Colorectal CancerPrehabNCT02531620
Prehabilitation in Elective Colorectal Resection: A Pilot Study (Prehab)
A study testing Physiatry Assessment and Routine Care in people with Colorectal Cancer, run by McMaster University at 1 site in Canada.
Trial summary
This is a pilot study designed to evaluate a programme of rehabilitation for patients undergoing elective colorectal resection surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Physiatry Assessment and Routine Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2015to Sep 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adult patient
- scheduled to undergo a colorectal resection as part of treatment for colorectal cancer.
- English speaking or have available a family member or substitute decision maker who can accompany you to all of your study visits.
Who cannot join
- geographic inaccessibility
- unwilling to provide consent
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
St Joseph Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
Nalin Amin, MD, 905.522.1155 ext. 37320
About this study
Official title: Prehabilitation Interventions in Elective Colorectal Resections: A Randomized Pilot Study (Prehab)
This is a pilot study designed to evaluate a programme of rehabilitation for patients undergoing elective colorectal resection surgery.
Read the detailed description
Operations on the colon and rectum are major abdominal operations and many individuals can become severely deconditioned or weakened afterwards. For some individuals this can even mean that they can no longer completely return to their usual way of life following one of these major operations. As part of this study the investigators are attempting to identify ways to maximize patients' recovery and to maximize their overall quality of life following these major operations. It is possible that preconditioning may make a difference to patient's overall quality of life, decreased or need for hospital length of stay and decreased postoperative medical complications occasionally seen during these operations, in essence provide an overall enhancement to their surgical recovery. Physiatrists are physicians who are medical experts in maximizing a patient's overall ability to function well and live independently. Investigators are proposing patient participation in an initial pilot study in order to test the question as to whether or not participation with a physiatrist and any interventions recommended by said physician would help improve a patient's postoperative recovery.
- Conditions
- Colorectal Cancer
- Being tested
- Physiatry Assessment, Routine Care
- Keywords
- prehabilitation, colorectal surgery
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physiatry AssessmentOther
Physiatrists are physicians who are medical experts in maximizing a patient's overall ability to function well and live independently. The Investigators are proposing your participation in an initial pilot study in order to test the question as to whether or not participation with a physiatrist and any interventions recommended by said physician would help improve a patient's postoperative recovery.
Routine CareOther
Also called Standard Care
Usual care for your disease process
| Study group | Role | What they receive |
|---|---|---|
| Physiatry | Experimental | Pre-operative Physiatry assessment and intervention Receives: Other: Physiatry Assessment |
| Routine Care | Other | Patients will receive routine pre-operative care, this study arm does not have an intervention. Receives: Other: Routine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants recruiting
Screening and recruiting of eligible patients
Measured: 6 months
Secondary outcomes (10)
Post-op complications
Post-op complications by Clavien-Dindo classification (pulmonary, DVT, MI) Completed by surgical team during admission, discharge and 30 days
Measured: 30 days
Mortality
Survival will be noted at completion of 6 month study period.
Measured: 6 months
Length of Stay
Length of stay in hospital will be collected and compared for the two treatment groups
Measured: 30 days post-op
Number of patients with readmissions
Number of patients with readmission to hospital during the 30 day and 6 month period will be compared for the two treatment groups
Measured: 30 days and 6 months
Physical Function Assessment (6 Minute Walk Test)
6 Minute Walk Test (6MWT)
Measured: 1, 3 and 6 months
Symptom Assessment (Edmonton Symptom Assessment System)
Edmonton Symptom Assessment System (ESAS)
Measured: 1, 3 and 6 months
Functional Independence Assessment (UK Functional Independence Measure and Functional Assessment Measure)
UK Functional Independence Measure and Functional Assessment Measure (UK FIM+FAM)
Measured: 1, 3 and 6 months
Quality of Life Survey (Short Form 36 Health Survey)
Short Form 36 Health Survey (SF-36)
Measured: 1, 3 and 6 months
Pain Assessment (Visual Analog Scale)
Pain score by Visual Analog Scale
Measured: 1, 3 and 6 months
Bowel Function Assessment
Bowel Function Index
Measured: 1, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2015 (estimated)
- Study startSep 2015
- Primary completionSep 2017 (estimated)
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nalin Amin, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02531620
- Sponsor's protocol ID
- 2015A1
- Acronym
- Prehab
- Status last verified
- Nov 2016
- First submitted
- 19 Aug 2015
- Last updated
- 23 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Wong SG, Maida E, Harvey D, Wagner N, Sonnadara R, Amin N. Evaluation of a physiatrist-directed prehabilitation intervention in frail patients with colorectal cancer: a randomised pilot study protocol. BMJ Open. 2017 Jun 9;7(6):e015565. doi: 10.1136/bmjopen-2016-015565.
