Prehabilitation in Gynaecological Cancer Patients

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Physiological intervention
  * Rehabilitation specialist consultation (3x) * Individualized home-based exercise plan * Functional capacity measuring
• Поведенческое Psychological intervention
  * Clinical psychologist consultation (3x) * Anxiety and depression scoring * Psychological support
• Пищевая добавка Nutritional intervention
  * Nutritional specialist consultation (3x) * Malnutrition scoring * Dietary supplementation

Первичные конечные точки

• Functional capacity changes [Срок оценки: 9-12weeks]

Вторичные конечные точки (11)

• Postoperative morbidity [Срок оценки: 9-12weeks]
• Length of postoperative hospital stay (days) [Срок оценки: 9-12weeks]
• Adherence to training program [Срок оценки: 9-12weeks]
• Effects of nutritional support program on body composition (weight of fat and lean body mass in kg) [Срок оценки: 9-12weeks]
• Effects of nutritional support program on resting energy expenditure (measured in kcal/kg). [Срок оценки: 9-12weeks]
• Effects of nutritional support program on Fatty acids composition of plasmatic and erythrocytes phospholipids (measured in mol%). [Срок оценки: 9-12weeks]
• Health-related quality of life [Срок оценки: 9-12weeks]
• Psychological health: DEPRESSION [Срок оценки: 9-12weeks]
• Psychological health: ANXIETY [Срок оценки: 9-12weeks]
• Psychological health: NONSPECIFIC PERCEIVED STRESS [Срок оценки: 9-12weeks]
• Psychological health: SPECIFIC PERCEIVED STRESS [Срок оценки: 9-12weeks]

Критерии участия

Критерии включения

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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

Чехия · 1 центр

• Gynecologic Oncology Center in Prague — Prague

Публикации

• 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

Идентификаторы

NCT: NCT04789694 · PHOCUS_38/20

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