NCT05169528

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable colorectal-cancer

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2020

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2021

Completed
27 days until next milestone

First Posted

Study publicly available on registry

December 27, 2021

Completed
Last Updated

December 27, 2021

Status Verified

December 1, 2021

Enrollment Period

1.5 years

First QC Date

November 30, 2021

Last Update Submit

December 13, 2021

Conditions

Keywords

ColorectalCancer PrehabilitationNovelModel of Care

Outcome Measures

Primary Outcomes (3)

  • 6-minute-walk-test

    Distance walked in 6 minutes under standardised conditions

    Baseline

  • 6-minute-walk-test

    Distance walked in 6 minutes under standardised conditions

    Pre-Operatively (after prehabilitation)

  • 6-minute-walk-test

    Distance walked in 6 minutes under standardised conditions

    Post-Operatively (3 months)

Secondary Outcomes (14)

  • 30-second-sit-to-stand-test

    Baseline

  • 30-second-sit-to-stand-test

    Pre-Operatively (after prehabilitation)

  • 30-second-sit-to-stand-test

    Post-Operatively (3 months)

  • Hospital Anxiety and Depression Scale

    Baseline

  • Hospital Anxiety and Depression Scale

    Pre-Operatively (after prehabilitation)

  • +9 more secondary outcomes

Study Arms (1)

Colorectal Cancer Prehabilitation Program

OTHER

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

Other: Colorectal Cancer Prehabilitation Programme

Interventions

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

Colorectal Cancer Prehabilitation Program

Eligibility Criteria

Age21 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • \. Patients' refusal to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changi General Hospital

Singapore, 529889, Singapore

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: before-after trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant

Study Record Dates

First Submitted

November 30, 2021

First Posted

December 27, 2021

Study Start

January 1, 2020

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

December 27, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations