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Prehabilitation in Gynaecological Cancer Patients

Study acronym: PHOCUS
StatusRecruiting
PhasePhase 3
Started
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Record History

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  1. Start date: Jan 25, 2021 to Mar 25, 2021 Show 4 more changesShow less
    • Study completion pushed from Jun 30, 2026 to Dec 31, 2026
    • Secondary endpoints: details revised at 5 of 11 entries
    • Publications: details revised at 41 of 42 entries
    • Eligibility criteria expanded, about 3 words
  2. Primary completion date: Jun 30, 2025 to Jun 30, 2026v4
  3. Collaborators expanded, about 14 wordsv3
  4. Phase: Not applicable to Phase 3v2 Show 9 more changesShow less
    • Enrollment target: 25 to 64
    • Primary completion date: Dec 1, 2021 to Jun 30, 2025
    • Start date: Dec 1, 2020 to Jan 25, 2021
    • Study completion date: Jun 1, 2022 to Jun 30, 2026
    • Eligibility criteria expanded, about 75 words
    • Secondary endpoints expanded, about 78 words
    • Study description expanded, about 76 words
    • Study title shortened, about 8 words
    • Study arms: 3 to 2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04789694
Lead Sponsor Charles University, Czech Republic
Collaborators: University Hospital Ostrava, University Hospital Olomouc, University Hospital Pilsen, The Faculty Hospital Na Bulovce
Conditions
(from sponsor)		 Ovarian Cancer, Ovarian Cancer Stage III, Ovarian Cancer Stage IV, Endometrial Cancer, Frailty
Related terms Endometrial Neoplasms, Frailty, Ovarian Neoplasms
Enrollment 64 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov