This Phase III trial will examine the efficacy of computerized cognitive training methods on perceived cognitive impairment in breast cancer survivors.
The goal of this trial is to determine the efficacy of advanced cognitive training for cancer survivors suffering from cancer- and cancer-treatment-related cognitive dysfunction. For millions of cancer survivors, cognitive dysfunction is a prevalent, severe, and persistent problem that has long been associated with poor work-related and health-related outcomes. Evidence suggests that a significant subset of breast cancer survivors (BCS) incur cognitive changes that may persist for years after treatment. Unfortunately, the scientific basis for managing these cognitive changes is extremely limited. Available evidence from pilot studies, including our work, suggests that advanced cognitive training, which is based on the principles of neuroplasticity (ability of brain neurons to re-organize and form new neural networks), may be a viable treatment option. However, previous trials to date have been limited by lack of attention-controlled designs, small samples of BCS, or limited outcome measures. Therefore, to overcome limitations of past studies and build on our pilot results, the purpose of this 2-group, double-blind, randomized controlled trial is to conduct a full-scale efficacy trial to compare advanced cognitive training to attention control in BCS.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
386
The program will includes 8 non-speeded exercises that include spin-offs of such games as breaking hex, lineup four, battleship, gems swap, double klondike, solitaire, reversi, word search, and sudoku. These games are well matched for time on task, novelty, and progression across levels. These are strategy-based games without adaptive, speeded, or accuracy-based algorithms underlying their personalization.
Cognitive training exercises include Double Decision (targets visual speed of processing and useful field of view), Target Tracker (targets visuospatial working memory capacity), Visual Sweeps (targets speed of processing), Syllable Stacks (targets auditory memory), Eye for Detail (targets eye movement speed and visuo-spatial working memory), Mind Bender (targets mental flexibility), Divided Attention (a shape-color-pattern inhibitory control exercise that focuses on rapidly determining whether flashing colors, shapes, or patterns meet a pre-specified rule), Right Turn (targets spatial reasoning).
Self-reported perceived cognitive impairment measured-post intervention
FACT-Cog PCI scale score (Functional Assessment of Cancer Therapy-Cognitive Function-perceived cognitive impairment)
Time frame: 12 weeks from randomization
Self-reported perceived cognitive impairment measured over time
FACT-Cog PCI scale score (Functional Assessment of Cancer Therapy-Cognitive Function-perceived cognitive impairment)
Time frame: 36 weeks from randomization
Objectively measured cognitive performance measured over time
Processing speed score as measured by Telephone-Based Assessment of Neuropsychological Status (TBANS) Symbol Digit Modalities Test
Time frame: 36 weeks from randomization
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