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.
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).
Age <70 years.
Refusal or inability to provide written informed consent and absence of a legally authorized representative.
Women aged ≥70 years with ovarian cancer undergoing active treatment will be recruited from the Oncogeriatric Outpatient Clinic of the Palliative Care and Geriatric Oncology Unit. Eligible patients will be referred by the Gynecologic Oncology Unit for pre-treatment geriatric assessment during the pre-admission evaluation, upon request from the Women's Cancer Day Hospital or the Clinical Pharmacology Day Hospital, or following multidisciplinary discussion at the Ovarian Cancer Tumor Board.
Cohort
Prospective
Not listed
Incident Cognitive Decline
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.
Prevalent Cognitive Impairment
Prevalent cognitive impairment at baseline, defined as an MMSE score \<26 and/or objective cognitive impairment based on 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 subjective cognitive impairment defined by a FACT-Cog Perceived Cognitive Impairment (PCI) score \<54.
Incident Delirium
Occurrence of delirium during hospitalization, including postoperative delirium, defined as a positive 4AT screening confirmed by the Confusion Assessment Method (CAM).
Incident Disability
Incident disability, defined as the development of new dependence in one or more Activities of Daily Living (ADL) or Instrumental Activities of Daily Living (IADL) during follow-up.
Change in Quality of Life
Decline in quality of life, defined as a decrease of at least 10 points in the EORTC QLQ-C30 global health status score during follow-up.
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