Prehabilitation in Gynaecological Cancer Patients

NCT04789694 | Recruiting Phase 3 DMC

• 1 other identifier: PHOCUS_38/20
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Prehabilitation; Epitelial ovarian cancer; Functional capacity; Quality of life; Multimodal prehabilitation; Frailty; Endometrial cancer

Outcome Measures

Primary Outcomes (1)

• Functional capacity changes

  Six-minute walking test (6MWT)

  9-12weeks

Secondary Outcomes (11)

• Postoperative morbidity

  9-12weeks

• Length of postoperative hospital stay (days)

  9-12weeks

• Adherence to training program

  9-12weeks

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

  9-12weeks

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

  9-12weeks

Study Arms (2)

A

NO INTERVENTION

Patients will be provided with a basic information and standard of care support.

B

EXPERIMENTAL

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; Behavioral: Psychological intervention; Dietary Supplement: Nutritional intervention

Interventions

Physiological intervention OTHER

* Rehabilitation specialist consultation (3x) * Individualized home-based exercise plan * Functional capacity measuring

B

Psychological intervention BEHAVIORAL

* Clinical psychologist consultation (3x) * Anxiety and depression scoring * Psychological support

B

Nutritional intervention DIETARY_SUPPLEMENT

* Nutritional specialist consultation (3x) * Malnutrition scoring * Dietary supplementation

B

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Charles University, Czech Republic: lead
• University Hospital Ostrava: collaborator
• University Hospital Olomouc: collaborator
• University Hospital Pilsen: collaborator
• The Faculty Hospital Na Bulovce: collaborator

Study Sites (1)

Gynecologic Oncology Center in Prague

Prague, 12000, Czechia

RECRUITING

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MeSH Terms

Conditions

Ovarian Neoplasms; Endometrial Neoplasms; Frailty

Interventions

Psychosocial Intervention

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Uterine Neoplasms; Uterine Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• David Cibula, prof.

  Charles University, Czech Republic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jana Stribrna

CONTACT

+420 224 967 432; jana.stribrna@vfn.cz

Stefan Lednicky, MD.

CONTACT

stefan.lednicky@vfn.cz

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: February 1, 2021
• First Posted: March 9, 2021
• Study Start: January 25, 2021
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

CZ (1)