Colorectal CancerNCT05169528
Colorectal Cancer Prehabilitation in Changi General Hospital
A study testing Colorectal Cancer Prehabilitation Programme in people with Colorectal Cancer, run by Changi General Hospital at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Colorectal Cancer Prehabilitation Programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Jan 2020to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. All newly diagnosed colorectal cancer patients planned for surgery in Changi General Hospital, Singapore
Who cannot join
- 1. Patients' refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Conditions
- Colorectal Cancer
- Being tested
- Colorectal Cancer Prehabilitation Programme
- Keywords
- Colorectal, Cancer Prehabilitation, Novel, Model of Care
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colorectal Cancer Prehabilitation ProgrammeOther
Assessment and Interventions involving the Prehabilitative domains of medical optimisation, exercise prescription, nutrition and mental health optimisation
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Colorectal Cancer Prehabilitation Programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute-walk-test
Distance walked in 6 minutes under standardised conditions
Measured: Baseline
6-minute-walk-test
Distance walked in 6 minutes under standardised conditions
Measured: Pre-Operatively (after prehabilitation)
6-minute-walk-test
Distance walked in 6 minutes under standardised conditions
Measured: Post-Operatively (3 months)
Secondary outcomes (14)
30-second-sit-to-stand-test
Number of repetitions of sit-to-stand within 30 seconds
Measured: Baseline
30-second-sit-to-stand-test
Number of repetitions of sit-to-stand within 30 seconds
Measured: Pre-Operatively (after prehabilitation)
30-second-sit-to-stand-test
Number of repetitions of sit-to-stand within 30 seconds
Measured: Post-Operatively (3 months)
Hospital Anxiety and Depression Scale
Divided into Anxiety (0-21 points) and Depression scale (0-21 points), the higher the worser
Measured: Baseline
Hospital Anxiety and Depression Scale
Divided into Anxiety (0-21 points) and Depression scale (0-21 points), the higher the worser
Measured: Pre-Operatively (after prehabilitation)
Hospital Anxiety and Depression Scale
Divided into Anxiety (0-21 points) and Depression scale (0-21 points), the higher the worser
Measured: Post-Operatively (3 months)
EuroQol- 5 Dimension
Health Score (visual analogue scale from 0-100), the higher the better
Measured: Baseline
EuroQol- 5 Dimension
Health Score (visual analogue scale from 0-100), the higher the better
Measured: Post-Operatively (3 months)
Post-Operative Hospital Length of Stay
Post-Operative Hospital Length of Stay
Measured: From Date of Admission for Surgery till Date of Discharge, assessed up to 100 weeks
30-Day Post-Operative Major Complications
30-Day Post-Operative Major Complications
Measured: From Surgery till 30 Days Post-op
30-Day Post-Operative Readmission Rates
30-Day Post-Operative Readmission Rates
Measured: From Surgery till 30 Days Post-op
30-Day Post-Operative Mortality
30-Day Post-Operative Mortality
Measured: From Surgery till 30 Days Post-op
Patient Satisfaction Survey
Patient Satisfaction Survey
Measured: Pre-Operatively (after prehabilitation)
Patient Satisfaction Survey
Patient Satisfaction Survey
Measured: Post-Operatively (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2021
- Study start1 Jan 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- before-after trial
- Masking
- None (open label)
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kwok Kah Meng, Changi General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05169528
- Sponsor's protocol ID
- CIRB Ref No.:2020/2063
- Status last verified
- Dec 2021
- First submitted
- 30 Nov 2021
- Last updated
- 27 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colorectal Cancer Prehabilitation in Changi General Hospital
- ClinicalTrials.gov ID
- NCT05169528
- Acronym / sponsor ID
- CIRB Ref No.:2020/2063
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal, Cancer Prehabilitation, Novel, Model of Care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 27 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- before-after trial
| Arm | Type | Receives |
|---|---|---|
| Colorectal Cancer Prehabilitation Program | Other | Other: Colorectal Cancer Prehabilitation ProgrammeThis 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 |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. All newly diagnosed colorectal cancer patients planned for surgery in Changi General Hospital, Singapore
Key exclusion criteria (1 listed)
- 1. Patients' refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colorectal Cancer Prehabilitation ProgrammeAssessment and Interventions involving the Prehabilitative domains of medical optimisation, exercise prescription, nutrition and mental health optimisation | Other | Colorectal Cancer Prehabilitation Program |
Primary outcome
6-minute-walk-test
Time frame: Baseline
Distance walked in 6 minutes under standardised conditions
6-minute-walk-test
Time frame: Pre-Operatively (after prehabilitation)
Distance walked in 6 minutes under standardised conditions
6-minute-walk-test
Time frame: Post-Operatively (3 months)
Distance walked in 6 minutes under standardised conditions
14 secondary outcomes
30-second-sit-to-stand-test
Time frame: Baseline
30-second-sit-to-stand-test
Time frame: Pre-Operatively (after prehabilitation)
30-second-sit-to-stand-test
Time frame: Post-Operatively (3 months)
Hospital Anxiety and Depression Scale
Time frame: Baseline
Hospital Anxiety and Depression Scale
Time frame: Pre-Operatively (after prehabilitation)
Hospital Anxiety and Depression Scale
Time frame: Post-Operatively (3 months)
EuroQol- 5 Dimension
Time frame: Baseline
EuroQol- 5 Dimension
Time frame: 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
30-Day Post-Operative Major Complications
Time frame: 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 Mortality
Time frame: From Surgery till 30 Days Post-op
Patient Satisfaction Survey
Time frame: Pre-Operatively (after prehabilitation)
Patient Satisfaction Survey
Time frame: Post-Operatively (3 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Colorectal Cancer Prehabilitation Programme in people with Colorectal Cancer, run by Changi General Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute-walk-test (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Dec 2021.