About this trial
Prehabilitation refers to interventions aiming to improve patients' resilience and functional capacity before a known stressful event, e.g., scheduled surgery. These interventions usually consist of physical activity and psychological and nutritional support. There is substantial evidence of the positive effect of multimodal prehabilitation among patients treated surgically for non-gynaecological cancers; however, no prospective data are available in gynaecological cancer patients.
PHOCUS trial is a prospective randomised trial aiming to evaluate the role of multimodal prehabilitation in patients with gynaecological cancer. Sixty-four patients will be randomised in single institution within 36 months with a 1:1 ratio into ARM A: control arm which will be provided with a basic information and standard of care support; ARM B: active arm undergoing multimodal prehabilitation composed of physical activity and psychological and nutritional support. All patients will be assessed at standard intervals (three times during the trial) by a spectrum of non-invasive tests, evaluating physical functional capacity, postoperative morbidity, nutritional status, level of stress and anxiety, and quality of life.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Second malignant tumour (under the treatment)
Patient is not suitable for any surgery delay
Patient is not physically able to meet the prehabilitation intervention plan or is unable to walk
Trial design
Parallel
Treatments tested in this trial
Physiological intervention
Other intervention* Rehabilitation specialist consultation (3x) * Individualized home-based exercise plan * Functional capacity measuring
Psychological intervention
Behavioral* Clinical psychologist consultation (3x) * Anxiety and depression scoring * Psychological support
Nutritional intervention
Dietary supplement* Nutritional specialist consultation (3x) * Malnutrition scoring * Dietary supplementation
Treatment groups
Trial outcomes
Primary outcomes
Functional capacity changes
Six-minute walking test (6MWT)
Secondary outcomes
Postoperative morbidity
Intraoperative and early postoperative complications until the 30th postoperative day will be classified according to the Clavien-Dindo and the Comprehensive Complication Index. Adverse events occurring after 30th postoperative day will be assessed according to NCI Common Terminology Criteria for Adverse Events Version 5.0
Length of postoperative hospital stay (days)
Adherence to training program
Daily step count and number of resistance exercises per week.
Effects of nutritional support program on body composition (weight of fat and lean body mass in kg)
Sponsors and contacts
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Charles University, Czech Republic
Lead sponsor
University Hospital Ostrava
Collaborator
University Hospital Olomouc
Collaborator
University Hospital Pilsen
Collaborator
The Faculty Hospital Na Bulovce
Collaborator