A Prospective Study of Cognitive Function During Chemotherapy for Front-Line Treatment of Ovarian, Primary Peritoneal or Fallopian Tube Cancer
N/A
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Female
Cognitive/Functional Effects, Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
Female
Cognitive/Functional Effects, Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
Trial Information
A Prospective Study of Cognitive Function During Chemotherapy for Front-Line Treatment of Ovarian, Primary Peritoneal or Fallopian Tube Cancer
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.
Inclusion Criteria
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
Type of Study:
Observational
Study Design:
N/A
Outcome Measure:
Cognitive function as measured by the HeadMinder Customized Research Tool (CRT)
Safety Issue:
No
Principal Investigator
Lisa M. Hess, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Indiana University School of Medicine
Authority:
Unspecified
Study ID:
CDR0000666786
NCT ID:
NCT01080521
Start Date:
April 2010
Completion Date:
Related Keywords:
- Cognitive/Functional Effects
- Fallopian Tube Cancer
- Ovarian Cancer
- Primary Peritoneal Cavity Cancer
- cognitive/functional effects
- ovarian sarcoma
- ovarian stromal cancer
- Brenner tumor
- ovarian carcinosarcoma
- ovarian clear cell cystadenocarcinoma
- ovarian endometrioid adenocarcinoma
- ovarian mixed epithelial carcinoma
- ovarian mucinous cystadenocarcinoma
- ovarian serous cystadenocarcinoma
- ovarian undifferentiated adenocarcinoma
- ovarian choriocarcinoma
- ovarian dysgerminoma
- ovarian embryonal carcinoma
- ovarian mixed germ cell tumor
- ovarian polyembryoma
- ovarian teratoma
- ovarian yolk sac tumor
- stage IA ovarian epithelial cancer
- stage IB ovarian epithelial cancer
- stage IC ovarian epithelial cancer
- stage IIA ovarian epithelial cancer
- stage IIB ovarian epithelial cancer
- stage IIC ovarian epithelial cancer
- stage IIIA ovarian epithelial cancer
- stage IIIB ovarian epithelial cancer
- stage IIIC ovarian epithelial cancer
- stage IV ovarian epithelial cancer
- stage IA ovarian germ cell tumor
- stage IB ovarian germ cell tumor
- stage IC ovarian germ cell tumor
- stage IIA ovarian germ cell tumor
- stage IIB ovarian germ cell tumor
- stage IIC ovarian germ cell tumor
- stage IIIA ovarian germ cell tumor
- stage IIIB ovarian germ cell tumor
- stage IIIC ovarian germ cell tumor
- stage IV ovarian germ cell tumor
- stage IA fallopian tube cancer
- stage IB fallopian tube cancer
- stage IC fallopian tube cancer
- stage IIA fallopian tube cancer
- stage IIB fallopian tube cancer
- stage IIC fallopian tube cancer
- stage IIIA fallopian tube cancer
- stage IIIB fallopian tube cancer
- stage IIIC fallopian tube cancer
- stage IV fallopian tube cancer
- stage IA primary peritoneal cavity cancer
- stage IB primary peritoneal cavity cancer
- stage IC primary peritoneal cavity cancer
- stage IIA primary peritoneal cavity cancer
- stage IIB primary peritoneal cavity cancer
- stage IIC primary peritoneal cavity cancer
- stage IIIA primary peritoneal cavity cancer
- stage IIIB primary peritoneal cavity cancer
- stage IIIC primary peritoneal cavity cancer
- stage IV primary peritoneal cavity cancer
- Ovarian Neoplasms
- Peritoneal Neoplasms
- Fallopian Tube Neoplasms
Name | Location |
|---|---|
| CCOP - Wichita | Wichita, Kansas 67214-3882 |
| Hurley Medical Center | Flint, Michigan 48503 |
| CCOP - Iowa Oncology Research Association | Des Moines, Iowa 50309-1016 |
| CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
| Baystate Regional Cancer Program at D'Amour Center for Cancer Care | Springfield, Massachusetts 01199 |
| CCOP - Michigan Cancer Research Consortium | Ann Arbor, Michigan 48106 |
| Saint Joseph Mercy Cancer Center | Ann Arbor, Michigan 48106-0995 |
