Cognitive Impact of Neoadjuvant Chemotherapy for Ovarian Cancer
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Patient Reported Outcomes Assessment, Cognitive and General Health Assessments.
- Кому может быть актуально
- Состояния в реестре: Ovarian Cancer, Cognitive Change. Базовые параметры: от 18 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The purpose of this research is to assess several components of cognition in patients recently diagnosed with advanced epithelial ovarian cancer and who will be undergoing neoadjuvant chemotherapy for treatment of the cancer. 18 participants will be enrolled and can expect to be on study for approximately 10 months.
Подробное описание
Participants undergoing neoadjuvant chemotherapy for newly diagnosed, advanced epithelial ovarian cancer will be assessed for patient reported outcomes (including subjective cognitive impairment) and objective cognitive function at baseline, following three cycles of neoadjuvant chemotherapy, at the completion of adjuvant chemotherapy or transition to alternate treatment regimen for patients who progress through primary treatment, and six months following treatment completion. Patient reported outcomes will be assessed using the FACT-O and subjective cognitive impairment will be assessed using the FACT-Cog surveys.
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.
Вмешательства
- Другое 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. - Другое 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
Первичные конечные точки
- The Mini Mental State Exam (MMSE) [Срок оценки: baseline, after 3 cycles of neoadjuvant chemotherapy (up to 2 months), after completion of adjuvant therapy (up to 4 months), and 6 months following treatment (up to 10 months on study)]
Вторичные конечные точки (6)
- Controlled Oral Word Association Test (COWAT) [Срок оценки: baseline, after 3 cycles of neoadjuvant chemotherapy (up to 2 months), after completion of adjuvant therapy (up to 4 months), and 6 months following treatment (up to 10 months on study)]
- Trail Making Test (TMT) Parts A and B [Срок оценки: baseline, after 3 cycles of neoadjuvant chemotherapy (up to 2 months), after completion of adjuvant therapy (up to 4 months), and 6 months following treatment (up to 10 months on study)]
- Patient Health Questionnaire-2 (PHQ-2) [Срок оценки: baseline, after 3 cycles of neoadjuvant chemotherapy (up to 2 months), after completion of adjuvant therapy (up to 4 months), and 6 months following treatment (up to 10 months on study)]
- Functional Assessment of Cancer Therapy - Ovarian (FACT-O) [Срок оценки: baseline, after 3 cycles of neoadjuvant chemotherapy (up to 2 months), after completion of adjuvant therapy (up to 4 months), and 6 months following treatment (up to 10 months on study)]
- Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog) [Срок оценки: baseline, after 3 cycles of neoadjuvant chemotherapy (up to 2 months), after completion of adjuvant therapy (up to 4 months), and 6 months following treatment (up to 10 months on study)]
- Rey Auditory Verbal Learning Test (RAVLT) [Срок оценки: baseline, after 3 cycles of neoadjuvant chemotherapy (up to 2 months), after completion of adjuvant therapy (up to 4 months), and 6 months following treatment (up to 10 months on study)]
Критерии участия
Критерии включения
- Age 18 or older
- 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
Критерии исключения
- History of diagnosed cognitive impairment, including dementia
- 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
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
США · 1 центр
- UW Carbone Cancer Center — Madison
Идентификаторы
NCT: NCT07125209 · 2025-1115 · SMPH/OB-GYN/GYN ONCOLOGY · Protocol Version 7/23/25 · UW25061