- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05169528
Colorectal Cancer Prehabilitation in Changi General Hospital
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Singapore, Singapore, 529889
- Changi General Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
1. All newly diagnosed colorectal cancer patients planned for surgery in Changi General Hospital, Singapore
Exclusion Criteria:
1. Patients' refusal to participate
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Colorectal Cancer Prehabilitation Program
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
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Assessment and Interventions involving the Prehabilitative domains of medical optimisation, exercise prescription, nutrition and mental health optimisation
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
6-minute-walk-test
Time Frame: Baseline
|
Distance walked in 6 minutes under standardised conditions
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Baseline
|
|
6-minute-walk-test
Time Frame: Pre-Operatively (after prehabilitation)
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Distance walked in 6 minutes under standardised conditions
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Pre-Operatively (after prehabilitation)
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6-minute-walk-test
Time Frame: Post-Operatively (3 months)
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Distance walked in 6 minutes under standardised conditions
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Post-Operatively (3 months)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
30-second-sit-to-stand-test
Time Frame: Baseline
|
Number of repetitions of sit-to-stand within 30 seconds
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Baseline
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30-second-sit-to-stand-test
Time Frame: Pre-Operatively (after prehabilitation)
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Number of repetitions of sit-to-stand within 30 seconds
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Pre-Operatively (after prehabilitation)
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30-second-sit-to-stand-test
Time Frame: Post-Operatively (3 months)
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Number of repetitions of sit-to-stand within 30 seconds
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Post-Operatively (3 months)
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|
Hospital Anxiety and Depression Scale
Time Frame: Baseline
|
Divided into Anxiety (0-21 points) and Depression scale (0-21 points), the higher the worser
|
Baseline
|
|
Hospital Anxiety and Depression Scale
Time Frame: Pre-Operatively (after prehabilitation)
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Divided into Anxiety (0-21 points) and Depression scale (0-21 points), the higher the worser
|
Pre-Operatively (after prehabilitation)
|
|
Hospital Anxiety and Depression Scale
Time Frame: Post-Operatively (3 months)
|
Divided into Anxiety (0-21 points) and Depression scale (0-21 points), the higher the worser
|
Post-Operatively (3 months)
|
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EuroQol- 5 Dimension
Time Frame: Baseline
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Health Score (visual analogue scale from 0-100), the higher the better
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Baseline
|
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EuroQol- 5 Dimension
Time Frame: Post-Operatively (3 months)
|
Health Score (visual analogue scale from 0-100), the higher the better
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Post-Operatively (3 months)
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Post-Operative Hospital Length of Stay
Time Frame: From Date of Admission for Surgery till Date of Discharge, assessed up to 100 weeks
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Post-Operative Hospital Length of Stay
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From Date of Admission for Surgery till Date of Discharge, assessed up to 100 weeks
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|
30-Day Post-Operative Major Complications
Time Frame: From Surgery till 30 Days Post-op
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30-Day Post-Operative Major Complications
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From Surgery till 30 Days Post-op
|
|
30-Day Post-Operative Readmission Rates
Time Frame: From Surgery till 30 Days Post-op
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30-Day Post-Operative Readmission Rates
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From Surgery till 30 Days Post-op
|
|
30-Day Post-Operative Mortality
Time Frame: From Surgery till 30 Days Post-op
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30-Day Post-Operative Mortality
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From Surgery till 30 Days Post-op
|
|
Patient Satisfaction Survey
Time Frame: Pre-Operatively (after prehabilitation)
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Patient Satisfaction Survey
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Pre-Operatively (after prehabilitation)
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Patient Satisfaction Survey
Time Frame: Post-Operatively (3 months)
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Patient Satisfaction Survey
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Post-Operatively (3 months)
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIRB Ref No.:2020/2063
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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