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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05169528
Other study ID # CIRB Ref No.:2020/2063
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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)
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