FRAGINOC Study: The Impact of FRAilty Screening and Geriatric Assessment and Intervention in Older Patients With Epithelial Ovarian Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 10
- 主要终点
- Interval Debulking Surgery
研究概览
简要总结
Ovarian cancer (OC) is the fifth most common cause of cancer death. More than 40% are older than 70 years. The standard treatment is radical surgery combined with chemotherapy. More than 40% of the Danish patients will never undergo surgery. Frail and immunodeficient older patients are at higher risk of complications, and immunomodulating treatment as chemotherapy results in different outcomes in comparable patients. No accurate validated screening tool to identify frail and immunodeficient OC women exists. Optimization through comprehensive geriatric assessment (CGA) and physical training before and during treatment may improve outcomes and decrease associated risks.
Aim: Primary endpoints will be to determine whether a CGA and physical training vs standard of care can increase the proportion of patients later on referred to interval debulking surgery, and examine the performance of validated screening tests in predicting impairments in CGA. Other endpoints will be to evaluate if intervention can improve completion of chemotherapy, to examine the association between frailty screening scores and selected biomarkers with treatment outcomes, including complications and quality of life, and ultimately to develop an improved frailty screening tool based on known screening tools, functional tests and biomarkers identifying patients who will benefit from CGA.
Method: This is a nationwide, randomized intervention study. Patients ≥70 years diagnosed with primary OC at the Gynecological departments of Rigshospitalet, Odense and Roskilde University Hospitals will be included. In an interdisciplinary collaboration between medical specialists in oncology, gynecology and geriatrics, included patients will be screened for frailty using validated screening tools and functional tests. Specific biomarkers and immunologic profile will be assessed in all patients. Patients selected for neoadjuvant chemotherapy will be randomized to receive CGA or standard of care. Patients selected for primary debulking surgery or palliation will be followed in an observational cohort.
Perspective: The development of a validated screening tool for frailty assessment and immunological status will help us identify frail patients who may need optimization before treatment, resulting in more patients getting optimal treatment (either surgery or chemotherapy), prevent post-treatment complications and avoid palliative patients from undergoing a redundant complex treatment.
详细描述
Introduction
Several studies have shown that a high percentage of patients with epithelial ovarian cancer (EOC) are undertreated due to their age, even in the absence of comorbidity. On the other hand, there seems to exist a group of frail patients unfit for extensive treatment that are over-treated. Therefore, it is of great interest to identify the group of older patients with EOC, who are frail and would benefit of a comprehensive geriatric assessment and optimisation, including individualised physical training. Unfortunately, no specific screening tool can be recommended or discouraged, and none of these tests are validated in patients with EOC.
Immunodeficiency and biomarkers regarding nutritional status, strength, and general health are not part of the standard evaluation, although several studies have shown a correlation between these factors and the functional independence of older patients, comorbidity, postoperative complications, tolerance to chemotherapy and quality of life.
In oncologic geriatrics a Comprehensive Geriatric Assessment (CGA - an examination performed by an interdisciplinary geriatric team) can be performed before start of treatment. Unfortunately, a complete CGA is both time and resource consuming, and the impact of interventions in older patients with EOC has never been examined.
Hypothesis and purpose
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 120 Years（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed ovarian cancer
- •Capable of understanding written and oral danish
排除标准
- •Other active cancers in the preceding 5 years
- •Severe psychiatric disease
- •Patients referred to primary debulking surgery will be followed in a observational design
结局指标
主要结局
Interval Debulking Surgery
时间窗: Up to 8 months
Proportion of patients referred to interval debulking surgery
Frailty screening questionnaires
时间窗: Up to 8 months
Specificity and positive and negative predictive values of Geriatric-8, modified Geriatric-8 and Clinical Frailty Scale, in predicting impairments in Comprehensive Geriatric assessment
次要结局
- Completion of chemotherapy treatment(Up to 8 months)
- Effect of physical training: Physical function in relation to balance(Up to 8 months)
- Effect of physical training: Clinical reported measurements(Up to 8 months)
- Effect of physical training: Self-reported measurements(Up to 8 months)
- Patient-reported outcomes measures (PROMs)(Up to 8 months)
- Effect of training: Physical capacity and endurance(Up to 8 months)
- Effect of physical training: Physical function in relation to basic mobility(Up to 8 months)
- Effect of training: Physical function and strength(Up to 8 months)
- Postoperative complications(Up to 8 months)
- Frailty screening combined tool(Up to 8 months)
- Progression Free-Survival(Up to 2 years)
研究者
Tine Henrichsen Schnack
MD, PhD, Associate Professor
Odense University Hospital