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Prehabilitation in Elective Colorectal Resection: A Pilot Study (Prehab) (Prehab)

Primary Purpose

Colorectal Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Physiatry Assessment
Routine Care
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colorectal Cancer focused on measuring prehabilitation, colorectal surgery

Eligibility Criteria

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

Inclusion Criteria:

  • adult patient
  • scheduled to undergo a colorectal resection as part of treatment for colorectal cancer.
  • English speaking or have available a family member or substitute decision maker who can accompany you to all of your study visits.

Exclusion Criteria:

  • geographic inaccessibility
  • unwilling to provide consent

Sites / Locations

  • St Joseph Healthcare HamiltonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Physiatry

Routine Care

Arm Description

Pre-operative Physiatry assessment and intervention

Patients will receive routine pre-operative care, this study arm does not have an intervention.

Outcomes

Primary Outcome Measures

Number of participants recruiting
Screening and recruiting of eligible patients

Secondary Outcome Measures

Post-op complications
Post-op complications by Clavien-Dindo classification (pulmonary, DVT, MI) Completed by surgical team during admission, discharge and 30 days
Mortality
Survival will be noted at completion of 6 month study period.
Length of Stay
Length of stay in hospital will be collected and compared for the two treatment groups
Number of patients with readmissions
Number of patients with readmission to hospital during the 30 day and 6 month period will be compared for the two treatment groups
Physical Function Assessment (6 Minute Walk Test)
6 Minute Walk Test (6MWT)
Symptom Assessment (Edmonton Symptom Assessment System)
Edmonton Symptom Assessment System (ESAS)
Functional Independence Assessment (UK Functional Independence Measure and Functional Assessment Measure)
UK Functional Independence Measure and Functional Assessment Measure (UK FIM+FAM)
Quality of Life Survey (Short Form 36 Health Survey)
Short Form 36 Health Survey (SF-36)
Pain Assessment (Visual Analog Scale)
Pain score by Visual Analog Scale
Bowel Function Assessment
Bowel Function Index

Full Information

First Posted
August 19, 2015
Last Updated
November 22, 2016
Sponsor
McMaster University
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1. Study Identification

Unique Protocol Identification Number
NCT02531620
Brief Title
Prehabilitation in Elective Colorectal Resection: A Pilot Study (Prehab)
Acronym
Prehab
Official Title
Prehabilitation Interventions in Elective Colorectal Resections: A Randomized Pilot Study (Prehab)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
September 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a pilot study designed to evaluate a programme of rehabilitation for patients undergoing elective colorectal resection surgery.
Detailed Description
Operations on the colon and rectum are major abdominal operations and many individuals can become severely deconditioned or weakened afterwards. For some individuals this can even mean that they can no longer completely return to their usual way of life following one of these major operations. As part of this study the investigators are attempting to identify ways to maximize patients' recovery and to maximize their overall quality of life following these major operations. It is possible that preconditioning may make a difference to patient's overall quality of life, decreased or need for hospital length of stay and decreased postoperative medical complications occasionally seen during these operations, in essence provide an overall enhancement to their surgical recovery. Physiatrists are physicians who are medical experts in maximizing a patient's overall ability to function well and live independently. Investigators are proposing patient participation in an initial pilot study in order to test the question as to whether or not participation with a physiatrist and any interventions recommended by said physician would help improve a patient's postoperative recovery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
prehabilitation, colorectal surgery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physiatry
Arm Type
Experimental
Arm Description
Pre-operative Physiatry assessment and intervention
Arm Title
Routine Care
Arm Type
Other
Arm Description
Patients will receive routine pre-operative care, this study arm does not have an intervention.
Intervention Type
Other
Intervention Name(s)
Physiatry Assessment
Intervention Description
Physiatrists are physicians who are medical experts in maximizing a patient's overall ability to function well and live independently. The Investigators are proposing your participation in an initial pilot study in order to test the question as to whether or not participation with a physiatrist and any interventions recommended by said physician would help improve a patient's postoperative recovery.
Intervention Type
Other
Intervention Name(s)
Routine Care
Other Intervention Name(s)
Standard Care
Intervention Description
Usual care for your disease process
Primary Outcome Measure Information:
Title
Number of participants recruiting
Description
Screening and recruiting of eligible patients
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Post-op complications
Description
Post-op complications by Clavien-Dindo classification (pulmonary, DVT, MI) Completed by surgical team during admission, discharge and 30 days
Time Frame
30 days
Title
Mortality
Description
Survival will be noted at completion of 6 month study period.
Time Frame
6 months
Title
Length of Stay
Description
Length of stay in hospital will be collected and compared for the two treatment groups
Time Frame
30 days post-op
Title
Number of patients with readmissions
Description
Number of patients with readmission to hospital during the 30 day and 6 month period will be compared for the two treatment groups
Time Frame
30 days and 6 months
Title
Physical Function Assessment (6 Minute Walk Test)
Description
6 Minute Walk Test (6MWT)
Time Frame
1, 3 and 6 months
Title
Symptom Assessment (Edmonton Symptom Assessment System)
Description
Edmonton Symptom Assessment System (ESAS)
Time Frame
1, 3 and 6 months
Title
Functional Independence Assessment (UK Functional Independence Measure and Functional Assessment Measure)
Description
UK Functional Independence Measure and Functional Assessment Measure (UK FIM+FAM)
Time Frame
1, 3 and 6 months
Title
Quality of Life Survey (Short Form 36 Health Survey)
Description
Short Form 36 Health Survey (SF-36)
Time Frame
1, 3 and 6 months
Title
Pain Assessment (Visual Analog Scale)
Description
Pain score by Visual Analog Scale
Time Frame
1, 3 and 6 months
Title
Bowel Function Assessment
Description
Bowel Function Index
Time Frame
1, 3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult patient scheduled to undergo a colorectal resection as part of treatment for colorectal cancer. English speaking or have available a family member or substitute decision maker who can accompany you to all of your study visits. Exclusion Criteria: geographic inaccessibility unwilling to provide consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nalin Amin, MD
Phone
905 522-1155
Ext
32938
Email
amin@mcmaster.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Susan Haley, BSc MSc
Phone
905 521-2100
Ext
32575
Email
haleys@mcmaster.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nalin Amin, MD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Joseph Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nalin Amin, MD
Phone
905.522.1155
Ext
37320

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28600373
Citation
Wong SG, Maida E, Harvey D, Wagner N, Sonnadara R, Amin N. Evaluation of a physiatrist-directed prehabilitation intervention in frail patients with colorectal cancer: a randomised pilot study protocol. BMJ Open. 2017 Jun 9;7(6):e015565. doi: 10.1136/bmjopen-2016-015565.
Results Reference
derived

Learn more about this trial

Prehabilitation in Elective Colorectal Resection: A Pilot Study (Prehab)

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