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.

View Full Description

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.

View Eligibility Criteria

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

Study is for people with:

Ovarian Cancer

Estimated Enrollment:

247

Study ID:

NCT01080521

Recruitment Status:

Completed

Sponsor:

Gynecologic Oncology Group

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There are 155 Locations for this study

See Locations Near You

University of Arizona Cancer Center-North Campus
Tucson Arizona, 85719, United States
University of Arkansas for Medical Sciences
Little Rock Arkansas, 72205, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank California, 91505, United States
Roy and Patricia Disney Family Cancer Center
Burbank California, 91505, United States
Cedars-Sinai Medical Center
Los Angeles California, 90048, United States
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles California, 90095, United States
Palo Alto Medical Foundation-Gynecologic Oncology
Mountain View California, 94040, United States
University of California San Diego
San Diego California, 92103, United States
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora Colorado, 80045, United States
Hartford Hospital
Hartford Connecticut, 06102, United States
Smilow Cancer Hospital Care Center at Saint Francis
Hartford Connecticut, 06105, United States
The Hospital of Central Connecticut
New Britain Connecticut, 06050, United States
Florida Hospital Orlando
Orlando Florida, 32803, United States
John B Amos Cancer Center
Columbus Georgia, 31904, United States
Northeast Georgia Medical Center
Gainesville Georgia, 30501, United States
Northwestern University
Chicago Illinois, 60611, United States
Decatur Memorial Hospital
Decatur Illinois, 62526, United States
NorthShore University HealthSystem-Evanston Hospital
Evanston Illinois, 60201, United States
Memorial Medical Center
Springfield Illinois, 62781, United States
Elkhart Clinic
Elkhart Indiana, 46514, United States
Michiana Hematology Oncology PC-Elkhart
Elkhart Indiana, 46514, United States
Elkhart General Hospital
Elkhart Indiana, 46515, United States
Indiana University/Melvin and Bren Simon Cancer Center
Indianapolis Indiana, 46202, United States
Community Howard Regional Health
Kokomo Indiana, 46904, United States
IU Health La Porte Hospital
La Porte Indiana, 46350, United States
Michiana Hematology Oncology PC-Mishawaka
Mishawaka Indiana, 46545, United States
Saint Joseph Regional Medical Center-Mishawaka
Mishawaka Indiana, 46545, United States
Michiana Hematology Oncology PC-Plymouth
Plymouth Indiana, 46563, United States
Memorial Hospital of South Bend
South Bend Indiana, 46601, United States
Michiana Hematology Oncology PC-South Bend
South Bend Indiana, 46601, United States
South Bend Clinic
South Bend Indiana, 46617, United States
Northern Indiana Cancer Research Consortium
South Bend Indiana, 46628, United States
Michiana Hematology Oncology PC-Westville
Westville Indiana, 46391, United States
Medical Oncology and Hematology Associates-West Des Moines
Clive Iowa, 50325, United States
Mercy Cancer Center-West Lakes
Clive Iowa, 50325, United States
Iowa Methodist Medical Center
Des Moines Iowa, 50309, United States
Iowa-Wide Oncology Research Coalition NCORP
Des Moines Iowa, 50309, United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines Iowa, 50309, United States
Medical Oncology and Hematology Associates-Laurel
Des Moines Iowa, 50314, United States
Mercy Medical Center - Des Moines
Des Moines Iowa, 50314, United States
Iowa Lutheran Hospital
Des Moines Iowa, 50316, United States
University of Iowa/Holden Comprehensive Cancer Center
Iowa City Iowa, 52242, United States
Methodist West Hospital
West Des Moines Iowa, 50266, United States
Mercy Medical Center-West Lakes
West Des Moines Iowa, 50266, United States
Cancer Center of Kansas - Chanute
Chanute Kansas, 66720, United States
Cancer Center of Kansas - Dodge City
Dodge City Kansas, 67801, United States
Cancer Center of Kansas - El Dorado
El Dorado Kansas, 67042, United States
Cancer Center of Kansas - Fort Scott
Fort Scott Kansas, 66701, United States
Cancer Center of Kansas-Independence
Independence Kansas, 67301, United States
University of Kansas Cancer Center
Kansas City Kansas, 66160, United States
Cancer Center of Kansas-Kingman
Kingman Kansas, 67068, United States
Lawrence Memorial Hospital
Lawrence Kansas, 66044, United States
Cancer Center of Kansas-Liberal
Liberal Kansas, 67905, United States
Cancer Center of Kansas - Newton
Newton Kansas, 67114, United States
Menorah Medical Center
Overland Park Kansas, 66209, United States
Saint Luke's South Hospital
Overland Park Kansas, 66213, United States
Cancer Center of Kansas - Parsons
Parsons Kansas, 67357, United States
