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

NCT07716800 | Not Yet Recruiting

• 1 other identifier: 27584
• Study Type: observational
• Target: 205
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Ovarian Cancer; Cognitive Decline; Delirium

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 12 months

Secondary Outcomes (6)

• 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

Study Arms (1)

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.

Eligibility Criteria

• Age: 70 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• Age \<70 years.
• Refusal or inability to provide written informed consent and absence of a legally authorized representative.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

MeSH Terms

Conditions

Ovarian Neoplasms; Cognitive Dysfunction; Delirium

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Maria Beatrice Zazzara

  Fondazione Policlinico Universitario Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Beatrice Zazzara, MD

CONTACT

+390630151; mariabeatrice.zazzara@policlinicogemelli.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 21, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): September 1, 2029
• Last Updated: July 21, 2026

Record last verified: 2026-06