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Treating Verbal Memory Deficits Following Chemotherapy for Breast Cancer

Primary Purpose

Breast Cancer Treatment, Cognitive Deficits

Status

Suspended

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Computerized cognitive treatment

About this trial

This is an interventional treatment trial for Breast Cancer Treatment focused on measuring Breast Cancer, Chemotherapy, Verbal Memory, Processing Speed

Eligibility Criteria

65 Years - 90 Years (Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Computerized cognitive treatment

Wait list control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Verbal Memory

Immediate and delayed verbal memory

Secondary Outcome Measures

Processing Speed measured via Lexical Decision Task

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

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.

Full Information

NCT ID

NCT03017560

First Posted

January 3, 2017

Last Updated

January 9, 2017

Sponsor

Northwestern University

Collaborators

Shirley Ryan AbilityLab

1. Study Identification

Unique Protocol Identification Number

NCT03017560

Brief Title

Treating Verbal Memory Deficits Following Chemotherapy for Breast Cancer

Official Title

Treating Verbal Memory Deficits Following Chemotherapy for Breast Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

January 2017

Overall Recruitment Status

Suspended

Why Stopped

Principal Investigator Medical Leave

Study Start Date

December 2015 (undefined)

Primary Completion Date

May 2017 (Anticipated)

Study Completion Date

May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Northwestern University

Collaborators

Shirley Ryan AbilityLab

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer Treatment, Cognitive Deficits

Keywords

Breast Cancer, Chemotherapy, Verbal Memory, Processing Speed

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Computerized cognitive treatment

Arm Type

Experimental

Arm Description

Arm Title

Wait list control

Arm Type

No Intervention

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Computerized cognitive treatment

Intervention Description

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 Outcome Measure Information:

Title

Verbal Memory

Description

Immediate and delayed 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.

Secondary Outcome Measure Information:

Title

Processing Speed measured via Lexical Decision Task

Description

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.

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

Title

Processing Speed measured via Stroop Color-Word Test

Description

Time Frame

Other Pre-specified Outcome Measures:

Title

The Functional Assessment of Cancer Therapy-Cognition

Description

Self-perception of cognitive ability

Time Frame

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

Title

Treatment satisfaction survey

Time Frame

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

65 Years

Maximum Age & Unit of Time

90 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Diane F Morean, PhD

Organizational Affiliation

Northwestern University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

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Treating Verbal Memory Deficits Following Chemotherapy for Breast Cancer

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