Treating Verbal Memory Deficits Following Chemotherapy for Breast Cancer
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|ClinicalTrials.gov Identifier: NCT03017560|
Recruitment Status : Suspended (Principal Investigator Medical Leave)
First Posted : January 11, 2017
Last Update Posted : January 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Treatment Cognitive Deficits||Behavioral: Computerized cognitive treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Treating Verbal Memory Deficits Following Chemotherapy for Breast Cancer|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||May 2017|
|Estimated Study Completion Date :||May 2017|
Experimental: 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.
Behavioral: Computerized 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.
No Intervention: Wait list control
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.
- 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
- 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.
- 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.
- 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
- Treatment satisfaction survey [ Time Frame: Pre-treatment/Baseline, Post-treatment/6 weeks, 1 month followup/10 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03017560
|Principal Investigator:||Diane F Morean, PhD||Northwestern University|