Computerized Cognitive Retraining in Improving Cognitive Function in Breast Cancer Survivors

Study Overview
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Brief Summary
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This randomized clinical trial studies computerized cognitive retraining in improving cognitive function in breast cancer survivors. Cancer-related cognitive deficits, such as thinking and memory issues, are common among breast cancer survivors. The severity of these cognitive deficits is associated with a significant negative impact on daily function and quality of life. A computerized cognitive retraining method may help researchers find ways to improve cognitive function and quality of life in breast cancer survivors.

Detailed Description
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PRIMARY OBJECTIVES: I. Evaluate the feasibility and acceptability of a 6-week computerized working memory training program in breast cancer survivors who subjectively report cognitive deficits: evaluate feasibility of study procedures (recruitment and screening procedures, number of participants recruited, screened, and retained, attrition rate and reason, weekly phone calls completed with participants); evaluate the acceptability of an adaptive computerized working memory training intervention (burden, adherence to training schedule, performance level achieved, and participant satisfaction with computerized exercises). SECONDARY OBJECTIVES: I. To evaluate the difference in the posttest means at T2 (week #7) adjusted for T1 (baselines) in the primary working memory outcomes of visuo-spatial working memory (VSWM), visual working memory (VWM), and executive function (EF) as measured by the neuropsychological tests (Rey Auditory Test, Wechsler Adult Intelligence Scale [WAIS] IV symbol test, WAIS IV coding test, Delis-Kaplan Executive Function System [DKFES] color tests, Trails A and Trails B tests, and WAIS IV Letter and Number sequencing test) and self-report Patient Reported Outcomes Measurement Information System (PROMIS) surveys (Applied Cognition General Concerns Short Form, Applied Cognition Executive Function Short Form, and Functional Assessment of Cancer Therapy [FACT] Cognitive Function) between the intervention group and wait control group. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I (COMPUTER-ASSISTED COGNITIVE TRAINING): Patients complete a computerized working memory training program (Cogmed) over 35 minutes a day, 5 times a week for 6 weeks. ARM II (WAIT LIST): Patients undergo standard follow-up care for 6 weeks. Following standard follow-up care, patients may complete Cogmed as in the Intervention Group in weeks 7-13.

Official Title
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Computerized Cognitive Retraining in Breast Cancer Survivors

Conditions
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Cancer Survivor, Stage 0 Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer

Intervention / Treatment
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* Other: Computer-Assisted Cognitive Training
* Other: Questionnaire Administration
* Procedure: Standard Follow-Up Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Breast cancer (stage 0, I, II, III), 18 months to 5 years post oncologic therapies of surgery, chemotherapy, and/or radiation therapy (does not exclude current selective estrogen receptor modulators or aromatase inhibitors) Able to read, write, and speak English Mini Mental State Exam score greater than or equal to 19 Have reliable internet and daily access to computer with audio/speakers Agree to travel to the Seattle Cancer Care Alliance (SCCA) or University of Washington (UW) School of Nursing for 2-3 in person assessments over the 12-13 weeks of the study Exclusion Criteria: History of multiple cancers History of central nervous system (CNS) disease, CNS radiation, intrathecal therapy, or CNS surgery History of traumatic brain injury Neurologic disorders of stroke, encephalitis, dementia, epilepsy, Alzheimer's disease, Parkinson's disease Self-report of learning disabilities Substance addiction Diagnosis of psychiatric disorders of psychosis, schizophrenia, or bipolar disorder Mini mental state exam score less than 19 Previous participation in cognitive training program Visual impairments such as uncorrected vision or color blindness Uncorrected hearing impairments Self-report that they are not pregnant or planning to become pregnant in the next four months Anticipate moving from the region in the next 4 months Inability to use a mouse or computer keys to navigate around the computer screen

Ages Eligible for Study
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Minimum Age: 18 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (computer-assisted cognitive training)<br>Patients complete a computerized working memory training program (Cogmed) over 35 minutes a day, 5 times a week for 6 weeks. | Other: Computer-Assisted Cognitive Training<br>* Participate in Cogmed computerized working memory training<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|
| Active Comparator: Arm II (wait-list)<br>Patients undergo standard follow-up care for 6 weeks. Following standard follow-up care, patients may complete Cogmed as in the Intervention Group in weeks 7-13. | Other: Questionnaire Administration<br>* Ancillary studies<br>Procedure: Standard Follow-Up Care<br>* Undergo standard follow-up care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attrition rate | Intervention completion percentage rate and the maximum level achieved for each working memory cognitive domain will be determined for each participant. | Up to 7 weeks | 
| Percentage of participants retained in the study | Intervention completion percentage rate and the maximum level achieved for each working memory cognitive domain will be determined for each participant. | Up to 7 weeks | 
| Percentage of participants who are recruited | Intervention completion percentage rate and the maximum level achieved for each working memory cognitive domain will be determined for each participant. | Up to 7 weeks | 
| Satisfaction, measured by the satisfaction survey | Satisfaction is measured on a 7-point Likert item questionnaire. The frequencies and the mode will be estimated from the satisfaction survey. | Up to 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | PROMIS Emotional Distress-Anxiety-Short Form. | Baseline to up to 7 weeks | 
| Cognition | FACT Cognitive Function, PROMIS Applied Cognition General Concerns Short Form, and Applied Cognition Executive Function Short Form. | Baseline to up to 7 weeks | 
| Depression | PROMIS Emotional Distress -Depression Short Form. | Baseline to up to 7 weeks | 
| Executive Function | D-KEFS color word tests, Trails A and B, and Letter-number sequencing. | Baseline to up to 7 weeks | 
| Fatigue | PROMIS Fatigue-Short Form. | Baseline to up to 7 weeks | 
| Verbal Working Memory | REY auditory verbal word memory recall and recognition test. | Baseline to up to 7 weeks | 
| Visuo Spatial Working Memory | Symbol recognition and coding test. | Baseline to up to 7 weeks |