Prehabilitation to Improve Cancer Surgery Outcomes (PICaSO)
Gastrointestinal Cancer, Prehabilitation, Surgery
About this trial
This is an interventional supportive care trial for Gastrointestinal Cancer focused on measuring Prehabilitation, Gastrointestinal Cancer, Physical Activity, Exercise, Surgery
Eligibility Criteria
Inclusion Criteria:
- ≥ 18 years of age
- 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:
- < 18 years old
- 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
Sites / Locations
- Sinai Health System - Mount Sinai HospitalRecruiting
- University Health NetworkRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Prehabilitation Study Arm
Usual Care 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.
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.