Overview

This trial is active, not recruiting.

Conditions cognitive side effects of cancer therapy, malignant ovarian epithelial tumor, malignant ovarian mixed epithelial tumor, ovarian brenner tumor, ovarian carcinosarcoma, ovarian choriocarcinoma, ovarian clear cell cystadenocarcinoma, ovarian dysgerminoma, ovarian embryonal carcinoma, ovarian endometrioid adenocarcinoma, ovarian mixed germ cell tumor, ovarian mucinous cystadenocarcinoma, ovarian polyembryoma, ovarian sarcoma, ovarian serous cystadenocarcinoma, ovarian teratoma, ovarian yolk sac tumor, stage i ovarian cancer, stage ia fallopian tube cancer, stage ia ovarian cancer, stage ia ovarian germ cell tumor, stage ib fallopian tube cancer, stage ib ovarian cancer, stage ib ovarian germ cell tumor, stage ic fallopian tube cancer, stage ic ovarian cancer, stage ic ovarian germ cell tumor, stage ii ovarian cancer, stage iia fallopian tube cancer, stage iia ovarian cancer, stage iia ovarian germ cell tumor, stage iib fallopian tube cancer, stage iib ovarian cancer, stage iib ovarian germ cell tumor, stage iic fallopian tube cancer, stage iic ovarian cancer, stage iic ovarian germ cell tumor, stage iiia fallopian tube cancer, stage iiia ovarian cancer, stage iiia ovarian germ cell tumor, stage iiia primary peritoneal cancer, stage iiib fallopian tube cancer, stage iiib ovarian cancer, stage iiib ovarian germ cell tumor, stage iiib primary peritoneal cancer, stage iiic fallopian tube cancer, stage iiic ovarian cancer, stage iiic ovarian germ cell tumor, stage iiic primary peritoneal cancer, stage iv fallopian tube cancer, stage iv ovarian cancer, stage iv ovarian germ cell tumor, stage iv primary peritoneal cancer, undifferentiated ovarian carcinoma
Treatments cognitive assessment, quality-of-life assessment
Sponsor Gynecologic Oncology Group
Collaborator National Cancer Institute (NCI)
Start date April 2010
End date January 2012
Trial size 242 participants
Trial identifier NCT01080521, CDR0000666786, GOG-0256, NCI-2011-02213, U10CA101165

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
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.
cognitive assessment
Ancillary studies
quality-of-life assessment Quality of Life Assessment
Ancillary studies

Primary Outcomes

Measure
Cognitive function as measured by the HeadMinder Customized Research Tool (CRT)
time frame: Up to 6 months after completion of chemotherapy

Secondary Outcomes

Measure
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

Eligibility Criteria

Female participants at least 18 years old.

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

Additional Information

Official title A Prospective Study of Cognitive Function During Chemotherapy for Front-Line Treatment of Ovarian, Primary Peritoneal or Fallopian Tube Cancer
Principal investigator Lisa Hess
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Gynecologic Oncology Group.