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
- Conditions
- Malignant Ovarian Epithelial TumorOvarian PolyembryomaStage I Ovarian CancerStage IA Ovarian CancerStage IA Ovarian Germ Cell TumorStage IB Ovarian Germ Cell TumorStage IC Fallopian Tube CancerStage IIC Ovarian Germ Cell TumorStage IIIA Ovarian CancerStage IIIA Primary Peritoneal Cancer
- Interventions
- Procedure: Cognitive AssessmentOther: Quality-of-Life Assessment
- Registration Number
- NCT01080521
- Lead Sponsor
- Gynecologic Oncology Group
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 247
-
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
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Observational (cognitive function during chemotherapy) Cognitive Assessment 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. Observational (cognitive function during chemotherapy) Quality-of-Life Assessment 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.
- Primary Outcome Measures
Name Time Method Cognitive function as measured by the HeadMinder Customized Research Tool (CRT) Up to 6 months after completion of chemotherapy
- Secondary Outcome Measures
Name Time Method Patient-reported cognitive function as measured by Patient Assessment Own Functioning scale and web CRT Up to 6 months after completion of chemotherapy
Trial Locations
- Locations (182)
Clements University Hospital
🇺🇸Dallas, Texas, United States
Marshfield Clinic Cancer Care at Saint Michael's Hospital
🇺🇸Stevens Point, Wisconsin, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Women's Cancer Center of Nevada
🇺🇸Las Vegas, Nevada, United States
Abbott-Northwestern Hospital
🇺🇸Minneapolis, Minnesota, United States
Hennepin County Medical Center
🇺🇸Minneapolis, Minnesota, United States
Huntsman Cancer Institute/University of Utah
🇺🇸Salt Lake City, Utah, United States
Cancer Center of Kansas-Liberal
🇺🇸Liberal, Kansas, United States
Cancer Center of Kansas - Newton
🇺🇸Newton, Kansas, United States
Cancer Center of Kansas - Pratt
🇺🇸Pratt, Kansas, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas - Parsons
🇺🇸Parsons, Kansas, United States
Cancer Center of Kansas - Winfield
🇺🇸Winfield, Kansas, United States
Kansas City NCI Community Oncology Research Program
🇺🇸Prairie Village, Kansas, United States
Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas - Wellington
🇺🇸Wellington, Kansas, United States
Lawrence Memorial Hospital
🇺🇸Lawrence, Kansas, United States
Menorah Medical Center
🇺🇸Overland Park, Kansas, United States
Cancer Center of Kansas - Salina
🇺🇸Salina, Kansas, United States
University of Oklahoma Health Sciences Center
🇺🇸Oklahoma City, Oklahoma, United States
NorthShore University HealthSystem-Evanston Hospital
🇺🇸Evanston, Illinois, United States
Michiana Hematology Oncology PC-Mishawaka
🇺🇸Mishawaka, Indiana, United States
Community Howard Regional Health
🇺🇸Kokomo, Indiana, United States
UCLA / Jonsson Comprehensive Cancer Center
🇺🇸Los Angeles, California, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
🇺🇸Burbank, California, United States
Roy and Patricia Disney Family Cancer Center
🇺🇸Burbank, California, United States
Michiana Hematology Oncology PC-South Bend
🇺🇸South Bend, Indiana, United States
Michiana Hematology Oncology PC-Elkhart
🇺🇸Elkhart, Indiana, United States
University of Kansas Cancer Center
🇺🇸Kansas City, Kansas, United States
Cancer Center of Kansas-Independence
🇺🇸Independence, Kansas, United States
Mercy Cancer Center-West Lakes
🇺🇸Clive, Iowa, United States
Decatur Memorial Hospital
