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

This trial does not accept healthy volunteers

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

Design model

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

64 Participants
are divided into 2 treatment groups
Group A: ANo intervention 0 interventions
Group B: BExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

Functional capacity changes

Six-minute walking test (6MWT)

Time frame
9-12weeks

Secondary outcomes

1

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

Time frame
9-12weeks
2

Length of postoperative hospital stay (days)

Time frame
9-12weeks
3

Adherence to training program

Daily step count and number of resistance exercises per week.

Time frame
9-12weeks
4

Effects of nutritional support program on body composition (weight of fat and lean body mass in kg)

Time frame
9-12weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Charles University, Czech Republic

Lead sponsor

University Hospital Ostrava

Collaborator

University Hospital Olomouc

Collaborator

University Hospital Pilsen

Collaborator

The Faculty Hospital Na Bulovce

Collaborator