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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Gynecologic Oncology Group.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Gynecologic Oncology Group
ClinicalTrials.gov Identifier:
NCT01080521
First received: March 3, 2010
Last updated: February 26, 2014
Last verified: November 2011

March 3, 2010
February 26, 2014
April 2010
January 2012   (final data collection date for primary outcome measure)
Cognitive function as measured by the HeadMinder Customized Research Tool (CRT) [ Time Frame: Up to 6 months after completion of chemotherapy ] [ Designated as safety issue: No ]
Cognitive function as measured by the HeadMinder Customized Research Tool (CRT) [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01080521 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Patient-reported cognitive function as measured by Patient Assessment Own Functioning scale and web CRT [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
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.

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.

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Ovarian, primary peritoneal or fallopian tube cancer patients

  • Brenner Tumor
  • Cognitive/Functional Effects
  • Ovarian Carcinosarcoma
  • Ovarian Choriocarcinoma
  • Ovarian Clear Cell Cystadenocarcinoma
  • Ovarian Dysgerminoma
  • Ovarian Embryonal Carcinoma
  • Ovarian Endometrioid Adenocarcinoma
  • Ovarian Mixed Epithelial Carcinoma
  • Ovarian Mixed Germ Cell Tumor
  • Ovarian Mucinous Cystadenocarcinoma
  • Ovarian Polyembryoma
  • Ovarian Sarcoma
  • Ovarian Serous Cystadenocarcinoma
  • Ovarian Stromal Cancer
  • Ovarian Teratoma
  • Ovarian Undifferentiated Adenocarcinoma
  • Ovarian Yolk Sac Tumor
  • Stage IA Fallopian Tube Cancer
  • Stage IA Ovarian Epithelial Cancer
  • Stage IA Ovarian Germ Cell Tumor
  • Stage IA Primary Peritoneal Cavity Cancer
  • Stage IB Fallopian Tube Cancer
  • Stage IB Ovarian Epithelial Cancer
  • Stage IB Ovarian Germ Cell Tumor
  • Stage IB Primary Peritoneal Cavity Cancer
  • Stage IC Fallopian Tube Cancer
  • Stage IC Ovarian Epithelial Cancer
  • Stage IC Ovarian Germ Cell Tumor
  • Stage IC Primary Peritoneal Cavity Cancer
  • Stage IIA Fallopian Tube Cancer
  • Stage IIA Ovarian Epithelial Cancer
  • Stage IIA Ovarian Germ Cell Tumor
  • Stage IIA Primary Peritoneal Cavity Cancer
  • Stage IIB Fallopian Tube Cancer
  • Stage IIB Ovarian Epithelial Cancer
  • Stage IIB Ovarian Germ Cell Tumor
  • Stage IIB Primary Peritoneal Cavity Cancer
  • Stage IIC Fallopian Tube Cancer
  • Stage IIC Ovarian Epithelial Cancer
  • Stage IIC Ovarian Germ Cell Tumor
  • Stage IIC Primary Peritoneal Cavity Cancer
  • Stage IIIA Fallopian Tube Cancer
  • Stage IIIA Ovarian Epithelial Cancer
  • Stage IIIA Ovarian Germ Cell Tumor
  • Stage IIIA Primary Peritoneal Cavity Cancer
  • Stage IIIB Fallopian Tube Cancer
  • Stage IIIB Ovarian Epithelial Cancer
  • Stage IIIB Ovarian Germ Cell Tumor
  • Stage IIIB Primary Peritoneal Cavity Cancer
  • Stage IIIC Fallopian Tube Cancer
  • Stage IIIC Ovarian Epithelial Cancer
  • Stage IIIC Ovarian Germ Cell Tumor
  • Stage IIIC Primary Peritoneal Cavity Cancer
  • Stage IV Fallopian Tube Cancer
  • Stage IV Ovarian Epithelial Cancer
  • Stage IV Ovarian Germ Cell Tumor
  • Stage IV Primary Peritoneal Cavity Cancer
  • Procedure: cognitive assessment
    Ancillary studies
  • Procedure: quality-of-life assessment
    Ancillary studies
    Other Name: quality of life assessment
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.
Interventions:
  • Procedure: cognitive assessment
  • Procedure: quality-of-life assessment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
249
Not Provided
January 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01080521
GOG-0256, NCI-2011-02213, GOG-0256, CDR0000666786, GOG-0256, GOG-0256, GOG-0256, U10CA101165
Not Provided
Gynecologic Oncology Group
Gynecologic Oncology Group
National Cancer Institute (NCI)
Principal Investigator: Lisa Hess Gynecologic Oncology Group
Gynecologic Oncology Group
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP