Ovarian Endometrioid Adenocarcinoma Clinical Trial
Official title:
A Prospective Study of Cognitive Function During Chemotherapy for Front-Line Treatment of Ovarian, Primary Peritoneal or Fallopian Tube Cancer
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.
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.
TERTIARY OBJECTIVES:
I. To explore the relationship between patient-reported quality of life as measured by the
FACT-O and cognitive function as measured by the web-based and patient-reported assessments,
respectively. (Exploratory) II. To explore whether the patient-reported cognitive function or
the web-based assessment of cognitive function is associated with anxiety and depression as
measured by the Hospital Anxiety and Depression Scale. (Exploratory) III. To explore the
changes in cognitive function using the web-assessed (CRT) and self-reported (PAF)
assessments, respectively, among patients with advanced ovarian cancer (stage III-IV,
optimally debulked disease at enrollment) receiving IV as compared to intraperitoneal
treatment. (Exploratory) IV. To explore whether the cognitive impairment as measured with
web-based assessment is associated with patient age, hemoglobin, platelet count,
patient-reported neurotoxicity symptoms as measured with FACT/GOG-Ntx subscale, or body
weight. (Exploratory)
OUTLINE: This is a multicenter study.
Patients receive standard chemotherapy. Treatment repeats for 6 courses. Patients complete
neurocognitive evaluations (Patient Assessment and Own Functioning scale and HeadMinder
Custom Research Tool) and quality-of-life assessments (Hospital Anxiety and Depression Scale,
FACT-O, and FACT/GOG-Ntx subscale) at baseline, before the fourth course of chemotherapy, at
3 weeks after the sixth course of chemotherapy, and at 6 months after the sixth course of
chemotherapy.
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