Computerized Cognitive Retraining in Improving Cognitive Function in Breast Cancer Survivors

Fred Hutchinson Cancer Center (FHCC)

Status: Completed

Conditions: Stage IIIA Breast Cancer; Stage IB Breast Cancer; Stage IIIB Breast Cancer; Stage IIB Breast Cancer; Stage IIA Breast Cancer; Stage IIIC Breast Cancer; Stage IA Breast Cancer; Cancer Survivor; Stage 0 Breast Cancer

Treatments: Other: Questionnaire Administration; Procedure: Standard Follow-Up Care; Other: Computer-Assisted Cognitive Training

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02662335

NCI-2015-02193 (Registry Identifier)

9363 (Other Identifier)

P30CA015704 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Arm I (computer-assisted cognitive training)

Experimental group

Description:

Patients complete a computerized working memory training program (Cogmed) over 35 minutes a day, 5 times a week for 6 weeks.

Treatment:

Other: Computer-Assisted Cognitive Training

Other: Questionnaire Administration

Arm II (wait-list)

Active Comparator group

Description:

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.

Treatment:

Procedure: Standard Follow-Up Care

Other: Questionnaire Administration