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RECRUITINGPhase 3INTERVENTIONAL

Prehabilitation in Gynaecological Cancer Patients

Prehabilitation in Patients With Gynaecological Cancer Planned for Postponed Surgical Management: A Prospective Randomised Trial.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Inclusion criteria Two groups of patients will be eligible for the trial: i) Epithelial ovarian cancer patients referred for NACT: a) FIGO stage III or IV disease; b) Patient is not a candidate for primary debulking surgery; c) Patient is a suitable candidate for standard of care combined chemotherapy; d) Patient is a candidate for interval.debulking surgery ii) Stage I or II endometrial cancer patients classifying as frail according to the validated modified Frailty Index: a) FIGO stage I or II; b) Patient is classified as frail; c) Patient is suitable candidate for hormonal therapy. Exclusion criteria 1. Second malignant tumour (under the treatment) 2. Patient is not suitable for any surgery delay 3. Patient is not physically able to meet the prehabilitation intervention plan or is unable to walk Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
Inclusion criteria Two groups of patients will be eligible for the trial: i) Epithelial ovarian cancer patients referred for NACT: a) FIGO stage III or IV disease; b) Patient is not a candidate for primary debulking surgery; c) Patient is a suitable candidate for standard of care combined chemotherapy; d) Patient is a candidate for interval.debulking surgery ii) Stage I or II endometrial cancer patients classifying as frail according to the validated modified Frailty Index: a) FIGO stage I or II; b) Patient is classified as frail; c) Patient is suitable candidate for hormonal therapy. Exclusion criteria 1. Second malignant tumour (under the treatment) 2. Patient is not suitable for any surgery delay 3. Patient is not physically able to meet the prehabilitation intervention plan or is unable to walk

Treatments Being Tested

OTHER

Physiological intervention

* Rehabilitation specialist consultation (3x) * Individualized home-based exercise plan * Functional capacity measuring

BEHAVIORAL

Psychological intervention

* Clinical psychologist consultation (3x) * Anxiety and depression scoring * Psychological support

DIETARY_SUPPLEMENT

Nutritional intervention

* Nutritional specialist consultation (3x) * Malnutrition scoring * Dietary supplementation

Locations (1)

Gynecologic Oncology Center in Prague
Prague, Czechia