ClinicalTrials.gov
ClinicalTrials.gov Menu

Treating Verbal Memory Deficits Following Chemotherapy for Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03017560
Recruitment Status : Suspended (Principal Investigator Medical Leave)
First Posted : January 11, 2017
Last Update Posted : January 11, 2017
Sponsor:
Collaborator:
Shirley Ryan AbilityLab
Information provided by (Responsible Party):
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.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years to 90 Years   (Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Sponsors and Collaborators
Northwestern University
Shirley Ryan AbilityLab
Investigators
Principal Investigator: Diane F Morean, PhD Northwestern University

Publications:
American Cancer Society (2014). Cancer prevalence: How many people have cancer? Retrieved March 24, 2015 from http://www.cancer.org/cancer/cancerbasics/cancer-prevalence.
Smith, A. (2014). Older adults and technology use. Pew Research Center. Retrieved on March 24, 2015 from http://www.pewinternet.org/2014/04/03/older-adults-and-technology-use/.

Responsible Party: Northwestern University
ClinicalTrials.gov Identifier: NCT03017560     History of Changes
Other Study ID Numbers: STU00200767
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: January 11, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Northwestern University:
Breast Cancer
Chemotherapy
Verbal Memory
Processing Speed

Additional relevant MeSH terms:
Breast Neoplasms
Cognition Disorders
Cognitive Dysfunction
Memory Disorders
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Neurocognitive Disorders
Mental Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms