Treating Verbal Memory Deficits Following Chemotherapy for Breast Cancer

Northwestern University

Status: Completed

Conditions: Breast Cancer Treatment; Cognitive Deficits

Treatments: Behavioral: Computerized cognitive treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03017560

STU00200767

Details and patient eligibility

About

The primary purpose of this study is to test the effects of a targeted, computerized cognitive training program on verbal memory in older women who have undergone chemotherapy treatment for early-stage breast cancer. As measured by neuropsychological assessment, this treatment will result in improved verbal memory. Secondarily, processing speed and naming abilities are expected to improve. Enhanced self-perception of cognitive ability is also expected.

Enrollment: 45 patients

Sex: Female

Ages: 65 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women ages 65-90
• Chemotherapy treatment for early-stage (I, IIa, IIb, IIIa) breast cancer
• Post-menopausal
• High school education or greater
• Geographically available for followup assessment
• Native English speaker
• Normal or corrected to near-normal hearing and vision

Exclusion criteria

• Psychiatric history including past or current psychotic spectrum disorders (schizophrenia, bipolar disorder, major depressive disorder, dementia, schizoaffective disorder)
• Brain injury (e.g., stroke, heart attack, aneurysm, tumor, concussion, head trauma)
• Brain disease
• History of brain irradiation or surgery
• Current or past disease/disorder of the central nervous system or medical condition affecting cognitive functioning (e.g., chronic migraine, epilepsy or history of seizures, encephalitis, meningitis, multiple sclerosis, thyroid condition, Parkinson's, Alzheimer's, Huntington's disease)
• Active diagnosis of autoimmune or inflammatory disorder (e.g., systemic lupus erythematosus, rheumatoid arthritis, vasculitis, insulin-dependent diabetes, Crohn's disease, uncontrolled allergic reaction or asthma)
• History of other cancer, except for basal cell carcinoma
• Development of a second primary malignancy during the study
• Drug or alcohol abuse (i.e., more than 7 drinks per week)
• Chronic use of oral steroid medication
• Former (prior to early-stage breast cancer) intrathecal therapy, radiation therapy, chemotherapy, or any neoadjuvant chemotherapy
• Acquired or developmental speech, language, or learning disorders (e.g., aphasia, dyslexia, dysgraphia, auditory processing disorder, autism, developmental delay)
• Hormone replacement therapy, excluding vaginal estrogen

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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45 participants in 2 patient groups

Computerized cognitive treatment

Experimental group

Description:

Chosen exercises from the rehabilitation package of a commercially available, computerized, cognitive training program called Happy Neuron Pro will be used. This program was designed by a team of neurologists, neuropsychologists and cognitive psychologists, and has been successfully adapted for varying conditions of cognitive dysfunction.

Treatment:

Behavioral: Computerized cognitive treatment

Wait list control

No Intervention group

Description:

Participants assigned to the wait list control arm will receive no treatment while the experimental arm is participating in the computerized treatment. However, the computerized treatment program will be made available for these participants to utilize at the end of the study period.