectal cancer age > 18 years old Exclusion Criteria: asa 4-5 Poor English or French comprehension severe co-morbid disease interfering with ability to perform exercise at home or complete testing
Facility Information:
Facility Name
McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G1A4
Country
Canada

12. IPD Sharing Statement

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
30025745
Citation
Gillis C, Fenton TR, Sajobi TT, Minnella EM, Awasthi R, Loiselle SE, Liberman AS, Stein B, Charlebois P, Carli F. Trimodal prehabilitation for colorectal surgery attenuates post-surgical losses in lean body mass: A pooled analysis of randomized controlled trials. Clin Nutr. 2019 Jun;38(3):1053-1060. doi: 10.1016/j.clnu.2018.06.982. Epub 2018 Jul 9.
Results Reference
derived
PubMed Identifier
23052535
Citation
Li C, Carli F, Lee L, Charlebois P, Stein B, Liberman AS, Kaneva P, Augustin B, Wongyingsinn M, Gamsa A, Kim DJ, Vassiliou MC, Feldman LS. Impact of a trimodal prehabilitation program on functional recovery after colorectal cancer surgery: a pilot study. Surg Endosc. 2013 Apr;27(4):1072-82. doi: 10.1007/s00464-012-2560-5. Epub 2012 Oct 9.
Results Reference
derived

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Multimodal Prehabilitation for Colorectal Surgery

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