Clinical trial NCT03017560: Treating Verbal Memory Deficits Following Chemotherapy for Breast Cancer
Official title: Treating Verbal Memory Deficits Following Chemotherapy for Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Treatment
Cognitive Deficits
Keywords: Breast Cancer
Chemotherapy
Verbal Memory
Processing Speed
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Shirley Ryan AbilityLab
First posted: 2017-01-11
Enrollment: 45
Sex: FEMALE
Minimum age (years): 65
Maximum age (years): 90
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Verbal Memory
timeFrame: 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.
Secondary outcomes:
measure: Processing Speed measured via Lexical Decision Task
timeFrame: 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
measure: Processing Speed measured via Stroop Color-Word Test
timeFrame: 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
Other outcomes:
measure: The Functional Assessment of Cancer Therapy-Cognition
timeFrame: Pre-treatment/Baseline, Post-treatment/6 weeks, 1 month followup/10 weeks
measure: Treatment satisfaction survey
timeFrame: Pre-treatment/Baseline, Post-treatment/6 weeks, 1 month followup/10 weeks
Locations:
Study officials:
affiliation: Northwestern University
name: Diane F Morean, PhD
role: PRINCIPAL_INVESTIGATOR
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