PubMed 28600373
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prehabilitation Interventions in Elective Colorectal Resections: A Randomized Pilot Study (Prehab)
- ClinicalTrials.gov ID
- NCT02531620
- Acronym / sponsor ID
- Prehab / 2015A1
- Conditions
- Colorectal Cancer
- Keywords
- prehabilitation, colorectal surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 24 Aug 2015 (estimated)
- 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.
This is a pilot study designed to evaluate a programme of rehabilitation for patients undergoing elective colorectal resection surgery.
Detailed description
Operations on the colon and rectum are major abdominal operations and many individuals can become severely deconditioned or weakened afterwards. For some individuals this can even mean that they can no longer completely return to their usual way of life following one of these major operations. As part of this study the investigators are attempting to identify ways to maximize patients' recovery and to maximize their overall quality of life following these major operations. It is possible that preconditioning may make a difference to patient's overall quality of life, decreased or need for hospital length of stay and decreased postoperative medical complications occasionally seen during these operations, in essence provide an overall enhancement to their surgical recovery. Physiatrists are physicians who are medical experts in maximizing a patient's overall ability to function well and live independently. Investigators are proposing patient participation in an initial pilot study in order to test the question as to whether or not participation with a physiatrist and any interventions recommended by said physician would help improve a patient's postoperative recovery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Physiatry | Experimental | Other: Physiatry AssessmentPre-operative Physiatry assessment and intervention |
| Routine Care | Other | Other: Routine CarePatients will receive routine pre-operative care, this study arm does not have an intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- adult patient
- scheduled to undergo a colorectal resection as part of treatment for colorectal cancer.
- English speaking or have available a family member or substitute decision maker who can accompany you to all of your study visits.
Key exclusion criteria (2 listed)
- geographic inaccessibility
- unwilling to provide consent
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 |
|---|---|---|
| Physiatry AssessmentPhysiatrists are physicians who are medical experts in maximizing a patient's overall ability to function well and live independently. The Investigators are proposing your participation in an initial pilot study in order to test the question as to whether or not participation with a physiatrist and any interventions recommended by said physician would help improve a patient's postoperative recovery. | Other | Physiatry |
| Routine CareAlso: Standard CareUsual care for your disease process | Other | Routine Care |
Primary outcome
Number of participants recruiting
Time frame: 6 months
Screening and recruiting of eligible patients
10 secondary outcomes
Post-op complications
Time frame: 30 days
Mortality
Time frame: 6 months
Length of Stay
Time frame: 30 days post-op
Number of patients with readmissions
Time frame: 30 days and 6 months
Physical Function Assessment (6 Minute Walk Test)
Time frame: 1, 3 and 6 months
Symptom Assessment (Edmonton Symptom Assessment System)
Time frame: 1, 3 and 6 months
Functional Independence Assessment (UK Functional Independence Measure and Functional Assessment Measure)
Time frame: 1, 3 and 6 months
Quality of Life Survey (Short Form 36 Health Survey)
Time frame: 1, 3 and 6 months
Pain Assessment (Visual Analog Scale)
Time frame: 1, 3 and 6 months
Bowel Function Assessment
Time frame: 1, 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2016.
- Derived from this study: PubMed 28600373Wong SG, Maida E, Harvey D, Wagner N, Sonnadara R, Amin N. Evaluation of a physiatrist-directed prehabilitation intervention in frail patients with colorectal cancer: a randomised pilot study protocol. BMJ Open. 2017 Jun 9;7(6):e015565. doi: 10.1136/bmjopen-2016-015565.
- 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.
Nalin Amin, MD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physiatry Assessment and Routine Care in people with Colorectal Cancer, run by McMaster University at 1 site in Canada.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 23 Nov 2016. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nalin Amin, MD (905 522-1155 ext. 32938, amin@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants recruiting (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02531620, which also lists 1 linked publication.
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 23 Nov 2016.