Ovarian Cancer Clinical Trial
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
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.
Full 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.
Eligibility Criteria
Inclusion Criteria:
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
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There are 155 Locations for this study
Tucson Arizona, 85719, United States
Little Rock Arkansas, 72205, United States
Burbank California, 91505, United States
Burbank California, 91505, United States
Los Angeles California, 90048, United States
Los Angeles California, 90095, United States
Mountain View California, 94040, United States
San Diego California, 92103, United States
Aurora Colorado, 80045, United States
Hartford Connecticut, 06102, United States
Hartford Connecticut, 06105, United States
New Britain Connecticut, 06050, United States
Orlando Florida, 32803, United States
Columbus Georgia, 31904, United States
Gainesville Georgia, 30501, United States
Chicago Illinois, 60611, United States
Decatur Illinois, 62526, United States
Evanston Illinois, 60201, United States
Springfield Illinois, 62781, United States
Elkhart Indiana, 46514, United States
Elkhart Indiana, 46514, United States
Elkhart Indiana, 46515, United States
Indianapolis Indiana, 46202, United States
Kokomo Indiana, 46904, United States
La Porte Indiana, 46350, United States
Mishawaka Indiana, 46545, United States
Mishawaka Indiana, 46545, United States
Plymouth Indiana, 46563, United States
South Bend Indiana, 46601, United States
South Bend Indiana, 46601, United States
South Bend Indiana, 46617, United States
South Bend Indiana, 46628, United States
Westville Indiana, 46391, United States
Clive Iowa, 50325, United States
Clive Iowa, 50325, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50316, United States
Iowa City Iowa, 52242, United States
West Des Moines Iowa, 50266, United States
West Des Moines Iowa, 50266, United States
Chanute Kansas, 66720, United States
Dodge City Kansas, 67801, United States
El Dorado Kansas, 67042, United States
Fort Scott Kansas, 66701, United States
Independence Kansas, 67301, United States
Kansas City Kansas, 66160, United States
Kingman Kansas, 67068, United States
Lawrence Kansas, 66044, United States
Liberal Kansas, 67905, United States
Newton Kansas, 67114, United States
Overland Park Kansas, 66209, United States
Overland Park Kansas, 66213, United States
Parsons Kansas, 67357, United States
Prairie Village Kansas, 66208, United States
Pratt Kansas, 67124, United States
Salina Kansas, 67401, United States
Shawnee Mission Kansas, 66204, United States
Wellington Kansas, 67152, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Winfield Kansas, 67156, United States
Portland Maine, 04102, United States
Springfield Massachusetts, 01199, United States
Ann Arbor Michigan, 48106, United States
Ann Arbor Michigan, 48106, United States
Battle Creek Michigan, 49017, United States
Big Rapids Michigan, 49307, United States
Dearborn Michigan, 48124, United States
Detroit Michigan, 48236, United States
Flint Michigan, 48502, United States
Flint Michigan, 48532, United States
Grand Blanc Michigan, 48439, United States
Grand Rapids Michigan, 49503, United States
Grand Rapids Michigan, 49503, United States
Grand Rapids Michigan, 49503, United States
Jackson Michigan, 49201, United States
Kalamazoo Michigan, 49001, United States
Kalamazoo Michigan, 49007, United States
Kalamazoo Michigan, 49007, United States
Lansing Michigan, 48912, United States
Livonia Michigan, 48154, United States
Muskegon Michigan, 49444, United States
Niles Michigan, 49120, United States
Pontiac Michigan, 48341, United States
Port Huron Michigan, 48060, United States
Royal Oak Michigan, 48073, United States
Saginaw Michigan, 48601, United States
Saint Joseph Michigan, 49085, United States
Saint Joseph Michigan, 49085, United States
Traverse City Michigan, 49684, United States
Warren Michigan, 48093, United States
Wyoming Michigan, 49519, United States
Burnsville Minnesota, 55337, United States
Coon Rapids Minnesota, 55433, United States
Edina Minnesota, 55435, United States
Fridley Minnesota, 55432, United States
Hutchinson Minnesota, 55350, United States
Maplewood Minnesota, 55109, United States
Maplewood Minnesota, 55109, United States
Minneapolis Minnesota, 55407, United States
Minneapolis Minnesota, 55415, United States
Robbinsdale Minnesota, 55422, United States
Saint Louis Park Minnesota, 55416, United States
Saint Louis Park Minnesota, 55416, United States
Saint Paul Minnesota, 55101, United States
Saint Paul Minnesota, 55102, United States
Shakopee Minnesota, 55379, United States
Stillwater Minnesota, 55082, United States
Waconia Minnesota, 55387, United States
Willmar Minnesota, 56201, United States
Woodbury Minnesota, 55125, United States
Jackson Mississippi, 39216, United States
Kansas City Missouri, 64108, United States
Kansas City Missouri, 64111, United States
Kansas City Missouri, 64114, United States
Kansas City Missouri, 64116, United States
Kansas City Missouri, 64118, United States
Kansas City Missouri, 64132, United States
Lee's Summit Missouri, 64086, United States
Liberty Missouri, 64068, United States
Saint Joseph Missouri, 64506, United States
Saint Joseph Missouri, 64507, United States
Springfield Missouri, 65804, United States
Las Vegas Nevada, 89169, United States
Lebanon New Hampshire, 03756, United States
Neptune New Jersey, 07753, United States
Durham North Carolina, 27710, United States
Pinehurst North Carolina, 28374, United States
Raleigh North Carolina, 27609, United States
Winston-Salem North Carolina, 27157, United States
Akron Ohio, 44304, United States
Akron Ohio, 44307, United States
Cleveland Ohio, 44106, United States
Columbus Ohio, 43214, United States
Mentor Ohio, 44060, United States
Oklahoma City Oklahoma, 73104, United States
Tulsa Oklahoma, 74146, United States
Philadelphia Pennsylvania, 19103, United States
Providence Rhode Island, 02905, United States
Easley South Carolina, 29640, United States
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29605, United States
Greenville South Carolina, 29615, United States
Greenwood South Carolina, 29646, United States
Greer South Carolina, 29650, United States
Greer South Carolina, 29650, United States
Seneca South Carolina, 29672, United States
Spartanburg South Carolina, 29307, United States
Sioux Falls South Dakota, 57105, United States
Dallas Texas, 75235, United States
Dallas Texas, 75390, United States
Dallas Texas, 75390, United States
Salt Lake City Utah, 84112, United States
Charlottesville Virginia, 22908, United States
Seattle Washington, 98101, United States
Seattle Washington, 98101, United States
Chippewa Falls Wisconsin, 54729, United States
Eau Claire Wisconsin, 54701, United States
Green Bay Wisconsin, 54301, United States
Green Bay Wisconsin, 54301, United States
Green Bay Wisconsin, 54303, United States
Green Bay Wisconsin, 54303, United States
Madison Wisconsin, 53792, United States
Marshfield Wisconsin, 54449, United States
Milwaukee Wisconsin, 53215, United States
Minocqua Wisconsin, 54548, United States
Rhinelander Wisconsin, 54501, United States
Rice Lake Wisconsin, 54868, United States
Sheboygan Wisconsin, 53081, United States
Stevens Point Wisconsin, 54481, United States
West Allis Wisconsin, 53227, United States
Weston Wisconsin, 54476, United States
Wisconsin Rapids Wisconsin, 54494, United States
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