Behavioral and Neural Indices of Cognitive Rehabilitation in Ovarian Cancer: A Pilot Study
PRIMARY OBJECTIVES:
I. To objectively assess changes in cognitive performance and quality of life (QOL) pre and
post participation in a cognitive rehabilitation intervention in ovarian cancer survivors
who have undergone chemotherapy.
II. To measure changes in neural function as measured by functional magnetic resonance
imaging (fMRI) blood oxygenation level dependent (BOLD) signal and corresponding behavioral
responses while performing cognitive tasks.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients participate in a memory and thinking skills workshop once weekly for 8
weeks. Patients complete cognitive tests and questionnaires at baseline and 7 weeks.
ARM II: Patients complete cognitive tests and questionnaires at baseline and 7 weeks.
Patients are then scheduled to participate in a later memory and thinking skills workshop.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Changes in cognitive performance and QOL pre and post participation in a cognitive rehabilitation intervention
The behavioral data (tests and questionnaires) will be entered into SPSS statistical software and analyzed. A mixed model (group by time) multivariate analysis of variance (MANOVA) will be used to determine if an interaction occurs between the treatment group and control (CL) over time, which will be further confirmed with post-hoc analyses.
Baseline to 7 weeks
No
Heidi Gray
Principal Investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Federal Government
7750
NCT01641068
September 2012
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |