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Идёт набор NCT07220512

The Better, Harder, Faster, Stronger Study

— Наблюдательное Frailty at Older Adults Ovarian Cancer Endometrial Cancer Cognitive Dysfunction

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: data collection.
Кому может быть актуально
Состояния в реестре: Frailty at Older Adults, Ovarian Cancer, Endometrial Cancer, Cognitive Dysfunction. Базовые параметры: от 55 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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Официальное название

The BHFS Study (Better, Harder, Faster, Stronger): Does Neoadjuvant Chemotherapy Improve Fitness for Surgery?

Обзор

The purpose of this study is to evaluate changes in the electronic Frailty Index (eFI) score following 3-4 cycles of neoadjuvant chemotherapy (NACT) in participants with advanced ovarian and endometrial cancer.

Подробное описание

This observation study is designed investigate changes in frailty and cognitive function in participants with advanced ovarian and endometrial cancer before and after undergoing NACT.

Changes in frailty and cognitive function will be measured using the eFI which is an automated EMR-based tool based that uses a combination of clinical encounters, diagnosis codes, laboratory workups, and Medicare annual wellness visit data as markers of frailty status.

Participants with either ovarian/primary peritoneal/fallopian tube carcinoma or endometrial carcinoma will be approached for interest in participating in this study.

Prior to the first prechemotherapy appointment, eFI will be collected as well as PROs (Functional Assessment of Cancer Therapy - Cognitive Function (FACT-Cog), Patient Health Questionnaire-2 and MoCA (Montreal Cognitive Assessment)) and historical data.

After 3-4 rounds of NACT, eFI, FACT-Cog and MoCA will be collected again. Data on intra-operative and post-operative complications will be collected after surgery.

Вмешательства

  • Другое data collection
    PROs, historical and longitudinal data collection and eFI calculation

Первичные конечные точки

  • Change in electronic frailty index (eFI) [Срок оценки: From pre- Neoadjuvant Chemotherapy (NACT; no later than 60 days after consent) to post-NACT (no later than 30 days after completion of the last cycle of NACT)]
Вторичные конечные точки (6)
  • Change in proportion of participants in the fit/pre-frail (eFI score ≤ 0.21) versus frail category (eFi score > 0.21) [Срок оценки: Before and after NACT - At visit 1, no later than 60 days after consent and no later than 30 days after completion of the last cycle of NACT.]
  • Prevalence of cognitive dysfunction [Срок оценки: Before NACT - At visit 1, no later than 60 days after consent]
  • Prevalence of patient-reported cognitive dysfunction [Срок оценки: Before NACT - At visit 1, no later than 60 days after consent]
  • Changes in cognitive function as measured by MoCA [Срок оценки: Before NACT - At visit 1, no later than 60 days after consent and Post-NACT - no later than 30 days after completion of the last cycle of NACT]
  • Changes in cognitive function as measured by FACT-Cog PCI [Срок оценки: Before NACT - At visit 1, no later than 60 days after consent and Post-NACT - no later than 30 days after completion of the last cycle of NACT]
  • Prevalence of mood disorder [Срок оценки: Before NACT - At visit 1, no later than 60 days after consent]

Критерии участия

Критерии включения

  • Ability to understand and willingness to sign an IRB-approved informed consent.
  • Age > 55 years at the time of enrollment.
  • Newly diagnosed suspected ovarian/primary peritoneal/fallopian tube carcinoma of any histological subtype, FIGO Stage II-IV, per enrolling investigator, or newly diagnosed suspected endometrial carcinoma of any histologic subtype, FIGO Stage II-IV, per enrolling investigator.
  • Planned for 3 or 4 cycles of NACT, with interval cytoreductive surgery planned thereafter.
  • Ability to read, understand, and write the English language.
  • As determined by the enrolling investigator, ability of the participant to understand and comply with study procedures for the entire length of the study.

Критерии исключения

  • History of brain metastases.
  • History of poorly controlled psychiatric conditions, defined as hospitalization within the prior 3 months for psychiatric disorders, traumatic brain injury, cerebrovascular event, or dementia, per the enrolling investigator.
  • Use of anti-amyloid agents, cholinesterase inhibitors, or Memantine for Alzheimers/cognitive impairment, at the time of enrollment.
  • Vision impairment that would impede completion of study assessments, per enrolling investigator.

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
  • Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem

Идентификаторы

NCT: NCT07220512 · IRB00129176 · ONC-GYN-2401

Первоисточники (государственные реестры)

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