Colorectal Cancer Prehabilitation in Changi General Hospital

December 13, 2021 updated by: Kwok Kah Meng, Changi General Hospital
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.

Study Overview

Status

Completed

Conditions

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

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Singapore, Singapore, 529889
        • Changi General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Assessment and Interventions involving the Prehabilitative domains of medical optimisation, exercise prescription, nutrition and mental health optimisation

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
Baseline
6-minute-walk-test
Time Frame: Pre-Operatively (after prehabilitation)
Distance walked in 6 minutes under standardised conditions
Pre-Operatively (after prehabilitation)
6-minute-walk-test
Time Frame: Post-Operatively (3 months)
Distance walked in 6 minutes under standardised conditions
Post-Operatively (3 months)

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
Baseline
30-second-sit-to-stand-test
Time Frame: Pre-Operatively (after prehabilitation)
Number of repetitions of sit-to-stand within 30 seconds
Pre-Operatively (after prehabilitation)
30-second-sit-to-stand-test
Time Frame: Post-Operatively (3 months)
Number of repetitions of sit-to-stand within 30 seconds
Post-Operatively (3 months)
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)
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)
EuroQol- 5 Dimension
Time Frame: Baseline
Health Score (visual analogue scale from 0-100), the higher the better
Baseline
EuroQol- 5 Dimension
Time Frame: Post-Operatively (3 months)
Health Score (visual analogue scale from 0-100), the higher the better
Post-Operatively (3 months)
Post-Operative Hospital Length of Stay
Time Frame: From Date of Admission for Surgery till Date of Discharge, assessed up to 100 weeks
Post-Operative Hospital Length of Stay
From Date of Admission for Surgery till Date of Discharge, assessed up to 100 weeks
30-Day Post-Operative Major Complications
Time Frame: From Surgery till 30 Days Post-op
30-Day Post-Operative Major Complications
From Surgery till 30 Days Post-op
30-Day Post-Operative Readmission Rates
Time Frame: From Surgery till 30 Days Post-op
30-Day Post-Operative Readmission Rates
From Surgery till 30 Days Post-op
30-Day Post-Operative Mortality
Time Frame: From Surgery till 30 Days Post-op
30-Day Post-Operative Mortality
From Surgery till 30 Days Post-op
Patient Satisfaction Survey
Time Frame: Pre-Operatively (after prehabilitation)
Patient Satisfaction Survey
Pre-Operatively (after prehabilitation)
Patient Satisfaction Survey
Time Frame: Post-Operatively (3 months)
Patient Satisfaction Survey
Post-Operatively (3 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2020

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

November 30, 2021

First Submitted That Met QC Criteria

December 13, 2021

First Posted (Actual)

December 27, 2021

Study Record Updates

Last Update Posted (Actual)

December 27, 2021

Last Update Submitted That Met QC Criteria

December 13, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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