Cognitive Impact of Neoadjuvant Chemotherapy for Ovarian Cancer
NCT ID: NCT07125209
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
18 participants
OBSERVATIONAL
2026-01-31
2027-11-30
Brief Summary
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Detailed Description
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The NCCN distress thermometer is used to screen for distress levels routinely in the gynecologic oncology clinic. For those who complete this screening as part of their clinical care, those results will also be used as a quality of life measure. The cognitive domains of learning and memory, processing speed, and executive function will be assessed using the Rey Verbal Learning Test, Trail Making Test, and the Controlled Oral Word Association of the Multilingual Aphasia Examination, as recommended by the International Cognition and Cancer Task force for studies of cognition in cancer patients.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Receiving Neoadjuvant Chemotherapy for Ovarian Cancer
Patient Reported Outcomes Assessment
Functional Assessment of Cancer Therapy - Ovarian (FACT-O) and Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) will be used to assess patient reported outcomes.
Cognitive and General Health Assessments
* Rey Verbal Learning Test
* Trail Making Test
* Patient Health Questionnaire (PHQ-2)
* Mini Mental State Exam (MMSE)
* Controlled Oral Word Association Test of the Multilingual Aphasia Examination
Interventions
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Patient Reported Outcomes Assessment
Functional Assessment of Cancer Therapy - Ovarian (FACT-O) and Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) will be used to assess patient reported outcomes.
Cognitive and General Health Assessments
* Rey Verbal Learning Test
* Trail Making Test
* Patient Health Questionnaire (PHQ-2)
* Mini Mental State Exam (MMSE)
* Controlled Oral Word Association Test of the Multilingual Aphasia Examination
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Pathological diagnosis of suspected epithelial ovarian cancer; of note, patients with suspected epithelial ovarian cancer who are pending a pathological diagnosis/biopsy may be enrolled onto the study ahead of their biopsy. If the biopsy result is later inconsistent with epithelial ovarian cancer, they will be removed from the study and replaced
* Planned to received neoadjuvant chemotherapy with carboplatin and paclitaxel; alternatives to these agents including abraxane, docetaxel, cisplatin may be used if patients have a chemotherapy reaction or otherwise cannot receive carboplatin and paclitaxel per usual standard of care
* Patients may be receiving bevacizumab and may receive PARP inhibitors as a maintenance treatment; those receiving any other targeted therapy will be excluded
Exclusion Criteria
* History of traumatic brain injury
* English is not their primary language
* Known hearing or visual impairment not corrected with hearing devices and glasses/contacts
* Upper extremity motor impairment that would impact ability to perform the Trail Making Test
* Baseline Mini Mental State Exam (MMSE) score less than 18
18 Years
FEMALE
No
Sponsors
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University of Wisconsin, Madison
OTHER
Responsible Party
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Principal Investigators
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Lisa Barroilhet, MD
Role: PRINCIPAL_INVESTIGATOR
UW Carbone Cancer Center
Locations
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UW Carbone Cancer Center
Madison, Wisconsin, United States
Countries
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Central Contacts
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Other Identifiers
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SMPH/OB-GYN/GYN ONCOLOGY
Identifier Type: OTHER
Identifier Source: secondary_id
Protocol Version 7/23/25
Identifier Type: OTHER
Identifier Source: secondary_id
UW25061
Identifier Type: OTHER
Identifier Source: secondary_id
2025-1115
Identifier Type: -
Identifier Source: org_study_id