🇺🇸Decatur, Illinois, United States
Indiana University/Melvin and Bren Simon Cancer Center
🇺🇸Indianapolis, Indiana, United States
Elkhart Clinic
🇺🇸Elkhart, Indiana, United States
Memorial Hospital of South Bend
🇺🇸South Bend, Indiana, United States
Saint Joseph Regional Medical Center-Mishawaka
🇺🇸Mishawaka, Indiana, United States
University of Iowa/Holden Comprehensive Cancer Center
🇺🇸Iowa City, Iowa, United States
Medical Oncology and Hematology Associates-West Des Moines
🇺🇸Clive, Iowa, United States
Memorial Medical Center
🇺🇸Springfield, Illinois, United States
Elkhart General Hospital
🇺🇸Elkhart, Indiana, United States
Saint Luke's South Hospital
🇺🇸Overland Park, Kansas, United States
Cancer Center of Kansas - Chanute
🇺🇸Chanute, Kansas, United States
Mercy Medical Center-West Lakes
🇺🇸West Des Moines, Iowa, United States
Cancer Center of Kansas - Fort Scott
🇺🇸Fort Scott, Kansas, United States
Cancer Center of Kansas-Kingman
🇺🇸Kingman, Kansas, United States
Cancer Center of Kansas - El Dorado
🇺🇸El Dorado, Kansas, United States
Shawnee Mission Medical Center-KCCC
🇺🇸Shawnee Mission, Kansas, United States
Metro Health Hospital
🇺🇸Wyoming, Michigan, United States
Cancer Center of Kansas - Wichita
🇺🇸Wichita, Kansas, United States
Mercy Hospital
🇺🇸Coon Rapids, Minnesota, United States
Michiana Hematology Oncology PC-Niles
🇺🇸Niles, Michigan, United States
Associates In Womens Health
🇺🇸Wichita, Kansas, United States
Baystate Medical Center
🇺🇸Springfield, Massachusetts, United States
Wichita NCI Community Oncology Research Program
🇺🇸Wichita, Kansas, United States
Mercy Health Saint Mary's
🇺🇸Grand Rapids, Michigan, United States
Allegiance Health
🇺🇸Jackson, Michigan, United States
Cancer Research Consortium of West Michigan NCORP
🇺🇸Grand Rapids, Michigan, United States
Hutchinson Area Health Care
🇺🇸Hutchinson, Minnesota, United States
Liberty Hospital
🇺🇸Liberty, Missouri, United States
Saint Joseph Mercy Port Huron
🇺🇸Port Huron, Michigan, United States
Munson Medical Center
🇺🇸Traverse City, Michigan, United States
Bronson Methodist Hospital
🇺🇸Kalamazoo, Michigan, United States
Saint Mary Mercy Hospital
🇺🇸Livonia, Michigan, United States
West Michigan Cancer Center
🇺🇸Kalamazoo, Michigan, United States
Fairview-Southdale Hospital
🇺🇸Edina, Minnesota, United States
Unity Hospital
🇺🇸Fridley, Minnesota, United States
FirstHealth of the Carolinas-Moore Regional Hosiptal
🇺🇸Pinehurst, North Carolina, United States
Case Western Reserve University
🇺🇸Cleveland, Ohio, United States
Minnesota Oncology and Hematology PA-Woodbury
🇺🇸Woodbury, Minnesota, United States
Regions Hospital
🇺🇸Saint Paul, Minnesota, United States
Summa Akron City Hospital/Cooper Cancer Center
🇺🇸Akron, Ohio, United States
Saint Francis Regional Medical Center
🇺🇸Shakopee, Minnesota, United States
North Memorial Medical Health Center
🇺🇸Robbinsdale, Minnesota, United States
United Hospital
🇺🇸Saint Paul, Minnesota, United States
Ridgeview Medical Center
🇺🇸Waconia, Minnesota, United States
Rice Memorial Hospital
🇺🇸Willmar, Minnesota, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
Riverside Methodist Hospital
🇺🇸Columbus, Ohio, United States
Lake University Ireland Cancer Center
🇺🇸Mentor, Ohio, United States
Duke Raleigh Hospital
🇺🇸Raleigh, North Carolina, United States
Oklahoma Cancer Specialists and Research Institute-Tulsa
🇺🇸Tulsa, Oklahoma, United States
Marshfield Clinic Cancer Center at Sacred Heart
🇺🇸Eau Claire, Wisconsin, United States
Parkland Memorial Hospital
🇺🇸Dallas, Texas, United States
