Colorectal Cancer Prehabilitation in Changi General Hospital

Colorectal Cancer Clinical Trial

Official title:

Colorectal Cancer Prehabilitation in Changi General Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05169528
• Other study ID #: CIRB Ref No.:2020/2063
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: December 2021
• Source: Changi General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 99 Years

Eligibility

Inclusion Criteria:

1. All newly diagnosed colorectal cancer patients planned for surgery in Changi General Hospital, Singapore

Exclusion Criteria:

1. Patients' refusal to participate

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Other:
• Colorectal Cancer Prehabilitation Programme
Assessment and Interventions involving the Prehabilitative domains of medical optimisation, exercise prescription, nutrition and mental health optimisation

Locations

Country	Name	City	State
Singapore	Changi General Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Changi General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-minute-walk-test	Distance walked in 6 minutes under standardised conditions	Baseline
Primary	6-minute-walk-test	Distance walked in 6 minutes under standardised conditions	Pre-Operatively (after prehabilitation)
Primary	6-minute-walk-test	Distance walked in 6 minutes under standardised conditions	Post-Operatively (3 months)
Secondary	30-second-sit-to-stand-test	Number of repetitions of sit-to-stand within 30 seconds	Baseline
Secondary	30-second-sit-to-stand-test	Number of repetitions of sit-to-stand within 30 seconds	Pre-Operatively (after prehabilitation)
Secondary	30-second-sit-to-stand-test	Number of repetitions of sit-to-stand within 30 seconds	Post-Operatively (3 months)
Secondary	Hospital Anxiety and Depression Scale	Divided into Anxiety (0-21 points) and Depression scale (0-21 points), the higher the worser	Baseline
Secondary	Hospital Anxiety and Depression Scale	Divided into Anxiety (0-21 points) and Depression scale (0-21 points), the higher the worser	Pre-Operatively (after prehabilitation)
Secondary	Hospital Anxiety and Depression Scale	Divided into Anxiety (0-21 points) and Depression scale (0-21 points), the higher the worser	Post-Operatively (3 months)
Secondary	EuroQol- 5 Dimension	Health Score (visual analogue scale from 0-100), the higher the better	Baseline
Secondary	EuroQol- 5 Dimension	Health Score (visual analogue scale from 0-100), the higher the better	Post-Operatively (3 months)
Secondary	Post-Operative Hospital Length of Stay	Post-Operative Hospital Length of Stay	From Date of Admission for Surgery till Date of Discharge, assessed up to 100 weeks
Secondary	30-Day Post-Operative Major Complications	30-Day Post-Operative Major Complications	From Surgery till 30 Days Post-op
Secondary	30-Day Post-Operative Readmission Rates	30-Day Post-Operative Readmission Rates	From Surgery till 30 Days Post-op
Secondary	30-Day Post-Operative Mortality	30-Day Post-Operative Mortality	From Surgery till 30 Days Post-op
Secondary	Patient Satisfaction Survey	Patient Satisfaction Survey	Pre-Operatively (after prehabilitation)
Secondary	Patient Satisfaction Survey	Patient Satisfaction Survey	Post-Operatively (3 months)