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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
Open (Enrolling)
Female
Cognitive/Functional Effects, Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Thank you

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 - WichitaWichita, Kansas  67214-3882
Hurley Medical CenterFlint, Michigan  48503
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Baystate Regional Cancer Program at D'Amour Center for Cancer CareSpringfield, Massachusetts  01199
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
Saint Joseph Mercy Cancer CenterAnn Arbor, Michigan  48106-0995
Oakwood Cancer Center at Oakwood Hospital and Medical CenterDearborn, Michigan  48123-2500
Genesys Hurley Cancer InstituteFlint, Michigan  48503
Van Elslander Cancer Center at St. John Hospital and Medical CenterGrosse Pointe Woods, Michigan  48236
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
St. John Macomb HospitalWarren, Michigan  48093
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Hutchinson Area Health CareHutchinson, Minnesota  55350
Minnesota Oncology Hematology, PA - MaplewoodMaplewood, Minnesota  55109
HealthEast Cancer Care at St. John's HospitalMaplewood, Minnesota  55109
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolis, Minnesota  55407
St. Francis Cancer Center at St. Francis Medical CenterShakopee, Minnesota  55379
Park Nicollet Cancer CenterSt. Louis Park, Minnesota  55416
Regions Hospital Cancer Care CenterSt. Paul, Minnesota  55101
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Minnesota Oncology Hematology, PA - WoodburyWoodbury, Minnesota  55125
Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
Avera Cancer InstituteSioux Falls, South Dakota  57105
University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadison, Wisconsin  53792-6164
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
Marshfield Clinic - Indianhead CenterRice Lake, Wisconsin  54868
Memorial Hospital of South BendSouth Bend, Indiana  46601
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - GreenvilleGreenville, South Carolina  29615
Virginia Mason Medical CenterSeattle, Washington  98111
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Saint Joseph Regional Medical CenterSouth Bend, Indiana  46617
Holden Comprehensive Cancer Center at University of IowaIowa City, Iowa  52242-1002
CCOP - Grand RapidsGrand Rapids, Michigan  49503
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
Vince Lombardi Cancer Clinic at Aurora St. Luke's Medical CenterMilwaukee, Wisconsin  53201-2901
Rebecca and John Moores UCSD Cancer CenterLa Jolla, California  92093-0658
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Kansas Masonic Cancer Research Institute at the University of Kansas Medical CenterKansas City, Kansas  66160-7353
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
Lake/University Ireland Cancer CenterMentor, Ohio  44060
Women and Infants Hospital of Rhode IslandProvidence, Rhode Island  02905
Florida Hospital Cancer Institute at Florida Hospital OrlandoOrlando, Florida  32803-1273
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Wake Forest University Comprehensive Cancer CenterWinston-Salem, North Carolina  27157-1096
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - DallasDallas, Texas  75390
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
St. Mary's Hospital Medical Center - Green BayGreen Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54301-3526
Green Bay Oncology, Limited at St. Mary's HospitalGreen Bay, Wisconsin  54303
Battle Creek Health System Cancer Care CenterBattle Creek, Michigan  49017
William Beaumont Hospital - Royal Oak CampusRoyal Oak, Michigan  48073
Munson Medical CenterTraverse City, Michigan  49684
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Samuel Oschin Comprehensive Cancer Institute at Cedars-Sinai Medical CenterLos Angeles, California  90048-1865
Jonsson Comprehensive Cancer Center at UCLALos Angeles, California  90095-1781
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
Butterworth Hospital at Spectrum HealthGrand Rapids, Michigan  49503-2560
Oklahoma University Cancer InstituteOklahoma City, Oklahoma  73104
Virginia Commonwealth University Massey Cancer CenterRichmond, Virginia  23298-0037
Huntsman Cancer Institute at University of UtahSalt Lake City, Utah  84112
University of Virginia Cancer CenterCharlottesville, Virginia  22908
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
Saint Francis/Mount Sinai Regional Cancer Center at Saint Francis Hospital and Medical CenterHartford, Connecticut  06105
Elkhart General HospitalElkhart, Indiana  46515
Howard Community HospitalKokomo, Indiana  46904
Maine Medical Center - Bramhall CampusPortland, Maine  04102
