Treating Verbal Memory Deficits Following Chemotherapy for Breast Cancer

Not Applicable

Completed

• Conditions: Breast Cancer Treatment; Cognitive Deficits
• Interventions: Behavioral: Computerized cognitive treatment

• Registration Number: NCT03017560
• Lead Sponsor: Northwestern University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2017-01-03
• Study First Submitted QC: 2017-01-09
• Study First Posted: 2017-01-11
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-04
• Last Update Posted: 2023-11-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Computerized cognitive treatment	Computerized cognitive treatment	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.