Computerized Cognitive Retraining in Improving Cognitive Function in Breast Cancer Survivors
NCT ID: NCT02662335
Last Updated: 2017-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
15 participants
INTERVENTIONAL
2016-05-31
2017-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
Computer-Assisted Cognitive Training
Participate in Cogmed computerized working memory training
Questionnaire Administration
Ancillary studies
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.
Questionnaire Administration
Ancillary studies
Standard Follow-Up Care
Undergo standard follow-up care
Interventions
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Computer-Assisted Cognitive Training
Participate in Cogmed computerized working memory training
Questionnaire Administration
Ancillary studies
Standard Follow-Up Care
Undergo standard follow-up care
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Fred Hutchinson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Kathleen Shannon Dorcy
Role: PRINCIPAL_INVESTIGATOR
Fred Hutch/University of Washington Cancer Consortium
Locations
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Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States
Countries
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Other Identifiers
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NCI-2015-02193
Identifier Type: REGISTRY
Identifier Source: secondary_id
9363
Identifier Type: OTHER
Identifier Source: secondary_id
9363
Identifier Type: -
Identifier Source: org_study_id