Prehabilitation to Improve Cancer Surgery Outcomes
- Conditions
- PrehabilitationSurgeryPhysical ActivityGastrointestinal Cancer
- Interventions
- Behavioral: Physical PrehabilitationBehavioral: Psychological Prehabilitation
- Registration Number
- NCT03502317
- Lead Sponsor
- Mount Sinai Hospital, Canada
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 128
- ≥ 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
-
< 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prehabilitation Study Arm Physical Prehabilitation 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. Prehabilitation Study Arm Psychological Prehabilitation 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.
- Primary Outcome Measures
Name Time Method Global Health Score Baseline to postoperative day 90 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
- Secondary Outcome Measures
Name Time Method Presence and severity of postoperative complications Postoperatively through to day 30 and day 90 The presence and severity of postoperative complications at 30 and 90 days will be recorded from the patient's medical records
Changes in health-related quality of life from baseline Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months HRQOL will be measured using the EQ-5D Health Questionnaire
Presence and severity of symptoms Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months The presence and severity of nine common symptoms in cancer patients will be examined using the Edmonton Symptom Assessment Scale (ESAS). This self-report measure examines: pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, wellbeing, and shortness of breath.
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. The patient's postoperative length of stay will be recorded from the medical records
Changes in functional capacity from baseline Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months Patients will perform a 6-Minute Walk Test.
Changes in self-reported physical activity from baseline Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months Changes in self-reported physical activity will be measured using the Godin Leisure-time Exercise Questionnaire
Changes in anxiety and depression from baseline Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months Changes in anxiety and depression will be examined using the Hospital Anxiety and Depression Scale (HADS). HADS assesses anxiety and depression through self-reporting based on the frequency of symptoms over the past week. There are 2 subscales, one for anxiety and for depression, each with 7 items. Items are scored on a 4 point Likert scale (0-3), with the subscale scores being sums of each item (0-21). A higher score is indicative of higher or worse anxiety and depression.
Changes in fatigue from baseline Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months Changes in cancer-specific fatigue will be assessed using the 13-item Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F).
Interference with occupational performance and productivity Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months The degree to which the patient's health problems interfere with occupational performance and productivity will be examined using the Work Limitations Questionnaire
Changes in multidimensional social support Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months Changes in the perceived availability of multidimensional social support will be evaluated using the Medical Outcomes Study Social Support Scale (MOS-SSS SF-20). The MOS-SSS SF-20 is a 20 item questionnaire that measures physical functioning, social functioning, mental health, current health perceptions, and pain. After reverse scoring of the appropriate items according to the MOS-SSS core scoring manual, a higher value indicates better functioning, health, and more pain in the respective measures. All measure scores are transformed linearly to scales from 0-100, with 100 being the highest score possible.
Health care utilization post-operatively at 3 and 6 months Health care utilization will be assessed at the postoperative 3 and 6 month time points using the Health Service Utilization Inventory
Changes in attachment (closeness in relationships with others) Baseline, immediately preoperatively, and postoperatively at 1, 3, and 6 months The Experiences in Close Relationships Scale (ECR M16) will be used to examine adult attachment or closeness in both romantic and non-romantic relationships. There are two domains that are measured - attachment anxiety and avoidance. Each domain includes 8 items. Items are scored on a 7 point Likert Scale (1-7). After appropriate reverse scoring, a high score indicates higher attachment anxiety or avoidance.
Trial Locations
- Locations (2)
University Health Network
🇨🇦Toronto, Ontario, Canada
Sinai Health System - Mount Sinai Hospital
🇨🇦Toronto, Ontario, Canada