Digital Home-Based Prehabilitation Before Surgery
- Conditions
- FrailtySurgeryCancer Colorectal
- Interventions
- Other: Prehabilitation
- Registration Number
- NCT06231576
- Lead Sponsor
- Vestre Viken Hospital Trust
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 140
- Planned for major gastrointestinal cancer surgery
- Fluent in Norwegian and able to consent and to understand questionnaires
- Inability to walk for six minutes or to rise independently from a chair
- Inability to comprehend exercise program or to comply with written and oral instructions
- Presence of a cardio-pulmonary condition that precludes exercise
- Living in very remote areas making a hospital-based intervention group impossible to implement
- Being without a permanent address
- Admittance to a hospital facility for > 50% of the time from diagnosis to surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Digital Prehabilitation Prehabilitation at home, with guidance from a dedicated physiotherapist through a digital platform, realtime. Hospital Prehabilitation Prehabilitation at the hospital, with guidance by a dedicated physiotherapist physically present.
- Primary Outcome Measures
Name Time Method 6MWT At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery Distance (in meters) walked in 6 minutes
- Secondary Outcome Measures
Name Time Method EuroQol Group Questionnaire 5D (EQ-5D) At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery 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.
Need of additional health care support 4-6 weeks after surgery Use of health care support from the municipality, nursing homes etc
European Organisation for Research and Treatment of Cancer Core Quality of Life questionnaire At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery 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.
Complications 3 months after surgery 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)
Generic Short Patient Experiences Questionnaire (GS-PEQ) At inclusion, prior to intervention. After intervention, prior to surgery. 4-6 weeks after surgery 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.
Mortality 3 months after surgery 90-day mortality
Aggregated length-of-stay (aLoS) 4-6 weeks after surgery Total time in hospital (from surgery and any readmittance) within 30-days from surgery
Cost-effectiveness 3 months after surgery 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