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
Recruitment status was Recruiting
RATIONALE: Learning about the effects of chemotherapy on brain function may help doctors plan cancer treatments.
PURPOSE: 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.
Fallopian Tube Cancer
Primary Peritoneal Cavity Cancer
Drug: systemic chemotherapy
Other: questionnaire administration
Procedure: assessment of therapy complications
Procedure: cognitive assessment
Procedure: quality-of-life assessment
|Official Title:||A Prospective Study of Cognitive Function During Chemotherapy for Front-Line Treatment of Ovarian, Primary Peritoneal or Fallopian Tube Cancer|
- Cognitive function as measured by the HeadMinder Customized Research Tool (CRT) [ Designated as safety issue: No ]
- Patient-reported cognitive function as measured by Patient Assessment Own Functioning scale and web CRT [ Designated as safety issue: No ]
|Study Start Date:||April 2010|
|Estimated Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
- 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).
- 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.
- 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.
- 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)
- 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)
- 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)
- 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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|Study Chair:||Lisa M. Hess, PhD||Indiana University School of Medicine|
|Investigator:||David S. Alberts, MD||University of Arizona|