Recruiting

Prehabilitation

Sponsor:

Mount Sinai Hospital, Canada

Code:

NCT03502317

Conditions

Gastrointestinal Cancer

Prehabilitation

Surgery

Physical Activity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Physical Prehabilitation

Psychological Prehabilitation

Study Details

Brief summary:

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.

Conditions

Gastrointestinal Cancer

Prehabilitation

Surgery

Physical Activity

Study ID

NCT03502317

Start date

Aug 14, 2018

Status verified date

Feb, 2020

Completion date

Mar 31, 2021

Anticipated

Primary completion date

Aug 31, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

128 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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.

no intervention: 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.

Interventions

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.

Primary outcome measure

  • Global Health Score [ Time Frame: Baseline to postoperative day 90 ]

Central Contacts and Locations

Central contacts

Emily Taylor

416-586-4800emily.taylor@sinaihealthsystem.ca

Rachel Aitken

rachel.aitken@mail.utoronto.ca

Locations

Sinai Health System - Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada, M5G1X5

Contacts

Emily Taylor

4165864800emily.taylor@sinaihealthsystem.ca

Rachel Aitken

6479735918rachel.aitken@mail.utoronto.ca

Principal Investigator:

Anand Govindarajan, MD, MSc

University Health Network

Recruiting

Toronto, Ontario, Canada

Contacts

Emily Taylor

4165864800emily.taylor@sinaihealthsystem.ca

Rachel Aitken

6479735918rachel.aitken@mail.utoronto.ca

Principal Investigator:

Anand Govindarajan, MD, MSc

More Information

Sponsor

Mount Sinai Hospital, Canada

Last update posted

Feb 27, 2020

Last verified

Feb, 2020

Keywords

  • Prehabilitation
  • Gastrointestinal Cancer
  • Physical Activity
  • Exercise
  • Surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mount Sinai Hospital, Canada on 2020-02-27.