A Prospective Study of Cognitive Function During Chemotherapy for Front-Line Treatment of Ovarian, Primary Peritoneal or Fallopian Tube Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 247
- 试验地点
- 182
- 主要终点
- Cognitive function as measured by the HeadMinder Customized Research Tool (CRT)
研究概览
简要总结
This clinical trial is studying changes in brain function in patients with stage I, stage II, stage III, or stage IV ovarian, primary peritoneal, or fallopian tube cancer who are receiving chemotherapy. Learning about the effects of chemotherapy on brain function may help doctors plan cancer treatments.
详细描述
PRIMARY OBJECTIVE:
I. To describe changes in cognitive function among patients with ovarian, primary peritoneal, or fallopian tube cancer receiving front-line chemotherapy as measured by a web-based assessment of cognitive function as measured by the HeadMinder Customized Research Tool (CRT).
SECONDARY OBJECTIVES:
I. To estimate the proportion of these patients who experience possible or probable acute or persistent impairment in cognitive function while receiving chemotherapy as measured by a web-based assessment of cognitive function as measured by the HeadMinder CRT.
II. To explore the association between the patient-reported neurocognitive function as measured by the Patient Assessment of Own Functioning (PAF) scale and web-based assessment of cognitive function as measured by the HeadMinder CRT.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Histologically or pathologically confirmed primary diagnosis of stage I-IV ovarian, primary peritoneal, or fallopian tube cancer (any cell type)
- •Planning to receive ≥ 6 courses of front-line chemotherapy
- •Have not yet received the first course of chemotherapy
- •GOG performance status 0-2
- •Able to read and understand English
- •No uncontrolled or severe cardiovascular disease, including any of the following:
- •Myocardial infarction within the past year
- •Uncontrolled hypertension
- •Congestive heart failure
- •No history of head injury with GCS < 13
- •No severe hemiparesis or other condition preventing bimanual keyboard operation
- •No distal neuropathy, action tremor, or other motor dysfunction that would substantially decrease keyboard accuracy
- •No severe motor or mental slowing (i.e., patient who is disoriented/level C on any criterion as assessed by the person-place-time criteria)
- •No other invasive malignancies within the past 5 years except for nonmelanoma skin cancer
- •More than 6 months since prior epoetin alfa, darbepoetin, or any investigational forms of erythropoietin
- •Patients may receive these agents during chemotherapy treatment as needed
- •No prior radiotherapy or chemotherapy
排除标准
- 未提供
结局指标
主要结局
Cognitive function as measured by the HeadMinder Customized Research Tool (CRT)
时间窗: Up to 6 months after completion of chemotherapy
次要结局
- Patient-reported cognitive function as measured by Patient Assessment Own Functioning scale and web CRT(Up to 6 months after completion of chemotherapy)