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Cognitive Side Effects of Cancer TherapyNCT01080521

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

An observational study of Cognitive Side Effects of Cancer Therapy and Malignant Ovarian Epithelial Tumor, run by Gynecologic Oncology Group at 182 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Cognitive Assessment and Quality-of-Life Assessment
Type of treatment
Surgery or procedure
How many people
247 participants
Where
182 sitesUnited States
Study dates
Apr 2010to 27 Jan 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients With Stage I, Stage II, Stage III, or Stage IV Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Who Are Receiving Chemotherapy

Who may be able to join

  • 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:
Show all 17Show fewer
  • 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

Who cannot join

None listed.

Trial locations and contacts

182 sites in 1 country.

182 sites in 1 country

United States182 sites

  • Summa Akron City Hospital/Cooper Cancer Center

    Akron, Ohio, 44304

  • Akron General Medical Center

    Akron, Ohio, 44307

  • Saint Joseph Mercy Hospital

    Ann Arbor, Michigan, 48106-0995

  • Michigan Cancer Research Consortium NCORP

    Ann Arbor, Michigan, 48106

  • University of Colorado Cancer Center - Anschutz Cancer Pavilion

    Aurora, Colorado, 80045

  • Bronson Battle Creek

    Battle Creek, Michigan, 49017

  • Spectrum Health Big Rapids Hospital

    Big Rapids, Michigan, 49307

  • Providence Saint Joseph Medical Center/Disney Family Cancer Center

    Burbank, California, 91505

  • Roy and Patricia Disney Family Cancer Center

    Burbank, California, 91505

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • University of Virginia Cancer Center

    Charlottesville, Virginia, 22908

  • Northwestern University

    Chicago, Illinois, 60611

  • Marshfield Clinic-Chippewa Center

    Chippewa Falls, Wisconsin, 54729

  • Case Western Reserve University

    Cleveland, Ohio, 44106

  • Medical Oncology and Hematology Associates-West Des Moines

    Clive, Iowa, 50325

  • Mercy Cancer Center-West Lakes

    Clive, Iowa, 50325

  • John B Amos Cancer Center

    Columbus, Georgia, 31904

  • Riverside Methodist Hospital

    Columbus, Ohio, 43214

  • Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Parkland Memorial Hospital

    Dallas, Texas, 75235

  • Clements University Hospital

    Dallas, Texas, 75390

  • UT Southwestern/Simmons Cancer Center-Dallas

    Dallas, Texas, 75390

  • Beaumont Hospital-Dearborn

    Dearborn, Michigan, 48124

  • Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • Iowa Methodist Medical Center

    Des Moines, Iowa, 50309

  • Iowa-Wide Oncology Research Coalition NCORP

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Des Moines

    Des Moines, Iowa, 50309

  • Medical Oncology and Hematology Associates-Laurel

    Des Moines, Iowa, 50314

  • Mercy Medical Center - Des Moines

    Des Moines, Iowa, 50314

  • Iowa Lutheran Hospital

    Des Moines, Iowa, 50316

  • Saint John Hospital and Medical Center

    Detroit, Michigan, 48236

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Greenville Health System Cancer Institute-Easley

    Easley, South Carolina, 29640

  • Marshfield Clinic Cancer Center at Sacred Heart

    Eau Claire, Wisconsin, 54701

  • Fairview-Southdale Hospital

    Edina, Minnesota, 55435

  • Cancer Center of Kansas - El Dorado

    El Dorado, Kansas, 67042

  • Elkhart Clinic

    Elkhart, Indiana, 46514-2098

  • Michiana Hematology Oncology PC-Elkhart

    Elkhart, Indiana, 46514

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • NorthShore University HealthSystem-Evanston Hospital

