Back to resultsColorectal Cancer Prehabilitation in Changi General Hospital
Primary Purpose
Colorectal Cancer
Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Colorectal Cancer Prehabilitation Programme
Sponsored by
About this trial
This is an interventional supportive care trial for Colorectal Cancer focused on measuring Colorectal, Cancer Prehabilitation, Novel, Model of Care
Eligibility Criteria
Inclusion Criteria:
1. All newly diagnosed colorectal cancer patients planned for surgery in Changi General Hospital, Singapore
Exclusion Criteria:
1. Patients' refusal to participate
Sites / Locations
- Changi General Hospital
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Colorectal Cancer Prehabilitation Program
Arm Description
This is a before-after trial. The same group of participants will have a series of outcome measures taken at baseline, which will then be compared to these same outcome measures when repeated after undergoing prehabilitation and at 3 months' post-operatively
Outcomes
Primary Outcome Measures
6-minute-walk-test
Distance walked in 6 minutes under standardised conditions
6-minute-walk-test
Distance walked in 6 minutes under standardised conditions
6-minute-walk-test
Distance walked in 6 minutes under standardised conditions
Secondary Outcome Measures
30-second-sit-to-stand-test
Number of repetitions of sit-to-stand within 30 seconds
30-second-sit-to-stand-test
Number of repetitions of sit-to-stand within 30 seconds
30-second-sit-to-stand-test
Number of repetitions of sit-to-stand within 30 seconds
Hospital Anxiety and Depression Scale
Divided into Anxiety (0-21 points) and Depression scale (0-21 points), the higher the worser
Hospital Anxiety and Depression Scale
Divided into Anxiety (0-21 points) and Depression scale (0-21 points), the higher the worser
Hospital Anxiety and Depression Scale
Divided into Anxiety (0-21 points) and Depression scale (0-21 points), the higher the worser
EuroQol- 5 Dimension
Health Score (visual analogue scale from 0-100), the higher the better
EuroQol- 5 Dimension
Health Score (visual analogue scale from 0-100), the higher the better
Post-Operative Hospital Length of Stay
Post-Operative Hospital Length of Stay
30-Day Post-Operative Major Complications
30-Day Post-Operative Major Complications
30-Day Post-Operative Readmission Rates
30-Day Post-Operative Readmission Rates
30-Day Post-Operative Mortality
30-Day Post-Operative Mortality
Patient Satisfaction Survey
Patient Satisfaction Survey
Patient Satisfaction Survey
Patient Satisfaction Survey
Full Information
NCT ID
NCT05169528
First Posted
November 30, 2021
Last Updated
December 13, 2021
Sponsor
Changi General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05169528
Brief Title
Colorectal Cancer Prehabilitation in Changi General Hospital
Official Title
Colorectal Cancer Prehabilitation in Changi General Hospital
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changi General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Cancer prehabilitation typically involves multiple pre-op visits. The investigators aim to assess the impact of their novel model, a "one-stop "service by a small, "levelled-up" core team on newly diagnosed colorectal cancer patients planned for surgery.
Detailed Description
Objective Cancer prehabilitation typically involves multiple pre-op visits. The investigators aim to assess the impact of their novel model, a "one-stop "service by a small, "levelled-up" core team on newly diagnosed colorectal cancer patients planned for surgery.
Design This is a before-after trial in a tertiary public hospital in Singapore, involving all newly diagnosed colorectal cancer patients planned for surgery who are referred to the Cancer Prehabilitation Program. The primary outcome measure is the 6-minute-walk-test. Others include physical, psychological, quality-of-life and post-operative measures, and patient-satisfaction-surveys, taken at baseline, pre-operatively (post-prehabilitation), and 3-months-post-operatively.
Keywords: Colorectal; Cancer Prehabilitation; Novel; Model of Care
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
Colorectal, Cancer Prehabilitation, Novel, Model of Care
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
before-after trial
Masking
None (Open Label)
Allocation
N/A
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Colorectal Cancer Prehabilitation Program
Arm Type
Other
Arm Description
This is a before-after trial. The same group of participants will have a series of outcome measures taken at baseline, which will then be compared to these same outcome measures when repeated after undergoing prehabilitation and at 3 months' post-operatively
Intervention Type
Other
Intervention Name(s)
Colorectal Cancer Prehabilitation Programme
Intervention Description
Assessment and Interventions involving the Prehabilitative domains of medical optimisation, exercise prescription, nutrition and mental health optimisation
Primary Outcome Measure Information:
Title
6-minute-walk-test
Description
Distance walked in 6 minutes under standardised conditions
Time Frame
Baseline
Title
6-minute-walk-test
Description
Distance walked in 6 minutes under standardised conditions
Time Frame
Pre-Operatively (after prehabilitation)
Title
6-minute-walk-test
Description
Distance walked in 6 minutes under standardised conditions
Time Frame
Post-Operatively (3 months)
Secondary Outcome Measure Information:
Title
30-second-sit-to-stand-test
Description
Number of repetitions of sit-to-stand within 30 seconds
Time Frame
Baseline
Title
30-second-sit-to-stand-test
Description
Number of repetitions of sit-to-stand within 30 seconds
Time Frame
Pre-Operatively (after prehabilitation)
Title
30-second-sit-to-stand-test
Description
Number of repetitions of sit-to-stand within 30 seconds
Time Frame
Post-Operatively (3 months)
Title
Hospital Anxiety and Depression Scale
Description
Divided into Anxiety (0-21 points) and Depression scale (0-21 points), the higher the worser
Time Frame
Baseline
Title
Hospital Anxiety and Depression Scale
Description
Divided into Anxiety (0-21 points) and Depression scale (0-21 points), the higher the worser
Time Frame
Pre-Operatively (after prehabilitation)
Title
Hospital Anxiety and Depression Scale
Description
Divided into Anxiety (0-21 points) and Depression scale (0-21 points), the higher the worser
Time Frame
Post-Operatively (3 months)
Title
EuroQol- 5 Dimension
Description
Health Score (visual analogue scale from 0-100), the higher the better
Time Frame
Baseline
Title
EuroQol- 5 Dimension
Description
Health Score (visual analogue scale from 0-100), the higher the better
Time Frame
Post-Operatively (3 months)
Title
Post-Operative Hospital Length of Stay
Description
Post-Operative Hospital Length of Stay
Time Frame
From Date of Admission for Surgery till Date of Discharge, assessed up to 100 weeks
Title
30-Day Post-Operative Major Complications
Description
30-Day Post-Operative Major Complications
Time Frame
From Surgery till 30 Days Post-op
Title
30-Day Post-Operative Readmission Rates
Description
30-Day Post-Operative Readmission Rates
Time Frame
From Surgery till 30 Days Post-op
Title
30-Day Post-Operative Mortality
Description
30-Day Post-Operative Mortality
Time Frame
From Surgery till 30 Days Post-op
Title
Patient Satisfaction Survey
Description
Patient Satisfaction Survey
Time Frame
Pre-Operatively (after prehabilitation)
Title
Patient Satisfaction Survey
Description
Patient Satisfaction Survey
Time Frame
Post-Operatively (3 months)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1. All newly diagnosed colorectal cancer patients planned for surgery in Changi General Hospital, Singapore
Exclusion Criteria:
1. Patients' refusal to participate
Facility Information:
Facility Name
Changi General Hospital
City
Singapore
ZIP/Postal Code
529889
Country
Singapore
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Colorectal Cancer Prehabilitation in Changi General Hospital
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