Stage IIIA Breast Cancer Clinical Trial
Official title:
Computerized Cognitive Retraining in Breast Cancer Survivors
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.
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