Lakeland Regional Cancer Care Center - St. JosephSt. Joseph, Michigan  49085
Cleveland Clinic Cancer Center at Fairview HospitalCleveland, Ohio  44111
Hillcrest Cancer Center at Hillcrest HospitalMayfield Heights, Ohio  44124
Cancer Care Associates - Saint Francis CampusTulsa, Oklahoma  74136-1929
Morgan Cancer Center at Lehigh Valley Hospital - Cedar CrestAllentown, Pennsylvania  18105
Parkland Memorial HospitalDallas, Texas  75235
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Medical Oncology and Hematology Associates at John Stoddard Cancer CenterDes Moines, Iowa  50309
Medical Oncology and Hematology Associates at Mercy Cancer CenterDes Moines, Iowa  50314
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Medical Oncology and Hematology Associates - West Des MoinesWest Des Moines, Iowa  50266
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Mecosta County Medical CenterBig Rapids, Michigan  49307
Palo Alto Medical FoundationPalo Alto, California  94301
Northeast Georgia Medical CenterGainesville, Georgia  30501
Evanston HospitalEvanston, Illinois  60201-1781
Michiana Hematology-Oncology, PC - ElkhartElkhart, Indiana  46514
Elkhart Clinic, LLCElkhart, Indiana  46514-2098
Michiana Hematology Oncology PC - La PorteLa Porte, Indiana  46350
Michiana Hematology-Oncology, PC - South BendMishawaka, Indiana  46545-1470
Michiana Hematology Oncology PC - PlymouthPlymouth, Indiana  46563
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas - Fort ScottFort Scott, Kansas  66701
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Lawrence Memorial HospitalLawrence, Kansas  66044
Cancer Center of Kansas, PA - LiberalLiberal, Kansas  67905
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Foote Memorial HospitalJackson, Michigan  49201
St. Mary Mercy HospitalLivonia, Michigan  48154
Michiana Hematology Oncology PC - NilesNiles, Michigan  49120
St. Joseph Mercy OaklandPontiac, Michigan  48341-2985
Mercy Regional Cancer Center at Mercy HospitalPort Huron, Michigan  48060
Seton Cancer Institute at Saint Mary's - SaginawSaginaw, Michigan  48601
Lakeside Cancer Specialists, PLLCSaint Joseph, Michigan  49085
Willmar Cancer Center at Rice Memorial HospitalWillmar, Minnesota  56201
Summa Center for Cancer Care at Akron City HospitalAkron, Ohio  44309-2090
Marshfield Clinic - Chippewa CenterChippewa Falls, Wisconsin  54729
Marshfield Clinic Cancer Care at Regional Cancer CenterEau Claire, Wisconsin  54701
Vince Lombardi Cancer Clinic - Green Bay at Aurora BayCare Medical CenterGreen Bay, Wisconsin  54311
Marshfield Clinic - Lakeland CenterMinocqua, Wisconsin  54548
Ministry Medical Group at Saint Mary's HospitalRhinelander, Wisconsin  54501
Vince Lombardi Cancer Clinic - SheboyganSheboygan, Wisconsin  53081
Marshfield Clinic at Saint Michael's HospitalStevens Point, Wisconsin  54481
Marshfield Clinic - Weston CenterWeston, Wisconsin  54476
Marshfield Clinic - Wisconsin Rapids CenterWisconsin Rapids, Wisconsin  54494
Woman's HospitalBaton Rouge, Louisiana  70815
FirstHealth Moore Regional Community Hospital Comprehensive Cancer CenterPinehurst, North Carolina  28374
Regional Cancer Center at Memorial Medical CenterSpringfield, Illinois  62781-0001
Genesys Regional Medical CenterGrand Blanc, Michigan  48439-8066
Duke Cancer InstituteDurham, North Carolina  27710
Cancer Centers of the Carolinas - Faris RoadGreenville, South Carolina  29605
Cancer Centers of the Carolinas - SenecaSeneca, South Carolina  29672
Cancer Centers of the Carolinas - SpartanburgSpartanburg, South Carolina  29307
Lacks Cancer Center at Saint Mary's Health CareGrand Rapids, Michigan  49503
Metro Health HospitalGrand Rapids, Michigan  49506
Gynecologic OncologyHinsdale, Illinois  60521
Women's Cancer Center - La CanadaLas Vegas, Nevada  89169
Mercy General Health PartnersMuskegon, Michigan  49443
University of Colorado Cancer Center at UC Health Sciences CenterAurora, Colorado  80045
Christus Schumpert Cancer Treatment CenterShreveport, Louisiana  71101
Jersey Shore Cancer Center at Jersey Shore University Medical CenterNeptune, New Jersey  07754-0397
Duke Health Raleigh HospitalRaleigh, North Carolina  27609
Humphrey Cancer Center at North Memorial Outpatient CenterRobbinsdale, Minnesota  55422-2900
Lakeview HospitalStillwater, Minnesota  55082
Florida Gynecologic Oncology - Fort MyersFort Myers, Florida  33905
St. Dominic Cancer CenterJackson, Mississippi  39216
Aurora Women's Pavilion of West Allis Memorial HospitalWest Allis, Wisconsin  53227
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical CenterBurbank, California  91505
Arizona Cancer Center at University Medical Center NorthTucson, Arizona  85719
Mercy Cancer Center - West LakesClive, Iowa  50325
Methodist West HospitalWest Des Moines, Iowa  50266-7700