Prehabilitation in Gynaecological Cancer Patients

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-85
SponsorCharles University, Czech Republic

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

Qualifiers

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

Treatments tested in this trial

  • Physiological intervention
  • Psychological intervention
  • Nutritional intervention

Treatment groups

64 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Charles University, Czech Republic

Lead sponsor

University Hospital Ostrava

Collaborator

University Hospital Olomouc

Collaborator

University Hospital Pilsen

Collaborator

The Faculty Hospital Na Bulovce

Collaborator