    Evanston, Illinois, 60201

  • Hurley Medical Center

    Flint, Michigan, 48502

  • Genesys Regional Medical Center-West Flint Campus

    Flint, Michigan, 48532

  • Cancer Center of Kansas - Fort Scott

    Fort Scott, Kansas, 66701

  • Unity Hospital

    Fridley, Minnesota, 55432

  • Northeast Georgia Medical Center

    Gainesville, Georgia, 30501

  • Genesys Regional Medical Center

    Grand Blanc, Michigan, 48439

  • Cancer Research Consortium of West Michigan NCORP

    Grand Rapids, Michigan, 49503

  • Mercy Health Saint Mary's

    Grand Rapids, Michigan, 49503

  • Spectrum Health at Butterworth Campus

    Grand Rapids, Michigan, 49503

  • Green Bay Oncology at Saint Vincent Hospital

    Green Bay, Wisconsin, 54301-3526

  • Saint Vincent Hospital

    Green Bay, Wisconsin, 54301

  • Green Bay Oncology Limited at Saint Mary's Hospital

    Green Bay, Wisconsin, 54303

  • Saint Mary's Hospital

    Green Bay, Wisconsin, 54303

  • Greenville Health System Cancer Institute-Andrews

    Greenville, South Carolina, 29605

  • Greenville Health System Cancer Institute-Butternut

    Greenville, South Carolina, 29605

  • Greenville Health System Cancer Institute-Faris

    Greenville, South Carolina, 29605

  • Greenville Memorial Hospital

    Greenville, South Carolina, 29605

  • Greenville Health System Cancer Institute-Eastside

    Greenville, South Carolina, 29615

  • Self Regional Healthcare

    Greenwood, South Carolina, 29646

  • Cancer Centers of the Carolinas-Greer Medical Oncology

    Greer, South Carolina, 29650

  • Greenville Health System Cancer Institute-Greer

    Greer, South Carolina, 29650

  • Hartford Hospital

    Hartford, Connecticut, 06102

  • Smilow Cancer Hospital Care Center at Saint Francis

    Hartford, Connecticut, 06105

  • Hutchinson Area Health Care

    Hutchinson, Minnesota, 55350

  • Cancer Center of Kansas-Independence

    Independence, Kansas, 67301

  • Indiana University/Melvin and Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

  • University of Iowa/Holden Comprehensive Cancer Center

    Iowa City, Iowa, 52242

  • Allegiance Health

    Jackson, Michigan, 49201

  • Saint Dominic-Jackson Memorial Hospital

    Jackson, Mississippi, 39216

  • Borgess Medical Center

    Kalamazoo, Michigan, 49001

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • University of Kansas Cancer Center

    Kansas City, Kansas, 66160

  • Truman Medical Center

    Kansas City, Missouri, 64108

  • Saint Luke's Hospital of Kansas City

    Kansas City, Missouri, 64111

  • Saint Joseph Health Center

    Kansas City, Missouri, 64114

  • North Kansas City Hospital

    Kansas City, Missouri, 64116

  • Heartland Hematology and Oncology Associates Incorporated

    Kansas City, Missouri, 64118

  • Research Medical Center

    Kansas City, Missouri, 64132

  • Cancer Center of Kansas-Kingman

    Kingman, Kansas, 67068

  • Community Howard Regional Health

    Kokomo, Indiana, 46904

  • IU Health La Porte Hospital

    La Porte, Indiana, 46350

  • Sparrow Hospital

    Lansing, Michigan, 48912

  • Women's Cancer Center of Nevada

    Las Vegas, Nevada, 89169

  • Lawrence Memorial Hospital

    Lawrence, Kansas, 66044

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Saint Luke's East - Lee's Summit

    Lee's Summit, Missouri, 64086

  • Cancer Center of Kansas-Liberal

    Liberal, Kansas, 67905

  • Liberty Hospital

    Liberty, Missouri, 64068

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • Saint Mary Mercy Hospital

    Livonia, Michigan, 48154

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • UCLA / Jonsson Comprehensive Cancer Center

    Los Angeles, California, 90095

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • Minnesota Oncology Hematology PA-Maplewood

    Maplewood, Minnesota, 55109

  • Saint John's Hospital - Healtheast

    Maplewood, Minnesota, 55109

  • Marshfield Clinic

    Marshfield, Wisconsin, 54449

  • Lake University Ireland Cancer Center

    Mentor, Ohio, 44060

  • Aurora Saint Luke's Medical Center

    Milwaukee, Wisconsin, 53215

  • Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 55415

  • Marshfield Clinic-Minocqua Center

    Minocqua, Wisconsin, 54548

  • Michiana Hematology Oncology PC-Mishawaka

    Mishawaka, Indiana, 46545

  • Saint Joseph Regional Medical Center-Mishawaka

    Mishawaka, Indiana, 46545

  • Palo Alto Medical Foundation-Gynecologic Oncology

    Mountain View, California, 94040

  • Mercy Health Mercy Campus

    Muskegon, Michigan, 49444

  • Jersey Shore Medical Center

    Neptune City, New Jersey, 07753

  • The Hospital of Central Connecticut

    New Britain, Connecticut, 06050

  • Cancer Center of Kansas - Newton

    Newton, Kansas, 67114

  • Michiana Hematology Oncology PC-Niles

    Niles, Michigan, 49120

  • University of Oklahoma Health Sciences Center

    Oklahoma City, Oklahoma, 73104

  • Florida Hospital Orlando

    Orlando, Florida, 32803

  • Menorah Medical Center

    Overland Park, Kansas, 66209

  • Saint Luke's South Hospital

    Overland Park, Kansas, 66213

  • Cancer Center of Kansas - Parsons

    Parsons, Kansas, 67357

  • Gynecologic Oncology Group

    Philadelphia, Pennsylvania, 19103

  • FirstHealth of the Carolinas-Moore Regional Hosiptal

    Pinehurst, North Carolina, 28374

  • Michiana Hematology Oncology PC-Plymouth

    Plymouth, Indiana, 46563

  • Saint Joseph Mercy Oakland

    Pontiac, Michigan, 48341

  • Saint Joseph Mercy Port Huron

    Port Huron, Michigan, 48060

  • Maine Medical Center-Bramhall Campus

    Portland, Maine, 04102

  • Kansas City NCI Community Oncology Research Program

    Prairie Village, Kansas, 66208

  • Cancer Center of Kansas - Pratt

    Pratt, Kansas, 67124

  • Women and Infants Hospital

    Providence, Rhode Island, 02905

  • Duke Raleigh Hospital

    Raleigh, North Carolina, 27609

  • Marshfield Clinic at James Beck Cancer Center

    Rhinelander, Wisconsin, 54501

  • Marshfield Clinic-Rice Lake Center

    Rice Lake, Wisconsin, 54868

  • North Memorial Medical Health Center

    Robbinsdale, Minnesota, 55422

  • William Beaumont Hospital-Royal Oak

    Royal Oak, Michigan, 48073

  • Saint Mary's of Michigan

    Saginaw, Michigan, 48601

  • Lakeland Hospital

    Saint Joseph, Michigan, 49085

  • Marie Yeager Cancer Center

    Saint Joseph, Michigan, 49085

  • Heartland Regional Medical Center

    Saint Joseph, Missouri, 64506

  • Saint Joseph Oncology Inc

    Saint Joseph, Missouri, 64507

  • Metro Minnesota Community Oncology Research Consortium

    Saint Louis Park, Minnesota, 55416

  • Park Nicollet Clinic - Saint Louis Park

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital

    Saint Paul, Minnesota, 55101

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Cancer Center of Kansas - Salina

    Salina, Kansas, 67401

  • Huntsman Cancer Institute/University of Utah

    Salt Lake City, Utah, 84112

  • University of California San Diego

    San Diego, California, 92103

  • Virginia Mason CCOP

    Seattle, Washington, 98101

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Greenville Health System Cancer Institute-Seneca

    Seneca, South Carolina, 29672

  • Saint Francis Regional Medical Center

    Shakopee, Minnesota, 55379

  • Shawnee Mission Medical Center-KCCC

    Shawnee Mission, Kansas, 66204

  • Vince Lombardi Cancer Clinic-Sheboygan

    Sheboygan, Wisconsin, 53081

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Michiana Hematology Oncology PC-South Bend

