Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109, United States
NCT Number: NCT02662335
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.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Seattle, Washington, 98109, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participate in Cogmed computerized working memory training
Ancillary studies
Undergo standard follow-up care
Time frame: Up to 7 weeks
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
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
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 is measured on a 7-point Likert item questionnaire. The frequencies and the mode will be estimated from the satisfaction survey.
Time frame: Baseline to up to 7 weeks
PROMIS Emotional Distress-Anxiety-Short Form.
Time frame: Baseline to up to 7 weeks
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
PROMIS Emotional Distress -Depression Short Form.
Time frame: Baseline to up to 7 weeks
D-KEFS color word tests, Trails A and B, and Letter-number sequencing.
Time frame: Baseline to up to 7 weeks
PROMIS Fatigue-Short Form.
Time frame: Baseline to up to 7 weeks
REY auditory verbal word memory recall and recognition test.
Time frame: Baseline to up to 7 weeks
Symbol recognition and coding test.
Fred Hutchinson Cancer Center
Other
Computerized Cognitive Retraining in Breast Cancer Survivors
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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