Breast Cancer Treatment, Cognitive Deficits
Conditions
Keywords
Breast Cancer, Chemotherapy, Verbal Memory, Processing Speed
Brief summary
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.
Interventions
BEHAVIORALComputerized cognitive treatment
Participants will engage in auditory and verbal memory exercises intended to improve verbal memory functioning. The exercises are: Elephant Memory, Words where are you?, Split words, Bird Songs, Sound check, and You've got voicemail. Participants will complete the exercises 1 hour per day, 6 days per week, for 6 weeks. The program automatically adjusts difficulty level according to individual performance. The program captures and reports all relevant data to the primary investigator, including accuracy and reaction time (speed), which will be used to measure progress.
Sponsors
Shirley Ryan AbilityLab
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
65 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Verbal Memory | Change in Verbal Memory scores from Pretreatment/Baseline to Posttreatment/6 weeks, from Posttreatment/6 weeks to 1 month followup/10 weeks, and from Pretreatment/Baseline to 1 month followup/10 weeks. | Immediate and delayed verbal memory |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Processing Speed measured via Lexical Decision Task | Change in Processing Speed scores from Pretreatment/Baseline to Posttreatment/6 weeks, from Posttreatment/6 weeks to 1 month followup/10 weeks, and from Pretreatment/Baseline to 1 month followup/10 weeks | The Lexical Decision Task is a computerized task that measures processing speed by calculating reaction times to verb and non-verb stimuli. Outcome is measured by reaction time in milliseconds. |
| Processing Speed measured via Stroop Color-Word Test | Change in Processing Speed scores from Pretreatment/Baseline to Posttreatment/6 weeks, from Posttreatment/6 weeks to 1 month followup/10 weeks, and from Pretreatment/Baseline to 1 month followup/10 weeks | The Stroop Color-Word task is a paper and pencil task that measures processing speed by assessing correct number of words read, correct number of color names read, and correct number of color-word interference pairs (i.e., names of colors printed in non-matching ink colors) read in 45 seconds. Outcomes are measured in raw scores and associated T-scores referenced against sex+age normative groups. The Stroop Color-Word Test scores will not be aggregated with the Lexical Decision Task scores. |
Other
| Measure | Time frame | Description |
|---|---|---|
| The Functional Assessment of Cancer Therapy-Cognition | Pre-treatment/Baseline, Post-treatment/6 weeks, 1 month followup/10 weeks | Self-perception of cognitive ability |
| Treatment satisfaction survey | Pre-treatment/Baseline, Post-treatment/6 weeks, 1 month followup/10 weeks | — |
Outcome results
None listed