Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2011-02213 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| GOG-0256 | |||
| CDR0000666786 | |||
| GOG-0256 | Other Identifier | Gynecologic Oncology Group | |
| GOG-0256 | Other Identifier | DCP | |
| GOG-0256 | Other Identifier | CTEP | |
| U10CA101165 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational (cognitive function during chemotherapy) | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Assessment | Procedure | Ancillary studies |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive function as measured by the HeadMinder Customized Research Tool (CRT) | Up to 6 months after completion of chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-reported cognitive function as measured by Patient Assessment Own Functioning scale and web CRT | Up to 6 months after completion of chemotherapy |
Not provided
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
GOG performance status 0-2
Able to read and understand English
No uncontrolled or severe cardiovascular disease, including any of the following:
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
No prior radiotherapy or chemotherapy
Not provided
Not provided
Not provided
Patients With Stage I, Stage II, Stage III, or Stage IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Who Are Receiving Chemotherapy
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lisa Hess | Gynecologic Oncology Group | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Arizona Cancer Center-North Campus | Tucson | Arizona | 85719 | United States | ||
| University of Arkansas for Medical Sciences |
Not provided
Not provided
Not provided
Not provided
| Quality-of-Life Assessment | Other | Ancillary studies |
|
|
| 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 | 46514-2098 | 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 | 50266-7700 | 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 | 48106-0995 | 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 City | 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 | 54301-3526 | 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 |
| ID | Term |
|---|---|
| D001948 | Brenner Tumor |
| D004407 | Dysgerminoma |
| C562731 | Teratoma, Ovarian |
| D010051 | Ovarian Neoplasms |
| D005185 | Fallopian Tube Neoplasms |
| ID | Term |
|---|---|
| D018225 | Neoplasms, Fibroepithelial |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009375 | Neoplasms, Glandular and Epithelial |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D018237 | Germinoma |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D005184 | Fallopian Tube Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000073216 | Mental Status and Dementia Tests |
| ID | Term |
|---|---|
| D009483 | Neuropsychological Tests |
| D011581 | Psychological Tests |
| D004191 | Behavioral Disciplines and Activities |
Not provided
Not provided