Identification of Clinical, Functional and Biological Predictors of Cognitive Decline and deliRium in Older Women Affected by Ovarian caNcer: the C.R.O.W.N. Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 205
- 主要终点
- Incident Cognitive Decline
研究概览
简要总结
Cognitive decline and delirium are common geriatric syndromes that adversely affect treatment adherence, functional independence, quality of life, and survival in older adults with cancer. Women aged 70 years and older with ovarian cancer are particularly vulnerable because of the combined effects of aging, frailty, multimorbidity, and cancer-related factors. However, the prevalence, incidence, determinants, and longitudinal trajectories of cognitive impairment and delirium in this population remain poorly characterized, and validated strategies for risk stratification are lacking.
The C.R.O.W.N. (Identification of clinical, functional and biological predictors of Cognitive decline and deliRium in Older Women affected by ovarian caNcer) study is a prospective, single-center, longitudinal observational cohort study designed to identify clinical, functional, and biological predictors of cognitive decline and delirium in older women with ovarian cancer undergoing active treatment. Women aged 70 years or older with newly diagnosed ovarian cancer or first relapse will undergo a comprehensive geriatric assessment before treatment initiation and will be followed for 12 months. Assessments will include standardized cognitive and neuropsychological testing, frailty and functional evaluation, quality-of-life assessment, and systematic delirium screening during hospitalizations. Blood samples will be collected at baseline to measure biomarkers of neurodegeneration and inflammation. Telemonitoring will complement in-person follow-up visits to improve retention and longitudinal assessment.
The primary objective is to evaluate the prevalence, incidence, and trajectory of cognitive decline and to identify its clinical, functional, and biological predictors. Secondary objectives include evaluating the occurrence and predictors of delirium, assessing the impact of cognitive disorders on disability, hospitalization, mortality, and quality of life, and developing an integrated risk prediction model combining geriatric assessment and blood-based biomarkers. The study aims to improve early identification of patients at high risk for adverse cognitive outcomes and support personalized oncogeriatric care pathways.
详细描述
Cognitive decline and delirium are frequent and clinically relevant geriatric syndromes among older adults with cancer. These conditions are associated with reduced treatment adherence, functional decline, poorer quality of life, increased hospitalization, and mortality. In older women with ovarian cancer, cognitive outcomes are influenced by a complex interaction between aging-related vulnerability, frailty, multimorbidity, cancer characteristics, and oncological treatments. Despite the increasing use of Comprehensive Geriatric Assessment (CGA) in oncology, important gaps remain in identifying patients at highest risk for cognitive decline and delirium and in understanding the biological mechanisms underlying these conditions.
The C.R.O.W.N. (Identification of clinical, functional and biological predictors of Cognitive decline and deliRium in Older Women affected by ovarian caNcer) study is a prospective, longitudinal, single-center observational cohort study designed to identify clinical, functional, and biological predictors of cognitive decline and delirium in older women with ovarian cancer undergoing active treatment.
Women aged 70 years or older with newly diagnosed ovarian cancer, regardless of disease stage, or with first disease recurrence will be enrolled before the initiation of any oncological treatment or invasive procedure. All participants will undergo a standardized Comprehensive Geriatric Assessment, including evaluation of comorbidities, medications, frailty, nutritional status, physical performance, disability, mood, quality of life, and cognitive function.
Cognitive assessment will combine subjective and objective measures. Standardized neuropsychological tests will evaluate memory, executive function, attention, verbal fluency, and global cognition, while validated patient-reported outcome measures will assess perceived cognitive impairment. Participants will undergo evaluations at baseline, 6 months, and 12 months to characterize longitudinal cognitive trajectories.
During hospital admissions, including postoperative hospitalization, participants will be systematically screened for delirium using validated assessment tools. In addition, a structured telemonitoring program based on telephone contacts, video consultations when necessary, and remote cognitive screening will support follow-up, minimize missing data, and facilitate early identification of cognitive changes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female sex with ovarian cancer.
- •Age ≥70 years.
- •Newly diagnosed ovarian cancer (any stage) or first disease recurrence.
- •Evaluation before initiation of any anticancer treatment or invasive procedure (e.g., primary cytoreductive surgery, neoadjuvant chemotherapy, image-guided biopsy, or exploratory laparoscopy).
- •Ability to understand and provide written informed consent, or availability of a legally authorized representative to provide consent.
排除标准
- •Age <70 years.
- •Refusal or inability to provide written informed consent and absence of a legally authorized representative.
结局指标
主要结局
Incident Cognitive Decline
时间窗: Baseline to 12 months
Incident cognitive decline will be defined as a clinically meaningful decline in cognitive performance, measured by a decrease of 1-3 points in the Mini-Mental State Examination (MMSE), or a decrease of ≥1.5 standard deviations in the composite score of the Trail Making Test (TMT), Hopkins Verbal Learning Test-Revised (HVLT-R), and Controlled Oral Word Association Test (COWA), and/or a decrease of ≥0.5 standard deviations in the Functional Assessment of Cancer Therapy-Cognitive Function Perceived Cognitive Impairment (FACT-Cog PCI) score.
次要结局
- Prevalent Cognitive Impairment(Baseline)
- Incident Delirium(During hospitalization, up to 12 months)
- Incident Disability(Baseline to 12 months)
- Change in Quality of Life(Baseline to 12 months)
- All-Cause Mortality(Baseline to 12 months)
- Hospitalizations(Baseline to 12 months)
研究者
Zazzara Maria Beatrice
MD, PhD
Fondazione Policlinico Universitario Agostino Gemelli IRCCS