Computerized Cognitive Retraining in Improving Cognitive Function in Breast Cancer Survivors



Status:Completed
Conditions:Breast Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:12/15/2017
Start Date:May 2016
End Date:November 30, 2017

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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.

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
We found this trial at
1
site
Seattle, Washington 98109
Principal Investigator: Kathleen Shannon Dorcy
Phone: 206-288-6586
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mi
from
Seattle, WA
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