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妇科癌症患者的预康复 (PHOCUS)

2026年9月24日 更新者:David Cibula、Charles University, Czech Republic

计划推迟手术治疗的妇科癌症患者的预康复:一项前瞻性随机试验。

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (估计的)

64

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

      • Prague、捷克语、12000
        • 招聘中
        • Gynecologic Oncology Center in Prague
        • 接触:
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 85年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

女性

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
无干预:A

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

实验性的: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.

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

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Functional capacity changes
大体时间:9-12weeks

Six-minute walking test (6MWT)

9-12weeks

次要结果测量

结果测量
措施说明
大体时间
术后住院时间(天)
大体时间:9-12周
9-12周
营养支持计划对身体成分的影响(脂肪重量和瘦体重,单位为 kg)
大体时间:9-12周
9-12周
营养支持计划对静息能量消耗的影响(以千卡/千克为单位)。
大体时间:9-12周
9-12周
营养支持计划对血浆和红细胞磷脂脂肪酸组成的影响(以 mol% 计)。
大体时间:9-12周
9-12周
Postoperative morbidity
大体时间:9-12weeks

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
Adherence to training program
大体时间:9-12weeks

Daily step count and number of resistance exercises per week.

9-12weeks
Health-related quality of life
大体时间:9-12weeks

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
大体时间:9-12weeks

The Beck Depression Inventory: a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression.

9-12weeks
Psychological health: ANXIETY
大体时间:9-12weeks

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
大体时间:9-12weeks

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
大体时间:9-12weeks

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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:David Cibula, prof.、Charles University, Czech Republic

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年3月25日

初级完成 (实际的)

2026年6月30日

研究完成 (估计的)

2026年12月31日

研究注册日期

首次提交

2021年2月1日

首先提交符合 QC 标准的

2021年3月8日

首次发布 (实际的)

2021年3月9日

研究记录更新

最后更新发布 (实际的)

2026年9月28日

上次提交的符合 QC 标准的更新

2026年9月24日

最后验证

2026年9月1日

更多信息

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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