Virginia Mason Medical Center
🇺🇸Seattle, Washington, United States
Vince Lombardi Cancer Clinic-Sheboygan
🇺🇸Sheboygan, Wisconsin, United States
Green Bay Oncology Limited at Saint Mary's Hospital
🇺🇸Green Bay, Wisconsin, United States
Greenville Health System Cancer Institute-Faris
🇺🇸Greenville, South Carolina, United States
Saint Mary's Hospital
🇺🇸Green Bay, Wisconsin, United States
University of Virginia Cancer Center
🇺🇸Charlottesville, Virginia, United States
Greenville Memorial Hospital
🇺🇸Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Eastside
🇺🇸Greenville, South Carolina, United States
Avera Cancer Institute
🇺🇸Sioux Falls, South Dakota, United States
Marshfield Clinic-Minocqua Center
🇺🇸Minocqua, Wisconsin, United States
Virginia Mason CCOP
🇺🇸Seattle, Washington, United States
Green Bay Oncology at Saint Vincent Hospital
🇺🇸Green Bay, Wisconsin, United States
Heartland Regional Medical Center
🇺🇸Saint Joseph, Missouri, United States
Saint Joseph Oncology Inc
🇺🇸Saint Joseph, Missouri, United States
Saint John's Hospital - Healtheast
🇺🇸Maplewood, Minnesota, United States
Metro Minnesota Community Oncology Research Consortium
🇺🇸Saint Louis Park, Minnesota, United States
Lakeview Hospital
🇺🇸Stillwater, Minnesota, United States
Michiana Hematology Oncology PC-Westville
🇺🇸Westville, Indiana, United States
Gynecologic Oncology Group
🇺🇸Philadelphia, Pennsylvania, United States
Aurora West Allis Medical Center
🇺🇸West Allis, Wisconsin, United States
Marshfield Clinic-Rice Lake Center
🇺🇸Rice Lake, Wisconsin, United States
Marshfield Clinic - Wisconsin Rapids Center
🇺🇸Wisconsin Rapids, Wisconsin, United States
Marshfield Clinic at James Beck Cancer Center
🇺🇸Rhinelander, Wisconsin, United States
University of Colorado Cancer Center - Anschutz Cancer Pavilion
🇺🇸Aurora, Colorado, United States
Saint Joseph Mercy Hospital
🇺🇸Ann Arbor, Michigan, United States
Michigan Cancer Research Consortium NCORP
🇺🇸Ann Arbor, Michigan, United States
Aurora Saint Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Saint Joseph Mercy Oakland
🇺🇸Pontiac, Michigan, United States
Marie Yeager Cancer Center
🇺🇸Saint Joseph, Michigan, United States
Borgess Medical Center
🇺🇸Kalamazoo, Michigan, United States
William Beaumont Hospital-Royal Oak
🇺🇸Royal Oak, Michigan, United States
Marshfield Clinic - Weston Center
🇺🇸Weston, Wisconsin, United States
Northern Indiana Cancer Research Consortium
🇺🇸South Bend, Indiana, United States
Genesys Regional Medical Center-West Flint Campus
🇺🇸Flint, Michigan, United States
Palo Alto Medical Foundation-Gynecologic Oncology
🇺🇸Mountain View, California, United States
IU Health La Porte Hospital
🇺🇸La Porte, Indiana, United States
Northeast Georgia Medical Center
🇺🇸Gainesville, Georgia, United States
John B Amos Cancer Center
🇺🇸Columbus, Georgia, United States
Michiana Hematology Oncology PC-Plymouth
🇺🇸Plymouth, Indiana, United States
South Bend Clinic
🇺🇸South Bend, Indiana, United States
Methodist West Hospital
🇺🇸West Des Moines, Iowa, United States
Cancer Center of Kansas - Dodge City
🇺🇸Dodge City, Kansas, United States
Genesys Regional Medical Center
🇺🇸Grand Blanc, Michigan, United States
Sparrow Hospital
🇺🇸Lansing, Michigan, United States
Bronson Battle Creek
🇺🇸Battle Creek, Michigan, United States
Saint John Hospital and Medical Center
🇺🇸Detroit, Michigan, United States
Beaumont Hospital-Dearborn
🇺🇸Dearborn, Michigan, United States
Spectrum Health Big Rapids Hospital
🇺🇸Big Rapids, Michigan, United States
Hurley Medical Center
🇺🇸Flint, Michigan, United States
