Predictors of Cognitive Decline and Delirium in Older Women With Ovarian Cancer
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
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Ovarian Cancer, Cognitive Decline, Delirium. Basic parameters: from 70 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
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Detailed description
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.
Blood samples collected before treatment initiation will be analyzed to measure biomarkers of neurodegeneration and systemic inflammation, including neurofilament light chain (NfL), glial fibrillary acidic protein (GFAP), phosphorylated tau, amyloid-beta peptides, inflammatory cytokines, C-reactive protein, and other laboratory markers. These biomarkers will be integrated with clinical and geriatric assessment data to investigate their contribution to cognitive decline and delirium.
The primary objective is to determine the prevalence and incidence of cognitive decline and to identify clinical, functional, and biological predictors associated with longitudinal cognitive deterioration. Secondary objectives include evaluating the incidence and predictors of delirium, assessing the association of cognitive disorders with disability, hospitalization, mortality, and quality of life, and developing a multivariable risk prediction model capable of stratifying patients according to their probability of adverse cognitive outcomes.
By integrating comprehensive geriatric assessment with blood-based biomarkers and longitudinal follow-up, the C.R.O.W.N. study aims to improve the early identification of vulnerable older women with ovarian cancer, support individualized oncogeriatric care, and provide evidence to inform future preventive and therapeutic strategies targeting cancer-related cognitive impairment and delirium.
Primary outcome measures
- Incident Cognitive Decline [Time frame: Baseline to 12 months]
Secondary outcome measures (6)
- Prevalent Cognitive Impairment [Time frame: Baseline]
- Incident Delirium [Time frame: During hospitalization, up to 12 months]
- Incident Disability [Time frame: Baseline to 12 months]
- Change in Quality of Life [Time frame: Baseline to 12 months]
- All-Cause Mortality [Time frame: Baseline to 12 months]
- Hospitalizations [Time frame: Baseline to 12 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Age <70 years.
- Refusal or inability to provide written informed consent and absence of a legally authorized representative.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07716800 · 27584