View Clinical Trial (Medical Research Study)
A Prospective Study of Cognitive Function During Chemotherapy for Front-Line Treatment of Ovarian, Primary Peritoneal or Fallopian Tube Cancer
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Providence |
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Rhode Island |
| Zip Code: |
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02905 |
| Conditions: |
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Cognitive/Functional Effects - Fallopian Tube Cancer - Ovarian Cancer - Primary Peritoneal Cavity Cancer |
| Purpose: |
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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.
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| Study Summary: |
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OBJECTIVES:
Primary
- 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
- 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.
Tertiary
- 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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| Criteria: |
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DISEASE CHARACTERISTICS:
- 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
PATIENT CHARACTERISTICS:
- 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
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- No prior radiotherapy or chemotherapy
- 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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| NCT ID: |
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NCT01080521 |
| Primary Contact: |
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Study Chair
Lisa M. Hess, PhD
Indiana University School of Medicine
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| Backup Contact: |
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N/A |
| Location Contact: |
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Providence, Rhode Island 02905
United States
Clinical Trials Office - Women and Infants Hospital of Rhode I
Phone: 401-274-1122
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 23, 2013 |
| Modifications to this listing: |
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