    South Bend, Indiana, 46601

  • South Bend Clinic

    South Bend, Indiana, 46617

  • Northern Indiana Cancer Research Consortium

    South Bend, Indiana, 46628

  • Greenville Health System Cancer Institute-Spartanburg

    Spartanburg, South Carolina, 29307

  • Memorial Medical Center

    Springfield, Illinois, 62781

  • Baystate Medical Center

    Springfield, Massachusetts, 01199

  • Mercy Hospital Springfield

    Springfield, Missouri, 65804

  • Marshfield Clinic Cancer Care at Saint Michael's Hospital

    Stevens Point, Wisconsin, 54481

  • Lakeview Hospital

    Stillwater, Minnesota, 55082

  • Munson Medical Center

    Traverse City, Michigan, 49684

  • University of Arizona Cancer Center-North Campus

    Tucson, Arizona, 85719

  • Oklahoma Cancer Specialists and Research Institute-Tulsa

    Tulsa, Oklahoma, 74146

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • Saint John Macomb-Oakland Hospital

    Warren, Michigan, 48093

  • Cancer Center of Kansas - Wellington

    Wellington, Kansas, 67152

  • Aurora West Allis Medical Center

    West Allis, Wisconsin, 53227

  • Methodist West Hospital

    West Des Moines, Iowa, 50266-7700

  • Mercy Medical Center-West Lakes

    West Des Moines, Iowa, 50266

  • Marshfield Clinic - Weston Center

    Weston, Wisconsin, 54476

  • Michiana Hematology Oncology PC-Westville

    Westville, Indiana, 46391

  • Associates In Womens Health

    Wichita, Kansas, 67208

  • Cancer Center of Kansas-Wichita Medical Arts Tower

    Wichita, Kansas, 67208

  • Cancer Center of Kansas - Wichita

    Wichita, Kansas, 67214

  • Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • Wichita NCI Community Oncology Research Program

    Wichita, Kansas, 67214

  • Rice Memorial Hospital

    Willmar, Minnesota, 56201

  • Cancer Center of Kansas - Winfield

    Winfield, Kansas, 67156

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

  • Marshfield Clinic - Wisconsin Rapids Center

    Wisconsin Rapids, Wisconsin, 54494

  • Minnesota Oncology and Hematology PA-Woodbury

    Woodbury, Minnesota, 55125

  • Metro Health Hospital

    Wyoming, Michigan, 49519

Other trials in United States

About this study

Official title: A Prospective Study of Cognitive Function During Chemotherapy for Front-Line Treatment of Ovarian, Primary Peritoneal or Fallopian Tube Cancer

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.

Read the detailed description

PRIMARY OBJECTIVE:

  1. 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:

  1. 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:

  1. 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.

Being tested
Cognitive Assessment, Quality-of-Life Assessment
Medical subject headings
Brenner Tumor, Dysgerminoma, Teratoma, Ovarian, Ovarian Neoplasms, Fallopian Tube Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive AssessmentProcedure or surgery

    Ancillary studies

  • Quality-of-Life AssessmentOther

    Also called Quality of Life Assessment

    Ancillary studies

Study groups in NCT01080521
Study groupRoleWhat they receive
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.
Receives: Procedure: Cognitive Assessment; Other: Quality-of-Life Assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cognitive function as measured by the HeadMinder Customized Research Tool (CRT)

    Measured: Up to 6 months after completion of chemotherapy

Secondary outcomes (1)

  1. Patient-reported cognitive function as measured by Patient Assessment Own Functioning scale and web CRT

    Measured: Up to 6 months after completion of chemotherapy

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Mar 2010 (estimated)
  2. Study startApr 2010
  3. Primary completionJan 2012
  4. Study completion27 Jan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
247 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01080521
Sponsor's protocol ID
GOG-0256
Other IDs
NCI-2011-02213, GOG-0256, CDR0000666786, GOG-0256, GOG-0256, GOG-0256, U10CA101165
Status last verified
Apr 2018
First submitted
3 Mar 2010
Last updated
12 Apr 2018
Results posted
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cognitive Side Effects of Cancer Therapy and Malignant Ovarian Epithelial Tumor, run by Gynecologic Oncology Group at 182 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 182 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cognitive function as measured by the HeadMinder Customized Research Tool (CRT) (time frame: Up to 6 months after completion of chemotherapy). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01080521.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2018.

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