Prehabilitation to Improve Cancer Surgery Outcomes (PICaSO)

Mount Sinai Hospital, Canada

Status: Unknown

Conditions: Physical Activity; Surgery; Gastrointestinal Cancer; Prehabilitation

Treatments: Behavioral: Physical Prehabilitation; Behavioral: Psychological Prehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT03502317

17-0185

Details and patient eligibility

About

This is a randomized control trial aiming to investigate the use of a prehabilitation regimen for patients undergoing major GI cancer surgery and its effects on measurements of HRQOL, LOS, and post-operative complications. Participants will be randomized to either the Prehabilitation arm or the Usual Care arm (control group). The Prehabilitation arm will be prescribed both physical and psychological prehabilitation prior to undergoing surgery for their GI cancer. The Usual Care arm will be counseled to continue their current level of activity and given the information on exercise as outlined in the Cancer Care Ontario guidelines. Participants in the Usual Care arm will also be given the same activity tracker as patients in the Prehabilitation arm in order to eliminate the activity tracker as an intervention itself. Clinical, patient-reported outcomes and health system outcomes will be evaluated. Outcomes will be measured at consent (baseline), immediately preoperatively, and postoperatively at 1, 3 and 6 months. The investigators will collect measures of recruitment, attrition and self-reported compliance via a log completed by the coordinator during weekly patient phone calls.

Enrollment: 128 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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128 participants in 2 patient groups

Prehabilitation Study Arm

Experimental group

Description:

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.

Treatment:

Behavioral: Psychological Prehabilitation

Behavioral: Physical Prehabilitation

Usual Care Study Arm

No Intervention group

Description:

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.