Prehabilitation in Gynaecological Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Physiological intervention, Psychological intervention, Nutritional intervention.
- Who it may be relevant to
- Registry conditions: Ovarian Cancer, Ovarian Cancer Stage III, Ovarian Cancer Stage IV, Endometrial Cancer. Basic parameters: 18 years — 85 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Czechia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prehabilitation in Patients With Gynaecological Cancer Planned for Postponed Surgical Management: A Prospective Randomised Trial.
Overview
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.
Interventions
- Other Physiological intervention
* Rehabilitation specialist consultation (3x) * Individualized home-based exercise plan * Functional capacity measuring - Behavioral Psychological intervention
* Clinical psychologist consultation (3x) * Anxiety and depression scoring * Psychological support - Dietary supplement Nutritional intervention
* Nutritional specialist consultation (3x) * Malnutrition scoring * Dietary supplementation
Primary outcome measures
- Functional capacity changes [Time frame: 9-12weeks]
Secondary outcome measures (11)
- Postoperative morbidity [Time frame: 9-12weeks]
- Length of postoperative hospital stay (days) [Time frame: 9-12weeks]
- Adherence to training program [Time frame: 9-12weeks]
- Effects of nutritional support program on body composition (weight of fat and lean body mass in kg) [Time frame: 9-12weeks]
- Effects of nutritional support program on resting energy expenditure (measured in kcal/kg). [Time frame: 9-12weeks]
- Effects of nutritional support program on Fatty acids composition of plasmatic and erythrocytes phospholipids (measured in mol%). [Time frame: 9-12weeks]
- Health-related quality of life [Time frame: 9-12weeks]
- Psychological health: DEPRESSION [Time frame: 9-12weeks]
- Psychological health: ANXIETY [Time frame: 9-12weeks]
- Psychological health: NONSPECIFIC PERCEIVED STRESS [Time frame: 9-12weeks]
- Psychological health: SPECIFIC PERCEIVED STRESS [Time frame: 9-12weeks]
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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
Czechia · 1 center
- Gynecologic Oncology Center in Prague — Prague
Publications
- Cook PC, Leit ME. Issues in the pediatric athlete. Orthop Clin North Am. 1995 Jul;26(3):453-64. PMID 7609960
- Althoff FC, Neb H, Herrmann E, Trentino KM, Vernich L, Fullenbach C, Freedman J, Waters JH, Farmer S, Leahy MF, Zacharowski K, Meybohm P, Choorapoikayil S. Multimodal Patient Blood Management Program Based on a Three-pillar Strategy: A Systematic Review and Meta-analysis. Ann Surg. 2019 May;269(5):794-804. doi: 10.1097/SLA.0000000000003095. PMID 30418206
- Peteroy ET, Pirrello PE, Adams N. The relationship between two Wiggins Content Scales and length of hospitalization. J Clin Psychol. 1982 Apr;38(2):344-6. doi: 10.1002/1097-4679(198204)38:23.0.co;2-z. PMID 7068871
- Barberan-Garcia A, Ubre M, Roca J, Lacy AM, Burgos F, Risco R, Momblan D, Balust J, Blanco I, Martinez-Palli G. Personalised Prehabilitation in High-risk Patients Undergoing Elective Major Abdominal Surgery: A Randomized Blinded Controlled Trial. Ann Surg. 2018 Jan;267(1):50-56. doi: 10.1097/SLA.0000000000002293. PMID 28489682
- Beck A, Vind Thaysen H, Hasselholt Soegaard C, Blaakaer J, Seibaek L. Prehabilitation in cancer care: patients' ability to prepare for major abdominal surgery. Scand J Caring Sci. 2021 Mar;35(1):143-155. doi: 10.1111/scs.12828. Epub 2020 Feb 11. PMID 32043644
- Benzo R, Wigle D, Novotny P, Wetzstein M, Nichols F, Shen RK, Cassivi S, Deschamps C. Preoperative pulmonary rehabilitation before lung cancer resection: results from two randomized studies. Lung Cancer. 2011 Dec;74(3):441-5. doi: 10.1016/j.lungcan.2011.05.011. Epub 2011 Jun 12. PMID 21663994
- Biglia N, Zanfagnin V, Daniele A, Robba E, Bounous VE. Lower Body Lymphedema in Patients with Gynecologic Cancer. Anticancer Res. 2017 Aug;37(8):4005-4015. doi: 10.21873/anticanres.11785. PMID 28739682
- Blackwell JEM, Doleman B, Boereboom CL, Morton A, Williams S, Atherton P, Smith K, Williams JP, Phillips BE, Lund JN. High-intensity interval training produces a significant improvement in fitness in less than 31 days before surgery for urological cancer: a randomised control trial. Prostate Cancer Prostatic Dis. 2020 Dec;23(4):696-704. doi: 10.1038/s41391-020-0219-1. Epub 2020 Mar 10. PMID 32157250
Identifiers
NCT: NCT04789694 · PHOCUS_38/20