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
- Conditions
- Malignant Ovarian Epithelial TumorOvarian PolyembryomaStage I Ovarian CancerStage IA Ovarian CancerStage IA Ovarian Germ Cell TumorStage IB Ovarian Germ Cell TumorStage IC Fallopian Tube CancerStage IIC Ovarian Germ Cell TumorStage IIIA Ovarian CancerStage IIIA Primary Peritoneal Cancer
- Registration Number
- NCT01080521
- Lead Sponsor
- Gynecologic Oncology Group
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 247
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Histologically or pathologically confirmed primary diagnosis of stage I-IV ovarian, primary peritoneal, or fallopian tube cancer (any cell type)
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Planning to receive ≥ 6 courses of front-line chemotherapy
- Have not yet received the first course of chemotherapy
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GOG performance status 0-2
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Able to read and understand English
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No uncontrolled or severe cardiovascular disease, including any of the following:
- Myocardial infarction within the past year
- Uncontrolled hypertension
- Congestive heart failure
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No history of head injury with GCS < 13
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No severe hemiparesis or other condition preventing bimanual keyboard operation
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No distal neuropathy, action tremor, or other motor dysfunction that would substantially decrease keyboard accuracy
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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)
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No other invasive malignancies within the past 5 years except for nonmelanoma skin cancer
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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
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No prior radiotherapy or chemotherapy
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cognitive function as measured by the HeadMinder Customized Research Tool (CRT) Up to 6 months after completion of chemotherapy
- Secondary Outcome Measures
Name Time Method Patient-reported cognitive function as measured by Patient Assessment Own Functioning scale and web CRT Up to 6 months after completion of chemotherapy
Trial Locations
- Locations (182)
University of Arizona Cancer Center-North Campus
🇺🇸Tucson, Arizona, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
🇺🇸Burbank, California, United States
Roy and Patricia Disney Family Cancer Center
🇺🇸Burbank, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
UCLA / Jonsson Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Palo Alto Medical Foundation-Gynecologic Oncology
🇺🇸Mountain View, California, United States
University of California San Diego
🇺🇸San Diego, California, United States
University of Colorado Cancer Center - Anschutz Cancer Pavilion
🇺🇸Aurora, Colorado, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Scroll for more (172 remaining)University of Arizona Cancer Center-North Campus🇺🇸Tucson, Arizona, United States