Pre-operative Prehabilitation in Cancer Surgery - Objective Recovery Assessment

Study Overview
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Brief Summary
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To compare prehabilitation with physical exercise, psychological support, nutritional support and smoke/alchol stop to standard of care before canceer surgery.

Official Title
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Pre-operative Prehabilitation in Cancer Surgery - Objective Recovery Assessment

Conditions
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Cancer

Intervention / Treatment
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* Other: Prehabilitation
* Other: Standard care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients, aged 18 or older, who have been evaluated as eligible for surgery for malignancy in the esophagus, rectum or liver (only metastases from colorectal cancer) will be evaluated for participation. Exclusion Criteria: Surgery is scheduled in less than 12 weeks. Paralytic or completely immobilized patient, condition making physical training impractical. Cognitive disability making participation impossible. Not speaking or understanding the Swedish language well enough to read and understand the informed consent form.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prehabilitation<br>Prehabilitation with physical exercise, psychological support, nutritional support and smoking/alchohol stop | Other: Prehabilitation<br>* prehabilitation<br>|
| Active Comparator: Standard care<br>Standard preoperative recomendations | Other: Standard care<br>* No intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 minute walk test (6mwt) | 6 minute walk test (6mwt) | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30 s chair stand test | 30 s chair stand test | 12 weeks | 
| Test of hand grip strength | Test of hand grip strength | 12 weeks | 
| International Physical Activity Questionnaire | International Physical Activity Questionnaire | 12 weeks | 
| Cardiopulmonary exercise test with ventilatory gas analysis | Cardiopulmonary exercise test with ventilatory gas analysis making it possible to calculate VOmax as well as other established measures of cardiopulmonary function | 12 weeks | 
| The presence of malnutrition evaluated with the Global Leadership Initiative on Malnutrition (GLM) criteria | The presence of malnutrition evaluated with the Global Leadership Initiative on Malnutrition (GLM) criteria | 12 weeks | 
| Appetite and eating behavior is evaluated with Eating Symptom Questionnaire (ESQ) | Appetite and eating behavior is evaluated with Eating Symptom Questionnaire (ESQ) | 12 weeks | 
| Appetite and eating behavior is evaluated with Disease Related Appetite Questionnaire (DRAQ) | Appetite and eating behavior is evaluated with Disease Related Appetite Questionnaire (DRAQ) | 12 weeks | 
| 4-week point prevalence of smoking abstinence (among baseline smokers) | 4-week point prevalence of smoking abstinence (among baseline smokers), measured with Fagerstroms scale | 12 weeks | 
| Weekly alcohol consumption | Weekly alcohol consumption as reported in standard units | 12 weeks | 
| Episodes of heavy drinking per month | Episodes of heavy drinking per month as reported in standard units at a single occation | 12 weeks | 
| The most severe complication occurring | The most severe complication occurring (according to the Clavien-Dindo scale) until 90 days after surgery | 90d after surgery | 
| Sum of all complications in each patient (comprehensive complication index, CCI) | Sum of all complications in each patient (comprehensive complication index, CCI) occuring up to 90 days after surgery | 90d after surgery | 
| Length of hospitalization | Length of hospitalization | 90d after surgery | 
| Time to functional recovery of physical status as compared to baseline values | Defined as number of days after surgery until the patient has reached all of the following: being mobile at the preoperative level, having sufficient pain control with only oral or transdermal medication, being able to maintain food intake without intravenous fluids and not being in need of intravenous medications | 90d after surgery | 
| Clinical Frailty Scale | Clinical Frailty Scale | 12 weeks | 
| Grade of sarcopenia | Grade of sarcopenia | 12 weeks | 
| The frequency of failures to go through the full treatment program as planned at the first MDT (including, but not limited to, the full oncological chemotherapy program, radiation treatment and final surgery) | The frequency of failures to go through the full treatment program as planned at the first MDT (including, but not limited to, the full oncological chemotherapy program, radiation treatment and final surgery) | 90 days | 
| Time from surgery until the day of first dose of adjuvant chemotherapy (among liver and rectal cancer patients for whom postoperative chemotherapy is planned) | Time from surgery until the day of first dose of adjuvant chemotherapy (among liver and rectal cancer patients for whom postoperative chemotherapy is planned) | 90 day after surgery | 
| Proportion of patients not able to receive all treatment despite no dissemination of disease | Proportion of patients not able to receive all treatment despite no dissemination of disease | 90 day after surgery | 
| Overall survival | Overall survival | 5 years | 
| Quality of Life (QoL) | Quality of Life (QoL) | 2 years after surgery | 
| Incremental cost-effectiveness ratio | Incremental cost-effectiveness ratio, calculated as the median cost divided by the quality adjusted life years obtained until 2 years after surgery | 2 years after surgery |