Prehabilitation in Gynaecological Cancer Patients

Summary

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.

Conditions

• Ovarian Cancer
• Ovarian Cancer Stage III
• Ovarian Cancer Stage IV
• Endometrial Cancer
• Frailty

Interventions

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

Sponsors & Collaborators

• University Hospital Ostrava

  collaborator OTHER

• University Hospital Olomouc

  collaborator OTHER

• University Hospital Pilsen

  collaborator OTHER

• The Faculty Hospital Na Bulovce

  collaborator OTHER

• Charles University, Czech Republic

  lead OTHER

Principal Investigators

• David Cibula, prof. · Charles University, Czech Republic

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-01-25

Primary Completion

2026-06-30

Completion

2026-06-30

Countries

• Czechia

Study Locations