Computerized Cognitive Retraining in Breast Cancer Survivors
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cancer Survivor
- Sponsor
- Fred Hutchinson Cancer Center
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Satisfaction, measured by the satisfaction survey
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Satisfaction, measured by the satisfaction survey
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.
Percentage of participants who are recruited
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.
Percentage of participants retained in the study
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.
Attrition rate
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.
Secondary Outcomes
- Depression(Baseline to up to 7 weeks)
- Anxiety(Baseline to up to 7 weeks)
- Cognition(Baseline to up to 7 weeks)
- Executive Function(Baseline to up to 7 weeks)
- Verbal Working Memory(Baseline to up to 7 weeks)
- Fatigue(Baseline to up to 7 weeks)
- Visuo Spatial Working Memory(Baseline to up to 7 weeks)