Prehabilitation in Gynaecological Cancer Patients

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Ovarian Cancer, Ovarian Cancer Stage III, Ovarian Cancer Stage IV, Endometrial Cancer, Frailty

Intervention / Treatment
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* Other: Physiological intervention
* Behavioral: Psychological intervention
* Dietary Supplement: Nutritional intervention


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: A<br>Patients will be provided with a basic information and standard of care support. | |
| Experimental: B<br>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<br>* Rehabilitation specialist consultation (3x) Individualized home-based exercise plan Functional capacity measuring<br>Behavioral: Psychological intervention<br>* Clinical psychologist consultation (3x) Anxiety and depression scoring Psychological support<br>Dietary Supplement: Nutritional intervention<br>* Nutritional specialist consultation (3x) Malnutrition scoring Dietary supplementation<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative morbidity | 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) |  | 9-12weeks | 
| Adherence to training program | 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) |  | 9-12weeks | 
| Effects of nutritional support program on resting energy expenditure (measured in kcal/kg). |  | 9-12weeks | 
| Effects of nutritional support program on Fatty acids composition of plasmatic and erythrocytes phospholipids (measured in mol%). |  | 9-12weeks | 
| Health-related quality of life | 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 | The Beck Depression Inventory: a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression. | 9-12weeks | 
| Psychological health: ANXIETY | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Frailty, Prehabilitation, Epitelial ovarian cancer, Functional capacity, Quality of life, Multimodal prehabilitation, Endometrial cancer