Kansas City NCI Community Oncology Research Program
Prairie Village Kansas, 66208, United States
Cancer Center of Kansas - Pratt
Pratt Kansas, 67124, United States
Cancer Center of Kansas - Salina
Salina Kansas, 67401, United States
Shawnee Mission Medical Center-KCCC
Shawnee Mission Kansas, 66204, United States
Cancer Center of Kansas - Wellington
Wellington Kansas, 67152, United States
Associates In Womens Health
Wichita Kansas, 67208, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita Kansas, 67208, United States
Cancer Center of Kansas - Wichita
Wichita Kansas, 67214, United States
Via Christi Regional Medical Center
Wichita Kansas, 67214, United States
Wichita NCI Community Oncology Research Program
Wichita Kansas, 67214, United States
Cancer Center of Kansas - Winfield
Winfield Kansas, 67156, United States
Maine Medical Center-Bramhall Campus
Portland Maine, 04102, United States
Baystate Medical Center
Springfield Massachusetts, 01199, United States
Saint Joseph Mercy Hospital
Ann Arbor Michigan, 48106, United States
Michigan Cancer Research Consortium NCORP
Ann Arbor Michigan, 48106, United States
Bronson Battle Creek
Battle Creek Michigan, 49017, United States
Spectrum Health Big Rapids Hospital
Big Rapids Michigan, 49307, United States
Beaumont Hospital-Dearborn
Dearborn Michigan, 48124, United States
Saint John Hospital and Medical Center
Detroit Michigan, 48236, United States
Hurley Medical Center
Flint Michigan, 48502, United States
Genesys Regional Medical Center-West Flint Campus
Flint Michigan, 48532, United States
Genesys Regional Medical Center
Grand Blanc Michigan, 48439, United States
Cancer Research Consortium of West Michigan NCORP
Grand Rapids Michigan, 49503, United States
Mercy Health Saint Mary's
Grand Rapids Michigan, 49503, United States
Spectrum Health at Butterworth Campus
Grand Rapids Michigan, 49503, United States
Allegiance Health
Jackson Michigan, 49201, United States
Borgess Medical Center
Kalamazoo Michigan, 49001, United States
Bronson Methodist Hospital
Kalamazoo Michigan, 49007, United States
West Michigan Cancer Center
Kalamazoo Michigan, 49007, United States
Sparrow Hospital
Lansing Michigan, 48912, United States
Saint Mary Mercy Hospital
Livonia Michigan, 48154, United States
Mercy Health Mercy Campus
Muskegon Michigan, 49444, United States
Michiana Hematology Oncology PC-Niles
Niles Michigan, 49120, United States
Saint Joseph Mercy Oakland
Pontiac Michigan, 48341, United States
Saint Joseph Mercy Port Huron
Port Huron Michigan, 48060, United States
William Beaumont Hospital-Royal Oak
Royal Oak Michigan, 48073, United States
Saint Mary's of Michigan
Saginaw Michigan, 48601, United States
Lakeland Hospital
Saint Joseph Michigan, 49085, United States
Marie Yeager Cancer Center
Saint Joseph Michigan, 49085, United States
Munson Medical Center
Traverse City Michigan, 49684, United States
Saint John Macomb-Oakland Hospital
Warren Michigan, 48093, United States
Metro Health Hospital
Wyoming Michigan, 49519, United States
Fairview Ridges Hospital
Burnsville Minnesota, 55337, United States
Mercy Hospital
Coon Rapids Minnesota, 55433, United States
Fairview-Southdale Hospital
Edina Minnesota, 55435, United States
Unity Hospital
Fridley Minnesota, 55432, United States
Hutchinson Area Health Care
Hutchinson Minnesota, 55350, United States
Minnesota Oncology Hematology PA-Maplewood
Maplewood Minnesota, 55109, United States
Saint John's Hospital - Healtheast
Maplewood Minnesota, 55109, United States
Abbott-Northwestern Hospital
Minneapolis Minnesota, 55407, United States
Hennepin County Medical Center
Minneapolis Minnesota, 55415, United States
North Memorial Medical Health Center
Robbinsdale Minnesota, 55422, United States
Metro Minnesota Community Oncology Research Consortium
Saint Louis Park Minnesota, 55416, United States
Park Nicollet Clinic - Saint Louis Park
Saint Louis Park Minnesota, 55416, United States
Regions Hospital
Saint Paul Minnesota, 55101, United States
United Hospital
Saint Paul Minnesota, 55102, United States
Saint Francis Regional Medical Center
Shakopee Minnesota, 55379, United States
Lakeview Hospital
Stillwater Minnesota, 55082, United States
Ridgeview Medical Center
Waconia Minnesota, 55387, United States
Rice Memorial Hospital
Willmar Minnesota, 56201, United States
Minnesota Oncology and Hematology PA-Woodbury
Woodbury Minnesota, 55125, United States
Saint Dominic-Jackson Memorial Hospital
Jackson Mississippi, 39216, United States
Truman Medical Center
Kansas City Missouri, 64108, United States
Saint Luke's Hospital of Kansas City
Kansas City Missouri, 64111, United States
Saint Joseph Health Center
Kansas City Missouri, 64114, United States
North Kansas City Hospital
Kansas City Missouri, 64116, United States
Heartland Hematology and Oncology Associates Incorporated
Kansas City Missouri, 64118, United States
