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.
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
- Conditions the study is for
- Cognitive Side Effects of Cancer Therapy, Malignant Ovarian Epithelial Tumor, Ovarian Brenner Tumor
- 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
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:
- 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:
- 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:
- 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.
- Conditions
- Cognitive Side Effects of Cancer Therapy, Malignant Ovarian Epithelial Tumor, Ovarian Brenner Tumor, Ovarian Carcinosarcoma, Ovarian Choriocarcinoma, Ovarian Clear Cell Cystadenocarcinoma
- 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 group | Role | What 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.
Cognitive function as measured by the HeadMinder Customized Research Tool (CRT)
Measured: Up to 6 months after completion of chemotherapy
Secondary outcomes (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.
- First posted4 Mar 2010 (estimated)
- Study startApr 2010
- Primary completionJan 2012
- Study completion27 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive Side Effects of Cancer TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Gynecologic Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lisa Hess, Principal investigator, Gynecologic Oncology Group
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
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study of Cognitive Function During Chemotherapy for Front-Line Treatment of Ovarian, Primary Peritoneal or Fallopian Tube Cancer
- ClinicalTrials.gov ID
- NCT01080521
- Acronym / sponsor ID
- GOG-0256
- Conditions
- Cognitive Side Effects of Cancer Therapy, Malignant Ovarian Epithelial Tumor, Ovarian Brenner Tumor, Ovarian Carcinosarcoma, Ovarian Choriocarcinoma, Ovarian Clear Cell Cystadenocarcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- Gynecologic Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Apr 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- 27 Jan 2018 (actual)
- First posted
- 4 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- 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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (cognitive function during chemotherapy) | – | Procedure: Cognitive Assessment, Other: Quality-of-Life AssessmentPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (17 listed)
- 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:
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive AssessmentAncillary studies | Procedure or surgery | Observational (cognitive function during chemotherapy) |
| Quality-of-Life AssessmentAlso: Quality of Life AssessmentAncillary studies | Other | Observational (cognitive function during chemotherapy) |
Primary outcome
Cognitive function as measured by the HeadMinder Customized Research Tool (CRT)
Time frame: Up to 6 months after completion of chemotherapy
1 secondary outcome
Patient-reported cognitive function as measured by Patient Assessment Own Functioning scale and web CRT
Time frame: Up to 6 months after completion of chemotherapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Hess principal investigator
Gynecologic Oncology Group
182 sites in 1 country: see every site and its status.
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?
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.