Predictors of Cognitive Decline and Delirium in Older Women With Ovarian Cancer

Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study ID
NCT07716800
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
FEMALE
Age
70 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

First listed
Jul 21, 2026
Start date
Sep 1, 2026
Status verified
Jun 2026
Primary completion
Jun 1, 2029
Completion
Sep 1, 2029

Study Design

Enrollment
205 participants (estimated)

Arms

  • Arm: Older Women With Ovarian Cancer
    Women aged 70 years or older with newly diagnosed ovarian cancer (any stage) or first disease recurrence, enrolled before initiation of any cancer treatment or invasive procedure. Participants will undergo comprehensive geriatric assessment, cognitive and functional evaluations, delirium screening during hospitalization, blood biomarker assessment, and longitudinal follow-up for 12 months.

Primary Outcome Measure

Incident Cognitive Decline [ Time Frame: Baseline to 12 months ]

Central Contacts

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