Pre-operative Prehabilitation in Cancer Surgery - Objective Recovery Assessment
- Conditions
- Cancer
- Interventions
- Other: Standard careOther: Prehabilitation
- Registration Number
- NCT05270577
- Lead Sponsor
- Linkoeping University
- Brief Summary
To compare prehabilitation with physical exercise, psychological support, nutritional support and smoke/alchol stop to "standard of care" before canceer surgery.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 90
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard care Standard care Standard preoperative recomendations Prehabilitation Prehabilitation Prehabilitation with physical exercise, psychological support, nutritional support and smoking/alchohol stop
- Primary Outcome Measures
Name Time Method 6 minute walk test (6mwt) 12 weeks 6 minute walk test (6mwt)
- Secondary Outcome Measures
Name Time Method Length of hospitalization 90d after surgery Length of hospitalization
Appetite and eating behavior is evaluated with Disease Related Appetite Questionnaire (DRAQ) 12 weeks Appetite and eating behavior is evaluated with Disease Related Appetite Questionnaire (DRAQ)
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 Time from surgery until the day of first dose of adjuvant chemotherapy (among liver and rectal cancer patients for whom postoperative chemotherapy is planned)
30 s chair stand test 12 weeks 30 s chair stand test
Test of hand grip strength 12 weeks Test of hand grip strength
Cardiopulmonary exercise test with ventilatory gas analysis 12 weeks Cardiopulmonary exercise test with ventilatory gas analysis making it possible to calculate VOmax as well as other established measures of cardiopulmonary function
Appetite and eating behavior is evaluated with Eating Symptom Questionnaire (ESQ) 12 weeks Appetite and eating behavior is evaluated with Eating Symptom Questionnaire (ESQ)
Weekly alcohol consumption 12 weeks Weekly alcohol consumption as reported in standard units
Sum of all complications in each patient (comprehensive complication index, CCI) 90d after surgery Sum of all complications in each patient (comprehensive complication index, CCI) occuring up to 90 days after surgery
Clinical Frailty Scale 12 weeks Clinical Frailty Scale
International Physical Activity Questionnaire 12 weeks International Physical Activity Questionnaire
Grade of sarcopenia 12 weeks Grade of sarcopenia
Incremental cost-effectiveness ratio 2 years after surgery Incremental cost-effectiveness ratio, calculated as the median cost divided by the quality adjusted life years obtained until 2 years after surgery
The presence of malnutrition evaluated with the Global Leadership Initiative on Malnutrition (GLM) criteria 12 weeks The presence of malnutrition evaluated with the Global Leadership Initiative on Malnutrition (GLM) criteria
Overall survival 5 years Overall survival
4-week point prevalence of smoking abstinence (among baseline smokers) 12 weeks 4-week point prevalence of smoking abstinence (among baseline smokers), measured with Fagerstroms scale
Episodes of heavy drinking per month 12 weeks Episodes of heavy drinking per month as reported in standard units at a single occation
The most severe complication occurring 90d after surgery The most severe complication occurring (according to the Clavien-Dindo scale) until 90 days after surgery
Time to functional recovery of physical status as compared to baseline values 90d after surgery 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
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 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)
Quality of Life (QoL) 2 years after surgery Quality of Life (QoL)
Proportion of patients not able to receive all treatment despite no dissemination of disease 90 day after surgery Proportion of patients not able to receive all treatment despite no dissemination of disease