| Oakwood Cancer Center at Oakwood Hospital and Medical Center | Dearborn, Michigan 48123-2500 |
| Genesys Hurley Cancer Institute | Flint, Michigan 48503 |
| Van Elslander Cancer Center at St. John Hospital and Medical Center | Grosse Pointe Woods, Michigan 48236 |
| Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
| West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
| Borgess Medical Center | Kalamazooaa, Michigan 49001 |
| Sparrow Regional Cancer Center | Lansing, Michigan 48912-1811 |
| St. John Macomb Hospital | Warren, Michigan 48093 |
| Fairview Ridges Hospital | Burnsville, Minnesota 55337 |
| Mercy and Unity Cancer Center at Mercy Hospital | Coon Rapids, Minnesota 55433 |
| Fairview Southdale Hospital | Edina, Minnesota 55435 |
| Mercy and Unity Cancer Center at Unity Hospital | Fridley, Minnesota 55432 |
| Hutchinson Area Health Care | Hutchinson, Minnesota 55350 |
| Minnesota Oncology Hematology, PA - Maplewood | Maplewood, Minnesota 55109 |
| HealthEast Cancer Care at St. John's Hospital | Maplewood, Minnesota 55109 |
| Hennepin County Medical Center - Minneapolis | Minneapolis, Minnesota 55415 |
| Virginia Piper Cancer Institute at Abbott - Northwestern Hospital | Minneapolis, Minnesota 55407 |
| St. Francis Cancer Center at St. Francis Medical Center | Shakopee, Minnesota 55379 |
| Park Nicollet Cancer Center | St. Louis Park, Minnesota 55416 |
| Regions Hospital Cancer Care Center | St. Paul, Minnesota 55101 |
| United Hospital | St. Paul, Minnesota 55102 |
| Ridgeview Medical Center | Waconia, Minnesota 55387 |
| Minnesota Oncology Hematology, PA - Woodbury | Woodbury, Minnesota 55125 |
| Case Comprehensive Cancer Center | Cleveland, Ohio 44106-5065 |
| Avera Cancer Institute | Sioux Falls, South Dakota 57105 |
| University of Wisconsin Paul P. Carbone Comprehensive Cancer Center | Madison, Wisconsin 53792-6164 |
| Marshfield Clinic - Marshfield Center | Marshfield, Wisconsin 54449 |
| Marshfield Clinic - Indianhead Center | Rice Lake, Wisconsin 54868 |
| Memorial Hospital of South Bend | South Bend, Indiana 46601 |
| CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
| CCOP - Greenville | Greenville, South Carolina 29615 |
| Virginia Mason Medical Center | Seattle, Washington 98111 |
| CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
| Saint Joseph Regional Medical Center | South Bend, Indiana 46617 |
| Holden Comprehensive Cancer Center at University of Iowa | Iowa City, Iowa 52242-1002 |
| CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
| Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center | Lebanon, New Hampshire 03756-0002 |
| Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
| CCOP - Virginia Mason Research Center | Seattle, Washington 98101 |
| Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical Center | Milwaukee, Wisconsin 53201-2901 |
| Rebecca and John Moores UCSD Cancer Center | La Jolla, California 92093-0658 |
| John Stoddard Cancer Center at Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
| Arkansas Cancer Research Center at University of Arkansas for Medical Sciences | Little Rock, Arkansas 72205 |
| Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
| Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
| St. John's Regional Health Center | Springfield, Missouri 65804 |
| McDowell Cancer Center at Akron General Medical Center | Akron, Ohio 44307 |
| Lake/University Ireland Cancer Center | Mentor, Ohio 44060 |
| Women and Infants Hospital of Rhode Island | Providence, Rhode Island 02905 |
| Florida Hospital Cancer Institute at Florida Hospital Orlando | Orlando, Florida 32803-1273 |
| Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
| Wake Forest University Comprehensive Cancer Center | Winston-Salem, North Carolina 27157-1096 |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390 |
