Prehabilitation in Gynaecological Cancer Patients

NCT ID: NCT04789694

Last Updated: 2023-08-31

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 64 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-25
• Study Completion Date: 2026-06-30

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.

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.

Conditions

Ovarian Cancer; Ovarian Cancer Stage III; Ovarian Cancer Stage IV; Endometrial Cancer; Frailty

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

A

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Physiological intervention

Intervention Type: OTHER

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

Psychological intervention

Intervention Type: BEHAVIORAL

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

Nutritional intervention

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Physiological intervention

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

Intervention Type: OTHER

Psychological intervention

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

Intervention Type: BEHAVIORAL

Nutritional intervention

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University Hospital Ostrava

OTHER

Sponsor Role: collaborator

University Hospital Olomouc

OTHER

Sponsor Role: collaborator

University Hospital Pilsen

OTHER

Sponsor Role: collaborator

The Faculty Hospital Na Bulovce

OTHER

Sponsor Role: collaborator

Charles University, Czech Republic

OTHER

Sponsor Role: lead

Responsible Party

David Cibula

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Cibula, prof.

Role: PRINCIPAL_INVESTIGATOR

Charles University, Czech Republic

Locations

Gynecologic Oncology Center in Prague

Prague, , Czechia

Site Status: RECRUITING

Countries

Czechia

Central Contacts

Jana Stribrna

Role: CONTACT

jana.stribrna@vfn.cz

+420 224 967 432

Stefan Lednicky, MD.

Role: CONTACT

stefan.lednicky@vfn.cz

Facility Contacts

David Cibula, M.D.

Role: primary

dc@davidcibula.cz

+420603547055

Jana Stribrna

Role: backup

jana.stribrna@vfn.cz

+420224967432

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Other Identifiers

PHOCUS_38/20

Identifier Type: -

Identifier Source: org_study_id