Colorectal Cancer, Colorectal Cancer Stage III
Conditions
Keywords
colorectal cancer, colorectal surgery, prehabilitation, surgical recovery, exercise, referred for scheduled resection
Brief summary
Despite advances in surgical care, the incidence of postoperative complications and prolonged recovery following colorectal surgery remains high. Efforts to improve the recovery process have primarily focused on the intraoperative (eg, minimally invasive surgery, afferent neural blockade) and post-operative periods (eg, fast track early nutrition and mobilization. The pre-operative period may in fact be a better time to intervene in the factors that contribute to recovery. The process of enhancing functional capacity of the individual in anticipation of an upcoming stressor has been termed prehabilitation. Based on the notion that preoperative exercise would have an impact on recovery of functional capacity after colorectal surgery, our group recently conducted a randomized controlled trial. Subgroup analysis identified that patients whose functional exercise capacity improved preoperatively, regardless of exercise technique, recovered well in the postoperative period. However, one-third of patients deteriorated preoperatively despite the exercise regimen, and these patients were also at greater risk for prolonged recovery after surgery. These results suggested that exercise alone is not sufficient to attenuate the stress response in all patients. In the present trial, the impact of a multimodal prehabilitation intervention composed of exercise, nutritional supplement and psychological well-being begun in the preoperative period will be compared to one begun in the postoperative period.
Interventions
BEHAVIORALmultimodal prehabilitation
multimodal prehabilitation program based on exercise, supplemental nutrition and psychological support starting 3-5 weeks before surgery and continuing postoperative for up to 8 weeks
Sponsors
Society of American Gastrointestinal and Endoscopic Surgeons
Immunotec Inc.
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* referred for scheduled surgery for nonmetastasized colorectal cancer * age \> 18 years old
Exclusion criteria
* asa 4-5 * Poor English or French comprehension * severe co-morbid disease interfering with ability to perform exercise at home or complete testing
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| six minute walk test | baseline, preop, 4 weeks, 8weeks postop | 6 MWT is a patient-relevant measure of functional walking capacity, reflective of the activities of daily living. Subjects are instructed to walk back and forth, in a 20 m stretch of hallway, for six minutes, at a pace that would make them tired by the end of the walk. The distance in meters is recorded. Reference equations are available for calculating percent of age- and gender-specific norms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| physical activity level | baseline, preop, 4 weeks, 8 weeks | Physical activity level will be measured through the Community Health Activities Model Program for Seniors (CHAMPS) questionnaire. CHAMPS is a self-reported measure of physical activity, comprising 41 activities evaluated according to the total number of hours done during an average week. Each physical activity is assigned a MET (metabolic equivalent) value yielding average weekly caloric expenditure for the listed physical activities |
| Depression and anxiety | baseline, preop, 4 weeks, 8 weeks | Depression and anxiety will be assessed by The Hospital Anxiety and Depression Scale (HADS), a 14-question measure with seven items each for depression and anxiety. HADS generates separate scores for anxiety and depression as well as a combined score of psychological distress. |
| Health-related quality of life | baseline, preop, 4 weeks, 8 weeks | The SF-36 is the most widely used HRQL measure and has been validated for surgical population; Canadian norms are also available. It incorporates behavioural functioning, subjective well-being and perceptions of health by assessing, on a 0 to 100 scale, eight health concepts. |
| postoperative complications | 4 weeks | Classified by Clavien Scale |
| Fatigue | baseline, preop, 4 wks, 8 wks | Fatugue Index |
| nutritional status | baseline, preop, 4 weeks, 8 weeks | Nutritional status will be assessed at baseline by measuring body mass index (BMI), body weight loss over the preceding three months (\> 10% ), and/or serum albumin \< 35 g -1 will define poor nutritional status. |
Countries
Canada
Outcome results
None listed