Prehabilitation in Gynaecological Cancer Patients (PHOCUS)

March 18, 2026 updated by: David Cibula, Charles University, Czech Republic

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The objective of the trial is to evaluate the impact of intensive multimodal prehabilitation protocol on pre-operative functional capacity, postoperative morbidity, and quality of life in patients undergoing surgical treatment for gynaecological cancer.

Two groups of patients scheduled for postponed surgical treatment will be eligible for the trial: i) advanced ovarian cancer patients referred for neoadjuvant chemotherapy and interval debulking surgery; ii) stage I-II endometrial cancer patients classifying as frail (according to the validated modified Frailty Index), who will be treated by hormonal therapy for three months, followed by surgical treatment.

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Czechia
      • Prague, Czechia, 12000
        • Recruiting
        • Gynecologic Oncology Center in Prague
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: A
Patients will be provided with a basic information and standard of care support.
Experimental: B
Active prehabilitation will be provided, composed of i) three physical activity-related interventions provided by a physical and rehabilitation medicine (PRM) specialist; iii) three 30 min consultations regarding nutritional status with physician or nutrition specialist; ii) three sessions with psychologist.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional capacity changes
Time Frame: 9-12weeks
Six-minute walking test (6MWT)
9-12weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative morbidity
Time Frame: 9-12weeks
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
9-12weeks
Length of postoperative hospital stay (days)
Time Frame: 9-12weeks
9-12weeks
Adherence to training program
Time Frame: 9-12weeks
Daily step count and number of resistance exercises per week.
9-12weeks
Effects of nutritional support program on body composition (weight of fat and lean body mass in kg)
Time Frame: 9-12weeks
9-12weeks
Effects of nutritional support program on resting energy expenditure (measured in kcal/kg).
Time Frame: 9-12weeks
9-12weeks
Effects of nutritional support program on Fatty acids composition of plasmatic and erythrocytes phospholipids (measured in mol%).
Time Frame: 9-12weeks
9-12weeks
Health-related quality of life
Time Frame: 9-12weeks

The analysis of the QoL of both study ARMs will be made based on EORTC validated questionnaires: QLQ-C30 and OV28 (for ovarian cancer patients)/ EN24 (for endometrial cancer patients.

QLQ-C30 was developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials. The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease.

The EORTC QLQ-OV28/ EN24 is used in conjunction with the EORTC QLQ-C30 and provides information on an additional 25 items specifically related to ovarian/ endometrial cancer.
9-12weeks
Psychological health: DEPRESSION
Time Frame: 9-12weeks
The Beck Depression Inventory: a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression.
9-12weeks
Psychological health: ANXIETY
Time Frame: 9-12weeks
The State-Trait Anxiety Inventory: a psychological inventory consisting of 40 self-report items on a 4-point Likert scale. The STAI measures two types of anxiety - state anxiety and trait anxiety.
9-12weeks
Psychological health: NONSPECIFIC PERCEIVED STRESS
Time Frame: 9-12weeks
Perceived stress scale: psychological instrument for measuring nonspecific perceived stress (stressfulness of situations, the effectiveness of stress-reducing interventions, and the extent to which there are associations between psychological stress and psychiatric and physical disorders).
9-12weeks
Psychological health: SPECIFIC PERCEIVED STRESS
Time Frame: 9-12weeks
Stress profile: questionnaire assessing the severity of stress in nine areas of life: social habits, social relationships, life events, sexual problems, sleep, psychiatric symptoms, old age, menstrual stresses, and 'stress and the heart'.
9-12weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charles University, Czech Republic

Collaborators

University Hospital Ostrava
University Hospital Olomouc
University Hospital Pilsen
The Faculty Hospital Na Bulovce

Investigators

  • Principal Investigator: David Cibula, prof., Charles University, Czech Republic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 25, 2021

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

February 1, 2021

First Submitted That Met QC Criteria

March 8, 2021

First Posted (Actual)

March 9, 2021

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 18, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHOCUS_38/20

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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