Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors

Study Overview
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Brief Summary
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This Phase III trial will examine the efficacy of computerized cognitive training (Brain HQ) compared to the attention control on perceived cognitive impairment post intervention as measured by the FACT-Cog PCI scale.

Detailed Description
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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.

Official Title
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Cognitive Training for Cancer Related Cognitive Impairment in Breast Cancer Survivors: A Multi-Center Randomized Double-Blinded Controlled Trial

Conditions
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Breast Cancer, Cognitive Impairments

Intervention / Treatment
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* Behavioral: Arm 1: Attention Control
* Behavioral: Arm 2: Computerized Training (BrainHQ)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The participant must provide study-specific informed consent prior to any study specific procedures and authorization permitting release of personal health information. The participant must have a first time diagnosis of non-metastatic breast cancer which is Stage I-III. The participant must have a score of less than 12 on the PROMIS Adult v2.0 - Cognitive Function 4a. Participants with greater than or equal to 6 months to 5 years post-treatment (completion of initial surgery +/- adjuvant chemotherapy/radiation therapy) except may still be taking endocrine therapy or HER2-directed adjuvant therapy. The participant must be able to understand, speak, read, and write in English or Spanish. Exclusion Criteria: Scoring less than or equal to 3 on the 6-item cognitive screen. Patient Health Questionnaire-2 item (PHQ-2) score of greater than or equal to 3. Definitive clinical or radiologic evidence of metastatic disease. Prior history of past or current other cancer, except for non-melanoma skin cancer or in situ cervical cancer within the past 5 years. Previous exposure to chemotherapy treatment for another cancer or due to other medical condition (e.g. methotrexate exposure for treatment of rheumatoid arthritis). Previous central nervous system (CNS) radiation, intrathecal therapy or CNS-involved surgery. Participants with history of stroke, traumatic brain injury, brain surgery, Alzheimer's disease or other dementia. Participants with active substance abuse and/or in treatment for substance abuse, or history of bipolar disorder, psychosis, schizophrenia, ADHD, or learning disability.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1: Attention Control<br>The computerized active attention control intervention is composed of computerized games. The computerized active attention control 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. | Behavioral: Arm 1: Attention Control<br>* 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.<br>|
| Experimental: Arm 2: Computerized Cognitive Training (BrainHQ)<br>BrainHQ provides 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 BrainHQ 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. | Behavioral: Arm 2: Computerized Training (BrainHQ)<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported perceived cognitive impairment measured-post intervention | FACT-Cog PCI scale score (Functional Assessment of Cancer Therapy-Cognitive Function-perceived cognitive impairment) | 12 weeks from randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported perceived cognitive impairment measured over time | FACT-Cog PCI scale score (Functional Assessment of Cancer Therapy-Cognitive Function-perceived cognitive impairment) | 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 | 36 weeks from randomization |