Prehabilitation to Improve Cancer Surgery Outcomes
PICaSO
1 other identifier
interventional
128
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2018
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2018
CompletedFirst Posted
Study publicly available on registry
April 18, 2018
CompletedStudy Start
First participant enrolled
August 14, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2021
CompletedFebruary 27, 2020
February 1, 2020
2 years
March 25, 2018
February 25, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Global Health Score
The primary outcome is the difference between the baseline and 90-day global health score on the European Organization for the Research and Treatment of Cancer (EORTC) QLC-C30
Baseline to postoperative day 90
Secondary Outcomes (12)
Presence and severity of postoperative complications
Postoperatively through to day 30 and day 90
Postoperative hospital length of stay
Length of stay will be calculated from the date of surgery until to the date of discharge from the hospital, reported in days, assessed up to 6 months postoperatively.
Changes in functional capacity from baseline
Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months
Changes in self-reported physical activity from baseline
Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months
Changes in health-related quality of life from baseline
Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months
- +7 more secondary outcomes
Study Arms (2)
Prehabilitation Study Arm
EXPERIMENTALPatients 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.
Usual Care Study Arm
NO INTERVENTIONNo 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 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 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
You may qualify if:
- ≥ 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
You may not qualify if:
- \< 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mount Sinai Hospital, Canadalead
- University Health Network, Torontocollaborator
Study Sites (2)
Sinai Health System - Mount Sinai Hospital
Toronto, Ontario, M5G1X5, Canada
University Health Network
Toronto, Ontario, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anand Govindarajan, MD MSc
MOUNT SINAI HOSPITAL
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2018
First Posted
April 18, 2018
Study Start
August 14, 2018
Primary Completion
August 31, 2020
Study Completion
March 31, 2021
Last Updated
February 27, 2020
Record last verified: 2020-02