| St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54307-3508 |
| St. Mary's Hospital Medical Center - Green Bay | Green Bay, Wisconsin 54303 |
| Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer Center | Green Bay, Wisconsin 54301-3526 |
| Green Bay Oncology, Limited at St. Mary's Hospital | Green Bay, Wisconsin 54303 |
| Battle Creek Health System Cancer Care Center | Battle Creek, Michigan 49017 |
| William Beaumont Hospital - Royal Oak Campus | Royal Oak, Michigan 48073 |
| Munson Medical Center | Traverse City, Michigan 49684 |
| Riverside Methodist Hospital Cancer Care | Columbus, Ohio 43214 |
| Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical Center | Los Angeles, California 90048-1865 |
| Jonsson Comprehensive Cancer Center at UCLA | Los Angeles, California 90095-1781 |
| Indiana University Melvin and Bren Simon Cancer Center | Indianapolis, Indiana 46202-5289 |
| Butterworth Hospital at Spectrum Health | Grand Rapids, Michigan 49503-2560 |
| Oklahoma University Cancer Institute | Oklahoma City, Oklahoma 73104 |
| Virginia Commonwealth University Massey Cancer Center | Richmond, Virginia 23298-0037 |
| Huntsman Cancer Institute at University of Utah | Salt Lake City, Utah 84112 |
| University of Virginia Cancer Center | Charlottesville, Virginia 22908 |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
| Decatur Memorial Hospital Cancer Care Institute | Decatur, Illinois 62526 |
| Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
| Elkhart General Hospital | Elkhart, Indiana 46515 |
| Howard Community Hospital | Kokomo, Indiana 46904 |
| Maine Medical Center - Bramhall Campus | Portland, Maine 04102 |
| Lakeland Regional Cancer Care Center - St. Joseph | St. Joseph, Michigan 49085 |
| Cleveland Clinic Cancer Center at Fairview Hospital | Cleveland, Ohio 44111 |
| Hillcrest Cancer Center at Hillcrest Hospital | Mayfield Heights, Ohio 44124 |
| Cancer Care Associates - Saint Francis Campus | Tulsa, Oklahoma 74136-1929 |
| Morgan Cancer Center at Lehigh Valley Hospital - Cedar Crest | Allentown, Pennsylvania 18105 |
| Parkland Memorial Hospital | Dallas, Texas 75235 |
| Center for Cancer Therapy at LaPorte Hospital and Health Services | La Porte, Indiana 46350 |
| John Stoddard Cancer Center at Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
| Medical Oncology and Hematology Associates at John Stoddard Cancer Center | Des Moines, Iowa 50309 |
| Medical Oncology and Hematology Associates at Mercy Cancer Center | Des Moines, Iowa 50314 |
| Mercy Cancer Center at Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
| Medical Oncology and Hematology Associates - West Des Moines | West Des Moines, Iowa 50266 |
| Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
| Mecosta County Medical Center | Big Rapids, Michigan 49307 |
| Palo Alto Medical Foundation | Palo Alto, California 94301 |
| Northeast Georgia Medical Center | Gainesville, Georgia 30501 |
| Evanston Hospital | Evanston, Illinois 60201-1781 |
| Michiana Hematology-Oncology, PC - Elkhart | Elkhart, Indiana 46514 |
| Elkhart Clinic, LLC | Elkhart, Indiana 46514-2098 |
| Michiana Hematology Oncology PC - La Porte | La Porte, Indiana 46350 |
| Michiana Hematology-Oncology, PC - South Bend | Mishawaka, Indiana 46545-1470 |
| Michiana Hematology Oncology PC - Plymouth | Plymouth, Indiana 46563 |
| Cancer Center of Kansas, PA - Chanute | Chanute, Kansas 66720 |
| Cancer Center of Kansas, PA - El Dorado | El Dorado, Kansas 67042 |
| Cancer Center of Kansas - Fort Scott | Fort Scott, Kansas 66701 |
| Cancer Center of Kansas-Independence | Independence, Kansas 67301 |
| Cancer Center of Kansas, PA - Kingman | Kingman, Kansas 67068 |
| Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
| Cancer Center of Kansas, PA - Liberal | Liberal, Kansas 67905 |
| Cancer Center of Kansas, PA - Newton | Newton, Kansas 67114 |
