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NCT Number: NCT04789694

Prehabilitation in Gynaecological Cancer Patients

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.

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Key information

Conditions

Ovarian Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Frailty Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Neoplasms Neoplasms by Site Ovarian Cancer Stage III Ovarian Cancer Stage IV Ovarian Diseases Ovarian Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Physiological intervention

Other
  • 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

Primary outcomes

  1. Functional capacity changes

    Time frame: 9-12weeks

    Six-minute walking test (6MWT)

Secondary outcomes

  1. 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

  2. Length of postoperative hospital stay (days)

    Time frame: 9-12weeks

  3. Adherence to training program

    Time frame: 9-12weeks

    Daily step count and number of resistance exercises per week.

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

    Time frame: 9-12weeks

  5. Effects of nutritional support program on resting energy expenditure (measured in kcal/kg).

    Time frame: 9-12weeks

  6. Effects of nutritional support program on Fatty acids composition of plasmatic and erythrocytes phospholipids (measured in mol%).

    Time frame: 9-12weeks

  7. 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.

  8. 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. 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.

  10. 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).

  11. 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'.

Study contacts

Contact information is provided by the study sponsor or research team.

Jana Stribrna

CONTACT

[email protected]

+420 224 967 432

Stefan Lednicky, MD.

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Collaborators

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

Registry information

Official study title

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

Acronym: PHOCUS

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Mar 9, 2021
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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