Research Medical Center
Kansas City Missouri, 64132, United States
Saint Luke's East - Lee's Summit
Lee's Summit Missouri, 64086, United States
Liberty Hospital
Liberty Missouri, 64068, United States
Heartland Regional Medical Center
Saint Joseph Missouri, 64506, United States
Saint Joseph Oncology Inc
Saint Joseph Missouri, 64507, United States
Mercy Hospital Springfield
Springfield Missouri, 65804, United States
Women's Cancer Center of Nevada
Las Vegas Nevada, 89169, United States
Dartmouth Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States
Jersey Shore Medical Center
Neptune New Jersey, 07753, United States
Duke University Medical Center
Durham North Carolina, 27710, United States
FirstHealth of the Carolinas-Moore Regional Hosiptal
Pinehurst North Carolina, 28374, United States
Duke Raleigh Hospital
Raleigh North Carolina, 27609, United States
Wake Forest University Health Sciences
Winston-Salem North Carolina, 27157, United States
Summa Akron City Hospital/Cooper Cancer Center
Akron Ohio, 44304, United States
Akron General Medical Center
Akron Ohio, 44307, United States
Case Western Reserve University
Cleveland Ohio, 44106, United States
Riverside Methodist Hospital
Columbus Ohio, 43214, United States
Lake University Ireland Cancer Center
Mentor Ohio, 44060, United States
University of Oklahoma Health Sciences Center
Oklahoma City Oklahoma, 73104, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
Tulsa Oklahoma, 74146, United States
Gynecologic Oncology Group
Philadelphia Pennsylvania, 19103, United States
Women and Infants Hospital
Providence Rhode Island, 02905, United States
Greenville Health System Cancer Institute-Easley
Easley South Carolina, 29640, United States
Greenville Health System Cancer Institute-Andrews
Greenville South Carolina, 29605, United States
Greenville Health System Cancer Institute-Butternut
Greenville South Carolina, 29605, United States
Greenville Health System Cancer Institute-Faris
Greenville South Carolina, 29605, United States
Greenville Memorial Hospital
Greenville South Carolina, 29605, United States
Greenville Health System Cancer Institute-Eastside
Greenville South Carolina, 29615, United States
Self Regional Healthcare
Greenwood South Carolina, 29646, United States
Cancer Centers of the Carolinas-Greer Medical Oncology
Greer South Carolina, 29650, United States
Greenville Health System Cancer Institute-Greer
Greer South Carolina, 29650, United States
Greenville Health System Cancer Institute-Seneca
Seneca South Carolina, 29672, United States
Greenville Health System Cancer Institute-Spartanburg
Spartanburg South Carolina, 29307, United States
Avera Cancer Institute
Sioux Falls South Dakota, 57105, United States
Parkland Memorial Hospital
Dallas Texas, 75235, United States
Clements University Hospital
Dallas Texas, 75390, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas Texas, 75390, United States
Huntsman Cancer Institute/University of Utah
Salt Lake City Utah, 84112, United States
University of Virginia Cancer Center
Charlottesville Virginia, 22908, United States
Virginia Mason CCOP
Seattle Washington, 98101, United States
Virginia Mason Medical Center
Seattle Washington, 98101, United States
Marshfield Clinic-Chippewa Center
Chippewa Falls Wisconsin, 54729, United States
Marshfield Clinic Cancer Center at Sacred Heart
Eau Claire Wisconsin, 54701, United States
Green Bay Oncology at Saint Vincent Hospital
Green Bay Wisconsin, 54301, United States
Saint Vincent Hospital
Green Bay Wisconsin, 54301, United States
Green Bay Oncology Limited at Saint Mary's Hospital
Green Bay Wisconsin, 54303, United States
Saint Mary's Hospital
Green Bay Wisconsin, 54303, United States
University of Wisconsin Hospital and Clinics
Madison Wisconsin, 53792, United States
Marshfield Clinic
Marshfield Wisconsin, 54449, United States
Aurora Saint Luke's Medical Center
Milwaukee Wisconsin, 53215, United States
Marshfield Clinic-Minocqua Center
Minocqua Wisconsin, 54548, United States
Marshfield Clinic at James Beck Cancer Center
Rhinelander Wisconsin, 54501, United States
Marshfield Clinic-Rice Lake Center
Rice Lake Wisconsin, 54868, United States
Vince Lombardi Cancer Clinic-Sheboygan
Sheboygan Wisconsin, 53081, United States
Marshfield Clinic Cancer Care at Saint Michael's Hospital
Stevens Point Wisconsin, 54481, United States
Aurora West Allis Medical Center
West Allis Wisconsin, 53227, United States
Marshfield Clinic - Weston Center
Weston Wisconsin, 54476, United States
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids Wisconsin, 54494, United States

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Estimated Enrollment:

247

Study ID:

NCT01080521

Recruitment Status:

Completed

Sponsor:


Gynecologic Oncology Group

How clear is this clinincal trial information?

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