Stage IIIA Breast Cancer Clinical Trial
Official title:
Computerized Cognitive Retraining in Breast Cancer Survivors
Verified date | December 2017 |
Source | Fred Hutchinson Cancer Research Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 15 |
Est. completion date | November 30, 2017 |
Est. primary completion date | December 13, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington |
Lead Sponsor | Collaborator |
---|---|
Fred Hutchinson Cancer Research Center | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Attrition rate | Intervention completion percentage rate and the maximum level achieved for each working memory cognitive domain will be determined for each participant. | Up to 7 weeks | |
Primary | 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. | Up to 7 weeks | |
Primary | 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. | Up to 7 weeks | |
Primary | 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. | Up to 7 weeks | |
Secondary | Anxiety | PROMIS Emotional Distress-Anxiety-Short Form. | Baseline to up to 7 weeks | |
Secondary | Cognition | FACT Cognitive Function, PROMIS Applied Cognition General Concerns Short Form, and Applied Cognition Executive Function Short Form. | Baseline to up to 7 weeks | |
Secondary | Depression | PROMIS Emotional Distress -Depression Short Form. | Baseline to up to 7 weeks | |
Secondary | Executive Function | D-KEFS color word tests, Trails A and B, and Letter-number sequencing. | Baseline to up to 7 weeks | |
Secondary | Fatigue | PROMIS Fatigue-Short Form. | Baseline to up to 7 weeks | |
Secondary | Verbal Working Memory | REY auditory verbal word memory recall and recognition test. | Baseline to up to 7 weeks | |
Secondary | Visuo Spatial Working Memory | Symbol recognition and coding test. | Baseline to up to 7 weeks |
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