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Completed

NCT Number: NCT03017560

Treating Verbal Memory Deficits Following Chemotherapy for Breast Cancer

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Computerized cognitive treatment

Behavioral

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.

Primary outcomes

  1. Verbal Memory

    Time frame: 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 outcomes

  1. Processing Speed measured via Lexical Decision Task

    Time frame: 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.

  2. Processing Speed measured via Stroop Color-Word Test

    Time frame: 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 outcomes

  1. The Functional Assessment of Cancer Therapy-Cognition

    Time frame: Pre-treatment/Baseline, Post-treatment/6 weeks, 1 month followup/10 weeks

    Self-perception of cognitive ability

  2. Treatment satisfaction survey

    Time frame: Pre-treatment/Baseline, Post-treatment/6 weeks, 1 month followup/10 weeks

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Shirley Ryan AbilityLab

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jan 11, 2017
Registry last updated
Nov 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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