Clinical trial NCT03502317: Prehabilitation to Improve Cancer Surgery Outcomes
Official title: Prehabilitation to Improve Cancer Surgery Outcomes (PICaSO): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastrointestinal Cancer
Prehabilitation
Surgery
Physical Activity
Keywords: Prehabilitation
Gastrointestinal Cancer
Physical Activity
Exercise
Surgery
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
Collaborators: name: University Health Network, Toronto
First posted: 2018-04-18
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Global Health Score
timeFrame: Baseline to postoperative day 90
Secondary outcomes:
measure: Presence and severity of postoperative complications
timeFrame: Postoperatively through to day 30 and day 90
measure: Postoperative hospital length of stay
timeFrame: 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.
measure: Changes in functional capacity from baseline
timeFrame: Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months
measure: Changes in self-reported physical activity from baseline
timeFrame: Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months
measure: Changes in health-related quality of life from baseline
timeFrame: Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months
measure: Presence and severity of symptoms
timeFrame: Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months
measure: Changes in anxiety and depression from baseline
timeFrame: Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months
measure: Changes in fatigue from baseline
timeFrame: Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months
measure: Interference with occupational performance and productivity
timeFrame: Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months
measure: Changes in multidimensional social support
timeFrame: Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months
measure: Changes in attachment (closeness in relationships with others)
timeFrame: Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months
measure: Health care utilization
timeFrame: post-operatively at 3 and 6 months
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Sinai Health System - Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Anand Govindarajan, MD MSc
role: PRINCIPAL_INVESTIGATOR
References: