Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
128 participants
INTERVENTIONAL
2018-08-14
2021-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Prehabilitation Study Arm
Patients will participate in a two-pronged prehabilitation strategy - physical prehabilitation and psychological prehabilitation. Prehabilitation will last from a minimum of 21 days to a maximum of 42 days before a patient's clinically indicated surgery.
Physical Prehabilitation
Physical prehabilitation will comprise a personalized, home-based exercise program designed to meet the Cancer Care Ontario Exercise Guidelines for Cancer Survivors. A Registered Kinesiologist (RKin) will complete a baseline physical assessment and prescribe an individualized multi-modal exercise program consisting of 4-5 days of 30+ minutes of aerobic exercise (brisk walking or equivalent to target heart rate of 40-60% of max) and 2-3 days of moderate intensity resistance training of major muscle groups (8-10 repetitions). Participants will be provided with a Fitbit with a heart rate monitor, resistance bands, and a stability ball. Patients will be required to wear their Fitbit and record the number of steps at the end of each day from randomization to 90 days post-surgery.
Psychological Prehabilitation
Psychological prehabilitation will consist of one in-person coaching session of a 'mindfulness' informed intervention conducted by a specially trained RKin. The 40 minute coaching session will include a guided mindfulness session and debriefing. Participants will be asked to practice for 20 minutes twice a day. The patients will be given access to an audio file that will walk them through the 20 minute sessions.
Usual Care Study Arm
No specific exercises or stress reduction techniques are prescribed and the patient will be counseled to continue their current level of activity, and will be given the information on exercise as outlined in the Cancer Care Ontario guidelines. Patients in the Usual Care arm will also be given the same Fitbit activity tracker as patients in the Prehabilitation arm in order to eliminate the activity tracker as an intervention itself and to be able to track the activity (steps) for comparison. Patients in the Usual Care arm will be required to wear their Fitbit activity tracker from the day of randomization to 90 days post-surgery. Patients will record their steps in the diary provided.
No interventions assigned to this group
Interventions
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Physical Prehabilitation
Physical prehabilitation will comprise a personalized, home-based exercise program designed to meet the Cancer Care Ontario Exercise Guidelines for Cancer Survivors. A Registered Kinesiologist (RKin) will complete a baseline physical assessment and prescribe an individualized multi-modal exercise program consisting of 4-5 days of 30+ minutes of aerobic exercise (brisk walking or equivalent to target heart rate of 40-60% of max) and 2-3 days of moderate intensity resistance training of major muscle groups (8-10 repetitions). Participants will be provided with a Fitbit with a heart rate monitor, resistance bands, and a stability ball. Patients will be required to wear their Fitbit and record the number of steps at the end of each day from randomization to 90 days post-surgery.
Psychological Prehabilitation
Psychological prehabilitation will consist of one in-person coaching session of a 'mindfulness' informed intervention conducted by a specially trained RKin. The 40 minute coaching session will include a guided mindfulness session and debriefing. Participants will be asked to practice for 20 minutes twice a day. The patients will be given access to an audio file that will walk them through the 20 minute sessions.
Eligibility Criteria
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Inclusion Criteria
* Fluent in English
* Able to comply with study procedures \& follow-up contained within the consent form
* Pathologically or radiologically confirmed diagnosis of a GI cancer
* GI cancer must be considered operable
* Expected LOS ≥ 5 days as calculated by the validated American College of Surgeons Surgical Risk Calculator
* \> 21 days between time of randomization and time of expected surgery
* Patient written, informed consent obtained according to ICH GCP guidelines and local regulations
Exclusion Criteria
* Not fluent in English
* Planned resection of bony pelvis, limbs, or major lower extremity neurovascular structures
* Significant comorbidity including any of the following:
* Canadian Cardiovascular Society class III/IV coronary disease
* New York Heart Association class III/IV congestive heart failure
* Neurologic or musculoskeletal disorder prohibiting exercise
* Major neuropsychiatric disorder
18 Years
ALL
No
Sponsors
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University Health Network, Toronto
OTHER
Mount Sinai Hospital, Canada
OTHER
Responsible Party
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Principal Investigators
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Anand Govindarajan, MD MSc
Role: PRINCIPAL_INVESTIGATOR
MOUNT SINAI HOSPITAL
Locations
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Sinai Health System - Mount Sinai Hospital
Toronto, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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17-0185
Identifier Type: -
Identifier Source: org_study_id
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