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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
15
Participate in Cogmed computerized working memory training
Ancillary studies
Undergo standard follow-up care
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Attrition rate
Intervention completion percentage rate and the maximum level achieved for each working memory cognitive domain will be determined for each participant.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 7 weeks
Anxiety
PROMIS Emotional Distress-Anxiety-Short Form.
Time frame: Baseline to up to 7 weeks
Cognition
FACT Cognitive Function, PROMIS Applied Cognition General Concerns Short Form, and Applied Cognition Executive Function Short Form.
Time frame: Baseline to up to 7 weeks
Depression
PROMIS Emotional Distress -Depression Short Form.
Time frame: Baseline to up to 7 weeks
Executive Function
D-KEFS color word tests, Trails A and B, and Letter-number sequencing.
Time frame: Baseline to up to 7 weeks
Fatigue
PROMIS Fatigue-Short Form.
Time frame: Baseline to up to 7 weeks
Verbal Working Memory
REY auditory verbal word memory recall and recognition test.
Time frame: Baseline to up to 7 weeks
Visuo Spatial Working Memory
Symbol recognition and coding test.
Time frame: Baseline to up to 7 weeks
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