Mercy Health Mercy Campus
🇺🇸Muskegon, Michigan, United States
Minnesota Oncology Hematology PA-Maplewood
🇺🇸Maplewood, Minnesota, United States
Saint John Macomb-Oakland Hospital
🇺🇸Warren, Michigan, United States
Saint Mary's of Michigan
🇺🇸Saginaw, Michigan, United States
Saint Dominic-Jackson Memorial Hospital
🇺🇸Jackson, Mississippi, United States
Park Nicollet Clinic - Saint Louis Park
🇺🇸Saint Louis Park, Minnesota, United States
Saint Luke's East - Lee's Summit
🇺🇸Lee's Summit, Missouri, United States
Akron General Medical Center
🇺🇸Akron, Ohio, United States
Women and Infants Hospital
🇺🇸Providence, Rhode Island, United States
Greenville Health System Cancer Institute-Seneca
🇺🇸Seneca, South Carolina, United States
UT Southwestern/Simmons Cancer Center-Dallas
🇺🇸Dallas, Texas, United States
Marshfield Clinic-Chippewa Center
🇺🇸Chippewa Falls, Wisconsin, United States
Marshfield Clinic
🇺🇸Marshfield, Wisconsin, United States
Saint Vincent Hospital
🇺🇸Green Bay, Wisconsin, United States
Florida Hospital Orlando
🇺🇸Orlando, Florida, United States
Truman Medical Center
🇺🇸Kansas City, Missouri, United States
Saint Luke's Hospital of Kansas City
🇺🇸Kansas City, Missouri, United States
Saint Joseph Health Center
🇺🇸Kansas City, Missouri, United States
North Kansas City Hospital
🇺🇸Kansas City, Missouri, United States
Heartland Hematology and Oncology Associates Incorporated
🇺🇸Kansas City, Missouri, United States
Research Medical Center
🇺🇸Kansas City, Missouri, United States
The Hospital of Central Connecticut
🇺🇸New Britain, Connecticut, United States
Maine Medical Center-Bramhall Campus
🇺🇸Portland, Maine, United States
University of Arizona Cancer Center-North Campus
🇺🇸Tucson, Arizona, United States
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Hartford Hospital
🇺🇸Hartford, Connecticut, United States
Smilow Cancer Hospital Care Center at Saint Francis
🇺🇸Hartford, Connecticut, United States
Mercy Hospital Springfield
🇺🇸Springfield, Missouri, United States
University of California San Diego
🇺🇸San Diego, California, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Greenville Health System Cancer Institute-Andrews
🇺🇸Greenville, South Carolina, United States
Self Regional Healthcare
🇺🇸Greenwood, South Carolina, United States
Jersey Shore Medical Center
🇺🇸Neptune, New Jersey, United States
Greenville Health System Cancer Institute-Easley
🇺🇸Easley, South Carolina, United States
Greenville Health System Cancer Institute-Butternut
🇺🇸Greenville, South Carolina, United States
Greenville Health System Cancer Institute-Spartanburg
🇺🇸Spartanburg, South Carolina, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
Cancer Centers of the Carolinas-Greer Medical Oncology
🇺🇸Greer, South Carolina, United States
Greenville Health System Cancer Institute-Greer
🇺🇸Greer, South Carolina, United States
Iowa Methodist Medical Center
🇺🇸Des Moines, Iowa, United States
Iowa-Wide Oncology Research Coalition NCORP
🇺🇸Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Des Moines
🇺🇸Des Moines, Iowa, United States
Medical Oncology and Hematology Associates-Laurel
🇺🇸Des Moines, Iowa, United States
Mercy Medical Center - Des Moines
🇺🇸Des Moines, Iowa, United States
Iowa Lutheran Hospital
🇺🇸Des Moines, Iowa, United States
University of Wisconsin Hospital and Clinics
🇺🇸Madison, Wisconsin, United States
Lakeland Hospital
🇺🇸Saint Joseph, Michigan, United States
Spectrum Health at Butterworth Campus
🇺🇸Grand Rapids, Michigan, United States
Fairview Ridges Hospital
🇺🇸Burnsville, Minnesota, United States