This clinical trial compares two different prehabilitation programs, with no organized prehabilitation, prior to major colorectal cancer surgery. The prehabilitation programs include intensive and coached physical exercise and optimized nutritional intake coupled with smoking cessation, physiological support and correction of poly-pharmacy.
Patients are randomized to either a digital home-based program, a physical hospital-based program or no-organized prehabilitation. The eligible patients are anyone scheduled for colorectal cancer surgery who are fluent in Norwegian able to consent and to understand questionnaires. The main question the study aims to answer is whether a digital home-based program is non-inferior to a hospital-based program in terms of improved physical capacity and maintenance of life-quality. In addition, blood samples will be drawn at three time points, at inclusion, after intervention (prior to surgery) and 6 weeks after surgery to analyze and search for biomarkers reflecting patients' individual surgical risk profile and response to prehabilitation. Participants randomized to intervention, will be given psychological coaching and support, individualized nutritionist counselling, coached, structured and repeated 60 minutes daily exercises for three weeks prior to surgery. The control group will receive no organized prehabilitation in the period of time between diagnose and surgery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
140
* Nutritional optimization: A nutritionist will perform a structured interview, comprehensive nutrition assessment, and provide personalized dietary advice. The main goal is to ensure optimal protein intake to support exercise-induced anabolism. A daily protein intake of 1.2-2.0 g/kg will meet needs as outlined in surgical nutrition guidelines. * Exercise: Based on current guidelines and instructed by a dedicated physiotherapist, for 1 hour per day preoperatively to increase muscle strength, aerobic capacity and physical endurance. Intensity will be based on the rate of perceived exertion using the Borg scale, a 15-graded scale ranging from very light to very hard. Resistance exercises will target upper/lower body, and abdominal muscles. * Psychological coaching and support: Performed as one interview during inclusion, followed by weekly phone calls by a study nurse coordinator during the preoperative intervention.
6MWT
Distance (in meters) walked in 6 minutes
Time frame: At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery
EuroQol Group Questionnaire 5D (EQ-5D)
EQ-5D is a standardized measure of health-related quality of life with 5 dimensions, each dimension represented by a value 1-5 where higher value represents worse outcome.
Time frame: At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery
European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire
The EORTC Core Quality of Life questionnaire (EORTC QLQ-C30) is designed to measure cancer patients' physical, psychological and social functions. The questionnaire range from 0 to 100; a higher score represents a higher ("better") level of functioning, or a higher ("worse") level of symptoms.
Time frame: At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery
Generic Short Patient Experiences Questionnaire (GS-PEQ)
GS-PEQ is a questionnaire for collecting data about user experiences across different types of services. The questionnaire has 12 questions ranging from 1-5; a higher score represents a higher ("better") experience.
Time frame: At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery
Mortality
90-day mortality
Time frame: 3 months after surgery
Complications
Comprehensive Complication Index (CCI) reflects the gravity of the overall complication burden on the patient on a scale from 0 (no complication) to 100 (death)
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Time frame: 3 months after surgery
Need of additional health care support
Use of health care support from the municipality, nursing homes etc
Time frame: 4-6 weeks after surgery
Aggregated length-of-stay (aLoS)
Total time in hospital (from surgery and any readmittance) within 30-days from surgery
Time frame: 4-6 weeks after surgery
Cost-effectiveness
An estimation of the resources used on the prehabilitation program will be compared to resources saved by shorter aLoS, less use of nursing home facilities and less need of community healthcare services
Time frame: 3 months after surgery