| Cancer Center of Kansas, PA - Parsons | Parsons, Kansas 67357 |
| Cancer Center of Kansas, PA - Pratt | Pratt, Kansas 67124 |
| Cancer Center of Kansas, PA - Salina | Salina, Kansas 67401 |
| Cancer Center of Kansas, PA - Wellington | Wellington, Kansas 67152 |
| Cancer Center of Kansas, PA - Wichita | Wichita, Kansas 67214 |
| Associates in Womens Health, PA - North Review | Wichita, Kansas 67208 |
| Cancer Center of Kansas, PA - Medical Arts Tower | Wichita, Kansas 67208 |
| Cancer Center of Kansas, PA - Winfield | Winfield, Kansas 67156 |
| Foote Memorial Hospital | Jackson, Michigan 49201 |
| St. Mary Mercy Hospital | Livonia, Michigan 48154 |
| Michiana Hematology Oncology PC - Niles | Niles, Michigan 49120 |
| St. Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
| Mercy Regional Cancer Center at Mercy Hospital | Port Huron, Michigan 48060 |
| Seton Cancer Institute at Saint Mary's - Saginaw | Saginaw, Michigan 48601 |
| Lakeside Cancer Specialists, PLLC | Saint Joseph, Michigan 49085 |
| Willmar Cancer Center at Rice Memorial Hospital | Willmar, Minnesota 56201 |
| Summa Center for Cancer Care at Akron City Hospital | Akron, Ohio 44309-2090 |
| Marshfield Clinic - Chippewa Center | Chippewa Falls, Wisconsin 54729 |
| Marshfield Clinic Cancer Care at Regional Cancer Center | Eau Claire, Wisconsin 54701 |
| Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical Center | Green Bay, Wisconsin 54311 |
| Marshfield Clinic - Lakeland Center | Minocqua, Wisconsin 54548 |
| Ministry Medical Group at Saint Mary's Hospital | Rhinelander, Wisconsin 54501 |
| Vince Lombardi Cancer Clinic - Sheboygan | Sheboygan, Wisconsin 53081 |
| Marshfield Clinic at Saint Michael's Hospital | Stevens Point, Wisconsin 54481 |
| Marshfield Clinic - Weston Center | Weston, Wisconsin 54476 |
| Marshfield Clinic - Wisconsin Rapids Center | Wisconsin Rapids, Wisconsin 54494 |
| Woman's Hospital | Baton Rouge, Louisiana 70815 |
| FirstHealth Moore Regional Community Hospital Comprehensive Cancer Center | Pinehurst, North Carolina 28374 |
| Regional Cancer Center at Memorial Medical Center | Springfield, Illinois 62781-0001 |
| Genesys Regional Medical Center | Grand Blanc, Michigan 48439-8066 |
| Duke Cancer Institute | Durham, North Carolina 27710 |
| Cancer Centers of the Carolinas - Faris Road | Greenville, South Carolina 29605 |
| Cancer Centers of the Carolinas - Seneca | Seneca, South Carolina 29672 |
| Cancer Centers of the Carolinas - Spartanburg | Spartanburg, South Carolina 29307 |
| Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
| Metro Health Hospital | Grand Rapids, Michigan 49506 |
| Gynecologic Oncology | Hinsdale, Illinois 60521 |
| Women's Cancer Center - La Canada | Las Vegas, Nevada 89169 |
| Mercy General Health Partners | Muskegon, Michigan 49443 |
| University of Colorado Cancer Center at UC Health Sciences Center | Aurora, Colorado 80045 |
| Christus Schumpert Cancer Treatment Center | Shreveport, Louisiana 71101 |
| Jersey Shore Cancer Center at Jersey Shore University Medical Center | Neptune, New Jersey 07754-0397 |
| Duke Health Raleigh Hospital | Raleigh, North Carolina 27609 |
| Humphrey Cancer Center at North Memorial Outpatient Center | Robbinsdale, Minnesota 55422-2900 |
| Lakeview Hospital | Stillwater, Minnesota 55082 |
| Florida Gynecologic Oncology - Fort Myers | Fort Myers, Florida 33905 |
| St. Dominic Cancer Center | Jackson, Mississippi 39216 |
| Aurora Women's Pavilion of West Allis Memorial Hospital | West Allis, Wisconsin 53227 |
| Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center | Burbank, California 91505 |
| Arizona Cancer Center at University Medical Center North | Tucson, Arizona 85719 |
| Mercy Cancer Center - West Lakes | Clive, Iowa 50325 |
| Methodist West Hospital | West Des Moines, Iowa 50266-7700 |
