Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors

Conditions

• Breast Cancer
• Cognitive Impairments

Eligibility Criteria

Sex

ALL

Age

18 Years - 100 Years

Healthy Volunteers

Not accepted

Interventions

• Arm 1: Computerized Cognitive Training-Global Stimulation Games — BEHAVIORAL
  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.
• Arm 2: Computerized Cognitive Training-Neuroplasticity Games — BEHAVIORAL
  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).

Study Details

This Phase III trial will examine the efficacy of computerized cognitive training methods on perceived cognitive impairment in breast cancer survivors.

Key Dates

Start date

Feb 29, 2024

Status verified

Apr 2026

Primary completion

Feb 28, 2027

Completion

Nov 30, 2027

Study Design

Enrollment

386 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Arms

• Active Comparator: Arm 1: Computerized Cognitive Training-Global Stimulation Games
  The global stimulation games active attention control intervention is composed of computerized games. These games are fully developed and are rated E (for everyone) by the Entertainment Software Rating Board. The program will present 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.
• Experimental: Arm 2: Computerized Cognitive Training-Neuroplasticity Games
  The neuroplasticity games provide core elements necessary for inducing neuroplasticity. The five core elements include the principles of speed of processing, accuracy of processing, adaptivity, generalizability, and engagement. Importantly, all of the exercises adapt to user skill and ability. Behavioral tracking built within the program is used to monitor individual performance and ensure that the person is training at their uppermost threshold level. Specifically, we will use eight of these exercises which are designed to address cognitive concerns most noted in BCS including exercises to improve attention and working memory, processing speed, and executive function.

Primary Outcome Measure

Self-reported perceived cognitive impairment measured-post intervention [ Time Frame: 12 weeks from randomization ]

Central Contacts

• Director Regulatory Affairs
  412-339-5300
  [email protected]
• Norman Wolmark, MD

Locations (673)